Page Range | 54709-55104 | |
FR Document |
Page and Subject | |
---|---|
81 FR 54717 - Providing an Order of Succession Within the National Endowment for the Humanities | |
81 FR 54715 - Designation of Officers of the Office of Personnel Management To Act as Director of the Office of Personnel Management | |
81 FR 54713 - Providing an Order of Succession Within the Environmental Protection Agency | |
81 FR 54711 - Providing an Order of Succession Within the Department of Veterans Affairs | |
81 FR 54709 - Providing an Order of Succession Within the Department of the Treasury | |
81 FR 54857 - In the Matter of Neuromama, Ltd.; Order of Suspension of Trading | |
81 FR 54916 - Petition for Waiver of Compliance | |
81 FR 54803 - MAVL Capital, Inc., IAM & AL Group Inc., and Maxim Ostrovskiy V. Marine Transport Logistics, Inc. and Dimitry Alper: Notice of Filing of Complaint and Assignment | |
81 FR 54739 - Special Local Regulations; Tall Ships Duluth 2016 Parade of Sail, Lake Superior, Duluth, MN | |
81 FR 54913 - Commission Meeting; Correction | |
81 FR 54789 - Approval of Subzone Status: Westlake Chemical Corporation, Geismar, Louisiana | |
81 FR 54803 - Plant-Incorporated Protectants: Proposed Modifications of Registration Procedures for Plant-Incorporated Protectants in Breeding Line Intermediates; Notice of Availability; Extension of Comment Period | |
81 FR 54853 - Arts Advisory Panel Meetings | |
81 FR 54809 - Agency Information Collection Activities; Submission for Office of Management and Budget Review Comment Request; Voluntary Qualified Importer Program Guidance for Industry | |
81 FR 54818 - 30-Day Notice of Proposed Information Collection: Energy and Performance Information Center (EPIC) | |
81 FR 54818 - 30-Day Notice of Proposed Information Collection: Public Housing Agency (PHA) Lease and Grievance Requirements | |
81 FR 54802 - Proposed Consent Decree, Clean Air Act Citizen Suit | |
81 FR 54800 - Proposed Consent Decree, Clean Air Act Citizen Suit | |
81 FR 54819 - 60-Day Notice of Proposed Information Collection: Uniform Physical Standards & Physical Inspection Requirements | |
81 FR 54790 - Department of Defense Military Family Readiness Council (MFRC); Notice of Federal Advisory Committee Meeting | |
81 FR 54804 - Notice of Agreements Filed | |
81 FR 54913 - 30-Day Notice of Proposed Information Collection: Shrimp Exporter's/Importer's Declaration | |
81 FR 54856 - Sunshine Notice-September 7, 2016 Public Hearing | |
81 FR 54849 - Notice of Federal Advisory Committee Meeting | |
81 FR 54853 - Notice of Centennial Challenges Space Robotics Challenge | |
81 FR 54917 - Proposed Agency Information Collection Activities; Comment Request | |
81 FR 54719 - Almonds Grown in California; Change in Quality Control Requirements | |
81 FR 54748 - Oranges and Grapefruit Grown in Lower Rio Grande Valley in Texas; Increased Assessment Rate | |
81 FR 54789 - Credit Union Advisory Council Meeting | |
81 FR 54721 - Energy Conservation Program: Test Procedures for Ceiling Fans; Correction | |
81 FR 54804 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
81 FR 54805 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
81 FR 54795 - Carib Energy (USA) LLC; Application for Long-Term, Multi-Contract Authorization To Export Liquefied Natural Gas to Non-Free Trade Agreement Nations in Central America, South America, or the Caribbean | |
81 FR 54787 - [Docket No. 160714611-6611-01] HEADOffice of Administration; Commerce Alternative Personnel System | |
81 FR 54850 - Notice of a Public Meeting of the Advisory Committee on Apprenticeship (ACA) | |
81 FR 54852 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Death Gratuity | |
81 FR 54851 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Prohibited Transaction Class Exemption for Certain Transactions Between Investment Companies and Employee Benefit Plans (PTE 1977-4) | |
81 FR 54807 - Proposed Information Collection Activity; Comment Request | |
81 FR 54792 - Strategic Environmental Research and Development Program, Scientific Advisory Board; Notice of Federal Advisory Committee Meeting | |
81 FR 54794 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and approval; Comment Request; Application for Grants Under the Upward Bound Program | |
81 FR 54786 - Revision of the Land Management Plan for Francis Marion National Forest | |
81 FR 54856 - Proposed Collection; Comment Request | |
81 FR 54791 - National Security Education Board; Notice of Federal Advisory Committee Meeting | |
81 FR 54915 - Ninety-Sixth Meeting Special Committee 159 Global Positioning System | |
81 FR 54918 - Notice and Request for Comments | |
81 FR 54744 - Fisheries of the Northeastern United States; Northeast Skate Complex Fishery; Framework Adjustment 3 and 2016-2017 Specifications | |
81 FR 54737 - Certifications and Exemptions Under the International Regulations for Preventing Collisions at Sea, 1972 | |
81 FR 54768 - Notice of Intent To Establish a Negotiated Rulemaking Committee | |
81 FR 54806 - Agency Forms Undergoing Paperwork Reduction Act Review | |
81 FR 54814 - National Indian Health Outreach and Education II Program; Correction | |
81 FR 54808 - Regulatory Classification of Pharmaceutical Co-Crystals; Draft Guidance for Industry; Availability | |
81 FR 54822 - Lawrence E. Stewart, M.D.; Decision and Order | |
81 FR 54914 - Request for Comments and Notice of Public Hearing Concerning Russia's Implementation of Its WTO Commitments | |
81 FR 54849 - Bulk Manufacturer of Controlled Substances Application: Stepan Company | |
81 FR 54919 - Privacy Act of 1974 | |
81 FR 54813 - Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments | |
81 FR 54811 - Use of Nucleic Acid Tests To Reduce the Risk of Transmission of Hepatitis B Virus From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry; Availability | |
81 FR 54901 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Amendment No. 1 and Order Granting Accelerated Approval of a Proposed Rule Change Amending Rule 12904 (Awards) of the Code of Arbitration Procedure for Customer Disputes and Rule 13904 (Awards) of the Code of Arbitration Procedure for Industry Disputes To Permit Award Offsets in Arbitration, as Modified by Amendment No. 1 | |
81 FR 54877 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing of Proposed Rule Change Amending the Co-location Services Offered by the Exchange To Add Certain Access and Connectivity Fees | |
81 FR 54897 - Self-Regulatory Organizations: Investors Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Conform to Rules of the Financial Industry Regulatory Authority | |
81 FR 54870 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to COPS | |
81 FR 54888 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of a Proposed Rule Change Amending Rule 12504 of the Code of Arbitration Procedure for Customer Disputes and Rule 13504 of the Code of Arbitration Procedure for Industry Disputes Relating to Motions To Dismiss in Arbitration | |
81 FR 54905 - Program for Allocation of Regulatory Responsibilities Pursuant to Rule 17d-2; Notice of Filing and Order Approving and Declaring Effective an Amendment to the Plan for the Allocation of Regulatory Responsibilities Between Bats BZX Exchange, Inc., Bats BYX Exchange, Inc., BOX Options Exchange LLC, Chicago Board Options Exchange, Incorporated, C2 Options Exchange, Incorporated, Chicago Stock Exchange, Inc., Bats EDGA Exchange, Inc., Bats EDGX Exchange, Inc., Financial Industry Regulatory Authority, Inc., International Securities Exchange, LLC, Investors Exchange LLC, ISE Gemini, LLC, ISE Mercury, LLC, Miami International Securities Exchange, LLC, The NASDAQ Stock Market LLC, NASDAQ BX, Inc., NASDAQ PHLX, Inc., National Stock Exchange, Inc., New York Stock Exchange LLC, NYSE MKT LLC, and NYSE Arca, Inc. | |
81 FR 54873 - Self-Regulatory Organizations; Investors Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Related to Transaction and Regulatory Fees | |
81 FR 54858 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of a Proposed Rule Change Amending the Code of Arbitration Procedure for Customer Disputes and the Code of Arbitration Procedure for Industry Disputes to Require All Parties Other Than Pro Se | |
81 FR 54887 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Change To Modify the NYSE Amex Options Fee Schedule | |
81 FR 54911 - Self-Regulatory Organizations; Miami International Securities Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Exchange Rule 517 | |
81 FR 54867 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Proposed Rule Change Amending Rule 6.91(b) To Provide for the Rejection of Certain Electronic Complex Orders | |
81 FR 54891 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the NYSE Arca Equities Schedule of Fees and Charges for Exchange Services Related to Tier 1 and Cross Asset Tier 2 Fees and Credits for Orders Executed on the Exchange, and Eliminate the Routable Retail Order Tier | |
81 FR 54893 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing of Proposed Rule Change Amending Rule 980NY(d) To Provide for the Rejection of Certain Electronic Complex Orders | |
81 FR 54904 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Related to Logical Port Fees | |
81 FR 54896 - Self-Regulatory Organizations; Bats BYX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Related to Logical Port Fees | |
81 FR 54797 - Notice of FERC Staff Attendance at the Entergy Regional State Committee Meeting | |
81 FR 54796 - Notice of Institution of Section 206 Proceeding and Refund Effective Date: Elwood Energy, LLC, Exelon Generation Company, LLC | |
81 FR 54798 - Northern Natural Gas Company; Notice of Application | |
81 FR 54799 - Notice of Application Millennium Pipeline Company, LLC | |
81 FR 54796 - Combined Notice of Filings #1 | |
81 FR 54804 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB | |
81 FR 54783 - Remove NASA FAR Supplement Clause, Engineering Change Proposals (2016-N030) | |
81 FR 54791 - Defense Acquisition University Board of Visitors; Notice of Federal Advisory Committee Meeting | |
81 FR 54805 - Maximum Per Diem Reimbursement Rates for the Continental United States (CONUS) | |
81 FR 54854 - Conduct of Operations | |
81 FR 54820 - Certain Foam Footwear; Institution of an Advisory Opinion Proceeding | |
81 FR 54821 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest | |
81 FR 54855 - Design, Inspection, and Testing Criteria for Air Filtration and Adsorption Units of Normal Atmosphere Cleanup Systems in Light Water Cooled Nuclear Power Plants | |
81 FR 54790 - Notice of Availability (NOA) of an Environmental Assessment (EA) Addressing Defense Logistics Agency Disposition Services Relocation and Expansion at Defense Supply Center, Richmond, Virginia | |
81 FR 54752 - Proposed Amendment of Class C Airspace; El Paso International Airport, TX | |
81 FR 54793 - Submission for OMB Review; Comment Request | |
81 FR 54721 - Revisions to the Export Administration Regulations (EAR): Harmonization of the Destination Control Statements | |
81 FR 54732 - Amendment to the International Traffic in Arms Regulations: Procedures for Obtaining State Department Authorization To Export Items Subject to the Export Administration Regulations; Revision to the Destination Control Statement; and Other Changes | |
81 FR 54817 - Prospective Grant of Exclusive Patent License: Development of T Cell Receptors (TCRs) Targeting the KRAS G12D Mutation for the Treatment of Cancer | |
81 FR 54816 - National Institute of Environmental Health Sciences; Notice of Meeting | |
81 FR 54815 - National Institute on Aging; Notice of Closed Meetings | |
81 FR 54817 - National Institute on Aging; Notice of Closed Meeting | |
81 FR 54816 - National Heart, Lung, and Blood Institute; Notice of Meeting | |
81 FR 54817 - National Cancer Institute; Amended Notice of Meeting | |
81 FR 54815 - National Cancer Institute; Notice of Meeting | |
81 FR 54815 - National Center for Advancing Translational Sciences; Notice of Closed Meeting | |
81 FR 54742 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Control of Volatile Organic Compound Emissions From Fiberglass Boat Manufacturing Materials | |
81 FR 54780 - Air Plan Approval; Kentucky; Removal of Stage II Gasoline Vapor Recovery Program | |
81 FR 54741 - Drawbridge Operation Regulation; Rockaway Inlet, Queens, NY | |
81 FR 54795 - Environmental Management Site-Specific Advisory Board, Paducah | |
81 FR 55058 - Endangered and Threatened Wildlife and Plants; Threatened Status for Lepidium papilliferum | |
81 FR 54789 - Submission for OMB Review; Comment Request | |
81 FR 54750 - Airworthiness Directives; The Boeing Company Airplanes | |
81 FR 54754 - Prohibition of Children's Toys and Child Care Articles Containing Specified Phthalates: Determinations Regarding Certain Plastics | |
81 FR 54960 - Substances Generally Recognized as Safe | |
81 FR 54926 - Energy Conservation Program: Test Procedure for Walk-in Coolers and Walk-in Freezers | |
81 FR 54763 - Importations of Certain Vehicles and Engines Subject to Federal Antipollution Emission Standards | |
81 FR 55086 - World Trade Center Health Program; Amendments to Definitions, Appeals, and Other Requirements | |
81 FR 54770 - Revision of the DOL FOIA Regulations |
Agricultural Marketing Service
Foreign-Trade Zones Board
Industry and Security Bureau
National Oceanic and Atmospheric Administration
Navy Department
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Children and Families Administration
Food and Drug Administration
Indian Health Service
National Institutes of Health
Coast Guard
U.S. Customs and Border Protection
Fish and Wildlife Service
Indian Affairs Bureau
Drug Enforcement Administration
Employment and Training Administration
National Endowment for the Arts
Federal Aviation Administration
Federal Railroad Administration
National Highway Traffic Safety Administration
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.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.thefederalregister.org and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.
Agricultural Marketing Service, USDA.
Interim rule with request for comments.
This rule implements a recommendation from the Almond Board of California (Board) to change the quality control requirements currently prescribed under the California almond marketing order (order). The order regulates the handling of almonds grown in California. The Board locally administers the order and is comprised of growers and handlers operating within California. This rule relaxes incoming quality requirements by increasing the inedible kernel tolerance from 0.50 percent to 2 percent. This relaxation decreases California almond handlers' disposition obligation. This change also allows handlers more flexibility in their operations while continuing to maintain quality control and ensuring compliance with the order's requirements.
Effective August 18, 2016; comments received by October 17, 2016 will be considered prior to issuance of a final rule.
Interested persons are invited to submit written comments concerning this rule. Comments must be sent to the Docket Clerk, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Fax: (202) 720-8938; or Internet:
Andrea Ricci, Marketing Specialist or Jeffrey Smutny, Regional Director, California Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (559) 487-5901, Fax: (559) 487-5906, or Email:
Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email:
This rule is issued under Marketing Order No. 981, as amended (7 CFR part 981), regulating the handling of almonds grown in California, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”
The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Orders 12866, 13563, and 13175.
This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
This rule implements a recommendation from the Almond Board of California (Board) to change the quality control requirements currently prescribed under the order. This rule relaxes incoming quality requirements by increasing the inedible kernel tolerance from 0.50 percent to 2 percent. This relaxation would decrease California almond handler's disposition obligation. This will allow handlers more flexibility in their operations while continuing to maintain quality control. In addition, this change will ensure that the reporting and outgoing quality requirements of the order are met. The Board unanimously recommended this change at its April 12, 2016, meeting.
Section 981.42 of the almond marketing order provides authority for quality control regulations. Paragraph (a) of that section requires that almonds must be inspected prior to processing to determine the percentage of inedible kernels in each lot. Inedible kernels are defined in § 981.408. The Board, with the approval of the Secretary, may change the approved percentage of inedible kernels for any crop year. Inedible kernels in excess of the approved percentage of the kernel weight constitute the handlers' inedible disposition weight obligation. Handlers must satisfy their obligation by disposing of inedible kernels in Board-accepted, non-human outlets such as animal feed or oil.
Section 981.442(a)(4)(i) of the order's rules and regulations currently specifies that the weight of inedible kernels in excess of 0.50 percent of kernel weight shall constitute the handler's disposition obligation. Pursuant to § 981.442(a)(5), handlers must meet their disposition obligation by delivering inedible kernels to crushers, feed manufacturers, feeders, or dealers in nut wastes on record with the Board as accepted users.
In the past several years, the total inedible kernel percentages have been trending lower. This is partially due to good agricultural practices used by growers and better technologies in handler facilities. At the same time, the market value of almonds has increased significantly. As a result, some Board-accepted outlets have started to clean and repurpose the disposition obligation delivered by handlers. After the inedible disposition is delivered to Board-accepted outlets, these accepted outlets provide to the Board a record of disposition receipt, which indicates what was received by the accepted outlet from handlers and how the accepted outlet disposed of the inedible disposition. However, such record of disposition receipt does not indicate whether the almonds have been pasteurized or treated for human consumption. Thus the action of repurposing has led to concern that the order's outgoing quality requirements are not being met.
By increasing the inedible kernel tolerance, handlers' disposition obligation will decrease or become zero, therefore reducing the quantity of product delivered to those specified outlets. This action will also provide handlers with more control over low quality product allowing one handler the flexibility to transfer the larger portion of low quality product to another handler for further cleaning. This action will require completion of an interhandler transfer form and help with traceability of low quality product. It also will help ensure that any product destined for human consumption was in compliance with the pertinent regulations under the order.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.
There are approximately 6,800 almond growers in the production area and approximately 100 handlers subject to regulation under the marketing order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts of less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,500,000 (13 CFR 121.201).
The National Agricultural Statistics Service (NASS) reported in its 2012 Agricultural Census that there were 6,841 almond farms in the production area (California), of which 6,204 had bearing acres. The following computation provides an estimate of the proportion of producers (farms) and agricultural service firms (handlers) that would be considered small under the SBA definitions.
The NASS Census data indicates that out of the 6,204 California farms with bearing acres of almonds, 4,471 (72 percent) have fewer than 100 bearing acres.
For the almond industry's most recently reported crop year (2014), NASS reported an average yield of 2,150 pounds per acre, and a season average grower price of $3.19 per pound. A 100-acre farm with an average yield of 2,150 pounds per acre would produce about 215,000 pounds of almonds. At $3.19 per pound, that farm's production would be valued at $685,850. Since Census of Agriculture indicates that the majority of California's almond farms are smaller than 100 acres, it could be concluded that the majority of growers had annual receipts from the sale of almonds in 2014-15 of less than $685,850, which is below the SBA threshold of $750,000. Thus, over 70 percent of California's almond growers would be considered small growers according to SBA's definition.
According to information supplied by the Board, approximately 30 percent of California's almond handlers shipped almonds valued under $7,500,000 during the 2014-15 crop year, and would, therefore, be considered small handlers according to the SBA definition.
This rule revises § 981.442(a)(4)(i) of the order's administrative rules and regulations regarding inedible kernel tolerance. Specifically, this action increases the inedible kernel tolerance from 0.50 percent to 2 percent, effectively decreasing handler's disposition obligation. Authority for this action is provided in § 981.42(a) of the order.
Regarding the impact of this action on affected entities, increasing the inedible kernel tolerance reduces disposition obligation on handlers and provides handlers with more flexibility and control over the poor quality product. This rule is not expected to change handler inspection costs, as handlers currently are required to have all lots inspected to determine the percentage of inedible kernels.
The Board considered alternatives to this action. It formed a taskforce to examine the current inedible program and investigate alternatives. The taskforce reviewed the program and recent data, surveyed handlers, and reported their findings to the Almond Quality and Food Safety Committee (Committee). Recent data showed that the overall inedible kernel percentages have been trending lower, regardless of crop size. Surveyed handlers who did not agree with the change raised the concern that increasing the tolerance could result in more poor quality almonds entering the market. The Committee discussed the concerns raised and concluded that changing the tolerance would give handlers more flexibility in maintaining quality. After discussing the taskforce's findings, the Committee unanimously recommended this increase in inedible tolerance to the Board.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order's information collection requirements have been previously approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0178 (Vegetable and Specialty Crops.) No changes are necessary in those requirements as a result of this action. Should any changes become necessary, they would be submitted to OMB for approval.
This rule will not impose any additional reporting or recordkeeping requirements on either small or large almond handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.
AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.
In addition, USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this rule.
Further, the Board's meeting was widely publicized throughout the almond industry and all interested persons were invited to attend the meeting and participate in Board deliberations. Like all Board meetings, the April 12, 2016, meeting was a public meeting and all entities, both large and
Also, the Board has a number of appointed committees to review certain issues and make recommendations to the Board. The Board's Almond Quality and Food Safety Committee met on April 5, 2016, and discussed this issue in detail. That meeting was also a public meeting, and both large and small entities were able to participate and express their views. Finally, interested persons are invited to submit comments on this interim rule, including the regulatory and informational impacts of this action on small businesses.
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
This rule invites comments on a change to the quality control requirements currently prescribed under the order. Any comments timely received will be considered prior to finalization of this rule.
After consideration of all relevant material presented, including the Board's recommendation, and other information, it is found that this interim rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.
Pursuant to 5 U.S.C. 553, it is also found and determined upon good cause that it is impracticable, unnecessary, and contrary to the public interest to give preliminary notice prior to putting this rule into effect and that good cause exists for not postponing the effective date of this rule until 30 days after publication in the
Almonds, Marketing agreements, Nuts, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, 7 CFR part 981 is amended as follows:
7 U.S.C. 601-674.
(a) * * *
(4)
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Final rule; technical correction.
On July 25, 2016, the U.S. Department of Energy published a final rule amending test procedures for ceiling fans. 81 FR 48619. This correction addresses an amendatory term error in that final rule.
The correction is effective August 24, 2016.
The U.S. Department of Energy (DOE) published a final rule in the
Bureau of Industry and Security, Department of Commerce.
Final rule.
This final rule implements changes that were proposed on May 22, 2015, in a proposed rule entitled
This rule is effective November 15, 2016.
Commerce's full retrospective regulatory review plan can be accessed at:
For questions about this rule, contact Timothy Mooney, Regulatory Policy Division, Office of Exporter Services, Bureau of Industry and Security, at 202-482-2440 or email:
This final rule is published in conjunction with the publication elsewhere in this issue of the
Prior to the effective date of this final rule, the EAR required exporters to include a destination control statement (“DCS”), specified in § 758.6 (Destination control statement and other information furnished to consignees) of the EAR, on certain export control documents that accompanied a shipment for most exports. The purpose of the DCS was to alert parties outside the United States that receive the item that the item was subject to the EAR, the item was exported in accordance with the EAR, and that diversion contrary to U.S. law was prohibited.
Prior to the effective date of the State final rule, the ITAR, under § 123.9(b)(1), included the same type of DCS requirement, but with slightly different text than that which was required by the EAR. The purpose of the DCS requirements was the same under both sets of export control regulations. As a general principle of the Export Control Reform (ECR) effort, wherever the ITAR and EAR have provisions that are intended to achieve the same purpose, the U.S. Government will harmonize the corresponding provisions.
As was stated in the Commerce and State proposed rules, the DCS under the ITAR and the EAR were an example of requirements that could and should be harmonized to reduce the burden on exporters, improve compliance, and ensure that the regulations are achieving their intended purpose for use under the U.S. export control system, specifically under the transactions “subject to the ITAR” and “subject to the EAR.” This final rule is revising § 758.6 of the EAR to harmonize the DCS requirement text with § 123.9(b)(1) of the ITAR.
Under the existing provisions, both regulations have a mandatory DCS that must be on the export control documents for shipments that include items subject to those regulations. This had caused confusion to exporters as to which statement to include on such mixed shipments, or whether to include both. The harmonization of these statements in this final rule will ease the regulatory burden on exporters, which, based on the public comments described below and the additional changes made in the Commerce and State final rules in response to those comments, will further the objectives of the DCS requirements.
The change is also being made in this final rule to harmonize the two sets of regulations, the EAR and the ITAR, per the President's instructions. While the creation of a single export control list and licensing agency would require legislation, the President has directed BIS and the Directorate of Defense Trade Controls at the Department of State to undertake all available actions to prepare for consolidation as a single agency with a single set of regulations. Harmonization, to the extent possible, of the existing export control regulations is one important step for preparing both regulators and the regulated public for the work that will be needed to create such regulations.
The public comment period on the May 22, 2015, proposed rule (80 FR 29551) closed on July 6, 2015. BIS received 17 public comments on the EAR proposed rule. Most of the commenters sent the same comments to Commerce and State expressing their support or concerns regarding the DCS related provisions included in the Commerce and State proposed rules. There were slightly different points of emphasis that were specific to the Commerce and State proposed rules, but substantively the comments were not different in any meaningful way in what the commenters thought needed to be changed in order to achieve the stated objectives in the Commerce and State proposed rules. The following describes the public comments and BIS's responses. After making changes to what was proposed to address the public comments and better achieve the stated objectives, Commerce and State are concurrently publishing final rules to harmonize the DCS provisions under the EAR and ITAR. Commerce and State agree with the public commenters that, as proposed, the harmonization did not go far enough and in order to have true harmonization and achieve the stated objectives that additional harmonization was needed. In addition, certain clarifications and refinements of what was originally proposed were needed in order to clarify and alleviate perceived concerns, in particular for exporters of non-600 series and non-9x515 items under the EAR. Where BIS has made regulatory changes to address the public comments, a description of those changes is included beneath the respective public comments and BIS responses. BIS has made these regulatory changes to § 758.6 to address the public comments and to better achieve the stated objectives of the rule. The public comment process was helpful in identifying areas where changes needed to be made to fully achieve the intended objectives for the DCS for use under the EAR and the ITAR. The following are the BIS responses to the comments:
The heading of § 758.6 of the EAR remains the same. However, the provisions that were under paragraph (b) prior to the effective date of this final rule are being moved to a new paragraph (a)(2). Further, new paragraph (a)(2) specifies that the ECCN for each 9x515 or “600 series” item being shipped (exported in tangible form) must be included. This is the same requirement that was in paragraph (b) prior to the effective date of this final rule, although it is slightly shortened because the introductory text of paragraph (a) is specifying some of the requirements that previously were included in paragraph (b), specifically the documents for which the 9x515 and “600 series” classification must be included under this section. The commercial invoice is the same document that the DCS is included on, so this change is shortening and simplifying this section by moving the text of paragraph (b) to paragraph (a)(2). This change will reduce the number of documents upon which this classification needs to be included on to conform with the DCS changes described below.
The introductory text paragraph (a) in this final rule specifies that the exporter shall incorporate the information specified under paragraphs (a)(1) (destination control statement) and (a)(2) (ECCN for 9x515 or “600 series” item being shipped (exported in tangible form)) as an integral part of the commercial invoice. The changes in this final rule mean this section of the EAR no longer includes, as of the effective date of this final rule, a requirement to include the DCS on the air waybill, bill
Consistent with the DCS provisions prior to the effective date of this final rule, this final rule is not requiring an EAR DCS for exports of EAR99 items or items exported under License Exception BAG or GFT. Any other shipment (tangible export) from the United States of any item on the CCL would require the DCS as specified in paragraph (a)(1) and any shipment (tangible export) of a 9x515 or “600 series” ECCN would also need to be specified on the commercial invoice as specified in paragraph (a)(2).
The text of the harmonized DCS in this final rule is being specified under revised paragraph (a)(1) of § 758.6 of the EAR. The new DCS this final rule adds does not include EAR-specific language, but rather adopts text that is equally applicable under the ITAR as well as the EAR. However, this final rule adds several clarifying notes to clarify how the DCS provisions are applied in the EAR context. The first sentence of the statement added by this final rule specifies that “these items are controlled by the U.S. Government and authorized for export only to the country of ultimate destination for use by the ultimate consignee or end-user(s) herein identified.” For clarification this final rule moved the position of the phrase “by the United States Government” to the first sentence. This is a clarification to ensure that exporters understand that “only” modifies “authorized” and not “controlled.” This first sentence is intended to alert the person outside the United States receiving the item that the item is subject to U.S. export laws and regulations and was authorized by the U.S. Government for export. In addition, the first sentence in this final rule specifies that the items are authorized for export only to the country of ultimate destination for use by the ultimate consignee or end-user(s). The new DCS included in this final rule uses the term authorized, but in the context of this EAR paragraph “authorized” would also include exports that were designated under No License Required (NLR). This final rule adds a new Note 1 to paragraph (a) to specify this in the regulatory text in regards to the applicability of NLR. This final rule adds Note 2 to paragraph (a) to specify the phrase “country of ultimate destination” means the country specified on the commercial invoice where the ultimate consignee or end user will receive the items as an “export.” This note will assist the exporter's understanding of the use of this phrase in the context of the EAR.
The second sentence of the new harmonized DCS being added in this final rule focuses on alerting the persons receiving the items that they may not be resold, transferred, or otherwise be disposed of, to any other country or to any person other than the authorized ultimate consignee or end-user(s), either in their original form or after being incorporated into other items, without first obtaining approval from the U.S. government or as otherwise authorized by U.S. law and regulations. Similar to the first sentence, this second sentence is adopting common text that can be used under the ITAR and the EAR. The application of this second sentence is different under the ITAR and the EAR due to the different types of authorizations and other approvals in the respective regulations, as well as other differences, such as the
The advantage of the text included in this final rule is that it adopts a new harmonized DCS, while at the same time is still flexible enough to not impact other ITAR or EAR provisions that do warrant differentiation, such as the availability of
Adopting a new harmonized DCS in the final rule will simplify export clearance requirements for exporters because they will not have to decide which DCS to include, especially for mixed shipments containing both ITAR and EAR items.
As of the effective date of the Commerce and State final rules, an exporter will still need to go through all of the steps to determine jurisdiction, classification, and license requirements, and to obtain and use the proper authorization under the respective regulations, prior to moving on to the respective export clearance requirements under the ITAR or EAR. It is important to remember when reviewing the changes included in the Commerce and State final rules that the regulations still need to be reviewed and evaluated in the context in which they are intended to be applied, including the steps for determining the applicable export control requirements under the ITAR and the EAR. For those parties outside the United States that will be receiving items under this new DCS once this final rule becomes effective on November 15, 2016, although the new DCS is not ITAR or EAR specific, in the case of the ITAR the classification of USML items will be required on the commercial invoice. This classification will alert the parties that the items are subject to the ITAR. For military items under the EAR, because of the requirement this final rule is including in paragraph (a)(2) (which was required under paragraph (b) prior to the effective date of this final rule) of § 758.6 of the EAR, anyone receiving a “600 series” military item or an ECCN 9x515 item will know that item is subject to the EAR because the classification information will also need to be included on the commercial invoice. For other EAR items, there is not a requirement to include the classification information, although BIS does encourage the inclusion of that information as an export compliance best practice.
BIS in this final rule removes the text that was in paragraph (c) of § 758.6 prior to the effective date of this final rule. BIS did not receive any comments on this proposed change and therefore is implementing this change in this final rule. Paragraph (c) was added recently (January 23, 2015, 80 FR 3463) and required prior to the effective date of this final rule a special DCS for items controlled under ECCNs for crime control columns 1 and 3 reasons or regional stability column 2 reasons when those items are destined to India. BIS proposed removing this requirement because the benefit of this requirement in paragraph (c) is outweighed by the added complexity to the EAR of including this country specific requirement. Therefore, consistent with the purpose of the retrospective regulatory review, BIS removes paragraph (c).
This final rule is the same as the May 22, 2015 proposed rule except for the refinements explained above. These changes address the public comments and will achieve the objectives of adopting a harmonized DCS requirement under the EAR and ITAR. These changes will help to further achieve the objectives of ECR to harmonize provisions between the EAR and the ITAR where warranted.
The changes in this final rule will ease the regulatory burden and complexity for exporters, in particular those with mixed shipments, which as noted above is now a much more common occurrence because of ECR. These changes and the corresponding reduction of documents that will require the DCS (now limited to the commercial invoices) will benefit all exporters under the EAR, not just exporters of “600 series” and 9x515 items. The DCS
These changes to the DCS provisions under the EAR and the ITAR move beyond harmonization for the sake of harmonization, which as discussed above was a concern of several of the commenters in response to the proposed rule. The changes in this final rule achieve true harmonization in this area of the U.S. export control system under the EAR and the ITAR, while at the same time improving the effectiveness of these provisions under the EAR and the ITAR, which ultimately will lead to better informed parties to transactions that are subject to U.S. export controls and better protecting U.S. national security and foreign policy interests. For the reasons described above, Commerce and State are publishing these final rules today.
As required by Executive Order (E.O.) 13563, BIS intends to review this rule's impact on the licensing burden on exporters. Commerce's full retrospective regulatory review plan is available at:
Although the Export Administration Act expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013) and as extended by the Notice of August 4, 2016, 81 FR 52587 (August 8, 2016), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act. BIS continues to carry out the provisions of the Export Administration Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222, as amended by Executive Order 13637.
1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distribute impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This final rule has been determined to be significant for purposes of Executive Order 12866.
2. Notwithstanding any other provision of law, no person is required to respond to, nor is subject to a penalty for failure to comply with, a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
3. This rule does not contain policies with Federalism implications as that term is defined under E.O. 13132.
4. The Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601
Administrative practice and procedure, Exports, Reporting and recordkeeping requirements.
Accordingly, part 758 of the Export Administration Regulations (15 CFR parts 730-774) is amended as follows:
50 U.S.C. 4601
(a) The exporter must incorporate the following information as an integral part of the commercial invoice whenever items on the Commerce Control List are shipped (
(1) The following statement: “These items are controlled by the U.S. Government and authorized for export only to the country of ultimate destination for use by the ultimate consignee or end-user(s) herein identified. They may not be resold, transferred, or otherwise disposed of, to any other country or to any person other than the authorized ultimate consignee or end-user(s), either in their original form or after being incorporated into other items, without first obtaining approval from the U.S. government or as otherwise authorized by U.S. law and regulations” and
(2) The ECCN(s) for any 9x515 or “600 series” “items” being shipped (
In paragraph (a)(1), the term `authorized' includes exports, reexports and transfers (in-country) designated under No License Required (NLR).
The phrase `country of ultimate destination' means the country specified on the commercial invoice where the ultimate consignee or end user will receive the items as an “export.”
The phrase `or as otherwise authorized by U.S. law and regulations' is included because the EAR contain specific exemptions from licensing (
(b) [Reserved]
Department of State.
Final rule.
As part of the President's Export Control Reform (ECR) initiative, the Department of State is amending the International Traffic in Arms Regulations (ITAR) to clarify rules pertaining to the export of items subject to the Export Administration Regulations (EAR), revise the destination control statement in ITAR § 123.9 to harmonize the language with the EAR, make conforming changes to ITAR §§ 124.9 and 124.14, and make several minor edits for clarity.
This rule is effective November 15, 2016.
Mr. C. Edward Peartree, Director, Office of Defense Trade Controls Policy, Department of State, telephone (202) 663-2792; email
The Department published a proposed rule on May 22, 2015 (80 FR 29565) and received 17 public comments on the proposed changes to the ITAR. The Department makes the following revisions in this final rule:
This final rule adds clarifying language to various provisions of the ITAR pertaining to the use of exemptions to the license requirements and the export of items subject to the EAR, when the EAR items are shipped with items subject to the ITAR. These revisions include guidance on the use of license exemptions for the export of such items, as well as clarification that items subject to the EAR are not defense articles, even when exported under a license or other approval, such as an exemption, issued by the Department of State. The Department received the following comments on the proposed changes, which are summarized here, along with the Department's responses:
One commenter raised a concern that the proposed revised language restricts industry's exemption options for items subject to the EAR to situations only when related USG authorization exists for the end item. The Department accepts the comment and has revised § 120.5(b) to state that items subject to the EAR may be exported pursuant to an ITAR exemption if exported with defense articles. ITAR exemptions may not be used for the independent export of items subject to the EAR,
One commenter noted that, the proposed § 120.5(b) inadvertently excluded the exemptions at Part 123 of the ITAR from the parenthetical list of applicable ITAR parts. The Department concurs with this comment and adds a reference to part 123 into the parenthetical phrase.
One commenter noted that the Department should provide clarification and guidance on the proper classification to be entered into the Automated Export System (AES) for items subject to the EAR shipped under an ITAR exemption. The commenter noted that proposed edits to § 123.9(b)(2) did not address AES filings. The Department notes that the Department of Commerce (U.S. Census Bureau and Bureau of Industry and Security) has already clarified this. The EAR classification needs to be provided in the export control information on the Electronic Export Information (EEI) filing in AES for all items subject to the EAR, including EAR99 designated items that are authorized for export under a State Department authorization.
One commenter noted that the changes in this rule require that if a shipment includes both ITAR and EAR controlled items then the Export Control Classification Number (ECCN) of items in the shipments must be listed, including any EAR99 designation (if the authorization for the export was through an approved State Department license), and requires the country of ultimate destination, end-user, licensee information to be provided on the export documents. The flexibility of exporting items subject to the EAR under a State Department authorization does warrant this additional level of identification for all of the items subject to the EAR that the Department authorizes for export. Therefore, although the Department understands the comment, given the hybrid nature of the ITAR authorization under the § 120.5(b) process, the Department has determined the requirements are warranted.
One commenter noted that the text under § 120.5(b) does not specify that “items subject to the EAR” exported under an exemption must be exported with the specific defense article. They recommend clarifying that this is the intent of the modification or if not, to change the text, so it comports with the requirements for “items subject to the EAR” exported under a license or other approval. The Department concurs with this comment. This final rule adds
This final rule does not revise the licensing exemption language in § 126.4. This section will be addressed in a separate rulemaking and comments submitted in response to the proposed rule on that topic will be addressed in that rulemaking.
This final rule revises the Destination Control Statement (DCS) in ITAR § 123.9 to harmonize the text with the text of the DCS in EAR § 758.6, which is the subject of a companion rule to be published by the Department of Commerce. The DCS revision is also reflected in § 124.9 and 124.14. This change is being made to facilitate the President's Export Control Reform initiative, which has transferred thousands of formerly ITAR-controlled defense article parts and components, along with other items, to the Commerce Control List in the EAR, which is under the jurisdiction of the Department of Commerce. This change in jurisdiction for many parts and components of military systems has increased the incidence of exporters shipping articles subject to both the ITAR and the EAR in the same shipment. Both regulations have a mandatory Destination Control Statement that must be on the export control documents for shipments that include items subject to both sets of regulations. This had previously caused confusion to exporters as to which statement to include on mixed shipments, or whether to include both. Harmonizing these statements will ease the regulatory burden on exporters.
Most of the public comments fell into one of four areas: (1) Harmonization of DCS language between the ITAR and the EAR; (2) harmonization of documentation between the ITAR and EAR; (3) providing exporters a sufficient implementation period to adjust to the new DCS requirements; and (4) consideration of the different documents required for shipping, with the commercial invoice being the clear favorite and most appropriate for the DCS to be included on.
This final rule includes an effective date 90 days after publication in the
The Department received a small number of comments on the proposed rule which were specific to the Commerce proposed rule, and Commerce is addressing these comments in its final rule.
Several commenters noted that harmonization represents a step in the right direction and will minimize confusion as to which DCS must be used depending on the jurisdiction of the item. The Department concurs with this comment.
Several commenters objected that the Department's requirements for placement of the DCS were out of step with Commerce and not harmonized in the proposed rule. The Department agrees, and the requirement for placement of the DCS is being harmonized by the Departments of State and Commerce.
Several commenters stated that the government should not specify the documents that require the DCS, but rather should impose a high level requirement and leave it to parties to choose which document(s) to include. The Department disagrees. Specifying which documents the DCS will be placed on will create greater transparency, as well as make it easier for various United States government agencies, as well as exporters and other consignees, to identify whether the DCS has been properly included.
One commenter noted that this appears to be a case of harmonization for the sake of harmonization, and would appear to have the potential to create substantial confusion among recipients, and impose significant burdens without a correspondingly significant benefit to the government. The Department disagrees. Ensuring the DCS reaches the parties that will receive items exported and/or reexported is key to the United States achieving its policy objectives.
One commenter stated that it was confusing that Commerce uses the term “commercial invoice” whereas the Department uses “invoice.” For some exporters, the term “invoice” refers to the final billing document that moves electronically, whereas the commercial invoice moves with the freight. The Department agrees that the terms should be harmonized. Based on other comments received, the term “commercial invoice” is well understood by industry, so this final rule adopts the term “commercial invoice” to reference the document that moves with the freight.
One commenter objected to the DCS, as it imposed additional burdens and costs on the public and trade. Further, the commenter noted that to add this information separately to the bill of lading, air waybill and other transportation documentation could have the unintended effect of signaling the package contents to third parties. The Department disagrees with the commenter's characterization as these statements are already required and the harmonization of the DCS will lower the administrative burden on exporters and re-exporters. In addition, and as noted elsewhere in this final rule, the Department is removing the requirement to include the DCS on transportation documents.
One commenter stated that the air waybill imposed a severe space limitation with regard to including the DCS. According to the commenter, including information regarding a country of ultimate destination, end-user, and license or other approval number or exemption citation information could be unduly burdensome. The Department concurs, as noted elsewhere in this final rule, and the requirement to include the DCS on transportation documents has been removed.
One commenter noted that the State Department should consider a shorter DCS, such as: “This shipment contains goods under the jurisdiction of the ITAR.” This statement could more easily be converted to an electronic format than the complete DCS. The Department disagrees, as an ITAR specific DCS would defeat the purpose of harmonization between the Departments of State and Commerce and would not address mixed shipments.
One commenter suggested that the DCS and other export control related information (
Numerous commenters requested a delay in the implementation date of between 180-240 days after publication of the final rule to allow sufficient time for affected parties to make the required changes to system programming, document revision and related procedural tasks. Other commenters requested a 180 day delayed effective date, along with a delayed compliance date. The Department agrees that industry will need time to update their systems and has included a delayed effective date of 90 days after publication of this final rule.
One commenter requested public meetings in order to comment on the proposed changes, and that State and Commerce also conduct outreach prior to new changes being implemented. The Department values public participation in the rulemaking process and has provided an opportunity for public review and comment on the proposed rules. For those commenters that raised concerns, the Department was generally able to refine what was proposed to address those comments and better achieve the stated objectives. Therefore, the Department does not see a need to conduct public meetings prior to publishing this final rule. In regards to outreach, the Department agrees that this is a good idea and intends to add updated DCS information to our already robust ECR related outreach activities.
The Department of State has revised the proposed changes to § 123.9 to address the public comments and to better achieve its stated objectives in this final rule. The public comment process was helpful in identifying areas where changes needed to be made to fully achieve the intended objectives for the DCS for use under the ITAR and the EAR.
This final rule adds a new paragraph (d) to § 123.9 to clarify the requirements for retransferring items subject to the EAR pursuant to a request for written approval from DDTC.
This final rule imposes the Code of Federal Regulations paragraph structure on § 124.8. The Department received no comments on § 124.8, and the provision is adopted as proposed.
This final rule replaces the previous Destination Control Statement in § 124.9(a)(6) with the new language found at § 123.9(b)(1)(iv). The Department received only one comment on this issue, which did not propose substantive changes, but advised that § 124.9(a)(6) needed to reflect the new Destination Control Statement language. The Department notes that the proposed rule did not revise the Destination Control Statement language of § 124.14(c)(7). Therefore, this final rule revises §§ 124.9 and 124.14 accordingly.
This final rule also changes the identification of the agency responsible for permanent import authorizations in § 123.4 from the Department of the Treasury to Department of Justice. The Department did not receive any comments on the proposed changes. Therefore, this final rule revises § 123.4 as proposed.
This final rule removes the pilot filing requirement found in § 123.13, given that, as noted in the proposed rule, it did not take into account the practices of modern airport operations and is no longer necessary. The Department did not receive any comments on the proposed change. Therefore, this final rule revises § 123.13 as proposed.
This final rule revises § 124.12(b) to correct the citations contained in the parenthetical from §§ 124.9 and 124.10 to §§ 124.8 and 124.9. This revision was not included in the proposed rule.
Additionally, the Department amends § 126.9, Advisory Opinions and Related Authorizations, to add a new paragraph (c) for requests to interpret ITAR requirements. This revision was not included in the proposed rule but is added to clarify the Department's practice. The Department is undertaking a review of the advisory opinion process which will be addressed in a future rule.
Finally, the Department notes that this final rule does not revise the NATO special retransfer authorizations language in § 124.16, which was contained in the proposed rule. By separate
The Department of State is of the opinion that controlling the import and export of defense articles and services is a foreign affairs function of the United States government and that rules implementing this function are exempt from §§ 553 (rulemaking) and 554 (adjudications) of the Administrative Procedure Act (APA). Although the Department is of the opinion that this rule is exempt from the rulemaking provisions of the APA, the Department published this rule with a 45-day provision for public comment and without prejudice to its determination that controlling the import and export of defense services is a foreign affairs function. The Department has made additional refinements to what was proposed based on the public comments received, which helps to further the objectives described in the proposed rule that is published as a final rule today. The Department is also adopting a delayed effective date of 90 days.
Since this final rule is exempt from the provisions of 5 U.S.C. 553, there is no requirement for an analysis under the Regulatory Flexibility Act.
This rulemaking does not involve a mandate that will result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.
The Department does not believe this rulemaking is a major rule as defined in 5 U.S.C. 804.
This rulemaking 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, it is determined that this rulemaking does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this proposed rulemaking.
Executive Orders 12866 and 13563 direct agencies to assess costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributed impacts, and equity). These executive orders stress the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated a “significant regulatory action” under Executive Order 12866. Accordingly, this final rule has been reviewed by the Office of Management and Budget (OMB).
The Department of State has reviewed this rulemaking in light of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.
The Department of State has determined that this rulemaking will not have tribal implications, will not impose substantial direct compliance costs on Indian tribal governments, and will not preempt tribal law. Accordingly, the provisions of Executive Order 13175 do not apply to this rulemaking.
This rule does not impose any new reporting or recordkeeping requirements subject to the Paperwork Reduction Act, 44 U.S.C. Chapter 35. This rule removes provisions that previously required the applicant to provide seven additional copies for various export license requests. As noted in the proposed rule, the Department believes that there would be little or no practical burden reduction since the use of electronic methods of filing has made the requirement for “seven copies” obsolete. The Department requested public comment on its estimate that there will be little or no change in the burdens associated with effected information collections as a result of this rulemaking. The Department received no public comments with respect to the information collections.
Arms and munitions, Classified information, Exports.
Arms and munitions, Exports, Reporting and recordkeeping requirements.
Arms and munitions, Exports, Technical assistance.
Arms and munitions, Exports.
Accordingly, for the reasons set forth above, title 22, chapter I, subchapter M, is amended as follows:
Secs. 2, 38, and 71, Pub. L. 90-629, 90 Stat. 744 (22 U.S.C. 2752, 2778, 2797); 22 U.S.C. 2794; 22 U.S.C. 2651a; Pub. L. 105-261, 112 Stat. 1920; Pub. L. 111-266; Section 1261, Pub. L. 112-239; E.O. 13637, 78 FR 16129.
(b) A license or other approval (see § 120.20) from the Department of State granted in accordance with this subchapter may also authorize the export of items subject to the EAR (see § 120.42). An exemption (see parts 123, 124, 125, and 126 of this subchapter) may only be used to export an item subject to the EAR that is for use in or with a defense article and is included in the same shipment as any defense article. No exemption under this subchapter may be utilized to export an item subject to the EAR if not accompanied by a defense article. Separate approval from the Department of Commerce is not required for these items. Those items subject to the EAR exported pursuant to a Department of State license or other approval would remain under the jurisdiction of the Department of Commerce for any subsequent transactions. The inclusion of items subject to the EAR on a Department of State license or other approval does not change the licensing jurisdiction of the items. (See § 123.1(b) of this subchapter for guidance on identifying items subject to the EAR in a license application to the Department of State.)
Secs. 2, 38, and 71, Pub. L. 90-629, 90 Stat. 744 (22 U.S.C. 2752, 2778, 2797); 22 U.S.C. 2753; 22 U.S.C. 2651a; 22 U.S.C. 2776; Pub. L. 105-261, 112 Stat. 1920; Sec. 1205(a), Pub. L. 107-228; Section 1261, Pub. L. 112-239; E.O. 13637, 78 FR 16129.
(a) * * *
(4) Has been rejected for permanent import by the Department of Justice and is being returned to the country from which it was shipped; or
(b) * * *
(1) The exporter must incorporate the following information as an integral part of the commercial invoice, whenever defense articles are to be shipped (exported in tangible form), retransferred (in tangible form), or reexported (in tangible form) pursuant to a license or other approval under this subchapter:
(i) The country of ultimate destination;
(ii) The end-user;
(iii) The license or other approval number or exemption citation; and
(iv) The following statement: “These items are controlled by the U.S. government and authorized for export only to the country of ultimate destination for use by the ultimate consignee or end-user(s) herein identified. They may not be resold, transferred, or otherwise disposed of, to any other country or to any person other than the authorized ultimate consignee or end-user(s), either in their original form or after being incorporated into other items, without first obtaining approval from the U.S. government or as otherwise authorized by U.S. law and regulations.”
The phrase “or as otherwise authorized by U.S. law and regulations” is included because U.S. regulations contain specific exemptions from licensing requirements (
(2) When exporting items subject to the EAR (see §§ 120.5, 120.42 and 123.1(b) of this subchapter) pursuant to a Department of State license or other approval, the U.S. exporter must also provide the end-user and consignees with the appropriate EAR classification information for each item. This includes the Export Control Classification Number (ECCN) or EAR99 designation.
(d) The Directorate of Defense Trade Controls may authorize reexport or retransfer of an item subject to the EAR provided that:
(1) The item was initially exported, reexported or transferred pursuant to a Department of State license or other approval;
(2) The item is for end-use in or with a defense article; and
(3) All requirements of paragraph (c) of this section are satisfied for the item subject to the EAR, as well as for the associated defense article.
A license is not required for the shipment by air of a defense article from one location in the United States to another location in the United States via a foreign country.
Sec. 2, 38, and 71, Pub. L. 90-629, 90 Stat. 744 (22 U.S.C. 2752, 2778, 2797); 22 U.S.C. 2651a; 22 U.S.C. 2776; Pub. L. 105-261; Section 1261, Pub. L. 112-239; E.O. 13637, 78 FR 16129.
The revision reads as follows:
(a) * * *
(1) The agreement must describe the defense article to be manufactured and all defense articles to be exported, including any test and support equipment or advanced materials. They should be described by military nomenclature, contract number, National Stock Number, nameplate data, or other specific information. Only defense articles listed in the agreement will be eligible for export under the exemption in § 123.16(b)(1) of this subchapter.
(a) * * *
(6) (Licensee) agrees to incorporate the following statement as an integral provision of a contract, commercial invoice or other appropriate document whenever the licensed articles are sold or otherwise transferred:
These items are controlled by the U.S. government and authorized for export only to the country of ultimate destination for use by the ultimate consignee or end-user(s) herein identified. They may not be resold, transferred, or otherwise disposed of, to any other country or to any person other than the authorized ultimate consignee or end-user(s), either in their original form or after being incorporated into other items, without first obtaining approval from the U.S. government or as otherwise authorized by U.S. law and regulations.
(a) An application for the approval of a manufacturing license or technical assistance agreement with a foreign person must be accompanied by an explanatory letter. The explanatory letter shall contain:
(b) * * *
(4) “If this agreement grants any rights to sub-license, it will be amended to require that all sub-licensing arrangements incorporate all the provisions of the basic agreement that refer to the U.S. Government and the Department of State (
(c) * * *
(7) “(Licensee) agrees to incorporate the following statement as an integral provision of a contract, invoice or other appropriate document whenever the articles covered by this agreement are sold or otherwise transferred: `These items are controlled by the U.S. government and authorized for export only to the country of ultimate destination for use by the ultimate consignee or end-user(s) herein identified. They may not be resold, transferred, or otherwise disposed of, to any other country or to any person other than the authorized ultimate consignee or end-user(s), either in their original form or after being incorporated into other items, without first obtaining approval from the U.S. government or as otherwise authorized by U.S. law and regulations.' ”
(e)
Secs. 2 and 38, Pub. L. 90-629, 90 Stat. 744 (22 U.S.C. 2752, 2778); 22 U.S.C. 2651a; E.O. 13637, 78 FR 16129.
(a)
(b) An application for the export of classified technical data or other classified defense articles must be accompanied by a completed form DSP-83 (
Secs. 2, 38, 40, 42, and 71, Pub. L. 90-629, 90 Stat. 744 (22 U.S.C. 2752, 2778, 2780, 2791, and 2797); 22 U.S.C. 2651a; 22 U.S.C. 287c; E.O. 12918, 59 FR 28205; 3 CFR, 1994 Comp., p. 899; Sec. 1225, Pub. L. 108-375; Sec. 7089, Pub. L. 111-117; Pub. L. 111-266; Section 7045, Pub. L. 112-74; Section 7046, Pub. L. 112-74; E.O. 13637, 78 FR 16129.
(a) Preliminary authorization determinations. A person may request information from the Directorate of Defense Trade Controls on whether it would likely grant a license or other approval for a particular defense article or defense service to a particular country. * * *
(c)
Department of the Navy, DoD.
Final rule.
The Department of the Navy (DoN) is amending its certifications and exemptions under the International Regulations for Preventing Collisions at Sea, 1972 (72 COLREGS), to reflect that the Deputy Assistant Judge Advocate General (DAJAG) (Admiralty and Maritime Law) has determined that USS GABRIELLE GIFFORDS (LCS 10) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with certain provisions of the 72 COLREGS without interfering with its special function as a naval ship. The intended effect of this rule is to warn mariners in waters where 72 COLREGS apply.
This rule is effective August 17, 2016 and is applicable beginning August 9, 2016.
Commander Theron R. Korsak, JAGC, U.S. Navy, Admiralty Attorney, (Admiralty and Maritime Law), Office of the Judge Advocate General, Department of the Navy, 1322 Patterson Ave. SE., Suite 3000, Washington Navy Yard, DC 20374-5066, telephone number: 202-685-5040.
Pursuant to the authority granted in 33 U.S.C. 1605, the DoN amends 32 CFR part 706.
This amendment provides notice that the DAJAG (Admiralty and Maritime Law), under authority delegated by the Secretary of the Navy, has certified that USS GABRIELLE GIFFORDS (LCS 10) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with the following specific provisions of 72 COLREGS without interfering with its special function as a naval ship: Annex I paragraph 2(a)(i), pertaining to the height of the forward masthead light above the hull; Annex I, paragraph 2(f)(i), pertaining to the placement of the masthead light or lights above and clear of all other lights and obstructions; Annex I, paragraph 3(a), pertaining to the location of the forward masthead light in the forward quarter of the ship, and the horizontal distance between the forward and after masthead light; Annex I, paragraph 3(c), pertaining to the task light's horizontal distance from the fore and aft centerline of the vessel in the athwartship direction. The DAJAG (Admiralty and Maritime Law) has also certified that the lights involved are located in closest possible compliance with the applicable 72 COLREGS requirements.
Moreover, it has been determined, in accordance with 32 CFR parts 296 and 701, that publication of this amendment for public comment prior to adoption is impracticable, unnecessary, and contrary to public interest since it is based on technical findings that the placement of lights on this vessel in a manner differently from that prescribed herein will adversely affect the vessel's ability to perform its military functions.
Marine safety, Navigation (water), Vessels.
For the reasons set forth in the preamble, the DoN amends part 706 of title 32 of the Code of Federal Regulations as follows:
33 U.S.C. 1605.
The additions read as follows:
15. * * *
16. * * *
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing temporary special local regulations on the navigable waters of Lake Superior and Duluth Harbor, Minnesota for the Tall Ships Duluth 2016 Parade of Sail. This action is necessary to provide for the safety of life and property on the navigable waters of Lake Superior and Duluth, Minnesota, during Tall Ships Duluth 2016 Parade of Sail on August 18, 2016. These temporary special local regulations would restrict vessel traffic in portions of Lake Superior and Duluth Harbor, Minnesota, unless authorized by the Captain of the Port (COTP) Duluth.
This rule is effective from 9:00 a.m. through 5:00 p.m. August 18, 2016.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Lieutenant Junior Grade John Mack, Waterways management, MSU Duluth, Coast Guard; telephone 218-725-3818, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable. Amplifying information regarding event schedule, plan, and vessel participants was not provided by the event sponsor with sufficient time to accommodate the comment period prior to the August 18, 2016 event. Thus, delaying the effective date of this rule to wait for the comment period to run would be both impracticable because it would be impossible to have the rule implemented before the date of the event.
We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1233. These temporary special local regulations will provide for the safety of life and protection of property on the navigable waters of Lake Superior and Duluth Harbor, Minnesota, by providing for the organized viewing of Tall Ships and preventing the large number of spectator vessels from interfering with the organized and controlled Parade of Sail.
Duluth, Minnesota will host the Tall Ships Duluth 2016 from August 18-21, 2016. This visit of sailing vessels is part of a recurring series of sail training races, rallies, cruises, and port festivals organized by Tall Ships America in conjunction with host ports in the United States and Canada. The Tall Ships Duluth 2016, including a Parade of Sail, is akin to similar events held several times in the past in Duluth, Minnesota, the most recent being in 2013.
The Tall Ships visit to Duluth, which will occur from August 18-21, 2016, will include a Parade of Sail on August 18, 2016. About 9 vessels are expected to participate in the Parade of Sail. These temporary special local regulations will provide for the safety of life and protection of property on the navigable waters of Lake Superior and Duluth Harbor, Minnesota, by providing for the organized viewing of Tall Ships and by preventing the large number of spectator vessels from interfering with the organized and controlled Parade of Sail. There may be vessels participating in the event from several foreign countries and the high visibility of this event warrants that temporary special local regulations be established to ensure the safety of vessels and spectators from hazards associated with Tall Ships Duluth 2016.
The participating vessels will berth at assigned facilities in Duluth, Minnesota, from August 18-21, 2016. On August 19, 2016, visitors will be permitted to board the berthed vessels from shore. On the morning of August 22, 2016, the Tall Ships will depart the Duluth Harbor.
The Coast Guard believes that vessel congestion due to the large number of participating and spectator vessels may pose a significant hazard to navigation. To reduce the risk associated with congested waterways the Coast Guard is proposing to establish regulated areas to restrict vessel movement around the location of the participating Tall Ships while participating in the Parade of Sail in Duluth Harbor. These temporary special local regulations would be in effect from 9:00 a.m. through 5:00 p.m. August 18, 2016.
Area “Duluth Harbor”: This Area includes all waters of Lake Superior and Duluth Harbor bounded by Rice's Point to the west and Duluth to the north, within the following boundaries: Beginning at position 46°49′11″ N., 92°02′20″ W., then due south to position 46°45′12″ N., 92°02′20″ W., and then west to position 46°45′12″ N., 92°05′40″ W. (Duluth Marine Terminal South Light (LLNR 15935)). This area is needed to protect the maritime public and participating vessels from hazards to navigation associated with numerous spectator craft during the Parade of Sail on August 18, 2016.
Area “Parade of Sail”: This Area includes all waters of Lake Superior and Duluth Harbor bounded by Duluth to the north, within the following
We developed this rule after considering numerous statutes and Executive order 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 rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.
This regulatory action determination is based on the size, location, duration, and time-of-year of the special local regulations. These proposed regulations involve only the Duluth portion of Duluth/Superior Harbor and would close the Duluth Entry Channel to commercial traffic only for several hours during the actual Parade of Sail on August 18, 2016. The Superior Entry would remain open to vessel traffic at all times. The impact of these proposed regulations will not be significant because these regulations would be in effect for only a portion of one day centered on the Parade of Sail, and most vessel traffic can pass safely around affected areas of Duluth Harbor by transiting through the Superior Entry.
Notice of these special local regulations will be provided prior to the event through Local Notice to Mariners and Broadcast Notice to Mariners. In addition, the sponsoring organization, Draw Events, LLC., is planning to publish information of the event in local newspapers, pamphlets, and Internet sites.
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 rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the regulated areas may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this 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
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will 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 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 rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does 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 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 rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this 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 determined 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 special local regulations lasting no more than 12 hours. It is categorically excluded from further review under paragraph 34(h) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:
33 U.S.C. 1233.
(a)
(2) Area Parade of Sail: This Area includes all waters of Lake Superior and Duluth Harbor bounded by Duluth to the north, within the following boundaries: Beginning at position 46°46′51.54″ N., 92°05′17.03″ W. (North Pier Light (LLNR 15855)), then northeast to position 46°47′18.96″ N., 92°4′0.84″ W., then south to position 46°47′11.04″ N., 92°03′55.08″ W., then southwest to position 46°46′48.46″ N., 92°05′15.02″ W. (South Breakwater Outer Light (LLNR 15845)), then to position 46°46′40.66″ N., 92°05′36.59″ W. near the Duluth Lift Bridge, then to position 46°46′34.04″ N., 92°05′39.64″ W. (Basin Buoy 1 (LLNR 15865)), and then west to position 46°46′36.42″ N., 92°06′07.86″ W.
(b)
(2) All persons and vessels are authorized by the COTP Duluth to enter areas of these special local regulations in accordance with the following restrictions:
(i) Area Duluth Harbor: Vessels transiting this Area must do so at a speed of not more than six (6) knots or at no wake speed, whichever is less. Vessels proceeding under sail will not be allowed in this Area unless also propelled by machinery, due to limited maneuvering ability around numerous other spectator craft viewing the Tall Ships.
(ii) Area Parade of Sail: This Area will be closed to all vessel traffic, except those vessels designated as participants.
(3) The Coast Guard will provide notice of the regulated areas prior to the event through Local Notice to Mariners and Broadcast Notice to Mariners. Notice will also be provided by on-scene representatives.
(4) The “on-scene representative” of the Captain of the Port is any Coast Guard commissioned, warrant, or petty officer and any Federal, State, or local officer designated by the Captain of the Port to act on his behalf.
(5) Vessel operators desiring to enter or operate within the regulated areas shall contact the Captain of the Port Duluth by telephone at 218-725-3818, or on-scene representative via VHF radio on channel 16, to obtain permission to do so. Vessel operators given permission to enter, operate, transit through, anchor in, or remain within the regulated areas must comply with all instructions given by COTP Duluth or on-scene representatives.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Marine Parkway Bridge across the Rockaway Inlet, mile 3.0, at Queens, New York. This deviation is necessary to allow the bridge owner to replace mechanical and electrical components for the lift span operation.
This deviation is effective from 7 a.m. on November 15, 2016 to 5 p.m. on May 13, 2017.
The docket for this deviation, [USCG-2016-0778] is available at
If you have questions on this temporary deviation, call or email Judy Leung-Yee, Project Officer, First Coast Guard District, telephone (212) 514-4330, email
The Marine Parkway Bridge, mile 3.0, across the Rockaway Inlet, has a vertical clearance in the closed position of 55 feet at mean high water and 59 feet at mean low water. The existing bridge operating regulations are found at 33 CFR 117.795(a).
The waterway is transited by commercial barge traffic of various sizes.
The bridge owner, MTA Bridges and Tunnels, requested a temporary deviation from the normal operating schedule to replace mechanical and electrical components for the lift span operation.
Under this temporary deviation, the Marine Parkway Bridge shall remain in the closed position from 7 a.m. on November 15, 2016 to 5 p.m. May 13, 2017.
Vessels able to pass under the bridge in the closed position may do so at any time. The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels to pass.
The Coast Guard will inform the users of the waterways through our Local Notice and Broadcast to Mariners of the change in operating schedule for the bridge so that vessel operations can arrange their transits to minimize any impact caused by the temporary deviation. The Coast Guard notified various companies of the commercial oil and barge vessels and they have no objections to 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).
Final rule.
The Environmental Protection Agency (EPA) is approving a revision to the Pennsylvania state implementation plan (SIP) submitted by the Commonwealth of Pennsylvania. This SIP revision pertains to Pennsylvania's regulation for fiberglass boat manufacturing materials found in section 129.74 of the Pennsylvania Code. This regulation meets the requirement to adopt reasonably available control technology (RACT) for sources covered by EPA's control techniques guidelines (CTG) standards for fiberglass boat manufacturing materials. EPA is, therefore, approving this revision to the Pennsylvania SIP in accordance with the requirements of the Clean Air Act (CAA).
This final rule is effective on September 16, 2016.
EPA has established a docket for this action under Docket ID Number EPA-R03-OAR-2016-0189. All documents in the docket are listed on the
Irene Shandruk, (215) 814-2166, or by email at
Section 172(c)(1) of the CAA provides that SIPs for nonattainment areas must include reasonably available control measures (RACM), including RACT, for sources of emissions. Section 182(b)(2)(A) provides that for certain nonattainment areas, states must revise their SIPs to include RACT for sources of volatile organic compound (VOC) emissions covered by a CTG document issued after November 15, 1990 and prior to the area's date of attainment. Furthermore, pursuant to section 184(b)(1)(B) of the CAA, all areas in the Ozone Transport Region (OTR), such as Pennsylvania, must submit SIP revisions that include implementation of RACT with respect to all sources of VOCs in the states covered by a CTG. EPA defines RACT as “the lowest emission limitation that a particular source is capable of meeting by the application of control technology that is reasonably available considering technological and economic feasibility.” 44 FR 53761 (September 17, 1979).
CTGs are intended to provide state and local air pollution control authorities information that should assist them in determining RACT for VOCs from various sources. The CTG for fiberglass boat manufacturing materials (Publication No. EPA 453/R-08-004; September 2008) provides control recommendations for reducing VOC emissions from the use of gel coats, resins, and materials used to clean application equipment in fiberglass boat manufacturing operations. This CTG applies to facilities that manufacture hulls or decks of boats from fiberglass, or build molds to make fiberglass boat hulls or decks. EPA's 2008 CTG recommends that the following operations should be covered: Open molding resin and gel coat operations (these include pigmented gel coat, clear gel coat, production resin, tooling gel coat, and tooling resin); resin and gel coat mixing operations; and resin and gel coat application equipment cleaning operations.
EPA's 2008 CTG recommends the following VOC reduction measures: VOC emission limits for molding resins and gel coats; work practices for resin and gel coat mixing containers; and VOC content and vapor pressure limits for cleaning materials. Recommended VOC emission limits for open molding resin and gel coat operations are shown in Table 1. A more detailed explanation for determining the VOC emission limits for molding resin and gel coats can be found in the Technical Support Document (TSD) for this rulemaking under Docket ID Number EPA-R03-OAR-2016-0189 and available online at
On March 2, 2016, the Pennsylvania Department of Environmental Protection (PADEP) submitted to EPA a SIP revision concerning implementation of RACT requirements for the control of VOC emissions from fiberglass boat manufacturing materials. Pennsylvania is adopting EPA's CTG standards for fiberglass boat manufacturing materials, including the emission limits found in Table 1. The regulation is contained in 25
On May 20, 2016 (81 FR 31885), EPA published a notice of proposed rulemaking (NPR) proposing to approve Pennsylvania's March 2, 2016 SIP revision. Other specific requirements and the rationale for EPA's approval action are explained in the NPR and TSD under Docket ID Number EPA-R03-OAR-2016-0189 and will not be restated here. No public comments were received on the NPR.
EPA is approving the March 2, 2016 Pennsylvania SIP revision concerning the addition of 25
In this rulemaking action, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Pennsylvania rule discussed in section II of this preamble. Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference by the Director of the Federal Register in the next update to the SIP compilation.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Publ. L. 104-4);
• does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 17, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action.
This action concerning Pennsylvania's control of VOC emissions from fiberglass boat manufacturing materials may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Incorporation by reference, Ozone, Volatile organic compounds.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
(c) * * *
(1) * * *
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
This rule approves regulations to implement Northeast Skate Complex Fishery Management Plan Framework Adjustment 3 management measures, including fishing year 2016-2017 specifications, and implements a new seasonal quota allocation for the skate wing fishery. This rule is necessary because it updates the Skate Fishery Management Plan to be consistent with the most recent scientific information and it improves management of the skate fisheries. The intended effect of this rule is to help conserve skate stocks while maintaining economic opportunities for the skate fisheries.
Effective on August 17, 2016.
Copies of Framework 3, including the Environmental Assessment and Regulatory Impact Review (EA/RIR), and other supporting documents for the action are available from Thomas A. Nies, Executive Director, New England Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950. The framework is also accessible via the Internet at:
William Whitmore, Fishery Policy Analyst, (978) 281-9182.
On June 6, 2016, we proposed in the
Specifications including the acceptable biological catch (ABC), annual catch limit (ACL), annual catch target (ACT), and total allowable landings (TALs) for the skate wing and bait fisheries, as well as possession limits, may be specified for up to 2 years. The 2016-2017 skate complex ABC and ACL is 31,081 metric tons (mt). After removing management uncertainty from the ABC, the ACT that remains is 23,311 mt. After removing discards and state landings from the ACT, the TAL that remains is 12,872 mt. Tables 1 and 2 (below) detail TALs and possession limits for the skate wing and skate bait fisheries—there are no possession limit changes from last year. These specifications and possession limits remain in effect until they are replaced.
Framework 3 modifies the skate wing TAL so that 57 percent of the skate wing TAL is allocated in Season 1 (May 1-August 31) with the remainder allocated in Season 2 (September 1-April 30). This modification was made because skate fishing effort is higher earlier in the fishing year and a seasonal apportionment with in-season change authority should ensure year-round fishing opportunities. Any portion of the Season 1 TAL that is unused is rolled over into Season 2. From May 1 through August 17, the Regional Administrator is required to reduce the directed skate wing possession limit for vessels fishing under a day-at-sea (DAS) from 2,600 lb (1,179 kg) to an incidental catch level of 500 lb (227 kg) when the fishery is projected to land 85 percent of its Season 1 quota. However, if harvest levels are projected to reach 85 percent sometime between August 18 and August 31 (the last two weeks of Season 1), the Regional Administrator maintains discretion on whether or not to reduce the directed possession limit. This option is included because it is difficult and sometimes impracticable for the agency to rapidly close a fishery immediately prior to the end of a season.
The DAS possession limit increases to 4,100 lb (1,860 kg) at the start of Season 2 (September 1) with the remainder of the annual skate wing TAL available in Season 2. In Season 2, the Regional Administrator may reduce the possession limit to 500 lb (227 kg) when 85 percent of the annual skate wing TAL is projected to have been landed, consistent with previous regulations. These in-season possession limit reductions are designed to mitigate the potential for prolonged closures for the directed skate fishery while still allowing some incidental catches to be landed.
We received four public comments on the proposed rule, including submissions on behalf of the Cape Cod Commercial Fishermen's Alliance and Shark Advocates International.
After further review of the regulatory text deemed by the Council and included in the proposed rule, we are revising the regulatory language previously proposed at § 648.322(b)(2) to be consistent with the Regional Administrator's discretion to reduce the Season 2 skate-wing possession limit as provided in Framework Adjustment 1 to the FMP (76 FR 28328; May 17, 2011). These regulatory language changes do not alter the management measures specified in the proposed rule and are consistent with the intent of Framework 3.
The Administrator, Greater Atlantic Region, NMFS, determined that Framework 3 to the FMP is necessary for the conservation and management of the northeast skate complex and that it is consistent with the Magnuson-Stevens Fishery Conservation and Management Act and other applicable laws.
There is good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effective date. This final rule reduces TALs which are administered through different fishing seasons. Season 1 for the skate wing fishery began on May 1 and ends on August 31. It is possible that the fishery could approach a seasonal landing limit which would require possession limits to be reduced to avoid overharvesting. Waiving the 30-day implementation delay is necessary to ensure timely implementation of the reduced catch limits. Retaining a 30-day delay in implementation would be contrary to the public interest because it could result in a catch limit being exceeded. Immediate implementation of the new TALs, including the new seasonal measures, will benefit fishermen by helping to prevent overages and potentially providing fishing opportunities more evenly throughout the fishing year. For these reasons, NMFS finds it both contrary to the public interest and unnecessary to provide a 30-day delay in implementation.
This final rule has been determined to be not significant for the purpose of E.O. 12866.
A final regulatory flexibility analysis (FRFA) was prepared. The FRFA incorporates the initial regulatory flexibility analysis (IRFA), a summary of the significant issues raised by the public comments in response to the IRFA, and NMFS responses to those comments. A copy of this analysis is available from the Council [or NMFS] (see
A description of the action, why it is being considered, and the legal basis were contained in the preamble of the proposed rule (81 FR 36251, June 6, 2016) and are not repeated here. The public did not provide any comments on the IRFA; therefore, there are no changes made in this final rule with regards to the economic analyses and impacts.
This final rule would impact fishing vessels, including commercial fishing entities. In 2014, there were 2,012 vessels that held an open access skate permit. However, only 431 of those permit holders were active participants in the commercial skate fishery (
On December 29, 2015, NMFS issued a final rule establishing a small business size standard of $11 million in annual gross receipts for all businesses primarily engaged in the commercial fishing industry (NAICS 11411) for Regulatory Flexibility Act (RFA) compliance purposes only (80 FR 81194, December 29, 2015). The $11 million standard became effective on July 1, 2016, and is to be used in place of the U.S. Small Business Administration's (SBA) previous standards of $20.5 million, $5.5 million, and $7.5 million for the finfish (NAICS 114111), shellfish (NAICS 114112), and other marine fishing (NAICS 114119) sectors, respectively, of the U.S. commercial fishing industry.
An IRFA was developed for this regulatory action prior to July 1, 2016, using SBA's previous size standards. Under the SBA's size standards, 3 of 364 skate fishing entities were determined to be large. NMFS has qualitatively reviewed the analyses prepared for this action using the new size standard. The new standard could result in a few more commercial shellfish businesses being considered small (due to the increase in small business size standards). In addition, the new standard could result in fewer commercial finfish businesses being considered small (due to the decrease in size standards). Skates are only responsible for a small fraction of total landings and revenue for any of these vessels so it is unlikely that these size-standard changes would have any impact on the previously conducted analyses.
This final rule does not introduce any new reporting, recordkeeping, or other compliance requirements.
The ACL alternative described in the preambles of the proposed rule and this rule represents an ACL reduction in comparison to previous years' ACLs (maintaining the status quo measures). However, we do not anticipate any significant economic impacts on small entities to result from this action. While there is an overall reduction in the TAL, Framework 3 analyses indicate that actual skate landings in recent years have been close to the TAL we are approving for fishing years 2016-2017. This suggests that it is unlikely that potential revenue losses would be directly commensurate with the TAL reduction. By contrast, maintaining the status quo ACL is inconsistent with the stated objectives because it does not represent the best available science or the goals and objectives of the FMP. The seasonal allocation for the skate-wing fishery effected by this rule was developed to coincide with fishing effort so that more quota is allocated during the months when there is greater fishing effort. This is expected to reduce the risk of the fishery approaching a seasonal quota and having its possession limits reduced. The Council considered reducing the skate-wing
Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. As part of this rulemaking process, a letter to permit holders that also serves as small entity compliance guide was prepared. Copies of this final rule are available from the Greater Atlantic Regional Fisheries Office (GARFO), and the compliance guide,
Fisheries, Fishing, Reporting and recordkeeping requirements.
For the reasons set out in the preamble, NMFS amends 50 CFR part 648 as follows:
16 U.S.C. 1801
(a) * * *
(1) A total of 66.5 percent of the annual skate complex TAL shall be allocated to the skate wing fishery. All skate products that are landed in wing form, for the skate wing market, or classified by Federal dealers as food as required under § 648.7(a)(1)(i), shall count against the skate wing fishery TAL. The annual skate wing fishery TAL shall be allocated in two seasonal quota periods as follows:
(i) Season 1—May 1 through August 31, 57 percent of the annual skate wing fishery TAL shall be allocated;
(ii) Season 2—September 1 through April 30, the remainder of the annual skate wing fishery TAL not landed in Season 1 shall be allocated.
(b) * * *
(2)
(i) When 85 percent of the Season 1 skate wing quota is projected to be landed between May 1 and August 17, the Regional Administrator shall reduce the skate wing possession limit to the incidental level described in paragraph (b)(2) of this section.
(ii) When 85 percent of the Season 1 skate wing quota is projected to be landed between August 18 and August 31, the Regional Administrator may reduce the skate wing possession limit to the incidental level described in paragraph (b)(2) of this section.
(iii) When 85 percent of the annual skate wing fishery TAL is projected to be landed in Season 2, the Regional Administrator may reduce the skate wing possession limit to the incidental level described in this paragraph, unless such a reduction would be expected to prevent attainment of the annual TAL.
Agricultural Marketing Service, USDA.
Proposed rule.
This proposed rule would implement a recommendation from the Texas Valley Citrus Committee (Committee) to increase the assessment rate established for the 2016-17 and subsequent fiscal periods from $0.08 to $0.09 per 7/10-bushel carton or equivalent of oranges and grapefruit handled under the marketing order (order). The Committee locally administers the order and is comprised of producers and handlers of oranges and grapefruit operating within the area of production. Assessments upon orange and grapefruit handlers are used by the Committee to fund reasonable and necessary expenses of the program. The fiscal period begins August 1 and ends July 31. The assessment rate would remain in effect indefinitely unless modified, suspended, or terminated.
Comments must be received by September 16, 2016.
Interested persons are invited to submit written comments concerning this proposed rule. Comments must be sent to the Docket Clerk, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Fax: (202) 720-8938; or Internet:
Doris Jamieson, Marketing Specialist, or Christian D. Nissen, Regional Director, Southeast Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (863) 324-3375, Fax: (863) 291-8614, or Email:
Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW., STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email:
This proposed rule is issued under Marketing Agreement and Order No. 906, as amended (7 CFR part 906), regulating the handling of oranges and grapefruit grown in the Lower Rio Grande Valley in Texas, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”
The Department of Agriculture (USDA) is issuing this proposed rule in conformance with Executive Orders 12866, 13563, and 13175.
This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order now in effect, orange and grapefruit handlers are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate as proposed herein would be applicable to all assessable oranges and grapefruit beginning on August 1, 2016, and continue until amended, suspended, or terminated.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
This proposed rule would increase the assessment rate established for the Committee for the 2016-17 and subsequent fiscal periods from $0.08 to $0.09 per 7/10-bushel carton or equivalent of oranges and grapefruit.
The Texas orange and grapefruit marketing order provides authority for the Committee, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members of the Committee are producers and handlers of Texas oranges and grapefruit. They are familiar with the Committee's needs and with the costs for goods and services in their local area and are thus in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.
For the 2015-16 and subsequent fiscal periods, the Committee recommended, and USDA approved, an assessment rate that would continue in effect from fiscal period to fiscal period unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other information available to USDA.
The Committee met on June 2, 2016, and unanimously recommended 2016-17 expenditures of $751,148 and an assessment rate of $0.09 per 7/10-bushel carton or equivalent of oranges and grapefruit. In comparison, last year's budgeted expenditures were $701,148. The assessment rate of $0.09 is $0.01 higher than the rate currently in effect.
The major expenditures recommended by the Committee for the 2016-17 year include $600,248 for the Mexican fruit fly control program, $77,200 for management, and $50,000 for compliance. Budgeted expenses for these items in 2015-16 were $600,248, $77,200, and $0, respectively.
The assessment rate recommended by the Committee was derived by dividing anticipated expenses by expected shipments of Texas oranges and grapefruit. Orange and grapefruit shipments for the 2016-17 year are estimated at 8 million 7/10-bushel cartons or equivalent, which should provide $720,000 in assessment income. Income derived from handler assessments, along with interest income and funds from the Committee's authorized reserve, would be adequate to cover budgeted expenses. Funds in the reserve (currently around $367,000) would be kept within the maximum permitted by the order (approximately one fiscal period's expenses as stated in § 906.35).
The proposed assessment rate would continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other available information.
Although this assessment rate would be in effect for an indefinite period, the Committee would continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA would evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking would be undertaken as necessary. The Committee's 2016-17 budget and those for subsequent fiscal periods would be reviewed and, as appropriate, approved by USDA.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this proposed rule on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.
There are approximately 170 producers of oranges and grapefruit in the production area and 13 handlers subject to regulation under the marketing order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,500,000 (13 CFR 121.201).
According to Committee data and information from the National Agricultural Statistics Service, the weighted average grower price for Texas citrus during the 2014-15 season was around $9.53 per box and total shipments were near 7.8 million boxes. Using the weighted average price and shipment information, and assuming a normal distribution of production, the majority of producers would have annual receipts of less than $750,000. In addition, based on Committee information, the majority of handlers have annual receipts of less than $7,500,000 and could be considered small businesses under SBA's definition. Thus, the majority of Texas citrus producers and handlers may be classified as small entities.
This proposal would increase the assessment rate established for the Committee and collected from handlers for the 2016-17 and subsequent fiscal periods from $0.08 to $0.09 per 7/10-bushel carton or equivalent of Texas oranges and grapefruit. The Committee unanimously recommended 2016-17 expenditures of $751,148 and an assessment rate of $0.09 per 7/10-bushel carton or equivalent handled. The proposed assessment rate of $0.09 is $0.01 higher than the 2015-16 rate. The quantity of assessable oranges and grapefruit for the 2016-17 season is estimated at 8 million 7/10-bushel cartons or equivalent. Thus, the $0.09 rate should provide $720,000 in assessment income. Income derived from handler assessments, along with interest income and funds from the Committee's authorized reserve, would be adequate to meet this year's expenses.
The major expenditures recommended by the Committee for the 2016-17 year include $600,248 for the Mexican fruit fly control program, $77,200 for management, and $50,000 for compliance. Budgeted expenses for these items in 2015-16 were $600,248, $77,200, and $0, respectively.
At the current assessment rate, assessment income would only equal around $640,000, an amount insufficient to cover the Committee's anticipated expenditures, which include a $50,000 increase in funding for compliance. The Committee considered the proposed expenses and recommended increasing the assessment rate.
Prior to arriving at this budget and assessment rate, the Committee considered information from various sources, such as the Committee's Budget and Personnel Committee, and Committee management. Alternative expenditure levels were discussed by these groups, based upon the relative value of various activities to the Texas citrus industry. Based on estimated shipments, the recommended assessment rate of $0.09 should provide $720,000 in assessment income. The Committee determined that the assessment revenue, along with funds from interest income and funds from reserves, would be adequate to cover budgeted expenses for the 2016-17 fiscal period.
A review of historical information and preliminary information pertaining to the upcoming crop year indicates that the average grower price for the 2016-17 season could be around $13.50 per 7/10-bushel carton or equivalent of oranges and grapefruit. Therefore, the estimated assessment revenue for the 2016-17 crop year as a percentage of total grower revenue would be around 0.6 percent.
This action would increase the assessment obligation imposed on handlers. While assessments impose some additional costs on handlers, the costs are minimal and uniform on all handlers. However, these costs would be offset by the benefits derived by the operation of the marketing order.
The Committee's meeting was widely publicized throughout the Texas citrus industry and all interested persons were invited to attend the meeting and participate in Committee deliberations on all issues. Like all Committee meetings, the June 2, 2016, meeting was a public meeting and all entities, both large and small, were able to express
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order's information collection requirements have been previously approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0189 Generic Fruit Crops. No changes in those requirements as a result of this action are necessary. Should any changes become necessary, they would be submitted to OMB for approval.
This proposed rule would impose no additional reporting or recordkeeping requirements on either small or large Texas orange and grapefruit handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.
AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.
USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this action.
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
A 30-day comment period is provided to allow interested persons to respond to this proposed rule. Thirty days is deemed appropriate because: (1) The 2016-17 fiscal period begins on August 1, 2016, and the marketing order requires that the rate of assessment for each fiscal period apply to all assessable Texas oranges and grapefruit handled during such fiscal period; (2) the Committee needs to have sufficient funds to pay its expenses which are incurred on a continuous basis; and (3) handlers are aware of this action which was unanimously recommended by the Committee at a public meeting and is similar to other assessment rate actions issued in past years.
Grapefruit, Marketing agreements, Oranges, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, 7 CFR part 906 is proposed to be amended as follows:
7 U.S.C. 601-674.
On and after August 1, 2016, an assessment rate of $0.09 per 7/10-bushel carton or equivalent is established for oranges and grapefruit grown in the Lower Rio Grande Valley in Texas.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 787-8 airplanes. This proposed AD was prompted by a report indicating that the fire block in the video control station and closets, and fire blocking tape in the floor panel opening in the forward and aft main passenger cabin, might be missing on some airplanes. This proposed AD would require installing fire block in the video control station and closets, as applicable, and installing fire blocking tape in the floor panel openings in the forward and aft main passenger cabin. We are proposing this AD to prevent propagation of a fire in the lower lobe cheek area outboard of a video control station and closet. Such propagation could result in an increased risk of smoke and/or fire propagation into the passenger cabin.
We must receive comments on this proposed AD by October 3, 2016.
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 Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone: 206-544-5000, extension 1; fax: 206-766-5680; Internet:
You may examine the AD docket on the Internet at
Francis Smith, Aerospace Engineer, Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6596; fax: 425-917-6590; email:
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
We have received a report from Boeing indicating that the fire block in the video control station and closets, and fire blocking tape in the floor panel opening in the forward and aft main passenger cabin might be missing on some airplanes. The materials were not installed during production. We are proposing this AD to prevent propagation of a fire in the lower lobe cheek area outboard of a video control station and closet. Such propagation could result in an increased risk of smoke and/or fire in the passenger cabin.
We reviewed the following service information:
Boeing Alert Service Bulletin B787-81205-SB250028-00, Issue 001, dated August 1, 2013. The service information describes procedures for installing fire block in the video control station and closets.
Boeing Alert Service Bulletin B787-81205-SB250070-00, Issue 001, dated March 10, 2015. The service information describes procedures for installing fire block in the video control station.
Boeing Alert Service Bulletin B787-81205-SB530018-00, Issue 001, dated June 7, 2013. The service information describes procedures for installing fire blocking tape in the floor panel openings in the forward and aft main passenger cabin.
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
We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This proposed AD would require accomplishing the actions specified in the service information described previously. For information on the procedures and compliance times, see this service information at
We estimate that this proposed AD affects 6 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:
According to the manufacturer, some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.
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.
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.
49 U.S.C. 106(g), 40113, 44701.
Docket No. FAA-2016-8844; Directorate Identifier 2016-NM-026-AD.
We must receive comments by October 3, 2016.
None.
This AD applies to The Boeing Company Model 787-8 airplanes, certificated in any category, as identified in Boeing Alert Service Bulletin B787-81205-SB530018-00, Issue 001, dated June 7, 2013; Boeing Alert Service Bulletin B787-81205-SB250028-00, Issue 001, dated August 1, 2013; and Boeing Alert Service Bulletin B787-81205-SB250070-00, Issue 001, dated March 10, 2015.
Air Transport Association (ATA) of America Code 25, Equipment/furnishings; 53, Fuselage.
This AD was prompted by a report indicating that the fire block in the video control station and closets, and fire blocking tape in the floor panel opening in the forward and aft main passenger cabin, might be missing on some airplanes. We are issuing this AD to prevent propagation of a fire in the lower lobe cheek area outboard of a video control station and closet. Such propagation could result in an increased risk of smoke and/or fire propagation into the passenger cabin.
Comply with this AD within the compliance times specified, unless already done.
Within 72 months after the effective date of this AD, do the actions specified in paragraphs (g)(1), (g)(2), and (g)(3) of this AD, as applicable.
(1) For airplanes specified in Boeing Alert Service Bulletin B787-81205-SB250028-00, Issue 001, dated August 1, 2013: Install fire block in the video control station and closets, as applicable, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin B787-81205-SB250028-00, Issue 001, dated August 1, 2013.
(2) For airplanes specified in Boeing Alert Service Bulletin B787-81205-SB250070-00, Issue 001, dated March 10, 2015: Install fire block in the video control station, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin B787-81205-SB250070-00, Issue 001, dated March 10, 2015.
(3) For airplanes specified in Boeing Alert Service Bulletin B787-81205-SB530018-00, Issue 001, dated June 7, 2013: Install fire blocking tape in the floor panel opening in the forward and aft main passenger cabin, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin B787-81205-SB530018-00, Issue 001, dated June 7, 2013.
(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (i)(1) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(4) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (h)(4)(i) and (h)(4)(ii) of this AD apply.
(i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. An AMOC is required for any deviations to RC steps, including substeps and identified figures.
(ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.
(1) For more information about this AD, contact Francis Smith, Aerospace Engineer, Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle ACO, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6596; fax: 425-917-6590; email:
(2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone: 206-544-5000, extension 1; fax: 206-766-5680; Internet:
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to modify Class C airspace at El Paso International Airport, El Paso, TX, by removing a cutout from the Class C airspace area that excludes the airspace within a 2-mile radius of West Texas Airport and the airspace beyond an 8-mile arc from the El Paso International Airport beginning at the 115° bearing from the airport clockwise to the Rio Grande River. Additionally, this proposal would update the El Paso International Airport geographic coordinates to reflect the current airport reference point (ARP) information in the FAA's aeronautical database and remove the West Texas Airport and geographic coordinate references from the Class C airspace description. The FAA is proposing this action to enable more efficient operations at El Paso International Airport.
Comments must be received on or before October 17, 2016.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE., West Building
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office between 9:00a.m. and 5:00 p.m., Monday through Friday, except Federal holidays. The Docket Office (telephone 1(800) 647-5527), is on the ground floor of the building at the above address.
FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Colby Abbott, Airspace Policy Group, Office of Airspace Services, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-8783.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would modify terminal airspace as required to preserve the safe and efficient flow of air traffic in the El Paso, TX, area.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers (FAA Docket No. FAA-2016-7417 and Airspace Docket No. 16-AWA-4) and be submitted in triplicate to the Docket Management Facility (see
Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2016-7417 and Airspace Docket No. 16-AWA-4.” The postcard will be date/time stamped and returned to the commenter.
All communications received on or before the specified comment closing date will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the comment closing date. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded through the internet at
You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see
This document proposes to amend FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the
The FAA is proposing an amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 to modify the El Paso International Airport, TX, Class C airspace area. The proposal would remove a cutout and reduced perimeter boundary arc that excludes the airspace within a 2-mile radius of the West Texas Airport and the airspace beyond an 8-mile arc from the El Paso International Airport beginning at the 115° bearing from the airport clockwise to the Rio Grande River. These exclusions from the Class C airspace area were established to accommodate operations at West Texas Airport, which was located approximately 9 nautical miles (NM) southeast of El Paso International Airport. The West Texas Airport (renamed Horizon Airport in 2004) is now permanently closed and the property sold for non-aviation uses. Since the original purpose for the exclusions no longer exists, the FAA is proposing to remove the words “. . . that airspace beyond an 8-mile arc from the El Paso International Airport beginning at the 115° bearing from the airport clockwise to the Rio Grande River, and that airspace within a 2-mile radius of the West Texas Airport, and . . .” from the regulatory text. The West Texas Airport and geographic coordinate references would also be removed from the Class C airspace description. These changes would restore the Class C airspace that extends upward from 5,200 feet MSL to 8,000 feet MSL to a standard configuration 10-NM radius boundary southeast of the El Paso International Airport and enhance the management of aircraft operations to and from the airport.
Additionally, the FAA would change the exclusion language pertaining to the Class C airspace extending upward from 5,200 feet MSL from “. . . that airspace within Mexico, and that airspace west of long 106°27′02″ W.” to “. . . that airspace west of long. 106°27′02″ W., and that airspace within Mexico.” This change would be editorial for format and clarity to standardize the exclusion
Lastly, this action would update the El Paso International Airport geographic coordinates to reflect the current ARP information in the FAA's aeronautical database from “lat. 31°48′24″ N., long. 106°22′40″ W.” to “lat. 31°48′26″ N., long. 106°22′35″ W.”
Class C airspace areas are published in paragraph 4000 of FAA Order 7400.9Z, dated August 6, 2015 and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class C airspace area modification proposed in this document would be published subsequently in the Order.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from the surface to and including 8,000 feet MSL within a 5-mile radius of the El Paso International Airport, excluding that airspace west of long. 106°27′02″ W., and that airspace within Mexico; and that airspace extending upward from 5,200 feet MSL to and including 8,000 feet MSL within a 10-mile radius of the El Paso International Airport, excluding that airspace west of long. 106°27′02″ W., and that airspace within Mexico.
U.S. Consumer Product Safety Commission.
Notice of proposed rulemaking.
The Consumer Product Safety Commission (Commission, or CPSC) is proposing a rule to determine that certain plastics with specified additives would not contain the specified phthalates prohibited in children's toys and child care articles. Based on these determinations, the specified plastics with specified additives would not require third party testing for compliance with the mandatory phthalates prohibitions on children's toys and child care articles.
Submit comments by October 31, 2016.
You may submit comments, identified by Docket No. CPSC-2016-0017, by any of the following methods:
Randy Butturini, Project Manager, Office of Hazard Identification and Reduction U.S. Consumer Product Safety Commission, 4330 East West Hwy., Room 814, Bethesda, MD 20814; 301-504-7562: email;
Section 14(a) of the Consumer Product Safety Act, (CPSA), as amended by the Consumer Product Safety Improvement Act of 2008 (CPSIA), requires that manufacturers of products subject to a consumer product safety rule or similar rule, ban, standard, or regulation enforced by the CPSC, must certify that the product complies with all applicable CPSC-enforced requirements. 15 U.S.C. 2063(a). For children's products, certification must be based on testing conducted by a CPSC-accepted third party conformity assessment body.
Section 108 of the CPSIA prohibits children's toys and child care articles that contain six specified phthalates in concentrations above 0.1 percent in “accessible plasticized component parts and other component parts made of materials that may contain phthalates.” The prohibited phthalates in section 108 of the CPSIA are listed in Table 1. Children's toys and child care articles subject to the content limits in section 108 of the CPSIA require third party testing for compliance with the phthalate content limits before the manufacturer can issue a Children's Product Certificate (CPC) and enter the children's toys or child care articles into commerce.
The CPSIA required the Commission to appoint a Chronic Hazard Advisory Panel (CHAP) to “study the effects on children's health of all phthalates and phthalate alternatives as used in children's toys and child care articles.” The CHAP issued its report in July 2014.
CPSC contracted with Toxicology Excellence for Risk Assessment (TERA) to conduct research on phthalates and provide CPSC with two research reports on phthalates relevant to this rulemaking. TERA conducted a literature search on the production and use of 11 specified phthalates in consumer products (Task 11 Report).
TERA used a tiered literature research approach to identify sources for review from among the “universe” of available data. The tiers were used to provide a structured search method to locate relevant sources and eliminate unrelated material. TERA used books, factsheets, journal articles, patents, and other sources as primary and secondary literature sources. The use of this tiered approach resulted in a comprehensive review of the available literature that is representative of the information available on the potential for the presence of any of the 11 phthalates in the 4 specified plastics.
TERA screened over 119,800 studies identified by the above described tiered search method for relevance to the 11 phthalates and 4 plastics. CPSC staff reviewed the information provided in the contractor report and formulated recommendations for Commission consideration based on TERA's research.
The plastics researched by TERA were:
• Polypropylene (PP);
• Polyethylene (PE);
• High-impact polystyrene (HIPS); and
• Acrylonitrile butadiene styrene (ABS).
TERA's research included the following factors:
• The raw materials used in the production of the specified plastics;
• The manufacturing processes used worldwide to produce the plastics;
• Typical applications for the specified plastics in consumer products, especially toys and child care articles, focusing on circumstances where the plastic could contain phthalates at concentrations greater than 0.1 percent;
• The potential use of recycled materials containing the specified phthalates in the production of the plastics; and
• The potential for phthalate contamination during packaging, storage, use, or other factors.
TERA's research indicated the production of PP plastic uses a PP monomer, ethylene, and other monomers, a hydrocarbon solvent, catalysts, nucleating agents or fillers, and a number of other additives, depending on the type of PP and other manufacturing considerations. Additives can be included in PP to achieve various chemical and mechanical characteristics. PP can include the following additives:
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The research showed that among all of these raw materials and additives, only Ziegler-Natta catalysts may contain one or more of the prohibited phthalates. Ziegler-Natta catalysts are generally titanium-based catalyst systems in combination with an organoaluminum co-catalyst, and an internal donor (a molecule that contributes an electron to the chemical reaction), such as DBP, DIBP or DEHP. As described in the Task 12 Report, these catalysts may survive the plastic's polymerization process, and the phthalates may be present in the final plastic pellets, theoretically at concentrations of about 1 mg/kg (1 part per million, “ppm”). The Task 12 Report references an industry analysis in the context of European regulations that indicates that phthalate concentrations in PP do not exceed 0.15 mg/kg (0.15 ppm) and are often below the measurement threshold of the analytical method of 0.01 mg/kg (0.01 ppm).
TERA's research indicated that PE is manufactured using PE monomers or certain copolymers or other monomers, and a number of additives. Additives can be included in PE to achieve various chemical and mechanical characteristics. PE can include the following additives:
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As with PP, PE catalysts include an internal donor, such as DBP, DIBP, or DEHP, although the phthalate concentration in the final plastic is generally well below 0.15 mg/kg (0.15 ppm).
One reference in the Task 12 report indicated that DOP can be used as a plasticizer in PE. Staff reviewed the cited references, as well as citations within the references, and found that uses of DOP in PE are mentioned in patents for specialized materials with no known current consumer product application, or may be used in materials, such as pavement marking, which are not children's products. One cited patent described use of phthalates in a PE microporous film used as an internal separator for lithium ion batteries.
The Task 12 Report cited a patent for a material made with PE plastic and DBP for use as a surface for outdoor athletic track, basketball, volleyball, and playgrounds. CPSC staff found no information indicating that such a product has been manufactured and marketed for consumer use. Furthermore, the applications for the material do not include children's toys or child care articles that are subject to the phthalate content restrictions.
TERA's research indicated that HIPS is a plastic blend generally produced from styrene, polybutadiene rubber, benzene, and a number of other substances. Additives can be included in HIPS to achieve various chemical and mechanical characteristics. HIPS can include the following additives:
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○ Aluminum chloride, ethyl chloride, hydrochloric acid;
○ Iron oxide, potassium oxide, chromium oxide; and
○ Bifunctional peroxides.
As with PP and PE, the polybutadiene used in HIPS production is made with the use of catalysts that include an internal donor, such as DBP, DIBP, or DEHP. Although no testing for phthalate content was located, because the use of phthalate in HIPS is as a catalyst, the concentration in the final product is expected to be well below 0.1 percent.
TERA's research indicated that ABS plastic is manufactured with specific monomers, such as acrylonitrile, butadiene, and styrene, trans-1,4-butadiene, cis-1,4-butadiene, and 1,2-butadiene. Additives are included in ABS to achieve various chemical and mechanical characteristics. ABS can include the following additives:
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TERA's research did not include an examination of the colorants in polyethylene, high-impact polystyrene, or acrylonitrile butadiene styrene. TERA's research also did not include an examination of the lubricants, activators, and antioxidants that could be used in the production of ABS. CPSC staff conducted additional research into these component parts of the plastics.
The Task 11 Report indicates that phthalates are used generally as plasticizers or softeners of certain plastics, primarily polyvinyl chloride (PVC), as solvents, and as components of inks, paints, adhesives, and sealants. Except for the general category of inks and colorants, the Task 11 Report did not indicate uses of the prohibited phthalates in any of the four plastics, in the raw materials, or in the types of additives that might be used in the four plastics.
The four plastics may also be used as ingredients in a variety of materials. For
The TERA Task 11 and Task 12 Reports indicate that the phthalates researched are not associated with the chemistry and applications of the plastics PP, PE, HIPS, or ABS. When these plastics are plasticized, materials other than the phthalates are used as plasticizers (
TERA's investigation of the uses of the four plastics shows that all four are used to make plastic consumer products and component parts. None of these applications specifically includes phthalates, although a few studies of the phthalate content of products were located.
Several studies evaluated food, beverage, and cosmetics packaging made with PP, PE, and polystyrene (PS). These studies generally measured migration of specified chemicals, including phthalates, from products purchased in retail stores. The references provided few or no details about all the materials used in the products, including whether other plastics were present, whether other component parts were present such as coatings, finishes, inks, or adhesives, or whether residues of the contained products were present.
The Task 12 Report also cited a Korean study of various products that reported low levels of phthalates in a toy car made with ABS. The study provided no details about other materials used in the product, including whether other plastics were present, or whether other component parts were present such as coatings, finishes, inks, or adhesives.
The Task 12 Report's detailed description of the raw materials and manufacturing processes for PP, PE, HIPS, and ABS plastics showed that phthalates are not present after these plastics are produced. However, the Task 11 Report describes uses of phthalates in materials on these plastics, such as coatings, inks, and adhesives. Because consumer products purchased in stores likely consist of a number of different component parts, some of which may have contained phthalates, the studies described above should not be considered to be evidence that phthalates were used in the manufacture of the PP, PE, HIPS, or ABS plastic component parts of consumer products subject to the phthalate content restrictions.
All four plastics may be recycled and reprocessed into new products. However, degradation of the original plastics during the recycling process and mixing with other plastics or materials in the recycling steam can reduce the quality of the recovered plastic and limit further commercial uses. In some cases, recovered plastics are mixed with virgin plastics to improve the products' quality and utility. The Task 12 Report indicated that few studies were located for analysis of phthalates in recycled plastics. One study found no phthalates in recycled PP carpet. Two studies analyzed solid waste consisting of PP or PE. One study reported detection of phthalates in recovered waste PP and PE material, but not in samples of virgin PP or PE plastic. The other study reported phthalates in recovered PE. The authors of the latter study suggested that the source of phthalates could have been the products that had been in contact with the plastic.
HIPS and ABS are generally used as rigid materials; available information does not indicate use of phthalates in such materials or associated with recycled HIPS or ABS.
Some studies indicated the potential for low, but detectable, levels of phthalates in plastics, such as PP or PE packaging that contained or had been in contact with a phthalate-containing product. Products made with such materials could contain residual phthalates, although at levels well below the maximum allowed concentration in children's products.
With the exception of the catalysts for polymerization, and certain, specific uses of phthalates in products without consumer product applications, neither of the TERA task reports, nor research by CPSC staff found that phthalates are used as a component part of the four plastics. In the case of the phthalate catalysts used in plastics manufacturing, the phthalate concentration in finished plastics is significantly below the maximum allowable concentration.
The two TERA task reports and CPSC staff research show that very little information exists that indicates that manufactured PP, PE, HIPS, and ABS plastics could contain the researched phthalates. The research located references, including patents, for uncommon and specialized products, and products that generally do not have applications to children's toys and child care articles.
Staff found no evidence that phthalates are present at concentrations above 0.1 percent in any of the four plastics (either virgin or using recycled material) for consumer products, especially children's products.
As noted above, section 14(a)(2) of the CPSA requires third party testing for children's products that are subject to a children's product safety rule. 15 U.S.C. 2063(a)(2). Children's toys and child care articles must comply with the phthalates prohibitions in section 108 of the CPSIA. 15 U.S.C. 2057c. In response to statutory direction, the Commission has investigated approaches that would reduce the burden of third party testing while also assuring compliance with CPSC requirements. As part of that endeavor, the Commission has considered whether certain materials used in children's toys and child care articles would not require third party testing.
To issue a determination that a plastic (including specified additives) does not require third party testing, the Commission must have sufficient evidence to conclude that the plastic and specified additives would consistently comply with the CPSC requirement to which the plastic (and specified additives) is subject so that third party testing is unnecessary to provide a high degree of assurance of compliance. Under 16 CFR part 1107 section 1107.2, “a high degree of assurance” is defined as “an evidence-based demonstration of consistent performance of a product regarding compliance based on knowledge of a product and its manufacture.”
For a material determination, a high degree of assurance of compliance means that the material will comply
Phthalates are not naturally occurring materials, but are intentionally created and used in specific applications (
Based on the discussion in section C of this preamble, the Commission proposes to determine that the specified four plastics and accompanying additives would comply with the phthalates prohibitions with a high degree of assurance. These determinations mean that third party testing for compliance with the phthalates prohibitions is not required for certification purposes for the specified four plastics. The Commission proposes to make these determinations to reduce the third party testing burden on children's product certifiers while continuing to assure compliance.
Section 3 of the CPSIA grants the Commission general rulemaking authority to issue regulations, as necessary, to implement the CPSIA. Public Law 110-314, sec. 3, Aug. 14, 2008. As noted previously, section 14 of the CPSA, which was amended by the CPSIA, requires third party testing for children's products subject to a children's product safety rule. 15 U.S.C. 2063(a)(2). Section 14(d)(3)(B) of the CPSA, as amended by Public Law 112-28, gives the Commission the authority to “prescribe new or revised third party testing regulations if it determines that such regulations will reduce third party testing costs consistent with assuring compliance with the applicable consumer product safety rules, bans, standards, and regulations.”
The proposed determinations would relieve the four specified plastics and accompanying additives from the third party testing requirement of section 14 of the CPSA for purposes of supporting the required certification. However, the proposed determinations would not be applicable to any other plastic or additives beyond those listed in the proposed rule.
The proposed determinations would only relieve the manufacturers' obligation to have the specified plastics and accompanying additives tested by a CPSC accepted third party conformity assessment body. Children's toys and child care articles must still comply with the substantive phthalates content limits in section 108 of the CPSIA regardless of any relief on third party testing requirements.
This proposed rule would create a new Part 1308 for “Prohibition of Children's Toys and Child Care Articles Containing Specified Phthalates: Determinations Regarding Certain Plastics.” The proposed rule would determine that the specified four plastics and accompanying additives do not contain the statutorily prohibited phthalates (DEHP, DBP, BBP, DINP, DIDP, DnOP) in concentrations above 0.1 percent, and thus, are not required to be third party tested to assure compliance with section 108 of the CPSIA. As discussed in section A.2 of the preamble, the agency is currently involved in rulemaking to determine whether to continue the interim prohibitions in section 108 and whether to prohibit any other children's products containing any other phthalates. TERA's examination covered all phthalates that are subject to the current permanent and interim prohibitions, as well as the additional phthalates the Commission proposed restricting in the phthalates proposed rule. If the Commission issues a final rule in the phthalates rulemaking before finalizing this determinations rulemaking, the Commission would modify the determinations proposed rule so that the determinations rule covers the same phthalates restricted by the final phthalates rule.
Section 1308.1 of the proposed rule explains the statutorily-created requirements for children's toys and child care articles under section 108 of the CPSIA and the third party testing requirements for children's products.
Section 1308.2(a) of the proposed rule would establish the Commission's determinations that the following plastics do not exceed the phthalates content limits with a high degree of assurance as that term is defined in 16 CFR part 1107:
• Polypropylene, with any of the following additives:
○ the plasticizers polybutenes, dioctyl sebacate, paraffinic oil, isooctyl tallate, mineral plasticizing oils, and polyol;
○ hydrocarbon solvents;
○ catalysts;
○ fillers;
○ nucleating agents;
○ primary and secondary antioxidants;
○ neutralizing agents;
○ antistatic agents;
○ slip agents;
○ metal deactivators;
○ quenchers;
○ UV stabilizers;
○ flame retardants;
○ blowing or foaming agents;
○ antiblocking agents;
○ lubricants; or
○ colorants.
• Polyethylene, with any of the following additives:
○ the plasticizers glyceryl tribenzoate, polyethylene glycol, sunflower oil, paraffin wax, paraffin oil, mineral oil, glycerin, EPDM rubber, and EVA polymer;
○ catalysts;
○ initiators;
○ promoters;
○ antistatic agents;
○ fillers;
○ flame retardants;
○ anti-blocking agents;
○ slip agents;
○ blowing agents;
○ cross-linking agents;
○ antioxidants;
○ carbon black; or
○ colorants.
• High-impact polystyrene, with any of the following additives:
○ catalysts;
○ internal lubricants;
○ chain transfer/transition agents;
○ stabilizers;
○ diluents;
○ colorants;
○ aluminum chloride, ethyl chloride, hydrochloric acid;
○ iron oxide, potassium oxide, chromium oxide; or
○ bifunctional peroxides.
• Acrylonitrile butadiene styrene, with any of the following additives:
○ the plasticizers phosphate esters, long chain fatty acid esters and aromatic sulfonamide;
○ hydrocarbon solvents;
○ stabilizers;
○ lubricants;
○ antioxidants;
○ molecular weight regulators;
○ initiators/catalysts,
○ activators;
○ emulsifiers; or
○ colorants.
Section C.2 of the preamble provides a more detailed discussion of the additives for each of the four plastics with the specified additives including definitions of the additives and various examples of the types of additives.
Section 1308.2(b) of the proposed rule states that accessible component parts of children's toys and child care articles made with the specified plastics, and specified additives listed in paragraph (a) of that section, are not required to be third party tested pursuant to section 14(a)(2) of the CPSA and 16 CFR part 1107. Proposed § 1308.2(b) is included in the rule to make clear that when the listed plastics and accompanying additives are used in children's toys and child care articles, manufacturers and importers are not required to conduct the third party testing required in section 14(a)(2) of the CPSA and 16 CFR part 1107. Section 1308.2(c) of the proposed rule states that accessible component parts of children's toys and child care articles made with a plastic or additives not listed in paragraph (a) of this section are required to be third party tested pursuant to section 14(a)(2) of the CPSA and 16 CFR part 1107. Proposed § 1308.2(c) is intended to make clear that if a manufacturer or importer uses any other plastic or additive in a children's toy or child care article not listed in proposed § 1308.1(a), that children's toy or child care article must be third party tested pursuant to section 14(a)(2) of the CPSA and 16 CFR part 1107. Finally, the determinations in proposed § 1308.2(a) would only remove the obligation to have children's toys and child care articles tested by a third party conformity assessment body. Regardless of any third party testing relief that the proposed rule would provide, the manufacturer or importer must still comply with the underlying phthalates content prohibitions in section 108 of the CPSIA.
The Administrative Procedure Act (APA) generally requires that a substantive rule must be published not less than 30 days before its effective date. 5 U.S.C. 553(d)(1). Because the proposed rule would provide relief from existing testing requirements under the CPSIA, the Commission proposes a 30 day effective date for the final rule.
The Regulatory Flexibility Act (RFA) requires that agencies review a proposed rule for the rule's potential economic impact on small entities, including small businesses. Section 603 of the RFA generally requires that agencies prepare an initial regulatory flexibility analysis (IRFA) and make the analysis available to the public for comment when the agency is required to publish a notice of proposed rulemaking, unless the agency certifies that the NPR will not have a significant economic impact on a substantial number of small entities. The IRFA must describe the impact of the proposed rule on small entities and identify any alternatives which accomplish the statutory objectives and may reduce the significant economic impact of the proposed rule on small entities. Specifically, the IRFA must contain:
• A description of the reasons why action by the agency is being considered;
• a succinct statement of the objectives of, and legal basis for, the proposed rule;
• a description of, and where feasible, an estimate of the number of small entities to which the proposed rule will apply;
• a description of the projected reporting, recordkeeping, and other compliance requirements of the proposed rule, including an estimate of the classes of small entities subject to the requirements and the types of professional skills necessary for the preparation of reports or records; and
• an identification, to the extent possible, of all relevant federal rules which may duplicate, overlap, or conflict with the proposed rule.
The Commission is proposing this NPR to reduce the burden of third party testing on toy and child care article manufacturers, especially the burden on those that are small entities. Based on an extensive literature review seeking information on the raw materials used in the manufacture of the specified plastics, the worldwide manufacturing practices of the plastics, the typical applications, and the potential for exposure to the specified phthalates through the use of recycled materials or due to contamination, the Commission concludes that there is a high degree of assurance that polypropylene, polyethylene, high impact polystyrene, and acrylonitrile butadiene styrene with the accompanying additives in the proposed rule will not contain any of the prohibited phthalates in concentrations above 0.1 percent when used in children's toys and child care articles. Therefore, third party testing is not necessary to assure that children's toys and child care articles with accessible component parts made from these plastics and accompanying additives do not contain the prohibited phthalates.
The proposed rule would apply to small entities that manufacture or import children's toys or child care articles that contain accessible polyethylene, polypropylene, high impact polystyrene, or acrylonitrile butadiene styrene and any accompanying additives in component parts. Toy manufacturers are classified in North American Industry Classification System (NAICS) category 33993 (“Doll, Toy, and Game Manufacturing”). According to the U.S. Bureau of the Census, in 2012 there were 559 toy manufacturers in the United States, of which 552 had fewer than 500 employees and would be considered small entities according to the Small Business Administration (SBA) criteria.
Toy importers may be either wholesale merchants or retailers. The proposed rule would not apply to toy wholesalers or retailers if they obtain their merchandise from domestic manufacturers or importers. Toy wholesalers are classified in NAICS category 42392 (“Toy and Hobby Goods and Supplies Merchant Wholesalers”). According to the U.S. Bureau of the Census, there were 2,096 firms in this category.
The phthalate regulations also apply to manufacturers and importers of child care articles. Child care articles include many types of products for which the CPSC has recently promulgated or proposed new or amended mandatory safety standards. These include toddler beds, full size and non-full size cribs, bassinets and cradles, bedside sleepers, high chairs, hook-on-chairs, and booster seats. Other child care articles include sleepwear, and crib or cradle bumpers. In its ongoing market research, CPSC staff has identified 364 suppliers of these products that would be considered small according to criteria established by the SBA. Additionally, there could be other child care articles, not listed above, for which CPSC has not yet developed a mandatory or proposed standard, but which nevertheless are covered by the phthalate requirements.
Child care articles would also include products such as teethers (if they are not medical devices), pacifiers, and bottle nipples. Manufacturers of these products are classified in NAICS category 326299 (“All other rubber product manufacturing”). There are 617 firms classified in this NAICS code of which 573 are considered to be small.
Although, as discussed above, the number of small companies that supply children's toys or child care articles to the U.S. market might be close to 10,000, the number that actually supply products with accessible polyethylene, polypropylene, high impact polystyrene, or acrylonitrile, butadiene styrene component parts is not known. Also not known is the number of children's toys and child care articles that contain these plastics. To develop comprehensive estimates of the number of products that contain these plastics and the number of firms that supply the products it would probably be necessary to survey a representative sample of toy and child care article suppliers to solicit information on their use of the four plastics or to collect a representative sample of children's toys and child care articles and analyze the accessible components to determine which ones contained one or more of the four plastics.
Although comprehensive estimates of the number of children's toys and child care articles that contain components made from the four plastics are not available, there is some evidence that these plastics are extensively used in children's toys. One source stated that polypropylene and high density polyethylene are used in 38 and 25 percent, respectively, of injection molded toys. Low density polyethylene and acrylonitrile butadiene styrene, are each used in less than 10 percent of the injection molded toys. Polystyrene may also be used in injection molded toys, but the source does not specify the proportion that is high impact polystyrene.
The proposed rule would determine that there is a high degree of assurance that four specific plastics with any of the accompanying additives will not contain any prohibited phthalates at concentrations above 0.1 percent prohibition level. As a result of the proposed determinations, manufacturers, importers, and private labelers of children's toys and child care articles that have accessible components that consist of these plastics and any accompanying additives will not have to obtain third party tests to certify that the accessible components do not contain the prohibited phthalates in concentrations above 0.1 percent.
The proposed rule would not impose any additional reporting, recordkeeping, or other compliance requirements on small entities. In fact, because the proposed rule would eliminate a testing requirement, there would be a small reduction in some of the recordkeeping burden under 16 CFR part 1107 and 16 CFR part 1109 because manufacturers would no longer have to maintain records of third party phthalate tests for the component parts manufactured from these four plastics.
A determination that specified plastics with accompanying additives used in children's toys and child care articles do not require third party testing is expected to be entirely beneficial to manufacturers and importers using those plastics in accessible component parts because manufacturers and importers could forego testing they otherwise would be required to conduct. However, staff believes the magnitude of that benefit is uncertain and could depend on factors such as:
• The extent to which manufacturers have already reduced their testing costs by using component part testing (as allowed in 16 CFR part 1109);
• the volume of children's toys and child care articles that contain PE, PP, HIPS, or ABS;
• whether importers who certify children's products are unsure what plastics are being used in the toys and child care articles they import, so they could not take advantage of the determinations without additional testing to assure that a component part is composed of one of the four plastics.
The Commission welcomes comments on the potential impact of the proposed rule on small entities. Comments are especially welcome on the following topics:
• The extent to which PP, PE, HIPS, or ABS are used in children's toys and child care articles, especially those manufactured or imported by small firms;
• The potential reduction in third party testing costs that might be provided by the Commission making the determinations, including the extent to which component part testing is already being used;
• Any situations or conditions in the proposed rule that would make it difficult to make use of the determinations to reduce third party testing costs; and
• Although the Commission expects that the impact of the proposed rule will be entirely beneficial, any potential negative impacts of the proposed rule.
We have not identified any Federal rules that duplicate or conflict with the proposed rule.
Under section 603(c) of the RFA, an initial regulatory flexibility analysis should “contain a description of any significant alternatives to the proposed rule which accomplish the stated objectives of the applicable statutes and which minimize any significant impact of the proposed rule on small entities.” Because the proposed rule is intended to reduce the cost of third party testing on small businesses and will not impose any additional burden, the Commission did not consider alternatives to the proposed rule that would reduce the burden of this rule on small businesses.
The Commission's regulations provide a categorical exclusion for Commission rules from any requirement to prepare an environmental assessment or an environmental impact statement because they “have little or no potential for affecting the human environment.” 16 CFR 1021.5(c)(2). This rule falls within the categorical exclusion, so no environmental assessment or environmental impact statement is required. The Commission's regulations state that safety standards for products normally have little or no potential for affecting the human environment. 16 CFR 1021.5(c)(1). Nothing in this rule alters that expectation.
Business and industry, Consumer protection, Imports, Infants and children, Product testing and certification, Toys.
Sec. 3, Pub. L. 110-314, 122 Stat. 3016; 15 U.S.C. 2063(d)(3)(B).
Section 108(a) of the Consumer Product Safety Improvement Act of 2008 (CPSIA) permanently prohibits any children's toy or child care article that contains concentrations of more than 0.1 percent of di-(2-ethylhexl) phthalate (DEHP), dibutyl phthalate (DBP), or benzyl butyl phthalate (BBP). Section 108(b)(1) of the CPSIA prohibits on an interim basis any children's toy that can be placed in a child's mouth or child care article that contains concentrations of more than 0.1 percent of diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), or di-n-octyl phthalate (DnOP). Materials used in children's toys and child care articles subject to section 108(a) and (b)(1) of the CPSIA must comply with the third party testing requirements of section 14(a)(2) of the Consumer Product Safety Act (CPSA), unless listed in § 1308.2.
(a) The following plastics do not exceed the phthalates content limits with a high degree of assurance as that term is defined in 16 CFR part 1107:
(1) Polypropylene (PP), with any of the following additives:
(i) The plasticizers polybutenes, dioctyl sebacate, paraffinic oil, isooctyl tallate, mineral plasticizing oils, and polyol;
(ii) Hydrocarbon solvents;
(iii) Catalysts;
(iv) Fillers;
(v) Primary and secondary antioxidants;
(vi) Neutralizing agents;
(vii) Antistatic agents;
(viii) Slip agents;
(ix) Metal deactivators;
(x) Quenchers;
(xi) UV stabilizers;
(xii) Nucleating agents;
(xiii) Flame retardants;
(xiv) Blowing or foaming agents;
(xv) Antiblocking agents;
(xvi) Lubricants; or
(xvii) Colorants.
(2) Polyethylene (PE), with any of the following additives:
(i) The plasticizers glyceryl tribenzoate, polyethylene glycol, sunflower oil, paraffin wax, paraffin oil, mineral oil, glycerin, EPDM rubber, and EVA polymer;
(ii) Initiators;
(iii) Promoters;
(iv) Catalysts;
(v) Fillers;
(vi) Antistatic agents;
(vii) Flame retardants;
(viii) Anti-blocking agents;
(ix) Slip agents;
(x) Blowing agents;
(xi) Ccross-linking agents;
(xii) Antioxidants;
(xiii) Carbon black; or
(xiv) Colorants.
(3) High-impact polystyrene (HIPS), with any of the following additives:
(i) Catalysts;
(ii) Internal lubricants;
(iii) Chain transfer/transition agents;
(iv) Stabilizers;
(v) Diluents;
(vi) Colorants;
(vii) Aluminum chloride, ethyl chloride, hydrochloric acid;
(viii) Iron oxide, potassium oxide, chromium oxide; or
(ix) Bifunctional peroxides.
(4) Acrylonitrile butadiene styrene (ABS), with any of the following additives:
(i) The plasticizers phosphate esters, long chain fatty acid esters and aromatic sulfonamide;
(ii) Hydrocarbon solvents
(iii) Stabilizers;
(iv) Lubricants;
(v) Antioxidants;
(vi) Molecular weight regulators;
(vii) Initiators/catalysts,
(viii) Activators;
(ix) Emulsifiers; or
(x) Colorants.
(b) Accessible component parts of children's toys and child care articles made with the specified plastics, and specified additives, listed in paragraph (a) of this section are not required to be third party tested pursuant to section 14(a)(2) of the CPSA and 16 CFR part 1107.
(c) Accessible component parts of children's toys and child care articles made with a plastic or additives not listed in paragraph (a) of this section are required to be third party tested pursuant to section 14(a)(2) of the CPSA and 16 CFR part 1107.
U.S. Customs and Border Protection, Department of Homeland Security; Department of the Treasury.
Notice of proposed rulemaking.
This document proposes amendments to the U.S Customs and Border Protection (CBP) regulations relating to the importation into the United States of certain vehicles and engines subject to federal antipollution emission standards under the Clean Air Act (CAA). Compliance with these emission standards must be demonstrated to CBP by either filing, or retaining and producing upon request, the appropriate U.S. Environmental Protection Agency (EPA) declaration form or by establishing that the subject imports are exempt from this requirement. CBP is proposing to amend its regulations to harmonize the documentation requirements applicable to different classes of vehicles and engines that are subject to the CAA's emission standards. This document also proposes to permit the required EPA emission compliance forms to be filed with CBP electronically. CBP is proposing other non-substantive amendments to update regulatory citations and delete obsolete provisions. The proposed changes set forth in this document support consistency in the administration of CBP's vehicle and engine imports program. In addition, electronic filing of EPA declaration forms will support key modernization initiatives, expedite the entry and clearance process, enhance targeting and enforcement objectives, and connect CBP with partner government agencies and the trade community through a single window access point.
Comments on the proposed rule must be received on or before September 16, 2016.
You may submit comments, identified by docket number, by
•
•
For questions related to the filing of EPA forms with CBP, please contact William Scopa, Partner Government Agencies Interagency Collaboration Division, Office of Trade, Customs and Border Protection, at
Interested persons are invited to participate in this rulemaking by submitting written data, views, or arguments on all aspects of the proposed rule. CBP also invites comments that relate to the economic, environmental, or federalism effects that might result from this proposed rule. If appropriate to a specific comment, the commenter should reference the specific portion of the proposed rule, explain the reason for any recommended change, and include data, information, or authority that supports such recommended change.
The Clean Air Act (CAA), as amended (42 U.S.C. 7401
These statutory provisions are implemented in the CBP regulations at §§ 12.73 and 12.74 of title 19 of the Code of Federal Regulations (19 CFR 12.73 and 12.74). Section 12.73 provides for “[M]otor vehicle and engine compliance with Federal antipollution emission requirements.” Corresponding EPA regulations for motor vehicles and engines are promulgated at 40 CFR parts 85 and 86. Section 12.74 provides for “[N]onroad and stationary engine compliance with Federal antipollution emission requirements.” Corresponding EPA regulations for nonroad and stationary engine compliance are promulgated at 40 CFR parts 1033 through 1068.
EPA requires the submission of certain documents for purposes of compliance with the CAA. EPA makes available EPA Declaration Form 3520-1 for the importation of passenger vehicles, highway motorcycles, and their corresponding engines into the United States, and EPA Declaration Form 3520-21 for the importation of heavy-duty highway engines and nonroad engines (gas, diesel, marine,
For importations that are covered by EPA Declaration Form 3520-1, existing § 12.73(i) of the CBP regulations (19 CFR 12.73(i)) requires importers to file the requisite information with CBP at the time of entry. An exemption from this requirement exists for motor vehicle imports that are covered by an EPA Certificate of Conformity (COC) which are labeled accordingly (
For importations that are covered by EPA Declaration Form 3520-21, existing § 12.74(b) (19 CFR 12.74(b)) requires importers to prepare the form and keep it on file for a period of at least five years from the date of entry in accordance with § 163.4 (19 CFR 163.4). The form must be made available upon request by CBP. Unlike motor vehicle manufacturers subject to § 12.73 (19 CFR 12.73), manufacturers that import products covered by EPA Declaration Form 3520-21 are not exempt from preparing this form even if the subject goods are covered by an EPA COC; they are required to prepare EPA Declaration Form 3520-21 and keep it on file for a period of at least five years from the date of entry.
In an effort to provide consistency in the administration of CBP's vehicle and engine imports program so that importers of both road vehicles and engines, as well as stationary and nonroad engines (including engines incorporated into vehicles or equipment), are subject to the same filing and recordkeeping requirements, CBP is proposing to conform the entry filing requirements applicable to the EPA Declaration Form 3520-21 to those that currently exist for EPA Declaration Form 3520-1. Specifically, CBP is proposing to amend 19 CFR 12.74(b) to require that importers of stationary, nonroad or heavy-duty highway engines (including engines incorporated into vehicles or equipment) file EPA Declaration Form 3520-21 at the time of entry, unless exempt. CBP is proposing to exempt an importer that manufactures nonroad or stationary engines, including engines incorporated into vehicles and equipment, from the requirement to file an EPA Declaration Form 3520-21 at the time of entry if that importer holds a valid EPA COC for those engines and the engines are labeled to show compliance with applicable emission requirements.
This document proposes to amend §§ 12.73 and 12.74 to permit the electronic filing of EPA Declaration Forms 3520-1 and 3520-21 to CBP in the Automated Commercial Environment (ACE) or to any other CBP-authorized electronic data interchange system. The EPA declaration forms may also still be filed with CBP in paper with a paper entry filing at the time of entry.
The electronic filing of these forms will support key modernization and compliance initiatives of the International Trade Data System, as established by section 405 of the Security and Accountability for Every (SAFE) Port Act of 2006, Public Law 109-347, 120 Stat. 1884, by utilizing a single portal system (ACE) for the collection and distribution of standard electronic import and export data required by participating Federal agencies. The electronic transmission to CBP of EPA declaration forms will automate and enhance the interaction between the EPA and CBP by facilitating electronic collection, processing, sharing, and review of requisite trade data and documents during the cargo import and export process. Electronic filing of these EPA declaration forms at the time of entry will provide for a quicker and more efficient clearance process and enhance CBP's ability to conduct targeting and enforcement of importation requirements. Electronic filing will also permit CBP to analyze and flag problems immediately, whereas paper filings result in an ad-hoc process that requires a physical inspection by a CBP or EPA inspector. CBP is of the view that requiring EPA Declaration Forms 3520-1 and 3520-21 to be filed with every appropriate entry (with the exception of certain importing manufacturers, as described above) will expedite the clearing of vehicles and engines that are compliant with applicable emissions requirements.
CBP is proposing other changes to §§ 12.73 and 12.74 to update regulatory citations, delete provisions that are no longer relevant, and provide non-substantive re-statements of existing regulatory text to enhance readability. CBP is also updating regulatory language to ensure that electronic filing can be accommodated. The proposed changes are described below:
• CBP is proposing to amend § 12.73(a) to reflect updated EPA regulatory citations and to provide a non-substantive re-statement of the existing regulatory text to enhance readability.
• This document proposes to remove § 12.73(c)(3) from the CBP regulations. Paragraph (c)(3) sets forth requirements for vehicles participating in EPA-approved catalytic converter or oxygen sensor control programs. EPA no longer has such programs.
• This document proposes to remove § 12.73(c)(4) from the CBP regulations. Paragraph (c)(4) pertains to vehicles of United States or foreign origin manufactured with a catalytic converter or oxygen sensor, or any previously imported vehicle subsequently modified with a catalytic converter or oxygen sensor. Under this provision, these vehicles are not considered to be in compliance with applicable emission requirements if used outside of the United States, Canada, Mexico, or other countries as EPA may designate, until the catalytic converter and/or oxygen sensor is replaced. This provision was intended to address vehicles that may have traveled to countries where only leaded fuel was available, which could have a detrimental effect on catalytic converters and/or oxygen sensors. Since leaded fuel is no longer available in
• CBP is proposing amendments to § 12.73(d) that further clarify the role of an Independent Commercial Importer, re-designate “working” days as “business” days, and provide a re-statement of existing regulatory text for enhanced readability.
• CBP is proposing amendments to § 12.73(e), in the introductory paragraph and paragraph (e)(4), that enhance readability and clarify that motorcycles are “highway” vehicles.
• CBP is proposing to amend § 12.73(f) by requiring that the designated motor vehicles be “new” in order to conform to the EPA regulatory requirements set forth in 40 CFR 85.1709. CBP also proposes editorial changes to enhance readability.
• In § 12.73(g)(2), CBP is proposing to change the existing reference to paragraph “(i)(4)” to “(i)(6)” to reflect that provision's proposed redesignation.
• The proposed amendments to § 12.73(h) enhance readability, reflect updated regulatory citations, and remove the word “motor” from the introductory text and from the regulatory text in paragraph (h)(5) pertaining to racing cars.
• CBP is proposing to amend § 12.73(i) by adding new paragraphs that prescribe methods of filing the EPA declaration forms and set forth applicable recordkeeping requirements, and by redesignating existing paragraph (i)(4) as new paragraph (i)(6).
• CBP is proposing to amend existing § 12.73(i)(4), redesignated in this proposed rule as paragraph (i)(6), by removing the requirement that diplomats and foreign military personnel must submit the emission declarations specified in existing 19 CFR 12.73(i)(2) (redesignated as 19 CFR 12.73(i)(3) in this proposed rule) with their entry, a copy of the motor vehicle importer's official orders or the name of the embassy to which the importer is accredited, if applicable. Pursuant to 19 CFR 148.82, the baggage and effects of diplomatic, consular, and other privileged personnel representing foreign governments are admitted free of duty without the filing of an entry upon the request of the Department of State. As State Department policy is to require that importation occur through the DS-1504 (“Request for Customs Clearance of Merchandise”) process and not through the entry process, it is proposed to amend existing § 12.73(i)(4)—redesignated as proposed 19 CFR 12.73(i)(6)—to no longer require the submission of emission documentation, official orders, or embassy information. Instead, it is proposed that a claim by diplomats and foreign military personnel for exemption from § 12.73(g)(2) emission requirements must be supported by a Department of State-approved form DS-1504 or its electronic equivalent.
• Section 12.73(m) is proposed to be amended to reflect updated EPA regulatory citations.
• CBP is proposing to amend §§ 12.73(j) and 12.74(c)(1) by adding language stating that bonds may be submitted to CBP electronically and may be filed by a surety.
• This document proposes to remove § 12.74(a)(1)-(3) from the CBP regulations as these paragraphs refer to obsolete EPA regulatory sections, and to add language clarifying the scope of the applicable EPA emission regulations.
• This document proposes to remove § 12.74(c)(3)(iv) from the CBP regulations. Paragraph (c)(3)(iv) prescribes precertification for vehicles, engines and equipment. This provision refers to obsolete requirements found in EPA regulation 40 CFR 89.611(b)(3) regarding Independent Commercial Importers. EPA will make conforming amendments to its regulations to delete this provision.
• CBP is proposing to amend § 12.74(c)(3) to add exemptions that conditionally allow for the importation of nonconforming vehicles, engines, and equipment. Exemptions for diplomatic and military personnel (40 CFR 1068.325(e)), partially complete engines (40 CFR 1068.325(f)), and delegated assembly (40 CFR 1068.325(g)) were codified in EPA regulations since changes were last made to 19 CFR 12.74(c)(3) and are being proposed to be added to 19 CFR 12.74(c)(3) to ensure consistency with EPA regulations.
• CBP is proposing editorial amendments to § 12.74(d) to enhance readability.
EPA regulations at 40 CFR parts 85 and 1068 also contain provisions related to the importation of vehicles, engines, and equipment. To the extent necessary to reflect the changes to the CBP regulations proposed in this document, EPA will make conforming amendments to its regulations in a separate action.
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 (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule is not a “significant regulatory action,” under section 3(f) of Executive Order 12866. Accordingly, the Office of Management and Budget (OMB) has not reviewed this regulation.
The Regulatory Flexibility Act (5 U.S.C. 601
This rule proposes modifications to the requirements for the submission of EPA Declaration Form 3520-21. Currently, importers are required to fill out the form, but are only required to submit it to CBP upon request. This proposed rule, if finalized, would require importers to file EPA Declaration Form 3520-21 with CBP at the time of entry, unless the importer is a manufacturer of nonroad or stationary engines, including engines incorporated into vehicles and equipment, and holds a valid EPA certificate of conformity for those engines and the engines are labeled to show compliance with applicable emission requirements. As this form is already complete at the time of entry, the cost of submitting it to CBP is negligible. This rule would also explicitly add electronic filing as an accepted method of form submission. Importers will still be able to file the form by paper if they so choose. This change will affect all importers who are covered by EPA Declaration Form 3520-21, including small importers. Therefore, it is likely to have an impact on a substantial number of small entities. However, the only costs to the public are the negligible costs of submitting the already completed form to CBP along with other required entry documents. These costs do not rise to the level of significance. Therefore, CBP certifies that this proposed rule will not have a significant economic impact on a substantial number of small entities.
The collection of information contained in this proposed rule was
This proposed regulation is being issued in accordance with 19 CFR 0.1(a)(1) pertaining to the Secretary of the Treasury's authority (or that of his delegate) to approve regulations related to certain customs revenue functions.
Air pollution control, Customs duties and inspection, Entry of merchandise, Imports, Labeling, Reporting and recordkeeping requirements, Restricted merchandise, Vehicles.
For the reasons set forth in the preamble, CBP proposes to amend 19 CFR part 12 as set forth below:
5 U.S.C. 301, 19 U.S.C. 66, 1202 (General Note 3(i), Harmonized Tariff Schedule of the United States), 1624.
The revisions read as follows:
(a)
(d)
(e)
(4) Highway motorcycles manufactured before January 1, 1978;
(f)
(h) * * *
(5)
(6)
(7)
(i)
(2)
(3)
(i) For heavy-duty motor vehicle engines, whether they are installed in a vehicle or separately imported as loose engines, submit EPA Declaration Form 3520-21, “Importation of Engines, Vehicles, and Equipment Subject to Federal Air Pollution Regulations;”
(ii) For all other motor vehicles, submit EPA Declaration Form 3520-1, “Importation of Motor Vehicles and Motor Vehicle Engines Subject to Federal Air Pollution Regulations.”
(4)
(5)
(6)
(j)
(k)
(m)
The revisions read as follows:
(a)
(b)
(2)
(3)
(4)
(5)
(c)
(2)
(3)
(i) Repairs or alterations (
(ii) Testing (
(iii) Display (
(iv) Export (
(v) Diplomatic or military (
(vi) Delegated assembly (
(vii) Partially complete engines, vehicles, or equipment (
(d)
Bureau of Indian Affairs, Interior.
Extension of comment and nomination periods.
On November 9, 2015, the Bureau of Indian Education (BIE) published a notice of intent requesting comments and nominations for Tribal representatives for the Accountability Negotiated Rulemaking Committee (Committee). The comment period for that notice of intent closed December 24, 2015. On April 14, 2016, the BIE reopened the comment and nomination period with a new deadline of May 31, 2016. The BIE is further extending the comment period for Tribes to nominate individuals for membership on the Committee. The BIE also solicits comments on the proposal to establish the Committee, including comments on additional interests not identified in this notice of intent and comments on the expansion of the scope of the Committee. The BIE is also correcting a drafting error in the April 14, 2016 Notice that omitted from Section III the central purpose of the Committee under the requirements of the Every Student Succeeds Act (ESSA), which requires the Secretary of the Interior, using a negotiated rulemaking process, to develop regulations for implementation no later than the 2017-2018 academic year. It also requires the Secretary to define the standards, assessments, and accountability system consistent with Section 1111 of the Elementary and Secondary Education Act (ESEA) for the schools funded by BIE on a national, regional, or tribal basis.
Submit nominations for Committee members or written
You may submit nominations for Committee members or written comments on this notice of intent to Ms. Jackie Cheek, Bureau of Indian Education, by any of the following methods:
• (Preferred method) Email to:
• Mail, hand-carry or use an overnight courier service to Ms. Jackie Cheek, Bureau of Indian Education, 1849 C Street NW., Mail Stop 3642, Washington, DC 20240.
Ms. Jackie Cheek, Bureau of Indian Education; telephone: (202) 208-6983.
On November 9, 2015, BIE published a notice of intent requesting nominations for a negotiated rulemaking committee to recommend revisions to the existing regulations for BIE's accountability system (80 FR 69161). In that notice of intent, the BIE solicited nominations from Tribes whose students attend BIE-funded schools operated either by the BIE or by the Tribe through a contract or grant, to nominate Tribal representatives to serve on the Committee and Tribal alternates to serve when the representative is unavailable.
Since that time, the Every Student Succeeds Act (ESSA), Public Law 114-95, became law requiring an update to the subject, scope, and issues that the Committee will address. On April 14, 2016, BIE then announced its intent to expand the scope of the committee and reopened the comment and nomination period, requesting comments and nominations by May 31, 2016. 81 FR 22039 (April 14, 2016).
The ESSA reauthorizes and amends the Elementary and Secondary Education Act of 1965 (ESEA). ESSA Section 8007(2) directs the Secretary of the Interior, in consultation with the Secretary of Education, if so requested, to use a negotiated rulemaking process to develop regulations for implementation no later than the 2017-2018 academic year. The regulations will define the standards, assessments, and accountability system consistent with Section 1111 of the ESEA, for BIE-funded schools on a national, regional, or Tribal basis. The regulations will be developed in a manner that considers the unique circumstances and needs of such schools and the students served by such schools.
ESSA Section 8007(2) also provides that if a Tribal governing body or school board of a BIE-funded school determines the requirements established by the Secretary of the Interior are inappropriate, they may waive, in part or in whole, such requirements. Where such requirements are waived, the Tribal governing body or school board shall, within 60 days, submit to the Secretary of the Interior a proposal for alternative standards, assessments, and an accountability system, if applicable, consistent with ESEA Section 1111. The proposal must take into account the unique circumstances and needs of the school or schools and the students served. The proposal will be approved by the Secretary of the Interior and the Secretary of Education, unless the Secretary of Education determines that the standards, assessments, and accountability system do not meet the requirements of ESEA Section 1111. Additionally, a Tribal governing body or school board of a BIE-funded school seeking a waiver may request, and the Secretary of the Interior and the Secretary of Education will provide, technical assistance.
Due to the statutory changes described above, BIE expanded the scope of the negotiated rulemaking committee to receive recommendations and revise our current regulations (25 CFR part 30). This document provides notice that BIE is extending the comment period for: (1) Nominations of individuals for membership on the Committee and (2) comments on the proposal to establish the Committee, including comments on additional interests not identified in this notice of intent and comments on the expansion of the scope of the Committee.
The BIE encourages Tribal self-determination in Native education, encouraging Tribes to develop alternative standards, assessments, and an accountability system and providing technical assistance.
The negotiated rulemaking committee would be charged, consistent with ESSA Section 8007, with developing regulations, no later than the 2017-2018 academic year, for implementation of the Secretary's responsibility to define the standards, assessments, and an accountability system consistent with ESEA Section 1111, for schools funded by the BIE on a national, regional, or tribal basis, as appropriate, taking into account the unique circumstances and needs of such schools and the students served by such schools. Additionally, the Committee will be asked to provide recommendations that encourage the exercise of the authority of Tribes to adopt their own standards, assessments, and an accountability system and also to provide recommendations on how BIE could best provide technical assistance under ESSA Section 8007(2).
Each nomination is expected to include a nomination for a representative and an alternate who can fulfill the obligations of membership should the representative be unable to attend. The Committee membership should also reflect the diversity of Tribal interests, and Tribes should nominate representatives and alternates who will:
• Have knowledge of school assessments and accountability systems;
• Have relevant experience as past or present superintendents, principals, teachers, or school board members, or possess direct experience with Adequate Yearly Progress (AYP);
• Be able to coordinate, to the extent possible, with other Tribes and schools who may not be represented on the Committee;
• Be able to represent the Tribe(s) with the authority to embody Tribal views, communicate with Tribal constituents, and have a clear means to reach agreement on behalf of the Tribe(s);
• Be able to negotiate effectively on behalf of the Tribe(s) represented;
• Be able to commit the time and effort required to attend and prepare for meetings; and
• Be able to collaborate among diverse parties in a consensus-seeking process.
The BIE will consider nominations for Tribal committee representatives only if they are nominated through the process identified in this notice of intent and in the
Based upon the proportionate share of students (see Section V of
Nominations must include the following information about each nominee:
(1) A letter from the Tribe supporting the nomination of the individual to serve as a Tribal representative for the Committee;
(2) A resume reflecting the nominee's qualifications and experience in Indian education; resume to include the nominee's name, Tribal affiliation, job title, major job duties, employer, business address, business telephone and fax numbers (and business email address, if applicable);
(3) The Tribal interest(s) to be represented by the nominee (see Section IV, Part F of
(4) A brief description of how the nominee will represent Tribal views, communicate with Tribal constituents, and have a clear means to reach agreement on behalf of the Tribe(s) they are representing.
(5) A statement on whether the nominee is only representing one Tribe's views or whether the expectation is that the nominee represents a specific group of Tribes.
To be considered, nominations must be received by the close of business on the date listed in the
If you already submitted a nomination prior to the December 24, 2015, deadline or May 31, 2016 deadline, your application will still be considered.
For the above reasons, I hereby certify that the Accountability Negotiated Rulemaking Committee is in the public interest.
Office of the Secretary, Department of Labor.
Notice of proposed rulemaking, request for comments.
This rule proposes revisions to the Department of Labor's regulations under the Freedom of Information Act (FOIA), found in our regulations. The regulations are being revised to update and streamline the language of several procedural provisions, and to incorporate changes brought about by amendments to the FOIA under the OPEN Government Act of 2007 and the FOIA Improvement Act of 2016.
Written comments must be postmarked and electronic comments must be submitted on or before October 17, 2016. Comments received by mail will be considered timely if they are postmarked on or before that date. The electronic Federal Docket Management System (
You may submit comments by any of the following methods:
•
•
•
•
• To ensure proper handling, please reference Docket No. DOL-2016-007 on your correspondence.
Ramona Branch Oliver, Director, Office of Information Services, 202-693-5391.
The proposed revisions to the Department's FOIA regulations in 29 CFR part 70 incorporate changes to the language and structure of the regulations. Revised provisions include § 70.1 (General provisions), § 70.2 (Definitions), § 70.3 (Policy), § 70.4 (Proactive disclosure of Department records), § 70.19 (Requirements for making a request), § 70.20 (Responsibility for responding to requests), § 70.21 (Responses to requests), § 70.25 (Time limits and order in which requests must be processed), § 70.38 (Definitions related to costs), and § 70.40 (Charges assessed for the production of records). Current sections have been renamed § 70.1 (from Purpose and scope to General provisions), § 70.4 (from Public reading rooms to Proactive disclosure of Departmental records), § 70.19 (from Requests for access to records to Requirements for making requests), § 70.21 (from Form and content of responses to Responses to requests), and § 70.26 (from Business information to Confidential commercial information). Also, in lieu of using the term “disclosure officer,” DOL is using the word “component” to refer to the decentralized agency FOIA components throughout the draft regulation.
As the Department of Labor was completing preparation of this Notice of Proposed Rulemaking to update its FOIA regulation, Congress passed on June 13, 2016 and the President signed on June 30, 2016, the FOIA Improvement Act of 2016. The Department has incorporated changes to this proposed rule to address provisions of the FOIA Improvement Act of 2016. Specifically, the following sections of this NPRM were revised to reflect statutory changes: Section 70.1(d) and (f); Sec. 70.3; Sec. 70.4; Sec. 70.19(d); Sec. 70.21(d) and (e); Sec. 70.25(c); and Sec. 70.40(e). Comments on these proposed provisions based on the text of the amended statute are welcomed. The Department will consider those comments, along with any other comments received, and if appropriate will revise the regulation to ensure the rule aligns with the amended statute.
Administrative practice and procedure; Freedom of Information Act; Privacy.
For the reasons stated in the preamble, the Department of Labor proposes to amend 29 CFR part 70, as follows:
5 U.S.C. 301, 29 U.S.C. 551
(a) This part is organized as follows: subpart A contains general information about Department of Labor policies and procedures; subpart B sets forth the procedures for obtaining access to records of the Department; subpart C contains the Department's regulations on fees; and subpart D sets forth the procedures for obtaining access to certain public records. Appendix A contains a list of all Department of Labor FOIA components from whom records may be obtained.
(b) This part contains the rules that the Department of Labor follows in processing requests for records under the Freedom of Information Act (FOIA), as amended, 5 U.S.C. 552. The rules in this part should be read together with the text of the FOIA, which provides additional information about access to records maintained by the Department. Additionally, the Department's “Guide to Submitting Requests under the FOIA” and related documents contain helpful information about the specific procedures particular to the Department with respect to making FOIA requests, and descriptions of the types of records maintained by different components of the Department. These references are available at
(c) Requests made by individuals for records about themselves under the Privacy Act of 1974, 5 U.S.C. 552a, are processed under 29 CFR part 71 as well as under this part. Information routinely provided to the public as part of a regular Department activity (for example, press releases issued by the Office of Public Affairs (OPA)) may be provided to the public without following this subpart.
(d) As set forth in Sec. 70.3, the Department operates its FOIA program with a presumption of openness and withholds records or information under the FOIA only when the Department reasonably foresees that disclosure would harm an interest protected by a FOIA exemption or when disclosure is prohibited by law.
(e) The Department has a decentralized system for processing requests, with each component handling requests for its own records. Each component has a FOIA Customer Service Center that can assist individuals in locating records and address questions regarding pending FOIA requests. A list of the Department's Customer Service Centers is available at
(f) The Secretary has designated a Chief FOIA Officer for the Department. Contact information for the Chief FOIA Officer is available on the Department's FOIA Web site,
(g) The Department has a designated FOIA Public Liaison who can assist individuals in locating records of a particular component and with resolving issues relating to the processing of a pending FOIA request. Information concerning the DOL FOIA Public Liaison is available at
As used in this part:
(a) The terms agency, person, party, rule, order, and adjudication have the meaning attributed to these terms by the definitions in 5 U.S.C. 551.
(b) Confidential commercial information means commercial or financial information received or obtained by the Department from a submitter, directly or indirectly, that arguably may be protected from disclosure under Exemption 4 of the FOIA.
(c) The Department means the Department of Labor.
(d) FOIA Component means an official component of the Department that has authority to disclose or withhold records under the FOIA and to whom requests to inspect or copy records in its custody should be addressed. Department of Labor components are listed in Appendix A to this part.
(e) Record means any information that would be an agency record subject to the requirements of this part when maintained by an agency in any format, including an electronic format, and any information described under this part that is maintained for an agency by an entity under Government contract, for the purposes of records management.
(f) Request means any written request for records made pursuant to 5 U.S.C. 552(a)(3) and which meets the requirements of this part.
(g) Requester means any person who makes a request.
(h) Search means to look for, manually or by automated means, Department records for the purpose of locating them in response to a pending request.
(i) The Secretary means the Secretary of Labor.
(j) Submitter means any person or entity from whom the Department receives or obtains confidential commercial or financial information, directly or indirectly. The term submitter includes, but is not limited to corporations, labor organizations, non-profit organizations, and local, state, and tribal and foreign governments.
(k) Unusual circumstances means, to the extent reasonably necessary for the proper processing of a FOIA request:
(1) The need to search for and collect the requested records from physically separate facilities;
(2) The need to search for, collect, and appropriately examine a voluminous amount of separate and distinct records that are demanded in a single request; or
(3) The need for consultation, which will be conducted with all practicable speed, with another agency having a substantial interest in the determination of the request.
All agency records, except those exempt from mandatory disclosure by one or more provisions of 5 U.S.C. 552(b), will be made promptly available to any person submitting a written request in accordance with the procedures of this part. The Department will withhold records under the FOIA only when the Department reasonably foresees that disclosure would harm an interest protected by a FOIA exemption or is prohibited by law. Whenever the Department determines that full disclosure of a requested record is not possible, the Department will consider whether partial disclosure is possible and will take reasonable steps to segregate and release nonexempt material. As set forth in Sec. 70.4, the Department proactively identifies and discloses records of interest to the public.
Records that are required by the FOIA, 5 U.S.C. 552 (a)(2), to be made available for public inspection in an electronic format may be accessed through the Department's Web site at
Nothing in 5 U.S.C. 552 or this part requires that any agency or component create a new record in order to respond to a request for records. A component must, however, make reasonable efforts to search for records that already exist in electronic form or format, except when such efforts would significantly interfere with the operation of the component's automated information systems. The component will determine what constitutes a reasonable effort on a case-by-case basis.
(a) No original record or file in the custody of the Department of Labor, or of any component or official thereof, will on any occasion be given to any agent, attorney, or other person not officially connected with the Department without the written consent of the Secretary, the Solicitor of Labor or the Inspector General.
(b) The individual authorizing the release of the original record or file must ensure that a copy of the document or file is retained in the component that had custody and/or control when an original document or file is released pursuant to this subpart.
(a) General information. The Department of Labor has a decentralized system for responding to requests submitted under the FOIA. Each agency component has the ability to receive FOIA requests in writing by mail, delivery service/courier or facsimile at its designated mailing address. Any FOIA request submitted electronically, by email, must be submitted to
(b) To make a request for records of the Department, whenever possible, a requester should write directly to the FOIA office of the component that maintains the records sought. Submitting the request directly to the FOIA office of the component that maintains the records sought will facilitate the quickest response. The requester must provide a mailing address to receive correspondence, and it may facilitate processing if telephone and email contact information are provided.
(1) The Department's components for the purposes of the FOIA are listed in Appendix A to this part. The function and mailing address of each Department of Labor component is available on the Department's FOIA Web site at
(2) Requesters who cannot determine the proper FOIA office component or who are requesting records from multiple components may also send requests to the Office of the Solicitor, Office of Information Services, 200 Constitution Avenue NW., Room N-2420, Washington, DC 20210 or by email to
(c) Description of records sought. Requesters must describe the record or records sought in sufficient detail to enable Department personnel to locate them with a reasonable amount of effort. To the extent possible, the request should provide enough identifying information to help the component identify the requested records, such as the subject of the record, the date or approximate date when the record was created, the record's title or name, case or file number, reference number, the person or office or the office location that created it, and any other pertinent identifying details. Prior to submitting the request, a requester may wish to consult the references provided in Sec. 70.1, the relevant FOIA Requester Service Center or the FOIA Public Liaison to discuss the records they are seeking and to receive assistance on how to describe the records.
(d) Deficient descriptions and revised requests. If the description is insufficient, so that a knowledgeable employee who is familiar with the subject area of the request cannot identify the record with a reasonable amount of effort, the component processing the request will notify the requester and describe what additional information is needed to process the request.
(1) Requesters who are attempting to modify or reformulate their requests may discuss their requests with the component's designated FOIA contact, the FOIA Public Liaison, or a representative of OIS, each of whom is available to assist the requester in reasonably describing the records sought. Every reasonable effort will be made to assist a requester in the identification and location of the records sought. If the requester fails to reasonably describe the records sought, the agency's response to the request may be delayed.
(2) Any amended request must be confirmed in writing and meet the requirements for a request under this part.
(3) While an agency component awaits a requester's modified FOIA request, the processing time limits described in Sec. 70.25(a)(1) will be tolled (that is, the processing time clock will be stopped) until clarification is received from the requester.
(a) In general. Except in the instances stated in paragraph (d) of this section, the component that first receives a request for a record and maintains that record is the component responsible for responding to the request. In determining which records are responsive to a request, a component ordinarily will include only records in its possession as of the date that the component begins the search; if any other date is used, the component will inform the requester of that date. A record that is excluded from the requirements of the FOIA pursuant to 5 U.S.C. 552(c), is not considered responsive to a request. When it is determined that records responsive to a request may be located in multiple components of the Department, the Office of Information Services may coordinate the Department's response. If the Office of Information Services deems a consolidated response appropriate, it will issue such a response on behalf of the Department.
(b) Authority to grant or deny requests. Pursuant to relevant exemptions under 5 U.S.C. 552(b), the head of a component, or designee, is authorized to grant or to deny any requests for records that are maintained by that component.
(c) Re-routing of misdirected requests. Where a component's FOIA office determines that a request was misdirected within the Department, the receiving component's FOIA office will work with OIS to facilitate the routing of the request to the FOIA office of the proper component(s).
(d) Consultations and referrals. When a component receives a request for a record, it will determine if another component of the Department, or of the Federal Government, is better able to determine whether the record can be disclosed or is exempt from disclosure under the FOIA. If the receiving component determines that it is not best able to process the record, then the receiving component will either:
(1) Respond to the request after consulting with the component or agency best able to determine whether to disclose the record and with any other component or agency that has a substantial interest in the record; or
(2) Refer the responsibility for responding to the request regarding that record to the component best able to determine whether to disclose it, or to another agency that originated the record (but only if that entity is subject to the FOIA). Ordinarily, the component or agency that originated the record will be presumed to be best able to determine whether to disclose it.
(e) Notice of referral. Whenever a component refers all or any part of the responsibility for responding to a request to another component or agency, the component will notify the requester of the referral and inform the requester of the name of each component or agency to which the request has been referred and provide contact information for that component or agency.
(f) Classified records. Any request for classified records which are in the custody of the Department of Labor will be referred to the classifying agency under paragraphs (d) and (e) of this section.
(a) In general. Components should, to the extent practicable, communicate with requesters using the method that is most likely to increase the speed and efficiency of the communication, including by electronic means, such as by email.
(b) Acknowledgements of requests. A component will acknowledge each new request and assign it an individualized tracking number. Components will include in the acknowledgment a brief description of the records sought to allow the requesters to more easily keep track of their requests.
(c) Granting a request. After a component makes a determination to grant a request in full or in part, the component will notify the requester in writing. The component will provide the record in the form or format requested if the record is readily reproducible in that form or format, provided the requester has agreed to pay and/or has paid any fees required by subpart C of this part. The component will determine on a case-by-case basis what constitutes a readily reproducible format. Each component should make reasonable efforts to maintain its records in commonly reproducible forms or formats.
(d) Adverse determinations of requests. A component making an adverse determination denying a request in any respect must notify the requester in writing. Adverse determinations, or denials of requests, include decisions that: the requested record is exempt, in whole or in part, from release pursuant to one or more exemptions under the FOIA, 5 U.S.C. 552; the request does not reasonably describe the records sought; the information requested is not a record subject to the FOIA; the requested record does not exist, cannot be located, or has been destroyed; or the requested record is not readily producible in the form or format sought by the requester. Adverse determinations also include denials involving fees or fee waiver matters or denials for requests for expedited processing.
(e) Content of the denial. The denial notice must be signed by the component agency head or a designee and will include:
(1) The name and title or position of the person responsible for the denial;
(2) A brief statement of the reason or reasons for the denial, including any FOIA exemption or exemptions applied or procedural reasons relied upon by the component in denying the request;
(3) An estimate of the volume of records or information withheld, in number of pages or in some other reasonable form of estimation. This estimate does not need to be provided if the volume is otherwise indicated through deletions on records disclosed in part, or if providing an estimate would harm an interest protected by the exemption under which the deletion was made;
(4) The right of the requester to seek assistance from the FOIA Public Liaison; and
(5) In the case of an adverse determination:
(i) a statement that the denial may be appealed as described under Sec. 70.22; and
(ii) a statement notifying the requester of the right to seek dispute resolution services from the Department's FOIA Public Liaison or the Office of Government Information Services (within the National Archives and Records Administration).
(f) Markings on released documents. Markings on released documents must be clearly visible to the requester. Records disclosed in part shall be marked to show the amount of information deleted and the exemption(s) under which the deletion was made unless doing so would harm an interest protected by an applicable exemption. The location of the information deleted shall also be indicated on the records, if technically feasible.
(a) A requester may appeal to the Solicitor of Labor when one or more of the following has occurred: A request for access to records has been denied in whole or in part; a requester disputes a determination that records cannot be located or have been destroyed; a requester disputes a determination by a component concerning the assessment or waiver of fees; a requester disputes the denial of a request for expedited processing or a component fails to respond to a request within the time limits set forth in the FOIA. The appeal must be filed within 90 days of the date of the action being appealed.
(b) The appeal must state in writing the grounds for appeal, and it may include any supporting statements or arguments, but such statements are not required. In order to facilitate processing of the appeal, the appeal must include the assigned request number (if applicable), appellant's mailing address and daytime telephone number, as well as copies of the initial request and the component's response. If mailed, the envelope and the letter of appeal should be clearly marked: “Freedom of Information Act Appeal.” Any amendment to the appeal must be in writing and received prior to a decision on the appeal.
(c) The appeal should be addressed to the Solicitor of Labor, Office of the Solicitor, FOIA Appeals Unit, Division of Management and Administrative Legal Services, U.S. Department of Labor, 200 Constitution Avenue NW., Room N-2420, Washington, DC 20210. Appeals also may be submitted by fax to 202-693-5538 or by email to
The Solicitor of Labor, or designee, will review the appellant's appeal and make a determination de novo whether the action of the component was proper and in accordance with the applicable law.
The disposition of an appeal will be issued by the Solicitor of Labor or designee in writing. A decision affirming, in whole or in part, the decision below will include a brief statement of the reason or reasons for the affirmance, including the FOIA exemption or exemptions relied upon, and its relation to each record withheld. Consistent with the statute, the appeal determination will also advise the requester of the availability of the mediation services of the Office of Government Information Services as a non-exclusive alternative to litigation, and the statutory right to judicial review of the denial by the United States District Court for the judicial district in which the requester resides or maintains his or her principal place of business, the judicial district in which the requested records are located, or the District of Columbia. If it is determined on appeal that a record should be disclosed, the record will be provided in accordance with the decision on appeal. If it is determined that records should be denied in whole or in part, the appeal determination will include an estimate of the volume of records or information withheld, in number of pages or in some other reasonable form of estimation. This estimate does not need to be provided if the volume is otherwise indicated through deletions on records disclosed in part, or if providing an estimate would harm an interest protected by an applicable exemption.
(a) Time limits. The FOIA establishes a 20 business day deadline for regular requests and appeals, and a 10 calendar day time limit for making determinations regarding expedited processing. Components of the Department of Labor will comply with the time limits required by the FOIA for responding to and processing requests and appeals, unless there are exceptional circumstances within the meaning of 5 U.S.C. 552(a)(6)(C). A component or the designated appeal authority will notify a requester whenever they are unable to respond to or process the request or appeal within the time limits established by the FOIA.
(b) Multitrack processing. All components must designate a specific track for requests that are granted expedited processing, in accordance with the standards set forth in paragraph (d) of this section. A component may also designate additional processing tracks that distinguish between simple and complex requests based on the estimated amount of work and/or time needed to process the request, including based on the number of pages involved and the need for consultations or referrals. Components shall advise the requesters of the track into which their request falls and, when appropriate, shall offer the requester an opportunity to limit the scope of their requests in order to qualify for faster processing within the specified limits of the component's faster track.
(c) Unusual circumstances.
(1) Where the statutory time limits for processing a request cannot be met because of “unusual circumstances,” as set forth in the FOIA at 5 U.S.C. 552(a)(6)(B)(i-iii), and the component determines to extend the time limits on that basis, the component shall, before the expiration of the 20 working day deadline to respond, notify the requester in writing of the unusual circumstances and of the date by which processing of the request can be expected to be completed. This extension should not ordinarily exceed ten business days. If the component intends to extend the
(i) Provide the requester with an opportunity either to modify the request so that it may be processed within the time limits or to arrange an alternative time period with the component for processing the request or a modified request;
(ii) Make available to the requester the contact information for the designated FOIA contact and the FOIA Public Liaison to assist the requester; and
(iii) Notify the requester of the right to seek dispute resolution services from the Office of Government Information Services (OGIS).
(d) Aggregating requests. Where a component reasonably believes that multiple requests submitted by a requester, or by a group of requesters acting in concert, constitute a single request that would otherwise involve unusual circumstances, and the requests involve clearly related matters, they may be aggregated. Components shall not aggregate multiple requests involving unrelated matters.
(e) Expedited processing.
(1) Requests and appeals will be taken out of order and given expedited treatment whenever it is determined that they involve:
(i) Circumstances in which the lack of expedited treatment could reasonably be expected to pose an imminent threat to the life or physical safety of an individual;
(ii) An urgency to inform the public about an actual or alleged federal government activity, if made by a person primarily engaged in disseminating information;
(iii) The loss of substantial due process rights; or
(iv) A matter of widespread and exceptional media interest in which there exists possible questions about the government's integrity which affect public confidence.
(2) A request for expedited processing may be made at the time of the initial request for records or at any later time. For a prompt determination, a request for expedited processing must be received by the proper component. Requests based on paragraphs (e)(1)(i), (ii), (iii), and (iv) of this section must be submitted to the component that maintains the records requested.
(3) A requester who seeks expedited processing must submit a statement, certified to be true and correct to the best of that person's knowledge and belief, explaining in detail the basis for requesting expedited processing. For example, a requester within the category in paragraph (e)(1)(ii) of this section, if not a full-time member of the news media, must establish that he or she is a person whose main professional activity or occupation is information dissemination, though it need not be his or her sole occupation. Such a requester also must establish a particular urgency to inform the public about the government activity involved in the request—one that goes beyond the public's general right to know about government activity. The existence of numerous articles published on a given subject can be helpful in establishing the requirement that there be an “urgency to inform” the public on a topic. As a matter of administrative discretion, a component may waive the formality of certification.
(4) Within ten calendar days of its receipt of a request for expedited processing, the proper component will decide whether to grant the request and will notify the requester of the decision. If a request for expedited treatment is granted, the request will be given priority and will be processed as soon as practicable. If a request for expedited processing is denied, any appeal of that decision will be acted on expeditiously.
(a) In general. Confidential commercial information will be disclosed under the FOIA only in accordance with this section and E.O. 12,600, “Predisclosure Notification Procedures for Confidential Commercial Information.”
(b) Designation of confidential commercial information. A submitter of confidential commercial information will use good-faith efforts to designate, by appropriate markings, either at the time of submission or at a reasonable time thereafter, any portions of its submission that it considers to be protected from disclosure under Exemption 4. These designations will expire ten years after the date of the submission unless the submitter requests, and provides justification for, a longer designation period.
(c) Notice to submitters. A component will provide a submitter with prompt written notice of a FOIA request that seeks its confidential commercial information whenever required under paragraph (d) of this section, except as provided in paragraph (g) of this section, in order to give the submitter an opportunity to object in writing to disclosure of any specified portion of that information under paragraph (e) of this section. The notice will either describe the confidential commercial information requested or include copies of the requested records or record portions containing the information. When notification to a voluminous number of submitters is required, notification may be made by posting or publishing notice reasonably likely to accomplish such notification.
(d) When notice is required. Notice will be given to a submitter whenever:
(1) The information requested under the FOIA has been designated in good faith by the submitter as information considered protected from disclosure under Exemption 4; or
(2) A component has reason to believe that the information requested under the FOIA may be protected from disclosure under Exemption 4, but has not yet determined whether the information is protected from disclosure under that exemption or any other applicable exemption.
(e) Opportunity to object to disclosure. A component will allow a submitter a reasonable time to respond to the notice described in paragraph (c) of this section taking into account the amount of material the submitter has to review and the deadlines imposed by the FOIA or agreed to with the requester. If a submitter has any objection to disclosure, it is required to submit a detailed written statement. The statement must show why the information is a trade secret or commercial or financial information that is privileged or confidential. In the event that a submitter fails to respond to the notice within the time specified, the submitter will be considered to have no objection to disclosure of the information. Information provided by a submitter under this paragraph may itself be subject to disclosure under the FOIA.
(f) Notice of intent to disclose. A component will consider a submitter's timely objections and specific grounds for non-disclosure in deciding whether to disclose confidential commercial information. Whenever a component decides to disclose confidential commercial information over the objection of a submitter, the component will give the submitter written notice, which will include:
(1) A statement of the reason(s) why each of the submitter's disclosure objections were not sustained;
(2) A description of the confidential commercial information to be disclosed; and
(3) A specified disclosure date, which will be a reasonable time subsequent to the notice.
(g) Exceptions to notice requirements. The notice requirements of paragraphs (c) and (f) of this section will not apply if:
(1) The component determines that the information should not be disclosed;
(2) The information lawfully has been published or has been officially made available to the public;
(3) Disclosure of the information is required by statute (other than the FOIA) or by a regulation issued in accordance with the requirements of Executive Order 12,600 (3 CFR 1988 Comp., p. 235); or
(4) The designation made by the submitter under paragraph (b) of this section appears obviously frivolous or such a designation would be unsupportable—except that, in such a case, the component will, within a reasonable time prior to a specified disclosure date, give the submitter written notice of any final decision to disclose the information.
(h) Notice of a FOIA lawsuit. Whenever a requester files a lawsuit seeking to compel the disclosure of confidential commercial information, the component will promptly notify the submitter.
(i) Corresponding notice to requesters. Whenever a component provides a submitter with notice and an opportunity to object to disclosure under paragraphs (d) and (e) of this section, the component will also notify the requester(s). Whenever a component notifies a submitter of its intent to disclose requested information under paragraph (f) of this section, the component will also notify the requester(s). Whenever a submitter files a lawsuit seeking to prevent the disclosure of confidential commercial information, the component will notify the requester(s).
(j) Notice requirements. The component will fulfill the notice requirements of this section by addressing the notice to the confidential commercial submitter or its legal successor at the address indicated on the records, or the last known address. If the notice is returned, the component will make a reasonable effort to locate the confidential commercial submitter or its legal successor. Where notification of a voluminous number of submitters is required, such notification may be accomplished by posting and publishing the notice in a place reasonably calculated to accomplish notification.
Each component will preserve all correspondence relating to the requests it receives under this part, and all records processed pursuant to such requests, until disposition or destruction of such correspondence and records is authorized by Title 44 of the United States Code or the National Archives and Records Administration's General Records Schedule 14. Records are not to be destroyed while they are the subject of a pending request, appeal, or lawsuit under the Act.
The following definitions apply to this subpart:
(a) Request, in this subpart, includes any request, as defined by Sec. 70.2(f), as well as any appeal filed in accordance with Sec. 70.22.
(b) Direct costs means those expenditures which a component actually incurs in searching for and duplicating (and in the case of commercial use requests, reviewing) records to respond to a FOIA request. Direct costs include, for example, the salary of the Federal employee performing work (the basic rate of pay for the Federal employee plus 16 percent of that rate to cover benefits) and the cost of operating duplication machinery. Not included in direct costs are overhead expenses such as costs of space, heating or lighting the facility in which the records are kept.
(c) Reproduction means the process of making a copy of a record necessary to respond to a request. Such copy can take the form of paper, microform, audio-visual materials or electronic records (such as a CD or other media).
(d) Search means the process of looking for and retrieving records or information that is responsive to a FOIA request. It includes page-by-page or line-by-line identification of information within records and also includes reasonable efforts to locate and retrieve information from records maintained in electronic form or format. FOIA components will ensure that searches are done in the most efficient and least expensive manner reasonably possible. A search does not include the review of material, as defined in paragraph (e) of this section, which is performed to determine whether material is exempt from disclosure.
(e) Review means the process of examining records, including audio-visual, electronic mail, etc., located in response to a request to determine whether any portion of the located record is exempt from disclosure, and accordingly may be withheld. It also includes the act of preparing materials for disclosure,
(f) Commercial use request means a request from or on behalf of a person who seeks information for a use or purpose that furthers his or her commercial, trade or profit interests, which can include furthering those interests through litigation. When considering fee issues, components will determine, whenever reasonably possible, the use to which a requester will put the requested records. When it appears that the requester will put the records to a commercial use, either because of the nature of the request itself or because a component has reasonable cause to doubt a requester's stated use, the component will provide the requester a reasonable opportunity to submit further clarification.
(g) Educational institution means an institution which:
(1) Is a preschool, public or private elementary or secondary school, an institution of undergraduate higher education, an institution of graduate higher education, an institution of professional education, or an institution of vocational education, or
(2) Operates a program or programs of scholarly research. To qualify under this definition, the program of scholarly research in connection with which the information is sought must be carried out under the auspices of the academic institution itself as opposed to the individual scholarly pursuits of persons affiliated with an institution. For example, a request from a professor for information that will assist in writing of a book, independent of his or her institutional responsibilities, would not qualify under this definition, whereas a request predicated upon research funding granted to the institution would meet its requirements. A request from a student enrolled in an individual course of study at an educational institution would not qualify as a request from the institution.
(h) Non-commercial scientific institution means an institution that is not operated on a commercial basis and that is operated solely for the purpose of conducting scientific research, the results of which are not intended to promote any particular product or industry.
(i) Representative of the news media means any person or entity that gathers information of potential interest to a segment of the public, uses its editorial skills to turn the raw materials into a distinct work, and distributes that work to an audience. Examples of news media
(1) Factors indicating status as a news media representative include press accreditation, guild membership, a history of continuing publication, business registration, and/or Federal Communication Commission licensing, among others.
(2) For purposes of this definition, news contemplates information that is about current events or that would be of current interest to the public.
(3) A freelance journalist will be treated as a representative of the news media if the person can demonstrate a solid basis for expecting publication of matters related to the requested information through a qualifying news media entity. A publication contract with a qualifying news media entity satisfies this requirement. An individual's past publication record with such organizations is also relevant in making this determination.
This subpart will not apply to fees charged under any statute, other than the FOIA, that specifically requires an agency to set and collect fees for particular types of records.
(a) General. Components shall charge for processing requests under the FOIA in accordance with the provisions of this section and with the OMB Guidelines. In order to resolve any fee issues that arise under this section, a component may contact a requester for additional information. Components will ensure that searches, review, and duplication are conducted in the most efficient and least expensive manner. A component ordinarily will collect all applicable fees before sending copies of records to the requester.
(b) There are three types of charges assessed in connection with the production of records in response to a request, specifically, charges for costs associated with:
(1) Searching for or locating responsive records (search costs),
(2) Reproducing such records (reproduction costs), and
(3) Reviewing records to determine whether any materials are exempt (review costs).
(c)(1) There are four types of requesters:
(i) Commercial use requesters,
(ii) Educational and non-commercial scientific institutions,
(iii) Representatives of the news media, and
(iv) All other requesters.
(2) Depending upon the type of requester, as set forth in paragraph (c)(1) of this section, the charges outlined in paragraph (d) of this section may be assessed.
(d) Types of charges that will be assessed for each type of request.
(1) Commercial use request. When a requester makes a commercial use request, search costs, reproduction costs and review costs will be assessed in their entirety.
(2) Educational or non-commercial scientific institution request. When an educational or non-commercial scientific institution makes a request, only reproduction costs will be assessed, excluding charges for the first 100 pages.
(3) Request by representative of news media. When a representative of the news media makes a request, only reproduction costs will be assessed, excluding charges for the first 100 pages.
(4) All other requesters. Requesters making a request which does not fall within paragraphs (d)(1), (2), or (3) of this section will be charged search costs and reproduction costs, except that the first 100 pages of reproduction and the first two hours of search time will be furnished without charge. Where computer searches are involved, the monetary equivalent of two hours of search time by a professional employee will be deducted from the total cost of computer processing time.
(e) Charges for each type of activity.
(1) Search costs.
(i) When a search for records is performed by a clerical employee, a rate of $5.00 per quarter hour will be applicable. When a search is performed by professional or supervisory personnel, a rate of $10.00 per quarter hour will be applicable. Components will charge for time spent searching even if they do not locate any responsive records or they withhold the records located as exempt from disclosure.
(ii) For computer searches of records, requesters will be charged the direct costs of conducting the search, except as provided in paragraph (e)(4) of this section.
(iii) If the search for requested records requires transportation of the searcher to the location of the records or transportation of the records to the searcher, all transportation costs in excess of $5.00 may be added to the search cost.
(2) Reproduction costs. The standard copying charge for records in black and white paper copy is $0.15 per page. This charge includes the operator's time to duplicate the record. When responsive information is provided in a format other than 8
(3) Review costs. Costs associated with the review of records, as defined in § 70.38(e), will be charged for work performed by a clerical employee at a rate of $5.00 per quarter hour when applicable. When professional or supervisory personnel perform work, a rate of $10.00 per quarter hour will be charged, when applicable. Except as noted in this paragraph, charges may only be assessed for review the first time the records are analyzed to determine the applicability of specific exemptions to the particular record or portion of the record. Thus a requester would not be charged for review at the administrative appeal level with regard to the applicability of an exemption already applied at the initial level. When, however, a record has been withheld pursuant to an exemption which is subsequently determined not to apply and is reviewed again at the appellate level to determine the potential applicability of other exemptions, the costs attendant to such additional review will be assessed.
(4) Limitations on charging fees. If a component fails to comply with the time limits in which to respond to a request it shall not assess certain fees except:
(i) If there are unusual circumstances (as that term is defined in Sec. 70.25(c)) and the component has provided timely written notice, the component is permitted ten additional days to respond to the request. After the expiration of the ten additional days, the component is no longer permitted to assess search fees or, in the instances of requests from requesters described in Sec. 70.38 (h) and (i), duplication fees.
(ii) If there are unusual circumstances (as that term is defined in Sec. 70.25(c)), and more than 5,000 pages of
(iii) If a court has determined that exceptional circumstances exist, as defined in the FOIA, 5 U.S.C. 552(a)(6)(C) the agency's failure to comply with any time limits of the FOIA are excused for the length of time provided by the court order.
(5) Mailing cost. Where requests for copies are sent by mail, no postage charge will be made for transmitting by regular mail a single copy of the requested record to the requester, or for mailing additional copies where the total postage cost does not exceed $5.00. However, where the volume of paper copy or method of transmittal requested is such that transmittal charges to the Department are in excess of $5.00, the transmittal costs will be added.
(f) Aggregating requests for purposes of assessing costs.
(1) Where a component reasonably believes that a requester or a group of requesters acting together is attempting to divide a request into a series of requests for the purpose of avoiding fees, the disclosure officer may aggregate those requests and charge accordingly.
(2) Components may presume that multiple requests of this type made within a 30-day period have been submitted in order to avoid fees. Where requests are separated by a longer period, disclosure officers will aggregate them only where a solid basis exists for determining that aggregation is warranted under all of the circumstances involved. Multiple requests involving unrelated matters will not be aggregated.
(g) Interest charges. Components will assess interest on an unpaid bill starting on the 31st day following the date of billing the requester. Interest charges will be assessed at the rate provided in 31 U.S.C. 3717 and will accrue from the date of the billing until payment is received by the component. Components will follow the provisions of the Debt Collection Act of 1982 (Pub. L. 97-365, 96 Stat. 1749), as amended, and its administrative procedures, including the use of consumer reporting agencies, collection agencies, and offset.
(h) Authentication of copies.
(1) Fees. The FOIA does not require certification or attestation under seal of copies of records provided in accordance with its provisions. Pursuant to provisions of the general user-charger statute, 31 U.S.C. 9701 and Subchapter II of title 29 U.S.C., the following charges will be made when, upon request, such services are rendered by the agency in its discretion:
(i) For certification of true copies, $10.00 each certification.
(ii) For attestation under the seal of the Department, $10.00 each attestation under seal.
(2) Authority and form for attestation under seal. Authority is hereby given to any officer or officers of the Department of Labor designated as authentication officer or officers of the Department to sign and issue attestations under the seal of the Department of Labor.
(i) Transcripts. Fees for transcripts of an agency proceeding, as defined in the Administrative Procedure Act, 5 U.S.C. 5521(12) will be assessed in accordance with the provisions of this subpart.
(j) Privacy Act requesters. A request from an individual or on behalf of an individual for a record maintained by that individual's name or other unique identifier which is contained within a component's system of records, will be treated under the fee provisions at 29 CFR 71.6.
(a) Requirements for waiver or reduction of fees.
(1) Records responsive to a request will be furnished without charge or at a charge reduced below that established under paragraph (e) of Sec. 70.40, where a Component determines, based on all available information, that the requester has demonstrated that:
(i) Disclosure of the requested information is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the government, and
(ii) Disclosure of the information is not primarily in the commercial interest of the requester.
(2) To determine whether the requirement of paragraph (a)(1)(i) of this section is met, components will consider the following factors:
(i) The subject of the request: Whether the subject of the requested records concerns “the operations or activities of the government.” The subject of the requested records must concern identifiable operations or activities of the federal government, with a connection that is direct and clear, not remote or attenuated.
(ii) The informative value of the information to be disclosed: Whether the disclosure is “likely to contribute” to an understanding of government operations or activities. The disclosable portions of the requested records must be meaningfully informative about government operations or activities in order to be “likely to contribute” to an increased public understanding of those operations or activities. The disclosure of information that already is in the public domain, in either a duplicative or a substantially identical form, would not be as likely to contribute to such understanding where nothing new would be added to the public's understanding.
(iii) The contribution to an understanding of the subject by the public likely to result from disclosure: Whether disclosure of the requested information will contribute to “public understanding.” The disclosure must contribute to the understanding of a reasonably broad audience of persons interested in the subject, as opposed to the individual understanding of the requester. A requester's expertise in the subject area and ability and intention to effectively convey information to the public will be considered. It will be presumed that a representative of the news media will satisfy this consideration.
(iv) The significance of the contribution to public understanding: Whether the disclosure is likely to contribute “significantly” to the public understanding of government operations or activities. The public's understanding of the subject in question must be enhanced by the disclosure to a significant extent.
(3) To determine whether the requirement of paragraph (a)(1)(ii) of this section is met, components will consider the following factors:
(i) The existence and magnitude of a commercial interest: Whether the requester has a commercial interest that would be furthered by the requested disclosure. The component will consider any commercial interest of the requester (with reference to the definition of “commercial use request” in Sec. 70.38(f)), or of any person on whose behalf the requester may be acting, that would be furthered by the requested disclosure. Requesters will be given an opportunity in the administrative process to provide explanatory information regarding this consideration.
(ii) The primary interest in disclosure: Whether any identified commercial interest of the requester is sufficiently large, in comparison with the public interest in disclosure, that disclosure is
(4) Where only some of the records to be released satisfy the requirements for a waiver of fees, a waiver will be granted only for those records.
(5) Requests for the waiver or reduction of fees should address the factors listed in paragraph (a) of this section, insofar as they apply to each request.
(b) Submission. Requests for a waiver or reduction of fees should be made when the request is first submitted to the component and should address the criteria referenced above. A requester may submit a fee waiver request at a later time so long as the underlying record request is pending or on administrative appeal. When a requester who has committed to pay fees subsequently asks for a waiver of those fees and that waiver is denied, the requester will be required to pay any costs incurred up to the date the fee waiver request was received.
(c) Appeal rights. Requesters dissatisfied with treatment of fee waiver or reduction requests may follow the procedures for appeal under Sections 70.22 and 70.23.
(a) The Department will not assess or collect fees where the fee to be assessed, after deducting any free pages and/or search time, is less than $25.00. When making a request, a requester may specify a willingness to pay up to a certain amount,
(b) No request will be processed if a component reasonably believes that the fees are likely to exceed the amount to which the requester has originally consented, absent supplemental written consent by the requester to proceed after being notified of this determination.
(c) When a component determines or estimates that the fees to be assessed in accordance with this section will exceed $25.00, the component shall notify the requester of the actual or estimated amount of the fees, including a breakdown of the fees for search, review or duplication, unless the requester has indicated a willingness to pay fees as high as those anticipated. If only a portion of the fee can be estimated readily, the component must advise the requester accordingly. Such notice may invite the requester to reformulate the request to satisfy his or her needs at a lower cost.
(d) Components must make available their FOIA contact to assist any requester in reformulating a request to meet the requester's needs at a lower cost.
(a) De minimis costs. As noted in Sec. 70.42(a), the Department has determined it will not assess or collect fees below $25.00. In these cases, the cost of collecting and processing a fee equals or exceeds the amount of the fee which would otherwise be assessed. The Department will assess fees where the costs to be assessed, after deduction of any free pages and/or search time, is $25.00 or higher.
(b) How payment will be made. Requesters will pay fees assessed by check or money order made payable to the Treasury of the United States, and sent to the component that is processing the request.
(c) Advance payments and billing.
(1) Prior to beginning to process a request, the component will make a preliminary assessment of the amount that can properly be charged to the requester for search and review time and copying costs. Where a component determines or estimates that a total fee to be charged under this section will be more than $250.00, the component will require the requester to make an advance payment of an amount up to the entire anticipated fee before beginning to process the request. The component may waive the advance payment where the component receives a satisfactory assurance of full payment from a requester who has a history of prompt payment of an amount similar to the one anticipated by the request.
(2) Where a requester has previously failed to pay a properly charged FOIA fee to any component of the Department of Labor within 30 days of the date of billing, a component will require the requester to pay the full amount due, plus any applicable interest as provided in Sec. 70.40(f) and to make an advance payment of the full amount of any anticipated fee, before the component begins to process a new request or appeal or continues to process a pending request or appeal from that requester.
(3) For a request other than those described in paragraphs (c)(1) and (2) of this section, a component will not require the requester to make an advance payment before beginning to process a request. Payment owed for work already completed on a request pursuant to consent of the requester is not an advance payment and a component may require the requester to make a payment for such work prior to releasing any records to the requester.
(d) Time limits to respond extended when advance payments are requested. When a component has requested an advance payment of fees in accordance with paragraph (c) of this section, the time limits prescribed in Sec. 70.25 will only begin to run after the component has received the advance payment.
Nothing in this subpart will be construed to entitle any person, as of right, to any service or to the disclosure of any records to which such person is not entitled under the FOIA.
(a) The following documents in the custody of the Office of Labor-Management Standards are public information available for inspection and/or purchase of copies in accordance with paragraphs (b) and (c) of this section.
(1) Data and information contained in any report or other document filed pursuant to sections 201, 202, 203, 211, 301 of the Labor-Management Reporting and Disclosure Act of 1959 (73 Stat. 524-28, 530, 79 Stat. 888, 73 Stat. 530, 29 U.S.C. 431-433, 441, 461).
(2) Data and information contained in any report or other document filed pursuant to the reporting requirements of 29 CFR part 458, which are the regulations implementing the standards of conduct provisions of the Civil Service Reform Act of 1978, 5 U.S.C. 7120, and the Foreign Service Act of 1980, 22 U.S.C. 4117. The reporting requirements are found in 29 CFR 458.3.
(3) Data and information contained in any report or other document filed pursuant to the Congressional Accountability Act of 1995, 2 U.S.C. 1351, 109 Stat. 19.
(b) The documents listed in paragraph (a) of this section are available from: U.S. Department of Labor, Office of Labor-Management Standards, Public Disclosure Room, N-5608, 200 Constitution Avenue NW., Washington, DC 20210. Reports filed pursuant to section 201 of the Labor-Management Reporting and Disclosure Act of 1959
(c) Pursuant to 29 U.S.C. 435(c) which provides that the Secretary will by regulation provide for the furnishing of copies of the documents listed in paragraph (a) of this section, upon payment of a charge based upon the cost of the service, these documents are available at a cost of $ .15 per page for record copies furnished. Authentication of copies is available in accordance with the fee schedule established in Sec. 70.40. In accordance with 5 U.S.C. 552(a)(4)(A)(vi), the provisions for fees, fee waivers and fee reductions in subpart C of this part do not supersede these charges for these documents.
(d) Upon request of the Governor of a State for copies of any reports or documents filed pursuant to sections 201, 202, 203, or 211 of the Labor-Management Reporting and Disclosure Act of 1959 (73 Stat. 524-528, 79 Stat. 888; 29 U.S.C. 431-433, 441), or for information contained therein, which have been filed by any person whose principal place of business or headquarters is in such State, the Office of Labor-Management Standards will:
(1) Make available without payment of a charge to the State agency designated by law or by such Governor, such requested copies of information and data, or
(2) Require the person who filed such reports and documents to furnish such copies or information and data directly to the State agency thus designated.
(a) The annual financial reports (Form 5500) and attachments/schedules as filed by employee benefit plans under the Employee Retirement Income Security Act (ERISA) are in the custody of the Employee Benefits Security Administration (EBSA) at the address indicated in paragraph (b) of this section, and the right to inspect and copy such reports, as authorized under ERISA, at the fees set forth in this part, may be exercised at such office.
(b) The mailing address for the documents described in this section
The following list identifies the individual agency components of the Department of Labor for the purposes of the FOIA. Each component is responsible for making records in its custody available for inspection and copying, in accordance with the provisions of the FOIA and this part. Unless otherwise specified, the mailing addresses for the following national office components are listed below. Updated contact information for national and regional offices can be found on the DOL Web site at
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve changes to the Kentucky State Implementation Plan (SIP) submitted by the Commonwealth of Kentucky through its Energy and Environment Cabinet (EEC) on May 3, 2016. This SIP revision seeks to remove Stage II vapor control requirements for new and upgraded gasoline dispensing facilities in the State and allow for the decommissioning of existing Stage II equipment in Boone, Campbell and Kenton Counties in Kentucky. EPA has preliminarily determined that Kentucky's May 3, 2016, SIP revision is approvable because it is consistent with the Clean Air Act (CAA or Act).
Written comments must be received on or before September 16, 2016.
Submit your comments, identified by Docket ID No. EPA-R04-OAR-2016-0312 at
Kelly Sheckler, Air Regulatory
Stage I vapor recovery is a type of emission control system that captures gasoline vapors that are released when gasoline is delivered to a storage tank. The vapors are returned to the tank truck as the storage tank is being filled with fuel, rather than released to the ambient air. Stage II and onboard refueling vapor recovery (ORVR) are two types of emission control systems that capture fuel vapors from vehicle gas tanks during refueling. Stage II systems are specifically installed at gasoline dispensing facilities and capture the refueling fuel vapors at the gasoline pump nozzle. The system carries the vapors back to the underground storage tank at the gasoline dispensing facility to prevent the vapors from escaping to the atmosphere. ORVR systems are carbon canisters installed directly on automobiles to capture the fuel vapors evacuated from the gasoline tank before they reach the nozzle. The fuel vapors captured in the carbon canisters are then combusted in the engine when the automobile is in operation.
Under section 182(b)(3) of the CAA, each state was required to submit a SIP revision to implement Stage II for all ozone nonattainment areas classified as moderate, serious, severe, or extreme, primarily for the control of volatile organic compounds (VOC)—a precursor to ozone formation.
CAA section 202(a)(6) also provides discretionary authority to the EPA Administrator to, by rule, revise or waive the section 182(b)(3) Stage II requirement for serious, severe, and extreme ozone nonattainment areas after the Administrator determines that ORVR is in widespread use throughout the motor vehicle fleet. On May 16, 2012, in a rulemaking entitled “Air Quality: Widespread Use for Onboard Refueling Vapor Recovery and Stage II Waiver,” EPA determined that ORVR technology is in widespread use throughout the motor vehicle fleet for purposes of controlling motor vehicle refueling emissions.
On November 6, 1991, EPA designated and classified Boone, Campbell and Kenton Counties in Kentucky (hereinafter referred to as the “Northern Kentucky Area” or “Area”) as part of the seven-county area in and around the Cincinnati-Hamilton, OH-KY, area as a moderate nonattainment area for the 1-hour ozone NAAQS.
On February 3, 1998, the Commonwealth of Kentucky submitted a SIP revision to address the Stage II
On December 13, 1999, Kentucky submitted to EPA a request to redesignate the Northern Kentucky Area to attainment for the 1-hour ozone standard and an associated maintenance plan. The maintenance plan, as required under section 175A of the CAA, showed that nitrogen oxides and VOC emissions in the Area would remain below the 1996 “attainment year” levels through the greater than ten-year period from 1996-2010. In making these projections, Kentucky factored in the emissions benefit of the Area's Stage II program, thereby maintaining this program as an active part of its 1-hour ozone SIP. Originally, the redesignation request and maintenance plan were approved by EPA, effective July 5, 2000. S
Subsequently, Boone, Campbell and Kenton Counties in Kentucky (or portions thereof) were designated nonattainment as a part of a larger tri-state nonattainment area which included Kentucky, Ohio and Indiana counties in and around the Cincinnati area for both the 1997 8-hour ozone and 2008 8-hour ozone NAAQS. On August 5, 2010, the Area (
On May 3, 2016, the Commonwealth of Kentucky submitted a SIP revision to EPA seeking modifications of the Stage II requirements in the Northern Kentucky Area. Specifically, it seeks the removal of the Stage II requirements in Kentucky regulation 401 KAR 59:174—
EPA's primary consideration for determining the approvability of the Commonwealth of Kentucky's request is whether this requested action complies with section 110(l) of the CAA.
In its May 3, 2016, SIP revision, Kentucky used EPA's guidance entitled “Guidance on Removing Stage II Gasoline Vapor Control Programs from State Implementation Plans and Assessing Comparable Measures” to conduct a series of calculations to determine the potential impact on air quality of removing the Stage II program.
Table 1 shows that the removal of Stage II vapor recovery systems in the Northern Kentucky Area starting in 2014 would have resulted and will result in a VOC emission decrease. If instead Stage II requirements are kept in place, VOC emissions will decrease by less, and it will less beneficial to air quality in Northern Kentucky to keep Stage II systems in operation.
The affected sources covered by Kentucky's Stage II vapor recovery requirements are sources of VOC. Other criteria pollutants (carbon monoxide, sulfur dioxide, nitrogen dioxide, particulate matter, and lead) are not emitted by gasoline dispensing facilities and will not be affected by the removal of Stage II controls.
The proposed revisions to 401 KAR 59:174 include that gasoline dispensing facilities located in Boone, Campbell and Kenton Counties shall decommission and remove the systems no later than December 31, 2018. Kentucky noted in its submission that the decommissioning procedures in the revised version of 401 KAR 59:174 follow Petroleum Equipment Institute (PEI) guidance, “Recommended Practices for Installation and Testing of Vapor Recovery Systems at Vehicle Refueling Sites,” PEI/RP300-09.
EPA is proposing to determine that Kentucky's technical analysis is consistent with EPA's guidance on removing Stage II requirements from a SIP, including as it relates to the decommissioning and phasing out of the Stage II requirements for the Northern Kentucky Area. EPA is also making the preliminary determination that Kentucky's SIP revision is consistent with the CAA and with EPA's regulations related to removal of Stage II requirements from the SIP and that these changes will not interfere with any applicable requirement concerning attainment or any other applicable requirement of the CAA, and therefore satisfy section 110(l).
In this rule, EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is proposing to incorporate by reference Kentucky Regulation 401 KAR 59:174—
EPA is proposing to approve the Commonwealth of Kentucky's May 3, 2016, SIP revision that changes Kentucky's Stage II rule, 401 KAR 59:174, to allow for the removal of the Stage II requirement and the orderly decommissioning of Stage II equipment. EPA is proposing this approval because the Agency has made the preliminary determination that the Commonwealth of Kentucky's May 3, 2016, SIP revision related to the Commonwealth's Stage II rule is consistent with the CAA and with EPA's regulations and guidance.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations.
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
Environmental protection, Air pollution control, Incorporation by reference, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
42 U.S.C. 7401
National Aeronautics and Space Administration.
Proposed rule.
National Aeronautics and Space Administration (NASA) is proposing to amend the NASA FAR Supplement (NFS) to remove NFS clause 1852.243-70, Engineering Change Proposals (ECPs) basic clause with its Alternate I & II and associated information collection from the NFS.
Comments on the proposed rule should be submitted in writing to the address shown below on or before October 17, 2016 to be considered in formulation of the final rule.
Submit comments identified by NFS Case 2016-N030, using any of the following methods:
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Andrew O'Rourke, NASA, Office of Procurement, Contract and Grant Policy Division, Suite 5L32, 300 E. Street SW., Washington, DC 20456-0001. Telephone (202) 358-4560; facsimile (202) 358-3082; email:
NASA FAR Supplement clause 1852.243-70, Engineering Change Proposals, requires NASA contractors and vendors to submit contract change proposal information. The Office of Management and Budget (OMB) has approved the collection of this information via OMB Control Number 2700-054 that expires on September 30, 2017. In processing the request for renewal of this information collection under OMB Control Number 2700-054 and as part of NASA's continuing retrospective review of existing regulations to reduce unnecessary, outdated and/or burdensome requirements, NASA Office of Procurement (OP) surveyed its procurement offices to ascertain whether or not NFS clause 1852.243-70, Engineering Change Proposals, was necessary. The results of the review indicated that NFS clause 1852.243-70 was no longer utilized in procurements. Instead, the FAR Changes clauses (FAR 52.243-1 through 52.243-5) were being utilized to process engineering change proposals in lieu of this NFS clause. Thus, NASA is proposing to delete NFS clause 1852.243-70, Engineering Change Proposals, with its Alternate I & II and the corresponding information collection under OMB Control Number 2700-054.
NASA is proposing the following revisions to eliminate unnecessary NFS requirements:
• Delete NFS segment 1843 and OMB Control Number 2700-054 from 1801.106-1.
• Remove the prescription at NFS 1843.205-70(a).
• Delete NFS clause 1852.243-70, Engineering Change Proposals.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This proposed rule is not a major rule under 5 U.S.C. 804.
NASA does not expect this proposed rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
In preparing the request for renewal of this information collection under OMB Control Number 2700-054 and as part of NASA's continuing retrospective review of existing regulations to reduce unnecessary, outdated and/or burdensome requirements, NASA Office of Procurement its procurement offices to ascertain whether or not NFS clause 1852.243-70, Engineering Change Proposals, was necessary. The results of the review indicated that NFS clause 1852.243-70 was no longer utilized in procurements. Instead, the FAR changes clauses were being utilized to process engineering change proposals in lieu of this NFS clause. Thus, NASA is proposing to delete NFS clause 1852.243-70, Engineering Change Proposals, with its Alternate I & II and the corresponding information collection under OMB Control Number 2700-054. This proposed rule does not include any new reporting, recordkeeping, or other compliance requirements for small businesses. The proposed rule does not duplicate, overlap, or conflict with any other Federal rules. No alternative approaches were considered.
NASA invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.
NASA will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (NFS case 2016-N030) in correspondence.
The rule contains information collection requirements that require the approval of the OMB under the Paperwork Reduction Act (44 U.S.C chapter 35); however, the proposed changes to the NFS would remove the information collection requirements previously approved under OMB Control Number 2700-0054, entitled NFS 1843 Contract Modifications for Engineering Change Proposals (ECP).
Government procurement.
Accordingly, 48 CFR parts 1801, 1843, and 1852 are proposed to be amended as follows:
51 U.S.C. 20113(a) and 48 CFR chapter 1.
The following OMB control numbers apply:
The contracting officer may insert a clause substantially as stated at 1852.243-72, Equitable Adjustments, in solicitations and contracts for—
(a) Dismantling, demolishing, or removing improvements; or
(b) Construction, when the contract amount is expected to exceed the simplified acquisition threshold and a fixed-price contract is contemplated.
Forest Service, USDA.
Notice of the opportunity to object to the Revised Land Management Plan for the Francis Marion National Forest prior to approval
The Francis Marion National Forest, located in South Carolina, has prepared an environmental impact statement, a revised land management plan and a draft record of decision. This notice is to inform the public that a 60-day period is being initiated where individuals or entities with specific concerns on the Francis Marion's Revised Land Management Plan and its associated Final Environmental Impact Statement may file an objection for a Forest Service review prior to the approval of the Revised Land Management Plan.
The Francis Marion's Revised Land Management Plan, Final Enviromental Impact Statement, Draft Record of Decision, and other supporting information, will be available for review at
A legal notice of the initiation of the 60-day objection period is also being published in the Francis Marion and Sumter National Forests newspaper of record, which is
Copies of the Revised Land Mangement Plan for the Francis Marion National Forest, Final Environment Impact Statement, and Draft Record of Decision can be obtained online at:
• Supervisor's Office, 4931 Broad River Road, Columbia, SC 29212 (Telephone: 803-561-4000)
• Francis Marion District Office, 2967 Steed Creek Road, Huger, SC 29450 (Telephone: 843-336-3248)
Objections must be submitted to the Reviewing Officer Tony Tooke, Regional Forester, at USDA-Forest Service, ATTN: Objection Reviewing Officer, 1720 Peachtree Street, Atlanta, GA 30309 (Telephone: 404-347-4177; Fax: 404-347-4821). Or objections may be submitted electronically at
Note that the office hours for submitting a hand-delivered objection are 8:00 a.m. to 4:30 p.m. Monday through Friday, excluding Federal holidays. Electronic objections must be submitted in a commonly used format such as an email message, plain text (.txt), rich text format (.rtf) or Microsoft Word® (.doc or .docx).
Mary Morrison, Forest Planner, Francis Marion National Forest at 803-561-4000. Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m. (Eastern time), Monday through Friday.
The Forest Service, Southern Region, Francis Marion National Forest, has prepared a Revised Land Mangement Plan, Final Environmental Impact Statement, and a Draft Record of Decision. This notice is to inform the public that a 60-day period is being initiated where individuals or entities with specific concerns on the Francis Marion's Revised Land Management Plan and its associated Final Environmental Impact Statement may file an objection for a Forest Service review prior to the approval of the Revised Land Management Plan. The publication date of the legal notice in the Francis Marion and Sumter National Forests newspaper of record,
The objection process under 36 CFR 219 subpart B, provides an opportunity for members of the public who have participated in the planning process for the Francis Marion National Forest to have any unresolved concerns reviewed by the Forest Service prior to a final decision by the Responsible Official. Only those who provided substantive formal comments during opportunities for public comment during the planning process are eligible to file an objection. Regulations at 36 CFR 219.62 define substantive formal comments as:
“Written comments submitted to, or oral comments recorded by, the responsible official or his designee during an opportunity for public participation provided during the planning process, and attributed to the individual or entity providing them. Comments are considered substantive when they are within the scope of the proposal, are specific to the proposal, have a direct relationship to the proposal, and include supporting reasons for the responsible official to consider.”
The Forest Service will accept mailed, emailed, faxed, and hand-delivered objections concerning the Revised Land Management Plan and associated Final Environmental Impact Statement for 60 calendar days following the date of the publication of the legal notice of this objection period in newspaper of record,
Objections must be submitted to the Reviewing Officer, who will be Tony Tooke, Regional Forester for the Southern Region, at the address shown in the
An objection must include the following (36 CFR 219.54(c)):
(1) The objector's name and address along with a telephone number or email address if available—in cases where no
(2) Signature or other verification of authorship upon request (a scanned signature for electronic mail may be filed with the objection);
(3) Identification of the lead objector, when multiple names are listed on an objection. The Forest Service will communicate to all parties to an objection through the lead objector. Verification of the identity of the lead objector must also be provided if requested;
(4) The name of the plan revision being objected to, and the name and title of the Responsible Official;
(5) A statement of the issues and/or parts of the plan revision to which the objection applies;
(6) A concise statement explaining the objection and suggesting how the proposed plan decision may be improved. If the objector believes that the plan revision is inconsistent with law, regulation, or policy, an explanation should be included;
(7) A statement that demonstrates the link between the objector's prior substantive formal comments and the content of the objection, unless the objection concerns an issue that arose after the opportunities for formal comment; and
(8) All documents referenced in the objection (a bibliography is not sufficient), except that the following need not be provided:
a. All or any part of a Federal law or regulation,
b. Forest Service Directive System documents and land management plans or other published Forest Service documents,
c. Documents referenced by the Forest Service in the planning documentation related to the proposal subject to objection, and
d. Formal comments previously provided to the Forest Service by the objector during the plan revision comment period.
The responsible official for the revision of the land management plan for the Francis Marion National Forest is Rick Lint, Forest Supervisor, Francis Marion and Sumter National Forests, 4931 Broad River Road, Columbia, SC 29212.
Office of Administration, Office of Human Resources Management, Department of Commerce.
Notice.
This notice announces modifications to the provisions of the Commerce Alternative Personnel System, formerly the Department of Commerce Personnel Management Demonstration Project, published in the
As published on January 2, 2015 (80 FR 25), the Commerce Alternative Personnel System implemented direct-hire authority, under section 3304(a)(3) of Title 5 of the United States Code, for recruitment of certain scientific and engineering positions in the ZP career path at the Pay Band IV and above. Direct-hire authority was authorized for positions located in the National Telecommunications and Information Administration (NTIA), employed under the First Responder Network Authority (FirstNet). The System was modified again, as published on June 22, 2016 (81 FR 40653), to increase the number of positions FirstNet could fill under direct-hire authority and to include certain occupational series in the ZP career path at the Pay Band III level and above.
This notice serves to make changes to the System to expand the use of direct-hire authority to the NTIA, Institute for Telecommunication Sciences (ITS), and authorizes ITS to fill certain ZP positions, on a limited basis, at the Pay Band III level and above. This notice also serves to announce the addition of the 1520—Mathematics occupational series to the Commerce Alternative Personnel System.
The amended Commerce Alternative Personnel System is effective August 17, 2016.
Department of Commerce—Sandra Thompson, U.S. Department of Commerce, 14th and Constitution Avenue NW., Room 51020, Washington, DC 20230, (202) 482-0056 or Valerie Smith at (202) 482-0272.
The Office of Personnel Management (OPM) approved the Department of Commerce (DoC) demonstration project for an alternative personnel management system and published the approval of the final plan in the
CAPS provides for modifications to be made as experience is gained, results are analyzed, and conclusions are reached on how the system is working. This notice announces that the DoC implements ITS' use of direct-hire authority under 5 U.S.C. 3304(a)(3) to fill specific scientific and engineering positions announced through this notice in the ZP career path and adds the occupational series: 1520—Mathematics to the ZP career path. The DoC will follow the CAPS plan, as published in the
CAPS is designed to (1) improve hiring and allow DoC to compete more effectively for high-quality candidates through direct hiring, selective use of higher entry salaries, and selective use of recruitment incentives; (2) motivate and retain staff through higher pay potential, pay-for-performance, more responsive personnel systems, and selective use of retention incentives; (3) strengthen the manager's role in personnel management through delegation of personnel authorities; and (4) increase the efficiency of personnel systems through the installation of a simpler and more flexible classification system based on pay banding through reduction of guidelines, steps, and paperwork in classification, hiring, and other personnel systems, and through automation.
The current participating organizations include 7 offices of the Chief Financial Officer/Assistant Secretary for Administration in the Office of the Secretary; the Bureau of Economic Analysis; the Institute for Telecommunication Sciences—National Telecommunications and Information Administration; the First Responder Network Authority—National Telecommunications and Information Administration; and 12 units of the National Oceanic and Atmospheric Administration: Office of Oceanic and Atmospheric Research, National Marine Fisheries Service, the National Environmental Satellite, Data, and Information Service, National Weather Service—Space Environment Center, National Ocean Service, Program Planning and Integration Office, Office of the Under Secretary, Marine and Aviation Operations, Office of the Chief Administrative Officer, Office of the Chief Financial Officer, the Workforce Management Office, and the Office of the Chief Information Officer.
This amendment modifies the June 22, 2016,
CAPS is designed to provide managers at the lowest organizational level the authority, control, and flexibility to recruit, retain, develop, recognize, and motivate its workforce, while ensuring adequate accountability and oversight.
ITS is responsible for providing core telecommunications research and engineering services to promote enhanced domestic competition and new technology deployment; advancing telecommunications and information services; improving foreign trade opportunities for U.S. telecommunication firms and more efficient use of the radio frequency spectrum. ITS also serves as a principal Federal resource for investigating the telecommunications challenges of other Federal agencies, state and local governments, private corporations and associations, and international organizations. In particular, this includes assisting Federal public safety agencies, the Federal Communications Commission, and agencies that use Federal spectrum. As specified in the June 28, 2010, Presidential Memorandum, “Unleashing the Wireless Broadband Revolution” NTIA is responsible for exploring innovative spectrum-sharing technologies. As the research and engineering laboratory for NTIA, ITS supports NTIA by performing research that enables the U.S. Government, national and international standards organizations, and many aspects of private industry to manage the radio spectrum and ensure that innovative, new technologies are recognized and effective. To continue to advance strategic initiatives to make additional spectrum available for commercial wireless use and to meet the increasing radio spectrum needs of both Federal and commercial users in the U.S. as efficiently and effectively as possible, ITS must quickly hire qualified individuals, for specialized roles, to advance communication technologies.
Section 3304(a)(3) of Title 5 United States Code provides agencies with the authority to appoint candidates directly to jobs for which the OPM determines that there is a severe shortage of candidates or a critical hiring need. OPM's direct-hire authority enables agencies to hire, after public notice is given, any qualified applicant without regard to 5 U.S.C. 3309-3318, 5 CFR part 211, or 5 CFR part 337, subpart A.
This notice implements ITS' use of direct-hire authority to fill up to 20 positions in the ZP career path, at Pay Band III or higher, in the following occupational series: 0854—Computer Engineering; 0855—Electronics Engineering; 1310—Physics; 1550—Computer Science; or 1520—Mathematics. The use of direct-hire authority to fill these positions will not exceed 20 positions in the ZP career path at any one time. ITS will track the number of hires made under direct-hire authority, ensuring numbers specified for the occupational series are not exceeded.
In 1997, with the approval of the DoC's Demonstration Project (62 FR 67434, December 24, 1997), OPM concurred that some occupations in the ZP career path at the Pay Band III and above constitute a shortage category, and some occupations for which there is a special rate under the General Schedule pay system constitute a shortage category. Past recruitment efforts have demonstrated a critical shortage of candidates possessing specialized technical expertise in spectrum measurements, spectrum monitoring, propagation modeling, 4G Long Term Evolution (LTE) technologies, mobile systems development, computer security, systems engineering, scientific software development, as well as expertise in public safety organizational operations and infrastructure capabilities. ITS will use direct-hire authority to recruit Computer Engineers, Electronics Engineers, Computer Scientists, Physicists and Mathematicians in the ZP career path, Pay Band III or higher, with efforts focused on recruiting individuals possessing the above listed specialized technical areas of expertise. Recruitment of individuals possessing this expertise is critical in order to measure, analyze, monitor, and evaluate cutting edge technologies and methods that will make spectrum sharing possible.
DoC's CAPS allows for modifications of procedures if no new waiver from law or regulation is added. Given that this expansion and modification is in accordance with existing law and regulation and CAPS is a permanent alternative personnel system, the DoC is authorized to make the changes described in this notice.
The CAPS at DoC, originally published in the
1. The following series is added to Table 2:
2. Section III Personnel System Changes, (B) Staffing: Replace the paragraph in subsection titled: “Direct-Hire Authority: Critical Shortage Occupations” to state:
DoC FirstNet and ITS use direct-hire procedures for categories of occupations that require skills that are in short supply. The following occupations and series constitute a shortage category at the Pay Band III and above in the ZP Career Path: Emergency Management Specialists (Public Safety) (0089), Electrical Engineers (0850), Computer Engineers (0854), Electronics Engineers, (0855), Physicists (1310), Computer Scientists (1550), and Mathematicians (1520). FirstNet is authorized to fill positions in the following occupational series using direct-hire procedures: 0089, 0850, 0854, 0855, and 1550 in all duty locations. ITS is authorized to fill positions in the following occupational series: 0854, 0855, 1310, 1550, and 1520 in all duty locations. Positions in these categories may be filled by FirstNet and ITS through direct-hire procedures in accordance with 5 U.S.C. 3304(a)(3). DoC FirstNet and ITS advertise the availability of job opportunities in direct-hire occupations by posting on the OPM USAJOBS Web site. DoC FirstNet and ITS will follow internal direct-hire procedures for accepting applications.
On May 25, 2016, the Executive Secretary of the Foreign-Trade Zones (FTZ) Board docketed an application submitted by the Greater Baton Rouge Port Commission, grantee of FTZ 154, requesting subzone status subject to the existing activation limit of FTZ 154, on behalf of Westlake Chemical Corporation in Geismar, Louisiana.
The application was processed in accordance with the FTZ Act and Regulations, including notice in the
Pursuant to the authority delegated to the FTZ Board's Executive Secretary (15 CFR Sec. 400.36(f)), the application to establish Subzone 154C is approved, subject to the FTZ Act and the Board's regulations, including Section 400.13, and further subject to FTZ 154's 2,000-acre activation limit.
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to OIRA
Bureau of Consumer Financial Protection.
Notice of public meeting.
This notice sets forth the announcement of a public meeting of the Credit Union Advisory Council (CUAC or Council) of the Consumer Financial Protection Bureau (CFPB or Bureau). The notice also describes the functions of the Council. Notice of the meeting is permitted by section 9 of the CUAC Charter and is intended to notify the public of this meeting. Specifically, section 9(d) of the CUAC Charter states:
(1) Each meeting of the Council shall be open to public observation, to the extent that a facility is available to accommodate the public, unless the Bureau, in accordance with paragraph (4) of this section, determines that the meeting shall be closed. The Bureau also will make reasonable efforts to make the meetings available to the public through live recording. (2) Notice of the time, place and purpose of each meeting, as well as a summary of the proposed agenda, shall be published in the
The meeting date is Thursday, September 1, 2016, 3:30 p.m. to 5:00 p.m. eastern daylight time.
The meeting location is the Consumer Financial Protection Bureau, 1275 First Street NE., Washington, DC 20002.
Crystal Dully, Outreach and Engagement Associate, 202-435-9588,
Section 2 of the CUAC Charter provides: “Pursuant to the executive and administrative powers conferred on the Consumer Financial Protection Bureau by section 1012 of the Dodd-
Section 3 of the CUAC Charter states: “a) The CFPB supervises depository institutions and credit unions with total assets of more than $10 billion and their respective affiliates, but other than the limited authority conferred by section 1026 of the Dodd-Frank Act, the CFPB does not have supervisory authority regarding credit unions and depository institutions with total assets of $10 billion or less. As a result, the CFPB does not have regular contact with these institutions, and it would therefore be beneficial to create a mechanism to ensure that their unique perspectives are shared with the Bureau. Small Business Regulatory Enforcement Fairness Act (SBREFA) panels provide one avenue to gather this input, but participants from credit unions must possess no more than $175 million in assets, which precludes the participation of many. b) The Advisory Council shall fill this gap by providing an interactive dialogue and exchange of ideas and experiences between credit union employees and Bureau staff. c) The Advisory Council shall advise generally on the Bureau's regulation of consumer financial products or services and other topics assigned to it by the Director. To carry out the Advisory Council's purpose, the scope of its activities shall include providing information, analysis, and recommendations to the Bureau. The output of Advisory Council meetings should serve to better inform the CFPB's policy development, rulemaking, and engagement functions.”
The Credit Union Advisory Council will discuss youth financial capability and debt collection. Persons who need a reasonable accommodation to participate should contact
Individuals who wish to attend the Credit Union Advisory Council meeting must RSVP to
The Council's agenda will be made available to the public on Wednesday, August 17, 2016, via
A recording and transcript of this meeting will be available after the meeting on the CFPB's Web site
Defense Logistics Agency (DLA), Department of Defense.
Notice of Availability (NOA) of an Environmental Assessment (EA) Addressing Defense Logistics Agency Disposition Services Relocation and Expansion at Defense Supply Center, Richmond, Virginia.
Defense Logistics Agency (DLA) announces the availability of an environmental assessment (EA) documenting the potential environmental effects associated with the Proposed Action to relocate and expand DLA Disposition Services at Richmond, which is at Defense Supply Center, Richmond, Virginia. The EA has been prepared as required under the National Environmental Policy Act (NEPA) (1969). In addition, the EA complies with DLA Regulation 1000.22. DLA has determined that the Proposed Action would not have a significant impact on the human environment within the context of NEPA. Therefore, the preparation of an environmental impact statement is not required.
The public comment period will end on September 16, 2016. Comments received by the end of the 30-day period will be considered when preparing the final version of the document. The Draft EA is available electronically at the Federal eRulemaking Portal at
You may submit comments to one of the following:
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Ira Silverberg at 703-767-0705 during normal business hours Monday through Friday, from 8:00 a.m. to 4:30 p.m. (EDT) or by email:
Department of Defense.
Notice.
The Department of Defense is publishing this notice to announce a Federal Advisory Committee meeting of the Department of Defense Military Family Readiness Council. This meeting will be open to the public.
Wednesday, September 14, 2016, from 1:00 p.m. to 3:00 p.m.
Pentagon Conference Center Room B6 (escorts will be provided from the Pentagon Metro entrance).
Ms. Melody McDonald or Ms. Betsy Graham, Office of the Deputy Assistant Secretary of Defense (Military Community & Family Policy), Office of Family Readiness Policy, 4800 Mark Center Drive Alexandria, VA 22350-2300, Room 3G15. Telephones (571) 372-0880; (571) 372-0881 and/or email: OSD Pentagon OUSD P-R Mailbox Family Readiness Council,
This meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C. Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150. The purpose of the Council is to review and make recommendations to the Secretary of Defense regarding policy and plans supporting military family readiness; monitor requirements for the support of military family readiness by the Department of Defense; and evaluate and assess the effectiveness of the military family readiness programs and activities of the Department of Defense.
Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, this meeting is open to the public, subject to the availability of space. Members of the public who are entering the Pentagon should arrive at the visitor center next to the Metro entrance 30 minutes before the scheduled meeting time to allow time to pass through the security check points. Members of the public need to email the Council at
The purpose of this meeting is to develop Fiscal Year 2016 recommendations for the Secretary of Defense regarding topics discussed at the June 16, 2016 meeting of the Council, including military family health and family financial readiness; and to determine Council focus items for Fiscal Year 2017.
The Office of the Under Secretary of Defense for Personnel and Readiness, Defense Language and National Security Education Office (DLNSEO), DoD.
Meeting notice.
The Department of Defense is publishing this notice to announce that the following Federal advisory committee meeting of the National Security Education Board (NSEB) will take place. This meeting is open to the public.
Thursday, September 8, 2016, from 10:30 a.m. to 4:45 p.m.
Capital Hilton Hotel, 1001 16th Street NW., Washington, DC 20036.
Alison Patz, telephone (571) 256-0771,
This meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150.
Agenda:
Pursuant to 102-3.140 and sections 10(a)(3) of the Federal Advisory Committee Act of 1972, the public or interested organizations may submit written statements to the Department of Defense National Security Education Board about its mission and functions. Written statements may be submitted at any time or in response to the stated agenda of the planned meeting.
All written statements shall be submitted to the Designated Federal Official for the National Security Education Board, and this individual will ensure that the written statements are provided to the membership for their consideration. Contact information for the Designated Federal Official can be obtained from the GSA's FACA Database—
Statements being submitted in response to the agenda mentioned in this notice must be received by the Designated Federal Official at the address listed in
The Designated Federal Official will review all timely submissions with the National Security Education Board and ensure they are provided to all members of the National Security Education Board before the meeting that is the subject of this notice.
Defense Acquisition University, DoD.
Meeting notice.
The Department of Defense is publishing this notice to announce a Federal Advisory Committee meeting of the Defense Acquisition University Board of Visitors. This meeting will be open to the public.
Wednesday, September 14, 2016, from 9:00 a.m. to 4:00 p.m.
DAU Headquarters, Bldg. 202, 9820 Belvoir Road, Ft. Belvoir, VA 22060.
Caren Hergenroeder, Protocol Director, DAU. Phone: 703-805-5134. Fax: 703-805-5940. Email:
This meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150.
All written statements shall be submitted to the Designated Federal Officer for the Defense Acquisition University Board of Visitors, and this individual will ensure that the written statements are provided to the membership for their consideration.
Statements being submitted in response to the agenda mentioned in this notice must be received by the Designated Federal Officer at least five calendar days prior to the meeting which is the subject of this notice. Written statements received after this date may not be provided to or considered by the Defense Acquisition University Board of Visitors until its next meeting. Committee's Designated Federal Officer or Point of Contact: Ms. Christen Goulding, 703-805-5412,
Department of Defense.
Notice.
The Department of Defense is publishing this notice to announce an open meeting of the Strategic Environmental Research and Development Program, Scientific Advisory Board (SAB). This meeting will be open to the public.
Tuesday, September 13, 2016, from 9:00 a.m. to 4:40 p.m. and Wednesday, September 14, 2016, from 8:30 a.m. to 4:15 p.m.
901 N. Stuart Street Suite 200, Arlington, VA 22203.
Dr. Herb Nelson, SERDP Office, 4800 Mark Center Drive, Suite 17D08, Alexandria, VA 22350-3605; or by telephone at (571) 372-6565.
This meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C. Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150. This notice is published in accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463).
Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, and the availability of space, this meeting is open to the public. Seating is on a first-come basis.
The purpose of the September 13-14, 2016 meeting is to review new start research and development projects requesting Strategic Environmental Research and Development Program funds as required by the SERDP Statute, U.S. Code—Title 10, Subtitle A, Part IV, Chapter 172, § 2904. The full agenda follows:
Pursuant to 41 CFR 102-3.140, and section 10(a)(3) of the Federal Advisory Committee Act of 1972, the public or interested organizations may submit written statements to the Strategic Environmental Research and Development Program, Scientific Advisory Board. Written statements may be submitted to the committee at any time or in response to an approved meeting agenda.
All written statements shall be submitted to the Designated Federal Officer (DFO) for the Strategic Environmental Research and Development Program, Scientific Advisory Board. The DFO will ensure that the written statements are provided to the membership for their consideration. Contact information for the DFO can be obtained from the GSA's FACA Database at
Time is allotted at the close of each meeting day for the public to make comments. Oral comments are limited to 5 minutes per person.
Notice.
The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by September 16, 2016.
Fred Licari, 571-372-0493.
Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
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Written requests for copies of the information collection proposal should be sent to Mr. Licari at WHS/ESD Directives Division, 4800 Mark Center Drive, East Tower, Suite 02G09, Alexandria, VA 22350-3100.
Office of Postsecondary Education (OPE), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501
Interested persons are invited to submit comments on or before September 16, 2016.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Ken Waters, 202-453-6273.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Department of Energy.
Notice of cancellation of open meeting.
On August 2, 2016, the Department of Energy (DOE) published a notice of open meeting announcing a meeting on August 18, 2016, of the Environmental Management Site-Specific Advisory Board, Paducah. This notice announces the cancellation of this meeting. The meeting is being cancelled because the board will not have a quorum due to scheduling conflicts by members. The next regular meeting will be held on September 15, 2016.
The meeting scheduled for August 18, 2016, announced in the August 2, 2016, issue of the
Jennifer Woodard, Deputy Designated Federal Officer, Department of Energy Paducah Site Office, Post Office Box 1410, MS-103, Paducah, Kentucky 42001, (270) 441-6825.
Office of Fossil Energy, DOE.
Notice of application.
The Office of Fossil Energy (FE) of the Department of Energy (DOE) gives notice of receipt of an application, filed on March 25, 2016 (Application), by Carib Energy (USA) LLC (Carib). Carib requests long-term, multi-contract authorization to export domestically produced liquefied natural gas (LNG) in a volume equivalent to approximately 1.3 billion cubic feet (Bcf) per year (0.0036 Bcf per day) of natural gas.
Protests, motions to intervene, notices of intervention, and written comments are invited.
Protests, motions to intervene or notices of intervention, as applicable, requests for additional procedures, and written comments are to be filed using procedures detailed in the Public Comment Procedures section no later than 4:30 p.m., Eastern time, October 17, 2016.
Beverly Howard, or Larine Moore, U.S. Department of Energy (FE-34), Office of Regulation and International Engagement, Office of Fossil Energy, Forrestal Building, Room 3E-042, 1000 Independence Avenue SW., Washington, DC 20585, (202) 586-9387; (202) 586-9478.
Edward Myers, U.S. Department of Energy (GC-76), Office of the Assistant General Counsel for Electricity and Fossil Energy, Forrestal Building, 1000 Independence Avenue SW., Washington, DC 20585, (202) 586-3397.
The Application will be reviewed pursuant to section 3(a) of the NGA, 15 U.S.C. 717b(a), and DOE will consider any issues required by law or policy. To the extent determined to be relevant, these issues will include the domestic need for the natural gas proposed to be exported, the adequacy of domestic natural gas supply, and U.S. energy security. DOE may also consider other factors bearing on the public interest, including the impact of the proposed exports on the U.S. economy, international considerations, and whether the authorization is consistent with DOE's policy of promoting competition in the marketplace by allowing commercial parties to freely negotiate their own trade arrangements. As part of this analysis, DOE will consider the following two studies examining the cumulative impacts of exporting domestically produced LNG:
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Additionally, DOE will consider the following environmental document:
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Parties that may oppose this Application should address these issues in their comments and/or protests, as well as other issues deemed relevant to the Application.
The National Environmental Policy Act (NEPA), 42 U.S.C. 4321
In response to this Notice, any person may file a protest, comments, or a motion to intervene or notice of intervention, as applicable. Due to the complexity of the issues raised by the Applicant, interested persons will be provided 60 days from the date of publication of this Notice in which to submit comments, protests, motions to intervene, or notices of intervention.
Any person wishing to become a party to the proceeding must file a motion to intervene or notice of intervention. The filing of comments or a protest with respect to the Application will not serve to make the commenter or protestant a party to the proceeding, although protests and comments received from persons who are not parties will be considered in determining the appropriate action to be taken on the Application. All protests, comments, motions to intervene, or notices of intervention must meet the requirements specified by the regulations in 10 CFR part 590.
Filings may be submitted using one of the following methods: (1) Emailing the filing to
A decisional record on the Application will be developed through responses to this notice by parties, including the parties' written comments and replies thereto. Additional procedures will be used as necessary to achieve a complete understanding of the facts and issues. If an additional procedure is scheduled, notice will be provided to all parties. If no party requests additional procedures, a final Opinion and Order may be issued based on the official record, including the Application and responses filed by parties pursuant to this notice, in accordance with 10 CFR 590.316.
The Application is available for inspection and copying in the Office of Regulation and International Engagement docket room, Room 3E-042, 1000 Independence Avenue SW., Washington, DC 20585. The docket room is open between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays.
The Application and any filed protests, motions to intervene or notice of interventions, and comments will also be available electronically by going to the following DOE/FE Web address:
On August 10, 2016, the Commission issued an order in Docket No. EL16-98-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e (2012), instituting an investigation into the justness and reasonableness of the Elwood Facility's reactive power rates.
The refund effective date in Docket No. EL16-98-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the
Any interested person desiring to be heard in Docket No. EL16-98-000 must file a notice of intervention or motion to intervene, as appropriate, with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rule 214 of the Commission's Rules of Practice and Procedure, 18 CFR 385.214, within 21 days of the date of issuance of the order.
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following public utility holding company filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of its staff may attend the meeting noted below. Their attendance is part of the Commission's ongoing outreach efforts.
This meeting will be held at the Capital Hotel, 111 West Markham St., Little Rock, AR 72201.
The discussions may address matters at issue in the following proceedings:
Docket No. EL95-33—
Docket No. EL00-66—
Docket No. EL01-88—
Docket No. EL09-61—
Docket No. EL10-65—
Docket No. EL14-19—Midcontinent Independent System Operator and Entergy Services, Inc.
Docket No. EL16-7—
Docket No. ER10-1350—
Docket No. ER13-432—
Docket No. ER13-948—
Docket No. ER13-1195—
Docket No. ER13-1508—
Docket No. ER13-1509—
Docket No. ER13-1510—
Docket No. ER13-1511—
Docket No. ER13-1512—
Docket No. ER13-1513—
Docket No. ER14-649—
Docket No. ER14-693—
Docket No. ER14-694—
Docket No. ER14-695—
Docket No. ER14-696—
Docket No. ER14-697—
Docket No. ER14-699—
Docket No. ER14-700—
Docket No. ER14-701—
Docket No. ER14-702—
Docket No. ER14-703—
Docket No. ER14-704—
Docket No. ER14-1640—
Docket No. ER14-1641—
Docket No. ER14-1642—
Docket No. ER14-1643—
Docket No. ER14-1644—
Docket No. ER14-2850—
Docket No. ER14-2851—
Docket No. ER15-1436—
Docket No. ER15-1453—
Docket No. ER15-1826—
Docket No. ER16-227—
Docket No. ER16-1087—
Docket No. ER16-1251—
Docket No. ER16-1316—
Docket No. ER16-1528—
Docket No. ER16-1806—
Docket No. ER16-1965—
Docket No. ER16-2034—
Docket No. ER16-2124—
Docket No. ER16-2125—
Docket No. ER16-2199—
Docket No. ER16-2200—
These meetings are open to the public.
For more information, contact Patrick Clarey, Office of Energy Market Regulation, Federal Energy Regulatory Commission at (317) 249-5937 or
Take notice that on July 29, 2016, Northern Natural Gas Company (Northern), 1111 South 103rd Street, Omaha, Nebraska 68124-1000, filed in Docket No. CP16-487-000 an application pursuant to section 7(c) of the Natural Gas Act (NGA), and Part 157 of the Commission's Regulations, requesting authorization to construct and operate 7.86-mile-long 20-inch-diameter pipeline with appurtenances located in Dakota County, Minnesota (Cedar Station Upgrade Project). Northern also requests a predetermination of rolled-in rate treatment, all as more fully set forth in the application which is on file with the Commission and open to public inspection.
The filing may also be viewed on the web at
Any questions concerning this application may be directed to Michael T. Loeffler, Senior Director, Certificates and External Affairs for Northern, 1111 South 103rd Street, Omaha, Nebraska 68124, or by calling (402) 398-7103.
Specifically, Northern designed the Cedar Station Upgrade Project to increase the delivery pressure at Northern's existing Cedar Station located in Eagan, Minnesota, in accordance with a contractual obligation for Northern States Power Company (NSP-MN). The proposed pipeline will originate at Northern's existing Rosemount Junction facility in Rosemount, Minnesota and extend to its existing Cedar Station. Northern states that due to mainline constraints upstream of the branch line, the proposed project is not expected to generate incremental capacity that can be sold. The requested order date and proposed in-service date are March 17, 2017 and November 1, 2017 respectively. The project cost is estimated at $49,865,629.
On October 9, 2015, the Commission staff granted Northern's request to utilize the Pre-Filing Process and assigned Docket No. PF15-32-000 to staff activities involved in the above referenced project. Now, as of the filing of the July 29, 2016 application, the Pre-Filing Process for this project has ended. From this time forward, this proceeding will be conducted in Docket No. CP16-487-000, as noted in the caption of this Notice.
Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or
There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below, file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit five copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.
However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.
Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commentors will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commentors will not be required to serve copies of filed documents on all other parties. However, the non-party commentors will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.
The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link at
Take notice that on July 29, 2016, Millennium Pipeline Company (Millennium), One Blue Hill Plaza, Pearl River, New York 10965, filed in Docket No. CP16-486-000 an application pursuant to section 7(c) of the Natural Gas Act (NGA), and Part 157 of the Commission's Regulations, requesting a certificate of public convenience and necessity authorizing their Eastern System Upgrade Project. This project will provide an additional 223 million cubic feet per day (MMcf/d) of firm transportation capacity from Millennium's Corning Compressor Station (CS) to an existing interconnection with Algonquin Gas Transmission, LLC located in Ramapo, New York, all as more fully set forth in the application which is on file with the Commission and open to public inspection.
The filing may also be viewed on the web at
Any questions concerning this application may be directed to Georgia Carter, Vice President and General Counsel, Millennium Pipeline Company, LLC, 109 North Post Oak Lane, Suite 210, Houston, TX 77024, by calling 804-921-1408, or emailing
Specifically, Millennium proposes to construct, operate, and maintain (1) Approximately 7.8-miles of 30- and 36-inch-diameter pipeline loop in Orange County, New York; (2) a new 22,400 horsepower (HP) compressor station in Sullivan County, New York; (3) additional 22,400 HP at the existing Hancock Compressor Station in Delaware County, New York; (4) modifications to the existing Ramapo Meter and Regulator Station in Rockland County, New York; (5) modifications to the Wagoner Interconnect in Orange County, New York; (6) additional pipeline appurtenant facilities at the existing Huguenot and Westtown Meter and Regulating Stations in Orange County, New York; and (7) an alternate interconnect to the 16-inch-diameter Valley Lateral at milepost 7.6 of the Project.
Millennium states that 202.5 MMcf/d of project capacity is committed under precedent agreements with local distribution companies and municipalities. Millennium requests that that the Commission issue the requested authorizations by July 31, 2017, in order to allow Millennium sufficient time to meet a targeted in-service date in September 2018. Millennium proposes to charge negotiated rates to its project shippers and existing Rate Schedule FT-1 rates for service on the expansion capacity created by the project. The cost of the project is $275,000,000.
On February 5, 2016, the Commission staff granted Millennium's request to utilize the Pre-Filing Process and assigned Docket No. PF16-3-000 to staff activities involved in the above referenced project. Now, as of the filing of the July 29, 2016 application, the Pre-Filing Process for this project has ended. From this time forward, this proceeding will be conducted in Docket No. CP16-486-000, as noted in the caption of this Notice.
Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the
There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below, file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit five copies of filings made with the Commission and must mail a copy to the applicant and to every other party in the proceeding. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.
However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.
Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commentors will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commentors will not be required to serve copies of filed documents on all other parties. However, the non-party commentors will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.
The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link at
Environmental Protection Agency (EPA).
Supplemental notice of proposed consent decree; request for public comment.
Supplemental notice is hereby given for the Wyoming portions of a proposed consent decree to address a lawsuit filed by the Sierra Club (“Plaintiff”) in the United States District Court for the Northern District of California:
Written comments on the Wyoming portions of the proposed consent decree must be received by September 1, 2016.
Submit your comments, identified by Docket ID number EPA-HQ-OGC-2016-0364, online at
Zachary Pilchen, Air and Radiation Law Office, Office of General Counsel, U.S. Environmental Protection Agency; telephone: (202) 564-2812; fax number (202) 564-5603; email address:
This proposed consent decree would resolve a lawsuit filed by Plaintiffs seeking to compel the Administrator to take action under Clean Air Act (“CAA”) section 110(k)(2)-(4). As relevant to this supplemental notice, Plaintiffs allege that the Administrator
EPA previously published notice of this proposed consent decree on June 29, 2016.
A separate part of that June 29, 2016 notice, however, included a scrivener's error. In the “Supplementary Information” section, the notice briefly summarized (in alphabetical order by state) the allegations regarding SIP submissions. As WDEQ noted in its comment letter, despite Wyoming's inclusion in the “Summary” section of the notice, the “Supplementary Information” section did not list Wyoming, and instead listed Wisconsin as both of the two final states.
WDEQ commented, however, that as a result of this error the notice was “unclear” about “what allegation details” apply to Wyoming.
The official public docket for this action (identified by Docket ID No. EPA-HQ-OGC-2016-0364) contains a copy of the proposed consent decree. The official public docket is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OEI Docket is (202) 566-1752.
An electronic version of the public docket is available through
It is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing online at
You may submit comments as provided in the
If you submit an electronic comment, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. Any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.
Use of the
Environmental Protection Agency (EPA).
Notice of proposed consent decree; request for public comment.
In accordance with section 113(g) of the Clean Air Act, as amended (“CAA” or the “Act”), 42 U.S.C. 7413(g), notice is hereby given of a proposed consent decree to address a lawsuit filed by Concerned Citizens of Seneca County, Inc. and Dixie D. Lemmon, (collectively “Plaintiffs”):
Written comments on the proposed consent decree must be received by September 16, 2016.
Submit your comments, identified by Docket ID number EPA-HQ-OGC-2016-0480, online at
Zachary Pilchen, Air and Radiation Law Office (2344A), Office of General Counsel, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW. Washington, DC 20460; telephone: (202) 564-2812; fax number (202) 564-5603; email address:
This proposed consent decree would resolve a lawsuit filed by Plaintiffs seeking to compel the Administrator to take actions under CAA section 505(b)(2). Under the terms of the proposed consent decree, EPA would agree to sign a response to the petition by December 9, 2016. The proposed consent decree also provides for the possibility that certain circumstances could delay compliance with the December 9, 2016 deadline, and provides a framework for extending that deadline. In addition, the proposed consent decree also establishes a framework for resolving any request for costs of litigation, including attorney fees, and provides that after such resolution the proposed consent decree will be terminated and the case dismissed.
For a period of thirty (30) days following the date of publication of this notice, the Agency will accept written comments relating to the proposed consent decree from persons who are not named as parties or intervenors to the litigation in question. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree if the comments disclose facts or considerations that indicate that such consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the Act. Unless EPA or the Department of Justice determines that consent to this consent decree should be withdrawn or withheld, the terms of the consent decree will be affirmed.
The official public docket for this action (identified by Docket ID No. EPA-HQ-OGC-2016-0480) contains a copy of the proposed consent decree. The official public docket is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OEI Docket is (202) 566-1752.
An electronic version of the public docket is available through
It is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing online at
You may submit comments as provided in the
If you submit an electronic comment, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment and with any disk or CD ROM you submit. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. Any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic
Use of the
Environmental Protection Agency (EPA).
Notice; extension of comment period.
EPA issued a notice in the
Comments, identified by docket identification (ID) number EPA-HQ-OPP-2016-0310, must be received on or before September 29, 2016.
Follow the detailed instructions provided under
Robert McNally, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
This document extends the public comment period established in the
To submit comments, or access the docket, please follow the detailed instructions provided under
7 U.S.C. 136
Notice is given that a Complaint has been filed with the Federal Maritime Commission (Commission) by MAVL Capital, Inc. (“MAVL”), IAM & AL GROUP INC. (“IAM”), and Maxim Ostrovskiy, hereinafter “Complainants,” against Marine Transport Logistics, Inc. (“MTL”) and Dimitry Alper, hereinafter “Respondents.” Complainants allege that Respondents are a non-vessel-operating common carrier (“NVOCC”) licensed by the Commission and its director of operations, “engaged in the business of exporting used cars, motorcycles, and other cargo . . . from the United States to ports abroad.” Complainants allege that they had a business relationship with Respondents, having hired Respondents to ship Complainants' vehicles.
Complainants allege that Respondents violated provisions of the Shipping Act of 1984, including 46 U.S.C. 41102, 41101 and 46 CFR part 515, by:
“i. Failing to establish, observe, and enforce just and reasonable regulations and practices relating to or connected with receiving, handling, storing, or delivering property;
ii. Unreasonably refusing to deal or negotiate;
iii. Retaliating against Complainants because the Complainants had patronized another carrier;
iv. Knowingly misdelivering Complainants' cargo; and
v. Converting Complainants' cargo under the false premise of having exercised a maritime lien.”
Complainants allege damages “in excess of $180,000” and request the following relief:
“(1) Respondents be required to answer the charges herein; (2) that after due hearing, an order be made commanding said respondent to pay to Complainants by way of reparations for the unlawful conduct hereinabove described, the sums described herein, with interest and attorney's fees, costs and expenses, or such other sum as the Commission may determine to be proper as an award of reparation; (3) that the Commission issue an Order holding that the respondents Dimitry Alper individually, and Marine Transport Logistics, Inc. violated the Shipping Act of 1984; and (4) that the Commission issue such other and further order or orders as the Commission determines to be just and proper.”
The full text of the complaint can be found in the Commission's Electronic Reading Room at
This proceeding has been assigned to the Office of Administrative Law Judges. The initial decision of the presiding officer in this proceeding shall be issued by August 11, 2017 and the final decision of the Commission shall be issued by February 26, 2018.
The Commission hereby gives notice of the filing of the following agreement under the Shipping Act of 1984. Interested parties may submit comments on the agreements to the Secretary, Federal Maritime Commission, Washington, DC 20573, within twelve days of the date this notice appears in the
By Order of the Federal Maritime Commission.
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 September 12, 2016.
A. Federal Reserve Bank of Richmond (Adam M. Drimer, Assistant Vice President) 701 East Byrd Street, Richmond, Virginia 23261-4528. Comments can also be sent electronically to or
1.
Board of Governors of the Federal Reserve System.
Notice is hereby given of the final approval of a proposed information collection by the Board of Governors of the Federal Reserve System (Board) under OMB delegated authority, as per 5 CFR 1320.16 (OMB Regulations on Controlling Paperwork Burdens on the Public). Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551, (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.
OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW., Washington, DC 20503.
Final approval under OMB delegated authority of the extension for three years, with revision, of the following reports:
Federal Reserve staff review the FR LL-10(b) to assess the adequacy of responses to items, disclosure of pertinent facts, and completeness in all material respects. This includes information concerning the date of consummation of transactions and the number of shares acquired.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than September 1, 2016.
A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:
1.
Office of Government-wide Policy (OGP), General Services Administration (GSA).
Notice of GSA Per Diem Bulletin FTR 17-01, Fiscal Year (FY) 2017 Continental United States (CONUS) per diem reimbursement rates.
The General Services Administration's Fiscal Year (FY) 2017 per diem reimbursement rates review has resulted in lodging and meal allowance changes for certain locations within CONUS to provide for reimbursement of Federal employees' subsistence expenses while on official travel.
For clarification of content, contact Ms. Jill Denning, Program Analyst, Office of Government-wide Policy, Office of Asset and Transportation Management, at 202-208-7642, or by email at
Please review numbers six and seven of GSA's per diem Frequently Asked Questions at (
GSA also now solely publishes the M&IE meal breakdown table, which is used when employees are required to deduct meals from their M&IE reimbursement pursuant to FTR § 301-11.18, at
The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (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,
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
Importation of Etiologic Agents (42 CFR 71.54) (OMB Control No. 0920-0199, exp. 1/31/2017)—Extension—Office of Public Health Preparedness and Response (OPHPR), Centers for Disease Control and Prevention (CDC).
Section 361 of the Public Health Service Act (42 U.S.C. 264), as amended, authorizes the Secretary of Health and Human Services to make and enforce such regulations as are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession. Part 71 of Title 42, Code of Federal Regulations (Foreign Quarantine) sets forth provisions to prevent the introduction, transmission, and spread of communicable disease from foreign countries into the United States. Subpart F—Importations—contains provisions for the importation of infectious biological agents, infectious substances, and vectors (42 CFR 71.54); requiring persons that import these materials to obtain a permit issued by the CDC.
CDC requests Office of Management and Budget approval to collect information for three years using the Application for Permit to Import Biological Agents, Infectious Substances and Vectors of Human Disease into the United States and Application for a Permit to Import or Transport Live Bats. We are also requesting a title change to read—
The Application for Permit to Import Biological Agents, Infectious Substances and Vectors of Human Disease into the United States form is used by laboratory facilities, such as those operated by government agencies, universities, and research institutions to request a permit for the importation of biological agents, infectious substances, or vectors of human disease. This form currently requests applicant and sender contact information; description of material for
The Application for Permit to Import or Transport Live Bats form is used by laboratory facilities such as those operated by government agencies, universities, research institutions, and for educational, exhibition, or scientific purposes to request a permit for the importation, and any subsequent distribution after importation, of live bats. This form currently requests the applicant and sender contact information; a description and intended use of bats to be imported; and facility isolation and containment information. CDC plans to make no changes to this application.
Estimates of burden for the survey are based on information obtained from the CDC import permit database on the number of permits issued on annual basis since 2010. The total estimated burden for the one-time data collection is 545 hours. There are no costs to respondents except their time.
The MSHS Study is a nationally representative study that will describe the characteristics and experiences of the children and families who enroll in MSHS and the practices and services of the MSHS programs that serve them. The findings will provide essential up-to-date information to the Office of Head Start, other federal government agencies, local MSHS programs, and the public. The study will be the first national MSHS study to include direct child assessments, which will provide valuable information about MSHS children that programs can use to inform program, center and classroom practices.
Data collection will involve mail surveys to selected MSHS center directors and all MSHS program directors nationwide about operational characteristics, program- and center-level policies and practices, and services and resources offered to MSHS families. The study will also conduct on-site data collection with children, parents, teachers, and classrooms in a nationally-representative sample of MSHS centers. The on-site data collection will include classroom observations, teacher surveys, child reports and child assessments to obtain information on classroom instruction and practices, children's abilities and families' well-being.
In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, 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: OPRE 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.
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 “Regulatory Classification of Pharmaceutical Co-Crystals.” This guidance provides applicants planning to submit new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. This guidance also provides information about the data that applicants should submit to support the appropriate classification of a co-crystal as well as the regulatory implications of the classification. This draft guidance revises the guidance for industry entitled “Regulatory Classification of Pharmaceutical Co-Crystals” issued in April 2013.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 17, 2016.
You may submit comments 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 Division of Dockets Management, 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
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
Richard (Rik) Lostritto, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4148, Silver Spring, MD 20993-0002, 301-796-1697.
FDA is announcing the availability of a draft guidance for industry entitled “Regulatory Classification of Pharmaceutical Co-Crystals.” This guidance provides NDA and ANDA applicants with information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms.
Co-crystals are crystalline materials composed of two or more different molecules, typically drug and co-crystal formers (“coformers”), in the same crystal lattice. Pharmaceutical co-crystals have opened up opportunities for engineering solid-state forms beyond conventional solid-state forms of an active pharmaceutical ingredient (API), such as salts and polymorphs. Co-crystals can be tailored to enhance drug product bioavailability and stability and to enhance the processability of APIs during drug product manufacture. Another advantage of co-crystals is that they generate a diverse array of solid-state forms for APIs that lack ionizable functional groups, which is a prerequisite for salt formation.
This guidance revises the guidance for industry “Regulatory Classification of Pharmaceutical Co-Crystals” issued in April 2013, which classifies co-crystals as a drug product intermediate (or as an in-process material). This classification has contributed to uncertainty regarding the interpretation of the guidance because in a commercial setting, co-crystals are typically manufactured in drug substance facilities, yet when classified as a drug product intermediate, additional current good manufacturing practice requirements apply. Therefore, the guidance has not been conducive to the development of co-crystals. In response to this and other feedback from stakeholders, FDA has reconsidered the appropriate classification of co-crystals. This revision addresses the concern by providing information on the appropriate classification of co-crystal solid-state forms, the data that should be submitted to support the classification, and the regulatory implications of such a classification.
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 regulatory classification of pharmaceutical co-crystals. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
This guidance refers to previously approved collections of information found in FDA regulations. This guidance refers to information collection provisions 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 314.50(d)(1) and 314.94(a)(5) and (a)(9) have been approved under OMB control number 0910-0001.
Persons with access to the Internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a 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 September 16, 2016.
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
FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 11601 Landsdown St., 10A63, North Bethesda, MD 20852,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables FDA to better protect public health by helping to ensure the safety and security of the food supply. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. FSMA recognizes the important role industry plays in ensuring the safety of the food supply, including the adoption of modern systems of preventive controls in food production. Under FSMA, those that import food have a responsibility to ensure that their suppliers produce food that meets U.S. safety standards.
FSMA also requires FDA to establish a voluntary, fee-based program for the expedited review and importation of foods by importers who achieve and maintain a high level of control over the safety and security of their supply chains. This control includes importation of food from facilities that have been certified under FDA's accredited third-party audit program, as well as other measures that support a high level of confidence in the safety and security of the food they import. Expedited entry incentivizes importers to adopt a robust system of supply chain management and further benefits public
Section 302 of FSMA amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding new section 806, Voluntary Qualified Importer Program (21 U.S.C. 384b). Section 806(a)(1) of the FD&C Act directs FDA to establish this voluntary program for the expedited review and importation of food, and to establish a process for the issuance of a facility certification to accompany food offered for importation by importers participating in VQIP. Section 806(a)(2) directs FDA to issue a guidance document related to participation in, revocation of such participation in, reinstatement in, and compliance with VQIP.
Accordingly, in the
Finally, one comment objected to the provision regarding respondents obtaining a Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number and providing it to the Agency. We have determined that the DUNS number is an appropriate unique facility identifier during Foreign Supplier Verification Program (FSVP) rulemaking. We expect that most VQIP importers will also be FSVP importers and will have obtained a DUNS number.
We estimate the burden for the collection of information as follows:
We estimate it will take a VQIP applicant no longer than 10 hours to develop its QAP, including compiling its company profile, organizational structure, corporate quality policy statement, procedures for QAP implementation, food safety and food defense policies and procedures, and procedures for record retention. On average, the preparation of a QAP by a VQIP applicant is estimated at approximately 160 hours (110 + 40 + 10). In estimation of the one-time recordkeeping burden to prepare a QAP manual, we assume that VQIP importers do not already have a similar manual in place (
A VQIP importer is expected to update its QAP on an ongoing basis. We estimate it would take 10 percent of the effort to prepare the QAP, or 16 hours, to update the QAP each year. Therefore, we estimate the annual recordkeeping burden of modification of the QAP for 200 VQIP importers at 3,200 hours (200 importers × 16 hours/importer). The VQIP food defense security criterion is similar to the Food Defense Plan requirement under § 121.126 (21 CFR 121.126) in the IA regulation. Under the IA regulation, the food defense plan must include the written identification of actionable process steps, focused mitigation strategies, procedures for monitoring, corrective action procedures, and verification procedures. Therefore, we estimate that, on average, it would take 40 hours for an applicant to prepare the food defense portion of the VQIP QAP.
The guidance will inform food importers of application procedures for VQIP. We estimate that up to 200 qualified importers will be accepted in the first year of VQIP. We estimate that it will take 80 person-hours to compile all the relevant information and complete the application for the VQIP program. For the purpose of this analysis, we assume that 50 percent of all applications received will require additional information and it would take an additional 20 person-hours by the importer to provide that information. Therefore, we estimate that 100 importers will spend 8,000 hours (80 hours/importer × 100 importers) and 100 importers will spend 10,000 hours (100 hours/importer × 100 importers) to submit their initial VQIP applications for a total one-time reporting burden of 18,000 hours (see table 3).
The guidance states that each VQIP participant will submit to FDA a notice of intent to participate in VQIP on an annual basis. We expect that each of the expected 200 importers in VQIP would apply in the subsequent year to participate in VQIP. We expect that an application to participate in VQIP in a subsequent year will take significantly less time to prepare than the initial application. We use 25 percent of the amount of effort to prepare and submit the initial application for acceptance in VQIP. Therefore, it is expected that, on average, each VQIP importer will spend 20 hours to complete and submit a VQIP application for each subsequent year. The annual burden of completing a subsequent year application to participate in VQIP status by 200 importers is estimated at 4,000 hours (200 applications × 20 hours/application) (see table 4).
Finally, we have added to the VQIP estimated annual reporting burden an estimate of the burden associated with importers' requests to reinstate participation in VQIP after their participation is revoked. We believe most participants will not need to use this provision, and we have included an estimate that reflects this. Upon implementation of the VQIP, we will reevaluate our estimate for future OMB submission and revise it accordingly.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled “Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry.” The guidance document provides establishments that make donor eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps), with recommendations concerning the use of FDA-licensed nucleic acid tests (NAT) in donor testing for hepatitis B virus (HBV) deoxyribonucleic acid (DNA). The guidance finalizes the draft guidance of the same title dated January 2016 and supplements previous FDA recommendations to HCT/P establishments concerning donor testing for hepatitis B surface antigen (HBsAg) and total antibody to hepatitis B core antigen (anti-HBc), in the document entitled “Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)” dated August 2007 (2007 Donor Eligibility Guidance).
Submit either electronic or written comments on Agency guidances at any time.
You may submit comments as follows:
Submit electronic comments in the following way:
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• 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 Division of Dockets Management, 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
Submit written requests for single copies of the guidance to the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010. See the
Angela Moy, 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 document entitled “Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry.” The guidance provides establishments that make donor eligibility determinations for donors of HCT/Ps, with recommendations concerning the use of FDA-licensed NAT in donor testing for HBV DNA. FDA considers the use of FDA-licensed HBV NAT in testing HCT/P donors to be necessary to adequately and appropriately reduce the risk of transmission of HBV. The FDA-licensed HBV NAT can detect evidence of the viral infection at an earlier stage than the HBsAg and total anti-HBc tests. Therefore, FDA recommends the use of FDA-licensed HBV NAT for testing donors of HCT/Ps for evidence of infection with HBV.
HBV is a major global public health concern and has been transmitted by blood transfusions and tissue transplantation. Available literature has indicated possible transmissions of HBV by hematopoietic stem cells and blood with HBV NAT positive/hepatitis B surface antibody (anti-HBs) positive/HBsAg negative blood, irrespective of anti-HBc test results. In blood donors, adding the HBV NAT testing for HBV reduces the residual risk of transmission of HBV infection beyond that which can be achieved by screening donors using only HBsAg and total anti-HBc tests. In addition, it can detect breakthrough infections in previously vaccinated individuals who are exposed to the virus, and HBV mutants appear to be more likely detected by HBV NAT than by HBsAg assays.
In the United States, there are currently FDA-licensed HBV NAT assays intended to screen blood samples from donors of whole blood and blood components, other living donors (individual organ donors when specimens are obtained while the donor's heart is still beating), and blood specimens from cadaveric (non-heart-beating) donors. Some of these are multiplex assays that can simultaneously detect HIV, HCV, and HBV in a single blood specimen, thus improving the feasibility of routine NAT testing for HBV. By analogy to the experience in the blood donor setting, it is reasonable to expect that the residual risk of transmission of HBV infection would be reduced by adding HBV NAT to the testing strategy for HCT/P donors. HBV NAT's potential utility in further reducing risk of HBV transmission by transplantation is mainly restricted to the early HBsAg-negative phase of infection. In summary, the available scientific data and the availability of FDA-licensed assays support a recommendation that all HCT/P donors should be tested using an FDA-licensed HBV NAT.
In the
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on the “Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Persons with access to the Internet may obtain the guidance at either
Food and Drug Administration, HHS.
Notice, establishment of a public docket; request for comments.
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee of the Pediatric Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
The meeting will be held on September 14, 2016, from 8 a.m. to 5:30 p.m.
DoubleTree by Hilton Hotel Bethesda-Washington DC, 8120 Wisconsin Ave., Bethesda, MD 20814, 301-652-2000. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at
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 Division of Dockets Management, 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 thatyou 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
Marieann Brill, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 240-402-3838,
The PAC will meet to discuss the following products (listed by FDA Center):
FDA will also provide an update of their additional ongoing analysis of a possible safety signal regarding the use of the drug product Exjade (deferasirox) in children with fever and dehydration that was discussed at the September 2015 PAC meeting.
For the products to be discussed at the PAC meeting, FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material will be available at
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
FDA is establishing a docket for public comment for the PAC meeting. The docket number is FDA-2016-N-0567. The docket will close on August 31, 2016. Comments received on or before August 31, 2016, will be provided to the committee. Comments received after the date will be taken into consideration by the Agency.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Marieann Brill at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Indian Health Service, HHS.
Notice; correction.
The Indian Health Service published a document in the
Ms. Michelle EagleHawk, Deputy Director, Office of Direct Service and Contracting Tribes, 5600 Fishers Lane, Mail Stop: 8E17, Rockville, Maryland 20857, Telephone: (301) 443-1104, email:
In the
Announcement Number: HHS-2016-IHS-NIHOE-2-BH-HIV-AIDS-0001.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Cancer Institute Clinical Trials and Translational Research Advisory Committee.
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. The meeting will also be videocast and can be accessed from the NIH Videocasting and Podcasting Web site (
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 (5 U.S.C. App.), notice is hereby given of a meeting of the National Advisory Environmental Health Sciences Council.
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 material, and personal information concerning individuals associated with the grant applications, 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.
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 (5 U.S.C. App.), notice is hereby given of a meeting of the National Heart, Lung, and Blood Advisory Council.
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.
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:
Notice is hereby given of a change in the meeting of the National Cancer Advisory Board, September 07, 2016, 09:00 a.m. to September 07, 2016, 5:00 p.m., National Institutes of Health, Building 31, 31 Center Drive, Conference Room 10, Bethesda, MD 20892 which was published in the
This meeting notice has been amended to change the end time of the open session to 2:45 p.m. The closed session has also been amended to begin at 3:00 p.m. and end at 4:15 p.m. The meeting is partially closed to the public.
National Institutes of Health, HHS.
Notice.
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Kite Pharma, Inc. (“Kite”) located in Santa Monica, CA to practice the inventions embodied in the following patent applications:
United States Provisional Patent Application No. 62/084,654, filed November 26, 2014, entitled “Anti-mutated KRAS T Cell Receptors” [HHS Reference No. E-028-2015/0-US-01]; and
PCT Application No. PCT/US2015/062269 filed November 24, 2015 entitled “Anti-mutated KRAS T Cell Receptors” [HHS Reference No. E-028-2015/1-PCT-01].
The patent rights in these inventions have been assigned to the government of the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the development, manufacture and commercialization of retrovirally-engineered mutated KRAS TCR-based autologous peripheral blood T cell therapy products as set forth in the Licensed Patent Rights for the treatment of human cancers.
Only written comments and/or applications for a license which are received by the National Cancer Institute on or before September 1, 2016 will be considered.
Requests for copies of the patent application, inquiries, and comments relating to the contemplated exclusive license should be directed to: Andrew Burke, Ph.D., Licensing and Patenting Manager, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, MSC 9702, Rockville, MD 20852; Telephone: (240) 276-5484; Email
The present invention describes an isolated T cell receptor (TCR) which recognizes the G12D mutation of the Kristen rat sarcoma viral oncogene homolog (KRAS) protein within the context of major histocompatibility complex HLA-A11 presentation.
KRAS is an oncogene with a well-characterized role in the formation of several human cancers, including: Pancreatic, colorectal and lung. Certain mutations, such as the substitution of aspartic acid or valine for glycine at codon 12 (termed G12D and G12V, respectively), occur at relatively high frequency and may represent amenable targets for immunotherapies. Due to the restricted expression of KRAS G12D in pre-cancerous and malignant cells, engineered T cell therapies based on the present invention may be useful for the treatment of select cancers.
The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the NCI receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.
Complete applications for a license in an appropriate field of use that are timely filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Office of the Chief Information Officer, HUD.
Notice.
HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-5806. Email:
Colette Pollard, Reports Management Officer, QMAC, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Colette Pollard at
Copies of available documents submitted to OMB may be obtained from Ms. Pollard.
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
The
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Office of the Chief Information Officer, HUD.
Notice.
HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-5806. Email:
Colette Pollard, Reports Management Officer, QMAC, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Colette Pollard at
Copies of available documents submitted to OMB may be obtained from Ms. Pollard.
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
The
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.
Notice.
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Room 4176, Washington, DC 20410-5000; telephone 202-402-3400 (this is not a toll-free number) or email at
Harry Messner, Program Analyst, Program Administration Office: Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email
Copies of available documents submitted to OMB may be obtained from Ms. Pollard.
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined to institute an advisory opinion proceeding in the above-captioned investigation.
Clint Gerdine, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 708-2310. 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 this investigation on May 11, 2006, based on a complaint, as amended, filed by Crocs, Inc. (“Crocs”) of Niwot, Colorado. 71 FR 27514-15 (May 11, 2006). The complaint alleged,
On July 25, 2008, the Commission issued its final determination finding no violation of section 337 based on non-infringement and non-satisfaction of the technical prong of the domestic industry requirement with respect to the '789 patent, and invalidity of the '858 patent as obvious under 35 U.S.C. 103. 73 FR 45073-74 (Aug. 1, 2008). On July 15, 2011, after an appeal to the U.S. Court of Appeals for the Federal Circuit and subsequent remand vacating the Commission's previous finding of no violation, the Commission found a violation of section 337 based on infringement of the asserted claims of the patents and issued a general exclusion order and,
On July 12, 2016, Double Diamond and U.S.A. Dawgs, Inc. (“USA Dawgs”) of Las Vegas, Nevada (collectively, the “requesters”) petitioned for institution of an advisory opinion proceeding as to whether their Fleece Dawgs footwear is covered by the general exclusion order or cease and desist order directed against Double Diamond. No responses were filed.
The Commission has determined that requesters' petition complies with the requirements for institution of an advisory opinion proceeding under Commission Rule 210.79 to determine whether their Fleece Dawgs footwear infringes the '789 patent or claims 1 or 2 of the '858 patent. Accordingly, the Commission has determined to institute an advisory opinion proceeding and refer requesters' petition to the Office of Unfair Import Investigations (“OUII”). The parties will furnish OUII with information as requested, and OUII shall investigate and issue a report to the Commission within ninety (90) days of the date of publication of this notice in the
The authority for the Commission's determination is contained in sections 335 and 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1335, 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By Order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled
Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at EDIS,
General information concerning the Commission may also be obtained by accessing its Internet server at United States International Trade Commission (USITC) at USITC.
The Commission has received a complaint and a submission pursuant to section 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Reebok International Ltd. and Reebok International Limited on August 10, 2016. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain athletic footwear. The complaint names as respondents TRB Acquisitions LLC of New York, NY; RBX Active 01 LLC of New York, NY; RBX DIRECT LLC of New York, NY; RBX.COM LLC of New York, NY; and Elite Performance Footwear, LLC of New York, NY. The complainant requests that the Commission issue a limited exclusion order, cease and desist orders and impose a bond upon respondents' alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).
Proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the complaint or section 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) Explain how the articles potentially subject to the requested remedial orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) explain how the requested remedial orders would impact United States consumers.
Written submissions must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to section 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (“Docket No. 3166”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of sections 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
On June 1, 2016, Administrative Law Judge (ALJ) Charles Wm. Dorman issued the attached Recommended Decision. Therein, the ALJ found that on multiple occasions, Respondent issued prescriptions outside of the usual course of professional practice and which lacked a legitimate medical purpose for schedule II controlled substances such as Norco 10/325mg (hydrocodone/acetaminophen) and Hycodan (hydrocodone/homatropine cough syrup),
More specifically, the evidence showed that Respondent prescribed the controlled substances to his girlfriend knowing that she was seeking the drugs to abuse them. The evidence also showed that while some of the prescriptions were issued in the name of Respondent's girlfriend, in multiple instances, Respondent issued prescriptions, including multiple prescriptions for Hycodan, listing his girlfriend's two children, who were then three and five years old respectively, as the patients, and that Respondent did so knowing that his girlfriend intended to use the cough syrup because she enjoyed drinking it. The evidence further showed that on multiple occasions, Respondent issued prescriptions for Norco
The ALJ also found that on multiple occasions, Respondent violated Rule 1.4 of the Mississippi State Board of Medical Licensure's Rules by failing to document in his girlfriend's chart the diagnosis or justification for issuing the prescription, as well as required information including the drug's name, the dose, strength and quantity. R.D. at 37-39 (citing Miss. Code R. § 30-17-2640:1.4; also citing
With respect to the phentermine prescriptions Respondent issued to his girlfriend, the ALJ found that he “completely failed to comply” with the Board's Rule 1.5 because he did not prescribe “adjunctively with caloric restriction,” “never conducted and recorded an initial comprehensive evaluation” including “a thorough patient history or physical examination,” and never recorded required histories, nor her height, weight, BMI, body measurements, and vital signs. R.D. 43. The ALJ also found that Respondent did not conduct a re-evaluation of his girlfriend every 30 days as required by Rule 1.5.
Based on these findings, the ALJ concluded that Respondent had engaged in “an egregious level of intentional diversion” and that the Government had satisfied its
Respondent filed Exceptions to the ALJ's Recommended Decision. Thereafter, the ALJ forwarded the record to me for Final Agency Action.
Having considered the record in its entirety, including Respondent's Exceptions, I have decided to adopt the ALJ findings of fact, conclusions of law, and recommended Order. However, before I address Respondent's Exceptions, I deem it necessary to address the ALJ's ruling on the admissibility of the FDA package insert for Hycodan (GX 4).
On motion of Respondent's counsel, the ALJ ruled inadmissible Government Exhibit 4, which the Government represented was the FDA package insert for Hycodan.
After the Government argued that the document was the FDA package insert, which is included “with every drug purchased or sold,”
The ALJ sustained the objection but provided no explanation as to his reason for doing so. I conclude, however, that the Exhibit was admissible. As the FDA has explained, the package insert “is part of the FDA-approved labeling,” and “[t]he FDA approved label is the official description of a drug product, which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses in pregnant women, children, and other populations; and safety information for the patient.”
Under the Food, Drug and Cosmetic Act, a drug “shall be deemed to be misbranded . . . [u]nless its labeling bears . . . such adequate warning against use . . . by children where its use may be dangerous to health.” 21 U.S.C. 352(f). Moreover, introducing a misbranded drug into interstate commerce is a violation of 21 U.S.C. 331(a). Thus, there are ample incentives for drug manufacturers to provide reliable information in the package insert. Based on the foregoing, I find that there are sufficient indicia of reliability to support the admission of the document into evidence and make it a part of the record.
As further noted above, in opposing the admission of the package insert, Respondent represented that it contained expert opinions from unidentified persons whom he could not cross-examine and thus was being offered in violation of the ALJ's Prehearing Order. However, in its pre-hearing statement, the Government provided notice that it intended to offer the Exhibit and pursuant to the ALJ's Prehearing Ruling, the Government was required to provide the document to Respondent by 2 p.m. on February 12, 2016. ALJ Ex. 9, at 2. No claim is made that the Government failed to comply with the ALJ's ruling.
While Respondent asserts that he was unable to cross-examine the persons who wrote the package insert, he made no attempt to subpoena either an FDA official involved in reviewing the document or an employee from the manufacturer who was involved in preparing it. Moreover, Respondent could have sought to challenge the reliability of the document by producing evidence (whether through expert testimony or studies) disputing the package insert's statement regarding the risks of prescribing the drug to children less than six years of age. Respondent, however, produced no evidence which calls into question the reliability of the statements contained in the insert.
Notably, the Hycodan package insert's safety information includes the following warning: “The use of HYCODAN is not recommended for use in children less than 6 years of age because of the risk of fatal respiratory depression.” GX 4, at 2. Notably, Respondent's girlfriend's daughter was not even five years old when he wrote the first Hycodan prescription in her name. GE 55, at 1-2. Respondent also wrote Hycodan prescriptions in the name of his girlfriend's son who was then three years old.
Respondent argues that the ALJ failed to give proper weight to the decision of Dr. Craig, the Medical Board's Executive Director, to close the Board's investigation of his prescribing practices without recommending the initiation of a formal action against his medical license. Exceptions, at 1-2. According to Respondent, the Board reviewed “all such clinical and prescription records” for his girlfriend and her children, and it “decided that there was no evidence of any breach of any medical standard of care sufficient to bring any administrative charge against [him] related to any such prescription.”
Respondent then argues that “[r]ather than . . . defer[] to the professional judgments made by [Dr. Craig as to] whether State laws were violated by [him], the ALJ['s] Recommendation proceeds to interpret and apply those State laws without the benefit of any medical evidence, or any medical opinion in any form, anywhere in the record of this case.”
I reject the Exception. As for the contention that Dr. Craig reviewed the medical records and prescriptions and did not find the evidence sufficient to initiate a proceeding against his license, Respondent ignores the credited testimony that the Board terminated its investigation upon the request of the Mississippi Bureau of Narcotics (MBN) after the latter informed the Board that it was conducting a criminal investigation. Tr. 60 (testimony of MBN agent); GE 3, at 2 (Board Complaint form entry dated “3-20-15” stating “MBN has asked that we hold off on doing anything to this doctor because they are working a criminal case on him”).
Moreover, even then the Board's letter cautioned Respondent “that authorizing
Under both this and his subsequent exception, Respondent argues that the ALJ's decision is unprecedented because the Government put forward no expert testimony to support the conclusion that he violated 21 CFR 1306.04(a) in issuing the various prescriptions. However, contrary to Respondent's understanding, numerous decisions of both the federal courts in criminal cases and this Agency have held that expert testimony is not necessarily required to prove that a physician acted outside of the usual course of professional practice and lacked a legitimate medical purpose in issuing a controlled substance prescription.
Thus, while expert testimony is typically necessary to establish a violation of 21 CFR 1306.04(a) “ `where a physician ma[kes] some attempt to comply with various state medical practice standards and the adequacy of those efforts is at issue,' . . . the facts and circumstances surrounding the issuance of the prescription may nonetheless establish a violation even without expert testimony.”
Here, as the ALJ found, Respondent issued multiple prescriptions to his girlfriend while failing to document the performance of a physical exam, as well as findings and diagnoses that would support the issuance of the prescriptions. Moreover, with respect to the hydrocodone cough syrup prescriptions Respondent issued to his girlfriend which listed her children as the patients, the ALJ credited her testimony that she told Respondent that she wanted the big bottle of hydrocodone cough syrup and he “knew I would drink it too.” R.D. 7; 11 (citing Tr. 216, 251-52, 268, 273);
Respondent further argues that the ALJ erred when he refused “to allow Respondent to seek clinical evidence about [his girlfriend's] medical history through third-party document subpoenas.” Exceptions, at 2. Prior to the hearing, Respondent requested that the ALJ issue eight subpoenas to health care providers for their medical records “which reflect, relate to, or explain the clinical or medical basis for prescribing” controlled substances (primarily hydrocodone with acetaminophen) to his girlfriend.
In seeking the subpoenas, Respondent maintained that “[i]n order for the truth about [his girlfriend's] medical condition and needs to be revealed . . . the clinical findings and judgment of all such health care providers should be available to the Court in order to allow a comparison between Dr. Stewart's judgment and the judgments of a substantial number of other health care professionals in the same community.” ALJ Ex. 13, at 3. On the various subpoenas, Respondent explained that because one of the Government's Exhibits (the PMP report, GE 49) shows that the other health care providers had also issued hydrocodone prescriptions to his girlfriend, “[t]he presumed legitimacy of the particular clinical findings which caused [the] other health care professionals in the same community to prescribe the same medication to [her] could be strongly probative of the medical inaccuracy of the . . . core allegations against” him.
The Government opposed the issuance of the subpoenas. It argued that
The ALJ agreed with the Government and denied Respondent's request. ALJ Ex. 16. The ALJ explained that having reviewed the allegations of the Show Cause Order, he agreed with “the Government's assessment that the question of whether [Respondent' girlfriend] needed a particular medication is not an issue before me.”
I conclude that the ALJ properly denied Respondent's request. I do not, however, read the Government's Opposition as expressing the position that his girlfriend's need for the Norco prescriptions was not at issue.
While the Government alleged that these particular prescriptions were unlawful because: (1) Respondent did not “conduct[] an examination of” of his girlfriend or “document[] such in her file,” or (2) Respondent did not note the prescriptions in her chart and thus violated the Board's Rules 1.4, 1.11(b) and 1.16, the Government also cited 21 CFR 1306.04(a)). Because “[a] prescription for a controlled substance to be effective must be issued for a legitimate medical purpose,” 21 CFR 1306.04(a), a patient's need for the drug is invariably at issue when a violation of this provision is alleged.
Standards of proper medical practice require that, upon any encounter with a patient, in order to establish proper diagnosis and regimen of treatment, a physician must take three steps: (a) Take and record an appropriate medical history, (b) carry out an appropriate physical examination, and (c) record the results. The observance of these principles as a function of the “course of legitimate professional practice” is particularly of importance in cases in which controlled substances are to play a part in the course of treatment. It is the responsibility of the physician to dispense, prescribe or administer such drugs with proper regard for the actual and potential dangers.
Miss. Code R. § 30-17-2640:1.4.
I nonetheless agree with the ALJ's conclusion that the information sought by the subpoenas was irrelevant. Notably, Respondent made no proffer that he had obtained and reviewed the records maintained by these other providers and had based his decisions to prescribe hydrocodone to his girlfriend on those records. Nor did Respondent proffer that he was acting as a covering physician for any of these other physicians (or any other authorized prescriber) when he prescribed the hydrocodone to his girlfriend.
Respondent further contends that the prescriptions issued by the other providers “strongly support a conclusion that [his] own prescriptions for [h]ydrocodone for use by [his girlfriend] were within the bounds of the medical standard of care practiced in that community.” Exceptions, at 4. However, were it the case that Respondent's prescribing of hydrocodone was within the bounds of professional practice, he could have put on an expert to testify as such.
Of further note, even if Respondent had put on testimony that the prescriptions were “consistent with [his] own standard professional practices,” that testimony would have been unavailing because the standard of professional practice is not defined by a physician's subjective belief as to the propriety of his practices but on the application of the standards of practice in the State where he practices.
Respondent also contends that the evidence is insufficient to show that the hydrocodone prescriptions lacked a legitimate medical purpose because “it is clear that during the months relevant to this case [his girlfriend] was in fact suffering from a chronic migraine condition and associated headache pain, and that [he] was treating her for that condition.” Exceptions, at 3. Respondent points to the testimony of his girlfriend that she was hospitalized for migraines “[t]hree times prior to the beginning of his treatment of her in February 2014, and a fourth time during that treatment in August of 2014.”
It is true that in two of the visit notes for his girlfriend (April 21 and Sept. 2, 2014), Respondent listed Maxalt, a non-controlled drug, and Norco (hydrocodone with acetaminophen), as the drugs he prescribed to her for this condition. GE 2, at 12. Yet prior to Respondent's issuance of the first Norco prescription to her, she had “asked him to write the big bottle” of hydrocodone cough syrup “so that [she] could have some too” and “told him I like to drink it” because she “like[d] the way it made [her] feel.” Tr. 251-52; 273. Thus, Respondent already knew that his girlfriend was a drug abuser.
To the extent Respondent believes that his misconduct in writing the Norco prescriptions should be excused because his girlfriend did not tell him why she was taking the Norco, the evidence is clear that she had previously asked him to prescribe the big bottle of cough syrup so that she “could have some too” and had told him that she “like[d] to drink it” because of “the way it made [her] feel.” Thus, Respondent clearly knew that his girlfriend was a drug abuser at the time he wrote her the first Norco prescription.
The evidence also shows that Respondent told his girlfriend that taking hydrocodone could itself “cause migraines.”
Respondent also appears to argue that the alprazolam prescription he issued to his girlfriend was not unlawful because she suffered from anxiety and he referred her to a psychiatrist who had prescribed the drug to her. Exceptions, at 4. While Respondent acknowledges that he did not “diagnose [her] himself as to anxiety,” he argues that he issued the prescription “in reliance on that psychiatrist's independent clinical judgment” and gave her a refill so that she could “avoid[] further one-hour trips to the psychiatrist to obtain a refill.”
I am not persuaded. Notably, the psychiatrist prescribed only a seven-day supply of alprazolam extended release in the .5 mg dosage. GE 49, at 1. Respondent, however, prescribed a stronger dosage of alprazolam and greater quantity, providing her with a prescription for 40 tablets of the 1mg immediate release dosage form, with a refill for an additional 40 tablets.
As for the phentermine prescriptions, Respondent again invokes Dr. Craig's letter in which he stated that the Board was closing its investigation while cautioning Respondent about the need to conduct an in-person re-evaluation every 30 days. Exceptions, at 4. Respondent revisits his argument that Dr. Craig “determined that there was no sufficient medical basis for alleging any violation . . . of any medical standard in Mississippi.”
Finally, Respondent argues that “[t]he DEA, through the CI [his girlfriend], effectively caused [him] to engage in conduct, which, according to the record . . . he apparently had never engaged in on any other occasion.” Exceptions, at 5. Continuing, Respondent argues that his “conduct, in issuing prescriptions for pain medications to third parties in an effort to provide the CI with continuing relief from her migraine conditions, arose from the peculiar combination of his personal relationship and familiarity with the CI and the CI's insistence that her `friends' were seeking medication for” her use.
I disagree. To the extent Respondent's argument sounds in the entrapment defense, I reject it as there is ample evidence that he was predisposed to issue the unlawful prescriptions given the multiple unlawful prescriptions he wrote for his girlfriend in 2014, prior to the involvement of the MBN and DEA.
Respondent's final contention is that the ALJ violated his Fifth Amendment privilege against self-incrimination when he denied his request to reschedule the hearing until after his criminal trial concluded. Exceptions, at 5-6. Notably, the Government did not call Respondent to testify and the ALJ declined to draw an adverse inference from his failure to testify on his own behalf even though doing so would have been warranted.
` Here, Respondent does not contend that the need to preserve his Fifth Amendment privilege prevented him
I reject Respondent's contention.
The Agency rejected Grider's arguments. As the Agency explained, “`as a general matter, due process is not infringed merely because an accused person is subjected, without his consent, to an administrative hearing concerning matters involved in a pending criminal proceeding.'”
To be sure, in
Here, I find no reason to conclude that the ALJ abused his discretion when he declined to continue the proceeding until the conclusion of Respondent's criminal trial. Notably, in his request for a continuance, Respondent provided no information to the ALJ as to when that trial would commence.
As for the burden on Respondent, it is true that courts have held that the prejudice to a respondent's Fifth Amendment privilege may be substantial where there are parallel administrative and criminal proceedings.
Notably, Respondent was not otherwise foreclosed from putting on a defense. Indeed, in its pre-hearing statement, Respondent proposed to call an expert witness who would testify that the prescriptions were lawfully issued but ultimately chose not to call this witness. Notably, in his Exceptions, Respondent does not maintain that because he invoked the privilege, he was precluded from refuting the factual basis of the allegations.
Instead, Respondent now contends that my consideration of the ALJ's recommendation “should await the disposition of the criminal case . . . following which he should be given an opportunity promptly and succinctly to tell his side of the story and express his complete remorse.” Exceptions, at 6. However, as discussed above, in his Exceptions, Respondent continues to dispute the allegations (as well as the ALJ's factual findings and legal conclusions) that he issued prescriptions outside of the usual course of professional practice and which lacked a legitimate medical purpose for each of the different drugs (
The Fifth Amendment privilege is not “a sword whereby a claimant asserting the privilege [is] freed from adducing proof in support of a burden which would otherwise have been his.”
As for the fourth
Accordingly, I reject Respondent's third exception and will adopt the ALJ's recommended sanction of revocation.
Pursuant to the authority vested in me by 21 U.S.C. 824(a) and 823(f), as well as 28 CFR 0.100(b), I order that DEA Certificate of Registration AS2286311 issued to Lawrence E. Stewart, M.D., be, and it hereby is, revoked. I further order that any application of Lawrence E. Stewart, M.D., to renew or modify the above registration, or for any additional registration be, and it hereby is, denied. This Order is effectively immediately.
Administrative Law Judge Charles Wm. Dorman. On December 9, 2015, the Drug Enforcement Administration (“DEA” or “Government”) served Lawrence E. Stewart, M.D. (“Respondent”), with an Order to Show Cause and Immediate Suspension of Registration (“OSC/ISO”), which immediately suspended the Respondent's DEA Certificate of Registration (“COR”), Number AS2286311. Administrative Law Judge Exhibit (“ALJ-”) 1-2. The Respondent's COR has remained suspended throughout these proceedings. In response to the OSC/ISO, the Respondent requested a hearing before an Administrative Law Judge. ALJ-3. That hearing was held in New Orleans, Louisiana on March 22 and 23, 2016. The issue currently before the Administrator is whether the Respondent's COR should be revoked, and applications for renewal or modification denied, because continued registration would be inconsistent with the public interest under 21 U.S.C. 823(f) and 824(a)(4). The following recommendations are based on my consideration of the entire administrative record, including all of the testimony, admitted exhibits, and the oral and written arguments of counsel.
1. From February 2014 to May 2015, the Respondent prescribed controlled substances, including hydrocodone and alprazolam, to a confidential informant (“CI”)
2. On four occasions, the Respondent prescribed phentermine to CI without adequate documentation, in violation of Mississippi Medical Board Administrative Rules Part 2640, Chapter 1, Rule 1.5, Mississippi Code §§ 73-25-29(3) and (13), and 21 CFR § 1306.04(a). ALJ-1, at 3.
3. From February 7, 2014 to November 19, 2014, the Respondent prescribed hydrocodone products to CI's children
4. On five occasions between March and October 2015, the Respondent prescribed controlled substances to undercover agents when he knew or should have known that the agents' prescription requests were fraudulent, in violation of 21 U.S.C. 841(a) and 842(a), and 21 CFR § 1306.04(a). ALJ-1, at 3. In total, the Respondent wrote seven prescriptions on five occasions to undercover agents, for a total of 190 dosage units of hydrocodone tablets and 72 dosage units of hydrocodone syrup. ALJ-1, at 11. On at least four of those occasions, the Respondent knew that CI would receive a portion of the prescribed controlled substances. ALJ-1, at 3-4. The Respondent also knew that CI had attempted to commit suicide using controlled substances that the Respondent had prescribed to her. ALJ-1, at 3-4.
5. From February 2014 to October 2015, the Respondent unlawfully prescribed controlled substances in violation of 21 U.S.C. 841(a) and 842(a). ALJ-1, at 2. Specifically, the Respondent prescribed controlled substances when he knew or should have known that the prescriptions were not for legitimate medical purposes and were not made in the usual course of professional practice, in violation of 21 CFR § 1306.04(a) and Mississippi Code §§ 41-29-137(a)(1) and 41-29-141(1). ALJ-1, at 2.
6. On September 2, 2014, the Respondent prescribed meperidine to CI. ALJ-1, at 3. The Respondent was the only practitioner to prescribe meperidine to CI. ALJ-1, at 3. CI used meperidine to attempt to commit suicide in December 2014. ALJ-1, at 3.
The Government and the Respondent stipulated to the following facts:
1. Respondent is registered with the DEA as a practitioner to handle controlled substances in Schedules II-V under DEA COR AS2286311 at 405 Marion Avenue, P.O. Box 666, McComb, Mississippi 39648-2709.
2. DEA COR AS2286311 will expire by its terms on February 28, 2018.
3. Respondent is presently licensed in Mississippi as a medical doctor (M.D.) with Medical License 11503.
4. CI is the mother of Kid 1 and Kid 2.
5. Hydrocodone-Acetaminophen 10-325 (Norco), Hydrocodone-Acetaminophen 7.5-325 (Norco), Hydrocodone-Acetaminophen 5-325 (Norco), and Hydrocodone-Homatropine Syrup (Hycodan) are all classified as Hydrocodone Combination Products.
6. Hydrocodone Combination Products are classified by DEA as Schedule II Controlled Substances and have been so classified since October 6, 2014. Before October 6, 2014, Hydrocodone Combination Products were classified by DEA as Schedule III Controlled Substances.
7. Alprazolam is classified by DEA as a Schedule IV Controlled Substance.
8. Phentermine (Adipex) is classified by DEA as a Schedule IV Controlled Substance.
9. Meperidine (Demerol) is classified by DEA as a Schedule II Controlled Substance.
The Government presented its case through the testimony of nine
Second, the Government called Mary Flinchum (“Flinchum”). Tr. 33. Flinchum is a lieutenant for the MBN and a task force officer for the DEA's Tactical Diversion Squad. Tr. 33-34. Flinchum received an intelligence report about the Respondent from MBN. Tr. 35. Flinchum interviewed CI and her husband, separately and together, about their complaint to MBN. Tr. 36, 82. Flinchum helped decide that MBN should investigate the Respondent. Tr. 36-37. Flinchum also communicated with the Mississippi State Board of Medical Licensure (“Mississippi Board”), which was conducting an independent investigation concerning the Respondent. Tr. 58-59. Flinchum was familiar with an undercover investigation of the Respondent during March, April, and October of 2015. Tr. 77-81. Later, Flinchum was recalled to offer further testimony concerning the October 2015 undercover operation. Tr. 449-50. Through Flinchum's testimony, the Government authenticated and successfully offered into evidence Government Exhibits (“GE-”) 13 through 21, 27 through 29, 38 through 40, and 53. Tr. 38-57. I find all of these exhibits to be accurate, authentic, and meriting credibility. On cross-examination, the Respondent authenticated and successfully offered into evidence GE-2. Tr. 62-63. I find that Flinchum's testimony was thorough, detailed, and internally consistent. Therefore, I merit her testimony as credible in this Recommended Decision.
Third, the Government called Undercover Agent #1
Fourth, the Government called Undercover Agent #2 (“Agent 2”). Tr. 141. Agent 2 is a female MBN agent. Tr. 141. Agent 2 participated in the undercover investigation of the Respondent. Tr. 142. Agent 2 attended an undercover medical appointment with the Respondent on April 29, 2015. Tr. 143. Through Agent 2's testimony, the Government authenticated and successfully offered into evidence GE-34 through 37. Tr. 143-51. I find these exhibits to be accurate, authentic, and meriting full credibility. I also find that Agent 2's testimony was thorough, detailed, and internally consistent. Therefore, I merit her testimony as credible in this Recommended Decision.
Fifth, the Government called MBN Agent Charles Causey (“Causey”). Tr. 159. In 2015, Causey assisted with audiovisual surveillance for the DEA and MBN's undercover investigation of the Respondent on March 27, April 8, April 29, and October 16. Tr. 162-63. Causey testified that the video recordings of these undercover operations may contain incorrect internal date/time stamps, and that the dates and times on the video recordings do not necessarily correspond to the actual dates and times on which the video recordings were made. Tr. 165-66. I find that Causey's testimony was thorough, detailed, and internally consistent. Therefore, I merit his testimony as credible in this Recommended Decision.
Sixth, the Government called Leslie Ross (“Ross”). Tr. 168. Ross is an investigations supervisor for the Mississippi Board and a task force officer for the DEA's Tactical Diversion Squad. Tr. 168-69. The Mississippi Board reviews and issues medical licenses, promulgates rules and regulations for the practice of medicine in Mississippi, investigates complaints about Mississippi licensees, and imposes disciplinary action when necessary. Tr. 170. Several days before the Mississippi Board closed its investigation concerning the Respondent, Ross received a call from Agent Flinchum, advising Ross that the DEA and the MBN were investigating the Respondent. Tr. 194-95, 210. Ross explained that the phone call influenced the Mississippi Board's decision to close its case because it was the Mississippi Board's custom “to back off and let a criminal agency pursue their case.” Tr. 210. Without interviewing CI, the Mississippi Board closed its investigation. Tr. 196. Ross also helped author part of Mississippi Administrative Rule 1.5, which regulates diet medication prescriptions in Mississippi. Tr. 172. Ross established the foundation for the Court to take official notice of Mississippi Administrative Rules 1.1, 1.2, 1.4, 1.10, and 1.16. Tr. 188-93. Additionally, while Ross did not conduct the Mississippi Board's investigation of the Respondent, she supervised Todd Pohnert, who conducted the investigation. Tr. 170, 173. Ross served administrative subpoenas for information about the Respondent to two Mississippi pharmacies, one in McComb and one in Brookhaven. Tr. 185. I find that Ross' testimony was thorough, detailed, and internally consistent. Therefore, I merit her testimony as credible in this Recommended Decision. Through Ross' testimony, the Government authenticated and successfully offered into evidence GE-3 and 8. Tr. 171-78. I find these exhibits to be accurate, authentic, and meriting credibility. Furthermore, through Ross' testimony, the Government established some foundation for GE-7 and 55. Tr. 185-88.
Seventh, the Government called CI. Tr. 212. CI testified about her relationship with the Respondent and
Eighth, the Government called James Pacheco (“Pacheco”). Tr. 385. Pacheco is an agent for the MBN and a task force officer for the DEA's Tactical Diversion Squad. Tr. 386. Pacheco participated in the undercover investigation of the Respondent by coordinating the surveillance aspect of the investigation. Tr. 388. Pacheco assisted with physical surveillance of the Respondent and CI during an undercover operation at a Walmart on April 8, 2015. Tr. 388-89. Pacheco personally observed most of the operation at Walmart. Tr. 389. Pacheco also testified that he listened to the undercover operation conducted at the Respondent's clinic in October 2015. Tr. 406-07. Through Pacheco's testimony, the Government authenticated and successfully offered into evidence GE-22 and 23. Tr. 387-93. I find these exhibits to be accurate, authentic, and meriting credibility. I also find that Pacheco's testimony was thorough, detailed, and internally consistent. Therefore, I merit his testimony as credible in this Recommended Decision.
The Government's ninth witness was Maria Gilbert (“Gilbert”). Tr. 409. Gilbert is a DEA diversion investigator, and was a case agent in the investigation of the Respondent. Tr. 409-10. Gilbert helped submit the evidence acquired by the undercover agents into a DEA evidence locker. Tr. 440. Gilbert also directed DEA personnel to obtain Prescription Monitoring Program (“PMP”) reports during the investigation. Tr. 438. Gilbert created the administrative subpoenas issued to pharmacies to obtain information about the Respondent. Tr. 412. Gilbert helped conduct an administrative search of the Respondent's office. Tr. 427-28. Through Gilbert's testimony, the Government authenticated and successfully offered into evidence GE-7, 41, 48, 50 through 52, 55, and 58 through 60. Tr. 411-18, 427-39. I find these exhibits to be accurate, uncontested, and meriting credibility. I also find that Gilbert's testimony was thorough, detailed, and internally consistent. Therefore, I merit her testimony as credible in this Recommended Decision.
The Respondent did not call any witnesses or offer any of his proposed exhibits into evidence. Tr. 458.
The factual findings below are based on a preponderance of the evidence, including the detailed, credible, and competent testimony of the aforementioned witnesses, the exhibits entered into evidence, and the record before me.
1. The Respondent has not previously been convicted of any crime related to controlled substances. GE-1, at 1. The Respondent has never had his state medical license revoked, suspended, denied, restricted, or placed on probation. GE-1, at 1.
2. The Respondent and CI became Facebook friends and began talking with each other in January 2014. Tr. 213, 237. CI asked the Respondent questions about the health of Kid 1.
3. In the spring of 2014, CI and the Respondent began to have a consensual sexual relationship. Tr. 213, 218-19, 290-92, 296, 359. During the summer of 2014, CI and the Respondent saw each other very often. Tr. 324. CI and the Respondent communicated frequently by texting and calling each other on their cell phones. Tr. 355-56.
4. CI engaged in a sexual affair with the Respondent because she was infatuated with him and because she wanted to obtain controlled substances for her recreational use. Tr. 291-92. The controlled substances, however, were not a prerequisite for sexual relations. Tr. 289.
5. The sexual relationship between CI and the Respondent ended in November 2014. Tr. 219.
6. The Respondent provided medical treatment to CI several times, beginning in 2010. GE-2, at 12-13; Tr. 215, 277. Specifically, the Respondent treated CI for a sinus infection, vertigo, and migraines. GE-2, at 12-13; Tr. 215, 277-78, 287, 321. CI had a serious migraine condition that caused her to seek treatment in emergency rooms on four occasions. Tr. 278-80, 347. CI discussed her migraines and hospitalizations with the Respondent, who gave her information about migraines. Tr. 282, 287. The Respondent prescribed Maxalt
7. The Respondent had a patient file for CI and wrote notes therein about her treatment.
8. CI took Kid 1 and Kid 2 to appointments with the Respondent. Tr. 219, 261-62, 285-86, 335-36, 338;
9. CI sent the Respondent at least one message via social media requesting his medical advice about Kid 1's condition. Tr. 262-63. CI communicated with the Respondent about the physical
10. Near a date stamp reading “February 4, 2014,” the Respondent recorded in Kid 1's medical file that CI had migraines, that she may call in for a prescription if needed, and that he discussed phentermine
11. Prior to her relationship with the Respondent, CI took controlled substances, including hydrocodone, which were prescribed by numerous other doctors to help treat pain resulting from four lithotripsies, kidney stones, a broken tailbone, a root canal, and TMJ
12. CI occasionally used Adderall for nonmedicinal purposes. Tr. 215. CI had not used cough syrup for nonmedicinal purposes prior to her relationship with the Respondent. Tr. 215.
13. After Kid 1 had his tonsils removed on January 30, 2014, CI took some of Kid 1's pain medication. Tr. 273-74, 276. As a result of the tonsillectomy, the Respondent prescribed two different forms of hydrocodone for Kid 1. GE-51, at 1; GE-57, at 6, 14, 22.
14. The Respondent first prescribed cough syrup for Kid 2 on January 24, 2014. GE-50, at 1; GE-56, at 4. The Respondent again prescribed cough syrup for Kid 2 in February 2014. Tr. 216, 258-59; GE-50, at 1; GE-56, at 4. The Respondent did not examine Kid 2 before he prescribed cough syrup for her. Tr. 217, 251;
15. CI talked with the Respondent about prescribing a “big bottle” of cough syrup so that CI could drink it. Tr. 216, 251-52, 268, 273. CI thought that the Respondent knew she did not have a cough. Tr. 216, 251-52, 268. In February 2014, CI asked the Respondent to prescribe
16. CI told the Respondent when Kid 1 or Kid 2 had a cough. Tr. 250. CI, however, did not bring her children to see the Respondent regarding a cough; she requested cough syrup from the Respondent because she liked drinking it. Tr. 220, 273;
17. The Respondent prescribed Norco, Xanax, and Adipex to CI on multiple occasions. Tr. 26; GE-49. The Respondent prescribed Norco
18. On several occasions, the Respondent provided prescriptions to CI while he was at CI's house. Tr. 217-18;
19. At times, CI told the Respondent about her children's pain or physical conditions to get prescriptions for her own personal use. Tr. 267. CI would occasionally administer the prescribed medication to her children. Tr. 270-72.
20. CI requested that the Respondent write a prescription for Adderall for her, but he declined to do so. Tr. 223. In the spring of 2014, CI asked the Respondent to write her a prescription for Adipex, a weight loss drug. Tr. 223-24, 288-89. The Respondent wrote prescriptions and refills for Adipex to CI. GE-49, at 1-2; Tr. 223-24. CI used Adipex for approximately three months. Tr. 224. The Respondent did not conduct a physical examination of CI focused on weight issues at any point before or while CI took Adipex, and the Respondent did not discuss alternative weight loss treatments with CI. Tr. 224-25;
21. CI had anxiety, which she discussed with the Respondent. Tr. 322. The Respondent told her to visit a certain psychiatrist. Tr. 225, 295. CI visited that psychiatrist twice. Tr. 225. The psychiatrist prescribed a low dosage of time-release Xanax
22. The Respondent wrote nine prescriptions
23. Two prescriptions written by the Respondent to Kid 1 are not documented in Kid 1's medical chart.
24. On one occasion in early fall of 2014, following CI's complaint of a severe migraine, the Respondent prescribed Demerol to CI. Tr. 222, 296-97, 317-18, 382. Next to the date “September 2, 2014” in CI's medical chart, the Respondent wrote that he refilled her prescription of phentermine, looked at her ears and nose, and counselled her. GE-2, at 12; Tr. 323. He also wrote that he prescribed Demerol and Xanax to CI. GE-2, at 12. CI did not ask the Respondent for Demerol. Tr. 296, 318.
25. CI's husband discovered that CI was having an affair with the Respondent. Tr. 26, 320. Sometime after the discovery, in December 2014, CI attempted suicide using the Demerol the Respondent prescribed to her. Tr. 222, 314-17. CI went to a mental institution for a week following her suicide attempt. Tr. 227, 309. In January 2015, CI told the Respondent that she had tried to kill herself. Tr. 226-27, 309-11.
26. After CI's husband discovered the affair and CI attempted to commit suicide, CI and her husband made a complaint against the Respondent to the MBN. Tr. 25, 29-31, 71, 228-29, 339-40. CI told MBN investigators that she got medications from the Respondent for nonmedicinal purposes because she enjoyed using them. Tr. 84.
27. The Mississippi Board received an unsigned letter, allegedly from CI's husband, which complained about the extramarital affair between CI and the Respondent. GE-3, at 3; Tr. 58, 66. The Mississippi Board and MBN both received a copy of the letter. Tr. 66-67, 70-71, 398-99. Several witnesses testified that CI's husband was not the author of this letter. Tr. 67-70, 326, 394, 396. The author of the letter is unknown. Tr. 67-70, 201, 326, 394-95.
28. The letter was written in the first person, and CI's husband's name was typewritten on the bottom of the letter, along with CI's date of birth and social security number. GE-3, at 3. The letter said that the author's wife, CI, had an affair with the Respondent for over a year, and that the author did not know about it until he found a box of empty pill bottles that the Respondent had prescribed to CI, even though CI was not his patient. GE-3, at 3. The letter was stamped as received by the Mississippi Board on February 19, 2015. GE-3, at 3.
29. By the time the MBN received a copy of the letter, it had already begun its investigation of the Respondent because of the complaint made by CI and her husband. Tr. 71, 74-76. After receiving a copy of the letter, the Mississippi Board began conducting an independent investigation of the Respondent. Tr. 58, 61, 203.
30. A Mississippi Board investigator met with the Respondent regarding the anonymous letter. GE-3, at 4-6. At that time, the Mississippi Board was unaware that the DEA was conducting a simultaneous investigation of the Respondent. Tr. 180.
31. In response to the investigator's inquiry, the Respondent said that he only saw CI when she or her children had appointments, and had not seen CI outside of his office. GE-3, at 5; Tr. 179, 202. The Respondent suggested that he had not engaged in sexual misconduct with CI. GE-3, at 5; Tr. 180, 207. The Respondent also suggested that he was not aware that CI had attempted to commit suicide or had been committed to a mental hospital. GE-3, at 5, 7.
32. The investigator made copies of CI's patient charts and found several shortcomings with CI's medical records. GE-3, at 4-5; Tr. 180, 197. First, the investigator found seven prescriptions in CI's PMP report that were not documented in the Respondent's patient file for CI. GE-3, at 5. The Respondent explained that he might have documented the missing prescriptions in his patient files for CI's children instead. GE-3, at 5.
33. Second, the investigator found that CI's patient file did not include any notes about CI's vitals, height/weight, BMI, or alternative weight control treatment plans, and did not indicate that CI received any counseling about other weight loss options. GE-3, at 5; Tr. 180.
34. Following the investigator's visit, the Mississippi Board sent the Respondent a copy of the anonymous letter purportedly from CI's husband.
35. The Respondent sent a letter to the Mississippi Board. GE-3, at 7-8; Tr. 179-80. Therein, the Respondent denied knowing that CI had overdosed.
36. The Mississippi Board contemplated closing its investigation of the Respondent because it did not have enough evidence supporting the allegations of the Respondent's sexual misconduct. Tr. 181, 184, 194-95, 197, 209-10. Throughout the course of its investigation, however, the Mississippi Board never interviewed CI. Tr. 196.
37. On March 20, 2015, while the Mississippi Board was contemplating closing its investigation, Flinchum
38. The Mississippi Board closed its investigation of the Respondent on March 23, 2015. GE-3, at 1; Tr. 181. A letter from the Mississippi Board to the Respondent terminated the Board's investigation. GE-3 at 1; Tr. 183. The letter stated that the Mississippi Board concluded its investigation and that, after a thorough review of the information and facts from the investigation, it decided not to recommend any formal action. GE-3, at 1. This letter was a truthful and accurate reflection of the Board's reasons for terminating the investigation. Tr. 64-65, 86, 195-97.
39. The letter also cautioned the Respondent against “authorizing refills for Phentermine/Adipex without benefit of a medical examination.” GE-3, at 1 (discussing Mississippi Administrative Rule 1.5(E)).
40. The letter told the Respondent that the Mississippi Board had found some deficiencies with his medical records. Tr. 181, 183-84, 203. The letter did not exonerate the Respondent, but warned him about his inadequate documentation of weight loss prescriptions. Tr. 184, 203.
41. The DEA began undercover operations concerning the Respondent in March 2015. Tr. 77-78.
42. CI was told that if she cooperated with law enforcement, she would not be in any trouble. Tr. 342-43. CI signed a confidential informant agreement with the DEA. Tr. 343-44, 394.
43. The DEA instructed CI not to have any contact
44. With CI's consent, the DEA gave CI a telephone number that recorded all calls and text messages exchanged between CI and the Respondent. Tr. 37-38, 84-85, 230. This telephone number operated through an application that the DEA installed on CI's cellular phone. Tr. 382. This application automatically recorded all calls, conversations, and multimedia messages exchanged between CI and the Respondent. Tr. 37-38, 85-86.
45. CI called and texted the Respondent outside of the presence of MBN and DEA agents. Tr. 85-86. The DEA did not tell CI what to say to the Respondent. Tr. 85-86.
46. The DEA agents asked CI to contact the Respondent by phone or by text message and ask him for Norco and cough syrup. Tr. 346, 348-49.
47. On March 16, 2015, at approximately 6:51 p.m., the Respondent and CI spoke on the phone. GE-15-16. CI asked the Respondent to meet her at Walmart and give her a prescription for something. GE-16, file 2015-03-16_18-51-48_EDT, at 19;
48. On March 17, 2015, at approximately 1:07 p.m., the Respondent and CI spoke on the phone. GE-15-16. CI asked the Respondent to slip “a couple Lorcets” into her mailbox. GE-16, file 2015-03-17_13-07-36_EDT, at 4. The Respondent joked, “I need to learn to play the guitar so you could be getting sex, drugs and rock and roll, you know.”
49. On March 18, 2015, at approximately 11:03 a.m., the Respondent and CI spoke on the phone. GE-15-16. CI suggested that the Respondent could write a prescription in Kid 1's name. GE-16, file 2015-03-18_11-03-33_EDT, at 1. The Respondent responded sarcastically and attempted to change the subject.
50. On March 25, 2015, at approximately 10:36 a.m., the Respondent and CI spoke on the phone. GE-17, at 1-5.
51. On March 25, 2015, at approximately 11:43 a.m., the Respondent texted CI, “I won't be in the office tomorrow. I could see her Friday.” GE-53, file 2015-03-25_11-43-42_EDT. CI texted back, “Ok:) she is a real cool girl. I use [sic] to party with her.” GE-53, file 2015-03-25_11-47-23_EDT;
52. On March 25, 2015, at approximately 2:36 p.m., the Respondent and CI spoke on the phone. GE-17, at 6-8.
53. On March 26, 2015, at approximately 11:18 a.m., the Respondent and CI spoke on the phone. GE-18.
54. Based on Findings of Fact 47 through 53 and the transcript at pages 91, 230, and 349, I find that, by the time the Respondent met with Agent 1 on March 27, 2015, the Respondent knew that Agent 1 was not a legitimate patient and that any medication he prescribed to her at that appointment would be given to and used by CI.
55. Agent 1's first appointment with the Respondent was on March 27, 2015. GE-10; Tr. 91. Upon arriving at the Respondent's clinic, Agent 1 signed in, completed paperwork, and waited in the Respondent's waiting room. GE-9; Tr. 92. The Respondent's nurse called Agent 1 back into an examination room and spoke briefly with her. GE-9; Tr. 92, 94.
56. Agent 1 met with the Respondent. GE-9-10; Tr. 91;
57. Agent 1 asked the Respondent if he could help her with her weight loss. GE-9-10. The Respondent declined to prescribe anything for weight loss to Agent 1; he said that it was not his area of expertise and it was heavily regulated by the Mississippi Board. GE-10, at 2. He recommended that she could go to a licensed diet center for assistance. GE-10, at 3.
58. The Respondent wrote two prescriptions for Agent 1: one non-refillable prescription for Norco, and one refillable prescription for Maxalt. GE-11-12; Tr. 95. The Respondent told Agent 1 that he would give her “lots of refills” on the Maxalt. GE-10, at 1.
59. That same day, CI and the Respondent had a phone conversation about the Respondent's meeting with CI's “friend,” Agent 1. GE-13-14; GE-20, file Post Buy CI Call With STEWART 3-27-2015. The Respondent said he enjoyed meeting Agent 1 and that he was “hopeful that that helps” CI. GE-14, at 1. CI said that she could get through because the Respondent “hooked” her up. GE-14, at 1. The Respondent responded, “absolutely that needs to be about as discreet as [unintelligible].” GE-14, at 1. The Respondent told CI to “not take that other stuff but one at a time.” GE-14, at 1. He said that, during Agent 1's appointment, he “talked about headaches and pretty much left it exactly at that.” GE-14, at 1. The Respondent told CI, “[s]o um you got refills on that Maxalt. Um she does,” and noted that he could not give refills “on the other one . . ..” GE-14, at 2.
60. On April 1, 2015, at approximately 8:28 p.m., the Respondent and CI spoke on the phone. GE-19.
61. On April 2, 2015, at approximately 2:15 p.m., the Respondent and CI spoke on the phone. GE-16, file 2015-04-02_14-15-50_EDT. CI told the Respondent that Agent 1 would come back and that she “took all” after CI “halved some with her.”
62. On April 2, 2015, at approximately 3:04 p.m., the Respondent and CI spoke on the phone. GE-16, file 2015-04-02_15-04-43_EDT. CI asked the Respondent whether he could write her “80” if someone came in to see him.
63. On April 6, 2015, at approximately 8:59 p.m., the Respondent and CI spoke on the phone. GE-16, file 2015-04-06_20-59-35_EDT. CI told the Respondent that she had talked to Agent 1, who was coming on Wednesday.
64. On April 7, 2015, at approximately 1:29 p.m., the Respondent and CI spoke on the phone. GE-16, file 2015-04-07_13-29-34_EDT. CI asked the Respondent if she could attend Agent 1's appointment.
65. On April 7, 2015, at approximately 6:28 p.m., the Respondent and CI spoke on the phone. GE-16, file 2015-04-07_18-28-45_EDT. CI asked the Respondent if he wanted her to come with Agent 1 to her appointment the next day.
66. On April 7, 2015, at approximately 7:04 p.m., CI texted the Respondent and asked if he would meet her at Walmart the next day around lunch. GE-20, file 2015-05-06_141328_601-904-1188_FROM_2015-04-01_TO_2015-04-30_ALL.
67. On April 8, 2015, at approximately 8:59 a.m., CI again texted the Respondent and asked him to go to Walmart on his lunch break so that she could “run into” him. GE-21, at 3. CI texted the Respondent that Agent 1 would be there and that Agent 1 knew about their relationship, but was “cool” and would “cover” for CI. GE-21, at 5-6.
68. On April 8, 2015, at approximately 10:16 a.m., the Respondent and CI spoke on the phone. GE-16, file 2015-04-08_10-16-03_EDT. The Respondent said he would love to see CI at Walmart at noon that day.
69. On April 8, 2015, at approximately 12:31 p.m., CI texted the Respondent and said, if he wanted to save Agent 1 some money, he could bring a prescription for her with him to Walmart. GE-21, at 8. At 12:37 p.m., the Respondent replied that he “MUST see her in the office. You know why.” GE-21, at 9.
70. On April 8, 2015, Agent 1 accompanied CI to Walmart at approximately 12:45 p.m. GE-22-23; Tr. 128-29, 133-34. The Respondent met CI in the home furnishings department. GE-22; Tr. 389. CI wore a video and audio recording device. Tr. 347-48, 389;
71. The Respondent told CI to tell Agent 1 to space out her appointments more. Tr. 129-30. The Respondent said, “[w]e will be good now, so but you can't come back like every week for a prescription cause they keep up, it's like every 4 weeks.” GE-23. CI asked the Respondent how she was “supposed to last that long.” GE-23. The Respondent told her to “go buy a bottle of Vodka . . . .” GE-23.
72. At approximately 3:29 p.m., CI texted the Respondent that she really felt fat and asked him to write Agent 1 “something for that too.” GE-21, at 13.
73. Based on Findings of Fact 47 through 53, Findings of Fact 56 through 72, and the transcript at pages 91, 230, and 349, I find that, by the time the Respondent met with Agent 1 on April 8, 2015, the Respondent knew that Agent 1 was not a legitimate patient and that at least some of the medication he prescribed at that appointment would be given to and used by CI.
74. Agent 1 had a second appointment with the Respondent that took place on April 8, 2015. GE-24-25; Tr. 102. The Respondent's nurse asked Agent 1 why she was back so soon after her first visit and if she was taking her medication correctly. GE-24; GE-25, at 1; Tr. 103. Agent 1 said she just “ran out” of medication and was taking it twice a day. GE-25, at 1.
The nurse told her that she did not need to take pain medication “every day all year long.” GE-25, at 1.
75. The Respondent met with Agent 1 and asked her what she had going on. GE-25, at 1. Agent 1 said, “Same thing. Same stuff.” GE-25, at 1. The Respondent asked if the medicine had helped. GE-25, at 1. Agent 1 said it helped “a little bit.” GE-25, at 1. The Respondent began writing almost immediately after he entered the room without conducting any sort of examination of Agent 1. GE-24-25; Tr. 103-04, 132. The appointment lasted approximately seven minutes. GE-24.
76. The Respondent and Agent 1 talked casually about boating and skiing. GE-25, at 2-3. The Respondent took out his prescription pad and wrote prescriptions for Agent 1. GE-25, at 3. The Respondent said, “[w]e need to kinda stretch this out [to] make it last a month.” GE-25, at 3.
77. The Respondent wrote two prescriptions
78. On April 8, 2015, at approximately 5:01 p.m., CI texted the Respondent and said “[t]hank u sweetheart for hooking me up again :).” GE-20, file 2015-05-06_141328_601-904-1188_FROM_2015-04-01_TO_2015-04-30_ALL.
79. On April 8, 2015, at approximately 6:15 p.m., the Respondent and CI spoke on the phone. GE-27.
80. On April 14, 2015, at approximately 3:48 p.m., CI texted the Respondent and asked him how many friends she could “send in ur office for `headaches' lol?” GE-20, file 2015-04-14_15-48-52_EDT.
81. On April 14, 2015, at approximately 6:47 p.m., the Respondent and CI spoke on the phone. GE-38.
82. On April 14, 2015, at approximately 7:02 p.m., CI texted the Respondent and asked if he had any Adipex left over from a prescription to his wife. GE-20.
83. On April 15, 2015, at approximately 9:30 p.m., the Respondent and CI spoke on the phone. GE-20, 28. CI talked about being severely depressed. GE-28, file 2015-04-15_21-30-59_EDT, at 9. The Respondent talked about how CI's husband would not let her “have drugs.”
84. On April 22, 2015, at approximately 10:28 a.m., the Respondent and CI spoke on the phone. GE-20, 28. CI told the Respondent that Agent 1 and some of her friends were coming next week to see the Respondent. GE-28, file 2015-04-22_10-28-41_EDT, at 3. The Respondent warned CI that he had to be careful because it was “super serious.”
85. On April 22, 2015, at approximately 12:10 p.m., the Respondent texted CI that he “CANNOT do anything other than legitimate medical stuff” because it was risky and CI's husband had everyone “on high alert.” GE-20. CI texted back and asked if he would see Agent 1 next week, and that Agent 1 and her friends would not “tell.” GE-20. CI asked him to “write in their chart it's for migraines like u always do.” GE-20. The Respondent texted back that he would see Agent 1 and treat her in a medically appropriate way. GE-20. The Respondent also texted that his usual prescription for Lorcet (40) “should last more than a month.” GE-20. The Respondent texted that his feelings for CI needed to be “totally separate from [his] medical practice.” GE-20.
86. On April 22, 2015, at approximately 1:03 p.m., the Respondent and CI spoke on the phone. GE-20, 28. The Respondent said that they had to be really careful because the Mississippi Board was watching him. GE-28, file 2015-04-22_13-03-23_EDT, at 1-2. He compared their situation to going to “buy drugs at a crack house.”
87. On April 22, 2015, at approximately 2:32 p.m., CI texted the Respondent, “[w]hat I wouldn't do for an aipex [sic] right now ! Omg :/.” GE-20, file 2015-04-22_14-32-41_EDT.
88. On April 27, 2015, at approximately 2:45 p.m., the Respondent and CI spoke on the phone. GE-20, 28. CI said she spoke to Agent 1, who was going to see the Respondent that Wednesday. GE-20, file 2015-04-27_14-45-16_EDT. The Respondent said he would be glad to see her.
89. On April 28, 2015, at approximately 8:23 p.m., the Respondent and CI spoke on the phone. GE-20, 28. CI told the Respondent to not forget that Agent 1 and Agent 2 were coming tomorrow. GE-28, file 2015-04-28_20-23-38_EDT, at 1. The Respondent acknowledged that he knew they were coming and said he would see them then.
90. On April 29, 2015, at approximately 9:38 a.m., the Respondent and CI spoke on the phone. GE-20, 28, 29. CI told the Respondent not to forget that Agent 1 was coming that day. GE-29, at 7. The Respondent replied that he would not forget and would “take care of her.” GE-29, at 7. CI told him to give her cough medicine. GE-29, at 7. The Respondent said he would see what he could do, but that CI was “really pushing [his] envelope.” GE-29, at 7.
91. On April 29, 2015, at approximately 3:40 p.m., CI texted the Respondent that Agent 1 said that Agent 2 “ `has a cough too' if u could hook her up with some cough med . . . Please :) .” GE-39, at 5.
92. Based on Findings of Fact 47 through 53, 56 through 72, and 75 through 91, and the transcript at pages 91, 136, 230, and 349, I find that, by the time the Respondent met with Agents 1 and 2 on April 29, 2015, the Respondent knew that Agent 1 and Agent 2 were not legitimate patients and that at least some of the medications that he prescribed to them during their appointments that day would be given to and used by CI and/or shared by the Agents.
93. Agent 1 had a third appointment with the Respondent, which occurred on April 29, 2015. GE-30-31; Tr. 111.
94. The Respondent met with Agent 1 and asked her, “Headaches for you?” GE-31, at 1. Agent 1 responded, “Yep.” GE-31, at 1. The Respondent performed a brief examination of Agent 1, checking her ears and nose. GE-30-31; Tr. 112, 132. The Respondent observed that Agent 1 still had “refills on the other.” GE-31, at 1.
95. Agent 1 told the Respondent that she talked on the phone with a friend of hers, who told her that she was coughing a lot and needed to get something for her cough; Agent 1 also told the Respondent that she had not paid it much attention to it. GE-31, at 1; Tr. 133, 138-39. The Respondent immediately told Agent 1 that he would give her some cough syrup. GE-30; Tr. 133, 139-40. Agent 1 was not coughing during the appointment. GE-30; Tr. 138. Agent 1 did not tell the Respondent that she had a cough. GE-30-31; Tr. 113, 132. Agent 1 did not directly request cough syrup from the Respondent. GE-30-31; Tr. 113.
96. The Respondent wrote two prescriptions to Agent 1: one for 40 Norco 10/325, and one for eight ounces of Hycodan. GE-32-33; Tr. 113.
97. Agent 2 also had an appointment with the Respondent on April 29, 2015. GE-34-35; Tr. 143.
98. The Respondent met with Agent 2. GE-34-35; Tr. 144;
99. The Respondent wrote two prescriptions for Agent 2: one for 40 Norco 10/325, and one for Maxalt with unlimited refills. GE-35, at 3; GE-36-37; Tr. 144.
100. On April 29, 2015, at approximately 1:48 p.m., the Respondent and CI spoke on the phone. GE-29, at 9. CI asked the Respondent if he had seen Agent 1. GE-29, at 9. The Respondent said he had. GE-29, at 9. CI asked him what he gave her. GE-29, at 9. The Respondent said, “appropriate medicine,” and laughed. GE-29, at 9. He said that he gave her something for her headache and cough. GE-29, at 9. CI thanked the Respondent. GE-29, at 9.
101. On April 30, 2015, at approximately 9:19 a.m., the Respondent and CI spoke on the phone. GE-40;
102. The DEA's investigation was suspended while the Respondent campaigned for political office. Tr. 78. The DEA contacted CI in October 2015 and asked her to talk to the Respondent again to try to get him to write another prescription. Tr. 358. CI said no. Tr. 358.
103. Agent 1 had a fourth appointment with the Respondent, which took place on October 16, 2015. Tr. 78, 119. The purpose of this appointment was to refresh the investigation concerning the Respondent. Tr. 78. Upon arriving at the Respondent's clinic, the Respondent's receptionist told Agent 1 that her chart had been misplaced,
Agent 1 waited for about an hour and twenty minutes before she was called into an exam room. GE-42; Tr. 406.
104. Agent 1 met with the Respondent. GE-42;
105. The Respondent discussed the most effective medication for Agent 1 to take for headaches. GE-43, at 2-3. Agent 1 asked the Respondent if he remembered Agent 2. GE-43, at 3. The Respondent stopped, thought about it, and said he did not. GE-42, 43.
106. Agent 1's recording device partially failed and did not record the last few minutes of Agent 1's appointment with the Respondent. Tr. 79, 451.
107. While the Respondent was writing prescriptions for Agent 1, she asked the Respondent if he had spoken with CI lately. Tr. 122, 135, 452-53. The Respondent paused and looked surprised, then continued writing the prescriptions and stated that he had not heard from CI lately. Tr. 122-23.
108. The Respondent wrote Agent 1 prescriptions for 30 Norco 5/325, four ounces of Hycodan, Maxalt, Zyrtec, and dexamethasone. GE-44-47, 54; Tr. 120, 126-27, 452. The Respondent discussed these prescriptions with Agent 1 during the appointment. Tr. 452-53, 455-56.
109. During this visit, Agent 1 did not say that she had a cough. GE-42-43; Tr. 126, 138-39, 454. Agent 1 only stated at the outset of the appointment that she needed the “same as before,” and did not tell the Respondent that she had any specific complaints. GE-42-43; Tr. 454. The Respondent nonetheless prescribed cough syrup to Agent 1. GE-45; Tr. 139.
110. The Respondent was arrested on December 9, 2015. Tr. 427, 432. That same day, the DEA searched the Respondent's office and examined his records and patient files. Tr. 427, 432. The Respondent's office kept patient files in a general population of files. Tr. 433.
111. The DEA unlocked the Respondent's desk drawer and discovered several patient files that had not been kept in the general population of patient files. Tr. 428, 432. In the Respondent's desk, the DEA found one patient file for Agent 1, one file for CI, one file for Kid 1, and one file for Kid 2. Tr. 428;
112. The DEA found a second patient file for Agent 1 within the general population of the Respondent's patient files. Tr. 433;
Additional facts required to resolve the issues in this case are included below in the Analysis section of this Recommended Decision.
To revoke a respondent's registration, the Government must prove, by a preponderance of the evidence, that the regulatory requirements for revocation are satisfied.
(1) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(2) The [registrant's] experience in dispensing, or conducting research with respect to controlled substances.
(3) The [registrant's] conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable State, Federal, or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health and safety.
These public interest factors are considered separately.
The Government bears the initial burden of proof, and must justify revocation by a preponderance of the evidence.
Neither party directly advanced an argument under Factor One. However, a substantial portion of the Respondent's post-hearing brief (“ALJ-34”) argues that the DEA should give significant deference to the Mississippi Board's termination of its investigation against the Respondent. ALJ-34, at 3-6. Therefore, by inference, the Respondent advanced a theory under Factor One that his license should not be revoked because the Mississippi Board declined to take formal disciplinary action against him.
Although the Mississippi Board did not make a formal recommendation to the DEA in this matter, the DEA interprets a state licensing board's “recommendation” broadly.
Here, the Mississippi Board has not revoked, suspended, or restricted the Respondent's license. GE-1, at 1; GE-3, at 1. The Mississippi Board investigated the Respondent in March 2015.
The fact “that a state has not acted against a registrant's medical license is not dispositive in this administrative determination as to whether continuation of a registration is consistent with the public interest.”
Allegations 1 through 5 all claim that the Respondent illegitimately prescribed controlled substances outside the course of his professional practice.
Under the Controlled Substances Act (“CSA”), it is unlawful for a person to distribute controlled substances, except as authorized under the CSA. 21 U.S.C. 841(a)(1). To combat drug abuse and trafficking of controlled substances, “Congress devised a closed regulatory system making it unlawful to manufacture, distribute, dispense, or possess any controlled substance except in a manner authorized by the CSA.”
A controlled substance prescription is not valid unless it is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR § 1306.04(a). Federal regulations further provide that “[a]n order purporting to be a prescription issued not in the usual course of professional treatment . . . is not a prescription within the meaning and intent of [21 U.S.C. § 829] and . . . the person issuing it, shall be subject to the penalties provided for violations of [controlled substance laws].”
Much like the federal regulations, the Mississippi Code provides that it is illegal to dispense Schedule II
The DEA recognizes several methods to show that a registrant wrote prescriptions without a legitimate medical purpose and outside of the usual course of professional practice.
Typically, the Government uses expert testimony to establish a violation of 21 CFR 1306.04(a).
In the Government's post-hearing brief (“ALJ-35”), it advanced two theories regarding how the Respondent violated 21 CFR § 1306.04(a): (1) the Respondent knowingly diverted controlled substances to CI, and (2) the Respondent violated state medical practice standards. ALJ-35, at 18-24. The Government can prove that a registrant acted outside of the usual course of professional practice and lacked a legitimate medical purpose by “providing evidence showing that [the registrant] knowingly diverted drugs.”
In Allegation 1, the Government claimed that the Respondent prescribed hydrocodone and alprazolam to CI from February 2014 to May 2015
Under the Mississippi Administrative Code, the Mississippi Board requires that a prescribing physician must:
maintain a complete record of his or her examination, evaluation and treatment of the patient which must include documentation of the diagnosis and reason for prescribing, dispensing or administering any controlled substance; the name, dose, strength, quantity of the controlled substance and the date that the controlled substance was prescribed, dispensed or administered.
Further, the Mississippi Board requires that a physician cannot prescribe a controlled substance “without a good faith prior examination and medical indication therefore.”
The evidence establishes that, on four occasions, the Respondent prescribed controlled substances to CI without writing any notes about any prescriptions or examinations in CI's patient file. On May 22, 2014, the Respondent prescribed 40 units of Norco 10/325 to CI. GE-41, at 4; GE-49, at 2. On June 17, 2014, the Respondent prescribed 40 units of Norco 7.5/325
Because of the complete absence of this required information in CI's patient file, the prescriptions that the Respondent wrote to CI on these four dates were improper under Mississippi Administrative Rule 1.4. The Government's allegations that these four prescriptions to CI violated Mississippi Administrative Rule 1.4 are
On October 6, 2014, the Respondent prescribed 40 units of alprazolam 1 mg, with one refill, to CI. GE-41, at 22; GE-49, at 1. In CI's medical file, near a date stamp reading September 2, 2014, the Respondent noted “Xanax 1mg (#40, 1),” but did not write any justification for this prescription, as is required by Mississippi Administrative Rule 1.4.
The Government also alleged that the Respondent prescribed 40 units of a hydrocodone product to CI on October 29, 2014. ALJ-1, at 2. Although this alleged prescription is noted on CI's PMP report,
Beyond the above-mentioned specific prescribing events, the Government provided ample evidence that, throughout 2014, the Respondent prescribed controlled substances to CI outside of the usual course of his professional practice and without a legitimate medical purpose. The DEA has held, even without the benefit of expert testimony, that a controlled substance prescription based on a patient's request “rather than the result of the application of the physician's medical judgment” lacks a medical purpose.
It is true that, at times, the Respondent intended to treat CI's medical conditions. GE-2, at 12-13; Tr. 215, 277-78, 287, 321. However, even if the Respondent subjectively intended to provide legitimate medical treatment to CI, “[t]he appropriate focus is not on the subjective intent of the doctor, but rather . . . whether the physician prescribe[d] medicine `in accordance with [the accepted] standard of medical practice.' ”
Here, CI took Norco daily and recreationally, and the Respondent gave prescriptions to CI upon her request. Tr. 297-99. The Respondent gave prescriptions to CI at her house, at her children's appointments, and in the garden section of Walmart. Tr. 26, 217-20. The Respondent did not provide CI with a diagnosis or perform physical examinations before giving these prescriptions to CI.
Importantly, the Respondent only made three entries in CI's patient file in 2014, on February 21, April 21, and September 2, and he made no entries in CI's patient chart in 2015.
In Allegation 2, Government claimed that the Respondent prescribed phentermine
The administration of weight loss medication is regulated by state medical standards.
1. Past medical history, past surgical history, social history, family history, weight history, dietary history, gynecological (GYN) history if female, review of systems, allergies and medications.
2. Height, weight, Body Mass Index (BMI), blood pressure, pulse, % body fat or waist circumference/weight hip ratio, HEENT, chest, heart, abdomen, extremities.
3. Appropriate testing related to medical weight loss . . . .
The Government presented evidence that the Respondent wrote four prescriptions for phentermine to CI. On April 9, 2014, the Respondent prescribed 30 units of Adipex 37.5 to CI. GE-7, at 1-2; GE-49, at 2. On May 19, 2014, the Respondent prescribed 30 units of Adipex 37.5, with one refill to CI. GE-7, at 3-4; GE-41, at 2-3; GE-49, at 2. On July 24, 2014, the Respondent prescribed 30 units of Adipex 37.5 to CI. GE-7, at 5-6; GE-41, at 12-13; GE-49, at 2. On September 8, 2014, the Respondent prescribed 30 units of phentermine 37.5 with two refills to CI. GE-7, at 7-8; GE-41, at 18-19; GE-49, at 2. During 2014, CI filled these prescriptions seven times. GE-49, at 1-2.
In the administrative record, there are only four notations in the Respondent's files related to phentermine, Adipex, or weight loss prescriptions. The first mention of phentermine is in the Respondent's patient file for Kid 1 near a date stamp reading February 4, 2014. GE-57, at 6; Tr. 286. That note reads, “Mother has migraines ? in children May call in Rx if needed. Discussed phentermine c
Accordingly, while prescribing phentermine to CI on April 9, May 19, July 24, and September 8, the Respondent completely failed to comply with the requirements of Mississippi Administrative Rule 1.5. The Respondent never prescribed phentermine adjunctively with caloric restriction. He never conducted and recorded an initial comprehensive evaluation. He never recorded a thorough patient history or physical examination. He never conducted an in-person re-evaluation of CI once every 30 days. He never recorded CI's, BMI, blood pressure, pulse, past medical history, social history, family history, dietary history, gynecological history, height, weight, or body measurements. He did not document CI's efforts to lose weight or note her response to treatment.
A prescriber lacks good faith if he prescribes controlled substances to a patient who the prescriber knew or should have known had no legitimate medical need for the controlled substances prescribed. Miss. Code R. § 30-17-2640:1.4. It is concerning that the Respondent wholly failed to document any justification whatsoever for CI's supposed need for weight loss medication. During 2014, CI went from 135 pounds down to 121 pounds. Tr. 224. At the hearing, CI presented with a slender body type. After observing CI's appearance, I find it difficult to comprehend, from even a layman's perspective, how the Respondent could have possibly believed that CI had a high enough BMI
The Respondent displayed a complete disregard for Mississippi's weight loss prescription requirements. He prescribed weight loss drugs to CI without any documented medical justification. GE-2, at 12-13. “[W]here a medical record contains no findings that support a diagnosis, . . . expert testimony is not necessary to conclude that a prescription lacked a legitimate medical purpose.”
The Respondent argued in his post-hearing brief that, after receiving the Mississippi Board's warning letter, he refused to prescribe weight loss medication to an undercover agent. ALJ-34, at 6. The Respondent argued that this refusal showed that he “came promptly into conformity” with Mississippi's weight loss medication prescribing standards. ALJ-34, at 6. However, even if the Respondent took remedial measures, those measures, standing alone, cannot rebut the Government's
In Allegation 3, the Government claimed that, from February 7 to November 19 of 2014, the Respondent prescribed hydrocodone products to CI's children without conducting examinations, and that the prescriptions were for CI's personal use, in violation of Mississippi Administrative Rules 1.4, 1.10, 1.11(b),
Additionally, the Government alleged that the Respondent prescribed hydrocodone-homatropine (“cough”) syrup, or Hycodan, to CI's children, who were under the age of six, even though cough syrup is not recommended for children under the age of six because of a risk of death. ALJ-1, at 3. The Government alleged that the Respondent prescribed adult dosages of this cough syrup to these children, even though the recommended dosage for children aged six to eleven is half of the adult dosage. ALJ-1, at 2-3.
The Government further alleged that the Respondent issued the following improper prescriptions for hydrocodone combination products to CI's children in
On February 7, 2014, the Respondent wrote a prescription for 240 units of Hycodan to Kid 2. GE-50, at 1; GE-55, at 1-2. The Respondent's medical file for Kid 2 appeared to contain a notation from 2014, possibly from February 7, documenting a Hycodan prescription.
CI testified that the Respondent did not examine Kid 2 before prescribing cough syrup to her in February. Tr. 217, 251. The Respondent's patient file for Kid 2 does not include any notes about any physical examination on that date. The Respondent did not document a diagnosis for Kid 2 on that date. Because this required information was not recorded prior to prescribing controlled substances to Kid 2, the Government's allegation that the Respondent violated Mississippi Administrative Rule 1.4 by failing to conduct a physical examination of Kid 2 is SUSTAINED by a preponderance of the evidence, and weighs in favor of the revocation sought by the Government. Because this prescription violated Mississippi Administrative Rule 1.4, it was issued outside of the course of the Respondent's legitimate professional practice under Mississippi Administrative Rule 1.16. Therefore, the Government's allegations that the Respondent violated Mississippi Administrative Rule 1.16, Mississippi Code §§ 73-25-29(3) and (13), and 21 CFR § 1306.04(a) on February 7, 2014, are also
Just 15 days before the February 7, 2014 prescription, the Respondent prescribed 120 units (or 24 days' worth) of Hycodan syrup to Kid 2.
The Respondent wrote three prescriptions to CI's children without recording the prescriptions in the children's medical records. First, on June 17, 2014, the Respondent wrote a prescription for six ounces (or 180 units) of Hycodan syrup to Kid 1. GE-51, at 1; GE-55, at 3-4. The Respondent's patient file for Kid 1 does not contain any notes dated on or about
The Respondent did not write the name, dose, strength, or quantity of any of these prescriptions in the medical records of CI's children. The Respondent did not record the dates of the prescriptions or the reasons for the prescriptions. The Respondent did not record any notes about any physical examinations on these dates. There is no evidence in the record before me indicating that the Respondent ever saw CI's children on the dates that he wrote these prescriptions to them. Even absent any expert testimony, failure to see a patient before prescribing medications to the patient is outside of the legitimate practice of medicine.
The Government further alleged that these prescriptions were issued for CI's personal use. The Government bears the burden of proof on this point. The administrative record in this case supports the conclusion that the Government established, by a preponderance of the evidence, that the Respondent knew that CI would consume at least part of the cough syrup he prescribed to CI's children on June 17, July 23, and November 19. In this regard, CI testified that: (1) she would tell the Respondent when her child would have a cough; (2) she never brought her children to see the Respondent regarding a cough; (3) she requested cough syrup from the Respondent because she enjoyed drinking it; and (4) she would request a big bottle of cough syrup. Tr. 220, 265-66, 273. In addition, the administrative record supports CI's testimony that she did not bring her children to see the Respondent regarding a cough, as evidenced by their medical charts. GE-
On September 2, 2014, the Respondent wrote a prescription for four ounces (or 120 units) of Hycodan for Kid 2. GE-50, at 1; GE-55, at 7-8. The Respondent's patient file for Kid 2 included some notes dated September 2, 2014. GE-56, at 3. These notes stated, “URI Ears clear Nose, OC/OP mildly inflamed Lungs clear Rx [illegible] 15 Hycodan.” GE-56, at 3. Because these notes indicate that the Respondent examined Kid 2, and because the Government did not enter any evidence contesting the accuracy of these notes, I find that the Government failed to show by substantial evidence that the Respondent did not conduct a physical examination of Kid 2 on September 2, and the Government's allegation to that effect is NOT SUSTAINED. However, Kid 2's medical record did not include any diagnosis or reason for prescribing Hycodan to Kid 2, as required by Mississippi Administrative Rule 1.4. Additionally, the medical record did not clearly include the dose, strength, or quantity of Hycodan prescribed to Kid 2, as required by Mississippi Administrative Rule 1.4. Because the medical record did not contain this information, the Government's allegation that the September 2, 2014 prescription to Kid 2 violated Mississippi Administrative Rule 1.4 is SUSTAINED by a preponderance of the evidence, and weighs in favor of the revocation sought by the Government. Because this prescription violated Mississippi Administrative Rule 1.4, it was issued outside of the course of the Respondent's legitimate professional practice under Mississippi Administrative Rule 1.16. Therefore, the Government's allegations that the Respondent violated Mississippi Administrative Rule 1.16, Mississippi Code §§ 73-25-29(3) and (13), and 21 CFR § 1306.04(a) by issuing the September 2, 2014 prescription are also SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government.
Similarly, on November 3, 2014, the Respondent wrote a prescription for six ounces (or 180 units) of Hycodan for Kid 2. GE-50, at 1; GE-55, at 9-10. The Respondent wrote a note near a date stamp reading November 4, 2014, in Kid 2's file. GE-56, at 2. This note said, “[illegible] 5 problems Rx Hycodan (6 oz) (requested).” GE-56, at 2. The medical record did not include documentation of a diagnosis and reason for prescribing controlled substances, other than the fact that it was “requested.” Moreover, the medical record did not include the dosage or strength of the Hycodan prescribed, as is required by Mississippi Administrative Rule 1.4. Further, the notes near the November 3, 2014 date stamp did not indicate that the Respondent conducted any examination prior to prescribing Hycodan to Kid 2, as is required by Mississippi Administrative Rule 1.4. Therefore, the Government's allegation that the November 3, 2014 prescription to Kid 2 violated Mississippi Administrative Rule 1.4 is SUSTAINED by a preponderance of the evidence, and weighs in favor of the revocation sought by the Government. Because this prescription violated Mississippi Administrative Rule 1.4, it was issued outside of the course of the Respondent's legitimate professional practice under Mississippi Administrative Rule 1.16. Therefore, the Government's allegations that the Respondent violated Mississippi Administrative Rule 1.16, Mississippi Code §§ 73-25-29(3) and (13), and 21 CFR § 1306.04(a) by issuing the November 3, 2014 prescription are also SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government.
The Government also alleged that the September 2 and November 3 prescriptions were issued for CI's personal use. The Government bears the burden of proof on this point. The administrative record in this case supports the conclusion that the Government established, by a preponderance of the evidence, that the Respondent knew that CI would consume at least part of the cough syrup he prescribed to CI's children on September 2 and November 3. In this regard, CI testified that: (1) she would tell the Respondent when her child would have a cough: (2) she never brought her children to see the Respondent regarding a cough; (3) she requested cough syrup from the Respondent because she enjoyed drinking it; and (4) she would request a big bottle of cough syrup. Tr. 220, 266, 273. In addition, the administrative record supports CI's testimony that she did not bring her children to see the Respondent regarding a cough, as evidenced by their medical charts. GE-56, at 2-4; GE-57, at 5-6. I find that CI's testimony, when considered cumulatively and in conjunction with other evidence of record, establishes that, at the time the Respondent wrote the September 2 and November 3 prescriptions, he knew that CI would drink at least some of the cough syrup, though there was no medical reason for her to do so. Therefore, the Government's allegations that these two prescriptions violated Mississippi Administrative Rule 1.10 and 21 CFR 1306.05(a) are SUSTAINED by a preponderance of the evidence, and weigh in favor of the revocation sought by the Government.
The Government alleged that the Respondent prescribed cough syrup to CI's children, who were under the age of six, even though cough syrup is not recommended for children under the age of six because of a risk of death. ALJ-1, at 3. The Government also alleged that the Respondent prescribed adult dosages of cough syrup to these children, even though the recommended dosage for children aged six to eleven is half of the adult dosage. ALJ-1, at 2-3.
There is no evidence on the record before me
In Allegation 4, the Government claimed that, on five occasions between March and October 2015, the Respondent prescribed controlled substances to undercover agents when he knew or should have known that the agents' prescription requests were fraudulent, in violation of 21 U.S.C. §§ 841(a) and 842(a) and 21 CFR § 1306.04(a). ALJ-1, at 3. The Government alleged that the Respondent wrote seven hydrocodone prescriptions on five occasions to undercover agents, for 190 total dosage units of hydrocodone tablets and 72 total dosage units of hydrocodone syrup. ALJ-1, at 11. The Government alleged that, on four of those occasions, the Respondent knew that CI would receive a portion of the prescribed medications. ALJ-1, at 3-4.
The evidence against the Respondent regarding the first four undercover appointments is significant, conclusive, and uncontested.
The Respondent compared his diversion of drugs to CI with going to “buy drugs at a crack house.” GE-28, file 2015-04-22_13-03-23_EDT, at 2. In some sense, this was an apt description. Whenever CI asked the Respondent for drugs, he would attempt to convey them to her. Prior to each of the first four undercover appointments, CI clearly and repeatedly asked the Respondent for controlled substances.
Even beyond this, the Respondent took extra efforts to facilitate the diversion of drugs to CI. The Respondent discussed the scheduling of Agent 1 and Agent 2's appointments with CI, and CI reminded him about the timing of those appointments.
It is true that the Respondent conducted appointments with Agents 1 and 2, and wrote notes in their medical files. In that aspect, this case is similar to
Moreover, the fact that a registrant conducted a medical appointment before prescribing controlled substances does not, standing by itself, validate the prescriptions issued; rather, an appointment may be used by a prescriber as “a sham justification to support an unlawful prescription.”
This is precisely what happened here. Before each of the first four undercover appointments, the record unambiguously shows that the Respondent knew exactly what he would prescribe to Agents 1 and 2 before they ever walked through his door, because he knew what drugs CI had requested. For example, the Respondent prescribed Hycodan to Agent 1, even though she was not coughing during her appointment, because he had told CI that he would get eight ounces of cough syrup to her. GE-33, at 1; GE-38, at 3-4, 8; Tr. 113. Following the second appointment, the Respondent himself acknowledged the sham nature of the appointment; he stated that he had made small talk with Agent 1 because “we had to be in there more than ten seconds” so that his “nosy nurse” would not think, “[d]ang, why is this appointment over with in ten seconds?” GE-27, at 1, 5. It is not surprising that, during Agent 1's second appointment, the Respondent did not bother to conduct even a sham physical examination.
The facts of this case present an appalling and flagrant disregard of a registrant's duty to prescribe controlled substances only to legitimate patients. While the Respondent told CI that his feelings fo