| Page Range | 58533-58705 | |
| FR Document |
| Page and Subject | |
|---|---|
| 82 FR 58705 - Delaying Submission of the Small Business Administration Report Under the Trade Facilitation and Trade Enforcement Act of 2015 | |
| 82 FR 58701 - Revising the Seal for the National Credit Union Administration | |
| 82 FR 58699 - Human Rights Day, Bill of Rights Day, and Human Rights Week, 2017 | |
| 82 FR 58603 - Sunshine Act Meeting | |
| 82 FR 58592 - Advisory Committee on Supply Chain Competitiveness Solicitation of Nominations for Membership | |
| 82 FR 58601 - Proposed Re-Issuance of a General NPDES Permit (GP) for Small Suction Dredges in Idaho | |
| 82 FR 58598 - Senior Executive Service Performance Review Board; Membership | |
| 82 FR 58600 - Integrated Science Assessment for Sulfur Oxides-Health Criteria | |
| 82 FR 58653 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-DVD Copy Control Association | |
| 82 FR 58653 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Cooperative Research Group on CHEDE-VII | |
| 82 FR 58597 - National Advisory Committee on Institutional Quality and Integrity | |
| 82 FR 58604 - Office of Federal High-Performance Buildings; Initiation of Periodic Review of High Performance Building Certification Systems | |
| 82 FR 58551 - Direct Investment Surveys: BE-12, Benchmark Survey of Foreign Direct Investment in the United States | |
| 82 FR 58562 - Certificate of Release or Discharge From Active Duty (DD Form 214/5 Series) | |
| 82 FR 58659 - PNC Capital Advisors, LLC; Notice of Application | |
| 82 FR 58673 - Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the Commonwealth of Puerto Rico | |
| 82 FR 58658 - New Postal Product | |
| 82 FR 58594 - Arms Sales Notification | |
| 82 FR 58673 - Presidential Declaration Amendment of a Major Disaster for the Commonwealth of Puerto Rico | |
| 82 FR 58626 - National Library of Medicine; Notice of Meetings | |
| 82 FR 58564 - International Fisheries; Western and Central Pacific Fisheries for Highly Migratory Species; 2017 Purse Seine FAD Fishery Closure | |
| 82 FR 58693 - Proposed Information Collection; Comment Request for Regulation Project | |
| 82 FR 58686 - Qualification of Drivers; Exemption Applications; Diabetes Mellitus | |
| 82 FR 58682 - Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders | |
| 82 FR 58681 - Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders | |
| 82 FR 58677 - Qualification of Drivers; Exemption Applications; Diabetes | |
| 82 FR 58683 - Qualification of Drivers; Exemption Applications; Diabetes Mellitus | |
| 82 FR 58678 - Qualification of Drivers; Exemption Applications; Hearing | |
| 82 FR 58593 - Technology Advisory Committee | |
| 82 FR 58680 - Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders | |
| 82 FR 58684 - Qualification of Drivers; Exemption Applications; Diabetes Mellitus | |
| 82 FR 58649 - Extension of Agency Information Collection Activity Under OMB Review: Imposition and Collection of Passenger Civil Aviation Security Service Fees | |
| 82 FR 58650 - Intent To Request Approval From OMB of One Current Public Collection of Information: Screening Partnership Program (SPP) | |
| 82 FR 58625 - Center for Scientific Review; Notice of Closed Meeting | |
| 82 FR 58624 - National Library of Medicine; Notice of Meeting | |
| 82 FR 58623 - National Library of Medicine; Notice of Meetings | |
| 82 FR 58626 - National Institute of Dental & Craniofacial Research; Notice of Closed Meetings | |
| 82 FR 58673 - 30-Day Notice of Proposed Information Collection: Electronic Medical Examination for Visa Applicant | |
| 82 FR 58594 - Charter Amendment of Department of Defense Federal Advisory Committees | |
| 82 FR 58654 - Importer of Controlled Substances Application: VHG Labs DBA LGC Standard Warehouse | |
| 82 FR 58575 - Schedules of Controlled Substances: Temporary Placement of Seven Fentanyl-Related Substances in Schedule I | |
| 82 FR 58557 - Schedules of Controlled Substances: Placement of MT-45 Into Schedule I | |
| 82 FR 58591 - Foreign-Trade Zone (FTZ) 26-Atlanta, Georgia; Authorization of Production Activity; Nisshinbo Automotive Manufacturing, Inc. (Automotive Brake Linings, Pads, and Disc Pads); Covington, Georgia | |
| 82 FR 58591 - Foreign-Trade Zone (FTZ) 122-Corpus Christi, Texas; Authorization of Production Activity; Voestalpine Texas, LLC; Subzone 122T (Hot Briquetted Iron By-Products); Portland, Texas | |
| 82 FR 58591 - Approval of Expanded Subzone Status; Orgill, Inc., Post Falls and Coeur d'Alene, Idaho | |
| 82 FR 58591 - Foreign-Trade Zone (FTZ) 106-Oklahoma City, Oklahoma; Authorization of Production Activity, Eastman Kodak Company (Printing Flexographic Plates), Weatherford, Oklahoma | |
| 82 FR 58591 - Foreign-Trade Zone (FTZ) 82-Mobile, Alabama; Notification of Proposed Production Activity, Aker Solutions, Inc., (Undersea Umbilicals), Mobile, Alabama | |
| 82 FR 58546 - Extension of the Prohibition Against Certain Flights in the Territory and Airspace of Somalia | |
| 82 FR 58675 - Petition for Exemption; Summary of Petition Received; Mr. James Giancola | |
| 82 FR 58675 - Random Drug and Alcohol Testing Percentage Rates of Covered Aviation Employees for the Period of January 1, 2018, Through December 31, 2018 | |
| 82 FR 58559 - Oklahoma Regulatory Program | |
| 82 FR 58583 - Fisheries of the Northeastern United States; Atlantic Mackerel, Squid, and Butterfish Fisheries; Specifications | |
| 82 FR 58596 - Notice of Availability of Government-Owned Inventions; Available for Licensing | |
| 82 FR 58651 - Endangered and Threatened Wildlife and Plants; Availability of Proposed Low-Effect Habitat Conservation Plan; Orange County Utilities, Malcolm Road Water Supply Facility, Orange County, FL | |
| 82 FR 58533 - Assessment and Apportionment of Administrative Expenses | |
| 82 FR 58612 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
| 82 FR 58578 - Special Local Regulation; Gasparilla Marine Parade; Hillsborough Bay; Tampa, FL | |
| 82 FR 58553 - Advisory Committee; Food Advisory Committee; Termination | |
| 82 FR 58618 - Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry; Availability | |
| 82 FR 58674 - 30-Day Notice of Proposed Information Collection: FLO Professional Development Fellowship (PDF) Application | |
| 82 FR 58652 - Certain Ink Cartridges and Components Thereof; Notice of Commission Determination Not to Review an Initial Determination Granting a Joint Motion To Terminate the Advisory Opinion Proceeding Based on a Settlement Agreement; Termination of the Advisory Opinion Proceeding | |
| 82 FR 58614 - Submission for OMB Review; Comment Request | |
| 82 FR 58694 - Office of the Assistant Secretary for International Affairs; Survey of U.S. Ownership of Foreign Securities as of December 31, 2017 | |
| 82 FR 58671 - Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Related to Transaction Fees for the Exchange's Equity Platform | |
| 82 FR 58662 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule Change Related to a Comprehensive Risk Management Framework | |
| 82 FR 58667 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Extend the Pilot Period for the Exchange's Retail Liquidity Program Until June 30, 2018 | |
| 82 FR 58670 - Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Clarify the Application of the Crossing Fee Cap | |
| 82 FR 58603 - Petition of Great White Fleet Liner Services Ltd. and Great White Fleet Corp.; Notice of Filing and Request for Comments | |
| 82 FR 58668 - Joint Industry Plan; Order Approving the Fourth Amendment to the Plan for the Purpose of Developing and Implementing Procedures Designed To Facilitate the Listing and Trading of Standardized Options | |
| 82 FR 58613 - Proposed Information Collection Activity; Comment Request | |
| 82 FR 58651 - Indian Gaming; Approval of an Amendment to a Tribal-State Class III Gaming Compact in the State of Oregon | |
| 82 FR 58631 - Agency Information Collection Activities: Proposed Collection; Comment Request; Application for Participation in the National Flood Insurance Program (NFIP) | |
| 82 FR 58615 - Proposed Information Collection Activity; Comment Request | |
| 82 FR 58643 - Changes in Flood Hazard Determinations | |
| 82 FR 58632 - Changes in Flood Hazard Determinations | |
| 82 FR 58648 - Final Flood Hazard Determinations | |
| 82 FR 58627 - Final Flood Hazard Determinations | |
| 82 FR 58639 - Changes in Flood Hazard Determinations | |
| 82 FR 58634 - Changes in Flood Hazard Determinations | |
| 82 FR 58657 - Southern Nuclear Operating Company, Inc., Vogtle Electric Generating Plant, Units 3 and 4; Inspections, Tests, Analyses, and Acceptance Criteria Consolidation | |
| 82 FR 58628 - Proposed Flood Hazard Determinations | |
| 82 FR 58637 - Proposed Flood Hazard Determinations | |
| 82 FR 58642 - Proposed Flood Hazard Determinations | |
| 82 FR 58629 - Proposed Flood Hazard Determinations | |
| 82 FR 58623 - National Library of Medicine; Notice of Closed Meetings | |
| 82 FR 58625 - National Library of Medicine; Notice of Meeting | |
| 82 FR 58623 - National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting | |
| 82 FR 58622 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting | |
| 82 FR 58624 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings | |
| 82 FR 58625 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings | |
| 82 FR 58624 - National Heart, Lung, and Blood Institute; Notice of Meeting | |
| 82 FR 58621 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data To Support Drug Product Communications as Used by the Food and Drug Administration | |
| 82 FR 58619 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Consultation Procedures: Foods Derived From New Plant Varieties | |
| 82 FR 58604 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
| 82 FR 58603 - Formations of, Acquisitions by, and Mergers of Savings and Loan Holding Companies | |
| 82 FR 58615 - Refuse To File: New Drug Application and Biologics License Application Submissions to the Center for Drug Evaluation and Research; Draft Guidance for Industry; Availability | |
| 82 FR 58617 - 21st Century Cures Act: Announcing the Establishment of the Susceptibility Test Interpretive Criteria Website | |
| 82 FR 58653 - Hearings of the Judicial Conference Advisory Committees on the Federal Rules of Appellate and Criminal Procedure and Rules of Evidence | |
| 82 FR 58590 - Notice of Request for Revision to and Extension of Approval of an Information Collection; Commercial Transportation of Equines for Slaughter | |
| 82 FR 58589 - General Conference Committee of the National Poultry Improvement Plan; Solicitation for Membership | |
| 82 FR 58588 - Submission for OMB Review; Comment Request | |
| 82 FR 58572 - Opioid Policy Steering Committee: Prescribing Intervention-Exploring a Strategy for Implementation; Public Hearing; Request for Comments | |
| 82 FR 58609 - Proposed Data Collection Submitted for Public Comment and Recommendations | |
| 82 FR 58606 - Proposed Data Collection Submitted for Public Comment and Recommendations | |
| 82 FR 58607 - Proposed Data Collections Submitted for Public Comment and Recommendations | |
| 82 FR 58605 - Agency Forms Undergoing Paperwork Reduction Act Review | |
| 82 FR 58608 - Agency Forms Undergoing Paperwork Reduction Act Review | |
| 82 FR 58611 - Agency Forms Undergoing Paperwork Reduction Act Review | |
| 82 FR 58602 - Agency Information Collection Activities; Safer Choice Product Recognition Program; Submitted to OMB for Review and Approval; Comment Request | |
| 82 FR 58599 - Agency Information Collection Activities; TSCA Section 4 Test Rules, Consent Orders, Enforceable Consent Agreements, Voluntary Testing Agreements, Voluntary Data Submissions, and Exemptions From Testing Requirements; Submitted to OMB for Review and Approval; Comment Request | |
| 82 FR 58599 - Agency Information Collection Activities; Compliance Requirement for Child-Resistant Packaging; Submitted to OMB for Review and Approval; Comment Request | |
| 82 FR 58676 - Noise Exposure Map Notice Louisville International Airport, Louisville, KY | |
| 82 FR 58613 - Agency Information Collection Activities: Submission for OMB Review; Comment Request | |
| 82 FR 58562 - Drawbridge Operation Regulation; Carquinez Strait, at Martinez, CA | |
| 82 FR 58563 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Adoption of Control Techniques Guidelines for Control of Volatile Organic Compound Emissions From Miscellaneous Metal Parts Surface Coating, Miscellaneous Plastic Parts Surface Coating, and Pleasure Craft Surface Coatings; Withdrawal of Direct Final Rule | |
| 82 FR 58563 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Pennsylvania's Adoption of Control Techniques Guidelines for Automobile and Light-Duty Truck Assembly Coatings; Withdrawal of Direct Final Rule | |
| 82 FR 58554 - New Animal Drugs; Approval of New Animal Drug Applications | |
| 82 FR 58580 - Revenue Deficiency | |
| 82 FR 58566 - Airworthiness Directives; Airbus Airplanes | |
| 82 FR 58533 - Airworthiness Directives; ATR-GIE Avions de Transport Régional Airplanes | |
| 82 FR 58582 - Hazardous Materials: Announcement of the Department of Transportation's Decision on Electronically Controlled Pneumatic Braking |
Animal and Plant Health Inspection Service
Economic Analysis Bureau
Foreign-Trade Zones Board
International Trade Administration
National Oceanic and Atmospheric Administration
Navy Department
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Children and Families Administration
Food and Drug Administration
National Institutes of Health
Coast Guard
Federal Emergency Management Agency
Transportation Security Administration
Fish and Wildlife Service
Indian Affairs Bureau
Surface Mining Reclamation and Enforcement Office
Antitrust Division
Drug Enforcement Administration
Federal Aviation Administration
Federal Motor Carrier Safety Administration
Pipeline and Hazardous Materials Safety Administration
Internal Revenue Service
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
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Farm Credit Administration.
Notification of effective date.
The Farm Credit Administration (FCA or we) issued a direct final rule adopting technical amendments to eliminate language that is obsolete, confusing, and unnecessary to determine the annual assessment amount of Farm Credit System institutions. In accordance with the law, the effective date of the rule is no earlier than 30 days from the date of publication in the
Jeremy R. Edelstein, Senior Policy Analyst, Office of Regulatory Policy, (703) 883-4497, TTY (703) 883-4056,
The Farm Credit Administration (FCA or we) issued a direct final rule adopting technical amendments to eliminate language that is obsolete, confusing, and unnecessary to determine the annual assessment amount of Farm Credit System institutions. In accordance with 12 U.S.C. 2252, the effective date of the final rule is no earlier than 30 days from the date of publication in the
Federal Aviation Administration (FAA), DOT.
Final rule; request for comments.
We are adopting a new airworthiness directive (AD) for certain ATR-GIE Avions de Transport Régional Model ATR42-500 and ATR72-212A airplanes. This AD requires revising the airplane flight manual to provide procedures to the flightcrew for operational restrictions affecting in-flight use of the autopilot (AP) or yaw damper (YD) during single source operation. This AD was prompted by flight test evaluations that revealed discrepancies with the YD and AP when in single source operation on certain airplanes. We are issuing this AD to address the unsafe condition on these products.
This AD becomes effective December 28, 2017.
We must receive comments on this AD by January 29, 2018.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
You may examine the AD docket on the internet at
Shahram Daneshmandi, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 1601 Lind Avenue SW, Renton, WA 98057-3356; telephone 425-227-1112; fax 425-227-1149.
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2016-0046, dated March 9, 2016 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition on certain ATR-GIE Avions de Transport Régional Model ATR42-500 and Model ATR72-212A airplanes. The MCAI states:
Following investigations after EASA AD 2015-0237R1 was issued, additional flight tests evaluations performed on ATR aeroplanes equipped with New Avionics Suite Standard 2 have revealed an unsatisfactory behaviour of the Yaw Damper/Autopilot (YD/AP), when in `single source operation' (
This unsatisfactory behavior is due to the YD limited authority in single source and is
This condition, if not corrected, could result in loss of control of the aeroplane.
For the reasons described above, this [EASA] AD requires amendment of the applicable Airplane Flight Manual (AFM) to introduce AP and YD operational restrictions, when in single source and operating at an IAS below 160kt.
This [EASA] AD is considered an interim action and further [EASA] AD action may follow.
You may examine the MCAI on the internet at
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI referenced above. We are issuing this AD because we evaluated all pertinent information and determined the unsafe condition exists and is likely to exist or develop on other products of these same type designs.
There are currently no domestic operators of this product. Therefore, we find good cause that notice and opportunity for prior public comment are unnecessary. In addition, for the reason(s) stated above, we find that good cause exists for making this amendment effective in less than 30 days.
This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
Currently, there are no affected U.S.-registered airplanes. If an affected airplane is imported and placed on the U.S. Register in the future, we provide the following cost estimates to comply with this AD:
We estimate that it will take about 1 work-hour per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $85 per product.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial 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.
For the reasons discussed above, I certify that this AD:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD becomes effective December 28, 2017.
None.
This AD applies to ATR-GIE Avions de Transport Régional Model ATR42-500 and ATR72-212A airplanes, certificated in any category, all manufacturer serial numbers, as specified in paragraphs (c)(1) and (c)(2) of this AD.
(1) Airplanes modified in production by incorporation of Avions de Transport Régional modification 6977 (New Avionics Suite Standard 2).
(2) Airplanes modified in service by incorporation of Avions de Transport Régional Service Bulletin ATR42-31-0091, Revision 02, January 18, 2016, or Avions de Transport Régional Service Bulletin ATR72-31-1092, Revision 03, dated January 18, 2016, as applicable.
Air Transport Association (ATA) of America Code 22, Auto Flight.
This AD was prompted by flight test evaluations that revealed discrepancies with
Comply with this AD within the compliance times specified, unless already done.
(1) Within 15 days after the effective date of this AD, revise the Limitations Section, Emergency Procedures section, and Procedures Following Failures section of the ATR-42 and ATR-72 airplane flight manuals (AFMs), as applicable, to include the information in figure 1 to paragraph (g) of this AD or figure 2 to paragraph (g) of this AD, as applicable; inform all flight crews; and thereafter operate the airplane accordingly.
(2) Revising the AFM as specified in paragraph (g)(1) of this AD can be done by inserting a copy of figure 1 to paragraph (g) of this AD or figure 2 to paragraph (g) of this AD, as applicable, into the applicable AFM.
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2016-0046, dated March 9, 2016, for related information. You may examine the MCAI on the internet at
(2) For more information about this AD, contact Shahram Daneshmandi, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 1601 Lind Avenue SW, Renton, WA 98057-3356; telephone 425-227-1112; fax 425-227-1149.
None.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
This action extends the expiration date for the Special Federal Aviation Regulation (SFAR) that prohibits certain flights in the territory and airspace of Somalia at altitudes below flight level (FL) 260 by all: United States (U.S.) air carriers; U.S. commercial operators; persons exercising the privileges of an airman certificate issued by the FAA, except when such persons are operating U.S.-registered aircraft for a foreign air carrier; and operators of U.S.-registered civil aircraft, except where the operator of such aircraft is a foreign air carrier. The FAA is taking this action because it has determined that there continues to be an unacceptable risk to U.S. civil aviation operating in the territory and airspace of Somalia at altitudes below FL260 resulting from terrorist and militant activity. The FAA also republishes, with minor revisions, the approval process and exemption information for this SFAR.
This final rule is effective on December 13, 2017.
Michael Filippell, Air Transportation Division, Flight Standards Service, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone (202) 267-8166; email
This action extends the prohibition of flight operations in the territory and airspace of Somalia at altitudes below FL260 by all: U.S. air carriers; U.S. commercial operators; persons exercising the privileges of an airman certificate issued by the FAA, except when such persons are operating U.S.-registered aircraft for a foreign air carrier; and operators of U.S.-registered civil aircraft, except where the operator of such aircraft is a foreign air carrier. The FAA finds this action necessary due to continued hazards to persons and aircraft engaged in such flight operations resulting from terrorist and militant activity, as described in the Background section of this rule.
The FAA is responsible for the safety of flight in the U.S. and for the safety of U.S. civil operators, U.S.-registered civil aircraft, and U.S.-certificated civil airmen throughout the world. The FAA's authority to issue rules on aviation safety is found in title 49, U.S. Code. Subtitle I, sections 106(f) and (g), describe the authority of the FAA Administrator. Subtitle VII of title 49, Aviation Programs, describes in more detail the scope of the agency's authority. Section 40101(d)(1) provides that the Administrator shall consider in the public interest, among other matters, assigning, maintaining, and enhancing safety and security as the highest priorities in air commerce. Section 40105(b)(1)(A) requires the Administrator to exercise his authority consistently with the obligations of the U.S. Government under international agreements.
This rulemaking is promulgated under the authority described in Subtitle VII, Part A, subpart III, section 44701, General requirements. Under that section, the FAA is charged broadly with promoting safe flight of civil aircraft in air commerce by prescribing, among other things, regulations and minimum standards for practices, methods, and procedures that the Administrator finds necessary for safety in air commerce and national security.
This regulation is within the scope of the FAA's authority under the statutes cited previously, because it continues to prohibit the persons described in paragraph (a) of SFAR No. 107, title 14 Code of Federal Regulations (CFR) 91.1613, from conducting flight operations in the territory and airspace of Somalia at altitudes below FL260 due to the continued hazards to the safety of such persons' flight operations, as described in the Background section of this final rule.
Title 5 U.S.C. 553(b)(3)(B) authorizes agencies to dispense with notice and comment procedures for rules when the agency for “good cause” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Section 553(d) also authorizes agencies to forgo the delay in the effective date of the final rule for good cause found and published with the rule. In this instance, the FAA finds good cause to forgo notice and comment, because notice and comment would be impracticable and contrary to the public interest. To the extent that the rule is based upon classified information, such information is not permitted to be shared with the general public. Also, threats to U.S. civil aviation and intelligence regarding these threats are fluid. As a result, the agency's original proposal could become unsuitable for minimizing the hazards to U.S. civil aviation in the affected airspace during or after the notice and comment process. The FAA further finds an immediate need to address the continued hazard to U.S. civil aviation that exists in the territory and airspace of Somalia at altitudes below FL260 from terrorist and militant activity. This hazard is further described in the Background section of this rule.
For the reasons described previously, the FAA finds good cause to forgo notice and comment and any delay in the effective date for this rule. The FAA also finds that this action is fully consistent with the obligations under 49 U.S.C. 40105(b)(1)(A) to ensure that the FAA exercises its duties consistently
On January 7, 2016, the FAA expanded its existing prohibition of U.S. civil aviation operations in the territory and airspace of Somalia, after determining that the risk from terrorist and militant activity made it unsafe for U.S. civil flights to operate in the territory and airspace of Somalia at altitudes below FL260. 81 FR 721. In taking that action, the FAA determined that international civil air routes that transit Somali airspace and aircraft operating to and from Somali airports remained at risk from terrorist and militant groups potentially employing anti-aircraft weapons, including man-portable air defense systems (MANPADS), small-arms fire and indirect fire from mortars and rockets targeting airports. Some of the weapons that the FAA was concerned about have the capability to target aircraft upon approach and departure and aircraft at higher altitudes. The terrorist group al-Shabaab remained active in Somalia and had demonstrated the capability and intent to target U.S. and Western interests, including aviation. Al-Shabaab had conducted multiple attacks against civil aviation, including attacks on two IL-76 aircraft near Aden Adde International Airport (then known as Mogadishu International Airport) (HCMM) in March 2007, likely using MANPADS. These attacks had formed part of the basis for the original SFAR. Al-Shabaab had also conducted ground assaults against Aden Adde International Airport (then known as Mogadishu International Airport) (HCMM), the most recent of which had occurred in December 2014. As stated in the January 2016 final rule, in the FAA's view, attacks against aircraft in-flight or Somali airports could occur with little or no warning.
Since January 2016, al-Shabaab has continued to directly target civil aviation using concealed improvised explosive devices (IEDs) in an effort to bypass security screening at Aden Adde International Airport (HCMM) to detonate the device onboard an aircraft. This was demonstrated when al-Shabaab claimed responsibility for the onboard detonation of a concealed IED on a Daallo Airlines Flight 159, which originated from Aden Adde International Airport (HCMM) in February 2016. Al-Shabaab has also conducted frequent terror attacks in close proximity to the airport and has conducted indirect fire attacks targeting facilities within the perimeter of the airport. Al-Shabaab has also conducted ground assaults against Aden Adde International Airport (formerly known as Mogadishu International Airport) (HCMM), the most recent of which included a vehicle-borne improvised explosive device in January 2017. Other extremists, to include elements of the Islamic State of Iraq and ash Sham (ISIS), also operate in Somalia and are capable of threatening civil aviation. With the unsettled security environment in Somalia, along with the continuing threat to civil aviation from al-Shabaab and/or ISIS-associated activity, the FAA continues to believe that attacks against aircraft in-flight or Somali airports can occur with little or no warning.
Therefore, as a result of the significant continuing risk to the safety of U.S. civil aviation in the territory and airspace of Somalia at altitudes below FL260, the FAA extends the expiration date of SFAR No. 107, § 91.1613, from January 7, 2018, to January 7, 2020, and maintains the prohibition on flight operations in the territory and airspace of Somalia at altitudes below FL260 by all: U.S. air carriers; U.S. commercial operators; persons exercising the privileges of an airman certificate issued by the FAA, except when such persons are operating U.S.-registered aircraft for a foreign air carrier; and operators of U.S.-registered civil aircraft, except where the operator of such aircraft is a foreign air carrier.
The FAA will continue to actively monitor the situation and evaluate the extent to which U.S. civil operators may be able to safely operate in the territory and airspace of Somalia at altitudes below FL260 in the future. Amendments to SFAR No. 107, § 91.1613, may be appropriate if the risk to aviation safety and security changes. The FAA may amend or rescind SFAR No. 107, § 91.1613, as necessary, prior to its expiration date.
The FAA also republishes, with minor revisions, the approval process and exemption information for this SFAR, so that persons described in paragraph (a) of the rule will be able to refer to this final rule, rather than having to search through previous final rules to find the relevant approval process and exemption information. This approval process and exemption information is consistent with other similar SFARs and recent agency practice.
If a department, agency, or instrumentality of the U.S. Government determines that it has a critical need to engage any person covered under SFAR No. 107, § 91.1613, including a U.S. air carrier or a U.S. commercial operator, to conduct a charter to transport civilian or military passengers or cargo, or other operations, in the territory and airspace of Somalia at altitudes below FL260, that department, agency, or instrumentality may request that the FAA approve persons covered under SFAR No. 107, § 91.1613, to conduct such operations. An approval request must be made directly by the requesting department, agency or instrumentality of the U.S. Government to the FAA's Associate Administrator for Aviation Safety in a letter signed by an appropriate senior official of the requesting department, agency, or instrumentality. Requests for approval submitted to the FAA by anyone other than the requesting department, agency, or instrumentality will not be accepted and will not be processed. In addition, the senior official signing the letter requesting FAA approval on behalf of the requesting department, agency, or instrumentality must be sufficiently highly placed within the organization to demonstrate that the senior leadership of the requesting department, agency, or instrumentality supports the request for approval and is committed to taking all necessary steps to minimize operational risks to the proposed flights. The senior official must also be in a position to: (1) Attest to the accuracy of all representations made to the FAA in the request for approval, and (2) ensure that any support from the requesting U.S. government department, agency, or instrumentality described in the request for approval is in fact brought to bear and is maintained over time. Unless justified by exigent circumstances, requests for approval must be submitted to the FAA no less than 30 calendar days before the date on which the requesting department, agency, or instrumentality wishes the proposed operations, if approved by the FAA, to commence.
The letter must be sent by the requesting department, agency, or instrumentality to the Associate Administrator for Aviation Safety, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591. Electronic submissions are acceptable, and the requesting entity may request that the FAA notify it electronically as to whether the approval request is granted. If a requestor wishes to make an electronic submission to the FAA, the requestor should contact the Air Transportation Division, Flight Standards Service, at (202) 267-8166 to obtain the appropriate email address. A single
• The proposed operation(s), including the nature of the mission being supported;
• The service to be provided by the person(s) covered by the SFAR;
• To the extent known, the specific locations in the territory and airspace of Somalia at altitudes below FL260 where the proposed operation(s) will be conducted, including, but not limited to, the flight path and altitude of the aircraft while it is operating in the territory and airspace of Somalia at altitudes below FL260 and the airports, airfields and/or landing zones at which the aircraft will take-off and land; and
• The method by which the department, agency, or instrumentality will provide, or how the operator will otherwise obtain, current threat information and an explanation of how the operator will integrate this information into all phases of the proposed operations (
The request for approval must also include a list of operators with whom the U.S. Government department, agency, or instrumentality requesting FAA approval has a current contract(s), grant(s), or cooperative agreement(s) (or with whom its prime contractor has a subcontract(s)) for specific flight operations in the territory and airspace of Somalia at altitudes below FL260. Additional operators may be identified to the FAA at any time after the FAA approval is issued. However, all additional operators must be identified to, and obtain an Operations Specification (OpSpec) or Letter of Authorization (LOA), as appropriate, from the FAA for operations in the territory and airspace of Somalia at altitudes below FL260, before such operators commence such operations. The approval conditions discussed below will apply to any such additional operators. Updated lists should be sent to the email address to be obtained from the Air Transportation Division by calling (202) 267-8166.
If an approval request includes classified information, requestors may contact Aviation Safety Inspector Michael Filippell for instructions on submitting it to the FAA. His contact information is listed in the
FAA approval of an operation under SFAR No. 107, § 91.1613, does not relieve persons subject to this SFAR of their responsibility to comply with all other applicable FAA rules and regulations. Operators of civil aircraft must also comply with the conditions of their certificate, OpSpecs, and LOAs, as applicable. Operators must further comply with all rules and regulations of other U.S. Government departments and agencies that may apply to the proposed operations, including, but not limited to, the Transportation Security Regulations issued by the Transportation Security Administration, Department of Homeland Security.
If the FAA approves the request, the FAA's Aviation Safety Organization (AVS) will send an approval letter to the requesting department, agency, or instrumentality informing it that the FAA's approval is subject to all of the following conditions:
(1) The approval will stipulate those procedures and conditions that limit, to the greatest degree possible, the risk to the operator, while still allowing the operator to achieve its operational objectives.
(2) Before any approval takes effect, the operator must submit to the FAA:
(a) A written release of the U.S. Government from all damages, claims, and liabilities, including without limitation legal fees and expenses, relating to any event arising out of or related to the approved operations in the territory and airspace of Somalia at altitudes below FL260; and
(b) the operator's agreement to indemnify the U.S. Government with respect to any and all third-party damages, claims, and liabilities, including without limitation legal fees and expenses, relating to any event arising out of or related to the approved operations in the territory and airspace of Somalia at altitudes below FL260.
(3) Other conditions that the FAA may specify, including those that may be imposed in OpSpecs or LOAs, as applicable.
The release and agreement to indemnify do not preclude an operator from raising a claim under an applicable non-premium war risk insurance policy issued by the FAA under chapter 443 of title 49, United States Code.
If the proposed operation(s) is approved, the FAA will issue an OpSpec or an LOA, as applicable, to the operator(s) identified in the original request authorizing them to conduct the approved operation(s), and will notify the department, agency, or instrumentality that requested the FAA's approval of any additional conditions beyond those contained in the approval letter. The requesting department, agency, or instrumentality must have a contract, grant, or cooperative agreement (or its prime contractor must have a subcontract) with the person(s) described in paragraph (a) of this SFAR No. 107, § 91.1613, on whose behalf the department, agency, or instrumentality requests FAA approval.
Any operations not conducted under an approval issued by the FAA through the approval process set forth previously must be conducted under an exemption from SFAR No. 107, § 91.1613. A request by any person covered under SFAR No. 107, § 91.1613, for an exemption must comply with 14 CFR part 11, and will require exceptional circumstances beyond those contemplated by the approval process set forth above. In addition to the information required by 14 CFR 11.81, at a minimum, the requestor must describe in its submission to the FAA—
• The proposed operation(s), including the nature of the operation;
• The service to be provided by the person(s) covered by the SFAR;
• The specific locations in the territory and airspace of Somalia at altitudes below FL260 where the proposed operation(s) will be conducted, including, but not limited to, the flight path and altitude of the aircraft while it is operating in the territory and airspace of Somalia at altitudes below FL260 and the airports, airfields and/or landing zones at which the aircraft will take-off and land;
• The method by which the operator will obtain current threat information, and an explanation of how the operator will integrate this information into all phases of its proposed operations (
• The plans and procedures that the operator will use to minimize the risks, identified in the Background section of this rule, to the proposed operations, so that granting the exemption would not adversely affect safety or would provide a level of safety at least equal to that provided by this SFAR. The FAA has found comprehensive, organized plans and procedures of this nature to be helpful in facilitating the agency's safety evaluation of petitions for exemption from other flight prohibition SFARs.
Additionally, the release and agreement to indemnify, as referred to above, will be required as a condition of
The FAA recognizes that operations that may be affected by SFAR No. 107, § 91.1613, including this amendment, may be planned for the governments of other countries with the support of the U.S. Government. While these operations will not be permitted through the approval process, the FAA will process exemption requests for such operations on an expedited basis and prior to any private exemption requests.
Changes to Federal regulations must undergo several economic analyses. First, Executive Orders 12866 and 13563 direct that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354), as codified in 5 U.S.C. 603
In conducting these analyses, the FAA has determined that this final rule has benefits that justify its costs and is a “significant regulatory action” as defined in section 3(f) of Executive Order 12866, because it raises novel policy issues contemplated under that Executive Order. The rule is also “significant” as defined in DOT's Regulatory Policies and Procedures. The final rule will not have a significant economic impact on a substantial number of small entities, will not create unnecessary obstacles to the foreign commerce of the United States, and will not impose an unfunded mandate on State, local, or tribal governments, or on the private sector, by exceeding the threshold identified previously.
Department of Transportation Order 2100.5 prescribes policies and procedures for simplification, analysis, and review of regulations. If the expected cost impact is so minimal that a proposed or final rule does not warrant a full evaluation, this order permits a statement to that effect and the basis for it to be included in the preamble if a full regulatory evaluation of the costs and benefits is not prepared. Such a determination has been made for this final rule. The reasoning for this determination follows.
Due to the significant hazards to U.S. civil aviation described in the Background section of this rule, this rule extends the prohibition against U.S. civil flights in the territory and airspace of Somalia at altitudes below FL260. The FAA believes there are very few, if any, U.S. operators who wish to overfly Somalia at altitudes below FL260 or operate to, from, or within Somalia. Since January 7, 2016, the FAA has received very few requests for approval or exemption to conduct flight operations in the territory and airspace of Somalia at altitudes below FL260, and at least one was abandoned by the requestor before FAA processing was completed.
Consequently, the FAA estimates the costs of this rule to be minimal. These minimal costs are exceeded by the benefits of avoided deaths, injuries, and property damage that could result from a U.S. operator's aircraft being shot down (or otherwise damaged) due to the hazards described in the Background section of this final rule.
The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA) establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objectives of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the businesses, organizations, and governmental jurisdictions subject to regulation. To achieve this principle, agencies are required to solicit and consider flexible regulatory proposals and to explain the rationale for their actions to assure that such proposals are given serious consideration.” The RFA covers a wide range of small entities, including small businesses, not-for-profit organizations, and small governmental jurisdictions.
Agencies must perform a review to determine whether a rule will have a significant economic impact on a substantial number of small entities. If the agency determines that it will, the agency must prepare a regulatory flexibility analysis as described in the RFA. However, if an agency determines that a rule is not expected to have a significant economic impact on a substantial number of small entities, section 605(b) of the RFA provides that the head of the agency may so certify and a regulatory flexibility analysis is not required. The certification must include a statement providing the factual basis for this determination, and the reasoning should be clear.
As noted previously, the FAA estimates that the costs of this rule will be minimal and that very few small entities will be adversely affected. Therefore, as provided in section 605(b), the head of the FAA certifies that this rulemaking will not have a significant economic impact on a substantial number of small entities.
The Trade Agreements Act of 1979 (Pub. L. 96-39) prohibits Federal agencies from establishing standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Pursuant to this Act, the establishment of standards is not considered an unnecessary obstacle to the foreign commerce of the United States, so long as the standard has a legitimate domestic objective, such as the protection of safety, and does not operate in a manner that excludes imports that meet this objective. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards.
The FAA has assessed the effect of this final rule and determined that its purpose is to protect the safety of U.S. civil aviation from a hazard to their operations in the territory and airspace of Somalia at altitudes below FL 260, a location outside the U.S. Therefore, the rule is in compliance with the Trade Agreements Act.
Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in an expenditure of $100 million or more (in 1995 dollars) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant
This final rule does not contain such a mandate. Therefore, the requirements of Title II of the Act do not apply.
The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that the FAA consider the impact of paperwork and other information collection burdens imposed on the public. The FAA has determined that there is no new requirement for information collection associated with this final rule.
In keeping with U.S. obligations under the Convention on International Civil Aviation, it is FAA's policy to conform to International Civil Aviation Organization (ICAO) Standards and Recommended Practices to the maximum extent practicable. The FAA has determined that there are no ICAO Standards and Recommended Practices that correspond to this regulation.
The FAA has analyzed this action under Executive Order 12114, Environmental Effects Abroad of Major Federal Actions (44 FR 1957, January 4, 1979), and DOT Order 5610.1C, Paragraph 16. Executive Order 12114 requires the FAA to be informed of environmental considerations and take those considerations into account when making decisions on major Federal actions that could have environmental impacts anywhere beyond the borders of the United States. The FAA has determined that this action is exempt pursuant to Section 2-5(a)(i) of Executive Order 12114, because it does not have the potential for a significant effect on the environment outside the United States.
In accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 8-6(c), FAA has prepared a memorandum for the record stating the reasons for this determination, which has been placed in the docket for this rulemaking.
The FAA has analyzed this final rule under the principles and criteria of Executive Order 13132, Federalism. The agency has determined that this action would not have a substantial direct effect on the States, or the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government, and, therefore, would not have Federalism implications.
The FAA analyzed this final rule under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (May 18, 2001). The agency has determined that it would not be a “significant energy action” under the executive order and would not be likely to have a significant adverse effect on the supply, distribution, or use of energy.
Executive Order 13609, Promoting International Regulatory Cooperation, (77 FR 26413, May 4, 2012) promotes international regulatory cooperation to meet shared challenges involving health, safety, labor, security, environmental, and other issues and to reduce, eliminate, or prevent unnecessary differences in regulatory requirements. The FAA has analyzed this action under the policies and agency responsibilities of Executive Order 13609, and has determined that this action would have no effect on international regulatory cooperation.
This rule is not subject to the requirements of EO 13771 (82 FR 9339, February 3, 2017) because it is issued with respect to a national security function of the United States.
An electronic copy of rulemaking documents may be obtained from the internet by—
• Searching the Federal eRulemaking Portal (
• Visiting the FAA's Regulations and Policies web page at
• Accessing the Government Publishing Office's web page at
Copies may also be obtained by sending a request (identified by amendment or docket number of this rulemaking) to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW, Washington, DC 20591, or by calling (202) 267-9677. Please identify the docket or amendment number of this rulemaking in your request.
Except for classified material, all documents the FAA considered in developing this rule, including economic analyses and technical reports, may be accessed from the internet through the Federal eRulemaking Portal referenced above.
The Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) requires FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. A small entity with questions regarding this document may contact its local FAA official, or the person listed under the
Air traffic control, Aircraft, Airmen, Airports, Aviation safety, Freight, Somalia.
In consideration of the foregoing, the Federal Aviation Administration amends chapter I of title 14, Code of Federal Regulations as follows:
49 U.S.C. 106(f), 106(g), 1155, 40101, 40103, 40105, 40113, 40120, 44101, 44111, 44701, 44704, 44709, 44711, 44712, 44715, 44716, 44717, 44722, 46306, 46315, 46316, 46504, 46506-46507, 47122, 47508, 47528-47531, 47534, Pub. L. 114-190, 130 Stat. 615 (49 U.S.C. 44703 note); articles 12 and 29 of the Convention on International Civil Aviation (61 Stat. 1180), (126 Stat. 11).
(e)
Bureau of Economic Analysis, Commerce.
Final rule.
This final rule amends regulations of the Department of Commerce's Bureau of Economic Analysis (BEA) to set forth the reporting requirements for the 2017 BE-12, Benchmark Survey of Foreign Direct Investment in the United States. The BE-12 survey is conducted every five years; the prior survey covered 2012. The benchmark survey covers the universe of foreign direct investment in the United States and is BEA's most detailed survey of such investment. For the 2017 benchmark survey, BEA will make changes in data items collected, the design of the survey forms, and the reporting requirements for the survey to satisfy changing data needs and to improve data quality and the effectiveness and efficiency of data collection.
This final rule is effective January 12, 2018.
Patricia Abaroa, Chief, Direct Investment Division (BE-49), Bureau of Economic Analysis, U.S. Department of Commerce, 4600 Silver Hill Road, Washington, DC 20233; phone (301) 278-9591; or via email at
On July 27, 2017, BEA published a notice of proposed rulemaking that set forth revised reporting criteria for the BE-12, Benchmark Survey of Foreign Direct Investment in the United States (82 FR 34894). No comments on the proposed rule were received.
This final rule amends 15 CFR part 801 to set forth the reporting requirements for the BE-12, Benchmark Survey of Foreign Direct Investment in the United States.
BEA conducts the BE-12 survey once every five years under the authority of the International Investment and Trade in Services Survey Act (22 U.S.C. 3101-3108).
In 2012, BEA issued a rule (77 FR 24373) that established guidelines for collecting data on international trade in services and direct investment through notices, rather than through rulemaking. Persons are required to respond to other BEA surveys conducted under these guidelines only when they are contacted by BEA. Under this final rule, however, persons subject to the reporting requirements of the BE-12, Benchmark Survey of Foreign Direct Investment in the United States, will be required to respond whether or not they are contacted by BEA.
The benchmark survey covers the universe of foreign direct investment in the United States in terms of value and is BEA's most detailed survey of such investment. Foreign direct investment in the United States is defined as the ownership or control, directly or indirectly, by one foreign person (foreign parent) of 10 percent or more of the voting securities of an incorporated U.S. business enterprise or an equivalent interest in an unincorporated U.S. business enterprise, including a branch.
The purpose of the benchmark survey is to obtain universe data on the financial and operating characteristics of U.S. affiliates and on positions and transactions between U.S. affiliates and their foreign parent groups (which are defined to include all foreign parents and foreign affiliates of foreign parents). These data are needed to measure the size and economic significance of foreign direct investment in the United States, measure changes in such investment, and assess its impact on the U.S. economy. Such data are generally found in enterprise-level accounting records of respondent companies. These data are used to derive current universe estimates of direct investment from sample data collected in other BEA surveys in non-benchmark years. In particular, they serve as benchmarks for the quarterly direct investment estimates included in the U.S. international transactions, international investment position, and national income and product accounts, and for annual estimates of the foreign direct investment position in the United States and of the activities of the U.S. affiliates of foreign companies.
This final rule amends the regulations (15 CFR part 801) and the survey forms for the BE-12 benchmark survey. These amendments include changes in data items collected, the design of the survey forms, and the reporting requirements for the survey.
BEA changes the reporting requirements for certain private funds that file the BE-12 survey. BEA, in cooperation with the U.S. Department of the Treasury, instructs reporters of investments in private funds that meet the definition of direct investment (that is, ownership by one person of 10 percent or more of the voting interest of a business enterprise) but display characteristics of portfolio investment (specifically, investors who do not intend to control or influence the management of an operating company) to report through the Treasury International Capital (TIC) reporting system, where other related portfolio investments are already being reported, and not to report on BEA's direct investment surveys. Direct investment in operating companies, including investment by and through private funds, will continue to be reported to BEA.
BEA adds, deletes, and modifies some items on the benchmark survey forms. The following items are added to the benchmark survey:
(1) Expand sales of services breakdown on the BE-12A form to include sales of services to other U.S. affiliates of the same affiliated foreign group, sales to unaffiliated U.S. persons or entities, sales to the affiliated foreign group, sales to foreign affiliates owned by the U.S. affiliate responding to the survey, and sales to all other foreign persons or entities.
(2) Expand state-level data items on the BE-12A and BE-12B forms to include manufacturing employment; gross book value of property, plant, and equipment; and the portion of the gross book value that is commercial property.
(3) Add state of location to the BE-12C form, Part I.
(4) Add a question to collect the 20-digit Legal Entity Identifier of the U.S. affiliate on the BE-12A and BE-12B forms.
(5) Add a question asking whether the U.S. affiliate is a publicly traded company, and if it is, collect the stock exchange on which it is listed and the ticker symbol on the BE-12A and BE-12B forms.
(6) Add questions separating payables, receivables, interest payments, and interest receipts by foreign parents and foreign affiliates of foreign parents (FAFPs) on the BE-12B form.
(7) Add a Part III to the BE-12C form to expand information collected on foreign ownership to better align the data collected on the BE-12 benchmark
(8) Add a private funds exemption option to the BE-12 Claim for Not Filing.
(9) Add U.S. tax withheld on dividends to the BE-12B Part III to better align the data collected on the BE-12 benchmark survey with the BE-605 quarterly survey and assist in updating the statistics on foreign direct investment to include the benchmark survey results.
(10) Add intercompany debt payables and receivables to the BE-12C Part I to provide information on debt transactions of smaller affiliates.
(11) Add questions to the BE-12C form to determine if the U.S. affiliate has consolidated and unconsolidated affiliates. Add Supplement A (list of the U.S. business enterprises consolidated) and Supplement B (list of U.S. business enterprises not consolidated) to the BE-12C form.
This final rule eliminates the following items from the benchmark survey:
(1) Questions on contract manufacturing services (BE-12A, items 24, 25, 26, and 27);
(2) Questions on wholesale and retail trade industry activities (BE-12A, items 63a, 63b, and 63c); and
(3) A question on prior year closing balance for voting interest (BE-12C).
In addition, this final rule makes the following modifications to the survey forms:
(1) Modify instructions on the BE-12B form for employment by location to explain the expanded state-level data items (see Item 2. in Additions).
(2) Modify question 87 on the BE-12A form to separate amounts reported for “change in entity” and “change in accounting methods or principles.”
(3) Add a checkbox asking if the change in accounting methods or principles is due in whole or in part to early implementation of FASB ASU No. 2016-02, Leases (Topic 842).
This final rule has been determined to be not significant for purposes of E.O. 12866.
This final rule does not contain policies with Federalism implications sufficient to warrant preparation of a Federalism assessment under Executive Order 13132.
The collection-of-information in this final rule was submitted to the Office of Management and Budget (OMB) pursuant to the requirements of the Paperwork Reduction Act (PRA). OMB approved the information collection under OMB control number 0608-0042.
Notwithstanding any other provisions of the law, no person is required to respond to, nor shall any 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 displays a currently valid OMB control number.
The BE-12 survey is expected to result in the filing of reports from approximately 22,700 U.S. affiliates. The respondent burden for this collection of information will vary from one company to another. The estimated average time per respondent is 11.0 hours, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Thus, the total respondent burden for this survey is estimated at 249,625 hours, compared to 194,150 hours for the previous (2012) benchmark survey. An increase in the number of foreign-owned companies accounts for over 80 percent of the increase in the estimated respondent burden, and the new survey questions account for the rest of the increase.
Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in the final rule should be sent to both BEA via email at
The Chief Counsel for Regulation, Department of Commerce, certified to the Chief Counsel for Advocacy, Small Business Administration, under the provisions of the Regulatory Flexibility Act (RFA), 5 U.S.C. 605(b), that this action will not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. No final regulatory flexibility analysis was prepared, as no comments were received regarding the determination that this action will not have a significant economic impact on a substantial number of small entities.
Economic statistics, Foreign investment in the United States, International transactions, Multinational enterprises, Penalties, Reporting and recordkeeping requirements.
For reasons set forth in the preamble, BEA amends 15 CFR part 801 as follows:
5 U.S.C. 301; 15 U.S.C. 4908; 22 U.S.C. 3101-3108; E.O. 11961 (3 CFR, 1977 Comp., p. 86), as amended by E.O. 12318 (3 CFR, 1981 Comp. p. 173); and E.O. 12518 (3 CFR, 1985 Comp. p. 348).
Except for surveys subject to rulemaking in §§ 801.7, 801.8, 801.9, and 801.10, reporting requirements for all other surveys conducted by the Bureau of Economic Analysis shall be as follows:
(a) Notice of specific reporting requirements, including who is required to report, the information to be reported, the manner of reporting, and the time and place of filing reports, will be published by the Director of the Bureau of Economic Analysis in the
(b) In accordance with section 3104(b)(2) of title 22 of the United States Code, persons notified of these surveys and subject to the jurisdiction of the United States shall furnish, under oath,
(c) Persons not notified in writing of their filing obligation by the Bureau of Economic Analysis are not required to complete the survey.
A BE-12, Benchmark Survey of Foreign Direct Investment in the United States, will be conducted covering 2017. All legal authorities, provisions, definitions, and requirements contained in §§ 801.1 through 801.2 and §§ 801.4 through 801.6 are applicable to this survey. Specific additional rules and regulations for the BE-12 survey are given in paragraphs (a) through (e) of this section. More detailed instructions are given on the report forms and instructions.
(a)
(b)
(c)
(i) Total assets (do not net out liabilities);
(ii) Sales or gross operating revenues, excluding sales taxes; or
(iii) Net income after provision for U.S. income taxes.
(2) Form BE-12B must be completed by:
(i) A majority-owned U.S. affiliate if, on a fully consolidated basis, or, in the case of real estate investment, on an aggregated basis, any one of the three items listed in paragraph (c)(1) of this section (not just the foreign parent's share), was greater than $60 million (positive or negative) but none of these items was greater than $300 million (positive or negative) at the end of, or for, its fiscal year that ended in calendar year 2017.
(ii) A minority-owned U.S. affiliate (for purposes of this survey, a “minority-owned” U.S. affiliate is one in which the combined direct and indirect ownership interest of all foreign parents of the U.S. affiliate is 50 percent or less) if, on a fully consolidated basis, or, in the case of real estate investment, on an aggregated basis, any one of the three items listed in paragraph (c)(1) of this section (not just the foreign parent's share), was greater than $60 million (positive or negative) at the end of, or for, its fiscal year that ended in calendar year 2017.
(3) Form BE-12C must be completed by a U.S. affiliate if, on a fully consolidated basis, or, in the case of real estate investment, on an aggregated basis, none of the three items listed in paragraph (c)(1) of this section for a U.S. affiliate (not just the foreign parent's share), was greater than $60 million (positive or negative) at the end of, or for, its fiscal year that ended in calendar year 2017.
(4) BE-12 Claim for Not Filing will be provided for response by persons that are not subject to the reporting requirements of the BE-12 survey but have been contacted by BEA concerning their reporting status.
(d)
(e)
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA) is announcing the termination of the Food Advisory Committee. This document removes the Food Advisory Committee from the Agency's list of standing advisory committees.
This rule is effective December 13, 2017.
Karen Strambler, Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration, 5001 Campus Dr., Rm. 1C-008, College Park, MD 20740, 240-402-2589, Fax: 301-436-2637,
The Food Advisory Committee (the Committee) was established on March 6, 1992 (57 FR 8064). The Committee provides advice to the Commissioner of Food and
The Committee is no longer needed and will be terminated on December 12, 2017. Over the past several years, the Committee has met very infrequently, and the effort and expense of maintaining the Committee are no longer justified. Any relevant food issues in the future could be addressed by FDA's Science Board and/or FDA's Risk Communication Advisory Committee, with additional augmentation of expertise by appropriate subject matter experts serving as temporary members on either of those committees. In addition, CFSAN will continue to hold workshops, meetings, conferences, and webinars to engage with its stakeholders.
Under 5 U.S.C. 553(b)(3)(B) and (d) and 21 CFR 10.40(d) and (e), the Agency finds good cause to dispense with notice and public comment procedures and to proceed to an immediate effective date on this rule. Notice and public comment and a delayed effective date are unnecessary because the Committee is not being adequately used, and the final rule merely removes the name of the Food Advisory Committee from the list of standing advisory committees in § 14.100 (21 CFR 14.100).
Therefore, the Agency is amending § 14.100(f) as set forth in the regulatory text of the document.
Administrative practice and procedure, Advisory committee, Color additives, Drugs, Radiation protection.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 14 is amended as follows:
5 U.S.C. App. 2; 15 U.S.C 1451-1461, 21 U.S.C. 41-50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264; Pub. L. 107-109; Pub. L. 108-155; Pub. L. 113-54.
Food and Drug Administration, HHS.
Final rule; technical amendments.
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for a new animal drug application (NADA) and abbreviated new animal drug applications (ANADAs) during May and June 2017. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the accuracy of the regulations.
This rule is effective December 13, 2017.
George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-5689,
FDA is amending the animal drug regulations to reflect approval actions for a NADA and ANADAs during May and June 2017, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the internet may obtain these documents at the CVM FOIA Electronic Reading Room:
Following the approval of ANADA 200-610, Modern Veterinary Therapeutics, LLC, will now be included in the lists of sponsors of approved applications in § 510.600(c) (21 CFR 510.600(c)).
We are making several technical amendments in 21 CFR part 558, which was amended on December 27, 2016 (81 FR 94991), and February 24, 2017 (82 FR 11510), as part of the FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative. We are also making several technical amendments to the regulations for dosage form drugs to reflect revised labeling. These actions are being taken to improve the accuracy of the regulations.
This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(i)), which requires
Although denominated a rule pursuant to the FD&C Act, this document does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a “rule of particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. Likewise, this is not a rule subject to Executive Order 12866, which defines a rule as “an agency statement of general applicability and future effect, which the agency intends to have the force and effect of law, that is designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency.”
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
Animal drugs.
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 510, 520, 522, 524, 529, and 558 are amended as follows:
21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
(c) * * *
(1) * * *
(2) * * *
21 U.S.C. 360b.
(a)
(b)
(1) No. 054771 for use of tablets and chewable tablets as in paragraph (c) of this section.
(2) No. 026637 for use of tablets as in paragraph (c) of this section.
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(1) * * *
(ii)
21 U.S.C. 360b.
(b)
(c) * * *
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(i)
(ii)
(2)
21 U.S.C. 360b.
21 U.S.C. 360b.
The revisions read as follows:
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(ii) All finfish. For control of external protozoa
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(i) * * *
(iii) For control of fungi of the family Saprolegniaceae on finfish eggs: Eggs of all finfish except Acipenseriformes, 1,000 to 2,000 μL/L (ppm) for 15 minutes; eggs of Acipenseriformes, up to 1,500 μL/L (ppm) for 15 minutes. A preliminary bioassay should be conducted on a small subsample of fish eggs to determine sensitivity before treating an entire group. This is necessary for all species because egg sensitivity can vary with species or strain and the unique conditions at each facility.
(3)
21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
Drug Enforcement Administration, Department of Justice.
Final order.
With the issuance of this final order, the Administrator of the Drug Enforcement Administration places the substance MT-45 (Systematic IUPAC Name: 1-cyclohexyl-4-(1,2-diphenylethyl)piperazine), including its salts, isomers, and salts of isomers into schedule I of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act and is required in order for the United States to discharge its obligations under the Single Convention on Narcotic Drugs, 1961. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research or conduct instructional activities with, or possess), or propose to handle, MT-45.
Effective January 12, 2018.
Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.
Section 201(d)(1) of the Controlled Substances Act (CSA) (21 U.S.C. 811(d)(1)) states that, if control of a substance is required “by United States obligations under international treaties, conventions, or protocols in effect on October 27, 1970, the Attorney General shall issue an order controlling such drug under the schedule he deems most appropriate to carry out such obligations, without regard to the findings required by subsection (a) of this section [811(a)] or section 812(b) . . . and without regard to the procedures prescribed by subsections (a) and (b) of this section [21 U.S.C. 811(a) and (b)] . . . .” If a substance is added to one of the schedules of the Single Convention on Narcotic Drugs, 1961 (“Single Convention”), then, in accordance with article 3, paragraph 7 of the Convention, as a signatory Member State, the United States is obligated to control the substance under its national drug control legislation, the CSA. The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.
On May 17, 2016, the Secretary-General of the United Nations advised the Secretary of State of the United States, by letter, that during the 59th session of the Commission on Narcotic Drugs, MT-45 was added to schedule I of the Single Convention. This letter was prompted by a decision at the 59th session of the Commission on Narcotic Drugs in March 2016 to schedule MT-45 under schedule I of the Single Convention. As a signatory Member State to the Single Convention, the United States is obligated to control MT-45 under its national drug control legislation, the CSA, in the schedule deemed most appropriate to carry out its international obligations. 21 U.S.C. 811(d)(1).
MT-45 is an opioid analgesic drug with pharmacological effects similar to morphine. MT-45 was demonstrated to produce physical dependence in mice. This compound is a piperazine derivative and is structurally unrelated to most other opioids. There are two enantiomers of MT-45 (
Starting in 2013, MT-45 began appearing on the internet for sale as a `legal' opioid. Recent reports from Japan have indicated that MT-45 is present in herbal and chemical mixtures containing synthetic cannabinoids and/or synthetic cathinones. Deaths associated with MT-45 abuse have occurred in the United States and in Europe. In addition, there have been at least 13 non-fatal overdoses associated with abuse of MT-45. There are no published studies as to the safety of MT-45 for human use. The DEA is not aware of any claims or any medical or scientific literature suggesting that MT-45 has a currently accepted medical use in treatment in the United States. Accordingly, the DEA has not requested that the Department of Health and Human Services (HHS) conduct a scientific and medical evaluation of the substance's medical utility. Furthermore, the DEA is not required under 21 U.S.C. 811(d)(1) to make any findings required by 21 U.S.C. 811(a) or 812(b), and is not required to follow the procedures prescribed by 21 U.S.C. 811(a) and (b). Therefore, consistent with the framework of 21 U.S.C. 811(d), the DEA concludes that MT-45 has no currently accepted medical use in treatment in the United States and is most appropriately placed in schedule I of the CSA.
In order to meet the obligations of the United States under the Single Convention on Narcotic Drugs, 1961, and because MT-45 has no currently accepted medical use in treatment in the United States, the Administrator of the Drug Enforcement Administration has determined that this substance should be placed in schedule I of the Controlled Substances Act.
Upon the effective date of this final order, MT-45 will become subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importation, exportation, engagement in research, and conduct of instructional
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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 does not have federalism implications warranting the application of Executive Order 13132. The action does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications warranting the application of Executive Order 13175. The action does not have substantial direct effects on one or more Indian tribes, 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.
The CSA provides for an expedited scheduling action where control is required by the United States obligations under international treaties, conventions, or protocols. 21 U.S.C. 811(d)(1). If control is required pursuant to such international treaty, convention, or protocol, the Attorney General must issue an order controlling such drug under the schedule he deems most appropriate to carry out such obligations, without regard to the findings or procedures otherwise required for scheduling actions.
To the extent that 21 U.S.C. 811(d)(1) directs that if control is required by the United States obligations under international treaties, conventions, or protocols in effect on October 27, 1970, scheduling actions shall be issued by order (as compared to scheduling pursuant to 21 U.S.C. 811(a) by rule), 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 scheduling action. In the alternative, even if this action does constitute “rule making” under 5 U.S.C. 551(5), this action is exempt from the notice and comment requirements of 5 U.S.C. 553 pursuant to 21 U.S.C. 553(a)(1) as an action involving a foreign affairs function of the United States given that this action is being done in accordance with 21 U.S.C. 811(d)(1)'s requirement that such action be taken to comply with the United States obligations under the specified international agreement.
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to rules that are subject to notice and comment under section 553(b) of the APA or any other law. As explained above, the CSA exempts this final order from notice and comment. Consequently, the RFA does not apply to this action.
This action does not impose a new collection of information under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. 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.
This action is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act (CRA)). This order will not result in: “an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on
Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements.
For the reasons set out above, 21 CFR part 1308 is amended as follows:
21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise noted.
The addition reads as follows:
(b) * * *
(40) MT-45 (1-cyclohexyl-4-(1,2-diphenylethyl)piperazine) . . . (9560)
Office of Surface Mining Reclamation and Enforcement, Interior.
Final rule; approval of amendment.
We, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are approving an amendment to the Oklahoma regulatory program (Oklahoma program) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Oklahoma proposed revisions to its regulations regarding: Permit eligibility for permits with violations on lands eligible for remining; permit suspension or rescission posting locations and appeal procedures; requiring GPS coordinates for aspects of permit maps; topsoil removal distances; blasting records requirements; annual reporting requirements; temporary cessation of operations requirements; casing and sealing temporary underground openings; right of entry requirements; surface drainage associated with auger mining; correcting reference errors; updating addresses; and correcting spelling and grammatical errors. Oklahoma intended to revise its program to be no less effective than the Federal regulations and to improve operational efficiency.
The effective date is January 12, 2018.
Bill Joseph, Director, Tulsa Field Office, Office of Surface Mining Reclamation and Enforcement, 1645 South 101st East Avenue, Suite 145, Tulsa, Oklahoma 74128-4629. Telephone: 918-581-6431 ext. 230. Email:
Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its program includes, among other things, State laws and regulations that govern surface coal mining and reclamation operations in accordance with the Act and consistent with the Federal regulations. See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Oklahoma program on January 19, 1981. You can find background information on the Oklahoma program, including the Secretary's findings, the disposition of comments, and the conditions of approval of the Oklahoma program in the January 19, 1981,
By letter dated September 25, 2015 (Administrative Record No. OK-1003), Oklahoma sent us an amendment to its program under SMCRA (30 U.S.C. 1201
We announced receipt of the proposed amendment in the February 8, 2016,
We are approving the amendment as described below. The following are the findings we made concerning Oklahoma's amendment under SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17. Any revisions that we do not specifically discuss below concerning non-substantive wording or editorial changes can be found in the full text of the program amendment available at
Oklahoma removed paragraphs 460:20-15-6.7(a)(2)(A) and (B) regarding permit eligibility and unabated violations at remining sites issued before September 30, 2004, and added language to paragraph (a)(2) to substantively match the Federal requirements of 30 CFR 773.13(a)(2).
Oklahoma modified section 460:20-15-10.1(c) regarding the suspension and rescission appeal process so that it substantively matches the counterpart Federal regulations at 30 CFR 773.23(c). Additionally, Oklahoma modified 460:20-15-10.1(d) and added paragraph (e) to substantively match the requirements of 30 CFR 773.23 (d).
We find that Oklahoma's changes to this subchapter substantively match the counterpart Federal requirements and do not make its rules or regulations less effective than the Federal requirements. Therefore, we are approving Oklahoma's revisions.
Oklahoma added the requirement for GPS coordinates for each building on permit application maps in section 460:20-29-10(4). Although there is no
Oklahoma added the permitting requirement to list the depth to mined coal in section 460:20-29-11(a)(5). Although there is no direct counterpart Federal regulation requiring this, the addition does not make Oklahoma's regulations less effective than the Federal requirements for map cross sections, maps, and plans at 30 CFR 783.25.
We find that Oklahoma's changes to this subchapter, although not specifically required by the counterpart Federal regulations, do not make its regulations less effective than the Federal requirements. Therefore, we are approving Oklahoma's revisions.
Oklahoma added paragraph 460:20-43-7(a)(1) requiring that topsoil be removed a minimum of 60 feet or one pit width, whichever is less, in advance of the active pit. Although there is no specific requirement in the counterpart Federal regulations at 30 CFR 816.22, this addition does not make Oklahoma's regulations less effective than the Federal requirements.
Oklahoma added new language to section 460:20-43-23 regarding blasting records. Oklahoma added the requirement that operators maintain the names of blasting crew members, expiration date of blaster's certification, a digital video of each blast, and drill logs. Although there is no specific requirement regarding this in the counterpart Federal regulations at 30 CFR 816.68, these additions do not make Oklahoma's regulations less effective than the Federal requirements.
Oklahoma added new language regarding annual reporting requirements for contemporaneous reclamation in section 460:20-43-37(2). Although there is no specific requirement regarding this in the counterpart Federal regulations, these additions do not make Oklahoma's regulations less effective than the Federal requirements.
Oklahoma added new language regarding qualification standards for temporary cessation of operations in section 460:20-43-49(a) and (c). For a site to qualify for temporary cessation, Oklahoma will now require that minable coal be available under a valid lease and it must be located within or adjacent to the current permit area. Additionally, other requirements have been added if temporary cessation exceeds twelve months. Although there are no specific requirements regarding this in the counterpart Federal regulations at 30 CFR 816.131, these additions do not make Oklahoma's regulations less effective than the Federal requirements.
We find that Oklahoma's changes to this subchapter, although not specifically required, do not make its rules or regulations less effective than the Federal requirements. Therefore, we are approving Oklahoma's revisions.
Oklahoma added paragraph 460:20-45-5(c) regarding casing and sealing underground openings during temporary cessation of operations. The language added is similar to that contained in the counterpart Federal regulation at 817.15. This addition does not make Oklahoma's regulations less effective than the Federal requirements.
Oklahoma added language regarding right of entry information in section 460:20-45-17(b). The new language requires proof that the applicant has legal rights to enter and begin underground coal mining and reclamation operations. Although there is no specific counterpart Federal requirement for underground mining permit applications, the language added is similar to the requirements for surface mining permit applications found in 30 CFR 778.15. This addition does not make Oklahoma's regulations less effective than the Federal requirements.
We find that Oklahoma's changes do not make its rules or regulations less effective than the Federal requirements. Therefore, we are approving Oklahoma's revision.
Oklahoma added new paragraph 460:20-47-4(d) requiring surface drainage to be directed away from highwalls during augering operations. There is no direct Federal counterpart to this requirement within 30 CFR 819. This addition does not make Oklahoma's regulations less effective than the Federal requirements.
We find that Oklahoma's changes do not make its rules or regulations less effective than the Federal requirements. Therefore, we are approving Oklahoma's revision.
We asked for public comments on the amendment but did not receive any.
On October 15, 2015, under 30 CFR 732.17(h)(11)(i) and section 503(b) of SMCRA, we requested comments on the amendment from various Federal agencies with an actual or potential interest in the Oklahoma program (Administrative Record No. OK-1003.01). We did not receive any comments.
Under 30 CFR 732.17(h)(11)(ii), we are required to get a written concurrence from EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251
Under 30 CFR 732.17(h)(4), we are required to request comments from the SHPO and ACHP on amendments that may have an effect on historic properties. On October 15, 2015, we requested comments on the amendment (Administrative Record No. OK-1003.01). We did not receive any comments.
Based on the above findings, we approve the amendment Oklahoma sent us on September 25, 2015 (Administrative Record No. OK-1003).
To implement this decision, we are amending the Federal regulations, at 30 CFR part 936, that codify decisions concerning the Oklahoma program. In accordance with the Administrative Procedure Act, this rule will take effect 30 days after the date of publication. Section 503(a) of SMCRA requires that the State's program demonstrate that the State has the capability of carrying out the provisions of the Act and meeting its
This rulemaking does not have takings implications. This determination is based on the analysis performed for the counterpart Federal regulation.
Pursuant to Office of Management and Budget (OMB) Guidance dated October 12, 1993, the approval of state program amendments is exempted from OMB review under Executive Order 12866.
The Department of the Interior has reviewed this rule as required by section 3(a) of Executive Order 12988. The Department determined that this
This rule is not a “[p]olicy that [has] Federalism implications” as defined by section 1(a) of Executive Order 13132 because it does 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.” Instead, this rule approves an amendment to the Oklahoma program submitted and drafted by that State. OSMRE reviewed the submission with fundamental federalism principles in mind as set forth in sections 2 and 3 of the Executive Order and with the principles of cooperative federalism set forth in SMCRA. See,
In accordance with Executive Order 13175, we have evaluated the potential effects of this rulemaking on Federally-recognized Indian tribes and have determined that the rulemaking does not have substantial direct effects on one or more Indian tribes, 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. The basis for this determination is that our decision is on a State regulatory program and does not involve Federal regulations involving Indian lands.
Executive Order 13211 of May 18, 2001, which requires agencies to prepare a Statement of Energy Effects for a rule that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rulemaking is exempt from review under Executive Order 12866 and is not expected to have a significant adverse effect on the supply, distribution, or use of energy, a Statement of Energy Effects is not required.
This rulemaking does not require an environmental impact statement because section 702(d) of SMCRA (30 U.S.C. 1292(d)) provides that agency decisions on proposed State regulatory program provisions do not constitute major Federal actions within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C)).
This rulemaking does not contain information collection requirements that require approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3507
The Department of the Interior certifies that this rulemaking will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
This rulemaking is not a major rulemaking under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rulemaking: (a) Does not have an annual effect on the economy of $100 million; (b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and (c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. This determination is based upon the fact that the State submittal, which is the subject of this rulemaking, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation was not considered a major rule.
This rulemaking will not impose an unfunded mandate on State, local, or tribal governments or the private sector of $100 million or more in any given year. This determination is based upon the fact that the State submittal, which is the subject of this rulemaking, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation did not impose an unfunded mandate.
Intergovernmental relations, Surface mining, Underground mining.
For the reasons set out in the preamble, 30 CFR part 936 is amended as set forth below:
30 U.S.C. 1201
Office of the Under Secretary of Defense for Personnel and Readiness, Department of Defense.
Final rule.
This final rule removes the DoD's regulation concerning the certificate of release or discharge from active duty (Department of Defense Form (DD Form) 214/5 Series). DoD has determined that the rule has no impact on the general public; rather, the rule focuses on internal DoD management and personnel matters. Therefore, this part is unnecessary and can be removed from the CFR.
This rule is effective on December 13, 2017.
Kent Bauer, 703-693-4204.
It has been determined that publication of this CFR part removal rule for public comment is unnecessary because it removes DoD internal policies and procedures that are publicly available on the Department's issuance website.
DoD internal guidance concerning the Certificate of Release or Discharge from Active Duty (DD Form 214/5 Series) will continue to be published in DoD Instruction 1336.01 and made available at
Repealing this part will reduce unnecessary Federal regulation and associated administrative costs. Because the rule focuses on internal DoD management and personnel matters, however, its repeal will not result in a cost savings for the public.
Armed forces reserves.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Benicia-Martinez Union Pacific Railroad Drawbridge across the Carquinez Strait, mile 7.0, at Martinez, CA. The deviation is necessary to allow the bridge owner to replace drawspan operational components. This deviation allows the bridge to remain in the closed-to-navigation position during the deviation period.
This deviation is effective from 8 a.m. on December 20, 2017, to 4 p.m. on January 10, 2018.
The docket for this deviation, USCG-2017-1075, is available at
If you have questions on this temporary deviation, call or email Carl T. Hausner, Chief, Bridge Section, Eleventh Coast Guard District; telephone 510-437-3516; email
Union Pacific Railroad has requested a temporary change to the operation of the Benicia-Martinez Railroad Drawbridge across the Carquinez Strait, mile 7.0, at Martinez, CA. The drawbridge navigation span provides a vertical clearance of 70 feet above Mean High Water in the closed-to-navigation position. The draw operates as required by 33 CFR 117.5. Navigation on the waterway is commercial and recreational.
The drawspan will be secured in the closed-to-navigation position from 8 a.m. to 4 p.m., December 20, 2017 through December 21, 2017, December 27, 2017 through December 28, 2017, December 30, 2017, January 3, 2018 through January 5, 2018, and January 8, 2018 through January 10, 2018 to allow the bridge owner to replace the down haul wire ropes of the drawspan. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised.
Vessels able to pass through the bridge in the closed position may do so at anytime. The bridge will not be able to open for emergencies and there is no alternative route for vessels to pass. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Environmental Protection Agency (EPA).
Withdrawal of direct final rule.
Due to receipt of an adverse comment, the Environmental Protection Agency (EPA) is withdrawing the October 16, 2017 direct final rule (DFR) that approved a revision to the Commonwealth of Pennsylvania's state implementation plan (SIP). The revision included amendments to the Pennsylvania Department of Environmental Protection's (PADEP) regulations and addressed the requirement to adopt reasonably available control technology (RACT) for sources covered by EPA's control techniques guidelines (CTG) standards for the following categories: Miscellaneous metal parts surface coating, miscellaneous plastic parts surface coating, and pleasure craft surface coatings, as well as related cleaning activities. The SIP revision also amended regulations for graphic arts systems and mobile equipment repair and refinishing as well as made general administrative changes. EPA stated in the direct final rule that if EPA received adverse comments by November 15, 2017, the rule would be withdrawn and not take effect. EPA subsequently received adverse comments. EPA will address the comments received in a subsequent final action based upon the proposed action also published on October 16, 2017. EPA will not institute a second comment period on this action.
The direct final rule published at 82 FR 47988 on October 16, 2017 is withdrawn as of December 13, 2017.
Gregory A. Becoat, (215) 814-2036, or by email at
On November 18, 2016, PADEP submitted a revision to the Pennsylvania SIP concerning the adoption of EPA's CTG for miscellaneous metal parts surface coating processes, miscellaneous plastic parts surface coating processes, and pleasure craft surface coatings. Specifically, PADEP amended 25 Pennsylvania Code (Pa. Code) Chapter 129 (relating to standards for sources) to address RACT and further reduce volatile organic compounds (VOC) emissions in Pennsylvania. In accordance with sections 172(c)(1), 182(b)(2)(A) and 184(b)(1)(B) of the CAA, Pennsylvania's SIP revision submittal established VOC emission limitations and other requirements consistent with the recommendations of EPA's 2008 Control Techniques Guidelines for Miscellaneous Metal and Plastic Parts Coatings (MMPP) (Publication No. EPA 453/R-08-003; September 2008) and Control Techniques Guidelines for Automobile and Light-Duty Truck Assembly Coatings for these sources in the Commonwealth of Pennsylvania (Publication No. EPA 453/R-08-006). In the direct final rule published on October 16, 2017 (82 FR 47988), EPA stated that if EPA received adverse comments by November 15, 2017, the rule would be withdrawn and not take effect. EPA subsequently received adverse comments. EPA will address the comments received in a subsequent final action based upon this proposed action and will not institute a second comment period on this action.
As a result of the comments received, EPA is withdrawing the DFR approving the Commonwealth of Pennsylvania's SIP revision adopting CTGs for miscellaneous metal parts surface coating, miscellaneous plastic parts surface coating, and pleasure craft surface coatings, as well as general administrative changes related to cleaning activities in the Pennsylvania SIP.
Environmental protection, Air pollution control, Incorporation by reference, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
Environmental Protection Agency (EPA).
Withdrawal of direct final rule.
Due to receipt of adverse comment, the Environmental Protection Agency (EPA) is withdrawing the direct final rule published on Tuesday, October 24, 2017 to approve revisions to the Pennsylvania state implementation plan (SIP) pertaining to the addition of new regulations to address the requirement to adopt reasonably available control technology (RACT) for sources covered by EPA's control techniques guidelines (CTG) for automobile and light-duty truck assembly coatings.
The direct final rule published at 82 FR 49128, on October 24, 2017, is withdrawn as of December 13, 2017.
Joseph Schulingkamp, (215) 814-2021, or by email at
On November 18, 2016, the Commonwealth
Because adverse comments were received, EPA is withdrawing the direct final rule promulgated by EPA on October 24, 2017 (82 FR 49128) approving the revision to the Pennsylvania SIP pertaining to the addition of new regulations to address the requirement to adopt RACT for sources covered by EPA's CTG for automobile and light-duty truck assembly coatings. EPA will respond to the adverse comments in a separate final rulemaking action.
Environmental protection, Air pollution control, Incorporation by reference, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; fishery closure.
NMFS announces that U.S. purse seine vessels will be prohibited from fishing on fish aggregating devices (FADs) in the area of application of the Convention on the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean (Convention) in the area between the latitudes of 20° N. and 20° S., as a result of reaching the 2017 limit on FAD sets. This action is taken to enable the United States to implement provisions of a conservation and management measure adopted by the Commission for the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean (WCPFC or Commission) and to satisfy the obligations of the United States under the Convention, to which it is a Contracting Party.
Effective 00:00 on December 24, 2017, universal time coordinated (UTC), until 24:00 on December 31, 2017 UTC.
Rini Ghosh, NMFS Pacific Islands Regional Office, 808-725-5033.
U.S. purse seine fishing in the area of application of the Convention, or Convention Area, is managed, in part, under the Western and Central Pacific Fisheries Convention Implementation Act (16 U.S.C. 6901,
Pursuant to WCPFC Conservation and Management Measure 2015-01, NMFS issued regulations that established a limit of 2,522 FAD sets that may be used by U.S. purse seine fishing vessels in the Convention Area between the latitudes of 20° N and 20° S in calendar year 2017 (see final rule at 81 FR 41239, June 24, 2016, codified at 50 CFR 300.223).
Based on data submitted in logbooks and other available information, NMFS expects that the limit of 2,522 FAD sets for 2017 will be reached and, in accordance with the procedures established at 50 CFR 300.223(b)(2)(iii), announces that restrictions on the use of FADs will be in effect starting at 00:00 on December 24, 2017, UTC. These restrictions will remain in effect until 24:00 on December 31, 2017, UTC.
The specific restrictions, detailed at 50 CFR 300.223(b)(1), prohibit owners, operators, and crew of fishing vessels of the United States from doing any of the following activities in the Convention Area in the area between 20° N latitude and 20° S latitude: (1) Set a purse seine around a FAD or within one nautical mile of a FAD; (2) set a purse seine in a manner intended to capture fish that have aggregated in association with a FAD or a vessel, such as by setting the purse seine in an area from which a FAD or a vessel has been moved or removed within the previous eight hours, or setting the purse seine in an area in which a FAD has been inspected or handled within the previous eight hours, or setting the purse seine in an area into which fish were drawn by a vessel from the vicinity of a FAD or a vessel; (3) deploy a FAD into the water; and (4) repair, clean, maintain, or otherwise service a FAD, including any electronic equipment used in association with a FAD, in the water or on a vessel while at sea. Notwithstanding the restrictions, a FAD may be inspected and handled as needed to identify the FAD, identify and release incidentally captured animals, un-foul fishing gear, or prevent damage to property or risk to human safety. A FAD may also be removed from the water and, if removed, may be cleaned, provided that it is not returned to the water. The following additional restriction also applies: owners, operators and crew of a U.S. fishing vessel shall not submerge lights under water, suspend or hang lights over the side of the purse seine vessel, skiff, watercraft or equipment, or direct or use lights in a manner other than as needed to illuminate the deck of the purse seine vessel or associated skiffs, watercraft or equipment, to comply with navigational requirements, and to ensure the health and safety of the crew. This final restriction does not apply in emergencies as needed to prevent human injury or the loss of human life, the loss of the purse seine vessel, skiffs, watercraft or aircraft, or environmental damage.
There is good cause under 5 U.S.C. 553(b)(B) to waive prior notice and opportunity for public comment on this action. Compliance with the notice and comment requirement would be impracticable and contrary to the public interest, because NMFS cannot ensure timely compliance with the 2017 limit on FAD sets in the Convention Area based on its receipt of the logbook data and other relevant information to calculate that the FAD limit has been reached. This action is based on the best available information on U.S. purse seine fishing effort on FADs in the Convention Area. The action is taken to enable the United States to comply with
This action is required by 50 CFR 300.223(b)(2)(iii) and is exempt from review under Executive Order 12866.
16 U.S.C. 6901
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to supersede Airworthiness Directive (AD) 2016-01-11, which applies to certain Airbus Model A320-211, -212, and -231 airplanes. AD 2016-01-11 requires repetitive inspections for cracking of the radius of the front spar vertical stringers and the horizontal floor beam on frame 36, repetitive inspections for cracking of the fastener holes of the front spar vertical stringers on frame 36, and repair if necessary. Since we issued AD 2016-01-11, we received a report that, during a center fuselage certification full scale fatigue test, cracks were found on the front vertical stringer at a certain frame. This proposed AD would add new thresholds and intervals for the repetitive inspections; would require, for certain airplanes, a modification of the center wing box area; and would expand the applicability. We are proposing this AD to address the unsafe condition on these products.
We must receive comments on this proposed AD by January 29, 2018.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Airbus, Airworthiness Office-EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
You may examine the AD docket on the internet at
Sanjay Ralhan, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 1601 Lind Avenue SW, Renton, WA 98057-3356; telephone 425-227-1405; fax 425-227-1149.
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
Fatigue damage can occur locally, in small areas or structural design details, or globally, in widespread areas. Multiple-site damage is widespread damage that occurs in a large structural element such as a single rivet line of a lap splice joining two large skin panels. Widespread damage can also occur in multiple elements such as adjacent frames or stringers. Multiple-site damage and multiple-element damage cracks are typically too small initially to be reliably detected with normal inspection methods. Without intervention, these cracks will grow, and eventually compromise the structural integrity of the airplane. This condition is known as widespread fatigue damage (WFD). It is associated with general degradation of large areas of structure with similar structural details and stress levels. As an airplane ages, WFD will likely occur, and will certainly occur if the airplane is operated long enough without any intervention.
The FAA's WFD final rule (75 FR 69746, November 15, 2010) became effective on January 14, 2011. The WFD rule requires certain actions to prevent structural failure due to WFD throughout the operational life of certain existing transport category airplanes and all of these airplanes that will be certificated in the future. For existing and future airplanes subject to the WFD rule, the rule requires that DAHs establish a limit of validity (LOV) of the engineering data that support the structural maintenance program. Operators affected by the WFD rule may not fly an airplane beyond its LOV, unless an extended LOV is approved.
The WFD rule (75 FR 69746, November 15, 2010) does not require identifying and developing maintenance actions if the DAHs can show that such actions are not necessary to prevent WFD before the airplane reaches the LOV. Many LOVs, however, do depend on accomplishment of future maintenance actions. As stated in the WFD rule, any maintenance actions
In the context of WFD, this action is necessary to enable DAHs to propose LOVs that allow operators the longest operational lives for their airplanes, and still ensure that WFD will not occur. This approach allows for an implementation strategy that provides flexibility to DAHs in determining the timing of service information development (with FAA approval), while providing operators with certainty regarding the LOV applicable to their airplanes.
We issued AD 2016-01-11, Amendment 39-18370 (81 FR 3316, January 21, 2016) (“AD 2016-01-11”), for certain Airbus Model A320-211, -212, and -231 airplanes. AD 2016-01-11 was prompted by reports that indicate new repetitive inspections having new thresholds and intervals were needed and that additional work was needed to accomplish the inspections on airplanes on which a previous modification has been accomplished. AD 2016-01-11 requires repetitive high frequency eddy current (HFEC) inspections for cracking of the radius of the front spar vertical stringers and the horizontal floor beam on frame 36, repetitive rototest inspections for cracking of the fastener holes of the front spar vertical stringers on frame 36, and repair if necessary. We issued AD 2016-01-11 to detect and correct fatigue cracking of the front spar vertical stringers on the wings, which could result in the reduced structural integrity of the airplane.
Since we issued AD 2016-01-11, the European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2017-0099, dated June 8, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A318 series airplanes; Model A319 series airplanes; Model A320-211, -212, -214, -231, -232, and -233 airplanes; and Model A321 series airplanes. The MCAI states:
During centre fuselage certification full scale fatigue test, cracks were found on the front vertical stringer at frame (FR) 36. Analysis of these findings indicated that a number of in-service aeroplanes could be similarly affected.
This condition, if not detected and corrected, could lead to crack propagation and consequent deterioration of the structural integrity of the aeroplane.
To address this potential unsafe condition, Airbus issued Airbus Service Bulletin (SB) A320-57-1016 to provide inspection instructions, and, consequently, [Directorate General for Civil Aviation] DGAC France issued AD 97-311-105 [which corresponds to FAA AD 98-18-26, Amendment 39-10742 (63 FR 47423, September 8, 1998)] to require those repetitive [high frequency eddy current (HFEC)] inspections [for cracking]. At the same time, modification in accordance with Airbus SB A320-57-1017 was introduced as (optional) terminating action for the repetitive inspections * * *.
After that [DGAC] AD was issued, and following new analysis, modification per Airbus SB A320-57-1017 was no longer considered to be terminating action for the repetitive inspections as required by DGAC France AD 97-311-105. Aeroplanes with [manufacturer serial number] MSN 0080 up to MSN 0155 inclusive were delivered with the addition of a 5 [millimeter] mm thick light alloy shim under the heads of 2 fasteners at the top end of the front spar vertical stringers (Airbus mod 21290P1546, which is the production line equivalent to in-service modification through Airbus SB A320-57-1017). Aeroplanes with MSN 0156 or higher are delivered with vertical stiffeners of the forward wing spar upper end with stiffener cap thickness increased from 4 to 6 mm (Airbus mod 21290P1547).
Prompted by these findings, Airbus issued SB A320-57-1178 Revision 01 to introduce new repetitive inspections and, consequently, EASA issued AD 2014-0069 [which corresponds to FAA AD 2016-01-11], superseding DGAC France AD 97-311-105 to require the new repetitive inspections, and, depending on findings, accomplishment of applicable corrective action(s).
Since AD 2014-0069 was issued, further investigations in the frame of the Widespread Fatigue Damage (WFD) campaign identified that some repetitive inspection thresholds and intervals have to be revised or introduced, and a new terminating action modification has been designed.
For the reasons described above, this [EASA] AD retains the requirements of EASA AD 2014-0069, which is superseded, revises and introduces thresholds and intervals for the repetitive inspections, and expands the Applicability.
Required actions also include reporting. Although this proposed AD does not explicitly restate the requirements of AD 2016-01-11, this proposed AD would retain certain requirements of AD 2016-01-11. Those requirements are referenced in the service information identified below in “Related Service Information under 1 CFR part 51,” which is referenced in paragraph (i)(1) of this proposed AD. You may examine the MCAI in the AD docket on the internet at
Airbus has issued the following service information:
• Service Bulletin A320-57-1178, Revision 03, dated November 29, 2016; excluding Appendixes 01 and 04, and including Appendix 03, all dated November 29, 2016. Appendix 02 does not exist. The service information describes procedures for a rototest inspection for cracking of the radius of the front spar vertical stringers on frame 36, a HFEC for cracking of the horizontal floor beam, and an HFEC inspection for cracking of the fastener holes of the front spar vertical stringers.
• Service Bulletin A320-57-1200, dated November 20, 2015. The service information describes procedures for modifying the center wing box area, which includes related investigative and corrective actions. Related investigative actions include an HFEC inspection on the radius of the rib flanges, a rototest inspection of the fastener holes, detailed and high frequency eddy current inspections for cracking on the cut edges, detailed and rototest inspections on all open fastener holes and an inspection to determine if secondary structure brackets are installed. Corrective action includes reworking the secondary structure bracket and repair.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.
The compliance time for the replacement specified in this proposed AD for addressing WFD was established to ensure that discrepant structure is replaced before WFD develops in airplanes. Standard inspection techniques cannot be relied on to detect WFD before it becomes a hazard to flight. We will not grant any extensions of the compliance time to complete any AD-mandated service bulletin related to WFD without extensive new data that would substantiate and clearly warrant such an extension.
We estimate that this proposed AD affects 815 airplanes of U.S. registry.
The actions required by AD 2016-01-11, take about 24 work-hours per product, at an average labor rate of $85 per work-hour. Based on these figures, the estimated cost of the actions that are required by AD 2016-01-11 is $2,040 per product.
We also estimate that it would take about 25 work-hours per product to comply with the basic requirements of this proposed AD and 1 work-hour for reporting. The average labor rate is $85 per work-hour. Required parts would cost about $180 per product. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $1,947,850, or $2,390 per product.
We have received no definitive data that would enable us to provide cost estimates for the repair of cracking specified in this proposed AD.
A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this NPRM is 2120-0056. The paperwork cost associated with this NPRM has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this NPRM is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW, Washington, DC 20591, ATTN: Information Collection Clearance Officer, AES-200.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial 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.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by January 29, 2018.
This AD replaces AD 2016-01-11, Amendment 39-18370 (81 FR 3316, January 21, 2016) (“AD 2016-01-11”).
This AD applies to Airbus Model A318-111, -112, -121, and -122 airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes; Model A320-211, -212, -214, -216, -231, -232, and -233 airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes; certificated in any category; all manufacturer serial numbers, except airplanes specified in paragraphs (c)(1) and (c)(2) of this AD.
(1) Model A319 and A320 series airplanes on which Airbus Modification (Mod) 160000 (structural reinforcement for sharklet installation) has been embodied in production.
(2) Model A321 series airplanes on which Airbus Modification (Mod) 160021 (structural reinforcement for sharklet installation) has been embodied in production.
Air Transport Association (ATA) of America Code 57, Wings.
This AD was prompted by a report that, during a center fuselage certification full scale fatigue test, cracks were found on the front vertical stringer at frame (FR) 36. We are issuing this AD to detect and correct fatigue cracking of the front spar vertical stringers on the wings, which could result in the reduced structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
For the purposes of this AD, airplane configurations are defined in table 1 to paragraphs (g), (h), (i)(1), and (j) of this AD and table 2 to paragraphs (g) and (i)(1) of this AD.
For Configuration 1, 2, or 3 airplanes, as identified in table 1 to paragraphs (g), (h), (i)(1), and (j) of this AD, on which the inspections specified in Airbus Service Bulletin A320-57-1178, dated October 29, 2013, have been accomplished before the effective date of this AD; but the additional work specified in Airbus Service Bulletin A320-57-1178, Revision 01, dated May 28, 2014, including Appendix 01, dated May 28, 2014, has not been accomplished before the effective date of this AD: Before accomplishing the initial inspection required by paragraph (i)(1) of this AD, contact the Manager, International Section, Transport Standards Branch, FAA; or the European Aviation Safety Agency (EASA); or Airbus's EASA Design Organization Approval (DOA) for further instructions and accomplish those instructions accordingly.
(1) Within the compliance time defined in table 3 to paragraph (i)(1) of this AD, as applicable to airplane configuration as identified in table 1 to paragraphs (g), (h),
(2) If no cracking is found during any inspection required by paragraph (i)(1) of this AD, repeat the inspection required by paragraph (i)(1) of this AD thereafter at intervals not to exceed the inspection interval values defined in table 4 to paragraphs (i)(2) and (l) of this AD, except as provided by paragraph (l) of this AD.
For A320 series airplanes, Configuration 1, 2, or 3 as identified in table 1 to paragraphs (g), (h), (i)(1), and (j) of this AD: Within the compliance time defined in table 5 to paragraph (j) of this AD, as applicable, modify the center wing box area, including doing all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-57-1200, dated November 20, 2015, except as required by paragraph (k) of this AD. Do all applicable related investigative and corrective actions before further flight.
If any crack is found during any inspection required by this AD: Before further flight, repair using a method approved by the Manager, International Section, Transport Standards Branch, FAA; or the EASA; or Airbus's EASA DOA. If approved by the DOA, the approval must include the DOA-authorized signature. Where Airbus Service Bulletin A320-57-1178, Revision 03, dated November 29, 2016; and Airbus Service Bulletin A320-57-1200, dated November 20, 2015; specify to contact Airbus for appropriate action, and specifies that action as “RC” (Required for Compliance), accomplish corrective actions in accordance with this paragraph.
For airplanes that have been repaired in the inspection area specified in paragraph (i)(1) of this AD before the effective date of this AD, using a method approved by the
Modification or repair of an airplane, as specified in paragraph (j) or (k) of this AD, does not constitute terminating action for the repetitive inspections required by this AD, unless it is specified otherwise in a repair method approved by the Manager, International Section, Transport Standards Branch, FAA; or the EASA; or Airbus's EASA DOA.
Submit a report of the findings (both positive and negative) of the inspections required by paragraphs (i) and (j) of this AD to “Airbus Service Bulletin Reporting Online Application” on Airbus World (
(1) If the inspection was done on or after the effective date of this AD: Report within 30 days after that inspection.
(2) If the inspection was done before the effective date of this AD: Report within 30 days after the effective date of this AD.
(1)
(2)
(3)
(4)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2017-0099, dated June 8, 2017, for related information. This MCAI may be found in the AD docket on the internet at
(2) For more information about this AD, contact Sanjay Ralhan, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 1601 Lind Avenue SW, Renton, WA 98057-3356; telephone 425-227-1405; fax 425-227-1149.
(3) For service information identified in this AD, contact Airbus, Airworthiness Office-EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
Food and Drug Administration, HHS.
Notification of public hearing; request for comments.
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public hearing entitled, “Opioid Policy Steering Committee: Prescribing Intervention—Exploring a Strategy for Implementation.” The purpose of the public hearing is to receive stakeholder input on how FDA might, under its Risk Evaluation and Mitigation Strategy (REMS) authority, improve the safe use of opioid analgesics by curbing overprescribing to decrease the occurrence of new addictions and limit misuse and abuse of opioid analgesics.
The public hearing will be held on January 30, 2018, from 8:30 a.m. to 4:30 p.m. The public hearing may be extended or may end early depending on the level of public participation. Persons seeking to attend, or to present at, the public hearing must register by January 16, 2018. Electronic or written comments will be accepted after the public hearing until March 16, 2018. See the
The public hearing will be held at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503 B and C), Silver Spring, MD 20993-0002. Entrance for public hearing participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to
You may submit comments as follows. Please note that late, untimely filed comments will not be considered.
Electronic comments must be submitted on or before March 16, 2018. The
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Kathleen Davies, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 2310, Silver Spring, MD 20993, 301-796-2205,
On May 23, 2017, the FDA Commissioner announced the establishment of an Opioid Policy Steering Committee (Steering Committee) to explore and develop additional approaches or strategies FDA could consider using to combat the opioid crisis. Given the unprecedented nature of the opioid crisis and the role of prescription opioids in the crisis, the Steering Committee is considering novel ways to reduce the number of new cases of addiction while continuing to ensure the benefits of opioid products outweigh their risks.
Recent studies suggest that prescriptions for opioid analgesics are frequently dispensed for a number of tablets that exceed those needed for adequate pain control, particularly for acute pain. The Steering Committee is considering whether current prescribing patterns are contributing to the development of new addiction in patients, and whether the excess unused pills are a gateway to misuse, abuse, and addiction among family members and others who might have access to the unused pills. Therefore, the Steering Committee is exploring, by means of FDA's REMS authorities, the option of facilitating appropriate prescribing by requiring sponsors to implement a prescriber intervention at the point when the prescriber determines an opioid analgesic prescription is necessary for a patient. For example, a REMS could impact prescribing by requiring that sponsors ensure that prescribers provide specific documentation for a prescription above a specified amount, such as a statement that the quantity prescribed is medically necessary for the patient. The documentation requirement would not be intended to prevent access for patients in whom chronic use of opioid analgesics is the most appropriate therapy. Instead, it would be designed to ensure that prescribers consider whether the amount prescribed is appropriate for the patient and, if above the specified amount, document that necessity. The Steering Committee's view is that one way sponsors could implement this type of prescribing documentation requirement is through an electronic system at the point of prescribing (
In this public hearing, FDA seeks stakeholder input on new approaches to promote the safe use of opioid analgesics using FDA's REMS
Many REMS programs rely on pharmacies to verify that required safe-use conditions have been documented prior to dispensing a drug product. One alternative approach under consideration would require sponsors to ensure that prescribers follow specific requirements outlined in the REMS for each opioid analgesic prescription for a quantity above a specified amount. This approach could involve use of an electronic system (
1. If a REMS were to specify threshold drug amounts for opioid analgesic prescriptions above which prescribers would be required to provide additional documentation of medical necessity, what should the amounts be and how should they be determined for various clinical indications? What data are there to support such amounts? What additional data would be useful?
2. If such measures were required, how should prescribers be made aware of them? Within the Agency's statutory REMS authority, how should the Agency require sponsors to ensure compliance with them? How should the Agency require sponsors to assess their effect in reducing misuse, abuse, and new addictions?
Health care providers generally have the capability to access state prescription drug monitoring program (PDMP) data that include patient prescription history and prescribing patterns. PDMPs are separately managed and maintained by the individual states, which may result in disparate data elements and data sharing challenges. Additionally, review of PDMP data requires health care providers to access a database that may not be integrated into their workflow.
Either in conjunction with, or separate from, the prescriber intervention approach discussed above, the Steering Committee is considering whether to require sponsors to create a system that would leverage a nationwide database to be more effective in helping health care providers identify potential misuse and abuse (
3. The Steering Committee requests input from the public on whether, in addition to, or in conjunction with the above described prescriber intervention, and to the extent consistent with its statutory authority, the Agency should consider requiring sponsors to create a system that utilizes a nationwide prescription history database to facilitate safe use of opioid analgesics.
4. If this approach were adopted, how should the Agency require sponsors to assess the impact of such requirements?
The Steering Committee acknowledges that the approaches described above emphasize specific components within the opioid prescribing pathway and might not address other areas where misuse and abuse may be occurring. The Steering Committee seeks input from the public on additional approaches the Agency may consider, within its statutory authority, to reduce misuse, abuse, and addiction associated with opioid analgesics.
5. The proposed Opioid Analgesics REMS includes a Medication Guide and a Patient Counseling Document to educate patients. It also includes a
6. Should the Agency consider additional measures intended to improve the safety of patient storage and handling of opioid analgesics?
7. How might use of unit-of-use packaging play a role in encouraging appropriate prescribing of opioid analgesics?
8. Should the Agency require sponsors to create a mechanism by which patients could return unused pills, and if so, to whom?
FDA will try to accommodate all persons who wish to make a presentation. Individuals wishing to present should identify the number of the question, or questions, they wish to address. This will help FDA organize the presentations. Individuals and organizations with common interests should consolidate or coordinate their presentations and request time for a joint presentation. FDA will notify registered presenters of their scheduled presentation times. Time allotted for each presentation will depend on the number of individuals who wish to speak. Once FDA notifies registered presenters of their scheduled times, they are encouraged to submit an electronic copy of their presentation (.DOC, .DOCX, .PPT, .PPTX, .XLS, .XLSX, .PDF formats preferred) to
If you need special accommodations due to a disability, please contact Kathleen Davies at least 7 days before the hearing.
If you have never attended a Connect Pro event before, test your connection at
The Commissioner of Food and Drugs is announcing that the public hearing will be held in accordance with part 15 (21 CFR part 15). The hearing will be conducted by a presiding officer, accompanied by FDA senior management from the Office of the Commissioner and the relevant centers/offices. Under § 15.30(f) (21 CFR 15.30(f)), the hearing is informal and the rules of evidence do not apply. Only the presiding officer and panel members may question any person during or at the conclusion of each presentation (§ 15.30(e)). Public hearings under part 15 are subject to FDA's policy and procedures for electronic media coverage of FDA's public administrative proceedings (21 CFR part 10, subpart C) (§ 10.203(a)). Under § 10.205, representatives of the electronic media may be permitted, subject to certain limitations, to videotape, film, or otherwise record FDA's public administrative proceedings, including presentations by participants. The hearing will be transcribed as stipulated in § 15.30(b) (see section V). To the extent that the conditions for the hearing as described in this document conflict with any provisions set out in part 15, this notice acts as a waiver of those provisions as specified in § 15.30(h).
Drug Enforcement Administration, Department of Justice.
Proposed amendment; notification of intent.
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule seven fentanyl-related substances in schedule I. These seven substances are:
December 13, 2017.
The DEA's three-factor analysis is available in its entirety under “Supporting and Related Material” of the public docket for this action at
Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.
This notice of intent contained in this document is issued pursuant to the temporary scheduling provisions of 21 U.S.C. 811(h). The Drug Enforcement Administration (DEA) intends to issue a temporary scheduling order (in the form of a temporary amendment) to add valeryl fentanyl,
Section 201 of the Controlled Substances Act (CSA), 21 U.S.C. 811, provides the Attorney General with the authority to temporarily place a substance in schedule I of the CSA for two years without regard to the requirements of 21 U.S.C. 811(b) if he finds that such action is necessary to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h)(1). In addition, if proceedings to control a substance are initiated under 21 U.S.C. 811(a)(1), the Attorney General may extend the temporary scheduling for up to one year. 21 U.S.C. 811(h)(2).
Where the necessary findings are made, a substance may be temporarily scheduled if it is not listed in any other schedule under section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or approval in effect for the substance under section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C. 811(h)(1); 21 CFR part 1308. The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.
Section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), requires the Administrator to notify the Secretary of the Department of Health and Human Services (HHS) of his intention to temporarily place a substance in schedule I of the CSA.
To find that placing a substance temporarily in schedule I of the CSA is necessary to avoid an imminent hazard to the public safety, the Administrator is required to consider three of the eight factors set forth in 21 U.S.C. 811(c): The substance's history and current pattern of abuse; the scope, duration and significance of abuse; and what, if any, risk there is to the public health. 21 U.S.C. 811(h)(3). Consideration of these factors includes actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution. 21 U.S.C. 811(h)(3).
A substance meeting the statutory requirements for temporary scheduling may only be placed in schedule I. 21 U.S.C. 811(h)(1). Substances in schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. 21 U.S.C. 812(b)(1).
The recent identification of valeryl fentanyl,
Available data and information for valeryl fentanyl,
The recreational abuse of fentanyl-related substances continues to be a significant concern. These substances are distributed to users, often with unpredictable outcomes. Evidence suggests that the pattern of abuse of these fentanyl-related substances parallels that of heroin and prescription opioid analgesics. Valeryl fentanyl,
On October 1, 2014, the DEA implemented STARLiMS (a web-based, commercial laboratory information management system) to replace the System to Retrieve Information from Drug Evidence (STRIDE) as its laboratory drug evidence data system of record. DEA laboratory data submitted after September 30, 2014, are reposited in STARLiMS. Data from STRIDE and STARLiMS were queried on November 2, 2017. STARLiMS registered the following reports: Valeryl fentanyl (15),
The National Forensic Laboratory Information System (NFLIS) is a national drug forensic laboratory reporting system that systematically collects results from drug chemistry analyses conducted by other federal, state, and local forensic laboratories across the country. NFLIS was queried on November 3, 2017
Fentanyl-related substances have recently re-emerged on the illicit market (
The identification of valeryl fentanyl,
With no legitimate medical use, valeryl fentanyl,
Based on information received by the DEA, the misuse and abuse of valeryl fentanyl,
In accordance with 21 U.S.C. 811(h)(3), based on the available data and information, summarized above, the uncontrolled manufacture, distribution, reverse distribution, importation, exportation, conduct of research and chemical analysis, possession, and abuse of valeryl fentanyl,
This notice of intent provides the 30-day notice pursuant to section 201(h) of the CSA, 21 U.S.C. 811(h), of DEA's intent to issue a temporary scheduling order. In accordance with the provisions of section 201(h) of the CSA, 21 U.S.C. 811(h), the Administrator considered available data and information, herein set forth the grounds for his determination that it is necessary to temporarily schedule valeryl fentanyl,
The temporary placement of valeryl fentanyl,
The CSA sets forth specific criteria for scheduling a drug or other substance. Regular scheduling actions in accordance with 21 U.S.C. 811(a) are subject to formal rulemaking procedures done “on the record after opportunity for a hearing” conducted pursuant to the provisions of 5 U.S.C. 556 and 557. 21 U.S.C. 811. The regular scheduling process of formal rulemaking affords interested parties with appropriate process and the government with any additional relevant information needed to make a determination. Final decisions that conclude the regular scheduling process of formal rulemaking are subject to judicial review. 21 U.S.C. 877. Temporary scheduling orders are not subject to judicial review. 21 U.S.C. 811(h)(6).
Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for a 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. Such an order may not be issued before the expiration of 30 days from (1) the publication of a notice in the
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, 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 notice of intent. In the alternative, even assuming that this notice of intent 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 issuance of temporary scheduling orders would be impracticable and contrary to the public interest in view of the manifest urgency to avoid an imminent hazard to the public safety.
Although the DEA believes this notice of intent to issue a temporary scheduling order is not subject to the notice and comment requirements of section 553 of the APA, the DEA notes that in accordance with 21 U.S.C. 811(h)(4), the Administrator took into consideration comments submitted by the Assistant Secretary in response to notice that DEA transmitted to the Assistant Secretary pursuant to section 811(h)(4).
Further, the DEA believes that this temporary scheduling action is not a “rule” as defined by 5 U.S.C. 601(2), and, accordingly, is not subject to the requirements of the Regulatory Flexibility Act (RFA). The requirements for the preparation of an initial regulatory flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as here, the DEA is not required by section 553 of the APA or any other law to publish a general notice of proposed rulemaking.
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.
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.
Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements.
For the reasons set out above, the DEA proposes to amend 21 CFR part 1308 as follows:
21 U.S.C. 811, 812, 871(b), unless otherwise noted.
(h) * * *
(23)
(24)
(25)
(26)
(27)
(28)
(29)
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard is establishing a special local regulation for the annual Gasparilla Marine Parade on the waters of Hillsborough Bay in the vicinity of Tampa, Florida. This event is expected to attract over 600 spectator craft along the parade route, with approximately 18 vessels participating in the official flotilla. The parade is scheduled to take place annually on the last Saturday in January. This regulation is necessary to ensure the safety of public, the official flotilla, and spectator vessels before, during, and after the conclusion of the parade.
Comments and related material must be received by the Coast Guard on or before January 12, 2018.
You may submit comments identified by docket number USCG-2017-0332 using the Federal eRulemaking Portal at
If you have questions about this proposed rulemaking, call or email Marine Science Technician First Class Michael D. Shackleford, Sector St. Petersburg Prevention Department, Coast Guard; telephone (813)228-2191, email
The Coast Guard proposes to establish a special local regulation on the waters of the Hillsborough Bay, Tampa, Florida
This rule establishes a temporary special local regulation for the Gasparilla Marine Parade on the waters of Hillsborough Bay in Tampa, Florida annually on the last saturday in January. This special regulation sets forth specific requirements for vessels operating within the regulated area during the period of enforcement.
Persons and vessels not meeting the requirements of this regulation may request authorization to enter, transit through, anchor in, or remain within the regulated area by contacting the Captain of the Port St. Petersburg by telephone at (727) 824-7506, or a designated representative via VHF radio on channel 16. If authorization to enter, transit through, anchor in, or remain within the regulated area is granted by the Captain of the Port St. Petersburg or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port St. Petersburg or a designated representative. The Coast Guard will provide notice of the special local regulations by Local Notice to Mariners, Broadcast Notice to Mariners, and/or on-scene designated representatives.
We developed this proposed rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive Orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget.
The economic impact of this rule is not significant for the following reasons: (1) The special local regulation will be enforced for only nine hours; (2) although certain persons and vessels are prohibited to enter, transit through, anchor in, or remain within the regulated area without authorization from the Captain of the Port St. Petersburg or a designated representative, they may operate in the surrounding area during the enforcement period; (3) the Coast Guard will provide advance notification of the special local regulations to the local maritime community by Local Notice to Mariners and/or Broadcast Notice to Mariners; and (4) persons and vessels not meeting the requirements of this regulation may request authorization to enter, transit through, anchor in, or remain within the regulated area by contacting the Captain of the Port or a designated representative.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.
This rule may affect the following entities, some of which may be small entities: The owners or operators of vessels intending to enter, transit through, anchor in, or remain within that portion of Hillsborough Bay, Tampa, FL, encompassed within the special local regulation annually on the last saturday in January. For the reasons stated in section IV.A above, this rule will not have a significant economic impact on a substantial number of small entities.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
This proposed rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial 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. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, 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. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the
We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a special local regulation issued in conjunction with a regatta or marine parade. This rule is categorically excluded from further review under paragraph (34) (h) of Figure 2-1 of Commandant Instruction M16475.lD. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comments can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at
Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 100 as follows:
33 U.S.C. 1233.
(a)
(b)
(2) The regulated area will include a 100 yard Safety Zone around the vessel JOSE GASPAR while docked at the Tampa Yacht Club until 6 p.m. EST on the day of the event.
(3) The regulated area is a “no wake” zone.
(4) All vessels within the regulated area shall stay 50 feet away from and give way to all officially entered vessels in parade formation in the Gasparilla Marine Parade.
(5) When within the marked channels of the parade route, vessels participating in the Gasparilla Marine Parade may not exceed the minimum speed necessary to maintain steerage.
(6) Jet skis and vessels without mechanical propulsion are prohibited from the parade route.
(7) Vessels less than 10 feet in length are prohibited from the parade route unless capable of safely participating.
(8) Vessels found to be unsafe to participate at the discretion of a present Law Enforcement Officer are prohibited from the parade route.
(9) Northbound vessels in excess of 65 feet in length without mooring arrangement made prior to the date of the event are prohibited from entering Seddon Channel unless the vessel is officially entered in the Gasparilla Marine Parade.
(10) Vessels not officially entered in the Gasparilla Marine Parade may not enter the parade staging area box within the following coordinates: 27°53′53″ N, 082°27′47″ W; 27°53′22″ N, 082°27′10″ W; 27°52′36″ N, 082°27′55″ W; 27°53′02″ N, 082°28′31″ W.
(c)
Postal Service
Proposed rule.
The Postal Service is proposing to amend
Submit comments on or before January 12, 2018.
Mail or deliver written comments to the manager, Product Classification, U.S. Postal Service, 475 L'Enfant Plaza SW, Room 4446, Washington, DC 20260-5015. If sending comments by email, include the name and address of the commenter and send to
You may inspect and photocopy all written comments, by appointment only, at USPS® Headquarters Library, 475 L'Enfant Plaza SW, 11th Floor North, Washington, DC, 20260. These records are available for review on Monday through Friday, 9 a.m.-4 p.m., by calling 202-268-2906.
Janet Meddick at (202) 268-2652, Pierre DeFelice at 724-993-3596, or Garry Rodriguez at (202) 268-7281.
The Postal Service is proposing to amend DMM section 604.10.0,
Additionally, the Postal Service will revise subsection 607.2.1 to include the relocation of subsection 604.10.2,
Administrative practice and procedure, Postal Service.
Although exempt from the notice and comment requirements of the Administrative Procedure Act (5 U.S.C. 553(b), (c)) regarding proposed rulemaking by 39 U.S.C. 410(a), the Postal Service invites public comments on the following proposed revisions to
Accordingly, 39 CFR part 111 is proposed to be amended as follows:
5 U.S.C. 552(a); 13 U.S.C. 301-307; 18 U.S.C. 1692-1737; 39 U.S.C. 101, 401, 403, 404, 414, 416, 3001-3011, 3201-3219, 3403-3406, 3621, 3622, 3626, 3632, 3633, and 5001.
The revenue deficiency process is an administrative process that supplements and does not diminish any rights the Postal Service has to recover revenue deficiencies through other legally available methods, such as when the deficiency arises as a result of fraud, misrepresentation, or the misuse of PC Postage products or other Postage Evidencing Systems.
Revenue deficiency definitions are as follows:
a.
b.
Postal officials review mailings, postage statements, and other relevant documentation in assessing a revenue deficiency. Mailers are required to cooperate and provide any documentation or information requested by postal officials during the review and assessment process. A mailer's failure to provide requested documentation or information during a review may result in a negative inference concerning the documentation or information requested.
Except as provided in 4.4.4 through 4.4.5, and 703.1.0, a mailer may appeal a revenue deficiency assessment by sending a written appeal to the postmaster or manager in 10.1.3a through 10.1.3c within 30 days of receipt of the notification. In all cases, the mailer may be asked to provide more information or documentation to support the appeal. Failure to do so within 30 days of the request is grounds for denying an appeal. Any decision that is not appealed as prescribed becomes the final agency decision. Mailers may send appeals as follows:
b. To the Postmaster; manager, Business Mail Entry; program manager, Revenue and Compliance; or other postal official for revenue deficiencies for postage. The appeal is then forwarded to the manager, PCSC, who issues the final agency decision.
Assessed revenue deficiencies may be subject to the following:
a. If a mailer fails to tender payment to the Postal Service within 30 days of receipt of a final agency decision, or fails to comply with the terms or conditions of a payment plan agreed to by the Postal Service concerning the final agency decision, or is suspected by the Postal Service of continuing to repeatedly short pay postage, the Postal Service may:
1. Deduct from the mailer's trust account or any other funds in USPS possession any deficiencies incurred within 12 months of the date of the final mailing on which the deficiency was assessed.
2. Initiate debt collection procedures.
3. Restrict or suspend discounted mailing privileges with the concurrence of the manager, Revenue Assurance and Vice President Controller, or as otherwise allowed by regulation, or in accordance with any agreement with the mailer.
b. Discounted mailing privileges may be suspended or restricted regardless of payment status of an assessed revenue deficiency if underpayment of postage occurs again after a mailer has been assessed a revenue deficiency.
c. Interest on assessed revenue deficiencies will accrue at a rate of 6% per annum beginning 30 days after the receipt of the final agency decision and will continue until the debt is paid.
d. Other fees and costs related to an assessed revenue deficiency may be
A mailer who disagrees with a classification decision by a local Post Office, whether on a pending or a proposed mailing, may send a written appeal to the postmaster within 30 days. The appeal is forwarded to the manager, Pricing and Classification Service Center (PCSC). The manager, PCSC issues the final agency decision. Only the manager, PCSC may rule on an appeal or initial request for a ruling on an exception to a USPS standard in the DMM.
Nonprofit mailers have two levels of appeal. They may appeal revenue deficiency assessments as follows:
All appeals must be submitted in writing within 30 days of the previous USPS decision. Any decision that is not appealed as prescribed becomes the final agency decision; no appeals are available within the USPS beyond the second appeal.
We will publish an appropriate amendment to 39 CFR part 111 to reflect these changes if this proposal is adopted.
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
Announcement of Department determination.
In this document, the Department of Transportation is announcing that after careful review, and as mandated by Section 7311 of the Fixing America's Surface Transportation (FAST) Act, the Department of Transportation has reviewed the final updated Regulatory Impact Analysis (RIA) and determined that the HM-251 Final Rule's electronically controlled pneumatic (ECP) brake requirements are not economically justified. As the expected benefits do not exceed the expected costs, PHMSA and the Federal Railroad Administration (FRA) will initiate a rulemaking to rescind the necessary regulatory provisions.
December 13, 2017.
All documents and comments related to this matter, including the final updated RIA, are still available for review at
For public affairs related questions, please contact Patricia Klinger, Deputy Director within PHMSA's Office of Governmental, International, and Public Affairs, by email at
On May 8, 2015, PHMSA, in coordination with FRA, published a Final Rule adopting requirements intended to reduce the consequences and, in some instances, reduce the probability of accidents involving trains transporting large quantities of flammable liquids.
In December 2015, Congress passed the FAST Act.
Section 7311 required DOT to enter into an agreement with National Academy of Sciences (NAS) to test ECP brakes and reevaluate the economic analysis supporting the ECP brake requirement of the Final Rule.
On October 16, 2017, PHMSA published a
The final updated RIA shows that the ECP brake requirements are not expected to be cost beneficial under any scenario assessed. These include a range of crude oil volume by rail forecasts—one that shows volumes shipped by rail rebounding over a period of time to close to the levels predicted at the rulemaking stage, one that shows levels flattening at those seen over the past few years, and a third showing declining volumes of crude oil shipped by rail. The estimated costs and benefits for the 20-year analysis are presented in the following (figures are in millions of dollars):
As mandated by Section 7311, the Department of Transportation has reviewed the final updated RIA and determined that the HM-251 final rule's ECP brake requirements are not economically justified as the final updated RIA demonstrates that the expected benefits do not exceed the expected costs. As such, PHMSA and FRA will initiate a rulemaking to rescind the necessary regulatory provisions.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule, request for comments.
NMFS proposes revised longfin squid,
Public comments must be received by January 12, 2018.
Copies of supporting documents used by the Mid-Atlantic Fishery Management Council, including the Environmental Assessment (EA), the Regulatory Impact Review (RIR), and the Regulatory Flexibility Act (RFA) analysis are available from: Dr. Christopher M. Moore, Executive Director, Mid-Atlantic Fishery Management Council, 800 North State Street, Suite 201, Dover, DE 19901, telephone (302) 674-2331. The EA/RIR/RFA analysis is also accessible via the internet at
You may submit comments, identified by NOAA-NMFS-2017-0089, by any of the following methods:
•
•
•
Douglas Christel, Fishery Policy Analyst, (978) 281-9141, fax (978) 281-9135.
This rule proposes specifications, which are the combined suite of commercial and recreational catch levels established for one or more fishing years. Section 302(g)(1)(B) of the Magnuson-Stevens Fishery Conservation and Management Act states that the Scientific and Statistical Committee (SSC) for each regional fishery management council shall provide its Council ongoing scientific advice for fishery management decisions, including recommendations for acceptable biological catch (ABC), preventing overfishing, ensuring maximum sustainable yield, and achieving rebuilding targets. The ABC is a level of catch that accounts for the scientific uncertainty in the estimate of the stock's defined overfishing level (OFL).
The regulations implementing the Atlantic Mackerel, Squid, and Butterfish Fishery Management Plan (FMP) require the Council's Atlantic Mackerel, Squid, and Butterfish Monitoring Committee to develop specification recommendations for each species based upon the ABC advice of the Council's SSC. The FMP regulations also require the specification of annual catch limits (ACLs) and accountability measure (AM) provisions for butterfish. Both squid species are exempt from the ACL/AM requirements because they have a life cycle of less than one year. In addition, the regulations require the specification of domestic annual harvest (DAH), domestic annual processing (DAP), total allowable level of foreign fishing (TALFF), joint venture processing (JVP), commercial and recreational annual catch targets (ACT), the butterfish mortality cap in the longfin squid fishery, and initial optimum yield (IOY) for both squid species.
The Council's SSC met on May 17 and 18, 2017, and the Monitoring Committee met on June 7, 2017, to recommend revised longfin squid,
This action does not consider revisions to existing specifications for Atlantic mackerel. On April 26, 2016, we implemented Atlantic mackerel specifications for fishing years 2016-2018 (81 FR 24504). That action implemented a 2018 mackerel ABC of 19,898 mt, an ACL of 11,009 mt, a commercial ACT of 9,294 mt, a commercial DAH of 9,177 mt, and a recreational ACT of 614 mt. A new stock assessment for Atlantic mackerel is expected to be completed as part of Stock Assessment Workshop 64 in November 2017. This will inform updated mackerel specifications starting in fishing year 2019.
The
The Council recommended that the ABC be reduced by the status quo discard rate of 4.52 percent, which results in an IOY, DAH, and DAP of 22,915 mt for 2018 that would be maintained for the 2019 and 2020 fishing years. These are the same specifications for the
The most recent longfin squid assessment, the 51st Northeast Regional Stock Assessment Workshop published in January 2011, found that the longfin squid stock was not overfished in 2009 based on recent biomass estimates from NMFS surveys. The Workshop concluded that the overfishing status was unknown in 2009 because the short lifespan of longfin squid and the lack of evidence correlating fishing effort with changes in biomass prevented the estimation of a fishing mortality reference point. The SSC considered the results of an April 2017 assessment update for longfin squid, which included more recent fishery dependent and independent information on longfin catch and abundance. Based on that update, the longfin squid stock was not overfished in 2016 because the average swept-area biomass estimates derived from recent surveys were much higher (73,762 mt) than the threshold biomass proxy (21,203 mt) for determining overfished status and the target biomass proxy at maximum sustainable yield (42,205 mt). Thus, the current stock biomass is estimated to be approximately 174 percent of the biomass target. The assessment concluded that the stock is likely lightly exploited because annual catches since 1987 were less than annual biomass and did not result in a multi-year decrease in biomass. Based on the above, the SSC recommended maintaining current levels for another three years, subject to annual review, resulting in a proposed ABC of 23,400 mt for 2018 and projected ABCs for 2019 and 2020. This recommendation corresponds to catch in the year with the highest observed exploitation fraction (catch divided by estimated biomass) during a period of light exploitation (1976-2009), interpreting this level of exploitation to be sustainable over the long term.
The Council recommended reducing the ABC by an updated discard rate of 2.0 percent derived from the April 2017 assessment update. This discard rate is lower than previous discard rates estimated at 4.08 percent, and reflects the discards observed since 2007, the year in which the current trimester management approach was implemented. Using this updated discard estimate results in a recommended IOY, DAH, and DAP of 22,932 mt for 2018 and the same projected catch levels for 2019 and 2020. Consistent with the Council's recommendation, NMFS proposes an ABC of 23,400 mt, and an IOY, DAH, and DAP of 22,932 mt for 2018 and projects the same catch levels for 2019 and 2020.
The Council did not recommend any changes to the trimester allocation of the 2018-2020 longfin DAH. Therefore, allocations would remain consistent with the distribution implemented since 2007 according to percentages specified in the FMP, as follows:
The status of the butterfish stock was last assessed in the 58th Northeast Regional Stock Assessment Workshop (March 2014), and updated through a March 2017 assessment update. The 2017 assessment update concluded that the stock was neither overfished, nor subject to overfishing. The butterfish stock biomass is estimated to be 64,376 mt, well above the target stock biomass at maximum sustainable yield (45,616 mt). In addition, the fishing mortality rate was estimated to be very low (0.05), well below the overfishing reference point of 0.81. However, trawl survey
The SSC derived OFLs for 2018 and projected OFLs for 2019-2020 by applying estimated natural and fishing mortality to the size of the existing stock, assuming the ABCs are fully harvested each year (see Table 4). However, the SSC noted that the estimated uncertainties from the OFLs derived from the assessment make them unrealistic for setting ABCs. In addition, the SSC was concerned about the declining trend in recruitment from recent trawl surveys, suggesting that catch projections may be overly optimistic. As a result, the SSC recommended an ABC of 17,801 mt in 2018, 27,108 mt in 2019, and 32,063 mt in 2020. The low 2018 ABC is 42 percent below the 2017 ABC and reflects projections using low recruitment estimates from 2016. In contrast, the 2019 and 2020 ABC recommendations are based upon long-term average recruitment. The SSC admitted that these catch levels are very conservative, estimating that the probability of overfishing is very low (8 percent).
At its June 2017 meeting, the Council adopted the SSC's butterfish ABC recommendations subject to annual review, as required by existing regulations. The Monitoring Committee indicated that discards and landings are adequately controlled under existing measures. Accordingly, the Monitoring Committee and the Council recommended using a lower estimate of management uncertainty when setting ACTs, adopting a 5-percent management uncertainty buffer in 2018, a 7.5-percent buffer in 2019, and maintaining the current 10-percent buffer for 2020. The Council reasoned that there is a lower likelihood of an unexpected change in butterfish discarding in the directed fishery with lower catch levels, allowing for a smaller ACT buffer in 2018 and 2019. This results in a proposed commercial ACT of 12,093 mt in 2018, and proposed ACTs of 25,075 mt in 2019 and 28,857 in 2020.
To prevent butterfish catch from exceeding the ACT, the Council subtracts butterfish catch in the longfin squid fishery, catch in other fisheries, and discards in the directed fishery. The Council recommended maintaining the butterfish cap for the longfin squid fishery at the 2014 level of 3,884 mt for 2018 and projected maintaining that level for 2019 and 2020. This cap is not constraining on the longfin fishery and reserves most of the available butterfish quota for the directed butterfish fishery. The maximum amount of butterfish discards in non-longfin fisheries from 2011-2013 was 637 mt. The Council did not indicate that there is a need to revise this estimate. Therefore, 4,521 mt (the 3,884-mt butterfish cap plus 637 mt of discards) would be subtracted from the ACT, as recommended. Next, the Council deducts an estimate of butterfish discards in the directed fishery to calculate the DAH (
Current regulations require butterfish specifications to establish a buffer to account for butterfish landings once the directed fishery is closed and a 5,000-lb (2,268-kg) incidental limit is imposed. Based on previous analysis, if such an incidental limit is implemented, less than 700 mt of butterfish would be landed after the directed fishery is closed. Therefore, the Council recommended closing the directed butterfish fishery once 11,093 mt is caught in 2018, 19,061 mt is caught in 2019, and 22,752 is caught in 2020. This would provide a 1,000-mt set aside in each year to account for incidental landings of butterfish after a closure of the directed fishery.
NMFS proposes specifications, consistent with the Council's recommendations, as outlined in Table 4. Because the Council did not recommend any changes to the allocation of the butterfish mortality cap on the longfin squid fishery, we also propose that the 2018-2020 butterfish mortality cap be allocated to Trimesters as follows:
Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed rule is consistent with the Atlantic Mackerel, Squid, and Butterfish FMP, other provisions of the Magnuson-Stevens Act, and other applicable law, subject to further consideration after public comment.
This proposed rule has been determined to be not significant for purposes of Executive Order 12866. This proposed rule is not expected to be an Executiver Order 13771 regulatory action because this proposed rule is not significant under Executive Order 12866.
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The purpose, context, and statutory basis for this action is described above and not repeated here. Business entities affected by this action include vessels that are issued limited access longfin squid/butterfish and
Any entity with combined annual fishery landing receipts less than $11 million is considered a small entity based on standards published in the
The existing
This action would reduce current commercial butterfish landing limits in 2018 and 2019. Compared to the 2017 commercial butterfish landing limit (20,652 mt), the proposed 2018 and projected 2019 commercial landing limits are 41 and 3 percent lower (12,093 mt and 20,061 mt, respectively), while the projected 2020 landing limit (23,752 mt) is 15 percent higher. Since 2014, the butterfish fishery has not landed more than 3,135 mt in any year. Recent landings peaked at 4,435 mt in 2001, representing only 37 percent of the proposed quota for 2018. Even at its peak, domestic landings reached 11,715 mt in 1984, which is still 3 percent shy of the proposed 2018 commercial quota. It is possible for the fishery to substantially increase butterfish landings compared to recent years without approaching the reduced limits proposed in this action. Therefore, although the proposed action would substantially reduce commercial butterfish landing limits in 2018, such a reduction is unlikely to impede commercial operations or reduce domestic butterfish landings from recent levels. Based on 2016 prices, if the fishery fully harvested the proposed 2018 commercial limit, it may generate nearly $17 million in fishery revenue, which would be a 41-percent reduction from potential revenue under landing limits consistent with 2017 landing limits. However, because we expect the fishery to land much less than the landing limit, these potential revenues are not realistic. Instead, we expect that the fishery would maintain recent catch levels, which would produce $2.3 million in fishing revenue based on average landings since 2012 and 2016 price estimates.
In determining the significance of the economic impacts of the proposed action, we considered the following two criteria outlined in applicable National Marine Fisheries Service guidance: Disproportionality and profitability. The proposed measures would not place a substantial number of small entities at a significant competitive disadvantage to large entities; all entities affected by this action would be equally affected. Accordingly, there are no distributional economic effects from this action between small and large entities. Proposed measures would not reduce fishing opportunities based on recent squid and butterfish landings, change any entity's access to these resources, or impose any costs to affected entities. Therefore, it is unlikely that this action would reduce revenues or profit for affected entities. Based on the above justification, the proposed action is not expected to have a significant economic impact on a substantial number of small entities.
16 U.S.C. 1801
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the 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 burden including the validity of the methodology and assumptions used; (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, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Comments regarding this information collection received by January 12, 2018 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725 17th Street NW, Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to:
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Animal and Plant Health Inspection Service, USDA.
Notice of solicitation for membership.
We are giving notice that the Secretary of Agriculture is soliciting nominations for the election of a member at-large and regional members and their alternates for the General Conference Committee of the National Poultry Improvement Plan.
Consideration will be given to nominations received on or before May 1, 2018.
Completed nomination forms should be sent to the person listed under
Dr. Denise L. Brinson, Senior Coordinator, National Poultry Improvement Plan, VS, APHIS, USDA, 1506 Klondike Road, Suite 101, Conyers, GA 30094; phone (770) 922-3496; fax (770-922-3498;
The General Conference Committee (the Committee) of the National Poultry Improvement Plan (NPIP) is the Secretary's Advisory Committee on poultry health. The Committee serves as a forum for the study of problems relating to poultry health and, as necessary, makes specific recommendations to the Secretary concerning ways the U.S. Department of Agriculture may assist the industry in addressing these problems. The Committee assists the Department in planning, organizing, and conducting the Biennial Conference of the NPIP. The Committee recommends whether new proposals should be considered by the delegates to the Biennial Conference and serves as a direct liaison between the NPIP and the United States Animal Health Association.
The Committee consists of an elected member-at-large who is an NPIP participant and an elected member (and alternate) from each of the six U.S. regions represented on the Committee. Terms will expire for three current regional members of the Committee, as well as the member-at-large, in June 2018. We are soliciting nominations from interested organizations and individuals to replace the member-at-large and members from the North Atlantic (Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, and Vermont), East North Central (Illinois, Indiana, Michigan, Ohio, and Wisconsin), and Western (Alaska, Arizona, California, Colorado, Hawaii, Idaho, Montana, Nevada, New Mexico, Oregon, Utah, Washington, and Wyoming) regions.
Member selection is determined by a majority vote of the NPIP delegates from the respective regions. The member-at-large will be elected by a majority vote of all official delegates. There must be at least two nominees for each position. Persons interested in serving on the Committee or nominating another individual to serve must complete Form AD-755, which is available on the internet at
To ensure the recommendations of the Committee have taken into account the needs of the diverse groups served by the Department, membership should include, to the extent practicable, individuals with demonstrated ability to represent underrepresented groups (minorities, women, and persons with disabilities). At least one nominee from each of the three regions, as well as for the member-at-large, must be from an underrepresented group. The voting will be by secret ballot of official delegates, and the results will be recorded.
Animal and Plant Health Inspection Service, USDA.
Revision to and extension of approval of an information collection; comment request.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request a revision to and extension of approval of an information collection associated with the regulations for the commercial transportation of equines to slaughtering facilities.
We will consider all comments that we receive on or before February 12, 2018.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
For information on the regulations for the commercial transportation of equines for slaughter, contact Mr. Joseph Astling, Compliance & Outreach, Commercial Transport of Equines for Slaughter, Surveillance, Preparedness, and Response Services, VS, APHIS, 4700 River Road, Unit 46, Riverdale, MD 20737; (817) 247-3704. For copies of more detailed information on the information collection, contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2843.
The regulations in part 88 provide minimum standards that cover, among other things, the food, water, and rest provided to such equines prior to transportation. The regulations also prohibit the commercial transportation for slaughter of equines considered to be unfit for travel, the use of electric prods on such animals in commercial transportation for slaughter, and the use of double-deck trailers for commercial transportation of equines for slaughter.
APHIS' regulations also require the application of backtags and the completion of owner/shipper certificates of fitness to travel to a slaughter facility that include identification of the animals, details of the transportation, and signatures attesting to compliance with the provision of food, rest, and water, and to the animal's fitness to travel. In addition, any owner/shipper transporting equines to slaughtering facilities outside the United States must present the owner-shipper certificates to USDA representatives at the U.S. border.
Implementing these regulations entails the use of information collection activities, such as providing business information, completing owner/shipper certificates of fitness to travel to a slaughter facility, certificates of veterinary inspection, maintaining records of the owner/shipper certificate and continuation sheet, and applying backtags, as needed.
The information collection requirements above are currently approved by the Office of Management and Budget (OMB) for the commercial transportation of equines for slaughter under OMB control numbers 0579-0332 and 0579-0160. After OMB approves this combined information collection package (0579-0332), APHIS will retire OMB control number 0579-0160.
We are asking OMB to approve our use of these information collection activities, as described, for an additional 3 years.
The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:
(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the 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, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies;
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
On August 10, 2017, the Georgia Foreign Trade Zone, Inc., grantee of FTZ 26, submitted a notification of proposed activity to the FTZ Board on behalf of Nisshinbo Automotive Manufacturing, Inc., within FTZ 26, Site 33, in Covington, Georgia.
The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the
On June 12, 2017, the Port of Corpus Christi Authority, grantee of FTZ 122, submitted a notification of proposed production activity to the FTZ Board on behalf of Voestalpine Texas, LLC, within Subzone 122T, in Portland, Texas.
The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the
On October 13, 2017, the Executive Secretary of the Foreign-Trade Zones (FTZ) Board docketed an application submitted by the Southwest Idaho Manufacturers' Alliance, grantee of FTZ 280, requesting expanded subzone status subject to the existing activation limit of FTZ 280, on behalf of Orgill, Inc., in Coeur d'Alene, Idaho.
The application was processed in accordance with the FTZ Act and Regulations, including notice in the
On June 21, 2017, Eastman Kodak Company submitted a notification of proposed production activity to the FTZ Board for its facility within Subzone 106F, in Weatherford, Oklahoma.
The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the
The City of Mobile, grantee of FTZ 82, submitted a notification of proposed production activity to the FTZ Board on behalf of Aker Solutions, Inc. (Aker), located in Mobile, Alabama. The notification conforming to the requirements of the regulations of the
Aker already has authority for the production of undersea umbilicals within Site 7 of FTZ 82. The current request would add finished products and foreign status materials/components to the scope of authority. Pursuant to 15 CFR 400.14(b), additional FTZ authority would be limited to the specific foreign-status materials/components and specific finished products described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.
Production under FTZ procedures could exempt Aker from customs duty payments on the foreign-status materials/components used in export production. On its domestic sales, for the foreign-status materials/components noted below and in the existing scope of authority, Aker would be able to choose the duty rates during customs entry procedures that apply to: Steel tube flying leads; hydraulic flying leads; cobra head terminations; umbilical termination assemblies; subsea distribution assemblies; mud mat assemblies; and, integrated controls jumpers/hydraulic bridge jumpers (duty rate ranges from duty-free to 3.7%). Aker would be able to avoid duty on foreign-status components which become scrap/waste. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.
The materials/components sourced from abroad include: Super duplex steel tubes; electrical cables exceeding 1000V; electrical cables exceeding 600V; fiber optic cables; rotary disc valves; valve bodies, bonnets, gates, seats, stems, non-elastomeric seals, elastomeric seals and fastener hardware for rotary disc valves; clamp connector assemblies; inboard hub forgings of low alloy steel; inboard hub flanges of low alloy steel; outboard hub forgings of low alloy steel; hub retainer flanges of low alloy steel; pressure cap forgings of low alloy steel; rotary gate valves; hydraulic gate valves; vertical connection system guide cone weldments; left/right retainer ring elements for clamp connector assemblies; and, top ring elements for clamp connector assemblies (duty rate ranges from duty-free to 5.3%).
Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is January 22, 2018.
A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230-0002, and in the “Reading Room” section of the Board's website, which is accessible via
For further information, contact Elizabeth Whiteman at
International Trade Administration, U.S. Department of Commerce.
Notice of an opportunity to apply for membership on the Advisory Committee on Supply Chain Competitiveness.
The Department of Commerce, International Trade Administration (ITA), is requesting nominations for the Advisory Committee on Supply Chain Competitiveness (“The Committee”). The Committee was established under the Federal Advisory Committee Act. The Committee was first chartered on November 21, 2011, and subsequently renewed on November 20, 2013, and November 17, 2015. The Department of Commerce most recently renewed the Committee for another two-year term beginning on November 16, 2017. The Committee has functioned effectively, and the Department has an on-going need for consensus advice regarding U.S. supply chain competitiveness. The Committee advises the Secretary on the necessary elements of a comprehensive policy approach to supply chain competitiveness designed to support U.S. export growth and national economic competitiveness, encourage innovation, facilitate the movement of goods, and improve the competitiveness of U.S. supply chains for goods and services in the domestic and global economy; and provides advice to the Secretary on regulatory policies and programs and investment priorities that affect the competitiveness of U.S. supply chains. The Department is seeking nominations for the newly-rechartered Committee.
Applications for immediate consideration for appointment must be received on or before 5:00 p.m. EDT on January 12, 2018. After that date, the Department of Commerce will continue to accept applications to fill any vacancies that may arise during the charter period.
Richard Boll, Office of Supply Chain, Professional & Business Services, Room 11014, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; phone 202-482-1135; email:
Richard Boll, Office of Supply Chain, Professional & Business Services, Room 11014, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; phone 202-482-1135; email:
The Committee has a maximum of 45 members. The Department of Commerce is seeking nominations for immediate consideration to fill positions on the Committee for the 2017-2019 charter term, and will continue to accept nominations under this notice on an on-going basis for two-years for consideration to fill vacancies that may arise during the charter term. Member appointment terms run for two-years concurrently with the Committee charter. Members will be selected based upon their ability to advise the Secretary of Commerce on the necessary elements of a comprehensive policy approach to supply chain competitiveness designed to support U.S. export growth and national economic competitiveness, encourage innovation, facilitate the movement of goods, and improve the competitiveness of U.S. supply chains for goods and services in the domestic and global economy; and to provide advice to the Secretary on regulatory policies and programs and investment priorities that affect the competitiveness of U.S. supply chains. The Committee provides detailed policy and technical advice, information, and recommendations to the Secretary regarding:
(1) National, state, or local factors in trade programs and policies that affect the efficient domestic and international operation and competitiveness of U.S. global supply chains from point of origin to destination;
(2) elements of national policies affecting the movement of goods, infrastructure, investment, and
(3) information and data systems to generate metrics that can be used to quantify and improve supply chain performance.
Members shall be selected in a manner that ensures that the Committee remains balanced in terms of product and service lines and reflects the diversity of the supply chain sector, including in terms of geographic location and company size.
Members of the Committee shall represent companies, organizations, and stakeholders involved in the U.S. supply chain, with at least one individual representing each of the following: Supply chain firms or their associations; users of supply chains (
Other than the experts from academia, all members shall serve in a representative capacity, expressing the views and interests of a U.S. company or U.S. organization, as well as its particular sector. Members serving in such a representative capacity are not Special Government Employees. The members from academia serve as experts and therefore are Special Government Employees (SGEs) and shall be subject to the ethical standards applicable to SGEs. Members who serve as SGEs must certify that they are not Federally-registered lobbyists.
Each member of the Committee must be a U.S. citizen and not registered as a foreign agent under the Foreign Agents Registration Act. All appointments are made without regard to political affiliation. Self-nominations will be accepted.
Members of the Committee will not be compensated for their services or reimbursed for their travel expenses. The Committee shall meet approximately quarterly, or as determined by the DFO.
Members shall serve at the pleasure of the Secretary.
All nominations for membership on the Committee should provide the following information:
(1) Name, title, and relevant contact information (including phone, fax, and email address) of the individual requesting consideration; and
(2) An affirmative statement that the applicant is not required to register as a foreign agent under the Foreign Agents Registration Act of 1938.
In addition to the above requirements for all nominations, nominations for representatives of companies, organizations, and stakeholders involved in the U.S. supply chain, including supply chain firms or their associations; users of supply chains (
(1) A sponsor letter on the letterhead of the sponsoring U.S. company or U.S. organization to be represented, containing a brief description why the nominee should be considered for membership;
(2) Short biography of nominee including credentials;
(3) Brief description of the U.S. company or U.S. organization to be represented and its activities and size (number of employees or members and annual sales, if applicable); and
(4) An affirmative statement that the applicant meets all Committee eligibility requirements for representative members, including that the applicant represents a U.S. company or U.S. organization.
a. For purposes of Committee eligibility, a U.S. company is at least 51 percent owned by U.S. persons.
b. For purposes of Committee eligibility, a U.S. organization is controlled by U.S. persons, as determined based on its board of directors (or comparable governing body), membership, and funding sources, as applicable.
In addition to the above requirements for all nominations, nominations for experts from academia should also provide the following information:
(1) A description of the nominee's area(s) of expertise;
(2) A concise Curriculum Vitae (CV) or resume that covers education, experience, and relevant publications and summarizes how this expertise addresses supply chain competitiveness;
(3) An affirmative statement that the applicant meets all Committee eligibility requirements.
Please do not send company or organization brochures.
Nominations may be emailed to
Commodity Futures Trading Commission.
Notice of meeting.
The Commodity Futures Trading Commission (CFTC) announces that on January 23, 2018, from 10:00 a.m. to 4:00 p.m., the Technology Advisory Committee (TAC) will hold a public meeting in the Conference Center at the CFTC's Washington, DC, headquarters. At this meeting, the TAC will: (1) Discuss the scope, plan, and approach for the Committee's efforts in 2018; (2) explore timely topics and issues involving financial technology in CFTC regulated markets, potentially including blockchain/DLT, data standardization and analytics, algorithmic trading, virtual currencies, cybersecurity, and RegTech; and (3) identify work streams and/or subcommittee groups that can help generate actionable recommendations to the Commission on select issues.
The meeting will be held on January 23, 2018, from 10:00 a.m. to 4:00 p.m. Members of the public who wish to submit written statements in connection with the meeting should submit them by January 30, 2018.
The meeting will take place in the Conference Center at the CFTC's headquarters, Three Lafayette Centre, 1155 21st Street NW, Washington, DC 20581. Written statements should be submitted by mail to: Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW, Washington, DC 20581, attention: Office of the Secretary; or by electronic mail to:
Daniel Gorfine, TAC Designated Federal Officer, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street, NW, Washington, DC 20581; (202) 418-5625.
The meeting will be open to the public with seating on a first-come, first-served basis. Members of the public may also listen to the meeting by telephone by calling a domestic toll-free telephone or international toll or toll-free number to connect to a live, listen-only audio feed. Call-in participants should be prepared to provide their first name, last name, and affiliation.
The meeting agenda may change to accommodate other TAC priorities. For agenda updates, please visit the TAC committee site at:
After the meeting, a transcript of the meeting will be published through a link on the CFTC's website,
5 U.S.C. app. 2 § 10(a)(2).
Department of Defense.
Amendment of Federal Advisory Committee.
The Department of Defense (DoD) is publishing this notice to announce that it is amending the charter for the Defense Policy Board.
Jim Freeman, Advisory Committee Management Officer for the Department of Defense, 703-692-5952.
This committee's charter is being amended in accordance with the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended) and 41 CFR 102-3.50(d). The amended charter and contact information for the Designated Federal Officer (DFO) can be obtained at
The DoD is amending the charter for the Defense Policy Board previously announced in the
Defense Security Cooperation Agency, Department of Defense.
Arms sales notice.
The Department of Defense is publishing the unclassified text of an arms sales notification.
Pamela Young, (703) 697-9107,
This 36(b)(1) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 17-51 with attached Policy Justification and Sensitivity of Technology.
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(vii)
(viii)
*As defined in Section 47(6) of the Arms Export Control Act.
The Government of Norway requested a possible sale of sixty (60) AIM-120 C-7 Advanced Medium Range Air-to-Air Missiles (AMRAAM) and four (4) AMRAAM guidance section spares. Also included are missile containers, weapon system support, support equipment, spare and repair parts, publications and technical documentation, personnel training, training equipment, U.S. Government and contractor engineering, logistics, technical and support services, and other related elements of logistics and program support. The estimated total case value is $170 million.
This proposed sale will support the foreign policy and national security objectives of the United States by improving the security of a NATO ally which continues to be an important force for political stability and economic progress in Europe.
The proposed sale will improve Norway's capabilities for mutual defense, regional security, force modernization, and U.S. and NATO interoperability. This sale will enhance the Royal Norwegian Air Force's ability to defend Norway against future threats and contribute to current and future NATO operations. This is a follow-on buy of additional AIM-120 C-7 missiles. Norway will be able to absorb these additional missiles and support into its armed forces.
The proposed sale of this equipment and support will not alter the basic military balance in the region.
The prime contractor will be Raytheon Missile Systems, Tucson, AZ. 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 personnel or contractor representatives to Norway.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
(vii)
1. AIM-120C Advanced Medium Range Air-to-Air Missile (AMRAAM) is a radar guided missile featuring digital technology and micro-miniature solid-state electronics. AMRAAM capabilities include look-down/shoot-down, multiple launches against multiple targets, resistance to electronic counter measures, and interception of high flying, low flying and maneuvering targets. The AMRAAM is classified CONFIDENTIAL, major components and subsystems range from UNCLASSIFIED to CONFIDENTIAL, and technology data and other documentation are classified up to SECRET.
2. If a technologically advanced adversary obtains knowledge of the specific hardware and software elements, the information could be used to develop countermeasures or equivalent systems that might reduce weapon system effectiveness or be used in the development of a system with similar or advanced capabilities.
3. A determination has been made that Norway can provide substantially the same degree of protection for the sensitive technology being released as the U.S. Government. This proposed sale is necessary to the furtherance of the U.S. foreign policy and national security objectives outlined in the policy justification.
4. All defense articles and services listed in this transmittal are authorized for release and export to the Government of Norway.
Department of the Navy; DoD.
Notice of availability for licensing.
The inventions listed below are assigned to the United States Government as represented by the Secretary of the Navy and are available for domestic and foreign licensing by the Department of the Navy.
The following patents are available for licensing://U.S. Patent No. 9,459,079: LIGHTWEIGHT ARMOR WITH SLIDE REGION FOR SLIDABLY REDIRECTING PROJECTILES//U.S. Patent No. 9,499,890: HIGH-STRENGTH, HIGH-TOUGHNESS STEEL ARTICLES FOR BALLISTIC AND CRYOGENIC APPLICATIONS AND METHOD OF MAKING THEREOF//U.S. Patent No. 9,524,358: CORE-MODULAR INTEROPERABILITY ARCHITECTURE FOR MODELING AND SIMULATION//U.S. Patent No. 9,557,414: ULTRA-BROADBAND COHERENT RADAR TRANSPONDER FOR PRECISION TRACKING//U.S. Patent No. 9,588,011: SHIP RESISTANCE PREDICTION USING A TURBULENT SPOT INDUCER IN MODEL TESTING//U.S. Patent No. 9,628,314: DIGITAL I/Q REPROCESSING DEMODULATOR (DIRD)//U.S. Patent No. 9,630,812: LOAD TRANSFER ACCESSORY FOR DIMINISHING UNWANTED MOTION OF CYLINDRICAL CARGO DURING LOADING OPERATIONS//U.S. Patent No. 9,651,374: METHOD AND SYSTEM FOR MEASURING PHYSICAL PHENOMENA IN AN OPEN WATER ENVIRONMENT//U.S. Patent No. 9,666,864: VERTICALLY ORIENTED GRAPHENE-SUPPORTED ANODE//U.S. Patent No. 9,667,349: DYNAMIC RANGE EXTENSION OF HETERODYNE FIBER-OPTIC INTERFEROMETERS VIA
Requests for copies of the patents cited should be directed to Office of Counsel, Naval Surface Warfare Center Carderock Division, 9500 MacArthur Blvd., West Bethesda, MD 20817-5700.
Dr. Joseph Teter, Director, Technology Transfer Office, Naval Surface Warfare Center Carderock Division, Code 00T, 9500 MacArthur Blvd., West Bethesda, MD 20817-5700, telephone 301-227-4299.
35 U.S.C. 207, 37 CFR part 404.
National Advisory Committee on Institutional Quality and Integrity, U.S. Department of Education.
Notice of membership.
This notice lists the members of the National Advisory Committee on Institutional Quality and Integrity (NACIQI). This notice is required under the Higher Education Act of 1965, as amended (HEA).
U.S. Department of Education, Office of Postsecondary Education, 400 Maryland Ave. SW, Room 6W250, Washington, DC 20202.
Jennifer Hong, Executive Director/Designated Federal Official, NACIQI, U.S. Department of Education, 400 Maryland Ave. SW, Room 6W250, Washington, DC 20202, telephone: (202) 453-7805, or email
NACIQI is established under Section 114 of the HEA, and is composed of 18 members appointed—
(A) On the basis of the individuals' experience, integrity, impartiality, and good judgment;
(B) From among individuals who are representatives of, or knowledgeable concerning, education and training beyond secondary education, representing all sectors and types of institutions of higher education; and,
(C) On the basis of the individuals' technical qualifications, professional standing, and demonstrated knowledge in the fields of accreditation and administration of higher education.
NACIQI meets at least twice a year and advises the Secretary of Education with respect to:
• The establishment and enforcement of the standards of accrediting agencies or associations under subpart 2 of part G of Title IV of the HEA;
• The recognition of specific accrediting agencies or associations;
• The preparation and publication of the list of nationally recognized accrediting agencies and associations;
• The eligibility and certification process for institutions of higher education under Title IV of the HEA and part C of subchapter I of chapter 34 of Title 42, together with recommendations for improvements in such process;
• The relationship between (1) accreditation of institutions of higher education and the certification and eligibility of such institutions, and (2) State licensing responsibilities with respect to such institutions; and
• Any other advisory functions relating to accreditation and institutional eligibility that the Secretary of Education may prescribe by regulation.
The term of office of each member is six years. Any member appointed to fill a vacancy occurring prior to the expiration of the term for which the member's predecessor was appointed shall be appointed for the remainder of such term.
The current members of the NACIQI are:
• Simon J. Boehme (Student Member), Independent Consultant, San Francisco, California.
• Roberta L. Derlin, Ph.D., Associate Provost Emeritus, New Mexico State University, Albuquerque, New Mexico.
• John Etchemendy, Ph.D., Provost Emeritus, Stanford University, Stanford, California.
• Susan D. Phillips, Ph.D., Professor, University at Albany/SUNY and Leadership Fellow, SAIL Institute, Albany, New York.
• Frank H. Wu, J.D., Distinguished Professor, University of California Hastings College of Law, San Francisco, California.
• Federico Zaragoza, Ph.D., Vice Chancellor for Economic and Workforce Development, Alamo Colleges, San Antonio, Texas.
• Kathleen Sullivan Alioto, Ed.D., Strategic Advisor, Fundraiser, and Consultant, New York, New York, San Francisco, California, and Boston, Massachusetts.
• George T. French, Jr., Ph.D., President, Miles College, Fairfield, Alabama.
• Brian W. Jones, J.D., President, Strayer University.
• Arthur E. Keiser, Ph.D., Chancellor, Keiser University, Fort Lauderdale, Florida.
• Arthur J. Rothkopf, J.D., President Emeritus, Lafayette College, Washington, DC.
• Ralph Wolff, J.D., President, The Quality Assurance Commons for Higher and Postsecondary Education, Oakland, California.
• Jill Derby, Ph.D., Senior Consultant, Association of Governing Boards of Universities and Colleges, Gardnerville, Nevada.
• Paul J. LeBlanc, Ph.D., President, Southern New Hampshire University, Manchester, New Hampshire.
• Anne D. Neal, J.D., Senior Fellow, American Council of Trustees and Alumni, Washington, DC.
• Richard F. O'Donnell, Founder and CEO, Skills Fund, Austin, Texas.
• Claude O. Pressnell, Jr., Ed.D., President, Tennessee Independent Colleges and Universities Association.
• Steven Van Ausdle, Ph.D., President Emeritus, Walla Walla Community College, Walla Walla, Washington.
Section 114 of the HEA.
U.S. Environmental Protection Agency (EPA).
Notice.
Notice is hereby given of the membership of the U.S. Environmental Protection Agency (EPA) Performance Review Board for 2017.
Vickie H. Tellis, Acting Director, Executive Resources Division, 3606A, Office of Human Resources, Office of Administration and Resources Management, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460 (202) 564-2653.
Section 4314(c)(1) through (5) of Title 5, U.S.C., requires each agency to establish in accordance with regulations prescribed by the Office of Personnel Management, one or more SES performance review boards. This board shall review and evaluate the initial appraisal of a senior executive's performance by the supervisor, along with any recommendations to the appointment authority relative to the performance of the senior executive.
Members of the 2017 EPA Performance Review Board are:
Environmental Protection Agency (EPA).
Notice.
EPA has submitted the following information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA): “Compliance Requirement for Child-Resistant Packaging” and identified by EPA ICR No. 0616.12 and OMB Control No. 2070-0052. The ICR, which is available in the docket along with other related materials, provides a detailed explanation of the collection activities and the burden estimate that is only briefly summarized in this document. EPA has addressed the comments received in response to the previously provided public review opportunity issued in the
Additional comments may be submitted on or before January 12, 2018.
Submit your comments, referencing Docket ID Number EPA-HQ-OPP-2016-0630, to both EPA and OMB as follows:
• To EPA online using
• To OMB via email to
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.
Joe Hogue, Field and External Affairs Division, Office of Pesticide Programs, 7506P, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 703-308-9072; email address:
Environmental Protection Agency (EPA).
Notice.
EPA has submitted the following information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA): “TSCA Section 4 Test Rules, Consent Orders, Enforceable Consent Agreements, Voluntary Testing Agreements, Voluntary Data
Comments must be received on or before January 12, 2018.
Submit your comments, identified by Docket ID number EPA-HQ-OPPT-2015-0436, to both EPA and OMB as follows:
• To EPA online using
• To OMB via email to
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.
Colby Lintner, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 554-1404; email address:
EPA must assure that appropriate tests are performed on a chemical if it decides: (1) That a chemical being considered under TSCA section 4(a) may pose an “unreasonable risk” or is produced in “substantial” quantities that may result in substantial or significant human exposure or substantial environmental release of the chemical; (2) that additional data are needed to determine or predict the impacts of the chemical's manufacture, processing, distribution, use or disposal; and (3) that testing is needed to develop such data. Rules and consent orders under TSCA section 4 require that one manufacturer or processor of a subject chemical perform the specified testing and report the results of that testing to EPA. TSCA section 4 also allows a manufacturer or processor of a subject chemical to apply for an exemption from the testing requirement if that testing will be or has been performed by another party. This information collection applies to reporting and recordkeeping activities associated with the information that EPA requires industry to provide in response to TSCA section 4 test rules, consent orders, test rule exemptions and other data submissions.
Environmental Protection Agency (EPA).
Notice of availability.
EPA is announcing the availability of a final document titled, “Integrated Science Assessment for Sulfur Oxides—Health Criteria” (EPA/600/R-17/451). The document was prepared by the National Center for Environmental Assessment (NCEA) within EPA's Office of Research and Development (ORD) as part of the review of the primary (health-based) National Ambient Air Quality Standards (NAAQS) for sulfur oxides (SO
The “Integrated Science Assessment for Sulfur Oxides—Health Criteria” will be available on or before December 14, 2017.
The “Integrated Science Assessment for Sulfur Oxides—Health Criteria” will be available primarily via the internet on EPA's Integrated Science Assessment for Sulfur Oxides (Health Criteria) home page at
For technical information, contact Dr. Tom Long, NCEA; phone: 919-541-1880; fax: 919-541-1818; or email:
Section 108(a) of the Clean Air Act directs the Administrator to identify certain pollutants which, among other things, “cause or contribute to air pollution which may reasonably be anticipated to endanger public health or welfare” and to issue air quality criteria for them. These air quality criteria are to “accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare which may be expected from the presence of [a] pollutant in the ambient air . . . .” Under section 109 of the Act, EPA is then to establish NAAQS for each pollutant for which EPA has issued criteria. Section 109(d) of the Act subsequently requires periodic review and, if appropriate, revision of existing air quality criteria to reflect advances in scientific knowledge on the effects of the pollutant on public health or welfare. EPA is also required to periodically review and, if appropriate, revise the NAAQS, based on the revised air quality criteria (for more information on the NAAQS review process, see
Sulfur oxides are one of six criteria pollutants for which EPA has established NAAQS. Periodically, EPA reviews the scientific basis for these standards by preparing an ISA (formerly called an Air Quality Criteria Document). The ISA provides a comprehensive review, synthesis, and evaluation of the most policy-relevant science to serve as the scientific foundation for EPA's review of the current primary NAAQS for SO
On May 10, 2013 (78 FR 27387), EPA formally initiated its current review of the air quality criteria for the health effects of sulfur oxides and the primary (health-based) NAAQS for SO
EPA has considered comments by the CASAC panel and by the public in preparing this final ISA.
Environmental Protection Agency, Region 10.
Proposed reissuance of a general permit.
The EPA is proposing to reissue a National Pollutant Discharge Elimination System (NPDES) General Permit (IDG370000) for small suction dredge operations in Idaho (intake nozzle size of 5 inches in diameter or a diametric equivalent or less and with equipment rated at 15 horsepower or less). The current permit established effluent limitations, standards, prohibitions and other conditions on discharges from covered facilities. These conditions are based on existing national effluent guidelines, the state of Idaho's Water Quality Standards and material contained in the administrative record. The EPA is proposing to retain most conditions of the current General Permit. A description of the basis for the conditions and requirements of the proposed general permit is given in the Fact Sheet. This is also notice of the draft Section 401 Certification provided by the state of Idaho.
Interested persons may submit comments on the proposed reissuance of the general permit to EPA, Region 10 at the address below. Comments must be postmarked by January 29, 2018.
Comments on the draft General Permit should be sent to Director, Office of Water and Watersheds; USEPA Region 10; 1200 Sixth Avenue, Suite 900, OWW-191; Seattle, WA 98101 and may also be submitted by fax to (206) 553-1280 or electronically to
Comments on the draft § 401 Certification should be sent to Nicole Deinarowicz, Idaho Department of Environmental Quality, 1410 N. Hilton, Boise, Idaho 83706 or electronically to
These documents may be found on the EPA Region 10 website at
Environmental Protection Agency (EPA).
Notice.
EPA has submitted the following information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA): “Safer Choice Product Recognition Program” and identified by EPA ICR No. 2302.03 and OMB Control No. 2070-0178. The ICR, which is available in the docket along with other related materials, provides a detailed explanation of the collection activities and the burden estimate that is only briefly summarized in this document. EPA did not receive any comments in response to the previously provided public review opportunity issued in the
Comments must be received on or before January 12, 2018.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2015-0437, to (1) EPA online using
EPA's policy is that all comments received will be included in the 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. Do not submit electronically any information you consider to be CBI or information whose disclosure is restricted by statute.
Colby Lintner, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 554-1404; email address:
Information collection activities associated with this program will assist the Agency in meeting the goals of the Pollution Prevention Act (PPA) by providing resources and recognition for businesses committed to promoting and using safer chemical products. In turn, the program will help businesses meet corporate sustainability goals by providing the means to, and an objective measure of, environmental stewardship. Investment analysts and advisers seek these types of measures in evaluating a corporation's sustainability profile and investment worthiness. Safer Choice Product Recognition program partnership is an important impetus for prioritizing and completing the transition to safer chemical products. The Safer Choice Product Recognition program is also needed to promote greater use of safer chemical products by companies unaware of the benefits of such a change.
EPA has tailored its request for information, and especially the Safer Choice Product Recognition program application forms, to ensure that the Agency requests only that information essential to verify applicants' eligibility for recognition.
82 FR 56827.
Tuesday, December 5, 2017 at 10:00 a.m. and its continuation at the conclusion of the open meeting on December 7, 2017.
This meeting also discussed:
Matters concerning participation in civil actions or proceedings or arbitration.
Judith Ingram, Press Officer, Telephone: (202) 694-1220.
Notice is hereby given that Great White Fleet Liner Services Ltd. and Great White Fleet Corp. (“Petitioners”), have petitioned the Commission pursuant to 46 U.S.C. 40103 of the Shipping Act of 1984 and Rules 92 and 94 of the Commission's Rules of Practice and Procedure, 46 CFR 502.92, and 46 CFR 502.94, for an exemption from “the provisions of 46 CFR 530.10 requiring each service contract amendment to be signed by both parties and filed with the Commission.”
The Petitioners state that a pending corporate restructuring will result in Great White Fleet Liner Services Ltd. transferring agreed upon assets and services to Great White Fleet Corp. As some of the transferred services will be “. . . service contracts with shippers filed with the Commission under the Shipping Act . . . ,” the Petitioners are requesting an exemption from 46 CFR 530.10 that requires “. . . all amendments to service contracts to be manually amended by both parties, including amendments changing the carrier party to a successor carrier, eve to an affiliate.” The Petitioners claim that “. . . approximately 300 service contracts would require manual amendments” which would “place a severe administrative burden upon the carriers and shippers alike . . .” among other issues. The Petitioners claim that “the potential for negative competitive or commercial effects is minimal . . .” due to the terms of their corporate restructuring.
In order for the Commission to make a thorough evaluation of the exemption requested in the Petition, pursuant to 46 CFR 502.92, interested parties are requested to submit views or arguments in reply to the Petition no later than December 27, 2017. Replies shall be sent to the Secretary by email to
Non-confidential filings may be submitted in hard copy to the Secretary at the above address or by email as a PDF attachment to
The companies listed in this notice have applied to the Board for approval, pursuant to the Home Owners' Loan Act (12 U.S.C. 1461
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank
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 January 8, 2018.
1.
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 January 8, 2018.
A. Federal Reserve Bank of Minneapolis (Mark A. Rauzi, Vice President) 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291:
1.
Office of Government-wide Policy (OGP); General Services Administration, (GSA).
Notice.
GSA is initiating its high-performance building certification systems review, required every five years by the Energy Independence and Security Act (EISA) of 2007. GSA will identify a system(s) and certification level that “will be most likely to encourage a comprehensive and environmentally sound approach” to the certification of high-performance Federal buildings.
December 13, 2017.
Mr. Patrick R. Dale, Office of Federal High-Performance Buildings, Management and Program Analyst, 1800 F Street NW, Washington, DC, 20405, telephone 202-999-9607, or via email, at
In this review cycle, GSA will be directly contacting representatives of systems that have passed GSA's screening criteria, described below, to request completion of a survey designed to provide GSA with detailed information about the identified system, in order to support its data collection process.
Systems deemed to meet all of the criteria will be evaluated in detail. GSA's screening criteria follow:
1. The certification system is currently available for use in the U.S. commercial buildings market and is not limited to one climate zone or geographic region.
2. The certification system addresses buildings (rather than individual products) with multiple performance and sustainable design attributes identified in EISA, including (but not limited to) energy, water, natural resources and environmental quality.
3. The certification system is validated by an independent, third-party assessor.
4. The certification system incorporates (where feasible), measurable and/or calculated metrics to assess building performance as opposed to evidence of intent.
GSA will request input from representatives of certification systems meeting the above screening criteria, to better inform its recommendation to the Secretary of Energy on what certification system(s) best meet(s) the requirements described in Section 436 of EISA.
GSA will provide the findings from its evaluation and set of recommendations to the Secretary of Energy who, in consultation with the Department of Defense and GSA, may identify the system(s) to recommend for use across the Federal Government.
Additional information can be found online at:
In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled Fellowship Management System to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on September 5, 2017 to obtain comments from the public and affected agencies. CDC received two non-substantive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:
(a) 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;
(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to be collected;
(d) 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,
(e) Assess information collection costs.
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to
Fellowship Management System, (OMB Control Number 0920-0765, Expiration date April 30, 2018)—Extension—Division of Scientific Education and Professional Development, Centers for Disease Control and Prevention (CDC).
The Division of Scientific Education and Professional Development (DSEPD) requests a three-year extension to continue use of CDC's Fellowship Management System (FMS) that allow individuals to apply to fellowships online, allow public health agencies to submit fellowship assignment proposals online, and track applicant and alumni information.
FMS is key to CDC's ability to protect the public's health by supporting training opportunities that strengthen the public health workforce. Since 2015, OMB has approved non-substantive changes to FMS information collection to accurately reflect evolving fellowship eligibility requirements, provide clarification of existing questions, accommodate the changing needs of host organizations, and to account for the addition of 150 new applicants to the Science Ambassadors Fellowship. A three-year extension will allow applicants, public health agencies, and alumni continued use of FMS for submission of electronic data.
The mission of DSEPD is to improve health outcomes through a competent, sustainable, and empowered public health workforce. Professionals in public health, epidemiology, medicine, economics, information science, veterinary medicine, nursing, public policy, and other related professionals seek opportunities, through CDC fellowships, to broaden their knowledge, skills, and experience to improve the science and practice of public health. CDC fellows are assigned to state, tribal, local, and territorial public health agencies; federal government agencies, including CDC and Department of Health and Human Services' operational divisions, such as Centers for Medicare & Medicaid Services; and to nongovernmental organizations, including academic institutions, tribal organizations, and private public health organizations.
FMS allows CDC to efficiently and effectively collect and process fellowship applications, fellowship assignment proposals, and fellowship alumni information from nonfederal persons. FMS is a flexible and robust data management system that is standardized and tailored for each CDC fellowship. CDC collects only the minimum amount of information required, thereby streamlining CDC's decision processes and reducing burden for respondents.
Respondent types vary depending on fellowship eligibility requirements. Responses to FMS questions are voluntary, and there are no costs to respondents other than their time.
CDC uses the information gathered to identify participants for its fellowship programs and address each program's needs and the needs of the public. By allowing online submissions of applications to fellowships and proposals for fellowship assignments, FMS can track fellowship applicants, alumni, and public health service agency employees seeking to host and work with fellows, all in one integrated database.
The total estimated annual burden hours are 4,556.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled
CDC must receive written comments on or before February 12, 2018.
You may submit comments, identified by Docket No. CDC-2017-0113 by any of the following methods:
•
To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
Under the Paperwork Reduction Act of 1995 (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. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
The OMB is particularly interested in comments that will help:
1. 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;
2. 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;
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,
5. Assess information collection costs.
Focus Group Testing to Effectively Plan and Tailor Cancer Prevention and Control Communications Campaigns—(OMB No. 0920-0800, exp. 12/31/2017)—Reinstatement without Change—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).
The mission of the CDC's Division of Cancer Prevention and Control (DCPC) is to reduce the burden of cancer in the United States through cancer prevention, reduction of risk, early detection, better treatment, and improved quality of life for cancer survivors. Toward this end, the DCPC supports the scientific development and implementation of various health communication campaigns with an emphasis on specific cancer burdens.
This process requires testing of messages, concepts, and materials prior to their final development and dissemination, as described in the second step of the health communication process. The health communication process is a scientific model developed by the U.S. Department of Health and Human Services' National Cancer Institute to guide sound campaign development. The communication literature supports various data collection methods, one of which is focus groups, to conduct credible formative, concept, message, and materials testing. The purpose of focus groups is to ensure that the public and other key audiences, like health professionals, clearly understand cancer-specific information and concepts, are motivated to take the desired action, and do not react negatively to the messages.
CDC is currently approved to collect information needed to plan and tailor cancer communication campaigns (OMB No. 0920-0800, expiration date 12/31/2017), and seeks OMB approval to extend the existing generic clearance.
Information collection will involve focus groups to assess numerous qualitative dimensions of cancer prevention and control messages including, but not limited to, cancer knowledge, attitudes, beliefs, behavioral intentions, information needs and sources, clinical practices (among healthcare providers), and compliance with recommended cancer screening. Insights gained from the focus groups will assist in the development and/or refinement of future campaign messages and materials.
Respondents will include healthcare providers as well as members of the general public. Communication campaigns and messages will vary according to the type of cancer, the qualitative dimensions of the message described above, and the type of respondents.
DCPC plans to conduct or sponsor up to 80 focus groups per year over a three-year period. An average of 10 respondents will participate in each
A separate information collection request will be submitted to OMB for approval of each focus group activity. The request will describe the purpose of the activity and include the customized information collection instruments.
OMB approval is requested for three years. There are no changes to information collection purpose or methodology. Participation is voluntary and there are no costs to respondents except their time.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled the National Vital Statistics Report Forms. These are the data collection forms used by State and/or county vital registration offices to report to the Federal government (a) provisional counts of births, deaths, and infant deaths at the end of each month and (b) annual counts of marriages and divorces/annulments in support of the National Vital Statistics System. This submission contains no changes to the actual data collection forms. However, the number of respondent for the monthly and annual forms have shifted from 91 and 58 respectively to 58 and 91, since the 33 New Mexico Counties only send marriage and divorce information that is now only captured in the annual report.
CDC must receive written comments on or before February 12, 2018.
You may submit comments, identified by Docket No. CDC-2017-0107 by any of the following methods:
•
•
To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
Under the Paperwork Reduction Act of 1995 (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. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
1. 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;
2. 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;
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,
5. Assess information collection costs.
National Vital Statistics Report Forms (OMB Control Number 0920-0213, expires 04/30/2018)—Revision—National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC).
The compilation of national vital statistics dates back to the beginning of the 20th century and has been conducted since 1960 by the Division of Vital Statistics of the National Center for Health Statistics, CDC. The collection of the data is authorized by 42 U.S.C. 242k. This submission requests approval to collect the monthly and annually summary statistics for three years.
The Monthly Vital Statistics Report forms provide counts of monthly occurrences of births, deaths, and infant deaths. Similar data have been published since 1937 and are the sole source of these data at the National level. The data are used by the Department of Health and Human Services and by other government, academic, and private research and commercial organizations in tracking changes in trends of vital events. Respondents for the Monthly Vital Statistics Reports Form are registration officials in each State and Territory, the District of Columbia, and New York City. This form is also designed to collect counts of monthly occurrences of births, deaths, and infant deaths immediately following the month of occurrence.
The Annual Vital Statistics Occurrence Report Form collects final annual counts of marriages and divorces by month for each State and Territory, the District of Columbia, and New York City as well as 33 counties in New Mexico. These final counts are usually available from State or county officials about eight months after the end of the data year. The data are widely used by government, academic, private research, and commercial organizations in tracking changes in trends of family formation and dissolution.
There are no costs to respondents other than their time.
In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled
CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:
(a) 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;
(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to be collected;
(d) 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,
(e) Assess information collection costs.
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to
Drug Overdose Response Investigation (DORI) Data Collections (OMB Control Number 0920-1054, Expiration 03/31/2018)—Extension—National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC).
In 2015, CDC received a three-year OMB approval (OMB Control Number 0920-1054) for a new generic clearance plan to collect information in response to urgent requests from state and local health authorities to provide epidemiological information that allows for the selection of interventions to curb local epidemics of drug overdose. CDC seeks OMB approval for an extension of this generic clearance plan for another three-year period.
Drug Overdose Response Investigation (DORI) are to be conducted in response to urgent requests from state and local health authorities to provide
CDC requests this plan to ensure that timely information is collected during a DORI, which allows NCIPC to maintain critical mission function by working with state and local health authorities to protect the public's health. During an unanticipated rise in nonfatal or fatal drug overdose where the substances responsible for the health event need to be identified, drivers and risk factors are undetermined, and/or subgroups at risk need to be identified, immediate action by CDC is necessary to minimize or prevent public harm. CDC must have the ability to rapidly deploy data collection tools to understand the scope of the problem and determine appropriate action. Procedures for each investigation, including specific data collection plans, depend on the time and resources available, number of persons involved, and other circumstances unique to the urgent conditions at hand. Data are collected by epidemiologists, psychologists, medical professionals, subject matter experts, and biostatisticians.
Data collected during a DORI are used to understand sudden increases in drug use and misuse associated with fatal and nonfatal overdoses, understand the drivers and risk factors associated with those trends, and identify the groups most affected. This allows CDC to effectively advise states on actions that could be taken to control the local epidemic.
During a DORI, data are collected once, with the rare need for follow-up. The estimated annual burden hours are 1,000, there is no increase in the burden hours from the previously approved collection. There are no costs to respondents other than their time.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed extension of the existing information
CDC must receive written comments on or before February 12, 2018.
You may submit comments, identified by Docket No. CDC-2017-0108 by any of the following methods:
•
•
To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
Under the Paperwork Reduction Act of 1995 (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. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
The OMB is particularly interested in comments that will help:
1. 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;
2. 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;
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,
5. Assess information collection costs.
Message Testing for Tobacco Communication Activities (MTTCA)(OMB Control Number 0920-0910, expires 03/31/2018)—Extension—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).
In 2012, CDC's Office on Smoking and Health obtained OMB approval of a generic clearance plan to support the development and testing of tobacco-related health messages, including messages disseminated through multiple phases of a media campaign (Message Testing for Tobacco Communication Activities (MTTCA), OMB No. 0920-0910, expiration 1/31/2015). In 2014, OSH obtained approval for a modification to the MTTCA clearance that granted a three-year extension and an increase in respondents and burden hours (MTTCA, OMB Control Number 0920-0910, exp. 3/31/2018). This MTTCA clearance was approved with 44,216 annualized responses and 10,998 annualized burden hours. CDC's authority to collect information for public health purposes is provided by the Public Health Service Act (41 U.S.C. 241) Section 301.
CDC has employed the MTTCA data collection plan to collect information about adult smokers' and nonsmokers' attitudes and perceptions, and to pretest draft messages and materials for clarity, salience, appeal, and persuasiveness. The MTTCA clearance has been used to obtain OMB approval for a variety of message testing activities, with particular emphasis on communications supporting CDC's National Tobacco Education Campaign (NTEC) called the
Information collection modes under the MTTCA plan that are supported include in-depth interviews; in-person focus groups; online focus groups; computer-assisted, in-person, or telephone interviews; and online surveys. Each project approved under the MTTCA framework is outlined in a project-specific Information Collection Request that describes its purpose and methodology. Messages developed from MTTCA data collection have been disseminated via multiple media channels including television, radio, print, out-of-home, and digital formats.
CDC requests OMB approval to extend the MTTCA generic information collection plan, without changes, for three years. No modification is requested for information collection activities, methodology, respondents, or burden from the existing generic clearance. The extension is needed to support CDC's planned information collections and to accommodate additional needs that CDC may identify during the next three years. For example, the MTTCA generic plan may be used to facilitate the development of tobacco-related health communications of interest for CDC's collaborative efforts with other federal partners including, but not limited to, the Food and Drug Administration's Center for Tobacco Products. At this time, the respondents and burden outlined in the existing MTTCA clearance are expected to be sufficient to test tobacco related messages developed by CDC for the general U.S. population and subpopulations of interest. The MTTCA clearance should not replace the need for additional generic clearance mechanisms of HHS and other federal partners that may need to test tobacco messages related to their campaigns and initiatives.
The existing MTTCA clearance was granted approval for a total of 132,648 respondents and 32,994 burden hours over a three-year period (annualized number of respondents of 44,216 and annualized burden hours to 10,998). To date, there have been 57,612 respondents and 10,515 burden hours used for this project, leaving a balance of 75,036 respondents and 22,479 burden hours (annualized number of respondents of 25,012 and annualized burden hours to 7,256 for each of the three years in the requested extension).
CDC will continue to use the MTTCA clearance to develop and test messages and materials. Participation is voluntary and there are no costs to respondents, other than their time.
In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled National Program of Cancer Registries Program Evaluation Instrument (NPCR_PEI) to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on January 5, 2017 to obtain comments from the public and affected agencies. CDC did not receive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:
(a) 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;
(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to be collected;
(d) 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,
(e) Assess information collection costs.
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to
National Program of Cancer Registries Program Evaluation Instrument (NPCR-PEI)—(OMB Control Number 0920-0706, expired 05/31/2016)—Reinstatement with change—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).
CDC is responsible for administering and monitoring the National Program of Cancer Registries (NPCR). The NPCR provides technical assistance and funding and sets program standards to assure that complete local, state, regional, and national cancer incidence data are available for national and state cancer control and prevention activities and health planning activities.
CDC has used the Program Evaluation Instrument for 24 years to monitor the performance of NPCR grantees in meeting the required Program Standards. In 2009, CDC reduced the frequency of the data collection from an annual to a biennial schedule in odd-numbered years.
CDC currently supports 48 population-based central cancer registries (CCR) in 45 states, one territory, the District of Columbia, and the Pacific Islands. The National Cancer Institute supports the operations of CCRs in the five remaining states.
CDC released a new Funding Opportunity Announcement (FOA) (DP17-1701) on December 15, 2017. This FOA closed on March 24, 2017. A new project period began on July 1, 2017. DP17-1701 allowed previously unfunded states to apply for NPCR funding. DP17-1701 NPCR eligibility will include the 48 awardees funded under the DP12-1205 FOA and potentially two previously unfunded State health departments or their Bona Fide Agents, and US territories.
The Program Evaluation Instrument (NCPR-PEI) includes questions about the following categories of registry operations: (1) Staffing, (2) legislation, (3) administration, (4) reporting completeness, (5) data exchange, (6) data content and format, (7) data quality assurance, (8) data use, (9) collaborative relationships, (10) advanced activities, and (11) survey feedback.
Examples of possible obtainable information include, but are not limited to: (1) Number of filled staff full-time positions by position responsibility; (2) revision to cancer reporting legislation; (3) various data quality control activities; (4) data collection activities as they relate to achieving NPCR program standards for data completeness; and (5) whether registry data is being used for comprehensive cancer control programs, needs assessment/program planning, clinical studies, or incidence and mortality estimates.
The NPCR-PEI is needed to receive, process, evaluate, aggregate, and disseminate NPCR program information. The CDC and NPCR-funded registries use this information to monitor progress toward meeting established program standards, goals, and objectives; to evaluate various attributes of the registries funded by NPCR; and to respond to data inquiries made by CDC and other agencies of the federal government.
CDC requests a three-year OMB approval to collect information in the winter of 2017 and 2019. There are no costs to respondents except their time. CDC estimates 66 hours a year in time burden for the respondents.
Centers for Medicare & Medicaid Services, HHS.
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 February 12, 2018.
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' website 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.
William Parham at (410) 786-4669.
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
1.
Centers for Medicare & Medicaid Services, HHS.
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 (PRA), federal agencies are required to publish notice in the
Comments on the collection(s) of information must be received by the OMB desk officer by January 12, 2018.
When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806
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 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.
William Parham at (410) 786-4669.
Under the Paperwork Reduction Act of 1995 (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 (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the
1.
The development of streamlined submissions forms enhances the collaboration and partnership between states and CMS by documenting our policy for states to use as they are developing program changes. Streamlined forms improve efficiency of administration by creating a common and user-friendly understanding of the information we need to quickly process requests for state plan amendments, waivers, and demonstration, as well as ongoing reporting.
2.
In compliance with the requirements of the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chap 35), the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW, Washington, DC 20201. Attn: ACF Reports Clearance Officer. Email address:
The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.
The data collected will inform State/Tribal/Federal policy decisions, program management, and responses to Congressional and Departmental inquiries. Specifically, the data are used for short/long-term budget projections, trend analysis, child and family service reviews, and to target areas for improved technical assistance. The data will provide information about foster care placements, adoptive parents, length of time in care, delays in termination of parental rights and placement for adoption.
Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L'Enfant Promenade SW, Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address:
OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the
In compliance with the requirements of the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chap 35), the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW, Washington, DC 20201. Attn: ACF Reports Clearance Officer. Email address:
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Refuse to File: NDA and BLA Submissions to CDER.” The purpose of this guidance is to clarify certain circumstances under which FDA's Center for Drug Evaluation and Research (CDER) may refuse to file a new drug application (NDA) or
Submit either electronic or written comments on the draft guidance by February 12, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
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. Send one self-addressed adhesive label to assist that office in processing your requests. See the
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.
FDA is announcing the availability of a draft guidance for industry entitled “Refuse to File: NDA and BLA Submissions to CDER.” The purpose of this guidance is to clarify certain circumstances under which CDER may refuse to file an NDA or supplemental NDA, or a BLA or supplemental BLA submitted to CDER, and to underscore the importance of submitting a complete application to minimize the chance of an RTF action by FDA. Since the early 1990s, in conjunction with the Prescription Drug User Fee Act, FDA's processes and timelines for reviewing newly submitted applications have substantially evolved. The administrative complexity of applications, with corresponding determinations of
Incomplete applications, including applications for which minor components not received within 30 calendar days after receipt of the original application, as may have been agreed upon at a presubmission meeting, may be refused for filing.
This guidance focuses on FDA's policy for refusing to file an NDA under 21 CFR 314.101(d)(3) because the NDA is incomplete because it does not on its face contain information required under section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) and 21 CFR 314.50. FDA considers incompleteness to be a basis for refusal to file for BLAs as well (21 CFR 601.2(a)).
On May 19, 2017, FDA withdrew its previously published guidance for industry entitled “Refusal to File” (issued July 12, 1993). FDA is issuing this guidance to update and clarify CDER's procedures for determining whether an application should be
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 refusal to file NDA and BLA submissions to CDER. 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 is not subject to Executive Order 12866.
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 314 have been approved under OMB control number 0910-0001. The collections of information in 21 CFR part 601 have been approved under OMB control number 0910-0338.
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, the Agency, or we) is announcing the establishment of the Susceptibility Test Interpretive Criteria Website. The Susceptibility Test Interpretive Criteria Website will help to efficiently update susceptibility test interpretive criteria for antimicrobial drugs when necessary for public health and may allow for more efficient development and evaluation of antimicrobial susceptibility test (AST) devices. These changes may lead to better patient care and reduce antimicrobial resistance through improved antibiotic stewardship. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act (Cures Act).
Katherine Schumann, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6242, Silver Spring, MD 20993-0002, 301-796-1182,
Antimicrobial susceptibility testing is used to determine if certain microorganisms that are isolated from a patient with an infection are likely to be killed or inhibited by a particular antimicrobial drug. It is important that the in vitro susceptibility test methods and susceptibility test interpretive criteria for systemic antibacterial or antifungal drugs be reviewed on a regular basis and updated to reflect the most current information. The development of new mechanisms of resistance in bacteria or fungi may result in decreased susceptibility to a particular drug. Decreased susceptibility may raise efficacy or safety concerns when out-of-date susceptibility test interpretive criteria are used in guiding the treatment of patients.
Historically, susceptibility test interpretive criteria have been contained in the Microbiology subsection of antimicrobial drug labeling, and there have been significant challenges associated with ensuring that this information is up-to-date in individual antimicrobial drug labels. For some time, FDA and other stakeholders have recognized that susceptibility test interpretive criteria standards established by nationally or internationally recognized standard development organizations (SDOs) can be useful sources of information to identify and update susceptibility test interpretive criteria.
Section 511A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360a-2), as added by section 3044 of the Cures Act (Pub. L. 114-255), was signed into law on December 13, 2016. This provision clarifies FDA's authority to identify and efficiently update susceptibility test interpretive criteria, including through the recognition by FDA of standards established by SDOs. It also clarifies that sponsors of AST devices may rely upon listed susceptibility interpretive criteria to support premarket authorization of their devices, provided they meet certain conditions, which provides for a more streamlined process for incorporating up-to-date information into such devices.
Section 511A of the FD&C Act requires FDA to establish within 1 year after the date of enactment of the Cures Act an Interpretive Criteria Website that contains a list of FDA-recognized susceptibility test interpretive criteria standards, as well as other susceptibility test interpretive criteria identified by FDA. FDA is announcing the establishment of this Interpretive Criteria Website, which can be found here:
This website recognizes susceptibility test interpretive criteria established by an SDO that fulfills the requirements under section 511A(b)(2)(A) of the FD&C Act; identifies when FDA does not recognize, in whole or in part, susceptibility test interpretive criteria established by an SDO; and lists susceptibility test interpretive criteria identified by FDA outside the SDO process. The susceptibility test interpretive criteria listed by FDA on the Interpretive Criteria Website are deemed to be recognized as a standard under section 514(c)(1) of the FD&C Act (21 U.S.C. 360d(c)(1)).
At least every 6 months after the establishment of the Interpretive Criteria Website, FDA will publish on the Interpretive Criteria Website a notice recognizing new or updated susceptibility test interpretive criteria standards, or parts of standards; withdrawing recognition of susceptibility test interpretive criteria standards, or parts of standards; and making any other necessary updates to the lists published on the Interpretive Criteria Website. Once a year FDA will compile the notices from that year and publish them in the
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Gluten in Drug Products and Associated Labeling Recommendations.” This draft guidance is intended to convey to drug manufacturers FDA's recommendations on how certain oral drug products should be labeled regarding gluten, a matter of interest to individuals with celiac disease. Some individuals with celiac disease have faced difficulty when trying to determine whether specific drug products contain gluten. This draft guidance encourages drug manufacturers to have accurate information about their products' gluten content available so they can respond to questions from consumers and health care professionals.
Submit either electronic or written comments on the draft guidance by February 12, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
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 to the Office of Communication, Outreach and Development, 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
Marci Kiester, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2258, Silver Spring, MD 20993-0002, 301-796-0600; 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 “Gluten in Drug Products and Associated Labeling
Celiac disease is an immune-based reaction to dietary gluten that primarily affects the small intestine in susceptible individuals; unmanaged celiac disease can lead to serious health complications. Approximately 1 percent of the U.S. population has celiac disease (Binder, 2015, “Disorders of Absorption,” in
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 Gluten in Drug Products and Associated Labeling Recommendations. 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 is not subject to Executive Order 12866.
This draft 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 discussed in the draft guidance have been approved by OMB under the following control numbers:
The recommended labeling statement in this draft guidance, “Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)” is information provided by FDA to applicants and manufacturers for disclosure to the public and therefore does not constitute a collection of information under 5 CFR 1320.3(c)(2).
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 or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by February 12, 2018.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before February 12, 2018. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Ila Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
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. “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 (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
This information collection supports the above captioned Agency guidance document. FDA recommends that producers who use biotechnology in the manufacture or development of foods and food ingredients work cooperatively with FDA to ensure that products derived through biotechnology are safe and comply with all applicable legal requirements and has instituted a voluntary consultation process with industry. To facilitate this process, the Agency has issued a guidance entitled, “Guidance on Consultation Procedures: Foods Derived From New Plant Varieties,” which is available on our website at
Since 1992, when FDA issued its “Statement of Policy: Foods Derived From New Plant Varieties” (the 1992 policy) (57 FR 22984, May 29, 1992), FDA has encouraged developers of new plant varieties, including those varieties that are developed through biotechnology, to consult with FDA during the plant development process to discuss possible scientific and regulatory issues that might arise. In the 1992 policy, FDA explained that, under the FD&C Act, developers of new foods (in this document food refers to both human food and animal feed) have a responsibility to ensure that the foods they offer to consumers are safe and in compliance with all requirements of the FD&C Act (57 FR 22984 at 22985).
FDA estimates the burden of this collection of information as follows:
We have retained the currently approved burden estimate for this information collection and discuss the information collection activities below.
Initial consultations are generally a one-time burden, although a developer might return more than once to discuss additional issues before submitting a final consultation. As noted in the guidance, FDA encourages developers to consult early in the development phase of their products, and as often as necessary. Historically, firms developing a new bioengineered plant variety intended for food use have generally initiated consultation with FDA early in the process of developing such a variety, even though there is no legal obligation for such consultation. These consultations have served to make FDA aware of foods and food ingredients before these products are distributed commercially, and have provided FDA with the information necessary to address any potential questions regarding the safety, labeling, or regulatory status of the food or food ingredient. As such, these consultations have provided assistance to both industry and the Agency in exercising their mutual responsibilities under the FD&C Act.
FDA estimates that its Center for Veterinary Medicine and its Center for Food Safety and Applied Nutrition jointly received an average of 40 initial consultations per year in the last 3 years via telephone, email, or written letter. Based on this information, we expect to receive no more than 40 annually in the next 3 years.
Final consultations are a one-time burden. At some stage in the process of research and development, a developer will have accumulated the information that the developer believes is adequate to ensure that food derived from the new plant variety is safe and that it demonstrates compliance with the relevant provisions of the FD&C Act. The developer will then be in a position to conclude any ongoing consultation with FDA. The developer submits to FDA a summary of the safety and nutritional assessment that has been conducted about the bioengineered food that is intended to be introduced into commercial distribution. FDA evaluates the submission to ensure that all potential safety and regulatory questions have been addressed. FDA has developed a form that prompts a developer to include certain elements in the final consultation in a standard format: Form FDA 3665 entitled, “Final Consultation for Food Derived From a New Plant Variety (Biotechnology Final Consultation).” The form, and elements that would be prepared as attachments to the form, can be submitted in electronic format.
We base our estimate of the average time to prepare a submission on informal contact with firms that made one or more biotechnology consultation submission under the voluntary biotechnology consultation process. As such, we estimate the average time to prepare a submission for final consultation to be 150 hours.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by January 12, 2018.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7729,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed
This information collection supports Agency outreach efforts. Testing of communication messages in advance of a communication campaign provides an important role in improving FDA communications as they allow for an in-depth understanding of individuals' attitudes, beliefs, motivations, and feelings. The methods to be employed include individual in-depth interviews, general public focus group interviews, intercept interviews, self-administered surveys, gatekeeper surveys, and professional clinician focus group interviews, all on a voluntary basis. The methods to be used serve the narrowly defined need for direct and informal opinion on a specific topic and, as a qualitative research tool, have two major purposes: To obtain information that is useful for developing variables and measures for formulating the basic objectives of risk communication campaigns, and to assess the potential effectiveness of messages and materials in reaching and successfully communicating with their intended audiences.
FDA will use these methods to test and refine its ideas and to help develop messages and other communications but will generally conduct further research before making important decisions, such as adopting new policies and allocating or redirecting significant resources to support these policies. FDA will use this mechanism to test messages about regulated drug products on a variety of subjects related to consumer, patient, or health care professional perceptions and about use of drug products and related materials, including but not limited to, direct-to-consumer prescription drug promotion, physician labeling of prescription drugs, medication guides, over-the-counter drug labeling, emerging risk communications, patient labeling, online sale of medical products, and consumer and professional education. Annually, FDA projects about 45 communication studies using the variety of test methods listed in this document. FDA is requesting an extension of these burden hours so as not to restrict the Agency's ability to gather information on public sentiment for its proposals in its regulatory and communications programs.
In the
We therefore estimate the burden of this collection of information as follows:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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, notice is hereby given of a meeting of the Board of Scientific Counselors, Lister Hill National Center for Biomedical Communications.
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 meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for review, discussion, and evaluation of individual intramural programs and projects conducted by the NATIONAL LIBRARY OF MEDICINE, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
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.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the meetings.
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 materials, 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, 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(a) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Sleep Disorders Research Advisory Board.
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.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of meetings of the NHLBI Special Emphasis Panel.
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, notice is hereby given of a meeting of the Board of Scientific Counselors, National Center for Biotechnology Information.
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 meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for review, discussion, and evaluation of individual intramural programs and projects conducted by the NATIONAL LIBRARY OF MEDICINE, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
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
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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, notice is hereby given of the following meetings of the NHLBI Special Emphasis Panel.
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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, 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, notice is hereby given of a meeting of the Literature Selection Technical Review Committee.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and
The portions of the meeting devoted to the review and evaluation of journals for potential indexing by the National Library of Medicine will be closed to the public in accordance with the provisions set forth in section 552b(c)(9)(B), Title 5 U.S.C., as amended. Premature disclosure of the titles of the journals as potential titles to be indexed by the National Library of Medicine, the discussions, and the presence of individuals associated with these publications could significantly frustrate the review and evaluation of individual journals.
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.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Board of Regents of the National Library of Medicine.
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 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 materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Closed: 7:45 a.m. to 8:45 a.m.
Open: February 13, 2018, 9:00 a.m. to 4:00 p.m.
Closed: February 13, 2018, 4:00 p.m. to 4:30 p.m.
Open: February 14, 2018, 9:00 a.m. to 12:00 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:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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,
Federal Emergency Management Agency, DHS.
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 date of April 18, 2018 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
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, 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 Insurance and 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.
Federal Emergency Management Agency, DHS.
Notice.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. 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). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings.
Comments are to be submitted on or before March 13, 2018.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location
You may submit comments, identified by Docket No. FEMA-B-1764, to Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed 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. These 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 built after the FIRM and FIS report become effective.
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location
Federal Emergency Management Agency, DHS.
Notice.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. 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). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new
Comments are to be submitted on or before March 13, 2018.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location
You may submit comments, identified by Docket No. FEMA-B-1763, to Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed 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. These 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 built after the FIRM and FIS report become effective.
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location
Federal Emergency Management Agency, DHS.
Notice and request for comments.
The Federal Emergency Management Agency, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on a reinstatement, without change, of a previously approved information collection for which approval has expired. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning the collection of information under which communities submit information to FEMA for application and continued participation in the National Flood Insurance Program (NFIP).
Comments must be submitted on or before February 12, 2018.
To avoid duplicate submissions to the docket, please use only one of the following means to submit comments:
(1)
(2)
All submissions received must include the agency name and Docket ID. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at
Adrienne L. Sheldon, Supervisory Emergency Management Specialist, Floodplain Management Division (202) 212-3966. You may contact the Records Management Division for copies of the proposed collection of information at email address:
The National Flood Insurance Program (NFIP), codified at 42 U.S.C. 4001,
This information collection expired on September 30, 2017. FEMA is requesting a reinstatement, without change, of a previously approved information collection for which approval has expired.
To qualify for the NFIP, a participating community must adopt certain minimum standards in accordance with FEMA's regulations at 44 CFR 60.3, 60.4, and 60.5. In order to verify whether communities maintain such standards, the NFIP requires participating communities to retain documentation on development taking place in the flood hazard areas within the community. 44 CFR 59.22. Such information will be made available to FEMA upon request. This information assists FEMA in evaluating the effectiveness of a community's floodplain management program and participating property owners' eligibility for flood insurance.
This reinstatement does not propose any change in the information solicited from respondents through this information collection; however, the number of burden hours has been updated to reflect changing number of respondents and responses received through this collection over time. These changes have occurred naturally, and do not result from specific action taken by FEMA.
The “Application for Participation in the NFIP” and the “NFIP and the Community Development Permit Process” are separate actions documented under the same collection.
Comments may be submitted as indicated in the
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 be finalized 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 Insurance and Mitigation reconsider the changes. The flood hazard determination information may be changed during the 90-day period.
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.
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, 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
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.
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
These flood hazard determinations will be finalized 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 Insurance and Mitigation reconsider the changes. The flood hazard determination information may be changed during the 90-day period.
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.
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, 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.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. 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). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings.
Comments are to be submitted on or before March 13, 2018.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location
You may submit comments, identified by Docket No. FEMA-B-1769, to Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed 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. These 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 built after the FIRM and FIS report become effective.
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location
Federal Emergency Management Agency, DHS.
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.
Each LOMR was finalized as 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
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, 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 Insurance and 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).
These 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.
Notice.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. 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). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings.
Comments are to be submitted on or before March 13, 2018.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location
You may submit comments, identified by Docket No. FEMA-B-1766, to Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed 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. These 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 built after the FIRM and FIS report become effective.
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The watersheds and/or communities affected are listed in the tables below.
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 be finalized 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 Insurance and Mitigation reconsider the changes. The flood hazard determination information may be changed during the 90-day period.
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.
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, 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
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.
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 date of May 2, 2018 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
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, 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 Insurance and 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.
Transportation Security Administration, DHS.
30-Day Notice.
This notice announces that the Transportation Security Administration (TSA) has forwarded the Information Collection Request (ICR), Office of Management and Budget (OMB) control number 1652-0001, abstracted below to OMB for review and approval of an extension of the currently approved collection under the Paperwork Reduction Act (PRA). The ICR describes the nature of the information collection and its expected burden. The collection involves air carriers and foreign air carriers maintaining an accounting system to account for the passenger civil aviation security service fees collected and reporting this information to TSA on a quarterly basis, as well as retaining the data used for these reports for three fiscal years.
Send your comments by January 12, 2018. A comment to OMB is most effective if OMB receives it within 30 days of publication.
Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, OMB. Comments should be addressed to Desk Officer, Department of Homeland Security/TSA, and sent via electronic mail to
Christina A. Walsh, TSA PRA Officer, Office of Information Technology (OIT), TSA-11, Transportation Security Administration, 601 South 12th Street, Arlington, VA 20598-6011; telephone (571) 227-2062; email
TSA published a
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
(1) Evaluate whether the proposed information requirement is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden;
(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 using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Consistent with the requirements of Executive Order (EO) 13771, Reducing Regulation and Controlling Regulatory Costs, and EO 13777, Enforcing the Regulatory Reform Agenda, TSA is also requesting comments on the extent to which this request for information could be modified to reduce the burden on respondents.
Transportation Security Administration, DHS.
60-Day notice.
The Transportation Security Administration (TSA) invites public comment on one currently approved Information Collection Request (ICR), Office of Management and Budget (OMB) control number 1652-0064, abstracted below that we will submit to OMB for an extension in compliance with the Paperwork Reduction Act (PRA). The ICR describes the nature of the information collection and its expected burden. The collection involves an application completed by airports desiring to opt-out of passenger and baggage security screening performed by federal employees, preferring a qualified private screening company to perform security screening functions under a contract entered into with TSA.
Send your comments by February 12, 2018.
Comments may be emailed to
Christina A. Walsh at the above address, or by telephone (571) 227-2062.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
(1) Evaluate whether the proposed information requirement is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden;
(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 using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Consistent with the requirements of Executive Order (EO) 13771, Reducing Regulation and Controlling Regulatory Costs, and EO 13777, Enforcing the Regulatory Reform Agenda, TSA is also requesting comments on the extent to which this request for information could be modified to reduce the burden on respondents.
The application process is the initial notification to TSA of an airport's desire to opt-out of the security screening provided by TSA Federal employees. The SPP application collects the following from each airport seeking to participate in SPP:
• Basic airport information: Airport name, FAA identifier, and airport operating authority.
• Authorized Requestor information: Name, position, primary and alternate phone number, mailing address and email address.
• An indication of whether or not the airport authority desires to provide its own private security screening services.
• A recommendation on which private screening company should perform the screening function and the basis for the recommendation.
• Information on any major activities scheduled to occur at the airport within the next 18 months that could impact the transition from Federal screening to private screening (for example, major construction).
• Optional information may be provided to support the consideration of their application.
TSA will acknowledge receipt of the application, review for completeness, and provide an official response within 120 days from the date of acknowledgement. The application contains no personally identifiable information, sensitive security information, or classified information, so no special handling or protection is required.
TSA currently has a screening presence at approximately 450 airports, of which 22 airports are participating in SPP, an increase from the 18 airports that participated in 2014. The annual burden for the information collection related to SPP is estimated to be 30 minutes (0.5 hours). While TSA estimates that only two airports will respond annually, it is presumed that ten or more airports could respond. The agency estimates that each respondent airport will spend approximately one-quarter (.25) hour to complete the application for a total burden of one-half hour (0.50 hours). TSA does not require the airports to maintain records of the application submission. However, if the airport chooses to do so, the burden associated with this action is anticipated to be minimal.
Fish and Wildlife Service, Interior.
Notice of availability; request for comments/information.
We, the U.S. Fish and Wildlife Service (Service), have received an application for an incidental take permit (ITP) under the Endangered Species Act of 1973, as amended (Act). Orange County Utilities (Applicant) is requesting a 10-year ITP. We request public comment on the permit application and accompanying proposed Malcolm Road Water Supply Habitat Conservation Plan (HCP), as well as on our preliminary determination that the plan qualifies as low effect under the National Environmental Policy Act. To make this determination, we used our environmental action statement and low-effect screening form, which are also available for review.
To ensure consideration, please send your written comments by January 12, 2018.
If you wish to review the application and HCP, you may request documents by email, U.S. mail, or phone (see below). These documents are also available for public inspection by appointment during normal business hours at the office below. Send your comments or requests by any one of the following methods.
Tera Baird, telephone: (904) 731-3196; email:
Section 9 of the Act (16 U.S.C. 1531
Regulations governing incidental take permits for threatened and endangered species are at 50 CFR 17.32 and 17.22, respectively. The Act's take prohibitions do not apply to federally listed plants on private lands unless such take would violate State law. In addition to meeting other criteria, an incidental take permit's proposed actions must not jeopardize the existence of federally listed fish, wildlife, or plants.
Orange County Utilities is requesting take of approximately 10.9 acres of occupied sand skink (
We have determined that the applicants' proposal, including the proposed mitigation and minimization measures, would have minor or negligible effects on the species covered in the HCP. Therefore, our proposed issuance of the requested ITP qualifies as a categorical exclusion under the National Environmental Policy Act (NEPA), as provided by Department of the Interior implementing regulations in part 46 of title 43 of the Code of Federal Regulations (43 CFR 46.205, 46.210, and 46.215). A low-effect HCP involves: (1) Minor or negligible effects on federally listed or candidate species and their habitats, and (2) minor or negligible effects on other environmental values or resources.
We will evaluate the HCP and comments we receive to determine whether the ITP application meets the requirements of section 10(a) of the Act (16 U.S.C. 1531
If you wish to comment on the permit application, HCP, and associated documents, you may submit comments by any one of the methods in
Before including your address, phone number, email address, or other personal identifying information in your comments, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
We provide this notice under section 10 of the Act and NEPA regulations (40 CFR 1506.6).
Bureau of Indian Affairs, Interior.
Notice.
The Confederated Tribes of the Grand Ronde Community of Oregon negotiated the Amendment to the Amended and Restated Tribal-State
This compact takes effect on December 13, 2017.
Ms. Paula L. Hart, Director, Office of Indian Gaming, Office of the Assistant Secretary—Indian Affairs, Washington, DC 20240, (202) 219-4066.
Section 11 of the Indian Gaming Regulatory Act (IGRA) requires the Secretary of the Interior to publish in the
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (“ID”) (Order No. 6) granting a joint motion to terminate the consolidated advisory opinion proceeding in the above-captioned investigations based on a settlement agreement. The consolidated advisory opinion proceeding is terminated.
Cathy Chen, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2392. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its internet server at
The Commission instituted Inv. No. 337-TA-565 on March 23, 2006, based on a complaint filed by Epson Portland, Inc. of Hillsboro, Oregon, Epson America, Inc. of Long Beach, California, and Seiko Epson Corporation of Nagano-Ken, Japan (collectively, “Epson”). 71 FR 14720 (Mar. 23, 2006). The complaint alleged violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, by reason of infringement of certain claims of U.S. Patent Nos. 5,615,957; 5,622,439; 5,158,377; 5,221,148; 5,156,472; 5,488,401; 6,502,917; 6,550,902; 6,955,422; 7,008,053; and 7,011,397. The Commission's notice of investigation named 24 respondents including Ninestar Technology Company Ltd. of Montclair, California (“Ninestar”). The Office of Unfair Import Investigations (“OUII”) participated in the investigation. Several respondents were terminated from the investigation on the basis of settlement agreements or consent orders or were found in default. On October 19, 2007, the Commission issued a general exclusion order (“GEO”) and a limited exclusion order. The Commission also issued cease and desist orders (“CDO”) directed to several domestic respondents.
The Commission instituted Inv. No. 337-TA-946 on January 27, 2015, based on a complaint filed by Epson. 80 FR 4314-16 (Jan. 27, 2015). That complaint alleged violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, by reason of infringement of certain claims of U.S. Patent Nos. 8,366,233; 8,454,116; 8,794,749; 8,801,163; and 8,882,513. The Commission's notice of investigation named numerous respondents. OUII participated in the investigation. All the participating respondents were terminated from the investigation as a result of settlement agreements and/or consent motion stipulations. A number of the named respondents defaulted. On October 28, 2015, the presiding administrative law judge (ALJ) issued an initial determination granting Epson's motion for summary determination of violation of section 337 by the defaulting respondents. Based on evidence of a pattern of violation and difficulty ascertaining the source of the infringing products, the Commission issued a GEO and CDOs directed to two defaulted domestic respondents on May 26, 2016.
On April 26, 2017, Ninestar, Ninestar Image Tech. Ltd., and Apex Microtech Ltd. (collectively, “Requesters”) filed a request for a consolidated advisory opinion proceeding in both investigations pursuant to Commission Rule 210.79 (19 CFR 210.79). Specifically, Requesters seek an advisory opinion that will declare that their refurbished Epson ink cartridges remanufactured using empty Epson ink cartridges collected from the United States are outside the scope of the GEOs and CDOs issued in both investigations. Requesters also ask that the consolidated advisory opinion proceeding be conducted in an expedited manner pursuant to
On June 16, 2017, the Commission determined to institute a consolidated advisory opinion proceeding in both investigations and referred the request to the Chief ALJ to designate a presiding ALJ. 82 FR 27723 (Jun. 16, 2017). Epson, the Requesters, and OUII were named as parties to the proceeding. The Commission also determined to deny Requesters' motion for leave to file a reply.
On November 17, 2017, Epson and the Requesters filed a joint motion to terminate the consolidated advisory opinion proceeding based on a settlement agreement. The joint motion included a confidential version of the settlement agreement. A public version of the agreement was filed with the public version of the joint motion. That same day, OUII filed a response in support of the joint motion. On November 22, 2017, the ALJ issued the subject ID (Order No. 6) granting the joint motion to terminate the consolidated advisory opinion proceeding. No petitions for review were filed.
The Commission has determined not to review the subject ID. The Commission agrees with the ALJ that the joint motion to terminate the consolidated advisory opinion proceeding complies with the Commission's rules for termination and that there is no evidence that termination of the proceeding will adversely affect the public interest. Order No. 6 at 2-3.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
Advisory Committees on the Federal Rules of Appellate and Criminal Procedure, and Rules of Evidence, Judicial Conference of the United States.
Notice of cancellation of public hearings.
The January 5, 2018 public hearings in Phoenix, Arizona, on proposed amendments to the Appellate, Criminal and Evidence Rules, the Rules Governing Section 2254 Cases in the United States District Courts, and the Rules Governing Section 2255 Proceedings for the United States District Courts have been canceled.
Rebecca A. Womeldorf, Rules Committee Secretary, Rules Committee Staff, Administrative Office of the United States Courts, Washington, DC 20544, telephone (202) 502-1820.
Announcement for this hearing was previously published in 82 FR 37610.
Notice is hereby given that, on November 21, 2017, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Also, ArcSoft Inc., Freemont, CA; ASD Electronics, Kowloon, HONG KONG-CHINA; EDC GmbH, Langenhagen, GERMANY; Orion Electric Co., Ltd., Fukui, JAPAN; Pixela Corporation, Osaka, JAPAN; TEAC Corporation, Tokyo, JAPAN; and Yamaha Corporation, Hamamatsu, JAPAN, have withdrawn as parties to this venture.
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and DVD CCA intends to file additional written notifications disclosing all changes in membership.
On April 11, 2001, DVD CCA filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on August 23, 2017. A notice was published in the
Notice is hereby given that, on November 8, 2017, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research
On January 6, 2016, CHEDE-VII filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on February 13, 2017. A notice was published in the
Notice of application.
Registered bulk manufacturers of the affected basic classes and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before January 12, 2018. Such persons may also file a written request for a hearing on the application on or before January 12, 2018.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA
The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix of subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on April 4, 2017, VHG LABS DBA LGC Standards Warehouse, 3 Perimeter Road, Manchester, New Hampshire 03103 applied to be registered as an importer of the following basic classes of controlled substances:
The company plans to import analytical reference standards for distribution to its customers for research and analytical purposes. Placement of these drug codes onto the company's registration does not translate into automatic approval of subsequent permit applications to import controlled substances. Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or non-approved finished dosage forms for commercial sale.
Nuclear Regulatory Commission.
Exemption and combined license amendment; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is granting an exemption to allow a departure from elements of the certification information of Tier 1 of the generic AP1000 design control document (DCD) and is issuing License Amendment Nos. 85 and 84 to Combined Licenses (COL), NPF-91 and NPF-92, respectively. The COLs were issued to Southern Nuclear Operating Company, Inc. (SNC), and Georgia Power Company, Oglethorpe Power Corporation, MEAG Power SPVM, LLC, MEAG Power SPVJ, LLC, MEAG Power SPVP, LLC, Authority of Georgia, and the City of Dalton, Georgia (the licensee); for construction and operation of the Vogtle Electric Generating Plant (VEGP) Units 3 and 4, located in Burke County, Georgia.
The granting of the exemption allows the changes to Tier 1 information asked for in the amendment. Because the acceptability of the exemption was determined in part by the acceptability of the amendment, the exemption and amendment are being issued concurrently.
The exemption and amendment were issued on August 24, 2017.
Please refer to Docket ID NRC-2008-0252 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
•
•
•
William (Billy) Gleaves, Office of New Reactors, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-5848; email:
The NRC is granting an exemption from paragraph B of section III, “Scope and Contents,” of appendix D, “Design Certification Rule for the AP1000,” to part 52 of title 10 of the
Part of the justification for granting the exemption was provided by the review of the amendment. Because the exemption is necessary in order to issue the requested license amendment, the NRC granted the exemption and issued the amendment concurrently, rather than in sequence. This included issuing a combined safety evaluation containing the NRC staff's review of both the exemption request and the license amendment. The exemption met all applicable regulatory criteria set forth in §§ 50.12, 52.7, and section VIII.A.4 of appendix D to 10 CFR part 52. The license amendment was found to be acceptable as well. The combined safety evaluation is available in ADAMS under Accession No. ML17216A065.
Identical exemption documents (except for referenced unit numbers and license numbers) were issued to the licensee for VEGP Units 3 and 4 (COLs NPF-91 and NPF-92). The exemption documents for VEGP Units 3 and 4 can be found in ADAMS under Accession Nos. ML17216A070 and ML17216A069, respectively. The exemption is reproduced (with the exception of abbreviated titles and additional citations) in Section II of this document. The amendment documents for COLs NPF-91 and NPF-92 are available in ADAMS under Accession Nos. ML17216A072 and ML17216A071, respectively. A summary of the amendment documents is provided in Section III of this document.
Reproduced below is the exemption document issued to VEGP Units 3 and Unit 4. It makes reference to the combined safety evaluation that provides the reasoning for the findings made by the NRC (and listed under Item 1) in order to grant the exemption:
1. In a letter dated March 2, 2017, as supplemented by letter dated July 28, 2017, Southern Nuclear Operating Company, Inc., (licensee) requested from the Nuclear Regulatory Commission (NRC or Commission) an exemption to allow departures from Tier 1 information in the certified DCD incorporated by reference in 10 CFR part 52, appendix D, “Design Certification Rule for the AP1000 Design,” as part of license amendment request (LAR) 17-006, “Inspections, Tests, Analyses, and Acceptance Criteria (ITAAC) Consolidation.”
For the reasons set forth in Section 3.1 of the NRC staff's Safety Evaluation, which can be found at ADAMS Accession No. ML17216A065, the Commission finds that
A. the exemption is authorized by law;
B. the exemption presents no undue risk to public health and safety;
C. the exemption is consistent with the common defense and security;
D. special circumstances are present in that the application of the rule in this circumstance is not necessary to serve the underlying purpose of the rule;
E. the special circumstances outweigh any decrease in safety that may result from the reduction in standardization caused by the exemption; and
F. the exemption will not result in a significant decrease in the level of safety otherwise provided by the design.
2. Accordingly, the licensee is granted an exemption from the certified DCD Tier 1 information, with corresponding changes to Appendix C of the Facility Combined License as described in the licensee's request dated March 2, 2017, as supplemented by letter dated July 28, 2017. This exemption is related to, and necessary for, the granting of License Amendment No. 85 and 84, respectively, which is being issued concurrently with this exemption.
3. As explained in Section 6.0 of the NRC staff's Safety Evaluation (ADAMS Accession No. ML17216A065, this exemption meets the eligibility criteria for categorical exclusion set forth in 10 CFR 51.22(c)(9). Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment needs to be prepared in connection with the issuance of the exemption.
4. This exemption is effective as of the date of its issuance.
By letter dated March 2, 2017 (ADAMS Accession No. ML17061A747), as supplemented by letter dated July 28, 2017 (ADAMS Accession No. ML17209A770), the licensee requested that the NRC amend the COLs for VEGP, Units 3 and 4, COLs NPF-91 and NPF-92. The proposed amendment is described in Section I of this
The Commission has determined for these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR Chapter I, which are set forth in the license amendment.
A notice of consideration of issuance of amendment to facility operating license or COL, as applicable, proposed no significant hazards consideration determination, and opportunity for a hearing in connection with these actions, was published in the
The Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments.
Using the reasons set forth in the combined safety evaluation, the staff granted the exemption and issued the amendment that the licensee requested on March 2, 2017, as supplemented by letter dated July 28, 2017.
The exemption and amendment were issued on August 24, 2017, as part of a combined package to the licensee (ADAMS Accession No. ML17216A064).
For the Nuclear Regulatory Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. 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.
The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the market dominant or the competitive product list, or the modification of an existing product currently appearing on the market dominant or the competitive product list.
Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.
The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern market dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3010, and 39 CFR part 3020, subpart B. For request(s) that the Postal Service states concern competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comment deadline(s) for each request appear in section II.
1.
This notice will be published in the
Securities and Exchange Commission (“Commission”).
Notice of application for an exemptive order under Section 206A of the Investment Advisers Act of 1940 (the “Advisers Act”) and Rule 206(4)-5(e).
PNC Capital Advisors, LLC (“Applicant” or “Adviser”).
Exemption requested under Section 206A of the Advisers Act and Rule 206(4)-5(e) from Rule 206(4)-5(a)(1) under the Advisers Act.
Applicant requests that the Commission issue an order under Section 206A of the Advisers Act and Rule 206(4)-5(e) exempting it from Rule 206(4)-5(a)(1) under the Advisers Act to permit Applicant to receive compensation from certain government entities for investment advisory services provided to the government entities within the two-year period following a contribution by a covered associate of the Applicant to an official of the government entities.
The application was filed on April 18, 2017, and an amended and restated application was filed on October 10, 2017.
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 Applicant with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on January 2, 2018, and should be accompanied by proof of service on Applicant, in the form of an affidavit or, for lawyers, a certificate of service. Pursuant to Rule 0-5 under the Advisers Act, hearing requests should state the nature of the writer's interest, any facts bearing upon the desirability of a hearing on the matter, the reason for the request, and the issues contested. Persons may request notification of a hearing by writing to the Commission's Secretary.
Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090. Applicant: PNC Capital Advisors, LLC, One East Pratt Street, Baltimore, MD 21202.
Kyle R. Ahlgren, Senior Counsel, at (202) 551-6857 or Holly L. Hunter-Ceci, Assistant Chief Counsel, 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 website at
1. Applicant is a financial services firm registered with the Commission as an investment adviser pursuant to the Advisers Act. Applicant provides discretionary investment advisory services to a wide variety of investors. Applicant is a wholly-owned subsidiary of PNC Bank, National Association (the “Bank”), and the Bank is a wholly-owned subsidiary of PNC Financial Services Group, Inc. (“PNC”).
2. Certain Ohio government entities have established separately managed accounts to which the Adviser provides investment advisory services (each such government entity, a “Client” and collectively, the “Clients”). Each Client is a “government entity” within the meaning of Rule 206(4)-5(f)(5).
3. The individual who made the campaign contribution (the “Contributor”) that triggered the two-year compensation ban (the “Contribution”) is a dual-hatted employee of the Bank and the Adviser. In his role as a business development officer of both the Adviser and the Bank, he solicited and continues to solicit business for the Adviser and the Bank from private corporations and non-profit entities in Pennsylvania, West Virginia, California and Texas. The Contributor
4. In June 2016, the Bank began to contemplate promoting the Contributor to Market Director, a position that has oversight over all sales operations in parts of Pennsylvania for investment advisory services business. In anticipation of this promotion, in December 2016 the Contributor solicited a government entity for investment advisory services for the first time (a local government entity in Pennsylvania). However, after the PNC Corporate Ethics Department's discovery of the Contribution, a hold was placed on the Contributor's promotion. The hold remains in effect.
5. The Contributor was at the time of the Contribution a “covered associate” within the meaning of Rule 206(4)-5(f)(2), and the Contribution triggers the compensation ban under the two-year lookback provision in Rule 206(4)-5(b)(2). At no time has the Contributor been involved in soliciting the Clients, and has never communicated with the Clients. The Contributor has never solicited any other state or local Ohio government entity. The Contributor has never made presentations for, or met with, any representatives of any Client or with any other Ohio government entities, or supervised any person who met with any Client or other Ohio government entity. If promoted to Market Director, the Contributor will neither meet with any Ohio government entities personally, nor supervise any person who solicits investment advisory services business from Ohio government entities.
6. The recipient of the Contribution was John Kasich (the “Official”), Governor of Ohio, in his campaign for President of the United States. The Clients are overseen by boards of trustees or directors to which the Governor appoints certain members and which have influence over selecting an investment adviser. Due to the power of appointment, the Governor is, and at the time of the Contribution was, an “official” of each Client within the meaning of Rule 206(4)-5(f)(6).
7. The Contributor, a long-time Republican, attended an April 2016 fundraiser for Governor Kasich's presidential campaign in Pittsburgh, Pennsylvania. Governor Kasich spoke at the fundraiser, and the Contributor made a $1,000 donation to the Kasich campaign. The Contribution was reported by the campaign as received on April 22, 2016, according to a report filed with, and made available online by, the Federal Election Commission. Other than being an attendee at the event, the Contributor has had no interactions with the Official, his staff, or any other Ohio official regarding the Contribution or any other matter.
8. The Contributor made the Contribution without pre-clearance from PNC's Corporate Ethics Department, and without disclosing the Contribution in his quarterly certification (as clearly required by PNC's policies, procedures and annual training). The Contributor did not appreciate that both Rule 206(4)-5 (the “Rule”) and the Adviser's policy required him to pre-clear and disclose the Contribution because the Contributor was focused on the Official in his capacity as a candidate for President of the United States. At no time did any employee of PNC or the Adviser or the Bank (other than the Contributor) have any knowledge that the Contribution had been made prior to its discovery on February 17, 2017. Applicant represents that the Contribution was not motivated by a desire to influence the award of investment advisory business.
9. The Contribution was discovered by PNC's Corporate Ethics Department on February 17, 2017 through the controls built into its compliance procedures. As part of PNC's required background check for his promotion to Market Director, the Contributor disclosed the Contribution in the political contribution lookback form, in which any individual who is about to take a covered associate position must disclose any contribution he or she made during the prior two years. Upon discovery of the Contribution, PNC immediately notified the Contributor that the Contribution was against PNC policy and a violation of the Rule, and a refund was requested from the campaign on March 8, 2017. The Contributor received the refund on May 3, 2017. All compensation earned that is attributable to the Clients' investments since the Contribution Date has been placed in escrow. Absent exemptive relief from the Commission, Applicant undertakes to refund the escrowed compensation consistent with applicable laws and the Rule.
10. The initial selection process pursuant to which the various Clients decided to establish a separate account with the Adviser, or enter into a separate account that is sub-advised by the Adviser, was completed between 1996 and 2010. One Client opened two accounts with the Adviser after the Contribution Date pursuant to the Client's pre-existing relationship with the Adviser where the Client would, as it had done in prior years, open an account when it issues debt in order to manage the proceeds of such issuance. While some Clients have added funds to their accounts post-Contribution, Clients on the whole have withdrawn more funds than they have added, resulting in a net decrease in assets under management across all Clients combined.
11. PNC's pay-to-play policies and procedures (the “Policy”) apply to PNC's subsidiaries (including the Adviser) and were adopted and implemented on March 14, 2011, well before the Contribution was made. The Policy requires that all contributions to any person (including any election committee for such person) who was, at the time of the contribution, an incumbent, candidate or successful candidate for elective office of a government entity, including a state or local official running for federal office, must be pre-cleared. There is no
12. PNC has amended the quarterly certification for covered associates to specifically explain that the requirement to report “all” contributions includes contributions to federal candidates who are state or local officials at the time of the contribution. This amended quarterly certification has been rolled out to covered associates for the quarter ending September 30, 2017.
1. Rule 206(4)-5 under the Advisers Act prohibits a registered investment adviser from providing “investment advisory services for compensation to a government entity within two years after a contribution to an official of the government entity is made by the investment adviser or any covered associate of the investment adviser.” Each Client is a “government entity” within the meaning of Rule 206(4)-5(f)(5), the Contributor was at the time
2. Section 206A of the Advisers Act authorizes the Commission to “conditionally or unconditionally exempt any person or transaction . . . from any provision or provisions of [the Act] or of any rule or regulation thereunder, if and to the extent that such exemption 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].”
3. Rule 206(4)-5(e) provides that the Commission may exempt an investment adviser from the prohibition under Rule 206(4)-5(a)(1) upon consideration of the factors listed below, among others:
(1) Whether the exemption 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 Advisers Act;
(2) Whether the investment adviser: (i) Before the contribution resulting in the prohibition was made, adopted and implemented policies and procedures reasonably designed to prevent violations of the Rule; and (ii) prior to or at the time the contribution which resulted in such prohibition was made, had no actual knowledge of the contribution; and (iii) after learning of the contribution: (A) Has taken all available steps to cause the contributor involved in making the contribution which resulted in such prohibition to obtain a return of the contribution; and (B) has taken such other remedial or preventive measures as may be appropriate under the circumstances;
(3) Whether, at the time of the contribution, the contributor was a covered associate or otherwise an employee of the investment adviser, or was seeking such employment;
(4) The timing and amount of the contribution which resulted in the prohibition;
(5) The nature of the election (
(6) The contributor's apparent intent or motive in making the contribution which resulted in the prohibition, as evidenced by the facts and circumstances surrounding such contribution.
4. Applicant requests an order pursuant to Section 206A and Rule 206(4)-5(e), exempting it from the two-year prohibition on compensation imposed by Rule 206(4)-5(a)(1) with respect to investment advisory services provided to the Clients within the two-year period following the Contribution.
5. Applicant contends that given the nature of the Contribution, and the lack of any evidence that the Adviser or the Contributor intended to, or actually did, interfere with the Clients' merit-based process for the selection or retention of advisory services, the Clients' interests are best served by allowing the Adviser and its Clients to continue their relationships uninterrupted. Applicant states that causing the Adviser to serve without compensation for a two- year period could result in a financial loss of approximately $700,000, or 700 times the amount of the Contribution. Applicant contends that the policy underlying the Rule is served by ensuring that no improper influence is exercised over investment decisions by governmental entities as a result of campaign contributions, and not by withholding compensation as a result of unintentional violations.
6. Applicant submits that the exemption is necessary and appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Advisers Act. As summarized below and detailed in the Application, Applicant further submits that the other factors set forth in Rule 206(4)-5(e) similarly weigh in favor of granting an exemption to the Applicant to avoid consequences disproportionate to the violation.
7. Applicant states that the Adviser adopted and implemented the Policy, which is fully compliant with and more rigorous than the Rule's requirements, on March 14, 2011, well before the Contribution Date.
8. Applicant states that aside from the Contributor, no executives, employees or covered associates of the Adviser knew of the Contribution until it was self-reported by the Contributor as a result of the multiple controls PNC uses in connection with promotions and transfers.
9. Applicant states that after learning of the Contribution, the Adviser, through its outside counsel, immediately requested a full refund of the Contribution, which was subsequently received. Applicant further states that the Adviser then established escrow accounts and moved all monies impacted by the two-year compensation ban into those escrow accounts.
10. Applicant states that in response to the Contribution, the Adviser reviewed and assessed the continued effectiveness of its Policy and determined that while the Policy was strong and robust, it undertook to enhance the employees' understanding of the Policy through additional education, training, and clarification to the wording of the covered associates' quarterly certification form.
11. Applicant states that the Contributor did not solicit a government entity until December 2016 (in Pennsylvania, not Ohio), that his geographic area for soliciting clients or supervising others does not include Ohio, and that he has never solicited or otherwise communicated with the Clients.
12. Applicant states that the Clients' initial investments with the Adviser substantially pre-date the Contribution and were made on at arm's length basis, and neither the Contributor nor the Adviser took any action to have the Official influence those investments, directly or indirectly. Applicant further states that the Contributor did not solicit or supervise anyone who solicited the Clients with respect to these investments, and any new investments were made in the ordinary course of business and had nothing to do with the Contribution.
13. Applicant states that the Contributor's intent in making the Contribution was not to influence the selection or retention of the Adviser, and that the Contributor is a long-time Republican who was spontaneously motivated to make the Contribution solely because of his personal political beliefs.
The Applicant agrees that any order of the Commission granting the requested relief will be subject to the following conditions:
1. The Contributor will be prohibited from soliciting investment from any “government entity” client or prospective client for which the Official is an “official” as defined in Rule 206(4)-5(f) until April 22, 2018.
2. The Contributor will receive a written notification of this condition and will provide a quarterly certification of compliance until April 22, 2018. Copies of the certifications will be maintained and preserved in an easily accessible place for a period of not less than five years, the first two years in an appropriate office of the Adviser, and be available for inspection by the staff of the Commission.
3. The Adviser will conduct testing reasonably designed to prevent violations of the conditions of the Order and maintain records regarding such
For the Commission, by the Division of Investment Management, under delegated authority.
On October 10, 2017, The Options Clearing Corporation (“OCC”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change SR-OCC-2017-005 pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
OCC proposes to adopt a new Risk Management Framework (“RMF”) document. The purpose of the RMF is to describe OCC's framework for comprehensive risk management, including OCC's framework to identify, measure, monitor, and manage all risks faced by OCC in the provision of clearing, settlement, and risk management services. More specifically, the RMF would establish the context for OCC's risk management framework, outline OCC's risk management philosophy, describe OCC's Risk Appetite Framework and use of Risk Tolerances,
The RMF would begin by establishing the context for OCC's risk management framework. More specifically, OCC is a Systemically Important Financial Market Utility (“SIFMU”)
OCC states that the proposed RMF would describe its risk management philosophy. As a SIFMU, OCC must be mindful of the public interest and its obligation to promote financial stability, reduce the potential for systemic contagion, and support the smooth functioning of the U.S. financial markets. Furthermore, as a CCP, OCC concentrates financial risks for the markets it serves by acting as the CCP for all of the transactions that it clears. As a result of this concentration, OCC's primary objective is to ensure that it properly manages the financial risks associated with functioning as a CCP, which primarily relate to potential clearing member default scenarios.
As a CCP, OCC's daily operations, among other things, involve managing financial, operational, and business risks. In managing these risks, OCC's daily operations—which are guided by policies, procedures, and controls—are designed to ensure that financial exposures and service disruptions are within acceptable limits set by OCC as part of its Risk Appetite Framework (“RAF”) as described below.
The proposed RMF would describe OCC's RAF and use of Risk Tolerances. The purpose of the RAF is to establish OCC's overall approach to managing risks at the enterprise level in an effective and integrated fashion. The RAF establishes the level and types of Key Risks, described in further detail below, that OCC is willing and able to assume in accordance with OCC's mission as a SIFMU. Under the RAF, Risk Appetite Statements
Under the RMF, Risk Appetite Statements would be set annually by each department associated with a Key Risk in cooperation with OCC's Enterprise Risk Management department (“ERM”) according to applicable procedures. OCC's risk appetite levels would be classified into four categories:
1.
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3.
4.
Under the RMF, OCC's Board would have ultimate responsibility for reviewing and approving the Risk Appetite Statements in connection with each Key Risk on an annual basis upon recommendation of OCC's Management Committee.
The Risk Appetite Statements would allow OCC to carefully calibrate the levels of risk it accepts for each of its Key Risks to be consistent with OCC's core mission of promoting financial stability in the markets it serves. Accordingly, the RAF helps to ensure that OCC has an effective and comprehensive framework for managing its Key Risks (
In addition to Risk Appetite Statements, the RMF would require that OCC assign Risk Tolerances to the Key Risks contained within the RMF as approved by OCC's Board. While the Risk Appetite Statements would be more high-level and principles-based, Risk Tolerances would comparatively be more granular and represent the application of OCC's risk appetite to specific sub-categories or aspects of Key Risks. The purpose of the proposed Risk Tolerances is to help ensure that OCC sets acceptable levels of risk within those specified sub-categories of Key Risks. Risk Tolerances would be stated in either quantitative or qualitative terms, depending on the nature of the risk and OCC's ability to measure it.
Under the RMF, each department would be required to establish Risk Tolerances at least annually for sub-categories of Key Risks that are within their relevant domains of responsibility and would be responsible for managing applicable risks within established tolerance levels. ERM staff would monitor Risk Tolerances through quantitative metrics, where applicable, and compile such monitoring in a report that the Chief Risk Officer shall present to OCC's Management Committee and Board (or a committee thereof) at least quarterly. In addition, the RMF would require that OCC's Board evaluate its Risk Tolerances at least annually, and more frequently if necessary as a result of changes to products, processes, market conventions or other changes to OCC's material risks.
The proposed RMF would identify risks that could affect OCC's ability to perform services as expected, and the process for identifying such risks would take a broad view to include: (i) Direct financial and operational risks that may prevent the smooth functioning of CCP services; (ii) reputational risks that could undermine the perception of OCC as a sound pillar in the financial market; and (iii) the risks OCC faces from third parties, such as custodians and settlement banks, that are critical to the design and operation of OCC's infrastructure and risk management. OCC believes that identifying Key Risks in this manner would facilitate its ability to manage comprehensively the legal, credit, liquidity, operational, general business, investment, custody, and other risks that arise in or are borne by it. Based on this identification process, the RMF would define OCC's Key Risks as described below.
The RMF would indicate that financial risk encompasses many aspects of risk at OCC, including the risks that a Clearing Member will be unable to meet its obligations when due or that OCC will not maintain sufficient financial resources to cover exposures (
The proposed RMF would require OCC's credit risk management framework to encompass policies and procedures for maintaining sufficient prefunded resources in the form of margin and Clearing Fund deposits, accepting collateral from participants that is low-risk and high-quality, monitoring the creditworthiness and operational reliability of all counterparties, including participants, custodians, settlement banks, liquidity providers, and linked financial market utilities (“FMUs”), and maintaining a waterfall of resources to be used in the event of participant default and a process for replenishing resources.
In addition, the RMF would require OCC's liquidity risk framework to encompass sizing liquidity resources to cover liquidity needs in the event of the default of the largest Clearing Member Group, forecasting daily settlement needs under normal market conditions, maintaining liquid resources in the form of cash and committed facilities, maintaining a contingency funding plan and periodically reviewing the size of liquidity resources, maintaining liquidity resources at creditworthy custodians and monitoring the financial and operational performance of financial institutions and committed liquidity facilities, and investing liquidity resources in safe overnight investments or at a Federal Reserve Bank.
Moreover, the RMF would require OCC to address investment risks by maintaining an account at a Federal Reserve Bank, which bears no investment risk, and investing funds not held at the Federal Reserve Bank in high-quality liquid assets. The RMF would also require OCC to manage model risk through a model development program, independent model validation and strong governance arrangements for the approval of new models or models with material changes in accordance with relevant policies.
The RMF would define operational risk as the risk of disruptions in OCC's CCP services due to: (i) Deficiencies in internal controls, processes or information systems; (ii) human error or misconduct; or (iii) external events or intrusions. The definition of operational risk would also cover deficiencies related to information technology (“IT”), such as data security and IT systems reliability. To reflect the importance OCC assigns to managing IT risks, the RMF would also categorize IT risk as a separate Key Risk, discussed below.
The RMF would also assert that OCC manages operational risks in number of ways, including that OCC: (i) Maintains an Enterprise Project Management Program that performs initial assessments of proposed projects and manages project execution, to help ensure that proper oversight exists during the initiation, planning, execution, and delivery of OCC corporate projects; (ii) maintains a Business Continuity Program to support
The RMF also would address operational risks specifically related to IT as a distinct Key Risk. Operational risk related to IT would be defined as the risk that inadequate levels of system functionality, confidentiality, integrity, availability, capacity, or resiliency for systems that support core clearing, settlement, or risk management services or critical business functions results in disruptions in OCC services. In addition to the ways described above that OCC manages operational risks generally, the RMF would also provide that OCC manages IT operational risks by maintaining: (i) A Quality Standards Program, which includes targets that set performance standards for systems operations; (ii) a cybersecurity program; and (iii) a program to maintain system functionality and capacity.
The RMF would define legal risk as the risk that OCC's by-laws, rules, policies, and procedures do not provide for a well-founded, clear, transparent, and enforceable legal basis for each aspect of its activities in all relevant jurisdictions. The RMF would also provide that OCC manages legal risk by: (i) Maintaining rules, policies, and contracts that are consistent with applicable laws and regulations; and (ii) maintaining legal agreements that establish counterparty obligations regarding the material aspects of its clearing, settlement, and risk management services, including, but not limited to, settlement finality, vendor performance, exchange performance, options exercise, and cross-margining obligations.
The RMF would define general business risk as the risk of any potential impairment of OCC's financial condition due to declines in its revenue or growth in its expenses arising from OCC's administration and operation as a business enterprise (as opposed to a participant's default), resulting in expenses that exceed revenues and losses that must be charged against OCC's capital.
The RMF would provide that OCC manages general business risk by: (i) Maintaining a target capital level of liquid net assets funded by equity equal to the greater of six-months' operating expenses or the amount sufficient to ensure a recovery or orderly wind-down of OCC's operations as set forth in OCC's recovery and wind-down plan, and a plan that provides for capital replenishment in the event of non-default losses in excess of target capital; (ii) maintaining a corporate planning program to manage new business activity; and (iii) actively managing the public perception of OCC.
The RMF would describe the governance arrangements through which OCC implements its risk management philosophy. These governance arrangements would include the responsibilities of the Board, the Board's committees, and management in establishing and executing OCC's risk management framework. These responsibilities are described in further detail below.
The RMF would provide that OCC's risk governance framework follows a hierarchical structure that begins with the Board, which has ultimate oversight responsibility for OCC's risk management activities. The Board performs an oversight role to help ensure that OCC is managed and operated in a manner consistent with OCC's regulatory responsibilities as a SIFMU providing clearance and settlement services. The Board also is responsible for helping ensure that OCC has governance arrangements that, among other things, prioritize the safety and efficiency of OCC through the proposed risk management framework. Moreover, under the RMF, the Board is responsible for overseeing OCC's risk management policies, procedures, and systems designed to identify, measure, monitor, and manage risks consistent within the Risk Appetite Statements and Risk Tolerances approved by the Board. The RMF also provides that the Board is responsible for overseeing and approving OCC's recovery and orderly wind-down plan (consistent with OCC's Board of Directors Charter).
To carry out these responsibilities, the RMF would indicate that the Board has established Committees to assist in overseeing OCC's Key Risks. These Committees are: (i) The Audit Committee; (ii) the Compensation and Performance Committee; (iii) the Governance and Nominating Committee; (iv) the Risk Committee; and (v) the Technology Committee. The responsibilities of these committees to manage OCC's Key Risks are outlined in their respective committee charters.
The RMF would also provide that OCC's Management Committee is responsible for annually reviewing and approving the RMF—and the Risk Appetite Statements and Risk Tolerances established thereunder—and recommending further approval thereof to the Board. The Management Committee would also review reports related to metrics for assessing Risk Tolerances to determine whether OCC's Key Risks are behaving within established tolerances and take or recommend action as needed to return Key Risks to their appropriate levels and escalate exceptions to Risk Tolerances and Risk Appetite Statements to relevant Board committees. The Management Committee would also be permitted to establish working groups to assist it in the management of Key Risks.
The RMF would describe OCC's program for enterprise-wide risk management. The internal structures for risk management described in the proposed RMF are intended to follow programs generally accepted in the financial services industry, including the “three lines of defense” model (
To maintain a resilient risk management and internal control infrastructure, the RMF would formalize OCC's “three lines of defense” model, which allows OCC to manage its control infrastructure with clarity of ownership and accountability. The first line of defense consists of OCC's operational business units, including Financial Risk Management, National Operations, technology, legal, regulatory affairs and
The first line is supported and monitored by the second line of defense, which consists of the ERM, Compliance, Security Services, and Model Validation Group functions. The second line is an oversight function and is responsible for designing, implementing and maintaining an enterprise-wide risk management and compliance program and tools to assess and manage risk at the enterprise level. The second line would also work with the first line to assess risks and establish policies and guidelines, and advise, monitor, and report on the first line's effectiveness at managing risk and maintaining and operating a resilient control infrastructure. The second line reports to OCC's Management Committee and Board (or committee thereof) on the first line of defense's effectiveness at managing risk and compliance and an assessment of whether OCC's services are being delivered within Risk Appetite Statements and Risk Tolerances.
The third line of defense consists of OCC's internal audit function. The third line reports to the Audit Committee of the Board and is accountable for designing, implementing, and maintaining a comprehensive audit program that allows senior management and the Board to receive independent and objective assurance that the quality of OCC's risk management and internal control infrastructure is consistent with OCC's risk appetite and Risk Tolerances. The RMF also would require that OCC's Internal Audit department maintains a diverse and skilled team of professionals with a variety of business, technology, and audit skills, and perform all of its activities in compliance with the Institute of Internal Auditors' standards found in the International Professional Practices Framework.
The “three lines of defense” model is designed to provide for a robust governance structure that distinguishes among the three lines involved in the effective and comprehensive management of risk at OCC: (i) The functions that own and manage risks; (ii) the functions that oversee and provide guidance on the management of risks; and (iii) and the functions that provide independent and objective assurance of the robustness and appropriateness of risk management and internal controls.
In furtherance of the “three lines of defense” model, the RMF would provide for risk identification and assessment programs described below to identify, measure, and monitor current and emerging risks at OCC. Findings or recommendations that result from the assessments would be documented, monitored, and escalated through the appropriate governance according to applicable OCC policies and procedures.
One such assessment—the Enterprise Risk Assessment—would be conducted by OCC's first line of defense in conjunction with ERM. The Enterprise Risk Assessment would analyze risks based on: (i) Inherent Risk;
Another such assessment—the Scenario Analysis Program—would be a method for identifying risks that may not be otherwise captured in OCC's risk statements. ERM, in cooperation with the first line of defense, would design simulations of potential disruptions, and business unit staff would be able to identify risks that may not have been previously uncovered or identify weaknesses in current controls. ERM would include potential risks identified through the Scenario Analysis Program in its analysis of, and reporting on, the quantity of risk within a certain Key Risk and whether the Key Risk is within appetite.
A third assessment—the IT Risk Assessment Program—would be conducted by OCC's Security Services department prior to the procurement, development, installation, and operation of IT services and systems. This assessment would be triggered by certain events that may affect the nature or level of IT risks OCC faces, such as evaluation or procurement of a new system or technology, changes in OCC business processes that affect current services and systems, and the emergence of new threats that subvert existing controls and that require a new technology mitigation. OCC would also conduct periodic assessments.
A fourth assessment would be conducted by OCC's compliance function to identify and measure regulatory compliance risks. The assessment would also provide OCC's compliance function with a basis for prioritizing testing and training activities.
Under the RMF, ERM would be responsible for completing a review and reporting process that provides OCC's Management Committee and Board (or committee thereof) with the information necessary to fulfill their obligations for risk management and oversight of risk management activities, respectively. This reporting would be designed to assist OCC's Management Committee and Board (or committee thereof) in understanding the most significant risks faced by OCC from a process perspective and determining whether Risk Tolerances are being managed in accordance with Risk Appetite Statements. On a quarterly basis, ERM would provide a risk report with a summary analysis of risk appetite and risk profile that includes analysis of Residual Risks from the Enterprise Risk Assessment program, reporting on Risk Tolerances and recommendations for prioritization of risk mitigation activities. The reporting process would indicate procedures for escalation in the event of a breach of Risk Tolerance.
Under the RMF, the Compliance Department would be responsible for maintaining an inventory of all business processes and associated controls. OCC would also provide guides to assist staff in documenting their control activities in a consistent way and periodically conduct training on the importance of a strong risk and control environment. In addition, on at least an annual basis, the Compliance Department would be required to conduct training to assist OCC staff in understanding their respective responsibilities in implementing OCC's risk and control environment.
Section 19(b)(2)(C) of the Act directs the Commission to approve a proposed rule change of a self-regulatory organization if it finds that such proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to such organization.
Section 17A(b)(3)(F) of the Act requires that the rules of a registered clearing agency be designed to do, among other things, the following: (1) Promote the prompt and accurate clearance and settlement of securities transactions; (2) assure the safeguarding of securities and funds which are in the custody or control of the clearing agency or for which it is responsible; and (3) in general protect investors and the public interest.
As described above, the RMF would address and clarify different ways OCC comprehensively manages Key Risks, which include legal, credit, liquidity, operational, general business, investment, custody, and other risks that arise in or are borne by OCC. For example, the RMF would describe OCCs overall framework for comprehensive risk management, including OCC's framework to identify, measure, monitor, and manage all risks faced by OCC in the provision of clearing, settlement, and risk management services. The RMF would also establish the context for OCC's risk management framework, outline OCC's risk management philosophy, describe OCC's Risk Appetite Framework and use of Risk Tolerances, describe the governance arrangements that implement risk management, outline OCC's identification of Key Risks, and describe OCC's program for enterprise-wide risk management, including the “three lines of defense” structure and OCC's approach to risk monitoring, assessment, and reporting.
By providing these clarifications and adding transparency to OCC's risk management practices, the RMF is designed to help OCC be in a better position to identify, measure, monitor, and manage the various risks that may arise in or be borne by OCC. By better identifying, measuring, monitoring, and managing the risks that may arise in or be borne by OCC, the RMF is designed to help reduce the possibility that OCC fails in providing its critical operations and services to the financial markets. By better positioning OCC to continue its critical operations and services, and mitigating the risk of financial loss contagion caused by its failure, the RMF is designed to promote the prompt and accurate clearance and settlement of securities transactions and help assure the safeguarding of securities and funds which are in the custody or control of OCC, or for which OCC is responsible. As a result, the Commission finds that the proposed rule change, in general, protects investors and the public interest. Accordingly, the Commission believes that the proposed rule change is consistent with Section 17A(b)(3)(F) of the Act.
Rule 17Ad-22(e)(3) under the Act requires, in part, that a covered clearing agency “establish, implement, maintain and enforce written policies and procedures reasonably designed to . . . [m]aintain a sound risk management framework for comprehensively managing legal, credit, liquidity, operational, general business, investment, custody, and other risks that arise in or are borne by the covered clearing agency, which . . . [i]ncludes risk management policies, procedures, and systems designed to identify, measure, monitor, and manage the range of risks that arise in or are borne by the covered clearing agency, that are subject to review on a specified periodic basis and approved by the board of directors annually . . .”
As described above, the RMF describes OCC's comprehensive framework for identifying, measuring, monitoring, and managing the risks that arise within OCC or are borne by it, including legal, credit, liquidity, operational, general business, investment, and custody risk. For example, the RMF describes OCC's framework for identifying its Key Risks and the relevant policies that OCC maintains to address those risks.
The RMF also describes OCC's RAF and use of Risk Appetite Statements and Risk Tolerances to help ensure that OCC sets appropriate levels and types of Key Risks that OCC is willing and able to assume in accordance with the performance of its critical role in the financial markets. For example, the use of Risk Appetite Statements helps ensure that OCC can carefully calibrate the levels of risk it accepts for each Key Risk in a manner consistent with OCC's core mission of promoting financial stability in the markets it serves. In addition, the use of Risk Tolerances helps ensure that OCC sets acceptable levels of risk within specified sub-categories of Key Risks, and that also may be used to set thresholds for acceptable variability in risk levels and to provide clear and transparent escalation triggers when the thresholds are breached.
Moreover, the Commission believes the RMF would clarify the foundation of OCC's risk management practices by describing OCC's enterprise-wide risk management framework. This framework incorporates established principles employed across the financial services industry such as the “three lines of defense” model for enterprise-wide risk management to help ensure that OCC maintains and operates a resilient, effective, and reliable risk management and internal control infrastructure that assures risk management and processing outcomes expected by OCC stakeholders. This framework also describes how OCC's second line of defense monitors the risks that arise in or are borne by OCC through a variety of risk assessment, risk reporting, and internal control management activities. Finally, the RMF also states that the RMF and related documents are subject to annual board approval.
For the above specified reasons, the Commission therefore believes that the proposed rule change: (i) Provides a variety of risk assessment, risk reporting, and internal control management activities; and (ii) provides for a sound, comprehensive framework for identifying, measuring, monitoring, and managing the range of risks that arise in or are borne by OCC. The Commission therefore finds that these changes are consistent with the requirements of Rule 17Ad-22(e)(3).
On the basis of the foregoing, the Commission finds that the proposed change is consistent with the requirements of the Act, and in particular, with the requirements of
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to extend the pilot period for the Exchange's Retail Liquidity Program (the “Retail Liquidity Program” or the “Program”), which is currently scheduled to expire on December 31, 2017, until June 30, 2018. The proposed rule change is available on the Exchange's website at
In its filing with the Commission, the self-regulatory organization 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 those 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 parts of such statements.
The purpose of this filing is to extend the pilot period of the Retail Liquidity Program, currently scheduled to expire on December 31, 2017,
In July 2012, the Commission approved the Retail Liquidity Program on a pilot basis.
The Retail Liquidity Program was approved by the Commission on a pilot basis. Pursuant to NYSE Rule 107C(m), the pilot period for the Program is scheduled to end on December 31, 2017.
The Exchange established the Retail Liquidity Program in an attempt to attract retail order flow to the Exchange by potentially providing price improvement to such order flow. The Exchange believes that the Program promotes competition for retail order flow by allowing Exchange members to submit RPIs to interact with Retail Orders. Such competition has the ability to promote efficiency by facilitating the price discovery process and generating additional investor interest in trading securities, thereby promoting capital formation. The Exchange believes that extending the pilot is appropriate because it will allow the Exchange and the Commission additional time to analyze data regarding the Program that the Exchange has committed to provide.
The proposed rule change is consistent with Section 6(b) of the Act,
The Exchange 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. The proposed rule change simply extends an established pilot program for an additional six months, thus allowing the Retail Liquidity Program to enhance competition for retail order flow and contribute to the public price discovery process.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of such 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 shall institute proceedings under Section 19(b)(2)(B)
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.
All submissions should refer to File Number SR-NYSE-2017-64 and should be submitted on or before January 3, 2018.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On August 16, 2017, Chicago Board Options Exchange, Incorporated (now known as Cboe Exchange, Inc.), on behalf of the BATS Exchange, Inc. (now known as Cboe BZX Exchange, Inc.); Box Options Exchange, LLC; C2 Exchange, Incorporated (now known as Cboe C2 Exchange, Inc.); EDGX Exchange, Inc. (now known as Cboe EDGX Exchange, Inc.); Miami International Securities Exchange, LLC; MIAX PEARL, LLC; Nasdaq BX, Inc.; Nasdaq GEMX, LLC; Nasdaq ISE, LLC; Nasdaq MRX, LLC; Nasdaq Options Market, LLC; Nasdaq PHLX, LLC; NYSE American, LLC; NYSE Arca, Inc.; and the Options Clearing Corporation (“OCC”) (together, the “Plan Sponsors”), filed with the Securities and Exchange Commission (“Commission” or “SEC”) pursuant to Section 11A(a)(3) of the Securities Exchange Act of 1934 (“Act”)
The Plan Sponsors propose to amend the Plan to: (1) Change the earliest date on which new January Long-term Equity AnticiPation (“LEAP”) series on equity options, options on Exchange Traded Funds (“ETF”), or options on Trust Issued Receipts (“TIR”) may be added to a single date (from three separate months); (2) allow equity, ETF, and TIR option series to be added based on trading after regular trading hours; (3) make technical and procedural changes to the certification processes for new option classes and communication provisions; and (4) correct a cross-referencing error in the Plan.
The Commission finds that the Amendment is consistent with the requirements of the Act and the rules and regulations thereunder. Specifically, the Commission finds that the Amendment is consistent with Section 11A(a)(1) of the Act
The Plan Sponsors propose to consolidate the addition of new January LEAP options series so that they all may be added in September. Because the addition of new January LEAP options historically has been a manual process, to avoid potential operational issues, the Plan currently requires that the addition of these LEAP options series take place over three calendar months (September, October, and November). The Plan Sponsors state that today, however, new January LEAP options now can be added in bulk electronically and, therefore, the operational concerns relating to the historic manual process have been alleviated. Thus, the Plan Sponsors propose to consolidate the addition of new January LEAP options series so that they all may be added in September.
The Plan Sponsors also propose to amend the Plan to add options series based on trading of the underlying securities after regular trading hours (“post-market”), based on the most recent share price reported by all national securities exchanges between 3:15 p.m. and 5:00 p.m. CT. This change would allow an options exchange to add a new options series in response to post-market trading activity the same day as when the post-market trading occurred, with the series available for trading on the opening of the regular trading session (
In addition, the Amendment proposes to streamline the processes by which the options exchanges seek to trade a new option class. Currently, the OLPP requires an options exchange to submit a certificate containing certain specified information to the OCC (“Certificate”) when it seeks to trade an option class that is not currently trading on another registered options exchange or that has not been previously certified for listing and trading on any registered options exchange. Because sometimes more than one options exchange will submit a Certificate to the OCC seeking to list and trade the same selected option class, the OLPP requires the OCC to determine which Certificate was submitted first among all the Certificates it received,
In addition, the Amendment would allow Certificates and any associated information and/or documentation to be submitted to the OCC via electronic means that is reasonably agreed upon by the Plan Sponsors, rather than via telefacsimile, as is currently required. The proposed amendment would also allow all other notices required under the terms of the OLPP to be given through “electronic mail or other electronic means reasonably agreed upon by the Plan Sponsors.”
Finally, the Plan Sponsors propose to amend the Plan to make a non-substantive edit to correct an inaccurate cross-reference to “Section 8” in Section 7(ii) of the Plan with “Section 9.” The Commission believes that it is appropriate in the public interest, for the protection of investors and the maintenance of a fair and orderly market to approve this proposed change because it will clarify and correct an inaccuracy in the Plan.
For the reasons discussed above, the Commission finds that Amendment No. 4 is consistent with Section 11A of the Act
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend the Exchange's Schedule of Fees to clarify the application of the Crossing Fee Cap.
The text of the proposed rule change is available on the Exchange's website at
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 purpose of the proposed rule change is to provide greater clarity as to the manner in which the Exchange applies the Crossing Fee Cap.
By way of background, Crossing Orders are contracts that are submitted as part of a Facilitation, Solicitation, PIM, Block or QCC Order. Crossing Order fees are capped at $90,000 per month per member on all Firm Proprietary and Non-Nasdaq ISE Market Maker transactions that are part of the originating or contra side of a Crossing Order.
The Exchange proposes to make clear how it attributes eligible volume for purposes of the Crossing Fee Cap. The Exchange proposes to add the following language to the rule text, “For purposes of the Crossing Fee Cap the Exchange will attribute eligible volume to the ISE Member on whose behalf the Crossing Order was executed.” Only ISE Members are subject to the Crossing Fee Cap. This is the manner in which the Exchange attributes eligible volume for purposes of the Crossing Fee Cap today. To provide greater transparency to the Schedule of Fees, the Exchange proposes to include this language in the rule text. While the Exchange is not aware of any confusion with respect to this fee with its Members, the Exchange believes this specificity will avoid any confusion.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange's proposal to add the clarifying language regarding the Crossing Fee Cap to the Schedule of Fees is reasonable because the proposed rule text will bring greater clarity to the manner in which the Exchange attributes eligible volume for purposes of the Crossing Fee Cap today and applies the Crossing Fee Cap. The calculation and the application of the Crossing Fee Cap are not changing with this proposal. This rule text is intended to provide additional clarity to the current rule to describe who benefits from the volume for purposes of the application of the cap.
The Exchange's proposal to add the clarifying language regarding the Crossing Fee Cap to the Schedule of Fees is equitable and not unfairly discriminatory because the Exchange
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The proposal is intended to provide greater transparency to the Schedule of Fees and does not amend the current manner in which the Exchange calculates or applies the Crossing Fee Cap. The Exchange's proposal to add the clarifying language regarding the Crossing Fee Cap to the Schedule of Fees does not impose an undue burden on competition because the Exchange will continue to calculate and apply the Crossing Fee Cap in a uniform manner to all ISE Members that are eligible for this cap.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act,
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.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange filed a proposal to amend the fee schedule applicable to Members
The text of the proposed rule change is available at the Exchange's website at
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
The Exchange proposes to amend its fee schedule to delete the Retail Order Tier under footnote 11. Fee code ZA is appended to Retail Orders that add liquidity on the Exchange. Retail Orders which yield fee code ZA currently receive a rebate of $0.0032 per share in securities priced at or above $1.00 and are charged no fee in securities priced below $1.00. Currently, under the Retail Order Tier, a Retail Order
The Exchange believes that the proposed rule change is consistent with the objectives of Section 6 of the Act,
The Exchange believes that the proposed rule change is consistent with the objectives of Section 6 of the Act,
The Exchange has not solicited, and does not intend to solicit, comments on this proposed rule change. The Exchange has not received any unsolicited written comments from Members or other interested parties.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
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 Brent J. Fields, 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.
U.S. Small Business Administration.
Amendment 3.
This is an amendment of the Presidential declaration of a major disaster for the Commonwealth of Puerto Rico (FEMA-4339-DR), dated 09/20/2017.
Issued on 12/06/2017.
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, (202) 205-6734.
The notice of the President's major disaster declaration for the Commonwealth of Puerto Rico, dated 09/20/2017, is hereby amended to establish the incident period for this disaster as beginning 09/17/2017 and continuing through 11/15/2017.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the Commonwealth of Puerto Rico (FEMA-4339-DR), dated 11/02/2017.
Issued on 12/06/2017.
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, (202) 205-6734.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the Commonwealth of Puerto Rico, dated 11/02/2017, is hereby amended to establish the incident period for this disaster as beginning 09/17/2017 and continuing through 11/15/2017.
All other information in the original declaration remains unchanged.
Notice of request for public comment and submission to OMB of proposed collection of information.
The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995 we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.
Submit comments directly to the Office of Management and Budget (OMB) up to January 12, 2018.
Direct comments to the Department of State Desk Officer in the Office of Information and Regulatory Affairs at the Office of Management and Budget (OMB). You may submit comments by the following methods:
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Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents, to S. Taylor at
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We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.
In the paper version of the forms (OMB 1405-0113), the Department of Homeland Security (DHS) usually provides the results of visa applicant medical examinations to the Centers for Disease Control and Prevention (CDC). As the Department transitions to the electronic environment, the information from the medical examinations will be provided directly to CDC and DHS for uses relevant to their respective roles in the admission process and statutory missions. This change will promote efficiency in the process.
Notice of request for public comment and submission to OMB of proposed collection of information.
The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995 we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.
Submit comments directly to the Office of Management and Budget (OMB) up to January 12, 2018.
Direct comments to the Department of State Desk Officer in the Office of Information and Regulatory Affairs at the Office of Management and Budget (OMB). You may submit comments by the following methods:
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Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents, to Ramona Sandoval, 2201 C Street NW, Washington, DC, who may be reached on 202-647-1076 or at
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We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.
FLO needs the information collected in the PDF application to determine who will receive a Professional Development Fellowship. The information is provided to selection committees that use a set of criteria to score the applications. Respondents are spouses and partners of direct-hire U.S. government employees from all agencies serving overseas under Chief of Mission who want to maintain, enhance, and/or develop professional skills while overseas. The information is sought pursuant to 22 U.S.C. 2651a—Organization of the Department of State, 22 U.S.C. 3921—Management of the Foreign Service.
Applicants will email the completed application to FLO's PDF program manager.
Federal Aviation Administration (FAA), DOT.
Notice.
The FAA has determined that the minimum random drug and alcohol testing percentage rates for the period January 1, 2018, through December 31, 2018, will remain at 25 percent of safety-sensitive employees for random drug testing and 10 percent of safety-sensitive employees for random alcohol testing.
Ms. Vicky Dunne, Office of Aerospace Medicine, Drug Abatement Division, Program Policy Branch (AAM-820), Federal Aviation Administration, 800 Independence Avenue SW, Room 806, Washington, DC 20591; Telephone (202) 267-8442.
Similarly, 14 CFR 120.2 17(c), requires the decision on the minimum annual random alcohol testing rate to be based on the random alcohol test violation rate. If the violation rate remains less than 0.50%, the Administrator may continue the minimum random alcohol testing rate at 10%. In 2016, the random alcohol test violation rate was 0.121%. Therefore, the minimum random alcohol testing rate will remain at 10% for calendar year 2018.
If you have questions about how the annual random testing percentage rates are determined please refer to the Code of Federal Regulations Title 14, section 120 .109(b) (for drug testing), and 120.217(c) (for alcohol testing).
Federal Aviation Administration (FAA), DOT.
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before January 2, 2018.
Send comments identified by docket number FAA-2017-1037 using any of the following methods:
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Keira Jones (202) 267-6109, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
The petitioner also seeks an exemption from the requirement of § 61.155(d) that an applicant who passes the knowledge test prior to August 1, 2014, but fails to successfully complete the airplane category with a multiengine class rating practical test within 24 months must complete the airline transport pilot certification training program specified in § 61.156 and retake the knowledge test prior to applying for the airplane category with a multiengine class rating practical test.
The petitioner seeks an exemption from the requirement of SFAR 100-2, Para 2(c) authorizing Flight Standards District Offices to accept an expired written test report to show eligibility under 14 CFR part 61 to take a practical test if the eligible person completes the appropriate practical test within 6 calendar months after returning to the United States.
Federal Aviation Administration, United States Department of Transportation.
Notice.
The Federal Aviation Administration (FAA) announces its determination that the Noise Exposure Maps submitted by the Louisville Regional Airport Authority for the Louisville International Airport are in compliance with applicable requirements.
The FAA's determination on the noise exposure maps was made as of August 10, 2017.
Felicia Johnson, Federal Aviation Administration, Southern Region/Atlanta Airports District Office, 1701 Columbia Ave., Room 220, College Park, GA 30337. (404) 305-6708.
This notice announces that the FAA finds that the Noise Exposure Maps submitted for Louisville International Airport are in compliance with applicable requirements of 14 CFR part 150, as of August 10, 2017. Under 49 U.S.C. 47503, or the Aviation Safety and Noise Abatement Act of 1979 (the Act), an airport operator may submit to the FAA Noise Exposure Maps which meet applicable regulations and which depict non-compatible land uses as of the date of submission of such maps, a description of projected aircraft operations, and the ways in which such operations will affect such maps. The Act requires such maps to be developed in consultation with interested and affected parties in the local community, government agencies, and persons using the airport. An airport operator who has submitted Noise Exposure Maps that are found by FAA to be in compliance with the requirements of 14 CFR part 150, promulgated pursuant to the Act, may submit a Noise Compatibility Program for FAA approval which sets forth the measures the airport operator has taken or proposes to take to reduce existing non-compatible uses and prevent the introduction of additional non-compatible uses.
The FAA has completed its review of the Noise Exposure Maps and accompanying documentation submitted by the Louisville Regional Airport Authority. The documentation that constitutes the “Noise Exposure Maps” as defined in 14 CFR part 150.7 includes: Figure 1. Louisville International Airport and Surrounding Communities; Figure 4. Existing Condition (2016) Noise Exposure Map; Figure 5. Forecast Condition (2021) Noise Exposure Map; Figure 6. Comparison of Existing (2016) and Forecast (2021) Noise Exposure Maps; Figure 7. South Flow Arrival and Departure Tracks; Figure 8. North Flow Arrival and Departure Tracks; Figure 9. Military Arrival and Departure Tracks; Figure 10. Flight Track Density Plot for Louisville International Airport Jet Departures; Figure 11. Flight Track Density Plot for Louisville International Airport Jet Arrivals; Table 1. 14 CFR part 150 Noise/Land Use Compatibility Guidelines; Table 2. 14 CFR part 150 Noise Exposure Map Checklist; Table 3. Runway Details; Table 4. 2016 Operations Summary; Table 5. Modeled Average Daily Aircraft Operations for 2016; Table 6. 2021 Operations Summary; Table 7. Modeled Average Daily Aircraft Operations for 2021; Table 8. Overall Runway Use Percentages for 2016; Table 9. Modeled Average Daily Runway Use for 2016; Table 10. Modeled Average Daily Civilian Turbojet Runway Use by Time of Day for 2016; Table 11. Annual Average Contraflow Percentages; Table 12. Two-Year Historical Average Daily Runway Use for Late Morning Time of Day; Table 13. Overall Runway Use Percentages for 2021; Table 14. Modeled Average Daily Runway Use for 2021; Table 15. Modeled Average Daily Civilian Turbojet Runway Use by Time of Day for 2021; Table 16. Military Fixed-Wing Aircraft Flight Tracks and Use; Table 17. Comparison of Land Area Enclosed by the 2016 and 2021 decibel (dB) Day-Night Sound Level (DNL) Contours; Table 18. Number of Historic Resources and Non-Residential Sensitive Receptors within the 2016 and 2021 DNL Contours 58; Table 19. Listing of Historic Resources and Non-Residential Sensitive Receptors within the 2016 and 2021 DNL Contours 59; Table 20. Estimated Residential Population within 20J 6 and 2021 DNL Contours. The FAA has determined that these Noise Exposure Maps and accompanying documentation are in compliance with applicable requirements. This determination is made as of August 10, 2017.
FAA's determination on the airport operator's Noise Exposure Maps is limited to a finding that the maps were developed in accordance with the procedures contained in Appendix A of 14 CFR part 150. Such determination does not constitute approval of the airport operator's data, information or plans, or a commitment to approve a Noise Compatibility Program or to fund the implementation of that Program. If questions arise concerning the precise relationship of specific properties to noise exposure contours depicted on a Noise Exposure Map submitted under 49 U.S.C. 47503, it should be noted that the FAA is not involved in any way in determining the relative locations of specific properties with regard to the depicted noise exposure contours, or in interpreting the Noise Exposure Maps to resolve questions concerning, for example, which properties should be covered by the provisions of 49 U.S.C. 47506. These functions are inseparable from the ultimate land use control and planning responsibilities of local government. These local responsibilities are not changed in any way under 14 CFR part 150 or through FAA's review of the Noise Exposure Maps. Therefore, the responsibility for the detailed overlaying of noise exposure contours onto the map depicting properties on the surface rests exclusively with the airport operator that submitted those maps, or with those public agencies and planning agencies with which consultation is required under 49 U.S.C. 47503. The FAA has relied on the certification by the airport operator, under 14 CFR 150.21, that the statutorily required consultation has been accomplished.
Copies of the full Noise Exposure Map documentation and the FAA's evaluation of the maps are available for examination by appointment at the following locations: Federal Aviation Administration Memphis Airports District Office, 2600 Thousand Oaks Blvd., Suite 2250, Memphis, TN 38118; Regional Airport Authority of Louisville and Jefferson County, P.O. Box 9129, Louisville, Kentucky 40209.
Any questions or requests for such an appointment may be directed to the individual named under the
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of final disposition.
FMCSA announces its decision to renew exemptions for 121 individuals from its prohibition in the Federal Motor Carrier Safety Regulations (FMCSRs) against persons with insulin-treated diabetes mellitus (ITDM) from operating commercial motor vehicles (CMVs) in interstate commerce. The exemptions enable these individuals with ITDM to continue to operate CMVs in interstate commerce.
Each group of renewed exemptions were applicable on the dates stated in the discussions below and will expire on the dates stated in the discussions below.
Ms. Christine A. Hydock, Chief, Medical Programs Division, 202-366-4001,
You may see all the comments online through the Federal Document Management System (FDMS) at:
On August 22, 2017, FMCSA published a notice announcing its decision to renew exemptions for 121 individuals from the insulin-treated diabetes mellitus prohibition in 49 CFR 391.41(b)(3) to operate a CMV in interstate commerce and requested comments from the public (82 FR 39943). The public comment period ended on September 21, 2017 and two comments were received.
As stated in the previous notice, FMCSA has evaluated the eligibility of these applicants and determined that renewing these exemptions would achieve a level of safety equivalent to or greater than the level that would be achieved by complying with the current regulation 49 CFR 391.41(b)(3).
The physical qualification standard for drivers regarding diabetes found in 49 CFR 391.41(b)(3) states that a person is physically qualified to drive a CMV if that person has no established medical history or clinical diagnosis of diabetes mellitus currently requiring insulin for control.
FMCSA received two comments in this preceding. Perdro Fravien asked if these drivers were type 1 or type 2 diabetics. He stated that the drivers should be type 1 because if they don't have immediate access to medication it may cause an accident. Amber Brooks commented that FMCSA “wants to disallow the issuance of drivers licenses to commercial vehicles”. She referred to several studies on diabetes. FMCSA has evaluated the eligibility of the 121 applicants and determined that granting the exemptions to these individuals would achieve a level of safety equivalent to or greater than the level that would be achieved by complying with the current regulation 49 CFR 391.41(b)(3).
Based upon its evaluation of the 121 renewal exemption applications and comments received, FMCSA confirms its' decision to exempt the following drivers from the rule prohibiting drivers with ITDM from driving CMVs in interstate commerce in 49 CFR 391.64(3):
As of September 2, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following three individuals have satisfied the renewal conditions for obtaining an exemption from the rule prohibiting drivers with ITDM from driving CMVs in interstate commerce (70 FR 23898; 70 FR 52465): Lee R. Kumm (WI), Mitchell L. Pullen (NE), Steven R. Zoller (MN).
The drivers were included in docket number FMCSA-2005-20721. Their exemptions are applicable as of September 2, 2017, and will expire on September 2, 2019.
As of September 9, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 28 individuals have satisfied the renewal conditions for obtaining an exemption from the rule prohibiting drivers with ITDM from driving CMVs in interstate commerce (80 FR 47024; 80 FR 79411):
The drivers were included in docket number FMCSA-2015-0064. Their exemptions are applicable as of September 9, 2017, and will expire on September 9, 2019.
As of September 12, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 29 individuals have satisfied the renewal conditions for obtaining an exemption from the rule prohibiting drivers with ITDM from driving CMVs in interstate commerce (80 FR 48396; 80 FR 77079):
The drivers were included in docket number FMCSA-2015-0065. Their exemptions are applicable as of September 12, 2017, and will expire on September 12, 2019.
As of September 17, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 40 individuals have satisfied the renewal conditions for obtaining an exemption from the rule prohibiting drivers with ITDM from driving CMVs in interstate commerce (80 FR 49304; 80 FR 79399):
The drivers were included in docket number FMCSA-2015-0066. Their exemptions are applicable as of September 17, 2017, and will expire on September 17, 2019.
As of September 18, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following six individuals have satisfied the renewal conditions for obtaining an exemption from the rule prohibiting drivers with ITDM from driving CMVs in interstate commerce (78 FR 38439; 78 FR 60014):
The drivers were included in docket number FMCSA-2013-0020. Their exemptions are applicable as of September 18, 2017, and will expire on September 18, 2019.
As of September 22, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 15 individuals have satisfied the renewal conditions for obtaining an exemption from the rule prohibiting drivers with ITDM from driving CMVs in interstate commerce (74 FR 37288; 74 FR 48641):
The drivers were included in docket number FMCSA-2009-0174. Their exemptions are applicable as of September 22, 2017, and will expire on September 22, 2019.
In accordance with 49 U.S.C. 31315, each exemption will be valid for two years from the effective date unless revoked earlier by FMCSA. The exemption will be revoked if the following occurs: (1) The person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained prior to being granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136 and 31315.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of renewal of exemptions; request for comments.
FMCSA announces its decision to renew exemptions for five individuals from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) for interstate commercial motor vehicle (CMV) drivers. The exemptions enable these hard of hearing and deaf individuals to continue to operate CMVs in interstate commerce.
The exemptions were applicable on October 22, 2017. The exemptions expire on October 22, 2019. Comments must be received on or before January 12, 2018.
Ms. Christine A. Hydock, Chief, Medical Programs Division, 202-366-4001,
You may submit comments bearing the Federal Docket Management System (FDMS) Docket No. FMCSA-2014-0387 using any of the following methods:
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Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption for five years if it finds “such exemption would likely achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.” The statute also allows the Agency to renew exemptions at the end of the five-year period. FMCSA grants exemptions from the FMCSRs for a two-year period to align with the maximum duration of a driver's medical certification.
The physical qualification standard for drivers regarding hearing found in 49 CFR 391.41(b)(11) states that a person is physically qualified to driver a CMV if that person first perceives a forced whispered voice in the better ear at not less than 5 feet with or without the use of a hearing aid or, if tested by use of an audiometric device, does not have an average hearing loss in the better ear greater than 40 decibels at 500 Hz, 1,000 Hz, and 2,000 Hz with or without a hearing aid when the audiometric device is calibrated to American National Standard (formerly ASA Standard) Z24.5—1951.
49 CFR 391.41(b)(11) was adopted in 1970, with a revision in 1971 to allow drivers to be qualified under this standard while wearing a hearing aid, 35 FR 6458, 6463 (April 22, 1970) and 36 FR 12857 (July 3, 1971).
The five individuals listed in this notice have requested renewal of their exemptions from the hearing standard in 49 CFR 391.41(b)(11), in accordance with FMCSA procedures. Accordingly, FMCSA has evaluated these applications for renewal on their merits and decided to extend each exemption for a renewable two-year period.
Interested parties or organizations possessing information that would otherwise show that any, or all, of these drivers are not currently achieving the statutory level of safety should immediately notify FMCSA. The Agency will evaluate any adverse evidence submitted and, if safety is being compromised or if continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315, FMCSA will take immediate steps to revoke the exemption of a driver.
In accordance with 49 U.S.C. 31136(e) and 31315, each of the five applicants has satisfied the renewal conditions for obtaining an exemption from the hearing requirement. The five drivers in this notice remain in good standing with the Agency. In addition, for Commercial Driver's License (CDL) holders, the Commercial Driver's License Information System (CDLIS) and the Motor Carrier Management Information System (MCMIS) are searched for crash and violation data. For non-CDL holders, the Agency reviews the driving records from the State Driver's Licensing Agency (SDLA). These factors provide an adequate basis for predicting each driver's ability to continue to safely operate a CMV in interstate commerce. Therefore, FMCSA concludes that extending the exemption for each of these drivers for a period of two years is likely to achieve a level of safety equal to that existing without the exemption.
As of October 22, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following five individuals have satisfied the renewal conditions for obtaining an exemption from the hearing requirement in the FMCSRs for interstate CMV drivers.
The drivers were included in docket number FMCSA-2014-0387. Their exemptions are applicable as of October 22, 2017, and will expire on October 22, 2019.
The exemptions are extended subject to the following conditions: (1) Each driver must report any crashes or accidents as defined in 49 CFR 390.5; and (2) report all citations and convictions for disqualifying offenses under 49 CFR part 383 and 49 CFR 391 to FMCSA; and (3) each driver prohibited from operating a motorcoach or bus with passengers in interstate commerce. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official. In addition, the exemption does not exempt the individual from meeting the applicable CDL testing requirements. Each exemption will be valid for two years unless rescinded earlier by FMCSA. The exemption will be rescinded if: (1) The person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained before it was granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315.
During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with this exemption with respect to a person operating under the exemption.
Based upon its evaluation of the five exemption applications, FMCSA renews the exemptions of the aforementioned drivers from the hearing requirement in 49 CFR 391.41 (b)(11). In accordance with 49 U.S.C. 31136(e) and 31315, each exemption will be valid for two years unless revoked earlier by FMCSA.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of renewal of exemptions; request for comments.
FMCSA announces its decision to renew exemptions for six individuals from the requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) that interstate commercial motor vehicle (CMV) drivers have “no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.” The exemptions enable these individuals who have had one or more seizures and are taking anti-seizure medication to continue to operate CMVs in interstate commerce.
The exemptions were applicable on November 6, 2017. The exemptions expire on November 6, 2019. Comments must be received on or before January 12, 2018.
Ms. Christine A. Hydock, Chief, Medical Programs Division, 202-366-4001,
You may submit comments bearing the Federal Docket Management System (FDMS) Docket No. FMCSA-2011-0389; FMCSA-2012-0094; FMCSA-2013-0107; FMCSA-2014-0381; FMCSA-2015-0116; using any of the following methods:
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Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption for five years if it finds “such exemption would likely achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.” The statute also allows the Agency to renew exemptions at the end of the five-year period. FMCSA grants exemptions from the FMCSRs for a two-year period to align with the maximum duration of a driver's medical certification.
The physical qualification standard for drivers regarding epilepsy found in 49 CFR 391.41(b)(8) states that a person is physically qualified to drive a CMV if that person has no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause the loss of consciousness or any loss of ability to control a CMV.
In addition to the regulations, FMCSA has published advisory criteria to assist Medical Examiners in determining whether drivers with certain medical conditions are qualified to operate a CMV in interstate commerce. [49 CFR part 391, APPENDIX A TO PART 391—MEDICAL ADVISORY CRITERIA, section H. Epilepsy: § 391.41(b)(8), paragraphs 3, 4, and 5.]
The six individuals listed in this notice have requested renewal of their exemptions from the epilepsy and seizure disorders prohibition in 49 CFR 391.41(b)(8), in accordance with FMCSA procedures. Accordingly, FMCSA has evaluated these applications for renewal on their merits and decided to extend each exemption for a renewable two-year period.
Interested parties or organizations possessing information that would otherwise show that any, or all, of these drivers are not currently achieving the statutory level of safety should immediately notify FMCSA. The Agency will evaluate any adverse evidence submitted and, if safety is being compromised or if continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315, FMCSA will take immediate steps to revoke the exemption of a driver.
In accordance with 49 U.S.C. 31136(e) and 31315, each of the six applicants has satisfied the renewal conditions for obtaining an exemption from the epilepsy and seizure disorders prohibition. The six drivers in this notice remain in good standing with the Agency, have maintained their medical monitoring and have not exhibited any medical issues that would compromise their ability to safely operate a CMV during the previous two-year exemption period. In addition, for Commercial Driver's License (CDL) holders, the Commercial Driver's License Information System (CDLIS) and the Motor Carrier Management Information System (MCMIS) are searched for crash and violation data. For non-CDL holders, the Agency reviews the driving records from the State Driver's Licensing Agency (SDLA). These factors provide an adequate basis for predicting each driver's ability to continue to safely operate a CMV in interstate commerce. Therefore, FMCSA concludes that extending the exemption for each renewal applicant for a period of two years is likely to achieve a level of safety equal to that existing without the exemption.
As of November 6, 2017, and in accordance with 49 U.S.C. 31136(e) and
The drivers were included in docket numbers FMCSA-2011-0389; FMCSA-2012-0094; FMCSA-2013-0107; FMCSA-2014-0381; FMCSA-2015-0116. Their exemptions are applicable as of November 6, 2017, and will expire on November 6, 2019.
The exemptions are extended subject to the following conditions: (1) Each driver must remain seizure-free and maintain a stable treatment during the two-year exemption period; (2) each driver must submit annual reports from their treating physicians attesting to the stability of treatment and that the driver has remained seizure-free; (3) each driver must undergo an annual medical examination by a certified Medical Examiner, as defined by 49 CFR 390.5; and (4) each driver must provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or keep a copy of his/her driver's qualification file if he/she is self-employed. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official. The exemption will be rescinded if: (1) The person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained before it was granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315.
During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with this exemption with respect to a person operating under the exemption.
Based upon its evaluation of the six exemption applications, FMCSA renews the exemptions of the aforementioned drivers from the epilepsy and seizure disorders prohibition in 49 CFR 391.41 (b)(8). In accordance with 49 U.S.C. 31136(e) and 31315, each exemption will be valid for two years unless revoked earlier by FMCSA.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of final disposition.
FMCSA announces its decision to renew exemptions for five individuals from the requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) that interstate commercial motor vehicle (CMV) drivers have “no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.” The exemptions enable these individuals who have had one or more seizures and are taking anti-seizure medication to continue to operate CMVs in interstate commerce.
The exemptions were applicable on July 12, 2017. The exemptions expire on July 12, 2019.
Ms. Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001,
You may see all the comments online through the Federal Document Management System (FDMS) at:
On August 22, 2017, FMCSA published a notice announcing its decision to renew exemptions for five individuals from the epilepsy and seizure disorders prohibition in 49 CFR 391.41(b)(8) to operate a CMV in interstate commerce and requested comments from the public (82 FR 39945). The public comment period ended on September 21, 2017, and two comments were received.
As stated in the previous notice, FMCSA has evaluated the eligibility of these applicants and determined that renewing these exemptions would achieve a level of safety equivalent to or greater than the level that would be achieved by complying with the current regulation 49 CFR 391.41(b)(8).
The physical qualification standard for drivers regarding epilepsy found in 49 CFR 391.41(b)(8) states that a person is physically qualified to drive a CMV if that person has no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause the loss of consciousness or any loss of ability to control a CMV.
In addition to the regulations, FMCSA has published advisory criteria to assist Medical Examiners in determining whether drivers with certain medical conditions are qualified to operate a CMV in interstate commerce. [49 CFR part 391, APPENDIX A TO PART 391—MEDICAL ADVISORY CRITERIA, section H. Epilepsy: § 391.41(b)(8), paragraphs 3, 4, and 5.]
FMCSA received two comments in this proceeding. Both comments supported FMCSA granting these exemptions. However, in one, the author believed that the exemption renewals should be granted, but, that frequent visits to relevant agencies would greatly slow down the process for no real additional benefits. FMCSA interprets this comment as referring to visits to the medical specialist as part of
Based upon its evaluation of the five exemption applications, FMCSA exempts the following drivers from the epilepsy and seizure disorder prohibition, 49 CFR 391.41(b)(8), subject to the requirements cited above:
In accordance with 49 U.S.C. 31315, each exemption will be valid for two years from the effective date unless revoked earlier by FMCSA. The exemption will be revoked if the following occurs: (1) The person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained prior to being granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136 and 31315.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of final disposition.
FMCSA announces its decision to exempt five individuals from the requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) that interstate commercial motor vehicle (CMV) drivers have “no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.” The exemptions enable these individuals who have had one or more seizures and are taking anti-seizure medication to operate CMVs in interstate commerce.
The exemptions were applicable on November 14, 2017. The exemptions expire on November 14, 2019.
Ms. Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001,
You may see all the comments online through the Federal Document Management System (FDMS) at:
On October 11, 2017, FMCSA published a notice announcing receipt of applications from five individuals requesting an exemption from the epilepsy and seizure disorders prohibition in 49 CFR 391.41(b)(8) and requested comments from the public (82 FR 47299). The public comment period ended on November 13, 2017, and no comments were received.
FMCSA has evaluated the eligibility of these applicants and determined that granting exemptions to these individuals would achieve a level of safety equivalent to or greater than the level that would be achieved by complying with the current regulation 49 CFR 391.41(b)(8).
The physical qualification standard for drivers regarding epilepsy found in 49 CFR 391.41(b)(8) states that a person is physically qualified to drive a CMV if that person has no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause the loss of consciousness or any loss of ability to control a CMV.
In addition to the regulations, FMCSA has published advisory criteria
FMCSA received no comments in this proceeding.
Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption from the epilepsy and seizure disorder prohibition in 49 CFR 391.41(b)(8) if the exemption is likely to achieve an equivalent or greater level of safety than would be achieved without the exemption. The exemption allows the applicants to operate CMVs in interstate commerce.
In reaching the decision to grant these exemption requests, FMCSA considered the 2007 recommendations of the Agency's Medical Expert Panel (MEP). The January 15, 2013,
The Agency's decision regarding these exemption applications is based on an individualized assessment of each applicant's medical information, including the root cause of the respective seizure(s) and medical information about the applicant's seizure history, the length of time that has elapsed since the individual's last seizure, the stability of each individual's treatment regimen and the duration of time on or off of anti-seizure medication. In addition, the Agency reviewed the treating clinician's medical opinion related to the ability of the driver to safely operate a CMV with a history of seizure and each applicant's driving record found in the Commercial Driver's License Information System (CDLIS) for commercial driver's license (CDL) holders, and interstate and
These five applicants have been seizure-free over a range of 23 years while taking anti-seizure medication and maintained a stable medication treatment regimen for the last two years. In each case, the applicant's treating physician verified his or her seizure history and supports the ability to drive commercially.
The Agency acknowledges the potential consequences of a driver experiencing a seizure while operating a CMV. However, the Agency believes the drivers granted this exemption have demonstrated that they are unlikely to have a seizure and their medical condition does not pose a risk to public safety.
Consequently, FMCSA finds that in each case exempting these applicants from the epilepsy and seizure disorder prohibition in 49 CFR 391.41(b)(8) is likely to achieve a level of safety equal to that existing without the exemption.
The terms and conditions of the exemption are provided to the applicants in the exemption document and includes the following: (1) Each driver must remain seizure-free and maintain a stable treatment during the two-year exemption period; (2) each driver must submit annual reports from their treating physicians attesting to the stability of treatment and that the driver has remained seizure-free; (3) each driver must undergo an annual medical examination by a certified Medical Examiner, as defined by 49 CFR 390.5; and (4) each driver must provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or keep a copy of his/her driver's qualification file if he/she is self-employed. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official.
During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with this exemption with respect to a person operating under the exemption.
Based upon its evaluation of the five exemption applications, FMCSA exempts the following drivers from the epilepsy and seizure disorder prohibition, 49 CFR 391.41(b)(8), subject to the requirements cited above:
In accordance with 49 U.S.C. 31315(b)(1), each exemption will be valid for two years from the effective date unless revoked earlier by FMCSA. The exemption will be revoked if the following occurs: (1) The person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained prior to being granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136 and 31315.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of final disposition.
FMCSA announces its decision to exempt 51 individuals from the prohibition in the Federal Motor Carrier Safety Regulations (FMCSRs) against persons with insulin-treated diabetes mellitus (ITDM) from operating a commercial motor vehicle (CMV) in interstate commerce. The exemptions enable these individuals with ITDM to operate CMVs in interstate commerce.
The exemptions were applicable on September 26, 2017. The exemptions expire on September 26, 2019.
Ms. Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001,
You may see all the comments online through the Federal Document Management System (FDMS) at:
On August 24, 2017, FMCSA published a notice announcing receipt of applications from 51 individuals requesting an exemption from diabetes requirement in 49 CFR 391.41(b)(3) and requested comments from the public (82 FR 40221). The public comment period ended on September 25, 2017, and four comments were received.
FMCSA has evaluated the eligibility of these applicants and determined that granting the exemptions to these individuals would achieve a level of safety equivalent to or greater than the level that would be achieved by complying with the current regulation 49 CFR 391.41(b)(3).
The physical qualification standard for drivers regarding diabetes found in 49 CFR 391.41(b)(3) states that a person is physically qualified to drive a CMV if that person has no established medical history or clinical diagnosis of diabetes mellitus currently requiring insulin for control.
FMCSA received four comments in this proceeding. Randall Lambdin, Trenton Colyer, and Joe Schneider stated that they are in favor of granting Matthew Follis an exemption because they believe he is a safe driver. Vicky Johnson stated that Minnesota DVS is in favor of granting exemptions to the
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption from the diabetes standard in 49 CFR 391.41(b)(3) if the exemption is likely to achieve an equivalent or greater level of safety than would be achieved without the exemption. The exemption allows the applicants to operate CMVs in interstate commerce.
The Agency's decision regarding these exemption applications is based on the program eligibility criteria and an individualized assessment of information submitted by each applicant. The qualifications, experience, and medical condition of each applicant were stated and discussed in detail in the August 24, 2017,
These 51 applicants have had ITDM over a range of one to 47 years. These applicants report no severe hypoglycemic reactions resulting in loss of consciousness or seizure, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning symptoms, in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the past five years. In each case, an endocrinologist verified that the driver has demonstrated a willingness to properly monitor and manage his/her diabetes mellitus, received education related to diabetes management, and is on a stable insulin regimen. These drivers report no other disqualifying conditions, including diabetes related complications. Each meets the vision requirement at 49 CFR 391.41(b)(10).
Consequently, FMCSA finds that in each case exempting these applicants from the diabetes requirement in 49 CFR 391.41(b)(3) is likely to achieve a level of safety equal to that existing without the exemption.
The terms and conditions of the exemption are provided to the applicants in the exemption document and includes the following: (1) Each driver must submit a quarterly monitoring checklist completed by the treating endocrinologist as well as an annual checklist with a comprehensive medical evaluation; (2) each driver must report within two business days of occurrence, all episodes of severe hypoglycemia, significant complications, or inability to manage diabetes; also, any involvement in an accident or any other adverse event in a CMV or personal vehicle, whether or not it is related to an episode of hypoglycemia; (3) each driver must provide a copy of the ophthalmologist's or optometrist's report to the Medical Examiner at the time of the annual medical examination; and (4) each driver must provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or keeping a copy in his/her driver's qualification file if he/she is self-employed. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official.
During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with this exemption with respect to a person operating under the exemption.
Based upon its evaluation of the 51 exemption applications, FMCSA exempts the following drivers from the diabetes requirement in 49 CFR 391.41(b)(10), subject to the requirements cited above:
In accordance with 49 U.S.C. 31136(e) and 31315, each exemption will be valid for two years from the effective date unless revoked earlier by FMCSA. The exemption will be revoked if the following occurs: (1) The person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained prior to being granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of final disposition.
FMCSA announces its decision to exempt 31 individuals from the prohibition in the Federal Motor Carrier Safety Regulations (FMCSRs) against persons with insulin-treated diabetes mellitus (ITDM) from operating a commercial motor vehicle (CMV) in interstate commerce. The exemptions enable these individuals with ITDM to operate CMVs in interstate commerce.
The exemptions were applicable on October 20, 2017. The exemptions expire on October 20, 2019.
Ms. Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001,
You may see all the comments online through the Federal Document Management System (FDMS) at:
On September 19, 2017, FMCSA published a notice announcing receipt of applications from 31 individuals requesting an exemption from diabetes requirement in 49 CFR 391.41(b)(3) and requested comments from the public (82 FR 43810). The public comment period ended on October 19, 2017, and no comments were received.
FMCSA has evaluated the eligibility of these applicants and determined that granting the exemptions to these individuals would achieve a level of safety equivalent to or greater than the level that would be achieved by complying with the current regulation 49 CFR 391.41(b)(3).
The physical qualification standard for drivers regarding diabetes found in 49 CFR 391.41(b)(3) states that a person is physically qualified to drive a CMV if that person has no established medical history or clinical diagnosis of diabetes mellitus currently requiring insulin for control.
FMCSA received no comments in this proceeding.
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption from the diabetes standard in 49 CFR 391.41(b)(3) if the exemption is likely to achieve an equivalent or greater level of safety than would be achieved without the exemption. The exemption allows the applicants to operate CMVs in interstate commerce.
The Agency's decision regarding these exemption applications is based on the program eligibility criteria and an individualized assessment of information submitted by each applicant. The qualifications, experience, and medical condition of each applicant were stated and discussed in detail in the September 19, 2017
These 31 applicants have had ITDM over a range of 1 to 30 years. These applicants report no severe hypoglycemic reactions resulting in loss of consciousness or seizure, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning symptoms, in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the past five years. In each case, an endocrinologist verified that the driver has demonstrated a willingness to properly monitor and manage his/her diabetes mellitus, received education related to diabetes management, and is on a stable insulin regimen. These drivers report no other disqualifying conditions, including diabetes related complications. Each meets the vision requirement at 49 CFR 391.41(b)(10).
Consequently, FMCSA finds that in each case exempting these applicants from the diabetes requirement in 49 CFR 391.41(b)(3) is likely to achieve a level of safety equal to that existing without the exemption.
The terms and conditions of the exemption are provided to the applicants in the exemption document and includes the following: (1) Each driver must submit a quarterly monitoring checklist completed by the treating endocrinologist as well as an annual checklist with a comprehensive medical evaluation; (2) each driver must report within two business days of occurrence, all episodes of severe hypoglycemia, significant complications, or inability to manage diabetes; also, any involvement in an accident or any other adverse event in a CMV or personal vehicle, whether or not it is related to an episode of hypoglycemia; (3) each driver must provide a copy of the ophthalmologist's or optometrist's report to the Medical Examiner at the time of the annual medical examination; and (4) each driver must provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or keeping a copy in his/her driver's qualification file if he/she is self-employed. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official.
During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with this exemption with respect to a person operating under the exemption.
Based upon its evaluation of the 31 exemption applications, FMCSA exempts the following drivers from the diabetes requirement in 49 CFR 391.41(b)(10), subject to the requirements cited above:
In accordance with 49 U.S.C. 31136(e) and 31315, each exemption will be valid for two years from the effective date unless revoked earlier by FMCSA. The exemption will be revoked if the following occurs: (1) The person fails to
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of applications for exemption; request for comments.
FMCSA announces receipt of applications from 49 individuals for an exemption from the prohibition in the Federal Motor Carrier Safety Regulations (FMCSRs) against persons with insulin-treated diabetes mellitus (ITDM) operating a commercial motor vehicle (CMV) in interstate commerce. If granted, the exemptions would enable these individuals with ITDM to operate CMVs in interstate commerce.
Comments must be received on or before January 12, 2018.
You may submit comments bearing the Federal Docket Management System (FDMS) Docket No. FMCSA-2017-0236 using any of the following methods:
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Ms. Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001,
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption from the FMCSRs for a five-year period if it finds “such exemption would likely achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.” The statute also allows the Agency to renew exemptions at the end of the five-year period. FMCSA grants exemptions from the FMCSRs for a two-year period to align with the maximum duration of a driver's medical certification.
The 49 individuals listed in this notice have requested an exemption from the diabetes prohibition in 49 CFR 391.41(b)(3). Accordingly, the Agency will evaluate the qualifications of each applicant to determine whether granting the exemption will achieve the required level of safety mandated by statute.
The physical qualification standard for drivers regarding diabetes found in 49 CFR 391.41(b)(3) states that a person is physically qualified to drive a CMV if that person has no established medical history or clinical diagnosis of diabetes mellitus currently requiring insulin for control. The Agency established the current requirement for diabetes in 1970 because several risk studies indicated that drivers with diabetes had a higher rate of crash involvement than the general population. The Agency established the current requirement for diabetes in 1970 because several risk studies indicated that drivers with diabetes had a higher rate of crash involvement than the general population.
FMCSA established its diabetes exemption program, based on the Agency's July 2000 study entitled “A Report to Congress on the Feasibility of a Program to Qualify Individuals with Insulin-Treated Diabetes Mellitus to Operate in Interstate Commerce as Directed by the Transportation Act for the 21st Century.” The report concluded that a safe and practicable protocol to allow some drivers with ITDM to operate CMVs is feasible. The September 3, 2003 (68 FR 52441),
FMCSA notes that section 4129 of the Safe, Accountable, Flexible and Efficient Transportation Equity Act: A Legacy for Users requires the Secretary to revise its diabetes exemption program established on September 3, 2003 (68 FR 52441). The revision must provide for individual assessment of drivers with diabetes mellitus, and be consistent with the criteria described in section 4018 of the Transportation Equity Act for the 21st Century (49 U.S.C. 31305). Section 4129 requires: (1) Elimination of the requirement for three years of experience operating CMVs while being treated with insulin; and (2) establishment of a specified minimum period of insulin use to demonstrate stable control of diabetes before being allowed to operate a CMV.
In response to section 4129, FMCSA made immediate revisions to the diabetes exemption program established by the September 3, 2003 notice. FMCSA discontinued use of the three-year driving experience and fulfilled the requirements of section 4129 while continuing to ensure that operation of CMVs by drivers with ITDM will
The FMCSA concluded that all of the operating, monitoring and medical requirements set out in the September 3, 2003, notice, except as modified, were in compliance with section 4129(d). Therefore, all of the requirements set out in the September 3, 2003, notice, except as modified by the notice in the
Mr. Barr, 31, has had ITDM since 2017. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Barr understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Barr meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds a Class C CDL from Michigan.
Mr. Bass, 43, has had ITDM since 2016. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Bass understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Bass meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from New Mexico.
Mr. Beaty, 49, has had ITDM since 2010. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Beaty understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Beaty meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Alaska.
Mr. Bier, 57, has had ITDM since 2016. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Bier understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Bier meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Washington.
Mr. Botkin, 55, has had ITDM since 1991. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Botkin understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Botkin meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds an operator's license from California.
Mr. Breuklander, 67, has had ITDM since 2002. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Breuklander understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Breuklander meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2017 and certified that he has stable proliferative diabetic retinopathy. He holds a Class A CDL from Missouri.
Mr. Brown, 41, has had ITDM since 2016. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Brown understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Brown meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds an operator's license from Georgia.
Mr. Burke, 32, has had ITDM since 2017. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Burke understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Burke meets the
Mr. Corbett, 42, has had ITDM since 2015. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Corbett understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Corbett meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from South Carolina.
Mr. Covel, 50, has had ITDM since 2014. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Covel understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Covel meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Nebraska.
Mr. Curtis, 67, has had ITDM since 2017. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Curtis understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Curtis meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Connecticut.
Mr. Dillow, 56, has had ITDM since 2016. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Dillow understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Dillow meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2017 and certified that he has stable proliferative diabetic retinopathy. He holds a Class A CDL from Indiana.
Mr. Drake, 61, has had ITDM since 2007. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Drake understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Drake meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2017 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from Vermont.
Mr. Edmonds, 70, has had ITDM since 2014. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Edmonds understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Edmonds meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2017 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from West Virginia.
Mr. Engbretson, 42, has had ITDM since 2007. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Engbretson understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Engbretson meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2017 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from Iowa.
Mr. Erbar, 61, has had ITDM since 1996. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Erbar understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Erbar meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds a Class B CDL from Washington.
Mr. Finn, 59, has had ITDM since 2010. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function
Mr. Garetson, 24, has had ITDM since 2017. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Garetson understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Garetson meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Iowa.
Mr. Gladson, 68, has had ITDM since 2011. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Gladson understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Gladson meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds an operator's license from Tennessee.
Mr. Gray, 58, has had ITDM since 2008. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Gray understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Gray meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2017 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from Pennsylvania.
Mr. Harrell, 61, has had ITDM since 2016. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Harrell understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Harrell meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds an operator's license from Florida.
Mr. Harris, 48, has had ITDM since 1984. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Harris understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Harris meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2017 and certified that he has stable proliferative diabetic retinopathy. He holds an operator's license from Maine.
Mr. Holland, 28, has had ITDM since 2016. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Holland understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Holland meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Pennsylvania.
Mr. Huxman, 27, has had ITDM since 2014. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Huxman understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Huxman meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds an operator's license from Kansas.
Mr. Knudsen, 71, has had ITDM since 2016. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Knudsen understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Knudsen meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds a Class B CDL from Virginia.
Mr. Kropf, 42, has had ITDM since 2016. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Kropf understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Kropf meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Oregon.
Mr. LaDuke, 55, has had ITDM since 1989. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. LaDuke understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. LaDuke meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds an operator's license from Arizona.
Mr. Malonson, 56, has had ITDM since 2014. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Malonson understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Malonson meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds a Class B CDL from Massachusetts.
Mr. Martin, 57, has had ITDM since 2016. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Martin understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Martin meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds a Class B CDL from Massachusetts.
Mr. Medley, 39, has had ITDM since 1992. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Medley understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Medley meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds an operator's license from Indiana.
Ms. Merchant, 49, has had ITDM since 2014. Her endocrinologist examined her in 2017 and certified that she has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. Her endocrinologist certifies that Ms. Merchant understands diabetes management and monitoring has stable control of her diabetes using insulin, and is able to drive a CMV safely. Ms. Merchant meets the requirements of the vision standard at 49 CFR 391.41(b)(10). Her optometrist examined her in 2017 and certified that she does not have diabetic retinopathy. She holds a Class B CDL from Alabama.
Mr. Moore, 58, has had ITDM since 2017. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Moore understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Moore meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2017 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from New Jersey.
Mr. Nash, 54, has had ITDM since 2017. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Nash understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Nash meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds an operator's license from Indiana.
Mr. Ninke, 68, has had ITDM since 2014. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Ninke understands diabetes management and monitoring,
Mr. Pothast, 63, has had ITDM since 2016. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Pothast understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Pothast meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2017 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from Ohio.
Mr. Sills, 38, has had ITDM since 2017. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Sills understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Sills meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Indiana.
Mr. Singh, 45, has had ITDM since 2017. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Singh understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Singh meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2017 and certified that he has stable nonproliferative diabetic retinopathy. He holds an operator's license from Michigan.
Mr. Singh, 41, has had ITDM since 2016. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Singh understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Singh meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Oklahoma.
Mr. Skovbroten, 60, has had ITDM since 2016. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Skovbroten understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Skovbroten meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Wisconsin.
Mr. Sprague, 60, has had ITDM since 2017. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Sprague understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Sprague meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2017 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class A CDL from Maine.
Mr. Stenberg, 58, has had ITDM since 2017. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Stenberg understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Stenberg meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds an operator's license from Utah.
Mr. TenEyck, 54, has had ITDM since 2012. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. TenEyck understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. TenEyck meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds an operator's license from Nebraska.
Mr. Tolbert, 46, has had ITDM since 2017. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting
Mr. Torres, 48, has had ITDM since 2017. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Torres understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Torres meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from Texas.
Mr. Ussery, 69, has had ITDM since 2014. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Ussery understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Ussery meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds an operator's license from Louisiana.
Mr. Watkins, 50, has had ITDM since 2016. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Watkins understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Watkins meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist examined him in 2017 and certified that he has stable nonproliferative diabetic retinopathy. He holds a Class B CDL from North Carolina.
Mr. Weihler, 66, has had ITDM since 2016. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Weihler understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Weihler meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds an operator's license from Illinois.
Mr. Whitley, 66, has had ITDM since 2017. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Whitley understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Whitley meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds a Class A CDL from New Mexico.
Mr. Yakimow, 24, has had ITDM since 2015. His endocrinologist examined him in 2017 and certified that he has had no severe hypoglycemic reactions resulting in loss of consciousness, requiring the assistance of another person, or resulting in impaired cognitive function that occurred without warning in the past 12 months and no recurrent (two or more) severe hypoglycemic episodes in the last five years. His endocrinologist certifies that Mr. Yakimow understands diabetes management and monitoring, has stable control of his diabetes using insulin, and is able to drive a CMV safely. Mr. Yakimow meets the requirements of the vision standard at 49 CFR 391.41(b)(10). His optometrist examined him in 2017 and certified that he does not have diabetic retinopathy. He holds an operator's license from Ohio.
In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests public comment from all interested persons on the exemption petitions described in this notice. We will consider all comments received before the close of business on the closing date indicated in the dates section of the notice.
You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.
To submit your comment online, go to
We will consider all comments and materials received during the comment
To view comments, as well as any documents mentioned in this preamble, go to
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Internal Revenue Service, 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 continuing information collections, as required by the Paperwork Reduction Act of 1995. IRS is soliciting comments concerning Rulings and determination letters.
Written comments should be received on or before February 12, 2018 to be assured of consideration.
Direct all written comments to T. Pinkston, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224.
Please send separate comments for each specific information collection listed below. You must reference the information collection's title, form number, reporting or record-keeping requirement number, and OMB number (if any) in your comment. Requests for additional information, or copies of the information collection and instructions, or copies of any comments received, contact Elaine Christophe, at (202) 317-5745, at Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or through the internet, at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Internal Revenue Service, 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 continuing information collections, as required by the Paperwork Reduction Act of 1995. IRS is soliciting comments concerning Limitations on Net Operating Loss Carryforwards and Certain Built-in Losses and Credits Following.
Written comments should be received on or before February 12, 2018 to be assured of consideration.
Direct all written comments to T. Pinkston, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224.
Please send separate comments for each
The IRS is seeking comments concerning the reporting and/or record-keeping requirements of TD 8824.
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Departmental Offices, Department of the Treasury.
Notice of reporting requirements.
By this Notice, the Department of the Treasury is informing the public that it is conducting a mandatory survey of ownership of foreign securities by U.S. residents as of December 31, 2017. This Notice constitutes legal notification to all United States persons (defined below) who meet the reporting requirements set forth in this Notice that they must respond to, and comply with, this survey. The reporting form SHCA (2017) and instructions may be printed from the internet at:
(b) This seal is of suitable design and appropriate for adoption as the official seal of the NCUA.
(c) I hereby approve this seal as the official seal of the NCUA.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
| 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 |