| Page Range | 27851-28151 | |
| FR Document |
| Page and Subject | |
|---|---|
| 80 FR 28048 - Notification of Citizens Coinage Advisory Committee; Public Meeting | |
| 80 FR 27851 - Continuation of the National Emergency With Respect to Yemen | |
| 80 FR 28015 - Sunshine Act Meetings | |
| 80 FR 27950 - Environmental Impact Statements; Notice of Availability | |
| 80 FR 28047 - Georges Creek Railway, LLC-Operation Exemption-Lines of CSX Transportation, Inc. | |
| 80 FR 27973 - Food and Drug Administration-American Urological Association-Society of Urologic Oncology Workshop on Partial Gland Ablation for Prostate Cancer; Public Workshop | |
| 80 FR 27952 - Consumer Advisory Committee | |
| 80 FR 27857 - Benefits Payable in Terminated Single-Employer Plans; Interest Assumptions for Paying Benefits | |
| 80 FR 27897 - Reorganization and Expansion of Foreign-Trade Zone 49 Under Alternative Site Framework, Newark/Elizabeth, New Jersey | |
| 80 FR 27896 - Approval of Subzone Status; Spectro Coating Corporation d/b/a Claremont Flock, LLC, Leominster, Massachusetts | |
| 80 FR 27994 - Agency Information Collection Activities: Submission for OMB Review; Comment Request; Manufactured Housing Operations Forms | |
| 80 FR 27994 - Agency Information Collection Activities: Submission for OMB Review; Comment Request; Direct Housing Program Forms | |
| 80 FR 27990 - Changes in Flood Hazard Determinations | |
| 80 FR 28002 - Notice of Federal Competitive Coal Lease Sale, Utah | |
| 80 FR 27985 - Final Flood Hazard Determinations | |
| 80 FR 27897 - Foreign-Trade Zone (FTZ) 84-Houston, Texas; Authorization of Production Activity MHI Compressor International Corporation (Gas Compressors, Compressor Sets, Electrical Generators and Generating Sets), Pearland, Texas | |
| 80 FR 28043 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel WATERBOUND; Invitation for Public Comments | |
| 80 FR 27987 - Changes in Flood Hazard Determinations | |
| 80 FR 28043 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel HULA GIRL; Invitation for Public Comments | |
| 80 FR 28044 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel ZUIMACO; Invitation for Public Comments | |
| 80 FR 27984 - Kentucky; Major Disaster and Related Determinations | |
| 80 FR 28046 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel LIMITLESS; Invitation for Public Comments | |
| 80 FR 28045 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel SEA FOX; Invitation for Public Comments | |
| 80 FR 28044 - Request for Comments of a Previously Approved Information Collection: Requirements for Eligibility of U.S.-Flag Vessels of 100 Feet or Greater in Registered Length To Obtain a Fishery Endorsement | |
| 80 FR 27990 - Kentucky; Amendment No. 1 to Notice of a Major Disaster Declaration | |
| 80 FR 27874 - Proposed Priority and Definitions-Demonstration and Training Program: Career Pathways for Individuals With Disabilities | |
| 80 FR 27868 - Proposed Priority-Rehabilitation Training: Vocational Rehabilitation Technical Assistance Center-Youth With Disabilities | |
| 80 FR 27985 - Tennessee; Amendment No. 2 to Notice of a Major Disaster Declaration | |
| 80 FR 27988 - Final Flood Hazard Determinations | |
| 80 FR 27982 - Certificate of Alternative Compliance for the P/V LUCIA, 1257462 | |
| 80 FR 27983 - Agency Information Collection Activities: Guarantee of Payment | |
| 80 FR 27853 - Foreign Trade Regulations (FTR): Reinstatement of Exemptions Related to Temporary Exports, Carnets, and Shipments Under a Temporary Import Bond | |
| 80 FR 27858 - Special Local Regulation; Annual Marine Events on the Colorado River, Between Davis Dam (Bullhead City, Arizona) and Headgate Dam (Parker, Arizona) Within the San Diego Captain of the Port Zone | |
| 80 FR 27998 - 60-Day Notice of Proposed Information Collection: Application for FHA Insured Mortgages | |
| 80 FR 27996 - Notice of Emergency Information Collection and Request for Comment: Assessment of Technology Needs in HUD-Subsidized Housing | |
| 80 FR 27995 - Notice of Extension of Time for Completion of Manufacturer Notification and Correction Plan | |
| 80 FR 27853 - Noise, Fuel Burn, and Emissions Modeling Using the Aviation Environmental Design Tool Version 2b | |
| 80 FR 27949 - Proposed Information Collection Request; Comment Request; Data Reporting Requirements for State and Local Vehicle Emission Inspection and Maintenance (I/M) Programs | |
| 80 FR 27859 - National Oil and Hazardous Substance Pollution Contingency Plan; National Priorities List: Deletion of the Burrows Sanitation Superfund Site | |
| 80 FR 27883 - National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List Deletion of the Burrows Sanitation Superfund Site | |
| 80 FR 28007 - Agency Information Collection Activities: United States Extractive Industries Transparency Initiative (USEITI) Revenue Information Collection-OMB Control Number 1012-0NEW; Comment Request | |
| 80 FR 27971 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
| 80 FR 28046 - Eighteen Thirty Group, LLC-Acquisition Exemption-Lines of CSX Transportation, Inc. | |
| 80 FR 27895 - Notice of Public Meeting of the Michigan Advisory Committee for a Meeting To Discuss Potential Project Topics | |
| 80 FR 28003 - Agency Information Collection Activities: Royalty and Production Reporting--OMB Control Number 1012-0004; Comment Request | |
| 80 FR 27863 - Atlantic Highly Migratory Species; Atlantic Bluefin Tuna Fisheries | |
| 80 FR 27951 - Application for Final Commitment for a Long-Term Loan or Financial Guarantee in Excess of $100 Million: AP088970XX | |
| 80 FR 27951 - Application for Final Commitment for a Long-Term Loan or Financial Guarantee in Excess of $100 Million: AP088969XX | |
| 80 FR 27941 - Environmental Management Site-Specific Advisory Board, Paducah | |
| 80 FR 28048 - Citizens Coinage Advisory Committee Membership Applications | |
| 80 FR 27975 - U.S. National Authority for the WHO Global Code of Practice on the International Recruitment of Health Personnel; Notice of Public Meeting | |
| 80 FR 28047 - San Joaquin Valley Railroad Co.-Lease Amendment and Operation Exemption Including Interchange Commitment-BNSF Railway Company | |
| 80 FR 27928 - First Responder Network Authority; First Responder Network Authority Board Meetings | |
| 80 FR 28009 - Sugar From Mexico; Revised Schedule for the Subject Investigations | |
| 80 FR 27942 - New York Public Service Commission, New York Power Authority, New York State Energy Research, and Development Authority v. New York Independent System Operator, Inc.; Notice of Complaint | |
| 80 FR 27947 - Tallgrass Interstate Gas Transmission, LLC; Notice of Request Under Blanket Authorization | |
| 80 FR 27945 - Entergy Gulf States Louisiana, L.L.C., Entergy Louisiana, LLC, Entergy Louisiana Power, LLC; Notice of Filing | |
| 80 FR 27944 - Warmsprings Irrigation District; Notice of Effectiveness of Withdrawal of License Application | |
| 80 FR 27942 - Tri-Dam Project; Notice of Application and Soliciting Comments, Motions To Intervene, and Protests | |
| 80 FR 27948 - Huskilson, Christopher G.; Aftanas, Stephen D.; Balfour, Scott C.; Bennett, Robert R.; Notice of Filing | |
| 80 FR 27948 - Greenleaf Power Management LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 80 FR 27898 - FY 15 Coastal Ecosystem Resiliency Grants Program | |
| 80 FR 28009 - Importer of Controlled Substances Registration: Cambrex Charles City | |
| 80 FR 27943 - Combined Notice of Filings #1 | |
| 80 FR 27854 - Schedules of Controlled Substances: Extension of Temporary Placement of UR-144, XLR11, and AKB48 in Schedule I of the Controlled Substances Act | |
| 80 FR 28011 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act, Clean Water Act, and Emergency Planning and Community Right To Know Act | |
| 80 FR 28050 - Agency Information Collection (Supplier Perception Survey) Activities Under OMB Review | |
| 80 FR 27897 - Mid-Atlantic Fishery Management Council (MAFMC); Fisheries of the Northeastern United States; Public Meetings | |
| 80 FR 27927 - New England Fishery Management Council; Public Meeting | |
| 80 FR 27953 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
| 80 FR 27929 - Procurement List Proposed Addition and Deletions | |
| 80 FR 27930 - Information Collection To Be Submitted to the Office of Management and Budget (OMB) for Approval Under the Paperwork Reduction Act; Initial Certification | |
| 80 FR 27928 - Marine Mammals; File No. 19526 | |
| 80 FR 27885 - Agency Information Collection Activities: Proposed Collection; Comment Request-Supplemental Nutrition Assistance Program Forms: Applications, Periodic Reporting and Notices | |
| 80 FR 28050 - Proposed Information Collection (Notice of Lapse-Government Life Insurance); Comment Request | |
| 80 FR 27970 - General Services Administration Acquisition Regulation (GSAR; Information Collection; Environmental Conservation, Occupational Safety, and Drug-Free Workplace | |
| 80 FR 27945 - Oncor Electric Delivery Company LLC; Notice of Filing | |
| 80 FR 28014 - Notice of Information Collection | |
| 80 FR 28016 - Privacy Act of 1974; New and Revised Systems of Records | |
| 80 FR 28010 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act | |
| 80 FR 27886 - Inviting Applications for Value-Added Producer Grants | |
| 80 FR 27887 - Notice of Solicitation of Applications for the Rural Community Development Initiative for Fiscal Year 2015 | |
| 80 FR 27896 - Notice of Petitions by Firms for Determination of Eligibility To Apply for Trade Adjustment Assistance | |
| 80 FR 28011 - Proposed Collection, Comment Request | |
| 80 FR 27944 - Enterprise Texas Pipeline LLC; Notice of Staff Protest To Petition for Rate Approval | |
| 80 FR 27947 - Blue Cube Operations LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 80 FR 27946 - Combined Notice of Filings #1 | |
| 80 FR 28010 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Previously Approved Collection; COPS Extension Request Form | |
| 80 FR 28027 - Business Development Corporation of America, et al.; Notice of Application | |
| 80 FR 28031 - The MainStay Funds, et al.; Notice of Application | |
| 80 FR 28036 - Submission for OMB Review; Comment Request | |
| 80 FR 28021 - Submission for OMB Review; Comment Request | |
| 80 FR 28014 - Notice of Centennial Challenges 3D Printed Habitat Challenge-Design Competition | |
| 80 FR 27930 - Agency Information Collection Activities: Notice of Intent To Renew Collection 3038-0092, Customer Clearing Documentation and Timing of Acceptance for Clearing | |
| 80 FR 27939 - 36(b)(1) Arms Sales Notification | |
| 80 FR 27961 - Holcim Ltd. and Lafarge S.A.; Analysis of Proposed Consent Orders To Aid Public Comment | |
| 80 FR 27932 - 36(b)(1) Arms Sales Notification | |
| 80 FR 27862 - Specifications for Medical Examinations of Coal Miners | |
| 80 FR 27954 - ZF Friedrichshafen AG and TRW Automotive Holdings Corp; Analysis of Proposed Consent Order To Aid Public Comment | |
| 80 FR 27983 - Agency Information Collection Activities: Entry and Manifest of Merchandise Free of Duty, Carrier's Certificate and Release | |
| 80 FR 27936 - 36(b)(1) Arms Sales Notification | |
| 80 FR 27878 - Health Care for Certain Children of Vietnam Veterans and Certain Korea Veterans-Covered Birth Defects and Spina Bifida | |
| 80 FR 27975 - Center for Scientific Review; Notice of Closed Meetings | |
| 80 FR 28021 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Related to Floor Broker Errors and the Use of Floor Broker Error Accounts | |
| 80 FR 28035 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing of Proposed Rule Change Relating to Finance Procedures To Add Clearstream Banking as a Triparty Collateral Service Provider | |
| 80 FR 27934 - 36(b)(1) Arms Sales Notification | |
| 80 FR 28013 - Petitions for Modification of Application of Existing Mandatory Safety Standards | |
| 80 FR 27978 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting | |
| 80 FR 27978 - Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting | |
| 80 FR 27981 - Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting | |
| 80 FR 27980 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting | |
| 80 FR 27978 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting | |
| 80 FR 27981 - National Institute of Dental & Craniofacial Research; Notice of Closed Meetings | |
| 80 FR 27979 - National Institute on Alcohol Abuse and Alcoholism; Amended Notice of Meeting | |
| 80 FR 27981 - National Cancer Institute; Notice of Closed Meetings | |
| 80 FR 27979 - National Cancer Institute; Notice of Meeting | |
| 80 FR 27982 - National Cancer Institute; Notice of Meeting | |
| 80 FR 27979 - Center for Scientific Review; Notice of Closed Meetings | |
| 80 FR 27901 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Shallow Geohazard Survey in the Beaufort Sea, Alaska | |
| 80 FR 27925 - Endangered and Threatened Species; Draft Recovery Plan for the Cook Inlet Beluga Whale | |
| 80 FR 28037 - Data Collection Available for Public Comments | |
| 80 FR 28039 - Tennessee Disaster Number TN-00087 | |
| 80 FR 28037 - SBIR/STTR Logo Design Competition Announcement; Correction | |
| 80 FR 28039 - Florida Disaster #FL-00105 | |
| 80 FR 27949 - Mid-Atlantic Hydro, LLC; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications | |
| 80 FR 27948 - Spartanburg Water System; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications | |
| 80 FR 27945 - Village of Morrisville, Vermont; Notice of Authorization for Continued Project Operation | |
| 80 FR 27941 - Agency Information Collection Activities; Comment Request; Health Education Assistance Loan (HEAL) Program: Forms | |
| 80 FR 27973 - Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry; Availability | |
| 80 FR 27975 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Generic Clearance for the Collection of Qualitative Feedback on Food and Drug Administration Service Delivery | |
| 80 FR 27856 - Passports: Official Passports for Officials or Employees of State, Local, Tribal or Territorial Governments Traveling Abroad and Carrying Out Official Duties in Support of the U.S. Government | |
| 80 FR 27972 - Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators; Draft Guidance for Industry; Availability | |
| 80 FR 28015 - Change in Postal Prices | |
| 80 FR 28002 - Notice of Temporary Closures of Public Land in Washoe County, Nevada | |
| 80 FR 28049 - Expanded Access to Non-VA Care Through the Veterans Choice Program Activities: Under OMB Review | |
| 80 FR 28039 - Projects Approved for Consumptive Uses of Water | |
| 80 FR 27938 - Proposed Collection; Comment Request | |
| 80 FR 27999 - Tribal Education Department Grant Program | |
| 80 FR 28041 - Notice of Final Federal Agency Actions on Proposed Highways in Colorado | |
| 80 FR 27926 - Availability of Seats for National Marine Sanctuary Advisory Councils | |
| 80 FR 28101 - Mandatory Guidelines for Federal Workplace Drug Testing Programs | |
| 80 FR 28054 - Mandatory Guidelines for Federal Workplace Drug Testing Programs | |
| 80 FR 27997 - Federal Property Suitable as Facilities To Assist the Homeless | |
| 80 FR 28001 - Draft Environmental Impact Statement for the Proposed Aiya Solar Project, Clark County, Nevada | |
| 80 FR 27862 - Suspension of September 1, 2015 Digital Transition Date for Low Power Television and TV Translator Stations |
Food and Nutrition Service
Rural Business-Cooperative Service
Rural Housing Service
Census Bureau
Economic Development Administration
Foreign-Trade Zones Board
National Oceanic and Atmospheric Administration
National Telecommunications and Information Administration
Federal Energy Regulatory Commission
Centers for Medicare & Medicaid Services
Food and Drug Administration
National Institutes of Health
Substance Abuse and Mental Health Services Administration
Coast Guard
Federal Emergency Management Agency
U.S. Customs and Border Protection
Indian Affairs Bureau
Land Management Bureau
Office of Natural Resources Revenue
Drug Enforcement Administration
Labor Statistics Bureau
Mine Safety and Health Administration
Federal Aviation Administration
Federal Highway Administration
Maritime Administration
Surface Transportation Board
United States Mint
Consult the Reader Aids section at the end of this page for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
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Federal Aviation Administration (FAA), DOT.
Policy statement.
This document provides a statement of FAA policy concerning the required use of the Aviation Environmental Design Tool version 2b (AEDT 2b) to analyze noise, fuel burn, and emissions for FAA actions. The policy statement is intended to ensure consistency and quality of analysis performed to assess noise, fuel burn, and emissions impacts of such actions under the National Environmental Policy Act of 1969 (NEPA), as amended, 42 U.S.C. 4321
Effective May 29, 2015.
Fabio Grandi, Office of Environment and Energy (AEE), Federal Aviation Administration, 800 Independence Ave. SW., Washington, DC 20591; Telephone: (202) 267-9099.
FAA Order 1050.1, Environmental Impacts: Policies and Procedures, describes FAA policies and procedures for compliance with the National Environmental Policy Act (NEPA).
Aircraft noise, air pollutant emissions, and fuel burn are interdependent and occur simultaneously throughout all phases of flight. AEDT 2b is a comprehensive software tool that provides information to FAA stakeholders on each of these specific environmental impacts. AEDT 2b facilitates environmental review activities required under NEPA by consolidating the modeling of these environmental impacts in a single tool. For air traffic airspace and procedure actions, AEDT 2b replaces AEDT 2a, which was released by the FAA in March 2012. For other FAA actions, AEDT 2b replaces the Integrated Noise Model (INM) for analyzing aircraft noise and the Emissions and Dispersion Modeling System (EDMS) for developing emissions inventories and modeling emissions dispersion. AEDT 2b applies to analyses initiated after May 29, 2015.
Effective May 29, 2015, AEDT 2b replaces AEDT 2a, INM, and EDMS as the required tool for noise, fuel burn, and emissions modeling of FAA actions. Consistent with current FAA policy and practice, the use of AEDT 2b is not required for projects whose analysis began before the effective date of this policy. In the event AEDT 2b is updated after the environmental analysis process is underway, the updated version may, but need not, be used to provide additional disclosure concerning noise, fuel burn, and emissions.
This policy statement is issued to ensure consistency and quality of analysis performed to comply with requirements under the National Environmental Policy Act of 1969 (NEPA), as amended, 42 U.S.C. 4321
Bureau of the Census, Commerce Department.
Final rule.
The Bureau of the Census (Census Bureau) issued a final rule amending the Foreign Trade Regulations (FTR) to eliminate the reporting requirement for temporary exports, which includes Carnets, and goods previously imported on a Temporary Import Bond (TIB). This final rule is being implemented to ensure consistency with the Customs Convention on the ATA Carnet for the Temporary Admission of Goods (ATA Convention) and reduce filing burden on the trade community. On September 12, 2014, the Census Bureau published this rule on an interim final basis. The Census Bureau is finalizing this rule without change.
Dale C. Kelly, Chief, International Trade Management Division, U.S. Census Bureau, 4600 Silver Hill Road, Room 6K032, Washington, DC 20233-6700, by phone (301) 763-6937, by fax (301) 763-8835, or by email <
The Census Bureau is responsible for collecting, compiling, and publishing export trade statistics for the United States under the provisions of Title 13, United States Code (U.S.C.), Chapter 9, Section 301(a). The Automated Export System (AES) is the primary instrument used for collecting export trade data, which are used by the Census Bureau
The Census Bureau published a Final Rule in the
In accordance with the Interim Final Rule published on September 12, 2014, this rule clarifies that the reporting requirement for temporary exports, which includes Carnets, and goods previously imported on a TIB is eliminated. This revision reinstates exemptions for temporary exports/Carnets and for goods that were imported under a TIB for return in the same condition as when imported. The U.S. Department of State and the U.S. Department of Homeland Security concur with the provision contained in this rule.
The Census Bureau received one comment on the Interim Final Rule published in the
The Census Bureau finds good cause pursuant to Title 5, U.S.C., 553(b)(3)(B) to waive prior notice and opportunity for public comment, as contrary to the public interest. The Census Bureau is undertaking this amendment in order to reduce filing burden on the trade community and to ensure consistency with the ATA Carnets for the Temporary Admission of Goods (ATA Convention). In particular, this rule reinstates the previous filing exemptions in § 30.37(q) and (r) of the FTR for temporary exports, including Carnets, and goods that were imported under a TIB for return in the same condition as when imported, which will ensure consistency with the ATA Convention, reduce filing requirements, avoid confusion, and ease compliance with the FTR. Additionally, and for similar reasons, the Census Bureau finds good cause pursuant to 5 U.S.C. 553(d) to waive the 30-day delay in effectiveness for this rule. This rule allows for an exemption to the AES filing requirements and imposes no additional requirements or obligations on any member of the public; therefore, delaying its effectiveness is unnecessary.
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) that this rule will not have a significant impact on a substantial number of small entities.
The purpose and goal of this rule are explained in the preamble, and are not repeated here. This rule does not mandate any new filing requirements and does not directly impact any small or large entities. We received no comments on the certification in the proposed rule; accordingly, no Regulatory Flexibility analysis is required and none has been prepared.
This rule has been determined to be not significant for purposes of Executive Orders 12866 and 13563, and has been drafted according to the requirements of those Executive Orders. It has also been determined that this rule does not contain policies with federalism implications as that term is defined under Executive Order 13132.
This rule does not contain any information collection subject to the Paperwork Reduction Act (PRA). However, notwithstanding any other provision of law, no person is required to respond to, nor shall a person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a current and valid Office of Management and Budget (OMB) control number.
Economic statistics, Exports, Foreign trade, Reporting and recordkeeping requirements.
Drug Enforcement Administration, Department of Justice.
Final order.
The Administrator of the Drug Enforcement Administration (DEA) is
This final order is effective May 15, 2015.
John R. Scherbenske, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.
On May 16, 2013, the Deputy Administrator of the Drug Enforcement Administration published a Final Order in the
In this case, the DEA initiated permanent scheduling proceedings on its own motion pursuant to 21 U.S.C. 811(a). The DEA has gathered and reviewed the available information regarding the pharmacology, chemistry, trafficking, actual abuse, pattern of abuse, and the relative potential for abuse for these three synthetic cannabinoids. On August 31, 2013, the DEA submitted a request to the HHS to provide the DEA with a scientific and medical evaluation of available information and a scheduling recommendation for UR-144, XLR11, and AKB48, pursuant to 21 U.S.C. 811(b) and (c). Upon evaluating the scientific and medical evidence, the HHS on May 12, 2015, submitted to the Administrator of the DEA its three scientific and medical evaluations entitled, “Basis For the Recommendation to Place 1-pentyl-1
In accordance with this final order, the schedule I requirements for handling UR-144, XLR11, and AKB48, including their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, will remain in effect until May 15, 2016, or until the permanent scheduling proceeding is completed, whichever occurs first.
Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for an expedited temporary scheduling action where such action is necessary to avoid an imminent hazard to the public safety. As provided in this subsection, the Attorney General may, by order, schedule a substance in schedule I on a temporary basis. Section 201(h) of the CSA, 21 U.S.C. 811(h) also provides that the temporary scheduling of a substance shall expire at the end of two years from the date of the issuance of the order scheduling such substance, except that the Attorney General may, during the pendency of proceedings to permanently schedule the substance, extend the temporary scheduling for up to one year.
Inasmuch as section 201(h) of the CSA directs that temporary scheduling actions be issued by order and sets forth the procedures by which such orders are to be issued and extended, the DEA believes that the notice and comment requirements of section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553, do not apply to this extension of the temporary scheduling action. In the alternative, even assuming that this action might be subject to section 553 of the APA, the Administrator finds that there is good cause to forgo the notice and comment requirements of section 553, as any further delays in the process for extending the temporary scheduling order would be impracticable and contrary to the public interest in view of the manifest urgency to avoid an imminent hazard to the public safety. Further, the DEA believes that this final order extending the temporary
Additionally, this action is not a significant regulatory action as defined by Executive Order 12866 (Regulatory Planning and Review), section 3(f), and, accordingly, this action has not been reviewed by the Office of Management and Budget (OMB).
This action will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132 (Federalism) it is determined that this action does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.
Pursuant to section 808(2) of the Congressional Review Act (CRA), “any rule for which an agency for good cause finds * * * that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest, shall take effect at such time as the Federal agency promulgating the rule determines.” 5 U.S.C. 808(2). It is in the public interest to maintain the temporary placement of UR-144, XLR11, and AKB48 in schedule I because they pose a public health risk. The temporary scheduling action was taken pursuant to 21 U.S.C. 811(h), which is specifically designed to enable the DEA to act in an expeditious manner to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h) exempted the temporary scheduling order from standard notice and comment rulemaking procedures to ensure that the process moved swiftly, and this extension of the temporary scheduling order continues to serve that purpose. For the same reasons that underlie 21 U.S.C. 811(h), that is, the DEA's need to place these substances in schedule I because they pose an imminent hazard to public safety, it would be contrary to the public interest to delay implementation of this extension of the temporary scheduling order. Therefore, in accordance with section 808(2) of the CRA, this final order extending the temporary scheduling order shall take effect immediately upon its publication. Pursuant to the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act) (5 U.S.C. 801-808), the DEA has submitted a copy of this final order to both Houses of Congress and to the Comptroller General.
Department of State.
Interim final rule.
This rule amends the passport rules for the Department of State to authorize issuing an official passport to an official or employee of a state, local, tribal, or territorial government traveling abroad to carry out official duties in support of the U.S. government.
This rule is effective May 15, 2015.
The Department of State will accept comments until July 14, 2015.
You may make comments by any of the following methods, and you must include the RIN in the subject line of your message.
•
•
• Persons with access to the Internet may view this rule and submit comments by going to
Alice Kottmyer, Attorney-Adviser,
22 CFR 51.3(b) provides that an “official passport” may be issued to: An official or employee of the U.S. government traveling abroad to carry out official duties; spouses and family members of such persons; and, when authorized by the Department of State, U.S. government contractors traveling abroad to carry out official duties on behalf of the U.S. government.
Increasingly, the federal government utilizes officials or employees of state, local, tribal, and territorial governments in support of federal activities, both domestically and overseas, such as the Federal Bureau of Investigation's Joint Terrorism Task Force. When required to travel internationally in support of such federal activities, these individuals are not currently eligible for official passports. Issuance of an official passport to such individuals signifies to foreign governments that they are carrying out official duties in support of the U.S. government. The activities undertaken by these officials are often of pressing national security, law enforcement, or humanitarian importance and occur with little advance notice. It is in the U.S. government's interest to provide these individuals the travel documents necessary to allow them to travel in a timely manner.
Under 22 U.S.C. 211a
The Department is publishing this rule as an interim final rule, effective on the date of publication, pursuant to the “good cause” exemption of the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(3)(B). The Department finds that delaying the effect of this rule until after notice and comment would be impractical, unnecessary, and contrary to public interest. The Department finds that providing the necessary travel documents to these individuals to allow them to travel in support of U.S. government interests provides a compelling justification for immediate approval of this rule. Therefore, this rule is effective on the date of publication.
The Department, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 605(b), has reviewed this rule and, by
This rule will not result in the expenditure by state, local, tribal, or territorial governments, in the aggregate, or by the private sector, of $100 million or more in any year and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1501
This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996, since it will not result in an annual effect on the economy of $100 million or more.
This rule is not economically significant under Executive Order 12866, section 3(f)(1), because it will not have an annual effect on the economy of $100 million or more. The Department expects the rule's impact on the public to be minimal. The Department has reviewed this rule to ensure its consistency with the regulatory philosophy and principles set forth in the Executive Orders.
This rule will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, the Department has determined that this rule does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement.
The Department of State has determined that this rulemaking will not have tribal implications, will not impose substantial direct compliance costs on Indian tribal governments, and will not preempt tribal law. Accordingly, Executive Order 13175 does not apply to this rulemaking.
This rule does not impose or alter any reporting or record-keeping requirements under the Paperwork Reduction Act.
Passports.
Accordingly, for the reasons stated in the preamble, 22 CFR part 51 is amended as follows:
8 U.S.C. 1504; 18 U.S.C. 1621; 22 U.S.C. 211a, 212, 213, 213n (Pub. L. 106-113 Div. B, Sec. 1000(a)(7) [Div. A, Title II, Sec. 236], 113 Stat. 1536, 1501A-430); 214, 214a, 217a, 218, 2651a, 2671(d)(3), 2705, 2714, 2721, & 3926; 26 U.S.C. 6039E; 31 U.S.C. 9701; 42 U.S.C. 652(k) [Div. B, Title V of Pub. L. 103-317, 108 Stat. 1760]; E.O. 11295, Aug. 6, 1966, FR 10603, 3 CFR, 1966-1970 Comp., p. 570; Sec. 1 of Pub. L. 109-210, 120 Stat. 319; Sec. 2 of Pub. L. 109-167, 119 Stat. 3578; Sec. 5 of Pub. L. 109-472, 120 Stat. 3554; Pub. L. 108-447, Div. B, Title IV, Dec. 8, 2004, 118 Stat. 2809; Pub. L. 108-458, 118 Stat. 3638, 3823 (Dec. 17, 2004).
(b)
(1) An official or employee of the U.S. government traveling abroad to carry out official duties, and family members of such persons;
(2) A U.S. government contractor traveling abroad to carry out official duties on behalf of the U.S. government; or
(3) An official or employee of a state, local, tribal, or territorial government traveling abroad to carry out official duties in support of the U.S. government.
Pension Benefit Guaranty Corporation.
Final rule.
This final rule amends the Pension Benefit Guaranty Corporation's regulation on Benefits Payable in Terminated Single-Employer Plans to prescribe interest assumptions under the regulation for valuation dates in June 2015. The interest assumptions are used for paying benefits under terminating single-employer plans covered by the pension insurance system administered by PBGC.
Effective June 1, 2015.
Catherine B. Klion (
PBGC's regulation on Benefits Payable in Terminated Single-Employer Plans (29 CFR part 4022) prescribes actuarial assumptions—including interest assumptions—for paying plan benefits under terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions in the regulation are also published on PBGC's Web site (
PBGC uses the interest assumptions in Appendix B to Part 4022 to determine whether a benefit is payable as a lump sum and to determine the amount to pay. Appendix C to Part 4022 contains interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using PBGC's historical methodology. Currently, the rates in Appendices B and C of the benefit payment regulation are the same.
The interest assumptions are intended to reflect current conditions in the financial and annuity markets. Assumptions under the benefit payments regulation are updated monthly. This final rule updates the benefit payments interest assumptions for June 2015.
The June 2015 interest assumptions under the benefit payments regulation will be 0.75 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. In comparison with the interest
PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect current market conditions as accurately as possible.
Because of the need to provide immediate guidance for the payment of benefits under plans with valuation dates during June 2015, PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.
PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.
Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2).
Employee benefit plans, Pension insurance, Pensions, Reporting and recordkeeping requirements.
In consideration of the foregoing, 29 CFR part 4022 is amended as follows:
29 U.S.C. 1302, 1322, 1322b, 1341(c)(3)(D), and 1344.
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the Great Western Parker Tube Float marine event and associated waterway special local regulations from 7 a.m. through 4 p.m. on June 6, 2015. This annual marine event occurs in the navigable waters of the Colorado River in Parker, Arizona, covering eight miles of the waterway from the La Paz County Park to the Headgate Dam. This action is necessary to provide for the safety of the participants, crew, spectators, safety vessels, and general users of the waterway. During the enforcement period, persons and vessels are prohibited from entering into, transiting through, or anchoring within this regulated area unless authorized by the Captain of the Port, or his designated representative.
The regulations in 33 CFR 100.1102, Table 1, item 9 will be enforced from 7 a.m. through 4 p.m. on June 6, 2015.
If you have questions on this document, call or email Petty Officer Nick Bateman, Waterways Management, U.S. Coast Guard Sector San Diego, CA; telephone 619-278-7656,
The Coast Guard will enforce the special local regulations for the annual Great Western Parker Tube Float in 33 CFR 100.1102, Table 1, Item 9 from 7 a.m. to 4 p.m. on June 6, 2015.
Under the provisions of 33 CFR 100.1102, persons and vessels are prohibited from entering into, transiting through, or anchoring within this regulated area of the Colorado River unless authorized by the Captain of the Port, or his designated representative. The Coast Guard may be assisted by other Federal, State, or local law
This document is issued under authority of 33 CFR 100.1102 and 5 U.S.C. 552(a). In addition to this document in the
If the Captain of the Port Sector San Diego or his designated representative determines that the regulated area need not be enforced for the full duration stated on this document, he or she may use a Broadcast Notice to Mariners or other communications coordinated with the event sponsor to grant general permission to enter the regulated area.
Environmental Protection Agency.
Direct final rule.
The U.S. Environmental Protection Agency (EPA) Region 5 is publishing a direct final Notice of Deletion of the Burrows Sanitation Superfund Site (Site), located in Hartford Township, Van Buren County, Michigan from the National Priorities List (NPL). The NPL, promulgated pursuant to Section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix to the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). This direct final deletion is being published by EPA with the concurrence of the State of Michigan, through the Michigan Department of Environmental Quality (MDEQ), because EPA has determined that all appropriate response actions under CERCLA have been completed. However, this deletion does not preclude future actions under Superfund.
This direct final deletion is effective July 14, 2015 unless EPA receives adverse comments by June 15, 2015. If adverse comments are received, EPA will publish a timely withdrawal of the direct final deletion in the
Submit your comments, identified by Docket ID no. EPA-HQ-SFUND-1986-0005, by one of the following methods:
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• U.S. Environmental Protection Agency—Region 5, 77 West Jackson Boulevard, Chicago, IL 60604, Phone: (312) 353-1063, Hours: Monday through Friday, 8:30 a.m. to 4:30 p.m. CST, excluding federal holidays.
• Hartford Public Library, 15 Franklin Street, Hartford, MI 49057, Phone: (269) 621-3408, Hours: Monday through Wednesday, 10:00 a.m. to 7:00 p.m., Thursday and Friday 10:00 a.m. to 5:00 p.m., Saturday 10:00 a.m. to 5:00 p.m.
Jeffrey Gore, Remedial Project Manager, U.S. Environmental Protection Agency (SR-6J), 77 West Jackson Boulevard, Chicago, IL 60604, (312) 886-6552, or
EPA Region 5 is publishing this direct final Notice of Deletion of the Burrows Sanitation Superfund Site (Site) from the National Priorities List (NPL) and requests public comment on this action. The NPL constitutes appendix B of 40 CFR part 300, which is the National Oil and Hazardous Substances Pollution Contingency Plan (NCP), which EPA promulgated pursuant to Section 105 of the Comprehensive Environmental
Because EPA considers this action to be noncontroversial and routine, this action will be effective July 14, 2015 unless EPA receives adverse comments by June 15, 2015. Along with this direct final Notice of Deletion, EPA is co-publishing a Notice of Intent to Delete in the
Section II of this document explains the criteria for deleting sites from the NPL. Section III discusses procedures that EPA is using for this action. Section IV discusses the Burrows Sanitation Site and demonstrates how it meets the deletion criteria. Section V discusses EPA's action to delete the site from the NPL unless adverse comments are received during the public comment period.
The NCP establishes the criteria that EPA uses to delete sites from the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted from the NPL where no further response is appropriate. In making such a determination pursuant to 40 CFR 300.425(e), EPA will consider, in consultation with the State, whether any of the following criteria have been met:
i. Responsible parties or other persons have implemented all appropriate response actions required;
ii. All appropriate Fund-financed response under CERCLA has been implemented, and no further response action by responsible parties is appropriate; or
iii. The remedial investigation has shown that the release poses no significant threat to public health or the environment and, therefore, the taking of remedial measures is not appropriate.
Pursuant to CERCLA section 121(c) and the NCP, EPA conducts five-year reviews to ensure the continued protectiveness of remedial actions where hazardous substances, pollutants, or contaminants remain at a site above levels that allow for unlimited use and unrestricted exposure. EPA conducts such five-year reviews at these sites even if the site is deleted from the NPL. EPA may initiate further action to ensure continued protectiveness at a deleted site if new information becomes available that indicates it is appropriate. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazard ranking system.
The following procedures apply to deletion of the Burrows Sanitation Site:
(1) EPA consulted with the State of Michigan prior to developing this direct final Notice of Deletion and the Notice of Intent to Delete co-published today in the
(2) EPA has provided the State thirty (30) working days for review of this notice and the parallel Notice of Intent to Delete prior to their publication today, and the State, through the MDEQ, has concurred on the deletion of the Site from the NPL.
(3) Concurrently with the publication of this direct final Notice of Deletion, a notice of the availability of the parallel Notice of Intent to Delete is being published in a major local newspaper, the “Tri-City Record Newspaper”. The newspaper notice announces the 30-day public comment period concerning the Notice of Intent to Delete the Site from the NPL.
(4) EPA placed copies of documents supporting the proposed deletion in the deletion docket and made these items available for public inspection and copying at the Site information repositories identified above.
(5) If adverse comments are received within the 30-day public comment period on this deletion action, EPA will publish a timely notice of withdrawal of this direct final Notice of Deletion before its effective date and will prepare a response to comments and continue with the deletion process on the basis of the Notice of Intent to Delete and the comments already received.
Deletion of a site from the NPL does not itself create, alter, or revoke any individual's rights or obligations. Deletion of a site from the NPL does not in any way alter EPA's right to take enforcement actions, as appropriate. The NPL is designed primarily for informational purposes and to assist EPA management. Section 300.425(e)(3) of the NCP states that the deletion of a site from the NPL does not preclude eligibility for future response actions, should future conditions warrant such actions.
The following information provides EPA's rationale for deleting the Burrows Sanitation Superfund Site from the NPL.
The Burrows Sanitation Site (CERCLIS ID: MID98410617) is approximately 10 acres. The Site is located on 54th Avenue in Hartford Township, Van Buren County, Michigan. The property is located in a rural part of Hartford on a portion of property owned by a resident of Hartford Township. Much of the Site is covered with trees, and there are intermittent open areas to the east and northwest of the Site. The property owner lives west of the Site and another homeowner lives south of the Site across 54th Avenue. There are approximately 150 people living in residences further west along 54th Avenue in a trailer park and a small number of other homes. The residences have historically obtained water from private wells that vary in depth up to 100 feet.
The Site property became contaminated when it was owned by Duane and Evelyn Funk, who agreed to allow Burrows Sanitation, a small septic hauler, to dispose of waste on a remote portion of their property. Burrows Sanitation disposed of wastes on the Site which it had collected from Du-Wel Products Inc., Auto Specialties Manufacturing Company (AUSCO), and Whirlpool Corporation. The wastes were primarily by-products of metal finishing and plating operations, which consisted of hydroxide sludges containing chromium, other metals, as well as some cyanide. The metal hydroxide wastes were deposited in unlined pits when the disposal was taking place between 1970 and 1977.
In 1976, the Michigan Department of Natural Resources (MDNR) took samples
EPA began remedial planning as the Burrows Sanitation Site was proposed for the NPL on September 8, 1983, (48 FR 40674). The Site was listed on the NPL on September 21, 1989, (49 FR 37070).
The objectives of the 1986 Record of Decision (ROD) for the Site included the following:
The remedial action objectives for the selected remedy at the Burrows Sanitation Site are to protect human health by preventing dermal exposure and ingestion of contaminated sludge and soil from the site, prevent ingestion of contaminated groundwater exceeding drinking water criteria, and prevent exposure of aquatic life from contaminated surface waters. The remedy will achieve Safe Drinking Water Act Primary and Secondary Maximum Contaminant Levels (MCLs) by groundwater treatment and by surface and subsurface soil excavation and off-site disposal.
The components of the 1986 ROD for the Site included the following:
• Purge and treat the contaminated groundwater for approximately 3 years;
• Drain the artificial Northwest Wetland; and
• Remove and treat approximately 250 cubic yards of metal hydroxide sludge from the Spill Area No. 2 and the Northwest Wetland. Dispose of the treated waste at an off-site RCRA facility which is in compliance with EPA policy.
• A scaled down groundwater extraction system based on additional groundwater monitoring since the 1986 ROD.
• Off-site treatment of contaminated groundwater instead of on-site treatment.
The 1991 ESD also documented that the soil removal and off-site disposal actions outlined in the 1986 ROD had been completed.
The 1994 ESD for the Site documented the change in the EPA MCL for chromium which was raised from 50 ppb to 100 ppb (effective July 30, 1992).
The first phase of the Remedial Action (RA) was completed in May, 1989. During this first phase of the RA, 320 cubic yards of contaminated surface soils and sediments from the spill area identified in the RI/FS were excavated and transported off-site to a RCRA facility. The soil removal was based on soil sampling investigation results completed and reported in 1986, which outlined the area of contaminated soil and how deeper soils for the location at the water table produced chemical concentrations comparable to background. The blockage in the artificial Northwest Wetland was removed and re-channeled. As a result, only the groundwater remained to be treated.
The additional groundwater investigations undertaken in 1989 involved the installation of five new PVC monitoring well nests on the Site. Three rounds of additional groundwater sampling were completed at the Burrows Site in 1990, one each in March, June, and September of that year. Groundwater samples were analyzed for the chemicals of concern, which included dissolved zinc, dissolved chromium, dissolved copper, dissolved lead, and dissolved nickel. Analytical results for the three rounds of groundwater sampling determined that all chemicals of concern were below the groundwater cleanup standards except for an exceedance of dissolved chromium.
The groundwater extraction system including an extraction well, storage tank, and associated equipment for extracting groundwater and removing it for off-site treatment was constructed at the Site between July and September 1991. Groundwater extraction began at the Burrows Site in August of 1992 and continued until December 1993. During that period a total of 2,600,000 gallons of groundwater were extracted and taken for off-site treatment and disposal to the Kalamazoo, Michigan Water Reclamation Plant.
Remedial Action construction activities officially concluded in April of 1993 with the completion and signing of the Preliminary Close-Out Report for the Burrows Site.
Institutional Controls (“ICs”) are non-engineered instruments, such as administrative and legal controls, that help to minimize the potential for exposure to contamination and that protect the integrity of the remedy. ICs are required to assure the long-term protectiveness for any areas which do not allow for unlimited use and unrestricted exposure (UU/UE). As explained further, none of EPA's decision documents (ROD, ESD, CD or Amended CD) for this Site required ICs in order to assure Site protectiveness since UU/UE would be allowed for all Site areas. The remedy is considered by EPA to be protective of human health and the environment without the need for ICs.
EPA sent out a letter in October 1999 notifying the Burrows Settling Defendants of Completion of Remedial Action under the requirements of the 1992 Amended CD. Site access and use of the land by property owners is now unrestricted, based on completion of the remedial action requirements under the 1992 Amended CD. Both the 1990 CD and the 1992 Amended CD provided that after EPA certification of completion of the remedial action, additional response actions could be required if conditions previously unknown to the United States are discovered or information is received which indicate that the remedial action is not protective of human health and the environment. EPA believes the remedial action completed at this Site is protective of human health and the environment, and it does not plan to require additional remedial action.
The post-ROD groundwater monitoring conducted to date by EPA shows that the groundwater has met the drinking water standards outlined in the decision documents and the Amended CD. Therefore, the remedial action conducted at the Site has achieved UU/UE for all site areas. Since the Site remedy has achieved UU/UE, no ICs are required at the Site to assure long-term protectiveness.
MDEQ has conducted independent residential well sampling in the area surrounding the Burrows Site through various County Health Departments from 2002 to 2014. EPA concurred with the MDEQ residential well sampling program. MDEQ contacted the Van Buren-Cass County District Health Department to arrange for sampling of local residential wells beginning in 2002. Van Buren-Cass County District Health Department implemented an annual sampling program for volatile organic compounds (VOCs) at local residential wells. The 2007 sampling results at the five locations were consistent with previous results, which demonstrated that the presence of
Since the 2008 five year review, MDEQ coordinated with Berrien County to collect samples at local residential wells. The 2012 and 2013 results continued to show no detections of volatile organic compounds. Some of the locations were also sampled for metals analysis. None of the metals were detected at concentrations above MCLs although residences exceeded the aesthetic drinking water value of 0.3 mg/l for iron in a range of 0.72-1.42 mg/l. Since no site-related impacts have been seen in the area residential well monitoring conducted over the last several years, MDEQ now believes that it is appropriate to delete the site from the NPL.
While MDEQ had historical concerns regarding the adequacy of groundwater plume characterization, MDEQ now agrees that the implemented remedial actions have been sufficient to address the known risks at the Site.
EPA has determined that the Site is subject to zoning by the local government and the Site is currently zoned for agricultural use. However, limiting the Site to agricultural land use is not a condition of the Superfund remedy.
The implemented remedial actions have been sufficient to address the known risks at the Site. In addition, no-site related impacts have been seen in the residential wells that have been monitored by the MDEQ over the past several years. Effective immediately, the MDEQ will terminate monitoring of the residential wells in the vicinity of the Burrows Sanitation Superfund Site.
A Five Year Review Report for the Site was completed in February 2013. In the report, EPA viewed the Burrows Sanitation Site as eligible for deletion from the NPL. There were no recommendations and follow-up actions noted in the 2013 Five Year Review Report. Since all clean up goals have been achieved and the site is now unlimited use/unrestricted exposure no additional Five Year Reviews are necessary.
Public participation activities have been satisfied as required in CERCLA Section 113(k), 42 U.S.C. 9613(k), and CERCLA section 117, 42 U.S.C. 9617. Documents in the deletion docket which EPA relied on for recommendation of the deletion of this site from the NPL are available to the public in the information repositories and at
The implemented remedy achieves the degree of cleanup specified in the ROD for all pathways of exposure. All selected remedial action objectives and clean-up goals are consistent with agency policy and guidance. No further Superfund response is needed to protect human health and the environment at the Site.
The NCP (40 CFR 300.425(e)) states that a site may be deleted from the NPL when no further response action is appropriate. EPA, in consultation with the State of Michigan, has determined that all required response actions have been implemented and no further response action by the responsible parties is appropriate.
EPA, with concurrence from the State of Michigan through the Michigan Department of Environmental Quality, has determined that all appropriate response actions under CERCLA have been completed. Therefore, EPA is deleting the Site from the NPL.
Because EPA considers this action to be noncontroversial and routine, EPA is taking it without prior publication. This action will be effective July 14, 2015 unless EPA receives adverse comments by June 15, 2015. If adverse comments are received within the 30-day public comment period, EPA will publish a timely withdrawal of this direct final Notice of Deletion before the effective date of the deletion, and it will not take effect. EPA will prepare a response to comments and continue with the deletion process on the basis of the Notice of Intent to Delete and the comments already received. There will be no additional opportunity to comment.
Environmental protection, Air pollution control, Chemicals, Hazardous substances, Hazardous waste, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements, Superfund, Water pollution control, and Water supply.
For the reasons set out in this document, 40 CFR part 300 is amended as follows:
33 U.S.C. 1321(d); 42 U.S.C. 9601-9657; E.O. 13626, 77 FR 56749, 3CFR, 2013 Comp., p. 306; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR, 1987 Comp., p. 193.
In Title 42 of the Code of Federal Regulations, Parts 1 to 399, revised as of October 1, 2014, on page 195, in § 37.204, remove the second introductory paragraph.
Federal Communications Commission.
Final rule; suspension of regulations.
In this document, the Media Bureau of the Federal Communications Commission (Commission) announced that, effective May 15, 2015, the September 1, 2015 digital transition date for low power television (LPTV) and TV translator stations is hereby suspended. The Commission will decide on a new transition date in the rulemaking proceeding in MB Docket No. 03-185. Until a decision is reached in the rulemaking and the Commission can determine the effect of the future incentive auction and repacking, LPTV and TV translator stations may delay
Effective May 15, 2015.
Shaun Maher, Video Division, Media Bureau, Federal Communications Commission,
Effective May 15, 2015, the September 1, 2015 digital transition date for LPTV and TV translator stations is suspended pending final action in the rulemaking proceeding in MB Docket No. 03-185 (79 FR 70824 (Nov. 28, 2014)). The Commission will decide on a new transition date in the rulemaking proceeding in MB Docket No. 03-185. Until a decision is reached in the rulemaking and the Commission can determine the effect of the future incentive auction and repacking, LPTV and TV translator stations may delay completing construction of their digital facilities. Class A television stations are still subject to the September 1, 2015 transition date and analog Class A stations may no longer operate in analog mode after 11:59 p.m., local time, on September 1, 2015. Class A television stations that have not completed constructing their digital facilities by the transition date must go silent while they complete construction.
Class A television stations are also reminded that the Commission has designated May 29, 2015, as the Pre-Auction Licensing Deadline by which Class A television stations' digital facilities must be licensed in order to be eligible for protection in the repacking process that will be part of the incentive auction. In order for a Class A television station's digital facility to be afforded protection in the repacking process, it must be licensed or have an application for a license to cover on file by the Pre-Auction Licensing Deadline. Although Class A television stations may wait until the September 1, 2015, digital transition deadline to complete construction and license their digital facilities, those that do not have their digital facilities licensed by May 29, 2015, will be afforded protection based only on the coverage area and population served by their analog facilities.
Television.
For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 74 as follows:
47 U.S.C. 154, 302a, 303, 307, 309, 336 and 554.
(l) After 11:59 p.m. local time on September 1, 2015, Class A television stations may no longer operate any facility in analog (NTSC) mode.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; General and Angling category retention limit adjustments for Atlantic bluefin tuna (BFT); Purse Seine category BFT fishery start date.
NMFS is adjusting the General category BFT daily retention limit for June 1 through August 31, 2015, and the Angling category BFT daily retention limit for the remainder of 2015. In addition, NMFS is announcing July 6, 2015, as the start date for this year's Purse Seine category fishery. The General category daily retention limit is adjusted to four large medium or giant BFT. This adjustment applies to Atlantic tunas General category (commercial) permitted vessels and HMS Charter/Headboat category permitted vessels when fishing commercially for BFT. The Angling category daily retention limit is adjusted to: Two school BFT and one large school/small medium BFT per vessel per day/trip for charter vessels (
The Angling category retention limit is effective May 15, 2015 through December 31, 2015. The General category retention limit is effective June 1, 2015, through August 31, 2015. The Purse Seine category fishery will start July 6, 2015, and continue through December 31, 2015.
Sarah McLaughlin or Brad McHale, 978-281-9260.
Regulations implemented under the authority of the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971
The currently codified baseline U.S. quota is 923.7 mt (not including the 25 mt ICCAT allocated to the United States to account for bycatch of BFT in pelagic longline fisheries in the Northeast Distant Gear Restricted Area). Among other things, Amendment 7 revised the allocations to all quota categories, effective January 1, 2015. See § 635.27(a).
The 2015 BFT fishing year, which is managed on a calendar-year basis and subject to an annual quota, began January 1, 2015. The Angling category
Currently, the default Angling category daily retention limit of one school, large school, or small medium BFT applies (§ 635.23(b)(2)). This retention limit applies to HMS Angling and to HMS Charter/Headboat category permitted vessels (when fishing recreationally for BFT). In 2014, NMFS adjusted the daily retention limit from the default level to one school BFT and one large school/small medium BFT for private vessels (
The General category season was open January 1 through March 31, 2015 (the “January” category time period), resumes on June 1, 2015, and continues through December 31, 2015. Unless changed, the General category daily retention limit would be the default retention limit of one large medium or giant BFT per vessel per day/trip (§ 635.23(a)(2)). The General category default retention limit applies to General category permitted vessels and to HMS Charter/Headboat category permitted vessels when fishing commercially for BFT.
For the 2014 fishing year, NMFS adjusted the General category limit from the default level of one large medium or giant BFT as follows: Two large medium or giant BFT for January (78 FR 77362, December 23, 2013), four large medium or giant BFT for June through August (79 FR 30745, May 29, 2014), and four large medium or giant BFT for September through December (79 FR 50854, August 26, 2014). NMFS adjusted the daily retention limit for the 2015 January subquota period from the default level of one large medium or giant BFT to three large medium or giant BFT (79 FR 77943, December 29, 2014). In that action, NMFS also transferred 21 mt of BFT quota from the December 2015 subquota to the January 2015 subquota period.
In adjusting the daily retention limits in this action, NMFS considered the factors required by regulatory criteria, as discussed in more detail, below.
Under § 635.23(a)(4), NMFS may increase or decrease the General category daily retention limit of large medium and giant BFT over a range of zero to a maximum of five per vessel. Under § 635.23(b)(3), NMFS may increase or decrease the Angling category retention limit for any size class of BFT. Any adjustments to retention limits must be based on consideration of the relevant criteria provided under § 635.27(a)(8), which include: The usefulness of information obtained from catches in the particular category for biological sampling and monitoring of the status of the stock; the catches of the particular category quota to date and the likelihood of closure of that segment of the fishery if no adjustment is made; the projected ability of the vessels fishing under the particular category quota to harvest the additional amount of BFT before the end of the fishing year; the estimated amounts by which quotas for other gear categories of the fishery might be exceeded; effects of the adjustment on BFT rebuilding and overfishing; effects of the adjustment on accomplishing the objectives of the fishery management plan; variations in seasonal distribution, abundance, or migration patterns of BFT; effects of catch rates in one area precluding vessels in another area from having a reasonable opportunity to harvest a portion of the category's quota; review of dealer reports, daily landing trends, and the availability of the BFT on the fishing grounds; optimizing fishing opportunity; accounting for dead discards, facilitating quota monitoring, supporting other fishing monitoring programs through quota allocations and/or generation of revenue; and support of research through quota allocations and/or generation of revenue. Recreational retention limits may be adjusted separately for specific vessel type, such as private vessels, headboats, or charter vessels.
NMFS has considered these criteria and their applicability to the General category BFT retention limit for June-August 2015 and to the Angling category BFT retention limit for the remainder of 2015. These considerations include, but are not limited to, the following. Biological samples collected from BFT landed by recreational and commercial fishermen and provided by BFT dealers continue to provide NMFS with valuable parts and data for ongoing scientific studies of BFT age and growth, migration, and reproductive status. A principal consideration is the objective of providing opportunities to harvest the full Angling category quota and the June—August General category subquota without exceeding them based upon the 2006 Consolidated HMS FMP goal: “Consistent with other objectives of this FMP, to manage Atlantic HMS fisheries for continuing optimum yield so as to provide the greatest overall benefit to the Nation, particularly with respect to food production, providing recreational opportunities, preserving traditional fisheries, and taking into account the protection of marine ecosystems.” It is also important that NMFS constrain landings to BFT subquotas both to adhere to the FMP quota allocations and to ensure that landings are as consistent as possible with the pattern of fishing mortality (
NMFS also considered the fact that it is in the process of proposing a rule that would implement and give domestic effect to the 2014 ICCAT recommendation on western Atlantic BFT management, which increased the U.S. BFT quota for 2015 and 2016 by 14 percent from the 2014 level. The domestic subquotas to be proposed in that action would result from application of the allocation process established in Amendment 7 to the increased U.S. quota. As explained below, however, the retention limits being set in this action are not dependent on those quota increases.
The currently codified Angling category quota is 168.6 mt (94.9 mt for school BFT, 69.8 mt for large school/small medium BFT, and 3.9 mt for large medium/giant BFT). If the proposed quota rule (discussed above) is finalized as proposed, the Angling category quota could be expected to increase to 195.2 mt (108.4 mt for school BFT, 82.3 mt for large school/small medium BFT, and 4.5 mt for large medium/giant BFT). The currently codified General category quota is 403 mt. Each of the General category time periods (“January,” June through August, September, October
In addition to the considerations that apply to both the General and Angling category retention limit adjustments, described above, NMFS has considered the regulatory determination criteria and their applicability to the Angling category BFT retention limit. These considerations include, but are not limited to, the following. Under the Angling category limits in effect for 2014 (described above), Angling category landings were approximately 112 mt (62 percent of the 182-mt subquota), with 24.7 mt of school BFT landed (26 percent of the 94.9-mt school BFT subquota). Given that the landings fell short of the available quota, that additional quota is anticipated to be available this year as a result of the 2014 ICCAT recommendation, and considering the regulatory criteria above, NMFS has determined that the Angling category retention limit applicable to participants on HMS Angling and HMS Charter/Headboat category permitted vessels should be adjusted upwards from the default level. NMFS has also concluded that implementation of separate limits for private and charter/headboat vessels remains appropriate, recognizing the different nature, socio-economic needs, and recent landings results of the two components of the recreational BFT fishery. For example, charter operators historically have indicated that a multi-fish retention limit is vital to their ability to attract customers. In addition, Large Pelagics Survey estimates indicate that charter/headboat BFT landings averaged approximately 30 percent of recent recreational landings for 2013 through 2014, with the remaining 70 percent landed by private vessels.
Therefore, for private vessels (
NMFS anticipates that the BFT daily retention limits in this action will result in landings during 2015 that would not exceed the available subquotas (both those codified and as expected to be proposed). Lower retention limits could result in substantial underharvest of the codified Angling category subquota, and increasing the daily limits further may risk exceeding the available quota, contrary to the objectives of the 2006 Consolidated HMS FMP, as amended. Further increasing the school BFT retention limit for private and charter vessels could be possible without exceeding the annual school BFT subquota (both the amount currently codified and the amount that NMFS anticipates proposing in the quota rule shortly), given that the 2014 Angling category landings represented 66 percent of the currently-codified Angling category quota and 57 percent of the soon-to-be-proposed Angling category quota. Nevertheless, NMFS has concluded that retention limits consistent with last year's remain appropriate given the need to not exceed the ICCAT tolerance limit on school BFT and other considerations, such as potential effort shifts to BFT fishing as a result of current, reduced recreational retention limits for New England groundfish and striped bass. NMFS will monitor 2015 landings closely and will make further adjustments, including closure if necessary, with an inseason action if warranted.
In addition to the considerations that apply to both the General and Angling category retention limit adjustments, described above, NMFS has considered the regulatory determination criteria and their applicability to the General category BFT retention limit for the June—August 2015 General category fishery. These considerations include, but are not limited to, the following. Commercial-size BFT are anticipated to migrate to the fishing grounds off the northeast U.S. coast by early June. Based on General category landings rates during the June through August time period over the last several years, it is highly unlikely that the June through August subquota (both the currently codified amount and the amount that will be proposed) will be filled with the default daily retention limit of one BFT per vessel, and it may not be filled at a three-BFT limit if recent patterns of BFT availability and landings rates continue. During the June—August 2013 period, under a three-fish limit, BFT landings were approximately 108 mt (50 percent of the available subquota for that period). In the June—August 2014 period, under a four-fish limit, BFT landings were approximately 107 mt (49 percent of the subquota). For the entire 2014 fishing year, 94.6 percent of the General category quota was filled.
A limit lower than four fish could result in unused quota being added to the later portion of the General category season (
Based on these considerations, NMFS has determined that a four-fish General category retention limit is warranted. It would provide a reasonable opportunity to harvest the U.S. quota of BFT, without exceeding it, while maintaining an equitable distribution of fishing opportunities; help achieve optimum yield in the General category BFT fishery; allow the collection of a broad range of data for stock monitoring purposes; and be consistent with the objectives of the 2006 Consolidated HMS FMP, as amended. Therefore, NMFS increases the General category retention limit from the default limit to four large medium or giant BFT per
Regardless of the duration of a fishing trip, the daily retention limit applies upon landing. For example, during the June through August period, whether a vessel fishing under the General category limit takes a two-day trip or makes two trips in one day, the day/trip limit of four fish applies and may not be exceeded upon landing. This General category retention limit is effective in all areas, except for the Gulf of Mexico, where NMFS prohibits targeting fishing for BFT, and applies to those vessels permitted in the General category, as well as to those HMS Charter/Headboat permitted vessels fishing commercially for BFT.
These retention limit adjustments are intended to provide a reasonable opportunity to harvest the U.S. quota of BFT without exceeding it, while maintaining an equitable distribution of fishing opportunities; and to be consistent with the objectives of the 2006 Consolidated HMS FMP, as amended. The adjustments are consistent with the quotas previously implemented and analyzed in the 2011 BFT quota final rule, as adjusted by the final rule to implement Amendment 7, and consistent with the objectives of the 2006 Consolidated HMS FMP and amendments, and are not expected to negatively impact stock health. The adjustments also are supported by the Supplemental Environmental Assessment prepared for the 2013 quota specifications and the Final Environmental Impact Statement/Regulatory Impact Review/Final Regulatory Flexibility Analysis prepared for Amendment 7.
NMFS will continue to monitor the BFT fisheries closely through the mandatory landings and catch reports. Dealers are required to submit landing reports within 24 hours of a dealer receiving BFT. General, HMS Charter/Headboat, Harpoon, and Angling category vessel owners are required to report the catch of all BFT retained or discarded dead, within 24 hours of the landing(s) or end of each trip, by accessing
HMS Angling and HMS Charter/Headboat category permit holders may catch and release (or tag and release) BFT of all sizes, subject to the requirements of the catch-and-release and tag-and-release programs at § 635.26. Anglers are also reminded that all BFT that are released must be handled in a manner that will maximize survival, and without removing the fish from the water, consistent with requirements at § 635.21(a)(1). For additional information on safe handling, see the “Careful Catch and Release” brochure available at
Depending on the level of fishing effort and catch rates of BFT, NMFS may determine that additional retention limit adjustments or closures are necessary to ensure available quota is not exceeded or to enhance scientific data collection from, and fishing opportunities in, all geographic areas. Subsequent actions, if any, will be published in the
Amendment 7 revised the fishery start date to be set annually by NMFS between June 1 and August 15. The start date was made more flexible to optimize fishing opportunity for Purse Seine category vessels and to minimize potential gear conflicts or the impacts of oversupply on the market.
Under § 635.27(a)(4), NMFS may start the Purse Seine category BFT fishery between June 1 and August 15. Annually, NMFS will make a determination when the Purse Seine category fishery will start, based on variations in seasonal distribution, abundance or migration patterns of BFT, cumulative and projected landings in other commercial fishing categories, the potential for gear conflicts on the fishing grounds, or market impacts due to oversupply. In the past, NMFS has received comments from fishermen that use commercial handgear expressing concern that purse seining activity may disrupt their ability to capture BFT at the surface (
In 2004 through 2014, the Purse Seine category BFT fishery started on July 15 of each year (68 FR 74504, December 24, 2003). Since 2006, Purse Seine category landings have been low relative to available quota for the category, with no BFT harvested in 2008, 2010, and 2011.
Based on these considerations, NMFS has determined that a 2015 Purse Seine category BFT fishery start date of July 6 is warranted. The July 6 start date would alleviate issues with potential gear conflicts in June and early July (including over the July 4 holiday weekend) and concerns about market impacts caused by potential oversupply, thus balancing the needs of the Harpoon, General, and Purse Seine category fisheries. It would provide a reasonable opportunity to harvest the U.S. BFT quota, without exceeding it, while maintaining an equitable distribution of fishing opportunities; help achieve optimum yield in the Purse Seine category BFT fishery; and be consistent with the objectives of the 2006 Consolidated HMS FMP, as amended. Therefore, NMFS sets the purse seine fishery start date for July 6, 2015, through December 31, 2015.
NMFS will continue to monitor the Purse Seine category BFT fishery closely through the mandatory landings and catch reports. Consistent with the regulations implementing Amendment 7, purse seine vessel operators are required to use their vessel monitoring system (VMS) to report to NMFS as follows: For each purse seine set, as instructed by NMFS, the date and area of the set, and the length of all BFT retained (actual), and the length of all BFT discarded dead or alive (approximate), must be reported within 12 hours of the completion of the retrieval of each set.
The Assistant Administrator for NMFS (AA) finds that it is impracticable and contrary to the public interest to provide prior notice of, and an opportunity for public comment on, this action for the following reasons:
The regulations implementing the 2006 Consolidated HMS FMP, as amended, provide for inseason retention limit adjustments to respond to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. Based on available BFT quotas, fishery performance in recent years, the availability of BFT on the fishing grounds, among other considerations, adjustment to the General and Angling category BFT daily retention limits from the default levels is warranted. Analysis of available data shows that adjustment to the BFT daily retention limit from the default level would result in minimal
Delays in increasing these retention limits would adversely affect those HMS General, Angling, and Charter/Headboat category vessels that would otherwise have an opportunity to harvest more than the default retention limit of one school, large school, or small medium BFT per day/trip for the Angling category, or one BFT per day/trip for the General category, and may exacerbate the problem of low catch rates and quota rollovers. In addition, delays in starting the Purse Seine category BFT fishery would adversely affect those purse seine vessels that would otherwise harvest BFT during that time. Limited opportunities to harvest the respective quotas may have negative social and economic impacts for U.S. fishermen that depend upon catching the available quota within the time periods designated in the 2006 Consolidated HMS FMP, as amended. Purse Seine category fishermen need sufficient advance notice of the specific start date of the fishery in order to plan fishing trips, including meeting VMS requirements and arranging for observer coverage. Adjustment of the General category retention limit needs to be effective June 1, 2015, or as soon as possible thereafter, to minimize any unnecessary disruption in fishing patterns, to allow the impacted sectors to benefit from the adjustment, and to not preclude fishing opportunities for fishermen who have access to the fishery only during this time period. In addition, fisheries under the Angling category daily retention limit are currently underway and delaying this action would be contrary to the public interest. Therefore, the AA finds good cause under 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment. For all of the above reasons, there is good cause under 5 U.S.C. 553(d) to waive the 30-day delay in effectiveness.
This action is being taken under §§ 635.23(a)(4), 635.23(b)(3), and 635.27(a)(4) and is exempt from review under Executive Order 12866.
16 U.S.C. 971
Office of Special Education and Rehabilitative Services, Department of Education.
Proposed priority.
The Assistant Secretary for Special Education and Rehabilitative Services proposes a priority under the Rehabilitation Training program. The Assistant Secretary may use this priority for competitions in fiscal year (FY) 2015 and later years. This priority is designed to ensure that professionals working in State vocational rehabilitation (VR) agencies receive the technical assistance they need to provide youth with disabilities with services and supports that lead to postsecondary education and competitive integrated employment.
We must receive your comments on or before June 15, 2015.
Submit your comments through the Federal eRulemaking Portal or via postal mail, commercial delivery, or hand delivery. We will not accept comments submitted by fax or by email or those submitted after the comment period. To ensure that we do not receive duplicate copies, please submit your comments only once. In addition, please include the Docket ID at the top of your comments.
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The Department's policy is to make all comments received from members of the public available for public viewing in their entirety on the Federal eRulemaking Portal at
Tara Jordan. Telephone: (202) 245-7341 or by email:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
We invite you to assist us in complying with the specific requirements of Executive Orders 12866 and 13563 and their overall requirement of reducing regulatory burden that might result from this proposed priority. Please let us know of any further ways we could reduce potential costs or increase potential benefits while preserving the effective and efficient administration of the program.
During and after the comment period, you may inspect all public comments about these proposed regulations by accessing Regulations.gov. You may also inspect the comments in person in room 5040, 550 12th Street SW., PCP, Washington, DC, 20202-2800, between the hours of 8:30 a.m. and 4:00 p.m., Washington, DC time, Monday through Friday of each week except Federal holidays. Please contact the person listed under
29 U.S.C. 772(a)(1).
This notice contains one proposed priority.
State vocational rehabilitation (VR) agencies provide employment-related services to students and youth with disabilities in order to facilitate a smooth transition from school to post-school activities and to assist them in obtaining the training and skills they need to achieve competitive integrated employment. The Workforce Innovation and Opportunity Act (WIOA) amended the Rehabilitation Act by expanding the kinds of services that State VR agencies may provide to students and youth with disabilities and adding definitions of the terms “student with a disability” and “youth with a disability”.
The new definition for “student with a disability” at section 7(37)(A) of the Rehabilitation Act, as amended by WIOA, renumbered here for ease of reading, is an individual with a disability who—
(a)(1)(i) is not younger than the earliest age for the provision of transition services under section
(ii) if the State involved elects to use a lower minimum age for receipt of pre-employment transition services under this Act, is not younger than that minimum age; and
(2)(i) is not older than 21 years of age; or
(ii) if the State law for the State provides for a higher maximum age for receipt of services under the Individuals with Disabilities Education Act (20 U.S.C. 1400
(b)(1) is eligible for, and receiving, special education or related services under Part B of the Individuals with Disabilities Education Act (20 U.S.C. 1411
(2) is an individual with a disability, for purposes of section 504.
The new definition for “youth with a disability” at section 7(42)(A) of the Rehabilitation Act, as amended by WIOA, also renumbered here for ease of reading, is an individual with a disability who (a) is not younger than 14 years of age; (b) is not older than 24 years of age.
Historically, State VR agencies have had difficulty in locating and serving students with disabilities who are not served under the IDEA and youth with disabilities who are no longer in school. Therefore, the proposed Vocational Rehabilitation Technical Assistance Center for Youth with Disabilities (VRTAC-Y) would focus on providing technical assistance to State VR agencies on locating and serving students with disabilities not served under the IDEA and youth with disabilities who are not enrolled in school and who are not employed. Additionally, the National Technical Assistance Center on Transition, jointly funded by the Office of Special Education Programs (OSEP) and the Rehabilitation Services Administration (RSA), already provides technical assistance on the provision of transition services to students who are served under the IDEA.
The difficulty in locating and serving students with disabilities who are not served under the IDEA arises because these students usually do not have a lead teacher or advocate in the school system with the responsibility to facilitate the connection of students with disabilities to VR or to other services in the community. Without these connections, students may not obtain the necessary services and supports they need to be successful in education and training programs or competitive integrated employment after exiting high school.
Similarly, youth with disabilities who are not enrolled in school are usually not connected to the local adult service systems and, as a consequence, are not referred to the State VR agency for transition services or to other programs and services they may need. In particular, youth with disabilities who are high school dropouts, exiting the foster care system, or juvenile offenders are at high risk for not transitioning into successful and economically self-sufficient adult lives, and the consequences of this failure are considerable. Students with disabilities, particularly students with emotional or behavioral disabilities and learning disabilities, are at greater risk for dropping out of school (Lehr, et al. 2004). Youth with disabilities who drop out of high school experience substantial economic and social problems, including unemployment, poverty, homelessness, and incarceration. In addition, youth with disabilities who age out of the foster care system or are exiting correctional facilities often have multiple needs and may face additional challenges in connecting to appropriate community services and supports.
There are a number of promising and innovative practices aimed at assisting students and youth with disabilities to succeed in transitioning to adulthood, particularly education and competitive integrated employment, which are useful to State VR agencies. “Guideposts for Success” is a comprehensive resource of such practices focusing on the needs of youth with disabilities and vulnerable populations, such as youth in foster care and youth involved or at risk of becoming involved in the juvenile justice system (see
In addition, collaboration among State educational agencies (SEAs), local educational agencies (LEAs), State VR agencies, and other service providers helps to ensure the delivery of coordinated transition services. (Landmark, et al., 2010; National Council on Disability, 2008). Systems coordination promotes easier access to services for students and youth with disabilities and strengthens results and accountability leading to more positive outcomes (Russ and Fryar 2014).
The proposed VRTAC-Y would provide training and technical assistance to State VR agencies to assist them in identifying and serving students and youth with disabilities; designing and implementing collaborative and integrative approaches to serving students and youth with disabilities; and strengthening and expanding coordination of services to students and youth with disabilities, particularly those not served under the IDEA.
The purpose of this proposed priority is to fund a cooperative agreement to establish a Vocational Rehabilitation Technical Assistance Center—Youth with Disabilities (VRTAC-Y). The focus of this proposed priority is to provide technical assistance (TA) to State vocational rehabilitation (VR) agencies to improve services to and outcomes of: (1) students with disabilities, as defined in section 7(37) of the Rehabilitation Act, who are in school and who are not receiving services under the IDEA; and (2) youth with disabilities, as defined in section 7(42) of the Rehabilitation Act, who are no longer in school and who are not employed. For purposes of this priority, “Students and youth with disabilities” refers to these two groups.
The VRTAC-Y is designed to achieve, at a minimum, the following outcomes:
(a) Assist State VR agencies to identify and meet the VR needs of students and youth with disabilities consistent with
(b) Improve the ability of State VR agencies to develop partnerships with State and local agencies, service providers, or other entities to ensure that students and youth with disabilities are referred for VR services and have access to coordinated supports, services, training, and employment opportunities, including: (1) increasing the number of referrals and applications received by State VR agencies from agencies, service providers and others serving students and youth with disabilities; and (2) increasing the number of students and youth with disabilities receiving VR services;
(c) Improve the ability of VR personnel to develop individualized plans for employment that ensure the successful transition of students and youth with disabilities and the achievement of post-school goals; and
(d) Increase the number of students and youth with disabilities served by VR agencies (particularly dropouts, foster care youth and youth involved in the correctional system) who are engaged in education and training programs leading to the attainment of postsecondary skills and credentials needed for employment in high-demand occupations.
Under this proposed priority, the VRTAC-Y must develop and provide training and TA to State VR agency staff and related rehabilitation professionals and service providers in the following topic areas:
(a) Developing and maintaining formal and informal partnerships and relationships with relevant stakeholders (including, but not limited to, school systems, institutions of higher education (IHEs), State and local service agencies, community rehabilitation programs, correctional facilities and programs, and employers) to increase referral of students and youth with disabilities to the State VR system for the supports and services they need to achieve competitive integrated employment;
(b) Developing and implementing outreach policies and procedures using evidence-based and promising practices that ensure that students and youth with disabilities in the State are located, identified, and evaluated for services; and
(c) Developing and implementing collaborative and coordinated service strategies, such as higher education and training services; and internship, apprenticeship, and other work experience services designed to increase the number of students and youth with disabilities who are served by the State VR agency who obtain competitive integrated employment.
Under this proposed priority, the VRTAC-Y must, at a minimum, conduct the following activities:
(a) In the first year, collect information from the literature and from existing Federal, State, and other programs on evidence-based and promising practices relevant to the work of the VRTAC-Y and make this information publicly available in a searchable, accessible, and useful format. The VRTAC-Y must review, at a minimum:
(1) State VR agency State plan descriptions of outreach plans and procedures, coordination and collaboration with other agencies, and coordination and collaboration with education officials relating to students and youth with disabilities;
(2) State VR agency formal interagency agreements with SEAs for the coordination of transition services, including the provision of pre-employment transition services;
(3) The results of State VR agency monitoring conducted by RSA, when available;
(4) State VR agency program and performance data; and
(5) Information on promising practices and VR needs of students and youth with disabilities from TA centers that serve relevant public and private non-profit agencies, as well as existing RSA and OSEP TA centers and RSA and OSEP Parent Training and Information Centers.
(b) In the first year, conduct a survey of relevant stakeholders and VR service providers to identify TA needs that the VRTAC-Y can meet and develop a process by which TA solutions can be offered to State VR agencies and their partners. The VRTAC-Y must survey, at a minimum:
(1) State VR agency staff;
(2) Relevant RSA staff;
(3) Grantees of the National Institute on Disability, Independent Living, and Rehabilitation Research that are researching topics related to the work of the VRTAC-Y; and
(4) Educators or other professionals conducting research on topics related to the work of the VRTAC-Y.
(a) Over the five-year grant period, provide intensive TA to a minimum of 10 State VR agencies and their associated rehabilitation professionals and service providers in the topic areas set out in this proposed priority.
(1) For topic area (a)—
(i) Identification of key stakeholders in the State or region who can improve the State VR agency's ability to perform outreach activities and meet the employment and training needs of students and youth with disabilities;
(ii) Effective marketing and outreach to school and community services personnel, such as how best to present information about VR supports, training, and programming for students and youth with disabilities; and
(iii) How to develop formal and informal service and outreach agreements with relevant stakeholders to meet the employment and training needs of students and youth with disabilities.
(2) For topic area (b)—
(i) How to conduct an analysis and assessment of outreach strategies to determine gaps between service delivery systems, as well as the need for coordinated services and supports across service systems for students and youth with disabilities;
(ii) How to access and leverage partnerships across agencies and service delivery systems to increase the number of students and youth with disabilities provided with relevant and accessible information regarding services available through the State VR agency.
(3) For topic area (c)—
(i) Evidence-based and promising practices in the development and implementation of vocational services to meet the employment and training needs of students and youth with disabilities;
(ii) How to incorporate students and youth with disabilities into training programs in which they have been historically underrepresented; and
(iii) How to assist students and youth with disabilities in accessing customized vocational, occupational, or
(b) In the first year, develop and refine a minimum of five curriculum guides for VR staff training in topics related to the work of the VRTAC-Y, which must include:
(1) Partnership development across service delivery systems for purposes of leveraging resources and coordinating supports, services, training, and employment opportunities for students and youth with disabilities;
(2) Development, implementation, and dissemination of effective model outreach strategies, policies, and procedures to improve access for students and youth with disabilities to VR services and supports;
(3) Development of customized training, other career training, and work experience programs for students and youth with disabilities;
(4) Development and delivery of support services to providers of career training programs that facilitate completion of training and result in competitive integrated employment for students and youth with disabilities; and
(5) Delivery of support services to employers who hire students and youth with disabilities from customized or career training programs or who offer internships and work experience opportunities.
(c) Provide a range of targeted and general TA products and services on the topic areas in this proposed priority. Such TA must include, at a minimum, the following activities:
(1) Developing and maintaining a state-of-the-art information technology (IT) platform sufficient to support Webinars, teleconferences, video conferences, and other virtual methods of dissemination of information and TA;
All products produced by the VRTAC-Y must meet government and industry-recognized standards for accessibility, including section 508 of the Rehabilitation Act. The VRTAC-Y may either develop a new platform or system, or modify existing platforms or systems, so long as the requirements of the priority are met.
(2) Ensuring that all TA products are sent to the National Center for Rehabilitation Training Materials, including: course curricula; audiovisual materials; Webinars; examples of emerging and best practices related to the topic areas in this proposed priority; and any other TA products; and
(3) Providing a minimum of four Webinars or video conferences on each of the topic areas in this proposed priority to describe and disseminate information about emerging and promising practices in each area.
(a) Establish a community of practice for all interested State VR agencies that will act as a vehicle for communication, exchange of information among State VR agencies and partners, and a forum for sharing the results of TA projects that are in progress or have been completed. Such community of practice must be focused on partnerships across service systems, outreach and identification strategies for students and youth with disabilities, and the development and provision of vocational services and vocational training to students and youth with disabilities.
(b) Communicate and coordinate, on an ongoing basis, with other Department-funded projects and those supported by the Departments of Labor and Commerce; and
(c) Maintain ongoing communications with the RSA project officer.
To be funded under this proposed priority, applicants must meet the proposed application requirements in this proposed priority. RSA encourages innovative approaches to meet these requirements. The proposed application requirements are:
(a) Demonstrate, in the narrative section of the application, under “Significance of the Project,” how the proposed project will—
(1) Address State VR agencies' capacity to meet the employment and training needs of students and youth with disabilities. To meet this requirement, the applicant must:
(i) Demonstrate knowledge of emerging and best practices in conducting outreach and providing VR services to students and youth with disabilities;
(ii) Demonstrate knowledge of current applicable Federal statutes and regulations, current RSA guidance, and State and Federal initiatives designed to improve employment outcomes for students and youth with disabilities; and
(iii) Present information about the difficulties that State VR agencies and service providers have encountered in developing and implementing effective outreach and service delivery plans for students and youth with disabilities; and
(2) Result in increases in both the number of students and youth with disabilities receiving services from State VR agencies and related agencies and the number and quality of employment outcomes in competitive integrated employment for students and youth with disabilities;
(b) Demonstrate, in the narrative section of the application, under “Quality of Project Services,” how the proposed project will—
(1) Achieve its goals, objectives, and intended outcomes. To meet this requirement, the applicant must provide—
(i) Measurable intended project outcomes;
(ii) A plan for how the proposed project will achieve its intended outcomes; and
(iii) A plan for communicating and coordinating with key staff in State VR agencies, State and local partner programs, advocates for students and youth with disabilities, RSA partners such as the Council of State Administrators of Vocational Rehabilitation (CSAVR), the National Council of State Agencies for the Blind (NCSAB), and other TA Centers and relevant programs within the Departments of Education, Labor, and Commerce;
(2) Use a conceptual framework to develop project plans and activities, describing any underlying concepts, assumptions, expectations, beliefs, or theories, as well as the presumed relationships or linkages among these variables, and any empirical support for this framework;
(3) Be based on current research and make use of evidence-based and promising practices. To meet this requirement, the applicant must describe—
(i) The current research on emerging, promising, and evidence-based practices in the topic areas in this proposed priority;
(ii) How the current research about adult learning principles and implementation science will inform the proposed TA; and
(iii) How the proposed project will incorporate current research and evidence-based practices in the development and delivery of its products and services;
(4) Develop products and provide services that are of high quality and sufficient intensity and duration to achieve the intended outcomes of the proposed project. To address this
(i) Its proposed activities to identify or develop the knowledge base on emerging and promising practices in the topic areas in this proposed priority;
(ii) Its proposed approach to universal, general TA;
(iii) Its proposed approach to targeted, specialized TA,
(A) The intended recipients of the products and services under this approach; and
(B) Its proposed approach to measure the readiness of State VR agencies to work with the proposed project, assessing, at a minimum, their current infrastructure, available resources, and ability to effectively respond to the TA, as appropriate;
(iv) Its proposed approach to intensive, sustained TA, which must identify—
(A) The intended recipients of the products and services under this approach;
(B) Its proposed approach to measure the readiness of the State VR agencies to work with the proposed project including the State VR agencies' commitment to the TA initiatives, appropriateness of the initiatives, current infrastructure, available resources, and ability to respond effectively to the TA, as applicable;
(C) Its proposed plan for assisting State VR agencies to build training systems that include professional development based on adult learning principles and coaching; and
(D) Its proposed plan for developing intensive TA agreements with State VR agencies to provide intensive, sustained TA. The plan must describe how the intensive TA agreements will outline the purposes of the TA, the intended outcomes of the TA, and the measurable objectives of the TA that will be evaluated;
(5) Develop products and implement services to maximize the project's efficiency. To address this requirement, the applicant must describe—
(i) How the proposed project will use technology to achieve the intended project outcomes; and
(ii) With whom the proposed project will collaborate and the intended outcomes of this collaboration;
(c) Demonstrate, in the narrative section of the application under “Quality of the Evaluation Plan,” how the proposed project will—
(1) Measure and track the effectiveness of the TA provided. To meet this requirement, the applicant must describe its proposed approach to—
(i) Collecting data on the effectiveness of each TA activity from State VR agencies, partners, or other sources, as appropriate; and
(ii) Analyzing data and determining the effectiveness of each TA activity, including any proposed standards or targets for determining effectiveness. At a minimum, the VRTAC-Y must analyze data on school and service system referrals to State VR agencies and employment outcomes of students and youth with disabilities, including type of employment, wages, hours worked, weeks of employment, and public benefits received;
(2) Collect and analyze data on specific and measurable goals, objectives, and intended outcomes of the project, including measuring and tracking the effectiveness of the TA provided. To address this requirement, the applicant must describe—
(i) Its proposed evaluation methodologies, including instruments, data collection methods, and analyses;
(ii) Its proposed standards or targets for determining effectiveness;
(iii) How it will use the evaluation results to examine the effectiveness of its implementation and its progress toward achieving the intended outcomes; and
(iv) How the methods of evaluation will produce quantitative and qualitative data that demonstrate whether the project and individual TA activities achieved their intended outcomes;
(d) Demonstrate, in the narrative section of the application under “Adequacy of Project Resources,” how—
(1) The proposed project will encourage applications for employment from persons who are members of groups that have historically been underrepresented based on race, color, national origin, gender, age, or disability, as appropriate;
(2) The proposed key project personnel, consultants, and subcontractors have the qualifications and experience to provide TA to State VR agencies and their partners in each of the topic areas in this proposed priority and to achieve the project's intended outcomes;
(3) The applicant and any key partners have adequate resources to carry out the proposed activities; and
(4) The proposed costs are reasonable in relation to the anticipated results and benefits;
(e) Demonstrate, in the narrative section of the application under “Quality of the Management Plan,” how—
(1) The proposed management plan will ensure that the project's intended outcomes will be achieved on time and within budget. To address this requirement, the applicant must describe—
(i) Clearly defined responsibilities for key project personnel, consultants, and subcontractors, as applicable; and
(ii) Timelines and milestones for accomplishing the project tasks;
(2) Key project personnel and any consultants and subcontractors that will be allocated to the project and how these allocations are appropriate and adequate to achieve the project's intended outcomes, including an assurance that such personnel will have adequate availability to ensure timely communications with stakeholders and RSA;
(3) The proposed management plan will ensure that the products and services provided are of high quality; and
(4) The proposed project will benefit from a diversity of perspectives, including those of State and local personnel, TA providers, researchers, and policy makers, among others, in its development and operation.
When inviting applications for a competition using one or more priorities, we designate the type of each priority as absolute, competitive preference, or invitational through a notice in the
Final Priority:
We will announce the final priority in a notice in the
This notice does
Under Executive Order 12866, the Secretary must determine whether this proposed regulatory action is “significant” and, therefore, subject to the requirements of the Executive order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—
(1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities in a material way (also referred to as an “economically significant” rule);
(2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the Executive order.
This proposed regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.
We have also reviewed this proposed regulatory action under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—
(1) Propose or adopt regulations only on a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);
(2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;
(3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);
(4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and
(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.
Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”
We are issuing this proposed priority only on a reasoned determination that its benefits would justify its costs. In choosing among alternative regulatory approaches, we selected those approaches that would maximize net benefits. Based on the analysis that follows, the Department believes that this regulatory action is consistent with the principles in Executive Order 13563.
We also have determined that this regulatory action would not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.
In accordance with both Executive orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.
The benefits of the Rehabilitation Training program have been well established over the years through the successful completion of similar projects. This proposed priority will better prepare State VR agency personnel to assist the students and youth with disabilities who are the focus of this priority to achieve competitive integrated employment in today's challenging labor market.
This document provides early notification of our specific plans and actions for this program.
You may also access documents of the Department published in the
Office of Special Education and Rehabilitative Services, Department of Education.
Proposed priority and definitions.
The Assistant Secretary for Special Education and Rehabilitative Services proposes a priority and definitions under the Demonstration and Training program. The Assistant Secretary may use this priority and one or more of these definitions for competitions in fiscal year (FY) 2015 and later years. This priority and these definitions are designed to support projects that develop and implement career pathways for individuals with disabilities.
We must receive your comments on or before June 15, 2015.
Submit your comments through the Federal eRulemaking Portal or via postal mail, commercial delivery, or hand delivery. We will not accept comments submitted by fax or by email or those submitted after the comment period. To ensure that we do not receive duplicate copies, please submit your comments only once. In addition, please include the Docket ID at the top of your comments.
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The U.S. Department of Education's (Department's) policy is to make all comments received from members of the public available for public viewing in their entirety on the Federal eRulemaking Portal at
RoseAnn Ashby. Telephone: (202) 245-7258 or by email:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
We invite you to assist us in complying with the specific requirements of Executive Orders 12866 and 13563 and their overall requirement of reducing regulatory burden that might result from this proposed priority and these proposed definitions. Please let us know of any further ways we could reduce potential costs or increase potential benefits while preserving the effective and efficient administration of the program.
During and after the comment period, you may inspect all public comments about this notice by accessing Regulations.gov. You may also inspect the comments in person in Room 5055, 550 12th Street SW., PCP, Washington, DC 20202-2800, between the hours of 8:30 a.m. and 4:00 p.m., Washington, DC time, Monday through Friday of each week except Federal holidays. Please contact the person listed under
29 U.S.C. 773(b).
This notice contains one proposed priority.
Despite largely positive trends in U.S. economic indicators, including a declining trend in the overall unemployment rate,
With nearly one in five people in the United States identified as having a disability, strategies designed to encourage the growth of the recovering economy will need to include initiatives to tap the skills and knowledge of this underutilized human resource. While recent data show that the labor force participation rate for working-age people with disabilities is beginning to increase, it is far below the rate for individuals without disabilities (31.1 percent for individuals with disabilities compared to 75.7 percent for the working-age people without disabilities).
One strategy for assisting individuals to acquire skills relevant in today's economy is to develop and use a career pathway. By preparing workers for high-demand occupations, career pathways offer a promising approach for improving the foundation skills of young adults and low-skilled adults, including individuals with disabilities, and the Nation's overall economic prosperity. A “career pathway,” as defined in section 3(7) of the Workforce Innovation and Opportunity Act (WIOA), is a combination of rigorous and high-quality education, training, and other services that is aligned with the skill needs of industries in the State
One of the benefits of a career pathways approach is the integration of educational instruction, workforce development, and human and social services and supports that are linked to labor market trends and employer needs leading to stackable credentials.
The State Vocational Rehabilitation (VR) Services program is the primary Federal vehicle in the workforce development system for assisting individuals with disabilities, particularly individuals with the most significant disabilities, to prepare for, obtain, retain, or advance in competitive integrated employment. As required partners in the one-stop service delivery system established under WIOA for accessing employment and training services, State VR agencies must coordinate and collaborate with other entities, including employers, educational and non-educational agencies working with youth, and other agencies and programs providing services to individuals with disabilities. However, to increase the employment of individuals with disabilities, State VR agencies need employment approaches that are effective in assisting individuals to attain knowledge and skills that can lead to employment in high-demand occupations.
Through this proposed priority, the Office of Special Education and Rehabilitative Services seeks to support collaborations between State VR agencies, secondary and postsecondary educational institutions, workforce centers and other training providers, human and social service agencies, employers, and other community stakeholders. These collaborations will demonstrate how career pathways can help individuals with disabilities served by State VR agencies to acquire the marketable skills and to attain recognized postsecondary credentials that lead to employment in high-demand occupations.
The Assistant Secretary for Special Education and Rehabilitative Services proposes a priority designed to demonstrate promising practices in the use of career pathways (as defined in this notice) in order to improve employment outcomes for individuals with disabilities (as defined in this notice). Specifically, the purpose of the proposed priority is to establish a model demonstration project designed to promote State vocational rehabilitation (VR) agency partnerships in the development and use of career pathways to help individuals with disabilities eligible for VR services, including youth with disabilities (as defined in this notice), to acquire marketable skills and recognized postsecondary credentials (as defined in this notice).
(a) Develop and implement a collaborative model project demonstrating promising practices and strategies in the use of career pathways to improve the skills of individuals with disabilities, including youth with disabilities, and help them attain credentials that lead to employment in high-demand occupations. The model must be implemented at multiple sites to ensure its replicability. The career pathways must lead to one or more occupational clusters (as defined in this notice);
(b) Establish partnerships between the VR agencies, employers, agencies, and entities that are critical to the development of career pathways and the alignment of education, training, employment, and human and social services. At a minimum, the partnership should include representatives from the public educational agency or agencies responsible for providing transition services to students with disabilities under the Individuals with Disabilities Education Act and representatives from two-year and four-year institutions of higher education, American Job Centers, workforce training providers (including apprenticeship providers), and employers who will work in collaboration to develop and provide postsecondary education and training for individuals with disabilities served under this project;
(c) Include the following career pathway components:
(1) Alignment of secondary and postsecondary education, training, employment, and human services with the skill needs of targeted industry sectors important to local, regional, or State economies;
(2) Rigorous, sequential, connected, and efficient curricula that connect basic education and skills training courses and that integrate education with training;
(3) Multiple entry and exit points for individuals with disabilities entering and exiting training;
(4) Comprehensive support services that are designed to ensure the individual's success in completing education and training programs:
(i) Financial supports, career counseling, child care, and transportation;
(ii) Educational supports (
(iii) Self-advocacy training (
(iv) Appropriate assistive technology services and devices;
(5) Flexible design of education and training programs and services to meet the particular needs of individuals with disabilities, including flexible work schedules, alternative class times and locations, and the innovative use of technology;
(6) Education and training programs that focus on the attainment of secondary education and recognized postsecondary credentials, sector-specific employment, educational advancement over time and employment within a sector, including curriculum and instructional strategies designed to develop the following knowledge and skills:
(i) Career exploration and career readiness skills;
(ii) Basic academic skills needed to demonstrate knowledge competencies in an occupation or occupational cluster, including remedial skills to address gaps in basic reading, writing, and math skills;
(iii) Career and technical skills leading to employment in technical careers, including employment in the skilled trades; and
(iv) Soft skills (
(d) Collaborate with other federally-funded career pathway initiatives conducting activities relevant to the work of its proposed project; and
(e) Develop and conduct an evaluation of the project's performance in achieving project goals and objectives, including an evaluation of the effectiveness of the practices and strategies implemented by the project.
(a) A detailed review of the literature that supports the potential effectiveness of the proposed model, its components, and processes to improve outcomes for individuals with disabilities;
(b) A logic model that communicates how the demonstration project will achieve its outcomes and provides a framework for project evaluation. The logic model must depict, at a minimum, the goals, activities, outputs, and outcomes of the proposed model demonstration project;
(c) A description of the applicant's plan for implementing the project, including a description of—
(1) A cohesive, articulated model of partnership and coordination among the participating agencies and organizations;
(2) The coordinated set of promising practices and strategies in the use and development of career pathways that are aligned with employment, training, and education programs and reflect the needs of employers and individuals with disabilities; and
(3) How the proposed project will—
(i) Identify local workforce needs, aligned with the skill needs of targeted industry sectors important to local, regional, or State economies;
(ii) Involve employers in the project design and in partnering with project staff to develop integrated community settings for assessments, job shadowing, internships, apprenticeships, and other paid and unpaid work experiences that are designed to lead to competitive integrated employment for individuals with disabilities, including youth with disabilities;
(iii) Conduct outreach activities to identify individuals with disabilities for whom the career pathways approach would enable them to achieve competitive integrated employment in career clusters identified in their application; and
(iv) Develop strategies for involving families that will increase the likelihood for successful educational and employment outcomes for individuals with disabilities.
(d) The methods and criteria that will be used to select the sites at which the project activities will be implemented;
(e) Evidence (
(f) A plan for evaluating the project's performance, including an evaluation of the effectiveness of the practices and strategies implemented by the project, in achieving project goals and objectives. Specifically, the evaluation plan must include a description of:
(1) Project goals, measurable objectives, and operational definitions;
(2) the data to be collected;
(3) how the data will be analyzed; and
(4) the outcomes for individuals with disabilities served by the project compared with the outcomes of individuals with disabilities not receiving project services.
(g) At a minimum, the data collected must include:
(1) the relevant RSA-911 Case Service Report data for each project participant;
(2) the number of participants who enter a career pathway;
(3) the number of participants who complete training in a career pathway; and
(4) the number of participants who attain a recognized postsecondary credential and the type of credentials attained.
(h) A plan for systematic dissemination of project findings and knowledge gained that will assist State and local agencies in adapting or replicating the model career pathways developed and implemented by the project, which could include elements such as development of a Web site, community of practice, and participation in national and State conferences;
(i) An assurance that the employment goal for all individuals served under this priority will be competitive integrated employment, including customized or supported employment; and
(j) An assurance that the project will collaborate with other federally-funded career pathway initiatives conducting activities relevant to its work.
When inviting applications for a competition using one or more priorities, we designate the type of each priority as absolute, competitive preference, or invitational through a notice in the
The following definitions are proposed to ensure that applicants have a clear understanding of how we are using these terms in the priority. These definitions are based on defined statutory terms in WIOA, the Rehabilitation Act and definitions that the Department uses or relies on in other contexts. Although we cannot make changes to the text of statutory definitions, we announce them along with our other proposed definitions below to provide notice of our intent to use them in the context of this program.
The Assistant Secretary proposes the following definitions for this program. We may apply one or more of these definitions in any year in which this program is in effect.
(a) Aligns with the skill needs of industries in the economy of the State or regional economy involved;
(b) Prepares an individual to be successful in any of a full range of secondary or postsecondary education options, including apprenticeships registered under the Act of August 16, 1937 (commonly known as the “National Apprenticeship Act”; 50 Stat. 664, chapter 663; 29 U.S.C. 50
(c) Includes counseling to support an individual in achieving the individual's education and career goals;
(d) Includes, as appropriate, education offered concurrently with and in the same context as workforce preparation activities and training for a specific occupation or occupational cluster;
(e) Organizes education, training, and other services to meet the particular needs of an individual in a manner that accelerates the educational and career advancement of the individual to the extent practicable;
(f) Enables an individual to attain a secondary school diploma or its recognized equivalent, and at least one recognized postsecondary credential; and
(g) Helps an individual enter or advance within a specific occupation or occupational cluster. Source: Section 3(7) of WIOA.
(a) For which an individual—
(1) Is compensated at a rate that—
(i)(A) Shall be not less than the higher of the rate specified in section 6(a)(1) of the Fair Labor Standards Act of 1938 (29 U.S.C. 206(a)(1)) or the rate specified in the applicable State or local minimum wage law; and
(B) Is not less than the customary rate paid by the employer for the same or similar work performed by other employees who are not individuals with disabilities, and who are similarly situated in similar occupations by the same employer and who have similar training, experience, and skills; or
(ii) In the case of an individual who is self-employed, yields an income that is comparable to the income received by other individuals who are not individuals with disabilities, and who are self-employed in similar occupations or on similar tasks and who have similar training, experience, and skills; and
(2) Is eligible for the level of benefits provided to other employees;
(b) That is at a location where the employee interacts with other persons who are not individuals with disabilities (not including supervisory personnel or individuals who are providing services to such employee) to the same extent that individuals who are not individuals with disabilities and who are in comparable positions interact with other persons; and
(c) That, as appropriate, presents opportunities for advancement that are similar to those for other employees who are not individuals with disabilities and who have similar positions. Source: Section 7(5) of the Rehabilitation Act.
(a) Has a physical or mental impairment which for such individual constitutes or results in a substantial impediment to employment; and
(b) Can benefit in terms of an employment outcome from vocational rehabilitation services provided pursuant to Title I, III, or VI of the Rehabilitation Act. Source: Section 7(20) of the Rehabilitation Act.
(a) Is not younger than 14 years of age; and
(b) Is not older than 24 years of age.
Source: Section 7(42) of the Rehabilitation Act.
We will announce the final priority and definitions in a notice in the
This notice does
Under Executive Order 12866, the Secretary must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—
(1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities in a material way (also referred to as an “economically significant” rule);
(2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the Executive Order.
This proposed regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.
We have also reviewed this proposed regulatory action under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—
(1) Propose or adopt regulations only upon a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);
(2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;
(3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);
(4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and
(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.
Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”
We are issuing this proposed priority and these proposed definitions only on a reasoned determination that their benefits would justify their costs. In choosing among alternative regulatory approaches, we selected those approaches that would maximize net benefits. Based on the analysis that follows, the Department believes that this regulatory action is consistent with the principles in Executive Order 13563.
We also have determined that this regulatory action would not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.
In accordance with both Executive orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.
The benefits of the Demonstration and Training program have been well established over the years through the successful completion of similar projects. For example, the projects first funded in FY 2007 to demonstrate collaborative practices that lead to postsecondary education and employment of youth with disabilities have served as a rich source of practices for the VR field. This proposed priority and these proposed definitions would promote projects that would serve as models in developing and implementing career pathways for individuals with disabilities that could be replicated by other State VR agencies so that such agencies could improve employment outcomes for individuals with disabilities.
This document provides early notification of our specific plans and actions for this program.
You may also access documents of the Department published in the
Department of Veterans Affairs.
Proposed rule.
The Department of Veterans Affairs (VA) proposes to amend its regulations concerning the provisions of health care to birth children of Vietnam veterans and veterans of covered service in Korea diagnosed with spina bifida, except for spina bifida occulta, and certain other birth defects. The proposed changes would more clearly define the types of health care VA provides, including day health care and health-related services, which VA would define as homemaker or home health aide services that provide assistance with Activities of Daily Living or Instrumental Activities of Daily Living that have therapeutic value. We would also make changes to the list of health care services that require preauthorization by VA.
Comments must be received by VA on or before July 14, 2015.
Written comments may be submitted through
Karyn Barrett, Director, Program Administration Directorate, Chief Business Office Purchased Care (10NB3), Veterans Health Administration, Department of Veterans
Chapter 18 of title 38, United States Code, provides for benefits for certain birth children of Vietnam veterans and veterans of covered service in Korea who have been diagnosed with spina bifida, except spina bifida occulta, and certain other birth defects. These benefits include: (1) Monthly monetary allowances for various disability levels; (2) health care; and (3) vocational training and rehabilitation. VA has published regulations at 38 CFR 17.900 through 17.905 concerning health care for children authorized by 38 U.S.C. 1803 as well as 1813. Section 1803(a) authorizes VA to provide a child of a Vietnam veteran who is suffering from spina bifida, except spina bifida occulta, with health care. Section 1813(a) authorizes VA to provide a child of a woman Vietnam veteran who has been diagnosed with certain other birth defects needed health care for that child's covered birth defects or any disability that is associated with those birth defects. The definitions in section 1803(c) apply to both programs, with two narrow exceptions that are not relevant to this rulemaking.
The term “health care” under 38 U.S.C. 1803(c)(1) is defined as home care, hospital care, nursing home care, outpatient care, preventive care, habilitative and rehabilitative care, case management, and respite care. In addition, health care includes the training of appropriate members of a child's family or household in the care of the child; the provision of pharmaceuticals; supplies (including continence-related supplies such as catheters, pads, and diapers); equipment (including durable medical equipment); devices; appliances; assistive technology; and direct transportation costs to and from approved health care providers (including any necessary costs for meals and lodging en route and accompaniment by an attendant or attendants). Certain of these benefits and services require preauthorization by VA under § 17.902.
Health care that is not provided directly by VA must be provided by contract with an approved health care provider or by other arrangement with an approved health care provider. Under current § 17.900, “approved health care provider” means a health care provider currently approved by the Center for Medicare and Medicaid Services (CMS), Department of Defense TRICARE Program, Civilian Health and Medical Program of the Department of Veterans Affairs (CHAMPVA), Joint Commission on Accreditation of Health Care Organizations (JCAHO), or currently approved for providing health care under a license or certificate issued by a governmental entity with jurisdiction. An entity or individual will be deemed to be an approved health care provider only when acting within the scope of the approval, license, or certificate. We do not propose any substantive changes to the definition of approved health care provider, but the definition is relevant here because we use the term in this rulemaking.
VA has identified a need for certain types of care for these individuals and intends to clarify in regulation which services are authorized by 38 U.S.C. 1803 and 1813 and will be provided under this authority. We propose to amend our regulations to clarify what services constitute health care under § 17.900 and to revise the list of health care services that would require preauthorization by VA under § 17.902. These proposed changes are based on an advisory opinion from VA's Office of the General Counsel (OGC). VAOPGCADV 5-2013 (June 13, 2013). OGC issued this advisory opinion in response to a VA request for clarification as to whether VA is authorized by 38 U.S.C. 1803 to provide various types of health care services.
One of those services is day health care. Day health care services are a non-institutional alternative to nursing home care, and we believe that VA may reimburse these services under its authority in 38 U.S.C. 1803 to provide outpatient care and respite care.
Outpatient care is defined at 38 U.S.C. 1803(c)(6) to mean care and treatment of a disability, and preventive health services, furnished to an individual other than hospital care or nursing home care. The phrase “care and treatment” is also found in the definitions of hospital care, nursing home care, and preventive care at 38 U.S.C. 1803(c)(4) through (7). The inclusion of the phrase “care and treatment” in the definitions of the categories of authorized health care services indicates legislative intent that a therapeutic component must be part of the service provided. Accordingly, we would define day health care to also include a therapeutic component. So defined, we believe that day health care services constitute care and treatment furnished outside of hospital care or nursing home care, and, therefore, that VA may provide day health care services as part of outpatient care authorized by 38 U.S.C. 1803. We would also amend the definition of outpatient care to include day health care as an authorized health care service.
We would define “day health care” to mean a therapeutic program prescribed by an approved health care provider that provides necessary medical services, rehabilitation, therapeutic activities, socialization, nutrition, and transportation services in a congregate setting. Day health care services contemplated under this proposal are equivalent to adult day health care provided to disabled veterans under 38 CFR 17.111(c)(1), except that such services would be provided to individuals who are not veterans. The essential features are the therapeutic focus of the day health care services and provision of these services in a congregate setting.
Current § 17.900 defines outpatient care as care and treatment, including preventive health services, furnished to a child other than hospital care or nursing home care. We would amend this definition to include day health care to clarify that day health care is a component of outpatient care.
Day health care services are also a component of respite care. Respite care is currently defined at § 17.900 as care furnished by an approved health care provider on an intermittent basis for a limited period to an individual who resides primarily in a private residence when such care will help the individual continue residing in such private residence. Respite care is a service that pays for a person to come to an individual beneficiary's home or for the beneficiary to go to a program, including a day health care program, so the family caregiver can have a period during which the caregiver is not responsible to provide care to the beneficiary. Respite care allows the family caregiver to run errands without worrying about leaving the beneficiary alone at home. Respite care can help reduce the stress a family caregiver may feel when managing a beneficiary's long-term care needs at home, and therefore can improve the quality of care and assistance provided to the beneficiary. VA currently provides day health care to eligible beneficiaries as an element of respite care, and we would amend the definition of respite care to clarify that it is an included service.
Home care is defined at § 17.900 as medical care, habilitative and rehabilitative care, preventive health services, and health-related services furnished to a child in the child's home or other place of residence. The regulation also defines habilitative and rehabilitative care and preventive health care but does not define “health-related services.” We propose to define “health-
We would define homemaker services to mean certain activities that help to maintain a safe, healthy environment for an individual in the home or other place of residence. Such services contribute to the prevention, delay, or reduction of risk of harm or hospital, nursing home, or other institutional care. Homemaker services would include assistance with personal care; home management; completion of simple household tasks; nutrition, including menu planning and meal preparation; consumer education; and hygiene education. Homemaker services may include assistance with IADLs, such as: Light housekeeping; laundering; meal preparation; necessary services to maintain a safe and sanitary environment in the areas of the home used by the individual; and services essential to the comfort and cleanliness of the individual and ensuring individual safety. We would require that homemaker services must be provided according to the individual's written plan of care and must be prescribed by an approved health care provider.
Home health aide services would mean personal care and related support services to an individual in the home or other place of residence. Home health aide services may include assistance with ADLs such as: Bathing; toileting; eating; dressing; aid in ambulating or transfers; active and passive exercises; assistance with medical equipment; and routine health monitoring. We would also provide that home health aide services must be provided according to the individual's written plan of care and must be prescribed by an approved health care provider.
Homemaker and home health aide services that are provided outside the beneficiary's residence, such as services related to grocery shopping, would not be covered, because the definition of home care is limited to those services provided in the child's home or other place of residence. Activities that have no therapeutic value or are not medical in nature also would not be covered. These activities include assisting an individual with personal correspondence or paying bills. For this reason, we define “health-related services” to include only those ADLs and IADLs with therapeutic value.
As with all services under section 1803, however, only those health-related services that are medical in nature and provided by an approved health care provider are covered by VA. Health-related services generally are delivered by different types of providers including personal attendants, custodial care providers, or companion services providers, and there may be instances in which these service providers are not “approved health care providers” as that term is defined by statute and regulation. As discussed in further detail below, we propose to require preauthorization for homemaker services, which is a subset of health-related services, and would be a newly defined service provided under existing statutory authority. VA already has an established review and payment process in place for home health aide services. Preauthorization for certain health care services is covered in § 17.902 and is discussed below. We believe that these requirements appropriately balance the needs of the beneficiaries served through this program and the statutory and regulatory requirements that any services provided through the program must be medical in nature and provided by an approved health care provider.
As noted above, home care is furnished to a child in the child's home or other place of residence. The term “other place of residence” is not further defined. In general, we believe this term applies to those instances in which the child may need a level of assistance that is not available in the home, but a higher level of care such as admission to a nursing home is not needed. We propose to define “other place of residence” to include assisted living facilities or residential group homes, both of which provide an intermediate level of assistance. We note that, while VA would provide home care services in an assisted living facility or residential group home, VA is not authorized to pay for a child to stay in either an assisted living facility or residential group home. The types of alternatives to home care that VA may provide under section 1803 are nursing home care, hospital care, and respite care.
We would also add a definition of “long-term care” to clarify the types of long-term care VA is authorized to provide under these programs. The term “long-term care” is not currently defined, and VA is frequently asked what types of long-term care VA is authorized to provide. Generally, “long-term care” encompasses a variety of services that include medical and non-medical care to people who have a chronic illness or disability. However, VA is authorized to provide only those types of long-term care that constitute “health care” as defined in 38 U.S.C. 1803(c)(1)(A). The three categories of health care VA has determined would be considered long-term care are home care, nursing home care, and respite care. We propose to define the term “long-term care” consistent with that determination. We would also amend the definition of “health care” to include long-term care.
In addition to the definitional clarifications proposed above, we propose to amend § 17.902, which sets forth the list of services and benefits for which preauthorization by VA is required. Preauthorization allows VA to ensure that health care services are provided by approved health care providers, prescribed and medically necessary, and provided at a reasonable cost. Requiring prior approval also limits the likelihood that beneficiaries will incur liability for non-reimbursable expenses. In selecting those services that require preauthorization, we focused on those services where there is likely to be a high cost and some question regarding whether a particular health care service meets the requirements of §§ 17.900 and 17.901.
Preauthorization is currently required for all mental health services. We would amend § 17.902(a) to provide that preauthorization is required only for outpatient mental health services in excess of 23 visits in a calendar year. We believe this change would assist beneficiaries by providing them with greater flexibility in obtaining needed mental health services. The proposed change would also align the preauthorization requirements for these programs with CHAMPVA, which does not require preauthorization for inpatient mental health services and requires preauthorization for outpatient mental health services only after the 23rd visit in a calendar year. CHAMPVA likewise covers non-veteran beneficiaries, and following the CHAMPVA standard here would ensure consistency. In addition, this proposed change would decrease the administrative burden for beneficiaries and would ensure that there is no delay in initiating necessary outpatient mental health services.
We also propose to add homemaker services to the list of services that require preauthorization. Both homemaker services and home health aide services are defined as health-related services. We would not require preauthorization for home health aide services, because VA has an existing
As we noted above, day health care is an element of both outpatient care and respite care. VA already provides day health care to eligible beneficiaries as part of respite care, but it would now also be included as an element of outpatient care. Respite care, as a distinct class of services, does not require preauthorization. However, we would require preauthorization for day health care as part of outpatient care only to ensure that the day health care being claimed is a therapeutic program prescribed by an approved health care provider that provides necessary medical services, rehabilitation, therapeutic activities, socialization, and nutrition, and that the service is obtained at a reasonable cost. Preauthorization would still be required for dental services; substance abuse treatment; training; transplantation services; and travel (other than mileage at the General Services Administration rate for privately owned automobiles).
Current § 17.902(a) states that authorization will only be given in spina bifida cases where there is a demonstrated medical need. “Medically necessary” is a more easily understood and more commonly used term than is “demonstrated medical need” and we propose to amend this paragraph to reflect the more commonly used term.
Payment for health care services is addressed in § 17.903(a)(1). The current rule states that payment for health care services will be determined using the same payment methodologies as provided for under CHAMPVA regulations. VA recognizes that services covered by CHAMPVA change periodically, and there may be instances in which CHAMPVA does not have a payment methodology for all health care services available under §§ 17.900 through 17.905. For instance, homemaker services are excluded from CHAMPVA coverage at 38 CFR 17.272(a)(55) but may be covered as health-related services under § 17.900. To address this, we propose to amend this paragraph to state that payment for services or benefits covered by §§ 17.900 through 17.905 but not covered by CHAMPVA regulations will be determined using the same or similar payment methodologies applied by VA for the equivalent services or benefits provided to veterans. This may include negotiating a rate with the provider or using a national average or the Medicare rate.
We would make a technical edit to the definition of “approved health care provider” found in § 17.900. The current definition of “approved health care provider” includes health care providers currently approved by the Joint Commission on Accreditation of Health Care Organizations (JCAHO). In 2007, JCAHO changed its name to The Joint Commission and we would amend this definition to reflect that change.
Finally, we address the Office of Management and Budget (OMB) control number referenced in §§ 17.902 through 17.904. OMB had approved information collection for purposes of the Paperwork Reduction Act under OMB control number 2900-0578 for provision of health care, preauthorization, payment, review, and appeals. In 2010, OMB determined that information collection for the Spina Bifida Health Care Benefits program should be combined with a parallel information collection approved for CHAMPVA. This combined information collection was approved under OMB control number 2900-0219. We would make a technical edit to reflect the correct OMB control number.
The Code of Federal Regulations, as proposed to be revised by this proposed rulemaking, would represent the exclusive legal authority on this subject. No contrary rules or procedures would be authorized. All VA guidance would be read to conform with this proposed rulemaking if possible or, if not possible, such guidance would be superseded by this rulemaking.
This proposed rule includes provisions constituting a modification to a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) that requires approval by OMB. Accordingly, under 44 U.S.C. 3507(d), VA has submitted a copy of this rulemaking to OMB for review.
OMB assigns control numbers to collections of information it approves. VA may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Proposed § 17.902 contains a collection of information under the Paperwork Reduction Act of 1995. If OMB does not approve the modification as requested, VA will immediately remove the provisions containing a collection of information or take such other action as is directed by OMB.
Comments on the modification to the collection[s] of information contained in this proposed rule should be submitted to the Office of Management and Budget, Attention: Desk Officer for the Department of Veterans Affairs, Office of Information and Regulatory Affairs, Washington, DC 20503, with copies sent by mail or hand delivery to the Director, Regulation Policy and Management (02REG), Department of Veterans Affairs, 810 Vermont Avenue NW., Room 1068, Washington, DC 20420; fax to (202) 273-9026; or through
OMB is required to make a decision concerning the modification to the collection of information contained in this proposed rule between 30 and 60 days after publication of this document in the
VA considers comments by the public on proposed collections of information in—
• Evaluating whether the proposed collections of information are necessary for the proper performance of the functions of VA, including whether the information will have practical utility;
• Evaluating the accuracy of VA's estimate of the burden of the proposed collections of information, including the validity of the methodology and assumptions used;
• Enhancing the quality, usefulness, and clarity of the information to be collected; and
• Minimizing the burden of the collections of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
The modifications to the collection of information contained in 38 CFR 17.902 are described immediately following this paragraph, under their respective titles.
The Secretary hereby certifies that this proposed rule would not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This proposed rule would directly affect only individuals and would not directly affect small entities. Therefore, pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 12866 (Regulatory Planning and Review) defines a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB), unless OMB waives such review, as “any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order.”
The economic, interagency, budgetary, legal, and policy implications of this regulatory action have been examined, and it has been determined not to be a significant regulatory action under Executive Order 12866. VA's impact analysis can be found as a supporting document at
The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any 1 year. This proposed rule would have no such effect on State, local, and tribal governments, or on the private sector.
There are no Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document.
The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Jose D. Riojas, Chief of Staff, Department of Veterans Affairs, approved this document on April 2, 2015, for publication.
Administrative practice and procedure, Alcohol abuse, Alcoholism, Claims, Day care, Dental health, Drug abuse, Government contracts, Grant programs—health, Grant programs—veterans, Health care, Health facilities, Health professions, Health records, Homeless, Medical and dental schools, Medical devices, Medical research, Mental health programs, Nursing homes, Reporting and recordkeeping requirements, Travel and transportation expenses, Veterans.
For the reasons stated in the preamble, Department of Veterans Affairs proposes to amend 38 CFR part 17 as follows:
38 U.S.C. 501, and as noted in specific sections.
The additions and revision read as follows:
The revisions read as follows:
(a) Preauthorization from VA is required for the following services or benefits under §§ 17.900 through 17.905: Rental or purchase of durable medical equipment with a total rental or purchase price in excess of $300, respectively, day health care provided as outpatient care; dental services; homemaker services; outpatient mental health services in excess of 23 visits in a calendar year; substance abuse treatment; training; transplantation services; and travel (other than mileage at the General Services Administration rate for privately owned automobiles). Authorization will only be given in spina bifida cases where it is demonstrated that the care is medically necessary. In cases of other covered birth defects, authorization will only be given where it is demonstrated that the care is medically necessary and related to the covered birth defects. * * *
The addition reads as follows:
(a)(1) * * * For those services or benefits covered by §§ 17.900 through 17.905 but not covered by CHAMPVA we will use payment methodologies the same or similar to those used for equivalent services or benefits provided to veterans.
Environmental Protection Agency.
Proposed rule; notice of intent.
The U.S. Environmental Protection Agency (EPA) Region 5 is issuing a Notice of Intent to Delete the Burrows Sanitation Superfund Site located in Hartford Township, Van Buren County, Michigan from the National Priorities List (NPL) and requests public comments on this proposed action. The NPL, promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). EPA and the State of Michigan, through the Michigan Department of Environment Quality (MDEQ), have determined that all appropriate response actions under CERCLA have been completed. However, this deletion does not preclude future actions under Superfund.
Comments must be received by June 15, 2015.
Submit your comments, identified by Docket ID No. EPA-HQ-SFUND-1986-0005, by one of the following methods:
•
• Email: Jeffrey Gore, Remedial Project Manager, at
• Fax: Gladys Beard, NPL Deletion Process Manager, at (312) 697-2077.
• Mail: Jeffrey Gore, Remedial Project Manager, U.S. Environmental Protection Agency (SR-6J), 77 West Jackson Boulevard, Chicago, IL 60604, (312) 886-6552, or Cheryl Allen, Community Involvement Coordinator, U.S. Environmental Protection Agency (SI-7J), 77 West Jackson Boulevard, Chicago, IL 60604, (312) 353-6196 or (800) 621-8431.
• Hand delivery: Cheryl Allen, Community Involvement Coordinator, U.S. Environmental Protection Agency (SI-7J), 77 West Jackson Boulevard, Chicago, IL 60604. Such deliveries are only accepted during the docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information. The normal business hours are Monday through Friday, 8:30 a.m. to 4:30 p.m. CST, excluding federal holidays.
• U.S. Environmental Protection Agency—Region 5, 77 West Jackson Boulevard, Chicago, IL 60604, Phone: (312) 353-1063, Hours: Monday through Friday, 8:30 a.m. to 4:30 p.m. CST, excluding federal holidays.
• Harford Public Library, 15 Franklin Street, Hartford, MI 49057, Phone: (269) 621-3408, Hours: Monday through Wednesday, 10:00 a.m. to 7:00 p.m., Thursday and Friday 10:00 a.m. to 5:00 p.m., Saturday 10:00 a.m. to 5:00 p.m.
Jeffrey Gore, Remedial Project Manager, U.S. Environmental Protection Agency (SR-6J), 77 West Jackson Boulevard, Chicago, IL 60604, (312) 886-6552, or
In the “Rules and Regulations” section of today's
For additional information, see the direct final Notice of Deletion which is located in the “Rules and Regulations” section of this
Environmental protection, Air pollution control, Chemicals, Hazardous substances, Hazardous waste, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements, Superfund, Water pollution control, and Water supply.
33 U.S.C. 1321(d); 42 U.S.C. 9601-9657; E.O. 13626, 77 FR 56749, 3CFR, 2013 Comp., p. 306; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR, 1987 Comp., p. 193.
Food and Nutrition Service, USDA.
Notice.
In accordance with the Paperwork Reduction Act (PRA) of 1995, this Notice invites the general public and other public agencies to comment on proposed information collections. This collection is a revision of currently approved burden for the applications, periodic reporting, and notices burden calculations for the Supplemental Nutrition Assistance Program (SNAP). The revision also modifies the net estimates for PRA burden associated with proposed rule “Supplemental Nutrition Assistance Program (SNAP): Eligibility, Certification, and Employment and Training Provisions” published on May 4, 2011 at 76 FR 25413.
Written comments must be submitted on or before July 14, 2015 to be assured consideration.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate, automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Send comments to Sasha Gersten-Paal, Chief, Certification Policy Branch, Program Development Division, Food and Nutrition Service, U.S. Department of Agriculture, 3101 Park Center Drive, Room 812, Alexandria, VA 22302. Comments may also be submitted via fax to the attention of Sasha Gersten-Paal at 703-305-2486. Comments will also be accepted through the Federal eRulemaking Portal. Go to
All written comments will be open for public inspection during regular business hours (8:30 a.m. to 5 p.m., Monday through Friday) at the office of the Food and Nutrition Service, U.S. Department of Agriculture, 3101 Park Center Drive, Alexandria, Virginia 22302, Room 800.
All comments will be summarized and included in the request for Office of Management and Budget approval of the information collection. All comments will become a matter of public record.
Requests for additional information should be directed to Sasha Gersten-Paal at 703-305-2507.
After careful review and consideration of the burden inventory under OMB No. 0584-0064, FNS has determined the burden baseline does not accurately reflect the burden activities or hours required by the SNAP under this collection. We have corrected the burden inventory baseline to establish burden estimates under OMB No. 0584-0064 that more accurately reflect the information collection burdens of SNAP's existing application and recertification process. An overview is provided in this notice and additional details are available in the docket at [Placeholder].
Section 3502.2 of the PRA defines burden as “time, effort, or financial resources expended by a person to generate, maintain, or provide information to or for a Federal agency.”
In keeping with the PRA definition of burden, we created sub-activity categories that allowed for the inclusion of time and effort expended on behalf of households and State agencies and revised the time estimates. Note that no changes have been made to the existing reporting and recordkeeping requirements. The change in burden is due to formulating more accurate burden estimates associated with the existing requirements.
The following tables compare the time estimates for activities contained in the currently approved information collection with the revised burden baseline activities.
Additionally, the burden estimates included in this collection account for the burden applicable to each SNAP applicant. The estimated number of applicants has increased from the prior estimate of approximately 11 million applicants to over 14.5 million applicants in Fiscal Year 2014.
The net impact to the burden is summarized below.
Rural Business-Cooperative Service, USDA.
Notice, Correction.
The Rural Business-Cooperative Service published a Notice in the
Grants Division, Cooperative Programs, Rural Business-Cooperative Service, U.S. Department of Agriculture, 1400 Independence Avenue SW., MS 3253, Room 4008—South, Washington, DC 20250-3253, or call 202-690-1374.
In the Notice [FR Doc 2015-10040], published May 8, 2015 (80 FR 26528), column 2, under
In the Notice, [FR Doc 2015-10040] published May 8, 2015 (80 FR 26530), column 3, under “4. Submission Dates and Times.” The first sentence under “Explanation of Deadlines” should read “Paper applications must be postmarked and mailed, shipped, or sent overnight by July 7, 2015.”
In the Notice, [FR Doc 2015-10040] published May 8, 2015 (80 FR 26534), column 1, under “G. Agency Contacts,” The fourth sentence should read “You may also contact National Office staff: Tracey Kennedy, VAPG Program Lead,
Rural Housing Service, USDA.
Notice.
The Rural Housing Service (RHS), an agency within the USDA Rural Development mission area herein referred to as the Agency announces the acceptance of applications under the Rural Community Development Initiative (RCDI) program. Applicants must provide matching funds in an amount at least equal to the Federal grant. These grants will be made to qualified intermediary organizations that will provide financial and technical assistance to recipients to develop their capacity and ability to undertake projects related to housing, community facilities, or community and economic development that will support the community.
This Notice lists the information needed to submit an application for these funds. This Notice contains revised evaluation criteria that are streamlined, in order to enhance program efficiency and delivery.
The deadline for receipt of an application is 4 p.m. local time, August 13, 2015. The application date and time are firm. The Agency will not consider any application received after the deadline. Applicants intending to mail applications must provide sufficient time to permit delivery on or before the closing deadline date and time. Acceptance by the United States Postal Service or private mailer does not constitute delivery. Facsimile (FAX) and postage due applications will not be accepted.
Entities wishing to apply for assistance may download the application documents and requirements delineated in this Notice from the RCDI Web site:
Application information for electronic submissions may be found at
Applicants may also request paper application packages from the Rural Development office in their state. A list of Rural Development State offices can be found via
The Rural Development office for the state in which the applicant is located. A list of Rural Development State Office contacts is provided at the following link:
The paperwork burden has been cleared by the Office of Management and Budget (OMB) under OMB Control Number 0575-0180.
Congress first authorized the RCDI in 1999 (Pub. L. 106-78, which was amended most recently by The Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235)). The RCDI was authorized to develop the capacity and ability of qualified private, nonprofit community-based housing and community development organizations, low-income rural communities, and federally recognized Native American Tribes to undertake projects related to housing, community facilities, or community and economic development in rural areas. Strengthening the recipient's capacity in these areas will benefit the communities they serve. The RCDI structure requires the intermediary (grantee) to provide a program of financial and technical assistance to recipients. The recipients will, in turn, provide programs to their communities (beneficiaries).
Of particular note this year, the Agency is encouraging applications for projects based in or servicing high poverty areas. This emphasis will support Rural Development's (RD) mission of improving the quality of life for rural Americans and commitment to directing resources to those who most need them.
Congress, in The Continuing and Further Continuing Appropriations Act, 2015 (Pub.L. 113-235), appropriated $4,000,000 in FY 2015 for the RCDI program. The amount of funding received in the FY 2015 Appropriations Act can also be found at the following link:
Qualified private, nonprofit and public (including tribal) intermediary organizations proposing to carry out financial and technical assistance programs will be eligible to receive the grant funding.
The intermediary will be required to provide matching funds in an amount at least equal to the RCDI grant.
A grant will be the type of assistance instrument awarded to successful applications.
The respective minimum and maximum grant amount per intermediary is $50,000 and $250,000.
Grant funds must be utilized within 3 years from date of the award.
A grantee that has an outstanding RCDI grant over 3 years old, as of the application due date in this Notice, is not eligible to apply for this round of funding.
The intermediary must provide a program of financial and technical assistance to one or more of the following: A private, nonprofit community-based housing and development organization, a low-income rural community or a federally recognized tribe.
Applicants must meet all of the following eligibility requirements by the application deadline. Applications which fail to meet any of these requirements by the application deadline will be deemed ineligible and will not be evaluated further, and will not receive a Federal award.
(a) Qualified private, nonprofit, (including faith-based and community organizations and philanthropic foundations), in accordance with 7 CFR part 16, and public (including tribal) intermediary organizations are eligible applicants. Definitions that describe eligible organizations and other key terms are listed below.
(b) The recipient must be a nonprofit community-based housing and development organization, low-income rural community, or federally recognized tribe based on the RCDI definitions of these groups.
(c) Private nonprofit, faith or community-based organizations must provide a certificate of incorporation and good standing from the Secretary of the State of incorporation, or other similar and valid documentation of nonprofit status. For low-income rural community recipients, the Agency requires evidence that the entity is a public body and census data verifying that the median household income of the community where the office receiving the financial and technical assistance is located is at, or below, 80 percent of the State or national median household income, whichever is higher. For federally recognized tribes, the Agency needs the page listing their name from the current
(d) Any corporation (1) that has been convicted of a felony criminal violation under any Federal law within the past 24 months or (2) that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability; is not eligible for financial assistance provided with funds appropriated by the Consolidated and Further Continuing Appropriations Act, 2015, unless a Federal agency has considered suspension or debarment of the corporation and has made a determination that this further action is not necessary to protect the interests of the Government.
There is a matching requirement of at least equal to the amount of the grant. If this matching funds requirement is not met, the application will be deemed ineligible. See section D, Application and Submission Information, for required pre-award and post award matching funds documentation submission.
The intermediary must provide matching funds at least equal to the amount of the grant. Verification of matching funds must be submitted with the application. Matching funds must be committed for a period equal to the grant performance period. The intermediary will be required to provide matching funds in an amount at least equal to the RCDI grant. In-kind contributions such as salaries, donated time and effort, real and nonexpendable personal property and goods and services cannot be used as matching funds.
Matching funds are cash or confirmed funding commitments and must be at least equal to the grant amount and committed for a period of not less than the grant performance period. These funds can only be used for eligible RCDI activities. Matching funds must be used to support the overall purpose of the RCDI program.
In-kind contributions such as salaries, donated time and effort, real and nonexpendable personal property and goods and services cannot be used as matching funds.
Grant funds and matching funds must be used in equal proportions. This does not mean funds have to be used equally by line item.
The request for advance or reimbursement and supporting documentation must show that RCDI fund usage does not exceed the cumulative amount of matching funds used.
Grant funds will be disbursed pursuant to relevant provisions of 2 CFR parts 200 and 400. Verification of matching funds must be submitted with the application. See Section D, other program requirements, for matching funds documentation and pre-award requirements.
The intermediary is responsible for demonstrating that matching funds are available, and committed for a period of not less than the grant performance period to the RCDI proposal. Matching funds may be provided by the intermediary or a third party. Other Federal funds may be used as matching funds if authorized by statute and the purpose of the funds is an eligible RCDI purpose.
RCDI funds will be disbursed on an advance or reimbursement basis. Matching funds cannot be expended prior to execution of the RCDI Grant Agreement.
(a) The recipient and beneficiary, but not the intermediary, must be located in an eligible rural area. The physical location of the recipient's office that will be receiving the financial and technical assistance must be in an eligible rural area. If the recipient is a low-income community, the median household income of the area where the office is located must be at or below 80 percent of the State or national median household income, whichever is higher. The applicable Rural Development State Office can assist in determining the eligibility of an area.
A listing of Rural Development State Office contacts can be found at the following link:
(b) RCDI grantees that have an outstanding grant over 3 years old, as of the application due date in this Notice, will not be eligible to apply for this round of funding. Grant and matching funds must be utilized in a timely manner to ensure that the goals and objectives of the program are met.
(c) Individuals cannot be recipients.
(d) The intermediary must provide a program of financial and technical assistance to the recipient.
(e) The intermediary organization must have been legally organized for a minimum of 3 years and have at least 3 years prior experience working with private nonprofit community-based housing and development organizations, low-income rural communities, or tribal organizations in the areas of housing, community facilities, or community and economic development.
(f) Proposals must be structured to utilize the grant funds within 3 years from the date of the award.
(g) Each applicant, whether singularly or jointly, may only submit one application for RCDI funds under this Notice. This restriction does not preclude the applicant from providing matching funds for other applications.
(h) Recipients can benefit from more than one RCDI application; however, after grant selections are made, the recipient can only benefit from multiple RCDI grants if the type of financial and technical assistance the recipient will receive is not duplicative. The services described in multiple RCDI grant applications must have separate and identifiable accounts for compliance purposes.
(i) The intermediary and the recipient cannot be the same entity. The recipient can be a related entity to the intermediary, if it meets the definition of a recipient, provided the relationship does not create a Conflict of Interest that cannot be resolved to Rural Development's satisfaction.
(j) If the recipient is a low-income rural community, identify the unit of government to which the financial and technical assistance will be provided,
Fund uses must be consistent with the RCDI purpose. A nonexclusive list of eligible grant uses includes the following:
(a) Provide technical assistance to develop recipients' capacity and ability to undertake projects related to housing, community facilities, or community and economic development,
(b) Develop the capacity of recipients to conduct community development programs,
(c) Develop the capacity of recipients to conduct development initiatives,
(d) Develop the capacity of recipients to increase their leveraging ability and access to alternative funding sources by providing training and staffing.
(e) Develop the capacity of recipients to provide the technical assistance component for essential community facilities projects.
(f) Assist recipients in completing pre-development requirements for housing, community facilities, or community and economic development projects by providing resources for professional services,
(g) Improve recipient's organizational capacity by providing training and resource material on developing strategic plans, board operations, management, financial systems, and information technology.
(h) Purchase of computers, software, and printers, limited to $10,000 per award, at the recipient level when directly related to the technical assistance program being undertaken by the intermediary.
(i) Provide funds to recipients for training-related travel costs and training expenses related to RCDI.
The following is a list of ineligible grant uses:
(a) Pass-through grants, and any funds provided to the recipient in a lump sum that are not reimbursements.
(b) Funding a revolving loan fund (RLF).
(c) Construction (in any form).
(d) Salaries for positions involved in construction, renovations, rehabilitation, and any oversight of these types of activities.
(e) Intermediary preparation of strategic plans for recipients.
(f) Funding prostitution, gambling, or any illegal activities.
(g) Grants to individuals.
(h) Funding a grant where there may be a conflict of interest, or an appearance of a conflict of interest, involving any action by the Agency.
(i) Paying obligations incurred before the beginning date without prior Agency approval or after the ending date of the grant agreement.
(j) Purchasing real estate.
(k) Improvement or renovation of the grantee's, or recipient's office space or for the repair or maintenance of privately owned vehicles.
(l) Any purpose prohibited in 2 CFR part 200 or 400.
(m) Using funds for recipient's general operating costs.
(n) Using grant or matching funds for Individual Development Accounts.
(o) Purchasing vehicles.
The following are examples of eligible and ineligible purposes under the RCDI program. (These examples are illustrative and are not meant to limit the activities proposed in the application. Activities that meet the objectives of the RCDI program and meet the criteria outlined in this Notice will be considered eligible.)
(a) The intermediary must work directly with the recipient, not the ultimate beneficiaries. As an example:
The intermediary provides training to the recipient on how to conduct homeownership education classes. The recipient then provides ongoing homeownership education to the residents of the community—the ultimate beneficiaries. This “train the trainer” concept fully meets the intent of this initiative. The intermediary is providing technical assistance that will build the recipient's capacity by enabling them to conduct homeownership education classes for the public.
This is an eligible purpose. However, if the intermediary directly provided homeownership education classes to individuals in the recipient's service area, this would not be an eligible purpose because the recipient would be bypassed.
(b) If the intermediary is working with a low-income community as the recipient, the intermediary must provide the technical assistance to the entity that represents the low-income community and is identified in the application. Examples of entities representing a low-income community are a village board or a town council.
If the intermediary provides technical assistance to the Board of the low-income community on how to establish a cooperative, this would be an eligible purpose. However, if the intermediary works directly with individuals from the community to establish the cooperative, this is not an eligible purpose.
The recipient's capacity is built by learning skills that will enable them to support sustainable economic development in their communities on an ongoing basis.
(c) The intermediary may provide technical assistance to the recipient on how to create and operate a revolving loan fund. The intermediary may not
(d) The intermediary may work with recipients in building their capacity to provide planning and leadership development training. The recipients of this training would be expected to assume leadership roles in the development and execution of regional strategic plans. The intermediary would work with multiple recipients in helping communities recognize their connections to the greater regional and national economies.
(e) The intermediary could provide training and technical assistance to the recipients on developing emergency shelter and feeding, short-term housing, search and rescue, and environmental accident, prevention, and cleanup program plans. For longer term disaster and economic crisis responses, the intermediary could work with the recipients to develop job placement and training programs, and develop coordinated transit systems for displaced workers.
Entities wishing to apply for assistance may download the application documents and requirements delineated in this Notice from the RCDI Web site:
Application information for electronic submissions may be found at
Applicants may also request paper application packages from the Rural Development office in their state. A list of Rural Development State office contacts can be found via
If the applicant is ineligible or the application is incomplete, the Agency will inform the applicant in writing of the decision, reasons therefore, and its appeal rights and no further evaluation of the application will occur.
A complete application for RCDI funds must include the following:
(a) A summary page, double-spaced between items, listing the following: (This information should not be presented in narrative form.)
(1) Applicant's name,
(2) Applicant's address,
(3) Applicant's telephone number,
(4) Name of applicant's contact person and telephone number,
(5) Applicant's fax number,
(6) County where applicant is located,
(7) Congressional district number where applicant is located,
(8) Amount of grant request, and
(9) Number of recipients.
(b) A detailed Table of Contents containing page numbers for each component of the application.
(c) A project overview, no longer than five pages, including the following items, which will also be addressed separately and in detail under “Building Capacity and Expertise” of the “Evaluation Criteria.”
(1) The type of technical assistance to be provided to the recipients and how it will be implemented.
(2) How the capacity and ability of the recipients will be improved.
(3) The overall goals to be accomplished.
(4) The benchmarks to be used to measure the success of the program. Benchmarks should be specific and quantifiable.
(d) Organizational documents, such as a certificate of incorporation and a current good standing certification from the Secretary of State where the applicant is incorporated and other similar and valid documentation of non-profit status, from the intermediary that confirms it has been legally organized for a minimum of 3 years as the applicant entity.
(e) Verification of source and amount of matching funds,
The verification must show that matching funds are available for the duration of the grant performance period. The verification of matching funds must be submitted with the application or the application will be considered incomplete.
The applicant will be contacted by the Agency prior to grant award to verify that the matching funds provided with the application continue to be available. The applicant will have 15 days from the date contacted to submit verification that matching funds continue to be available.
If the applicant is unable to provide the verification within that timeframe, the application will be considered ineligible. The applicant must maintain bank statements on file or other documentation for a period of at least 3 years after grant closing except that the records shall be retained beyond the 3-year period if audit findings have not been resolved.
(f) The following information for each recipient:
(1) Recipient's entity name,
(2) Complete address (mailing and physical location, if different),
(3) County where located,
(4) Number of Congressional district where recipient is located,
(5) Contact person's name and telephone number, and
(6) Form RD 400-4, “Assurance Agreement.” If the Form RD 400-4 is not submitted for a recipient, the recipient will be considered ineligible. No information pertaining to that recipient will be included in the income or population scoring criteria and the requested funding may be adjusted due to the deletion of the recipient.
(g) Submit evidence that each recipient entity is eligible. Documentation must be submitted to verify recipient eligibility. Acceptable documentation varies depending on the type of recipient:
(1) Nonprofits—provide a current valid letter confirming non-profit status from the Secretary of the State of incorporation or the IRS, a current good standing certification from the Secretary of the State of incorporation, or other valid documentation of nonprofit status of each recipient. A nonprofit recipient must provide evidence that it is a valid nonprofit when the intermediary applies for the RCDI grant. Organizations with pending requests for nonprofit designations are not eligible.
(2) Low-income rural community—provide evidence the entity is a public body, and a copy of the 2010 census data to verify the population, and evidence that the median household income is at, or below, 80 percent of either the State or national median household income. We will only accept data and printouts from
(3) Federally recognized tribes—provide the page listing their name from the
(h) Each of the “Evaluation Criteria” must be addressed specifically and individually by category. Present these criteria in narrative form. Documentation must be limited to three pages per criterion. The “Population and Income” criteria for recipient locations can be provided in the form of a list; however, the source of the data must be included on the page(s).
(i) A timeline identifying specific activities and proposed dates for completion.
(j) A detailed project budget that includes the RCDI grant amount and matching funds. This should be a line-item budget, by category. Categories such as salaries, administrative, other, and indirect costs that pertain to the proposed project must be clearly defined. Supporting documentation listing the components of these categories must be included. The budget should be dated: year 1, year 2, year 3, as applicable.
(k) The indirect cost category in the project budget should be used only when a grant applicant has a federally negotiated indirect cost rate. A copy of the current rate agreement must be provided with the application. Non-federal entities that have never received a negotiated indirect cost rate may use the de minimis rate of 10% of modified total direct costs (MTDC).
(l) Form SF-424, “Application for Federal Assistance.” (Do not complete Form SF-424A, “Budget Information.” A separate line-item budget should be presented as described in No. 13 of this section.)
(m) Form SF-424B, “Assurances—Non-Construction Programs.”
(n) Form AD-1047, “Certification Regarding Debarment, Suspension, and Other Responsibility Matters—Primary Covered Transactions.”
(o) Form AD-1048, “Certification Regarding Debarment, Suspension, Ineligibility and Voluntary Exclusion—Lower Tier Covered Transactions.”
(p) Form AD-1049, “Certification Regarding Drug-Free Workplace Requirements.”
(q) Certification of Non-Lobbying Activities.
(r) Standard Form LLL, “Disclosure of Lobbying Activities,” if applicable.
(s) Form RD 400-4, “Assurance Agreement,” for the applicant.
(t) Identify and report any association or relationship with Rural Development employees. (A statement acknowledging whether or not a relationship exists is required).
(u) Form AD-3030, “Representations Regarding Felony Conviction and Tax Delinquent Status for Corporate Applicants,” if you are a corporation. A corporation is any entity that has filed articles of incorporation in one of the 50 States, the District of Columbia, the Federated States of Micronesia, the Republic of Palau, and the Republic of the Marshall Islands, or the various territories of the United States including American Samoa, Guam, Midway Islands, Northern Mariana Islands, Puerto Rico, or the U.S. Virgin Islands. Corporations include both for profit and non-profit entities.
Grant applicants must obtain a Dun and Bradstreet Data Universal Numbering System (DUNS) number and register in the System for Award Management (SAM) prior to submitting a pre-application pursuant to 2 CFR 25.200(b). In addition, an entity applicant must maintain registration in SAM at all times during which it has an active Federal award or an application or plan under construction by the Agency. Similarly, all recipients of Federal financial assistance are required to report information about first-tier subawards and executive compensation in accordance to 2 CFR part 170. So long as an entity applicant does not have an exception under 2 CFR 170.110(b), the applicant must have the necessary processes and systems in place to comply with the reporting requirements should the applicant receive funding. See 2 CFR 170.200(b).
An applicant, unless excepted under 2 CFR 25.110(b), (c), or (d), is required to:
(a) Be registered in SAM before submitting its application;
(b) Provide a valid DUNS number in its application; and
(c) Continue to maintain an active SAM registration with current information at all times during which it has an active Federal award or an application or plan under consideration by a Federal awarding agency.
The Federal awarding agency may not make a federal award to an applicant until the applicant has complied with all applicable DUNS and SAM requirements and, if an applicant has not fully complied with the requirements by the time the Federal awarding agency is ready to make a Federal award, the Federal awarding agency may determine that the applicant is not qualified to receive a Federal award and use that determination as a basis for making a Federal award to another applicant.
As required by the Office of Management and Budget (OMB), all grant applications must provide a DUNS number when applying for Federal grants, on or after October 1, 2003. Organizations can receive a DUNS number at no cost by calling the dedicated toll-free number at 1-866-705-5711 or via Internet at
The DUNS number should be identified in the “Organizational DUNS” field on Standard Form (SF) 424, “Application for Federal Assistance.” Since there are no specific fields for a Commercial and Government Entity (CAGE) code and expiration date, they may be identified anywhere on the Form SF 424. If the applicant does not provide the CAGE code and expiration date and the DUNS number in the application, it will not be considered for funding. The required forms and certifications can be downloaded from the RCDI Web site at:
The deadline for receipt of an application is 4 p.m. local time, August 13, 2015. The application date and time are firm. The Agency will not consider any application received after the deadline. You may submit your application in paper form or electronically through Grants.gov. Applicants intending to mail applications must provide sufficient time to permit delivery on or before the closing deadline date and time. Acceptance by the United States Postal Service or private mailer does not constitute delivery. Facsimile (FAX) and postage due applications will not be accepted.
To submit a paper application, the original application package must be submitted to the Rural Development State Office where the applicant's headquarters is located. A listing of Rural Development State Offices can be found via
Applications will not be accepted via FAX or electronic mail.
Applicants may file an electronic application at
Technical difficulties submitting an application through Grants.gov will not be a reason to extend the application deadline. If an application is unable to be submitted through Grants.gov, a paper application must be received in
First time Grants.gov users should carefully read and follow the registration steps listed on the Web site. These steps need to be initiated early in the application process to avoid delays in submitting your application online.
In order to register with System for Award Management (SAM), your organization will need a DUNS number. Be sure to complete the Marketing Partner ID (MPID) and Electronic Business Primary Point of Contact fields during the SAM registration process.
These are mandatory fields that are required when submitting grant applications through Grants.gov. Additional application instructions for submitting an electronic application can be found by selecting this funding opportunity on Grants.gov.
Meeting expenses. In accordance with 31 U.S.C. 1345, “Expenses of Meetings,” appropriations may not be used for travel, transportation, and subsistence expenses for a meeting. RCDI grant funds cannot be used for these meeting-related expenses. Matching funds may, however, be used to pay for these expenses.
RCDI funds may be used to pay for a speaker as part of a program, equipment to facilitate the program, and the actual room that will house the meeting.
RCDI funds cannot be used for meetings; they can, however, be used for travel, transportation, or subsistence expenses for program-related training and technical assistance purposes. Any training not delineated in the application must be approved by the Agency to verify compliance with 31 U.S.C. 1345. Travel and per diem expenses (including meals and incidental expenses) will be allowed in accordance with 2 CFR parts 200 and 400.
Applications will be evaluated using the following criteria and weights:
The applicant must demonstrate how they will improve the recipients' capacity, through a program of financial and technical assistance, as it relates to the RCDI purposes.
Capacity-building financial and technical assistance should provide new functions to the recipients or expand existing functions that will enable the recipients to undertake projects in the areas of housing, community facilities, or community and economic development that will benefit the community. Capacity-building financial and technical assistance may include, but is not limited to: Training to conduct community development programs,
The program of financial and technical assistance that is to be provided, its delivery, and the measurability of the program's effectiveness will determine the merit of the application.
All applications will be competitively ranked with the applications providing the most improvement in capacity development and measurable activities being ranked the highest.
The narrative response must contain the following items. This list also contains the points for each item.
(1) Describe the nature of financial and technical assistance to be provided to the recipients and the activities that will be conducted to deliver the technical assistance; (10 Points)
(2) Explain how financial and technical assistance will develop or increase the recipient's capacity. Indicate whether a new function is being developed or if existing functions are being expanded or performed more effectively; (7 Points)
(3) Identify which RCDI purpose areas will be addressed with this assistance: Housing, community facilities, or community and economic development; (3 Points)
(4) Describe how the results of the technical assistance will be measured. What benchmarks will be used to measure effectiveness? Benchmarks should be specific and quantifiable; (5 Points)
(5) Demonstrate that it has conducted programs of financial and technical assistance and achieved measurable results in the areas of housing, community facilities, or community and economic development in rural areas. (10 Points)
(6) Provide the name, contact information, and the type and amount of the financial and technical assistance the applicant organization has provided to the following for the last 3 years: (5 Points)
(i) Nonprofit organizations in rural areas.
(ii) Low-income communities in rural areas (also include the type of entity,
(iii) Federally recognized tribes or any other culturally diverse organizations.
The applicant can receive up to 15 points for soundness of approach. The overall proposal will be considered under this criterion. Applicants must list the page numbers in the application that address these factors.
The maximum 15 points for this criterion will be based on the following:
(1) The proposal fits the objectives for which applications were invited, is clearly stated, and the applicant has defined how this proposal will be implemented. (7 Points)
(2) The ability to provide the proposed financial and technical assistance based on prior accomplishments. (6 Points)
(3) Cost effectiveness will be evaluated based on the budget in the application. The proposed grant amount and matching funds should be utilized to maximize capacity building at the recipient level. (2 Points)
Population is based on the average population from the 2010 census data for the communities in which the recipients are located. The physical address, not mailing address, for each recipient must be used for this criterion. Community is defined for scoring purposes as a city, town, village, county, parish, borough, or census-designated place where the recipient's office is physically located.
The applicant must submit the census data from the following Web site in the form of a printout of the applicable “Fact Sheet” to verify the population figures used for each recipient. The data can be accessed on the Internet at
The average population of the recipient locations will be used and will be scored as follows:
The average of the median household income for the communities where the recipients are physically located will determine the points awarded. The physical address, not mailing address, for each recipient must be used for this criterion. Applicants may compare the average recipient median household income to the State median household income or the national median household income, whichever yields the most points. The national median household income to be used is $51,914.
The applicant must submit the income data in the form of a printout of the applicable information from the following Web site to verify the income for each recipient.
The data being used is from the 2010 census. The data can be accessed on the Internet at
(1) This criterion will be addressed by the Agency, not the applicant.
(2) Up to 10 points may be awarded by the Rural Development State Director to any application(s) that benefits their state regardless of whether the applicant is headquartered in their state. The total points awarded under this criterion, to all applications, will not exceed 10.
(3) When an intermediary submits an application that will benefit a state that is not the same as the state in which the intermediary is headquartered, it is the intermediary's responsibility to notify the State Director of the state which is receiving the benefit of their application. In such cases, State Directors awarding points to applications benefiting their state must notify the reviewing state in writing.
(4) Assignment of any points under this criterion requires a written justification and must be tied to and awarded based on how closely the application aligns with the Rural Development State Office's strategic goals.
This criterion will be addressed by the Agency, not the applicant. The Agency Administrator may award up to 20 points to any application to the extent that the application supports Strategic Goal One in the USDA Strategic Plan 2014-2018. This plan can be found at the following link:
Points may be awarded to applications that meet at least one of the following six criteria below (note: the maximum points can be given to any one of the following six criteria):
(1) The project is based in a census tract with poverty greater than or equal to 20%;
(2) The project is based in a community (village, town, city, or Census Designated Place) that is 75% CF grant eligible (rural community having a population of 5,000 or less and median household income (MHI) of 60% or less of the state's non-metropolitan median household income (NMHI);
(3) The project's service area includes at least one census tract with poverty greater than or equal to 20%;
(4) The project's service area includes at least one community (village, town, city, or Census Designated Place) that is 75% CF grant eligible (rural community having a population of 5,000 or less and MHI of 60% or less of the state's NMHI);
(5) The project serves a Strikeforce area (see link below).
(6) The project serves a Promise Zone (see link below) and eligible applicant provides evidence of partnership with a Promise Zone Lead Applicant organization.
For a listing of StrikeForce areas and designated Promise Zones, click on the following link:
(a) Rating and ranking.
Applications will be rated and ranked on a national basis by a review panel based on the “Evaluation Criteria” contained in this Notice.
If there is a tied score after the applications have been rated and ranked, the tie will be resolved by reviewing the scores for “Building Capacity and Expertise” and the applicant with the highest score in that category will receive a higher ranking. If the scores for “Building Capacity and Expertise” are the same, the scores will be compared for the next criterion, in sequential order, until one highest score can be determined.
(b) Initial screening.
The Agency will screen each application to determine eligibility during the period immediately following the application deadline. Listed below are examples of reasons for rejection from previous funding rounds. The following reasons for rejection are not all inclusive; however, they represent the majority of the applications previously rejected.
(1) Recipients were not located in eligible rural areas based on the definition in this Notice.
(2) Applicants failed to provide evidence of recipient's status,
(3) Applicants failed to provide evidence of committed matching funds or matching funds were not committed for a period at least equal to the grant performance period.
(4) Application did not follow the RCDI structure with an intermediary and recipients.
(5) Recipients were not identified in the application.
(6) Intermediary did not provide evidence it had been incorporated for at least 3 years as the applicant entity.
(7) Applicants failed to address the “Evaluation Criteria.”
(8) The purpose of the proposal did not qualify as an eligible RCDI purpose.
(9) Inappropriate use of funds (
(10) The applicant proposed providing financial and technical assistance directly to individuals.
(11) The application package was not received by closing date and time.
Within the limit of funds available for such purpose, the awarding official of the Agency shall make grants in ranked order to eligible applicants under the procedures set forth in this Notice.
Successful applicants will receive a selection letter by mail containing
The award is not approved until all information has been verified, and the awarding official of the Agency has signed Form RD 1940-1, “Request for Obligation of Funds” and the grant agreement.
Unsuccessful applicants will receive notification including appeal rights by mail.
Grantees will be required to do the following:
(a) Execute a Rural Community Development Initiative Grant Agreement.
(b) Execute Form RD 1940-1, “Request for Obligation of Funds.”
(c) Use Form SF 270, “Request for Advance or Reimbursement,” to request reimbursements. Provide receipts for expenditures, timesheets and any other documentation to support the request for reimbursement.
(d) Provide financial status and project performance reports on a quarterly basis starting with the first full quarter after the grant award.
(e) Maintain a financial management system that is acceptable to the Agency.
(f) Ensure that records are maintained to document all activities and expenditures utilizing RCDI grant funds and matching funds. Receipts for expenditures will be included in this documentation.
(g) Provide annual audits or management reports on Form RD 442-2, “Statement of Budget, Income and Equity,” and Form RD 442-3, “Balance Sheet,” depending on the amount of Federal funds expended and the outstanding balance.
(h) Collect and maintain data provided by recipients on race, sex, and national origin and ensure recipients collect and maintain the same data on beneficiaries. Race and ethnicity data will be collected in accordance with OMB
(i) Provide a final project performance report.
(j) Identify and report any association or relationship with Rural Development employees.
(k) The intermediary and recipient must comply with Title VI of the Civil Rights Act of 1964, Title IX of the Education Amendments of 1972, Section 504 of the Rehabilitation Act of 1973, Executive Order 12250, and 7 CFR part 1901, subpart E.
(l) The grantee must comply with policies, guidance, and requirements as described in the following applicable Code of Federal Regulations, and any successor regulations:
(i) 2 CFR parts 200 and 400 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements For Federal Awards).
(ii) 2 CFR parts 417 and 180 (Government-wide Debarment and Suspension (Nonprocurement)
(m) Form AD-3031, “Assurance Regarding Felony Conviction or Tax Delinquent Status for Corporate Applicants,” Must be signed by corporate applicants who receive an award under this Notice.
After grant approval and through grant completion, you will be required to provide the following, as indicated in the Grant Agreement:
(a) SF-425, “Federal Financial Report” and SF-PPR, “Performance Progress Report” will be required on a quarterly basis (due 30 working days after each calendar quarter). The Performance Progress Report shall include the elements described in the grant agreement.
(b) Final financial and performance reports will be due 90 calendar days after the period of performance end date.
(c) A summary at the end of the final report with elements as described in the grant agreement to assist in documenting the annual performance goals of the RCDI program for Congress.
Contact the Rural Development office in the State where the applicant's headquarters is located. A list of Rural Development State Offices can be found via
Survey on Ensuring Equal Opportunity for Applicants, OMB No. 1894-0010 (applies only to nonprofit applicants only—submission is optional).
No reimbursement will be made for any funds expended prior to execution of the RCDI Grant Agreement unless the intermediary is a non-profit or educational entity and has requested and received written Agency approval of the costs prior to the actual expenditure.
This exception is applicable for up to 90 days prior to grant closing and only applies to grantees that have received written approval but have not executed the RCDI Grant Agreement.
The Agency cannot retroactively approve reimbursement for expenditures prior to execution of the RCDI Grant Agreement.
Agency—The Rural Housing Service (RHS) or its successor.
Beneficiary—Entities or individuals that receive benefits from assistance provided by the recipient.
Capacity—The ability of a recipient to implement housing, community facilities, or community and economic development projects.
Conflict of interest—A situation in which a person or entity has competing personal, professional, or financial interests that make it difficult for the person or business to act impartially. Regarding use of both grant and matching funds, Federal procurement standards prohibit transactions that involve a real or apparent conflict of interest for owners, employees, officers, agents, or their immediate family members having a financial or other interest in the outcome of the project; or that restrict open and free competition for unrestrained trade. Specifically, project funds may not be used for services or goods going to, or coming from, a person or entity with a real or apparent conflict of interest, including, but not limited to, owner(s) and their immediate family members. An example of conflict of interest occurs when the grantee's employees, board of directors, or the immediate family of either, have the appearance of a professional or personal financial interest in the recipients receiving the benefits or services of the grant.
Federally recognized tribes—Tribal entities recognized and eligible for funding and services from the Bureau of Indian Affairs, based on the most recent notice in the
Financial assistance—Funds, not to exceed $10,000 per award, used by the intermediary to purchase supplies and equipment to build the recipient's capacity.
Funds—The RCDI grant and matching money.
Intermediary—A qualified private, nonprofit (including faith-based and community organizations and philanthropic organizations), or public (including tribal) organization that provides financial and technical assistance to multiple recipients.
Low-income rural community—An authority, district, economic development authority, regional council, or unit of government representing an incorporated city, town, village, county, township, parish, or borough whose income is at or below 80 percent of either the state or national Median Household Income as measured by the 2010 Census.
Matching funds—Cash or confirmed funding commitments. Matching funds must be at least equal to the grant amount and committed for a period of not less than the grant performance period.
Recipient—The entity that receives the financial and technical assistance from the Intermediary. The recipient must be a nonprofit community-based housing and development organization, a low-income rural community or a federally recognized Tribe.
Rural and rural area—Any area other than (i) a city or town that has a population of greater than 50,000 inhabitants; and (ii) the urbanized area contiguous and adjacent to such city or town.
Technical assistance—Skilled help in improving the recipient's abilities in the areas of housing, community facilities, or community and economic development.
The U.S. Department of Agriculture (USDA) prohibits discrimination against its customers, employees, and applicants for employment on the bases of race, color, national origin, age, disability, sex, gender identity, religion, reprisal, and where applicable, political beliefs, marital status, familial or parental status, sexual orientation, or all or part of an individual's income is derived from any public assistance program, or protected genetic information in employment or in any program or activity conducted or funded by the Department. (Not all prohibited bases will apply to all programs and/or employment activities.)
If you wish to file a Civil Rights program complaint of discrimination, complete the USDA Program Discrimination Complaint Form (PDF), found online at
You may also write a letter containing all of the information requested in the form. Send your completed complaint form or letter to us by mail at U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410, by fax (202) 690-7442 or email at
Individuals who are deaf, hard of hearing, or have speech disabilities and you wish to file either an EEO or program complaint please contact USDA through the Federal Relay Service at (800) 877-8339 or (800) 845-6136 (in Spanish).
Persons with disabilities who wish to file a program complaint, please see information above on how to contact us by mail directly or by email.
If you require alternative means of communication for program information (
All adverse determinations regarding applicant eligibility and the awarding of points as part of the selection process are appealable pursuant to 7 CFR part 11. Instructions on the appeal process will be provided at the time an applicant is notified of the adverse decision.
In the event the applicant is awarded a grant that is less than the amount requested, the applicant will be required to modify its application to conform to the reduced amount before execution of the grant agreement. The Agency reserves the right to reduce or withdraw the award if acceptable modifications are not submitted by the awardee within 15 working days from the date the request for modification is made. Any modifications must be within the scope of the original application.
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Michigan Advisory Committee (Committee) will hold a meeting on Monday, July 20, 2015, at 3:00 p.m. EST for the purpose of discussing civil rights topics in the state and begin consideration of future projects. The Committee met on May 11 to begin the discussion on civil rights issues in Michigan and will continue the discussion during this meeting, including review of concept papers developed by Committee members.
Members of the public can listen to the discussion. This meeting is available to the public through the following toll-free call-in number: 888-455-2263, conference ID: 2627011. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement at the end of the meeting. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.
Members of the public are also entitled to submit written comments; the comments must be received in the regional office by August 20, 2015. Written comments may be mailed to the Regional Programs Unit, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to Administrative Assistant, Carolyn Allen at
Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at
The meeting will be held on Monday, July 20, 2015, at 3:00 p.m. EST.
David Mussatt at
Economic Development Administration, Department of Commerce.
Notice and opportunity for public comment.
Pursuant to Section 251 of the Trade Act 1974, as amended (19 U.S.C. 2341
Any party having a substantial interest in these proceedings may request a public hearing on the matter. A written request for a hearing must be submitted to the Trade Adjustment Assistance for Firms Division, Room 71030, Economic Development Administration, U.S. Department of Commerce, Washington, DC 20230, no later than ten (10) calendar days following publication of this notice.
Please follow the requirements set forth in EDA's regulations at 13 CFR 315.9 for procedures to request a public hearing. The Catalog of Federal Domestic Assistance official number and title for the program under which these petitions are submitted is 11.313, Trade Adjustment Assistance for Firms.
Pursuant to its authority under the Foreign-Trade Zones Act of June 18, 1934, as amended (19 U.S.C. 81a-81u), the Foreign-Trade Zones Board (the Board) adopts the following Order:
Attest:__________
On January 12, 2015, MHI Compressor International Corporation submitted a notification of proposed production activity to the FTZ Board for its facility within FTZ 84—Site 37, in Pearland, Texas.
The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the
The amended application to reorganize and expand FTZ 49 under the ASF is approved, subject to the FTZ Act and the Board's regulations, including Section 400.13, to the Board's standard 2,000-acre activation limit for the zone, to an ASF sunset provision for magnet sites that would terminate authority for Sites 2, 3, 4, 6 and 13 if not activated within five years from the month of approval, and to an ASF sunset provision for usage-driven sites that would terminate authority for Sites 5, 14 and 15 if no foreign-status merchandise is admitted for a
ATTEST:__________
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public scoping meetings.
The Mid-Atlantic Fishery Management Council will hold five scoping hearings in June 2015 related to blueline tilefish management. The Council is considering developing a fishery management plan (FMP) for blueline tilefish and/or other deepwater species, or adding blueline tilefish to the existing golden tilefish FMP. There will also be a separate written comment period for Amendment scoping, which will be described in an upcoming
The meetings will be held over several weeks between June 1, 2015 and June 18, 2015 as described in
See
Christopher M. Moore, Ph.D., Executive Director, Mid-Atlantic Fishery Management Council; telephone: (302) 526-5255. The Council's Web site,
There will be five scoping meetings with the following dates/times/locations:
1. Monday, June 1, 2015, 6 p.m., Hyatt Place Long Island/East End, 451 E. Main St., Riverhead, NY 11901; telephone: (631) 208-0002.
2. Tuesday, June 2, 2015, 6 p.m., Congress Hall Hotel, 251 Beach Ave., Cape May, NJ 08204; telephone: (888) 944-1816.
3. Tuesday, June 16, 2015, 6 p.m., Dare County Administration Building, Commissioners Meeting Room, 954 Marshall C. Collins Drive, Manteo, NC 27954; telephone: (252) 475-5700.
4. Wednesday, June 17, 2015, 6 p.m., Hilton Virginia Beach Oceanfront, 3001 Atlantic Ave., Virginia Beach, VA 23451; telephone: (757) 213-3000.
5. Thursday, June 18, 2015, 5 p.m., Ocean City Chamber of Commerce, Eunice Q. Sorin Visitor & Conference Center, 12320 Ocean Gateway, Ocean City, MD 21842; telephone: (410) 213-0552.
The South Atlantic Fishery Management Council (SAFMC) manages blueline tilefish south of Virginia, but there is currently (as of May 11, 2015) no management of blueline tilefish in Federal waters north of North Carolina. Virginia and Maryland have instituted regulations for state waters, but catches in any Federal waters north of North Carolina may be landed from Delaware north without restriction. Blueline tilefish are susceptible to overfishing due to their biology (relatively long-lived, sedentary, slow growing, and late maturing) so the Council is considering developing management measures. These potential measures could be considered via an amendment to the Council's golden tilefish FMP, or a new FMP for blueline tilefish and/or other deep-water fish such as sand tilefish, snowy grouper, and black-bellied rosefish. Management measures could include a definition of the management unit, as well as acceptable biological catches, annual catch limits, trip limits, essential fish habitat, etc.
For waters north of North Carolina, in response to recent catch increases the Council has already requested that NMFS take emergency action to implement a 300 pound (whole weight) commercial trip limit and a seven fish per-person recreational possession limit. This request was the result of a February 25, 2015 Council Meeting, the details of which may be found at:
Through the SAFMC's Amendment 32 (
This is the first and best opportunity for members of the public to raise concerns related to the scope of issues that will be considered in the Amendment. The Council needs your input both to identify management issues and develop effective alternatives. Your comments early in the amendment development process will help us address issues of public concern in a thorough and appropriate manner. Comment topics could include the scope of issues in the amendment, concerns and potential alternatives related to blueline tilefish management, and the appropriate level of environmental analysis. Comments can be made during the scoping hearings as detailed above or in writing once the official NOI publishes. After scoping, the Council plans to develop a range of management alternatives to be considered and prepare a draft Environmental Impact Statement (DEIS) and/or other appropriate environmental analyses. These analyses will consider the impacts of the management alternatives being considered. Following a review of any comments on the draft analyses, the Council will then choose preferred management measures for submission with a Final EIS or Environmental Assessment to the Secretary of Commerce for publishing of a proposed and then final rule, both of which have additional comment periods.
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of funding availability.
The principal objective of the National Marine Fisheries Service's (NMFS) Coastal Ecosystem Resiliency Grants Program is to implement projects that use a proactive approach to improve or restore coastal habitat to: (1) Strengthen the resilience of our marine or coastal ecosystems to decrease the vulnerability of communities to extreme weather; and (2) support sustainable fisheries and contribute to the recovery of protected resources. See the full Coastal Ecosystem Resiliency Grants Federal Funding Opportunity (FFO), located on Grants.gov as described in the
Applications must be postmarked, provided to a delivery service, or received by
Complete application packages, including required Federal forms and instructions, can be found on
For further information, contact Melanie Gange at (301) 427-8664, or by email at
As noted above, the principal objective of the Coastal Ecosystem Resiliency Grants Program is to implement projects that use a proactive approach to improve or restore coastal habitat to: (1) Strengthen the resilience of our marine and coastal ecosystems to decrease the vulnerability of communities to extreme weather; and (2) support sustainable fisheries and contribute to the recovery of protected resources. Applications should demonstrate how the proposed project will enhance the resiliency of marine and coastal ecosystems to the impacts of extreme weather and changing environmental conditions thereby increasing community resilience and providing habitat to threatened and endangered species listed under the Endangered Species Act (hereafter, Listed Species), fish stocks managed under the Magnuson-Stevens Fishery Conservation and Management Act (hereafter, Managed Species), or other marine and coastal species with a nexus to NMFS management (such as through the Atlantic Coastal Fisheries Cooperative Management Act, Atlantic Striped Bass Conservation Act, Marine Mammal Protection Act, Coral Reef Conservation Act, or NMFS Species of Concern). Successful applications will (1) identify an issue limiting the resiliency of marine or coastal ecosystems to extreme weather events or changing environmental conditions at the proposed project site; (2) identify the proposed project's outcome goal(s) and describe in detail the actions and on-the-ground restoration to be undertaken to enhance resiliency and reduce risk and; (3) describe the measurable impact on the ecosystem, target species, and surrounding coastal communities to benefit from the proposed habitat restoration project. Applications selected for funding through this solicitation will primarily be funded through cooperative agreements.
Section IV.B. of the FFO describes the suggested information to include in the application narrative. Supplemental Guidance regarding application writing, a checklist to submit a complete application, and FAQs about this solicitation and the Regional Coastal Resilience Grants Program being administered by NOAA's National Ocean Service can be found at
This funding opportunity is one of two FFOs being administered by NOAA to build coastal resilience. The companion competition, Regional Coastal Resilience Grants Program, is being administered by NOAA's National Ocean Service to undertake activities that build resilience of coastal regions, communities, and economic sectors to the negative impacts from extreme weather events, climate hazards, and changing ocean conditions. The Regional Coastal Resilience Grants FFO is expected to be posted in May of 2015 and may be found on
Total anticipated funding for all awards is up to $4 million, subject to the availability of appropriations. NOAA anticipates typical awards will range from $500,000 to $1 million. NOAA will not accept applications requesting less than $200,000 or more than $2 million in Federal funds from NOAA under this solicitation and the exact amount of funds that may be awarded will be determined in pre-award negotiations between the applicant and NOAA. Any funds provided to successful applicants will be at the discretion of the NOAA Office of Habitat Conservation and the NOAA Grants Management Division (GMD). In no event will NOAA or the Department of Commerce be responsible for application preparation costs if programs fail to receive funding or are cancelled because of other agency priorities. Publication of this notice does not oblige NOAA to award any specific project or to obligate any available funds and there is no guarantee that sufficient funds will be available to make awards for all top-ranked applications. The number of awards to be made as a result of this solicitation will depend on the number of eligible applications received, the amount of funds requested for coastal ecosystem resiliency projects, and the merit and ranking of the applications.
Eligible applicants are institutions of higher education, non-profits, commercial (for profit) organizations, U.S. territories, and state, local and Native American tribal governments. Applications from individuals, Federal agencies, or employees of federal agencies will not be considered. Individuals and Federal agencies are strongly encouraged to work with states, non-governmental organizations, municipal and county governments, and others that are eligible to apply. In addition, NOAA will only award funds to projects that receive and demonstrate approval of the State's Governor to implement the proposed project as evidenced by a letter or other form of
The general evaluation criteria and selection factors that apply to full applications to this funding opportunity are summarized below. Further information about the evaluation criteria and selection factors can be found in the full FFO announcement in
Reviewers will assign scores to applications ranging from 0 to 100 points based on the following five standard NOAA evaluation criteria and respective weights specified below. Applications that best address these criteria will be most competitive.
1. Importance and Applicability (35 points): This criterion ascertains whether there is intrinsic value in the proposed work and/or relevance to NOAA, federal, regional, state or local activities.
2. Technical/Scientific Merit (25 points): This criterion assesses whether the project activity or approach is technically sound, if the methods are appropriate, and whether there are clear goals and objectives.
3. Overall Qualifications of Applicant (10 points): This criterion ascertains whether the applicant possesses the necessary education, experience, training, facilities, and administrative resources to support the proposed award.
4. Project Costs (20 points): This criterion evaluates the budget to determine if it is realistic and commensurate with the project's needs and time-frame.
5. Outreach and Education (10 points): NOAA assesses whether the award can deliver a focused and effective education and outreach strategy regarding NOAA's mission to protect the Nation's natural resources.
Applications will undergo an initial administrative review to determine if they are eligible and complete, per Section III of the full FFO posted at
Applications submitted under the FFO are subject to the provisions of Executive Order 12372, “Intergovernmental Review of Programs.” Any applicant submitting an application for funding is required to complete item 16 on Form SF-424 regarding clearance by the State Single Point of Contact (SPOC). To find out about and comply with a State's process under Executive Order 12372, the names, addresses and phone numbers of participating SPOC's are listed on the Office of Management and Budget's home page at:
In no event will NOAA or the Department of Commerce be responsible for proposal preparation costs if these programs fail to receive funding or are cancelled because of other agency priorities. Publication of this announcement does not oblige NOAA to award any specific project or to obligate any available funds.
NOAA must analyze the potential environmental impacts, as required by the National Environmental Policy Act (NEPA), for applicant projects or proposals which are seeking NOAA federal funding opportunities. Consequently, as part of an applicant's package, and under their description of their program activities, applicants are required to provide detailed information on the activities to be conducted, locations, sites, species and habitat to be affected, possible construction activities, and any environmental concerns that may exist. Applicants may also be requested to assist NOAA in drafting of an environmental assessment, or in identifying and implementing feasible measures to reduce or avoid any identified adverse environmental impacts of their proposal. The failure to do so shall be grounds for not selecting an application. Further details regarding NOAA's compliance with NEPA can be found in the full Federal Funding Opportunity.
The Department of Commerce Pre-Award Notification Requirements for Grants and Cooperative Agreements contained in the
This document contains collection-of-information requirements subject to the Paperwork Reduction Act (PRA). The use of Standard Forms 424, 424A, 424B, and SF-LLL and CD-346 has been approved by the Office of Management and Budget (OMB) under the respective control numbers 0348-0043, 0348-0044, 0348-0040, 0348-0046, and 0605-0001. Notwithstanding any other provision of law, no person is required to, nor shall a person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA unless that collection of information displays a currently valid OMB control number.
This notice has been determined to be not significant for purposes of Executive Order 12866.
It has been determined that this notice does not contain policies with implications as that term is defined in Executive Order 13132.
Prior notices and an opportunity for public comment are not required by the Administrative Procedure Act or any other law for rules concerning public property, loans, grants, benefits, and contracts (5 U.S.C. 553(a)(2)). Because notice and opportunity for comment are not required pursuant to 5 U.S.C. 553 or any other law, the analytical requirements for the Regulatory Flexibility Act (5 U.S.C. 601
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; proposed incidental harassment authorization; request for comments.
NMFS received an application from Hilcorp Alaska, LLC. (Hilcorp) for an Incidental Harassment Authorization (IHA) to take marine mammals, by harassment, incidental to shallow geohazard survey in the Beaufort Sea, Alaska. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an IHA to Hilcorp to take, by Level B harassment only, 6 species of marine mammals during the specified activity.
Comments and information must be received no later than June 15, 2015.
Comments on the application should be addressed to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service, 1315 East-West Highway, Silver Spring, MD 20910. The mailbox address for providing email comments is
Instructions: All comments received are a part of the public record and will generally be posted to
A copy of the application, which contains several attachments, including Hilcorp's marine mammal mitigation and monitoring plan (4MP), used in this document may be obtained by writing to the address specified above, telephoning the contact listed below (see
Shane Guan, Office of Protected Resources, NMFS, (301) 427-8401.
Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth. NMFS has defined “negligible impact” in 50 CFR 216.103 as “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.”
Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].
On December 1, 2014, NMFS received an application from Hilcorp for the taking of marine mammals incidental to shallow geohazard surveys in the Beaufort Sea. After receiving NMFS comments, Hilcorp submitted a revised IHA application on January 5, 2015. In addition, Hilcorp submitted a 4MP on January 21, 2015. NMFS determined that the application was adequate and complete on February 9, 2015.
The proposed activity would occur between July 1 and September 30, 2015. The actual survey is expected to be complete in 45 days, including weather and equipment downtime. Underwater noises generated from the sonar used for the survey are likely to result Level B harassment of individuals of 6 species of marine mammals.
Hilcorp plans to conduct a shallow geohazard survey and Strudel Scour survey with a transition zone component on state lands, and in federal and state waters of Foggy Island Bay in the Beaufort Sea during the open water season of 2015. The scope of this request is limited to the activities that will be conducted during the 2015 open water evaluation of the proposed Liberty field development.
Hilcorp seeks incidental harassment authorization for the period July 1 to September 30, 2015. The survey is expected to take approximately 45 days
The project area of the proposed Liberty shallow geohazard survey lies within Foggy Island Bay as shown in Figure 1 of Hilcorp's IHA application. The project area is 2.5 mi
The proposed sonar survey vessel (M/V
The total planned survey lines are approximately 300 miles, not including turns and cross-lines. Data will be acquired along the subsea pipeline corridor area using the single-beam or multibeam echosounder, side scan sonar, sub-bottom profilers, and the magnetometer. Because of the shallow nature of the project area and small size of the vessel, systems will be towed in optimal groupings that best facilitate safe operations and data quality. As necessary, a small vessel may be used to extend data collection into shallow waters. Planned survey lines will be designed to acquire 150% side scan sonar data coverage or as mandated, with line spacing dependent upon water depth. A 300 m corridor around the centerline of the proposed pipeline area will be covered.
A single-beam or multibeam echosounder and side scan sonar will be used to obtain high accuracy information regarding bathymetry of the seafloor. For accurate object detection, a side scan sonar survey is required to complement a multibeam echosounder survey.
The proposed multibeam echosounder operates at an rms source level of a maximum of 220 dB re 1 μPa @1 m. The multibeam echosounder emits high frequency (240 kHz) energy in a fan-shaped pattern of equidistant or equiangular beam spacing (Table 1). The beam width of the emitted sound energy in the along-track direction is 1.5 degrees, while the across track beam width is 1.8 degrees. The maximum ping rate of the multibeam echosounder is 40 Hz.
The proposed single-beam echosounder operates at an rms source level of approximately 220 dB re 1 μPa @1 m (Table 1). The transducer selected uses a frequency of 210 kHz and has a ping rate of up to 20 Hz. The transducer's beam width is approximately 3 degrees.
The proposed side scan sonar system will operate at about 400 kHz and 900 kHz. The rms source level is 215 dB re 1μPa @1 m. The sound energy is emitted in a narrow fan-shaped pattern, with a horizontal beam width of 0.45 degrees for 400 kHz and 0.25 degrees at 900 kHz, with a vertical beam width of 50 degrees (Table 1). The maximum ping rate is 75 Hz.
The proposed high-resolution sub-bottom profiler operates at an rms source level of 210db re 1 μPa @1 m. The proposed system emits energy in the frequency bands of 2 to 24 kHz. The beam width is 15 to 24 degrees (Table 1). Typical pulse rate is between 3 and 10 Hz.
The proposed low-resolution sub-bottom profiler operates at an rms source level of 212db re 1 μPa @1 m. This secondary sub-bottom profiler will be utilized as necessary to increase sub-bottom profile penetration. The proposed system emits energy in the frequency bands of 1 to 4 kHz.
The Beaufort Sea supports a diverse assemblage of marine mammals. Table 2 lists the 12 marine mammal species under NMFS jurisdiction with confirmed or possible occurrence in the proposed project area.
The highlighted (grayed out) species in Table 2 are so rarely sighted in the proposed project area that take is unlikely. Minke whales are relatively common in the Bering and southern Chukchi Seas and have recently also been sighted in the northeastern Chukchi Sea (Aerts
The Beaufort Sea is a main corridor of the bowhead whale migration route. The main migration periods occur in spring from April to June and in fall from late August/early September through October to early November. During the fall migration, several locations in the U.S. Beaufort Sea serve as feeding grounds for bowhead whales. Small numbers of bowhead whales that remain in the U.S. Arctic Ocean during summer also feed in these areas. The U.S. Beaufort Sea is not a main feeding or calving area for any other cetacean species. Ringed seals breed and pup in the Beaufort Sea; however, this does not occur during the summer or early fall. Further information on the biology and local distribution of these species can be found in Hilcorp's application (see
This section includes a summary and discussion of the ways that the types of stressors associated with the specified activity (
Sound is a physical phenomenon consisting of minute vibrations that travel through a medium, such as air or water, and is generally characterized by several variables. Frequency describes the sound's pitch and is measured in hertz (Hz) or kilohertz (kHz), while sound level describes the sound's intensity and is measured in decibels (dB). Sound level increases or decreases exponentially with each dB of change. The logarithmic nature of the scale means that each 10-dB increase is a 10-fold increase in acoustic power (and a 20-dB increase is then a 100-fold increase in power). A 10-fold increase in acoustic power does not mean that the sound is perceived as being 10 times louder, however. Sound levels are compared to a reference sound pressure (micro-Pascal) to identify the medium. For air and water, these reference pressures are “re: 20 µPa” and “re: 1 µPa,” respectively. Root mean square (RMS) is the quadratic mean sound pressure over the duration of an impulse. RMS is calculated by squaring all of the sound amplitudes, averaging the squares, and then taking the square root of the average (Urick, 1975). RMS accounts for both positive and negative values; squaring the pressures makes all values positive so that they may be accounted for in the summation of pressure levels. This measurement is often used in the context of discussing behavioral effects, in part, because behavioral effects, which often result from auditory cues, may be better expressed through averaged units rather than by peak pressures.
When considering the influence of various kinds of sound on the marine environment, it is necessary to understand that different kinds of marine life are sensitive to different frequencies of sound. Based on available behavioral data, audiograms have been derived using auditory evoked potentials, anatomical modeling, and other data, Southall
• Low frequency cetaceans (13 species of mysticetes): Functional hearing is estimated to occur between approximately 7 Hz and 30 kHz;
• Mid-frequency cetaceans (32 species of dolphins, six species of larger toothed whales, and 19 species of beaked and bottlenose whales): Functional hearing is estimated to occur between approximately 150 Hz and 160 kHz;
• High frequency cetaceans (eight species of true porpoises, six species of river dolphins, Kogia, the franciscana, and four species of cephalorhynchids): Functional hearing is estimated to occur between approximately 200 Hz and 180 kHz;
• Phocid pinnipeds in water: Functional hearing is estimated to occur between approximately 75 Hz and 100 kHz; and
• Otariid pinnipeds in water: Functional hearing is estimated to occur between approximately 100 Hz and 40 kHz.
As mentioned previously in this document, six marine mammal species (three cetaceans and three phocid pinnipeds) may occur in the proposed shallow hazard survey area. Of the three cetacean species likely to occur in the proposed project area and for which take is requested, two are classified as low-frequency cetaceans (
Although the analysis of impacts of underwater sound on marine mammals described below heavily based on studies from seismic airgun noises, Hilcorp's proposed shallow geohazard survey does not plan to use airguns. Therefore, the potential impacts to marine mammals are expected to be much lower. The reason that the analysis includes airgun impact research is because there are few studies on impacts of marine mammals from
Numerous studies have shown that underwater sounds from industry activities are often readily detectable by marine mammals in the water at distances of many kilometers. Numerous studies have also shown that marine mammals at distances more than a few kilometers away often show no apparent response to industry activities of various types (Miller
Masking is the obscuring of sounds of interest by other sounds, often at similar frequencies. Marine mammals use acoustic signals for a variety of purposes, which differ among species, but include communication between individuals, navigation, foraging, reproduction, avoiding predators, and learning about their environment (Erbe and Farmer, 2000). Masking, or auditory interference, generally occurs when sounds in the environment are louder than, and of a similar frequency as, auditory signals an animal is trying to receive. Masking is a phenomenon that affects animals that are trying to receive acoustic information about their environment, including sounds from other members of their species, predators, prey, and sounds that allow them to orient in their environment. Masking these acoustic signals can disturb the behavior of individual animals, groups of animals, or entire populations.
Masking occurs when anthropogenic sounds and signals (that the animal utilizes) overlap at both spectral and temporal scales. For the sonar sound generated from the proposed shallow geohazard survey, sound will consist of broadband (2-24 kHz) pulses with extremely short durations (less than one second). There is little concern regarding masking near the sound source due to the brief duration of these pulses and relatively longer silence between the pulses. However, at long distances (over tens of kilometers away), due to multipath propagation and reverberation, the durations of airgun pulses can be “stretched” to seconds with long decays (Madsen
Marine mammals may behaviorally react when exposed to anthropogenic sound. These behavioral reactions are often shown as: Changing durations of surfacing and dives, number of blows per surfacing, or moving direction and/or speed; reduced/increased vocal activities; changing/cessation of certain behavioral activities (such as socializing or feeding); visible startle response or aggressive behavior (such as tail/fluke slapping or jaw clapping); avoidance of areas where sound sources are located; and/or flight responses (
The biological significance of many of these behavioral disturbances is difficult to predict, especially if the detected disturbances appear minor. However, the consequences of behavioral modification have the potential to be biologically significant if the change affects growth, survival, or reproduction. Examples of significant behavioral modifications include:
• Drastic change in diving/surfacing patterns (such as those thought to be causing beaked whale stranding due to exposure to military mid-frequency tactical sonar);
• Habitat abandonment due to loss of desirable acoustic environment; and
• Cessation of feeding or social interaction.
The onset of behavioral disturbance from anthropogenic noise depends on both external factors (characteristics of noise sources and their paths) and the receiving animals (hearing, motivation, experience, demography, current activity, reproductive state) and is also difficult to predict (Gordon
Results of studies of gray, bowhead, and humpback whales have determined that received levels of pulses in the 160-170 dB re 1 µPa rms range seem to cause obvious avoidance behavior in a substantial fraction of the animals exposed. In many areas, seismic pulses from large arrays of airguns diminish to those levels at distances ranging from 2.8-9 mi (4.5-14.5 km) from the source. Baleen whales within those distances may show avoidance or other strong disturbance reactions to the airgun array. Subtle behavioral changes sometimes become evident at somewhat lower received levels, and recent studies have shown that some species of baleen whales, notably bowhead and humpback whales, at times show strong avoidance at received levels lower than 160-170 dB re 1 μPa rms. Bowhead whales migrating west across the Alaskan Beaufort Sea in autumn, in particular, are unusually responsive, with avoidance occurring out to distances of 12.4-18.6 mi (20-30 km) from a medium-sized airgun source (Miller
Malme
Data on short-term reactions (or lack of reactions) of cetaceans to impulsive noises do not necessarily provide information about long-term effects. While it is not certain whether impulsive noises affect reproductive rate or distribution and habitat use in subsequent days or years, certain species have continued to use areas ensonified by airguns and have continued to increase in number despite successive years of anthropogenic activity in the area. Gray whales continued to migrate annually along the west coast of North America despite intermittent seismic exploration and much ship traffic in that area for decades (Appendix A in Malme
Seismic operators and marine mammal observers sometimes see dolphins and other small toothed whales near operating airgun arrays, but, in general, there seems to be a tendency for most delphinids to show some limited avoidance of seismic vessels operating large airgun systems. However, some dolphins seem to be attracted to the seismic vessel and floats, and some ride the bow wave of the seismic vessel even when large arrays of airguns are firing. Nonetheless, there have been indications that small toothed whales sometimes move away or maintain a somewhat greater distance from the vessel when a large array of airguns is operating than when it is silent (
Captive bottlenose dolphins and (of more relevance in this project) beluga whales exhibit changes in behavior when exposed to strong pulsed sounds similar in duration to those typically used in seismic surveys (Finneran
Observers stationed on seismic vessels operating off the United Kingdom from 1997-2000 have provided data on the occurrence and behavior of various toothed whales exposed to seismic pulses (Stone, 2003; Gordon
Reactions of toothed whales to large arrays of airguns are variable and, at least for delphinids, seem to be confined to a smaller radius than has been observed for mysticetes. However, based on the limited existing evidence, belugas should not be grouped with delphinids in the “less responsive” category.
When animals exhibit reduced hearing sensitivity (
The following physiological mechanisms are thought to play a role in inducing auditory TS: Effects to sensory hair cells in the inner ear that reduce their sensitivity, modification of the chemical environment within the sensory cells, residual muscular activity in the middle ear, displacement of certain inner ear membranes, increased blood flow, and post-stimulatory reduction in both efferent and sensory neural output (Southall
PTS is considered auditory injury (Southall
Although the published body of scientific literature contains numerous theoretical studies and discussion papers on hearing impairments that can occur with exposure to a loud sound, only a few studies provide empirical information on the levels at which noise-induced loss in hearing sensitivity occurs in nonhuman animals. For marine mammals, published data are limited to the captive bottlenose dolphin, beluga, harbor porpoise, and Yangtze finless porpoise (Finneran
Marine mammal hearing plays a critical role in communication with conspecifics, and interpretation of environmental cues for purposes such as predator avoidance and prey capture. Depending on the degree (elevation of threshold in dB), duration (
Non-auditory physical effects might occur in marine mammals exposed to strong underwater sound. Possible types of non-auditory physiological effects or injuries that theoretically might occur in mammals close to a strong sound source include stress, neurological effects, bubble formation, and other types of organ or tissue damage. Some marine mammal species (
Classic stress responses begin when an animal's central nervous system perceives a potential threat to its homeostasis. That perception triggers stress responses regardless of whether a stimulus actually threatens the animal; the mere perception of a threat is sufficient to trigger a stress response (Moberg, 2000; Sapolsky
In the case of many stressors, an animal's first and most economical (in terms of biotic costs) response is behavioral avoidance of the potential stressor or avoidance of continued exposure to a stressor. An animal's second line of defense to stressors involves the sympathetic part of the autonomic nervous system and the classical “fight or flight” response, which includes the cardiovascular system, the gastrointestinal system, the exocrine glands, and the adrenal medulla to produce changes in heart rate, blood pressure, and gastrointestinal activity that humans commonly associate with “stress.” These responses have a relatively short duration and may or may not have significant long-term effects on an animal's welfare.
An animal's third line of defense to stressors involves its neuroendocrine or sympathetic nervous systems; the system that has received the most study has been the hypothalmus-pituitary-adrenal system (also known as the HPA axis in mammals or the hypothalamus-pituitary-interrenal axis in fish and some reptiles). Unlike stress responses associated with the autonomic nervous system, virtually all neuroendocrine functions that are affected by stress—including immune competence, reproduction, metabolism, and behavior—are regulated by pituitary hormones. Stress-induced changes in the secretion of pituitary hormones have been implicated in failed reproduction (Moberg, 1987), altered metabolism (Elasser
The primary distinction between stress (which is adaptive and does not normally place an animal at risk) and distress is the biotic cost of the response. During a stress response, an animal uses glycogen stores that can be quickly replenished once the stress is alleviated. In such circumstances, the cost of the stress response would not pose a risk to the animal's welfare. However, when an animal does not have sufficient energy reserves to satisfy the energetic costs of a stress response, energy resources must be diverted from other biotic functions, which impair those functions that experience the diversion. For example, when mounting a stress response diverts energy away from growth in young animals, those animals may experience stunted growth. When mounting a stress response diverts energy from a fetus, an animal's reproductive success and fitness will suffer. In these cases, the animals will have entered a pre-pathological or pathological state which is called “distress” (sensu Seyle, 1950) or “allostatic loading” (sensu McEwen and Wingfield, 2003). This pathological state will last until the animal replenishes its biotic reserves sufficient to restore normal function. Note that these examples involved a long-term (days or weeks) stress response exposure to stimuli.
Relationships between these physiological mechanisms, animal behavior, and the costs of stress responses have also been documented fairly well through controlled experiment; because this physiology exists in every vertebrate that has been studied, it is not surprising that stress responses and their costs have been documented in both laboratory and free-living animals (for examples see, Holberton
For example, Jansen (1998) reported on the relationship between acoustic exposures and physiological responses that are indicative of stress responses in humans (
Hearing is one of the primary senses marine mammals use to gather information about their environment and communicate with conspecifics. Although empirical information on the relationship between sensory impairment (TTS, PTS, and acoustic masking) on marine mammals remains limited, we assume that reducing a marine mammal's ability to gather information about its environment and communicate with other members of its species would induce stress, based on data that terrestrial animals exhibit those responses under similar conditions (NRC, 2003) and because marine mammals use hearing as their primary sensory mechanism. Therefore, we assume that acoustic exposures sufficient to trigger onset PTS or TTS would be accompanied by physiological stress responses. More importantly, marine mammals might experience stress responses at received levels lower than those necessary to trigger onset TTS. Based on empirical studies of the time required to recover from stress responses (Moberg, 2000), NMFS also assumes that stress responses could persist beyond the time interval required for animals to recover from TTS and might result in pathological and pre-pathological states that would be as significant as behavioral responses to TTS.
Resonance effects (Gentry, 2002) and direct noise-induced bubble formations (Crum
In general, very little is known about the potential for strong, anthropogenic underwater sounds to cause non-auditory physical effects in marine mammals. Such effects, if they occur at all, would presumably be limited to short distances and to activities that extend over a prolonged period. The available data do not allow identification of a specific exposure level above which non-auditory effects can be expected (Southall
Marine mammals close to underwater detonations of high explosive can be killed or severely injured, and the auditory organs are especially susceptible to injury (Ketten
Vessel activity and noise associated with vessel activity will temporarily increase in the action area during Hilcorp's shallow geohazard survey as a result of the operation of 1-2 vessels. To minimize the effects of vessels and noise associated with vessel activity, Hilcorp will alter speed if a marine mammal gets too close to a vessel. In addition, source vessels will be operating at slow speed (4-5 knots) when conducting surveys. Marine mammal monitoring observers will alert vessel captains as animals are detected to ensure safe and effective measures are applied to avoid coming into direct contact with marine mammals. Therefore, NMFS neither anticipates nor
McCauley
Palka and Hammond (2001) analyzed line transect census data in which the orientation and distance off transect line were reported for large numbers of minke whales. The authors developed a method to account for effects of animal movement in response to sighting platforms. Minor changes in locomotion speed, direction, and/or diving profile were reported at ranges from 1,847 to 2,352 ft (563 to 717 m) at received levels of 110 to 120 dB.
Odontocetes, such as beluga whales, killer whales, and harbor porpoises, often show tolerance to vessel activity; however, they may react at long distances if they are confined by ice, shallow water, or were previously harassed by vessels (Richardson
There are few data published on pinniped responses to vessel activity, and most of the information is anecdotal (Richardson
The addition of the vessels and noise due to vessel operations associated with the shallow geohazard survey is not expected to have effects that could cause significant or long-term consequences for individual marine mammals or their populations.
The primary potential impacts to marine mammal habitat and other marine species are associated with elevated sound levels produced by airguns and other active acoustic sources. However, other potential impacts to the surrounding habitat from physical disturbance are also possible. This section describes the potential impacts to marine mammal habitat from the specified activity. Because the marine mammals in the area feed on fish and/or invertebrates there is also information on the species typically preyed upon by the marine mammals in the area.
With regard to fish as a prey source for odontocetes and seals, fish are known to hear and react to sounds and to use sound to communicate (Tavolga
Fishes produce sounds that are associated with behaviors that include territoriality, mate search, courtship, and aggression. It has also been speculated that sound production may provide the means for long distance communication and communication under poor underwater visibility conditions (Zelick
Since objects in the water scatter sound, fish are able to detect these objects through monitoring the ambient noise. Therefore, fish are probably able to detect prey, predators, conspecifics, and physical features by listening to environmental sounds (Hawkins, 1981). There are two sensory systems that enable fish to monitor the vibration-based information of their surroundings. The two sensory systems, the inner ear and the lateral line, constitute the acoustico-lateralis system.
Although the hearing sensitivities of very few fish species have been studied to date, it is becoming obvious that the intra- and inter-specific variability is considerable (Coombs, 1981). Nedwell
Literature relating to the impacts of sound on marine fish species can be divided into the following categories: (1) Pathological effects; (2) physiological effects; and (3) behavioral effects. Pathological effects include lethal and sub-lethal physical damage to fish; physiological effects include primary and secondary stress responses; and behavioral effects include changes in exhibited behaviors of fish. Behavioral changes might be a direct reaction to a detected sound or a result of the anthropogenic sound masking natural sounds that the fish normally detect and to which they respond. The three types of effects are often interrelated in complex ways. For example, some physiological and behavioral effects could potentially lead to the ultimate pathological effect of mortality. Hastings and Popper (2005) reviewed what is known about the effects of sound on fishes and identified studies needed to address areas of uncertainty relative to measurement of sound and the responses of fishes. Popper
Potential effects of exposure to sound on marine fish include TTS, physical damage to the ear region, physiological stress responses, and behavioral responses such as startle response, alarm response, avoidance, and perhaps lack of response due to masking of acoustic cues. Most of these effects appear to be either temporary or intermittent and therefore probably do not significantly impact the fish at a population level. The studies that resulted in physical damage to the fish ears used noise exposure levels and durations that were far more extreme than would be encountered under conditions similar to those expected during Hilcorp's proposed survey.
The level of sound at which a fish will react or alter its behavior is usually well above the detection level. Fish have been found to react to sounds when the sound level increased to about
Investigations of fish behavior in relation to vessel noise (Olsen
Short, sharp sounds can cause overt or subtle changes in fish behavior. Chapman and Hawkins (1969) tested the reactions of whiting (hake) in the field to an airgun. When the airgun was fired, the fish dove from 82 to 180 ft (25 to 55 m) depth and formed a compact layer. The whiting dove when received sound levels were higher than 178 dB re 1 µPa (Pearson
Pearson
• Startle responses at received levels of 200-205 dB re 1 µPa and above for two sensitive species, but not for two other species exposed to levels up to 207 dB;
• Alarm responses at 177-180 dB for the two sensitive species, and at 186 to 199 dB for other species;
• An overall threshold for the above behavioral response at about 180 dB;
• An extrapolated threshold of about 161 dB for subtle changes in the behavior of rockfish; and
• A return to pre-exposure behaviors within the 20-60 minute exposure period.
In summary, fish often react to sounds, especially strong and/or intermittent sounds of low frequency. Sound pulses at received levels of 160 dB re 1 µPa may cause subtle changes in behavior. Pulses at levels of 180 dB may cause noticeable changes in behavior (Chapman and Hawkins, 1969; Pearson
Some of the fish species found in the Arctic are prey sources for odontocetes and pinnipeds. A reaction by fish to sounds produced by Hilcorp's proposed survey would only be relevant to marine mammals if it caused concentrations of fish to vacate the area. Pressure changes of sufficient magnitude to cause that type of reaction would probably occur only very close to the sound source, if any would occur at all. Impacts on fish behavior are predicted to be inconsequential. Thus, feeding odontocetes and pinnipeds would not be adversely affected by this minimal loss or scattering, if any, of reduced prey abundance.
Some mysticetes, including bowhead whales, feed on concentrations of zooplankton. Some feeding bowhead whales may occur in the Alaskan Beaufort Sea in July and August, but feeding bowheads are more likely to occur in the area after the cessation of survey operations. Reactions of zooplankton to sound are, for the most part, not known. Their ability to move significant distances is limited or nil, depending on the type of zooplankton. Behavior of zooplankters is not expected to be affected by the survey. These animals have exoskeletons and no air bladders. Many crustaceans can make sounds, and some crustacea and other invertebrates have some type of sound receptor. A reaction by zooplankton to sounds produced by the seismic survey would only be relevant to whales if it caused concentrations of zooplankton to scatter. Pressure changes of sufficient magnitude to cause that type of reaction would probably occur only very close to the sound source, if any would occur at all. Impacts on zooplankton behavior are predicted to be inconsequential. Thus, feeding mysticetes would not be adversely affected by this minimal loss or scattering, if any, of reduced zooplankton abundance.
Based on the preceding discussion, the proposed activity is not expected to have any habitat-related effects that could cause significant or long-term consequences for individual marine mammals or their populations.
In order to issue an incidental take authorization (ITA) under sections 101(a)(5)(A) and (D) of the MMPA, NMFS must, where applicable, set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses (where relevant). This section summarizes the contents of Hilcorp's Marine Mammal Monitoring and Mitigation Plan (4MP). Later in this document in the “Proposed Incidental Harassment Authorization” section, NMFS lays out the proposed conditions for review, as they would appear in the final IHA (if issued).
Hilcorp submitted a 4MP as part of its application (see ADDRESSES). Hilcorp's planned shallow geohazard survey incorporates both design features and operational procedures for minimizing potential impacts on marine mammals and on subsistence hunts. The 4MP is a combination of active monitoring in the area of operations and the implementation of mitigation measures designed to minimize project impacts to marine resources. Monitoring will provide information on marine mammals potentially affected by exploration activities, in addition to facilitating real time mitigation to prevent injury of marine mammals by industrial sounds or activities.
The general mitigation measures apply to all vessels that are part of the Foggy Island Bay sonar survey. The source vessel will operate under an additional set of specific mitigation measures during operations.
• To minimize collision risk with marine mammals, vessels shall not be operated at speeds that would make collisions likely. When weather conditions require, such as when visibility drops, vessels shall adjust speed accordingly to avoid the likelihood of marine mammal collisions.
• Vessel operators shall check the waters immediately adjacent to a vessel to ensure that no marine mammals will be injured when the vessel's propellers (or screws) are engaged.
• Vessel operators shall avoid concentrations or groups of whales and vessels shall not be operated in a way that separates members of a group. In proximity of feeding whales or aggregations, vessel speed shall be less than 10 knots.
• When within 900 ft. (300 m) of whales vessel operators shall take every effort and precaution to avoid harassment of these animals by:
○ Reducing speed and steering around (groups of) whales if circumstances allow, but never cutting off a whale's travel path;
○ Avoiding multiple changes in direction and speed.
• In general, the survey design will start in shallow water and work deeper to mitigate the potential “herding” effect.
Under current NMFS guidelines, the “exclusion zone” for marine mammal exposure to impulse sources is customarily defined as the area within which received sound levels are ≥180 dB (rms) re 1 μPa for cetaceans and ≥190 dB (rms) re 1 μPa for pinnipeds. These safety criteria are based on an assumption that SPL received at levels lower than these will not injure these animals or impair their hearing abilities, but at higher levels might have some such effects. Disturbance or behavioral effects to marine mammals from underwater sound may occur after exposure to sound at distances greater than the exclusion zones (Richardson
The sounds generated by the multibeam echosounder and sidescan sonar are outside the hearing range of marine mammals. Sounds generated by the sub-bottom profiler are within the hearing range of all marine mammal species occurring in the area. The distance to 160 dB re 1 µPa (rms) zone of influence (ZOI) is estimated at 30 m (Warner & McCrodan 2011). However, Hilcorp will establish a ZOI of 50 m around all sonar sources for more protective measures. The exclusion zones of all sonar equipment are less than 30 m from the sources.
A ramp up of the sub-bottom profiler provides a gradual increase in sound levels, and involves a step-wise increase in the number and incremental levels of the sub-bottom profiler firing until the maximum level is achieved. The purpose of a ramp up (or “soft start”) is to “warn” cetaceans and pinnipeds in the vicinity of the survey and to provide time for them to leave the area and thus reducing startling responses from marine mammals.
Although there is no exclusion zone expected from the sonar source operated by Hilcorp during its proposed shallow geohazard survey, Hilcorp proposes to implement shutdown measures when a marine mammals is sighted within the 50 m ZOI during the operation of the sub-bottom profiler.
After showdown for more than 10 minutes, ramp-up shall not start until after the marine mammal is visually seen left the ZOI; or 15 minutes have passed after the last detection of the marine mammal with shorter dive durations (pinnipeds and small odontocetes); or 30 minutes have passed after the last detection of the marine mammal with longer diver durations (mysticetes and large odontocetes, including beluga whales).
If during foggy conditions, heavy snow or rain, or darkness, the full 160 dB ZOI is not visible, sonar equipment cannot commence a ramp-up procedure from a full shut-down. If the sub-bottom profiler has been operational before nightfall or before the onset of poor visibility conditions, it can remain operational throughout the night or poor visibility conditions.
NMFS has carefully evaluated Hilcorp's proposed mitigation measures and considered a range of other measures in the context of ensuring that NMFS prescribes the means of effecting the least practicable impact on the affected marine mammal species and stocks and their habitat. Our evaluation of potential measures included consideration of the following factors in relation to one another:
• The manner in which, and the degree to which, the successful implementation of the measures are expected to minimize adverse impacts to marine mammals;
• The proven or likely efficacy of the specific measure to minimize adverse impacts as planned; and
• The practicability of the measure for applicant implementation.
Any mitigation measure(s) prescribed by NMFS should be able to accomplish, have a reasonable likelihood of accomplishing (based on current science), or contribute to the accomplishment of one or more of the general goals listed below:
1. Avoidance or minimization of injury or death of marine mammals wherever possible (goals 2, 3, and 4 may contribute to this goal).
2. A reduction in the numbers of marine mammals (total number or number at biologically important time or location) exposed to received levels of sub-bottom profiler, or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).
3. A reduction in the number of times (total number or number at biologically important time or location) individuals would be exposed to received levels of sub-bottom profiler or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).
4. A reduction in the intensity of exposures (either total number or number at biologically important time or location) to received levels of sub-bottom profiler or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing the severity of harassment takes only).
5. Avoidance or minimization of adverse effects to marine mammal habitat, paying special attention to the food base, activities that block or limit passage to or from biologically important areas, permanent destruction of habitat, or temporary destruction/disturbance of habitat during a biologically important time.
6. For monitoring directly related to mitigation—an increase in the probability of detecting marine mammals, thus allowing for more effective implementation of the mitigation.
Based on our evaluation of the applicant's proposed measures, as well as other measures considered by NMFS, NMFS has preliminarily determined that the proposed mitigation measures provide the means of effecting the least practicable impact on marine mammals species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance. Proposed measures to ensure availability of such species or stock for taking for certain subsistence uses are discussed later in this document (see “Impact on Availability of Affected Species or Stock for Taking for Subsistence Uses” section).
In order to issue an ITA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must set forth, “requirements pertaining to the monitoring and reporting of such taking.” The MMPA implementing regulations at 50 CFR 216.104 (a)(13) indicate that requests for ITAs must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area. Hilcorp submitted a marine mammal monitoring plan as part of the IHA application. The plan may be modified or supplemented based on comments or new information received from the public during the public comment period or from the peer review panel (see the “Monitoring Plan Peer Review” section later in this document).
Monitoring measures prescribed by NMFS should accomplish one or more of the following general goals:
1. An increase in our understanding of the likely occurrence of marine mammal species in the vicinity of the action,
2. An increase in our understanding of the nature, scope, or context of the likely exposure of marine mammal species to any of the potential stressor(s) associated with the action (
3. An increase in our understanding of how individual marine mammals respond (behaviorally or physiologically) to the specific stressors associated with the action (in specific contexts, where possible,
4. An increase in our understanding of how anticipated individual responses, to individual stressors or anticipated combinations of stressors, may impact either: the long-term fitness and survival of an individual; or the population, species, or stock (
5. An increase in our understanding of how the activity affects marine mammal habitat, such as through effects on prey sources or acoustic habitat (
6. An increase in understanding of the impacts of the activity on marine mammals in combination with the impacts of other anthropogenic activities or natural factors occurring in the region.
7. An increase in our understanding of the effectiveness of mitigation and monitoring measures.
8. An increase in the probability of detecting marine mammals (through improved technology or methodology), both specifically within the safety zone (thus allowing for more effective implementation of the mitigation) and in general, to better achieve the above goals.
Monitoring will provide information on the numbers of marine mammals potentially affected by the exploration operations and facilitate real-time mitigation to prevent injury of marine mammals by industrial sounds or activities. These goals will be accomplished in the Beaufort Sea during 2015 by conducting vessel-based monitoring and passive acoustic monitoring to document marine mammal presence and distribution in the vicinity of the survey area.
Visual monitoring by Protected Species Observers (PSOs) during shallow geohazard survey operations, and periods when these surveys are not occurring, will provide information on the numbers of marine mammals potentially affected by these activities and facilitate real-time mitigation to prevent impacts to marine mammals by industrial sounds or operations. Vessel-based PSOs onboard the survey vessels will record the numbers and species of marine mammals observed in the area and any observable reaction of marine mammals to the survey activities in the Beaufort Sea.
Vessel-based monitoring for marine mammals will be done by trained PSOs throughout the period of survey activities. The observers will monitor the occurrence of marine mammals near the survey vessel during all daylight periods during operation, and during most daylight periods when operations are not occurring. PSO duties will include watching for and identifying marine mammals; recording their numbers, distances, and reactions to the survey operations; and documenting “take by harassment.”
Two PSOs will be present on the main sonar vessel. The smaller skiff may only accommodate one at a time. Of these two PSOs, one will be on watch at all times, except during darkness.
PSO teams will consist of Inupiat observers and experienced field biologists. Each vessel will have an experienced field crew leader to supervise the PSO team.
Visual monitoring by the PSOs will be required to meet the following criteria:
• 100% monitoring coverage during all periods of survey operations in daylight;
• Maximum of 4 consecutive hours on watch per PSO; and
• Maximum of 12 hours of watch time per day per PSO.
Lead PSOs will be individuals with experience as observers during recent seismic, site clearance and shallow hazards, and other monitoring projects in Alaska or other offshore areas in recent years. New or inexperienced PSOs will be paired with an experienced PSO or experienced field biologist so that the quality of marine mammal observations and data recording is kept consistent.
Resumes for candidate PSOs will be provided to NMFS for review and acceptance of their qualifications. Inupiat observers will be experienced in the region and familiar with the marine mammals of the area. All observers will complete a training course designed to familiarize individuals with monitoring and data collection procedures.
The PSOs will watch for marine mammals during all periods of source operations and for a minimum of 30 minutes prior to the planned start of sonar operations after an extended shutdown. Marine mammal monitoring shall continue throughout sonar operations and last for 30 minutes after the finish of sonar operations during daylight hours. Hilcorp vessel crew and operations personnel will also watch for marine mammals, as practical, to assist and alert the PSOs for the sub-bottom profiler to be shut down if marine mammals are observed in or about to enter the 50-m ZOI.
PSOs will also perform vessel-based marine mammal monitoring during
The PSOs will watch for marine mammals from the best available vantage point on the vessels. The PSOs will scan the area around the vessel systematically with reticle binoculars (
The observers will give particular attention to the areas within the marine mammal exclusion zones around the source vessels.
When a marine mammal is seen approaching or within the 50-m ZOI, the survey crew will be notified immediately so that mitigation measures called for in the applicable authorization(s) can be implemented.
Information to be recorded by PSOs will include:
• Species, group size, age/size/sex categories (if determinable), physical description of features that were observed or determined not to be present in the case of unknown or unidentified animals;
• Behavior when first sighted and after initial sighting;
• Heading (if consistent), bearing and distance from observer;
• Apparent reaction to activities (
• Time, location, speed, and activity of the vessel, sea state, ice cover, visibility, and sun glare; and
• Positions of other vessel(s) (if present) in the vicinity of the observer location.
The vessel's position, speed, water depth, sea state, ice cover, visibility, and sun glare will also be recorded at the start and end of each observation watch, every 30 minutes during a watch, and whenever there is a change in any of those variables.
Passive acoustic monitoring (PAM) will be conducted to document ambient noise conditions, to examine the spatial and temporal distribution of marine mammals based on acoustic detections of their vocalizations, and to characterize the long-range propagation of sounds produced during the geohazard survey. The goal of the program is to address knowledge gaps about ambient sound levels and the distributions and migration paths of several marine mammal species including bowhead whales, beluga whales, and seals.
The acoustic data will be collected with Autonomous Multichannel Acoustic Recorder (AMAR) systems deployed on the seabed for an extended period. Two AMARs with different sampling rates will be deployed on the seabed for 3 months. An AMAR with a sampling rate of 64 kHz (24 bits) will be deployed at 500 m from the offshore end of the survey line and will record continuously. A high-frequency AMAR with a sampling rate of 380 kHz (16 bits) will be deployed at 5,000 m from the offshore end of the survey line. This high-frequency AMAR will be operated at 380 kHz (16 bits) for 2 minutes each hour and the rest of the time at 64 kHz (24 bits). The AMARs will be calibrated using pistonphone calibrators immediately before and after each deployment. These calibrations are accurate to less than 0.5 dB absolute.
The MMPA requires that monitoring plans be independently peer reviewed “where the proposed activity may affect the availability of a species or stock for taking for subsistence uses” (16 U.S.C. 1371(a)(5)(D)(ii)(III)). Regarding this requirement, NMFS' implementing regulations state, “Upon receipt of a complete monitoring plan, and at its discretion, [NMFS] will either submit the plan to members of a peer review panel for review or within 60 days of receipt of the proposed monitoring plan, schedule a workshop to review the plan” (50 CFR 216.108(d)).
NMFS has established an independent peer review panel to review Hilcorp's 4MP for the proposed shallow geohazard survey in the Beaufort Sea. The panel has met in early March 2015, and provided comments and recommendations to NMFS in April 2015. The full panel report can be viewed on the Internet at:
NMFS provided the panel with Hilcorp's IHA application and monitoring plan and asked the panel to answer the following questions:
1. Will the applicant's stated objectives effectively further the understanding of the impacts of their activities on marine mammals and otherwise accomplish the goals stated above? If not, how should the objectives be modified to better accomplish the goals above?
2. Can the applicant achieve the stated objectives based on the methods described in the plan?
3. Are there technical modifications to the proposed monitoring techniques and methodologies proposed by the applicant that should be considered to better accomplish their stated objectives?
4. Are there techniques not proposed by the applicant (
5. What is the best way for an applicant to present their data and results (formatting, metrics, graphics, etc.) in the required reports that are to be submitted to NMFS (
The peer-review panel report contains recommendations that the panel members felt were applicable to the Hilcorp' monitoring plans. The panel believes that the objectives for both vessel-based and passive acoustic monitoring are appropriate, and agrees that the objective of real-time mitigation of potential disturbance of marine mammals would be met through visual monitoring. Nevertheless, the panel is concerned that there may also be behavioral effects resulting from the use of single and multi-beam echosounders and side-scan sonar that may warrant real-time mitigation to avoid disturbance, and provide a series of recommendations to improve efficiencies and effectiveness of monitoring and mitigation measures.
Specific recommendations provided by the peer review panel to enhance marine mammal monitoring and reporting measures are:
(1) Deploying an additional observer on the source vessel such that at least two observers are on watch during all daylight hours;
(2) Monitoring for marine mammals also be conducted during non-survey activities to assist in the collection of baseline information from which to analyze the effects of the activities;
(3) Deploying a third autonomous multichannel acoustic recorder (AMAR) and arrange the AMARs in a triangular array, as depicted in Figure 1 of the panel report, with the 500 m AMAR be a high-frequency AMAR, for marine mammal monitoring;
(4) Using AMAR to collect data on cumulative sound exposure level over 24 hours (cSEL
(5) Ground-truthing data collected by AMARs in consultation with biologists experienced in Arctic species vocalizations and to include error rates for automatic detection to ensure the
(6) Collaborating with other entities collecting data on marine mammal vocalizations in the Beaufort Sea to improve auto-detection and manual capabilities for identifying species in which acoustic data are limited or lacking (
(7) Including information from high frequency acoustic recordings in reports to provide a better understanding of source levels and other acoustic characteristics of the active acoustics survey equipment, such as spectral content, and received levels in root-mean-squared (RMS) dB, sound exposure level (SEL), dB peak to peak and
In addition, although not requested by NMFS under the MMPA, the panel also provided several mitigation measures. These recommendations are:
(1) Hilcorp limit operations at night or during periods of low visibility so that marine mammals do not enter the safety zone undetected;
(2) Hilcorp specify that the delay for ramp-up and after a shut-down should be 15 minutes for species with short dive durations (small odontocetes and pinnipeds) and 30 minutes for species with longer diver durations (mysticetes and large odontocetes, including beluga whales);
(3) Additional sound source information from the various active acoustic equipment proposed for the survey be obtained by maneuvering the source vessels over the high frequency AMARs; and
(4) Hilcorp conduct the survey starting closest to shore and proceeding offshore to avoid any potential “herding” effect of marine mammals into shallow waters, as was implicated in a mass stranding of melon headed whales off Madagascar during a multi-beam echosounder survey (Southall et al. 2013).
NMFS discussed these recommendations with Hilcorp to improve its monitoring and reporting measures, and to some extent, as well as mitigation measures. As a result, Hilcorp agrees to implement the following recommendations:
(1) Hilcorp will perform vessel-based marine mammal monitoring by protected species observers (PSOs) during vessel transit when the shallow geohazard survey is not being conducted. Marine mammal sighting data collected during the non-survey period will be compared with those during the survey to analyze the effects of the activities.
(2) Hilcorp and its contractor JASCO will deploy a high-frequency AMAR at the 5000 m site for detecting beluga clicks. The high-frequency AMAR would be operated at 380 kHz (16 bits) for about 2 minutes each hour and the rest of the time at 64 kHz (24 bits) for the 3 months deployment. The reason for deploying the high-frequency AMAR at 5000 m location, which NMFS concurs, is that there is a higher likelihood of detecting marine mammal acoustics in the deeper water farther from the island.
(3) Hilcorp will work with JASCO to use AMAR to collect data on cumulative sound exposure level over 24 hours (cSEL
(4) Hilcorp will work with JASCO to ground-truth data collected by AMARs in consultation with biologists experienced in Arctic species vocalizations and to include error rates for automatic detection to ensure the accurate classification of vocalizations by species.
(5) Hilcorp is open to sharing data and work with its contractor JASCO to collaborate with other researchers. In addition, Hilcorp and JASCO will make the passive acoustic recording data, including data on marine mammal vocalizations, publically available for researchers. These data sharing/collaboration efforts will enable scientists to purse a variety of studies concerning the acoustic environment, marine mammal bioacoustics, and potential activity effects on marine mammals in the survey area.
(6) Hilcorp will including information from high frequency acoustic recordings in reports to provide a better understanding of source levels and other acoustic characteristics of the active acoustics survey equipment, such as spectral content, and received levels in root-mean-squared (RMS) dB, sound exposure level (SEL), dB peak to peak and
Furthermore, Hilcorp agrees to implement the following mitigation recommendation and provided additional information in regard to the peer-review panel report:
(1) Hilcorp will specify that the delay for ramp-up and after a shut-down should be 15 minutes for species with short dive durations (small odontocetes and pinnipeds) and 30 minutes for species with longer diver durations (mysticetes and large odontocetes, including beluga whales).
(2) Regarding sound source information from the various active acoustic equipment proposed for Hilcorp's shallow geohazard survey, acoustic characteristics of these equipment or its equivalents were previously measured by JASCO. The measurement results in the following reports that are posted on NMFS Web site:
• Statoil 2011 Shallow Hazards Survey 90-day Report (Chapter 3) (
• Shell 2013 Shallow Hazards Survey 90-day Report (Chapter 2) (
(3) Regarding the panel's recommendation on Hilcorp's survey transect design, Hilcorp states that it can start in shallow water and work deeper to mitigate the potential “herding” effect. Hilcorp's plan is to divide the corridor into multiple sub-sections based on depth and work each section independently. This method is necessary for side scan sonar operations as each subsection will have a different range setting and line spacing that is related to depth.
All these aforementioned recommendations from the peer-review panel are included in the proposed mitigation and monitoring measures for Hilcorp's 2015 open-water shallow geohazard survey in the Beaufort Sea.
However, Hilcorp will not able to increase the number of vessel-based PSOs onboard the survey vessel. The number of PSOs onboard the vessel is limited by the available berth space. The survey vessels used for the proposed shallow geohazard survey can only accommodate maximum of 2 PSOs. Nevertheless, NMFS considers that due to the exceptionally small ensonified zones (no exclusion zone, with the radius of ZOI at 30 m from the source), one PSO on watch onboard the survey vessel is adequate.
In regard to an additional AMAR to be deployed in the vicinity of the survey area, NMFS worked with Hilcorp and determined that deployment of three AMARs would be cost prohibitive to Hilcorp, given the small project budget of the shallow geohazard survey. In addition, due to the short duration and minimal impact of the proposed shallow geohazard survey, the currently passive acoustic monitoring, improved with a high-frequency AMAR, is adequate to provide needed information to assess potential environmental effects from the proposed project.
Finally, NMFS does not agree with one of the panel's recommendations that Hilcorp limit operations at night or during periods of low visibility so that marine mammals do not enter the safety zone undetected. As mentioned previously, there is not no safety zone (exclusion zone) because of the low intensity high-frequency sonar
The results of Hilcorp's 2015 vessel-based monitoring, including estimates of “take” by harassment, will be presented in a “90-day” draft Technical Report, to be submitted to NMFS within 90 days after the end of the shallow geohazard survey, and then in a final Technical Report, which will address any comments NMFS had on the draft. The Technical Report will include:
(a) Summaries of monitoring effort (
(b) Analyses of the effects of various factors influencing detectability of marine mammals (
(c) Species composition, occurrence, and distribution of marine mammal sightings, including date, water depth, numbers, age/size/gender categories (if determinable), group sizes, and ice cover;
(d) Data analysis separated into periods when a sonar source is operating and when it is not, to better assess impacts to marine mammals—the final and comprehensive report to NMFS should summarize and plot:
• Data for periods when a sonar source is active and when it is not; and
• The respective predicted received sound conditions over fairly large areas (tens of km) around operations;
(e) Sighting rates of marine mammals during periods with and without sonar activities (and other variables that could affect detectability), such as:
• Initial sighting distances versus sonar activity state;
• Closest point of approach versus sonar activity state;
• Observed behaviors and types of movements versus sonar activity state;
• Numbers of sightings/individuals seen versus sonar activity state;
• Distribution around the survey vessel versus sonar activity state; and
• Estimates of take by harassment;
(f) Results from all hypothesis tests, including estimates of the associated statistical power, when practicable;
(g) Estimates of uncertainty in all take estimates, with uncertainty expressed by the presentation of confidence limits, a minimum-maximum, posterior probability distribution, or another applicable method, with the exact approach to be selected based on the sampling method and data available; and
(h) A clear comparison of authorized takes and the level of actual estimated takes.
In addition, the technical report will include analysis on acoustic monitoring such as:
(a) Cumulative sound exposure level over 24 hours (cSEL
(b) Ground-truth of data collected by AMARs in consultation with biologists experienced in Arctic species vocalizations with error rates for automatic detection to ensure the accurate classification of vocalizations by species; and
(c) Information of source levels and other acoustic characteristics of the active acoustics survey equipment, such as spectral content, and received levels in root-mean-squared (RMS) dB, sound exposure level (SEL), dB peak to peak and
Finally, Hilcorp will share data and work with its contractor JASCO to collaborate with other researchers. The passive acoustic recording data, including data on marine mammal vocalizations, will be made publically available for researchers. These data sharing/collaboration efforts will enable scientists to purse a variety of studies concerning the acoustic environment, marine mammal bioacoustics, and potential activity effects on marine mammals in the survey area.
In the unanticipated event that the specified activity clearly causes the take of a marine mammal in a manner prohibited by the IHA, such as a serious injury, or mortality (
• Time, date, and location (latitude/longitude) of the incident;
• Name and type of vessel involved;
• Vessel's speed during and leading up to the incident;
• Description of the incident;
• Status of all sound source use in the 24 hours preceding the incident;
• Water depth;
• Environmental conditions (
• Description of all marine mammal observations in the 24 hours preceding the incident;
• Species identification or description of the animal(s) involved;
• Fate of the animal(s); and
• Photographs or video footage of the animal(s) (if equipment is available).
Activities would not resume until NMFS is able to review the circumstances of the prohibited take. NMFS would work with Hilcorp to determine what is necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. Hilcorp would not be able to resume its activities until notified by NMFS via letter, email, or telephone.
In the event that Hilcorp discovers a dead marine mammal, and the lead PSO determines that the cause of the death is unknown and the death is relatively recent (
In the event that Hilcorp discovers a dead marine mammal, and the lead PSO determines that the death is not associated with or related to the activities authorized in the IHA (
Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment]. Only take by Level B behavioral harassment is anticipated as a result of the proposed shallow geohazard survey. Noise propagation from subbottom profilers is expected to harass, through behavioral disturbance, affected marine mammal species or stocks.
The full suite of potential impacts to marine mammals from various industrial activities was described in detail in the “Potential Effects of the Specified Activity on Marine Mammals” section found earlier in this document. The potential effects of sound from the proposed shallow geohazard survey without any mitigation might include one or more of the following: Tolerance; masking of natural sounds; behavioral disturbance; non-auditory physical effects; and, at least in theory, temporary or permanent hearing impairment (Richardson
For impulsive sounds, such as the signals produced by the subbottom profiler sources during the shallow geohazard survey, NMFS uses a received level of 160-dB (rms) to indicate the onset of Level B harassment. Hilcorp provided calculations of the 160-dB isopleth produced by the subbottom profiler and then used that isopleth to estimate takes by harassment. Hilcorp provides a full description of the methodology used to estimate takes by harassment in its IHA application (see
Hilcorp has requested authorization to take bowhead, gray, humpback, minke, killer, and beluga whales, harbor porpoise, and ringed, spotted, bearded, and ribbon seals incidental to shallow geohazard survey in the Beaufort Sea. However, as stated previously in this document, humpback, minke, and killer whales, harbor porpoise, and ribbon seal are considered extralimital in the proposed shallow geohazard survey area. Therefore, NMFS is not proposing to authorize take of these species.
“Take by Harassment” is described in this section and was calculated in Hilcorp's application by multiplying the expected densities of marine mammals that may occur near the shallow geohazard survey areas where received noise levels are higher than 160 dB re 1 μPa (rms) created by the subbottom profiler during the survey.
Whale species are migratory and therefore show a seasonal distribution, with different densities for the summer period (covering July and August) and the fall period (covering September and October). Seal species in the Beaufort Sea do not show a distinct seasonal distribution during the open water period between July and October. Data acquisition of the proposed sonar survey will only take place in summer (before start of Nuiqsut whaling), therefore only estimates of marine mammal densities for the summer are included in the take calculation. Whale and seal densities in the Beaufort Sea will further depend on the presence of sea ice. However, if ice cover within or close to the sonar survey area is more than approximately 10%, sonar survey activities may not start or be halted for safety reasons. Densities related to ice conditions are therefore not included in the take estimates.
Spatial differentiation is another important factor for marine mammal densities, both in latitudinal and longitudinal gradient. Taking into account the shallow water operations of the proposed sonar survey area and the associated area of influence, data from the nearshore zone of the Beaufort Sea is used for the calculation of densities, if available.
Density estimates are based on best available data. Because available data did not always cover the area of interest, estimates are subject to large temporal and spatial variation. Though correction factors for perception and availability bias have been calculated for certain coastal areas they were not always known for this study area. There is some uncertainty in the 2014 raw data and assumptions were used in the estimated number of exposures. To provide allowance for these uncertainties, maximum density estimates have been provided in addition to average density estimates.
A summary of marine mammal density in the proposed Hilcorp survey area is provided in Table 3.
As discussed earlier in this document, the operating frequencies of the multibeam, single-beam, and sidescan sonar equipment in Hilcorp's proposed shallow geohazard survey are above the hearing range of all marine mammals and therefore are not expected to have take of marine mammals. Estimated distance to sound pressure levels of 160 dB re 1 μPa, generated by the proposed sub-bottom equipment is 30 m from the source. However, as stated in this document earlier, Hilcorp proposes to implement a 50 m shutdown zone for the Level B behavioral harassment. Therefore, the calculation of marine mammal take is based on the number of animals exposed within the 50 m radius.
This section provides estimates of the number of individuals potentially exposed to pulsed sound levels ≥160 dB re 1 μPa rms by shallow geohazard survey using a subbottom profiler. The estimates are based on a consideration of the number of marine mammals that might be affected by operations in the Beaufort Sea during 2015 and the anticipated area exposed to those sound levels.
The potential number of bowhead whales and belugas that might be exposed to the 160 dB re 1 μPa (rms) sound pressure level was calculated by multiplying:
• The expected bowhead and beluga density as provided in Table 3;
• The total 160 dB re 1 μPa (rms) ensonified area in a single hour by the vessel travelling at 3 knots; and
• The estimated number of hours that the source vessels are operating.
The calculated area (0.0079 km
The estimated number of 24-hr days of sonar operations was determined by assuming a 25% downtime during the planned 45-day time span of the sonar survey period. Downtime is related to weather, equipment maintenance, mitigation implementation, and other circumstances. The total number of full 24-hr days that data acquisition is expected to occur is ~34 days or 816 hours.
The total 160 dB re 1 μPa (rms) ensonified area in a single hour by the vessel is calculated as 0.556 km
The average and maximum number of bowhead whales potentially exposed to sonar sound levels of 160 dB re 1μPa (rms) or more is estimated at 4 and 9 respectively. The limited number of exposures is due to the low estimated density of bowheads in Foggy Island Bay during July and August, the short duration of the survey, and the small acoustic footprint. For the requested authorization, the maximum number was increased by three to account for unexpected bowhead occurrences.
The average and maximum number of potential beluga exposures to 160 dB is <1. Belugas are known to show aggregate behavior and can occur in large numbers in nearshore zones, as evidenced by the sighting from Endicott in August 2013. Although beluga whales are not expected to frequent the vicinity of the Liberty Unit shallow geohazard survey area, their occurrence is still a possibility. To account for the potential average take of 1 beluga whale per day during the 45-day survey period, NMFS proposes a take authorization of 45 beluga whales for Hilcorp's shallow geohazard survey. Chance encounters with small numbers of other whale species are possible, but exposures to 160 dB or more are very unlikely for these species.
Although gray whale density is not known, this species has been occasionally sited in the Arctic, and Hilcorp is requesting takes of 3 individuals of gray whales by Level B behavioral harassment (Table 4).
The estimated number of seals that might be exposed to pulsed sounds of 160 dB re 1 μPa (rms) is calculated by multiplying:
• The expected species specific sighting rate as provided in Table 3; and
• The total number of hours that each source vessel will be operating during the data acquisition period.
The estimated number of hours that the sonar equipment will operate was determined by assuming a 25% downtime during a 45-day survey period, which is a total of 816 hours (34 days of 24 hour operations).
These estimated exposures do not take into account the mitigation measures that will be implemented, such as marine mammal observers watching for animals, shutdowns or power downs of the equipment when marine mammals are seen within defined ranges. These measures will further reduce the number of exposures and expected short-term reactions, and minimize any effects on hearing sensitivity.
A summary of the request takes and percent take among the population is provided in Table 4.
Negligible impact is “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival” (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (
No injuries or mortalities are anticipated to occur as a result of Hilcorp's proposed shallow geohazard survey, and none are proposed to be authorized. Additionally, animals in the area are not expected to incur hearing impairment (
Most of the marine mammals encountered will likely show overt disturbance (avoidance) only if they receive sonar sounds with levels ≥ 160 dB re 1 μPa. However, the estimated 160 dB zone is only 30 m from the source, which means that the animals have to be very close to the source vessel to be exposure to noise levels that could cause Level B harassment. In addition, Hilcorp will implement shutdown measures if a marine mammal is sighted within or is moving towards the 160 dB isopleths.
Taking into account the mitigation measures that are planned, effects on marine mammals are generally expected to be restricted to avoidance of a limited area around Hilcorp's proposed open-water activities and short-term changes in behavior, falling within the MMPA definition of “Level B harassment.” Mitigation measures, such as controlled vessel speed, dedicated marine mammal observers, non-pursuit, ramp up procedures, and shut downs or power downs when marine mammals are seen within or approaching the ZOI, will further reduce short-term reactions. In all cases, the effects are expected to be short-term, with no lasting biological consequence.
Of the six marine mammal species likely to occur in the proposed marine survey area, bowhead whale and ringed seal are listed as endangered and threatened under the ESA, respectively. These species are also designated as “depleted” under the MMPA. Despite these designations, the Bering-Chukchi-Beaufort stock of bowheads has been increasing at a rate of 3.4 percent annually for nearly a decade (Allen and Angliss 2010). Additionally, during the 2001 census, 121 calves were counted, which was the highest yet recorded. The calf count provides corroborating evidence for a healthy and increasing population (Allen and Angliss 2010). There is no critical habitat designated in the U.S. Arctic for the bowhead whales. The Arctic stock of ringed seals have been listed by NMFS as threatened under the ESA. None of the other species that may occur in the project area are listed as threatened or endangered under the ESA or designated as depleted under the MMPA.
Potential impacts to marine mammal habitat were discussed previously in this document (see the “Anticipated Effects on Habitat” section). Although some disturbance of food sources of marine mammals is possible, any impacts are anticipated to be minor enough as to not affect rates of recruitment or survival of marine mammals in the area. The marine survey activities would occur in a localized area, and given the vast area of the Arctic Ocean where feeding by marine mammals occurs, any missed feeding opportunities in the direct project area could be offset by feeding opportunities in other available feeding areas.
In addition, no important feeding or reproductive areas are known in the vicinity of Hilcorp's proposed shallow geohazard survey. No critical habitat of ESA-listed marine mammal species occurs in the Beaufort Sea.
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the proposed monitoring and mitigation measures, NMFS preliminarily finds that the total marine mammal take from Hilcorp's proposed shallow geohazard survey in the Beaufort Sea, Alaska, will have a negligible impact on the affected marine mammal species or stocks.
The requested takes proposed to be authorized represent less than 0.2% of all populations or stocks potentially impacted (see Table 4 in this document). These take estimates represent the percentage of each species or stock that could be taken by Level B behavioral harassment if each animal is taken only once. The numbers of marine mammals estimated to be taken are small proportions of the total populations of the affected species or stocks. In addition, the mitigation and monitoring measures (described previously in this document) proposed for inclusion in the IHA (if issued) are expected to reduce even further any potential disturbance to marine mammals.
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the mitigation and monitoring measures, NMFS preliminarily finds that small numbers of marine mammals will be taken relative to the populations of the affected species or stocks.
Marine mammals are legally hunted in Alaskan waters by coastal Alaska Natives and represent between 60% and 80% of their total subsistence harvest. The species regularly harvested by subsistence hunters in and around the Beaufort Sea are bowhead and beluga whales, and ringed, spotted, and bearded seals. The importance of each of the subsistence species varies among the communities and is mainly based on availability and season.
The communities closest to the project area are, from west to east, the villages of Barrow, Nuiqsut and Kaktovik. Barrow is located >200 mi west from the Hilcorp's proposed survey area. It is the largest community on the Alaska's Beaufort Sea coast. Important marine subsistence resources for Barrow include bowhead and beluga whales, and ice seals. Nuiqsut is located near the mouth of the Colville River, about 55 mi southwest of the proposed project area. Most important marine subsistence resource for Nuiqsut is the bowhead whale, and to a lesser extent belugas and seals. Nuiqsut hunters use Cross Island, (~20 mi northwest of the project area) as a base to hunt for bowhead whales during the fall migration and have historically hunted bowhead whales as far east as Flaxman Island. Kaktovik is located on Barter Island, about 120 mi east of the project area. Major marine subsistence resources include bowhead and beluga whales, and seals.
The bowhead whale is a critical subsistence and cultural resource for the North Slope communities of Barrow, Nuiqsut, and Kaktovik. The level of allowable harvest is determined under a quota system in compliance with the International Whaling Commission (IWC 1980; Gambell 1982). The quota is based on the nutritional and cultural needs of Alaskan Natives as well as on estimates of the size and growth of the Bering-Chukchi-Beaufort seas stock of bowhead whales (Donovan 1982; Braund 1992). The AEWC allots the number of bowhead whales that each community is permitted to harvest. Contemporary whaling in Kaktovik dates from 1964 and in Nuiqsut from 1973 (EDAW/AECOM 2007; Galginaitis and Koski 2002). The number of boats used or owned in 2011 by the subsistence whaling crew of the villages of Kaktovik, Nuiqsut, and Barrow was 8, 12, and 40, respectively. These numbers presumably change from year to year.
Bowhead harvesting in Barrow occurs both during the spring (April-May) and fall (September-October) when the whales migrate relatively close to shore (ADNR 2009). During spring bowheads migrate through open ice leads close to shore. The hunt takes place from the ice using umiaks (bearded seal skin boats). During the fall, whaling is shore-based and boats may travel up to 30 mi a day (EDAW/AECOM 2007). In Barrow, most whales were historically taken during spring whaling. More recently, however, the efficiency of the spring harvest appeared to be lower than the autumn harvest due to ice and weather conditions as well as struck whales escaping under the ice (Suydam
Nuiqsut and Kaktovik hunters harvest bowhead whales only during the fall. The bowhead spring migration in the Beaufort Sea occurs too far from shore for hunting because ice leads do not open up nearshore (ADNR 2009). In Nuiqsut, whaling takes place from early September through mid-to-late September as the whales migrate west (EDAW/AECOM 2007). Three to five whaling crews base themselves at Cross Island, a barrier island approximately 20 mi northwest of the Liberty Unit shallow geohazard survey area. Nuiqsut whalers harvest an average of 2 bowheads each year. Whaling from Kaktovik also occurs in the fall, primarily from late August through late September or early October (EDAW/AECOM 2007). Kaktovik whalers hunt from the Okpilak and Hulahula rivers east to Tapkaurak Point (ADNR 2009). Whaling activities are staged from the community rather than remote camps; most whaling takes place within 12 mi of the community (ADNR 2009). Kaktovik whalers harvest an average of 2-3 bowhead whales each year.
The harvest of belugas is managed cooperatively through an agreement between NMFS and the Alaska Beluga Whale Committee (ABWC). From 2005-2009, between 5 and 48 belugas were harvested annually from the Beaufort Sea stock (Allen and Angliss 2014); with a mean annual take of 25.8 animals. Both Nuiqsut and Kaktovik harvest few belugas, mostly opportunistically during the fall bowhead hunt.
Seals represent an important subsistence resource for the North Slope communities. Harvest of bearded seals usually takes place during the spring and summer open water season from Barrow (EDAW/AECOM 2007) with only a few animals taken by hunters from Kaktovik or Nuiqsut. Seals are also taken during the ice-covered season, with peak hunting occurring in February (ADNR 2009). In 2003, Barrow-based hunters harvested 776 bearded seals, 413 ringed seals and 12 spotted seals (ADNR 2009). Nuiqsut hunters harvest seals in an area from Cape Halkett to Foggy Island Bay. For the period 2000-2001, Nuiqsut hunters harvested one bearded seal and 25 ringed seals (ADNR 2009). Kaktovik hunters also hunt seals year-round. In 2002-2003, hunters harvested 8 bearded seals and 17 ringed seals.
NMFS has defined “unmitigable adverse impact” in 50 CFR 216.103 as: “an impact resulting from the specified activity: (1) That is likely to reduce the availability of the species to a level insufficient for a harvest to meet subsistence needs by: (i) Causing the marine mammals to abandon or avoid hunting areas; (ii) Directly displacing subsistence users; or (iii) Placing physical barriers between the marine mammals and the subsistence hunters; and (2) That cannot be sufficiently mitigated by other measures to increase the availability of marine mammals to allow subsistence needs to be met.
The proposed shallow geohazard survey will take place between July 1 and September 30, 2015, with data acquisition occurring in July and August. The project area is located >200 mi east from Barrow, approximately 55 mi northeast from Nuiqsut (20 mi southeast of Cross Island), and 120 mi west from Kaktovik. Potential impact on the subsistence hunt from the planned activities is expected mainly from sounds generated by sonar equipment. Due to the timing of the project and the distance from the surrounding communities, there will be no effects on spring harvesting and little or no effects on the occasional summer harvest of beluga and subsistence seal hunts (ringed and spotted seals are primarily harvested in winter while bearded seals are hunted during July-September in the Beaufort Sea). The community of
Regulations at 50 CFR 216.104(a)(12) require IHA applicants for activities that take place in Arctic waters to provide a Plan of Cooperation (POC) or information that identifies what measures have been taken and/or will be taken to minimize adverse effects on the availability of marine mammals for subsistence purposes.
Hilcorp has prepared a draft POC and is currently establishing a dialogue to coordinate activities with the villages. A POC will include the aforementioned mitigation measures and includes plans for and results of meetings with Alaska Native communities.
Liberty Unit was transferred to Hilcorp ownership along with the Northstar, Milne Point and Endicott facilities. Previously, BP Exploration, Alaska (BPXA) coordinated with communities and stakeholders regarding the Liberty Unit work during the 2014 season:
• December 13-14, 2012: Meeting with the Alaska Eskimo Whaling Commission (AEWC) and Whaling Captains' Associations during the AEWC Quarterly meeting in Anchorage.
• February 7-8, 2013: CAA discussions with AEWC and Whaling Captains' Associations during the AEWC Annual Convention in Barrow.
Hilcorp plans to continue attending the above meetings and has engaged stakeholders and Native community members throughout 2014. A list of meetings follows:
• Informal engagement with AEWC—July 2014
• Meeting with Native Village of Barrow leadership—August 2014
• Meeting with North Slope Borough (NSB) Wildlife Management Dept.—August 2014
• Meeting with NSB Assembly—August 2014
• Meeting with NSB Planning Commission—October 2014
• Presentation and discussion with AEWC—October 2014
• Meeting with NSB Jacob Adams and NSB Counsel—October 2014
• Cultural awareness/subsistence presentation and Q&A with Uum's Consulting—October 2014
Additional pre-season meetings maybe planned if needed to address additional requests for coordination. Any subsistence discussions will be documented and forwarded to the NMFS as part of the POC.
Hilcorp has begun discussions with the AEWC to develop a Conflict Avoidance Agreement (CAA) intended to minimize potential interference with bowhead subsistence hunting. Hilcorp will attend and participate in the CAA meetings scheduled in 2015. The CAA, when executed, will describe measures to minimize any adverse effects on the availability of bowhead whales for subsistence uses.
The North Slope Borough Department of Wildlife Management (NSB-DWM) was consulted, and the project was also presented to the NSB Planning Commission in January 2015. Hilcorp will hold meetings with key stakeholders in the community of Nuiqsut, Barrow, and Kaktovik to present the proposed project, address questions and concerns, and provide them with contact information of project management to which they can direct concerns during the survey.
The following are measures that Hilcorp will take to reduce impacts to the subsistence community:
• Hilcorp will comply with the CAA terms to address plans to meet with the affected community to resolve conflicts and notify the communities of any changes in the operation.
• Inupiat Marine Mammal Observers on board the vessels are tasked with looking out for whales and other marine mammals in the vicinity of the vessel to assist the vessel captain in avoiding harm to whales and other marine mammals.
• Vessels will be operated in a manner to avoid areas where species that are sensitive to noise or movement are concentrated at times when such species are concentrated.
• Communications and conflict resolution are detailed in the CAA. Hilcorp is planning to participate in the Communications Center that is operated annually during the bowhead subsistence hunt.
• Communications with the villages of Barrow, Kaktovik, and Nuiqsut—discuss community questions or concerns including all subsistence hunting activities.
Hilcorp plans to engage with the relevant subsistence communities regarding its future Beaufort Sea activities. With regard to the 2015 Liberty Unit shallow geohazard survey project, Hilcorp will present the data on marine mammal sightings and the results of the marine mammal monitoring and mitigation as part of our 90-day report to the regulatory authorities.
NMFS considers that these mitigation measures including measures to reduce overall impacts to marine mammals in the vicinity of the proposed shallow geohazard survey area and measures to mitigate any potential adverse effects on subsistence use of marine mammals are adequate to ensure subsistence use of marine mammals in the vicinity of Hilcorp's proposed survey in the Beaufort Sea.
Based on the description of the specified activity, the measures described to minimize adverse effects on the availability of marine mammals for subsistence purposes, and the proposed mitigation and monitoring measures, NMFS has preliminarily determined that there will not be an unmitigable adverse impact on subsistence uses from Hilcorp's proposed activities.
There are two marine mammal species listed as endangered under the ESA with confirmed or possible occurrence in the proposed project area: The bowhead whale and ringed seal. NMFS' Permits and Conservation Division has initiated consultation with NMFS' Endangered Species Division under section 7 of the ESA on the issuance of an IHA to Hilcorp under section 101(a)(5)(D) of the MMPA for this activity. Consultation will be concluded prior to a determination on the issuance of an IHA.
NMFS is preparing an Environmental Assessment (EA), pursuant to NEPA, to determine whether the issuance of an IHA to Hilcorp for its 2015 shallow geohazard activities may have a significant impact on the human environment. NMFS has released a draft of the EA for public comment along with this proposed IHA.
As a result of these preliminary determinations, NMFS proposes to issue an IHA to Hilcorp for conducting shallow geohazard survey in the Beaufort Sea during the 2015 Arctic open-water season, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated. The proposed IHA language is provided next.
This section contains a draft of the IHA itself. The wording contained in this section is proposed for inclusion in the IHA (if issued).
(1) This Authorization is valid from July 1, 2015, through September 30, 2015.
(2) This Authorization is valid only for activities associated with Hilcorp's 2015 Beaufort Sea shallow geohazard survey. The specific area where Hilcorp's shallow geohazard survey will be conducted lies within Foggy Island Bay in the U.S. Beaufort Sea, as shown in Figure 1 of Hilcorp's IHA application.
(3)(a) The incidental taking of marine mammals, by Level B harassment only, is limited to the following species: Bowhead whale; gray whale; beluga whale; ringed seal; bearded seal; and spotted seal, as shown in Table 4.
(3)(b) The authorization for taking by harassment is limited to the following acoustic sources and from the following activities:
(i) Sonar sources used for shallow geohazard survey; and
(ii) Vessel activities related to the shallow geohazard survey.
(3)(c) The taking of any marine mammal in a manner prohibited under this Authorization must be reported within 24 hours of the taking to the Alaska Regional Administrator (907-586-7221) or his designee in Anchorage (907-271-3023), National Marine Fisheries Service (NMFS) and the Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS, at (301) 427-8401, or her designee (301-427-8418).
(4) The holder of this Authorization must notify the Chief of the Permits and Conservation Division, Office of Protected Resources, at least 48 hours prior to the start of shallow geohazard survey (unless constrained by the date of issuance of this Authorization in which case notification shall be made as soon as possible).
(a) The taking, by incidental harassment only, is limited to the species listed under condition 3(a) above and by the numbers listed in Table 4. The taking by injury or death of these species or the taking by harassment, injury or death of any other species of marine mammal is prohibited and may result in the modification, suspension, or revocation of this Authorization.
(b) The taking of any marine mammal is prohibited whenever the required source vessel protected species observers (PSOs), required by condition 7(a)(i), are not onboard in conformance with condition 7(a)(i) of this Authorization.
(a) Establishing Zone of Influence (ZOI)
(i) Establish and monitor with trained PSOs a ZOI zone surrounding the sub-bottom profiler on the source vessel where the received level would be 160 dB (rms) re 1 µPa for all marine mammals.
(ii) The sizes of the ZOI is 50 m radius from the source vessel.
(b) Vessel Movement Mitigation:
(i) Avoid concentrations or groups of whales by all vessels under the direction of Hilcorp.
(ii) If any vessel approaches within 1.6 km (1 mi) of observed bowhead whales, except when providing emergency assistance to whalers or in other emergency situations, the vessel operator will take reasonable precautions to avoid potential interaction with the bowhead whales by taking one or more of the following actions, as appropriate:
(A) Reducing vessel speed to less than 5 knots within 300 yards (900 feet or 274 m) of the whale(s);
(B) Steering around the whale(s) if possible;
(C) Operating the vessel(s) in such a way as to avoid separating members of a group of whales from other members of the group;
(D) Operating the vessel(s) to avoid causing a whale to make multiple changes in direction; and
(E) Checking the waters immediately adjacent to the vessel(s) to ensure that no whales will be injured when the propellers are engaged.
(iii) When weather conditions require, such as when visibility drops, adjust vessel speed accordingly, but not to exceed 5 knots, to avoid the likelihood of injury to whales.
(iv) In general, the survey design will start in shallow water and work deeper to mitigate the potential “herding” effect.
(c) Mitigation Measures for Sonar Sources
(i) Ramp-up:
(A) A ramp up, following a cold start, can be applied if the ZOI has been free of marine mammals for a consecutive 30-minute period. The entire ZOI must have been visible during these 30 minutes. If the entire ZOI is not visible, then ramp up from a cold start cannot begin.
(B) If a marine mammal(s) is sighted within the ZOI during the 30-minute watch prior to ramp up, ramp up will be delayed until the marine mammal(s) is sighted outside of the ZOI or the animal(s) is not sighted for at least 15 minutes for pinnipeds, or 30 minutes for cetaceans.
(C) If, for any reason, the sub-bottom profiler has been discontinued for a period of 10 minutes or more, ramp-up procedures shall be implemented. If the PSO watch has been suspended during that time, a 30-minute clearance of the ZOI is required prior to commencing ramp-up. Discontinuation of sonar activity for less than 10 minutes does not require a ramp-up.
(D) The survey operator and PSOs shall maintain records of the times when ramp-ups start and when the sub-bottom profiler reaches full power.
(ii) Power-down/Shutdown:
(A) The sub-bottom profiler shall be immediately powered down whenever a marine mammal is sighted approaching close to or within the sub-bottom profiler at full power, but is outside the ZOI of the sub-bottom profiler at reduced power.
(B) If a marine mammal is already within or is about to enter the ZOI when first detected, the sub-bottom profiler shall be shutdown immediately.
(C) After showdown for more than 10 minutes, ramp-up shall not start until after the marine mammal is visually seen left the ZOI; or 15 minutes have passed after the last detection of the marine mammal with shorter dive durations (pinnipeds and small odontocetes); or 30 minutes have passed after the last detection of the marine mammal with longer diver durations (mysticetes and large odontocetes, including beluga whales).
(iii) Poor Visibility Conditions:
(A) If during foggy conditions, heavy snow or rain, or darkness, the full 160 dB ZOI is not visible, the sub-bottom profiler cannot commence a ramp-up procedure from a full shut-down.
(B) If the sub-bottom profiler has been operational before nightfall or before the onset of poor visibility conditions, they can remain operational throughout the night or poor visibility conditions.
(iv) Firing Sub-bottom Profiler During Turns and Transits
(A) Throughout the shallow geohazard survey, during turning movements and short transits, Hilcorp will employ the use of the lowest setting for the sub-bottom profiler to deter marine mammals from being within the immediate area of the survey. The sub-bottom profiler would be operated at approximately one shot per minute and would not be operated for longer than three hours in duration.
(d) Mitigation Measures for Subsistence Activities:
(i) For the purposes of reducing or eliminating conflicts between
(ii) All vessels shall report to the appropriate Com-Center at least once every six hours, commencing each day with a call at approximately 06:00 hours.
(iii) The appropriate Com-Center shall be notified if there is any significant change in plans. The appropriate Com-Center also shall be called regarding any unsafe or unanticipated ice conditions.
(iv) Upon notification by a Com-Center operator of an at-sea emergency, the holder of this Authorization shall provide such assistance as necessary to prevent the loss of life, if conditions allow the holder of this Authorization to safely do so.
(v) Hilcorp shall monitor the positions of all of its vessels and exercise due care in avoiding any areas where subsistence activity is active.
(vi) Routing barge and transit vessels:
(A) Vessels transiting in the Beaufort Sea east of Bullen Point to the Canadian border shall remain at least 5 miles offshore during transit along the coast, provided ice and sea conditions allow.
(B) From August 31 to October 31, vessels in the Chukchi Sea or Beaufort Sea shall remain at least 20 miles offshore of the coast of Alaska from Icy Cape in the Chukchi Sea to Pitt Point on the east side of Smith Bay in the Beaufort Sea, unless ice conditions or an emergency that threatens the safety of the vessel or crew prevents compliance with this requirement. This condition shall not apply to vessels actively engaged in transit to or from a coastal community to conduct crew changes or logistical support operations.
(C) Vessels shall be operated at speeds necessary to ensure no physical contact with whales occurs, and to make any other potential conflicts with bowheads or whalers unlikely. Vessel speeds shall be less than 10 knots in the proximity of feeding whales or whale aggregations.
(D) If any vessel inadvertently approaches within 1.6 kilometers (1 mile) of observed bowhead whales, except when providing emergency assistance to whalers or in other emergency situations, the vessel operator will take reasonable precautions to avoid potential interaction with the bowhead whales by taking one or more of the following actions, as appropriate:
• Reducing vessel speed to less than 5 knots within 900 feet of the whale(s);
• Steering around the whale(s) if possible;
• Operating the vessel(s) in such a way as to avoid separating members of a group of whales from other members of the group;
• Operating the vessel(s) to avoid causing a whale to make multiple changes in direction; and
• Checking the waters immediately adjacent to the vessel(s) to ensure that no whales will be injured when the propellers are engaged.
(vii) Hilcorp shall complete operations in time to allow such vessels to complete transit through the Bering Strait to a point south of 59 degrees North latitude no later than November 15, 2015. Any vessel that encounters weather or ice that will prevent compliance with this date shall coordinate its transit through the Bering Strait to a point south of 59 degrees North latitude with the appropriate Com-Centers. Hilcorp vessels shall, weather and ice permitting, transit east of St. Lawrence Island and no closer than 10 miles from the shore of St. Lawrence Island.
(a) Vessel-based Visual Monitoring:
(i) Vessel-based visual monitoring for marine mammals shall be conducted by NMFS-approved PSOs throughout the period of survey activities.
(ii) PSOs shall be stationed aboard the survey vessels through the duration of the surveys.
(iii) A sufficient number of PSOs shall be onboard the survey vessel to meet the following criteria:
(A) 100% monitoring coverage during all periods of survey operations in daylight;
(B) Maximum of 4 consecutive hours on watch per PSO; and
(C) Maximum of 12 hours of watch time per day per PSO.
(iv) The vessel-based marine mammal monitoring shall provide the basis for real-time mitigation measures as described in (6)(c) above.
(v) Results of the vessel-based marine mammal monitoring shall be used to calculate the estimation of the number of “takes” from the marine surveys and equipment recovery and maintenance program.
(i) PSO teams shall consist of Inupiat observers and NMFS-approved field biologists.
(ii) Experienced field crew leaders shall supervise the PSO teams in the field. New PSOs shall be paired with experienced observers to avoid situations where lack of experience impairs the quality of observations.
(iii) Crew leaders and most other biologists serving as observers in 2015 shall be individuals with experience as observers during recent seismic or shallow hazards monitoring projects in Alaska, the Canadian Beaufort, or other offshore areas in recent years.
(iv) Resumes for PSO candidates shall be provided to NMFS for review and acceptance of their qualifications. Inupiat observers shall be experienced in the region and familiar with the marine mammals of the area.
(v) All observers shall complete a training course designed to familiarize individuals with monitoring and data collection procedures. The training course shall be completed before the anticipated start of the 2015 open-water season. The training session(s) shall be conducted by qualified marine mammalogists with extensive crew-leader experience during previous vessel-based monitoring programs.
(vi) Crew members should not be used as primary PSOs because they have other duties and generally do not have the same level of expertise, experience, or training as PSOs, but they could be stationed on the fantail of the vessel to observe the near field, especially the area around the survey vessels, and implement a power-down or shutdown if a marine mammal enters the safety zone (or exclusion zone).
(vii) If crew members are to be used as PSOs, they shall go through some basic training consistent with the functions they will be asked to perform. The best approach would be for crew members and PSOs to go through the same training together.
(viii) PSOs shall be trained using visual aids (
(ix) Hilcorp shall train its PSOs to follow a scanning schedule that consistently distributes scanning effort according to the purpose and need for observations. All PSOs should follow the same schedule to ensure consistency in their scanning efforts.
(x) PSOs shall be trained in documenting the behaviors of marine mammals. PSOs should record the primary behavioral state (
(i) PSOs shall watch for marine mammals from the best available vantage point on the survey vessels, typically the bridge.
(ii) Observations by the PSOs on marine mammal presence and activity shall begin a minimum of 30 minutes prior to the estimated time that the sub-bottom profiler is to be turned on and/or ramped-up. Monitoring shall continue during the survey operations and last until 30 minutes after the sonar equipment stop firing.
(iii) For comparison purposes, PSOs shall also document marine mammal occurrence, density, and behavior during at least some periods when the sonar equipment used for survey is off.
(iv) PSOs will scan the area around the vessel systematically with reticle binoculars (
(v) Personnel on the bridge shall assist the marine mammal observer(s) in watching for marine mammals.
(vi) PSOs aboard the marine survey vessel shall give particular attention to the areas within the marine mammal ZOI around the source vessel, as noted in (6)(a)(i) and (ii). They shall avoid the tendency to spend too much time evaluating animal behavior or entering data on forms, both of which detract from their primary purpose of monitoring the exclusion zone.
(vii) Monitoring shall consist of recording of the following information:
(A) The species, group size, age/size/sex categories (if determinable), the general behavioral activity, heading (if consistent), bearing and distance from survey vessel, sighting cue, behavioral pace, and apparent reaction of all marine mammals seen near the survey vessel (
(B) The time, location, heading, speed, and activity of the vessel (sub-bottom profiler firing or not), along with sea state, visibility, cloud cover and sun glare at (I) any time a marine mammal is sighted (including pinnipeds hauled out on barrier islands), (II) at the start and end of each watch, and (III) during a watch (whenever there is a change in one or more variable);
(C) The identification of all vessels that are visible within 5 km of the survey vessel whenever a marine mammal is sighted and the time observed;
(D) Any identifiable marine mammal behavioral response (sighting data should be collected in a manner that will not detract from the PSO's ability to detect marine mammals);
(E) Any adjustments made to operating procedures; and
(F) Visibility during observation periods so that total estimates of take can be corrected accordingly.
(vii) Distances to nearby marine mammals will be estimated with binoculars containing a reticle to measure the vertical angle of the line of sight to the animal relative to the horizon. Observers may use a laser rangefinder to test and improve their abilities for visually estimating distances to objects in the water.
(viii) PSOs shall understand the importance of classifying marine mammals as “unknown” or “unidentified” if they cannot identify the animals to species with confidence. In those cases, they shall note any information that might aid in the identification of the marine mammal sighted. For example, for an unidentified mysticete whale, the observers should record whether the animal had a dorsal fin.
(ix) Additional details about unidentified marine mammal sightings, such as “blow only,” mysticete with (or without) a dorsal fin, “seal splash,” etc., shall be recorded.
(x) When a marine mammal is seen approaching or within the exclusion zone applicable to that species, the marine survey crew shall be notified immediately so that mitigation measures described in (6) can be promptly implemented.
(i) PSOs aboard the vessels shall maintain a digital log of shallow geohazard survey, noting the date and time of all changes in survey activity (ramp-up, power-down, shutdowns, etc.) and any corresponding changes in monitoring radii in a software spreadsheet.
(ii) PSOs shall utilize a standardized format to record all marine mammal observations and mitigation actions (sub-bottom profiler power-downs, shut-downs, and ramp-ups).
(iii) Information collected during marine mammal observations shall include the following:
(iv) Data shall be recorded directly into handheld computers or as a back-up, transferred from hard-copy data sheets into an electronic database.
(v) A system for quality control and verification of data shall be facilitated by the pre-season training, supervision by the lead PSOs, and in-season data checks, and shall be built into the software.
(vi) Computerized data validity checks shall also be conducted, and the data shall be managed in such a way that it is easily summarized during and after the field program and transferred into statistical, graphical, or other programs for further processing.
(i) Hilcorp shall conduct passive acoustic monitoring using fixed hydrophone(s) to
(A) Document ambient noise conditions;
(B) Examine the spatial and temporal distribution of marine mammals based on acoustic detections of their vocalizations; and
(C) Characterize the long-range propagation of sounds produced during the geohazard survey; and
(ii) Bottom-Mounted Acoustic Sensors:
(A) Recorders shall be capable of recording marine mammal sounds and making both ambient and anthropogenic noise measurements.
(B) Two recorders be deployed near the Liberty prospect and be aligned with the geohazard survey line, at distances of 500 m (AMAR with sampling rate of 64 kHz) and 5000 m (AMAR with sampling rate of 380 kHz) from the offshore end of the survey line.
(C) Recorders shall be located inside of the barrier islands.
(a) Estimation of potential takes or exposures shall be improved for times with low visibility (such as during fog or darkness) through interpolation or possibly using a probability approach. Those data could be used to interpolate possible takes during periods of restricted visibility.
(b) Hilcorp shall provide the information collected, plus a number of summary analyses and graphics to help NMFS assess the potential impacts of
(i) A table or other summary of survey activities (
(ii) A table of sightings by time, location, species, and distance from the survey vessel;
(iii) A geographic depiction of sightings for each species by area and month;
(iv) A table and/or graphic summarizing behaviors observed by species;
(v) A table and/or graphic summarizing observed responses to the survey by species;
(vi) A table of mitigation measures (
(vii) A graphic of sightings by distance for each species and location;
(viii) A table or graphic illustrating sightings during the survey versus sightings when the sub-bottom profiler was silent; and
(ix) A summary of times when the survey was interrupted because of interactions with marine mammals.
(c) Hilcorp shall collaborate with other industrial operators in the area to integrate and synthesize monitoring results as much as possible (such as submitting “sightings” from their monitoring projects to an online data archive, such as OBIS-SEAMAP) and archive and make the complete databases available upon request.
(a) Technical report: A draft technical report will be submitted to the Director, Office of Protected Resources, NMFS, within 90 days after the end of HIlcorp's 2015 open-water shallow geohazard survey in the Beaufort Sea. The report will describe in detail:
(i) Summaries of monitoring effort (
(ii) Summaries that represent an initial level of interpretation of the efficacy, measurements, and observations, rather than raw data, fully processed analyses, or a summary of operations and important observations;
(iii) Summaries of all mitigation measures (
(iv) Analyses of the effects of various factors influencing detectability of marine mammals (
(v) Species composition, occurrence, and distribution of marine mammal sightings, including date, water depth, numbers, age/size/gender categories (if determinable), group sizes, and ice cover;
(vi) Data analysis separated into periods when the sub-bottom profiler is operating and when it is not, to better assess impacts to marine mammals;
(vii) Sighting rates of marine mammals during periods with and without the sub-bottom profiler (and other variables that could affect detectability), such as:
(A) Initial sighting distances versus survey activity state;
(B) Closest point of approach versus survey activity state;
(C) Observed behaviors and types of movements versus survey activity state;
(D) Numbers of sightings/individuals seen versus survey activity state;
(E) Distribution around the survey vessel versus survey activity state; and
(F) Estimates of take by harassment;
(viii) A clear comparison of authorized takes and the level of actual estimated takes;
(ix) Cumulative sound exposure level over 24 hours (cSEL
(x) Ground-truth of data collected by AMARs in consultation with biologists experienced in Arctic species vocalizations with error rates for automatic detection to ensure the accurate classification of vocalizations by species; and
(xi) Information of source levels and other acoustic characteristics of the active acoustics survey equipment, such as spectral content, and received levels in root-mean-squared (RMS) dB, sound exposure level (SEL), dB peak to peak and
(b) The draft technical report shall be subject to review and comment by NMFS. Any recommendations made by NMFS must be addressed in the final report prior to acceptance by NMFS. The draft report will be considered the final report for this activity under this Authorization if NMFS has not provided comments and recommendations within 90 days of receipt of the draft report.
(c) Hilcorp will share data and work with its contractor JASCO to collaborate with other researchers. The passive acoustic recording data, including data on marine mammal vocalizations, will be made publically available for researchers.
(10)(a) In the unanticipated event that survey operations clearly cause the take of a marine mammal in a manner prohibited by this Authorization, such as an injury or mortality (
(i) Time, date, and location (latitude/longitude) of the incident;
(ii) The name and type of vessel involved;
(iii) The vessel's speed during and leading up to the incident;
(iv) Description of the incident;
(v) Status of all sound source use in the 24 hours preceding the incident;
(vi) Water depth;
(vii) Environmental conditions (
(viii) Description of marine mammal observations in the 24 hours preceding the incident;
(ix) Species identification or description of the animal(s) involved;
(x) The fate of the animal(s); and
(xi) Photographs or video footage of the animal (if equipment is available).
Activities shall not resume until NMFS is able to review the circumstances of the prohibited take. NMFS shall work with Hilcorp to determine what is necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. Hilcorp may not resume their activities until notified by NMFS via letter, email, or telephone.
(b) In the event that Hilcorp discovers an injured or dead marine mammal, and the lead PSO determines that the cause of the injury or death is unknown and the death is relatively recent (
(c) In the event that Hilcorp discovers an injured or dead marine mammal, and the lead PSO determines that the injury or death is not associated with or related to the activities authorized in Condition 3 of this Authorization (
(11) Activities related to the monitoring described in this Authorization do not require a separate scientific research permit issued under section 104 of the Marine Mammal Protection Act.
(12) The Plan of Cooperation outlining the steps that will be taken to cooperate and communicate with the native communities to ensure the availability of marine mammals for subsistence uses, must be implemented.
(13) This Authorization may be modified, suspended, or withdrawn if the holder fails to abide by the conditions prescribed herein or if the authorized taking is having more than a negligible impact on the species or stock of affected marine mammals, or if there is an unmitigable adverse impact on the availability of such species or stocks for subsistence uses.
(14) A copy of this Authorization and the Incidental Take Statement must be in the possession of each survey vessel operator taking marine mammals under the authority of this Incidental Harassment Authorization.
(15) Hilcorp is required to comply with the Terms and Conditions of the Incidental Take Statement corresponding to NMFS' Biological Opinion.
NMFS requests comment on our analysis, the draft authorization, and any other aspect of the Notice of Proposed IHA for Hilcorp's proposed shallow geohazard survey in the Beaufort Sea. Please include with your comments any supporting data or literature citations to help inform our final decision on Hilcorp's request for an MMPA authorization.
National Marine Fisheries Service, National Oceanic and Atmospheric Administration, Commerce.
Notice of availability; request for comments.
The National Marine Fisheries Service (NMFS) announces the availability of the Cook Inlet Beluga Whale (
Comments on the draft Plan must be received by close of business on July 14, 2015.
You may submit comments on this document, identified by NOAA-NMFS-2015-0053 by either of the following methods:
•
1. Go to
2. Click the “Comment Now!” icon and complete the required fields,
3. Enter or attach your comments.
•
Mandy Migura (907-271-1332), email
Recovery plans describe actions beneficial to the conservation and recovery of species listed under the Endangered Species Act of 1973 (ESA), as amended (16 U.S.C. 1531
NMFS began conducting comprehensive and systematic aerial surveys of the Cook Inlet beluga whale population in 1993. These surveys documented a decline in abundance from 653 whales in 1994 to 347 whales in 1998, a decline of nearly 50 percent. This rapid decline was associated with a substantial, unregulated subsistence hunt. Subsequent cooperative efforts between NMFS and Alaska Native subsistence users dramatically reduced subsistence hunts beginning in 1999. If subsistence harvest was the only factor limiting population growth, this reduction in hunting should have allowed the Cook Inlet beluga whale population to begin recovering at a rate of 2 to 6 percent per year; however, survey data indicated that the population was not recovering upon removal of hunting pressure. This lack of population growth led NMFS to reevaluate the status of Cook Inlet beluga whales. In October 2008, NMFS listed the Cook Inlet beluga whale
The Cook Inlet belugas are the most reproductively and demographically isolated of all the Alaskan belugas, and are unique in Alaska because their habitat, a semi-enclosed tidal estuary in southcentral Alaska, is in close proximity to most of Alaska's human population. The distribution of Cook Inlet belugas has changed significantly since the 1970s; in recent years the summer range has contracted to the upper reaches of Cook Inlet near Anchorage. This range contraction was coincident with the decline in population size.
Ten potential threat types are identified and assessed in this draft recovery plan, based on current knowledge of threat factors. Assessments were made based on the information and data gaps presented in the plan's background section. Climate change, while considered a potential threat to Cook Inlet beluga recovery, is not addressed as a separate threat, but rather is discussed with respect to how it may affect each of the listed threats. The ten identified threats were ranked in order of their relative concern (high, medium, low) to the Cook Inlet beluga population.
Due to an incomplete understanding of the threats facing Cook Inlet beluga whales, NMFS is unable to identify with certainty the actions that will most immediately encourage recovery. Until we know which threats are limiting recovery, the strategy of this recovery plan is to focus on threats identified as medium or high concern. This should focus efforts and resources on actions that are more likely to benefit Cook Inlet beluga whale recovery.
Under section 4(f)(1) of the ESA, recovery plans must contain objective, measurable criteria which, when met, would result in a determination that the species be delisted. This recovery plan contains both demographic and threats-based criteria for down- and delisting. The threat-based recovery criteria are designed to evaluate the five ESA section 4(a)(1) factors described in the ESA listing determination of the Cook Inlet belugas. The draft recovery plan proposes that Cook Inlet beluga whales may be reclassified from endangered to threatened (
When determining recovery actions, we aimed to improve understanding of whether a particular threat is limiting recovery and to eliminate or mitigate that threat, or to improve our understanding of, and ability to manage, that threat. The actions in this recovery plan include research, management, monitoring, and outreach efforts, since a comprehensive approach to Cook Inlet beluga whale recovery is likely to have greater success than focusing on any one type of action. There are also actions targeted at incorporating new information and conducting regular reassessments, making this recovery plan an adaptive management plan.
The total time and cost to recovery are very difficult to predict with the current information, and the total cost to recovery will be largely dependent upon the number of recovery actions requiring implementation. Since that cannot be determined prior to implementation of portions of this plan, the total cost presented assumes implementation of all recovery actions. As recovery progresses and we better understand the relationship between discrete threats and population dynamics, it may become apparent that there are some threats that need not be addressed to achieve recovery. However, we expect that recovery may take at least two generations (50 years).
If every identified recovery action is implemented, and if recovery implementation lasts for 50 years (two generations), then the estimated cost of implementing this entire recovery program would be approximately $78.3 million. Any projections of total costs over the full recovery period are likely to be imprecise, and the cost estimates do not imply that funding will necessarily be available for all Cook Inlet beluga whale recovery tasks.
NMFS requests and will consider all substantive comments and information presented during the public comment period as we finalize this Plan. NMFS concludes that the Draft Recovery Plan meets the requirements of the ESA.
16 U.S.C. 1531
Office of National Marine Sanctuaries (ONMS), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice and request for applications.
ONMS is seeking applications for vacant seats for 7 of its 13 national marine sanctuary advisory councils and for the Northwestern Hawaiian Islands Coral Reef Ecosystem Reserve Advisory Council (advisory councils). Vacant seats, including positions (
Applications are due by June 30, 2015.
Application kits are specific to each advisory council. As such, application kits must be obtained from and returned to the council-specific addresses noted below.
• Channel Islands National Marine Sanctuary Advisory Council: Michael Murray, Channel Islands National Marine Sanctuary, University of California Santa Barbara, Ocean Science Education Building 514, MC 6155, Santa Barbara, CA, 93106-6155; (805) 893-
• Flower Garden Banks National Marine Sanctuary Advisory Council: Shelley DuPuy, Flower Garden Banks National Marine Sanctuary, 4700 Avenue U, Bldg. 216, Galveston, TX 77551; (409) 621-5151 extension 106; email
• Gray's Reef National Marine Sanctuary Advisory Council: Becky Shortland, Gray's Reef National Marine Sanctuary, 10 Ocean Science Circle, Savannah, GA 31411; (912) 598-2381; email
• Hawaiian Islands Humpback Whale National Marine Sanctuary Advisory Council: Inouye Regional Center, ATTN: NOS/ONMS/Shannon Lyday, 1845 Wasp Blvd., Building 176, Honolulu, HI 96818; (808) 725-5905; email
• Monitor National Marine Sanctuary Advisory Council: Katherine Van Dam, Monitor National Marine Sanctuary, 100 Museum Drive, Newport News, VA 23606; (757) 591-7350; email
• National Marine Sanctuary of American Samoa Advisory Council: Joseph Paulin, National Marine Sanctuary of American Samoa, Tauese P.F. Sunia Ocean Center, P.O. Box 4318 Pago Pago, American Samoa 96799; (684) 633-6500; email
• Stellwagen Bank National Marine Sanctuary Advisory Council: Elizabeth Stokes, Stellwagen Bank National Marine Sanctuary, 175 Edward Foster Road, Scituate MA 02066; (781) 545-8026 extension 201; email
For further information on a particular national marine sanctuary advisory council, please contact the individual identified in the
ONMS serves as the trustee for 14 marine protected areas encompassing more than 170,000 square miles of ocean and Great Lakes waters from the Hawaiian Islands to the Florida Keys, and from Lake Huron to American Samoa. National marine sanctuaries protect our Nation's most vital coastal and marine natural and cultural resources, and through active research, management, and public engagement, sustains healthy environments that are the foundation for thriving communities and stable economies. One of the many ways ONMS ensures public participation in the designation and management of national marine sanctuaries is through the formation of advisory councils. National marine sanctuary advisory councils are community-based advisory groups established to provide advice and recommendations to the superintendents of the national marine sanctuaries on issues including management, science, service, and stewardship; and to serve as liaisons between their constituents in the community and the sanctuary. Additional information on ONMS and its advisory councils can be found at
The following is a list of the vacant seats, including positions (
16 U.S.C. Sections 1431,
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The New England Fishery Management Council (Council) is scheduling a public meeting of its Habitat Committee to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
This meeting will be held on Monday, June 1, 2015 at 9 a.m.
The meeting will be held at the Holiday Inn, 300 Woodbury Avenue, Portsmouth, NH 03801; telephone: (603) 431-8000; fax: (603) 501-3733.
Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
The Habitat Committee will consider data and analyses related to current habitat management alternatives for Georges Bank as part of Omnibus Essential Fish Habitat Amendment 2. These will include analyses related to a new alternative identified during the April Council meeting. The Committee may choose to revise its preferred alternative recommendation for Georges Bank to the full Council. (The Council plans to take final action on Georges Bank habitat management alternatives during its June 16-18, 2015 meeting.)
The Committee may also discuss other matters related to the amendment, in particular the spawning management alternatives. (The spawning alternatives are also planned for final Council action in June.) They will discuss other business as necessary.
Although non-emergency issues not contained in this agenda may come before these groups for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application.
Notice is hereby given that Adam White, BBC Natural History Unit, The Limes, Lea, Malmesbury Wiltshire, SN16 9PG United Kingdom, has applied in due form for a permit to conduct commercial or educational photography on four species of cetaceans and five species of pinnipeds.
Written, telefaxed, or email comments must be received on or before June 15, 2015.
These documents are available upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.
Written comments on this application should be submitted to the Chief, Permits and Conservation Division, at the address listed above. Comments may also be submitted by facsimile to (301) 713-0376, or by email to
Those individuals requesting a public hearing should submit a written request to the Chief, Permits and Conservation Division at the address listed above. The request should set forth the specific reasons why a hearing on this application would be appropriate.
Carrie Hubard or Jennifer Skidmore, (301) 427-8401.
The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361
The applicant proposes to film a variety of marine mammals along the California coast from Point Año Nuevo south to the Channel Islands. A maximum of 1000 long-beaked common dolphins (
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Concurrent with the publication of this notice in the
First Responder Network Authority (FirstNet), U.S. Department of Commerce.
Notice of public meetings.
The Board of the First Responder Network Authority (FirstNet) will convene an open public meeting on June 3, 2015, preceded by open public meetings of the Board Committees on June 2, 2015.
On June 2, 2015 between 9:00 a.m. and 6:00 p.m. Pacific Daylight Time, there will be sequential open public meetings of FirstNet's four Board Committees: (1) Governance and Personnel; (2) Technology; (3) Outreach; and (4) Finance. The full FirstNet Board will hold an open public meeting on June 3, 2015 between 8:00 a.m. and 10:00 a.m. Pacific Daylight Time.
The meetings on June 2 and June 3, 2015 will be held at the Omni San Diego Hotel, 675 L Street, San Diego, CA 92101.
Uzoma Onyeije, Secretary, FirstNet, 12201 Sunrise Valley Drive, M/S 243,
This notice informs the public that the Board of FirstNet will convene an open public meeting on June 3, 2015, preceded by open public meetings of the Board Committees on June 2, 2015.
The meetings are accessible to people with disabilities. Individuals requiring accommodations, such as sign language interpretation or other ancillary aids, are asked to notify Uzoma Onyeije, Secretary, FirstNet, at (703) 648-4165 or
The meetings will also be webcast. Please refer to FirstNet's Web site at
Committee for Purchase From People Who Are Blind or Severely Disabled.
Proposed addition to and deletions from the Procurement List.
The Committee is proposing to add a service to the Procurement List that will be provided by nonprofit agency employing persons who are blind or have other severe disabilities, and deletes products previously furnished by such agencies.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.
Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.
If the Committee approves the proposed addition, the entities of the Federal Government identified in this notice will be required to procure the service listed below from the nonprofit agency employing persons who are blind or have other severe disabilities.
The following service is proposed for addition to the Procurement List for production by the nonprofit agency listed:
The following products are proposed for deletion from the Procurement List:
Committee for Purchase From People Who Are Blind or Severely Disabled.
Notice; request for comments.
Committee for Purchase From People Who Are Blind or Severely Disabled (Committee) will submit the collection of information listed below to OMB for approval under the provisions of the Paperwork Reduction Act. This notice solicits comments on this collection of information.
Submit your written comments on the information collection on or before July 15, 2015.
Mail your comments on the requirement to Lou Bartalot, Director Compliance, Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, VA 22202-4149; fax (703) 603-0655; or email
To request a copy of the applicable forms or explanatory material, contact Edward Yang at the address in the above paragraph or through the above email address.
The Office of Management and Budget (OMB) regulations at 5 CFR part 1320, which implement provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Federal agencies may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the current collections of information are 3037-0001 and 3037-0002. The OMB control number for the revised collection of information is 3037-0013.
The JWOD Act of 1971 (41 U.S.C. 8501-8506) is the authorizing legislation for the AbilityOne Program. The AbilityOne Program creates jobs and training opportunities for people who are blind or who have other severe disabilities. Its primary means of doing so is by requiring Government agencies to purchase selected products and services from nonprofit agencies employing such individuals. The AbilityOne Program is administered by the Committee. Two national, independent organizations, National Industries for the Blind (NIB) and SourceAmerica, help State and private nonprofit agencies participate in the AbilityOne Program.
The implementing regulations for the JWOD Act, which are located at 41 CFR Chapter 51, provide the requirements, procedures, and standards for the AbilityOne Program. Section 51-4.3 of the regulations sets forth the standards that a nonprofit agency must meet to maintain qualification for participation in the AbilityOne Program. Under this section of the regulations, a nonprofit agency that wants to continue to participate in the AbilityOne Program must submit a completed copy of the appropriate Annual Certification form (Committee Form 403 or 404). This documentation helps the Committee determine whether the applicant nonprofit agency is meeting the requirements of the AbilityOne Program.
This information collection request seeks approval for the Committee to continue to collect the information required under 41 CFR 51-4.3 of the regulations, but in a revised and expanded format, so that the Committee can continue to verify the appropriateness of nonprofit agencies that would like to participate in the AbilityOne Program. The previous separate forms have been combined into one form. The items being certified have been revised to match the regulatory requirements of section 51-4.3 and to collect other pertinent information on the qualifications of nonprofit agencies. New questions concerning nonprofit agency hours, wages, people performing direct labor, subcontracting and veterans have been added. In addition, the language at the bottom of the certification section has been revised.
We invite comments concerning this renewal on: (1) Whether the collection of information is necessary for the proper performance of our agency's functions, including whether the information will have practical utility; (2) the accuracy of our estimate of the burden of the collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents.
Commodity Futures Trading Commission.
Notice.
The Commodity Futures Trading Commission (“CFTC” or “Commission”) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (“PRA”), Federal agencies are required to publish notice in the
Comments must be submitted on or before July 14, 2015.
You may submit comments, identified by OMB Control No. 3038-0092, by any of the following methods:
• The Agency's Web site, at
•
•
•
Please submit your comments using only one method.
Christopher Hower, Special Counsel, Division of Clearing and Risk, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW., Washington, DC 20581; (202) 418-6703; email:
Under the PRA, Federal agencies must obtain approval from the Office of Management and Budget (“OMB”) for each collection of information they conduct or sponsor. “Collection of Information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal agencies to provide a 60-day notice in the
Pursuant to these provisions, the Commission adopted § 1.71(d)(1) relating to FCMs and § 23.605(d)(1) relating to swap dealers and major swap participants. These regulations prohibit swap dealers and major swap participants from interfering or attempting to influence the decisions of affiliated FCMs with regard to the provision of clearing services and activities and would prohibit FCMs from permitting them to do so. The Commission also adopted § 23.607 to prohibits a swap dealer and major swap participant from adopting any process or taking any action that results in any unreasonable restraint on trade or imposes any material anticompetitive burden on trading or clearing, unless necessary or appropriate to achieve the purposes of the Act. The Commission adopted § 39.12(b)(2) to require that derivatives clearing organization rules provide for the non-discriminatory clearing of swaps executed bilaterally or through an unaffiliated designated contract market or swap execution facility.
As discussed further below, the additional information collection burden arising from the regulations primarily is restricted to the costs associated with the affected registrants' obligation to maintain records related to clearing documentation between the customer and the customer's clearing member.
The information collection obligations imposed by the regulations are necessary to implement certain provisions of the CEA, including ensuring that registrants exercise effective risk management and for the efficient operation of trading venues among SDs, MSPs, FCMs, and DCOs.
With respect to the collection of information, the CFTC invites comments on:
• Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have a practical use;
• The accuracy of the Commission's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Ways to enhance the quality, usefulness, and clarity of the information to be collected; and
• Ways to minimize the burden of collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology;
All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to
The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse or remove any or all of your submission from
44 U.S.C. 3501
Defense Security Cooperation Agency, Department of Defense.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Ms. B. English, DSCA/DBO/CFM, (703) 601-3740.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittals 15-22 with attached transmittal, and policy justification.
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* as defined in Section 47(6) of the Arms Export Control Act.
The Government of Australia has requested a possible sale of follow-on sustainment support and services for twenty four (24) AF/A-18Fs Super Hornet and twelve (12) AEA-18G Growler aircraft. The sustainment efforts will include software and hardware updates, Engineering Change Proposals, System Configuration upgrades, system integration and testing, engine component improvement, tools and test equipment, spare and repair parts, support equipment, publications and technical documentation, personnel training and training equipment, aircrew trainer devices upgrades, U.S. Government and contractor technical assistance, and other related elements of logistics and program support. The estimated cost is $1.5 billion.
This sale will contribute to the foreign policy and national security of the United States by helping to improve the security of a major contributor to political stability, security, and economic development in Southeast Asia and around the world. Australia is an important ally and partner that contributes significantly to coalition, peacekeeping, and humanitarian operations around the world. It is vital to the U.S. national interest to assist our ally in developing and maintaining a strong and ready self-defense capability. This proposed sale is consistent with those objectives and facilitates burden sharing with a key ally.
The proposed sale of follow-on sustainment support and services will enable the Royal Australian Air Force to ensure the reliability and performance of its F/A-18 fleet. The follow-on support will allow Australia to maintain aircraft availability/operational rates, and enhance interoperability with the U.S. and other nations.
The proposed sale of this additional support will not alter the basic military balance in the region.
The principal contractor will be The Boeing Company in St. Louis, Missouri. There are no known offset agreements proposed in connection with this potential sale.
Implementation of this proposed sale may require continued assignment of U.S. Government and contractor representatives to Australia.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
Defense Security Cooperation Agency, Department of Defense.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Ms. B. English, DSCA/DBO/CFM, (703) 601-3740.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittals 15-15 with attached transmittal, policy justification, and Sensitivity of Technology.
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* As defined in Section 47(6) of the Arms Export Control Act.
The Government of India has requested a possible sale for follow on support for five years for their fleet of C-130J Super Hercules that includes 8 spare AN/ALE-47 Counter-Measures Dispensing Systems, 6 spare AN/ALR-56M Advanced Radar Warning Receivers, up to 9,000 flare cartridges, spare and repair parts, configuration updates, support and test equipment, publications and technical data, technical services, personnel training and training equipment, U.S. Government and contractor engineering and logistics support services, and other related elements of logistics support. The estimated cost is $96.0 million.
This proposed sale will contribute to the foreign policy and national security of the United States by helping to strengthen the U.S.-India strategic relationship and to improve the capabilities of a major South Asian partner which has been, and continues to be, an important force for economic progress and stability in South Asia.
India needs this support for its Super Hercules aircraft to ensure its aircraft operate effectively to serve its transport, local and international humanitarian assistance, and regional disaster relief needs. This proposed sale of additional equipment and support will enable the Indian Air Force to sustain a higher mission-ready status for its C-130J fleet.
The proposed sale of this equipment and support will not alter the basic military balance in the region.
The principal contractor will be the Lockheed-Martin Company in Marietta, Georgia. There are no known offset agreements proposed in connection with this potential sale.
Implementation of this proposed sale will not require the assignment of any additional U.S. Government or contractor personnel to India.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
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1. The AN/ALR-56M is a computer controlled radar warning receiver (RWR). It monitors the environment in an effort to detect radar signals. Upon detection and identification of a valid radar signal, emitter identification is conveyed to the AN/ALE-47 countermeasures dispenser system. The ALR-56M has thirteen line replaceable units (LRUs): four I/J band DF receivers, an Analysis Processor, a Superhet Controller, a Superhet Receiver, a C/D band Receiver/Power supply, four I/J band antennas, and one C/D band antenna. Hardware and software are classified up to Confidential. Technical data and documentation are classified up to Secret.
2. The AN/ALE-47 Counter-Measures Dispensing System (CMDS) is an integrated, threat-adaptive, software-programmable dispensing system capable of dispending chaff, flares, and active radio frequency expendables. The system is internally mounted and may be operated as a stand-alone system or may be integrated with other on-board electronic warfare and avionics systems. The AN/ALE-47 uses data received over the aircraft interfaces to assess the threat situation and to determine a response. Hardware and software are Unclassified. Technical data and documentation are classified up to Secret.
3. If a technologically advanced adversary were to obtain knowledge of the specific hardware and software elements, the information could be used to develop countermeasures which might reduce weapon system effectiveness or be used in the development of a system with similar or advanced capabilities.
4. A determination has been made that the recipient country can provide the same degree of protection for the sensitive technology being released as the U.S. Government. The sale is necessary in furtherance of the U.S. foreign policy and national security objectives outline in the Policy Justification.
5. All defense articles and services listed in this transmittal have been authorized for release and export to the Government of India.
Department of Defense, Defense Security Cooperation Agency.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Ms. B. English, DSCA/DBO/CFM, (703) 601-3740.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittals 15-19 with attached transmittal and policy justification.
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* As defined in Section 47(6) of the Arms Export Control Act.
The Government of Iraq has requested a possible sale of 5,000 81mm High Explosive Mortar Ammunition, 684,000 M203 40mm High Explosive Ammunition, 532,000 MK19 40mm High Explosive Dual Purpose Ammunition, and 40,000 155mm High Explosives. Also includes small arms ammunition, spare and repair parts, support equipment, publications and technical documentation, personnel training and training equipment, U.S. Government and contractor technical and logistics support services, and other related elements of logistical and program support. The estimated cost is $395 million.
This proposed sale will contribute to the foreign policy and national security of the United States by helping to improve the security of a strategic partner. This proposed sale directly supports the Government of Iraq and serves the interests of the people of Iraq and the United States.
This proposed sale of additional ammunition is critical in providing continued combat power capability as Iraq continues its fight against an organized insurgency of extremists in Iraq. Iraq will have no difficulty absorbing this additional ammunition into its armed forces.
The proposed sale of this additional ammunition will not alter the basic military balance in the region.
The principal contractors will be American Ordinance in Middletown, Iowa and AMTEC in Janesville, Wisconsin. There are no known offset agreements proposed in connection with this potential sale.
Implementation of this sale will not require U.S. Government representatives or contractors to travel to Iraq.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
Defense Security Service (DSS), DoD.
Notice.
In compliance with the
Consideration will be given to all comments received by July 14, 2015.
You may submit comments, identified by docket number and title, by any of the following methods:
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To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Defense Security Service, ATTN: Mr. Robert C. Morton, OCIO, Russell-Knox Building, 27130 Telegraph Road, Quantico, VA 22134-2253, or call Defense Security Service, (571) 305-6442.
DSS proposes to make changes to the DD Form 441 and SF 328. The requirement for execution of the corporate “Certificate” section and the use of a corporate seal is being deleted. Currently the government does not require all corporations to execute the corporate Certificate portion of the Forms. Only those corporations who are in possession of a seal were being required to execute the Certificate. Corporations that do not have a seal and other types of businesses structures
The execution of the DD Form 441, 441-1 and SF 328 is a factor in making a determination as to whether a contractor company is eligible to have a facility security clearance. It is also a legal basis for imposing NISP security requirements on eligible contractors. These requirements are necessary in order to preserve and maintain the security of the United States through establishing standards to prevent the improper disclosure of classified information.
Defense Security Cooperation Agency, Department of Defense.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Ms. B. English, DSCA/DBO/CFM, (703) 601-3740.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittals 15-26 with attached transmittal, and policy justification.
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* as defined in Section 47(6) of the Arms Export Control Act.
The Government of Australia has requested a possible sale of follow-on sustainment support and services in support of three (3) Hobart Class Destroyers. The sustainment efforts will include AEGIS computer software and hardware updates, system integration and testing, tools and test equipment, spare and repair parts, support equipment, publications and technical documentation, personnel training and training equipment, aircrew trainer devices upgrades, U.S. Government and contractor technical assistance, and other related elements of logistics and program support. The estimated cost is $275 million.
This sale will contribute to the foreign policy and national security of the United States by helping to improve the security of a major contributor to political stability, security, and economic development in Southeast Asia. Australia is an important ally and partner that contributes significantly to coalition, peacekeeping and humanitarian operations around the world. It is vital to the U.S. national interest to assist our ally in developing and maintaining a strong and ready self-defense capability. This proposed sale is consistent with those objectives and facilitates burden sharing with a key ally.
The proposed sale will improve Australia's capability in current and future coalition efforts. Australia will use the enhanced capability as a deterrent to regional threats and to strengthen its homeland defense. Australia will have no difficulty absorbing this additional support into its armed forces.
The proposed sale of this additional support will not alter the basic military balance in the region.
The principal contractor will be Lockheed Martin Mission Systems and Training in Washington, District of Columbia. There are no known offset agreements proposed in connection with this potential sale.
Implementation of this proposed sale will require the temporary assignment of approximately five U.S. Government or contractor representatives for a period of three years to Australia on an intermittent basis for the life of the case.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
Federal Student Aid (FSA), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501
Interested persons are invited to submit comments on or before July 14, 2015.
Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at
For specific questions related to collection activities, please contact Beth Grebeldinger, 202-377-4018.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Department of Energy (DOE).
Notice of open meeting.
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Paducah. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the
Thursday, June 18, 2015, 6:00 p.m.
Barkley Centre, 111 Memorial Drive, Paducah, Kentucky 42001.
Jennifer Woodard, Deputy Designated Federal Officer, Department of Energy Paducah Site Office, 1017 Majestic Drive, Suite 200, Lexington, Kentucky 40513, (270) 441-6820.
Take notice that on May 8, 2015, pursuant to sections 206 and 306 of the Federal Power Act, 16 U.S.C. 824(e) and 825(e) and Rule 206 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206, the New York Public Service Commission, the New York Power Authority, and the New York State Energy Research and Development Authority (Complainants), filed a formal complaint against the New York Independent System Operator, Inc. (Respondent), alleging that the Respondent's buyer-side market power mitigation measures contained in section 23.4 of Attachment H of the Respondent's Market Administration and Control Area Services Tariff are unjust, unreasonable, and unduly discriminatory and preferential.
The Complainants certify that a copy of the complaint has been served on the Respondent.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainants.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
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All documents may be filed electronically via the Internet. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site at
The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person whose name appears on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
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Private property owners hold fee title to real property which is adjacent to, abuts, and lies underneath portions of Tulloch Reservoir. Tri-Dam's proposed SMP affects only lands owned or controlled by the licensee. Property rights on privately-owned land are not being altered by this proceeding.
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m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
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Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and § 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
On April 15, 2013, the Warmsprings Irrigation District (District) filed a license application for an original major project—existing dam for the proposed Warm Springs Dam Hydroelectric Project No. 13570-002. On April 14, 2015, the District filed a letter informing the Commission that it was withdrawing its license application for the project due to unforeseen costs to connect to the grid.
No motion in opposition to the notice of withdrawal has been filed, and the Commission has taken no action to disallow the withdrawal. Pursuant to Rule 216(b) of the Commission's Rules of Practice and Procedure, the withdrawal of the application became effective April 29, 2015 and this proceeding is hereby terminated.
1. Commission staff hereby protests pursuant to the section 284.123(g)(4)(i) of the Commission's regulations,
2. Commission staff notes that Enterprise has not adequately supported its filing and shown that the proposed rates are fair and equitable. For instance, Enterprise has not provided sufficient support for the discount adjustment used in calculating the billing determinants. In addition, Enterprise has not provided adequate explanation and support for its proposed cost of service, rate base, cost of capital, and cost allocation, among other issues.
3. Commission staff's specific concerns include, in particular, Enterprise's development of its discount adjustment in designing rates. For example, in Zone 2 the proposed rates are significantly higher than the rates Enterprise proposed in its prior rate case, Docket No. PR10-14-000, even though the cost of service for Zone 2 is 20 percent lower and the throughput is 55 percent higher using the same rate design methodology and imputed billing determinants from its prior case. Similarly, using the same methodology to design rates for Zone 1, Enterprise proposes a rate of $0.7636 per Dth, yet the unit cost prior to any discount adjustment is $0.2006 per Dth.
4. Commission staff has concerns that Enterprise has not classified any costs as variable costs when calculating its rates. Enterprise calculated straight-fixed variable rates for Zone 2 but did not classify any costs as variable cost rates. However, since Enterprise included $91.6 million in Account No. 368, Compressor Station Equipment, it follows that there should be variable costs associated with operating and maintaining compressors. Moreover, Account No. 855, Other Fuel and Power for Compressor Stations, typically
5. Commission staff has concerns regarding the allocation of Administrative and General (A&G) Expenses between Enterprise's two delivery zones. Exhibit H-1 shows that Enterprise allocated only 7.5 percent of A&G Expenses to Zone 2 which seems low considering that over 15 percent of Operating and Maintenance (O&M) Expenses, 15 percent of gross plant and over 14 percent of revenues were derived from Zone 2.
6. Enterprise proposes to include both gathering and storage plant in rate base. This is inconsistent with prior cases, where Enterprise has sometimes included gathering in rate base (see Docket No. PR07-12-000) and also excluded it from rate base (see Docket No. PR10-14-000). Enterprise has provided little to support its proposed treatment of gathering plant. In addition, Commission staff notes that Enterprise has market-based rate authority to provide storage services. Enterprise has not provided sufficient support to include storage plant in rate base for the first time. Further, Enterprise has not included any storage related O&M expenses to operate the plant.
7. Finally, Enterprise has requested a weighted average cost of capital of 10.41 percent without adequate support for either the proposed capital structure or the individual capital cost components.
Take notice that on April 30, 2015, Oncor Electric Delivery Company LLC submitted its tariff filing per 35.28(e): Oncor TFO Tariff Rate Changes to be effective March 20, 2015.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on April 24, 2015, Entergy Services, Inc. on behalf of its current and prospective public utility affiliates Entergy Gulf States Louisiana, L.L.C. (EGSL), Entergy Louisiana, LLC, (ELL) and Entergy Louisiana Power, LLC (ELP), (collectively, applicants) submitted a request proposing that ELP be allowed to account for the intercompany receivable created on its books following the Business Combination in Account 190, Accumulated Deferred Income Taxes, in a manner consistent with the instructions to FERC's Uniform System of Accounts and guidance provided by the Chief Accountant.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 or 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
On April 25, 2013 the Village of Morrisville (Vermont), licensee for the Morrisville Hydroelectric Project, filed an Application for a New License
The license for Project No. 2629 was issued for a period ending April 30, 2015. Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1), requires the Commission, at the expiration of a license term, to issue from year-to-year an annual license to the then licensee under the terms and conditions of the prior license until a new license is issued, or the project is otherwise disposed of as provided in section 15 or any other applicable section of the FPA. If the project's prior license waived the applicability of section 15 of the FPA, then, based on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c), and as set forth at 18 CFR 16.21(a), if the licensee of such project has filed an application for a subsequent license, the licensee may continue to operate the project in accordance with the terms and conditions of the license after the minor or minor part license expires, until the Commission acts on its application. If the licensee of such a project has not filed an application for a subsequent license, then it may be required, pursuant to 18 CFR 16.21(b), to continue project operations until the Commission issues someone else a license for the project or otherwise orders disposition of the project.
If the project is subject to section 15 of the FPA, notice is hereby given that an annual license for Project No. 2629 is issued to the licensee for a period effective May 1, 2015 through April 30, 2016 or until the issuance of a new license for the project or other disposition under the FPA, whichever comes first. If issuance of a new license (or other disposition) does not take place on or before April 30, 2016, notice is hereby given that, pursuant to 18 CFR 16.18(c), an annual license under section 15(a)(1) of the FPA is renewed automatically without further order or notice by the Commission, unless the Commission orders otherwise. If the project is not subject to section 15 of the FPA, notice is hereby given that the licensee, the Village of Morrisville (Vermont), is authorized to continue operation of the Morrisville Hydroelectric Project, until such time as the Commission acts on its application for a subsequent license.
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following qualifying facility filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that on April 29, 2015, Tallgrass Interstate Gas Transmission, LLC (Tallgrass), 4200 West 115th Street, Suite 350, Leawood, Kansas 66211-2609 filed a prior notice request pursuant to sections 157.205, 157.208 and 157.213 of the Commission's regulations under the Natural Gas Act for authorization to convert the HS-18 observation well in its Huntsman Storage Facility, located in Cheyenne County, Nebraska to an injection and withdrawal well and to construct and operate certain appurtenant pipeline measurement facilities necessary to connect the converted well to the storage facility, all as more fully set forth in the application which is on file with the Commission and open to public inspection. The project will have no impact on the certificated parameters of the Huntsman Storage Facility.
The filing may also be viewed on the Web at
Any questions regarding this Application should be directed to David Haag, Vice President of Regulatory, Tallgrass Interstate Gas Transmission, LLC, 370 Van Gordon Street, Lakewood, Colorado 80228-1519, by phone at (303) 763-3258.
Any person may, within 60 days after the issuance of the instant notice by the Commission, file pursuant to Rule 214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to intervene or notice of intervention. Any person filing to intervene or the Commission's staff may, pursuant to section 157.205 of the Commission's Regulations under the NGA (18 CFR 157.205) file a protest to the request. If no protest is filed within the time allowed therefore, the proposed activity shall be deemed to be authorized effective the day after the time allowed for protest. If a protest is filed and not withdrawn within 30 days after the time allowed for filing a protest, the instant request shall be treated as an application for authorization pursuant to section 7 of the NGA.
Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.
Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenter's will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with he Commission's environmental review process. Environmental commenter's will not be required to serve copies of filed documents on all other parties. However, the non-party commentary, will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.
The Commission strongly encourages electronic filings of comments, protests, and interventions via the internet in lieu of paper. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site (
This is a supplemental notice in the above-referenced proceeding, of Blue Cube Operations LLC's application for market-based rate authority, with an accompanying rate schedule, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability is May 28, 2015.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission,
The filings in the above-referenced proceeding(s) are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
This is a supplemental notice in the above-referenced proceeding of Greenleaf Power Management LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is June 1, 2015.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that on May 8, 2015, Christopher G. Huskilson, Stephen D. Aftanas, Scott C. Balfour, and Robert R. Bennett submitted for filing, an application for authority to hold interlocking positions, pursuant to section 305(b) of the Federal Power Act (FPA), 16 U.S.C. 825d(b), Part 45.8 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR part 45.8.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
On April 3, 2015, Spartanburg Water System filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of the Fingerville Project to be located at the existing Fingerville Dam, on the North Pacolet River, near the town of Fingerville, Spartanburg County, South Carolina. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit
The proposed project would consist of: (1) An existing 11.3-foot-high, 171-foot-long wooden dam, owned by Spartanburg; (2) a reservoir with a surface area of 11.69 acres; (3) a 130-foot-long headrace channel; (4) a powerhouse containing one generating unit with a total capacity of 150.0 kilowatts (kW); (4) a tailrace; and (5) a 450-foot-long, 12 kilo-volt (KV) transmission line. The project would have an estimated average annual generation of 770.0 megawatt-hours (MWh).
Deadline for filing comments, motions to intervene, competing applications (without notices of intent), or notices of intent to file competing applications: 60 days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36.
The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of Commission's Web site at
On April 21, 2015, Mid-Atlantic Hydro, LLC, filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of the Milford Hydroelectric Project (Milford Project) to be located on Republic River, near Junction City, Geary County, Kansas. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.
The proposed project would consist of the following: (1) A 30-foot-long, 50-foot-wide, 30-foot-high bifurcation structure connecting to the end of an existing 615.5-foot-long, 21-foot-wide concrete horseshoe-shaped conduit serving as the outlet for the Milford Dam Reservoir; (2) a 7-foot-diameter penstock extending from the bifurcation to the powerhouse; (3) a 50-foot-long, 50-foot-wide, 30-foot-high concrete powerhouse located downstream of the existing Milford Dam and adjacent to the south abutment, containing two 1.5 megawatts Francis turbine generating units; (4) a 75-foot-long, 50-foot-wide concrete tailrace directing flows from the powerhouse back to the existing stilling basin; (5) a 4,440-foot-long, 12.7-kilovolt transmission line delivering the project power to a distribution line belonging to the local electric cooperative; (6) a 40-foot-long, 40-foot-wide switchyard containing a three-phase step-up transformer, protective equipment, and metering; (7) appurtenant facilities. The estimated annual generation of the Milford Project would be 15,000 megawatt-hours annually.
Deadline for filing comments, motions to intervene, competing applications (without notices of intent), or notices of intent to file competing applications: 60 days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36.
The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of Commission's Web site at
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency is planning to submit an
Comments must be submitted on or before July 14, 2015.
Submit your comments, referencing Docket ID No. EPA-HQ-OAR-2008-0707, online using
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Dave Sosnowski, Transportation and Climate Division, State Measures and Transportation Planning Center, Office of Transportation and Air Quality, U.S. Environmental Protection Agency, 2000 Traverwood, Ann Arbor, Michigan 48105; telephone number:734-214-4823; fax number: 734-214-4052; email address:
Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at
Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology,
• An annual report providing general program operating data and summary statistics, addressing the program's current design and coverage, a summary of testing data, enforcement program efforts, quality assurance and quality control efforts, and other miscellaneous information allowing for an assessment of the program's relative effectiveness; and
• A biennial report on any changes to the program over the two-year period and the impact of such changes, including any weaknesses discovered and corrections made or planned.
General program effectiveness is determined by the degree to which a program misses, meets, or exceeds the emission reductions committed to in the state's approved SIP, which, in turn, must meet or exceed the minimum emission reductions expected from the relevant performance standard, as promulgated under EPA's revisions to 40 CFR, part 51, subpart S, in response to requirements established in section 182 of the Clean Air Act. This information is used by EPA to determine a program's progress toward meeting requirements under 40 CFR, part 51, subpart S, and to provide background information in support of program evaluations. Additional information regarding the current renewal of this ICR as well as previous renewals can be found in Docket ID No. EPA-HQ-OAR-2008-0707.
Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at:
Export-Import Bank of the United States.
Notice.
This Notice is to inform the public, in accordance with Section 3(c)(10) of the Charter of the Export-Import Bank of the United States (“Ex-Im Bank”), that Ex-Im Bank has received an application for final commitment for a long-term loan or financial guarantee in excess of $100 million (as calculated in accordance with Section 3(c)(10) of the Charter). Comments received within the comment period specified below will be presented to the Ex-Im Bank Board of Directors prior to final action on this Transaction. Comments received will be made available to the public.
Comments must be received on or before June 9, 2015 to be assured of consideration before final consideration of the transaction by the Board of Directors of Ex-Im Bank.
Comments may be submitted through Regulations.gov at
To support the export of U.S.-manufactured goods and services to be used in Pemex oil and gas projects.
To be used for Pemex's on- and off-shore oil and gas exploration and production areas.
To the extent that Ex-Im Bank is reasonably aware, the item(s) being exported are not expected to produce exports or provide services in competition with the exportation of goods or provision of services by a United States industry.
Drilling rigs, platform rentals, compressors, oil field services and related equipment.
Export-Import Bank of the United States.
Notice.
This Notice is to inform the public, in accordance with Section 3(c)(10) of the Charter of the Export-Import Bank of the United States (“Ex-Im Bank”), that Ex-Im Bank has received an application for final commitment for a long-term loan or financial guarantee in excess of $100 million (as calculated in accordance with Section 3(c)(10) of the Charter). Comments received within the comment period specified below will be presented to the Ex-Im Bank Board of Directors prior to final action on this Transaction. Comments received will be made available to the public.
Comments must be received on or before June 9, 2015 to be assured of consideration before final consideration of the transaction by the Board of Directors of Ex-Im Bank.
Comments may be submitted through Regulations.gov at
To support the export of U.S. small business manufactured goods and services to be used in Pemex oil and gas projects.
To be used for Pemex's on- and off-shore oil and gas exploration and production areas.
To the extent that Ex-Im Bank is reasonably aware, the item(s) being exported are not expected to produce exports or provide services in competition with the exportation of goods or provision of services by a United States industry.
Drilling rigs, platform rentals, compressors, oil field services and related equipment.
Federal Communications Commission.
Notice.
The Commission announces renewal of charter, appointment of members and designation of chairperson of its Consumer Advisory Committee (Committee). The Commission further announces the Committee's next meeting date, time, and agenda. The mission of the Committee is to make recommendations to the Commission regarding consumer issues within the jurisdiction of the Commission and to facilitate the participation of consumers (including underserved populations, such as Native Americans, persons living in rural areas, older persons, people with disabilities, and persons for whom English is not their primary language) in proceedings before the Commission.
The meeting of the Committee will take place on Friday June 12, 2015, 9:00 a.m. to 4:00 p.m., at the Commission's Headquarters Building, Commission Meeting Room TW-C305.
Federal Communications Commission, 445 12th Street SW., Washington, DC 20554.
Scott Marshall, Consumer and Governmental Affairs Bureau, (202) 418-2809 (voice or Relay), or email
This is a summary of the Commission's documents [DA 15-535] dated and released May 5, 2015, [DA 15-324] dated and released March 17, 2015 and [DA-14-1806] dated and released December 10, 2014.
By Public Notice [DA 14-1806] dated and released December 10, 2014, the Commission announced the renewal of the Committee for an eighth two year term, and solicited applications for membership thereon. This renewal was necessary and in the public interest. Numerous applications were received through January 20, 2015, at which time the period for receipt of applications closed.
On March 12, 2015, the Commission released a Report and Order on Remand, Declaratory Ruling, and Order in the Matter of Protecting and Promoting the Open Internet (NG Docket No. 1428), adopted on February 26, 2015. The Commission's Open Internet Order directed the CAC to “formulate and submit to the Commission a proposed [Open Internet enhanced transparency rule] disclosure format, based on input from a broad range of stakeholders, within six months of the time that its new membership is reconstituted, but, in any event, no later than October 31, 2015.” This disclosure format must be accessible to persons with disabilities. The Commission stated its expectation that the CAC “will consider whether to propose the same or different formats for fixed and mobile broadband providers.” Additionally, the Commission expects the CAC to consider “whether and how a standard format for mobile broadband providers will allow providers to continue to differentiate their services competitively, as well as how mobile broadband providers can effectively disclose commercial terms to consumers regarding myriad plans in a manner that is not administratively burdensome.” This recommendation may serve as a potential safe harbor for broadband providers seeking to meet the Commission's Open Internet transparency requirements.
To assist the Committee in responding to this charge and in furtherance of the Committee's other responsibilities, the Commission, by public Notice [DA 15-324], dated and released March 17, 2015 announced a second solicitation of applications for membership on the Committee. Several additional applications were received through April 1, 2015, at which time the period for receipt of second round applications closed.
The Committee will operate in accordance with the provisions of the Federal Advisory Committee Act, 5 U.S.C. App. 2 (1988). Each meeting of the Committee will be open to the public. A notice of each meeting will be published in the
During the Committee's eighth term, it is anticipated that the Committee will meet in Washington, DC for a minimum of two (2) one-day plenary meetings per year. In addition, as needed, working groups or subcommittees will be established to facilitate the Committee's work between meetings of the full Committee. Meetings will be fully accessible to individuals with disabilities.
Members must be willing to commit to a two (2) year term of service, and should be willing and able to attend a minimum of two (2) one-day plenary committee meetings per year in Washington, DC Committee members are also expected to participate in deliberations of at least one (1) working group or subcommittee.
By Public Notice [DA 15-535] dated and released May 5, 2015, the Commission announced the appointment of thirty-seven (37 members of the Committee. Of these, twenty-one (21) represent general consumer organizations/academia, two (2) represent disability organizations, eight (8) represent industry, four (4) represent regulators, one (1) represents seniors, and one (1) represents unions. The Committee's membership is designed to be representative of the Commission's many constituencies, and the diversity of the selected members will provide a balanced point of view as
The Committee's roster by organization name and primary representative is as follows:
The first meeting of the Committee under its renewed charter will take place on June 12, 2015, from 9:00 a.m. to 4:00 p.m. at the Commission's headquarters building, Commission Meeting Room TW-C305, 445 12th Street SW., Washington, DC 20554.
At its June 12, 2015 meeting, the Committee will consider administrative and procedural matters relating to its functions and will also discuss development of a proposed Open Internet enhanced transparency rule disclosure format, as directed in the Commission's Open Internet Order referenced above.
The Committee may receive briefings from commission staff and/or outside speakers on issues of interest to the Committee. A limited amount of time will be available on the agenda for comments from the public. If time permits, the public may ask questions of presenters via the email address
The meeting is open to the public and the site is fully accessible to people using wheelchairs or other mobility aids. Sign language interpreters, open captioning, assistive listening devices, and Braille copies of the agenda and committee roster will be provided on site. Meetings of the Committee are also broadcast live with open captioning over the Internet from the FCC Live Web page at
Other reasonable accommodations for people with disabilities are available upon request. The request should include a detailed description of the accommodation needed and contact information. Please provide as much advance notice as possible; last minute requests will be accepted, but may not be possible to fill. To request an accommodation, send an email to
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than June 11, 2015.
A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:
1.
Board of Governors of the Federal Reserve System, May 12, 2015.
Federal Trade Commission.
Proposed consent agreement.
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent order—embodied in the consent agreement—that would settle these allegations.
Comments must be received on or before June 5, 2015.
Interested parties may file a comment at
Stephen Antonio, Bureau of Competition, (202-326-2536), 600 Pennsylvania Avenue NW., Washington, DC 20580.
Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing consent orders to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for May 5, 2015), on the World Wide Web, at
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before June 5, 2015. Write “ZF Friedrichshafen AG's and TRW Automotive Holdings Corp.—Consent Agreement; File No. 141-0235” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at
Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which . . . is privileged or confidential,” as discussed in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.
If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c).
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at
If you file your comment on paper, write “ZF Friedrichshafen AG's and TRW Automotive Holdings Corp.—Consent Agreement; File No. 141-0235” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.
Visit the Commission Web site at
The Federal Trade Commission (“Commission”) has accepted from ZF Friedrichshafen AG (“ZF”) and TRW Automotive Holdings Corp. (“TRW”), subject to final approval, an Agreement Containing Consent Order (“Consent Agreement”) designed to remedy the anticompetitive effects resulting from ZF's proposed acquisition of TRW.
Pursuant to an Agreement and Plan of Merger dated September 15, 2014, the parties agreed that ZF would acquire TRW for $105.60 per share in an all-cash deal valued at approximately $12.4 billion (“the Acquisition”). The proposed Acquisition would result in a duopoly in the heavy vehicle tie rod market. The Commission's Complaint alleges that the proposed Acquisition, if consummated, would violate Section 7 of the Clayton Act, as amended, 15 U.S.C. 18, and Section 5 of the FTC Act, as amended, 15 U.S.C. 45, by substantially lessening competition in the market for heavy vehicle tie rods in North America.
Under the terms of the proposed Decision and Order (“Order”) contained in the Consent Agreement, the parties are required to divest TRW's Linkage and Suspension Business in a manner, and to an acquirer, that meets Commission approval. The divestiture package includes five manufacturing facilities in North America and Europe, along with related assets including intellectual property. The acquirer also has the option to enter into transitional services and supply agreements. The Consent Agreement provides an acquirer with everything needed to compete effectively in the North American heavy vehicle tie rod market. The parties must complete the divestiture within six months of executing the Consent Agreement.
The Consent Agreement has been placed on the public record for 30 days to solicit comments from interested persons. Comments received during this period will become part of the public record. After 30 days, the Commission will again review the Consent Agreement and the comments received, and decide whether it should withdraw from the Consent Agreement, modify it, or make it final.
Headquartered in Friedrichshafen, Germany, ZF is a privately held global automotive and industrial products manufacturer. ZF makes light and heavy vehicle components for the powertrain, chassis, and driveline. ZF designs, manufacturers, and sells heavy vehicle tie rods, amongst several other products, in its chassis division.
Headquartered in Livonia, Michigan, TRW sells chassis systems, electronic systems, passive occupant safety systems, and other automotive components. Like ZF, TRW designs, manufactures, and sells heavy vehicle tie rods.
The relevant line of commerce in which to analyze the effects of the Acquisition is heavy vehicle tie rods. A heavy vehicle is generally defined as one that weighs six tons or more, and a tie rod is a rigid connecter that links a vehicle's individual wheels with the steering control mechanism. Customers and other market participants did not identify any substitutes for heavy vehicle tie rods.
North America is the relevant geographic market in which to analyze the effects of the Acquisition on the heavy vehicle tie rod market. The size and weight of heavy vehicle tie rods generally make it uneconomical to ship them long distances. Customers interviewed primarily consider manufacturers in North America, and have found more distant firms uncompetitive for reasons including: (1) Price; (2) logistics; and (3) quality. Therefore, North America is the relevant geographic market.
The market for heavy vehicle tie rods in North America is highly concentrated. It is served primarily by ZF, TRW, and USK Internacional S.A. DE C.V. (“Urresko”). These three firms have a share of nearly 99% of the market based on unit sales. The merger would reduce the number of competitors from three to two, and increase the Herfindahl-Hirschman Index from 4,218 to 5,046, an increase of 828.
Entry into the North American heavy vehicle tie rod market is not likely to deter or counteract any anticompetitive effects of the proposed Acquisition. Entry is unlikely in light of the relatively small market size, strong position of incumbents, high capital costs, switching costs, and knowledge barriers that exist. The parties did not identify any likely entrants, and those firms best situated for entry—manufacturers of related heavy vehicle components—expressed no interest in entering the North American heavy vehicle tie rod market.
The proposed Acquisition would increase the likelihood of coordinated interaction among the remaining competitors in the North American heavy vehicle tie rod market. The combined company would have only one remaining significant competitor in North America, Urresko. Reducing the number of competitors from three to two would eliminate much uncertainty and make it easier for the remaining firms to reach agreement on terms of coordination, whether the coordination focuses on customer allocation, price, or some other aspect of competition.
Additionally, the proposed Acquisition would eliminate direct competition between ZF and TRW, resulting in the increased probability that customers would pay higher prices for heavy vehicle tie rods. In the past, customers have been able to use competition between ZF and TRW to obtain better prices by obtaining competing bids. Customers have also switched between ZF and TRW. That competition would be lost absent the merger.
The Consent Agreement eliminates the competitive concerns raised by ZF's proposed acquisition of TRW by requiring the parties to divest TRW's North American and European Linkage and Suspension Business (“the L&S Business”). The proposed divestiture includes everything needed for an acquirer to compete effectively in the North American market for heavy vehicle tie rods, and also includes additional products that ensure the business will be viable. Given the robust nature of the divested business, the Commission is confident that a post-order divestiture is sufficient to protect its interest in restoring competition.
Pursuant to the Order, the parties are required, no later than six months from execution of the Consent Agreement, to divest the L&S Business to a Commission-approved acquirer. That business consists of both heavy and light vehicle components, and includes—in addition to tie rods—control arms, ball joints, stabilizer links, conventional steering linkages, drag links, V-links, radius rods, and I-shafts. The divestiture buyer will receive all rights and assets relating to the L&S Business, including five TRW manufacturing facilities, Portland (U.S.), Tillsonburg-Plant 2 (Canada), St. Catharines (Canada), Dacice (Czech Republic), and Krefeld-Gellep (Germany), as well as leased space previously occupied by L&S research
To ensure that the divestiture is successful, the Order requires the parties to provide transition services such as logistical and administrative support at the option of the acquirer. Moreover, the acquirer will have the option to enter into a transition supply agreement with the parties for key manufacturing inputs necessary to perform existing customer contracts. The Consent Agreement also includes other standard terms designed to ensure the viability of the divestiture, including requirements that the parties assist the acquirer in hiring the existing work force of the business, and refrain from soliciting those employees for up to two years.
Given the robustness of the divested business and the protections contained in the Order, the Commission is confident that a post-order divestiture will be sufficient to preserve competition. The L&S Business has been run largely as a standalone business within TRW, and potential buyers have confirmed that the divested assets include everything necessary to compete effectively as a viable business. Similarly, potential customers have confirmed that an acquirer of the L&S Business would be a workable option as a supplier.
To ensure compliance with the Order, the Commission will appoint an Interim Monitor to oversee ZF's and TRW's performance of their obligations pursuant to the Consent Agreement, and to keep the Commission informed about the status of the divestiture. The Order also allows the Commission to appoint a Divestiture Trustee to accomplish the divestiture if the parties fail to divest within the required timeframe. Lastly, the Consent Agreement contains standard reporting requirements and terminates in ten years.
The Commission has also issued an Order to Hold Separate and Maintain Assets to protect the assets until they are divested. During the hold separate period, the parties must fund the business' operations, including capital projects, according to existing plans. To ensure compliance with the Hold Separate Order, a Commission-approved Hold Separate Monitor will oversee the L&S Business during the interim period.
The purpose of this analysis is to facilitate public comment on the Consent Agreement to aid the Commission in determining whether it should make the Consent Agreement final. This analysis is not an official interpretation of the proposed Consent Agreement and does not modify its terms in any way.
By direction of the Commission, Commissioner Wright dissenting.
The Commission has issued a proposed complaint and consent order to address narrow competitive concerns associated with ZF Friedrichshafen AG's proposed $12.4 billion acquisition of TRW Automotive Holdings Corp.
ZF and TRW are global automotive parts manufacturers. Both companies manufacture and sell a wide variety of components for discrete systems within a motor vehicle such as the chassis, powertrain, and suspension systems. They each have production facilities located throughout the United States, Canada, and Mexico.
The proposed transaction will create the second-largest global auto parts supplier. Our competitive concerns arise from a limited aspect of the proposed combination, namely, its likely effect in the market for the manufacture and sale of heavy vehicle tie rods for customers in North America. Tie rods are part of a motor vehicle's steering and linkage system; they are rigid connectors that link the wheels to the vehicle's steering control mechanism. To perform their intended function within the linkage systems of vehicles weighing six tons or more, these tie rods have to be large (approximately three to six feet long) and heavy (weighing approximately 50 pounds). This means that tie rods designed for light vehicles are not practical substitutes since they would be too small and light and therefore not as strong structurally. At the same time, tie rods designed for much heavier, industrial vehicles (like mining vehicles weighing hundreds of tons) would not be substitutes either.
Because of their weight, it is not economical to ship heavy vehicle tie rods over long distances. For this reason, North American customers primarily consider manufacturers with production facilities in the United States, Canada, and Mexico and generally do not regard suppliers outside of North America as viable options for reasons of price, logistics, and quality. As a result, ZF and TRW, together with a Mexican firm, USK Internacional, S.A. de C.V. (“Urresko”), account for virtually all (99%) of the sales of heavy vehicle tie rods in North America. We estimate the market shares of ZF, TRW, and Urresko to be 23%, 18%, and 58%, respectively. Fringe competitors hold the remaining 1% market share.
The parties' proposed combination will therefore reduce the number of significant competitors in the relevant market from three to two and substantially increase concentration in an already highly concentrated market.
In light of the foregoing, we respectfully disagree with Commissioner Wright's assertions that we lack a “credible basis” on which to conclude that the merger may enhance
Despite Commissioner Wright's insistence to the contrary, our inquiry extended beyond consideration of market concentration and application of the Guidelines presumption of competitive harm. We also examined the transaction's likely anticompetitive effects, and are satisfied that there is sufficient evidence to support the issuance of our complaint and proposed consent order.
First, as noted above, the proposed transaction results in a highly concentrated relevant market.
Our concern that the merger may enhance the relevant market's vulnerability to coordination is backed by the well-accepted view that markets with only two or three firms are more conducive to anticompetitive outcomes than markets with four or more firms.
Additionally, there is no evidence that fringe competitors, which have higher prices, or new entrants, which are unlikely to materialize, could disrupt any coordination between the combined firm and Urresko. For these reasons, we have ample basis to conclude that the merger may enhance the vulnerability to coordinated effects that already exists in the relevant market.
As we noted above, the parties have chosen to address our limited competitive concerns in the heavy vehicle tie rods market through a proposal to divest TRW's linkage and suspension business in North America and Europe. This allows the parties to address our competition concerns, as well as those of the European Commission. The EC has already
In sum, because we have reason to believe that customers and consumers are likely to suffer a substantial loss of competition as a result of the proposed transaction, and there are no demonstrated countervailing efficiencies, we believe the public interest is best served by accepting the proposed consent order to remedy our competitive concerns.
I voted in favor of issuing for public comment the proposed consent agreement in this matter. As discussed below, there is sufficient evidence to provide me with a reason to believe that, absent a remedy, the transaction is likely to violate Section 7 of the Clayton Act. I also find that the proposed consent, which is intended to remedy any such violation, is in the public interest.
Based on the evidence presented to me—including the evidence discussed in the Analysis to Aid Public Comment and the majority statement in this matter—I am satisfied that the “reason to believe” prong that the Commission must assess in issuing a complaint, including in the consent context, is met here. It is important to note that the Commission makes the reason to believe determination before a full evidentiary and legal record is developed during a trial on the merits, which suggests that the standard must necessarily be lower than what the Commission or a court should apply for finding ultimate liability. Individual Commissioners, of course, have different views on how much evidence is necessary to satisfy the reason to believe standard. Unfortunately, there does not appear to be a consensus view on what the standard requires. I respect Commissioner Wright's view that the standard was not met for him in this case. For the reasons identified in the majority statement in this matter, I determined that there is a credible basis on which to conclude that this merger may enhance the vulnerability to coordinated effects that already exists in the relevant market at issue.
I further view this consent to be in the public interest. In my time as a Commissioner, I have advocated for transparency, predictability, and fairness across a variety of settings.
The Commission has voted to issue a Complaint and Decision & Order against ZF Friedrichshafen AG (“ZF”) to remedy the allegedly anticompetitive effects of ZF's proposed acquisition of TRW Automotive Holdings Corp. (“TRW”). I respectfully dissent because the evidence is insufficient to provide reason to believe ZF's acquisition will substantially lessen competition for heavy vehicle tie rods sold in North America. In particular, I believe the Commission has not met its burden to show that the acquisition will result in an increased likelihood of harm from coordinated effects or from unilateral effects. As a consequence, the Commission should close the investigation and allow the parties to complete the proposed transaction without imposing a remedy.
I write separately today to explain my vote and to discuss the quality and quantity of evidence necessary to support a coordinated and unilateral effects challenge under the 2010
The Complaint alleges the proposed transaction increases the likelihood of coordinated effects and unilateral effects in the market for heavy vehicle tie rods sold in North America.
The Complaint implicates an important question with regard to coordinated effects: What evidence is necessary to establish reason to believe a proposed transaction may substantially lessen competition by “enabling or encouraging post-merger coordinated interaction among firms in the relevant market that harms customers.”
The
The second and third conditions are at issue here and worthy of further discussion.
The record evidence is mixed with respect to the second condition, whether the market shows signs of vulnerability to coordinated conduct. Evidence that the market is generally conducive to coordinated interaction includes the fact that heavy vehicle tie rods are fairly homogeneous goods and are purchased using relatively short-term contracts.
Also potentially germane to assessing the vulnerability of the relevant market to coordinated conduct are previous episodes of coordination by the same players in different markets. In 2012, a German subsidiary of TRW Automotive, TRW Deutschland Holding GmbH, pled guilty to a conspiracy to fix prices of seatbelts, airbags, and steering wheels sold to two German automobile customers for vehicles manufactured or sold in the United States.
There are other considerations, however, that indicate the market for heavy vehicle tie rods is not particularly vulnerable to coordination. First, while the product might be fairly homogeneous, there are significant switching costs including the time and cost involved with validation testing of the new supplier's tie rods. All else equal, significant switching costs make markets less vulnerable to coordination because they diminish firms' ability to punish effectively deviations from the coordinated price. Second, cost and demand fluctuations appear to be relatively frequent and large, which increase the information costs needed to detect accurately deviations.
Ultimately, however, I do not have reason to believe the proposed transaction is likely to result in coordinated effects because the record evidence does not satisfy the third condition—that is, there is no “credible basis on which to conclude that the merger may
The
The sole evidence offered in favor of the proposition that the proposed transaction will
As I have stated previously, “there is no basis in modern economics to conclude with any modicum of reliability that increased concentration—without more—will increase post-merger incentives to coordinate. Thus, the
The sole evidence offered in favor of the Commission's allegation that the merger will render unilateral price effects likely is that some customers have used the competition between ZF and TRW to obtain better pricing and some customers have switched between the two suppliers.
Moreover, unilateral effects in a homogeneous goods market principally involve reductions in output.
The Commission insists that a different “lens” should be used to evaluate evidence in markets where the number of firms is reduced by merger to three or two.
The second is a laboratory experiment and does not involve the behavior of actual firms and certainly cannot provide sufficient economic evidence to support a presumption that four-to-three and three-to-two mergers in real-world markets will result in anticompetitive coordination.
Finally, the Commission cites a draft article, authored by Steve Salop, in support of its view that economic evidence supports a presumption that four-to-three and three-to-two mergers are competitively suspect.
It is important to note that the Commission and I have no disagreement over the proposition that the number of competitors within a market is a relevant fact to assess the likely competitive effects of a transaction. The relevant question is not whether the number of firms matters but how much it matters—and in particular, whether a movement to three or two firms warrants a generally applicable presumption that a transaction is more likely than not to harm competition. I do not believe it does. The Commission disagrees.
The
This is not to say that evidence of changes in market structure cannot ever warrant such a presumption. It does when the evidence warrants as much. The Commission has in certain contexts found reason to believe competition would be substantially lessened based simply upon a reduction of firms in the relevant market. See
To summarize, there are three-to-two mergers that give rise to unilateral effects, and three-to-two mergers that give rise to coordinated effects. It is our burden to show that
Finally, the Commission and Commissioner Ohlhausen each claim that the quantity, and presumably the quality, of the evidence is not the same for investigations truncated by remedy proposals compared to cases where a full phase investigation is completed or compared to a completed trial, respectively.
For these reasons, I cannot join my colleagues in supporting the consent order because I do not have reason to believe the transaction violates Section 7 of the Clayton Act nor that a consent ordering divestiture is in the public interest.
Federal Trade Commission.
Proposed consent agreement.
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent orders—embodied in the consent agreement—that would settle these allegations.
Comments must be received on or before June 4, 2015.
Interested parties may file a comment at
James Southworth, Bureau of Competition, (202-326-2822), 600 Pennsylvania Avenue NW., Washington, DC 20580.
Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing consent orders to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for May 4, 2015), on the World Wide Web, at
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before June 4, 2015. Write “Holcim Ltd. and Lafarge SA—Consent Agreement; File No. 141-0129” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at
Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which . . . is privileged or confidential,” as discussed in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.
If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c).
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at
If you file your comment on paper, write “Holcim Ltd. and Lafarge SA—Consent Agreement; File No. 141-0129” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.
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The Federal Trade Commission (“Commission”) has accepted, subject to final approval, an Agreement Containing Consent Orders (“Consent Agreement”) designed to remedy the anticompetitive effects resulting from the proposed acquisition of Lafarge S.A (“Lafarge”) by Holcim Ltd. (“Holcim”). Under the terms of the proposed Consent Agreement, Lafarge is required to divest to Continental Cement Company (“Continental”) its Davenport cement plant and quarry located in Buffalo, Iowa along with cement terminals and associated distribution assets in Minneapolis and St. Paul, Minnesota; La Crosse, Wisconsin; Memphis, Tennessee; and Convent and New Orleans, Louisiana. The Consent Agreement also requires Holcim to divest its Skyway slag cement plant located in Chicago, Illinois to Eagle Materials Inc. (“Eagle”), its slag cement plant located in Camden, New Jersey and its terminal near Boston, Massachusetts to Essroc Cement Corporation (“Essroc”), and its cement terminals in Grandville and Elmira, Michigan and Rock Island, Illinois to Buzzi Unicem USA (“Buzzi”). Finally, the Consent Agreement requires Holcim to divest to a buyer or buyers approved by the Commission (1) Holcim's Trident, Montana cement plant and two related terminals in Alberta, Canada, and (2) Holcim's Mississauga cement plant located in Ontario, Canada and related cement terminals in Duluth, Minnesota; Detroit and Dundee, Michigan; Cleveland, Ohio; and Buffalo, New York.
The Consent Agreement has been placed on the public record for 30 days to solicit comments from interested persons. Comments received during this period will become part of the public record. After 30 days, the Commission will again review the Consent
Pursuant to a Combination Agreement dated July 7, 2014, Holcim proposes to acquire 100 percent of the existing shares of Lafarge in a transaction valued at $24.95 billion at that time. The Commission's Complaint alleges that the proposed acquisition, if consummated, would violate Section 7 of the Clayton Act, as amended, 15 U.S.C. 18, and Section 5 of the Federal Trade Commission Act, as amended, 15 U.S.C. 45, by substantially lessening competition in certain regional markets in the United States for the manufacture and sale of portland cement and slag cement. The proposed Consent Agreement will remedy the alleged violations by preserving the competition that would otherwise be eliminated by the proposed acquisition.
Holcim is a Swiss-based, vertically integrated global building materials company. The company's products include cement, clinker, concrete, lime, and aggregates. In the United States, Holcim currently operates nine portland cement and three slag grinding plants, as well as a large network of distribution assets.
Lafarge is a vertically-integrated global building materials company incorporated in France and headquartered in Paris. Lafarge primarily produces and sells cement, aggregates, and ready-mix concrete. In the United States, Lafarge currently operates six portland cement and three slag cement grinding plants as well as numerous distribution terminals.
In the United States, both parties manufacture and sell portland cement. Portland cement is an essential ingredient in making concrete, a cheap and versatile building material. Because portland cement has no close substitute and the cost of cement usually represents a relatively small percentage of a project's overall construction costs, few customers are likely to switch to other products in response to a small but significant increase in the price of portland cement.
Both parties also manufacture and sell ground, granulated blast furnace slag (“slag cement”), a specialty cement product with unique characteristics that can serve as a partial substitute for portland cement. Customers add slag cement to portland cement to enhance the physical properties of a concrete mixture. It is appropriate to treat slag cement as a separate relevant product because an insufficient number of purchasers would switch to other products in response to a small but significant increase in the price of slag cement to render such a price increase unprofitable.
The primary purchasers of portland and slag cement are ready-mix concrete firms and producers of concrete products. These customers usually pick up portland and slag cement from a cement company's plant or terminal in trucks. Because portland and slag cement are heavy and relatively cheap commodities, transportation costs limit the distance customers can economically travel to pick up the products. The precise scope of the area that can be served by a particular plant or terminal depends on a number of factors, including the density of the specific region and local transportation costs.
Due to transportation costs, cement markets are local or regional in nature. The relevant geographic markets in which to analyze the effects of the proposed acquisition on portland cement competition are (1) the Minneapolis-St. Paul, Minnesota area; (2) the Duluth, Minnesota area; (3) western Wisconsin; (4) eastern Iowa; (5) the Memphis, Tennessee area; (6) the Baton Rouge, Louisiana area; (7) the New Orleans, Louisiana area; (8) the Detroit, Michigan area; (9) northern Michigan; (10) the Grand Rapids, Michigan area; (11) western Montana; and (12) the Boston, Massachusetts/Providence, Rhode Island area. The proper geographic markets in which to analyze the effects of the proposed transaction on slag cement are (1) the Mid-Atlantic region and (2) the western Great Lakes region.
The relevant markets for portland cement and slag cement are already highly concentrated. For each of the relevant markets, the parties are either the only suppliers in the market, two of only three suppliers, or two of only four suppliers.
Entry into the relevant portland cement and slag cement markets would not be timely, likely, or sufficient in magnitude, character, and scope to deter or counteract the anticompetitive effects of the proposed transaction. The cost to construct a new portland cement plant of sufficient size to be competitive would likely cost over $300 million and take more than five years to permit, design, and construct while the expansion of an existing facility would likely cost hundreds of millions of dollars and take four or more years to complete. Building competitive cement distribution terminals is also difficult and time consuming. It can take more than two years to obtain the necessary permits and complete construction of a competitive terminal in the relevant markets. New entrants into slag cement markets face the additional hurdle of having to obtain a cost-effective source for the raw material. There are few domestic sources for granulated blast furnace slag because there are a limited number of active blast furnaces in the United States. Given the difficulties of entry, it is unlikely that any new entry could be accomplished in a timely manner in the relevant markets to defeat a likely price increase caused by the proposed acquisition.
Unless remedied, the proposed merger would likely result in competitive harm in each of the relevant portland and slag cement markets. The merger would eliminate substantial head-to-head competition between the parties in each of these markets and significantly increase market concentration. For many customers in these markets, the merger would combine the two closest competitors for their business, leaving the merged entity with the power to increase prices to these customers unilaterally. Further, because the merger would reduce the number of significant competitors to, at most, two or three in the relevant markets, it would enhance the likelihood of collusion or coordinated action between the remaining competitors by reducing impediments to reaching common terms of coordination and making it easier to monitor and retaliate against potential deviation from a coordinated scheme.
The proposed Consent Agreement eliminates the competitive concerns raised by Holcim's proposed acquisition of Lafarge by requiring the parties to divest assets in each relevant market. Lafarge is required to divest a cement plant in Buffalo, Iowa and a network of distribution terminals along the Mississippi River in Louisiana, Tennessee, Wisconsin, and Minnesota to Continental. Continental, in turn, will sell its cement terminal located in Bettendorf, Iowa to Lafarge in order to eliminate the competitive overlap that would otherwise be created by its acquisition of Lafarge's Davenport cement plant. Because Lafarge will be
The Commission's goal in evaluating possible purchasers of divested assets is to maintain the competitive environment that existed prior to the proposed acquisition. If the Commission determines that any of the identified buyers is not an acceptable acquirer, the proposed Order requires the parties to divest the assets to a Commission-approved acquirer within 90 days of the Commission notifying the parties that the proposed acquirer is not acceptable. If the Commission determines that the manner in which any divestiture was accomplished is not acceptable, the Commission may direct the parties, or appoint a divestiture trustee, to effect such modifications as may be necessary to satisfy the requirements of the Order.
Finally, the proposed Consent Agreement requires Holcim to divest to a buyer or buyers approved by the Commission (1) a cement plant in Trident, Montana and two distribution terminals in Alberta, Canada (the “Trident Assets”), and (2) a cement plant in Mississauga, Ontario and cement terminals in Minnesota, Michigan, Ohio, and New York (the “Great Lakes Assets”). The divestiture of the Trident plant would eliminate the proposed merger's potential anticompetitive impact on purchasers of portland cement located in western Montana. The two Alberta terminals distribute cement produced at the Trident plant and are included in the Consent Agreement in order to preserve the viability and marketability of the Trident Assets. Holcim's Mississauga plant supplies portland cement into the United States both directly and via terminals located in Duluth; Detroit; Dundee, Michigan; Cleveland, Ohio; and Buffalo, New York. The divestiture of the Great Lakes Assets would remedy the proposed merger's anticompetitive effects in the Duluth and Detroit areas. The Cleveland and Buffalo terminals are included in the Consent Agreement in order to preserve the viability and marketability of the Great Lakes Assets. The Trident Assets and Great Lakes Assets are also part of a larger group of Holcim assets located in Canada that the Respondents have agreed to divest in order to resolve competitive concerns raised by the Canadian Competition Bureau (“CCB”). Commission staff worked cooperatively with staff from the CCB to ensure that our respective proposed remedies would be consistent and effective.
The proposed Order provides that Holcim must find a buyer (or buyers) for the Trident Assets and the Great Lakes Assets, at no minimum price, that is acceptable to the Commission, no later than 120 days from the date on which the parties consummate the proposed acquisition. The Consent Agreement also contains an Order to Hold Separate and Maintain Assets, which will serve to ensure that these assets are held separate and operated independently from the merged company and protect the viability, marketability, and competitiveness of the divestiture asset packages until the assets are divested to a buyer or buyers approved by the Commission.
To ensure compliance with the proposed Order, the Commission has agreed to appoint an Interim Monitor to ensure that Holcim and Lafarge comply with all of their obligations pursuant to the Consent Agreement and to keep the Commission informed about the status of the transfer of the rights and assets to appropriate purchasers.
The purpose of this analysis is to facilitate public comment on the Consent Agreement, and it is not intended to constitute an official interpretation of the proposed Decision and Order or to modify its terms in any way.
By direction of the Commission, Commissioner Wright dissenting.
The Federal Trade Commission has voted to accept a settlement to resolve the likely anticompetitive effects of Holcim Ltd.'s (“Holcim”) proposed $25 billion acquisition of Lafarge S.A. (“Lafarge”). We have reason to believe that, absent a remedy, the proposed acquisition is likely to substantially reduce competition in the manufacture and sale of portland cement and slag cement. As we explain below, we believe the proposed remedy, tailored to counteract the likely anticompetitive effects of the proposed acquisition without eliminating any efficiencies that might arise from the combination of the two companies, is in the public interest.
Holcim is a Switzerland-based, vertically integrated global building materials company, with products that include cement, clinker, concrete, lime, and aggregates. Lafarge is a France-based, vertically integrated global building materials company that primarily produces and sells cement, aggregates, and ready-mix concrete.
The merged company will be the world's largest cement manufacturer, with combined 2014 revenues of approximately $35 billion and operations in more than 90 countries. Our competitive concerns pertain to specific geographic markets in the United States where Holcim and Lafarge each make significant cement sales. The proposed merger would likely harm competition for the distribution and sale of portland cement, an essential ingredient in making concrete, in 12 local or regional markets. It would also threaten to lessen competition for the distribution and sale of slag cement, a specialty cement product used in certain applications, in two other regional markets.
The merger would create a merger to monopoly in some of the challenged relevant markets, while in others at most three competitors would remain post-merger. Absent a remedy, the Herfindahl-Hirschman Index (“HHI”) in each of these markets would exceed 3,400, making every market highly concentrated according to the 2010 Horizontal Merger Guidelines.
In each of the relevant markets at issue, there is evidence that unilateral anticompetitive effects are likely. Substantial evidence demonstrates that, for many customers in the relevant areas, the merging firms are their preferred suppliers and that customers have benefitted from substantial head-to-head competition between the parties
The evidence also suggests that the proposed acquisition would increase the ability and incentives of the combined firm and other market participants to engage in coordinated behavior that would result in harm to consumers. The relevant markets have characteristics that make them susceptible to coordination. They are highly concentrated; the products are homogeneous; overall market elasticity is low; customer switching costs are low; and sales are relatively small, frequent, and usually not made pursuant to long-term contracts. There is also a high degree of transparency in these markets. Competitors are aware of each other's production capacities, costs, sales volumes, prices, and customers. Our concern about the potential for coordinated effects in these markets is heightened by evidence that cement suppliers, including the same global firms that compete in these markets, have expressly colluded in other geographic markets with similar characteristics.
In his dissent, Commissioner Wright takes issue with our decision to seek a remedy in six markets, going to great lengths to argue that we are improperly relying solely on the increase in market concentration to justify our action, that we are creating new presumptions of harm, that we lack a “credible basis” on which to conclude that the merger may enhance the vulnerability of the relevant markets to coordination, and that our action is otherwise inconsistent with the Guidelines. We respectfully disagree with Commissioner Wright's various characterizations of the Commission's statement in this matter. The Guidelines make clear that a substantial increase in concentration caused by a merger continues to be a significant factor in merger analysis because highly concentrated markets with only two or three large firms are more likely to lead to anticompetitive outcomes.
Moreover, despite Commissioner Wright's assertion to the contrary, our investigation went beyond consideration of market concentration and application of the Guidelines presumption of competitive harm and, as noted above, produced additional evidence supporting our belief that the effect of the proposed acquisition would be to substantially lessen competition and harm cement customers in the relevant markets. On coordinated effects, we found numerous characteristics of the market making it vulnerable to collusion. It is particularly troubling that existing cement suppliers have expressly colluded in other geographic markets with similar characteristics. We also examined whether other market factors, such as the possibility of entry or expansion, might alleviate our competitive concerns. The evidence demonstrates the presence of high barriers to entry for both portland cement and slag cement, including significant capital costs and regulatory requirements. Entry sufficient to deter or counteract the likely harm from the proposed transaction would thus be neither timely nor likely.
In the face of our competitive concerns, based on what we had learned about the nature and conditions of the relevant markets, the parties proposed divestitures to remedy our concerns in each of those markets. The parties did not comply with our Second Requests. While continued investigation may have produced more evidentiary support for our complaint, including those markets for which Commissioner Wright dissents, we do not think such a course would have been justified. We have ample evidence to support our allegations of anticompetitive harm and had no reason to burden the parties with the expense and delay of further inquiry for the sole purpose of obtaining additional, cumulative evidence. Nor would further inquiry have been a good use of Commission resources.
Merger analysis is necessarily predictive. The evidence in this case provides us with sufficient reason to believe that the proposed acquisition is likely to substantially reduce competition, and there is no evidence of countervailing efficiencies that weigh against the remedy. We believe that the public interest is best served by remedying the competitive concerns as set forth in our proposed consent order.
The Commission has voted to issue a Complaint and a Decision & Order against Holcim Ltd. (“Holcim”) and Lafarge S.A. (“Lafarge”) to remedy the allegedly anticompetitive effects of the proposed merger of the two companies. I dissent in part from and concur in part with the Commission's decision because the evidence is insufficient to provide a reason to believe the proposed transaction is likely to substantially lessen competition, in violation of Section 7 of the Clayton Act, in several of the portland cement markets identified in the Complaint.
The Commission articulates coordinated effects and unilateral effects theories of harm arising from the proposed transaction in all of the fourteen relevant geographic markets defined in the Complaint (the “Relevant Markets”).
In those markets in which I conclude the record evidence supports neither a coordinated nor a unilateral effects theory, the Commission relies upon little more than the change in market structure to support each of its allegations. Without particularized evidence substantiating a unilateral effects or coordinated effects theory of harm arising from the proposed transaction, a structural theory alone cannot provide a sufficient basis to establish reason to believe a transaction violates the Clayton Act. It follows, in my view, that the Commission should refrain from imposing a remedy in the markets for which the evidence is insufficient to support either a coordinated effects theory or a unilateral effects theory.
The Commission argues mergers that reduce the number of competitors in a relevant market to three or two are unique in the sense that they warrant a presumption of competitive harm and illegality,
The Commission cites in support of its structural theory and presumption three academic articles written by economists.
The second article is a laboratory experiment and does not involve the behavior of actual firms and certainly cannot provide sufficient economic evidence to support a presumption that four-to-three and three-to-two mergers in real-world markets will result in anticompetitive coordination.
Finally, the Commission cites a draft article, authored by Steve Salop, in support of its view that economic evidence supports a presumption that four-to-three and three-to-two mergers are competitively suspect.
There is simply no empirical economic evidence sufficient to warrant a
To the contrary, this approach is inconsistent with Agency practice and the letter and spirit of the more economically sophisticated approach adopted in the
Rather than relying upon economic evidence to defend the Commission's structural presumption, the Commission highlights case law supporting a presumption of illegality for mergers to duopoly or that substantially increase concentration.
I therefore find any reliance upon structural changes alone to be economically untenable and insufficient to give me reason to believe the proposed transaction will violate Section 7 in the vast majority of Relevant Markets.
The
The first and second elements of the
The Commission asserts that the facts that the market is highly concentrated, that it is vulnerable to coordination, and that the merger reduces “the number of significant competitors to only two or three”
The first interpretation is that the satisfaction of the first and second elements of the
The second plausible interpretation of the Commission's analysis is that the reduction in the number of competitors in a market is itself sufficient evidence to provide a credible basis that a merger will enhance a market's vulnerability to coordination and thus satisfy the third element of the
As I have stated previously, “there is no basis in modern economics to conclude with any modicum of reliability that increased concentration—without more—will increase post-merger incentives to coordinate.”
The Commission alleges the proposed transaction is likely to result in unilateral price effects in the Relevant Markets. Unilateral effects arise when the reduction in direct competition between merging firms is sufficient to create post-merger market power. The
The potential unilateral effects theories in this case fall broadly within one of three categories. The first category involves straightforward merger-to-monopoly markets. In these markets, the theory of harm is that Holcim and Lafarge are the only two meaningful suppliers for all customers in the Relevant Market. The second
Unilateral price effects are “most apparent in a merger to monopoly in a relevant market.”
The analysis is necessarily more nuanced for theories falling within the second category of theories of unilateral price effects. These theories involve Relevant Markets where the proposed transaction would reduce the number of competitors from four to three or three to two, and the market share for the merged entity would not be large enough to infer it would have the power to raise market prices unilaterally. In these markets, particularized evidence is required to establish reason to believe the merged firm will gain unilateral pricing power. In many Relevant Markets, staff was successful in uncovering the required evidence. For example, in some Relevant Markets, there was evidence of a significant subset of customers for whom a sole market participant would be the only remaining acceptable supplier, due either to physical proximity or to some other preference rendering alternatives an unacceptable source of portland or slag cement. The Commission's example of ready-mix concrete producers,
In other Relevant Markets, the allegation that there will remain only one acceptable supplier for a significant subset of customers after the proposed transaction lacks evidentiary support. Specifically, in these markets, the record evidence does not indicate that a material number of customers view Holcim and Lafarge as closest supply alternatives or that they view other potential suppliers as unacceptable supply sources and would continue to do so in the face of a post-merger unilateral price increase.
The final category of potential unilateral effects theories, like the second category, also involves Relevant Markets where the proposed transaction would reduce the number of competitors from four to three or three to two, but the post-merger market share would not be large enough to infer it would have the power to raise market prices unilaterally. However, unlike the second category, in these Relevant Markets, it is not customer preference that limits the number of available competitors to one. Rather, in these Relevant Markets, the proposed transaction is effectively a merger to monopoly or near monopoly because alternative suppliers would be unwilling or unable to compete with the merged entity in the face of a price increase. In some Relevant Markets, the investigation uncovered particularized evidence sufficient to establish a reason to believe such unilateral effects are likely, including evidence that other competitors are experiencing, or soon will experience, capacity constraints, rendering them unable or unwilling to compete for market share, or that other suppliers will not constrain the merged entity's prices. Several Relevant Markets fall into this third category.
Relevant Markets where the “reason to believe” standard is not satisfied lacked record evidence necessary to corroborate any of these three theories.
Prior to entering into a consent agreement with the merging parties, the Commission must first find reason to believe that a merger likely will substantially lessen competition under Section 7 of the Clayton Act. A presumption that such reason to believe exists when a merger decreases in the number of competitors in a market to three or two is misguided. Additionally, when the Commission alleges coordinated or unilateral effects arising from a proposed transaction, this standard requires more than a mere counting of pre- and post-merger firms. In particular, reason to believe a proposed transaction is likely to result in coordinated effects requires evidence—absent from the record here—that the merger will
Similarly, substantiating a unilateral effects theory requires particularized evidence—also absent from the record here in some Relevant Markets—that a merger will reduce or eliminate competitive constraints, permitting the merged entity to increase prices. Without such evidence, a unilateral effects theory reduces to little more than a complaint about market structure coupled with speculation about the circumstances under which unilateral effects might occur in a post-merger world. The
This is not to suggest the “reason to believe” standard requires access to every piece of relevant information and a full and complete economic analysis of a proposed transaction, regardless of whether the parties wish to propose divestitures before complying with a Second Request. Rather, the standard requires only evidence sufficient to establish that competitive harm is likely. Such evidence, although quite minimal—indeed, a handful of facts in most instances—is indeed available in some Relevant Markets in this matter, and it is in those markets that I concur with the Commission's decision. While I appreciate the practical complications of requesting additional information during the course of a merger investigation, as well as the desire to conduct efficient investigations, these important pragmatic considerations do not trump the Commission's primary obligation to collect evidence sufficient to establish reason to believe the merger will harm competition before issuing a complaint and accepting a consent.
For the reasons I explain above, I find reason to believe the proposed transaction is likely to result in unilateral price effects, and thus violate the Clayton Act, in the Twin Cities, Duluth, western Wisconsin, New Orleans, western Montana, Boston/Providence, the Mid-Atlantic region, and the western Great Lakes region. I conclude there is no reason to believe the proposed transaction will violate Section 7 in eastern Iowa, Memphis, Baton Rouge, Detroit, northern Michigan, and Grand Rapids; it follows that I believe the Commission should refrain from imposing a remedy in these markets.
Office of Acquisition Policy, General Services Administration (GSA).
Notice of request for comments regarding the extension of a previously existing OMB clearance.
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•
Kevin Funk, Procurement Analyst, General Services Acquisition Policy Division, GSA, at telephone 215-446-4860 or via email to
The Federal Hazardous Substance Act and Hazardous Material Transportation Act prescribe standards for packaging of hazardous substances. To meet the requirements of the Acts, the General Services Administration Regulation prescribes provision 552.223-72, Hazardous Material Information, to be inserted in solicitations and contracts that provides for delivery of hazardous materials on an f.o.b. origin basis.
This information collection will be accomplished by means of the provision which requires the contractor to identify for each National Stock Number, the DOT Shipping Name, DOT Hazards Class, and whether the item requires a DOT label. Contracting Officers and technical personnel use the information to monitor and ensure contract requirements based on law and regulation.
Properly identified and labeled items of hazardous material allows for appropriate handling of such items throughout GSA's supply chain system. The information is used by GSA, stored in an NSN database and provided to GSA customers. Non-Collection and/or a less frequently conducted collection of the information resulting from provision 552.223-72 would prevent the Government from being properly notified. Government activities may be hindered from apprising their employees of; (1) All hazards to which they may be exposed; (2) Relative symptoms and appropriate emergency treatment; and (3) Proper conditions and precautions for safe use and exposure.
Public Comments are particularly invited on: Whether this collection of information is necessary and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate and based on valid assumptions and methodology; and ways to enhance the quality, utility, and clarity of the information to be collected.
Please cite OMB Control No. 3090-0205, Environmental Conservation, Occupational Safety, and Drug-Free Workplace, in all correspondence.
Centers for Medicare & Medicaid Services.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the
Comments must be received by July 14, 2015.
When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:
1.
2.
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' Web site address at
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786-1326.
Reports Clearance Office at (410) 786-1326.
This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see
Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the
1.
We propose to continue to use the Criteria Worksheets (Forms CMS-437A and CMS-437B) for verifying first-time exclusions from the IPPS, for complaint surveys, for its annual 5 percent validation sample, and for facility self-attestation. These forms are related to the survey and certification and Medicare approval of the IPPS-excluded rehabilitation units and rehabilitation hospitals.
For rehabilitation hospitals and rehabilitation units already excluded from the IPPS, annual onsite re-verification surveys by the SA are not required. These hospitals and units will be provided with a copy of the appropriate CMS-437 Worksheet at least 5-months prior to the beginning of its cost reporting period, so that the hospital/unit official may complete and sign an attestation statement and complete and return the appropriate CMS-437A or CMS-437B at least 5-months prior to the beginning of its cost reporting period. Fiscal Intermediaries will continue to verify, on an annual basis, compliance with the 60 percent rule (42 CFR 412.29(b)(2)) for rehabilitation hospitals and rehabilitation units through a sample of medical records and the SA will verify the medical director requirement.
The SA will maintain the documents unless instructed otherwise by the RO.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators.” The purpose of this guidance is to assist sponsor-investigators in preparing and submitting complete investigational new drug applications (INDs) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at FDA. Although not an exhaustive step-by-step instruction manual, this guidance highlights certain elements of this process to facilitate a sponsor-investigator's successful submission of an IND. This guidance also discusses the IND review process and general responsibilities of sponsor-investigators related to clinical investigations. Details of the informational content of an IND as well as information needed to complete required forms also are provided throughout this guidance.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 14, 2015.
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of Communication, Outreach, and Development (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Submit electronic comments on the draft guidance to
Amalia Himaya, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6439, Silver Spring, MD 20993-0002, 301-796-0700; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
FDA is announcing the availability of a draft guidance for industry entitled “Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators.” The purpose of this guidance is to assist investigators in preparing and submitting complete INDs to CDER and CBER at FDA. Sponsor-investigators seeking to do clinical research often do not have the regulatory knowledge or the resources to hire experts to help them with the IND submission process. Although not an exhaustive step-by-step instruction manual, this guidance highlights certain elements of this process to facilitate a sponsor-investigator's successful submission of an IND. This guidance also discusses the IND review process and general responsibilities of sponsor-investigators related to clinical investigations. The guidance does not include discussions of all of the requirements that apply to the IND submission and review process or to conducting clinical research.
This guidance is directed primarily at those sponsor-investigators who are seeking to evaluate a drug that is either currently approved or is being investigated under an existing IND for a different indication. This guidance is not intended for sponsor-investigators who are developing a drug for commercial purposes (
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on INDs prepared and submitted by sponsor-investigators. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014.
Interested persons may submit either electronic comments regarding this document to
Persons with access to the Internet may obtain the document at
Food and Drug Administration, HHS.
Notice of public workshop.
The Food and Drug Administration (FDA) is announcing the following public workshop entitled “AUA-FDA-SUO Workshop on Partial Gland Ablation for Prostate Cancer.” The topics to be discussed are the technologies and imaging used in partial gland ablation, and the design of clinical trials to measure the most appropriate endpoints for partial gland ablation for prostate cancer. The workshop will be part of the American Urological Association (AUA) annual meeting in New Orleans, LA.
The public workshop will be held on Sunday, May 17, 2015, from 1 p.m. to 6 p.m.
The workshop will be held at the New Orleans Ernest N. Morial Convention Center, 900 Convention Center Blvd., New Orleans, LA 70130.
If you need special accommodations due to a disability, please contact Ms. Susan Monahan, 301-796-5661, email:
For more information on the workshop, please visit FDA's Medical Devices News & Events—Workshops & Conferences calendar at
John Baxley, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G210, Silver Spring, MD 20993, 301-796-6549, email:
FDA's Center for Devices and Radiological Health, the AUA, and the Society of Urologic Oncology (SUO) are cosponsoring this workshop. The purpose is to provide a forum to discuss the development of products that ablate prostatic tissue, particularly products that target ablation to regions of known cancer while intentionally sparing the remainder of the prostate from treatment.
The majority of cases of prostate cancer diagnosed in the United States represent low risk, organ-confined disease, which may be overtreated if conventional treatment methods (
The purposes of this public workshop are to: (1) Foster collaboration and receive input from experts within the scientific community; (2) obtain input from various stakeholders including patients, investigators and industry regarding the development of minimally invasive devices to ablate prostatic tissue; (3) foster clinical research; (4) discuss strategies to accelerate anticancer device development; and (5) provide transparency via a public forum regarding the regulatory challenges of developing products for management of patients with localized prostate cancer.
The following topics will be discussed at this workshop:
• Regulatory issues in partial gland ablation for prostate cancer;
• overview of technology and consensus reports;
• the use of imaging and biopsy for patient selection and treatment targeting; and
• the design of clinical trials to measure cancer-specific and patient-centered outcomes.
The workshop will consist of formal presentations examining these regulatory, scientific and clinical topics, followed by panel discussion. During panel discussion, there will also be the opportunity for public participation and input.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 14, 2015.
Submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-7800. See the
Submit electronic comments on the draft guidance to
Valerie A. Butler, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
FDA is announcing the availability of a draft document entitled “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Draft Guidance for Industry.” The emergence of Acquired Immune Deficiency Syndrome (AIDS) in the early 1980s and the recognition that it could be transmitted by blood and blood products had profound effects on the U.S. blood system. Although initially identified in men who have sex with men (MSM) and associated with male-to-male sexual contact, AIDS was soon noted to be potentially transmitted by transfusion of blood components, and by infusion of clotting factor concentrates in individuals with hemophilia. Beginning in 1983, the FDA, issued recommendations for providing donors with education material on risk factors for AIDS and for deferring donors with such risk factors in an effort to prevent transmission of AIDS (later understood to be caused by HIV) by blood and blood products.
Since September 1985, FDA has recommended that blood establishments indefinitely defer male donors who have had sex with another male, even one time, since 1977, due to the strong clustering of AIDS illness in the MSM community and the subsequent discovery of high rates of HIV infection in that population. On April 23, 1992, FDA issued the 1992 blood memo, which contains the current recommendations regarding the deferral for MSM, as well as the deferral recommendations for other persons with behaviors associated with high rates of HIV exposure, namely commercial sex workers, intravenous drug users, and certain other individuals with other risk factors.
The use of donor education material, specific deferral questions and advances in HIV donor testing have reduced the risk of HIV transmission from blood transfusion from about 1 in 2500 units prior to HIV testing to a current estimated residual risk of about 1 in 1.47 million transfusions. During the period from 1997 to 2014, FDA and the Department of Health and Human Services (HHS) held a number of public meetings, including scientific workshops and meetings of the Blood Products Advisory Committee and the HHS Advisory Committee on Blood Safety and Availability to further review evidence and discuss FDA's blood donor deferral policies to reduce the risk of transmission of HIV by blood and blood products. Studies that might support a policy change were carried out by the Public Health Service agencies in 2011-2014. A policy change to the blood donor deferral period for MSM from indefinite deferral to 1 year since the last sexual contact was announced by the FDA Commissioner in December 2014. The draft guidance, when finalized, will implement that policy change.
In addition to providing donor deferral recommendations for individuals at increased risk for transmitting HIV infection, the draft guidance document incorporates certain recommendations contained in the 1992 blood memo. Certain other recommendations from the 1992 blood memo have not been included in the draft guidance document because they have become outdated over time, superseded by subsequent regulations or guidance documents, or have been incorporated into other guidance documents. However, to ensure that the final guidance document provides comprehensive recommendations for reducing the risk of HIV transmission by blood and blood products, we invite comments on the recommendations contained in the 1992 blood memo that have not been included in the draft guidance. Further, the draft guidance does not provide a specific list of recommended signs and symptoms associated with HIV for inclusion in the donor education materials. We invite comments and the submission of data on what specific signs and symptoms associated with HIV infection would be most appropriate for inclusion in education material in the blood donor setting. The draft guidance, when finalized, is intended to supersede the 1992 blood memo.
The draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
The draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under
The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit either electronic comments regarding this document to
Persons with access to the Internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a collection of information entitled, “Generic Clearance for the Collection of Qualitative Feedback on Food and Drug Administration Service Delivery” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
On September 24, 2014, the Agency submitted a proposed collection of information entitled, “Generic Clearance for the Collection of Qualitative Feedback on Food and Drug Administration Service Delivery” to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0697. The approval expires on November 30, 2017. A copy of the supporting statement for this information collection is available on the Internet at
The meeting will be open to the public as indicated above, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify within their RSVP at least 10 business days prior to the meeting. Foreign nationals planning to attend the session in person will require additional paperwork for security clearance and that this clearance process requires a minimum of 10 business days.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App. 2), notice is hereby given of the Joint meeting of the National Cancer Advisory Board (NCAB) and NCI Board of Scientific Advisors (BSA).
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The open session will be videocast and can be accessed from the NIH Videocasting and Podcasting Web site (
A portion of the National Cancer Advisory Board meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Open: June 23, 2015, 6:30 p.m. to 8:00 p.m.
Open: June 24, 2015, 9:00 a.m. to 4:00 p.m.
Closed: June 24, 2015, 4:00 p.m. to 5:30 p.m.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Information is also available on the Institute's/Center's home page: NCAB:
Notice is hereby given of a change in the meeting of the National Advisory Council on Alcohol Abuse and Alcoholism, June 10, 2015, 09:15 a.m. to June 10, 2015, 04:00 p.m., National Institutes of Health, 5635 Fishers Lane, Terrace Conference Rooms, Bethesda, MD 20892 which was published in the
This notice is being amended to change the start times of the closed session from 9:15 a.m. to 9:00 a.m. and the open session from 11:00 a.m. to 10:15 a.m. on June 10, 2015. The meeting is partially closed to the public.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the President's Cancer Panel.
The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
Information is also available on the Institute's/Center's home page:
Coast Guard, DHS.
Notice.
The Coast Guard announces that a Certificate of Alternative Compliance was issued for the passenger vessel LUCIA as required by 33 U.S.C. 1605(c) and 33 CFR 81.18.
The Certificate of Alternative Compliance was issued on April 3, 2015.
The docket for this notice is available for inspection or copying at the Docket Management Facility (M-30), U.S. Department of Transportation, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. You may also find this docket on the Internet by going to
If you have questions on this notice, call LT Steven Melvin, District Nine, Prevention Branch, U.S. Coast Guard, telephone 216-902-6343. If you have questions on viewing or submitting material to the docket, call Cheryl Collins, Program Manager, Docket Operations, telephone 202-366-9826.
As required by 33 U.S.C. 1605(c) and 33 CFR 81.18, the Coast Guard gives notice that it has issued a certificate of alternative compliance for the P/V LUCIA. The vessel's primary purpose is a passenger-touring vessel that operates on the Chicago River and near coastal waters of Lake Michigan in Southern Illinois. The unique design of the vessel did not lend itself to full compliance with Annex I of the Inland Rules Act, 33 U.S.C. 2071.
The Commandant, U.S. Coast Guard, certifies that full compliance with the Inland Rules Act would interfere with
The Certificate of Alternative Compliance authorizes the P/V LUCIA to deviate from the requirements set forth in Annex I of the Inland Rules Act by placing its masthead light on the pilothouse visor at a height of 13′7″ above the main deck.
This notice is issued under authority of 5 U.S.C. 552(a), 33 U.S.C. 1605(c), and 33 CFR 81.18.
U.S. Customs and Border Protection, Department of Homeland Security.
30-Day notice and request for comments; Extension of an existing collection of information.
U.S. Customs and Border Protection (CBP) of the Department of Homeland Security will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: Entry and Manifest of Merchandise Free of Duty, Carrier's Certificate and Release (CBP Form7523). This is a proposed extension of an information collection that was previously approved. CBP is proposing that this information collection be extended with no change to the burden hours or to the information collected. This document is published to obtain comments from the public and affected agencies.
Written comments should be received on or before June 15, 2015 to be assured of consideration.
Interested persons are invited to submit written comments on this proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the OMB Desk Officer for Customs and Border Protection, Department of Homeland Security, and sent via electronic mail to
Requests for additional information should be directed to Tracey Denning, U.S. Customs and Border Protection, Regulations and Rulings, Office of International Trade, 90 K Street NE., 10th Floor, Washington, DC 20229-1177, at 202-325-0265.
This proposed information collection was previously published in the
U.S. Customs and Border Protection, Department of Homeland Security.
30-Day notice and request for comments; extension of an existing collection of information.
U.S. Customs and Border Protection (CBP) of the Department of Homeland Security will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: Guarantee of Payment (CBP Form I-510). This is a proposed extension of an information collection
Written comments should be received on or before June 15, 2015 to be assured of consideration.
Interested persons are invited to submit written comments on this proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the OMB Desk Officer for Customs and Border Protection, Department of Homeland Security, and sent via electronic mail to
Requests for additional information should be directed to Tracey Denning, U.S. Customs and Border Protection, Regulations and Rulings, Office of International Trade, 90 K Street NE., 10th Floor, Washington, DC 20229-1177, at 202-325-0265.
This proposed information collection was previously published in the
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the Commonwealth of Kentucky (FEMA-4217-DR), dated May 1, 2015, and related determinations.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
Notice is hereby given that, in a letter dated May 1, 2015, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
I have determined that the damage in certain areas of the Commonwealth of Kentucky resulting from severe storms, tornadoes, flooding, landslides, and mudslides during the period of April 2-17, 2015, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses.
You are authorized to provide Individual Assistance and Public Assistance in the designated areas and Hazard Mitigation throughout the Commonwealth. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation and Other Needs Assistance will be limited to 75 percent of the total eligible costs. Federal funds provided under the Stafford Act for Public Assistance also will be limited to 75 percent of the total eligible costs, with the exception of projects that meet the eligibility criteria for a higher Federal cost-sharing percentage under the Public Assistance Alternative Procedures Pilot Program for Debris Removal implemented pursuant to section 428 of the Stafford Act.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The time period prescribed for the implementation of section 310(a), Priority to Certain Applications for Public Facility and Public Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed six months after the date of this declaration.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Joe M. Girot, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster.
The following areas of the Commonwealth of Kentucky have been designated as adversely affected by this major disaster:
Bath, Bourbon, Carter, Elliott, Franklin, Jefferson, Lawrence, Madison, Rowan, and Scott Counties for Individual Assistance.
Bath, Bourbon, Breathitt, Bullitt, Clark, Elliott, Estill, Franklin, Jefferson, Johnson, Lawrence, Lee, Lewis, Madison, Magoffin, Metcalfe, Morgan,
Owsley, and Wolfe Counties for Public Assistance.
All areas within the Commonwealth of Kentucky are eligible for assistance under the Hazard Mitigation Grant Program.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Tennessee (FEMA-4211-DR), dated April 2, 2015, and related determinations.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of Tennessee is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of April 2, 2015.
Claiborne, Cocke, Davidson, DeKalb, Greene, Hawkins, Pickett, Rhea, and Wayne Counties for Public Assistance.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Final Notice.
Flood hazard determinations, which may include additions or modifications of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where applicable, in the supporting Flood Insurance Study (FIS) reports have been made final for the communities listed in the table below.
The FIRM and FIS report are the basis of the floodplain management measures that a community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the Federal Emergency Management Agency's (FEMA's) National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report are used by insurance agents and others to calculate appropriate flood insurance premium rates for buildings and the contents of those buildings.
The effective date of July 6, 2015 which has been established for the FIRM and, where applicable, the supporting FIS report showing the new or modified flood hazard information for each community.
The FIRM, and if applicable, the FIS report containing the final flood hazard information for each community is available for inspection at the respective Community Map Repository address listed in the tables below and will be available online through the FEMA Map Service Center at
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the new or modified flood hazard information for each community listed. Notification of these changes has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Mitigation has resolved any appeals resulting from this notification.
This final notice is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.
Interested lessees and owners of real property are encouraged to review the new or revised FIRM and FIS report
The flood hazard determinations are made final in the watersheds and/or communities listed in the table below.
Federal Emergency Management Agency, DHS.
Final notice.
New or modified Base (1-percent annual chance) Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, and/or regulatory floodways (hereinafter referred to as flood hazard determinations) as shown on the indicated Letter of Map Revision (LOMR) for each of the communities listed in the table below are finalized. Each LOMR revises the Flood Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance Study (FIS) reports, currently in effect for the listed communities. The flood hazard determinations modified by each LOMR will be used to calculate flood insurance premium rates for new buildings and their contents.
The effective date for each LOMR is indicated in the table below.
Each LOMR is available for inspection at both the respective Community Map Repository address listed in the table below and online through the FEMA Map Service Center at
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
The Federal Emergency Management Agency (FEMA) makes the final flood hazard determinations as shown in the LOMRs for each community listed in the table below. Notice of these modified flood hazard determinations has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Mitigation has resolved any appeals resulting from this notification.
The modified flood hazard determinations are made pursuant to section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001
For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.
The new or modified flood hazard information is the basis for the floodplain management measures that the community is required either to adopt or to show evidence of being already in effect in order to remain qualified for participation in the National Flood Insurance Program (NFIP).
This new or modified flood hazard information, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities.
This new or modified flood hazard determinations are used to meet the floodplain management requirements of the NFIP and also are used to calculate the appropriate flood insurance premium rates for new buildings, and for the contents in those buildings. The changes in flood hazard determinations are in accordance with 44 CFR 65.4.
Interested lessees and owners of real property are encouraged to review the final flood hazard information available at the address cited below for each community or online through the FEMA Map Service Center at
Federal Emergency Management Agency, DHS.
Final notice.
Flood hazard determinations, which may include additions or modifications of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where applicable, in the supporting Flood Insurance Study (FIS) reports have been made final for the communities listed in the table below.
The FIRM and FIS report are the basis of the floodplain management measures that a community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the Federal Emergency Management Agency's (FEMA's) National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report are used by insurance agents and others to calculate appropriate flood insurance premium rates for buildings and the contents of those buildings.
The effective date of June 16, 2015 which has been established for the FIRM and, where applicable, the supporting FIS report showing the new or modified flood hazard information for each community.
The FIRM, and if applicable, the FIS report containing the final flood hazard information for each community is available for inspection at the respective Community Map Repository address listed in the tables below and will be available online through the FEMA Map Service Center at
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the new or modified flood hazard information for each community listed. Notification of these changes has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Mitigation has resolved any appeals resulting from this notification.
This final notice is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.
Interested lessees and owners of real property are encouraged to review the new or revised FIRM and FIS report available at the address cited below for each community or online through the FEMA Map Service Center at
The flood hazard determinations are made final in the watersheds and/or communities listed in the table below.
I. Watershed-based studies:
II. Non-watershed-based studies:
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the Commonwealth of Kentucky (FEMA-4217-DR), dated May 1, 2015, and related determinations.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the Commonwealth of Kentucky is hereby amended to make available all Individual Assistance programs for the following areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of May 1, 2015.
Bath, Bourbon, Carter, Elliott, Franklin, Jefferson, Lawrence, Madison, Rowan, and Scott Counties for Individual Assistance.
Federal Emergency Management Agency, DHS.
Notice.
This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The FIRM, and where applicable, portions of the FIS report, have been revised to reflect these flood hazard determinations through issuance of a Letter of Map Revision (LOMR), in accordance with Title 44, part 65 of the Code of Federal Regulations (44 CFR part 65). The LOMR will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings. For rating purposes, the currently effective community number is shown in the table below and must be used for all new policies and renewals.
These flood hazard determinations will become effective on the dates listed in the table below and revise the FIRM panels and FIS report in effect prior to this determination for the listed communities.
From the date of the second publication of notification of these changes in a newspaper of local circulation, any person has 90 days in which to request through the community that the Deputy Associate Administrator for Mitigation reconsider the changes. The flood hazard
The affected communities are listed in the table below. Revised flood hazard information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Submit comments and/or appeals to the Chief Executive Officer of the community as listed in the table below.
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
The specific flood hazard determinations are not described for each community in this notice. However, the online location and local community map repository address where the flood hazard determination information is available for inspection is provided.
Any request for reconsideration of flood hazard determinations must be submitted to the Chief Executive Officer of the community as listed in the table below.
The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001
The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
These flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. The flood hazard determinations are in accordance with 44 CFR 65.4.
The affected communities are listed in the following table. Flood hazard determination information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Federal Emergency Management Agency, DHS.
Notice.
The Federal Emergency Management Agency (FEMA) will submit the information collection abstracted below to the Office of Management and Budget for review and clearance in accordance with the requirements of the Paperwork Reduction Act of 1995. The submission will describe the nature of the information collection, the categories of respondents, the estimated burden (
Comments must be submitted on or before June 15, 2015.
Submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the Desk Officer for the Department of Homeland Security, Federal Emergency Management Agency, and sent via electronic mail to
Requests for additional information or copies of the information collection should be made to Director, Records Management Division, 500 C Street SW., Washington, DC 20472-3100, facsimile number (202) 212-4701, or email address
Federal Emergency Management Agency, DHS.
Notice.
The Federal Emergency Management Agency (FEMA) will submit the information collection abstracted below to the Office of Management and Budget for review and clearance in accordance with the requirements of the Paperwork Reduction Act of 1995. The submission will describe the nature of the information collection, the categories of respondents, the estimated burden (
Comments must be submitted on or before June 15, 2015.
Submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the Desk Officer for the Department of Homeland Security, Federal Emergency Management Agency, and sent via electronic mail to
Requests for additional information or copies of the information collection should be made to Director, Records Management Division, 500 C Street SW., Washington, DC 20472-3100, facsimile number (202) 212-4701, or email address
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, Department of Housing and Urban Development (HUD).
Notice of extension of time.
This notice advises the public that HUD received a request from Cavco Industries (Cavco) for an extension of time to fully implement its plan to notify purchasers and correct certain manufactured homes built and sold by Cavco that were installed with Kidde combined smoke and carbon monoxide alarms imported by Walter Kidde Portable Equipment Inc., that were subsequently recalled by the Consumer Product Safety Commission. After reviewing Cavco's request, HUD determined that Cavco has shown good cause and granted its request for an extension. The requested extension is granted until August 24, 2015.
Pamela Beck Danner, Administrator and Designated Federal Official (DFO), Office of Manufactured Housing Programs, Office of Housing Department of Housing and Urban Development, 451 Seventh Street SW., Room 9166, Washington, DC 20410, telephone 202-708-6423 (this is not a toll-free number). Persons who have difficulty hearing or speaking may access this number via TTY by calling the toll-free Federal Relay Service at 800-877-8339.
The National Manufactured Housing Construction and Safety Standards Act of 1974 (42 U.S.C. 5401-5426) (the Act) authorizes HUD to establish the Federal Manufactured Home Construction and Safety Standards (Construction and Safety Standards), codified in 24 CFR part 3280. Section 615 of the Act (42 U.S.C. 5414) requires that manufacturers of manufactured homes notify purchasers if the manufacturer determines, in good faith, that a defect exists or is likely to exist in more than one home manufactured by the manufacturer and the defect relates to the Construction and Safety Standards or constitutes an imminent safety hazard to the purchaser of the manufactured home. The notification shall also inform purchasers whether the defect is one that the manufacturer will have corrected at no cost or is one that must be corrected at the expense of the purchaser/owner. The manufacturer is responsible to notify purchasers of the defect within a reasonable time after discovering the defect.
HUD's procedural and enforcement provisions at 24 CFR part 3282, subpart I (Subpart I) implement these notification and correction requirements. If a manufacturer determines that it is responsible for providing notification under 3282.405 and correction under 3282.406, the manufacturer must prepare a plan for notifying purchasers of the homes containing the defect pursuant to 3282.408 and 3282.409. Notification of purchasers must be accomplished by certified mail or other more expeditious means that provides a receipt. Notification must be provided to each retailer or distributor to whom any manufactured home in the class of homes containing the defect was delivered, to the first purchaser of each manufactured home in the class of manufactured homes containing the defect, and to other persons who are a registered owners of a manufactured home in the class of homes containing the defect. The manufacturer must complete the implementation of the plan for notification and correction on or before the deadline approved by the State Administrative Agency or HUD. Under 3282.410(c), the manufacturer may request an extension of the deadline if it shows good cause for the extension and the Secretary of HUD decides that the extension is justified and not contrary to the public interest. If the request for extension is approved, 3282.410(c) requires that HUD publish notice of the extension in the
On November 14, 2014, Cavco
Since receipts for all certified letters were not returned and in some cases a valid phone number was not available, Cavco, by letter dated April 24, 2015, requested an extension of 120 days to complete the notification and correction process. This notice advises that HUD finds that Cavco has shown good cause and that the extension is justified and not contrary to the public interest and, on April 24, 2015, granted the requested extension until August 24, 2015, to permit Cavco to continue its good faith efforts to contact the affected homeowners who did not receive a certified letter, and to replace Kidde combined smoke and carbon monoxide alarms at no cost to affected homeowners.
Office of the General Counsel, HUD.
Notice.
Through this notice, and in accordance with the Paperwork Reduction Act of 1995, HUD invites comment on a proposed information collection for the purpose of helping HUD assess technology needs, such as access to high-speed Internet, in HUD-subsidized housing. HUD is requesting emergency processing of this request because philanthropic foundations, nonprofit organizations, private sector entities, and others have expressed interest in helping residents housed with HUD assistance to narrow their technology infrastructure and digital literacy gaps. The questions included in the information collection will enable HUD to assess the technology needs of residents housed with HUD assistance, the commitment of communities and Public Housing Agencies (PHAs) to narrowing these technology gaps, and the capacity of such jurisdictions to successfully utilize the type of assistance that is being offered. The earlier that HUD can obtain this information, the earlier that HUD may be able to benefit from the generosity of the various organizations that have offered assistance.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Room 4176, Washington, DC 20410-5000; telephone 202-402-3400 (this is not a toll-free number) or email at
Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Colette Pollard at
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Office of the Assistant Secretary for Community Planning and Development, HUD.
Notice.
This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for use to assist the homeless.
Juanita Perry, Department of Housing and Urban Development, 451 Seventh Street SW., Room 7266, Washington, DC 20410; telephone (202) 402-3970; TTY number for the hearing- and speech-impaired (202) 708-2565 (these telephone numbers are not toll-free), or call the toll-free Title V information line at 800-927-7588.
In accordance with 24 CFR part 581 and section 501 of the Stewart B. McKinney Homeless Assistance Act (42 U.S.C. 11411), as amended, HUD is publishing this Notice to identify Federal buildings and other real property that HUD has reviewed for suitability for use to assist the homeless. The properties were reviewed using information provided to HUD by Federal landholding agencies regarding unutilized and underutilized buildings and real property controlled by such agencies or by GSA regarding its inventory of excess or surplus Federal property. This Notice is also published in order to comply with the December 12, 1988 Court Order in
Properties reviewed are listed in this Notice according to the following categories: Suitable/available, suitable/unavailable, and suitable/to be excess, and unsuitable. The properties listed in the three suitable categories have been reviewed by the landholding agencies, and each agency has transmitted to HUD: (1) Its intention to make the property available for use to assist the homeless, (2) its intention to declare the property excess to the agency's needs, or (3) a statement of the reasons that the property cannot be declared excess or made available for use as facilities to assist the homeless.
Properties listed as suitable/available will be available exclusively for homeless use for a period of 60 days from the date of this Notice. Where property is described as for “off-site use only” recipients of the property will be required to relocate the building to their own site at their own expense. Homeless assistance providers interested in any such property should send a written expression of interest to HHS, addressed to: Ms. Theresa M. Ritta, Chief Real Property Branch, the Department of Health and Human Services, Room 5B-17, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857, (301) 443-2265 (This is not a toll-free number.) HHS will mail to the interested provider an application packet, which will include instructions for completing the application. In order to maximize the opportunity to utilize a suitable property, providers should submit their written expressions of interest as soon as possible. For complete details concerning the processing of applications, the reader is encouraged to refer to the interim rule governing this program, 24 CFR part 581.
For properties listed as suitable/to be excess, that property may, if subsequently accepted as excess by GSA, be made available for use by the homeless in accordance with applicable law, subject to screening for other Federal use. At the appropriate time, HUD will publish the property in a Notice showing it as either suitable/available or suitable/unavailable.
For properties listed as suitable/unavailable, the landholding agency has decided that the property cannot be declared excess or made available for use to assist the homeless, and the property will not be available.
Properties listed as unsuitable will not be made available for any other purpose for 20 days from the date of this Notice. Homeless assistance providers interested in a review by HUD of the determination of unsuitability should call the toll free information line at 1-800-927-7588 for detailed instructions or write a letter to Ann Marie Oliva at the address listed at the beginning of this Notice. Included in the request for review should be the property address (including zip code), the date of publication in the
For more information regarding particular properties identified in this Notice (
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.
Notice.
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Room 4176, Washington, DC 20410-5000; telephone 202-402-3400 (this is not a toll-free number) or email at
Graham Mayfield, Reports The office of Single Family, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email at
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following: Form HUD 92900-A has been revised as follows:
B. (1) The information contained in the initial Uniform Residential Loan Application and this Addendum was obtained from the Borrower by an employee of the undersigned lender/mortgagee or its duly authorized agent and is to the best of lender/mortgagee's knowledge true, complete and accurate as of the date the Borrower provided the information to the undersigned lender/mortgagee or its duly authorized agent.
(2) The information contained in the final Uniform Residential Loan Application, which was signed by the Borrower at the time of settlement, was obtained by an employee of the undersigned lender/mortgagee or its duly authorized agent is to the best of lender/mortgagee's knowledge true, complete and accurate as of the date verified by the lender/mortgagee.
E. (1) To the best of my knowledge, neither I nor any parties to this transaction are suspended, debarred, under a limited denial of participation, or otherwise restricted under 2 CFR part 2424, or under similar procedures of any other federal agency.
(2) The lender/mortgagee involved in this transaction is not suspended, debarred, under a limited denial of participation, or otherwise restricted under 2 CFR part 2424 or 24 CFR part 25, or under similar procedures of any other federal agency.
Part V, Borrower Certification, 25; Added the following:
(2) Occupancy: HUD Only
I, the Borrower or Co-Borrower will occupy the property within 60 days of signing the security instrument, and intend to continue occupancy for at least one year. I do not intend to occupy the property as my primary residence.
Direct Endorsement Approval for a HUD FHA-Insured Mortgage; Added:
This mortgage was rated as an “accept” or “approve” by FHA's TOTAL Mortgage Scorecard and the undersigned Direct Endorsement underwriter certifies that I have personally reviewed and underwritten the appraisal according to standard FHA requirements.
This mortgage was rated as a “refer” by a FHA's TOTAL Mortgage Scorecard, or was manually underwritten by a Direct Endorsement underwriter. As such, the undersigned Direct Endorsement Underwriter certifies that I have personally reviewed the appraisal report (if applicable), credit application, and all associated documents used in underwriting this mortgage. I further certify that:
I have approved this loan and my Final Underwriting Decision was made having exercised the required level of Care and Due Diligence;
I have performed all Specific Underwriter Responsibilities for Underwriters and my underwriting of the borrower's Credit and Debt, Income, Qualifying Ratios and Compensating Factors, if any, and the borrower's DTI with Compensating Factors, if any, are within the parameters established by FHA and the borrower has assets to satisfy any required down payment and closing costs of this mortgage; and
I have verified the Mortgage Insurance Premium and Mortgage Amount are true and correct and this loan is in an amount that is permitted by FHA for this loan type, property type, and geographic area.
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Bureau of Indian Education, Interior.
Notice of availability and request for proposals.
The Bureau of Indian Education (BIE) announces the
Grant proposals must be received by June 15, 2015, at 5:00 p.m. Eastern Standard Time. The BIE will hold pre-application training sessions, see
Complete details on requirements for proposals and the evaluation and selection process can be found on the BIE Web site at this address:
Ms. Wendy Greyeyes, Bureau of Indian Education, Office of the BIE Director, (202) 208-5810;
The Secretary of the Interior, through BIE, may solicit grant proposals from federally recognized tribes and their tribal education departments (TEDs) for projects defined by 25 U.S.C. 2020. These funds will support the program goals for the following areas to promote tribal education capacity building within Indian reservations to:
• Provide for the development and enforcement of tribal educational codes, including tribal educational policies and tribal standards applicable to curriculum, personnel, students, facilities, and support programs;
• Facilitate tribal control in all matters relating to the education of Indian children on reservations (and on former Indian reservations in Oklahoma); and
• Provide for the development of coordinated educational programs (including all preschool, elementary, secondary, and higher or vocational educational programs funded by tribal, Federal, or other sources) on reservations (and on former Indian reservations in Oklahoma) by encouraging administrative support of all BIE-funded educational programs and encouraging tribal cooperation and coordination with entities carrying out all educational programs receiving financial support from other Federal agencies, State agencies, or private entities.
Grant awards will range from $25,000 to $150,000 per fiscal year depending on the number of projects, number of educational programs impacted, project design and expected outcomes. Subject to the availability of appropriated funds, a grant provided under 25 U.S.C. 2020 shall be provided for a period of three years. If the performance of a grant recipient is satisfactory to the Secretary, the grant may be renewed for an additional two-year term. As defined by 25 U.S.C. 2020, top priority will be given to proposals that meet the following:
• Serve three or more separate BIE-funded schools;
• Provide coordinating services and technical assistance to all relevant BIE-funded schools;
• Plan to monitor and audit grant funds by or through the TED; and/or
• Provide a plan and schedule that:
○ Provides for:
The assumption, by the TED, of all assets and functions of the BIE agency office associated with the tribe, to the extent the assets and functions relate to education; and
the termination by BIE of such functions and office at the time of such assumption; and
○ provides that the assumption will occur over the term of the grant, unless mutually agreeable to the tribal governing body and the Assistant Secretary—Indian Affairs, the period in which such assumption is to occur may be modified, reduced, or extended after the initial year of the grant.
BIE is seeking proposals from tribes that support the development of TEDs to improve educational outcomes for students and improve efficiencies and effectiveness in the operation of BIE-funded schools. Each proposal must include a project narrative, a budget narrative, and a work plan outline. Grant recipients must submit quarterly budget updates and an annual report at the end of each project year to ensure that the TED fulfills the obligations of the grant. Complete details on requirements for proposals and the evaluation and selection process can be found on the BIE Web site at the address in the
The grant proposal is due June 15, 2015, at 5:00 p.m. Eastern Time. The proposal should be packaged for delivery to permit timely arrival and sent or hand-delivered to the address in the
Fax applications will NOT be accepted. Email submissions will be accepted at the address in the
Proposals submitted by Federal Express or Express Mail should be sent two or more days before the closing date to ensure receipt by the deadline. The proposal package should be sent to the address shown in the
Bureau of Indian Affairs, Interior.
Notice of Availability.
In accordance with the National Environmental Policy Act (NEPA), the Bureau of Indian Affairs (BIA), as the lead Federal agency, with the Bureau of Land Management (BLM), the Environmental Protection Agency (EPA), U.S. Fish and Wildlife Service (USFWS), and the Moapa Band of Paiute Indians (Tribe) as Cooperating Agencies, has prepared a draft environmental impact statement (DEIS) for the proposed Aiya Solar Project on the Moapa River Indian Reservation (Reservation) in Clark County, Nevada. This notice announces that the DEIS is now available for public review and that BIA will hold public meetings to solicit comments on the DEIS.
The date and locations of the public meetings will be announced at least 15 days in advance through notices in the following local newspapers: Las Vegas Sun, Las Vegas Review Journal and the Moapa Valley Progress and on the following Web site:
You may mail, email, hand deliver or telefax written comments to Mr. Chip Lewis, Acting Regional Environmental Protection Officer, BIA Western Regional Office, Branch of Environmental Quality Services, 2600 North Central Avenue, 4th Floor Mail Room, Phoenix, Arizona 85004-3008; fax (602) 379-3833; email:
To obtain a compact disk copy of the DEIS, please provide your name and address in writing or by voicemail to Mr. Chip Lewis or Mr. Garry Cantley. Their contact information is listed in the
Mr. Chip Lewis, BIA Western Regional Office, Branch of Environmental Quality Services, 2600 North Central Avenue, Phoenix, Arizona 85004-3008, telephone (602) 379-6782; or Mr. Garry Cantley at (602) 379-6750.
The proposed Federal action, taken under 25 U.S.C. 415, is BIA's approval of a solar energy ground lease and associated agreements entered into by the Tribe with Aiya Solar Project, LLC (Aiya Solar or Applicant), a wholly owned subsidiary of First Solar, Inc. (First Solar), to provide for construction and operation of an up-to 100 megawatt (MW) alternating current solar photovoltaic (PV) electricity generation facility located entirely on the Reservation and specifically on lands held in trust by BIA for the Tribe. The proposed 230 kilovolt (kV) generation-tie transmission line required for interconnection would be located on Tribal lands, private lands and Federal lands administered and managed by BLM. The Applicant has accordingly requested that BIA and BLM additionally approve right-of-ways (ROWs) authorizing the construction and operation of the transmission line. Together, the proposed solar energy facility, transmission line, and other associated facilities make up the proposed Aiya Solar Project (Project).
The Project would be located in Township 14 South, Range 66 East, Sections 29, 30, 31, and 32 Mount Diablo Meridian, Nevada. The generation facility would generate electricity using PV panels. Also included would be inverters, a collection system, an on-site substation to step-up the voltage to transmission level voltage at 230 kV, an operations and maintenance building, and other related facilities. A single overhead 230 kV generation-tie transmission line, approximately 1.5 to 3 miles long, would connect the solar project to NV Energy's Reid-Gardner 230kV substation through a point northeast of the existing Reid-Gardner substation where a new NV Energy collector station would be built in the future.
Construction of the Project is expected to take approximately 12 to 15 months. The Applicant is expected to operate the energy facility for 30 years, with two options to renew the lease for an additional 10 years, if mutually acceptable to the Tribe and Applicant. During construction, the PV panels will be placed on top of fixed-tilt and/or single-axis tracking mounting systems that are set on steel posts embedded in the ground. Other foundation design techniques may be used depending on the site topography and conditions. No water will be used to generate electricity during operations. Water will be needed during construction for dust control and a minimal amount will be needed during operations for landscape irrigation and administrative and sanitary water use on site. The water supply required for construction of the Project would be leased from the Tribe and would be provided via a new temporary intake installed in the Muddy River and a new temporary above-ground pipeline approximately two miles in length. Operational water would be provided through a tap into an existing water pipeline that crosses the solar site. Access to the Project will be provided via State Highway 168.
The purposes of the Project are to: (1) Provide a long-term, diverse, and viable economic revenue base and job opportunities for the Tribe; (2) help Nevada and neighboring states to meet their state renewable energy needs; and (3) allow the Tribe, in partnership with the Applicant, to optimize the use of the lease site while maximizing the potential economic benefit to the Tribe.
The BIA and BLM will use the EIS to make decisions on the land lease and ROW applications under their respective jurisdiction. The EPA may use the document to make decisions under its authorities. The Tribe may use the EIS to make decisions under its Tribal Environmental Policy Ordinance. The USFWS may use the EIS to support its decision under the Endangered Species Act.
This notice is published in accordance with section 1503.1 of the Council on Environmental Quality regulations (40 CFR part 1500
Bureau of Land Management, Interior.
Notice.
As authorized under the provisions of the Federal Land Policy and Management Act of 1976 and relevant regulations, certain public land near Stead, Nevada, will be temporarily closed to all public use to provide for public safety during the 2015 Reno Air Racing Association Pylon Racing Seminar and the Reno National Championship Air Races.
Temporary closure periods are June 17 through June 20, 2015, and September 16 through September 20, 2015.
Leon Thomas, 775-885-6000, email:
This closure applies to all public use, including pedestrian use and vehicles. The public lands affected by this closure are described as follows:
The area described contains 450 acres, more or less, in Washoe County, Nevada.
The closure notice and map of the closure area will be posted at the BLM Carson City District Office, 5665 Morgan Mill Road, Carson City, Nevada and on the BLM Web site:
43 CFR 8360.0-7 and 8364.1.
Bureau of Land Management, Interior.
Notice.
Notice is hereby given that the United States Department of the Interior, Bureau of Land Management (BLM) Utah State Office will offer certain coal resources described below as the Flat Canyon Tract (UTU-77114) in Sanpete County, Utah, for competitive sale by sealed bid, in accordance with the Federal regulations for competitive lease sale notices and the Mineral Leasing Act of 1920, as amended and supplemented.
The lease sale will be held at 1:00 p.m. on June 17, 2015. Sealed bids must be sent by certified mail, return receipt requested, to the Collections Officer, BLM Utah State Office or be hand delivered to the public room Contact Representatives, BLM Utah State Office at the address indicated below, and must be received on or before 10:00 a.m. on June 17, 2015. Any bid received after the time specified will not be considered and will be returned.
The BLM public room Contact Representative will issue a receipt for each hand-delivered sealed bid. The outside of the sealed envelope containing the bid must clearly state that the envelope contains a bid for Coal Lease Sale UTU-77114 and is not to be opened before the date and hour of the sale.
The lease sale will be held in the Monument Conference Room at the following address: BLM-Utah State Office, Suite 500, 440 West 200 South, Salt Lake City, Utah 84101. Sealed bids can be hand delivered to the BLM public room Contact Representative or mailed to the Collections Officer, BLM Utah State Office, at the address given above.
Contact Jeff McKenzie, 440 West 200 South, Suite 500 Salt Lake City, Utah 84101-1345 or telephone 801-539-4038. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 to leave a message or question for the above individual. The FIRS is available 24 hours a day, 7 days a week. Replies are provided during normal business hours.
This coal lease sale is being held in response to a lease by application (LBA) submitted by Canyon Fuel Company, LLC. to the BLM on March 18, 1998. The successful bidder must pay to the BLM the cost BLM incurs regarding the publishing of this sale notice. If there is no successful bidder, the applicant will be responsible for all publishing costs.
The coal resources to be offered consist of all reserves recoverable by underground methods available in the following-described lands located in Sanpete County, Utah, approximately 10 miles southeast of Scofield, Utah, under both private and public surface.
Containing approximately 2,692.16 acres.
The tract is adjacent to the Skyline mine which contains other federal coal leases. The coal beds contained in this tract are under an average of 1,700 feet cover from the surface. The coal in the Flat Canyon tract has two economical coal beds; the Lower O'Conner B and the Flat Canyon beds. The minable portions of these coal beds are approximately 6 to 14 feet in thickness. The tract contains approximately 42 million tons of recoverable high-volatile B bituminous coal. The coal quality is based on an “as received basis” as follows: 12,400 Btu/lb., 5.80 percent moisture, 7.1 percent ash, 42.8 percent volatile matter, 43.8 percent fixed carbon and 0.50 percent sulfur.
The tract will be leased to the qualified bidder of the highest cash amount provided that the high bid meet or exceeds the BLM's estimate of the fair market value (FMV) of the tract. The minimum bid for the tract is $100 per acre or fraction thereof. No bid that is less than $100 per acre, or fraction thereof, will be considered. The minimum bid is not intended to represent FMV. The FMV of the tract will be determined by the Authorized Officer after the sale.
The BLM held a public hearing and requested comments on the Environmental Impact Statement (EIS) and the FMV of the Dry Canyon Tract on June 21, 2001. The BLM/U.S. Forest Service (USFS) prepared a Final Environmental Impact Statement and a Record of Decision on January 3, 2002. No appeals of the BLM decision to lease were filed during the appeal period. The USFS issued consent to lease on February 4, 2013. On December 24, 2014, the Governor of the State of Utah recommended proceeding with this lease sale.
The lease that may be issued as a result of this offering will provide for payment of an annual rental of $3 per acre or fraction thereof, and a royalty of 8 percent of the value of the coal produced by underground mining methods. The value of the coal will be determined in accordance with 30 CFR 1206.250.
The detailed statement for the offered tract, including bidding instructions and sales procedures under 43 CFR 3422.3-2, and the terms and conditions of the proposed coal lease, is available from the BLM-Public Room, Utah State Office, Suite 500, 440 West 200 South, Salt Lake City, Utah 84101. Case file documents, UTU-77114, are available for inspection during normal business hours in the BLM-Public Room, Suite 500.
Approved:
Office of Natural Resources Revenue (ONRR), Interior.
Notice of extension.
To comply with the Paperwork Reduction Act of 1995 (PRA), ONRR is inviting comments on a collection of information request that we will submit to the Office of Management and Budget (OMB) for review and approval of the paperwork requirements in the regulations under title 30,
Submit written comments on or before July 14, 2015.
You may submit comments on this ICR to ONRR by using one of the following three methods (please reference “ICR 1012-0004” in your comments):
1. Electronically go to
2. Mail comments to Mr. Luis Aguilar, Regulatory Specialist, ONRR, P.O. Box 25165, MS 61030A, Denver, Colorado 80225-0165.
3. Hand-carry or mail comments, using an overnight courier service, to ONRR. Our courier address is Building 85, Room A-614, Denver Federal Center, West 6th Ave. and Kipling St., Denver, Colorado 80225.
For questions on technical issues, contact Lee-Ann Martin, Reporting and Solid Minerals Services, ONRR, telephone (303) 231-3313, or email
The Secretary of the United States Department of the Interior is responsible for collecting royalties from lessees who produce minerals from leased Federal and Indian lands and the Outer-Continental Shelf (OCS). The Secretary's responsibility, under various laws, is to manage mineral resource production from Federal and Indian lands and the OCS, collect the royalties and other mineral revenues due, and distribute the funds collected under those laws. ONRR performs the royalty management functions for the Secretary.
We have posted those laws pertaining to mineral leases on Federal and Indian lands and the OCS at
The Secretary also has a trust responsibility to manage Indian lands and seek advice and information from Indian beneficiaries. ONRR performs the minerals revenue management functions and assists the Secretary in carrying out the Department's trust responsibility for Indian lands. When a company or an individual enters into a lease to explore, develop, produce, and dispose of minerals from Federal or Indian lands, that company or individual agrees to pay the lessor a share in an amount or value of production from the leased lands. The lessee, or his designee, is required to report various kinds of information to the lessor relative to the disposition of the leased minerals.
The ONRR financial accounting system is an integrated computer system that includes royalty, rental, bonus, and other payments; sales volumes and values; and royalty values as submitted by reporters. In the system, ONRR compares production volumes with royalty volumes to verify that reporters reported and paid proper royalties for the minerals produced. Additionally, we share the data electronically with the Bureau of Safety and Environmental Enforcement, Bureau of Land Management, Bureau of Indian Affairs, and Tribal and State governments so they can perform their lease management responsibilities.
We use the information collected in this ICR to ensure that royalty is appropriately paid, based on accurate
The regulations require payors (reporters) to report and to remit royalties on oil, gas, and geothermal resources produced from leases on Federal and Indian lands. The following form is used for royalty reporting:
The regulations require operators (reporters) to submit production reports if they operate a Federal or Indian onshore or offshore oil and gas lease, or Federally approved unit or communitization agreement. The ONRR financial accounting system tracks minerals produced from Federal and Indian lands, from the point of production to the point of disposition, or royalty determination, and/or point of sale. The reporters use the following forms for production accounting and reporting:
We will request OMB approval to continue to collect this information. If ONRR does not collect this information, this would limit the Secretary's ability to discharge fiduciary duties and may also result in loss of royalty payments. We protect the proprietary information that we receive and do not collect items of a sensitive nature. It is mandatory that the reporters submit Forms ONRR-2014, ONRR-4054, and ONRR-4058.
We have changed our estimates of the number of respondents due to updated data.
We have not included in our estimates certain requirements performed in the normal course of business, considered as usual and customary. We display the estimated annual burden hours by CFR section and paragraph in the following chart.
The PRA also requires agencies to estimate the total annual reporting “non-hour cost” burden to respondents or recordkeepers resulting from the collection of information. If you have costs to generate, maintain, and disclose this information, you should comment and provide your total capital and startup cost components or annual operation, maintenance, and purchase of service components. You should describe the methods that you use to estimate (1) major cost factors, including system and technology acquisition, (2) expected useful life of capital equipment, (3) discount rate(s), and (4) the period over which you incur costs. Capital and startup costs include, among other items, computers and software that you purchase to prepare for collecting information and monitoring, sampling, and testing equipment, and record storage facilities. Generally, your estimates should not include equipment or services purchased: (i) Before October 1, 1995; (ii) to comply with requirements not associated with the information collection; (iii) for reasons other than to provide information or keep records for the Federal Government; or (iv) as part of customary and usual business, or private practices.
Office of Natural Resources Revenue (ONRR), Interior.
Notice for OMB approval.
To comply with the Paperwork Reduction Act of 1995 (PRA), we are notifying the public that we have submitted this Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. This ICR covers the paperwork requirements for participation in the United States implementation of the Extractive Industries Transparency Initiative (USEITI). This notice also provides the public a second opportunity to comment on the paperwork burden of these regulatory requirements.
OMB has up to 60 days to approve or disapprove this information collection request but may respond after 30 days; therefore, you should submit your public comments to OMB by June 15, 2015 for the assurance of consideration.
You may submit your written comments directly to the Desk Officer for the Department of the Interior (OMB Control Number 1012—NEW), Office of Information and Regulatory Affairs, OMB, by email to
For questions on technical issues, contact Jonathan Swedin, Program & Performance Analysis, ONRR, telephone (303) 231-3028, or email
The Secretary of the U.S. Department of the Interior is responsible for mineral resource development on Federal and Indian lands and the Outer Continental Shelf (OCS). Under various laws, the Secretary's responsibility is to manage mineral resources production on Federal and Indian lands and the OCS, collect the royalties and other mineral revenues due, and distribute the funds collected under those laws. ONRR performs the royalty management functions and assists the Secretary in carrying out the Department's responsibility. We have posted those laws pertaining to mineral leases on Federal and Indian lands and the OCS at
In September 2011, President Obama announced the U.S. commitment to domestic implementation of EITI, a key element of the President's Open Government Partnership commitments. President Obama appointed the Secretary of the Interior as the senior U.S. official to lead the USEITI implementation. EITI is a voluntary global effort designed to strengthen transparency, accountability, and public trust for the revenues paid and received for a country's oil, gas, and mineral resources. The Administration renewed its commitment to implement EITI in the December 2013 U.S. Open Government National Action Plan. By signing onto the global EITI standard, the U.S. Government will help ensure that American taxpayers are receiving every dollar due for the extraction of these valuable public resources. The EITI Standard contains the set of requirements that countries need to meet in order to be recognized first as an EITI Candidate and ultimately as an EITI Compliant Country. In March 2014, the U.S. became the first G7 country to achieve Candidate Country status. When fully implemented, EITI will ensure more transparency in how the country's natural resources are governed and also will provide full disclosure of government revenues from its extractive sector.
The following laws and executive initiative are applicable to USEITI, including the Secretary's and ONRR's management of mineral resource production, revenue, and information disclosure obligations:
International EITI requirements direct participating governments to publish annual reports to help citizens understand how governments manage their extractive sectors. The U.S. Open Government National Action Plan commits the U.S. to publish the first United States EITI report in 2015 and to achieve EITI compliance in 2016. An Independent Administrator produces the annual reports, which include parallel public disclosures by both the government and companies. These disclosures relate to the payments that companies have made to the government on their oil, gas, and mining development.
In order to produce the USEITI annual reports, the Independent Administrator, in partnership with industry and DOI, created a document called the “USEITI Reporting Form,” including reporting instructions, which provide guidance on how to complete this form. The Independent Administrator will use this form to collect revenue information from extractive companies which paid more than $20 million to ONRR in a given year. The form will collect information on the amounts of royalties, rentals, and other payments related to mineral development that companies have made to the Federal Government. The Independent Administrator will collect this information; however, it will not collect items of a sensitive nature such as proprietary data, Personally Identifiable Information, etc. EITI is a voluntary initiative, and companies are not required to provide the requested information.
We are requesting OMB's approval to collect this information. This ICR is necessary to successfully implement EITI in the U.S. Not collecting this information would limit the Secretary's ability to implement the U.S. Open Government National Action Plan and could prevent the Independent Administrator from creating and completing the annual USEITI report. If the annual USEITI report is not completed, the U.S. will not become an EITI Compliant Country.
Section 3506(c)(2)(A) of the PRA requires each agency to “
To comply with the public consultation process, we published a notice in the
If you wish to comment in response to this notice, you may send your comments to the offices listed under the
United States International Trade Commission.
Notice.
Amy Sherman (202-205-3289), Office of Investigations, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
On November 3, 2014, the Commission established a schedule for the conduct of the final phase of the subject investigations (79 FR 75591, December 18, 2014). On December 19, 2014, the Department of Commerce suspended the antidumping and countervailing duty investigations on sugar from Mexico (79 FR 78039, 78044, December 29, 2014). Subsequently, the Department of Commerce received timely requests to continue the antidumping and countervailing duty investigations on sugar from Mexico and resumed its investigations on May 4, 2015 (80 FR 25278, May 4, 2015). The Commission, therefore, is revising its schedule to conform with Commerce's new schedule.
The Commission's new schedule for the investigation is as follows. The prehearing staff report will be placed in the nonpublic record on August 28, 2015. The deadline for filing prehearing briefs is September 4, 2015. Requests to appear at the hearing must be filed with the Secretary to the Commission not later than September 11, 2015. The prehearing conference will be held at the U.S. International Trade Commission Building on September 14, 2015, if deemed necessary. The hearing will be held at the U.S. International Trade Commission Building at 9:30 a.m. on September 16, 2015. The deadline for filing posthearing briefs is September 23, 2015. The Commission will make its final release of information on October 14, 2015; and final party comments are due on October 16, 2015.
For further information concerning these investigations see the Commission's notice cited above and the Commission's Rules of Practice and Procedure, part 201, subparts A through E (19 CFR part 201), and part 207, subparts A and C (19 CFR part 207).
These investigations are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.21 of the Commission's rules.
By order of the Commission.
Notice of registration.
Cambrex Charles City applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Cambrex Charles City registration as an importer of those controlled substances.
By notice dated January 21, 2015, and published in the
The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Cambrex Charles City to import the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history.
Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above-named company is granted registration as an importer of the basic classes of controlled substances:
The company plans to import the listed controlled substances for internal use, and to manufacture bulk intermediates for sale to its customers.
On September 29, 2014, Cambrex Charles City withdrew its request for the addition of Cocaine (9041), to this registration.
On May 7, 2015, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the District of Idaho in the lawsuit entitled
The Complaint alleges that the City of Jerome discharged pollutants from its publicly owned wastewater treatment facility and sanitary sewer collection system, in violation of its National Pollutant Discharge Elimination System permit, issued by EPA pursuant to the Clean Water Act. Under the proposed Consent Decree, the City commits to upgrading the capacity of its wastewater treatment facility and payment of $86,000 in penalty. Pursuant to Section 309(e) of the Clean Water Act, 33 U.S.C. 1319(e), the State of Idaho is named as a co-plaintiff.
The publication of this notice opens a period for public comment on the Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to
During the public comment period, the Consent Decree may be examined and downloaded at this Justice Department Web site:
Please enclose a check or money order for $11 (25 cents per page reproduction cost) payable to the United States Treasury.
Community Oriented Policing Services (COPS) Office, Department of Justice.
60-Day notice.
The Department of Justice (DOJ), Community Oriented Policing Services (COPS) Office, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for 60 days until July 14, 2015.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Kimberly J. Brummett, Program Specialist, Department of Justice, Community Oriented Policing Services (COPS) Office, 145 N Street NE., Washington, DC 20530 (202-353-9769).
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
Overview of this information collection:
1.
2.
3.
4.
5.
6.
If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405B, Washington, DC 20530.
On May 11, 2015, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the Western District of New York in the lawsuit entitled
The Consent Decree resolves the claims of the United States and the State of New York set forth in the complaint against Tonawanda Coke Corporation for violations of the Clean Air Act, the Clean Water Act, and the Emergency Planning and Community Right to Know Act, in connection with its facility located in Tonawanda, New York. Under the Consent Decree, Tonawanda Coke Corporation has agreed to pay a civil penalty of $2,750,000. Of that penalty, $1,750,000 will be paid to the United States and $1,000,000 will be paid to the State of New York. Tonawanda Coke Corporation will also perform a wetlands preservation supplemental environmental project valued at $357,143 and fund a $1,000,000 state-led environmental benefit project fund. In addition, Tonawanda Coke Corporation will perform the injunctive relief required under the Consent Decree.
The publication of this notice opens a period for public comment on the Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division and should refer to
During the public comment period, the Consent Decree may be examined and downloaded at this Justice Department Web site:
Please enclose a check or money order for $29.50 (25 cents per page reproduction cost) payable to the United States Treasury. For a paper copy without the exhibits and signature pages, the cost is $20.50.
Notice.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The Bureau of Labor Statistics (BLS) is soliciting comments concerning the proposed extension of the International Price Program U.S. Import and Export Price Indexes. A copy of the proposed information collection request (ICR) can be obtained by contacting the individual listed below in the Addresses section of this notice.
Written comments must be submitted to the office listed in the
Send comments to Nora Kincaid, BLS Clearance Officer, Division of Management Systems, Bureau of Labor Statistics, Room 4080, 2 Massachusetts Avenue NE., Washington, DC 20212. Written comments also may be transmitted by fax to 202-691-5111 (this is not a toll free number).
Nora Kincaid, BLS Clearance Officer, 202-691-7628 (this is not a toll free number). (See
The U.S. Import and Export Price Indexes, produced by the Bureau of Labor Statistics' International Price Program (IPP), measure price change over time for all categories of imported and exported products, as well as selected services. The IPP has produced the U.S. Import Price Indexes continuously since 1973 and the U.S. Export Price Indexes continuously since 1971. The Office of Management and Budget has listed the Import and Export Price Indexes as a Principal Federal Economic Indicator since 1982. The indexes are widely used in both the public and private sectors. The primary public sector use is the deflation of the U.S. monthly Trade Statistics and the quarterly estimates of U.S. Gross Domestic Product; the indexes also are used in formulating U.S. trade policy and in trade negotiations with other countries. In the private sector, uses of the Import Price Indexes include market analysis, inflation forecasting, contract escalation, and replacement cost accounting.
The IPP indexes are closely followed statistics, and are viewed as a key indicator of the economic environment. The U.S. Department of Commerce uses the monthly statistics to produce monthly and quarterly estimates of inflation-adjusted trade flows. Without continuation of data collection, it would be extremely difficult to construct accurate estimates of the U.S. Gross Domestic Product. In fact, DOL-BLS'
Additionally, Federal policymakers in the Department of Treasury, the Council of Economic Advisers, and the Federal Reserve Board utilize these statistics on a regular basis to improve these agencies' formulation and evaluation of monetary and fiscal policy and evaluation of the general business environment.
Office of Management and Budget clearance is being sought for the U.S. Import and Export Price Indexes. The IPP continues to modernize data collection and processing to permit more timely release of its indexes, and to reduce reporter burden. The IPP has expanded the use of its web application, introduced in 2003 to allow respondents to update their data online and more rapidly than using a paper-based form. Through March 2015, 89 percent of IPP respondents were providing prices via the web application or had agreed to start using this repricing method. Field Economists currently offer web repricing to all new respondents and at initiation, it is the preferred method of collection offered to companies. IPP continues to reduce burden for web respondents through system enhancements.
IPP has also facilitated the registration process for respondents who are currently using web repricing to provide prices for the Producer Price Index and who have also been initiated to provide prices (online) for IPP. The new process allows these multi-program respondents to self-register following the steps outlined in a pamphlet. Under the old process, IPP staff had to work with PPI staff on technical changes before multi-program respondents could set up and begin web repricing for IPP. Respondents therefore had to wait (multiple days) for an IPP staff member to contact them and walk them through the web repricing set-up.
The Program also continues its multi-year effort to develop a more effective sampling and collection strategy for companies that are considered major importers or exporters. Research has shown that, while hundreds of thousands of companies import and export goods into and from the United States each year, the volume of trade (in terms of dollar value) is heavily concentrated on a very small percentage of these companies. IPP is developing a plan for conducting a pilot for a limited set of major companies for the selected alternative resampling strategy. This approach would reduce burden by avoiding continual visits that are part of the current resampling strategy.
The Bureau of Labor Statistics is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility.
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they also will become a matter of public record.
Mine Safety and Health Administration, Labor.
Notice.
Section 101(c) of the Federal Mine Safety and Health Act of 1977 and Title 30 of the Code of Federal Regulations, 30 CFR part 44, govern the application, processing, and disposition of petitions for modification. This notice is a summary of petitions for modification submitted to the Mine Safety and Health Administration (MSHA) by the parties listed below.
All comments on the petitions must be received by the Office of Standards, Regulations, and Variances on or before June 15, 2015.
You may submit your comments, identified by “docket number” on the subject line, by any of the following methods:
1.
2.
3.
MSHA will consider only comments postmarked by the U.S. Postal Service or proof of delivery from another delivery service such as UPS or Federal Express on or before the deadline for comments.
Barbara Barron, Office of Standards, Regulations, and Variances at 202-693-9447 (Voice),
Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor determines that:
1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or
2. That the application of such standard to such mine will result in a diminution of safety to the miners in such mine.
In addition, the regulations at 30 CFR 44.10 and 44.11 establish the requirements and procedures for filing petitions for modification.
1. This wheelchair lift will not carry miners into the mine on regularly scheduled shifts.
2. The wheelchair lift is located on the South end of our two-story bathhouse next to the stairs accessing the second floor where Engineering and Superintendent offices are located. GCC Energy LLC is in a new building located on the surface area of an underground mine site. A new two-stop limited use/limited application elevator system has been installed. The purpose and intent of the hoist is for handicap access to the offices on the second floor of the bathhouse.
3. The wheelchair lift is installed and designed to comply with the Americans with Disabilities Act.
4. Title 30 CFR 77.1403 requires daily examinations of hoists and elevators, and 30 CFR 77.1404 requires that the person making the examination certify that the examination has been made. The records are to be kept for one year.
5. The Colorado Department of Labor and Employment, Division of Oil and Public Safety (OPS), Conveyance Program protects the riding public and industry personnel in the State of Colorado from the hazards of dangerous conveyances. To achieve this mission, the OPS requires the following:
(a) That all elevators, escalators, dumbwaiters, wheelchair lifts, APM and other regulated conveyances located in Colorado be registered with OPS.
(b) The installation, alteration, maintenance, testing, and annual inspection of regulated conveyances be completed according to the Colorado conveyance regulations, industry code and standard adopted in statute and regulation.
(c) That all conveyance contractors, mechanics, and inspectors maintain a current license issued by OPS and that the installation, alteration, maintenance, and examinations of regulated conveyances are completed by licensed and qualified personnel.
6. The petitioner states that GCC Energy does not employ a licensed OPS inspector. Accordingly, GCC seeks relief from the requirements of daily examination and recordkeeping of hoisting equipment. GCC Energy changes light bulbs in the cabin and records the phase 1 fire tests done monthly in the cabin. The control panel or inspection covers are not opened by GCC, and GCC does not perform any service or maintenance on the lift. Every five years a witness test with a licensed mechanic must be performed.
7. The elevator is a wheelchair lift with a single hydraulic cylinder traveling approximately 12 feet, not to exceed 30 feet per minute, that is roped so as not to allow over-extension. The cabin is attached to the cylinder. There are no wire ropes, sheave wheels, sheaves, or thimbles that must be examined daily for wear, and no damaged or worn bearings or broken wires.
8. GCC Energy, LLC is petitioning to allow the licensed inspectors to do the examinations and the licensed mechanics to do all repairs.
The petitioner asserts that the proposed alternative method will
(1) The existing standard for self-propelled nonpermissible diesel-powered equipment does not address equipment with more than four wheels, specifically the Getman RDG-1504S Road Builder with six wheels. This machine has dual brake systems on the four rear wheels and it is designed to prevent a loss of braking due to a single component failure.
(2) The speed of the machine will be limited to 10 miles per hour by permanently blocking out any gear that would provide higher speed, or transmission and differential ratios that would limit the maximum speed to 10 miles per hour will be used.
(3) The grader operators will be trained to recognize appropriate speeds for different road conditions and slopes.
(4) The grader operators will be trained to lower the grader blade to provide additional stopping capability.
(5) The petitioner proposes to transfer the RDG-1540S Road Builder, serial number 6739, from the Gateway Mine that will be closing, to the New Gateway North Mine.
The petitioner asserts that if the machine is operated as described in the petition, the safety of the miners will not be compromised.
National Aeronautics and Space Administration (NASA).
Notice of Centennial Challenges 3D Printed Habitat Challenge—Design Competition.
This notice is issued in accordance with 51 U.S.C. 20144(c). The 3D Printed (3DP) Habitat Challenge—Design Competition is scheduled and teams that wish to compete may now register. Centennial Challenges is a program of prize competitions to stimulate innovation in technologies of interest and value to NASA and the nation. The 3DP Habitat Challenge is a prize competition designed to encourage development of new technologies, or application of existing technologies, in unique ways to advance additive construction systems and to advance multi-material usage. NASA is providing the prize purse.
The Design Competition registration opens May 16, 2015, and the competition will conclude on September 27, 2015.
The 3DP Habitat Challenge—Design Competition will initially be conducted virtually via electronic submissions. After a scored down select process, the remaining submissions will compete at the New York City Maker Faire.
To register for or get additional information regarding the 3D Printed Habitat Challenge—Design Competition, please visit:
For general information on the NASA Centennial Challenges Program please visit:
Competitors will design habitats making full (better) use of additive construction (manufacturing) processes and techniques. Designs will be rated on concept, innovation, documentation, habitability, constructability, functionality, energy efficiency, and public appeal. Prizes will be awarded for first, second, and third place based on subject matter expert scoring and public voting.
The total 3DP Habitat Challenge Design Competition prize purse is $50,000 (fifty thousand U.S. dollars). First place will receive $25,000 (twenty-five thousand U.S. dollars). Second place will receive $15,000 (fifteen thousand U.S. dollars). Third place will receive $10,000 (ten thousand U.S. dollars). Entries must meet specific requirements detailed in the Rules to be eligible for prize awards.
To be eligible to win a prize, competitors must;
(1) Register and comply with all requirements in the rules and competitor agreement;
(2) In the case of a private entity, shall be incorporated in and maintain a primary place of business in the United States, and in the case of an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States; and
(3) Not be a Federal entity or Federal employee acting within the scope of their employment.
The complete rules for the 3DP Habitat Challenge—Design Competition can be found at:
National Aeronautics and Space Administration (NASA).
Notice of information collection.
The National Aeronautics and Space Administration, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. 3506(c)(2)(A)).
All comments should be submitted within 60 calendar days from the date of this publication.
All comments should be addressed to Fran Teel, Mail Code JF000, National Aeronautics and Space Administration, Washington, DC 20546-0001 or
Requests for additional information or copies of the information collection
NASA promotes activities to demonstrate innovative uses and practical benefits of NASA Earth science data, scientific knowledge, and technology. NASA's Applied Sciences Program established the DEVELOP National Program to research environmental management and public policy issues at the state and local level. Under the guidance of NASA and partner organization science advisors, DEVELOP enables participants to lead research projects that utilize NASA Earth observations to address community concerns and public policy issues. Through teams, DEVELOP participants gain experience by (1) utilizing NASA's Earth Science satellite and airborne resources, to include remote sensing and geographic information systems (GIS), and (2) communicating research results. DEVELOP projects serve the global community and extend NASA Earth Science research and technology to benefit society. A focus on both professional and personal development is central to DEVELOP's ten week sessions, which are conducted annually during the spring, summer, and fall.
The DEVELOP research opportunity is available to individuals 18 years and older and includes transitioning career professionals (including veterans of the Armed Forces), recent college/university graduates, and currently enrolled students. Information is collected through an online process from individuals interested in participating in the NASA DEVELOP Program for a ten week session. Information collected from individuals includes a completed application, academic transcript, resume, and two letters of recommendation references per applicant.
With the growing societal role of science and technology in today's global workplace, DEVELOP is fostering an adept corps of tomorrow's scientists and leaders.
Electronic.
June 1, 2015, at 11 a.m.; September 3, 2015, at 11 a.m.; December 3, 2015, at 11 a.m.
Commission hearing room, 901 New York Avenue NW., Suite 200, Washington, DC 20268-0001.
The Postal Regulatory Commission will hold public meetings to discuss the agenda items outlined below. Part of the meetings will be open to the public as well as audiocast, and the audiocast may be accessed via the Commission's Web site at
The agenda for the Commission's June 1, 2015 meeting, September 3, 2015 meeting, and December 3, 3015 meeting include the items identified below.
1. Report from the Office of Public Affairs and Government Relations.
2. Report from the Office of General Counsel.
3. Report from the Office of Accountability and Compliance.
4. Discussion of pending litigation.
David A. Trissell, General Counsel, Postal Regulatory Commission, 901 New York Avenue NW., Suite 200, Washington, DC 20268-0001, at 202-789-6820 (for agenda-related inquiries) and Shoshana M. Grove, Secretary of the Commission, at 202-789-6800 or
By direction of the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning a change in prices for Global Expedited Package Services Contracts Non-Published Rates 5. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
On May 7, 2015, the Postal Service filed notice of a change in prices not of general applicability for Global Expedited Package Services—Non-
To support its Notice, the Postal Service filed a copy of the GEPS-NPR 5 Version 2 model contract; a copy of the Governors' Decision authorizing the product; a set of maximum and minimum prices; a certification of compliance with 39 U.S.C. 3633(a); a copy of a related management analysis; an application for non-public treatment; and supporting financial workpapers. The Postal Service also identified the Commission docket and the Governors' Decision associated with the price changes and addressed several differences between the GEPS—NPR 5 Version 2 model contract and the original GEPS—NPR 5 model contract.
The Commission establishes Docket Nos. MC2015-23 and CP2015-65 for consideration of matters raised by the Notice.
The Commission invites comments on whether the Postal Service's filings are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR 3015.5, and 39 CFR part 3020, subpart B. Comments are due no later than May 18, 2015. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Curtis Kidd to serve as Public Representative in these dockets.
1. The Commission establishes Docket Nos. MC2015-23 and CP2015-65 to consider the matters raised by the Notice.
2. Pursuant to 39 U.S.C. 505, Curtis Kidd is appointed to serve as officer of the Commission (Public Representative) to represent the interests of the general public in these proceedings.
3. Comments by interested persons in these proceedings are due no later than May 18, 2015.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Railroad Retirement Board.
Notice: Publication of an updated routine use for RRB Privacy Act Systems of Records, RRB-21 and RRB-22.
We are updating an existing routine use to release railroad worker identifying information to any last employer, or their designee allowing the RRB to verify entitlement for benefits.
These changes become effective as proposed without further notice on June 24, 2015. We will file a report of these Systems of Records Notices with the Committee on Homeland Security and Governmental Affairs of the Senate; the Committee on Oversight and Government Reform of the House of Representatives; and the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB).
Send comments to Ms. Martha P. Rico, Secretary to the Board, Railroad Retirement Board, 844 North Rush Street, Chicago, Illinois 60611-2092.
Mr. Timothy Grant, Chief Privacy Officer, Railroad Retirement Board, 844 North Rush Street, Chicago, Illinois 60611-2092; telephone 312-751-4869, or email at
We are adding the term `or their designee' to the existing routine uses for our Privacy Act System of Records Notices (SORNs), RRB-21(q) and RRB-22(d) respectively. This will allow the RRB to verify entitlement for benefits if the railroad worker's previous employer has designated a third party provider to manage their employment information.
By Authority of the Board.
Railroad Unemployment and Sickness Insurance Benefit System
U.S. Railroad Retirement Board, 844 Rush Street, Chicago, Illinois 60611. Regional and District Offices: See
None.
Applicants and claimants for unemployment and sickness (including maternity) benefits under the Railroad Unemployment Insurance Act: Some railroad employees injured at work who did not apply for Railroad Unemployment Insurance Act benefits; all railroad employees paid separation allowances.
Information pertaining to payment or denial of an individual's claim for benefits under the Railroad Unemployment Insurance Act: Name, address, sex, social security number, date of birth, total months of railroad service (including creditable military service), total creditable compensation for base year, last employer and date last worked before applying for benefits, last rate of pay in base year, reason not working, applications and claims filed, benefit information for each claim filed, disqualification periods and reasons for disqualification, entitlement to benefits under other laws, benefit recovery information about personal injury claims and pay for time not worked, medical reports, placement data, correspondence and telephone inquiries to and about the claimant, record of protest or appeal by claimant of adverse determinations made on his claims.
Section 12(l) of the Railroad Unemployment Insurance Act (45 U.S.C. 351,
The purpose of this system of records is to carry out the function of collecting and storing information in order to administer the benefit program under the Railroad Unemployment Insurance Act.
a. Beneficiary identifying information may be disclosed to third party contacts to determine if incapacity of the beneficiary or potential beneficiary to understand or use benefits exists, and to determine the suitability of a proposed representative payee.
b. In the event the Board has determined to designate a person to be the representative payee of an incompetent beneficiary, disclosure of information concerning the benefit amount and other similar information may be made to the representative payee from the record of the individual.
c. Beneficiary identifying information, address, check rate, date and number may be released to the Treasury Department to control for reclamation and return outstanding benefit payments, to issue benefit payments, respond to reports of non-delivery and to insure delivery of check to the correct address or account of the beneficiary or representative payee.
d. Beneficiary identifying information, address, payment rate, date and number, plus other necessary supporting evidence may be released to the U.S. Postal Service for investigation of alleged forgery or theft of railroad unemployment/sickness benefit payments.
e. A record from this system of records may be disclosed to a Federal agency, in response to its request, in connection with the hiring or retention of an employee, the issuance of a security clearance, the reporting of an investigation of an employee, the letting of a contract, the issuance of a license, grant, or other benefit by the requesting agency, to the extent that the information is relevant and necessary to the requesting agency's decision in the matter, provided that disclosure would be clearly in the furtherance of the interest of the subject individual.
f. Under Section 2(f), the Railroad Retirement Board has the right to recover benefits paid to an employee who later receives remuneration for the same period, therefore, the Railroad Retirement Board may notify the person or company paying the remuneration of the Board's right to recovery and the amount of benefits to be refunded.
g. Under Section 12(o), the Railroad Retirement Board is entitled to reimbursement of sickness benefits paid on account of the infirmity for which damages are paid, consequently, the Railroad Retirement Board may send a notice of lien to the liable party, and, upon request by the liable party, advise the amount of benefits subject to reimbursement.
h. Beneficiary identifying information, rate and entitlement data may be released to the Social Security Administration to correlate actions with the administration of the Social Security Act.
i. The last addresses and employer information may be released to Department of Health and Human Services in conjunction with the Parent Locator Service.
j. Benefit rate, entitlement and periods paid may be disclosed to the Social Security Administration, Bureau of Supplemental Security Income to federal, state and local welfare or public aid agencies to assist them in processing applications for benefits under their respective programs.
k. Beneficiary identifying information, entitlement, rate and other pertinent data may be released to the Department of Labor in conjunction with payment of benefits under the Federal Coal Mine and Safety Act.
l. Records may be referred to the General Accountability Office for auditing purposes and for collection of debts arising from overpayments under the Railroad Unemployment Insurance Act.
m. If a request for information pertaining to an individual is made by an official of a labor organization, of which the individual is a member, information from the record of the individual concerning his benefit or anticipated benefit and concerning the method of calculating that benefit may be disclosed to the labor organization official.
n. Pursuant to a request from an employer covered by the Railroad Retirement Act or the Railroad Unemployment Insurance Act, or from an organization under contract to an employer or employers, information regarding the Board's payment of unemployment or sickness benefits, the methods by which such benefits are calculated, entitlement data and present address may be released to the requesting employer or the organization under contract to an employer or employers for the purposes of determining entitlement to and rates of private supplemental pension, sickness or unemployment benefits and to calculate estimated benefits due.
o. Records may be disclosed in a court proceeding relating to any claims for benefits by the beneficiary under the Railroad Unemployment Insurance Act and may be disclosed during the course of an administrative appeal to individuals who need the records to prosecute or decide the appeal or to individuals who are requested to provide information relative to an issue involved in the appeal.
p. Beneficiary identifying information, entitlement data, benefit rates and periods paid may be released to the Veterans Administration to verify continued entitlement to benefits.
q. (Updated) Identifying information such as full name, social security number, employee identification number, date last worked, occupation, and location last worked may be released to any last employer,
r. The amount of unemployment benefits paid, if 10 dollars or more in a calendar year, and claimant identifying information, may be furnished to the Internal Revenue Service for tax administration purposes.
s. The name and address of a claimant may be released to a Member of Congress when the Member requests it in order that he or she may communicate with the claimant about legislation which affects the railroad unemployment insurance system.
t. Beneficiary identifying and claim period information may be furnished to states for the purposes of their notifying the RRB whether claimants were paid state unemployment or sickness benefits and also whether wages were reported for them. For claimants that a state identifies as having received state unemployment or sickness benefits, RRB benefit information may be furnished the state for the purpose of recovery of the amount of the duplicate payments which is made.
u. The amount of each sickness benefit that is subject to a tier 1 railroad retirement tax and the amount of the tier 1 tax withheld may be disclosed to the claimant's last railroad employer to enable that employer to compute its tax liability under the Railroad Retirement Tax Act.
v. The amount of sickness benefits paid and claimant identifying information, except for sickness benefits paid for an on-the-job injury, may be furnished to the Internal Revenue Service for tax administration purposes.
w. Entitlement data and benefit rates may be released to any court, state agency, or interested party, or to the representative of such court, state agency, or interested party in connection with contemplated or actual legal or administrative proceedings concerning domestic relations and support matters.
x. Identifying information and information about a claim for benefits filed may be disclosed to an employee's
y. Non-medical information relating to the determination of sickness benefits may be disclosed to an insurance company administering a medical insurance program for railroad workers for purposes of determining entitlement to benefits under that program.
z. Scrambled Social Security Number and complete home address information of unemployment claimants may be furnished to the Bureau of Labor Statistics for use in its Local Area Unemployment Statistics (LAUS) program.
None.
Paper, microforms, magnetic tape, magnetic disk.
Social Security number (claim number) and name.
Office of Programs—Director of Policy and Systems, Railroad Retirement Board, 844 Rush Street, Chicago, Illinois 60611-2092.
Requests for information regarding an individual's record should be in writing, including the full name, social security number and railroad retirement claim number (if any) of the individual. Before information about any record will be released, the individual may be required to provide proof of identity, or authorization from the individual to permit release of information. Such requests should be sent to: Office of Programs—Director of Unemployment & Program Support Division, Railroad Retirement Board, 844 Rush Street, Chicago, Illinois 60611.
See Notification section above.
See Notification section above.
Applicant, claimant or his or her representative, physicians, employers, labor organizations, federal, state, and local government agencies, all Railroad Retirement Board files, insurance companies, attorneys, Congressmen, liable parties (in personal injury cases), funeral homes and survivors (for payment of death benefits).
None.
Railroad Retirement, Survivor, and Pensioner Benefit System.
U.S. Railroad Retirement Board, 844 Rush Street, Chicago, Illinois 60611 Regional and District Offices: See
None.
(Updated) Applicants for retirement and survivor benefits, (spouses, divorced spouses, widows, surviving divorced spouses, children, students, parents, grandchildren), and individuals who filed for lump-sum death benefits and/or residual payments.
Information pertaining to the payment or denial of an individual's claim for benefits under the Railroad Retirement Act: Name, address, social security number, claim number, proofs of age, marriage, relationship, death, military service, creditable earnings and service months (including military service), entitlement to benefits under the Social Security Act, programs administered by the Veterans Administration, or other benefit systems, rates, effective dates, medical reports, correspondence and telephone inquiries to and about the beneficiary, suspension and termination dates, health insurance effective date, option, premium rate and deduction, direct deposit data, employer pension information, citizenship status and legal residency status (for annuitants living outside the United States), and tax withholding information (instructions of annuitants regarding number of exemptions claimed and additional amounts to be withheld, as well as actual amounts withheld for tax purposes).
Section 7(b)(6) of the Railroad Retirement Act of 1974 (U.S.C. 231f(b)(6)).
Records in this system of records are maintained to administer the benefit provisions of the Railroad Retirement Act, sections of the Internal Revenue Code related to the taxation of railroad retirement benefits, and Title XVIII of the Social Security Act as it pertains to Medicare coverage for railroad retirement beneficiaries.
a. Beneficiary identifying information may be disclosed to third party contacts
b. In the event the Board has determined to designate a person to be the representative payee of an incompetent beneficiary, disclosure of information concerning the benefit amount and other similar information may be made to the representative payee from the record of the individual.
c. Entitlement and benefit rates may be released to primary beneficiaries regarding secondary beneficiaries (or vice versa) when the addition of such beneficiary affects either the entitlement or benefit payment.
d. (Updated) Identifying information such as full name, address, date of birth, social security number, employee identification number, and date last worked, may be released to any last employer,
e. Beneficiary identifying information, address, check rates, number and date may be released to the Department of the Treasury to control for reclamation and return of outstanding benefit payments, to issue benefit payments, act on report of non-receipt, to insure delivery of payments to the correct address of the beneficiary or representative payee or to the proper financial organization, and to investigate alleged forgery, theft or unlawful negotiation of railroad retirement benefit checks or improper diversion of payments directed to a financial organization.
f. Beneficiary identifying information, address, check rate, date, number and other supporting evidence may be released to the U.S. Postal Service for investigation of alleged forgery or theft of railroad retirement or social security benefit checks.
g. Beneficiary identifying information, entitlement data, medical evidence and related evaluatory data and benefit rate may be released to the Social Security Administration and the Centers for Medicare & Medicaid Services to correlate actions with the administration of Title II and Title XVIII of the Social Security Act, as amended.
h. (Updated) Beneficiary identifying information, including social security account number, and supplemental annuity amounts may be released to the Internal Revenue Service.
i. Beneficiary identifying information, entitlement, benefit rates, medical evidence and related evaluatory data, and months paid may be furnished to the Veterans Administration for the purpose of assisting that agency in determining eligibility for benefits or verifying continued entitlement to and the correct amount of benefits payable under programs which it administers.
j. Beneficiary identifying information, entitlement data and benefit rates may be released to the Department of State and embassy and consular officials, the American Institute on Taiwan, and to the Veterans Administration Regional Office, Philippines, to aid in the development of applications, supporting evidence, and the continued eligibility of beneficiaries and potential beneficiaries living abroad.
k. Beneficiary identifying information, entitlement, benefit rates and months paid may be released to the Social Security Administration (Bureau of Supplemental Security Income) the Centers for Medicare & Medicaid Services, to federal, state and local welfare or public aid agencies to assist them in processing applications for benefits under their respective programs.
l. The last addresses and employer information may be released to the Department of Health and Human Services in conjunction with the Parent Locator Service.
m. Beneficiary identifying information, entitlement, rate and other pertinent data may be released to the Department of Labor in conjunction with payment of benefits under the Federal Coal Mine and Safety Act.
n. Medical evidence may be released to Board-appointed medical examiners to carry out their functions.
o. Information obtained in the administration of Title XVIII (Medicare) which may indicate unethical or unprofessional conduct of a physician or practitioner providing services to beneficiaries may be released to Professional Standards Review Organizations and State Licensing Boards.
p. Information necessary to study the relationship between benefits paid by the Railroad Retirement Board and civil service annuities may be released to the Office of Personnel Management.
q. Records may be disclosed to the General Accountability Office for auditing purposes and for collection of debts arising from overpayments under Title II and Title XVIII of the Social Security Act, as amended, or the Railroad Retirement Act.
r. Pursuant to a request from an employer covered by the Railroad Retirement Act or the Railroad Unemployment Insurance Act, or from an organization under contract to an employer or employers, information regarding the Board's payment of retirement benefits, the methods by which such benefits are calculated, entitlement data and present address may be released to the requesting employer or the organization under contract to an employer or employers for the purposes of determining entitlement to and rates of private supplemental pension, sickness or unemployment benefits and to calculate estimated benefits due.
s. If a request for information pertaining to an individual is made by an official of a labor organization of which the individual is a member and the request is made on behalf of the individual, information from the record of the individual concerning his benefit or anticipated benefit and concerning the method of calculating that benefit may be disclosed to the labor organization official.
t. Records may be disclosed in a court proceeding relating to any claims for benefits by the beneficiary under the Railroad Retirement Act, and may be disclosed during the course of an administrative appeal to individuals who need the records to prosecute or decide the appeal or to individuals who are requested to provide information relative to an issue involved in the appeal.
u. The amount of a residual lump-sum payment and the identity of the payee may be released to the Internal Revenue Service for tax audit purposes.
v. The amount of any death benefit or annuities accrued but unpaid at death and the identity of such payee may be released to the appropriate state taxing authorities for tax assessment and auditing purposes.
w. Beneficiary identifying information, including but not limited to name, address, social security account number, payroll number and occupation, the fact of entitlement and benefit rate may be released to the Pension Benefit Guaranty Corporation to enable that agency to determine and pay supplemental pensions to qualified railroad retirees.
x. Medical records may be disclosed to vocational consultants in administrative proceedings.
y. Date employee filed application for annuity to the last employer under the Railroad Retirement Act for use in determining entitlement to continued major medical benefits under insurance programs negotiated with labor organizations.
z. Information regarding the determination and recovery of an overpayment made to an individual may be released to any other individual from whom any portion of the overpayment is being recovered.
aa. The name and address of an annuitant may be released to a Member of Congress when the Member requests it in order that he or she may communicate with the annuitant about legislation which affects the railroad retirement system.
bb. Certain identifying information about annuitants, such as name, social security number, RRB claim number, and date of birth, as well as address, year and month last worked for a railroad, last railroad occupation, application filing date, annuity beginning date, identity of last railroad employer, total months of railroad service, sex, disability onset date, disability freeze onset date, and cause and effective date of annuity termination may be furnished to insurance companies for administering group life and medical insurance plans negotiated between certain participating railroad employers and railway labor organizations.
cc. For payments made after December 31, 1983, beneficiary identifying information, address, amounts of benefits paid and repaid, beneficiary withholding instructions, and amounts withheld by the RRB for tax purposes may be furnished to the Internal Revenue Service for tax administration purposes.
dd. Last address and beneficiary identifying information may be furnished to railroad employers for the purpose of mailing railroad passes to retired employees and their families.
ee. Entitlement data and benefits rates may be released to any court, state agency, or interested party, or to the representative of such court, state agency, or interested party, in connection with contemplated or actual legal or administrative proceedings concerning domestic relations and support matters.
ff. Identifying information about annuitants and applicants may be furnished to agencies and/or companies from which such annuitants and applicants are receiving or may receive worker's compensation, public pension, or public disability benefits in order to verify the amount by which Railroad Retirement Act benefits must be reduced, where applicable.
gg. Disability annuitant identifying information may be furnished to state employment agencies for the purpose of determining whether such annuitants were employed during times they receive disability benefits.
hh. Identifying information about Medicare-entitled beneficiaries who may be working may be disclosed to the Centers for Medicare & Medicaid Services for the purposes of determining whether Medicare should be the secondary payer of benefits for such individuals.
ii. Disclosure of information in claim folders is authorized for bonafide researchers doing epidemiological/mortality studies approved by the RRB who agree to record only information pertaining to deceased beneficiaries.
jj. Identifying information for beneficiaries, such as name, SSN, and date of birth, may be furnished to the Social Security Administration and to any State for the purpose of enabling the Social Security Administration or State through a computer or manual matching program to assist the RRB in identifying female beneficiaries who remarried but who may not have notified the RRB of their remarriage.
kk. An employee's date last worked, annuity filing date, annuity beginning date, and the month and year of death may be furnished to AMTRAK when such information is needed by AMTRAK to make a determination whether to award a travel pass to either the employee or the employee's widow.
ll. The employee's social security number may be disclosed to an individual eligible for railroad retirement benefits on the employee's earnings record when the employee's social security number would be contained in the railroad retirement claim number.
None.
Paper, microforms, magnetic tape and magnetic disk.
Claim number, social security number and full name.
Electronically imaged documents. Destroy/delete individual claimant data 7 years after the close of the fiscal year determined to be inactive.
Office of Programs—Director of Policy and Systems, Railroad Retirement Board, 844 Rush Street, Chicago, Illinois 60611-2092
Requests for information regarding an individual's records should be in writing, including the full name, social security number and railroad retirement claim number(if any) of the individual. Before information about any records will be released, the individual may be required to provide proof of identity, or authorization from the individual to permit release of information. Such requests should be sent to: Director of Unemployment & Programs Support Division, Railroad Retirement Board, 844 Rush Street, Chicago, Illinois 60611-2092.
See Notification section above.
See Notification section above.
Individual applicants or their representatives, railroad employers, other employers, physicians, labor organizations, federal, state and local government agencies, attorneys, funeral
None.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Rule 15g-5 requires brokers and dealers to disclose to customers the amount of compensation to be received by their sales agents in connection with penny stock transactions. The purpose of the rule is to increase the level of disclosure to investors concerning penny stocks generally and specific penny stock transactions.
The Commission estimates that approximately 221 broker-dealers will spend an average of 87 hours annually to comply with the rule. Thus, the total compliance burden is approximately 19,245 burden-hours per year.
Rule 15g-5 contains record retention requirements. Compliance with the rule is mandatory.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
The public may view background documentation for this information collection at the following Web site:
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange seeks to update its rules related to floor broker errors and the use of floor broker error accounts. The text of the proposed rule change is provided below.
(e)
(f)
(g)
. . .Interpretations and Policies:
The text of the proposed rule change is also available on the Exchange's Web site (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange is proposing to adopt new Rule 6.79 to codify policies related to floor broker errors and the use of floor broker error accounts. The proposed rule incorporates several aspects of CBOE Regulatory Circular RG95-49.
First, with proposed Rule 6.79(a), the Exchange proposes to clarify and amend its policy related to a floor broker representing orders for the floor broker's own error account. The general principle is that for a position obtained as a result of a bona fide error, a broker may reduce or liquidate a position in the floor broker's error account (“error account position”) in accordance with proposed Rule 6.79, but any profit/loss from the liquidation or reduction belongs to the floor broker (“liquidating floor broker”). Furthermore, a liquidating floor broker may personally represent an order that will liquidate or reduce the floor broker's error account position (“liquidation order”). As stated, the proposed rule does not prohibit floor brokers from personally representing a liquidation order, except in limited circumstances. For example, a liquidating floor broker may not cross a liquidation order with a client's order
Next, proposed Rule 6.79(b) requires erroneously executed orders (
In addition to the above restriction, proposed Rule 6.79(b)(i) provides that if a floor broker discovers an order was erroneously executed on the Exchange, the floor broker shall generally proceed as follows: If a better price is available at the time the error was discovered, the client's order is entitled to be executed at the better price. If a better price is not available, then the floor broker is responsible at the price at which the client's order should have been executed, and the floor broker shall either: (1) Execute the order at the available market and give the client a “difference check” or (2) execute the order out of the floor broker's error account
Next, proposed Rule 6.79(c) seeks to codify policies related to lost or misplaced market orders.
Next, proposed Rule 6.79(d) sets forth specific policies related to legging multi-part orders.
Next proposed Rule 6.79(e) seeks to codify policies related to print-throughs.
Next, proposed Rule 6.79(f) seeks to codify its policy related to stopping orders. Again, pursuant to Rule 8.8, the Exchange believes it is a violation of Rule 8.8 for a broker to “Stop” or guarantee an execution on a client's order he is holding from the floor broker's error account. The Exchange believes that prohibiting floor brokers from stopping orders or guaranteeing an execution on a client's order from the floor broker's error account ensures that the floor broker is acting in the best interest of the floor broker's client; rather than the interest of the broker's proprietary position.
Next, proposed Rule 6.79(g) seeks to codify its policy related to the documentation of errors and record keeping requirements. The proposed rule mandates that “[a]ll transactions executed for a floor broker's error account must be documented.” In addition, the “records must be retained for a minimum of three years, the first two years in an easily accessible place.” In addition, in order to further stress the importance of maintaining adequate and complete records, the Exchange specifies some of the records that must be maintained in accordance with the Securities Exchange Act of 1934, SEC Rules 17a-3 and 17a-4, and CBOE Rules 4.2 (“Adherence to Law”) and 15.1 (“Maintenance, Retention and Furnishing of Books, Records and Other Information), including all cancelled orders and unexecuted orders.
Next, the Exchange proposes to adopt Interpretation and Policy .01 to provide clarity regarding its policy prohibiting floor brokers from acting as market-makers. According to CBOE rules
Finally, the Exchange proposes to adopt Interpretation and Policy .02 to make it clear that a broker's agency business takes priority over a floor broker's liquidation orders. For example, marketable agency orders should be executed prior to a broker attempting to liquidate or reduce the broker's error account position.
To conclude, the Exchange believes that the proposed rule is in furtherance of the Act because it will allow floor broker's a straight-forward mechanism for liquidating error account positions while protecting investors. As stated above, the Exchange intends to release a Regulatory Circular to announce the implementation of the Rule and other specifics surrounding the procedures of the implementation. In addition, prior to implementation, the Exchange will ensure it has proper policies and procedures in place to correctly administer the Rule.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
In particular, in addition to codifying relevant portions of RG95-49, the Exchange believes that the proposed rule change enhances several aspects of RG95-49, which helps perfect the mechanism of a free and open market and protect investors and the public interest. Where RG95-49 disallows a floor broker from crossing a client order with an order for the broker's error account (
In addition, where RG95-49 ensured that a customer is entitled to only ten contracts at the disseminated bid or offer when a broker loses or misplaces
Additionally, the proposed rule prevents fraudulent and manipulative acts and practices by requiring brokers to clear errors in their own accounts unless nullified pursuant to a mutually agreement under Exchange rules. Furthermore, requiring floor brokers to notify the Exchange after executing an order for the floor broker's error account or providing a fill to a client via the floor broker's error account will aid the Exchange in the surveillance of error account activity, which helps prevent fraudulent and manipulative acts and practices and promotes just and equitable principles of trade. Finally, the Exchange believes the proposed rule promotes just and equitable principles of trade by ensuring client orders are not harmed for mistakes that are the fault of brokers. The Exchange does not believe the proposed rule is unfairly discriminatory toward customers, issuers, or brokers because the proposed rule simply sets forth the process for floor brokers to correct certain mistakes.
Finally, the proposed rule change is also consistent with Section 11(a)(1) of the Act and the rules promulgated thereunder. Generally, Section 11(a)(1) of the Act restricts any member of a national securities exchange from effecting any transaction on such exchange for (i) the member's own account, (ii) the account of a person associated with the member, or (iii) an account over which the member or a person associated with the member exercises discretion, unless a specific exemption is available. Examples of common exemptions include the exemption for transactions by broker dealers acting in the capacity of a market maker under Section 11(a)(1)(A), the “G” exemption for yielding priority to non-members under Section 11(a)(1)(G) of the Act and Rule 11a1-1(T) thereunder, and “Effect vs. Execute” exemption under Rule 11a2-2(T) under the Act. In this regard, we note that, consistent with existing Exchange Rules for effecting proprietary orders from on the floor of the Exchange, Floor Broker TPHs effecting orders for their error accounts and relying on the G exemption would be required to yield priority to any interest in the electronic book at the same price (not just public customer orders) to ensure that non-member interest is protected.
CBOE does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. More specifically, the Exchange does not believe the proposed rule changes will impose any burden on intramarket competition because it will be applicable to all floor brokers. In addition, the Exchange does not believe the proposed changes will impose any burden on intermarket competition because proposed Rule 6.79 simply provides a clearer mechanism for correcting errors.
The Exchange neither solicited nor received comments on the proposed rule change.
Because the foregoing proposed rule change does not:
A. Significantly affect the protection of investors or the public interest;
B. impose any significant burden on competition; and
C. become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission will institute proceedings to determine whether the proposed rule change should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Securities and Exchange Commission (“Commission”).
Notice of application for an order under sections 17(d) and 57(i) of the Investment Company Act of 1940 (the “Act”) and rule 17d-1 under the Act to permit certain joint transactions otherwise prohibited by sections 17(d) and 57(a)(4) of the Act and rule 17d-1 under the Act.
Applicants request an order to permit business development companies (“BDCs”) to co-invest in portfolio companies with each other and with affiliated investment funds.
Business Development Corporation of America (“BDCA”); Business Development Corporation of America II (“BDCA II”); BDCA Venture, Inc. (“BDCA Venture,” and BDCA Venture together with BDCA and BDCA II, the “BDCA Funds”), BDCA Adviser, LLC (“BDCA Adviser”), on behalf of itself and its successors;
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving applicants with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on June 8, 2015, and should be accompanied by proof of service on applicants, in the form of an affidavit or, for lawyers, a certificate of service. Hearing requests should state the nature of the writer's interest, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary.
Secretary, U.S. Securities and Exchange Commission, 100 F St. NE., Washington, DC 20549-1090. Applicants: James A. Tanaka, General Counsel, RCS Capital, 405 Park Avenue, 14th Floor, New York, NY, 10022.
Michael S. Didiuk, Senior Counsel, at (202) 551-6839 or Holly Hunter-Ceci, Branch Chief, at (202) 551-6869 (Chief Counsel's Office, Division of Investment Management).
The following is a summary of the application. The complete application may be obtained via the Commission's Web site by searching for the file number, or for an applicant using the Company name box, at
1. BDCA, BDCA II and BDCA Venture are Maryland corporations organized as closed-end management investment companies that have elected to be regulated as BDCs under Section 54(a) of the Act.
2. The board of directors of BDCA (the “BDCA Board”) is comprised of five directors, three of whom are not “interested persons,” within the meaning of Section 2(a)(19) of the 1940 Act (the “Non-Interested Directors”), of BDCA. The board of directors of BDCA II (the “BDCA II Board”) is comprised of five directors, three of whom are Non-Interested Directors of BDCA II. The board of directors of BDCA Venture (the “BDCA Venture Board,” and collectively with the BDCA Board and the BDCA II Board, and any board of directors of a Future Regulated Fund, the “Boards” and each a “Board,” as applicable) consists of five directors, four of whom are Non-Interested Directors of BDCA Venture.
3. BDCA Adviser is a Delaware limited liability company that is registered as an investment adviser under the Investment Advisers Act of 1940 (the “Advisers Act”). BDCA Adviser serves as investment adviser to BDCA. BDCA Adviser II is a Delaware limited liability company that is registered as an investment adviser under the Advisers Act. BDCA Adviser II serves as investment adviser to BDCA II. BDCA Venture Adviser is a Delaware limited liability company that is registered as an investment adviser under the Advisers Act. BDCA Venture Adviser serves as investment adviser to BDCA Venture.
4. Applicants seek an order (“Order”) to permit a Regulated Fund
5. Applicants state that a Regulated Fund may, from time to time, form one or more Wholly-Owned Investment Subs.
6. When considering Potential Co-Investment Transactions for any Regulated Fund, the applicable Adviser will consider only the Objectives and Strategies, investment policies, investment positions, capital available for investment, and other pertinent factors applicable to that Regulated Fund. The Regulated Funds' Advisers expect that any portfolio company that is an appropriate investment for a Regulated Fund should also be an appropriate investment for one or more other Regulated Funds and/or one or more Future Affiliated Funds, with certain exceptions based on available capital or diversification.
7. Other than pro rata dispositions and Follow-On Investments as provided in conditions 7 and 8, and after making the determinations required in conditions 1 and 2(a), the Adviser will present each Potential Co-Investment Transaction and the proposed allocation to the directors of the Board eligible to vote under section 57(o) of the Act (“Eligible Directors”), and the “required majority,” as defined in section 57(o) of the Act (“Required Majority”)
8. With respect to the pro rata dispositions and Follow-On Investments provided in conditions 7 and 8, a Regulated Fund may participate in a pro rata disposition or Follow-On Investment without obtaining prior approval of the Required Majority if, among other things: (i) The proposed participation of each Regulated Fund and Future Affiliated Fund in such disposition is proportionate to its
9. No Non-Interested Director of a Regulated Fund will have a financial interest in any Co-Investment Transaction, other than through share ownership in one of the Regulated Funds.
1. Section 57(a)(4) of the Act prohibits certain affiliated persons of a BDC from participating in joint transactions with the BDC or a company controlled by a BDC in contravention of rules as prescribed by the Commission. Under section 57(b)(2) of the Act, any person who is directly or indirectly controlling, controlled by, or under common control with a BDC is subject to section 57(a)(4). Applicants submit that each of the Regulated Funds and Future Affiliated Funds be deemed to be a person related to each Regulated Fund in a manner described by section 57(b) by virtue of being under common control. Section 57(i) of the Act provides that, until the Commission prescribes rules under section 57(a)(4), the Commission's rules under section 17(d) of the Act applicable to registered closed-end investment companies will be deemed to apply to transactions subject to section 57(a)(4). Because the Commission has not adopted any rules under section 57(a)(4), rule 17d-1 also applies to joint transactions with Regulated Funds that are BDCs. Section 17(d) of the Act and rule 17d-1 under the Act are applicable to Regulated Funds that are registered closed-end investment companies.
2. Section 17(d) of the Act and rule 17d-1 under the Act prohibit affiliated persons of a registered investment company from participating in joint transactions with the company unless the Commission has granted an order permitting such transactions. In passing upon applications under rule 17d-1, the Commission considers whether the company's participation in the joint transaction is consistent with the provisions, policies, and purposes of the Act and the extent to which such participation is on a basis different from or less advantageous than that of other participants.
3. Applicants state that in the absence of the requested relief, the Regulated Funds would be, in some circumstances, limited in their ability to participate in attractive and appropriate investment opportunities. Applicants believe that the proposed terms and conditions will ensure that the Co-Investment Transactions are consistent with the protection of each Regulated Fund's shareholders and with the purposes intended by the policies and provisions of the Act. Applicants state that the Regulated Funds' participation in the Co-Investment Transactions will be consistent with the provisions, policies, and purposes of the Act and on a basis that is not different from or less advantageous than that of other participants.
4. Under condition 14, if the Advisers, the Principals, any person controlling, controlled by, or under common control with the Advisers or the Principals, and the Affiliated Funds (collectively, the “Holders”) own in the aggregate more than 25% of the outstanding voting securities of a Regulated Fund (“Shares”), then the Holders will vote such Shares as directed by an independent third party when voting on matters specified in the condition. Applicants believe that this condition will ensure that the Non-Interested Directors will act independently in evaluating the Co-Investment Program, because the ability of the Advisers or the Principals to influence the Non-Interested Directors by a suggestion, explicit or implied, that the Non-Interested Directors can be removed will be limited significantly. Applicants represent that the Non-Interested Directors will evaluate and approve any such voting trust or proxy adviser, taking into accounts its qualifications, reputation for independence, cost to the shareholders, and other factors that they deem relevant.
Applicants agree that the Order will be subject to the following conditions:
1. Each time an Adviser considers a Potential Co-Investment Transaction for a Future Affiliated Fund or another Regulated Fund that falls within a Regulated Fund's then-current Objectives and Strategies, the Regulated Fund's Adviser will make an independent determination of the appropriateness of the investment for such Regulated Fund in light of the Regulated Fund's then-current circumstances.
2. (a) If the Adviser deems a Regulated Fund's participation in any Potential Co-Investment Transaction to be appropriate for the Regulated Fund, it will then determine an appropriate level of investment for the Regulated Fund.
(b) If the aggregate amount recommended by the applicable Adviser to be invested by the applicable Regulated Fund in the Potential Co-Investment Transaction, together with the amount proposed to be invested by the other participating Regulated Funds and Future Affiliated Funds, collectively, in the same transaction, exceeds the amount of the investment opportunity, the investment opportunity will be allocated among them pro rata based on each participating party's capital available for investment in the asset class being allocated, up to the amount proposed to be invested by each. The applicable Adviser will provide the Eligible Directors of each participating Regulated Fund with information concerning each participating party's available capital to assist the Eligible Directors with their review of the Regulated Fund's investments for compliance with these allocation procedures.
(c) After making the determinations required in conditions 1 and 2(a), the applicable Adviser will distribute written information concerning the Potential Co-Investment Transaction (including the amount proposed to be invested by each participating Regulated Fund and Future Affiliated Fund) to the Eligible Directors of each participating Regulated Fund for their consideration. A Regulated Fund will co-invest with one or more other Regulated Funds and/or one or more Future Affiliated Funds only if, prior to the Regulated Fund's participation in the Potential Co-Investment Transaction, a Required Majority concludes that:
(i) The terms of the Potential Co-Investment Transaction, including the consideration to be paid, are reasonable and fair to the Regulated Fund and its shareholders and do not involve overreaching in respect of the Regulated Fund or its shareholders on the part of any person concerned;
(ii) the Potential Co-Investment Transaction is consistent with:
(A) The interests of the shareholders of the Regulated Fund; and
(B) the Regulated Fund's then-current Objectives and Strategies;
(iii) the investment by any other Regulated Funds or Future Affiliated Funds would not disadvantage the Regulated Fund, and participation by
(A) The Eligible Directors will have the right to ratify the selection of such director or board observer, if any;
(B) the applicable Adviser agrees to, and does, provide periodic reports to the Regulated Fund's Board with respect to the actions of such director or the information received by such board observer or obtained through the exercise of any similar right to participate in the governance or management of the portfolio company; and
(C) any fees or other compensation that any Future Affiliated Fund or any Regulated Fund or any affiliated person of any Future Affiliated Fund or any Regulated Fund receives in connection with the right of an Future Affiliated Fund or a Regulated Fund to nominate a director or appoint a board observer or otherwise to participate in the governance or management of the portfolio company will be shared proportionately among the participating Future Affiliated Funds (who each may, in turn, share its portion with its affiliated persons) and the participating Regulated Funds in accordance with the amount of each party's investment; and
(iv) the proposed investment by the Regulated Fund will not benefit the Advisers, the Future Affiliated Funds or the other Regulated Funds or any affiliated person of any of them (other than the parties to the Co-Investment Transaction), except (A) to the extent permitted by condition 13, (B) to the extent permitted by sections 17(e) or 57(k) of the Act, as applicable, (C) indirectly, as a result of an interest in the securities issued by one of the parties to the Co-Investment Transaction, or (D) in the case of fees or other compensation described in condition 2(c)(iii)(C).
3. Each Regulated Fund has the right to decline to participate in any Potential Co-Investment Transaction or to invest less than the amount proposed.
4. The applicable Adviser will present to the Board of each Regulated Fund, on a quarterly basis, a record of all investments in Potential Co-Investment Transactions made by any of the other Regulated Funds or Future Affiliated Funds during the preceding quarter that fell within the Regulated Fund's then-current Objectives and Strategies that were not made available to the Regulated Fund, and an explanation of why the investment opportunities were not offered to the Regulated Fund. All information presented to the Board pursuant to this condition will be kept for the life of the Regulated Fund and at least two years thereafter, and will be subject to examination by the Commission and its staff.
5. Except for Follow-On Investments made in accordance with condition 8,
6. A Regulated Fund will not participate in any Potential Co-Investment Transaction unless the terms, conditions, price, class of securities to be purchased, settlement date, and registration rights will be the same for each participating Regulated Fund and Future Affiliated Fund. The grant to a Future Affiliated Fund or another Regulated Fund, but not the Regulated Fund, of the right to nominate a director for election to a portfolio company's board of directors, the right to have an observer on the board of directors or similar rights to participate in the governance or management of the portfolio company will not be interpreted so as to violate this condition 6, if conditions 2(c)(iii)(A), (B) and (C) are met.
7. (a) If any Future Affiliated Fund or any Regulated Fund elects to sell, exchange or otherwise dispose of an interest in a security that was acquired in a Co-Investment Transaction, the applicable Advisers will:
(i) Notify each Regulated Fund that participated in the Co-Investment Transaction of the proposed disposition at the earliest practical time; and
(ii) formulate a recommendation as to participation by each Regulated Fund in the disposition.
(b) Each Regulated Fund will have the right to participate in such disposition on a proportionate basis, at the same price and on the same terms and conditions as those applicable to the participating Future Affiliated Funds and Regulated Funds.
(c) A Regulated Fund may participate in such disposition without obtaining prior approval of the Required Majority if: (i) The proposed participation of each Regulated Fund and each Future Affiliated Fund in such disposition is proportionate to its outstanding investments in the issuer immediately preceding the disposition; (ii) the Board of the Regulated Fund has approved as being in the best interests of the Regulated Fund the ability to participate in such dispositions on a pro rata basis (as described in greater detail in the application); and (iii) the Board of the Regulated Fund is provided on a quarterly basis with a list of all dispositions made in accordance with this condition. In all other cases, the Adviser will provide its written recommendation as to the Regulated Fund's participation to the Eligible Directors, and the Regulated Fund will participate in such disposition solely to the extent that a Required Majority determines that it is in the Regulated Fund's best interests.
(d) Each Future Affiliated Fund and each Regulated Fund will bear its own expenses in connection with any such disposition.
8. (a) If any Future Affiliated Fund or any Regulated Fund desires to make a Follow-On Investment in a portfolio company whose securities were acquired in a Co-Investment Transaction, the applicable Advisers will:
(i) Notify each Regulated Fund that participated in the Co-Investment Transaction of the proposed transaction at the earliest practical time; and
(ii) formulate a recommendation as to the proposed participation, including the amount of the proposed Follow-On Investment, by each Regulated Fund.
(b) A Regulated Fund may participate in such Follow-On Investment without obtaining prior approval of the Required Majority if: (i) The proposed participation of each Regulated Fund and each Future Affiliated Fund in such investment is proportionate to its outstanding investments in the issuer immediately preceding the Follow-On Investment; and (ii) the Board of the Regulated Fund has approved as being in the best interests of the Regulated Fund the ability to participate in Follow-On Investments on a pro rata basis (as described in greater detail in the application). In all other cases, the Adviser will provide its written recommendation as to the Regulated Fund's participation to the Eligible Directors, and the Regulated Fund will participate in such Follow-On Investment solely to the extent that a
(c) If, with respect to any Follow-On Investment:
(i) The amount of the opportunity is not based on the Regulated Funds' and the Future Affiliated Funds' outstanding investments immediately preceding the Follow-On Investment; and
(ii) the aggregate amount recommended by the Adviser to be invested by each Regulated Fund in the Follow-On Investment, together with the amount proposed to be invested by the participating Future Affiliated Funds in the same transaction, exceeds the amount of the opportunity; then the amount invested by each such party will be allocated among them pro rata based on each participating party's capital available for investment in the asset class being allocated, up to the amount proposed to be invested by each.
(d) The acquisition of Follow-On Investments as permitted by this condition will be considered a Co-Investment Transaction for all purposes and subject to the other conditions set forth in the application.
9. The Non-Interested Directors of each Regulated Fund will be provided quarterly for review all information concerning Potential Co-Investment Transactions and Co-Investment Transactions, including investments made by other Regulated Funds or Future Affiliated Funds that the Regulated Fund considered but declined to participate in, so that the Non-Interested Directors may determine whether all investments made during the preceding quarter, including those investments that the Regulated Fund considered but declined to participate in, comply with the conditions of the Order. In addition, the Non-Interested Directors will consider at least annually the continued appropriateness for the Regulated Fund of participating in new and existing Co-Investment Transactions.
10. Each Regulated Fund will maintain the records required by section 57(f)(3) of the Act as if each of the Regulated Funds were a BDC and each of the investments permitted under these conditions were approved by the Required Majority under section 57(f) of the Act.
11. No Non-Interested Director of a Regulated Fund will also be a director, general partner, managing member or principal, or otherwise an “affiliated person” (as defined in the Act), of a Future Affiliated Fund.
12. The expenses, if any, associated with acquiring, holding or disposing of any securities acquired in a Co-Investment Transaction (including, without limitation, the expenses of the distribution of any such securities registered for sale under the Securities Act) will, to the extent not payable by the Advisers under their respective investment advisory agreements with Future Affiliated Funds and the Regulated Funds, be shared by the Regulated Funds and the Future Affiliated Funds in proportion to the relative amounts of the securities held or to be acquired or disposed of, as the case may be.
13. Any transaction fee
14. If the Holders own in the aggregate more than 25% of the outstanding Shares, then the Holders will vote such Shares as directed by an independent third party (such as the trustee of a voting trust or a proxy adviser) when voting on (1) the election of directors; (2) the removal of one or more directors; or (3) any matters requiring approval by the vote of a majority of the outstanding voting securities, as defined in Section 2(a)(42) of the Act.
For the Commission, by the Division of Investment Management, under delegated authority.
Securities and Exchange Commission (“Commission”).
Notice of an application under section 6(c) of the Investment Company Act of 1940 (“Act”) for an exemption from section 15(a) of the Act and rule 18f-2 under the Act, as well as from certain disclosure requirements.
Applicants request an order that would permit them to enter into and materially amend subadvisory agreements with Wholly-Owned Subadvisers (as defined below) and Non-Affiliated Subadvisers (as defined below) without shareholder approval and would grant relief from certain disclosure requirements. The requested order would supersede a prior order that granted relief solely with respect to Non-Affiliated Subadvisers.
The MainStay Funds, MainStay Funds Trust and MainStay VP Funds Trust (each, a “Trust”) and New York Life Investment Management LLC (the “Adviser” or “New York Life Investments”).
The application was filed on September 19, 2014, and amended on February 3, 2015, and April 3, 2015.
An order granting the application will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving applicants with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on June 5, 2015, and should be accompanied by proof of service on applicants, in the form of an affidavit or, for lawyers, a certificate of service. Hearing requests should state
Secretary, U.S. Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090. Applicants, c/o J. Kevin Gao, Esq., New York Life Investment Management LLC, 169 Lackawanna Avenue, Parsippany, New Jersey 07054.
Elizabeth G. Miller, Senior Counsel, at (202) 551-8707, or Holly Hunter-Ceci, Branch Chief, at (202) 551-6825 (Division of Investment Management, Chief Counsel's Office).
The following is a summary of the application. The complete application may be obtained via the Commission's Web site by searching for the file number or an applicant using the Company name box, at
1. Each Trust is registered with the Commission as an open-end management investment company under the Act. Each of MainStay Funds Trust and MainStay VP Funds Trust is organized as a Delaware statutory trust, and The MainStay Funds is organized as a Massachusetts business trust. Each Trust may offer one or more series of shares (each a “Fund,” and collectively the “Funds”), each with its own distinct investment objectives, policies and restrictions. Shares of MainStay VP Funds Trust will be offered and sold through insurance company accounts, which are used to fund variable annuity contracts. The Adviser is a Delaware limited liability company registered with the Commission as an investment adviser under the Investment Advisers Act of 1940 (the “Advisers Act”), and serves as investment adviser to the Funds.
2. Applicants request an order to permit the Adviser,
3. New York Life Investments serves as the investment adviser to each Fund pursuant to an investment advisory agreement with the applicable Trust (each an “Investment Advisory Agreement” and together the “Investment Advisory Agreements”). Any future Adviser also will be registered with the Commission as an investment adviser under the Advisers Act. Each Investment Advisory Agreement has been or will be approved by the applicable Board, including a majority of the Independent Trustees, and by the shareholders of the relevant Fund in the manner required by sections 15(a) and 15(c) of the Act and rule 18f-2 thereunder. The terms of the Investment Advisory Agreements comply or will comply with section 15(a) of the Act.
4. Pursuant to the terms of each Investment Advisory Agreement, the Adviser, subject to the oversight of the applicable Board, has agreed or will agree to provide a continuous investment program for each Fund and determine the securities and other investments to be purchased, retained, sold or loaned by each Fund and the portion of such assets to be invested or held uninvested as cash. The Adviser will periodically review each Fund's investment policies and strategies and, based on the need of a particular Fund, may recommend changes to the investment policies and strategies of the Fund for consideration by the Board. For its services to each Fund, the Adviser receives or will receive an investment advisory fee from that Fund as specified in the applicable Investment Advisory Agreement. Consistent with the terms of each Subadvised Fund's Investment Advisory Agreement, the Adviser may, subject to the approval of the Board, including a majority of the Independent Trustees, and the shareholders of the applicable Subadvised Fund (if required), delegate portfolio management responsibilities of all or a portion of the assets of a Subadvised Fund to a Subadviser. The Adviser continues to have overall responsibility for the management and
5. Pursuant to the authority under the Investment Advisory Agreements, the Adviser may enter into Subadvisory Agreements with various Subadvisers on behalf of the Funds. The Adviser has entered into a Subadvisory Agreement with the following Subadvisers: Candriam Belgium S.A., Cornerstone Capital Management Holdings LLC; Cushing® Asset Management, LP; Eagle Asset Management, Inc.; Epoch Investments Partners, Inc.; Institutional Capital LLC; Janus Capital Management LLC; MacKay Shields LLC; Marketfield Asset Management LLC; Markston International LLC; Massachusetts Financial Services Company; NYL Investors LLC; Pacific Investment Management Company LLC; T. Rowe Price Associates, Inc.; Van Eck Associates Corporation; and Winslow Capital Management LLC. The Adviser also may, in the future, enter into Subadvisory Agreements with other Subadvisers on behalf of the Funds. The Subadvisory Agreements were or will be approved by the applicable Board, including a majority of the Independent Trustees, and the shareholders of the Subadvised Fund in accordance with sections 15(a) and 15(c) of the Act and rule 18f-2 thereunder. In addition, the terms of the Subadvisory Agreements comply or will comply fully with the requirements of section 15(a) of the Act. The Subadvisers, subject to the oversight of the Adviser and the applicable Board, determine or will determine the securities and other instruments to be purchased, sold or entered into by a Subadvised Fund's portfolio or a portion thereof, and place orders with brokers or dealers that they select. The Adviser will compensate the Subadvisers out of the fee received by the Adviser from the applicable Subadvised Fund under the applicable Investment Advisory Agreement.
6. Subadvised Funds will inform shareholders of the hiring of a new Subadviser pursuant to the following procedures (“Modified Notice and Access Procedures”): (a) Within 90 days after a new Subadviser is hired for any Subadvised Fund, that Subadvised Fund will send its shareholders either a Multi-manager Notice or a Multi-manager Notice and Multi-manager Information Statement;
A “Multi-manager Information Statement” will meet the requirements of Regulation 14C, Schedule 14C and Item 22 of Schedule 14A under the Exchange Act for an information statement, except as modified by the order to permit Aggregate Fee Disclosure. Multi-manager Information Statements will be filed with the Commission via the EDGAR system.
7. Applicants also request an order under section 6(c) of the Act exempting the Subadvised Funds from certain disclosure obligations that may require each Subadvised Fund to disclose fees paid by the Adviser to each Subadviser. Applicants seek relief to permit each Subadvised Fund to disclose (as a dollar amount and a percentage of a Subadvised Fund's net assets) (a) the aggregate fees paid to the Adviser and any Wholly-Owned Subadvisers; (b) the aggregate fees paid to Non-Affiliated Subadvisers; and (c) the fee paid to each Affiliated Subadviser (collectively, the “Aggregate Fee Disclosure”). An exemption is requested to permit a Subadvised Fund to include only the Aggregate Fee Disclosure. All other items required by Sections 6-07(2)(a), (b) and (c) of Regulation S-X will be disclosed.
1. Section 15(a) of the Act states, in part, that it is unlawful for any person to act as an investment adviser to a registered investment company “except pursuant to a written contract, which contract, whether with such registered company or with an investment adviser of such registered company, has been approved by the vote of a majority of the outstanding voting securities of such registered company.” Rule 18f-2 under the Act provides that each series or class of stock in a series investment company affected by a matter must approve that matter if the Act requires shareholder approval.
2. Form N-1A is the registration statement used by open-end investment companies. Item 19(a)(3) of Form N-1A requires a registered investment company to disclose in its statement of additional information the method of computing the “advisory fee payable” by the investment company, including the total dollar amounts that the investment company “paid to the adviser (aggregated with amounts paid to affiliated advisers, if any), and any advisers who are not affiliated persons of the adviser, under the investment advisory contract for the last three fiscal years.”
3. Rule 20a-1 under the Act requires proxies solicited with respect to a registered investment company to comply with Schedule 14A under the Exchange Act. Items 22(c)(1)(ii), 22(c)(1)(iii), 22(c)(8) and 22(c)(9) of Schedule 14A, taken together, require a proxy statement for a shareholder meeting at which the advisory contract will be voted upon to include the “rate of compensation of the investment adviser,” the “aggregate amount of the investment adviser's fee,” a description of the “terms of the contract to be acted upon,” and, if a change in the advisory fee is proposed, the existing and proposed fees and the difference between the two fees.
4. Regulation S-X sets forth the requirements for financial statements required to be included as part of a registered investment company's registration statement and shareholder reports filed with the Commission. Sections 6-07(2)(a), (b) and (c) of Regulation S-X require a registered investment company to include in its financial statement information about the investment advisory fees.
5. Section 6(c) of the Act provides that the Commission may exempt any person, security, or transaction or any class or classes of persons, securities, or transactions from any provisions of the Act, or from any rule thereunder, if such
6. Applicants assert that the shareholders expect the Adviser, subject to the review and approval of the applicable Board, to select a Subadviser who is in the best position to achieve the Subadvised Fund's investment objective. Applicants assert that, from the perspective of the shareholder, the role of the Subadvisers is substantially equivalent to the role of the individual portfolio managers employed by an investment adviser to a traditional investment company. Applicants believe that permitting the Adviser to perform the duties for which the shareholders of a Subadvised Fund are paying the Adviser—the selection, supervision and evaluation of the Subadviser—without incurring unnecessary delays or expenses is appropriate and in the interest of a Subadvised Fund's shareholders and will allow such Subadvised Fund to operate more efficiently. Applicants state that each Investment Advisory Agreement will continue to be fully subject to section 15(a) of the Act and rule 18f-2 under the Act and approved by the relevant Board, including a majority of the Independent Trustees, in the manner required by sections 15(a) and 15(c) of the Act. Applicants are not seeking an exemption with respect to the Investment Advisory Agreements.
7. Applicants assert that disclosure of the individual fees that the Adviser would pay to the Subadvisers does not serve any meaningful purpose. Applicants contend that the primary reasons for requiring disclosure of individual fees paid to Subadvisers are to inform shareholders of expenses to be charged by a particular Subadvised Fund and to enable shareholders to compare the fees to those of other comparable investment companies. Applicants believe that the requested relief satisfies these objectives because the advisory fee paid to the Adviser will be fully disclosed and, therefore, shareholders will know what a Subadvised Fund's fees and expenses are and will be able to compare the advisory fees a Subadvised Fund is charged to those of other investment companies. Applicants assert that the requested disclosure relief would benefit shareholders of the Subadvised Funds because it would improve the Adviser's ability to negotiate the fees paid to Subadvisers. Applicants state that the Adviser may be able to negotiate rates that are below a Subadviser's “posted” amounts if the Adviser is not required to disclose the Subadvisers' fees to the public. Applicants assert that the relief will also encourage Subadvisers to negotiate lower subadvisory fees with the Adviser if the lower fees are not required to be made public.
8. Applicants submit that the requested relief meets the standards for relief under section 6(c) of the Act. Applicants state that the operation of a Subadvised Fund in the manner described in the application must be approved by shareholders of the Subadvised Fund before that Subadvised Fund may rely on the requested order. In addition, applicants state that any conflict of interest or economic incentive that may exist in connection with the Adviser selecting a Wholly-Owned Subadviser to manage all or a portion of the assets of a Subadvised Fund are addressed under the terms and conditions of the application and will be disclosed to shareholders and considered by the applicable Board when it reviews the selection or termination of Subadvisers. Applicants also assert that conditions 6, 7, 10 and 11 are designed to provide the Board with sufficient independence and the resources and information it needs to monitor and address any conflicts of interest. Applicants state that, accordingly, they believe the requested relief is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act.
Applicants agree that any order granting the requested relief will be subject to the following conditions:
1. Before a Subadvised Fund may rely on the order requested in the application, the operation of the Subadvised Fund in the manner described in the application, including the hiring of Wholly-Owned Subadvisers, will be, or has been, approved by a majority of the Subadvised Fund's outstanding voting securities (or if the Subadvised Fund serves as a funding medium for any sub-account of a registered separate account, pursuant to voting instructions provided by variable contract owners with to whom units of the sub-account are credited), as defined in the Act, or, in the case of a Subadvised Fund whose public shareholders (or variable contract owners through a registered separate account) purchase shares on the basis of a prospectus containing the disclosure contemplated by condition 2 below, by the initial shareholder before such Subadvised Fund's shares are offered to the public (or the variable contract owners through a separate account).
2. The prospectus for each Subadvised Fund will disclose the existence, substance, and effect of any order granted pursuant to the application. In addition, each Subadvised Fund will hold itself out to the public as employing the multi-manager structure described in the application. The prospectus will prominently disclose that the Adviser has the ultimate responsibility, subject to oversight by the applicable Board, to oversee the Subadvisers and recommend their hiring, termination and replacement.
3. The Adviser will provide general management services to each Subadvised Fund, including overall supervisory responsibility for the general management and investment of the Subadvised Fund's assets, and subject to review and approval of the applicable Board, will (i) set the Subadvised Fund's overall investment strategies; (ii) evaluate, select, and recommend Subadvisers to manage all or a portion of the Subadvised Fund's assets; (iii) allocate and, when appropriate, reallocate the Subadvised Fund's assets among Subadvisers; (iv) monitor and evaluate the Subadvisers' performance; and (v) implement procedures reasonably designed to ensure that Subadvisers comply with the Subadvised Fund's investment objective, policies and restrictions.
4. A Subadvised Fund will not make any Ineligible Subadviser Changes without the approval of the shareholders (or, if the Subadvised Fund serves as a funding medium for any sub-account of a registered separate account, the Adviser will inform the unitholders of the sub-account) of the applicable Subadvised Fund.
5. Subadvised Funds will inform shareholders (or, if the Subadvised Fund serves as a funding medium for any sub-account of a registered separate account, the Adviser will inform the unitholders of the sub-account) of the hiring of a new Subadviser within 90 days after the hiring of the new Subadviser pursuant to the Modified Notice and Access Procedures.
6. At all times, at least a majority of the applicable Board will be Independent Trustees, and the selection and nomination of new or additional Independent Trustees will be placed within the discretion of the then-existing Independent Trustees.
7. Independent Legal Counsel, as defined in rule 0-1(a)(6) under the Act,
8. The Adviser will provide the applicable Board, no less frequently than quarterly, with information about the profitability of the Adviser on a per Subadvised Fund basis. The information will reflect the impact on profitability of the hiring or termination of any Subadviser during the applicable quarter.
9. Whenever a Subadviser is hired or terminated, the Adviser will provide the applicable Board with information showing the expected impact on the profitability of the Adviser.
10. Whenever a Subadviser change is proposed for a Subadvised Fund with an Affiliated Subadviser or a Wholly-Owned Subadviser, the applicable Board, including a majority of the Independent Trustees, will make a separate finding, reflected in the applicable Board minutes, that the change is in the best interests of the Subadvised Fund and its shareholders and does not involve a conflict of interest from which the Adviser or the Affiliated Subadviser or Wholly-Owned Subadviser derives an inappropriate advantage.
11. No Trustee or officer of a Subadvised Fund, or director, manager or officer of the Adviser, will own directly or indirectly (other than through a pooled investment vehicle that is not controlled by such person), any interest in a Subadviser except for (a) ownership of interests in the Adviser or any entity, other than a Wholly-Owned Subadviser, that controls, is controlled by or is under common control with the Adviser, or (b) ownership of less than 1% of the outstanding securities of any class of equity or debt of a publicly-traded company that is either a Subadviser or an entity that controls, is controlled by, or is under common control with a Subadviser.
12. Each Subadvised Fund will disclose in its registration statement the Aggregate Fee Disclosure.
13. In the event that the Commission adopts a rule under the Act providing substantially similar relief to that requested in the application, the requested order will expire on the effective date of that rule.
14. Any new Subadvisory Agreement or any amendment to a Subadvised Fund's existing investment advisory agreement or Subadvisory Agreement that directly or indirectly results in an increase in the aggregate advisory fee rate payable by the Subadvised Fund will be submitted to the Subadvised Fund's shareholders (or, if the Subadvised Fund serves as a funding medium for any sub-account of a registered separate account, the Adviser will inform the unitholders of the sub-account) for approval.
For the Commission, by the Division of Investment Management, under delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
ICE Clear Europe proposes amendments to its Finance Procedures in order to facilitate the use by CDS Clearing Members of Clearstream Banking as a triparty collateral service provider.
In its filing with the Commission, ICE Clear Europe included statements concerning the purpose of and basis for the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. ICE Clear Europe has prepared summaries, set forth in sections A, B and C below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to modify the Finance Procedures to allow Clearstream Banking to serve as a triparty collateral service provider for initial or original margin provided in respect of all product categories, including CDS Contracts. (Clearstream Banking currently serves as a triparty collateral service provider solely for original margin provided in respect of F&O Contracts).
Specifically, paragraph 3.1 of the Finance Procedures is revised to remove the existing restriction that Clearstream Banking may only act as a triparty collateral service provider with respect to Original Margin in respect of F&O Contracts. As a result of such change, Clearstream Banking would be permitted to act as a triparty collateral service provider for initial or original margin in respect of any product category, including the CDS product category. (The other currently authorized triparty collateral service provider, Euroclear Bank, is similarly eligible to act as such for any product category.) A correction is also made in paragraph 3.20 to provide that the specified instruction deadlines apply to triparty collateral arrangements with both Euroclear Bank and Clearstream Banking.
ICE Clear Europe believes that the proposed rule change is consistent with the requirements of Section 17A of the Act
The proposed amendments are intended to extend the Clearing House's existing triparty collateral service to allow optional use by Clearing Members of Clearstream Banking as a triparty collateral service provider with respect to initial and original margin for the CDS (and FX) product categories, in
ICE Clear Europe does not believe the proposed rule change would have any impact, or impose any burden, on competition not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule change will provide additional flexibility to Clearing Members by permitting the use, on a voluntary basis, of Clearstream Banking as a triparty collateral service provider for original or initial margin for all product categories. The proposed rule change will otherwise not affect the terms or conditions of any cleared contract or the standards or requirements for participation in or use of the Clearing House. Accordingly, the proposed rule change should not, in the Clearing House's view, affect the availability of clearing, access to clearing services or the costs of clearing for clearing members or other market participants.
Written comments relating to the proposed rule change have not been solicited or received. ICE Clear Europe will notify the Commission of any written comments received by ICE Clear Europe.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove the proposed rule change or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The title for the collection of information is “Form N-6 (17 CFR 239.17c and 274.11d) under the Securities Act of 1933 (15 U.S.C. 77a
The Commission estimates that approximately 472 registration statements (396 post-effective amendments plus 76 initial registration statements) are filed on Form N-6 annually. The estimated hour burden per portfolio for preparing and filing an initial registration statement on Form N-6 is 770.25 hours. The estimated annual hour burden for preparing and filing initial registration statements is 58,539 hours (76 initial registration statements annually times 770.25 hours per registration statement). The Commission estimates that the hour burden for preparing and filing a post-effective amendment on Form N-6 is 67.5 hours. The total annual hour burden for preparing and filing post-effective amendments is 26,730 hours (396 post-effective amendments annually times 67.5 hours per amendment). The frequency of response is annual. The total annual hour burden for Form N-6, therefore, is estimated to be 85,269 hours (58,539 hours for initial registration statements plus 26,730 hours for post-effective amendments).
The Commission estimates that the cost burden for preparing an initial Form N-6 filing is $24,169 per portfolio and the current cost burden for preparing a post-effective amendment to a previously effective registration statement is $8,788 per portfolio. The Commission estimates that, on an annual basis, 76 portfolios will be referenced in an initial Form N-6 and 396 portfolios will be referenced in a post-effective amendment of Form N-6. Thus, the total cost burden allocated to Form N-6 would be $5,316,892.
The information collection requirements imposed by Form N-6 are mandatory. Responses to the collection of information will not be kept confidential. Estimates of average burden hours are made solely for the purposes of the Paperwork Reduction Act, and are not derived from a comprehensive or even a representative survey or study of the costs of Commission rules and forms. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid control number.
The public may view the background documentation for this information collection at the following Web site,
The Small Business Administration published a document in the
The initial and corrected documents did not include a monetary prize to be awarded to the winner. By way of this memo, SBA has made a determination that the document needs to be corrected again to include a prize of $2,500.
In the document printed on May 5, 2015, the first full sentence on page 25764 under the caption: “4.
4.
60-Day notice and request for comments.
The Small Business Administration (SBA) intends to request approval, from the Office of Management and Budget (OMB) for the new collection of information described below. The Paperwork Reduction Act (PRA) of 1995, 44 U.S.C. Chapter 35 requires federal agencies to publish a notice in the
Submit comments on or before July 14, 2015.
Send all comments to Delcine Montgomery, Contracting Officer Technical Representative, Office of Native American Affairs, U.S. Small Business Administration, 409 3rd Street SW., Suite 6700, Washington, DC 20416.
Delcine Montgomery, Contracting Officer Technical Representative, 202-205-6195 or
In October 2013, the SBA's Office of the Native Business Development awarded a contract to Cherokee Nation Technology Solutions, LLC (CNTS) to provide 8(a) Business Development Program training to American Indian Tribes (AITs) Alaskan Native Corporations (ANCs) and Native Hawaiian Organizations (NHOs). The primary purpose of Native American 8(a) Business Development Program Workshops Training Initiative (the Native American 8(a) BD Workshops) is to improve the Native American business owners and entrepreneur's understanding of the SBA 8(a) Business Development program's eligibility requirements and application process, business operation features for successful contract management, revenue-generating/job-
SBA plans to conduct a performance evaluation of the Native American 8(a) BD Workshops to assess the training services provided to individuals who directly and indirectly obtained the information and knowledge from the workshops, the preliminary impact of training on the business goals of direct and indirect participants, participant satisfaction with the training provider, and lessons learned and recommendations by the CNTS and the participants in the workshops. One unique feature of the implementation of the Native American 8(a) BD Workshops is that a significant number of participants were representing tribal organizations such as Leadership, Tribal Council, and Economic/Business Development. With the participation of the tribal representatives, there is a strong possibility that the knowledge learned from Native American 8(a) BD Workshops could be further disseminated by these tribal representatives to the other members/business owners of the tribes. Therefore, SBA plans to enhance and increase the data collection of performance metrics and collect survey data from participants who attended the workshops and the individuals who indirectly obtained the related knowledge from the tribal representatives. These data will facilitate the comprehensive assessment of Native American 8(a) BD workshop operations, outcomes and impacts.
Specifically, SBA proposes the use of two different instruments for data collection and analysis: (1) The Native American 8(a) Business Development Program Workshops Training Initiative Direct Participant Survey; and (2) the Native American 8(a) Business Development Program Workshops Training Initiative Indirect Participant Survey. Both of the surveys will be administered electronically and will contain both open- and close-ended questions. The types of information that will be collected in the instruments can be found in the “Summary of Information Collection” section below. Both quantitative and qualitative data analyses will be conducted. Quantitative analysis will consist of univariate and multivariate statistical techniques to summarize surveys results and explore the relationships among various data elements. The qualitative analysis will consist of identifying and interpreting themes for the open-ended survey questions. The information collected and analyzed from the survey instruments will be used to develop performance metrics, establish the achievement of the program's goals as well as providing recommendations on improving program operations.
SBA is requesting comments on (a) whether the collection of information is necessary for the agency to properly perform its functions; (b) whether the burden estimates are accurate; (c) whether there are ways to minimize the burden, including through the use of automated techniques or other forms of information technology; and (d) whether there are ways to enhance the quality, utility, and clarity of the information.
The direct participants survey will consist of questions about the demographics of participants, their business characteristics, needs and goals, whether the workshop staff effectively assessed their business needs before conducting the training services, the types of training received, the training resources other than Native American 8(a) BD Workshops that they used, participant outcomes, impact of training, and participant satisfaction with the workshops.
U.S. Small Business Administration.
Notice.
This is a notice of an Administrative declaration of a disaster for the State of Florida dated 05/08/2015.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the Administrator's disaster declaration, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 14301 C and for economic injury is 14302 0.
The State which received an EIDL Declaration # is Florida.
U.S. Small Business Administration.
Amendment 2.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Tennessee (FEMA-4211-DR), dated 04/02/2015.
Submit completed loan applications to: U.S. Small Business Administration Processing, and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
The notice of the President's major disaster declaration for private non-profit organizations in the State of Tennessee, dated 04/02/2015, is hereby amended to include the following areas as adversely affected by the disaster.
All other information in the original declaration remains unchanged.
Susquehanna River Basin Commission.
Notice.
This notice lists the projects approved by rule by the Susquehanna River Basin Commission during the period set forth in
February 1-28, 2015.
Susquehanna River Basin Commission, 4423 North Front Street, Harrisburg, PA 17110-1788.
Jason E. Oyler, Regulatory Counsel, telephone: (717) 238-0423, ext. 1312; fax: (717) 238-2436; email:
This notice lists the projects, described below, receiving approval for the consumptive use of water pursuant to the Commission's approval by rule process set forth in 18 CFR 806.22(f) for the time period specified above:
1. Chesapeake Appalachia, LLC, Pad ID: Duane, ABR-20100601.R1, Leroy Township, Bradford County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 2, 2015.
2. Chesapeake Appalachia, LLC, Pad ID: Finnerty, ABR-20100602.R1, West Burlington Township, Bradford County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 2, 2015.
3. Chesapeake Appalachia, LLC, Pad ID: Allen, ABR-20100606.R1, Wysox Township, Bradford County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 2, 2015.
4. Chesapeake Appalachia, LLC, Pad ID: Rylee, ABR-20100610.R1, Auburn Township, Susquehanna County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 2, 2015.
5. Chesapeake Appalachia, LLC, Pad ID: Stalford, ABR-20100617.R1, Wyalusing Township, Bradford County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 2, 2015.
6. Chesapeake Appalachia, LLC, Pad ID: Shaw, ABR-20100634.R1, Windham Township, Wyoming County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 2, 2015.
7. Chesapeake Appalachia, LLC, Pad ID: Cannella, ABR-20100637.R1, Auburn Township, Susquehanna County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 2, 2015.
8. Chesapeake Appalachia, LLC, Pad ID: BDF, ABR-20100640.R1, Smithfield Township, Bradford County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 2, 2015.
9. Chesapeake Appalachia, LLC, Pad ID: Akita NEW, ABR-20100689.R1, Smithfield Township, Bradford County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 2, 2015.
10. Chesapeake Appalachia, LLC, Pad ID: Hilltop NEW, ABR-201006102.R1, Jessup Township, Susquehanna County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 2, 2015.
11. Chesapeake Appalachia, LLC, Pad ID: Kipar NEW, ABR-201006107.R1, Auburn Township, Susquehanna County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 2, 2015.
12. Chesapeake Appalachia, LLC, Pad ID: Curtain NEW, ABR-201006110.R1, Windham Township, Wyoming County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 2, 2015.
13. Carrizo (Marcellus), LLC, Pad ID: Baker 2H, ABR-201008137.R1, Forest Lake Township, Susquehanna County, Pa.; Consumptive Use of Up to 1.400 mgd; Approval Date: March 10, 2015.
14. SWEPI, LP, Pad ID: Cascarino 443, ABR-20100222.R1, Shippen Township, Tioga County, Pa.; Consumptive Use of Up to 3.000 mgd; Approval Date: March 10, 2015.
15. Chesapeake Appalachia, LLC, Pad ID: Bonin, ABR-20100639.R1, Orwell Township, Bradford County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 13, 2015.
16. Chesapeake Appalachia, LLC, Pad ID: Alderfer NEW, ABR-20100671.R1, Litchfield Township, Bradford County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 13, 2015.
17. Chesapeake Appalachia, LLC, Pad ID: Cranrun, ABR-20100680.R1, Leroy Township, Bradford County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 13, 2015.
18. Chesapeake Appalachia, LLC, Pad ID: Black Creek, ABR-20100686.R1, Forks Township, Sullivan County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 13, 2015.
19. Chesapeake Appalachia, LLC, Pad ID: Beebe, ABR-20100687.R1, Asylum Township, Bradford County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 13, 2015.
20. Chesapeake Appalachia, LLC, Pad ID: Linski, ABR-20100662.R1, Tuscarora Township, Bradford County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 16, 2015.
21. Chesapeake Appalachia, LLC, Pad ID: Lillie-NEW, ABR-201006104.R1, Herrick Township, Bradford County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 16, 2015.
22. Chesapeake Appalachia, LLC, Pad ID: Jacobs, ABR-201007028.R1, Rome Township, Bradford County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 16, 2015.
23. Chesapeake Appalachia, LLC, Pad ID: Dewees, ABR-201007063.R1, Rome Township, Bradford County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 16, 2015.
24. Chesapeake Appalachia, LLC, Pad ID: Towner, ABR-20100638.R1, Rome Township, Bradford County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 17, 2015.
25. Chesapeake Appalachia, LLC, Pad ID: Them, ABR-20100642.R1, Wysox Township, Bradford County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 17, 2015.
26. Chesapeake Appalachia, LLC, Pad ID: Rowe, ABR-201007101.R1, Rome Township, Bradford County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 17, 2015.
27. Range Resources—Appalachia, LLC, Pad ID: Shohocken Hunt Club Unit #1H-#6H, ABR-20100646.R1, Cummings Township, Lycoming County, Pa.; Consumptive Use of Up to 5.000 mgd; Approval Date: March 17, 2015.
28. SWEPI, LP, Pad ID: Sharretts 805, ABR-20100229.R1, Clymer Township, Tioga County, Pa.; Consumptive Use of Up to 3.000 mgd; Approval Date: March 17, 2015.
29. SWEPI, LP, Pad ID: Parthemer 284, ABR-20100311.R1, Charleston Township, Tioga County, Pa.; Consumptive Use of Up to 4.000 mgd; Approval Date: March 17, 2015.
30. XTO Energy Incorporated, Pad ID: Hazlak 8504, ABR-20100211.R1, Shrewsbury Township, Lycoming County, Pa.; Consumptive Use of Up to 4.000 mgd; Approval Date: March 17, 2015.
31. Chesapeake Appalachia, LLC, Pad ID: Henderson, ABR-201006103.R1, Fox Township, Sullivan County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 20, 2015.
32. Chesapeake Appalachia, LLC, Pad ID: Coveytown, ABR-201007014.R1, Cherry Township, Sullivan County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 20, 2015.
33. Chesapeake Appalachia, LLC, Pad ID: Insinger, ABR-201007023.R1, Forks Township, Sullivan County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 20, 2015.
34. Range Resources—Appalachia, LLC, Pad ID: Ogontz 41H-43H, ABR-201503001, Cummings Township, Lycoming County, Pa.; Consumptive Use of Up to 5.000 mgd; Approval Date: March 20, 2015.
35. Range Resources—Appalachia, LLC, Pad ID: Laurel Hill 17H-22H, ABR-201503002, Jackson Township, Lycoming County, Pa.; Consumptive Use of Up to 5.000 mgd; Approval Date: March 20, 2015.
36. Range Resources—Appalachia, LLC, Pad ID: Laurel Hill D Pad, ABR-201503003, Cogan House and Jackson Townships, Lycoming County, Pa.; Consumptive Use of Up to 5.000 mgd; Approval Date: March 23, 2015.
37. SWN Production Company, LLC, Pad ID: NR-24 BUCKHORN-PAD, ABR-201503004, Oakland Township, Susquehanna County, Pa.; Consumptive Use of Up to 4.999 mgd; Approval Date: March 27, 2015.
38. Anadarko E&P Onshore, LLC, Pad ID: COP Tr 231 C, ABR-20100304.R1, Boggs Township, Centre County, Pa.; Consumptive Use of Up to 3.000 mgd; Approval Date: March 30, 2015.
39. Anadarko E&P Onshore, LLC, Pad ID: COP Tr 342 D, ABR-20100349.R1, Beech Creek Township, Clinton County, Pa.; Consumptive Use of Up to 3.000 mgd; Approval Date: March 30, 2015.
40. Anadarko E&P Onshore, LLC, Pad ID: COP Tr 231 D, ABR-20100530.R1, Snow Shoe Township, Centre County, Pa.; Consumptive Use of Up to 3.000 mgd; Approval Date: March 30, 2015.
41. Anadarko E&P Onshore, LLC, Pad ID: COP Tr 289 C, ABR-20100636.R1, McHenry Township, Lycoming County, Pa.; Consumptive Use of Up to 3.000 mgd; Approval Date: March 30, 2015.
42. Anadarko E&P Onshore, LLC, Pad ID: COP Tr 342 A, ABR-20100695.R1, Beech Creek Township, Clinton County, Pa.; Consumptive Use of Up to 3.000 mgd; Approval Date: March 30, 2015.
43. Cabot Oil & Gas Corporation, Pad ID: DavisG P1, ABR-201007120.R1, Gibson Township, Susquehanna County, Pa.; Consumptive Use of Up to 3.575 mgd; Approval Date: March 30, 2015.
44. Cabot Oil & Gas Corporation, Pad ID: AdamsJ P1, ABR-201007121.R1, Harford Township, Susquehanna County, Pa.; Consumptive Use of Up to 3.575 mgd; Approval Date: March 30, 2015.
45. Cabot Oil & Gas Corporation, Pad ID: PlonskiJ P1, ABR-201008009.R1, Brooklyn Township, Susquehanna County, Pa.; Consumptive Use of Up to 3.575 mgd; Approval Date: March 30, 2015.
46. Cabot Oil & Gas Corporation, Pad ID: Maiolini P3, ABR-201008114.R1, Auburn Township, Susquehanna County, Pa.; Consumptive Use of Up to 3.575 mgd; Approval Date: March 30, 2015.
47. Cabot Oil & Gas Corporation, Pad ID: StockholmK P2, ABR-201008134.R1, Rush Township, Susquehanna County, Pa.; Consumptive Use of Up to 3.575 mgd; Approval Date: March 30, 2015.
48. Cabot Oil & Gas Corporation, Pad ID: HallidayA P1, ABR-201503005, Bridgewater Township, Susquehanna County, Pa.; Consumptive Use of Up to 4.250 mgd; Approval Date: March 30, 2015.
49. Cabot Oil & Gas Corporation, Pad ID: BolcatoG P1, ABR-201503006, Gibson Township, Susquehanna County, Pa.; Consumptive Use of Up to 4.250 mgd; Approval Date: March 30, 2015.
50. Chesapeake Appalachia, LLC, Pad ID: Lopatofsky NEW, ABR-201007100.R1, Washington Township, Wyoming County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 30, 2015.
51. Chesapeake Appalachia, LLC, Pad ID: Slumber Valley, ABR-201008015.R1, Meshoppen Township, Wyoming County, Pa.; Consumptive Use of Up to 7.500 mgd; Approval Date: March 30, 2015.
52. Chief Oil & Gas, LLC, Pad ID: Allen Drilling Pad #1, ABR-201009002.R1, Asylum Township, Bradford County, Pa.; Consumptive Use of Up to 2.000 mgd; Approval Date: March 30, 2015.
53. Chief Oil & Gas, LLC, Pad ID: Hemlock Hunting Club Drilling Pad #1, ABR-201009070.R1, Elkland Township, Sullivan County, Pa.; Consumptive Use of Up to 2.000 mgd; Approval Date: March 30, 2015.
54. EXCO Resources (PA), LLC, Pad ID: Confer (Pad 32), ABR-20100669.R1, Burnside Township, Centre County, Pa.; Consumptive Use of Up to 3.000 mgd; Approval Date: March 30, 2015.
55. SWEPI LP, Pad ID: Paul 906, ABR-20100314.R1, West Branch Township, Potter County, Pa.; Consumptive Use of Up to 4.990 mgd; Approval Date: March 30, 2015.
56. SWEPI LP, Pad ID: Waskiewicz 445, ABR-20100330.R1, Delmar Township, Tioga County, Pa.; Consumptive Use of Up to 1.000 mgd; Approval Date: March 30, 2015.
57. SWEPI LP, Pad ID: Webster 549, ABR-20100335.R1, Delmar Township, Tioga County, Pa.; Consumptive Use of Up to 1.000 mgd; Approval Date: March 30, 2015.
58. XTO Energy Incorporated, Pad ID: Dietterick, ABR-20100315.R1, Jordan Township, Lycoming County, Pa.; Consumptive Use of Up to 4.000 mgd; Approval Date: March 30, 2015.
Pub. L. 91-575, 84 Stat. 1509,
Federal Highway Administration (FHWA), DOT.
Notice of limitation on claims for judicial review of actions by FHWA and other Federal agencies.
This notice announces actions taken by the FHWA and other Federal agencies that are final within the meaning of 23 U.S.C. 139(l)(1). The actions relate to various proposed highway projects in the State of Colorado. Those actions grant licenses, permits, and approvals for the projects.
By this notice, the FHWA is advising the public of final agency actions subject to 23 U.S.C. 139(l)(1). A claim seeking judicial review of the Federal agency actions on any of the listed highway projects will be barred unless the claim is filed on or before October 13, 2015. If the Federal law that authorizes judicial review of a claim provides a time period of less than 150 days for filing such claim, then that shorter time period still applies.
Stephanie Gibson, Environmental Program Manager, Federal Highway Administration Colorado Division, 12300 W. Dakota Avenue, Lakewood, Colorado 80228, 720-963-3013,
Notice is hereby given that the FHWA and other Federal agencies have taken final agency actions by issuing licenses, permits, and approvals for the highway projects in the State of Colorado that are listed below. The actions by the Federal agencies on a project, and the laws under which such actions were taken, are described in the environmental assessment (EA) or environmental impact statement (EIS) issued in connection with the project and in other key project documents. The EA or EIS, and other key documents for the listed projects are available by contacting the FHWA or the Colorado Department of Transportation at the addresses provided above. The EA, Finding of No Significant Impact (FONSI), Final EIS, and Record of Decision (ROD) documents can be viewed and downloaded from the Web sites listed below.
This notice applies to all Federal agency decisions on each project as of the issuance date of this notice and all laws under which such actions were taken. This notice does not, however, alter or extend the limitation period of 150 days for challenges to final agency actions subject to previous notices published in the
This notice applies to all Federal agency decisions, actions, approvals, licenses and permits on the project as of the issuance date of this notice, including but not limited to those arising under the following laws, as amended:
1. General: National Environmental Policy Act [42 U.S.C. 4321-4370h]; Federal-Aid Highway Act [23 U.S.C. 109].
2. Air: Clean Air Act, as amended [42 U.S.C. 7401-7671(q)] (transportation conformity).
3. Land: Section 4(f) of the Department of Transportation Act of 1966 [49 U.S.C. 303]; Landscaping and Scenic Enhancement (Wildflowers) [23 U.S.C. 319].
4. Wildlife: Endangered Species Act [16 U.S.C. 1531-1544]; Fish and Wildlife Coordination Act [16 U.S.C. 661-667(e)]; Migratory Bird Treaty Act [16 U.S.C. 703-712].
5. Historic and Cultural Resources: Section 106 of the National Historic Preservation Act of 1966 [54 U.S.C. 306108]; Archaeological Resources Protection Act of 1977 [16 U.S.C. 470aa-
6. Social and Economic: Civil Rights Act of 1964 [42 U.S.C. 2000(d)-2000(d)(1)]; American Indian Religious Freedom Act [42 U.S.C. 1996]; Farmland Protection Policy Act [7 U.S.C. 4201-4209]; the Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970 [42 U.S.C. 61].
7. Wetlands and Water Resources: Clean Water Act [33 U.S.C. 1251-1387] (Section 404, Section 401, Section 319); Land and Water Conservation Fund Act [16 U.S.C. 460l-4-460l-11]; Safe Drinking Water Act [42 U.S.C. 300f-300j-9.]; Rivers and Harbors Act of 1899 [33 U.S.C. 401-406]; Transportation Equity Act for the 21st Century (TEA-21) [23 U.S.C. 103(b)(6)(m), 133(b)(11)] (wetlands mitigation banking); Flood Disaster Protection Act of 1973 [42 U.S.C. 4001-4129].
8. Hazardous Materials: Comprehensive Environmental Response, Compensation, and Liability Act [42 U.S.C. 9601-9675]; Superfund Amendments and Reauthorization Act of 1986 [Pub. L. 99-499]; Resource Conservation and Recovery Act [42 U.S.C. 6901-6992(k)].
9. Executive Orders: E.O. 11990 Protection of Wetlands; E.O. 11988 Floodplain Management; E.O. 12898 Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations; E.O. 11593 Protection and Enhancement of Cultural Resources; E.O. 13007 Indian Sacred Sites; E.O. 13287 Preserve America; E.O. 13175 Consultation and Coordination with Indian Tribal Governments; E.O. 11514 Protection and Enhancement of Environmental Quality; E.O. 13112 Invasive Species.
The projects subject to this notice are:
1.
2.
3.
4.
5.
6.
7.
8.
23 U.S.C. 139(l)(1).
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before June 15, 2015.
Comments should refer to docket number MARAD-2015-0059. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Linda Williams, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-0903, Email
As described by the applicant the intended service of the vessel WATERBOUND is:
INTENDED COMMERCIAL USE OF VESSEL: “This waiver will allow only one additional Uninspected Passenger Vessel to begin operations in the Honolulu area. The vessel will only operate part time with not more than 6 passengers. The intended use is sightseeing captained charters, sailing lessons, underwater robotic sightseeing and short term captained charters. I am currently a Ph.D. candidate at the University of Hawaii and will also use the vessel to demonstrate underwater robotics to university students. These activities will supplement my education and income while at UH.”
GEOGRAPHIC REGION: “Hawaii”
The complete application is given in DOT docket MARAD-2015-0059 at
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime
Submit comments on or before June 15, 2015.
Comments should refer to docket number MARAD-2015-0060. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Linda Williams, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-0903, Email
As described by the applicant the intended service of the vessel
The complete application is given in DOT docket MARAD-2015-0060 at
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Maritime Administration (MARAD), DOT.
Notice and request for comments.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Comments must be submitted on or before June 15, 2015.
Michael C. Pucci, (202) 366-5167, Division of Maritime Programs, Maritime Administration, 1200 New Jersey Avenue SE., Washington, DC 20590.
Send comments regarding the burden estimate, including suggestions for reducing the burden, to the Office of Management and Budget, Attention: Desk Officer for the Office of the Secretary of Transportation, 725 17th Street NW., Washington, DC 20503.
Comments are invited on: Whether the proposed collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; the accuracy of the Department's estimate of the burden of the proposed information collection; ways to enhance the quality, utility and clarity of the information to be collected; and ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology.
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended; and 49 CFR 1.93.
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation,
Submit comments on or before June 15, 2015.
Comments should refer to docket number MARAD-2015-0061. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Linda Williams, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-0903, Email
As described by the applicant the intended service of the vessel ZUIMACO is:
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before June 15, 2015.
Comments should refer to docket number MARAD-2015-0057. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Linda Williams, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-0903, Email
As described by the applicant the intended service of the vessel SEA FOX is:
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before June 15, 2015.
Comments should refer to docket number MARAD-2015-0058. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Linda Williams, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-0903, Email
As described by the applicant the intended service of the vessel LIMITLESS is:
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Eighteen Thirty Group, LLC (Eighteen Thirty), a Class III rail carrier, has filed a verified notice of exemption under 49 CFR 1150.41 to acquire from CSX Transportation, Inc. (CSXT) approximately 5.4 miles of rail line in Allegany County, Md., consisting of: (1) Approximately 4.8 miles of CSXT's Georges Creek Subdivision between Barton, approximately milepost BAI 27.0, and Westernport, approximately milepost BAI 31.6; and (2) approximately 0.60 miles of CSXT's Thomas Subdivision, namely the two tracks running parallel to the Thomas mainline track between approximately milepost BAH 26.2 and approximately milepost BAH 26.8.
This transaction is related to a concurrently filed verified notice of exemption in
Eighteen Thirty certifies that: (1) Its projected annual revenues as a result of the transaction will not exceed $5 million and will not result in the creation of a Class II or Class I rail carrier; and (2) the Transaction Agreement between CSXT and Eighteen Thirty, which is dated April 10, 2015, does not contain an interchange commitment.
The transaction may be consummated on or after May 31, 2015, the effective date of the exemption.
If the verified notice contains false or misleading information, the exemption is void
An original and 10 copies of all pleadings, referring to Docket No. FD 35927, must be filed with the Surface Transportation Board, 395 E Street SW., Washington, DC 20423-0001. In addition, a copy of each pleading must be served on Fritz R. Kahn, Fritz R. Kahn, P.C., 1919 M Street NW., 7th Floor, Washington, DC 20036.
Board decisions and notices are available on our Web site at “
By the Board, Joseph H. Dettmar, Acting Director, Office of Proceedings.
San Joaquin Valley Railroad Co. (SJVR), a Class III rail carrier, has filed a verified notice of exemption under 49 CFR 1150.41 to continue to lease from BNSF Railway Company (BNSF) and operate the Landco spur line between the Porterville Subdivision, MP 111+ 4029 feet, near Oil Junction, Cal., and milepost 113 + 3717 feet at or near Bakersfield, Cal., a distance of approximately 2.0 ± miles (the Leased Line).
SJVR states that it has entered into an amendment to extend the term of, and make other minor changes to, the lease, which originally was part of a broader agreement between SJVR's predecessor, Tulare Valley Railroad Company, and BNSF's predecessor, The Atchison, Topeka and Santa Fe Railway Company (ATSF). SJVR states that it will continue to be the operator of the Leased Line.
According to SJVR, the agreement between SJVR and BNSF contains an interchange commitment that affects interchange with carriers other than ATSF, now BNSF. In its verified notice of exemption, SJVR submits a map of the affected interchange points. As required under 49 CFR 1150.43(h)(1), SJVR also provided additional information regarding the interchange commitment.
SJVR has certified that its projected annual revenues as a result of this transaction will not result in its becoming a Class II or Class I rail carrier. However, SJVR's projected annual revenues following this transaction will exceed $5 million. Accordingly, SJVR is required by Board regulations to send notice of the transaction to the national offices of the labor unions with employees on the affected lines at least 60 days before this exemption is to become effective, to post a copy of the notice at the workplace of the employees on the affected lines, and to certify to the Board that it has done so. 49 CFR 1150.42(e).
SJVR, concurrently with its verified notice of exemption, filed a request for waiver of the 60-day advance labor notice requirement under 49 CFR 1150.42(e). In that request SJVR asserts that: (1) No employees of the transferring carrier, BNSF, will be affected by the lease and no employees of BNSF or its predecessor have worked on the Leased Line since 1992; (2) no SJVR employees will be affected by the lease and there will be no operational changes; and (3) posting notices on the Leased Line would be futile because no BNSF employees work on the Leased Line. SJVR's waiver request will be addressed in a separate decision.
SJVR states that it expects to consummate the transaction on the effective date of this exemption. The Board will establish in the decision on the waiver request the earliest date this transaction may be consummated.
If the notice contains false or misleading information, the exemption is void
An original and 10 copies of all pleadings, referring to Docket No. FD 35772, must be filed with the Surface Transportation Board, 395 E Street SW., Washington, DC 20423-0001. In addition, one copy of each pleading must be served on Eric M. Hocky, Clark Hill PLC, One Commerce Square, 2005 Market Street, Suite 1000, Philadelphia, PA 19103.
Board decisions and notices are available on our Web site at
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
Georges Creek Railway, LLC (GCK), a Class III rail carrier, has filed a verified notice of exemption under 49 CFR 1150.41 to operate approximately 5.4 miles of rail line currently owned by CSX Transportation, Inc. (CSXT) in Allegany County, Md., consisting of: (1) Approximately 4.8 miles of CSXT's Georges Creek Subdivision between Barton, approximately milepost BAI 27.0, and Westernport, approximately milepost BAI 31.6; and (2) approximately 0.60 miles of CSXT's Thomas Subdivision, namely the two tracks running parallel to the Thomas mainline track between approximately milepost BAH 26.2 and approximately milepost BAH 26.8.
This transaction is related to a concurrently filed verified notice of exemption in
GCK certifies that: (1) Its projected annual revenues as a result of the transaction will not exceed $5 million and will not result in the creation of a Class II or Class I rail carrier; and (2) the Transaction Agreement between CSXT and Eighteen Thirty, which is dated April 10, 2015, does not contain an interchange commitment.
The transaction may be consummated on or after May 31, 2015, the effective date of the exemption.
If the verified notice contains false or misleading information, the exemption is void
An original and 10 copies of all pleadings, referring to Docket No. FD 35928, must be filed with the Surface Transportation Board, 395 E Street SW., Washington, DC 20423-0001. In addition, a copy of each pleading must be served on Fritz R. Kahn, Fritz R. Kahn, P.C., 1919 M Street NW., 7th Floor, Washington, DC 20036.
Board decisions and notices are available on our Web site at
By the Board, Joseph H. Dettmar, Acting Director, Office of Proceedings.
Request for Citizens Coinage Advisory Committee Membership Applications.
Pursuant to United States Code, Title 31, section 5135 (b), the United States Mint is accepting applications for appointment to the Citizens Coinage Advisory Committee (CCAC) as a member representing the
Advise the Secretary of the Treasury on any theme or design proposals relating to circulating coinage, bullion coinage, Congressional Gold Medals, and national and other medals produced by the United States Mint.
Advise the Secretary of the Treasury with regard to the events, persons, or places that the CCAC recommends to be commemorated by the issuance of commemorative coins in each of the five calendar years succeeding the year in which a commemorative coin designation is made.
Make recommendations with respect to the mintage level for any commemorative coin recommended.
Total membership consists of 11 voting members appointed by the Secretary of the Treasury:
One person specially qualified by virtue of his or her education, training, or experience as nationally or internationally recognized curator in the United States of a numismatic collection;
One person specially qualified by virtue of his or her experience in the medallic arts or sculpture;
One person specially qualified by virtue of his or her education, training, or experience in American history;
One person specially qualified by virtue of his or her education, training, or experience in numismatics;
Three persons who can represent the interests of the general public in the coinage of the United States; and
Four persons appointed by the Secretary of the Treasury on the basis of the recommendations by the House and Senate leadership.
Members are appointed for a term of four years. No individual may be appointed to the CCAC while serving as an officer or employee of the Federal Government.
The CCAC is subject to the direction of the Secretary of the Treasury. Meetings of the CCAC are open to the public and are held approximately five to seven times per year. The United States Mint is responsible for providing the necessary support, technical services, and advice to the CCAC. CCAC members are not paid for their time or services, but, consistent with Federal Travel Regulations, members are reimbursed for their travel and lodging expenses to attend meetings. Members are Special Government Employees and are subject to the Standards of Ethical Conduct for Employees of the Executive Branch (5 CFR part 2653).
The United States Mint will review all submissions and will forward its recommendations to the Secretary of the Treasury for appointment consideration. Candidates should include specific skills, abilities, talents, and credentials to support their applications. The United States Mint is interested in candidates who are recognized as having unique and valued talents or as an accomplished professional; have demonstrated experience, knowledge, interest or background in a variety of fields, including numismatics, art, education, working with youth, or American heritage and culture; have demonstrated interest and a commitment to actively participate in CCAC meetings and activities, and a demonstrated understanding of the role of the CCAC and the obligations of a Special Government Employee; possess demonstrated leadership skills in their fields of expertise or discipline; possess a demonstrated desire for public service; and have a history of honorable professional and personal conduct, as well as successful standing in their communities; and who are free of professional, political, or financial interests that could negatively affect their ability to provide impartial advice.
First-class mail to the United States Mint is put through an irradiation process to protect against biological contamination. Support materials put through this process may suffer irreversible damage. We encourage you to consider using alternate delivery services, especially when sending time-sensitive material.
William Norton, United States Mint Liaison to the CCAC; 801 9th Street NW., Washington, DC 20220, or call 202-354-7458.
Pursuant to United States Code, Title 31, section 5135(b)(8)(C), the United States Mint announces the Citizens Coinage Advisory Committee (CCAC) public meeting scheduled for June 16-17, 2015.
In accordance with 31 U.S.C. 5135, the CCAC:
Advises the Secretary of the Treasury on any theme or design proposals relating to circulating coinage, bullion coinage, Congressional Gold Medals, and national and other medals.
Advises the Secretary of the Treasury with regard to the events, persons, or places to be commemorated by the issuance of commemorative coins in each of the five calendar years succeeding the year in which a commemorative coin designation is made.
Makes recommendations with respect to the mintage level for any commemorative coin recommended.
William Norton, United States Mint Liaison to the CCAC; 801 9th Street NW., Washington, DC 20220; or call 202-354-7200.
Any member of the public interested in submitting matters for the CCAC's consideration is invited to submit them by fax to the following number: 202-756-6525.
31 U.S.C. 5135(b)(8)(C).
Veterans Health Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Health Administration (VHA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and includes the actual data collection instrument.
Written comments and recommendations on the proposed collection of information should be received on or before June 15, 2015.
Submit written comments on the collection of information through
Crystal Rennie, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 632-7492 or email
Under the PRA of 1995 (Public Law 104-13; 44 U.S.C. 3501-3521), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VHA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VHA's functions, including whether the information will have practical utility; (2) the accuracy of VHA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary:
Office of Acquisition and Logistics, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that The Office of Operations, Security, and Preparedness, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Comments must be submitted on or before June 15, 2015.
Submit written comments on the collection of information through
Crystal Rennie, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 632-7492 or email
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before June 15, 2015.
Submit written comments on the collection of information through
Crystal Rennie, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 632-7492 or email
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501—3521), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
a. Notice of Lapse—Government Life Insurance, VA Form 29-389.
b. Application for Reinstatement, VA Form 29-389-1.
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
a. VA Form 29-389—3,399 hours.
b. VA Form 29-389-1—1,060 hours.
a. VA Form 29-389—12 minutes.
b. VA Form 29-389-1—10 minutes.
a. VA Form 29-389—16,993.
b. VA Form 29-389-1—6,359.
By direction of the Secretary.
Substance Abuse and Mental Health Services Administration (SAMHSA), HHS.
Notice of the mandatory guidelines proposed by the Secretary of Health and Human Services.
The Department of Health and Human Services (“HHS” or “Department”) is proposing to establish scientific and technical guidelines for the inclusion of oral fluid specimens in the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Guidelines).
Submit comments on or before July 14, 2015.
In commenting, please refer to file code SAMHSA-2015-2. Because of staff and resource limitations, SAMHSA cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one of the ways listed):
•
•
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Charles LoDico, M.S., DABFT, Division of Workplace Programs, Center for Substance Abuse Prevention (CSAP), SAMHSA mail to: 1 Choke Cherry Road, Room 7-1045, Rockville, MD 20850, telephone (240) 276-2600, fax (240) 276-2610, or email at
This notice of proposed revisions to the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Guidelines) will allow federal executive branch agencies to collect and test an oral fluid specimen as part of their drug testing programs. In addition, some agencies, such as the Department of Transportation, are required to follow these guidelines in developing drug testing programs for their regulated industries, whereas others, such as the Nuclear Regulatory Commission (NRC), use the guidelines as part of the regulatory basis for their federal drug testing programs. These proposed Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) establish standards and technical requirements for oral fluid collection devices, initial oral fluid drug test analytes and methods, confirmatory oral fluid drug test analytes and methods, processes for review by a Medical Review Officer (MRO), and requirements for federal agency actions.
These Guidelines provide flexibility for federal agency workplace drug testing programs to address testing needs and remove the requirement to collect only a urine specimen, which has existed since the Guidelines were first published in 1988. Federal agencies, MROs, and regulated industries using these Guidelines will continue to adhere to all other federal standards established for workplace drug testing programs. These proposed OFMG provide the same scientific and forensic supportability of drug test results as the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (URMG).
The Department of Health and Human Services, by authority of Section 503 of Public Law 100-71, 5 U.S.C. Section 7301, and Executive Order No. 12564, establishes the scientific and technical guidelines for federal workplace drug testing programs and establishes standards for certification of laboratories engaged in urine drug testing for federal agencies. These proposed OFMG establish standards for certification of laboratories engaged in oral fluid drug testing for federal agencies and the use of oral fluid testing in federal drug-free workplace programs.
The promulgation of the OFMG allows federal agencies to collect and test oral fluid specimens in their workplace drug testing programs. The collection process for oral fluids provides that the specimen collection will be under observation. The OFMG enable split specimen testing by requiring two specimens to be obtained from the donor, either concurrently or serially, using separate collection devices or a single collection device that can be split into two separate specimens. Unlike the urine Mandatory Guidelines for Federal Workplace Drug Testing Programs (UrMG), Instrumented Initial Test Facilities are not practical and will not be allowed due primarily to the limited sample volume of oral fluid collected from the donor. With the exception of 6-acetylmorphine, a metabolite of heroin, and benzoylecgonine, a metabolite of cocaine, the analytes detected in oral fluids are primarily parent compounds. The OFMG analyte cutoffs are much lower than those specified for urine in the UrMG because drug analyte concentrations in oral fluid are much lower than urine concentrations. The Department is proposing that all specimens be tested for either albumin or Immunoglobulin G (IgG) to determine whether the specimen is valid. In the event that an individual is unable to provide an oral fluid specimen, the federal agency may authorize the collection of a urine specimen. With the inclusion of oral fluid testing in federal agency workplace programs, medical review of drug test results will become more complex. The MRO must interpret laboratory reported drug test results for both urine and oral fluid specimens. To ensure that MROs remain up-to-date on drug testing issues, pharmacological and toxicological information, and federal agency rules and regulations, the OFMG require MRO requalification training and reexamination on a regular basis (
Using data obtained from the Federal Workplace Drug Testing Programs and HHS certified laboratories, the Department estimates the number of specimens tested annually for federal
In Section 3.4, the Department is proposing criteria for calibrating initial tests for grouped analytes such as opiates and amphetamines, and specifying the cross-reactivity of the immunoassay to the other analytes(s) within the group. These proposed Guidelines allow the use of methods other than immunoassay for initial testing. In addition, these proposed Guidelines include an alternative for laboratories to continue to use existing FDA-cleared immunoassays which do not have the specified cross-reactivity, by establishing a decision point with the lowest-reacting analyte. An immunoassay manufacturer may incur costs if they choose to alter their existing product and resubmit the immunoassay for FDA clearance.
Costs associated with the addition of oral fluid testing and testing for oxycodone, oxymorphone, hydrocodone and hydromorphone will be minimal based on information from some HHS certified laboratories currently testing non-regulated oral fluid specimens. Likewise, there will be minimal costs associated with changing initial testing to include methylenedioxyamphetamine (MDA) and methylenedioxyethylamphetamine (MDEA) since current immunoassays can be adapted to test for these analytes. Prior to being allowed to test regulated oral fluid specimens, laboratories must be certified by the Department through the National Laboratory Certification Program (NLCP). Laboratories choosing to apply for HHS certification will incur some administrative costs associated with adding the matrix and these analytes. However, laboratories performing urine and oral fluid drug testing have trained personnel, drug testing methods, and the infrastructure (
The following estimated costs are based on current costs for urine testing. Once oral fluid testing has been implemented, the cost per specimen for each initial test will range from $.06 to $0.20, due to reagent costs. Estimated costs for each confirmatory test range from $5.00 to $10.00 for each specimen reported as positive, due to costs of sample preparation and analysis. Based on information from non-regulated workplace drug testing, approximately 1% of the submitted specimens is expected to be confirmed as positive for one or more of the following analytes: Oxycodone, oxymorphone, hydrocodone, and/or hydromorphone. Therefore, the added cost for confirmatory testing will be $0.05 to $0.10 per submitted specimen. This would indicate that the total cost per specimen submitted for testing will increase by $0.11-$0.30. These costs for the laboratories or federal agencies choosing to use oral fluid in their drug testing programs will be incorporated into the overall testing cost for the federal agency submitting the specimen to the laboratory. Agencies choosing to use oral fluid in their drug testing programs may also incur some costs for training of federal employees such as drug program coordinators.
Based on current figures, approximately 7% (or 10,500) of the 150,000 specimens tested per year for HHS will be oral fluid, 180,000 oral fluid specimens for DOT, and 14,000 oral fluid specimens for NRC.
The federal agencies choosing to use oral fluid in their drug testing program may see many benefits including a reduction in time of the collection process; an observed collection method leading to reductions in rejected, invalid, substituted, and adulterated specimens; and an effective tool in post-accident testing identifying the parent or active drug. Productivity for federal agencies related to the drug free workplace program is expected to improve. For example, administrative data indicates it takes, on average, about 4 hours from the start of the notification of the drug test to the actual time a donor reports back to the worksite. Since oral fluid collection does not have the same privacy concerns as urine collection, onsite collections are likely, thereby reducing the time a donor is away from the worksite. The Department estimates the time savings to be between 1 and 3 hours. The Department believes the cost reduction as outlined in this Preamble will benefit the federal agencies and drug free workplace program.
The Department of Health and Human Services (HHS) by the authority of Section 503 of Public Law 100-71, 5 U.S.C. Section 7301, and Executive Order No. 12564 has established the scientific and technical guidelines for federal workplace drug testing programs and established standards for certification of laboratories engaged in urine drug testing for federal agencies. As required, HHS originally published the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Guidelines) in the
A focus of the HHS mission is to maintain the integrity and ensure the quality of federal drug-free workplace programs by a commitment to identify and mandate the use of the most accurate, reliable drug tests and methods available. To accomplish that goal, the Department has implemented an ongoing scientific review and program collaboration with federal regulators, researchers, the drug testing industry, and public and private sector employers. As the use of alternative specimens (other than urine), analytical test technologies, and types of commercial workplace drug testing products have increased over the past decade in the private sector, the Department, through SAMHSA's Drug Testing Advisory Board (DTAB), has responded by review of these new products and began a dedicated assessment of drug testing using alternative specimens, such as oral fluid (saliva), hair and sweat for possible application in federal agency workplace testing programs.
The following OFMG are the result of a directed Departmental assessment that began in 1997 with a 3-day scientific meeting of the DTAB. During that meeting, the DTAB members discussed drug testing using alternative specimens and the use of new and developing drug testing technologies that could be applicable to workplace drug testing programs. The DTAB meeting was open to the public. Following the initial meeting, members of the DTAB continued to review and analyze all available information on alternative specimens and testing technologies. These efforts resulted in identifying specific scientific, administrative, and procedural requirements necessary for a comprehensive federal workplace drug testing program that included alternative specimens and technologies.
For more than 15 years, the DTAB has continued to evaluate the science and information submitted by industry representatives on alternative specimens and technologies. The following section presents a chronology of meetings and events leading to these proposed Guidelines for the testing of oral fluid.
The first working draft of new guidelines, including the testing of alternative specimens, was presented at the June 2000 DTAB meeting. These initial, “work-in-progress” guidelines were placed on the SAMHSA Web site and the public was invited to submit supplemental information and informal comments to improve the draft and further SAMHSA's knowledge base. Twenty-eight separate comments were submitted. All comments were summarized, incorporated into the draft Guidelines and presented at the next DTAB meeting held in September 2000. At that DTAB meeting, a second working (revised) draft of the Guidelines was presented and, again, comments were requested from all interested parties. At the December 2000 DTAB meeting, the public comments submitted were used to prepare the third working draft of the Guidelines. Concurrently, SAMHSA organized three expert groups [Oral Fluid, Hair, and Sweat] that included members from science and industry.
To assess laboratory performance and utility of alternative specimen testing for use in federal workplace programs, the Department initiated a voluntary pilot proficiency testing (PT) program. This pilot program provides PT samples, developed and prepared at government expense, to a number of laboratories for testing. Participating laboratories used their routine procedures to test oral fluid, hair and sweat specimens and shared their PT results with SAMHSA. This pilot PT program was established for two reasons. The first was to determine if it was possible to prepare stable and accurate PT samples for the proposed specimen type that could be used in a laboratory certification program. Second, the PT results reported by the laboratories could be used to help establish criteria for the analysis of alternative specimens.
Based on data obtained from the pilot PT program, it appeared that valid PT samples could be prepared but refinement was needed. The results in the pilot PT program were encouraging, and both individual laboratory and collective performance improved over time; however, there remained some concern about the performance differences among the participating laboratories, and the applicability of some testing technologies used by the laboratories. By 2004, the working groups reached consensus and proposed standards for laboratory-based oral fluid, hair, and sweat testing procedures.
In April 2004, the Department issued a
The complexity of responses to the 2004 notice made it clear that if the Department were to subsequently authorize alternative specimens for the Mandatory Guidelines for Federal Workplace Drug Testing Programs, each specimen matrix would need a separate set of guidelines. Additionally, the Department proposed to stagger the timeline for the review and potential incorporation of alternative specimens, and to begin with oral fluid. The decision to begin with oral fluid was supported by fewer legal and policy concerns, and current peer-reviewed literature that existed with oral fluid.
Methods developed since 2004 offer enhanced analytical sensitivity and specificity for testing drugs in oral fluid. The scientific literature base for oral fluid testing and interpretation of results has grown substantially. Many non-regulated private sector organizations have incorporated oral fluid testing into their workplace programs. Also, during this period, SAMHSA funded a review of a Medical Review Officer (MRO) database of laboratory-reported results for urine and alternative specimens from both regulated and non-regulated workplaces. The study showed a dramatic increase in the use of oral fluid testing from 2003 to 2009.
At the open session of the January 2011 DTAB meeting, SAMHSA shared with DTAB and the public the most current information on the oral fluid specimen. During the meeting, experts made scientific presentations concerning oral fluid as a specimen for workplace drug testing, including: Physiological composition of oral fluid, tested drugs and cutoffs, collection devices, and best practices laboratory methodologies (initial and confirmatory testing). At approximately the same time, SAMHSA entered into an Interagency Agreement (IAA) with the Office of National Drug Control Policy (ONDCP) and received funding to update and expand the laboratory standards for federal forensic drug testing. The overall goal of this IAA was
Subsequent to the IAA and the January 2011 DTAB meeting, several working group meetings were held to discuss the oral fluid science and develop proposed Guidelines using oral fluid specimens. Working group members included federal partners, subject matter experts, industry leaders, stakeholders, and representatives from the National Laboratory Certification Program (NLCP).
In June 2011, SAMHSA solicited comments regarding the science and practice of oral fluid testing via a Request for Information (RFI) [76 FR 34086]. The notice requested written opinions from the public and industry stakeholders regarding a variety of issues related to oral fluid testing, including potential analytes, cutoff concentrations, specimen validity, specimen collection, collection devices, testing methods and interpretation of analytical results. The RFI was an effort to give the public and industry stakeholders an additional opportunity to provide information and comments for consideration during the development of the draft Guidelines for oral fluid testing. The Department received 18 comments from drug testing laboratories, MROs, oral fluid collection device manufacturers, drug testing industry associations, and the public [available at
At the July 2011 meeting of the DTAB, Board members voted unanimously for the following:
(1) Based on review of the science, DTAB recommends that SAMHSA include oral fluid as an alternative specimen in the Mandatory Guidelines for Federal Workplace Drug Testing Programs; and (2) DTAB recommends the inclusion of additional Schedule II prescription medications (
At the January 2012 DTAB meeting, the SAMHSA Administrator received the DTAB recommendations from the July 2011 meeting.
The DTAB recommendations, the results from the SAMHSA-funded PT program, and the private sector experience have led the Department to conclude that oral fluid should be included in the federal program as an alternative specimen.
The scientific basis for use of oral fluid as an alternative specimen for drug testing has been broadly established.
Oral fluid and urine test results have been shown to be substantially similar, and oral fluid may have some inherent advantages as a drug test specimen. Oral fluid collection will occur under observation, which should substantially lessen the risk of specimen substitution and adulteration and, unlike direct observed urine collections, the collector need not be the same gender as the donor.
Oral fluid is the physiological fluid that can be collected from the oral cavity of the mouth. Oral fluid is comprised primarily of saliva produced by the submandibular, sublingual, and parotid glands.
Drugs enter oral fluid primarily by diffusion from blood and from active drug use by oral, transmucosal, smoked, inhaled, and insufflated routes. Oral cavity tissues have a rich blood supply. The movement of drugs from blood (plasma) to oral fluid depends upon certain physicochemical properties of the drug. The primary restricting factors are drug lipophilicity, degree of ionization, and the degree of drug binding with plasma proteins.
Deposition of drugs in oral fluid can also occur from external sources. For example, drugs in food sources (
Detection times are influenced by many pharmacological and chemical factors associated with the drug, dose, route of administration, frequency of drug use, biology of the individual, specimen type, and the sensitivity of the detection system. In general, detection times in oral fluid are somewhat shorter
In the absence of paired specimen collections (
The workplace positivity rates for drugs in oral fluid appear to be generally comparable to corresponding rates reported for urine. The 2013 Drug Testing Index (DTI) by Quest Diagnostics for drugs in the general workforce indicated positivity rates for oral fluid as 0.59 percent amphetamines (combined percentages of amphetamine and methamphetamine), 0.31 percent cocaine, 4.0 percent marijuana, 0.88 percent opiates, and 0.02 percent PCP and, for urine, as 0.87 percent amphetamines, 0.21 percent cocaine, 2.0 percent marijuana, 0.44 percent opiates and 0.01 percent PCP.
Only limited studies have compared positivity rates from “paired” specimen collections in the same population. A clinical study involving compliance monitoring of pain patients compared test results for oral fluid to urine specimens collected in “near simultaneous fashion.”
Another study compared positivity rates from paired specimens from 45 subjects (164 paired sets of specimens) of treatment patients stabilized on either methadone or buprenorphine.
Several studies have been reported comparing oral fluid testing to urinalysis for individuals under criminal justice supervision.
The selection of analytes for testing was based on known drug disposition patterns in oral fluid. Some drug disposition patterns in oral fluid are similar to urine and others differ in relative amounts of parent drug versus metabolite and in type of metabolite. The mechanisms of drug excretion in oral fluid are somewhat different than in urine. In some cases, direct deposition of parent drug in oral fluid may occur by oral, snorted (insufflated), transmucosal, inhaled, and smoked routes of administration. When this occurs, the metabolites generally appear later in oral fluid. For some drugs (
The route of administration influences the time course of both drug and metabolites in oral fluid.
In regard to specimen validity testing for oral fluid, the Department considered measuring various oral fluid components (
Review of the literature for concentrations of albumin in oral fluid found that healthy subjects were characterized by concentrations ranging from 2.6-23.8 mg/dL
Literature concerning the concentrations of IgG in oral fluid found that only predentate babies exhibited IgG concentrations below 1 mg/L.
To avoid prohibiting other oral fluid specimen validity tests that may become available, the Department is also authorizing additional specimen validity testing as described in Section 3.1.d and Section 3.5.
The Department maintains that allowing tests for biomarkers other than albumin and IgG can be useful. The draft OFMG requirements are analogous to the current urine drug testing requirements in that laboratories
The Department recognizes that methods for collection of oral fluid specimens vary by manufacturers of devices and that new, innovative methods may be developed that offer improvements over existing methods. Two basic types of collection devices currently exist: One is designed to collect undiluted (neat) oral fluid by expectoration; the second type makes use of an absorbent pad that is inserted into the oral cavity for specimen collection and then placed in a tube containing a diluent. The Department is recommending that all collection devices maintain the integrity of the specimen during collection, storage and transport to the laboratory for testing. All devices must have an indicator that demonstrates the adequacy of the volume of collected specimen; have a sealable, non-leaking container; and have components that ensure pre-analytical drug and drug metabolite stability; and the device components must not substantially affect the composition of drugs and drug metabolites in the oral fluid specimen.
The Department proposes that a collection device should collect either a minimum of 1 mL of undiluted (neat) oral fluid or, for those collection devices containing a diluent (or other component, process, or method that modifies the volume of the specimen), that the volume of oral fluid collected should be within 0.1 mL of the target volume and the volume of diluent in the device should be within 0.05 mL of the diluent target volume. The Department recommends that the device maintain stability of drug and/or drug metabolite in the oral fluid specimen allowing ≥90 percent recovery for one week at room temperature (18-25 °C). To ensure that collection device components do not substantially affect the composition of drugs and/or drug metabolites in the oral fluid specimen, the Department recommends that the device performance characteristics are such that there is ≥90 percent recovery (but no more than 120 percent) of drug and/or drug metabolite in the undiluted (neat) oral fluid at (or near) the initial test cutoff concentration. The established upper range is to minimize a collection device concentrating the specimen on the collection pad and/or the device. Numerous studies of stability and recovery of drugs from commercial oral fluid collection devices indicate wide variability in performance characteristics.
The Department notes that these collection devices are subject to clearance by the FDA. The Department requests comments on whether HHS should publish a list of FDA-cleared oral fluid collection devices.
The Department is recommending that a split specimen be collected either (1) as two specimens collected simultaneously or serially with two separate collection devices, or (2) collected with a collection device that subdivides the specimen into two separate collection tubes. If collected serially, collection of the second specimen must begin within two minutes after the completion of the first collection. The Department believes this allows sufficient time for the collector to begin the second specimen collection in a timely manner, to minimize differences in oral fluid collected using two separate collection devices. Oral fluid test results for delta-9-tetrahydrocannabinol (THC) in simultaneously collected specimens with an absorbent pad have been reported to be highly correlated.
In addition, the Omnibus Transportation Employee Testing Act (OTETA), which governs the DOT-regulated testing programs as well as the Federal Aviation Administration's federal employee testing program, requires that collected specimens must be able to be subdivided, to allow for additional testing upon request of the employee.
Therefore, the Department requests comments on whether serial or simultaneous collection using two collection devices constitutes a split
Since the late 1980's, multiple recommendations have been made that additional drugs be considered for inclusion in workplace drug testing. These recommendations resulted in the Ecstasy-related drugs—methylenedioxymethamphetamine (MDMA), methylenedioxyamphetamine (MDA), and methylenedioxyethylamphetamine (MDEA)—being included for testing in 2008. The 2012 National Survey on Drug Use and Health (NSDUH) indicated that past month illicit drug use of psychotherapeutics was second only to marijuana in prevalence among persons aged 12 or older in the United States. Prescription psychotherapeutics include pain relievers, tranquilizers, stimulants, and sedatives.
Like heroin, many are derived from opium, but are synthetic analogs. Oxycodone and hydrocodone top the list of narcotic pain relievers causing visits to hospital emergency departments due to non-medical use,
Hydrocodone is metabolized in the body to hydromorphone and excreted in biological fluids.
In accordance with the current practice, an HHS contractor will perform certain functions on behalf of the Department. These functions include maintaining laboratory inspection and PT programs that satisfy the requirements described in the Guidelines. These activities include, but are not limited to, reviewing inspection reports submitted by inspectors, reviewing PT results submitted by laboratories, preparing inspection and PT result reports, and making recommendations to the Department regarding certification or suspension/revocation of laboratories' certification. It is important to note that, although a contractor gathers and evaluates information provided by the inspectors or laboratories, all final decisions regarding laboratory certification, suspension or revocation of certification are made by the Secretary.
In addition, a contractor has historically collected certain fees from the laboratories for services related to the certification process, specifically for laboratory application and inspection and PT activities for laboratories applying to become HHS-certified, and for inspection and PT activities for laboratories maintaining HHS certification. All fees collected by a contractor are applied to its costs under the contract.
This same process, used since the inception of the laboratory certification program, will also be used by an HHS contractor to collect similar fees from laboratories that seek, achieve, and continue HHS certification to test oral fluid. The Department also contributes funds to this contract for purposes not directly related to laboratory certification activities, such as evaluating technologies and instruments and providing an assessment of their potential applicability to workplace drug testing programs.
This preamble describes the differences between the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine Specimens (UrMG) and the proposed Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid Specimens (OFMG), and provides the rationale for the differences. In addition, the Preamble presents a number of the remaining issues raised during the development of Guidelines for oral fluid drug testing. The issues are organized and presented first in summary as they appear in the text of the proposed OFMG and later as issues of special interest for which the Department is seeking specific public comment.
Sections 1.1, 1.2, 1.3, and 1.4 contain the same policies as described in the current UrMG with regard to who is covered by the Guidelines, who is responsible for the development and implementation of the Guidelines, how a federal agency requests a change from these Guidelines and how these Guidelines are revised.
In section 1.5, where terms are defined, the Department proposes to add terms that apply specifically to oral fluid (
Sections 1.6, 1.7, and 1.8 contain the same policies as described in the current UrMG with regard to what an agency is required to do to protect employee records, the conditions that constitute refusal to take a federally regulated drug test, and the consequences of a refusal to take a federally regulated drug test.
In section 2.1, the Department proposes to expand the drug-testing program for federal agencies to permit the use of oral fluid specimens. There is no requirement for federal agencies to use oral fluid as part of their program. A federal agency may choose to use urine, oral fluid, or both specimen types in their drug testing program. However, any agency choosing to use oral fluid is required to follow the OFMG. For example, an agency program can randomly assign individuals to either urine or OF testing, for random or pre-employment testing. This would not only help reduce subversion, but would allow comparison of urine and OF testing outcomes for planning purposes.
Section 2.2 describes the circumstances under which an oral fluid specimen may be collected. The Department has included this section to ensure that the circumstances described are consistent with the reasons for collecting a specimen as listed on the Federal Custody and Control Form (Federal CCF). The Department will review comments on the reasons that are appropriate for oral fluid testing.
Section 2.3 describes how each oral fluid specimen is collected for testing. The Department is seeking comment on whether the described procedures are consistent with the established requirement for all specimens to be collected as a split specimen and recommendations for other processes that enable subdividing the collected specimen.
Section 2.4 establishes a known volume that must be collected for each specimen.
Section 2.5 describes how a split oral fluid specimen is collected.
Section 2.6 clarifies that all entities and individuals identified in Section 1.1 of these Guidelines are prohibited from
While these Guidelines do not authorize the release of specimens, or portions thereof, to federal employees, the Guidelines afford employees a variety of protections that ensure the identity, security and integrity of their specimens from the time of collection through final disposition of the specimen. There are also procedures that allow federal employees to request the retesting of their specimen (for drugs or adulteration) at a different certified laboratory. Furthermore, the Guidelines grant federal employees access to a wide variety of information and records related to the testing of their specimens, including a documentation package that includes, among other items, a copy of the Federal CCF with any attachments, internal chain of custody records for the specimen, and any memoranda generated by the laboratory.
Therefore, the Guidelines offer federal employees and federal agencies transparent and definitive evidence of a specimen's identity, security, control and chain of custody. However, the Guidelines do not entitle employees access to the specimen itself or to a portion thereof. The reason for this prohibition is that specimens collected under the Guidelines are uniquely designed for the purpose of drug and validity testing only. They are not designed for other purposes such as deoxyribonucleic acid (DNA) testing. Furthermore, conducting additional testing outside the parameters of the Guidelines would not guarantee incorporation of the safeguards, quality control protocols, and the exacting scientific standards developed under the Guidelines to ensure the security, reliability and accuracy of the drug testing process.
Section 3.1 describes the tests to be performed on each oral fluid specimen. This is the same policy that is in the current UrMG regarding which drug tests must be performed on a specimen. A federal agency is required to test all specimens for marijuana and cocaine and is authorized to also test specimens for opiates, amphetamines, and phencyclidine. The Department realizes that most federal agencies typically test for all five drug classes authorized by the existing Guidelines, but has not made this a mandatory requirement, and will continue to rely on the individual agencies and departments to determine their testing needs above the required minimum. The Department included requirements for federal agencies to test all oral fluid specimens for either albumin or IgG to determine specimen validity, but specifically requests public comment on requiring these tests.
The policy in section 3.2 is the same as that for urine testing. Any federal agency that wishes to routinely test its specimens for any drug not included in the Guidelines must obtain approval from the Department before expanding its program. A specimen may be tested for any drug listed in Schedule I or II of the Controlled Substances Act when there is reasonable suspicion/cause to believe that a donor may have used a drug not included in these Guidelines. When reasonable suspicion/cause exists to test for another drug, the federal agency must document the possibility that the use of another drug exists, attach the documentation to the original Federal CCF, and ensure that the HHS-certified laboratory has the capability to test for the additional drug. The HHS-certified laboratory performing such additional testing must validate the test methods and meet the quality control requirements as described in the Guidelines for the other drug analyses.
Section 3.3 states that specimens must only be tested for drugs and to determine their validity in accordance with Subpart C of these Guidelines. Additional explanation is provided above, in comments for Section 2.6.
Section 3.4 lists the proposed analytes and cutoff concentrations for undiluted (neat) oral fluid. The table in Section 3.4 specifies both initial and confirmatory cutoff concentrations for each drug test analyte. Footnote 2 of the table addresses requirements that differ for initial tests using immunoassay-based technology and those using an “alternate” technology. Over the last 5 years, technological advances have been made to techniques (
Considerable research and discussion were conducted regarding the complex issues surrounding the specification of each cutoff concentration. The Department solicited input from laboratories, reagent and device manufacturers, subject matter experts, and the Food and Drug Administration (FDA). The cutoff concentrations are the outcome of the lengthy discussion process and represent the best approach currently available. The proposed analytes follow:
The Department is proposing to test for delta-9-tetrahydrocannabinol (THC) using a 4 ng/mL cutoff concentration for the initial test. For the confirmatory test, the Department is proposing to test for THC using a 2 ng/mL cutoff concentration.
Marijuana (cannabis) continues to be the most prevalent drug of abuse in the U.S. THC is the primary psychoactive ingredient of marijuana and is rapidly transferred from the lungs to blood during smoking.
Positive prevalence rates for THC in oral fluid specimens collected from workplace drug testing programs appear to be comparable or greater than 11-nor-delta-9-tetrahydrocannabinol-9-carboxylic acid (THCA) rates for urine drug testing in the general workforce. A 2002 study of 77,218 oral fluid specimens revealed a positive prevalence of 3.22 percent compared to a 3.17 percent positivity rate for more than 5,200,000 urine specimens collected during the same period.
Once absorbed and distributed to tissues, THC is ultimately transformed by oxidative metabolic enzymes to THCA. Further metabolism of THCA leads to formation of a glucuronide
In contrast to urine, there is a paucity of scientific data on the time course of excretion or the detection window of THC, THCA, and conjugated THCA in oral fluid following marijuana use.
The proposed initial test cutoff for THC (4 ng/mL) and confirmatory test cutoff for THC (2 ng/mL) are the same as those proposed in the 2004 Guidelines. The detection time for THC in oral fluid appears to be shorter than the detection time for THCA in urine;
The Department had considered proposing to test for THCA (
Currently, few laboratories perform confirmatory testing for THCA in oral fluid testing. Thus, there is limited data on the positivity rates for these analytes in a workplace population. In a study of 143 specimens positive by immunoassay using the proposed 4 ng/mL initial test cutoff,
Also, testing for THCA requires a larger sample volume than testing for THC. This may affect the ability of a laboratory to perform additional testing as required. To avoid the risk of positive test results from passive exposure, some investigators have recommended that THCA be included in confirmatory testing.
A number of passive exposure studies have been conducted under a variety of exposure conditions.
The Department is not aware of any studies that demonstrate passive exposure causing a positive oral fluid THC result when the donor would not be aware of that exposure. Nor does there appear to be evidence that incidental exposure to marijuana smoke can cause an oral fluid specimen to be reported positive for THC using the proposed cutoff levels. Therefore, passive exposure would not be a reasonable defense for a positive result for THC in oral fluid testing.
The Department recognizes that THCA testing may be useful, because THC and THCA may be present singly or in combination in a marijuana user's oral fluid specimen depending on the length of time between use and collection. However, Current technology for conducting a confirmatory test for THCA at pg/mL concentrations requires the use of specialized materials, instrumentation, and methods.
The Department is proposing to test for cocaine/benzoylecgonine using an initial cutoff concentration of 15 ng/mL and 8 ng/mL for the confirmatory cutoff concentrations. Cocaine appears in oral fluid within minutes after use following intravenous, nasal and smoked administration.
An immunoassay initial test for cocaine/benzoylecgonine should be calibrated with one of the two analytes and demonstrate sufficient cross-reactivity with the other analyte. The Department recommends that the minimum cross-reactivity with either analyte be 80 percent or greater. If an alternate technology initial test is performed instead of immunoassay, either one or both analytes in the group should be used to calibrate, depending on the technology. The quantitative sum of the two analytes must be equal to or greater than 15 ng/mL. The quantitative sum of the two analytes must be based on quantitative values for each analyte that are equal to or above the laboratory's validated limit of quantification.
The 8 ng/mL confirmatory test cutoff concentration applies equally to cocaine and benzoylecgonine. A positive test would be comprised of either or both analytes with a confirmed concentration equal to or greater than 8 ng/mL.
The Department is proposing to test for codeine/morphine using a 30 ng/mL cutoff concentration for the initial test and 15 ng/mL for the confirmatory test cutoff concentrations. After single oral use, codeine has been reported to appear in oral fluid within an hour, quickly reach maximum concentration and decline over a period of approximately 24 hours.
An immunoassay initial test for codeine/morphine should be calibrated with one of the two analytes and demonstrate sufficient cross-reactivity with the other analyte. The Department proposes that the minimum cross-reactivity with either analyte be 80 percent or greater. If an alternate technology initial test is performed instead of immunoassay, either one or both analytes in the group should be used to calibrate, depending on the technology. The quantitative sum of the two analytes must be equal to or greater than 30 ng/mL. The quantitative sum of the two analytes must be based on quantitative values for each analyte that are equal to or above the laboratory's validated limit of quantification.
The 15 ng/mL confirmatory test cutoff concentration applies equally to codeine and morphine. A positive test would be comprised of either or both analytes with a confirmed concentration equal to or greater than 15 ng/mL.
The Department is proposing to test for 6-acetylmorphine using a 3 ng/mL cutoff concentration for the initial test and 2 ng/mL for the confirmatory test cutoff concentration. 6-acetylmorphine, a unique metabolite of heroin, appears in oral fluid within minutes following smoked or injected heroin administration.
The Department is proposing to test for phencyclidine using a 3 ng/mL cutoff concentration for the initial test and 2 ng/mL for the confirmatory test cutoff concentration. Phencyclidine has been measured in oral fluid following different routes of administration.
The Department is proposing to test for amphetamine/methamphetamine using a 25 ng/mL cutoff concentration for the initial test and 15 ng/mL for the confirmatory test cutoff concentration. Amphetamine appears rapidly in oral fluid following administration
An immunoassay initial test for amphetamine/methamphetamine should be calibrated with one of the two analytes and demonstrate sufficient cross-reactivity with the other analyte. The Department recommends that the minimum cross-reactivity with either analyte be 80 percent or greater. If an alternate technology initial test is performed instead of immunoassay, either one or both analytes in the group should be used to calibrate, depending on the technology. The quantitative sum of the two analytes must be equal to or greater than 25 ng/mL. The quantitative sum of the two analytes must be based on quantitative values for each analyte that are equal to or above the laboratory's validated limit of quantification.
The 15 ng/mL confirmatory test cutoff concentration applies equally to amphetamine and methamphetamine. A positive test would be comprised of either or both analytes with a confirmed concentration equal to or greater than 15 ng/mL.
The Department is proposing to test for MDMA/MDA/MDEA using a 25 ng/mL cutoff concentration for the initial test and 15 ng/mL for the confirmatory test cutoff concentration. MDMA appears in oral fluid approximately 0.25-1.5 hours following oral administration and demonstrates similar kinetic patterns as plasma concentrations.
An immunoassay initial test for MDMA/MDA/MDEA should be calibrated with one of the three analytes and demonstrate sufficient cross-reactivity with each analyte. The Department recommends that the minimum cross-reactivity with each analyte be 80 percent or greater. If an alternate technology initial test is performed instead of immunoassay, either one or all analytes in the group should be used to calibrate, depending on the technology. The quantitative sum of the three analytes must be equal to or greater than 25 ng/mL. The quantitative sum of the three analytes must be based on quantitative values for each analyte that are equal to or above the laboratory's validated limit of quantification.
The 15 ng/mL confirmatory test cutoff concentration applies equally to MDMA, MDA and MDEA. A positive test would be comprised of one or more of the three analytes with a confirmed concentration equal to or greater than 15 ng/mL.
Misuse and abuse of psychotherapeutic prescription drugs, including opoid pain relievers, are issues of concern for all populations regardless of age, gender, ethnicity, race, or community. Recent data show that opoid-related overdose deaths in the U.S. now outnumber overdose deaths involving all illicit drugs such as heroin and cocaine combined. In addition to overdose deaths, emergency department visits, substance abuse treatment admissions, and economic costs associated with opioid abuse have all increased in recent years. The Department is continuing to work with partners at the federal, state, and local levels to implement policies and programs to reduce prescription drug abuse and improve public health.
The Department proposes the inclusion of additional Schedule II prescription medications (
The use of medications, specifically Schedule II drugs, without a prescription is a growing concern for the Department in workplace drug testing, and the proposal for their inclusion offers the opportunity to deter nonmedical use of these drugs among federal workers. The Department does note that in recognition of the prescription drug abuse issue, the Department of Defense issued a memorandum on January 30, 2012, announcing the expansion of their drug testing panel to include hydrocodone and benzodiazepines starting on May 1, 2012. Similarly, the Department proposes that federal agencies include the testing of oxycodone, oxymorphone, hydrocodone, and hydromorphone in oral fluid specimens as described below.
The Department is proposing to test for oxycodone/oxymorphone using a 30 ng/mL cutoff concentration for the initial test and 15 ng/mL for the confirmatory test cutoff concentrations. Both oxycodone and oxymorphone have been reported to be readily detectable in oral fluid specimens collected from pain patients.
An immunoassay initial test for oxycodone/oxymorphone should be calibrated with one of the two analytes and demonstrate sufficient cross-reactivity with the other analyte. The Department recommends that the minimum cross-reactivity with either analyte be 80 percent or greater. If an alternate technology initial test is performed instead of immunoassay, either one or both analytes in the group should be used to calibrate, depending on the technology. The quantitative sum of the two analytes must be equal to or greater than 30 ng/mL. The quantitative sum of the two analytes must be based on quantitative values for each analyte that are equal to or above the laboratory's validated limit of quantification.
The 15 ng/mL confirmatory test cutoff concentration applies equally to oxycodone and oxymorphone. A positive test would be comprised of either or both analytes with a confirmed concentration equal to or greater than 15 ng/mL.
The Department is proposing to test for hydrocodone/hydromorphone using a 30 ng/mL cutoff concentration for the initial test and 15 ng/mL for the confirmatory test cutoff concentration. Hydromorphone appears rapidly in oral fluid following intravenous administration and follows a similar kinetic profile as that observed in plasma.
An immunoassay initial test for hydrocodone/hydromorphone should be calibrated with one of the two analytes and demonstrate sufficient cross reactivity with the other analyte. The Department proposes that the minimum cross-reactivity with either analyte be 80 percent or greater. If an alternate technology initial test is performed instead of immunoassay, either one or both analytes in the group should be used to calibrate, depending on the technology. The quantitative sum of the two analytes must be equal to or greater than 30 ng/mL. The quantitative sum of the two analytes must be based on quantitative values for each analyte that are equal to or above the laboratory's validated limit of quantification.
The confirmatory test cutoff concentration applies equally to hydrocodone and hydromorphone. A positive test would be comprised of either or both analytes with a confirmed equal to or greater than 15 ng/mL.
In 2009, the U.S. Drug Enforcement Administration (DEA) asked the U.S. Department of Health and Human Services (HHS) for a recommendation regarding whether to change the schedule for hydrocodone combination drug products, such as Vicodin. The proposed change was from Schedule III to Schedule II, which would increase the controls on these products. Due to the unique history of this issue and the tremendous amount of public interest, in October 2013, the FDA Center for Drug Evaluation and Research announced the agency's intent to recommend to HHS that hydrocodone combination drug products should be reclassified to Schedule II. FDA stated that this determination came after a thorough and careful analysis of extensive scientific literature, review of hundreds of public comments on the issue, and several public meetings, during which FDA received input from a wide range of stakeholders, including patients, health care providers, outside experts, and other government entities.
In December 2013, FDA, with the concurrence of the National Institute on Drug Abuse (NIDA), submitted a formal recommendation package to HHS to reclassify hydrocodone combination drug products into Schedule II. Also in December 2013, the Secretary of HHS submitted the scientific and medical evaluation and scheduling recommendation to the DEA for its consideration. On August 22, 2014, DEA published the Final Rule that moves hydrocodone combination drug products from Schedule III to Schedule II.
Section 3.5 authorizes HHS-certified laboratories to perform additional tests to assist the MRO in making a determination of positive or negative results. The Department believes that additional tests can be requested by the MRO to further inform them to determine the veracity of the medical explanation of the donor. An example of an additional test currently requested by an MRO is when the laboratory reports a positive methamphetamine result. The MRO may request a d,l-stereoisomer determination for methamphetamine, to determine whether the result could be attributed to use of an over-the-counter nasal inhaler. Another example of current practice is when the laboratory reports a positive THCA result, and the MRO requests testing for cannabivarin, to distinguish marijuana use from dronabinol (
Section 3.6 includes criteria for reporting an oral fluid specimen as adulterated. While there are no known oral fluid adulterants at this time, the Department is proposing to establish criteria similar to that for urine specimens, to ensure procedures that are forensically acceptable and
Section 3.7 incorporates criteria from the UrMG that are applicable for reporting an invalid result for an oral fluid specimen, and includes an additional criterion to enable laboratories to perform specimen validity testing using biomarkers other than IgG and albumin.
Sections 4.1 through 4.5 contain the same policies as described in the current UrMG in regard to who may or may not collect a specimen, the requirements to be a collector, the requirements to be a trainer for collectors, and what a federal agency must do before a collector is permitted to collect a specimen.
Sections 5.1 through 5.5 address requirements for collection sites, collection site records, how a collector ensures the security and integrity of a specimen at the collection site, and the privacy requirements when collecting a specimen.
Sections 6.1 and 6.2 are the same as in the current UrMG, requiring an OMB-approved Federal CCF be used to document custody and control of each specimen at the collection site, and specifying what should occur if the correct OMB-approved CCF is not used.
Section 7.1 describes the type of collection device that must be used to collect an oral fluid specimen. A single use device that has been cleared by the FDA for the collection of oral fluid must be used.
Section 7.2 describes specific requirements for the oral fluid collection device, to ensure that the device provides a sufficient volume for laboratory analysis and maintains the integrity of the specimen. The Department has determined that it is essential that the device have a volume adequacy indicator showing that a minimum volume of 1 mL oral fluid has been collected; that the container be sealable and non-leaking; and that all components of the device ensure drug and metabolite stability and do not substantially affect the composition of drug and/or drug metabolites in the specimen.
Section 7.3 details the minimum performance requirements for a collection device. Considering the variety of oral fluid collection devices available, the Department considers it necessary to require that any device used meet minimum standards to ensure the integrity of the specimen and the standardization of the laboratory analysis process.
This subpart addresses the same topics, in the same order, as the UrMG procedures for urine specimen collection.
Section 8.1 specifies the procedures required to provide privacy for the oral fluid donor during the collection procedure.
Sections 8.2 through 8.5 describe the responsibilities and procedures the collector must follow before, during, and after an oral fluid collection.
Section 8.6 describes the procedures the collector must follow when a donor is unable to provide an oral fluid specimen.
Section 8.7 prohibits collection of an alternate specimen when a donor is unable to provide an adequate oral fluid specimen, unless specifically authorized by the Mandatory Guidelines for Federal Workplace Drug Testing Programs and by the federal agency.
Section 8.8 describes how the collector prepares the oral fluid specimens, including the description of the oral fluid split specimen collection.
Section 8.9 specifies how a collector is to report a refusal to test.
Section 8.10 is the same as that in the UrMG in regard to federal agency responsibilities for ensuring that each collection site complies with all provisions of the Mandatory Guidelines. An example of appropriate action that may be taken in response to a reported collection site deficiency is self-assessment using the Collection Site Checklist for the Collection of Oral Fluid Specimens for Federal Agency Workplace Drug Testing Programs. This document will be available on the SAMHSA Web site
This subpart addresses the same topics for HHS certification of laboratories to test oral fluid specimens, as are included in the UrMG for HHS certification of laboratories to test urine specimens.
Sections 9.1 through 9.4 contain the same policies as in the current UrMG for laboratories to become HHS-certified and to maintain HHS certification to conduct oral fluid testing for a federal agency, as well as what a laboratory must do when certification is not maintained.
Section 9.5 contains specifications for PT samples, Section 9.6 contains PT requirements for an applicant laboratory, and Section 9.7 contains PT requirements for an HHS-certified laboratory. These sections incorporate the applicable requirements from the current UrMG, but exclude UrMG requirements that are specific for urine testing and include those specific for oral fluid testing.
The remaining Sections 9.8 through 9.17 contain the same policies as the UrMG. These sections address inspection requirements for applicant and HHS-certified laboratories, inspectors, consequences of an applicant or HHS-certified laboratory failing to meet PT or inspection performance requirements, factors considered by the Secretary in determining the revocation or suspension of HHS-certification, the procedure for notifying a laboratory that adverse action (
Section 9.17 states that a list of laboratories certified by HHS to conduct forensic drug testing for federal agencies will be published monthly in the
This subpart (Sections 10.1 through 10.4) describes the same policies for federal agency blind samples as the UrMG, with two exceptions. Oral fluid blind samples that challenge specimen validity tests are not required, and the blind supplier must validate blind samples in the selected manufacturer's collection device.
This subpart addresses the same topics, in the same order, as the UrMG procedures for laboratories testing urine specimens. As appropriate, the section includes requirements that are specific for oral fluid testing.
Sections 11.1 through 11.8 include the same requirements that are contained in the current UrMG for the laboratory standard operating procedure (SOP) manual; responsibilities and scientific qualifications of the
Sections 11.9 through 11.14 include the same requirements as in the current UrMG in regard to initial and confirmatory drug test requirements, validation, and batch quality control as described in each section below.
Section 11.9 describes the requirements for the initial drug test which permit the use of an immunoassay or alternate technology (
Sections 11.10 and 11.11 cover validation and quality control requirements for the initial test.
Section 11.12 describes the requirements for a confirmatory drug test. The Department proposes to allow analytical procedures using mass spectrometry or other equivalent technologies. Based on ongoing reviews of the scientific and forensic literature, and the assessment of a DTAB working group that has studied newer instruments and technologies, the Department believes that scientifically valid confirmatory methods other than combined chromatographic and mass spectrometric methods can be used to successfully detect and report the cutoff concentrations proposed in Subpart C-Oral Fluid Specimen Drug Tests.
Sections 11.13 and 11.14 cover validation and quality control requirements for the confirmatory tests.
Sections 11.15 and 11.16 address specimen validity tests that a laboratory performs for oral fluid specimens. The Department included requirements in the OFMG to test all specimens for albumin or IgG and to allow laboratories to perform other specimen validity tests. All specimen validity tests must use appropriate analytical methods that are properly controlled and validated, to provide scientifically supportable and forensic acceptable results to the MRO.
Section 11.17 describes in detail how a certified laboratory is required to report test results to MRO for oral fluid specimens.
Sections 11.18 and 11.19 contain the same requirements as the UrMG for specimen and record retention.
Section 11.20 describes the statistical summary report that a laboratory must provide to a federal agency for oral fluid testing. This section is comparable to the same section in the UrMG, differing only in that the statistical report elements are specific for oral fluid testing.
Section 11.21 addresses the laboratory information to be made available to a federal agency and describes the contents of a standard laboratory documentation package. This is the same policy as in the UrMG.
Section 11.22 addresses the laboratory information to be made available to a federal employee upon written request through the MRO, and clarifies that specimens are not a part of the information package that donors can receive from HHS-certified laboratories. This is the same policy as in the UrMG.
The remaining section, Section 11.23, describes the relationships that are prohibited between an HHS-certified laboratory and an MRO. These are the same as in the UrMG.
This subpart emphasizes that federal agencies may choose to use IITFs for urine testing but not for oral fluid testing. Section 12.1 clearly states that only HHS-certified laboratories are authorized to test oral fluid specimens for federal agency workplace drug testing programs. Instrumented Initial Test Facilities are not practical and will not be allowed due primarily to the limited sample volume of oral fluid collected from the donor.
This subpart addresses the same topics, in the same order, as the UrMG procedures for Medical Review Officers (MROs).
Section 13.1 describes who may serve as an MRO. With the inclusion of additional Schedule II prescription medications in the Mandatory Guidelines and the ever-changing field of drug testing, medical review of drug test results is more complex today than before. Therefore, the Department proposes to incorporate MRO requalification training and reexamination on a regular basis (at least every five years). The URMG and OFMG do not include a requirement for MROs to obtain continuing education units (CEUs). The Department understands that it would be difficult to determine whether CEUs obtained are related to federal agency drug testing. The requalification requirement every five years will assure agency auditors and inspectors and regulated employers that MROs are appropriately qualified. This requirement is not expected to increase costs to MROs. Current practices for MRO requirements have equivalent standards but vary among MRO training entities. These requirements will standardize the length of time each MRO is required to take a requalification examination. Currently, some MRO requalification periods are longer than five years, while others are less than five years. The Department assumes that the costs to those MROs that have requalification periods over five years will be offset by the cost savings to MROs that have periods shorter than five years. Thus, the Department has not estimated any costs associated with this provision, but it welcomes comment on this assumption.
The Department anticipates that MROs will continue to obtain CEUs by virtue of maintaining their medical licensure requirements. In addition, the MRO certification/training entities provide MRO manuals and periodic newsletters with updates on federal drug testing program requirements. However, the Department is seeking comments on requiring MRO requalification CEUs and on the optimum number of credits and the appropriate CEU accreditation bodies should CEUs be required as part of MRO requalification.
MROs play a key role in the federal safety program and maintain the balance between the safety and privacy objectives of the program. The MRO's role in gathering and evaluating the medical evidence and providing due process is imperative. These are duties that must be carried out by the MRO and cannot be delegated to other personnel who are not certified by an MRO entity.
The MRO is charged with certain important medical and administrative duties. The MRO must have detailed knowledge of the effects of medications and other potential alternative medical explanations for laboratory reported drug test results. He or she is responsible for determining whether legitimate medical explanations are available to explain an employee's drug test result. This medical review process has become far more complex as a result of specimen validity testing and the myriad of medical explanations for adulterated, substituted, and invalid laboratory test results. These complexities have made MRO knowledge of the effects of drugs and medications even more important.
In addition, MROs confer with prescribing physicians in making decisions about prescription changes so that alternative medications can be used that will not impact public safety. Similarly, the MRO is required to report
Section 13.2 describes how nationally recognized entities or subspecialty boards that certify MROs are approved.
Section 13.3 describes the training that is required before a physician may serve as an MRO. The Department has added a requirement for MRO training to include information about how to discuss substance misuse and abuse and how to access those services. MROs performing the review of federal employee drug test results should be aware of prevention and treatment opportunities for individuals and can provide information to the donor.
Section 13.4 describes the responsibilities of an MRO.
Section 13.5 describes an MRO's actions when reviewing an oral fluid specimen's test results. This section includes procedures that are specific to oral fluid specimen results.
In Section 13.5, item c(2)(ii), the Department proposes a morphine or codeine confirmatory concentration that the MRO verifies as positive without requiring clinical evidence of illegal drug use, when the donor does not have a legitimate medical explanation. As in the UrMG, this section states that the MRO must not consider consumption of food products as a legitimate explanation for the donor having morphine or codeine at or above the specified concentration in his or her oral fluid. There is limited information in the scientific literature on the codeine and/or morphine concentrations seen in oral fluid after consumption of poppy seed food products. Therefore, the Department is proposing a conservative concentration of 150 ng/mL (
Section 13.6 describes what an MRO must do when the collector reports that a donor did not provide a sufficient amount of oral fluid for a drug test. This section contains the same procedures as the UrMG, with information specific to oral fluid specimens.
Section 13.7 describes what an MRO must do when a donor has a permanent or long-term medical condition that prevents him or her from providing a sufficient amount of oral fluid for a federal agency applicant/pre-employment, follow-up, or return-to-duty test. These procedures are the same as in the UrMG.
The remaining sections, Sections 13.8, 13.9, and 13.10, are the same as in the UrMG, addressing who may request a test of the split (B) specimen, how an MRO reports a primary (A) specimen result, and the types of relationship that are prohibited between an MRO and an HHS- certified laboratory.
Sections 14.1 and 14.2 include the same policies as the UrMG in regard to when a split (B) specimen may be tested and the testing requirements for a split specimen when the primary specimen was reported positive for a drug(s).
Section 14.3 specifies how the split testing laboratory tests a split (B) oral fluid specimen when the primary (A) specimen was reported as adulterated. As noted previously in this Preamble, the Department is not aware of any adulterants being used for oral fluid specimens, but has included policies in these Guidelines to allow for the testing and reporting of adulterants in oral fluid.
Section 14.4 includes the same policy as the UrMG, requiring the laboratory to report the split (B) specimen result to the MRO.
In Section 14.5, the Department is proposing the actions an MRO must take after receiving the split (B) specimen result. This section is analogous to the corresponding section in the UrMG, with differences where applicable for oral fluid specimen reports.
Section 14.6 is the same as the UrMG in regard to how an MRO reports a split (B) specimen result to an agency.
Section 14.7 is the same as the UrMG, requiring the HHS-certified laboratory to retain a split oral fluid specimen for the same length of time that the primary specimen is retained.
Sections 15.1 and 15.2 contain the same policies as the current UrMG for discrepancies requiring a laboratory to reject a specimen and for discrepancies that require a laboratory to reject a specimen unless the discrepancy is corrected.
Section 15.3 lists those discrepancies that would not affect either testing or reporting of an oral fluid specimen result. These are similar to the corresponding section in the UrMG, with differences where applicable for oral fluid specimens.
Section 15.4 describes the discrepancies that may require the MRO to cancel a test, which are the same as those in the UrMG.
In this subpart, the Department proposes the same procedures that are described in the UrMG to revoke or suspend the HHS-certification of laboratories.
The Department is aware that these proposed new Guidelines may impact the Department of Transportation (DOT) and Nuclear Regulatory Commission (NRC) regulated industries depending on these agencies' decisions to incorporate the final OFMG into their programs under their own authority.
The Department requests public comment on all aspects of this notice. However, the Department is providing the following list of areas for which specific comments are requested.
Section 3.1 requires federal agencies to test all oral fluid specimens for either albumin or IgG to determine specimen validity. The Department specifically requests public comment on this requirement.
Section 3.4 lists the proposed cutoff concentrations. The Department is specifically requesting comments on the appropriateness of these proposed cutoffs.
Regarding Section 3.4, the Department is specifically interested in obtaining information on the capability of laboratories to test THCA analyte using a cutoff of 50 pg/mL and the validity of whether THCA can be established as an accurate, sensitive and valid marker for oral fluid testing to detect marijuana use. Additionally, the Department is interested in obtaining information whether THCA should be used to extend the window of detection of marijuana use. The Department is also interested in receiving comments on lowering the cutoff concentration for delta-9-tetrahydrocannabinol (THC) to either 2 or 3 ng/mL for the initial test cutoff concentration and to 1 ng/mL for the confirmatory cutoff concentration to extend the window of detection.
In section 7.3, the Department proposes performance requirements for a collection device. The Department is requesting specific comments on these requirements.
In Section 13.5, the Department proposes a concentration of 150 ng/mL morphine or codeine be used by the
The Department welcomes public comment on all figures and assumptions described in this section.
Executive Order 13563 of January 18, 2011 (Improving Regulation and Regulatory Review) states “Our regulatory system must protect public health, welfare, safety, and our environment while promoting economic growth, innovation, competitiveness, and job creation.” Consistent with this mandate, Executive Order 13563 requires agencies to tailor “regulations to impose the least burden on society, consistent with obtaining regulatory objectives.” Executive Order 13563 also requires agencies to “identify and consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice” while selecting “those approaches that maximize net benefits.” This notice proposes a regulatory approach that will reduce burdens to providers and to consumers while continuing to provide adequate protections for public health and welfare.
The Secretary has examined the impact of the proposed Guidelines under Executive Order 12866, which directs federal agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). In addition, the Department published a
According to Executive Order 12866, a regulatory action is “significant” if it meets any one of a number of specified conditions, including having an annual effect on the economy of $100 million; adversely affecting in a material way a sector of the economy, competition, or jobs; or if it raises novel legal or policy issues. The proposed Guidelines do establish additional regulatory requirements and allow an activity that was otherwise prohibited. The Administrative Procedure Act (APA) delineates an exception to its rulemaking procedures for “a matter relating to agency management or personnel” 5 U.S.C. 553(a)(2). Because the Guidelines issued by the Secretary govern federal workplace drug testing programs, HHS has taken the position that the Guidelines are a “matter relating to agency management or personnel” and, thus, are not subject to the APA's requirements for notice and comment rulemaking. This position is consistent with Executive Order 12564 regarding Drug-Free Workplaces, which directs the Secretary to promulgate scientific and technical guidelines for executive agency drug testing programs.
The proposed Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) will provide flexibility to address workplace drug testing needs of federal agencies while continuing to promulgate established standards to ensure the full reliability and accuracy of drug test results.
Medical conditions exist that may prevent a federal employee or applicant from providing sufficient urine or oral fluid for a drug test. When the OFMG are implemented, in the event that an individual is unable to provide a urine specimen, the federal agency may authorize the collection of an oral fluid specimen. In the event a federal agency adopts oral fluid testing and the donor is unable to collect an oral fluid specimen, the federal agency may also authorize the collection of a urine specimen. This will reduce both the need to reschedule collections and the need for the Medical Review Officer (MRO) to arrange a medical evaluation of a donor's inability to provide a specimen.
Urine collection requires use of a specialized collection facility, secured restrooms, the same gender, and other special requirements. Oral fluid may be collected in various settings. An acceptable oral fluid collection site must allow the collector to observe the donor, maintain control of the collection device(s) during the process, maintain record storage, and protect donor privacy.
Oral fluid collections will occur under observation, which should substantially lessen the risks of specimen substitution and adulteration that has been associated with urine specimen collections, most of which are unobserved. All oral fluid specimens will be tested for either albumin or immunoglobulin G (IgG) to identify invalid specimens.
Oral fluid collection can require less time than urine collection, reducing employee time away from the workplace and, therefore, reducing costs to the federal agency employer. Oral fluid collection does not require a facility that provides visual privacy during the collection. It is expected that many oral fluid collections will occur at or near the workplace, and not at a dedicated collection site, thereby reducing the amount of time away from the workplace. The collector is allowed to be in the vicinity of the donor, reducing the loss of productive time. The option to collect a urine specimen in the event that the donor cannot provide an oral fluid specimen (and vice versa) will reduce both the need to reschedule a collection and the need for the MRO to arrange a medical evaluation of a donor's inability to provide a specimen. Administrative data indicates it takes, on average, about 4 hours from the start of the notification of the drug test to the actual time a donor reports back to the worksite. Since oral fluid collection does not have the same privacy concerns as urine collection, onsite collections are likely, thereby reducing the time a donor is away from the worksite. The Department estimates the time savings to be between 1 and 3 hours. This range reflects uncertainty around the location of the collection. The lower bound represents an estimate of time savings if the collection was conducted at an offsite location. The upper bound estimate represents the time savings if the collection was conducted at the employee's workplace, and thus incorporates travel time savings. Using OPM's estimate for the average annual salary of Federal employees converted to an hourly wage, the savings generated for the Federal Government would be roughly $400,000 to $1.2 million a year, or $38 to $114 per test.
The time course of drugs and metabolites differs between oral fluid and urine, resulting in some differences in analytes and detection times. Oral fluid tests generally are positive as soon as the drug is absorbed into the body. In contrast, urine tests that are based solely on detection of a metabolite are
In the past, urine was the only permitted specimen for forensic workplace drug testing. However, some issues that previously deterred the use of oral fluid for drug testing have been resolved. The scientific basis for the use of oral fluid as an alternative specimen for drug testing has now been broadly established. For example, oral fluid collection devices and procedures have been developed that protect against biohazards, maintain the stability of analytes, and provide sufficient oral fluid for testing. In addition, OFMG analyte cutoff concentrations are much lower than those specified for urine in the Guidelines. Additionally, specimen volume is also much lower, saving time in collection and transport cost. Developments in analytical technologies have allowed their use as efficient and cost-effective methods that provide the needed analytical sensitivity and accuracy for testing oral fluid specimens.
Urine was the original specimen of choice for forensic workplace drug testing, and urine testing is expected to remain an established and reliable component of federal workplace drug testing programs. Urine testing provides scientifically accurate and legally defensible results and has proven to be an effective deterrent to drug use in the workplace.
A major challenge to urine drug testing has been the proliferation of commercial products used to adulterate or substitute a donor's urine specimen. Due to individual privacy rights, most urine collections are unobserved, allowing the opportunity to use such products. As the Department has established requirements and laboratories have developed procedures to control for adulterated and substituted specimens, manufacturers have developed new products to avoid detection. Current research indicates that some current substitution products are indistinguishable from human urine. The use of these products is expected to continue.
The transition to the testing of oral fluids will be gradual and steady over the course of four years, when it should plateau. By this time, it is expected that oral fluid tests will account for 25-30% of all regulated drug testing. This estimate is based on the non-regulated sector's time course of the testing of oral fluid and urine in the past four years.
Using data obtained from the Federal Workplace Drug Testing Programs and HHS certified laboratories, the Department estimates the number of specimens tested annually for federal agencies to be 150,000. HHS projects that approximately 7% (or 10,500) of the 150,000 specimens tested per year will be oral fluid specimens and 93% (or 139,500) will be urine specimens. The approximate annual numbers of regulated specimens for the Department of Transportation (DOT) and Nuclear Regulatory Commission (NRC) are 6 million and 200,000, respectively. Should DOT and NRC allow oral fluid testing in regulated industries' workplace programs, the estimated annual numbers of specimens for DOT would be 180,000 oral fluid and 5,820,000 urine, and numbers of specimens for NRC would be 14,000 oral fluid and 186,000 urine.
In Section 3.4, the Department is proposing criteria for calibrating initial tests for grouped analytes such as opiates and amphetamines, and specifying the cross-reactivity of the immunoassay to the other analytes(s) within the group. These proposed Guidelines allow the use of methods other than immunoassay for initial testing. In addition, these proposed Guidelines include an alternative for laboratories to continue to use existing FDA-cleared immunoassays which do not have the specified cross-reactivity, by establishing a decision point with the lowest-reacting analyte. An immunoassay manufacturer may incur costs if they choose to alter their existing product and resubmit the immunoassay for FDA clearance.
Costs associated with the addition of oral fluid testing and testing for oxycodone, oxymorphone, hydrocodone and hydromorphone will be minimal based on information from some HHS certified laboratories currently testing non-regulated oral fluid specimens. Likewise, there will be minimal costs associated with changing initial testing to include MDA and MDEA since current immunoassays can be adapted to test for these analytes. Prior to being allowed to test regulated oral fluid specimens, laboratories must be certified by the Department through the NLCP. Estimated laboratory costs to complete and submit the application are $2,000, and estimated costs for the Department to process the application are $7,200. These estimates are from SAMHSA are based on the NLCP fee schedule and historical costs. The initial certification process includes the requirement to demonstrate that their performance meets Guidelines requirements by testing three (3) groups of PT samples. The Department will provide the three groups of PT samples through the NLCP at no cost. Based on costs charged for urine specimen testing, laboratory costs to conduct the PT testing would range from $900 to $1,800 for each applicant laboratory.
Agencies choosing to use oral fluid in their drug testing programs may also incur some costs for training of federal employees such as drug program coordinators. Based on current training modules offered to drug program coordinators, and other associated costs including travel for 90% of drug program coordinators, the estimated total training cost for a one-day training session would be between $54,000 and $69,000. This training cost is included in the costs of the revised URMG.
Thus, the Department estimates one-time, upfront costs of between $360,000 and $400,000. While the Department has only monetized a small portion of the benefits (time savings) to a small subset of the workplace drug testing programs that could be affected by the OFMG (
For the reasons outlined above, the Secretary has determined that the proposed Guidelines will not have a significant impact upon a substantial number of small entities within the meaning of the Regulatory Flexibility Act [5 U.S.C. 605(b)]. The flexibility added by the OFMG will not require addition expenditures. Therefore, an initial regulatory flexibility analysis is not required for this notice.
As mentioned in the section on Executive Orders 13563 and 12866, the Secretary anticipates that there will be an overall reduction in costs if drug testing is expanded under the OFMG. The costs to implement this change to regulation are negligible. The added flexibility will permit federal agencies to select the specimen type best suited for their needs and to authorize collection of an alternative specimen type when an employee is unable to provide the originally authorized specimen type. Insofar as there are costs associated with each drug test, this could lead to lower overall testing costs for federal agencies. The added flexibility will also benefit federal employees, who should be able to provide one of the specimen types, thereby facilitating the drug test required for their employment.
The Secretary has determined that the proposed Guidelines are not a major rule for the purpose of congressional review. For the purpose of congressional review, a major rule is one which is likely to cause an annual effect on the economy of $100 million; a major increase in costs or prices; significant effects on competition, employment, productivity, or innovation; or significant effects on the ability of U.S.-based enterprises to compete with foreign-based enterprises in domestic or export markets. This is not a major rule under the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996.
The Secretary has examined the impact of the proposed Guidelines under the Unfunded Mandates Reform Act (UMRA) of 1995 (Pub. L. 104-4). This notice does not trigger the requirement for a written statement under section 202(a) of the UMRA because the proposed Guidelines do not impose a mandate that results in an expenditure of $100 million (adjusted annually for inflation) or more by either state, local, and tribal governments in the aggregate or by the private sector in any one year.
The Secretary has considered the environmental effects of the OFMG. No information or comments have been received that would affect the agency's determination there would be a significant impact on the human environment and that neither an environmental assessment nor an environmental impact statement is required.
The Secretary has analyzed the proposed Guidelines in accordance with Executive Order 13132: Federalism. Executive Order 13132 requires federal agencies to carefully examine actions to determine if they contain policies that have federalism implications or that preempt state law. As defined in the Order, “policies that have federalism implications” refer to regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
In this notice, the Secretary is proposing to establish standards for certification of laboratories engaged in oral fluid drug testing for federal agencies and the use of oral fluid testing in federal drug-free workplace programs. The Department of Health and Human Services, by authority of Section 503 of Public Law 100-71, 5 U.S.C. Section 7301, and Executive Order No. 12564, establishes the scientific and technical guidelines for federal workplace drug testing programs and establishes standards for certification of laboratories engaged in urine drug testing for federal agencies. Because the Mandatory Guidelines govern standards applicable to the management of federal agency personnel, there should be little, if any, direct effect on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the Secretary has determined that the Guidelines do not contain policies that have federalism implications.
The proposed Guidelines contain information collection requirements which are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 [the PRA 44 U.S.C. 3507(d)]. Information collection and recordkeeping requirements which would be imposed on laboratories engaged in drug testing for federal agencies concern quality assurance and quality control documentation, reports, performance testing, and inspections as set out in subparts H, I, K, L, M and N. To facilitate ease of use and uniform reporting, a Federal CCF for each type of specimen collected will be developed as referenced in section 6.1. The Department has submitted the information collection and recordkeeping requirements contained in the proposed Guidelines to OMB for review and approval.
The Secretary has determined that the Guidelines do not contain information collection requirements constituting a system of records under the Privacy Act. The
Executive Order 13175 (65 FR 67249, November 6, 2000) requires SAMHSA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” as defined in the Executive Order, include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the federal government and the Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes.” The proposed Guidelines do not have tribal implications. The Guidelines will not have substantial direct effects on tribal governments, on the relationship between the federal government and Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes, as specified in Executive Order 13175.
The information collection requirements (
The title, description and respondent description of the information collections are shown in the following paragraphs with an estimate of the annual reporting, disclosure and recordkeeping burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
The following reporting requirements are also in the proposed Guidelines, but have not been addressed in the above reporting burden table: Collector must report any unusual donor behavior or refuse to participate in the collection process on the Federal CCF (sections 1.8, 8.9); collector annotates the Federal CCF when a sample is a blind sample (section 10.3(a)); MRO notifies the federal agency and HHS when an error occurs on a blind sample (section 10.4(c)); section 13.5 describes the actions an MRO takes to report a primary specimen result; and section 14.5 describes the actions an MRO takes to report a split specimen result. SAMHSA has not calculated a separate reporting burden for these requirements because they are included in the burden hours estimated for collectors to complete Federal CCFs and for MROs to report results to federal agencies.
The following disclosure requirements are also included in the proposed Guidelines, but have not been addressed in the above disclosure burden table: The collector must explain the basic collection procedure to the donor and answer any questions (section 8.3(f) and (h), and must review the procedures for the oral fluid specimen collection device used with the donor (section 8.4(b)). SAMHSA believes having the collector explain the collection procedure to the donor and answer any questions is a standard business practice and not a disclosure burden.
The proposed Guidelines contain a number of recordkeeping requirements that SAMHSA considers not to be an additional recordkeeping burden. In subpart D, a trainer is required to document the training of an individual to be a collector [section 4.3(a)(3)] and the documentation must be maintained in the collector's training file [section 4.3(c)]. SAMHSA believes this training documentation is common practice and is not considered an additional burden. In subpart F, if a collector uses an incorrect form to collect a federal agency specimen, the collector is required to provide a statement [section 6.2(b)] explaining why an incorrect form was used to document collecting the specimen. SAMHSA believes this is an extremely infrequent occurrence and does not create a significant additional recordkeeping burden. Subpart H [sections 8.4(d) and 8.5(a)(1)] requires collectors to enter any information on the Federal CCF of any unusual findings during the oral fluid specimen collection procedure. These recordkeeping requirements are an integral part of the collection procedure and are essential to documenting the chain of custody for the specimens collected. The burden for these entries are included in the recordkeeping burden estimated to complete the Federal CCF and is, therefore, not considered an additional recordkeeping burden. Subparts K describe a number of recordkeeping requirements for laboratories associated with their testing procedures, maintaining chain of custody, and keeping records (
Thus the total annual response burden associated with the testing of oral fluid specimens by the laboratories is estimated to be 13,268 hours (that is, the sum of the total hours from the above tables). This is in addition to the 1,788,809 hours currently approved by OMB under control number 0930-0158 for urine testing under the current Guidelines.
As required by section 3507(d) of the PRA, the Secretary has submitted a copy of these proposed Guidelines to OMB for its review. Comments on the information collection requirements are specifically solicited in order to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of HHS's functions, including whether the information will have practical utility; (2) evaluate the accuracy of HHS's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) enhance the quality, utility, and clarity of the information to be collected; and (4) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
OMB is required to make a decision concerning the collection of information contained in these proposed Guidelines between 30 and 60 days after publication of this document in the
Organizations and individuals desiring to submit comments on the information collection requirements should direct them to the Office of Information and Regulatory Affairs, OMB, New Executive Office Building, 725 17th Street NW., Washington, DC 20502, Attn: Desk Officer for SAMHSA. Because of delays in receipt of mail, comments may also be sent to (202) 395-6974 (fax).
The Department believes that the benefits of the proposed Mandatory Guidelines using Oral Fluid Specimens outweigh the costs to include this additional specimen type in federal workplace drug testing programs. There is no requirement for federal agencies to use oral fluid as part of their drug testing program. A federal agency may choose to use urine, oral fluid, or both specimen types in their program based on the agency's mission, its employees' duties, and the danger to the public health and safety or to national security that could result from an employee's failure to carry out the duties of his or her position.
For reasons set forth in the preamble, the Department proposes to revise the Mandatory Guidelines for Federal Workplace Drug Testing Programs to include Mandatory Guidelines using Oral Fluid Specimens to read as follows:
(a) These Guidelines apply to:
(1) Executive Agencies as defined in 5 U.S.C. 105;
(2) The Uniformed Services, as defined in 5 U.S.C. 2101(3) (but excluding the Armed Forces as defined in 5 U.S.C. 2101(2));
(3) Any other employing unit or authority of the federal government except the United States Postal Service, the Postal Rate Commission, and employing units or authorities in the Judicial and Legislative Branches; and
(4) The Intelligence Community, as defined by Executive Order 12333, is subject to these Guidelines only to the extent agreed to by the head of the affected agency;
(5) Laboratories that provide drug testing services to the federal agencies;
(6) Collectors who provide specimen collection services to the federal agencies; and
(7) Medical Review Officers (MROs) who provide drug testing review and interpretation of results services to the federal agencies.
(b) These Guidelines do not apply to drug testing under authority other than Executive Order 12564, including testing of persons in the criminal justice system, such as arrestees, detainees, probationers, incarcerated persons, or parolees.
Although HHC has no authority to regulate the transportation industry, the Department of Transportation (DOT) does have such authority. DOT is required by law to develop requirements for its regulated industry that “incorporate the Department of Health and Human Services scientific and technical guidelines dated April 11, 1988 and any amendments to those guidelines . . .” See,
(a) Executive Order 12564 and Public Law 100-71 require the Department of Health and Human Services (HHS) to establish scientific and technical guidelines for federal workplace drug testing programs.
(b) The Secretary has the responsibility to implement these Guidelines.
(a) Each federal agency must ensure that its workplace drug testing program complies with the provisions of these Guidelines unless a waiver has been obtained from the Secretary.
(b) To obtain a waiver, a federal agency must submit a written request to the Secretary that describes the specific change for which a waiver is sought and a detailed justification for the change.
(a) To ensure the full reliability and accuracy of specimen tests, the accurate reporting of test results, and the integrity and efficacy of federal drug testing programs, the Secretary may make changes to these Guidelines to reflect improvements in the available science and technology.
(b) The changes will be published in final as a notice in the
The following definitions are adopted:
Consistent with 5 U.S.C. 552a and 48 CFR 24.101-24.104, all agency contracts with laboratories, collectors, and MROs must require that they comply with the Privacy Act, 5 U.S.C. 552a. In addition, the contracts must require compliance with employee access and confidentiality provisions of Section 503 of Public Law 100-71. Each federal agency must establish a Privacy Act System of Records or modify an existing system or use any applicable Government-wide system of records to cover the records of employee drug test results. All contracts and the Privacy Act System of Records must specifically require that employee records be maintained and used with the highest regard for employee privacy.
In addition, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule (Rule), 45 CFR parts 160 and 164, Subparts A and E, is applicable to certain health care providers with whom a federal agency may contract. If a health care provider is a HIPAA covered entity, the provider must protect the individually identifiable health information it maintains in accordance with the requirements of the Rule, which includes not using or disclosing the information except as permitted by the Rule and ensuring there are reasonable safeguards in place to protect the privacy of the information. For more information regarding the HIPAA Privacy Rule, please visit
(a) As a donor for a federally regulated drug test, you have refused to take a federally regulated drug test if you:
(1) Fail to appear for any test (except a pre-employment test) within a reasonable time, as determined by the federal agency, consistent with applicable agency regulations, after being directed to do so by the federal agency;
(2) Fail to remain at the collection site until the collection process is complete (with the exception of a donor who leaves the collection site before the collection process begins for a pre-employment test);
(3) Fail to provide a specimen (
(4) Fail or decline to participate in an alternate specimen collection (
(5) Fail to undergo a medical examination or evaluation, as directed by the MRO as part of the verification process (
(6) Fail to cooperate with any part of the testing process (
(7) Admit to the collector or MRO that you have adulterated or (for urine) substituted the specimen.
(a) As a federal agency employee or applicant, a refusal to take a test may result in the initiation of disciplinary or adverse action, up to and including removal from, or non-selection for, federal employment.
(b) When a donor has refused to participate in a part of the collection process, the collector must terminate that portion of the collection process and take action as described in Section 8.9: immediately notify the federal agency's designated representative by any means (
(c) When documenting a refusal to test during the verification process as described in Sections 13.4, 13.5, and 13.6, the MRO must complete the MRO copy of the Federal CCF to include:
(1) Checking the refusal to test box;
(2) Providing a reason for the refusal in the remarks line; and
(3) Signing and dating the MRO copy of the Federal CCF.
A federal agency may collect oral fluid and/or an alternate specimen type for its workplace drug testing program. Only specimen types authorized by Mandatory Guidelines for Federal Workplace Drug Testing Programs may be collected. An agency using oral fluid must follow these Guidelines.
A federal agency may collect an oral fluid specimen for the following reasons:
(a) Federal agency applicant/Pre-employment test;
(b) Random test;
(c) Reasonable suspicion/cause test;
(d) Post-accident test;
(e) Return to duty test; or
(f) Follow-up test.
Each oral fluid specimen is collected as a split specimen (
A known volume of at least 1 mL of undiluted (neat) oral fluid for each oral fluid specimen (designated “Tube A” and “Tube B”) is collected using a collection device.
The collector collects at least 1 mL of undiluted (neat) oral fluid in a collection device designated as “A” (primary) and at least 1 mL of undiluted (neat) oral fluid in a collection device designated as “B” (split) either simultaneously or serially (
Entities and individuals subject to these Guidelines under Section 1.1, may not release specimens collected pursuant to Executive Order 12564, Public Law 100-71 and these Guidelines, to donors or their designees. Specimens also may not be released to any other entity or individual unless expressly authorized by these Guidelines or by applicable federal law. This section does not prohibit a donor's request to have a split (B) specimen tested in accordance with Section 13.8.
A federal agency:
(a) Must ensure that each specimen is tested for marijuana and cocaine as provided under Section 3.4;
(b) Is authorized to test each specimen for opiates, amphetamines, and phencyclidine, as provided under Section 3.4; and
(c) Must ensure that the following specimen validity tests are conducted on each oral fluid specimen:
(1) Determine the albumin concentration on every specimen; or
(2) Determine the immunoglobulin G (IgG) concentration on every specimen.
(d) If a specimen exhibits abnormal characteristics (
(a) On a case-by-case basis, a specimen may be tested for additional drugs, if a federal agency is conducting the collection for reasonable suspicion or post accident testing. A specimen collected from a federal agency employee may be tested by the federal agency for any drugs listed in Schedule I or II of the Controlled Substances Act (other than the drugs listed in Section 3.1, or when used pursuant to a valid prescription or when used as otherwise authorized by law). The federal agency must request the HHS-certified laboratory to test for the additional drug, include a justification to test a specific specimen for the drug, and ensure that the HHS-certified laboratory has the capability to test for the drug and has established properly validated initial and confirmatory analytical methods. If an initial test procedure is not available upon request for a suspected Schedule I or Schedule II drug, the federal agency can request an HHS-certified laboratory to test for the drug by analyzing two separate aliquots of the specimen in two separate testing batches using the confirmatory analytical method. Additionally, the split (B) specimen will be available for testing if the donor requests a retest at another HHS-certified laboratory.
(b) A federal agency covered by these Guidelines must petition the Secretary in writing for approval to routinely test for any drug class not listed in Section 3.1. Such approval must be limited to the use of the appropriate science and technology and must not otherwise limit agency discretion to test for any drug tested under paragraph (a) of this section.
(a) Specimens collected pursuant to Executive Order 12564, Public Law 100-71, and these Guidelines must only be tested for drugs and to determine their validity in accordance with Subpart C of these Guidelines. Use of specimens by donors, their designees or any other entity, for other purposes (
(b) These Guidelines are not intended to prohibit federal agencies, specifically authorized by law to test a specimen for additional classes of drugs in its workplace drug testing program.
An HHS-certified laboratory is authorized to perform additional drug and/or specimen validity tests as necessary to provide information that the MRO would use to report a verified drug test result [
An HHS-certified laboratory reports an oral fluid specimen as adulterated
An HHS-certified laboratory reports a primary (A) oral fluid specimen as an invalid result when:
(a) The albumin concentration is less than 0.6 mg/dL for both the initial (first) test and the second test on two separate aliquots;
(b) The IgG concentration is less than 0.5 mg/L for both the initial (first) test and the second test on two separate aliquots;
(c) Interference occurs on the initial drug tests on two separate aliquots (
(d) Interference with the drug confirmatory assay occurs on two separate aliquots of the specimen and the laboratory is unable to identify the interfering substance;
(e) The physical appearance of the specimen (
(f) The specimen has been tested and the appearances of the primary (A) and the split (B) specimens (
(g) The concentration of a biomarker other than albumin or IgG is not consistent with that established for human oral fluid.
(a) A collector who has been trained to collect oral fluid specimens in accordance with these Guidelines and the manufacturer's procedures for the collection device.
(b) The immediate supervisor of a federal employee donor may only collect that donor's specimen when no other collector is available. The supervisor must be a trained collector.
(c) The hiring official of a federal agency applicant may only collect that federal agency applicant's specimen when no other collector is available. The hiring official must be a trained collector.
(a) A federal agency employee who is in a testing designated position and subject to the federal agency drug testing rules must not be a collector for co-workers in the same testing pool or who work together with that employee on a daily basis.
(b) A federal agency applicant or employee must not collect his or her own drug testing specimen.
(c) An employee working for an HHS-certified laboratory must not act as a collector if the employee could link the identity of the donor to the donor's drug test result.
(d) To avoid a potential conflict of interest, a collector must not be related to the employee (
(a) An individual may serve as a collector if he or she fulfills the following conditions:
(1) Is knowledgeable about the collection procedure described in these Guidelines;
(2) Is knowledgeable about any guidance provided by the federal agency's Drug-Free Workplace Program and additional information provided by the Secretary relating to these Guidelines;
(3) Is trained and qualified to use the specific oral fluid collection device. Training must include the following:
(i) All steps necessary to complete an oral fluid collection;
(ii) Completion and distribution of the Federal CCF;
(iii) Problem collections;
(iv) Fatal flaws, correctable flaws, and how to correct problems in collections; and
(v) The collector's responsibility for maintaining the integrity of the collection process, ensuring the privacy of the donor, ensuring the security of the specimen, and avoiding conduct or statements that could be viewed as offensive or inappropriate.
(4) Has demonstrated proficiency in collections by completing five consecutive error-free mock collections.
(i) The five mock collections must include two uneventful collection scenarios, one insufficient specimen quantity scenario, one scenario in which the donor refuses to sign the Federal CCF, and one scenario in which the donor refuses to initial the specimen collection device tamper-evident seal.
(ii) A qualified trainer for collectors must monitor and evaluate the individual being trained, in person or by a means that provides real-time observation and interaction between the trainer and the trainee, and the trainer must attest in writing that the mock collections are “error-free.”
(b) A trained collector must complete refresher training at least every five years that includes the requirements in paragraph (a) of this section.
(c) The collector must maintain the documentation of his or her training and provide that documentation to a federal agency when requested.
(d) An individual may not collect specimens for a federal agency until his or her training as a collector has been properly documented.
(a) Individuals are considered qualified trainers for collectors for a specific oral fluid collection device and may train others to collect oral fluid specimens using that collection device when they have completed the following:
(1) Qualified as a trained collector and regularly conducted oral fluid drug test collections using that collection device for a period of at least one year or
(2) Completed a “train the trainer” course given by an organization (
(b) A qualified trainer for collectors must complete refresher training at least every five years in accordance with the collector requirements in Section 4.3(a).
(c) A qualified trainer for collectors must maintain the documentation of his or her training and provide that documentation to a federal agency when requested.
A federal agency must ensure the following:
(a) The collector has satisfied the requirements described in Section 4.3;
(b) The collector, who may be self-employed, or an organization (
(c) The collector has been provided the name and telephone number of the federal agency representative.
(a) A collection site may be a permanent or temporary facility located either at the work site or at a remote site.
(b) In the event that an agency-designated collection site is not accessible and there is an immediate requirement to collect an oral fluid specimen (
The facility used as a collection site must have the following:
(a) Provisions to ensure donor privacy during the collection (as described in Section 8.1);
(b) A suitable and clean surface area that is not accessible to the donor for handling the specimens and completing the required paperwork;
(c) A secure temporary storage area to maintain specimens until the specimen is transferred to an HHS-certified laboratory;
(d) A restricted access area where only authorized personnel may be present during the collection;
(e) A restricted access area for the storage of collection supplies; and
(f) The ability to store records securely.
Collection site records must be stored at a secure site designated by the collector or the collector's employer.
Collection site records (
(a) A collector must do the following to maintain the security and integrity of a specimen:
(1) Not allow unauthorized personnel to enter the collection area during the collection procedure;
(2) Perform only one donor collection at a time;
(3) Restrict access to collection supplies before, during, and after collection;
(4) Ensure that only the collector and the donor are allowed to handle the unsealed specimen;
(5) Ensure the chain of custody process is maintained and documented throughout the entire collection, storage, and transport procedures;
(6) Ensure that the Federal CCF is completed and distributed as required; and
(7) Ensure that specimens transported to an HHS-certified laboratory are sealed and placed in transport containers designed to minimize the possibility of damage during shipment (
(b) Couriers, express carriers, and postal service personnel are not required to document chain of custody since specimens are sealed in packages that would indicate tampering during transit to the HHS-certified laboratory.
Collections must be performed at a site that provides reasonable privacy (as described in Section 8.1).
The OMB-approved Federal CCF must be used to document custody and control of each specimen at the collection site.
(a) The use of a non-federal CCF or an expired Federal CCF is not, by itself, a reason for the HHS-certified laboratory to automatically reject the specimen for testing or for the MRO to cancel the test.
(b) If the collector uses an incorrect form, the collector must document that it is a federal agency specimen collection and provide the reason that the incorrect form was used. Based on the information provided by the collector, the HHS-certified laboratory must handle and test the specimen as a federal agency specimen.
(c) If the HHS-certified laboratory or MRO discovers that an incorrect form was used by the collector, the laboratory or MRO must obtain a memorandum for the record from the collector describing the reason the incorrect form was used. If a memorandum for the record cannot be obtained, the HHS-certified laboratory must wait at least 5 business days before the laboratory reports a rejected for testing result to the MRO and the MRO cancels the test.
An FDA-cleared single-use collection device intended to collect an oral fluid specimen must be used. This collection device must maintain the integrity of such specimens during storage and transport so that the specimen contained therein can be tested in an HHS-certified laboratory for the presence of drugs or their metabolites.
An oral fluid specimen collection device must provide:
(a) An indicator that demonstrates the adequacy of the volume of oral fluid specimen collected;
(b) A sealable, non-leaking container that maintains the integrity of the specimen during storage and transport so that the specimen contained therein can be tested in an HHS-certified laboratory for the presence of drugs or their metabolites;
(c) Components that ensure pre-analytical drug and drug metabolite stability; and
(d) Components that do not substantially affect the composition of drugs and/or drug metabolites in the oral fluid specimen.
An oral fluid collection device must meet the following minimum performance requirements.
(a) Reliable and reproducible collection of a minimum of 1 mL of undiluted (neat) oral fluid;
(b) If the collection device contains a diluent (or other component, process, or method that modifies the volume of the testable specimen):
(1) The volume of oral fluid collected should be within 0.1 ml of the target volume, and
(2) The volume of diluent in the device should be within 0.05 ml of the diluent target volume;
(c) Stability (recoverable concentrations ≥90 percent of the concentration at the time of collection) of the drugs and/or drug metabolites for one week at room temperature (18-25 °C) and under intended shipping and storage conditions; and
(d) Recover ≥90 percent (but no more than 120 percent) of drug and/or drug metabolite in the undiluted (neat) oral fluid at (or near) the initial test cutoff (see Section 3.4).
The following privacy requirements apply when a donor is providing an oral fluid specimen:
(a) Only authorized personnel and the donor may be present in the restricted access area where the collection takes place.
(b) The collector is not required to be the same gender as the donor.
The collector must deter the adulteration or substitution of an oral fluid specimen at the collection site.
The collector must take the following steps before beginning an oral fluid specimen collection:
(a) If a donor fails to arrive at the collection site at the assigned time, the collector must follow the federal agency policy or contact the federal agency representative to obtain guidance on action to be taken.
(b) When the donor arrives at the collection site, the collector should begin the collection procedure without undue delay. For example, the collection should not be delayed because an authorized employer or employer representative is late in arriving.
(c) The collector requests the donor to present photo identification (
(d) The collector requests that the donor opens his or her mouth, and the collector inspects the oral cavity to ensure that it is free of any items that could impede or interfere with the collection of an oral fluid specimen (
(1) At this time, the collector starts the 10-minute wait period and proceeds with the steps below before beginning the specimen collection as described in Section 8.5.
(2) If the donor's mouth is not free of any items that could impede or interfere with the collection of an oral fluid specimen immediately prior to collection, or the donor claims to be a tobacco user, or claims to have “dry mouth,” the donor may drink while rinsing his or her mouth with water (up to 4 oz.) and wait 10 minutes before beginning the specimen collection.
(e) The collector must provide identification (
(f) The collector explains the basic collection procedure to the donor.
(g) The collector informs the donor that the instructions for completing the Federal Custody and Control Form are located on the back of the Federal CCF or available upon request.
(h) The collector answers any reasonable and appropriate questions the donor may have regarding the collection procedure.
(a) The collector will provide or the donor may select a specimen collection device that is clean, unused, and wrapped/sealed in original packaging. The specimen collection device will be opened in view of the donor.
(1) Both the donor and the collector must keep the unwrapped collection devices in view at all times until each collection device containing the donor's oral fluid specimen has been sealed and labeled.
(b) The collector reviews with the donor the procedures required for a successful oral fluid specimen collection as stated in the manufacturer's instructions for the specimen collection device.
(1) The collector may set a reasonable time limit for specimen collection (based on the device used, not to exceed 15 minutes per device).
(c) The collector notes any unusual behavior or appearance of the donor on the Federal CCF. If the collector detects any conduct that clearly indicates an attempt to tamper with a specimen, the collector must note the conduct on the Federal CCF.
Integrity and Identity of the Specimen. The collector must take the following steps during and after the donor provides the oral fluid specimen:
(a) The collector shall be present and maintain visual contact with the donor during the procedures outlined in this section.
(1) Under the observation of the collector, the donor is responsible for placing the specimen collection device in his or her mouth. The collector must ensure the collection is performed correctly and that the collection device is working properly. If the device fails to collect the specimen, the collector must begin the process again, beginning with Step 8.4(b), using a new specimen collection device (for both A and B specimens) and a new Federal CCF.
(2) The donor and collector must complete the collection in accordance with the manufacturer instructions for the collection device.
(b) If the donor fails to remain present through the completion of the collection, fails to follow the instructions for the collection device, refuses to provide a second specimen as required in step (a)(1) above, or refuses to provide an alternate specimen as authorized in Section 8.6, the collector stops the collection and reports the refusal to test in accordance with Section 8.9.
(a) If the donor states that he or she is unable to provide an oral fluid specimen during the collection process, the collector requests that the donor follow the collector instructions and attempt to provide an oral fluid specimen.
(b) The donor demonstrates his or her inability to provide a specimen when, after 15 minutes of using the collection device, there is insufficient volume or no oral fluid collected using the device.
(1) If the donor states that he or she could provide a specimen after drinking some fluids, the collector gives the donor a drink (up to 8 ounces) and waits an additional 10 minutes before beginning the specimen collection (a period of 1 hour must be provided or until the donor has provided a sufficient oral fluid specimen). If the donor simply needs more time before attempting to provide an oral fluid specimen, the donor is not required to drink any fluids during the 1 hour wait time. The collector must inform the donor that the donor must remain at the collection site (
(2) If the donor states that he or she is unable to provide an oral fluid specimen, the collector records the reason for not collecting an oral fluid
No, unless the alternate specimen type is authorized by Mandatory Guidelines for Federal Workplace Drug Testing Programs and specifically authorized by the federal agency.
(a) All federal agency collections are to be split specimen collections.
An oral fluid split specimen collection may be:
(1) Two specimens collected simultaneously with two separate collection devices;
(2) Two specimens collected serially with two separate collection devices. Collection of the second specimen must begin within two minutes after the completion of the first collection and recorded on the Federal CCF; or
(3) Two specimens collected simultaneously using a single collection device that directs the oral fluid into two separate collection tubes.
(b) A known volume of at least 1 mL of undiluted (neat) oral fluid is collected for the specimen designated as “Tube A” and a known volume of at least 1 mL of undiluted (neat) oral fluid is collected for the specimen designated as “Tube B”.
(c) In the presence of the donor, the collector places a tamper-evident label/seal from the Federal CCF over the cap of each specimen tube. The collector records the date of the collection on the tamper-evident labels/seals.
(d) The collector instructs the donor to initial the tamper-evident labels/seals on each specimen tube. If the donor refuses to initial the labels/seals, the collector notes the refusal on the Federal CCF and continues with the collection process.
(e) The collector must ensure that all the information required on the Federal CCF is provided.
(f) The collector asks the donor to read and sign a statement on the Federal CCF certifying that the specimens identified were collected from him or her. If the donor refuses to sign the certification statement, the collector notes the refusal on the Federal CCF and continues with the collection process.
(g) The collector signs and prints his or her name on the Federal CCF, completes the Federal CCF, and distributes the copies of the Federal CCF as required.
(h) The collector seals the specimens (Tube A and Tube B) in a package and, within 24 hours or during the next business day, sends them to the HHS-certified laboratory that will be testing the Tube A oral fluid specimen. The collector must also send a copy of the Federal CCF to the HHS-certified laboratory.
(i) If the specimen and Federal CCF are not immediately transported to an HHS-certified laboratory, they must remain under direct control of the collector or be appropriately secured under proper specimen storage conditions until transported.
If there is a refusal to test as defined in Section 1.7, the collector stops the collection, discards any oral fluid specimen collected and reports the refusal to test by:
(a) Notifying the federal agency by means (
(b) Documenting the refusal to test on the Federal CCF, and
(c) Sending all copies of the Federal CCF to the federal agency's designated representative.
(a) A federal agency must ensure that collectors and collection sites satisfy all requirements in subparts D, E, F, G, and H.
(b) A federal agency (or only one federal agency when several agencies are using the same collection site) must inspect 5 percent or up to a maximum of 50 collection sites each year, selected randomly from those sites used to collect agency specimens (
(c) A federal agency must investigate reported collection site deficiencies (
(a) The Secretary has broad discretion to take appropriate action to ensure the full reliability and accuracy of drug testing and reporting, to resolve problems related to drug testing, and to enforce all standards set forth in these Guidelines. The Secretary has the authority to issue directives to any HHS-certified laboratory, including suspending the use of certain analytical procedures when necessary to protect the integrity of the testing process; ordering any HHS-certified laboratory to undertake corrective actions to respond to material deficiencies identified by an inspection or through performance testing; ordering any HHS-certified laboratory to send specimens or specimen aliquots to another HHS-certified laboratory for retesting when necessary to ensure the accuracy of testing under these Guidelines; ordering the review of results for specimens tested under the Guidelines for private sector clients to the extent necessary to ensure the full reliability of drug testing for federal agencies; and ordering any other action necessary to address deficiencies in drug testing, analysis, specimen collection, chain of custody, reporting of results, or any other aspect of the certification program.
(b) A laboratory is prohibited from stating or implying that it is certified by HHS under these Guidelines to test oral fluid specimens for federal agencies unless it holds such certification.
(a) A laboratory seeking HHS certification must:
(1) Submit a completed OMB-approved application form (
(2) Have its application reviewed as complete and accepted by HHS;
(3) Successfully complete the PT challenges in 3 consecutive sets of initial PT samples;
(4) Satisfy all the requirements for an initial inspection; and
(5) Receive notification of certification from the Secretary before testing specimens for federal agencies.
(a) To maintain HHS certification, a laboratory must:
(1) Successfully participate in both the maintenance PT and inspection programs (
(2) Respond in an appropriate, timely, and complete manner to required corrective action requests if deficiencies are identified in the maintenance PT performance, during the inspections, operations, or reporting; and
(3) Satisfactorily complete corrective remedial actions, and undergo special inspection and special PT sets to maintain or restore certification when material deficiencies occur in either the PT program, inspection program, or in operations and reporting.
(a) A laboratory that does not maintain its HHS certification must:
(1) Stop testing federally regulated specimens;
(2) Ensure the security of federally regulated specimens and records throughout the required storage period described in Sections 11.18, 11.19, and 14.7;
(3) Ensure access to federally regulated specimens and records in accordance with Sections 11.21 and 11.22 and Subpart P; and
(4) Follow the HHS suspension and revocation procedures when imposed by the Secretary, follow the HHS procedures in Subpart P that will be used for all actions associated with the suspension and/or revocation of HHS-certification.
(a) PT samples used to evaluate drug tests will be prepared using the following specifications:
(1) PT samples may contain one or more of the drugs and drug metabolites in the drug classes listed in Section 3.4 and may be sent to the laboratory as undiluted (neat) oral fluid. The PT samples must satisfy one of the following parameters:
(i) The concentration of a drug or metabolite will be at least 20 percent above the initial test cutoff concentration for the drug or drug metabolite;
(ii) The concentration of a drug or metabolite may be less than 40 percent of the confirmatory test cutoff concentration when the PT sample is designated as a retest sample; or
(iii) The concentration of drug or metabolite may differ from 9.5(a)(1)(i) and 9.5(a)(1)(ii) for a special purpose.
(2) A PT sample may contain an interfering substance or other substances for special purposes.
(3) A negative PT sample will not contain a measurable amount of a target analyte.
(b) PT samples used to evaluate specimen validity tests shall satisfy, but are not limited to the following criteria:
(1) The concentration of albumin and/or IgG will be at least 20 percent below the cutoff; or
(2) The concentration of albumin and/or IgG may be another concentration for a special purpose.
(c) The laboratory must (to the greatest extent possible) handle, test, and report a PT sample in a manner identical to that used for a donor specimen, unless otherwise specified.
(a) An applicant laboratory that seeks certification under these Guidelines must satisfy the following criteria on three consecutive sets of PT samples:
(1) Have no false positive results;
(2) Correctly identify, confirm, and report at least 90 percent of the total drug challenges over the three sets of PT samples;
(3) Correctly identify at least 80 percent of the drug challenges for each initial drug test over the three sets of PT samples;
(4) For the confirmatory drug tests, correctly determine the concentrations [
(5) For the confirmatory drug tests, must not obtain any drug concentration that differs by more than ±50 percent from the appropriate reference or peer group mean;
(6) For each confirmatory drug test, correctly identify and determine the concentrations [
(7) Correctly identify at least 80 percent of the total specimen validity testing challenges over the three sets of PT samples;
(8) Correctly identify at least 80 percent of the challenges for each individual specimen validity test over the three sets of PT samples;
(9) For quantitative specimen validity tests, obtain quantitative values for at least 80 percent of the total challenges over the three sets of PT samples that satisfy the following criteria:
(i) Albumin concentrations are no more than ±20 percent or ±2 standard deviations from the appropriate reference or peer group mean; and
(ii) IgG values are no more than ±20 percent or ±2 standard deviations from the appropriate reference or peer group mean;
(b) Failure to satisfy these requirements will result in disqualification.
(a) A laboratory certified under these Guidelines must satisfy the following criteria on the maintenance PT samples:
(1) Have no false positive results;
(2) Correctly identify, confirm, and report at least 90 percent of the total drug challenges over two consecutive PT cycles;
(3) Correctly identify at least 80 percent of the drug challenges for each initial drug test over two consecutive PT cycles;
(4) For the confirmatory drug tests, correctly determine that the concentrations for at least 80 percent of the total drug challenges are no more than ±20 percent or ±2 standard deviations (whichever is larger) from the appropriate reference or peer group means over two consecutive PT cycles;
(5) For the confirmatory drug tests, obtain no more than one drug concentration on a PT sample that differs by more than ±50 percent from the appropriate reference or peer group mean over two consecutive PT cycles;
(6) For each confirmatory drug test, correctly identify and determine that the concentrations for at least 50 percent of the drug challenges for an individual drug are no more than ±20 percent or ±2 standard deviations (whichever is larger) from the appropriate reference or peer group means over two consecutive PT cycles;
(7) Correctly identify at least 80 percent of the total specimen validity testing challenges over two consecutive PT cycles;
(8) Correctly identify at least 80 percent of the challenges for each
(9) For quantitative specimen validity tests, obtain quantitative values for at least 80 percent of the total challenges over two consecutive PT cycles that satisfy the following criteria:
(i) Albumin concentrations are no more than ±20 percent or ±2 standard deviations from the appropriate reference or peer group mean; and
(ii) IgG values are no more than ±20 percent or ±2 standard deviations from the appropriate reference or peer group mean.
(b) Failure to participate in all PT cycles or to satisfy these requirements may result in suspension or revocation of an HHS-certified laboratory's certification.
(a) An applicant laboratory is inspected by a team of two inspectors.
(b) Each inspector conducts an independent review and evaluation of all aspects of the laboratory's testing procedures and facilities using an inspection checklist.
(a) An HHS-certified laboratory must undergo an inspection 3 months after becoming certified and at least every 6 months thereafter.
(b) An HHS-certified laboratory is inspected by one or more inspectors. The number of inspectors is determined according to the number of specimens reviewed. Additional information regarding inspections is available from SAMHSA.
(c) Each inspector conducts an independent evaluation and review of the HHS-certified laboratory's procedures, records, and facilities using guidance provided by the Secretary.
(d) To remain certified, an HHS-certified laboratory must continue to satisfy the minimum requirements as stated in these Guidelines.
(a) An individual may be selected as an inspector for the Secretary if he or she satisfies the following criteria:
(1) Has experience and an educational background similar to that required for either an HHS-certified laboratory responsible person or certifying scientist as described in Subpart K;
(2) Has read and thoroughly understands the policies and requirements contained in these Guidelines and in other guidance consistent with these Guidelines provided by the Secretary;
(3) Submits a resume and documentation of qualifications to HHS;
(4) Attends approved training; and
(5) Performs acceptably as an inspector on an inspection of an HHS-certified laboratory.
(b) The Secretary or a federal agency may conduct an inspection at any time.
If an applicant laboratory fails to satisfy the requirements established for the initial certification process, the laboratory must start the certification process from the beginning.
(a) If an HHS-certified laboratory fails to satisfy the minimum requirements for certification, the laboratory is given a period of time (
(b) A laboratory's HHS certification may be revoked, suspended, or no further action taken depending on the seriousness of the deficiencies and whether there is evidence that the deficiencies have been corrected and that current performance meets the requirements for certification.
(c) An HHS-certified laboratory may be required to undergo a special inspection or to test additional PT samples to address deficiencies.
(d) If an HHS-certified laboratory's certification is revoked or suspended in accordance with the process described in Subpart P, the laboratory is not permitted to test federally regulated specimens until the suspension is lifted or the laboratory has successfully completed the certification requirements as a new applicant laboratory.
(a) The Secretary shall revoke certification of an HHS-certified laboratory in accordance with these Guidelines if the Secretary determines that revocation is necessary to ensure fully reliable and accurate drug test results and reports.
(b) The Secretary shall consider the following factors in determining whether revocation is necessary:
(1) Unsatisfactory performance in analyzing and reporting the results of drug tests (
(2) Unsatisfactory participation in performance testing or inspections;
(3) A material violation of a certification standard, contract term, or other condition imposed on the HHS-certified laboratory by a federal agency using the laboratory's services;
(4) Conviction for any criminal offense committed as an incident to operation of the HHS-certified laboratory; or
(5) Any other cause that materially affects the ability of the HHS-certified laboratory to ensure fully reliable and accurate drug test results and reports.
(c) The period and terms of revocation shall be determined by the Secretary and shall depend upon the facts and circumstances of the revocation and the need to ensure accurate and reliable drug testing.
(a) The Secretary may immediately suspend (either partially or fully) a laboratory's HHS certification to conduct drug testing for federal agencies if the Secretary has reason to believe that revocation may be required and that immediate action is necessary to protect the interests of the United States and its employees.
(b) The Secretary shall determine the period and terms of suspension based upon the facts and circumstances of the suspension and the need to ensure accurate and reliable drug testing.
(a) When a laboratory's HHS certification is suspended or the Secretary seeks to revoke HHS certification, the Secretary shall immediately serve the HHS-certified laboratory with written notice of the suspension or proposed revocation by facsimile, mail, personal service, or registered or certified mail, return receipt requested. This notice shall state the following:
(1) The reasons for the suspension or proposed revocation;
(2) The terms of the suspension or proposed revocation; and
(3) The period of suspension or proposed revocation.
(b) The written notice shall state that the laboratory will be afforded an opportunity for an informal review of the suspension or proposed revocation if it so requests in writing within 30 days of the date the laboratory received the notice, or if expedited review is requested, within 3 days of the date the laboratory received the notice. Subpart P contains detailed procedures to be followed for an informal review of the suspension or proposed revocation.
(c) A suspension must be effective immediately. A proposed revocation must be effective 30 days after written notice is given or, if review is requested, upon the reviewing official's decision to uphold the proposed revocation. If the reviewing official decides not to uphold the suspension or proposed revocation, the suspension must terminate immediately and any proposed revocation shall not take effect.
(d) The Secretary will publish in the
Following revocation, a laboratory may apply for recertification. Unless otherwise provided by the Secretary in the notice of revocation under Section 9.15 or the reviewing official's decision under Section 16.9(e) or 16.14(a), a laboratory which has had its certification revoked may reapply for HHS certification as an applicant laboratory.
(a) The list of HHS-certified laboratories is published monthly in the
(b) An applicant laboratory is not included on the list.
(a) Each federal agency is required to submit blind samples for its workplace drug testing program. The collector must send the blind samples to the HHS-certified laboratory that the collector sends employee specimens.
(b) Each federal agency must submit at least 3 percent blind samples along with its donor specimens based on the projected total number of donor specimens collected per year (up to a maximum of 400 blind samples). Every effort should be made to ensure that blind samples are submitted quarterly.
(c) Approximately 75 percent of the blind samples submitted each year by an agency must be negative and 25 percent must be positive for one or more drugs.
(a) Drug positive blind samples must be validated by the supplier in the selected manufacturer's collection device as to their content using appropriate initial and confirmatory tests.
(1) Drug positive blind samples must be fortified with one or more of the drugs or metabolites listed in Section 3.4.
(2) Drug positive blind samples must contain concentrations of drugs between 1.5 and 2 times the initial drug test cutoff concentration.
(b) Drug negative blind samples (
(c) The supplier must provide information on the blind samples' content, validation, expected results, and stability to the collection site/collector sending the blind samples to the laboratory or IITF, and must provide the information upon request to the MRO, the federal agency for which the blind sample was submitted, or the Secretary.
(a) A blind sample must be submitted in the collection device with the current Federal CCF that the HHS-certified laboratory uses for donor specimens. The collector provides the required information to ensure that the Federal CCF has been properly completed and provides fictitious initials on the specimen label/seal. The collector must indicate that the specimen is a blind sample on the MRO copy where a donor would normally provide a signature.
(b) A collector should attempt to distribute the required number of blind samples randomly with donor specimens rather than submitting the full complement of blind samples as a single group.
If an HHS-certified laboratory reports a result for a blind sample that is inconsistent with the expected result (
(a) The MRO must contact the laboratory and attempt to determine if the laboratory made an error during the testing or reporting of the sample;
(b) The MRO must contact the blind sample supplier and attempt to determine if the supplier made an error during the preparation or transfer of the sample;
(c) The MRO must contact the collector and determine if the collector made an error when preparing the blind sample for transfer to the HHS-certified laboratory;
(d) If there is no obvious reason for the inconsistent result, the MRO must notify both the federal agency for which the blind sample was submitted and the Secretary; and
(e) The Secretary shall investigate the blind sample error. A report of the Secretary's investigative findings and the corrective action taken in response to identified deficiencies must be sent to the federal agency. The Secretary shall ensure notification of the finding as appropriate to other federal agencies and coordinate any necessary actions to prevent the recurrence of the error.
(a) An HHS-certified laboratory must have a standard operating procedure (SOP) manual that describes, in detail, all HHS-certified laboratory operations. When followed, the SOP manual ensures that all specimens are tested using the same procedures.
(b) The SOP manual must include at a minimum, but is not limited to, a detailed description of the following:
(1) Chain of custody procedures;
(2) Accessioning;
(3) Security;
(4) Quality control/quality assurance programs;
(5) Analytical methods and procedures;
(6) Equipment and maintenance programs;
(7) Personnel training;
(8) Reporting procedures; and
(9) Computers, software, and laboratory information management systems.
(c) All procedures in the SOP manual must be compliant with these Guidelines and all guidance provided by the Secretary.
(d) A copy of all procedures that have been replaced or revised and the dates on which the procedures were in effect must be maintained for at least 2 years.
(a) Manage the day-to-day operations of the HHS-certified laboratory even if another individual has overall responsibility for alternate areas of a multi-specialty laboratory.
(b) Ensure that there are sufficient personnel with adequate training and experience to supervise and conduct the work of the HHS-certified laboratory. The RP must ensure the continued competency of laboratory staff by documenting their in-service training, reviewing their work performance, and verifying their skills.
(c) Maintain a complete and current SOP manual that is available to all personnel of the HHS-certified laboratory and ensure that it is followed. The SOP manual must be reviewed, signed, and dated by the RP(s) when procedures are first placed into use and when changed or when a new individual assumes responsibility for the management of the HHS-certified laboratory. The SOP must be reviewed and documented by the RP annually.
(d) Maintain a quality assurance program that ensures the proper performance and reporting of all test results; verify and monitor acceptable analytical performance for all controls and calibrators; monitor quality control testing; and document the validity, reliability, accuracy, precision, and performance characteristics of each test and test system.
(e) Initiate and implement all remedial actions necessary to maintain satisfactory operation and performance of the HHS-certified laboratory in response to the following: quality control systems not within performance specifications; errors in result reporting or in analysis of performance testing samples; and inspection deficiencies. The RP must ensure that specimen results are not reported until all corrective actions have been taken and that the results provided are accurate and reliable.
The RP must have documented scientific qualifications in analytical toxicology. Minimum qualifications are:
(a) Certification or licensure as a laboratory director by the state in forensic or clinical laboratory toxicology, a Ph.D. in one of the natural sciences, or training and experience comparable to a Ph.D. in one of the natural sciences with training and laboratory/research experience in biology, chemistry, and pharmacology or toxicology;
(b) Experience in forensic toxicology with emphasis on the collection and analysis of biological specimens for drugs of abuse;
(c) Experience in forensic applications of analytical toxicology (
(d) Fulfillment of the RP responsibilities and qualifications, as demonstrated by the HHS-certified laboratory's performance and verified upon interview by HHS-trained inspectors during each on-site inspection; and
(e) Qualify as a certifying scientist.
(a) HHS-certified laboratories must have multiple RPs or one RP and an alternate RP. If the RP(s) are concurrently absent, an alternate RP must be present and qualified to fulfill the responsibilities of the RP.
(1) If an HHS-certified laboratory is without the RP and alternate RP for 14 calendar days or less (
(2) The Secretary, in accordance with these Guidelines, will suspend a laboratory's HHS certification for all specimens if the laboratory does not have an RP or alternate RP for a period of more than 14 calendar days. The suspension will be lifted upon the Secretary's approval of a new permanent RP or alternate RP.
(b) If the RP leaves an HHS-certified laboratory:
(1) The HHS-certified laboratory may maintain certification and continue testing federally regulated specimens under the direction of an alternate RP for a period of up to 180 days while seeking to hire and receive the Secretary's approval of the RP's replacement.
(2) The Secretary, in accordance with these Guidelines, will suspend a laboratory's HHS certification for all federally regulated specimens if the laboratory does not have a permanent RP within 180 days. The suspension will be lifted upon the Secretary's approval of the new permanent RP.
(c) To nominate an individual as an RP or alternate RP, the HHS-certified laboratory must submit the following documents to the Secretary: the candidate's current resume or curriculum vitae, copies of diplomas and licensures, a training plan (not to exceed 90 days) to transition the candidate into the position, an itemized comparison of the candidate's qualifications to the minimum RP qualifications described in the Guidelines, and have official academic transcript(s) submitted from the candidate's institution(s) of higher learning. The candidate must be found qualified during an on-site inspection of the HHS-certified laboratory.
(d) The HHS-certified laboratory must fulfill additional inspection and PT criteria as required prior to conducting federally regulated testing under a new RP.
(a) A certifying scientist must have:
(1) At least a bachelor's degree in the chemical or biological sciences or medical technology, or equivalent;
(2) Training and experience in the analytical methods and forensic procedures used by the HHS-certified laboratory relevant to the results that the individual certifies; and
(3) Training and experience in reviewing and reporting forensic test results and maintaining chain of custody, and an understanding of appropriate remedial actions in response to problems that may arise.
(b) A certifying technician must have:
(1) Training and experience in the analytical methods and forensic procedures used by the HHS-certified laboratory relevant to the results that the individual certifies; and
(2) Training and experience in reviewing and reporting forensic test results and maintaining chain of custody, and an understanding of appropriate remedial actions in response to problems that may arise.
(a) All HHS-certified laboratory staff (
(b) Each individual working in an HHS-certified laboratory must be properly trained (
(a) An HHS-certified laboratory must control access to the drug testing facility, specimens, aliquots, and records.
(b) Authorized visitors must be escorted at all times, except for individuals conducting inspections (
(c) An HHS-certified laboratory must maintain records documenting the identity of the visitor and escort, date, time of entry and exit, and purpose for access to the secured area.
(a) HHS-certified laboratories must use chain of custody procedures (internal and external) to maintain control and accountability of specimens from the time of receipt at the laboratory through completion of testing, reporting of results, during storage, and continuing until final disposition of the specimens.
(b) HHS-certified laboratories must use chain of custody procedures to document the handling and transfer of aliquots throughout the testing process until final disposal.
(c) The chain of custody must be documented using either paper copy or electronic procedures.
(d) Each individual who handles a specimen or aliquot must sign and complete the appropriate entries on the chain of custody form when the specimen or aliquot is handled or transferred, and every individual in the chain must be identified.
(e) The date and purpose must be recorded on an appropriate chain of custody form each time a specimen or aliquot is handled or transferred.
(a) An initial drug test may be:
(1) An immunoassay or
(2) An alternate technology (
(b) An HHS-certified laboratory must validate an initial drug test before testing specimens.
(c) Initial drug tests must be accurate and reliable for the testing of specimens when identifying drugs or their metabolites.
(d) An HHS-certified laboratory may conduct a second initial drug test using a method with different specificity, to rule out cross-reacting compounds. This second initial drug test must satisfy the batch quality control requirements specified in Section 11.11.
(a) An HHS-certified laboratory must demonstrate and document the following for each initial drug test:
(1) The ability to differentiate negative specimens from those requiring further testing;
(2) The performance of the test around the cutoff concentration, using samples at several concentrations between 0 and 150 percent of the cutoff concentration;
(3) The effective concentration range of the test (linearity);
(4) The potential for carryover;
(5) The potential for interfering substances; and
(6) The potential matrix effects if using an alternate technology.
(b) Each new lot of reagent must be verified prior to being placed into service.
(c) Each initial drug test using an alternate technology must be re-verified periodically or at least annually.
(a) Each batch of specimens must contain the following controls:
(1) At least one control certified to contain no drug or drug metabolite;
(2) At least one positive control with the drug or drug metabolite targeted at a concentration 25 percent above the cutoff;
(3) At least one control with the drug or drug metabolite targeted at a concentration 75 percent of the cutoff; and
(4) At least one control that appears as a donor specimen to the analysts.
(b) Calibrators and controls must total at least 10 percent of the aliquots analyzed in each batch.
(a) The analytical method must use mass spectrometric identification [
(b) A confirmatory drug test must be validated before it can be used to test federally regulated specimens.
(c) Confirmatory drug tests must be accurate and reliable for the testing of an oral fluid specimen when identifying and quantifying drugs or their metabolites.
(a) An HHS-certified laboratory must demonstrate and document the following for each confirmatory drug test:
(1) The linear range of the analysis;
(2) The limit of detection;
(3) The limit of quantification;
(4) The accuracy and precision at the cutoff concentration;
(5) The accuracy (bias) and precision at 40 percent of the cutoff concentration;
(6) The potential for interfering substances;
(7) The potential for carryover; and
(8) The potential matrix effects if using liquid chromatography coupled with mass spectrometry.
(b) Each new lot of reagent must be verified prior to being placed into service.
(c) HHS-certified laboratories must re-verify each confirmatory drug test method periodically or at least annually.
(a) At a minimum, each batch of specimens must contain the following calibrators and controls:
(1) A calibrator at the cutoff concentration;
(2) At least one control certified to contain no drug or drug metabolite;
(3) At least one positive control with the drug or drug metabolite targeted at 25 percent above the cutoff; and
(4) At least one control targeted at or less than 40 percent of the cutoff.
(b) Calibrators and controls must total at least 10 percent of the aliquots analyzed in each batch.
(a) Each specimen validity test result must be based on performing an initial specimen validity test on one aliquot and a second or confirmatory test on a second aliquot;
(b) The HHS-certified laboratory must establish acceptance criteria and analyze calibrators and controls as appropriate to verify and document the validity of the test results; and
(c) Controls must be analyzed concurrently with specimens.
An HHS-certified laboratory must demonstrate and document for each specimen validity test the appropriate performance characteristics of the test, and must re-verify the test periodically, or at least annually. Each new lot of reagent must be verified prior to being placed into service.
(a) Laboratories must report a test result to the agency's MRO within an average of 5 working days after receipt of the specimen. Reports must use the Federal CCF and/or an electronic report. Before any test result can be reported, it must be certified by a certifying scientist or a certifying technician (as appropriate).
(b) A primary (A) specimen is reported negative when each initial drug test is negative or if the specimen is negative upon confirmatory drug testing, and the specimen does not meet invalid criteria as described in items (e)(1) through (e)(4) below.
(c) A primary (A) specimen is reported positive for a specific drug or drug metabolite when both the initial drug test is positive and the confirmatory drug test is positive in accordance with Section 3.4.
(d) For a specimen that has an invalid result for one of the reasons stated in items (e)(1) through (e)(4) below, the HHS-certified laboratory shall contact the MRO and both will decide if testing by another HHS-certified laboratory would be useful in being able to report a positive or adulterated result. If no further testing is necessary, the HHS-certified laboratory then reports the invalid result to the MRO.
(e) A primary (A) oral fluid specimen is reported as an invalid result when:
(1) Interference occurs on the initial drug tests on two separate aliquots (
(2) Interference with the confirmatory drug test occurs on at least two separate aliquots of the specimen and the HHS-certified laboratory is unable to identify the interfering substance;
(3) The physical appearance of the specimen is such that testing the specimen may damage the laboratory's instruments;
(4) The physical appearances of Tubes A and B are clearly different (note: A is tested);
(5) The albumin concentration is less than 0.6 mg/dL for both the initial (first) test and the second test on two separate aliquots;
(6) The IgG concentration is less than 0.5 mg/L for both the initial (first) test and the second test on two separate aliquots; or
(7) The concentration of a biomarker other than albumin or IgG is not consistent with that established for human oral fluid.
(f) An HHS-certified laboratory shall reject a primary (A) oral fluid specimen for testing when a fatal flaw occurs as described in Section 15.1 or when a correctable flaw as described in Section 15.2 is not recovered. The HHS-certified laboratory will indicate on the Federal CCF that the specimen was rejected for testing and provide the reason for reporting the rejected for testing result.
(g) An HHS-certified laboratory must report all positive, adulterated, and invalid test results for an oral fluid specimen. For example, a specimen can be positive for a specific drug and adulterated.
(h) An HHS-certified laboratory must report the confirmatory concentration of each drug or drug metabolite reported for a positive result.
(i) An HHS-certified laboratory must report numerical values of the specimen validity test results that support a specimen that is reported adulterated or invalid (as appropriate).
(j) When the concentration of a drug or drug metabolite exceeds the validated linear range of the confirmatory test, HHS-certified laboratories may report to the MRO that the quantitative value exceeds the linear range of the test or that the quantitative value is greater than “insert the actual value for the upper limit of the linear range,” or laboratories may report a quantitative value above the upper limit of the linear range that was obtained by diluting an aliquot of the specimen to achieve a result within the method's linear range and multiplying the result by the appropriate dilution factor.
(k) HHS-certified laboratories may transmit test results to the MRO by various electronic means (
(l) HHS-certified laboratories must facsimile, courier, mail, or electronically transmit a legible image or copy of the completed Federal CCF and/or forward a computer-generated electronic report. The computer-generated report must contain sufficient information to ensure that the test results can accurately represent the content of the custody and control form that the MRO received from the collector.
(m) For positive, adulterated, invalid, and rejected specimens, laboratories must facsimile, courier, mail, or electronically transmit a legible image or copy of the completed Federal CCF.
(a) An HHS-certified laboratory must retain specimens that were reported as positive, adulterated, or as an invalid result for a minimum of 1 year.
(b) Retained specimens must be kept in secured frozen storage (−20 °C or less) to ensure their availability for retesting during an administrative or judicial proceeding.
(c) Federal agencies may request that the HHS-certified laboratory retain a specimen for an additional specified period of time and must make that request within the 1-year period.
(a) An HHS-certified laboratory must retain all records generated to support test results for at least 2 years. The laboratory may convert hardcopy records to electronic records for storage and then discard the hardcopy records after 6 months.
(b) A federal agency may request the HHS-certified laboratory to maintain a documentation package (as described in Section 11.21) that supports the chain of custody, testing, and reporting of a donor's specimen that is under legal challenge by a donor. The federal agency's request to the laboratory must be in writing and must specify the period of time to maintain the documentation package.
(c) An HHS-certified laboratory may retain records other than those included in the documentation package beyond the normal 2-year period of time.
(a) HHS-certified laboratories must provide to each federal agency for which they perform testing a semiannual statistical summary report that must be submitted by mail, facsimile, or email within 14 working days after the end of the semiannual period. The summary report must not include any personal identifying information. A copy of the semiannual statistical summary report will also be sent to the Secretary or designated HHS representative. The semiannual statistical report contains the following information:
(1) Reporting period (inclusive dates);
(2) HHS-certified laboratory name and address;
(3) Federal agency name;
(4) Number of specimen results reported;
(5) Number of specimens collected by reason for test;
(6) Number of specimens reported negative;
(7) Number of specimens rejected for testing because of a fatal flaw;
(8) Number of specimens rejected for testing because of an uncorrected flaw;
(9) Number of specimens tested positive by each initial drug test;
(10) Number of specimens reported positive;
(11) Number of specimens reported positive for each drug and drug metabolite;
(12) Number of specimens reported adulterated; and
(13) Number of specimens reported as invalid result.
(b) An HHS-certified laboratory must make copies of an agency's test results available when requested to do so by the Secretary or by the federal agency for which the laboratory is performing drug-testing services.
(c) An HHS-certified laboratory must ensure that a qualified individual is available to testify in a proceeding against a federal employee when the proceeding is based on a test result reported by the laboratory.
(a) Following a federal agency's receipt of a positive or adulterated drug test report, the federal agency may submit a written request for copies of the records relating to the drug test results or a documentation package or any relevant certification, review, or revocation of certification records.
(b) Standard documentation packages provided by an HHS-certified laboratory must contain the following items:
(1) A cover sheet providing a brief description of the procedures and tests performed on the donor's specimen;
(2) A table of contents that lists all documents and materials in the package by page number;
(3) A copy of the Federal CCF with any attachments, internal chain of custody records for the specimen, memoranda (if any) generated by the HHS-certified laboratory, and a copy of the electronic report (if any) generated by the HHS-certified laboratory;
(4) A brief description of the HHS-certified laboratory's initial drug and specimen validity testing procedures, instrumentation, and batch quality control requirements;
(5) Copies of the initial test data for the donor's specimen with all calibrators and controls and copies of all internal chain of custody documents related to the initial tests;
(6) A brief description of the HHS-certified laboratory's confirmatory drug (and specimen validity, if applicable) testing procedures, instrumentation, and batch quality control requirements;
(7) Copies of the confirmatory test data for the donor's specimen with all calibrators and controls and copies of all internal chain of custody documents related to the confirmatory tests; and
(8) Copies of the résumé or curriculum vitae for the RP(s) and the certifying technician or certifying scientist of record.
A federal employee who is the subject of a workplace drug test may submit a written request through the MRO and the federal agency requesting copies of any records relating to his or her drug test results or a documentation package as described in Section 11.21(b) and any relevant certification, review, or revocation of certification records. Federal employees, or their designees, are not permitted access to their specimens collected pursuant to Executive Order 12564, Public Law 100-71, and these Guidelines.
An HHS-certified laboratory must not enter into any relationship with a federal agency's MRO that may be construed as a potential conflict of interest or derive any financial benefit by having a federal agency use a specific MRO.
This means an MRO may be an employee of the agency or a contractor for the agency; however, an MRO shall not be an employee or agent of or have any financial interest in the HHS-certified laboratory for which the MRO is reviewing drug testing results. Additionally, an MRO shall not derive any financial benefit by having an agency use a specific HHS-certified laboratory or have any agreement with an HHS-certified laboratory that may be construed as a potential conflict of interest.
No, only HHS-certified laboratories are authorized to test oral fluid specimens for federal agency workplace drug testing programs in accordance with these Guidelines.
(a) A currently licensed physician who has:
(1) A Doctor of Medicine (M.D.) or Doctor of Osteopathy (D.O.) degree;
(2) Knowledge regarding the pharmacology and toxicology of illicit drugs and nonmedical use of prescription drugs;
(3) The training necessary to serve as an MRO as set out in Section 13.3;
(4) Satisfactorily passed an initial examination administered by a nationally recognized entity or subspecialty board that has been approved by the Secretary to certify MROs; and
(5) At least every five years, completed requalification training on the topics in Section 13.3 and satisfactorily passed a requalification examination administered by a nationally recognized entity or a subspecialty board that has been approved by the Secretary to certify MROs.
All nationally recognized entities or subspecialty boards which seek approval by the Secretary to certify and/or train physicians as MROs for federal workplace drug testing programs must submit their qualifications and, if
(a) A physician must receive training that includes a thorough review of the following:
(1) The collection procedures used to collect federal agency specimens;
(2) How to interpret test results reported by HHS-certified laboratories (
(3) Chain of custody, reporting, and recordkeeping requirements for federal agency specimens;
(4) The HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs for all authorized specimen types;
(5) Procedures for interpretation, review (
(6) Training in Substance Abuse including information about how to discuss substance misuse and abuse, and how individuals that test positive can access services.
(b) Nationally recognized entities or subspecialty boards that train or certify physicians as MROs should make the MROs aware of prevention and treatment opportunities for individuals after testing positive.
(a) The MRO must review all positive, adulterated, rejected for testing, invalid, and (for urine) substituted test results.
(b) Staff under the direct, personal supervision of the MRO may review and report negative and (for urine) negative/dilute test results to the agency's designated representative. The MRO must review at least 5 percent of all negative results reported by the MRO staff to ensure that the MRO staff are properly performing the review process.
(c) The MRO must discuss potential invalid results with the HHS-certified laboratory, as addressed in Section 11.17(d) to determine whether testing at another HHS-certified laboratory may be warranted.
(d) After receiving a report from an HHS-certified laboratory or (for urine) HHS-certified IITF, the MRO must:
(1) Review the information on the MRO copy of the Federal CCF that was received from the collector and the report received from the HHS-certified laboratory or HHS-certified IITF;
(2) Interview the donor when required;
(3) Make a determination regarding the test result; and
(4) Report the verified result to the federal agency.
(e) The MRO must maintain records for a minimum of 2 years while maintaining the confidentiality of the information. The MRO may convert hardcopy records to electronic records for storage and discard the hardcopy records after 6 months.
(f) The MRO must conduct a medical examination or a review of the examining physician's findings and make a determination of refusal to test or cancelled test when a collector reports that the donor was unable to provide a specimen, as addressed in Section 8.6.
(a) When the HHS-certified laboratory reports a negative result for the primary (A) specimen, the MRO reports a negative result to the agency.
(b) When the HHS-certified laboratory reports multiple results for the primary (A) specimen, as the MRO, you must follow the verification procedures described in 13.5(c) through (f) and:
(1) Report all verified positive and/or refusal to test results to the federal agency.
(2) If an invalid result was reported in conjunction with a positive or adulterated result, do not report the verified invalid result to the federal agency at this time. The MRO reports the verified invalid result(s) for the primary (A) specimen only if the split specimen is tested and reported as a failure to reconfirm as described in Section 14.5(c).
(c) When the HHS-certified laboratory reports a positive result for the primary (A) specimen, the MRO must contact the donor to determine if there is any legitimate medical explanation for the positive result.
(1) If the donor provides a legitimate medical explanation for the positive result, the MRO reports the test result as negative to the agency.
(2) If the donor is unable to provide a legitimate medical explanation, the MRO reports a positive result to the agency for all drugs except codeine and/or morphine as follows:
(i) For codeine and/or morphine less than 150 ng/mL and no legitimate medical explanation: the MRO must determine if there is clinical evidence of illegal use (in addition to the drug test result) to report a positive result to the agency. If there is no clinical evidence of illegal use, the MRO reports a negative result to the agency.
(ii) For codeine and/or morphine at or above 150 ng/mL and no legitimate medical explanation: the MRO reports a positive result to the agency. Consumption of food products must not be considered a legitimate medical explanation for the donor having morphine or codeine at or above this concentration.
(d) When the HHS-certified laboratory reports an adulterated result for the primary (A) oral fluid specimen, the MRO contacts the donor to determine if the donor has a legitimate medical explanation for the adulterated result.
(1) If the donor provides a legitimate medical explanation, the MRO reports a negative result to the federal agency.
(2) If the donor is unable to provide a legitimate medical explanation, the MRO reports a refusal to test to the federal agency because the oral fluid specimen was adulterated.
(e) When the HHS-certified laboratory reports an invalid result for the primary (A) oral fluid specimen, the MRO must contact the donor to determine if there is a legitimate explanation for the invalid result.
(1) If the donor provides a legitimate explanation (
(2) If the donor is unable to provide a legitimate explanation, the MRO reports a test cancelled result and directs the agency to collect another specimen from the donor.
(i) If the second specimen collected provides a valid result, the MRO follows the procedures in Section 13.5(a) through (d).
(ii) If the second specimen collected provides an invalid result, the MRO
(f) When the HHS-certified laboratory reports a rejected for testing result on the primary (A) specimen, the MRO reports a test cancelled result to the agency and recommends that the agency collect another specimen from the donor.
(a) When another specimen type (
(b) When the federal agency did not authorize the collection of an alternative specimen, the MRO consults with the federal agency. The federal agency immediately directs the donor to obtain, within five days, an evaluation from a licensed physician, acceptable to the MRO, who has expertise in the medical issues raised by the donor's failure to provide a specimen. The MRO may perform this evaluation if the MRO has appropriate expertise.
(1) For purposes of this section, a medical condition includes an ascertainable physiological condition. Permanent or long-term medical conditions are those physiological, anatomic, or psychological abnormalities documented as being present prior to the attempted collection, and considered not amenable to correction or cure for an extended period of time, if ever.
(2) As the MRO, if another physician will perform the evaluation, you must provide the other physician with the following information and instructions:
(i) That the donor was required to take a federally regulated drug test, but was unable to provide a sufficient amount of oral fluid to complete the test;
(ii) The consequences of the appropriate federal agency regulation for refusing to take the required drug test;
(iii) That, after completing the evaluation, the referral physician must agree to provide a written statement to the MRO with a recommendation for one of the determinations described in paragraph (b)(3) of this section and the basis for the recommendation. The statement must not include detailed information on the employee's medical condition beyond what is necessary to explain the referral physician's conclusion.
(3) As the MRO, if another physician performed the evaluation, you must consider and assess the referral physician's recommendations in making your determination. You must make one of the following determinations and report it to the federal agency in writing:
(i) A medical condition as defined in paragraph (b)(1) of this section has, or with a high degree of probability could have, precluded the employee from providing a sufficient amount of oral fluid, but is not a permanent or long-term disability. As the MRO, you must report a test cancelled result to the federal agency.
(ii) A permanent or long-term medical condition as defined in paragraph (b)(1) of this section has, or with a high degree of probability could have, precluded the employee from providing a sufficient amount of oral fluid and is highly likely to prevent the employee from providing a sufficient amount of oral fluid for a very long or indefinite period of time. As the MRO, you must follow the requirements of Section 13.7, as appropriate. If Section 13.7 is not applicable, you report a test cancelled result to the federal agency and recommend that the agency authorize collection of an alternative specimen type (
(iii) There is not an adequate basis for determining that a medical condition has or, with a high degree of probability, could have precluded the employee from providing a sufficient amount of oral fluid. As the MRO, you must report a refusal to test to the federal agency.
(4) When a federal agency receives a report from the MRO indicating that a test is cancelled as provided in paragraph (b)(3)(i) of this section, the agency takes no further action with respect to the donor. When a test is canceled as provided in paragraph (b)(3)(ii) of this section, the agency takes no further action with respect to the donor other than designating collection of an alternate specimen type (
(a) This section concerns a situation in which the donor has a medical condition that precludes him or her from providing a sufficient specimen for a federal agency applicant/pre-employment test, a follow-up test, or a return-to-duty test and the condition involves a permanent or long-term disability and the federal agency does not authorize collection of an alternative specimen. As the MRO in this situation, you must do the following:
(1) You must determine if there is clinical evidence that the individual is an illicit drug user. You must make this determination by personally conducting, or causing to be conducted, a medical evaluation and through consultation with the donor's physician and/or the physician who conducted the evaluation under Section 13.6.
(2) If you do not personally conduct the medical evaluation, you must ensure that one is conducted by a licensed physician acceptable to you.
(b) If the medical evaluation reveals no clinical evidence of drug use, as the MRO, you must report the result to the federal agency as a negative test with written notations regarding results of both the evaluation conducted under Section 13.6 and any further medical examination. This report must state the basis for the determination that a permanent or long-term medical condition exists, making provision of a sufficient oral fluid specimen impossible, and for the determination that no signs and symptoms of drug use exist. The MRO recommends that the agency authorize collection of an alternate specimen type (
(c) If the medical evaluation reveals clinical evidence of drug use, as the MRO, you must report the result to the federal agency as a cancelled test with written notations regarding results of both the evaluation conducted under Section 13.6 and any further medical examination. This report must state that a permanent or long-term medical condition [as defined in Section 13.6(b)(1)] exists, making provision of a sufficient oral fluid specimen impossible, and state the reason for the determination that signs and symptoms of drug use exist. Because this is a cancelled test, it does not serve the purposes of a negative test (
(a) For a positive or adulterated result reported on a primary (A) specimen, a donor may request through the MRO that the split (B) specimen be tested by a second HHS-certified laboratory to verify the result reported by the first HHS-certified laboratory.
(b) The donor has 72 hours (from the time the MRO notified the donor that his or her specimen was reported positive, adulterated, or (for urine) substituted to request a test of the split (B) specimen. The MRO must inform the donor that he or she has the opportunity to request a test of the split (B) specimen when the MRO informs the donor that a positive, adulterated, or (for urine) substituted result is being reported to the federal agency on the primary (A) specimen.
(a) The MRO must report all verified results to an agency using the completed MRO copy of the Federal CCF or a separate report using a letter/memorandum format. The MRO may use various electronic means for reporting (
(b) A verified result may not be reported to the agency until the MRO has completed the review process.
(c) The MRO must send a copy of either the completed MRO copy of the Federal CCF or the separate letter/memorandum report for all positive, adulterated, and (for urine) substituted results.
(d) The MRO must not disclose numerical values of drug test results to the agency.
An MRO must not be an employee, agent of, or have any financial interest in an HHS-certified laboratory for which the MRO is reviewing drug test results.
This means an MRO must not derive any financial benefit by having an agency use a specific HHS-certified laboratory or have any agreement with the HHS-certified laboratory that may be construed as a potential conflict of interest.
(a) The donor may verbally request through the MRO that the split (B) specimen be tested at a different (
(b) A donor has 72 hours to initiate the verbal request after being informed of the result by the MRO. The MRO must document in his or her records the verbal request from the donor to have the split (B) specimen tested.
(c) If a split (B) oral fluid specimen cannot be tested by a second HHS-certified laboratory (
(d) If a donor chooses not to have the split (B) specimen tested by a second HHS-certified oral fluid laboratory, a federal agency may have a split (B) specimen retested as part of a legal or administrative proceeding to defend an original positive, adulterated, or (for urine) substituted result.
(a) The testing of a split (B) specimen for a drug or metabolite is not subject to the testing cutoff concentrations established.
(b) The HHS-certified laboratory is only required to confirm the presence of the drug or metabolite that was reported positive in the primary (A) specimen.
(a) The HHS-certified laboratory must use its confirmatory specimen validity test at an established limit of quantification (LOQ) to reconfirm the presence of the adulterant.
(b) The second HHS-certified laboratory may only conduct the confirmatory specimen validity test(s) needed to reconfirm the adulterated result reported by the first HHS-certified laboratory.
The second HHS-certified laboratory must report the result to the MRO.
The MRO takes the following actions when the second HHS-certified laboratory reports the result for the split oral fluid specimen as:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(a) The MRO must report all verified results to an agency using the completed MRO copy of the Federal CCF or a separate report using a letter/memorandum format. The MRO may use various electronic means for reporting (
(b) A verified result may not be reported to the agency until the MRO has completed the review process.
(c) The MRO must send a copy of either the completed MRO copy of the Federal CCF or the separate letter/memorandum report for all split specimen results.
(d) The MRO must not disclose the numerical values of the drug test results to the agency.
A split (B) specimen is retained for the same period of time that a primary (A) specimen is retained and under the same storage conditions. This applies even for those cases when the split (B) specimen is tested by a second HHS-certified laboratory and the second HHS-certified laboratory does not confirm the original result reported by the first HHS-certified laboratory for the primary (A) specimen.
The following discrepancies are considered to be fatal flaws. The HHS-certified laboratory must stop the testing process, reject the specimen for testing, and indicate the reason for rejecting the specimen on the Federal CCF when:
(a) The specimen ID number on the specimen label/seal does not match the ID number on the Federal CCF, or the ID number is missing either on the Federal CCF or on either specimen label/seal;
(b) The primary (A) specimen label/seal is broken or shows evidence of tampering and the split (B) specimen cannot be re-designated as the primary (A) specimen;
(c) The collector's printed name and signature are omitted on the Federal CCF;
(d) There is an insufficient amount of specimen for analysis in the primary (A) specimen unless the split (B) specimen can be re-designated as the primary (A) specimen; or
(e) The accessioner failed to document the primary (A) specimen seal condition on the Federal CCF at the time of accessioning, and the split (B) specimen cannot be re-designated as the primary (A) specimen.
The following discrepancies are considered to be correctable:
(a) If a collector failed to sign the Federal CCF, the HHS-certified laboratory must attempt to recover the collector's signature before reporting the test result. If the collector can provide a memorandum for record recovering the signature, the HHS-certified laboratory may report the test result for the specimen. If, after holding the specimen for at least 5 business days, the HHS-certified laboratory cannot recover the collector's signature, the laboratory must report a rejected for testing result and indicate the reason for the rejected for testing result on the Federal CCF.
(b) If a specimen is submitted using a non-federal form or an expired Federal CCF, the HHS-certified laboratory must test the specimen and also attempt to obtain a memorandum for record explaining why a non-federal form or an expired Federal CCF was used and ensure that the form used contains all
(a) The following omissions and discrepancies on the Federal CCF that are received by the HHS-certified laboratory are considered insignificant and should not cause an HHS-certified laboratory to reject an oral fluid specimen or cause an MRO to cancel a test:
(1) An incorrect laboratory name and address appearing at the top of the form;
(2) Incomplete/incorrect/unreadable employer name or address;
(3) MRO name is missing;
(4) Incomplete/incorrect MRO address;
(5) A transposition of numbers in the donor's SSN;
(6) A telephone number is missing/incorrect;
(7) A fax number is missing/incorrect;
(8) A “reason for test” box is not marked;
(9) A “drug tests to be performed” box is not marked;
(10) A “specimen collection” box is not marked;
(11) The lot number of the collection device used for the collection is missing;
(12) The collection site address is missing;
(13) The collector's printed name is missing but the collector's signature is properly recorded;
(14) The time of collection is not indicated;
(15) The date of collection is not indicated;
(16) Incorrect name of delivery service;
(17) The collector has changed or corrected information by crossing out the original information on either the Federal CCF or specimen label/seal without dating and initialing the change; or
(18) The donor's name inadvertently appears on the HHS-certified laboratory copy of the Federal CCF or on the tamper-evident labels used to seal the specimens.
(b) The following omissions and discrepancies on the Federal CCF that are made at the HHS-certified laboratory are considered insignificant and should not cause an MRO to cancel a test:
(1) The testing laboratory fails to indicate the correct name and address in the results section when a different laboratory name and address is printed at the top of the Federal CCF;
(2) The accessioner fails to print his or her name;
(3) The certifying scientist or certifying technician fails to print his or her name;
(4) The certifying scientist or certifying technician accidentally initials the Federal CCF rather than signing for a specimen reported as rejected for testing;
(c) The above omissions and discrepancies are considered insignificant only when they occur no more than once a month. The expectation is that each trained collector and HHS-certified laboratory will make every effort to ensure that the Federal CCF is properly completed and that all the information is correct. When an error occurs more than once a month, the MRO must direct the collector or HHS-certified laboratory (whichever is responsible for the error) to immediately take corrective action to prevent the recurrence of the error.
(a) An MRO must attempt to correct the following errors:
(1) The donor's signature is missing on the MRO copy of the Federal CCF and the collector failed to provide a comment that the donor refused to sign the form;
(2) The certifying scientist failed to sign the Federal CCF for a specimen being reported drug positive, adulterated, invalid, or (for urine) substituted; or
(3) The electronic report provided by the HHS-certified oral fluid laboratory does not contain all the data elements required for the HHS standard laboratory electronic report for a specimen being reported drug positive, adulterated, invalid result, or (for urine) substituted.
(b) If error (a)(1) occurs, the MRO must contact the collector to obtain a statement to verify that the donor refused to sign the MRO copy. If, after at least 5 business days, the collector cannot provide such a statement, the MRO must cancel the test.
(c) If error (a)(2) occurs, the MRO must obtain a statement from the certifying scientist that he or she inadvertently forgot to sign the Federal CCF, but did, in fact, properly conduct the certification review. If, after at least 5 business days, the MRO cannot get a statement from the certifying scientist, the MRO must cancel the test.
(d) If error (a)(3) occurs, the MRO must contact the HHS-certified laboratory. If, after at least 5 business days, the laboratory does not retransmit a corrected electronic report, the MRO must cancel the test.
These procedures apply when:
(a) The Secretary has notified an HHS-certified laboratory in writing that its certification to perform drug testing under these Guidelines has been suspended or that the Secretary proposes to revoke such certification.
(b) The HHS-certified laboratory has, within 30 days of the date of such notification or within 3 days of the date of such notification when seeking an expedited review of a suspension, requested in writing an opportunity for an informal review of the suspension or proposed revocation.
The scope of review shall be limited to the facts relevant to any suspension or proposed revocation, the necessary interpretations of those facts, the relevant Mandatory Guidelines for Federal Workplace Drug Testing Programs, and other relevant law. The legal validity of these Guidelines shall not be subject to review under these procedures.
The appellant's request for review shall specify the name, address, and
(a) Within 30 days of the date of the notice of the suspension or proposed revocation, the appellant must submit a written request to the reviewing official seeking review, unless some other time period is agreed to by the parties. A copy must also be sent to the respondent. The request for review must include a copy of the notice of suspension or proposed revocation, a brief statement of why the decision to suspend or propose revocation is wrong, and the appellant's request for an oral presentation, if desired.
(b) Within 5 days after receiving the request for review, the reviewing official will send an acknowledgment and advise the appellant of the next steps. The reviewing official will also send a copy of the acknowledgment to the respondent.
Upon mutual agreement of the parties to hold these procedures in abeyance, the reviewing official will stay these procedures for a reasonable time while the laboratory attempts to regain compliance with the Guidelines or the parties otherwise attempt to settle the dispute. As part of an abeyance agreement, the parties can agree to extend the time period for requesting review of the suspension or proposed revocation. If abeyance begins after a request for review has been filed, the appellant shall notify the reviewing official at the end of the abeyance period, advising whether the dispute has been resolved. If the dispute has been resolved, the request for review will be dismissed. If the dispute has not been resolved, the review procedures will begin at the point at which they were interrupted by the abeyance agreement with such modifications to the procedures as the reviewing official deems appropriate.
The appellant and the respondent each participate in developing the file for the reviewing official and in submitting written arguments. The procedures for development of the review file and submission of written argument are:
(a)
(1) A review file containing the documents supporting appellant's argument, tabbed and organized chronologically, and accompanied by an index identifying each document. Only essential documents should be submitted to the reviewing official.
(2) A written statement, not to exceed 20 double-spaced pages, explaining why respondent's decision to suspend or propose revocation of appellant's certification is wrong (appellant's brief).
(b)
(1) A review file containing documents supporting respondent's decision to suspend or revoke appellant's certification to perform drug testing, which is tabbed and organized chronologically, and accompanied by an index identifying each document. Only essential documents should be submitted to the reviewing official.
(2) A written statement, not exceeding 20 double-spaced pages in length, explaining the basis for suspension or proposed revocation (respondent's brief).
(c)
(d)
(e)
(a)
(b)
(c)
(d)
(e)
(1)
(2)
(3)
(4)
(5)
(f)
(g)
(a)
(b)
(c)
(1) A review file containing essential documents relevant to the review, which is tabbed, indexed, and organized chronologically; and
(2) A written statement, not to exceed 20 double-spaced pages, explaining the party's position concerning the suspension and any proposed revocation. No reply brief is permitted.
(d)
(e)
(f)
Except for routine administrative and procedural matters, a party shall not communicate with the reviewing or presiding official without notice to the other party.
(a) Because of the importance of a timely review, the reviewing official should normally transmit written communications to either party by facsimile, secured electronic transmissions, or overnight mail in which case the date of transmission or day following mailing will be considered the date of receipt. In the case of communications sent by regular mail, the date of receipt will be considered 3 days after the date of mailing.
(b) In counting days, include Saturdays, Sundays, and federal holidays. However, if a due date falls on a Saturday, Sunday, or federal holiday, then the due date is the next federal working day.
In addition to any other authority specified in these procedures, the reviewing official and the presiding official, with respect to those authorities involving the oral presentation, shall have the authority to issue orders; examine witnesses; take all steps necessary for the conduct of an orderly hearing; rule on requests and motions; grant extensions of time for good reasons; dismiss for failure to meet deadlines or other requirements; order the parties to submit relevant information or witnesses; remand a case for further action by the respondent; waive or modify these procedures in a specific case, usually with notice to the parties; reconsider a decision of the reviewing official where a party promptly alleges a clear error of fact or law; and to take any other action necessary to resolve disputes in accordance with the objectives of these procedures.
The administrative record of review consists of the review file; other submissions by the parties; transcripts or other records of any meetings, conference calls, or oral presentation; evidence submitted at the oral presentation; and orders and other documents issued by the reviewing and presiding officials.
(a)
(b)
(c)
Before any legal action is filed in court challenging the suspension or proposed revocation, respondent shall exhaust administrative remedies provided under this subpart, unless otherwise provided by Federal Law. The reviewing official's decision, under Section 16.9(e) or 16.14(a) constitutes final agency action and is ripe for judicial review as of the date of the decision.
Substance Abuse and Mental Health Services Administration (SAMHSA), HHS.
Notice of proposed revisions to the mandatory guidelines by the Secretary of Health and Human Services.
The Department of Health and Human Services (“HHS” or “Department”) is proposing to revise the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Guidelines), 73 FR 71858 (November 25, 2008) for urine testing.
Submit comments on or before July 14, 2015.
In commenting, please refer to file code SAMHSA-2015-0002. Because of staff and resource limitations, SAMHSA cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one of the ways listed):
•
•
•
•
Charles LoDico, M.S., DABFT, Division of Workplace Programs, Center for Substance Abuse Prevention (CSAP), SAMHSA mail to: 1 Choke Cherry Road, Room 7-1045, Rockville, MD 20857, telephone (240) 276-2600, fax (240) 276-2610, or email at
This notice of proposed revisions to the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Guidelines) will revise the initial and confirmatory drug test analytes and methods for urine testing, revise the cutoff for reporting a specimen as adulterated based on low pH, revise the requalification requirements for individuals serving as Medical Review Officers (MROs) and, where appropriate, include references to the use of an alternate specimen in federal workplace drug testing programs. References to an alternate specimen are not applicable until final Guidelines are implemented for the use of the alternative specimen matrix. The Department is issuing a separate Notice in the
In particular, these revised Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG) allow federal executive branch agencies to test for additional Schedule II of the Controlled Substances Act prescription medications (
Using data obtained from the Federal Workplace Drug Testing Programs and HHS certified laboratories, the Department estimates the number of specimens tested annually for federal agencies to be 150,000. HHS projects that approximately 7% (or 10,500) of the 150,000 specimens tested per year will be oral fluid specimens and 93% (or 139,500) will be urine specimens once the proposed OFMG have been
In Section 3.4, the Department is proposing criteria for calibrating initial tests for grouped analytes such as opiates and amphetamines, and specifying the cross-reactivity of the immunoassay to the other analyte(s) within the group. These proposed Guidelines allow the use of methods other than immunoassay for initial testing. In addition, these proposed Guidelines include an alternative for laboratories to continue to use existing FDA-cleared immunoassays which do not have the specified cross-reactivity, by establishing a decision point with the lowest-reacting analyte. An immunoassay manufacturer may incur costs if they choose to alter their existing product and resubmit the immunoassay for FDA clearance.
For the added opiate analytes, the two immunoassays currently used for oxycodone and oxymorphone meet the requirements, and two of the three existing opiate immunoassays used in certified laboratories meet the requirements for hydrocodone and hydromorphone analysis. The opiate immunoassay that does not have sufficient cross-reactivity would be acceptable as an initial test under these Guidelines when the lowest-reacting analyte, hydromorphone, is used to establish a decision point.
For amphetamines, one of the three existing methylenedioxymethamphetamine (MDMA) immunoassays used in certified laboratories meets the requirements. The remaining two exhibit insufficient cross-reactivity for MDA. These two immunoassays would be acceptable as an initial test under these Guidelines when the lowest-reacting analyte, MDA, is used to establish a decision point. An immunoassay manufacturer may incur costs if they choose to alter their existing product and resubmit the immunoassay for FDA clearance.
Costs associated with the addition of oxycodone, oxymorphone, hydrocodone and hydromorphone will be minimal because the Department has determined that all HHS certified laboratories testing specimens from federal agencies are currently conducting tests for one or more of these analytes on non-regulated urine specimens. Likewise, there will be minimal costs associated with changing initial testing to include MDA and MDEA since the current immunoassays can be adapted to test for these analytes. Laboratory personnel are currently trained and test methods have been implemented. However, there will be some administrative costs associated with adding these analytes. Prior to being allowed to test regulated specimens for these compounds, HHS certified laboratories will be required to demonstrate that their performance meets Guideline requirements by testing three (3) groups of PT samples. The Department will provide the PT samples through the National Laboratory Certification Program (NLCP) at no cost to the certified laboratories. Based on costs charged for specimen testing, laboratory costs to conduct the PT testing would range from $900 to $1,800 for each of the certified laboratories.
Once the testing has been implemented, the cost per specimen for initial testing for the added analytes will range from $.06 to $0.20 due to reagent costs. Current costs for each confirmatory test range from $5.00 to $10.00 for each specimen reported as positive due to costs of sample preparation and analysis. Based on information from non-regulated workplace drug testing for these analytes in 2012 and testing performed by the Department on de-identified federally regulated specimens in 2011, approximately 1% of the submitted specimens is expected to be confirmed as positive for the added analytes. Therefore, the added cost for confirmatory testing will be $0.05 to $0.10 per submitted specimen. This would indicate that the total cost per specimen submitted for testing will increase by $0.11-$0.30.
The addition of the Schedule II prescription medications will require MRO review to verify legitimate drug use. Based on the positivity rates from non-regulated workplace drug testing for these analytes and this additional review of specimens confirmed positive for prescription medications, MRO costs are estimated to increase by approximately 3%.
The additional costs for testing and MRO review will be incorporated into the overall cost for the federal agency submitting the specimen to the laboratory. The estimation of costs incurred is based upon overall cost to the federal agency because cost is usually based on all specimens submitted from an agency, rather than individual specimen testing costs or MRO review of positive specimens. Agencies may also incur some costs for training of federal employees such as drug program coordinators due to implementation of the revised Guidelines. However, costs are expected to be minimal in the training process to understand the required changes in these Guidelines.
Based on the current figures, the cost for urine testing in the first year is estimated on 139,500 urine specimens for HHS, 5,820,000 urine specimens for DOT, and 186,000 urine specimens for NRC. Estimated costs are $99,045-$230,175 for HHS, $4,132,200-$9,603,000 for DOT, and $132,060-$306,900 for NRC.
The Department of Health and Human Services (HHS), by the authority of Section 503 of Public Law 100-71, 5 U.S.C. Section 7301, and Executive Order No. 12564, has established the scientific and technical guidelines for federal workplace drug testing programs and established standards for certification of laboratories engaged in urine drug testing for federal agencies. As required, HHS originally published the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Guidelines) in the
At the July 2011 meeting of SAMHSA's Drug Testing Advisory Board (DTAB), Board members voted unanimously for the following:
(1) Based on review of the science, DTAB recommends that SAMHSA include oral fluid as an alternative specimen in the Mandatory Guidelines for Federal Workplace Drug Testing Programs; and (2) DTAB recommends the inclusion of additional Schedule II prescription medications (
At the January 2012 DTAB meeting, the SAMHSA Administrator received the DTAB recommendations from the July 2011 meeting.
The responses to the April 13, 2004 notice proposing alternative specimen matrices (69 FR 19673) had made it clear that if the Department were to subsequently authorize alternative specimens for the Mandatory Guidelines for Federal Workplace Drug Testing Programs, separate Guidelines would be needed to provide clear and comprehensive information on the scientific and technical requirements for each specimen matrix. Therefore, HHS is proposing Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Urine (UrMG) and Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Oral Fluid (OFMG). The proposed UrMG and OFMG have been organized into analogous sections and use the same language where possible. The only differences are due to requirements that are specific for each specimen matrix.
Since the original Guidelines were published in 1988, a number of recommendations have been made for additional drugs to be included in federal workplace drug testing programs. Further, the Department monitors drug abuse trends and reviews information on new drugs of abuse from sources such as federal regulators, researchers, the drug testing industry, and public and private sector employers. The Department revised the Guidelines to include 6-acetylmorphine in 1998 (63 FR 63483) and three amphetamine analogues [methylenedioxymethamphetamine (MDMA), methylenedioxyamphetamine (MDA), and methylenedioxyethylamphetamine (MDEA)] in 2008 (73 FR 71858). The July 21, 2011 DTAB recommendations for the added drugs were based on the Board members' review of scientific information on the methods necessary to detect the analytes of these drugs and on drug abuse trends.
The DTAB recommendations, current drug abuse trends and other relevant information, and the private sector experience have led the Department to conclude that the additional opiates oxycodone, oxymorphone, hydrocodone, and hydromorphone should be added in the federal program.
In accordance with the current practice, an HHS contractor will perform certain functions on behalf of the Department. These functions include maintaining laboratory inspection and performance testing (PT) programs that satisfy the requirements described in the Guidelines. These activities include, but are not limited to, reviewing inspection reports submitted by inspectors, reviewing PT results submitted by laboratories, preparing inspection and PT result reports, and making recommendations to the Department regarding certification or suspension/revocation of laboratories' certification. It is important to note that, although a contractor gathers and evaluates information provided by the inspectors or laboratories, all final decisions regarding laboratory certification, suspension, or revocation of certification are made by the Secretary.
The Department contributes funds to this contract for purposes not directly related to laboratory certification activities, such as evaluating technologies and instruments and providing assessments of their potential applicability to workplace drug testing programs.
This preamble describes the differences between the current Mandatory Guidelines for Federal Workplace Drug Testing Programs (Guidelines) and the proposed Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine Specimens (UrMG), and the rationale for the differences. In addition, the Preamble presents two topics of special interest to be addressed for the revised Guidelines. These topics are presented first in summary as they appear in the text of the proposed UrMG and later as topics of special interest for which the Department is seeking public comments.
Section 1.5 defines terms used in the UrMG. Where possible, the Department proposes to revise the definitions in the current Guidelines to apply to any specimen matrix allowed in federal workplace drug testing programs, so the terms and their definitions will be identical in both the UrMG and the proposed Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid Specimens (OFMG). In addition, the Department proposes to add new definitions or revise the definitions in the current Guidelines as needed for terms that apply only to urine (
Sections 1.6, 1.7, and 1.8 contain the same policies as described in the current Guidelines with regard to what an agency is required to do to protect employee records, the conditions that constitute refusal to take a federally regulated drug test, and the consequences of a refusal to take a federally regulated drug test. In the proposed UrMG, Section 1.7 of the current Guidelines was divided into two sections for clarity: Section 1.7 describes what constitutes a refusal to test and Section 1.8 describes the subsequent actions and consequences. Section 1.7 also has been reworded as needed to address other authorized specimen types.
The Department proposes to revise Section 2.1 of the current Guidelines to reflect the Department's proposed expansion of the drug-testing program for federal agencies to permit the use of oral fluid specimens. There is no requirement for federal agencies to use oral fluid as part of their program. When the OFMG become effective and HHS has certified laboratories under the OFMG, a federal agency may choose to use urine, oral fluid, or both specimen types in their drug testing program. Any agency choosing to use urine is required to follow the UrMG and any agency choosing to use oral fluid is required to follow the OFMG. For example, an agency program can randomly assign
Section 2.6 was added to clarify that all entities and individuals identified in Section 1.1 of these Guidelines are prohibited from releasing specimens collected under the federal workplace drug testing program to any individual or entity unless expressly authorized by these Guidelines or in accordance with applicable federal law.
While these Guidelines do not authorize the release of specimens, or portions thereof, to federal employees, the Guidelines afford employees a variety of protections that ensure the identity, security and integrity of their specimens from the time of collection through final disposition of the specimen. There are also procedures that allow federal employees to request the retesting of their specimen (for drugs, adulteration, or substitution) at a different certified laboratory. Furthermore, the Guidelines grant federal employees access to a wide variety of information and records related to the testing of their specimens, including a documentation package that includes, among other items, a copy of the Federal CCF with any attachments, internal chain of custody records for the specimen, and any memoranda generated by the laboratory or Instrumented Initial Test Facility (IITF).
Therefore, the Guidelines offer federal employees and federal agencies transparent and definitive evidence of a specimen's identity, security, control and chain of custody. However, the Guidelines do not entitle employees access to the specimen itself or to a portion thereof. The reason for this prohibition is that specimens collected under the Guidelines are uniquely designed for the purpose of drug and validity testing only. They are not designed for other purposes such as deoxyribonucleic acid (DNA) testing. Furthermore, conducting additional testing outside the parameters of the Guidelines would not guarantee incorporation of the safeguards, quality control protocols, and the exacting scientific standards developed under the Guidelines to ensure the security, reliability and accuracy of the drug testing process.
Section 3.3(a) includes the same requirement as the current Guidelines for urine specimens collected for federal agency workplace drug testing programs to be tested only for drugs and to determine their validity. While satisfied that the policy as stated in the current Guidelines prohibits other testing (
Section 3.4 lists the drug test analytes and cutoff concentrations for urine. The table in Section 3.4 is the same in the current Guidelines with three notable exceptions. First, the proposed UrMG include the added opiates oxycodone, oxymorphone, hydrocodone, and hydromorphone as initial and confirmatory test analytes. Second, the proposed UrMG include methylenedioxyamphetamine (MDA) and methylenedioxyethylamphetamine (MDEA) as initial test and confirmatory test analytes. The current Guidelines include these two drugs as confirmatory test analytes only. Third, the requirement for initial testing using immunoassay-based technology has been changed to allow initial testing by “alternate” technologies (see footnote 2 of the table). This is also the reason for specifying the target analyte for each initial test. Considerable discussion was conducted in DTAB meetings regarding these proposed revisions. The DTAB received input from laboratories, reagent manufacturers, subject matter experts, and the FDA.
For initial tests for opiates and amphetamines using immunoassay, the Department is proposing that the immunoassay be calibrated with one analyte from the group that is identified as the target analyte. Footnote 2 of the table in Section 3.4 includes the proposed criteria for calibrating initial tests for these grouped analytes. The cross-reactivity of the immunoassay to the other analyte(s) within the group must be 80% or greater. The Department is aware that an FDA-cleared immunoassay meeting these criteria may not exist at the time of the UrMG effective date. If an FDA-cleared immunoassay does not demonstrate at least 80 percent cross-reactivity to each analyte, the laboratory or IITF may use the lowest-reacting analyte to establish a decision point to identify specimens as negative or requiring confirmatory testing. This is accomplished by calibrating the FDA-cleared immunoassay using the manufacturer's target analyte, including a control containing the lowest-reacting analyte at its cutoff concentration in each initial test batch, and comparing the immunoassay responses of specimens in the batch to that of the lowest-reacting analyte control. Alternatively, the laboratory or IITF must use separate immunoassays. The proposed analytes and cutoffs are addressed separately and in detail below. The Department is proposing to permit the use of technologies other than immunoassay techniques for initial drug testing. In recent years, technological advances have been made to techniques (
The proposed analytes and cutoffs follow.
Misuse and abuse of psychotherapeutic prescription drugs, including opioid pain relievers, are issues of concern for all populations regardless of age, gender, ethnicity, race, or community. Recent data show that opioid-related overdose deaths in the U.S. now outnumber overdose deaths involving all illicit drugs such as heroin and cocaine combined. In addition to overdose deaths, emergency department visits, substance treatment admissions and economic costs associated with opioid abuse have all increased in recent years. The Department is continuing to work with partners at the federal, state, and local levels to implement policies and programs to reduce prescription drug abuse and improve public health.
The Department proposes the inclusion of additional Schedule II prescription medications (
The addition of these Schedule II prescription medications will require MRO review to verify legitimate drug use. Consistent with the current Guidelines, the MRO must contact the donor to determine if there is a legitimate medical explanation for a positive result. If the donor provides a legitimate medical explanation (
The use of medications, specifically Schedule II drugs, without a prescription is a growing concern for the Department in workplace drug testing, and the proposal for their inclusion offers the opportunity to deter nonmedical use of these drugs among federal workers. The Department does note that in recognition of the prescription drug abuse issue, the Department of Defense issued a memorandum on January 30, 2012, announcing the expansion of their drug testing panel to include hydrocodone and benzodiazepines starting on May 1, 2012. Similarly, the Department proposes that federal agencies include the testing of oxycodone, oxymorphone, hydrocodone, and hydromorphone in urine specimens as described below.
The Department is proposing to test for oxycodone/oxymorphone using a 100 ng/mL cutoff concentration for the initial test and 50 ng/mL for the confirmatory test cutoff concentration. Both oxycodone and oxymorphone are potent analgesics that are available by prescription for pain relief. Oxycodone is partially metabolized by O-demethylation to oxymorphone and both parent drug and metabolite are excreted in urine following oxycodone administration.
An immunoassay initial test for oxycodone/oxymorphone should be calibrated with one of the two analytes and demonstrate sufficient cross-reactivity with the other analyte. The Department proposes that the minimum cross-reactivity with either analyte be 80 percent or greater. If an alternate technology initial test is performed instead of immunoassay, either one or both analytes in the group should be used to calibrate, depending on the technology. The quantitative sum of the two analytes must be equal to or greater than 100 ng/mL. The quantitative sum of the two analytes must be based on quantitative values for each analyte that are equal to or above the laboratory's validated limit of quantification.
The 50 ng/mL confirmatory test cutoff concentration applies equally to oxycodone and oxymorphone. A positive test would be comprised of either or both analytes with a confirmed concentration equal to or greater than 50 ng/mL.
The Department is proposing to test for hydrocodone/hydromorphone using a 300 ng/mL cutoff concentration for the initial test and 100 ng/mL for the confirmatory test cutoff concentration. Both hydrocodone and hydromorphone are potent analgesics that are available by prescription for pain relief. Hydrocodone is partially metabolized by O-demethylation to hydromorphone and both parent drug and metabolite are excreted in urine following hydrocodone administration.
An immunoassay initial test for hydrocodone/hydromorphone should be calibrated with one of the two analytes and demonstrate sufficient cross-reactivity with the other analyte. The Department proposes that the minimum cross-reactivity with either analyte be 80 percent or greater. If an alternate technology initial test is performed instead of immunoassay, either one or both analytes in the group should be used to calibrate, depending on the technology. The quantitative sum of the two analytes must be equal to or greater than 300 ng/mL. The quantitative sum of the two analytes must be based on quantitative values for each analyte that are equal to or above the laboratory's validated limit of quantification.
The confirmatory test cutoff concentration applies equally to hydrocodone and hydromorphone. A positive test would be comprised of either or both analytes with a confirmed concentration equal to or greater than 100 ng/mL.
In 2009, the U.S. Drug Enforcement Administration (DEA) asked the U.S. Department of Health and Human Services (HHS) for a recommendation regarding whether to change the schedule for hydrocodone combination drug products, such as Vicodin. The proposed change was from Schedule III to Schedule II, which would increase the controls on these products. Due to the unique history of this issue and the tremendous amount of public interest, in October 2013, the FDA Center for Drug Evaluation and Research announced the agency's intent to recommend to HHS that hydrocodone combination drug products should be reclassified to Schedule II. FDA stated that this determination came after a thorough and careful analysis of extensive scientific literature, review of hundreds of public comments on the issue, and several public meetings, during which FDA received input from a wide range of stakeholders, including patients, health care providers, outside experts, and other government entities.
In December 2013, FDA, with the concurrence of the National Institute on Drug Abuse (NIDA), submitted a formal recommendation package to HHS to
The Department proposes adding MDA and MDEA as initial test analytes in the list of authorized drug tests and cutoff concentrations. The current Guidelines include these two drugs as confirmatory test analytes only, in conjunction with an initial test for MDMA. Specifying these compounds as initial test analytes (in addition to MDMA) improves their detection by initial tests using immunoassay, and enables detection by initial tests using an alternate technology, as allowed under these proposed Guidelines. All three analytes are Schedule I drugs. The Department is proposing to test for MDMA/MDA/MDEA using a 500 ng/mL cutoff concentration for the initial test and 250 ng/mL for the confirmatory test cutoff concentration.
An immunoassay initial test for MDMA/MDA/MDEA should be calibrated with one of the three analytes and demonstrate sufficient cross-reactivity with the other analytes. The Department proposes that the minimum cross-reactivity with each analyte be 80 percent or greater. If an alternate technology initial test is performed instead of immunoassay, either one or all analytes in the group should be used to calibrate, depending on the technology. The quantitative sum of the three analytes must be equal to or greater than 500 ng/mL. The quantitative sum of the three analytes must be based on quantitative values for each analyte that are equal to or above the laboratory's validated limit of quantification.
The confirmatory test cutoff concentration applies equally to MDMA, MDA, and MDEA. A positive test would be comprised of one or more analytes with a confirmed concentration equal to or greater than 250 ng/mL.
Section 3.5 authorizes HHS-certified laboratories to perform additional tests to assist the Medical Review Officer (MRO) in making a determination of positive or negative results. The Department believes that additional tests requested by the MRO can provide useful information to determine the veracity of a donor's medical explanation. This is a revision to the current Guidelines, but is consistent with current practices. An example of an additional test currently requested by an MRO is when the laboratory reports a positive methamphetamine result. The MRO may request a d,l-stereoisomer determination for methamphetamine, to determine whether the result could be attributed to use of an over-the-counter nasal inhaler. Another example of current practice is when the laboratory reports a positive THCA result, and the MRO requests testing for cannabivarin, to distinguish marijuana use from dronabinol (
In Section 3.6, the Department proposes to revise the criteria to report a urine specimen as adulterated based on pH. Specifically, in paragraph 3.6(a), the Department is proposing to raise the low pH cutoff for adulteration from less than 3 to less than 4. This decision is based on the fact that the physiologically minimum achievable urine pH that can be produced by the kidneys is about pH 4.5.
Section 3.8 contains the same criteria as the current Guidelines for reporting a urine specimen as dilute in conjunction with positive or negative drug test results. The section has been revised to clarify the criteria for specific gravity results measured to four-decimal places (
Section 3.9 contains the criteria for reporting an invalid result for a urine specimen. This section contains the same criteria for reporting an invalid result for a urine specimen as in the current Guidelines with four revisions. Paragraph 3.9(b) contains the criteria for reporting a specimen as invalid based on pH. The lower pH range has been changed to “equal to or greater than 4 and less than 4.5,” consistent with the proposed change to the low pH cutoff for adulteration [
Sections 4.1 through 4.6 contain the same policies as the current Guidelines in regard to who may or may not collect a specimen, the requirements to be a collector, the requirements to be an observer for a direct observed collection, the requirements to be a trainer for collectors, and what a federal agency must do before a collector is permitted to collect a specimen. The only changes from the current Guidelines are some rewording for clarity and a minor change in the type of mock collections required for collector training in Section 4.3(a)(4).
Sections 5.1 through 5.6 address requirements for collection sites, collection site records, how a collector ensures the security and integrity of a specimen at the collection site, and the privacy requirements when collecting a specimen. Most requirements are the same as in the current Guidelines, but some items have been reworded for clarity. The Department added a new Section 5.3 clarifying that collection site records must be stored at a secure site designated by the collector or the collector's employer. The Department also revised Section 5.4 to allow hardcopy records to be discarded 6 months after conversion to electronic records. This change ensures the availability of the records while reducing the recordkeeping burden, and is consistent with the Paperwork Reduction Act.
Sections 6.1 and 6.2 are the same as in the current Guidelines, requiring an OMB-approved Federal CCF be used to document custody and control of each specimen at the collection site, and specifying what should occur if the correct OMB-approved CCF is not used.
Sections 7.1 through 7.3 describe requirements for the collection container, temperature strip, and bottles that must be used to for urine specimen collections. The Department has added detailed requirements for these items, to enable proper collection and maintenance of the urine specimen.
Section 7.1 requires a single use container that has a means to measure urine temperature and two specimen bottles for urine collection.
Section 7.2 requires that the urine collection container, including the temperature strip and the bottles, not substantially affect the composition of drug and/or drug metabolites in the specimen. In addition, the two bottles must be sealable and non-leaking and maintain the integrity of the specimen during storage and transport, and must be sufficiently transparent to enable an objective assessment of the A and B specimens' appearance and identification of abnormal physical characteristics upon receipt at the HHS-certified laboratory or IITF.
Section 7.3 details the minimum performance requirements for a collection container and bottles (
This subpart addresses the same topics, in the same order, as the OFMG procedures for oral fluid specimen collection. While the procedure is essentially the same as described in the current Guidelines, the Department has reordered and/or reworded steps for clarity and for consistency with the proposed OFMG. Differences exist due to the differences in urine and oral fluid collection procedures. In addition, the Department is proposing to allow federal agencies to authorize collection of oral fluid as an alternate specimen when a donor does not provide an adequate urine specimen. References to agency authorization and collection procedures for oral fluid are applicable only when the OFMG become effective and HHS has certified laboratories to perform oral fluid testing under the Guidelines.
Section 8.5 describes the responsibilities and procedures the collector must follow during and after a urine collection. The Department has revised Section 8.5 to enable a federal agency to authorize collection of oral fluid as an alternate specimen when a donor is unable to provide a sufficient volume of urine within the allowed wait period (
Section 8.6 describes the procedures the collector must follow when a donor is unable to provide a urine specimen. The Department has revised Section 8.5 to enable a federal agency to authorize collection of oral fluid as an alternate specimen when a donor is unable to provide a urine specimen. As noted above, this revision will be applicable when the OFMG become effective and HHS has certified laboratories to perform oral fluid testing under the Guidelines. Specifically, Paragraph 8.6(b)(2) instructs the collector to request authorization for the alternate specimen collection when he/she notifies the federal agency representative of the donor's inability to provide a urine specimen.
Section 8.7 prohibits collection of an alternate specimen when a donor is unable to provide an adequate urine specimen, unless specifically authorized by the Mandatory Guidelines for Federal Workplace Drug Testing Programs and by the federal agency. As noted above, Paragraphs 8.5(f)(2)(iii) and 8.6(b)(2) describe the circumstances in which the federal agency representative can authorize the collector to collect an alternate specimen (
Section 8.14 describes a federal agency's responsibilities for a collection site. The Department has included an additional example of appropriate action that may be taken in response to a reported collection site deficiency: Self-assessment using the Collection Site Checklist for the Collection of Urine Specimens for Federal Agency Workplace Drug Testing Programs. This document is available on the SAMHSA Web site
This subpart contains the same requirements for HHS certification of laboratories and instrumented initial test facilities (IITFs) as the current Guidelines.
Section 9.5 includes the same qualitative and quantitative specifications for PT samples as the current Guidelines. Section 9.19 describes where the monthly list of laboratories and IITFs certified by HHS to conduct forensic drug testing for federal agencies is published. The list will indicate the type of specimen (
This subpart describes the policies for federal agency blind samples. In Section 10.1, the Department is keeping the annual 3 percent requirement for federal agency blind samples (
Section 10.2 includes the same requirements for a blind sample as the current Guidelines. The Department has reworded the section for clarity. Also, in Paragraph 10.2(e), the Department added information that blind sample suppliers must provide and specified that the information is to be provided to the collection site/collector sending the sample and, upon request, to the MRO, federal agency, or the Secretary.
In Section 10.4, the Department added that the MRO must contact the laboratory or IITF as the first step after receiving a report for a blind sample with a result that is inconsistent with the expected result.
Section 11.10 addresses initial drug test requirements. These are the same as the current Guidelines requirements, except that the Department is proposing to allow the use of technologies other than immunoassay (
Section 11.11 describes validation requirements for initial drug tests. The Department has included a requirement in Paragraph 11.11(a)(5) for laboratories to assess potential interferences during assay validation. The revision is consistent with current requirements for HHS-certified laboratories. In Paragraphs 11.11(a)(6) and 11.11(c), the Department is proposing additional requirements for alternate technology initial drug tests based on the characteristics of these technologies.
Section 11.13 addresses confirmatory drug test requirements. The Department is proposing to allow analytical procedures using mass spectrometry or other equivalent technologies. Based on ongoing reviews of the scientific and forensic literature, and the assessment of a DTAB working group that has studied newer instruments and technologies, the Department believes that scientifically valid confirmatory methods other than combined chromatographic and mass spectrometric methods can be used to successfully detect and report the drug analytes in Subpart C—Urine Specimen Drug Tests.
Section 11.14 describes validation requirements for confirmatory tests. The Department has included a requirement for laboratories to assess matrix effects when validating a confirmatory drug test using liquid chromatography coupled with mass spectrometry and has added the requirement for laboratories to verify each new lot of reagent prior to placement into service. These revisions are consistent with current requirements for HHS-certified laboratories.
In Section 11.17, the Department added the requirement for laboratories to verify each new lot of reagent for specimen validity testing prior to placement into service, consistent with current requirements for HHS-certified laboratories.
The requirements for conducting each specimen validity test are the same as the current Guidelines, with the exception of pH testing and quality control requirements in Section 11.18(c) which have been revised in accordance with the proposed change to the low pH cutoff for adulteration [
Section 11.19 addresses laboratory requirements for reporting test results. The Department made a change to wording in Section 11.19(a), deleting the requirement for laboratories to report results directly to the MRO, to allow the use of external service providers. Providing test results electronically to MROs can be timely and cost-effective, and is expected to increase following implementation of the Federal Custody and Control Form (CCF) as an electronic document. Section 11.19(n) was revised to require HHS-certified laboratories and external service providers to maintain the confidentiality, integrity, and availability of the data, which includes test results and donor personal identifying information (PII), and to limit access to any data transmission, storage, and retrieval system. Changes have been made to the criteria for reporting a specimen as adulterated or as invalid based on low pH [
The Department revised Section 11.21(a) to allow hardcopy records to be discarded 6 months after conversion to electronic records. This change ensures the availability of the records while reducing the recordkeeping burden, and is consistent with the Paperwork Reduction Act.
Section 11.22 describes the semiannual statistical summary report that a laboratory must provide to a federal agency for urine testing. The Department is proposing to require the laboratory to submit a copy (paper or electronic) of each statistical summary report to the Secretary or designated HHS representative.
Section 11.23 is a new section addressing the laboratory information to be made available to a federal agency and describes the contents of a standard laboratory documentation package, which are the same as in the current Guidelines. The Department is proposing that a federal agency may obtain laboratory information related to a positive, adulterated, or substituted drug test reported for a federal employee tested in its workplace program, as well as any relevant certification, review, or revocation of certification records for the laboratory.
Section 11.24 was modified to clarify that specimens are not a part of the information package that donors can receive from HHS-certified laboratories.
This subpart addresses requirements for IITFs. Most requirements remain the same as the current Guidelines. The proposed revisions, detailed below, are consistent with the proposed revisions for laboratories in Section 11.
Section 12.9 addresses initial drug test requirements for IITFs. The Department is proposing to allow IITFs to use technologies other than immunoassay (
Section 12.10 describes validation requirements for initial drug tests. The Department has included a requirement in Paragraph 12.10(a)(5) for IITFs to assess potential interferences during assay validation. The revision is consistent with current requirements for HHS-certified IITFs. In Paragraphs 12.10(a)(6) and 12.10(c), the Department is proposing additional requirements for alternate technology initial drug tests based on the characteristics of these technologies.
In Section 12.13, the Department added the requirement for IITFs to verify each new lot of reagent for specimen validity testing prior to placement into service, consistent with current requirements for HHS-certified IITFs.
Section 12.15 addresses IITF requirements for reporting test results. The Department made a change to wording in Section 12.15(a), deleting the requirement for IITFs to report results directly to the MRO, to allow the use of external service providers. Providing test results electronically to MROs can be timely and cost-effective, and is expected to increase following implementation of the Federal Custody and Control Form (CCF) as an electronic document. Section 12.15(e) was revised to require HHS-certified IITFs and external service providers to maintain the confidentiality, integrity, and availability of the data, which includes test results and donor PII, and to limit access to any data transmission, storage, and retrieval system. In Section 12.15(g), the Department has added the requirement for the IITF to send a legible image or copy of the Federal CCF for rejected specimens to the MRO.
The Department revised Section 12.18(a) to allow hardcopy records to be discarded 6 months after conversion to electronic records. This change ensures the availability of the records while reducing the recordkeeping burden, and
Section 12.19 describes the semiannual statistical summary report that an IITF must provide to a federal agency for urine testing. The Department is proposing to require the IITF to submit a copy of each semiannual statistical summary report (paper or electronic) to the Secretary or designated HHS representative.
Section 12.20 is a new section addressing the IITF information to be made available to a federal agency and describes the contents of a standard IITF documentation package, which are the same as in the current Guidelines. The Department is proposing that a federal agency may obtain IITF information related to a positive, adulterated, or substituted drug test reported by a laboratory for a federal employee tested in its workplace program, as well as any relevant certification, review, or revocation of certification records for the IITF.
Section 13.1 describes who may serve as an MRO. With the inclusion of additional Schedule II prescription medications in the Guidelines and the ever-changing field of drug testing, medical review of drug test results is more complex today than before. Therefore, the Department proposes to incorporate MRO requalification training and reexamination on a regular basis (at least every five years). The UrMG and OFMG do not include a requirement for MROs to obtain continuing education units (CEUs). The Department understands that it would be difficult to determine whether CEUs obtained are related to federal agency drug testing. The requalification requirement every five years will assure agency auditors and inspectors and regulated employers that MROs are appropriately qualified. This requirement is not expected to increase costs to MROs. Current practices for MRO requirements have equivalent standards but vary among MRO training entities. These requirements will standardize the length of time each MRO is required to take a requalification examination. Currently, some MRO requalification periods are longer than five years, while others are less than five years. The Department assumes that the costs to those MROs that have requalification periods over five years will be offset by the cost savings to MROs that have periods shorter than five years. Thus, the Department has not estimated any costs associated with this provision, but it welcomes comment on this assumption.
The Department anticipates that MROs will continue to obtain CEUs by virtue of maintaining their medical licensure requirements. In addition, the MRO certification/training entities provide MRO manuals and periodic newsletters with updates on federal drug testing program requirements. However, the Department is seeking comments on requiring MRO requalification CEUs and on the optimum number of credits and the appropriate CEU accreditation bodies should CEUs be required as part of MRO requalification.
MROs play a key role in the federal safety program and maintain the balance between the safety and privacy objectives of the program. The MRO's role in gathering and evaluating the medical evidence and providing due process is imperative. These are duties that must be carried out by the MRO, and cannot be delegated to other personnel who are not certified by an MRO entity.
The MRO is charged with certain important medical and administrative duties. The MRO must have detailed knowledge of the effects of medications and other potential alternative medical explanations for laboratory reported drug test results. He or she is responsible for determining whether legitimate medical explanations are available to explain an employee's drug test result. This medical review process has become far more complex as a result of specimen validity testing and the myriad of donor explanations for adulterated, substituted, and invalid laboratory test results.
In addition, MROs confer with prescribing physicians in making decisions about prescription changes so that alternative medications can be used that will not impact public safety. Similarly, the MRO is required to report to employers the employees' prescription and over-the-counter medication use (or dangerous combinations of use) that the MRO believes will negatively affect duty performance. In addition, the MRO is required to medically assess referral physician examinations and evaluations in certain positive and refusal-to-test situations. These, too, have become more complex over time.
Section 13.2 describes how nationally recognized entities or subspecialty boards that certify MROs are approved. The Department is proposing to extend the due date for resubmission of qualifications for HHS approval from each year to every two years and to publish the list of approved entities at least every two years, rather than annually. The revised time periods appear sufficient to ensure that educational material is updated at least every two years and the Department requiring the nationally recognized entities that approves MROs ensures the qualifications are being met. The Department has also revised this section to require submission of the certification examination delivery method along with other documentation for review.
Section 13.3 describes the training that is required before a physician may serve as an MRO. With the issue of prescription drug abuse and the inclusion of additional opiates to the federal drug-testing panel, MROs have the difficult task of interpreting positive drug test results from prescription drugs. Further guidance on these drug test results will be included in the MRO manual. The Department has added a requirement for MRO training to include information about how to discuss substance misuse and abuse and how to access those services. MROs performing the review of federal employee drug test results should be aware of prevention and treatment opportunities for individuals and can provide information to the donor.
The Department also revised Section 13.4 to allow the MRO to discard hardcopy records 6 months after conversion to electronic records. This change ensures the availability of the records while reducing the recordkeeping burden, and is consistent with the Paperwork Reduction Act.
Section 13.5 describes MRO actions when reviewing a urine specimen's test results. Section 13.5(d) contains the same procedure as the current Guidelines: When the HHS-certified laboratory reports a positive result for the primary (A) specimen, the MRO must contact the donor to determine if there is any legitimate medical explanation for the positive result. If the donor provides a legitimate medical explanation for the positive result, the MRO reports the test result as negative to the agency. The Department added a new Section 13.5(c) to address multiple test results for one specimen and added Section 13.5(h) to address MRO procedures for multiple specimens from the same testing event (
Section 13.6 describes what an MRO must do when the collector reports that a donor did not provide a sufficient amount of urine for a drug test. For those instances in which the donor did not provide an adequate urine specimen and the federal agency authorized collection of another specimen type (
Section 13.7 describes what an MRO must do when a donor has a permanent or long-term medical condition that prevents him or her from providing a sufficient amount of urine, a negative test is required (
Section 13.9 describes how an MRO reports a primary (A) specimen result to an agency. The Department revised Section 13.9(a) to address MRO use of external service providers. The revised section requires MROs and external service providers to maintain the confidentiality, integrity, and availability of the data, which includes donor PII, and to limit access to any data transmission, storage, and retrieval system. The Department is also proposing to delete the requirement in Paragraph 13.9(c) for the MRO to send a paper copy of the Federal CCF or separate letter/memorandum. The MRO may report results electronically.
The Department is proposing to revise Section 14.1(c) to clarify that, in a case where a B specimen is not available for testing, the MRO reports only to the federal agency and not to the donor. This is consistent with the requirement in the next sentence that no notice be given to the donor until immediately before the observed recollection.
Section 14.3(a) addresses criteria for reconfirming an adulterated result. The low pH cutoff in Section 14.3(a)(1) has been changed to reflect the proposed change to the low pH cutoff for adulteration [
Section 14.5 describes who receives the split specimen report from the laboratory. The Department reworded this section to address MRO use of external service providers, similar to the change made to Section 11.19(a) for primary specimen reports.
Section 14.7 describes how an MRO reports a split (B) specimen result to an agency. The Department revised Section 14.7(a) to address MRO use of external service providers. The revised section requires MROs and external service providers to maintain the confidentiality, integrity, and availability of the data, which includes donor PII, and to limit access to any data transmission, storage, and retrieval system. The Department revised Section 14.7(c) to clarify that MRO must use the Federal CCF or separate letter/memorandum to report all split specimens (
In Section 15.1, the Department is proposing a new Paragraph 15.1(e) requiring specimen rejection if the accessioner has not documented the primary (A) seal condition at the time of accessioning and the split (B) specimen cannot be redesignated as the primary (A) specimen. This is consistent with current practice. The Department maintains that relying on the accessioner's recall of a particular specimen's bottle seal condition is not a forensically acceptable practice.
This subpart includes procedures to revoke or suspend the HHS-certification of laboratories and IITFs. These are the same as in the current Guidelines.
The Department is aware that these proposed new Guidelines may impact the Department of Transportation (DOT) and Nuclear Regulatory Commission (NRC) regulated industries depending on these agencies' decisions to incorporate the final UrMG revisions into their programs under their own authority.
The Department requests public comment on all aspects of this notice. However, the Department is providing the following list of areas for which specific comments are requested.
Section 3.4 lists the proposed new analytes oxycodone, oxymorphone, hydrocodone, and hydromorphone and their cutoff concentrations. The Department is specifically requesting comments on these revisions.
Section 13.1 describes proposed requirements for MRO requalification training and reexamination on a regular basis (
The Department welcomes public comment on all figures and assumptions used for the regulatory impact assessment described in this section.
Executive Order 13563 of January 18, 2011 (Improving Regulation and Regulatory Review) states “Our regulatory system must protect public health, welfare, safety, and our environment while promoting economic growth, innovation, competitiveness, and job creation.” Consistent with this mandate, Executive Order 13563 requires agencies to tailor “regulations to impose the least burden on society, consistent with obtaining regulatory objectives.” Executive Order 13563 also requires agencies to “identify and consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice” while selecting “those approaches that maximize net benefits.” This notice proposes a
The Secretary has examined the impact of the proposed Guidelines under Executive Order 12866, which directs federal agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity).
According to Executive Order 12866, a regulatory action is “significant” if it meets any one of a number of specified conditions, including having an annual effect on the economy of $100 million; adversely affecting in a material way a sector of the economy, competition, or jobs; or if it raises novel legal or policy issues. The proposed Guidelines do establish additional regulatory requirements and allow an activity that was otherwise prohibited. The Administrative Procedure Act (APA) delineates an exception to its rulemaking procedures for “a matter relating to agency management or personnel” 5 U.S.C. 553(a)(2). Because the Guidelines issued by the Secretary govern federal workplace drug testing programs, HHS has taken the position that the Guidelines are a “matter relating to agency management or personnel” and, thus, are not subject to the APA's requirements for notice and comment rulemaking. This position is consistent with Executive Order 12564 regarding Drug-Free Workplaces, which directs the Secretary to promulgate scientific and technical guidelines for executive agency drug testing programs. However, the statute under which the mandatory guidelines were created (Pub. L. 100-71, section 503(a)(3)) required notice and comment apart from the APA. This provision provides the following: Notwithstanding any provision of chapter 5 of title 5, United States Code, the mandatory guidelines to be published pursuant to subsection (a)(l)(A)(ii) shall be published and made effective exclusively according to the provisions of this paragraph. Notice of the mandatory guidelines proposed by the Secretary of Health and Human Services shall be published in the
The inclusion of oxycodone, oxymorphone, hydrocodone and hydromorphone in the URMG was recommended by the DTAB, reviewed by the Department's Prescription Drug Subcommittee of the Behavioral Health Coordinating Committee, and approved by the SAMHSA Administrator in January 2012. This action is supported by various data, described in this preamble.
Costs associated with the implementation of testing for oxycodone, oxymorphone, hydrocodone and hydromorphone will be minimal because the Department has determined that all HHS certified laboratories testing specimens from federal agencies are currently conducting tests for one or more of these analytes on non-regulated urine specimens. Likewise, there will be minimal costs associated with changing initial testing to include MDA and MDEA since the current immunoassays can be adapted to test for these analytes. Laboratory personnel are currently trained and test methods have been implemented. However, there will be some administrative costs associated with adding these analytes. Prior to being allowed to test regulated specimens for these compounds, HHS certified laboratories will be required to demonstrate that their performance meets Guideline requirements by testing three (3) groups of PT samples. The Department will provide the PT samples through the National Laboratory Certification Program (NLCP) at no cost to the certified laboratories. Based on costs charged for specimen testing, laboratory costs to conduct the PT testing would range from $900 to $1,800 for each certified laboratory.
In Section 3.4, the Department is proposing criteria for calibrating initial tests for grouped analytes such as opiates and amphetamines, and specifying the cross-reactivity of the immunoassay to the other analytes(s) within the group. These proposed Guidelines allow the use of methods other than immunoassay for initial testing. In addition, these proposed Guidelines include an alternative for laboratories to continue to use existing FDA-cleared immunoassays which do not have the specified cross-reactivity, by establishing a decision point with the lowest-reacting analyte. An immunoassay manufacturer may incur costs if they choose to alter their existing product and resubmit the immunoassay for FDA clearance.
For the added opiate analytes, the two immunoassays currently used for oxycodone and oxymorphone meet the requirements, and two of the three existing opiate immunoassays used in certified laboratories meet the requirements for hydrocodone and hydromorphone analysis. The opiate immunoassay that does not have sufficient cross-reactivity would be acceptable as an initial test under these Guidelines when the lowest-reacting analyte, hydromorphone, is used to establish a decision point. Therefore, the Department assumes that all certified laboratories will elect to use existing immunoassays. Thus, the costs associated with implementing the initial tests for these analytes are expected to be
For amphetamines, one of the three existing methylenedioxymethamphetamine (MDMA) immunoassays used in certified laboratories meets the requirements. The remaining two exhibit insufficient cross-reactivity for MDA. These two immunoassays would be acceptable as an initial test under these Guidelines when the lowest-reacting analyte, MDA, is used to establish a decision point. An immunoassay manufacturer may incur costs if they choose to alter their existing product and resubmit the immunoassay for FDA clearance. Again, the Department assumes that certified laboratories will use the existing immunoassays and incur
Once the testing has been implemented, the cost per specimen for initial testing for the added analytes will range from $.06 to $0.20 due to reagent costs. Current costs for each confirmatory test range from $5.00 to $10.00 for each specimen reported positive, due to sample preparation and analysis costs. Based on information from non-regulated workplace drug testing for these analytes and testing performed by the Department on de-identified federally regulated specimens in 2011, approximately 1% of the submitted specimens is expected to be confirmed as positive for the added analytes. Therefore, the added cost for confirmatory testing will be $0.05 to $0.10 per submitted specimen. This
The addition of the Schedule II prescription medications will require MRO review to verify legitimate drug use. Based on the positivity rates from non-regulated workplace drug testing for these analytes and the additional review of specimens confirmed positive for prescription medications, MRO costs are estimated to increase by approximately 3%. This 3% cost increase is expected to occur gradually as agencies' existing contracts expire and they renegotiate the terms of new contracts, with an increase to the total cost of a federal drug test over time to between $0.60-$1.35. This cost would indicate a total cost for federal agencies of $83,700 to $188,325 in the urine testing program.
The additional costs for testing and MRO review will be incorporated into the overall cost for the federal agency submitting the specimen to the laboratory. The estimation of costs incurred is based upon overall cost to the federal agency because the review of positive specimens is usually based on all specimens submitted from an agency, rather than individual specimen testing costs or MRO review of positive specimens. Agencies may also incur some costs for training of federal employees such as drug program coordinators due to implementation of the revised Guidelines. Based on current training modules offered to drug program coordinators, and other associated costs including travel for 90% of drug program coordinators, the estimated total training cost for a one-day training session would be between $54,000 and $69,000 (
The potential benefits of deterring use of oxycodone, oxymorphone, hydrocodone and hydromorphone are the prevention of their side effects (
Considering the potential health and performance costs of narcotic abuse, the benefits to the federal workplace and the individuals within that workplace justify the inclusion of oxycodone, oxymorphone, hydrocodone and hydromorphone in Federal Workplace Drug Testing programs.
For the reasons outlined above, the Secretary has determined that the proposed Guidelines will not have a significant impact upon a substantial number of small entities within the meaning of the Regulatory Flexibility Act [5 U.S.C. 605(b)]. The flexibility added by the UrMG will not require addition expenditures. Therefore, an initial regulatory flexibility analysis is not required for this notice.
The Secretary has determined that the proposed Guidelines are not a major rule for the purpose of congressional review. For the purpose of congressional review, a major rule is one which is likely to cause an annual effect on the economy of $100 million; a major increase in costs or prices; significant effects on competition, employment, productivity, or innovation; or significant effects on the ability of U.S.-based enterprises to compete with foreign-based enterprises in domestic or export markets. This is not a major rule under the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996.
The Secretary has examined the impact of the proposed Guidelines under the Unfunded Mandates Reform Act (UMRA) of 1995 (Pub. L. 104-4). This notice does not trigger the requirement for a written statement under section 202(a) of the UMRA because the proposed Guidelines do not impose a mandate that results in an expenditure of $100 million (adjusted annually for inflation) or more by either state, local, and tribal governments in the aggregate or by the private sector in any one year.
The Secretary has considered the environmental effects of the UrMG. No information or comments have been received that would affect the agency's determination there would be a significant impact on the human environment and that neither an environmental assessment nor an environmental impact statement is required.
The Secretary has analyzed the proposed Guidelines in accordance with Executive Order 13132: Federalism.
In this notice, the Secretary is proposing to revise the standards for certification of laboratories engaged in urine fluid drug testing for federal agencies and the use of urine testing in federal drug-free workplace programs. The Department of Health and Human Services, by authority of Section 503 of Public Law 100-71, 5 U.S.C. Section 7301, and Executive Order No. 12564, establishes the scientific and technical guidelines for federal workplace drug testing programs and establishes standards for certification of laboratories engaged in urine drug testing for federal agencies. Because the Mandatory Guidelines govern standards applicable to the management of federal agency personnel, there should be little, if any, direct effect on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the Secretary has determined that the Guidelines do not contain policies that have federalism implications.
The proposed Guidelines contain information collection requirements which are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 [the PRA 44 U.S.C. 3507(d)]. Information collection and recordkeeping requirements which would be imposed on laboratories engaged in drug testing for federal agencies concern quality assurance and quality control documentation, reports, performance testing, and inspections as set out in subparts H, I, K, L, M and N. To facilitate ease of use and uniform reporting, a Federal CCF for each type of specimen collected will be developed as referenced in section 6.1. The Department has submitted the information collection and recordkeeping requirements contained in the proposed Guidelines to OMB for review and approval.
The Secretary has determined that the Guidelines do not contain information collection requirements constituting a system of records under the Privacy Act. The
Executive Order 13175 (65 FR 67249, November 6, 2000) requires SAMHSA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” as defined in the Executive Order, include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the federal government and the Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes.” The proposed Guidelines do not have tribal implications. The Guidelines will not have substantial direct effects on tribal governments, on the relationship between the federal government and Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes, as specified in Executive Order 13175.
The information collection requirements (
The title, description and respondent description of the information collections are shown in the following paragraphs with an estimate of the annual reporting, disclosure and recordkeeping burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
The following reporting requirements are also in the proposed Guidelines, but have not been addressed in the above reporting burden table: Collector must report any unusual donor behavior or refusal to participate in the collection process on the Federal CCF [Sections 1.8, 8.9]; collector annotates the Federal CCF when a sample is a blind sample [Section 10.3(a)]; MRO notifies the federal agency and HHS when an error occurs on a blind sample [Section 10.4(c)]; and Sections 13.6 and 13.7 describe the actions an MRO takes for the medical evaluation of a donor who cannot provide a urine specimen. SAMHSA has not calculated a separate reporting burden for these requirements because they are included in the burden hours estimated for collectors to complete Federal CCFs and for MROs to report results to federal agencies.
The following disclosure requirements are also included in the proposed Guidelines, but have not been addressed in the above disclosure burden table: The collector must explain the basic collection procedure to the donor and answer any questions [Section 8.3(e) and (g)]. SAMHSA believes having the collector explain the collection procedure to the donor and answer any questions is a standard business practice and not a disclosure burden.
The proposed Guidelines contain a number of recordkeeping requirements that SAMHSA considers not to be an additional recordkeeping burden. In subpart D, a trainer is required to document the training of an individual to be a collector [Section 4.3(a)(3)] and the documentation must be maintained in the collector's training file [Section 4.3(c)]. SAMHSA believes this training documentation is common practice and is not considered an additional burden. In subpart F, if a collector uses an incorrect form to collect a federal agency specimen, the collector is required to provide a statement [Section 6.2(b)] explaining why an incorrect form was used to document collecting the specimen. SAMHSA believes this is an extremely infrequent occurrence and does not create a significant additional recordkeeping burden. Subpart H [Sections 8.4(c), 8.5(d)(2), 8.5(e)(1) and (2)] requires collectors to enter any information on the Federal CCF of any unusual findings during the urine specimen collection procedure. These recordkeeping requirements are an integral part of the collection procedure and are essential to documenting the chain of custody for the specimens collected. The burden for these entries are included in the recordkeeping burden estimated to complete the Federal CCF and is, therefore, not considered an additional recordkeeping burden. Subpart K describes a number of recordkeeping requirements for laboratories associated with their testing procedures, maintaining chain of custody, and keeping records [
Thus the total annual response burden associated with the testing of urine specimens by the laboratories and IITFs is estimated to be 13,268 hours (that is, the sum of the total hours from the above tables). This is in addition to the 1,788,809 hours currently approved
As required by section 3507(d) of the PRA, the Secretary has submitted a copy of these proposed Guidelines to OMB for its review. Comments on the information collection requirements are specifically solicited in order to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of HHS's functions, including whether the information will have practical utility; (2) evaluate the accuracy of HHS's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) enhance the quality, utility, and clarity of the information to be collected; and (4) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
OMB is required to make a decision concerning the collection of information contained in these proposed Guidelines between 30 and 60 days after publication of this document in the
Organizations and individuals desiring to submit comments on the information collection requirements should direct them to the Office of Information and Regulatory Affairs, OMB, New Executive Office Building, 725 17th Street NW., Washington, DC 20502, Attn: Desk Officer for SAMHSA. Because of delays in receipt of mail, comments may also be sent to 202-395-6974 (fax).
For reasons set forth in the preamble, the Department proposes to revise the Mandatory Guidelines for Federal Workplace Drug Testing Programs to include Mandatory Guidelines using Urine Specimens to read as follows:
(a) These Guidelines apply to:
(1) Executive Agencies as defined in 5 U.S.C. 105;
(2) The Uniformed Services, as defined in 5 U.S.C. 2101(3) (but excluding the Armed Forces as defined in 5 U.S.C. 2101(2));
(3) Any other employing unit or authority of the federal government except the United States Postal Service, the Postal Rate Commission, and employing units or authorities in the Judicial and Legislative Branches; and
(4) The Intelligence Community, as defined by Executive Order 12333, is subject to these Guidelines only to the extent agreed to by the head of the affected agency;
(5) Laboratories and instrumented initial test facilities (IITFs) that provide drug testing services to the federal agencies;
(6) Collectors who provide specimen collection services to the federal agencies; and
(7) Medical Review Officers (MROs) who provide drug testing review and interpretation of results services to the federal agencies.
(b) These Guidelines do not apply to drug testing under authority other than Executive Order 12564, including testing of persons in the criminal justice
Although HHS has no authority to regulate the transportation industry, the Department of Transportation (DOT) does have such authority. DOT is required by law to develop requirements for its regulated industry that “incorporate the Department of Health and Human Services scientific and technical guidelines dated April 11, 1988, and any amendments to those guidelines . . .” See 49 U.S.C. 20140(c)(2). In carrying out its mandate, DOT requires by regulation at 49 CFR part 40 that its federally-regulated employers use only HHS-certified laboratories in the testing of employees, 49 CFR 40.81, and incorporates the scientific and technical aspects of the HHS Mandatory Guidelines.
(a) Executive Order 12564 and Public Law 100-71 require the Department of Health and Human Services (HHS) to establish scientific and technical guidelines for federal workplace drug testing programs.
(b) The Secretary has the responsibility to implement these Guidelines.
(a) Each federal agency must ensure that its workplace drug testing program complies with the provisions of these Guidelines unless a waiver has been obtained from the Secretary.
(b) To obtain a waiver, a federal agency must submit a written request to the Secretary that describes the specific change for which a waiver is sought and a detailed justification for the change.
(a) To ensure the full reliability and accuracy of specimen tests, the accurate reporting of test results, and the integrity and efficacy of federal drug testing programs, the Secretary may make changes to these Guidelines to reflect improvements in the available science and technology.
(b) The changes will be published in final as a notice in the
The following definitions are adopted:
Consistent with 5 U.S.C. 552a and 48 CFR 24.101-24.104, all agency contracts with laboratories, IITFs, collectors, and MROs must require that they comply with the Privacy Act, 5 U.S.C. 552a. In addition, the contracts must require compliance with employee access and confidentiality provisions of Section 503 of Public Law 100-71. Each federal agency must establish a Privacy Act System of Records or modify an existing system or use any applicable Government-wide system of records to cover the records of employee drug test results. All contracts and the Privacy Act System of Records must specifically require that employee records be maintained and used with the highest regard for employee privacy.
In addition, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule (Rule), 45 CFR parts 160 and 164, Subparts A and E, is applicable to certain health care providers with whom a federal agency may contract. If a health care provider is a HIPAA covered entity, the provider must protect the individually identifiable health information it maintains in accordance with the requirements of the Rule, which includes not using or disclosing the information except as permitted by the Rule and ensuring there are reasonable safeguards in place to protect the privacy of the information. For more information regarding the HIPAA Privacy Rule, please visit
(a) As a donor for a federally regulated drug test, you have refused to take a federally regulated drug test if you:
(1) Fail to appear for any test (except a pre-employment test) within a reasonable time, as determined by the federal agency, consistent with applicable agency regulations, after being directed to do so by the federal agency;
(2) Fail to remain at the collection site until the collection process is complete (with the exception of a donor who leaves the collection site before the collection process begins for a pre-employment test);
(3) Fail to provide a specimen (
(4) In the case of a direct observed or monitored collection, fail to permit the observation or monitoring of your provision of a specimen when required as described in Sections 8.9 and 8.10;
(5) Fail to provide a sufficient amount of urine when directed, and it has been determined, through a required medical evaluation, that there was no legitimate medical explanation for the failure as determined by the process described in Section 13.5;
(6) Fail or decline to participate in an alternate specimen collection (
(7) Fail to undergo a medical examination or evaluation, as directed by the MRO as part of the verification process (
(8) Fail to cooperate with any part of the testing process (
(9) For an observed collection, fail to follow the observer's instructions related to the collection process;
(10) Possess or wear a prosthetic or other device that could be used to interfere with the collection process; or
(11) Admit to the collector or MRO that you have adulterated or (for urine) substituted the specimen.
(a) As a federal agency employee or applicant, a refusal to take a test may result in the initiation of disciplinary or adverse action, up to and including removal from, or non-selection for, federal employment.
(b) When a donor has refused to participate in a part of the collection process, the collector must terminate that portion of the collection process and take action as described in Section 8.9; immediately notify the federal agency's designated representative by any means (
(c) When documenting a refusal to test during the verification process as described in Sections 13.4, 13.5, and 13.6, the MRO must complete the MRO copy of the Federal CCF to include:
(1) Checking the refusal to test box;
(2) Providing a reason for the refusal in the remarks line; and
(3) Signing and dating the MRO copy of the Federal CCF.
A federal agency may collect urine and/or an alternate specimen type for its workplace drug testing program. Only specimen types authorized by Mandatory Guidelines for Federal Workplace Drug Testing Programs may be collected. An agency using urine must follow these Guidelines.
A federal agency may collect a urine specimen for the following reasons:
(a) Federal agency applicant/Pre-employment test;
(b) Random test;
(c) Reasonable suspicion/cause test;
(d) Post-accident test;
(e) Return to duty test; or
(f) Follow-up test.
Each urine specimen is collected as a split specimen as described in Section 2.5.
A donor is expected to provide at least 45 mL of urine for a specimen.
The collector pours at least 30 mL into a specimen bottle that is designated as A (primary) and then pours at least 15 mL into a specimen bottle that is designated as B (split).
Entities and individuals subject to these Guidelines under Section 1.1 may not release specimens collected pursuant to Executive Order 12564, Public Law 100-71, and these Guidelines to donors or their designees. Specimens also may not be released to any other entity or individual unless expressly authorized by these Guidelines or by applicable federal law. This section does not prohibit a donor's request to have a split (B) specimen tested in accordance with Section 13.8.
A federal agency:
(a) Must ensure that each specimen is tested for marijuana and cocaine metabolites as provided under Section 3.4;
(b) Is authorized to test each specimen for opiates, amphetamines, and phencyclidine, as provided under Section 3.4; and
(c) Must ensure that the following specimen validity tests are conducted on each urine specimen:
(1) Determine the creatinine concentration on every specimen;
(2) Determine the specific gravity on every specimen for which the creatinine concentration is less than 20 mg/dL;
(3) Determine the pH on every specimen; and
(4) Perform one or more specimen validity tests for oxidizing adulterants on every specimen.
(d) If a specimen exhibits abnormal characteristics (
(a) On a case-by-case basis, a specimen may be tested for additional drugs, if a federal agency is conducting the collection for reasonable suspicion or post accident testing. A specimen collected from a federal agency employee may be tested by the federal agency for any drugs listed in Schedule I or II of the Controlled Substances Act (other than the drugs listed in Section 3.1, or when used pursuant to a valid prescription or when used as otherwise authorized by law). The federal agency must request the HHS-certified laboratory to test for the additional drug, include a justification to test a specific specimen for the drug, and ensure that the HHS-certified laboratory has the capability to test for the drug and has established properly validated initial and confirmatory analytical methods. If an initial test procedure is not available upon request for a suspected Schedule I or Schedule II drug, the federal agency can request an HHS-certified laboratory
(b) A federal agency covered by these Guidelines must petition the Secretary in writing for approval to routinely test for any drug class not listed in Section 3.1. Such approval must be limited to the use of the appropriate science and technology and must not otherwise limit agency discretion to test for any drug tested under paragraph (a) of this section.
(a) Specimens collected pursuant to Executive Order 12564, Public Law 100-71, and these Guidelines must only be tested for drugs and to determine their validity in accordance with Subpart C of these Guidelines. Use of specimens by donors, their designees, or any other entity, for other purposes (
(b) These Guidelines are not intended to prohibit federal agencies, specifically authorized by law to test a specimen for additional classes of drugs in its workplace drug testing program.
An HHS-certified laboratory is authorized to perform additional drug and/or specimen validity tests as necessary to provide information that the MRO would use to report a verified drug test result (
An HHS-certified laboratory reports a primary (A) specimen as adulterated when:
(a) The pH is less than 4 or equal to or greater than 11 using either a pH meter or a colorimetric pH test for the initial test on the first aliquot and a pH meter for the confirmatory test on the second aliquot;
(b) The nitrite concentration is equal to or greater than 500 mcg/mL using either a nitrite colorimetric test or a general oxidant colorimetric test for the initial test on the first aliquot and a different confirmatory test (
(c) The presence of chromium (VI) is verified using either a general oxidant colorimetric test (with an equal to or greater than 50 mcg/mL chromium (VI)-equivalent cutoff) or a chromium (VI) colorimetric test (chromium (VI) concentration equal to or greater than 50 mcg/mL) for the initial test on the first aliquot and a different confirmatory test (
(d) The presence of halogen (
(e) The presence of glutaraldehyde is verified using either an aldehyde test (aldehyde present) or the characteristic
(f) The presence of pyridine (pyridinium chlorochromate) is verified using either a general oxidant colorimetric test (with an equal to or greater than 200 mcg/mL nitrite-equivalent cutoff or an equal to or greater than 50 mcg/mL chromium (VI)-equivalent cutoff) or a chromium (VI) colorimetric test (chromium (VI) concentration equal to or greater than 50 mcg/mL) for the initial test on the first aliquot and a different confirmatory test (
(g) The presence of a surfactant is verified by using a surfactant colorimetric test with an equal to or greater than 100 mcg/mL dodecylbenzene sulfonate-equivalent cutoff for the initial test on the first aliquot and a different confirmatory test (
(h) The presence of any other adulterant not specified in paragraphs (b) through (g) of this section is verified using an initial test on the first aliquot and a different confirmatory test on the second aliquot.
An HHS-certified laboratory reports a primary (A) specimen as substituted when the creatinine concentration is less than 2 mg/dL on both the initial and confirmatory creatinine tests on two separate aliquots (
A dilute result may be reported only in conjunction with the positive or negative drug test results for a specimen.
(a) An HHS-certified laboratory or an HHS-certified IITF reports a primary (A) specimen as dilute when the creatinine concentration is greater than 5 mg/dL but less than 20 mg/dL and the specific gravity is equal to or greater than 1.002 but less than 1.003 on a single aliquot.
(b) In addition, an HHS-certified laboratory reports a primary (A) specimen as dilute when the creatinine concentration is equal to or greater than 2 mg/dL but less than or equal to 5 mg/dL and the specific gravity is greater than 1.0010 but less than 1.0030.
An HHS-certified laboratory reports a primary (A) specimen as an invalid result when:
(a) Inconsistent creatinine concentration and specific gravity results are obtained (
(b) The pH is equal to or greater than 4 and less than 4.5 or equal to or greater than 9 and less than 11 using either a colorimetric pH test or pH meter for the initial test and a pH meter for the confirmatory test on two separate aliquots;
(c) The nitrite concentration is equal to or greater than 200 mcg/mL using a nitrite colorimetric test or equal to or greater than the equivalent of 200 mcg/mL nitrite using a general oxidant colorimetric test for both the initial (first) test and the second test or using either initial test and the nitrite concentration is equal to or greater than 200 mcg/mL but less than 500 mcg/mL for a different confirmatory test (
(d) The possible presence of chromium (VI) is determined using the same chromium (VI) colorimetric test with a cutoff equal to or greater than 50 mcg/mL chromium (VI) for both the initial (first) test and the second test on two separate aliquots;
(e) The possible presence of a halogen (
(f) The possible presence of glutaraldehyde is determined by using the same aldehyde test (aldehyde present) or characteristic immunoassay response on one or more drug immunoassay tests for both the initial (first) test and the second test on two separate aliquots;
(g) The possible presence of an oxidizing adulterant is determined by using the same general oxidant colorimetric test (with an equal to or greater than 200 mcg/mL nitrite-equivalent cutoff, an equal to or greater than 50 mcg/mL chromium (VI)-equivalent cutoff, or a halogen concentration is equal to or greater than the LOQ) for both the initial (first) test and the second test on two separate aliquots;
(h) The possible presence of a surfactant is determined by using the same surfactant colorimetric test with an equal to greater than 100 mcg/mL dodecylbenzene sulfonate-equivalent cutoff for both the initial (first) test and the second test on two separate aliquots or a foam/shake test for the initial test;
(i) Interference occurs on the immunoassay or alternate technology initial drug tests on two separate aliquots (
(j) Interference with the drug confirmatory assay occurs on two separate aliquots of the specimen and the laboratory is unable to identify the interfering substance;
(k) The physical appearance of the specimen (
(l) The specimen has been tested and the appearances of the primary (A) and the split (B) specimens (
(m) The concentration of a biomarker is not consistent with that established for human urine.
(a) A collector who has been trained to collect urine specimens in accordance with these Guidelines.
(b) The immediate supervisor of a federal employee donor may only collect that donor's specimen when no other collector is available. The supervisor must be a trained collector.
(c) The hiring official of a federal agency applicant may only collect that federal agency applicant's specimen when no other collector is available.
(a) A federal agency employee who is in a testing designated position and subject to the federal agency drug testing rules must not be a collector for co-workers in the same testing pool or who work together with that employee on a daily basis.
(b) A federal agency applicant or employee must not collect his or her own drug testing specimen.
(c) An employee working for an HHS-certified laboratory or IITF must not act as a collector if the employee could link the identity of the donor to the donor's drug test result.
(d) To avoid a potential conflict of interest, a collector must not be related to the employee (
(a) An individual may serve as a collector if he or she fulfills the following conditions:
(1) Is knowledgeable about the collection procedure described in these Guidelines;
(2) Is knowledgeable about any guidance provided by the federal agency's Drug-Free Workplace Program and additional information provided by the Secretary relating to these Guidelines;
(3) Is trained and qualified to collect a urine specimen. Training must include the following:
(i) All steps necessary to complete a urine collection;
(ii) Completion and distribution of the Federal CCF;
(iii) Problem collections;
(iv) Fatal flaws, correctable flaws, and how to correct problems in collections; and
(v) The collector's responsibility for maintaining the integrity of the collection process, ensuring the privacy of the donor, ensuring the security of the specimen, and avoiding conduct or statements that could be viewed as offensive or inappropriate.
(4) Has demonstrated proficiency in collections by completing five consecutive error-free mock collections.
(i) The five mock collections must include one uneventful collection scenario, one insufficient specimen quantity, one temperature out of range scenario, one scenario in which the donor refuses to sign the Federal CCF, and one scenario in which the donor refuses to initial the specimen bottle tamper-evident seal.
(ii) A qualified trainer for collectors must monitor and evaluate the individual being trained, in person or by a means that provides real-time observation and interaction between the trainer and the trainee, and the trainer must attest in writing that the mock collections are “error-free.”
(b) A trained collector must complete refresher training at least every five years that includes the requirements in paragraph (a) of this section.
(c) The collector must maintain the documentation of his or her training and provide that documentation to a federal agency when requested.
(d) An individual may not collect specimens for a federal agency until his or her training as a collector has been properly documented.
(a) An individual may serve as an observer for a direct observed collection when the individual has satisfied the requirements:
(1) Is knowledgeable about the direct observed collection procedure described in Section 8.9 of these Guidelines;
(2) Is knowledgeable about any guidance provided by the federal agency's Drug-Free Workplace Program or additional information provided by the Secretary relating to the direct observed collection procedure described in these Guidelines;
(3) Has received training on the following subjects:
(i) All steps necessary to perform a direct observed collection; and
(ii) The observer's responsibility for maintaining the integrity of the collection process, ensuring the privacy of individuals being tested, ensuring that the observation is done in a professional manner that minimizes the discomfort to the employee so observed, ensuring the security of the specimen by maintaining visual contact with the collection container until it is delivered to the collector, and avoiding conduct or statements that could be viewed as offensive or inappropriate.
(b) The observer must be the same gender as the donor.
(c) The observer is not required to be a trained collector.
(a) Individuals are considered qualified trainers for collectors and may train others to collect urine specimens when they have completed the following:
(1) Qualified as a trained collector and regularly conducted urine drug test collections for a period of at least one year or
(2) Completed a “train the trainer” course given by an organization (
(b) A qualified trainer for collectors must complete refresher training at least every five years in accordance with the collector requirements in Section 4.3(a).
(c) A qualified trainer for collectors must maintain the documentation of his or her training and provide that documentation to a federal agency when requested.
A federal agency must ensure the following:
(a) The collector has satisfied the requirements described in Section 4.3;
(b) The collector, who may be self-employed, or an organization (
(c) The collector has been provided the name and telephone number of the federal agency representative.
(a) A collection site may be a permanent or temporary facility located either at the work site or at a remote site.
(b) In the event that an agency-designated collection site is not accessible and there is an immediate requirement to collect a urine specimen (
The facility used as a collection site must have the following:
(a) Provisions to ensure donor privacy during the collection (as described in Section 8.1);
(b) A suitable and clean surface area that is not accessible to the donor for handling the specimens and completing the required paperwork;
(c) A secure temporary storage area to maintain specimens until the specimen is transferred to an HHS-certified laboratory or IITF;
(d) A restricted access area where only authorized personnel may be present during the collection;
(e) A restricted access area for the storage of collection supplies;
(f) The ability to store records securely; and
(g) The ability to restrict the donor access to potential diluents in accordance with Section 8.2.
Collection site records must be stored at a secure site designated by the collector or the collector's employer.
Collection site records (
(a) A collector must do the following to maintain the security and integrity of a specimen:
(1) Not allow unauthorized personnel to enter the collection area during the collection procedure;
(2) Perform only one donor collection at a time;
(3) Restrict access to collection supplies before, during and after collection;
(4) Ensure that only the collector and the donor are allowed to handle the unsealed specimen;
(5) Ensure the chain of custody process is maintained and documented throughout the entire collection, storage, and transport procedures;
(6) Ensure that the Federal CCF is completed and distributed as required; and
(7) Ensure that specimens transported to an HHS-certified laboratory or IITF are sealed and placed in transport containers designed to minimize the possibility of damage during shipment (
(b) Couriers, express carriers, and postal service personnel are not required to document chain of custody since specimens are sealed in packages that would indicate tampering during transit to the HHS-certified laboratory or IITF.
Collections must be performed at a site that provides reasonable privacy (as described in Section 8.1).
The OMB-approved Federal CCF must be used to document custody and control of each specimen at the collection site.
(a) The use of a non-federal CCF or an expired Federal CCF is not, by itself, a reason for the HHS-certified laboratory or IITF to automatically reject the specimen for testing or for the MRO to cancel the test.
(b) If the collector uses an incorrect form, the collector must document that it is a federal agency specimen collection and provide the reason that the incorrect form was used. Based on the information provided by the collector, the HHS-certified laboratory or IITF must handle and test the specimen as a federal agency specimen.
(c) If the HHS-certified laboratory, HHS-certified IITF, or MRO discovers that an incorrect form was used by the collector, the laboratory, IITF, or MRO must obtain a memorandum for the record from the collector describing the reason the incorrect form was used. If a memorandum for the record cannot be obtained, the HHS-certified laboratory or IITF must wait at least 5 business days before the laboratory or IITF reports a rejected for testing result to the MRO and the MRO cancels the test.
A single-use collection container with a means (
(a) The collection container, the thermometer, and the specimen bottles must not substantially affect the composition of drugs and/or metabolites in the urine specimen.
(b) The two specimen bottles must be sealable and non-leaking, and must maintain the integrity of the specimen during storage and transport so that the specimen contained therein can be tested in an HHS-certified laboratory or IITF for the presence of drugs or their metabolites.
(c) The two specimen bottles must be sufficiently transparent to enable an objective assessment of specimen appearance and identification of abnormal physical characteristics without opening the bottle.
(a) The collection container must be capable of holding at least 55 mL and have a volume marking clearly noting a level of 45 mL.
(b) One of the two specimen bottles must be capable of holding at least 35 mL and the other at least 20 mL, and each must have a volume marking clearly noting the appropriate level (30 mL for the primary specimen and 15 mL for the split specimen).
(c) The thermometer may be affixed to or built into the collection container and must provide graduated temperature readings from 32-38 °C/90-100 °F. Alternatively, the collector may use another technology to measure specimen temperature (
The following privacy requirements apply when a donor is providing a urine specimen:
(a) Only authorized personnel and the donor may be present in the restricted access area where the collection takes place.
(b) The collector is not required to be the same gender as the donor. The observer for a direct observed collection (
(c) The collector must give the donor visual privacy while providing the specimen. The donor is allowed to provide a urine specimen in an enclosed
The collector must deter the dilution or substitution of a specimen at the collection site by:
(a) Placing a toilet bluing agent in a toilet bowl or toilet tank, so the reservoir of water in the toilet bowl always remains blue. If no bluing agent is available or if the toilet has an automatic flushing system, the collector shall turn the water supply off to the toilet and flush the toilet to remove the water in the toilet when possible.
(b) Secure other sources of water (
The collector must take the following steps before beginning a urine specimen collection:
(a) If a donor fails to arrive at the collection site at the assigned time, the collector must follow the federal agency policy or contact the federal agency representative to obtain guidance on action to be taken.
(b) When the donor arrives at the collection site, the collector should begin the collection procedure without undue delay. For example, the collection should not be delayed because the donor states that he or she is unable to urinate or an authorized employer or employer representative is late in arriving.
(c) The collector requests the donor to present photo identification (
(d) The collector must provide identification (
(e) The collector explains the basic collection procedure to the donor.
(f) The collector informs the donor that the instructions for completing the Federal Custody and Control Form are located on the back of the Federal CCF or available upon request.
(g) The collector answers any reasonable and appropriate questions the donor may have regarding the collection procedure.
(h) The collector asks the donor to remove any unnecessary outer garments (
(1) The collector must ensure that all personal belongings (
(2) The collector asks the donor to empty his or her pockets and display any items that could be used to adulterate or substitute the specimen.
(3) If no items are present that can be used to adulterate or substitute the specimen, the donor can place the items back into his or her pockets and continue the collection procedure.
(4) If an item is present that appears to have been brought to the collection site with the intent to adulterate or substitute the specimen, a direct observed collection procedure is used in accordance with Section 8.9. If the item appears to be inadvertently brought to the collection site, the collector must secure the item and continue the normal collection procedure.
(5) If the donor refuses to show the collector the items in his or her pockets, this is considered a “refusal to test.” The collector must stop the collection and report the refusal to test as described in Section 8.13.
(i) The collector shall instruct the donor to wash and dry his or her hands prior to urination. After washing his or her hands, the donor must remain in the presence of the collector and must not have access to any water fountain, faucet, soap dispenser, cleaning agent, or any other materials which could be used to adulterate or substitute the specimen.
(1) If the donor refuses to wash his or her hands when instructed by the collector, this is considered a “refusal to test.” The collector must stop the collection and report the refusal to test as described in Section 8.13.
(a) The collector will provide or the donor may select a specimen collection container that is clean, unused, wrapped/sealed in original packaging and compliant with Subpart G. The specimen collection container will be opened in view of the donor.
(b) The collector instructs the donor to provide his or her specimen in the privacy of a stall or otherwise partitioned area that allows for individual privacy. The collector directs the donor to provide a specimen of at least 45 mL, to not flush the toilet, and to return with the specimen as soon as the donor has completed the void.
(1) Except in the case of a direct observed collection (
(2) The collector may set a reasonable time limit for specimen collection.
(c) The collector notes any unusual behavior or appearance of the donor on the Federal CCF. If the collector detects any conduct that clearly indicates an attempt to tamper with a specimen (
Integrity and Identity of the Specimen. The collector must take the following steps during and after the donor provides the urine specimen:
(a) The collector must inform the donor that, once the collection procedure has begun, the donor must remain at the collection site (
(b) After providing the specimen, the donor gives the specimen collection container to the collector. Both the donor and the collector must keep the specimen container in view at all times until the collector seals the specimen bottles as described in Section 8.8.
(c) After the donor has given the specimen to the collector, whenever practical, the donor shall be allowed to wash his or her hands and the donor may flush the toilet.
(d) The collector must measure the temperature of the specimen within 4 minutes of receiving the specimen from the donor. The collector records on the Federal CCF whether or not the
(1) The temperature measuring device must accurately reflect the temperature of the specimen and not contaminate the specimen.
(2) If the temperature of the specimen is outside the range of 32°-38°C/90°-100 °F, that is a reason to believe that the donor may have adulterated or substituted the specimen. Another specimen must be collected under direct observation in accordance with Section 8.9. The collector will forward both specimens (
(e) The collector must inspect the specimen to determine if there is any sign indicating that the specimen may not be a valid urine specimen (
(1) The collector notes any unusual finding on the Federal CCF. A specimen suspected of not being a valid urine specimen must be forwarded to an HHS-certified laboratory for testing.
(2) When there is any reason to believe that a donor may have adulterated or substituted the specimen, another specimen must be obtained as soon as possible under direct observation in accordance with Section 8.10. The collector will forward both specimens (
(f) The collector must determine the volume of urine in the specimen container. The collector must never combine urine collected from separate voids to create a specimen.
(1) If the volume is at least 45 mL, the collector will proceed with steps described in Section 8.8.
(2) If the volume is less than 45 mL, the collector discards the specimen and immediately collects a second specimen using the same procedures as for the first specimen (including steps in paragraphs c and d of this section).
(i) The collector may give the donor a reasonable amount of liquid to drink for this purpose (
(ii) If the donor provides a sufficient urine specimen (
(iii) If the employee has not provided a sufficient specimen (
(g) If the donor fails to remain present through the completion of the collection, declines to have a direct observed collection as required in steps (d)(2) or (e)(2) above, refuses to provide a second specimen as required in step (f)(2) above, or refuses to provide an alternate specimen as authorized in step (f)(2)(iii) above, the collector stops the collection and reports the refusal to test in accordance with Section 8.13.
(a) If the donor states that he or she is unable to provide a urine specimen during the collection process, the collector requests that the donor enter the restroom (stall) and attempt to provide a urine specimen.
(b) The donor demonstrates his or her inability to provide a specimen when he or she comes out of the stall with an empty collection container.
(1) If the donor states that he or she could provide a specimen after drinking some fluids, the collector gives the donor a reasonable amount of liquid to drink for this purpose (
(2) If the donor states that he or she is unable to provide a urine specimen, the collector records the reason for not collecting a urine specimen on the Federal CCF, notifies the federal agency's designated representative for authorization of an alternate specimen to be collected, and sends the appropriate copies of the Federal CCF to the MRO and to the federal agency's designated representative. If an alternate specimen is authorized, the collector may begin the collection procedure for the alternate specimen (see Section 8.7) in accordance with the Mandatory Guidelines for Federal Workplace Drug Testing Programs using the alternative specimen.
No, unless the alternate specimen type is authorized by Mandatory Guidelines for Federal Workplace Drug Testing Programs and specifically authorized by the federal agency.
(a) All federal agency collections are to be split specimen collections.
(b) The collector, in the presence of the donor, pours the urine from the collection container into two specimen bottles to be labeled “A” and “B”. The collector pours at least 30 mL of urine into Bottle A and at least 15 mL into Bottle B, and caps each bottle.
(c) In the presence of the donor, the collector places a tamper-evident label/seal from the Federal CCF over each specimen bottle cap. The collector records the date of the collection on the tamper-evident labels/seals.
(d) The collector instructs the donor to initial the tamper-evident labels/seals on each specimen bottle. If the donor refuses to initial the labels/seals, the collector notes the refusal on the Federal CCF and continues with the collection process.
(e) The collector must ensure that all the information required on the Federal CCF is provided.
(f) The collector asks the donor to read and sign a statement on the Federal CCF certifying that the specimens identified were collected from him or her. If the donor refuses to sign the certification statement, the collector notes the refusal on the Federal CCF and continues with the collection process.
(g) The collector signs and prints his or her name on the Federal CCF, completes the Federal CCF, and distributes the copies of the Federal CCF as required.
(h) The collector seals the specimens (Bottle A and Bottle B) in a package and, within 24 hours or during the next business day, sends them to the HHS-certified laboratory or IITF that will be testing the Bottle A urine specimen. The collector must also send a copy of the Federal CCF to the HHS-certified laboratory or IITF.
(i) If the specimen and Federal CCF are not immediately transported to an HHS-certified laboratory or IITF, they must remain under direct control of the collector or be appropriately secured under proper specimen storage conditions until transported.
(j) The collector must discard any urine left over in the collection container after both specimen bottles have been appropriately filled and sealed. There is one exception to this requirement: The collector may use excess urine to conduct clinical tests (
A direct observed collection procedure must be conducted when:
(a) The agency has authorized a direct observed collection because:
(1) The donor's previous drug test result was reported by an MRO as positive, adulterated, or substituted; or
(2) The HHS-certified laboratory reports to the MRO that a specimen is invalid, and the MRO reported to the agency that there was not a legitimate medical explanation for the result; or
(3) The MRO reported to the agency that the primary bottle (A) specimen was positive, adulterated, or substituted result had to be cancelled because the test of the split specimen could not be tested and/or the split specimen bottle (B) failed to reconfirm; or
(b) At the collection site, an immediate collection of a second urine specimen is required because:
(1) The temperature of the specimen collected during a routine collection is outside the acceptable temperature range;
(2) The collector suspects that the donor has tampered with the specimen during a routine collection (
(3) The collector observes conduct by the donor that indicates a possible attempt to adulterate or substitute the specimen; or
(4) The collector observed materials brought by the donor to the collection site for the purpose of adulterating, substituting, or diluting the specimen.
(c) The collector must contact a collection site supervisor to review and concur in advance with any decision by the collector to obtain a specimen under direct observation.
(d) If the donor declines to have a direct observed collection, the collector reports a refusal to test (
A direct observed collection procedure is the same as that for a routine collection, except an observer watches the donor urinate into the collection container. The observer must be the same gender as the donor with no exception to this requirement. If there is no collector available of the same gender as the donor, the collector or collection site supervisor shall select an observer trained in direct observed specimen collection as described in Section 4.4. The observer may be an individual that is not a trained collector.
At the point in a routine collection where the donor enters the restroom with the collection container, a direct observed collection includes the following additional steps:
(a) The observer enters the restroom with the donor;
(b) The observer must directly watch the urine go from the donor's body into the collection container (the use of mirrors or video cameras is not permitted);
(c) The observer must not touch or handle the collection container unless the observer is also serving as the collector;
(d) After the donor has completed urinating into the collection container:
(1) If the same person serves as the observer and collector, he or she may receive the collection container from the donor while they are both in the restroom;
(2) If the observer is not serving as the collector, the donor and observer leave the restroom and the donor hands the collection container directly to the collector. The observer must maintain visual contact of the collection container until the donor hands the container to the collector.
(e) The collector checks the box for an observed collection on the Federal CCF and writes the name of the observer and the reason for an observed collection on the Federal CCF; and
(f) The collector then continues with the routine collection procedure in Section 8.3.
(a) In the event that an agency-designated collection site is not available and there is an immediate requirement to collect a specimen (
(b) If the enclosure used by the donor to provide a specimen has a source of water that cannot be disabled or secured, a monitored collection must be conducted.
(c) If the donor declines to permit a collection to be monitored when required, the collector reports a refusal to test (
A monitored collection is the same as that for a routine collection, except that a monitor accompanies the donor into the restroom to check for signs that the donor may be tampering with the specimen. The monitor remains in the restroom, but outside the stall, while the donor is providing the specimen. A person of the same gender as the donor shall serve as the monitor, unless the monitor is a medical professional (
(a) The collector secures the restroom being used for the monitored collection so that no one except the employee and the monitor can enter the restroom until after the collection has been completed.
(b) The monitor enters the restroom with the donor.
(c) The monitor must not watch the employee urinate into the collection container. If the monitor hears sounds or makes other observations indicating an attempt by the donor to tamper with a specimen, there must be an additional collection under direct observation in accordance with Section 8.9.
(d) The monitor must not touch or handle the collection container unless the monitor is also the collector.
(e) After the donor has completed urinating into the collection container:
(1) If the same person serves as the monitor and collector, he or she may receive the collection container from the donor while they are both in the restroom;
(2) If the monitor is not serving as the collector, the donor and monitor leave the restroom and the donor hands the collection container directly to the collector. The monitor must ensure that the employee takes the collection container directly to the collector as soon as the employee has exited the enclosure.
(f) If the monitor is not serving as the collector, the collector writes the name of the monitor on the Federal CCF.
(g) The collector then continues with the routine collection procedure in Section 8.3.
If there is a refusal to test as defined in Section 1.7, the collector stops the collection, discards any urine collected and reports the refusal to test by:
(a) Notifying the federal agency by means (
(b) Documenting the refusal to test on the Federal CCF, and
(c) Sending all copies of the Federal CCF to the federal agency's designated representative.
(a) A federal agency must ensure that collectors and collection sites satisfy all requirements in subparts D, E, F, G, and H.
(b) A federal agency (or only one federal agency when several agencies are using the same collection site) must inspect 5 percent or up to a maximum of 50 collection sites each year, selected randomly from those sites used to collect agency specimens (
(c) A federal agency must investigate reported collection site deficiencies (
(a) The Secretary has broad discretion to take appropriate action to ensure the full reliability and accuracy of drug testing and reporting, to resolve problems related to drug testing, and to enforce all standards set forth in these Guidelines. The Secretary has the authority to issue directives to any HHS-certified laboratory or IITF including suspending the use of certain analytical procedures when necessary to protect the integrity of the testing process; ordering any HHS-certified laboratory or IITF to undertake corrective actions to respond to material deficiencies identified by an inspection or through performance testing; ordering any HHS-certified laboratory or IITF to send specimens or specimen aliquots to another HHS-certified laboratory for retesting when necessary to ensure the accuracy of testing under these Guidelines; ordering the review of results for specimens tested under the Guidelines for private sector clients to the extent necessary to ensure the full reliability of drug testing for federal agencies; and ordering any other action necessary to address deficiencies in drug testing, analysis, specimen collection, chain of custody, reporting of results, or any other aspect of the certification program.
(b) A laboratory or IITF is prohibited from stating or implying that it is certified by HHS under these Guidelines to test urine specimens for federal agencies unless it holds such certification.
(a) A laboratory or IITF seeking HHS certification must:
(1) Submit a completed OMB-approved application form (
(2) Have its application reviewed as complete and accepted by HHS;
(3) Successfully complete the PT challenges in 3 consecutive sets of initial PT samples;
(4) Satisfy all the requirements for an initial inspection; and
(5) Receive notification of certification from the Secretary before testing specimens for federal agencies.
(a) To maintain HHS certification, a laboratory or IITF must:
(1) Successfully participate in both the maintenance PT and inspection programs (
(2) Respond in an appropriate, timely, and complete manner to required corrective action requests if deficiencies are identified in the maintenance PT performance, during the inspections, operations, or reporting; and
(3) Satisfactorily complete corrective remedial actions, and undergo special inspection and special PT sets to maintain or restore certification when material deficiencies occur in either the PT program, inspection program, or in operations and reporting.
(a) A laboratory or IITF that does not maintain its HHS certification must:
(1) Stop testing federally regulated specimens;
(2) Ensure the security of federally regulated specimens and records throughout the required storage period described in Sections 11.20, 11.21, 12.18, and 14.8;
(3) Ensure access to federally regulated specimens and records in accordance with Sections 11.23, 11.24, 12.20, 12.21, and Subpart P; and
(4) Follow the HHS suspension and revocation procedures when imposed by the Secretary, follow the HHS procedures in Subpart P that will be used for all actions associated with the suspension and/or revocation of HHS-certification.
(a) PT samples used to evaluate drug tests will be prepared using the following specifications:
(1) PT samples may contain one or more of the drugs and drug metabolites in the drug classes listed in Section 3.4 and must satisfy one of the following parameters:
(i) The concentration of a drug or metabolite will be at least 20 percent above the initial test cutoff concentration for the drug or drug metabolite;
(ii) The concentration of a drug or metabolite may be less than 40 percent of the confirmatory test cutoff concentration when the PT sample is designated as a retest sample; or
(iii) The concentration of drug or metabolite may differ from 9.5(a)(1)(i) and 9.5(a)(1)(ii) for a special purpose.
(2) A PT sample may contain an interfering substance, an adulterant, or satisfy the criteria for a substituted specimen, dilute specimen, or invalid result.
(3) A negative PT sample will not contain a measurable amount of a target analyte.
(b) PT samples used to evaluate specimen validity tests shall satisfy, but
(1) The nitrite concentration will be at least 20 percent above the cutoff;
(2) The pH will be between 1.5 and 5.0 or between 8.5 and 12.5;
(3) The concentration of an oxidant will be at a level sufficient to challenge a laboratory's ability to identify and confirm the oxidant;
(4) The creatinine concentration will be between 0 and 20 mg/dL; or
(5) The specific gravity will be less than or equal to 1.0050 or between 1.0170 and 1.0230.
(c) For each PT cycle, the set of PT samples going to each HHS-certified laboratory or IITF will vary but, within each calendar year, each HHS-certified laboratory or IITF will analyze essentially the same total set of samples.
(d) The laboratory or IITF must (to the greatest extent possible) handle, test, and report a PT sample in a manner identical to that used for a donor specimen, unless otherwise specified.
(a) An applicant laboratory that seeks certification under these Guidelines must satisfy the following criteria on three consecutive sets of PT samples:
(1) Have no false positive results;
(2) Correctly identify, confirm, and report at least 90 percent of the total drug challenges over the three sets of PT samples;
(3) Correctly identify at least 80 percent of the drug challenges for each initial drug test over the three sets of PT samples;
(4) For the confirmatory drug tests, correctly determine the concentrations [
(5) For the confirmatory drug tests, must not obtain any drug concentration that differs by more than ±50 percent from the appropriate reference or peer group mean;
(6) For each confirmatory drug test, correctly identify and determine the concentrations [
(7) Correctly identify at least 80 percent of the total specimen validity testing challenges over the three sets of PT samples;
(8) Correctly identify at least 80 percent of the challenges for each individual specimen validity test over the three sets of PT samples;
(9) For quantitative specimen validity tests, obtain quantitative values for at least 80 percent of the total challenges over the three sets of PT samples that satisfy the following criteria:
(i) Nitrite and creatinine concentrations are no more than ±20 percent or ±2 standard deviations from the appropriate reference or peer group mean; and
(ii) pH values are no more than ±0.3 pH units from the appropriate reference or peer group mean using a pH meter; and
(iii) Specific gravity values are no more than ±0.0003 specific gravity units from the appropriate reference or peer group mean when the mean is less than 1.0100 and specific gravity values are no more than ±0.0004 specific gravity units from the appropriate reference or peer group mean when the mean is equal to or greater than 1.0100;
(10) Must not obtain any quantitative value on a specimen validity test PT sample that differs from the appropriate reference or peer group mean by more than ±50 percent for nitrite and creatinine concentrations, ±0.8 pH units using a pH meter, ±0.0006 specific gravity units when the mean is less than 1.0100, or ±0.0007 specific gravity units when the mean is equal to or greater than 1.0100; and
(11) Must not report any sample as adulterated with a compound that is not present in the sample, adulterated based on pH when the appropriate reference or peer group mean is within the acceptable pH range, or substituted when the appropriate reference or peer group means for both creatinine and specific gravity are within the acceptable range.
(b) Failure to satisfy these requirements will result in disqualification.
(a) A laboratory certified under these Guidelines must satisfy the following criteria on the maintenance PT samples:
(1) Have no false positive results;
(2) Correctly identify, confirm, and report at least 90 percent of the total drug challenges over two consecutive PT cycles;
(3) Correctly identify at least 80 percent of the drug challenges for each initial drug test over two consecutive PT cycles;
(4) For the confirmatory drug tests, correctly determine that the concentrations for at least 80 percent of the total drug challenges are no more than ±20 percent or ±2 standard deviations (whichever is larger) from the appropriate reference or peer group means over two consecutive PT cycles;
(5) For the confirmatory drug tests, obtain no more than one drug concentration on a PT sample that differs by more than ±50 percent from the appropriate reference or peer group mean over two consecutive PT cycles;
(6) For each confirmatory drug test, correctly identify and determine that the concentrations for at least 50 percent of the drug challenges for an individual drug are no more than ±20 percent or ±2 standard deviations (whichever is larger) from the appropriate reference or peer group means over two consecutive PT cycles;
(7) Correctly identify at least 80 percent of the total specimen validity testing challenges over two consecutive PT cycles;
(8) Correctly identify at least 80 percent of the challenges for each individual specimen validity test over two consecutive PT cycles;
(9) For quantitative specimen validity tests, obtain quantitative values for at least 80 percent of the total challenges over two consecutive PT cycles that satisfy the following criteria:
(i) Nitrite and creatinine concentrations are no more than ±20 percent or ±2 standard deviations from the appropriate reference or peer group mean;
(ii) pH values are no more than ±0.3 pH units from the appropriate reference or peer group mean using a pH meter; and
(iii) Specific gravity values are no more than ±0.0003 specific gravity units from the appropriate reference or peer group mean when the mean is less than 1.0100 and specific gravity values are no more than ±0.0004 specific gravity units from the appropriate reference or peer group mean when the mean is equal to or greater than 1.0100;
(10) Obtain no more than one quantitative value over 2 consecutive PT cycles on a specimen validity test PT sample that differs from the appropriate reference or peer group mean by more than ±50 percent for nitrite and creatinine concentrations, ±0.8 pH units using a pH meter, ±0.0006 specific gravity units when the mean is less than 1.0100, or ±0.0007 specific gravity units when the mean is equal to or greater than 1.0100; and
(11) Do not report any PT sample as adulterated with a compound that is not present in the sample, adulterated based on pH when the appropriate reference or peer group mean is within the
(b) Failure to participate in all PT cycles or to satisfy these requirements may result in suspension or revocation of an HHS-certified laboratory's certification.
(a) An applicant IITF that seeks certification under these Guidelines must satisfy the following criteria on three consecutive sets of PT samples:
(1) Correctly identify at least 90 percent of the total drug challenges over the three sets of PT samples;
(2) Correctly identify at least 80 percent of the drug challenges for each individual drug test over the three sets of PT samples;
(3) Correctly identify at least 80 percent of the total specimen validity test challenges over the three sets of PT samples;
(4) Correctly identify at least 80 percent of the challenges for each individual specimen validity test over the three sets of PT samples;
(5) For quantitative specimen validity tests, obtain quantitative values for at least 80 percent of the total specimen validity test challenges over the three sets of PT samples that satisfy the following criteria:
(i) Creatinine concentrations are no more than ±20 percent or ±2 standard deviations (whichever is larger) from the appropriate reference or peer group mean; and
(ii) Specific gravity values are no more than ±0.001 specific gravity units from the appropriate reference or peer group mean; and
(6) Must not obtain any quantitative value on a specimen validity test PT sample that differs from the appropriate reference or peer group mean by more than ±50 percent for creatinine concentration, or ±0.002 specific gravity units for specific gravity.
(b) Failure to satisfy these requirements will result in disqualification.
(a) An IITF certified under these Guidelines must satisfy the following criteria on the maintenance PT samples to maintain its certification:
(1) Correctly identify at least 90 percent of the total drug challenges over two consecutive PT cycles;
(2) Correctly identify at least 80 percent of the drug challenges for each individual drug test over two consecutive PT cycles;
(3) Correctly identify at least 80 percent of the total specimen validity test challenges over two consecutive PT cycles;
(4) Correctly identify at least 80 percent of the challenges for each individual specimen validity test over two consecutive PT cycles;
(5) For quantitative specimen validity tests, obtain quantitative values for at least 80 percent of the total specimen validity test challenges over two consecutive PT cycles that satisfy the following criteria:
(i) Creatinine concentrations are no more than ±20 percent or ±2 standard deviations (whichever is larger) from the appropriate reference or peer group mean; and
(ii) Specific gravity values are no more than ±0.001 specific gravity units from the appropriate reference or peer group mean; and
(6) Obtain no more than one quantitative value over 2 consecutive PT cycles on a specimen validity test PT sample that differs from the appropriate reference or peer group mean by more than ±50 percent for creatinine concentration, or ±0.002 specific gravity units for specific gravity.
(b) Failure to participate in all PT cycles or to satisfy these requirements may result in suspension or revocation of an HHS-certified IITF's certification.
(a) An applicant laboratory or IITF is inspected by a team of two inspectors.
(b) Each inspector conducts an independent review and evaluation of all aspects of the laboratory's or IITF's testing procedures and facilities using an inspection checklist.
(a) An HHS-certified laboratory or IITF must undergo an inspection 3 months after becoming certified and at least every 6 months thereafter.
(b) An HHS-certified laboratory or IITF is inspected by one or more inspectors. The number of inspectors is determined according to the number of specimens reviewed. Additional information regarding inspections is available from SAMHSA.
(c) Each inspector conducts an independent evaluation and review of the HHS-certified laboratory's or IITF's procedures, records, and facilities using guidance provided by the Secretary.
(d) To remain certified, an HHS-certified laboratory or IITF must continue to satisfy the minimum requirements as stated in these Guidelines.
(a) An individual may be selected as an inspector for the Secretary if he or she satisfies the following criteria:
(1) Has experience and an educational background similar to that required for either the responsible person or the certifying scientist as described in Subpart K for an HHS-certified laboratory or as a responsible technician as described in Subpart L;
(2) Has read and thoroughly understands the policies and requirements contained in these Guidelines and in other guidance consistent with these Guidelines provided by the Secretary;
(3) Submits a resume and documentation of qualifications to HHS;
(4) Attends approved training; and
(5) Performs acceptably as an inspector on an inspection of an HHS-certified laboratory or IITF.
(b) The Secretary or a federal agency may conduct an inspection at any time.
If an applicant laboratory or IITF fails to satisfy the requirements established for the initial certification process, the laboratory or IITF must start the certification process from the beginning.
(a) If an HHS-certified laboratory or IITF fails to satisfy the minimum requirements for certification, the laboratory or IITF is given a period of time (
(b) A laboratory's or IITF's HHS certification may be revoked, suspended, or no further action taken depending on the seriousness of the deficiencies and whether there is evidence that the deficiencies have been corrected and that current performance meets the requirements for certification.
(c) An HHS-certified laboratory or IITF may be required to undergo a special inspection or to test additional PT samples to address deficiencies.
(d) If an HHS-certified laboratory's or IITF's certification is revoked or suspended in accordance with the process described in Subpart P, the laboratory or IITF is not permitted to test federally regulated specimens until the suspension is lifted or the laboratory or IITF has successfully completed the certification requirements as a new applicant laboratory or IITF.
(a) The Secretary shall revoke certification of an HHS-certified laboratory or IITF in accordance with these Guidelines if the Secretary determines that revocation is necessary to ensure fully reliable and accurate drug and specimen validity test results and reports.
(b) The Secretary shall consider the following factors in determining whether revocation is necessary:
(1) Unsatisfactory performance in analyzing and reporting the results of drug and specimen validity tests (
(2) Unsatisfactory participation in performance testing or inspections;
(3) A material violation of a certification standard, contract term, or other condition imposed on the HHS-certified laboratory or IITF by a federal agency using the laboratory's or IITF's services;
(4) Conviction for any criminal offense committed as an incident to operation of the HHS-certified laboratory or IITF; or
(5) Any other cause that materially affects the ability of the HHS-certified laboratory or IITF to ensure fully reliable and accurate drug test results and reports.
(c) The period and terms of revocation shall be determined by the Secretary and shall depend upon the facts and circumstances of the revocation and the need to ensure accurate and reliable drug testing.
(a) The Secretary may immediately suspend (either partially or fully) a laboratory's or IITF's HHS certification to conduct drug testing for federal agencies if the Secretary has reason to believe that revocation may be required and that immediate action is necessary to protect the interests of the United States and its employees.
(b) The Secretary shall determine the period and terms of suspension based upon the facts and circumstances of the suspension and the need to ensure accurate and reliable drug testing.
(a) When laboratory's or IITF's HHS certification is suspended or the Secretary seeks to revoke HHS certification, the Secretary shall immediately serve the HHS-certified laboratory or IITF with written notice of the suspension or proposed revocation by facsimile, mail, personal service, or registered or certified mail, return receipt requested. This notice shall state the following:
(1) The reasons for the suspension or proposed revocation;
(2) The terms of the suspension or proposed revocation; and
(3) The period of suspension or proposed revocation.
(b) The written notice shall state that the laboratory or IITF will be afforded an opportunity for an informal review of the suspension or proposed revocation if it so requests in writing within 30 days of the date the laboratory or IITF received the notice, or if expedited review is requested, within 3 days of the date the laboratory or IITF received the notice. Subpart P contains detailed procedures to be followed for an informal review of the suspension or proposed revocation.
(c) A suspension must be effective immediately. A proposed revocation must be effective 30 days after written notice is given or, if review is requested, upon the reviewing official's decision to uphold the proposed revocation. If the reviewing official decides not to uphold the suspension or proposed revocation, the suspension must terminate immediately and any proposed revocation shall not take effect.
(d) The Secretary will publish in the
Following revocation, a laboratory or IITF may apply for recertification. Unless otherwise provided by the Secretary in the notice of revocation under Section 9.17 or the reviewing official's decision under Section 16.9(e) or 16.14(a), a laboratory or IITF which has had its certification revoked may reapply for HHS certification as an applicant laboratory or IITF.
(a) The list of HHS-certified laboratories and IITFs is published monthly in the
(b) An applicant laboratory or IITF is not included on the list.
(a) Each federal agency is required to submit blind samples for its workplace drug testing program. The collector must send the blind samples to the HHS-certified laboratory or IITF that the collector sends employee specimens.
(b) Each federal agency must submit at least 3 percent blind samples along with its donor specimens based on the projected total number of donor specimens collected per year (up to a maximum of 400 blind samples). Every effort should be made to ensure that blind samples are submitted quarterly.
(c) Approximately 75 percent of the blind samples submitted each year by an agency must be negative, 15 percent must be positive for one or more drugs, and 10 percent must either be adulterated or substituted.
(a) Drug positive blind samples must be validated by the supplier as to their content using appropriate initial and confirmatory tests.
(1) Drug positive blind samples must be fortified with one or more of the drugs or metabolites listed in Section 3.4.
(2) Drug positive blind samples must contain concentrations of drugs between 1.5 and 2 times the initial drug test cutoff concentration.
(b) Drug negative blind samples (
(c) A blind sample that is adulterated must be validated using appropriate initial and confirmatory specimen validity tests, and have the characteristics to clearly show that it is an adulterated sample at the time of validation.
(d) A blind sample that is substituted must be validated using appropriate initial and confirmatory specimen validity tests, and have the characteristics to clearly show that it is a substituted sample at the time of validation.
(e) The supplier must provide information on the blind samples' content, validation, expected results, and stability to the collection site/collector sending the blind samples to the laboratory or IITF, and must provide the information upon request to the MRO, the federal agency for which the blind sample was submitted, or the Secretary.
(a) A blind sample must be submitted with the current Federal CCF that the HHS-certified laboratory or IITF uses for donor specimens. The collector provides the required information to ensure that the Federal CCF has been properly completed and provides fictitious initials on the specimen label/seal. The collector must indicate that the specimen is a blind sample on the MRO copy where a donor would normally provide a signature.
(b) A collector should attempt to distribute the required number of blind samples randomly with donor specimens rather than submitting the full complement of blind samples as a single group.
If an HHS-certified laboratory or IITF reports a result for a blind sample that is inconsistent with the expected result (
(a) The MRO must contact the laboratory or IITF and attempt to determine if the laboratory or IITF made an error during the testing or reporting of the sample;
(b) The MRO must contact the blind sample supplier and attempt to determine if the supplier made an error during the preparation or transfer of the sample;
(c) The MRO must contact the collector and determine if the collector made an error when preparing the blind sample for transfer to the HHS-certified laboratory or IITF;
(d) If there is no obvious reason for the inconsistent result, the MRO must notify both the federal agency for which the blind sample was submitted and the Secretary; and
(e) The Secretary shall investigate the blind sample error. A report of the Secretary's investigative findings and the corrective action taken in response to identified deficiencies must be sent to the federal agency. The Secretary shall ensure notification of the finding as appropriate to other federal agencies and coordinate any necessary actions to prevent the recurrence of the error.
(a) An HHS-certified laboratory must have a standard operating procedure (SOP) manual that describes, in detail, all HHS-certified laboratory operations. When followed, the SOP manual ensures that all specimens are tested using the same procedures.
(b) The SOP manual must include at a minimum, but is not limited to, a detailed description of the following:
(1) Chain of custody procedures;
(2) Accessioning;
(3) Security;
(4) Quality control/quality assurance programs;
(5) Analytical methods and procedures;
(6) Equipment and maintenance programs;
(7) Personnel training;
(8) Reporting procedures; and
(9) Computers, software, and laboratory information management systems.
(c) All procedures in the SOP manual must be compliant with these Guidelines and all guidance provided by the Secretary.
(d) A copy of all procedures that have been replaced or revised and the dates on which the procedures were in effect must be maintained for at least 2 years.
(a) Manage the day-to-day operations of the HHS-certified laboratory even if another individual has overall responsibility for alternate areas of a multi-specialty laboratory.
(b) Ensure that there are sufficient personnel with adequate training and experience to supervise and conduct the work of the HHS-certified laboratory. The RP must ensure the continued competency of laboratory staff by documenting their in-service training, reviewing their work performance, and verifying their skills.
(c) Maintain a complete and current SOP manual that is available to all personnel of the HHS-certified laboratory and ensure that it is followed. The SOP manual must be reviewed, signed, and dated by the RP(s) when procedures are first placed into use and when changed or when a new individual assumes responsibility for the management of the HHS-certified laboratory. The SOP must be reviewed and documented by the RP annually.
(d) Maintain a quality assurance program that ensures the proper performance and reporting of all test results; verify and monitor acceptable analytical performance for all controls and calibrators; monitor quality control testing; and document the validity, reliability, accuracy, precision, and performance characteristics of each test and test system.
(e) Initiate and implement all remedial actions necessary to maintain satisfactory operation and performance of the HHS-certified laboratory in response to the following: quality control systems not within performance specifications; errors in result reporting or in analysis of performance testing samples; and inspection deficiencies. The RP must ensure that specimen results are not reported until all corrective actions have been taken and that the results provided are accurate and reliable.
The RP must have documented scientific qualifications in analytical toxicology. Minimum qualifications are:
(a) Certification or licensure as a laboratory director by the state in forensic or clinical laboratory toxicology, a Ph.D. in one of the natural sciences, or training and experience comparable to a Ph.D. in one of the natural sciences with training and laboratory/research experience in biology, chemistry, and pharmacology or toxicology;
(b) Experience in forensic toxicology with emphasis on the collection and analysis of biological specimens for drugs of abuse;
(c) Experience in forensic applications of analytical toxicology (
(d) Fulfillment of the RP responsibilities and qualifications, as demonstrated by the HHS-certified laboratory's performance and verified upon interview by HHS-trained inspectors during each on-site inspection; and
(e) Qualify as a certifying scientist.
(a) HHS-certified laboratories must have multiple RPs or one RP and an alternate RP. If the RP(s) are concurrently absent, an alternate RP must be present and qualified to fulfill the responsibilities of the RP.
(1) If an HHS-certified laboratory is without the RP and alternate RP for 14 calendar days or less (
(2) The Secretary, in accordance with these Guidelines, will suspend a laboratory's HHS certification for all specimens if the laboratory does not have an RP or alternate RP for a period of more than 14 calendar days. The suspension will be lifted upon the Secretary's approval of a new permanent RP or alternate RP.
(b) If the RP leaves an HHS-certified laboratory:
(1) The HHS-certified laboratory may maintain certification and continue testing federally regulated specimens under the direction of an alternate RP for a period of up to 180 days while seeking to hire and receive the Secretary's approval of the RP's replacement.
(2) The Secretary, in accordance with these Guidelines, will suspend a laboratory's HHS certification for all federally regulated specimens if the laboratory does not have a permanent RP within 180 days. The suspension will be lifted upon the Secretary's approval of the new permanent RP.
(c) To nominate an individual as an RP or alternate RP, the HHS-certified laboratory must submit the following documents to the Secretary: The candidate's current resume or curriculum vitae, copies of diplomas and licensures, a training plan (not to exceed 90 days) to transition the candidate into the position, an itemized comparison of the candidate's qualifications to the minimum RP qualifications described in the Guidelines, and have official academic transcript(s) submitted from the candidate's institution(s) of higher learning. The candidate must be found qualified during an on-site inspection of the HHS-certified laboratory.
(d) The HHS-certified laboratory must fulfill additional inspection and PT criteria as required prior to conducting federally regulated testing under a new RP.
(a) A certifying scientist must have:
(1) At least a bachelor's degree in the chemical or biological sciences or medical technology, or equivalent;
(2) Training and experience in the analytical methods and forensic procedures used by the HHS-certified laboratory relevant to the results that the individual certifies; and
(3) Training and experience in reviewing and reporting forensic test results and maintaining chain of custody, and an understanding of appropriate remedial actions in response to problems that may arise.
(b) A certifying technician must have:
(1) Training and experience in the analytical methods and forensic procedures used by the HHS-certified laboratory relevant to the results that the individual certifies; and
(2) Training and experience in reviewing and reporting forensic test results and maintaining chain of custody, and an understanding of appropriate remedial actions in response to problems that may arise.
(a) All HHS-certified laboratory staff (
(b) Each individual working in an HHS-certified laboratory must be properly trained (
(a) An HHS-certified laboratory must control access to the drug testing facility, specimens, aliquots, and records.
(b) Authorized visitors must be escorted at all times, except for individuals conducting inspections (
(c) An HHS-certified laboratory must maintain records documenting the identity of the visitor and escort, date, time of entry and exit, and purpose for access to the secured area.
(a) HHS-certified laboratories must use chain of custody procedures (internal and external) to maintain control and accountability of specimens from the time of receipt at the laboratory through completion of testing, reporting of results, during storage, and continuing until final disposition of the specimens.
(b) HHS-certified laboratories must use chain of custody procedures to document the handling and transfer of aliquots throughout the testing process until final disposal.
(c) The chain of custody must be documented using either paper copy or electronic procedures.
(d) Each individual who handles a specimen or aliquot must sign and complete the appropriate entries on the chain of custody form when the specimen or aliquot is handled or transferred, and every individual in the chain must be identified.
(e) The date and purpose must be recorded on an appropriate chain of custody form each time a specimen or aliquot is handled or transferred.
An HHS-certified laboratory must test the specimen in the same manner as a specimen that had not been previously tested.
(a) An initial drug test may be:
(1) An immunoassay or
(2) An alternate technology (
(b) An HHS-certified laboratory must validate an initial drug test before testing specimens.
(c) Initial drug tests must be accurate and reliable for the testing of specimens when identifying drugs or their metabolites.
(d) An HHS-certified laboratory may conduct a second initial drug test using a method with different specificity, to rule out cross-reacting compounds. This second initial drug test must satisfy the batch quality control requirements specified in Section 11.12.
(a) An HHS-certified laboratory must demonstrate and document the following for each initial drug test:
(1) The ability to differentiate negative specimens from those requiring further testing;
(2) The performance of the test around the cutoff concentration, using samples at several concentrations between 0 and 150 percent of the cutoff concentration;
(3) The effective concentration range of the test (linearity);
(4) The potential for carryover;
(5) The potential for interfering substances; and
(6) The potential matrix effects if using an alternate technology.
(b) Each new lot of reagent must be verified prior to being placed into service.
(c) Each initial drug test using an alternate technology must be re-verified periodically or at least annually.
(a) Each batch of specimens must contain the following controls:
(1) At least one control certified to contain no drug or drug metabolite;
(2) At least one positive control with the drug or drug metabolite targeted at a concentration 25 percent above the cutoff;
(3) At least one control with the drug or drug metabolite targeted at a concentration 75 percent of the cutoff; and
(4) At least one control that appears as a donor specimen to the analysts.
(b) Calibrators and controls must total at least 10 percent of the aliquots analyzed in each batch.
(a) The analytical method must use mass spectrometric identification [
(b) A confirmatory drug test must be validated before it can be used to test federally regulated specimens.
(c) Confirmatory drug tests must be accurate and reliable for the testing of a urine specimen when identifying and quantifying drugs or their metabolites.
(a) An HHS-certified laboratory must demonstrate and document the following for each confirmatory drug test:
(1) The linear range of the analysis;
(2) The limit of detection;
(3) The limit of quantification;
(4) The accuracy and precision at the cutoff concentration;
(5) The accuracy (bias) and precision at 40 percent of the cutoff concentration;
(6) The potential for interfering substances;
(7) The potential for carryover; and
(8) The potential matrix effects if using liquid chromatography coupled with mass spectrometry.
(b) Each new lot of reagent must be verified prior to being placed into service.
(c) HHS-certified laboratories must re-verify each confirmatory drug test method periodically or at least annually.
(a) At a minimum, each batch of specimens must contain the following calibrators and controls:
(1) A calibrator at the cutoff concentration;
(2) At least one control certified to contain no drug or drug metabolite;
(3) At least one positive control with the drug or drug metabolite targeted at 25 percent above the cutoff; and
(4) At least one control targeted at or less than 40 percent of the cutoff.
(b) Calibrators and controls must total at least 10 percent of the aliquots analyzed in each batch.
(a) Each specimen validity test result must be based on performing an initial specimen validity test on one aliquot and a second or confirmatory test on a second aliquot;
(b) The HHS-certified laboratory must establish acceptance criteria and analyze calibrators and controls as appropriate to verify and document the validity of the test results (required specimen validity tests are addressed in Section 11.18); and
(c) Controls must be analyzed concurrently with specimens.
An HHS-certified laboratory must demonstrate and document for each specimen validity test the appropriate performance characteristics of the test, and must re-verify the test periodically, or at least annually. Each new lot of reagent must be verified prior to being placed into service.
(a) The requirements for measuring creatinine concentration are as follows:
(1) The creatinine concentration must be measured to one decimal place on both the initial creatinine test and the confirmatory creatinine test;
(2) The initial creatinine test must have the following calibrators and controls:
(i) A calibrator at 2 mg/dL;
(ii) A control in the range of 1.0 mg/dL to 1.5 mg/dL;
(iii) A control in the range of 3 mg/dL to 20 mg/dL; and
(iv) A control in the range of 21 mg/dL to 25 mg/dL.
(4) The confirmatory creatinine test (performed on those specimens with a creatinine concentration less than 2 mg/dL on the initial test) must have the following calibrators and controls:
(i) A calibrator at 2 mg/dL;
(ii) A control in the range of 1.0 mg/dL to 1.5 mg/dL; and
(iii) A control in the range of 3 mg/dL to 4 mg/dL.
(b) The requirements for measuring specific gravity are as follows:
(1) For specimens with initial creatinine test results greater than 5 mg/dL and less than 20 mg/dL, laboratories may perform a screening test using a refractometer that measures urine specific gravity to at least three decimal places to identify specific gravity values that are acceptable (equal to or greater than 1.003) or dilute (equal to or greater than 1.002 and less than 1.003). Specimens must be subjected to an initial specific gravity test using a four decimal place refractometer when the initial creatinine test result is less than or equal to 5 mg/dL or when the screening specific gravity test result using a three decimal place refractometer is less than 1.002.
(2) The screening specific gravity test must have the following calibrators and controls:
(i) A calibrator or control at 1.000;
(ii) One control targeted at 1.002;
(iii) One control in the range of 1.004 to 1.018.
(3) For the initial and confirmatory specific gravity tests, the refractometer must report and display specific gravity to four decimal places. The refractometer must be interfaced with a laboratory information management system (LIMS), computer, and/or generate a paper copy of the digital electronic display to document the numerical values of the specific gravity test results;
(4) The initial and confirmatory specific gravity tests must have the following calibrators and controls:
(i) A calibrator or control at 1.0000;
(ii) One control targeted at 1.0020;
(iii) One control in the range of 1.0040 to 1.0180; and
(iv) One control equal to or greater than 1.0200 but not greater than 1.0250.
(c) Requirements for measuring pH are as follows:
(1) Colorimetric pH tests that have the dynamic range of 3 to 12 to support the 4 and 11 pH cutoffs and pH meters must be capable of measuring pH to one decimal place. Colorimetric pH tests, dipsticks, and pH paper (
(2) For the initial and confirmatory pH tests, the pH meter must report and display pH to at least one decimal place. The pH meter must be interfaced with a LIMS, computer, and/or generate a paper copy of the digital electronic display to document the numerical values of the pH test results;
(3) pH screening tests must have, at a minimum, the following controls:
(i) One control below the lower decision point in use;
(ii) One control between the decision points in use; and
(iii) One control above the upper decision point in use;
(4) An initial colorimetric pH test must have the following calibrators and controls:
(i) One calibrator at 4;
(ii) One calibrator at 11;
(iii) One control in the range of 3 to 3.8;
(iv) One control in the range 4.2 to 5;
(v) One control in the range of 5 to 9;
(vi) One control in the range of 10 to 10.8; and
(vii) One control in the range of 11.2 to 12;
(5) An initial pH meter test, if a pH screening test is not used, must have the following calibrators and controls:
(i) One calibrator at 3;
(ii) One calibrator at 7;
(iii) One calibrator at 10;
(iv) One control in the range of 3 to 3.8;
(v) One control in the range 4.2 to 5;
(vi) One control in the range of 10 to 10.8; and
(vii) One control in the range of 11.2 to 12;
(6) An initial pH meter test (if a pH screening test is used) or confirmatory pH meter test must have the following calibrators and controls when the result of the preceding pH test indicates that the pH is below the lower decision point in use:
(i) One calibrator at 4;
(ii) One calibrator at 7;
(iii) One control in the range of 3 to 3.8; and
(iv) One control in the range 4.2 to 5; and
(7) An initial pH meter test (if a pH screening test is used) or confirmatory pH meter test must have the following calibrators and controls when the result of the preceding pH test indicates that the pH is above the upper decision point in use:
(i) One calibrator at 7;
(ii) One calibrator at 10;
(iii) One control in the range of 10 to 10.8; and
(iv) One control in the range of 11.2 to 12.
(d) Requirements for performing oxidizing adulterant tests are as follows:
(1) The initial test must include an appropriate calibrator at the cutoff specified in Sections 11.19(d)(2), (3), or (4) for the compound of interest, a control without the compound of interest (
(2) A confirmatory test for a specific oxidizing adulterant must use a different analytical method than that used for the initial test. Each confirmatory test batch must include an appropriate calibrator, a control without the compound of interest (
(e) The requirements for measuring the nitrite concentration are that the initial and confirmatory nitrite tests must have a calibrator at the cutoff concentration, a control without nitrite (
(a) Laboratories must report a test result to the agency's MRO within an average of 5 working days after receipt of the specimen. Reports must use the Federal CCF and/or an electronic report. Before any test result can be reported, it must be certified by a certifying scientist or a certifying technician (as appropriate).
(b) A primary (A) specimen is reported negative when each initial drug test is negative or if the specimen is negative upon confirmatory drug testing, and the specimen does not meet invalid criteria as described in items (h)(1) through (h)(12) below.
(c) A primary (A) specimen is reported positive for a specific drug or drug metabolite when both the initial drug test is positive and the confirmatory drug test is positive in accordance with Section 3.4.
(d) A primary (A) urine specimen is reported adulterated when:
(1) The pH is less than 4 or equal to or greater than 11 using either a pH meter or a colorimetric pH test for the initial test on the first aliquot and a pH meter for the confirmatory test on the second aliquot;
(2) The nitrite concentration is equal to or greater than 500 mcg/mL using either a nitrite colorimetric test or a general oxidant colorimetric test for the initial test on the first aliquot and a different confirmatory test (
(3) The presence of chromium (VI) is verified using either a general oxidant colorimetric test (with an equal to or greater than 50 mcg/mL chromium (VI)-equivalent cutoff) or a chromium (VI) colorimetric test (chromium (VI) concentration equal to or greater than 50 mcg/mL) for the initial test on the first aliquot and a different confirmatory test (
(4) The presence of halogen (
(5) The presence of glutaraldehyde is verified using either an aldehyde test (aldehyde present) or the characteristic immunoassay response on one or more drug immunoassay tests for the initial test on the first aliquot and a different confirmatory method (
(6) The presence of pyridine (pyridinium chlorochromate) is verified using either a general oxidant colorimetric test (with an equal to or greater than 200 mcg/mL nitrite-equivalent cutoff or an equal to or greater than 50 mcg/mL chromium (VI)-equivalent cutoff) or a chromium (VI) colorimetric test (chromium (VI) concentration equal to or greater than 50 mcg/mL) for the initial test on the first aliquot and a different confirmatory method (
(7) The presence of a surfactant is verified by using a surfactant colorimetric test with an equal to or greater than 100 mcg/mL dodecylbenzene sulfonate-equivalent cutoff for the initial test on the first aliquot and a different confirmatory test (
(8) The presence of any other adulterant not specified in paragraphs d(2) through d(7) of this section is verified using an initial test on the first aliquot and a different confirmatory test on the second aliquot.
(e) A primary (A) urine specimen is reported substituted when the creatinine concentration is less than 2 mg/dL and the specific gravity is less than or equal to 1.0010 or equal to or greater than 1.0200 on both the initial and confirmatory creatinine tests (
(f) A primary (A) urine specimen is reported dilute when the creatinine concentration is equal to or greater than 2 mg/dL but less than 20 mg/dL and the specific gravity is greater than 1.0010 but less than 1.0030 on a single aliquot.
(g) For a specimen that has an invalid result for one of the reasons stated in items (h)(4) through (h)(12) below, the HHS-certified laboratory shall contact the MRO and both will decide if testing by another HHS-certified laboratory would be useful in being able to report a positive or adulterated result. If no further testing is necessary, the HHS-certified laboratory then reports the invalid result to the MRO.
(h) A primary (A) urine specimen is reported as an invalid result when:
(1) Inconsistent creatinine concentration and specific gravity results are obtained (
(2) The pH is equal to or greater than 4 and less than 4.5 or equal to or greater than 9 and less than 11 using either a colorimetric pH test or pH meter for the initial test and a pH meter for the confirmatory test on two separate aliquots;
(3) The nitrite concentration is equal to or greater than 200 mcg/mL using a nitrite colorimetric test or equal to or greater than the equivalent of 200 mcg/mL nitrite using a general oxidant colorimetric test for both the initial (first) test and the second test or using either initial test and the nitrite concentration is equal to or greater than 200 mcg/mL but less than 500 mcg/mL for a different confirmatory test (
(4) The possible presence of chromium (VI) is determined using the same chromium (VI) colorimetric test with a cutoff equal to or greater than 50 mcg/mL chromium (VI) for both the initial (first) test and the second test on two separate aliquots;
(5) The possible presence of a halogen (
(6) The possible presence of glutaraldehyde is determined by using the same aldehyde test (aldehyde present) or characteristic immunoassay response on one or more drug immunoassay tests for both the initial (first) test and the second test on two separate aliquots;
(7) The possible presence of an oxidizing adulterant is determined by using the same general oxidant colorimetric test (with an equal to or greater than 200 mcg/mL nitrite-equivalent cutoff, an equal to or greater than 50 mcg/mL chromium (VI)-equivalent cutoff, or a halogen concentration is equal to or greater than the LOQ) for both the initial (first) test and the second test on two separate aliquots;
(8) The possible presence of a surfactant is determined by using the same surfactant colorimetric test with an equal to or greater than 100 mcg/mL dodecylbenzene sulfonate-equivalent cutoff for both the initial (first) test and the second test on two separate aliquots or a foam/shake test for the initial test;
(9) Interference occurs on the initial drug tests on two separate aliquots (
(10) Interference with the confirmatory drug test occurs on at least two separate aliquots of the specimen and the HHS-certified laboratory is unable to identify the interfering substance;
(11) The physical appearance of the specimen is such that testing the specimen may damage the laboratory's instruments; or
(12) The physical appearances of the A and B specimens are clearly different (note: A is tested).
(i) An HHS-certified laboratory shall reject a primary (A) urine specimen for testing when a fatal flaw occurs as described in Section 15.1 or when a correctable flaw as described in Section 15.2 is not recovered. The HHS-certified laboratory will indicate on the Federal CCF that the specimen was rejected for testing and provide the reason for reporting the rejected for testing result.
(j) An HHS-certified laboratory must report all positive, adulterated, substituted, and invalid test results for a urine specimen. For example, a specimen can be positive for a specific drug and adulterated.
(k) An HHS-certified laboratory must report the confirmatory concentration of each drug or drug metabolite reported for a positive result.
(l) An HHS-certified laboratory must report numerical values of the specimen validity test results that support a specimen that is reported adulterated, substituted, or invalid (as appropriate).
(m) When the concentration of a drug or drug metabolite exceeds the validated
(n) HHS-certified laboratories may transmit test results to the MRO by various electronic means (
(o) HHS-certified laboratories must facsimile, courier, mail, or electronically transmit a legible image or copy of the completed Federal CCF and/or forward a computer-generated electronic report. The computer-generated report must contain sufficient information to ensure that the test results can accurately represent the content of the custody and control form that the MRO received from the collector.
(p) For positive, adulterated, substituted, invalid, and rejected specimens, laboratories must facsimile, courier, mail, or electronically transmit a legible image or copy of the completed Federal CCF.
(a) An HHS-certified laboratory must retain specimens that were reported as positive, adulterated, substituted, or as an invalid result for a minimum of one year.
(b) Retained specimens must be kept in secured frozen storage (−20 °C or less) to ensure their availability for retesting during an administrative or judicial proceeding.
(c) Federal agencies may request that the HHS-certified laboratory retain a specimen for an additional specified period of time and must make that request within the one-year period.
(a) An HHS-certified laboratory must retain all records generated to support test results for at least two years. The laboratory may convert hardcopy records to electronic records for storage and then discard the hardcopy records after six months.
(b) A federal agency may request the HHS-certified laboratory to maintain a documentation package (as described in Section 11.23) that supports the chain of custody, testing, and reporting of a donor's specimen that is under legal challenge by a donor. The federal agency's request to the laboratory must be in writing and must specify the period of time to maintain the documentation package.
(c) An HHS-certified laboratory may retain records other than those included in the documentation package beyond the normal two-year period of time.
(a) HHS-certified laboratories must provide to each federal agency for which they perform testing a semiannual statistical summary report that must be submitted by mail, facsimile, or email within 14 working days after the end of the semiannual period. The summary report must not include any personal identifying information. A copy of the semiannual statistical summary report will also be sent to the Secretary or designated HHS representative. The semiannual statistical report contains the following information:
(1) Reporting period (inclusive dates);
(2) HHS-certified laboratory name and address;
(3) Federal agency name;
(4) Number of specimen results reported;
(5) Number of specimens collected by reason for test;
(6) Number of specimens reported negative and the number reported negative/dilute;
(7) Number of specimens rejected for testing because of a fatal flaw;
(8) Number of specimens rejected for testing because of an uncorrected flaw;
(9) Number of specimens tested positive by each initial drug test;
(10) Number of specimens reported positive;
(11) Number of specimens reported positive for each drug and drug metabolite;
(12) Number of specimens reported adulterated;
(13) Number of specimens reported substituted; and
(14) Number of specimens reported as invalid result.
(b) An HHS-certified laboratory must make copies of an agency's test results available when requested to do so by the Secretary or by the federal agency for which the laboratory is performing drug-testing services.
(c) An HHS-certified laboratory must ensure that a qualified individual is available to testify in a proceeding against a federal employee when the proceeding is based on a test result reported by the laboratory.
(a) Following a federal agency's receipt of a positive, adulterated, or substituted drug test report, the federal agency may submit a written request for copies of the records relating to the drug test results or a documentation package or any relevant certification, review, or revocation of certification records.
(b) Standard documentation packages provided by an HHS-certified laboratory must contain the following items:
(1) A cover sheet providing a brief description of the procedures and tests performed on the donor's specimen;
(2) A table of contents that lists all documents and materials in the package by page number;
(3) A copy of the Federal CCF with any attachments, internal chain of custody records for the specimen, memoranda (if any) generated by the HHS-certified laboratory, and a copy of the electronic report (if any) generated by the HHS-certified laboratory;
(4) A brief description of the HHS-certified laboratory's initial drug and specimen validity testing procedures, instrumentation, and batch quality control requirements;
(5) Copies of the initial test data for the donor's specimen with all calibrators and controls and copies of all internal chain of custody documents related to the initial tests;
(6) A brief description of the HHS-certified laboratory's confirmatory drug (and specimen validity, if applicable) testing procedures, instrumentation, and batch quality control requirements;
(7) Copies of the confirmatory test data for the donor's specimen with all calibrators and controls and copies of all internal chain of custody documents related to the confirmatory tests; and
(8) Copies of the résumé or curriculum vitae for the RP(s) and the certifying technician or certifying scientist of record.
A federal employee who is the subject of a workplace drug test may submit a written request through the MRO and/or the federal agency requesting copies of any records relating to his or her drug
An HHS-certified laboratory must not enter into any relationship with a federal agency's MRO that may be construed as a potential conflict of interest or derive any financial benefit by having a federal agency use a specific MRO.
This means an MRO may be an employee of the agency or a contractor for the agency; however, an MRO shall not be an employee or agent of or have any financial interest in the HHS-certified laboratory for which the MRO is reviewing drug testing results. Additionally, an MRO shall not derive any financial benefit by having an agency use a specific HHS-certified laboratory or have any agreement with an HHS-certified laboratory that may be construed as a potential conflict of interest.
An HHS-certified laboratory can enter into any relationship with an HHS-certified IITF.
(a) An HHS-certified IITF must have a standard operating procedure (SOP) manual that describes, in detail, all HHS-certified IITF operations. When followed, the SOP manual ensures that all specimens are tested consistently using the same procedures.
(b) The SOP manual must include at a minimum, but is not limited to, a detailed description of the following:
(1) Chain of custody procedures;
(2) Accessioning;
(3) Security;
(4) Quality control/quality assurance programs;
(5) Analytical methods and procedures;
(6) Equipment and maintenance programs;
(7) Personnel training;
(8) Reporting procedures; and
(9) Computers, software, and laboratory information management systems.
(c) All procedures in the SOP manual must be compliant with these Guidelines and all guidance provided by the Secretary.
(d) A copy of all procedures that have been replaced or revised and the dates on which the procedures were in effect must be maintained for two years.
(a) Manage the day-to-day operations of the HHS-certified IITF even if another individual has overall responsibility for alternate areas of a multi-specialty facility.
(b) Ensure that there are sufficient personnel with adequate training and experience to supervise and conduct the work of the HHS-certified IITF. The RT must ensure the continued competency of IITF personnel by documenting their in-service training, reviewing their work performance, and verifying their skills.
(c) Maintain a complete and current SOP manual that is available to all personnel of the HHS-certified IITF, and ensure that it is followed. The SOP manual must be reviewed, signed, and dated by the RT when procedures are first placed into use or changed or when a new individual assumes responsibility for the management of the HHS-certified IITF. The SOP must be reviewed and documented by the RT annually.
(d) Maintain a quality assurance program that ensures the proper performance and reporting of all test results; verify and monitor acceptable analytical performance for all controls and calibrators; monitor quality control testing; and document the validity, reliability, accuracy, precision, and performance characteristics of each test and test system.
(e) Initiate and implement all remedial actions necessary to maintain satisfactory operation and performance of the HHS-certified IITF in response to the following: Quality control systems not within performance specifications, errors in result reporting or in analysis of performance testing samples, and inspection deficiencies. The RT must ensure that specimen results are not reported until all corrective actions have been taken and that the results provided are accurate and reliable.
An RT must:
(a) Have at least a bachelor's degree in the chemical or biological sciences or medical technology, or equivalent;
(b) Have training and experience in the analytical methods and forensic procedures used by the HHS-certified IITF;
(c) Have training and experience in reviewing and reporting forensic test results and maintaining chain of custody, and an understanding of appropriate remedial actions in response to problems that may arise;
(d) Be found to fulfill RT responsibilities and qualifications, as demonstrated by the HHS-certified IITF's performance and verified upon interview by HHS-trained inspectors during each on-site inspection; and
(e) Qualify as a certifying technician.
(a) HHS-certified IITFs must have an RT and an alternate RT. When an RT is absent, an alternate RT must be present and qualified to fulfill the responsibilities of the RT.
(1) If an HHS-certified IITF is without the RT and alternate RT for 14 calendar days or less (
(2) The Secretary, in accordance with these Guidelines, will suspend an IITF's HHS certification for all specimens if the IITF does not have an RT or alternate RT for a period of more than 14 calendar days. The suspension will be lifted upon the Secretary's approval of a new permanent RT or alternate RT.
(b) If the RT leaves an HHS-certified IITF:
(1) The HHS-certified IITF may maintain certification and continue testing federally regulated specimens under the direction of an alternate RT for a period of up to 180 days while seeking to hire and receive the Secretary's approval of the RT's replacement.
(2) The Secretary, in accordance with these Guidelines, will suspend an IITF's HHS certification for all federally regulated specimens if the IITF does not have a permanent RT within 180 days. The suspension will be lifted upon the Secretary's approval of the new permanent RT.
(c) To nominate an individual as the RT or alternate RT, the HHS-certified IITF must submit the following documents to the Secretary: The candidate's current resume or curriculum vitae, copies of diplomas
(d) The HHS-certified IITF must fulfill additional inspection and PT criteria as required prior to conducting federally regulated testing under a new RT.
A certifying technician must have:
(a) Training and experience in the analytical methods and forensic procedures used by the HHS-certified IITF relevant to the results that the individual certifies; and
(b) Training and experience in reviewing and reporting forensic test results and maintaining chain of custody, and an understanding of appropriate remedial actions in response to problems that may arise.
(a) All HHS-certified IITF staff (
(b) Each individual working in an HHS-certified IITF must be properly trained (
(a) An HHS-certified IITF must control access to the drug testing facility, specimens, aliquots, and records.
(b) Authorized visitors must be escorted at all times except for individuals conducting inspections (
(c) An HHS-certified IITF must maintain records documenting the identity of the visitor and escort, date, time of entry and exit, and purpose for the access to the secured area.
(a) HHS-certified IITFs must use chain of custody procedures (internal and external) to maintain control and accountability of specimens from the time of receipt at the IITF through completion of testing, reporting of results, during storage, and continuing until final disposition of the specimens.
(b) HHS-certified IITFs must use chain of custody procedures to document the handling and transfer of aliquots throughout the testing process until final disposal.
(c) The chain of custody must be documented using either paper copy or electronic procedures.
(d) Each individual who handles a specimen or aliquot must sign and complete the appropriate entries on the chain of custody form when the specimen or aliquot is handled or transferred, and every individual in the chain must be identified.
(e) The date and purpose must be recorded on an appropriate chain of custody form each time a specimen or aliquot is handled or transferred.
(a) An initial drug test may be:
(1) An immunoassay or
(2) An alternate technology (
(b) An HHS-certified IITF must validate an initial drug test before testing specimens;
(c) Initial drug tests must be accurate and reliable for the testing of urine specimens when identifying drugs or their metabolites.
(d) An HHS-certified IITF may conduct a second initial drug test using a method with different specificity, to rule out cross-reacting compounds. This second initial drug test must satisfy the batch quality control requirements specified in Section 12.11.
(a) An HHS-certified IITF must demonstrate and document the following for each initial drug test:
(1) The ability to differentiate negative specimens from those requiring further testing;
(2) The performance of the test around the cutoff concentration, using samples at several concentrations between 0 and 150 percent of the cutoff concentration;
(3) The effective concentration range of the test (linearity);
(4) The potential for carryover;
(5) The potential for interfering substances; and
(6) The potential matrix effects if using an alternate technology.
(b) Each new lot of reagent must be verified prior to being placed into service.
(c) Each initial drug test using an alternate technology must be re-verified periodically or at least annually.
(a) Each batch of specimens must contain the following calibrators and controls:
(1) At least one control certified to contain no drug or drug metabolite;
(2) At least one positive control with the drug or drug metabolite targeted at a concentration 25 percent above the cutoff;
(3) At least one control with the drug or drug metabolite targeted at a concentration 75 percent of the cutoff; and
(4) At least one control that appears as a donor specimen to the analysts.
(b) Calibrators and controls must total at least 10 percent of the aliquots analyzed in each batch.
(a) Each specimen validity test result must be based on performing a single test on one aliquot;
(b) The HHS-certified IITF must establish acceptance criteria and analyze calibrators and controls as appropriate to verify and document the validity of the test results in accordance with Section 12.14; and
(c) Controls must be analyzed concurrently with specimens.
An HHS-certified IITF must demonstrate and document for each specimen validity test the appropriate performance characteristics of the test, and must re-verify the test periodically, or at least annually. Each new lot of reagent must be verified prior to being placed into service.
(a) The requirements for measuring creatinine concentration are as follows:
(1) The creatinine concentration must be measured to one decimal place on the test;
(2) The creatinine test must have the following calibrators and controls:
(i) A calibrator at 2 mg/dL;
(ii) A control in the range of 1.0 mg/dL to 1.5 mg/dL;
(iii) A control in the range of 3 mg/dL to 20 mg/dL; and
(iv) A control in the range of 21 mg/dL to 25 mg/dL.
(b) The requirements for measuring specific gravity are as follows:
(1) For specimens with creatinine test results greater than 5 mg/dL and less than 20 mg/dL, an IITF must perform a screening test using a refractometer to identify specific gravity values that are acceptable (equal to or greater than 1.003) or dilute (equal to or greater than 1.002 and less than 1.003). Specimens must be forwarded to an HHS-certified laboratory when the creatinine test result is less than or equal to 5 mg/dL or when the screening specific gravity test result is less than 1.002.
(2) The screening specific gravity test must have the following calibrators and controls:
(i) A calibrator or control at 1.000;
(ii) One control targeted at 1.002; and
(iii) One control in the range of 1.004 to 1.018.
(c) The requirements for measuring pH are as follows:
(1) The IITF may perform the pH test using a pH meter, colorimetric pH test, dipsticks, or pH paper. Specimens must be forwarded to an HHS-certified laboratory when the pH is less than 4.5 or equal to or greater than 9.0.
(2) The pH test must have, at a minimum, the following calibrators and controls:
(i) One control below 4.5;
(ii) One control between 4.5 and 9.0;
(iii) One control above 9.0; and
(iv) One or more calibrators as appropriate for the test. For a pH meter: Calibrators at 4, 7, and 10.
(d) The requirements for measuring the nitrite concentration are that the nitrite test must have a calibrator at 200 mcg/mL nitrite, a control without nitrite (
(e) Requirements for performing oxidizing adulterant tests are that the test must include an appropriate calibrator at the cutoff specified in Sections 11.19(d)(3), (4), or (6) for the compound of interest, a control without the compound of interest (
(a) An HHS-certified IITF must report a test result to the agency's MRO within an average of 3 working days after receipt of the specimen. Reports must use the Federal CCF and/or an electronic report. Before any test result can be reported, it must be certified by a certifying technician.
(b) A primary (A) specimen is reported negative when each drug test is negative and each specimen validity test result indicates that the specimen is a valid urine specimen.
(c) A primary (A) urine specimen is reported dilute when the creatinine concentration is greater than 5 mg/dL but less than 20 mg/dL and the specific gravity is equal to or greater than 1.002 but less than 1.003.
(d) An HHS-certified IITF shall reject a urine specimen for testing when a fatal flaw occurs as described in Section 15.1 or when a correctable flaw as described in Section 15.2 is not recovered. The HHS-certified IITF will indicate on the Federal CCF that the specimen was rejected for testing and provide the reason for reporting the rejected for testing result.
(e) HHS-certified IITFs may transmit test results to the MRO by various electronic means (
(f) HHS-certified IITFs must facsimile, courier, mail, or electronically transmit a legible image or copy of the completed Federal CCF and/or forward a computer-generated electronic report. The computer-generated report must contain sufficient information to ensure that the test results can accurately represent the content of the custody and control form that the MRO received from the collector.
(g) For rejected specimens, IITFs must facsimile, courier, mail, or electronically transmit a legible image or copy of the completed Federal CCF.
(a) The remaining specimen is resealed using a tamper-evident label/seal;
(b) The individual resealing the remaining specimen initials and dates the tamper-evident label/seal; and
(c) The resealed specimen and split specimen and the Federal CCF are sealed in a leak-proof plastic bag, and are sent to an HHS-certified laboratory under chain of custody within one day after completing the drug and specimen validity tests.
A specimen that is negative, negative/dilute, or rejected for testing is discarded.
(a) An HHS-certified IITF must retain all records generated to support test results for at least 2 years. The IITF may convert hardcopy records to electronic records for storage and then discard the hardcopy records after six months.
(b) A federal agency may request the HHS-certified IITF to maintain a documentation package (as described in Section 12.20) that supports the chain of custody, testing, and reporting of a donor's specimen that is under legal challenge by a donor. The federal agency's request to the IITF must be in writing and must specify the period of time to maintain the documentation package.
(c) An HHS-certified IITF may retain records other than those included in the documentation package beyond the normal two-year period of time.
(a) HHS-certified IITFs must provide to each federal agency for which they perform testing a semiannual statistical summary report that must be submitted by mail, facsimile, or email within 14 working days after the end of the semiannual period. The summary report must not include any personal identifying information. A copy of the semiannual statistical summary report will also be sent to the Secretary or designated HHS representative. The semiannual statistical report contains the following information:
(1) Reporting period (inclusive dates);
(2) HHS-certified IITF name and address;
(3) Federal agency name;
(4) Total number of specimens tested;
(5) Number of specimens collected by reason for test;
(6) Number of specimens reported negative and the number reported negative/dilute;
(7) Number of specimens rejected for testing because of a fatal flaw;
(8) Number of specimens rejected for testing because of an uncorrected flaw;
(9) Number of specimens tested positive by each initial drug test; and
(10) Number of specimens forwarded to an HHS-certified laboratory for testing.
(b) An HHS-certified IITF must make copies of an agency's test results available when requested to do so by the Secretary or by the federal agency for which the IITF is performing drug-testing services.
(c) An HHS-certified IITF must ensure that a qualified individual is available to testify in a proceeding against a federal employee when the proceeding is based on a test result reported by the IITF.
(a) Following a federal agency's receipt of a positive, adulterated, or substituted drug test report from a laboratory, the federal agency may submit a written request for copies of the IITF records relating to the drug test results or a documentation package or any relevant certification, review, or revocation of certification records.
(b) Standard documentation packages provided by an HHS-certified IITF must contain the following items:
(1) A cover sheet providing a brief description of the procedures and tests performed on the donor's specimen;
(2) A table of contents that lists all documents and materials in the package by page number;
(3) A copy of the Federal CCF with any attachments, internal chain of custody records for the specimen, memoranda (if any) generated by the HHS-certified IITF, and a copy of the electronic report (if any) generated by the HHS-certified IITF;
(4) A brief description of the HHS-certified IITF's drug and specimen validity testing procedures, instrumentation, and batch quality control requirements;
(5) Copies of all test data for the donor's specimen with all calibrators and controls and copies of all internal chain of custody documents related to the tests; and
(6) Copies of the résumé or curriculum vitae for the RT and for the certifying technician of record.
A federal employee who is the subject of a drug test may provide a written request through the MRO and/or the federal agency requesting access to any records relating to his or her drug test results or a documentation package (as described in Section 12.20) and any relevant certification, review, or revocation of certification records.
An HHS-certified IITF must not enter into any relationship with a federal agency's MRO that may be construed as a potential conflict of interest or derive any financial benefit by having a federal agency use a specific MRO.
This means an MRO may be an employee of the agency or a contractor for the agency; however, an MRO shall not be an employee or agent of or have any financial interest in the HHS-certified IITF for which the MRO is reviewing drug testing results. Additionally, an MRO shall not derive any financial benefit by having an agency use a specific HHS-certified IITF or have any agreement with an HHS-certified IITF that may be construed as a potential conflict of interest.
An HHS-certified IITF can enter into any relationship with an HHS-certified laboratory.
(a) A currently licensed physician who has:
(1) A Doctor of Medicine (M.D.) or Doctor of Osteopathy (D.O.) degree;
(2) Knowledge regarding the pharmacology and toxicology of illicit drugs and nonmedical use of prescription drugs;
(3) The training necessary to serve as an MRO as set out in Section 13.3;
(4) Satisfactorily passed an initial examination, administered by a nationally recognized entity or a subspecialty board that has been approved by the Secretary to certify MROs; and
(5) At least every five years, completed requalification training on the topics in Section 13.3 and satisfactorily passed a requalification examination administered by a nationally recognized entity or a subspecialty board that has been approved by the Secretary to certify MROs.
All nationally recognized entities or subspecialty boards which seek approval by the Secretary to certify and/or train physicians as MROs for federal workplace drug testing programs must submit their qualifications and, if applicable, a sample examination. Approval will be based on an objective review of qualifications that include a copy of the MRO applicant application form, the course syllabus and materials, documentation that the continuing education courses are accredited by a professional organization, and, if applicable, the delivery method and content of the examination. Each approved MRO training/certification entity must resubmit their qualifications for approval every two years. The Secretary shall publish at least every two years a notice in the
(a) A physician must receive training that includes a thorough review of the following:
(1) The collection procedures used to collect federal agency specimens;
(2) How to interpret test results reported by HHS-certified IITFs and laboratories (
(3) Chain of custody, reporting, and recordkeeping requirements for federal agency specimens;
(4) The HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs for all authorized specimen types;
(5) Procedures for interpretation, review (
(6) Training in Substance Abuse including information about how to discuss substance misuse and abuse, and how individuals that test positive can access services.
(b) Nationally recognized entities or subspecialty boards that train or certify physicians as MROs should make the MROs aware of prevention and treatment opportunities for individuals after testing positive.
(a) The MRO must review all positive, adulterated, rejected for testing, invalid, and (for urine) substituted test results.
(b) Staff under the direct, personal supervision of the MRO may review and report negative and (for urine) negative/dilute test results to the agency's designated representative. The MRO must review at least 5 percent of all negative results reported by the MRO staff to ensure that the MRO staff are properly performing the review process.
(c) The MRO must discuss potential invalid results with the HHS-certified laboratory, as addressed in Section 11.19(g) to determine whether testing at another HHS-certified laboratory may be warranted.
(d) After receiving a report from an HHS-certified laboratory or (for urine) HHS-certified IITF, the MRO must:
(1) Review the information on the MRO copy of the Federal CCF that was received from the collector and the report received from the HHS-certified laboratory or HHS-certified IITF;
(2) Interview the donor when required;
(3) Make a determination regarding the test result; and
(4) Report the verified result to the federal agency.
(e) The MRO must maintain records for a minimum of two years while maintaining the confidentiality of the information. The MRO may convert hardcopy records to electronic records for storage and discard the hardcopy records after six months.
(f) The MRO must conduct a medical examination or a review of the examining physician's findings and make a determination of refusal to test or cancelled test when a collector reports that the donor was unable to provide a specimen, as addressed in Section 8.6.
(a) When the HHS-certified laboratory or HHS-certified IITF reports a negative result for the primary (A) specimen, the MRO reports a negative result to the agency.
(b) When the HHS-certified laboratory or HHS-certified IITF reports a negative/dilute result for the primary (A) urine specimen, the MRO reports a negative/dilute result to the agency and directs the agency to immediately collect another specimen from the donor.
(1) If the recollected specimen provides a negative or negative/dilute result, the MRO reports a negative result to the agency, with no further action required.
(2) If the recollected specimen provides a result other than negative or negative/dilute, the MRO follows the procedures in 13.5(c) through (g) for the recollected specimen.
(c) When the HHS-certified laboratory reports multiple results for the primary (A) urine specimen, as the MRO, you must follow the verification procedures described in 13.5(c) through (g) and:
(1) Report all verified positive and/or refusal to test results to the federal agency.
(2) If an invalid result was reported in conjunction with a positive, adulterated, or substituted result, do not report the verified invalid result to the federal agency at this time. The MRO reports the verified invalid result(s) for the primary (A) urine specimen only if the split specimen is tested and reported as a failure to reconfirm as described in Section 14.6(l).
(d) When the HHS-certified laboratory reports a positive result for the primary (A) specimen, the MRO must contact the donor to determine if there is any legitimate medical explanation for the positive result.
(1) If the donor provides a legitimate medical explanation for the positive result, the MRO reports the test result as negative to the agency. If the laboratory also reports that the urine specimen is dilute, the MRO reports a negative/dilute result to the agency and directs the agency to immediately collect another specimen from the donor. The MRO follows the procedures in Section 13.5(b)(1) or (2) for the recollected specimen.
(2) If the donor is unable to provide a legitimate medical explanation, the MRO reports a positive result to the agency. If the laboratory also reports that the urine specimen is dilute, the MRO may choose not to report the dilute result.
(e) When the HHS-certified laboratory reports a positive result for opiates for the primary (A) urine specimen, the MRO must determine if there is clinical evidence (in addition to the test result) of illegal use of any opium, or opiates, listed in Schedule I or II of the Controlled Substances Act. However, this requirement does not apply if the laboratory confirms the presence of 6-acetylmorphine (
(f) When an HHS-certified laboratory reports an adulterated or substituted result for the primary (A) urine specimen, the MRO contacts the donor to determine if the donor has a legitimate medical explanation for the adulterated or substituted result.
(1) If the donor provides a legitimate medical explanation, the MRO reports a negative result to the federal agency.
(2) If the donor is unable to provide a legitimate explanation, the MRO reports a refusal to test to the federal agency because the urine specimen was adulterated or substituted.
(g) When the HHS-certified laboratory reports an invalid result for the primary (A) urine specimen, the MRO must contact the donor to determine if there is a legitimate explanation for the invalid result. In the case of an invalid result based on pH of 9.0 to 9.5, when an employee has no other medical explanation for the pH in this range, the MRO must consider whether there is evidence of elapsed time and high temperature that could account for the pH value. The MRO may contact the collection site, HHS-certified IITF, and/or HHS-certified laboratory to discuss time and temperature issues (
(1) If the donor provides a legitimate explanation (
(2) If the donor is unable to provide a legitimate explanation or if the MRO determines that time and temperature fail to account for the pH in the 9.0-9.5 range, the MRO reports a test cancelled result with the reason for the invalid result and directs the federal agency to immediately collect another urine specimen from the donor using a direct observed collection.
(i) If the specimen collected under direct observation provides a valid
(ii) If the specimen collected under direct observation provides an invalid result, the MRO reports this specimen as test cancelled and recommends that the agency collect another authorized specimen type (
(h) When two separate specimens collected during the same testing event were sent to the HHS-certified laboratory for testing (
(1) If both specimens were verified negative, report the result as negative.
(2) If one specimen was verified negative and the other was not (
(3) If both specimens were verified as positive, adulterated, and/or substituted, report all results. For example, if you verified one specimen as positive and the other as a refusal to test because the specimen was adulterated, report the positive and the refusal results to the federal agency.
(4) If one specimen has been verified and the HHS-certified laboratory has not reported the result(s) of the other specimen,
(i) Report verified result(s) of positive, adulterated, or substituted immediately and do not wait to receive the result(s) of the other specimen.
(ii) Do not report a verified result of negative, negative/dilute, or invalid for the first specimen to the federal agency. Hold the report until results of both specimens have been received and verified.
(5) When the HHS-certified laboratory reports an invalid result for one or both specimens, follow the procedures in paragraph c above.
(i) When the HHS-certified laboratory or HHS-certified IITF reports a rejected for testing result for the primary (A) specimen, the MRO reports a test cancelled result to the agency and recommends that the agency collect another specimen from the donor. The recollected specimen must be the same type (
(a) When another specimen type (
(b) When the federal agency did not authorize the collection of an alternative specimen, the MRO consults with the federal agency. The federal agency immediately directs the donor to obtain, within five days, an evaluation from a licensed physician, acceptable to the MRO, who has expertise in the medical issues raised by the donor's failure to provide a specimen. The MRO may perform this evaluation if the MRO has appropriate expertise.
(1) For purposes of this section, a medical condition includes an ascertainable physiological condition (
(2) As the MRO, if another physician will perform the evaluation, you must provide the other physician with the following information and instructions:
(i) That the donor was required to take a federally regulated drug test, but was unable to provide a sufficient amount of urine to complete the test;
(ii) The consequences of the appropriate federal agency regulation for refusing to take the required drug test;
(iii) That, after completing the evaluation, the referral physician must agree to provide a written statement to the MRO with a recommendation for one of the determinations described in paragraph (b)(3) of this section and the basis for the recommendation. The statement must not include detailed information on the employee's medical condition beyond what is necessary to explain the referral physician's conclusion.
(3) As the MRO, if another physician performed the evaluation, you must consider and assess the referral physician's recommendations in making your determination. You must make one of the following determinations and report it to the federal agency in writing:
(i) A medical condition as defined in paragraph (b)(1) of this section has, or with a high degree of probability could have, precluded the employee from providing a sufficient amount of urine, but is not a permanent or long-term disability. As the MRO, you must report a test cancelled result to the federal agency.
(ii) A permanent or long-term medical condition as defined in paragraph (b)(1) of this section has, or with a high degree of probability could have, precluded the employee from providing a sufficient amount of urine and is highly likely to prevent the employee from providing a sufficient amount of urine for a very long or indefinite period of time. As the MRO, you must follow the requirements of Section 13.7, as appropriate. If Section 13.7 is not applicable, you report a test cancelled result to the federal agency and recommend that the agency authorize collection of an alternative specimen type (
(iii) There is not an adequate basis for determining that a medical condition has, or with a high degree of probability could have, precluded the employee from providing a sufficient amount of urine. As the MRO, you must report a refusal to test to the federal agency.
(4) When a federal agency receives a report from the MRO indicating that a test is cancelled as provided in paragraph (b)(3)(i) of this section, the agency takes no further action with respect to the donor. When a test is canceled as provided in paragraph (b)(3)(ii) of this section, the agency takes no further action with respect to the donor other than designating collection of an alternate specimen type (
(a) This section concerns a situation in which the donor has a medical condition that precludes him or her from providing a sufficient specimen for a federal agency applicant/pre-employment test, a follow-up test, or a return-to-duty test and the condition involves a permanent or long-term disability and the federal agency does not authorize collection of an alternative specimen. As the MRO in this situation, you must do the following:
(1) You must determine if there is clinical evidence that the individual is an illicit drug user. You must make this determination by personally conducting, or causing to be conducted, a medical evaluation and through consultation with the donor's physician and/or the physician who conducted the evaluation under Section 13.6.
(2) If you do not personally conduct the medical evaluation, you must ensure that one is conducted by a licensed physician acceptable to you.
(b) If the medical evaluation reveals no clinical evidence of drug use, as the MRO, you must report the result to the federal agency as a negative test with written notations regarding results of both the evaluation conducted under Section 13.6 and any further medical examination. This report must state the basis for the determination that a permanent or long-term medical condition exists, making provision of a sufficient urine specimen impossible, and for the determination that no signs and symptoms of drug use exist. The MRO recommends that the agency authorize collection of an alternate specimen type (
(c) If the medical evaluation reveals clinical evidence of drug use, as the MRO, you must report the result to the federal agency as a cancelled test with written notations regarding results of both the evaluation conducted under Section 13.6 and any further medical examination. This report must state that a permanent or long-term medical condition [as defined in Section 13.6(b)(1)] exists, making provision of a sufficient urine specimen impossible, and state the reason for the determination that signs and symptoms of drug use exist. Because this is a cancelled test, it does not serve the purposes of a negative test (
(a) For a positive, adulterated, or substituted result reported on a primary (A) specimen, a donor may request through the MRO that the split (B) specimen be tested by a second HHS-certified laboratory to verify the result reported by the first HHS-certified laboratory.
(b) The donor has 72 hours (from the time the MRO notified the donor that his or her specimen was reported positive, adulterated, or (for urine) substituted to request a test of the split (B) specimen. The MRO must inform the donor that he or she has the opportunity to request a test of the split (B) specimen when the MRO informs the donor that a positive, adulterated, or (for urine) substituted result is being reported to the federal agency on the primary (A) specimen.
(a) The MRO must report all verified results to an agency using the completed MRO copy of the Federal CCF or a separate report using a letter/memorandum format. The MRO may use various electronic means for reporting (
(b) A verified result may not be reported to the agency until the MRO has completed the review process.
(c) The MRO must send a copy of either the completed MRO copy of the Federal CCF or the separate letter/memorandum report for all positive, adulterated, and (for urine) substituted results.
(d) The MRO must not disclose numerical values of drug test results to the agency.
An MRO must not be an employee, agent of, or have any financial interest in an HHS-certified laboratory or an HHS-certified IITF for which the MRO is reviewing drug test results.
This means an MRO must not derive any financial benefit by having an agency use a specific HHS-certified laboratory or HHS-certified IITF, or have any agreement with the HHS-certified laboratory or the HHS-certified IITF that may be construed as a potential conflict of interest.
(a) The donor may verbally request through the MRO that the split (B) specimen be tested at a different (
(b) A donor has 72 hours to initiate the verbal request after being informed of the result by the MRO. The MRO must document in his or her records the verbal request from the donor to have the split (B) specimen tested.
(c) If a split (B) urine specimen cannot be tested by a second HHS-certified laboratory (
(d) If a donor chooses not to have the split (B) specimen tested by a second HHS-certified laboratory, a federal agency may have a split (B) specimen retested as part of a legal or administrative proceeding to defend an original positive, adulterated, or (for urine) substituted result.
(a) The testing of a split (B) specimen for a drug or metabolite is not subject to the testing cutoff concentrations established.
(b) The HHS-certified laboratory is only required to confirm the presence of the drug or metabolite that was reported positive in the primary (A) specimen.
(c) For a split (B) urine specimen, if the second HHS-certified laboratory fails to reconfirm the presence of the drug or drug metabolite that was reported by the first HHS-certified laboratory, the second laboratory must conduct specimen validity tests in an attempt to determine the reason for being unable to reconfirm the presence
(a) An HHS-certified laboratory must use one of the following criteria to reconfirm an adulterated result when testing a split (B) urine specimen:
(1) pH must be measured using the laboratory's confirmatory pH test with the appropriate cutoff (
(2) Nitrite must be measured using the laboratory's confirmatory nitrite test with a cutoff concentration of equal to or greater than 500 mcg/mL;
(3) Surfactant must be measured using the laboratory's confirmatory surfactant test with a cutoff concentration of equal to or greater than 100 mcg/mL dodecylbenzene sulfonate-equivalent cutoff; or
(4) For adulterants without a specified cutoff (
(b) The second HHS-certified laboratory may only conduct the confirmatory specimen validity test(s) needed to reconfirm the adulterated result reported by the first HHS-certified laboratory.
(a) An HHS-certified laboratory must use the following criteria to reconfirm a substituted result when testing a split (B) urine specimen:
(1) The creatinine must be measured using the laboratory's confirmatory creatinine test with a cutoff concentration of less than 2 mg/dL; and
(2) The specific gravity must be measured using the laboratory's confirmatory specific gravity test with the specified cutoffs of less than or equal to 1.0010 or equal to or greater than 1.0200.
(b) The second HHS-certified laboratory may only conduct the confirmatory specimen validity test(s) needed to reconfirm the substituted result reported by the first HHS-certified laboratory.
The second HHS-certified laboratory must report the result to the MRO.
The MRO takes the following actions when the second HHS-certified laboratory reports the result for the split (B) urine specimen as:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(n)
(o)
(p)
(q)
(a) The MRO must report all verified results to an agency using the completed MRO copy of the Federal CCF or a separate report using a letter/memorandum format. The MRO may use various electronic means for reporting (
(b) A verified result may not be reported to the agency until the MRO has completed the review process.
(c) The MRO must send a copy of either the completed MRO copy of the Federal CCF or the separate letter/memorandum report for all split specimen results.
(d) The MRO must not disclose the numerical values of the drug test results to the agency.
A split (B) specimen is retained for the same period of time that a primary (A) specimen is retained and under the same storage conditions. This applies even for those cases when the split (B) specimen is tested by a second HHS-certified laboratory and the second HHS-certified laboratory does not confirm the original result reported by the first HHS-certified laboratory for the primary (A) specimen.
The following discrepancies are considered to be fatal flaws. The HHS-certified laboratory or IITF must stop the testing process, reject the specimen for testing, and indicate the reason for rejecting the specimen on the Federal CCF when:
(a) The specimen ID number on the specimen label/seal does not match the ID number on the Federal CCF, or the ID number is missing either on the Federal CCF or on either specimen label/seal;
(b) The primary (A) specimen label/seal is broken or shows evidence of tampering and the split (B) specimen cannot be re-designated as the primary (A) specimen;
(c) The collector's printed name and signature are omitted on the Federal CCF;
(d) There is an insufficient amount of specimen for analysis in the primary (A) specimen unless the split (B) specimen can be re-designated as the primary (A) specimen; or
(e) The accessioner failed to document the primary (A) specimen seal condition on the Federal CCF at the time of accessioning, and the split (B) specimen cannot be re-designated as the primary (A) specimen.
The following discrepancies are considered to be correctable:
(a) If a collector failed to sign the Federal CCF, the HHS-certified laboratory or IITF must attempt to recover the collector's signature before reporting the test result. If the collector can provide a memorandum for record recovering the signature, the HHS-certified laboratory or IITF may report the test result for the specimen. If, after holding the specimen for at least 5 business days, the HHS-certified laboratory or IITF cannot recover the collector's signature, the laboratory or IITF must report a rejected for testing result and indicate the reason for the rejected for testing result on the Federal CCF.
(b) If a specimen is submitted using a non-federal form or an expired Federal
(a) The following omissions and discrepancies on the Federal CCF that are received by the HHS-certified laboratory or IITF are considered insignificant and should not cause an HHS-certified laboratory or IITF to reject a urine specimen or cause an MRO to cancel a test:
(1) An incorrect laboratory name and address appearing at the top of the form;
(2) Incomplete/incorrect/unreadable employer name or address;
(3) MRO name is missing;
(4) Incomplete/incorrect MRO address;
(5) A transposition of numbers in the donor's SSN;
(6) A telephone number is missing/incorrect;
(7) A fax number is missing/incorrect;
(8) A “reason for test” box is not marked;
(9) A “drug tests to be performed” box is not marked;
(10) A “specimen collection” box is not marked;
(11) The “observed” box is not marked (if applicable);
(12) The collection site address is missing;
(13) The collector's printed name is missing but the collector's signature is properly recorded;
(14) The time of collection is not indicated;
(15) The date of collection is not indicated;
(16) Incorrect name of delivery service;
(17) The collector has changed or corrected information by crossing out the original information on either the Federal CCF or specimen label/seal without dating and initialing the change; or
(18) The donor's name inadvertently appears on the HHS-certified laboratory or IITF copy of the Federal CCF or on the tamper-evident labels used to seal the specimens.
(19) The collector failed to check the specimen temperature box and the “Remarks” line did not have a comment regarding the temperature being out of range. If, after at least 5 business days, the collector cannot provide a memorandum for record to attest to the fact that he or she did measure the specimen temperature, the HHS-certified laboratory or IITF may report the test result for the specimen but indicates that the collector could not provide a memorandum to recover the omission.
(b) The following omissions and discrepancies on the Federal CCF that are made at the HHS-certified laboratory or IITF are considered insignificant and should not cause an MRO to cancel a test:
(1) The testing laboratory or IITF fails to indicate the correct name and address in the results section when a different laboratory or IITF name and address is printed at the top of the Federal CCF;
(2) The accessioner fails to print his or her name;
(3) The certifying scientist or certifying technician fails to print his or her name;
(4) The certifying scientist or certifying technician accidentally initials the Federal CCF rather than signing for a specimen reported as rejected for testing;
(c) The above omissions and discrepancies are considered insignificant only when they occur no more than once a month. The expectation is that each trained collector and HHS-certified laboratory or IITF will make every effort to ensure that the Federal CCF is properly completed and that all the information is correct. When an error occurs more than once a month, the MRO must direct the collector, HHS-certified laboratory, or HHS-certified IITF (whichever is responsible for the error) to immediately take corrective action to prevent the recurrence of the error.
(a) An MRO must attempt to correct the following errors:
(1) The donor's signature is missing on the MRO copy of the Federal CCF and the collector failed to provide a comment that the donor refused to sign the form;
(2) The certifying scientist failed to sign the Federal CCF for a specimen being reported drug positive, adulterated, invalid, or (for urine) substituted; or
(3) The electronic report provided by the HHS-certified laboratory or HHS-certified IITF does not contain all the data elements required for the HHS standard laboratory or IITF electronic report for a specimen being reported drug positive, adulterated, invalid result, or (for urine) substituted.
(b) If error (a)(1) occurs, the MRO must contact the collector to obtain a statement to verify that the donor refused to sign the MRO copy. If, after at least 5 business days, the collector cannot provide such a statement, the MRO must cancel the test.
(c) If error (a)(2) occurs, the MRO must obtain a statement from the certifying scientist that he or she inadvertently forgot to sign the Federal CCF, but did, in fact, properly conduct the certification review. If, after at least 5 business days, the MRO cannot get a statement from the certifying scientist, the MRO must cancel the test.
(d) If error (a)(3) occurs, the MRO must contact the HHS-certified laboratory or HHS-certified IITF. If, after at least 5 business days, the laboratory or IITF does not retransmit a corrected electronic report, the MRO must cancel the test.
These procedures apply when:
(a) The Secretary has notified an HHS-certified laboratory or IITF in writing that its certification to perform drug testing under these Guidelines has been suspended or that the Secretary proposes to revoke such certification.
(b) The HHS-certified laboratory or IITF has, within 30 days of the date of such notification or within 3 days of the date of such notification when seeking an expedited review of a suspension, requested in writing an opportunity for an informal review of the suspension or proposed revocation.
The scope of review shall be limited to the facts relevant to any suspension or proposed revocation, the necessary interpretations of those facts, the relevant Mandatory Guidelines for Federal Workplace Drug Testing Programs, and other relevant law. The legal validity of these Guidelines shall not be subject to review under these procedures.
The appellant's request for review shall specify the name, address, and telephone number of the appellant's representative. In its first written submission to the reviewing official, the respondent shall specify the name, address, and telephone number of the respondent's representative.
(a) Within 30 days of the date of the notice of the suspension or proposed revocation, the appellant must submit a written request to the reviewing official seeking review, unless some other time period is agreed to by the parties. A copy must also be sent to the respondent. The request for review must include a copy of the notice of suspension or proposed revocation, a brief statement of why the decision to suspend or propose revocation is wrong, and the appellant's request for an oral presentation, if desired.
(b) Within 5 days after receiving the request for review, the reviewing official will send an acknowledgment and advise the appellant of the next steps. The reviewing official will also send a copy of the acknowledgment to the respondent.
Upon mutual agreement of the parties to hold these procedures in abeyance, the reviewing official will stay these procedures for a reasonable time while the laboratory or IITF attempts to regain compliance with the Guidelines or the parties otherwise attempt to settle the dispute. As part of an abeyance agreement, the parties can agree to extend the time period for requesting review of the suspension or proposed revocation. If abeyance begins after a request for review has been filed, the appellant shall notify the reviewing official at the end of the abeyance period advising whether the dispute has been resolved. If the dispute has been resolved, the request for review will be dismissed. If the dispute has not been resolved, the review procedures will begin at the point at which they were interrupted by the abeyance agreement with such modifications to the procedures as the reviewing official deems appropriate.
The appellant and the respondent each participate in developing the file for the reviewing official and in submitting written arguments. The procedures for development of the review file and submission of written argument are:
(a)
(1) A review file containing the documents supporting appellant's argument, tabbed and organized chronologically, and accompanied by an index identifying each document. Only essential documents should be submitted to the reviewing official.
(2) A written statement, not to exceed 20 double-spaced pages, explaining why respondent's decision to suspend or propose revocation of appellant's certification is wrong (appellant's brief).
(b)
(1) A review file containing documents supporting respondent's decision to suspend or revoke appellant's certification to perform drug testing, which is tabbed and organized chronologically, and accompanied by an index identifying each document. Only essential documents should be submitted to the reviewing official.
(2) A written statement, not exceeding 20 double-spaced pages in length, explaining the basis for suspension or proposed revocation (respondent's brief).
(c)
(d)
(e)
(a)
(b)
(c)
(d)
(e)
(1)
(2)
(3)
(4)
(5)
(f)
(g)
(a)
(b)
(c)
(1) A review file containing essential documents relevant to the review, which is tabbed, indexed, and organized chronologically; and
(2) A written statement, not to exceed 20 double-spaced pages, explaining the party's position concerning the suspension and any proposed revocation. No reply brief is permitted.
(d)
(e)
(f)
Except for routine administrative and procedural matters, a party shall not communicate with the reviewing or presiding official without notice to the other party.
(a) Because of the importance of a timely review, the reviewing official should normally transmit written communications to either party by facsimile, secured electronic transmissions, or overnight mail in which case the date of transmission or day following mailing will be considered the date of receipt. In the case of communications sent by regular mail, the date of receipt will be considered 3 days after the date of mailing.
(b) In counting days, include Saturdays, Sundays, and federal holidays. However, if a due date falls on a Saturday, Sunday, or federal holiday, then the due date is the next federal working day.
In addition to any other authority specified in these procedures, the reviewing official and the presiding official, with respect to those authorities involving the oral presentation, shall have the authority to issue orders; examine witnesses; take all steps necessary for the conduct of an orderly hearing; rule on requests and motions; grant extensions of time for good reasons; dismiss for failure to meet deadlines or other requirements; order the parties to submit relevant information or witnesses; remand a case for further action by the respondent; waive or modify these procedures in a specific case, usually with notice to the parties; reconsider a decision of the reviewing official where a party promptly alleges a clear error of fact or law; and to take any other action
The administrative record of review consists of the review file; other submissions by the parties; transcripts or other records of any meetings, conference calls, or oral presentation; evidence submitted at the oral presentation; and orders and other documents issued by the reviewing and presiding officials.
(a)
(b)
(c)
Before any legal action is filed in court challenging the suspension or proposed revocation, respondent shall exhaust administrative remedies provided under this subpart, unless otherwise provided by Federal Law. The reviewing official's decision, under Section 16.9(e) or 16.14(a) constitutes final agency action and is ripe for judicial review as of the date of the decision.
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration |