Page Range | 81641-83105 | |
FR Document |
Page and Subject | |
---|---|
81 FR 81818 - Sunshine Act Meeting Notice | |
81 FR 81769 - Sunshine Act; Notice of Board Member Meeting | |
81 FR 81813 - Sunshine Act Meeting: Board of Directors and Operations & Regulations Committee Telephonic Meetings | |
81 FR 81807 - Government in the Sunshine Act Meeting Notice | |
81 FR 81798 - Notice of Proposed Withdrawal and Notice of Public Meeting; California | |
81 FR 81801 - Notice of Realty Action: Application for Conveyance of Federally Owned Mineral Interests in Lee County, FL | |
81 FR 81765 - Registration Review; Draft Malathion Human Health Risk Assessment; Extension of Comment Period | |
81 FR 81761 - Notice of Receipt of Requests to Voluntarily Cancel Certain Pesticide Registrations and Amend Registrations To Terminate Certain Uses | |
81 FR 81857 - Virginia Disaster Number VA-00065 | |
81 FR 81856 - North Carolina Disaster #NC-00086 | |
81 FR 81780 - Determination That BENEMID (Probenecid) Tablet and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness | |
81 FR 81772 - Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification | |
81 FR 81765 - Environmental Impact Statements; Notice of Availability | |
81 FR 81785 - Use of The Seafood List To Determine Acceptable Seafood Names; Draft Compliance Policy Guide; Availability | |
81 FR 81783 - Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability | |
81 FR 81744 - Procurement List; Proposed Deletions | |
81 FR 81776 - Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Special Protocol Assessment | |
81 FR 81787 - Submission for OMB Review; 30-Day Comment Request: A National Survey of Nurse Coaches (NIH Clinical Center) | |
81 FR 81685 - Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements | |
81 FR 81866 - Submission for OMB Review; Comment Request | |
81 FR 81772 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
81 FR 81788 - Certificate of Alternative Compliance for the TUG MAXWELL PAUL MORAN | |
81 FR 81857 - SJI Board of Directors Meeting, Notice | |
81 FR 81699 - Fisheries of the Northeastern United States; Atlantic Herring Fishery; 2016 Management Area 1B Directed Fishery Closure | |
81 FR 81807 - Certain Mobile Electronic Devices; Institution of Investigation | |
81 FR 81768 - Notice of Proposals To Engage in or To Acquire Companies Engaged in Permissible Nonbanking Activities | |
81 FR 81769 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
81 FR 81748 - Notice of Public Meetings for the Draft Environmental Impact Statement for EA-18G “Growler” Airfield Operations at the Naval Air Station Whidbey Island Complex, Washington | |
81 FR 81698 - Fisheries of the Northeastern United States; Northeast Multispecies Fishery; Georges Bank Cod Trimester Total Allowable Catch Area Closure and Possession and Trip Limit Reductions for the Common Pool Fishery | |
81 FR 81786 - Notice of Joint Meeting by the Urology Interagency Coordinating Committee and the Diabetes Mellitus Interagency Coordinating Committee Meeting | |
81 FR 81736 - Proposed Information Collection; Comment Request; Voluntary Self-Disclosure of Violations of the Export Administration Regulations | |
81 FR 81733 - Submission for OMB Review; Comment Request | |
81 FR 81739 - Submission for OMB Review; Proposed Information Collection; Comment Request; Limited Access Death Master File Accredited Conformity Assessment Body Application for Firewalled Status | |
81 FR 81766 - Proposed Collection; Comment Request | |
81 FR 81745 - Procurement List; Additions | |
81 FR 81738 - Solid Urea From Russia: Final Results of Antidumping Duty Administrative and New Shipper Reviews; 2014-2015 | |
81 FR 81818 - Information Collection Request; Submission for OMB Review | |
81 FR 81814 - Applied Sciences Advisory Committee; Meeting | |
81 FR 81755 - Waterford Power, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
81 FR 81752 - Lawrenceburg Power, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request For Blanket Section 204 Authorization | |
81 FR 81758 - Gavin Power, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
81 FR 81757 - Pima Energy Storage System, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request For Blanket Section 204 Authorization | |
81 FR 81758 - Columbia Gas Transmission, LLC; Notice of Request Under Blanket Authorization | |
81 FR 81754 - Combined Notice of Filings #2 | |
81 FR 81751 - Combined Notice of Filings #1 | |
81 FR 81759 - Commission Information Collection Activities (FERC-511, FERC-515, & FERC-574); Comment Request | |
81 FR 81751 - Northern Indiana Public Service Company; Notice of Availability of Final Environmental Assessment | |
81 FR 81750 - PacifiCorp, Klamath River Renewal Corporation; Notice of Applications Filed With the Commission | |
81 FR 81753 - Entergy Arkansas, Inc.; Notice of Application Accepted for Filing, Soliciting Comments, Motions To Intervene, and Protests | |
81 FR 81755 - Commission Information Collection Activities (FERC-547); Comment Request | |
81 FR 81753 - Three Peaks Power, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
81 FR 81756 - Darby Power, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
81 FR 81753 - Midwest Generation, LLC; Notice of Filing | |
81 FR 81817 - Advisory Committee on Reactor Safeguards (ACRS), Meeting of the ACRS Subcommittee on Fukushima; Notice of Meeting | |
81 FR 81741 - Request for Comments and Notice of Public Meeting on a Preliminary Draft Convention on the Recognition and Enforcement of Foreign Judgments Currently Being Negotiated at The Hague Conference on Private International Law | |
81 FR 81817 - Advisory Committee on Reactor Safeguards (ACRS) Meeting of the ACRS Subcommittee on APR 1400; Notice of Meeting | |
81 FR 81819 - New Postal Products | |
81 FR 81858 - Ninety Seventh Plenary for RTCA SC-159 Navigation Equipment Using the Global Positioning System | |
81 FR 81859 - Thirtieth RTCA SC-216 Aeronautical Systems Security Plenary | |
81 FR 81857 - Thirteenth RTCA SC-231 TAWS Plenary | |
81 FR 81860 - Sixteenth Meeting of the RTCA Tactical Operations Committee | |
81 FR 81816 - Advisory Committee on Reactor Safeguards (ACRS) Meeting of the ACRS Subcommittee on Planning and Procedures; Notice of Meeting | |
81 FR 81719 - International Sanitary and Phytosanitary Standard-Setting Activities | |
81 FR 81816 - Notice of Permit Modification Received Under the Antarctic Conservation Act of 1978 | |
81 FR 81814 - Notice of Permit Applications Received Under the Antarctic Conservation Act of 1978 | |
81 FR 81815 - Notice of Permit Modification Received Under the Antarctic Conservation Act of 1978 | |
81 FR 81734 - Order Denying Export Privileges | |
81 FR 81735 - Order Denying Export Privileges | |
81 FR 81737 - Order Denying Export Privileges | |
81 FR 81732 - Order Denying Export Privileges | |
81 FR 81746 - Lake Eufaula Advisory Committee Meeting Notice | |
81 FR 81746 - Notice of Intent To Grant Exclusive Patent License to Per Vivo Labs, Inc.; Kingsport, TN | |
81 FR 81731 - Order Denying Export Privileges | |
81 FR 81808 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Applicant Information Form (1-783) | |
81 FR 81808 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of a Currently Approved Collection: National Clandestine Laboratory Seizure Report | |
81 FR 81733 - Order Denying Export Privileges | |
81 FR 81719 - Submission for OMB Review; Comment Request | |
81 FR 81747 - Government-Industry Advisory Panel; Notice of Federal Advisory Committee Meeting | |
81 FR 81663 - Temporary General License: Extension of Validity | |
81 FR 81787 - Government-Owned Inventions; Availability for Licensing and/or Co-Development | |
81 FR 81782 - Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications | |
81 FR 81779 - Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates; Guidance for Industry; Availability | |
81 FR 81796 - Incidental Take Permit Applications for Alabama Beach Mouse; Gulf Shores, Alabama | |
81 FR 81802 - Filing of Plats of Survey; NV | |
81 FR 81798 - Filing of Plats of Survey: Oregon/Washington | |
81 FR 81778 - Bacillus Calmette-Guerin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment; Draft Guidance for Industry; Availability | |
81 FR 81774 - Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments; Guidance for Industry; Availability | |
81 FR 81766 - Notice to All Interested Parties of Intent To Terminate the Receivership of 10400, Sun Security Bank, Ellington, Missouri | |
81 FR 81861 - Maritime Environmental and Technical Assistance (META) Program Workshop on Battery Applications in Maritime Transportation | |
81 FR 81756 - Combined Notice of Filings #2 | |
81 FR 81752 - Combined Notice of Filings #1 | |
81 FR 81761 - Utilization In the Organized Markets of Electric Storage Resources as Transmission Assets Compensated Through Transmission Rates, for Grid Support Services Compensated in Other Ways, and for Multiple Services; Notice Inviting Post-Technical Conference Comments | |
81 FR 81856 - Proposed Collection; Comment Request | |
81 FR 81825 - Proposed Collection; Comment Request | |
81 FR 81820 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending the Fees for NYSE Arca BBO and NYSE Arca Trades To Lower the Enterprise Fee | |
81 FR 81835 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Related to Fees for Use of Bats BZX Exchange, Inc. | |
81 FR 81834 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the Fee Schedule on the BOX Market LLC (“BOX”) Options Facility | |
81 FR 81842 - Self-Regulatory Organizations; Bats BYX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Related to Fees for Use of Bats BYX Exchange, Inc. | |
81 FR 81828 - Self-Regulatory Organizations; Bats EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change to Fees for Use of Bats EDGX Exchange, Inc. | |
81 FR 81832 - Self-Regulatory Organizations; Bats EDGA Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Related to Fees for Use of Bats EDGA Exchange, Inc. | |
81 FR 81825 - Self-Regulatory Organizations; The Depository Trust Company; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Modify the DTC Settlement Service Guide and Distributions Guide Relating to the Anticipated U.S. Market Transition to a Shortened Settlement Cycle | |
81 FR 81854 - Self-Regulatory Organizations; Miami International Securities Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Its Fee Schedule | |
81 FR 81830 - Self-Regulatory Organizations; The Depository Trust Company; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Modify the DTC Settlement Service Guide With Respect to Settlement Instructions Provided to DTC by Matching Utilities | |
81 FR 81844 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving 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 Customers To File and Serve Pleadings and Documents Through the FINRA Office of Dispute Resolution's Party Portal and To Permit Mediation Parties To Use the Portal | |
81 FR 81837 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Notice of Filing of a Proposed Rule Change To Extend the MSRB's Customer Complaint and Related Recordkeeping Rules to Municipal Advisors and To Modernize Those Rules | |
81 FR 81866 - Sanctions Actions Pursuant to Executive Order 13660 | |
81 FR 81745 - Fair Credit Reporting Act Disclosures | |
81 FR 81726 - Notice of Solicitation of Applications (NOSA) Inviting Applications for the Rural Business Development Grant Program To Provide Technical Assistance for Rural Transportation Systems | |
81 FR 81697 - Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements | |
81 FR 81805 - Notice of Temporary Concession Contracts for Certain Visitor Services in Acadia National Park | |
81 FR 81724 - Applications for Licensing as a Non-Leveraged Rural Business Investment Company Under the Rural Business Investment Program | |
81 FR 81858 - Thirteenth RTCA SC-228 Focused Plenary | |
81 FR 81789 - Agency Information Collection Activities: Record of Vessel Foreign Repair or Equipment Purchase | |
81 FR 81805 - Notice of Continuation of Concession Contracts | |
81 FR 81802 - Notice of Extension of Concession Contracts | |
81 FR 81857 - Revocation of License of Small Business Investment Company | |
81 FR 81769 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
81 FR 81859 - Forty Sixth RTCA SC-206 Aeronautical Information and Meteorological Data Link Services Plenary | |
81 FR 81860 - Forty Fifth RTCA SC-224 Airport Security Access Control Systems Plenary | |
81 FR 81812 - Mine Safety and Health Administration | |
81 FR 81810 - Petitions for Modification of Application of Existing Mandatory Safety Standards | |
81 FR 81861 - Agency Information Collection Activities: Information Collection Revision; Submission for OMB Review; Diversity Self-Assessment Template for OCC-Regulated Entities | |
81 FR 81863 - Agency Information Collection Activities: Information Collection Renewal; Comment Request; Reporting, Recordkeeping, and Disclosure Requirements Associated With Proprietary Trading and Certain Interests in and Relationships With Covered Funds | |
81 FR 81765 - SES Performance Review Board-Appointment of Members | |
81 FR 81819 - New Postal Product | |
81 FR 81820 - Order Approving Public Company Accounting Oversight Board Supplemental Budget for Calendar Year 2016 | |
81 FR 81740 - Proposed Information Collection; Comment Request; Limited Access Death Master File Systems Safeguards Attestation Forms | |
81 FR 81867 - National Research Advisory Council; Notice of Meeting | |
81 FR 81770 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
81 FR 81797 - Invasive Species Advisory Committee; Meeting | |
81 FR 81805 - 1-Hydroxyethylidene-1,1-Diphosphonic Acid from China; Scheduling of the Final Phase of Countervailing Duty and Antidumping Duty Investigations | |
81 FR 83104 - Federal Acquisition Regulation; Federal Acquisition Circular 2005-92; Small Entity Compliance Guide | |
81 FR 81664 - Used Motor Vehicle Trade Regulation Rule | |
81 FR 83103 - Federal Acquisition Regulation; Technical Amendments | |
81 FR 83092 - Federal Acquisition Regulation; Federal Acquisition Circular 2005-92; Introduction | |
81 FR 83092 - Federal Acquisition Regulation; Public Disclosure of Greenhouse Gas Emissions and Reduction Goals-Representation | |
81 FR 83097 - Federal Acquisition Regulation: Removal of Regulations Relating to Telegraphic Communication | |
81 FR 81712 - Approval and Disapproval and Promulgation of Air Quality Implementation Plans; Interstate Transport for Wyoming | |
81 FR 81711 - Revisions to the Prevention of Significant Deterioration (PSD) and Title V Greenhouse Gas (GHG) Permitting Regulations and Establishment of a Significant Emissions Rate (SER) for GHG Emissions Under the PSD Program | |
81 FR 81657 - Pima Agriculture Cotton Trust Fund and Agriculture Wool Apparel Manufacturers Trust Fund | |
81 FR 83008 - Waste Prevention, Production Subject to Royalties, and Resource Conservation | |
81 FR 81709 - Airworthiness Directives; Zodiac Aero Evacuation Systems | |
81 FR 81789 - Federal Property Suitable as Facilities To Assist the Homeless | |
81 FR 82398 - Retention of EB-1, EB-2, and EB-3 Immigrant Workers and Program Improvements Affecting High-Skilled Nonimmigrant Workers | |
81 FR 81704 - Airworthiness Directives; Learjet Inc. Airplanes | |
81 FR 81707 - Airworthiness Directives; The Boeing Company Airplanes | |
81 FR 81701 - Occupational Radiation Protection | |
81 FR 81660 - Airworthiness Directives; Various Aircraft Equipped With BRP-Powertrain GmbH & Co KG 912 A Series Engine | |
81 FR 81809 - Notice of Intent To Prepare a Supplemental Revised Final Environmental Impact Statement for the Proposed United States Penitentiary and Federal Prison Camp in Letcher County, Kentucky | |
81 FR 81641 - Standards of Ethical Conduct for Employees of the Executive Branch; Amendment to the Standards Governing Solicitation and Acceptance of Gifts from Outside Sources | |
81 FR 81870 - Investment Company Reporting Modernization | |
81 FR 82142 - Investment Company Liquidity Risk Management Programs | |
81 FR 82084 - Investment Company Swing Pricing | |
81 FR 82494 - Walking-Working Surfaces and Personal Protective Equipment (Fall Protection Systems) | |
81 FR 82272 - Protection of Stratospheric Ozone: Update to the Refrigerant Management Requirements Under the Clean Air Act |
Animal and Plant Health Inspection Service
Commodity Credit Corporation
Rural Business-Cooperative Service
Industry and Security Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
National Technical Information Service
Patent and Trademark Office
Army Department
Navy Department
Federal Energy Regulatory Commission
Agency for Healthcare Research and Quality
Centers for Medicare & Medicaid Services
Food and Drug Administration
National Institutes of Health
Coast Guard
U.S. Customs and Border Protection
Fish and Wildlife Service
Land Management Bureau
National Park Service
Prisons Bureau
Mine Safety and Health Administration
Occupational Safety and Health Administration
Federal Aviation Administration
Maritime Administration
Comptroller of the Currency
Foreign Assets Control Office
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Office of Government Ethics (OGE).
Final rule.
The U.S. Office of Government Ethics is issuing a final rule revising the portions of the Standards of Ethical Conduct for Executive Branch Employees that govern the solicitation and acceptance of gifts from outside sources. The final rule modifies the existing regulations to more effectively advance public confidence in the integrity of Federal officials. The final rule also incorporates past interpretive guidance, adds and updates regulatory examples, improves clarity, updates citations, and makes technical corrections.
This final rule is effective January 1, 2017.
Leigh J. Francis, Assistant Counsel, or Christopher J. Swartz, Assistant Counsel, Office of Government Ethics, Suite 500, 1201 New York Avenue NW., Washington, DC 20005-3917; Telephone: 202-482-9300; TTY: 800-877-8339; FAX: 202-482-9237.
On November 27, 2015, the U.S. Office of Government Ethics (OGE) published for public comment a proposed rule setting forth comprehensive revisions to subpart B of the Standards of Ethical Conduct for Employees of the Executive Branch (Standards of Ethical Conduct), 5 CFR part 2635. 80 FR 74004 (Nov. 27, 2015). Subpart B of part 2635 contains the regulations governing the solicitation and acceptance of gifts from outside sources by officers and employees of the Executive Branch. These regulations implement the gift restrictions set forth in 5 U.S.C. 7353 and section 101(d) of Executive Order 12674, as modified by Executive Order 12731. The proposed rule was issued following OGE's retrospective review of the regulations found in subpart B, pursuant to section 402(b)(12) of the Ethics in Government Act of 1978, Public Law 95-521, codified at 5 U.S.C. Appendix IV, sec. 402(b)(12). Prior to publishing the proposed rule, OGE consulted with the Office of Personnel Management and the Department of Justice in accordance with section 402(b) of the Ethics in Government Act and section 201(a) of Executive Order 12674, as modified by Executive Order 12731, and with other officials throughout the Federal Government.
The proposed rule provided a 60-day comment period, which ended on January 26, 2016. OGE received ten timely and responsive comments, which were submitted by four individuals, three professional associations, two Federal agencies, and a law firm. After carefully considering all comments and making appropriate modifications, and for the reasons set forth below and in the preamble to the proposed rule at
OGE received one comment from an individual observing that various references to spousal and dating relationships in the examples used dual-gendered relationships and gender-specific pronouns. The commenter expressed concern that such examples could be read as excluding same-sex marriages or relationships. OGE treats same-sex spouses the same as opposite-sex spouses for the purposes of all of its regulations. OGE Legal Advisory LA-13-10 (Aug. 19, 2013). OGE has therefore reviewed the examples highlighted by the commenter and has replaced the terms “husband” and “wife” with the gender-neutral term “spouse.”
Various commenters suggested that one or more of the proposed amendments to the rule might negatively impact the ability of the public to interact with Federal employees. These commenters pointed out the beneficial impact of this interaction and encouraged OGE to consider this equity in drafting gift regulations. As a general matter, OGE agrees with the commenters' proposition that communication between the Government and the public is vital to ensuring that Government decisions are responsive to citizen needs. Public interaction done in a non-preferential manner may: (1) Provide executive branch decisionmakers with information and data they may not otherwise possess; (2) identify policy options and alternatives that may not have been raised internally; and (3) produce better and more thoughtful decisions. These interactions must, however, occur in an environment that promotes the public's confidence in the integrity of Government decisionmaking. When Federal employees accept or solicit gifts from members of the public who have interests that are affected by the employee's agency, the public's confidence can be eroded as “[s]uch gifts may well provide a source of illicit influence over the government official; in any case they create a suspicious and unhealthy appearance.”
OGE received comments from three sources on proposed § 2635.201(b)(1). Section 2635.201(b)(1) establishes a non-binding standard that can assist employees in considering whether to decline an otherwise permissible gift. The standard encourages employees to consider whether their acceptance of a gift that would otherwise be permissible to accept would nonetheless create the appearance that their integrity or ability
Based on past experience with executive branch agencies applying subpart B of part 2635, OGE is concerned that employees and ethics officials may not be sufficiently analyzing appearance concerns and, instead, may be focusing exclusively on whether a gift can be accepted under a regulatory gift exception. This kind of analysis may unintentionally overlook other important considerations, such as “whether acceptance of the gift could affect the perceived integrity of the employee or the credibility and legitimacy of [an] agency's programs.” 80 FR 74004, 74004 (Nov. 27, 2015). The non-binding standard in § 2635.201(b)(1) was explicitly included in subpart B to correct for this tendency and to enhance the overall quality of employees' ethical decisionmaking.
Commenters on this section raised concerns with the new standard and the factors for applying the standard. OGE appreciates the concerns raised by commenters, which are examined in detail below. OGE has addressed these concerns by making appropriate adjustments to the standard, rather than adopting some of the commenters' requests for the outright removal of this section. The changes make the standard easier for employees to understand and apply.
A few commenters suggested that ethics training would be more effective than a regulatory change in ensuring that employees consider appearance issues before accepting gifts. OGE fully agrees with the commenters' suggestions that ethics education is important. Without this amendment of the regulation, however, there would not be a uniform standard upon which to base ethics training regarding appearance issues in connection with gifts. Prior to this amendment, the regulation cautioned only that “it is never inappropriate and frequently prudent for an employee to decline a gift,” but the regulation did not articulate an applicable standard or any factors for employees to use in identifying the frequently arising circumstances when it would be prudent to decline a gift. OGE believes it is imperative that the regulatory framework itself enable and encourage employees to meaningfully consider the appearances of accepting gifts. By articulating the standard and relevant factors, the amended § 2635.201(b)(1) will increase the value and uniformity of agency ethics training because that standard and those factors will become a focus of ethics training.
One commenter believed that the proposed standard creates confusion because it moves away from the previous system of bright-line rules regarding gift acceptance. Specifically, the commenter requested that OGE amend the regulation in a way that sets out definitive rules as to whether “a gift is simply permissible or impermissible, without further parsing the permissible gifts into additional categories,
The commenters also suggested that employees will feel compelled by this non-binding standard to always decline legally permissible gifts. OGE does not agree that the standard creates a presumption that all legally permissible gifts should be declined. Although some employees will decline legally permissible gifts after carefully analyzing them under the standard that § 2635.201(b)(1) establishes, the standard does not change the fact that the determination as to whether a legally permissible gift should be accepted is the employee's to make. Section 2635.201(b)(1) is designed to increase uniformity and promote public trust by articulating factors, which are informed by the ethical values consistent with the executive branch's Principles of Ethical Conduct, in order to guide the employee's decisionmaking process. This section provides employees an effective means of adequately assessing whether, notwithstanding a gift exception, the specific factual circumstances may raise appearance concerns weighing against acceptance of a gift.
In light of the comments referenced above, however, OGE has streamlined the language of § 2635.201(b). OGE has also clarified the overarching objective of that provision by placing the emphasis in § 2635.201(b)(1) on an assessment as to whether “a reasonable person with knowledge of the relevant facts would question the employee's integrity or impartiality.” In the proposed rule, substantially similar language appeared in the list of factors in § 2635.201(b)(2). Because this language articulates the standard to be applied, however, it is more appropriately included in paragraph (b)(1), which establishes the standard, than in paragraph (b)(2), which provides factors for determining whether the standard has been met. Using this “reasonable person” language in the articulated standard has the added benefit of addressing a commenter's concern regarding the potential for confusion, as executive branch employees have extensive experience applying this particular standard, which has long been used to address appearance concerns under § 2635.502. At the end of § 2635.201(b)(1), OGE has also added “as a result of accepting the gift” in order to tie the appearance concerns to the specific action giving rise to them.
As a final note, one commenter was concerned that the application of the reasonable person standard could vary, resulting in the “unequal application” of the standard. Reliance on a reasonable person standard, however, is not a novel approach in Government ethics. The Standards of Ethical Conduct at part 2635 have successfully employed the reasonable person standard for over two decades.
Two commenters requested that OGE remove § 2635.201(b)(2), which sets out factors that employees may consider when determining whether to decline
OGE reviewed each of the proposed factors closely to determine whether any could be removed, streamlined, or changed to eliminate unnecessary complexity or confusion. OGE removed several factors that appeared in the proposed rule on the basis that clarification of the reasonable person standard in § 2635.201(b)(1) in the final rule has rendered them unnecessary:
• Whether acceptance of the gift would lead the employee to feel a sense of obligation to the donor;
• Whether acceptance of the gift would cause a reasonable person to question the employee's ability to act impartially; and
• Whether acceptance of the gift would interfere with the employee's conscientious performance of official duties.
OGE has also revised the factor articulated at § 2635.201(b)(2)(iv). The proposed language read: “Whether acceptance of the gift would reasonably create an appearance that the employee is providing the donor with preferential treatment or access to the Government.” OGE's intent was that the word “preferential” would be read to modify both “treatment” and “access.” In light of concerns the commenters expressed regarding the clarity of § 2635.201(b)(2) generally, OGE has determined that the proposed language could have been clearer in this respect. In reviewing this language, OGE also noted that the phrase “preferential treatment” is redundant of the phrase “preferential . . . access to the Government,” in that the specific preferential treatment at issue is the preferential access that the donor may be perceived as having received. The concern is that a donor may offer a gift that, by its nature, would provide the donor with significantly disproportionate access to the employee. This concern can arise in connection with gifts such as frequent lunches, trips, social invitations, free attendance at widely attended gatherings, and other items. If such gifts were to result in an employee spending considerable time with a donor, the donor may appear to have inordinate opportunities to discuss matters of interest to the donor and, thereby, unduly influence the employee. Accordingly, OGE has simplified this language and made it more specific. The language at § 2635.201(b)(2)(iv) now reads: “Acceptance of the gift would provide the donor with significantly disproportionate access.” This language should not be read as discouraging employees from attending events merely because they present opportunities to discuss official business. There is no requirement to provide exact parity in all cases with regard to the level of access afforded to those with competing viewpoints, but there is a value in guarding against any person, or multiple persons with a common interest or viewpoint, from enjoying significantly disproportionate access as a result of having given gifts to employees. An employee who is concerned about the level of access provided to those with a particular viewpoint may choose to decline the offered gifts or may take steps to ensure that those with different viewpoints are able to communicate with the employee, such as by taking their telephone calls, agreeing to meet with them in the employee's office, or convening a public forum.
OGE has also removed the following two factors:
• With regard to a gift of free attendance at an event, whether the Government is also providing persons with views or interests that differ from those of the donor with access to the Government;
• With regard to a gift of free attendance at an event, whether the event is open to interested members of the public or representatives of the news media.
OGE believes that these changes to § 2635.201(b)(2) diminish the potential for confusion created by the longer list of factors included in the proposed rule while continuing to provide guidance as to how employees should apply the standard in § 2635.201(b)(1) in the areas that OGE believes raise the greatest potential for appearance problems.
One commenter raised a concern about the language OGE used in § 2635.201(b)(4), which reminds employees to contact an appropriate agency ethics official if they have questions regarding whether acceptance of a gift is permissible and advisable. The commenter was concerned that the statement “[e]mployees who have questions regarding . . . whether the employee
Nevertheless, to partly address the commenter's concern, OGE has deleted the reference to § 2635.107(b) at the end of § 2635.201(b)(4). After considering the commenter's concern, OGE recognized that the reference to § 2635.107(b) was potentially confusing because that section provides a safe harbor against disciplinary action in certain circumstances when an employee has consulted an agency ethics official. As § 2635.201(b)(3) makes clear, however, employees may not be disciplined under this provision and have no need for the safe harbor provision in connection with the appearance analysis under § 2635.201(b).
One commenter suggested that OGE should add examples to the regulation to indicate how to apply new § 2635.201(b). OGE has added Example 1 to paragraph (b) in order to illustrate how an employee may use the standard and factors found in § 2635.201(b). The same commenter also suggested that OGE provide additional guidance documents to further assist agency officials and employees in understanding how to apply the standard found in § 2635.201(b). OGE intends to provide additional guidance and training as needed on an ongoing basis.
OGE received no comments on § 2635.202. OGE is adopting the amendments to this section as proposed for the reasons described in the preamble to the proposed rule. A small change to Example 1 to paragraph (c) was made after the Supreme Court's recent decision in
OGE received a number of comments on the definitions of the terms “gift,” “market value,” “indirectly solicited or accepted,” and “free attendance.” In regard to the definition of “gift,” all comments focused on the exclusions to the definition. The comments for these terms are separately addressed in greater detail below.
OGE received three comments on proposed Example 1 to § 2635.203(b)(1). Section 2635.203(b)(1) explains that the definition of “gift” for purposes of subpart B excludes “[m]odest items of food and refreshments, such as soft drinks, coffee and donuts, offered other than as part of a meal.” Proposed Example 1 to paragraph (b)(1) was included for the purpose of making explicit OGE's longstanding interpretation that alcohol is not a modest item of refreshment under § 2635.203(b)(1). Because none of the beverages currently listed in the regulation are alcoholic and the exclusion specifically refers to “soft,” meaning non-alcoholic drinks, OGE has long treated alcoholic beverages as not being part of the class of modest refreshments covered by the exclusion.
All three of the commenters were concerned that the example seemed to indicate that attendance at an event where alcohol is served is
OGE received two comments on the proposed revisions to § 2635.203(b)(2). The first comment, from a professional association, was in favor of the proposal to modify the exclusion for presentation items. The second comment, from an individual, requested that OGE further amend the regulation to state that “items with little intrinsic value . . . intended primarily for presentation” are excluded from the definition of “gift” only if they “do not have significant independent use.” The individual noted that OGE used this phrase in proposed Example 2 to paragraph (b)(2) when explaining why a $25 portable music player would not be excluded from the definition of “gift” under this provision. OGE has decided not to adopt this change. As evidenced by the example, the fact that an item lacks other uses is a legitimate consideration in support of a finding that the item is intended “primarily for presentation.” The regulation does not, however, require that an item lack any potential other use in order to qualify as an item intended “primarily for presentation.”
OGE received one comment on the proposed example to § 2635.203(b)(7), which states that Federal employees may retain certain “travel promotional items, such as frequent flyer miles, received as a result of [] official travel, if done in accordance with 5 U.S.C. 5702, note, and 41 CFR part 301-53.” The commenter explained: (1) That employees who receive such frequent flyer miles should be encouraged to use such frequent flyer miles for subsequent official travel; and (2) that no personal use should be allowed for employees of the Federal Aviation Administration. OGE has not changed the substance of this example. As explained in the example, Congress passed a statute specifically permitting employees to accept these types of travel-related benefits. The General Services Administration (GSA) has primary authority for implementing that statute, and has done so through regulations found at 41 CFR part 301-53. To partly address the commenter's concern, however, OGE revised the language “if done in accordance with 5 U.S.C. 5702, note, and 41 CFR part 301-53,” to read “to the extent permitted by 5 U.S.C. 5702, note, and 41 CFR part 301-53,” in order to clarify that OGE's regulation does not create any new authority for accepting these travel related benefits beyond what Congress and GSA provided for in the statute and the regulation.
One commenter requested that OGE expand § 2635.203(b)(8) to exclude from the definition of “gift” free attendance at events where employees are speaking in their personal capacity on matters that are unrelated to their duties. The commenter noted that § 2635.203(b)(8) excludes free attendance in connection with official speaking engagements and requested a parallel exclusion for personal speaking engagements. OGE has not adopted this change. Normally, the Standards of Ethical Conduct would not prohibit an employee from accepting free attendance at an event at which the employee has a
OGE received two comments on the proposed amendments to the definition of “market value,” as used throughout the regulation, as well as the examples following the definition. OGE proposed to amend “market value” to mean “the cost that a member of the general public would reasonably expect to incur to purchase the gift.” One commenter was generally in favor of the amendment, as well as the examples illustrating how the definition would be applied in
OGE received one comment on § 2635.203(f), which establishes when a gift will be deemed to have been accepted or solicited indirectly. The commenter was in favor of OGE's amendment at § 2635.203(f)(2). OGE has adopted the language as proposed for the reasons set forth in the preamble to the proposed rule.
OGE received two comments in favor of the proposed subpart-wide definition of “free attendance” at § 2635.203(g). Both commenters supported OGE's amendment allowing employees who are presenting at an event to accept attendance at “speakers' meals” provided by the sponsor of the event. OGE has adopted the language as proposed for the reasons set forth in the preamble to the proposed rule.
Although OGE did not receive a specific comment on the title of the regulation, OGE has made a technical change to the title of this section for clarity and to more closely track the substance of the regulation.
OGE has also revised the introductory text to remind employees to consider the standard found in § 2635.201(b) when determining whether to rely on an exception. The revised language is modeled on the introductory text found in the current version of § 2635.204, but cross-references § 2635.201(b).
OGE received two comments requesting that OGE raise the regulatory dollar thresholds found in the gift exception at § 2635.204(a). Pursuant to § 2635.204(a), an employee may accept otherwise prohibited gifts not exceeding $20 per occasion so long as he or she does not accept more than $50 worth of gifts from the same person per year. In support of this request, one commenter pointed out the effect that inflation has had on the value of this
OGE carefully considered these commenters' suggestions. As OGE explained when it issued the final gift regulations, the
OGE received one comment in support of the new Example 3 to § 2635.204(b), which provides guidance on assessing whether a gift provided by a social media contact falls within the bounds of the gift exception. OGE has adopted the text of § 2635.204(b) substantially as proposed for the reasons set forth in the preamble to the proposed rule.
OGE did not make changes based on comments received from two individuals on proposed § 2635.204(d). Section 2635.204(d) permits employees to accept gifts of certain awards and honorary degrees, including items incident to such awards and degrees. The first commenter suggested that OGE relocate the two examples following paragraph (d)(1) so that they would appear after paragraph (d)(2). OGE has not adopted the suggestion. These examples address paragraph (d)(1), which establishes the several requirements for accepting awards, and do not specifically address paragraph (d)(2), which defines the term “established program of recognition.”
The second commenter addressed the acceptance of qualifying honorary degrees from certain “foreign institution[s] of higher education.”
OGE received one comment on the proposed amendments to § 2635.204(e), which sets forth various exceptions to the general prohibitions on accepting and soliciting gifts when such gifts are offered as a result of an outside business or employment relationship. The commenter was generally in favor of the amendments. OGE has retained the exception as proposed for the reasons set out in the preamble to the proposed rule.
OGE received a number of comments related to the exception at § 2635.204(g), permitting employees to accept offers of free attendance to widely attended gatherings (WAGs) if certain criteria are met. In the proposed rule, OGE presented a number of amendments to the WAG, including changes to: (1) Make it clear that an event does not qualify as a WAG if it does not present “an opportunity to exchange ideas and views among invited persons”; (2) require employees to obtain written authorizations before accepting gifts of free attendance at WAGs; and (3) require agency designees to weigh the agency's interest in employees' attendance at WAGs against the possibility that acceptance of gifts of free attendance will influence their decisionmaking or create the appearance that they will be influenced in their decisionmaking.
One commenter expressed concern about the proposed amendment to the definition of “widely attended gatherings.” The proposed language clarifies that events do not qualify as WAGs unless there is “an opportunity to exchange ideas and views among invited persons.” The commenter suggested that this language would narrow the rule to apply to only “panel or roundtable events.” OGE believes that this is a mischaracterization of the regulatory amendment. Nothing in the amendment would narrow the definition exclusively to roundtable or panel events. The amendment reflects only OGE's longstanding interpretation that the event must present an opportunity for an “exchange” or “interchange” of ideas among attendees.
Several commenters objected to the change requiring written authorizations because it might increase the workload of ethics officials. Three commenters raised workload concerns in connection with the requirement that an employee obtain a written authorization from an agency designee prior to accepting free attendance to a WAG, though one commenter acknowledged that a requirement to obtain written authorization “protects both the employee and the private sector sponsors.” OGE has not eliminated the requirement to obtain written authorization before an employee attends a WAG. Any additional burden on ethics officials will not be so substantial as to outweigh the potential benefits of recording WAG authorizations. In this regard, it is worth noting that agency ethics officials have long been required to make several of the findings required by § 2635.204(g)(3), as proposed. In addition, some agencies have already adopted the practice of recording all WAG authorizations in writing. In any case, most of the work required of ethics officials under the amended regulation will stem from the requirement to make a number of determinations that have always been required under the regulation. After making these determinations, ethics officials have discretion to determine the level of detail to include in the written authorization. The amended regulation does not, however, require a “formal written opinion” as one commenter suggested.
One commenter noted that the amended rule requires agencies to determine in all cases whether “[t]he agency's interest in the employee's attendance outweighs the concern that the employee may be, or may appear to be, improperly influenced in the performance of [his or her] official duties.” The regulation did not previously require this determination in every case, but agency officials have always been charged with evaluating “all the relevant circumstances of any proposed WAG before an employee is authorized to accept free attendance.” OGE Informal Advisory Opinion 07 x 14 (Dec. 5, 2007). The determination now required in all cases is consistent with this preexisting requirement, inasmuch as improper influence, or the appearance of improper influence, would necessarily have been a relevant circumstance to be analyzed under the regulation even prior to the current amendment.
Two commenters expressed concern that ethics officials will approve attendance at fewer events for substantive reasons. However, the new regulation does not significantly change the substantive analysis, which remains focused, as it always has been, on the potential for improper influence and the appearance of improper influence. Disapproval of a gift of free attendance, when an agency has determined that an employee's acceptance of the gift would result in improper influence or the appearance of improper influence, is a proper outcome under any responsible ethics regime.
OGE received two additional comments related to § 2635.204(g). One commenter posited a hypothetical case under § 2635.204(g)(1). OGE is not in a position to assess the interests of a hypothetical agency or other relevant factual circumstances not specified in the commenter's hypothetical. At the request of the other commenter, however, OGE has inserted a reference to the written determination requirement in proposed Example 4 to paragraph (g).
OGE received one comment from an agency on proposed § 2635.204(h), which permits an employee and accompanying guests to accept certain benefits that are provided at a “social event” so long as the person extending the invitation is not a prohibited source. The proposed rule added a requirement that employees receive a written determination that such attendance would not cause a reasonable person to question the employee's integrity if the event is sponsored by, or the invitation is from, an organization. The commenting agency questioned the purpose of this amendment and suggested that it could increase the workload of agency ethics officials.
Although OGE understands the programmatic consideration raised by the commenter, OGE does not believe that those concerns weigh significantly against the written determination requirement. In many cases, OGE believes that the analysis as to whether a reasonable person would question the employee's integrity or impartiality in attending will be relatively easy to assess, particularly given that the offeror cannot be a prohibited source. Likewise, the standard should be easier to meet if the circumstances indicate that the event is for purely social reasons or is open to a wide variety of attendees. Moreover, ethics officials have discretion to determine the level of detail to include in the written authorization and to choose an appropriate means, such as email, for transmitting the authorization. OGE does not, therefore, believe that the amended regulation will substantially increase the burden on ethics officials. At the same time, there is a heightened risk for, at a minimum, an appearance that the motivation for the gift is to advance a business objective when the sponsor of the event, or offeror of the invitation, is an organization. For this reason, OGE believes that the additional requirement with regard to organizations is warranted.
OGE has made three technical changes to the language of this exception for consistency with other sections and for clarity. First, OGE added the phrase “with knowledge of the relevant facts” to the language in § 2635.204(h)(3), which establishes a reasonable person standard for consistency with the wording of the reasonable person standard in § 2635.201(b) and elsewhere in the Standards of Ethical Conduct.
OGE has made a technical correction to § 2635.204(l)(1) so that the language tracks the interpreting regulation for 5 U.S.C. 4111 at part 410 of this title.
Two professional associations and an individual commented on the new exception at § 2635.204(m). The exception permits employees to accept qualifying gifts of informational materials. The exception also sets out certain procedural safeguards and defines what constitutes “informational materials” for the purposes of this provision.
One professional association welcomed the addition of the new exception on the basis that it will allow a flow of useful information to employees. The second professional association also supported the new exception, but requested that OGE amend the rule in two ways: (1) Clarify that the rule would permit the acceptance of “marketing and promotional materials”; and (2) clarify that when a gift of informational materials exceeds $100, an agency may authorize the employee to accept the gift on behalf of the agency if the agency has separate statutory authority. OGE has decided not to revise the proposed exception to include “marketing and promotional materials” as a specific category of acceptable informational materials. Whether an item qualifies for the exception will depend on whether the factual circumstances support a determination that the item offered meets the specific criteria set forth in § 2635.204(m). OGE has likewise decided not to amend the regulatory text to clarify that agencies may accept gifts of informational materials when the gift exceeds $100. Agencies with gift acceptance authorities have established their own procedures and policies regarding the acceptance of such gifts consistent with their interpretations of those authorities, and OGE is not in a position to direct another agency on the use of its gift acceptance authority.
Another commenter raised two general concerns with the regulatory exception. The first concern is that employees who accept informational materials might sell them. Although it might prove somewhat difficult to sell used informational materials, OGE is generally sensitive to the underlying concern expressed by the commenter. To address this concern, OGE has amended the regulation to add an additional limitation on the use of this exception. As revised, the exception will now require employees to obtain written authorization from the agency designee before accepting informational materials from a single person that in the aggregate exceed $100 in a calendar year. The commenter's other concern is that gifts relating to an employee's official duties, the agency's mission, or a subject matter of interest to the agency “ought to be a gift to the Agency.” The commenter questions whether such gifts might be construed as augmenting an agency's appropriations. Such gifts would not implicate augmentation concerns, however, because, as with all of OGE's regulatory gift exceptions, the items accepted are for personal use, not the agency's use.
Following careful review of the regulation, OGE has also reorganized § 2635.204(m) to move the limitations on what constitutes permissible “informational materials” to § 2635.204(m)(2), which contains the definition of “informational materials.” OGE refined the language indicating that, to qualify as “informational material,” an item must be “primarily provided for educational or instructive purposes,” changing it to state more clearly that the item must be “educational or instructive in nature.” As previously written, the regulation could have been misconstrued as requiring employees to ascertain the donor's intent in offering an item. As modified, the regulation now makes clear that the focus is on the objective nature of the gift, and not the subjective intent of the donor. A corresponding change replaces “not including,” with “Are not primarily,” at the beginning of the phrase “Are not primarily created for entertainment, display, or decoration.” This change is intended to avoid excluding items that are clearly educational or instructive in nature but may have some tangential or incidental qualities that could arguably be characterized as entertaining or visually attractive. OGE believes this modification will make the rule easier to understand and apply.
OGE further reorganized the exception to reduce its structural complexity. As proposed, § 2635.204(m) had several tiers, including: a first tier denoted by numbers, such as the number “(2)”; a second tier denoted by lowercase roman numerals, such as the numeral “(ii)”; a third tier denoted by capital letters, such as the letter “(B)”; and a fourth tier denoted again by numbers, such as the number “(2).” By reorganizing the language of this section, OGE was able to eliminate the fourth tier.
OGE has made four other technical changes for consistency and clarity. First, OGE used the word “person” in paragraphs (m)(1)(i) and (ii) to be consistent with the language in § 2635.204(a), when aggregating gifts. Second, OGE changed the language “an agency designee makes a written determination that,” at § 2635.204(m)(1)(ii)(B) of the proposed rule, to “an agency designee has made a written determination after finding that,” now at § 2635.204(m)(1)(ii). The change makes the language of this paragraph consistent with the language used in § 2635.204(g)(3) and § 2635.204(h)(3). Third, OGE has added “provided that” to the opening language of § 2635.204(m)(1) in order to clarify that the $100 limit in § 2635.204(m)(1)(i) applies in every case unless an employee first obtains a written determination under § 2635.204(m)(1)(ii). Fourth, OGE has revised the reference to “programs and operations” of the agency so that it reads “programs or operations” of the agency. It was not OGE's intention to require that the subject matter relate to both a program and an operation, or to require that employees somehow distinguish “programs” from “operations.”
OGE received no comments on § 2635.205. OGE is adopting the amendments to this section as proposed for the reasons set forth in the preamble to the proposed rule. OGE, however, has replaced the period with a semi-colon in the phrase: “Accept a gift in violation of any statute; relevant statutes applicable to all employees include, but are not limited to,” found at § 2635.205(d). OGE has made this change for clarity because paragraph (d) in that section is part of a longer list that is connected by a semi-colon and the word “or” after paragraph (e) in that same section. By eliminating the period, OGE seeks to ensure that the period is not misconstrued as invalidating paragraphs (e) and (f) in the remainder of that list.
OGE received four comments on § 2635.206, which explains what steps an employee must take to properly dispose of a prohibited gift. OGE amended this section to provide additional guidance on what steps are required to comply with the disposition authorities. One commenter was generally supportive of the additional guidance provided by OGE. Three commenters expressed concern that OGE's amendment of § 2635.206(a)(1) to allow employees to destroy prohibited tangible gifts worth $100 or less was wasteful. These three commenters also recommended that OGE amend § 2635.206(a)(1) to permit employees to donate prohibited tangible gifts worth $100 or less to charity.
For the following reasons, OGE has not accepted the commenters' suggestions. Allowing the destruction of relatively low-value, tangible gifts provides useful flexibility, while continuing to prohibit employees from retaining impermissible gifts. Setting the value threshold at $100 establishes a reasonable range that imposes minimal administrative burden in determining whether most low value items qualify for destruction. Setting the threshold far below that level would increase transaction costs because official time would necessarily have to be expended researching the precise market value of inexpensive items in order to determine whether they could be destroyed. It bears noting that, as is explained in § 2635.206(a), an employee is not required to destroy prohibited gifts; destruction is only one of several authorized options for disposition. Other options include returning the gift to the donor, paying the donor the gift's market value, or not accepting the gift in the first instance. Whenever the value of an item approaches the higher end of the $100 range, employees and agency ethics officials may be disinclined to destroy the item; in fact, the administrative burden of researching the item's precise market value in order to avoid exceeding the permissible value threshold creates a natural incentive to choose another option for disposition of more expensive items.
Authorizing donations to charity in lieu of destruction would present other problems. OGE has considered and rejected this option in the past.
OGE has, however, revised § 2635.206(a)(1) for clarity. In the proposed regulation, the first sentence read: “The employee must promptly return any tangible item to the donor, or pay the donor its market value, or, in the case that the tangible item has a market value not in excess of $100, the employee may destroy the item.” In the final regulation, that sentence now reads: “The employee must promptly return any tangible item to the donor or pay the donor its market value; or, in the case of a tangible item with a market value of $100 or less, the employee may destroy the item.” The meaning of the sentence is unchanged, but the revised sentence is easier to understand. In addition, OGE has removed the legal citation at the end of that paragraph, which referred to the definition of “market value” at § 2635.203(c), because the cross reference was unnecessary and potentially confusing to the reader.
As Director of the Office of Government Ethics, I certify under the Regulatory Flexibility Act (5 U.S.C. chapter 6) that this final rule would not have a significant economic impact on a substantial number of small entities because it primarily affects current Federal executive branch employees.
The Paperwork Reduction Act (44 U.S.C. chapter 35) does not apply because this regulation does not contain information collection requirements that require approval of the Office of Management and Budget.
For purposes of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. chapter 5, subchapter II), this final rule would not significantly or uniquely affect small governments and will not result in increased expenditures by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (as adjusted for inflation) in any one year.
Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select the regulatory approaches that maximize net benefits (including 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 has been designated as a “significant regulatory action,” although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, this rule has been reviewed by the Office of Management and Budget.
As Director of the Office of Government Ethics, I have reviewed this final rule in light of section 3 of Executive Order 12988, Civil Justice Reform, and certify that it meets the applicable standards provided therein.
Conflict of interests, Executive Branch standards of ethical conduct, Government employees.
Accordingly, for the reasons set forth in the preamble, the Office of Government Ethics is amending 5 CFR part 2635, as set forth below:
5 U.S.C. 7301, 7351, 7353; 5 U.S.C. App. (Ethics in Government Act of 1978); E.O. 12674, 54 FR 15159, 3 CFR, 1989 Comp., p. 215, as modified by E.O. 12731, 55 FR 42547, 3 CFR, 1990 Comp., p. 306.
(a)
(b)
(2) An employee who is considering whether acceptance of a gift would lead a reasonable person with knowledge of the relevant facts to question his or her integrity or impartiality may consider, among other relevant factors, whether:
(i) The gift has a high market value;
(ii) The timing of the gift creates the appearance that the donor is seeking to influence an official action;
(iii) The gift was provided by a person who has interests that may be substantially affected by the performance or nonperformance of the employee's official duties; and
(iv) Acceptance of the gift would provide the donor with significantly disproportionate access.
(3) Notwithstanding paragraph (b)(1) of this section, an employee who accepts a gift that qualifies for an exception under § 2635.204 does not violate this subpart or the Principles of Ethical Conduct set forth in § 2635.101(b).
(4) Employees who have questions regarding this subpart, including whether the employee should decline a gift that would otherwise be permitted under an exception found in § 2635.204, should seek advice from an agency ethics official.
An employee of the Peace Corps is in charge of making routine purchases of office supplies. After a promotional presentation to highlight several new products, a vendor offers to buy the employee lunch, which costs less than $20. The employee is concerned that a reasonable person may question her impartiality in accepting the free lunch, as the timing of the offer indicates that the donor may be seeking to influence an official action and the company has interests that may be substantially affected by the performance or nonperformance of the employee's duties. As such, although acceptance of the gift may be permissible under § 2635.204(a), the employee decides to decline the gift.
(a)
(1) Solicit a gift from a prohibited source; or
(2) Solicit a gift to be given because of the employee's official position.
(b)
(1) Accept a gift from a prohibited source; or
(2) Accept a gift given because of the employee's official position.
(c)
A Government contractor who specializes in information technology software has offered an employee of the Department of Energy's information technology acquisition division a $15 gift card to a local restaurant if the employee will recommend to the agency's contracting officer that she select the contractor's products during the next acquisition. Even though the gift card is less than $20, the employee may not accept the gift under § 2635.204(a) because it is conditional upon official action by the employee. Pursuant to §§ 2635.202(c) and 2635.205(a), notwithstanding any exception to the rule, an employee may not accept a gift in return for being influenced in the performance of an official act.
For purposes of this subpart, the following definitions apply:
(a)
(b)
(1) Modest items of food and non-alcoholic refreshments, such as soft drinks, coffee and donuts, offered other than as part of a meal;
(2) Greeting cards and items with little intrinsic value, such as plaques, certificates, and trophies, which are intended primarily for presentation;
After giving a speech at the facility of a pharmaceutical company, a Government employee is presented with a glass paperweight in the shape of a pill capsule with the name of the company's latest drug and the date of the speech imprinted on the side. The employee may accept the paperweight because it is an item with little intrinsic value which is intended primarily for presentation.
After participating in a panel discussion hosted by an international media company, a Government employee is presented with an inexpensive portable music player emblazoned with the media company's logo. The portable music player has a market value of $25. The employee may not accept the portable music player as it has a significant independent use as a music player rather than being intended primarily for presentation.
After giving a speech at a conference held by a national association of miners, a Department of Commerce employee is presented with a block of granite that is engraved with the association's logo, a picture of the Appalachian Mountains, the date of the speech, and the employee's name. The employee may accept this item because it is similar to a plaque, is designed primarily for presentation, and has little intrinsic value.
(3) Loans from banks and other financial institutions on terms generally available to the public;
(4) Opportunities and benefits, including favorable rates and commercial discounts, available to the public or to a class consisting of all Government employees or all uniformed military personnel, whether or not restricted on the basis of geographic considerations;
(5) Rewards and prizes given to competitors in contests or events, including random drawings, open to the public unless the employee's entry into the contest or event is required as part of the employee's official duties;
A Government employee is attending a free trade show on official time. The trade show is held in a public shopping area adjacent to the employee's office building. The employee voluntarily enters a drawing at an individual vendor's booth which is open to the public. She fills in an entry form on the vendor's display table and drops it into the contest box. The employee may accept the resulting prize because entry into the contest was not required by or related to her official duties.
Attendees at a conference, which is not open to the public, are entered in a drawing for a weekend getaway to Bermuda as a result of being registered for the conference. A Government employee who attends the
(6) Pension and other benefits resulting from continued participation in an employee welfare and benefits plan maintained by a current or former employer;
(7) Anything which is paid for by the Government or secured by the Government under Government contract;
An employee at the Occupational Safety and Health Administration is assigned to travel away from her duty station to conduct an investigation of a collapse at a construction site. The employee's agency is paying for her travel expenses, including her airfare. The employee may accept and retain travel promotional items, such as frequent flyer miles, received as a result of her official travel, to the extent permitted by 5 U.S.C. 5702, note, and 41 CFR part 301-53.
(8) Free attendance to an event provided by the sponsor of the event to:
(i) An employee who is assigned to present information on behalf of the agency at the event on any day when the employee is presenting;
(ii) An employee whose presence on any day of the event is deemed to be essential by the agency to the presenting employee's participation in the event, provided that the employee is accompanying the presenting employee; and
(iii) The spouse or one other guest of the presenting employee on any day when the employee is presenting, provided that others in attendance will generally be accompanied by a spouse or other guest, the offer of free attendance for the spouse or other guest is unsolicited, and the agency designee, orally or in writing, has authorized the presenting employee to accept;
An employee of the Department of the Treasury who is assigned to participate in a panel discussion of economic issues as part of a one-day conference may accept the sponsor's waiver of the conference fee. Under the separate authority of § 2635.204(a), the employee may accept a token of appreciation that has a market value of $20 or less.
An employee of the Securities and Exchange Commission is assigned to present the agency's views at a roundtable discussion of an ongoing working group. The employee may accept free attendance to the meeting under paragraph (b)(8) of this section because the employee has been assigned to present information at the meeting on behalf of the agency. If it is determined by the agency that it is essential that another employee accompany the presenting employee to the roundtable discussion, the accompanying employee may also accept free attendance to the meeting under paragraph (b)(8)(ii) of this section.
An employee of the United States Trade and Development Agency is invited to attend a cocktail party hosted by a prohibited source. The employee believes that he will have an opportunity to discuss official matters with other attendees while at the event. Although the employee may voluntarily discuss official matters with other attendees, the employee has not been assigned to present information on behalf of the agency. The employee may not accept free attendance to the event under paragraph (b)(8) of this section.
(9) Any gift accepted by the Government under specific statutory authority, including:
(i) Travel, subsistence, and related expenses accepted by an agency under the authority of 31 U.S.C. 1353 in connection with an employee's attendance at a meeting or similar function relating to the employee's official duties which take place away from the employee's duty station, provided that the agency's acceptance is in accordance with the implementing regulations at 41 CFR chapter 304; and
(ii) Other gifts provided in-kind which have been accepted by an agency under its agency gift acceptance statute; and
(10) Anything for which market value is paid by the employee.
(c)
An employee who has been given a watch inscribed with the corporate logo of a prohibited source may determine its market value based on her observation that a comparable watch, not inscribed with a logo, generally sells for about $50.
During an official visit to a factory operated by a well-known athletic footwear manufacturer, an employee of the Department of Labor is offered a commemorative pair of athletic shoes manufactured at the factory. Although the cost incurred by the donor to manufacture the shoes was $17, the market value of the shoes would be the $100 that the employee would have to pay for the shoes on the open market.
A prohibited source has offered a Government employee a ticket to a charitable event consisting of a cocktail reception to be followed by an evening of chamber music. Even though the food, refreshments, and entertainment provided at the event may be worth only $20, the market value of the ticket is its $250 face value.
A company offers an employee of the Federal Communication Commission (FCC) free attendance for two to a private skybox at a ballpark to watch a major league baseball game. The skybox is leased annually by the company, which has business pending before the FCC. The skybox tickets provided to the employee do not have a face value. To determine the market value of the tickets, the employee must add the face value of two of the most expensive publicly available tickets to the game and the market value of any food, parking or other tangible benefits provided in connection with the gift of attendance that are not already included in the cost of the most expensive publicly available tickets.
An employee of the Department of Agriculture is invited to a reception held by a prohibited source. There is no entrance fee to the reception event or to the venue. To determine the market value of the gift, the employee must add the market value of any entertainment, food, beverages, or other tangible benefit provided to attendees in connection with the reception, but need not consider the cost incurred by the sponsor to rent or maintain the venue where the event is held. The employee may rely on a per-person cost estimate provided by the sponsor of the event, unless the employee or an agency designee has determined that a reasonable person would find that the estimate is clearly implausible.
(d)
(1) Is seeking official action by the employee's agency;
(2) Does business or seeks to do business with the employee's agency;
(3) Conducts activities regulated by the employee's agency;
(4) Has interests that may be substantially affected by the performance or nonperformance of the employee's official duties; or
(5) Is an organization a majority of whose members are described in paragraphs (d)(1) through (4) of this section.
(e)
Gifts between employees are subject to the limitations set forth in subpart C of this part.
Where free season tickets are offered by an opera guild to all members of the Cabinet, the gift is offered because of their official positions.
Employees at a regional office of the Department of Justice (DOJ) work in Government-leased space at a private office building, along with various
(f)
(1) Given with the employee's knowledge and acquiescence to the employee's parent, sibling, spouse, child, dependent relative, or a member of the employee's household because of that person's relationship to the employee; or
(2) Given to any other person, including any charitable organization, on the basis of designation, recommendation, or other specification by the employee, except the employee has not indirectly solicited or accepted a gift by the raising of funds or other support for a charitable organization if done in accordance with § 2635.808.
An employee who must decline a gift of a personal computer pursuant to this subpart may not suggest that the gift be given instead to one of five charitable organizations whose names are provided by the employee.
(g)
Subject to the limitations in § 2635.205, this section establishes exceptions to the prohibitions set forth in § 2635.202(a) and (b). Even though acceptance of a gift may be permitted by one of the exceptions contained in this section, it is never inappropriate and frequently prudent for an employee to decline a gift if acceptance would cause a reasonable person to question the employee's integrity or impartiality. Section 2635.201(b) identifies considerations for declining otherwise permissible gifts.
(a)
An employee of the Securities and Exchange Commission and his spouse have been invited by a representative of a regulated entity to a community theater production, tickets to which have a face value of $30 each. The aggregate market value of the gifts offered on this single occasion is $60, $40 more than the $20 amount that may be accepted for a single event or presentation. The employee may not accept the gift of the evening of entertainment. He and his spouse may attend the play only if he pays the full $60 value of the two tickets.
An employee of the National Geospatial-Intelligence Agency has been invited by an association of cartographers to speak about her agency's role in the evolution of missile technology. At the conclusion of her speech, the association presents the employee a framed map with a market value of $18 and a ceramic mug that has a market value of $15. The employee may accept the map or the mug, but not both, because the aggregate value of these two tangible items exceeds $20.
On four occasions during the calendar year, an employee of the Defense Logistics Agency (DLA) was given gifts worth $10 each by four employees of a corporation that is a DLA contractor. For purposes of applying the yearly $50 limitation on gifts of $20 or less from any one person, the four gifts must be aggregated because a person is defined at § 2635.102(k) to mean not only the corporate entity, but its officers and employees as well. However, for purposes of applying the $50 aggregate limitation, the employee would not have to include the value of a birthday present received from his cousin, who is employed by the same corporation, if he can accept the birthday present under the exception at paragraph (b) of this section for gifts based on a personal relationship.
Under the authority of 31 U.S.C. 1353 for agencies to accept payments from non-Federal sources in connection with attendance at certain meetings or similar functions, the Environmental Protection Agency (EPA) has accepted an association's gift of travel expenses and conference fees for an employee to attend a conference on the long-term effect of radon exposure. While at the conference, the employee may accept a gift of $20 or less from the association or from another person attending the conference even though it was not approved in advance by the EPA. Although 31 U.S.C. 1353 is the authority under which the EPA accepted the gift to the agency of travel expenses and conference fees, a gift of $20 or less accepted under paragraph (a) of this section is a gift to the employee rather than to her employing agency.
During off-duty time, an employee of the Department of Defense (DoD) attends a trade show involving companies that are DoD contractors. He is offered software worth $15 at X Company's booth, a calendar worth $12 at Y Company's booth, and a deli lunch worth $8 from Z Company. The employee may accept all three of these items because they do not exceed $20 per source, even though they total more than $20 at this single occasion.
An employee of the Department of Defense (DoD) is being promoted to a higher level position in another DoD office. Six individuals, each employed by a different defense contractor, who have worked with the DoD employee over the years, decide to act in concert to pool their resources to buy her a nicer gift than each could buy her separately. Each defense contractor employee contributes $20 to buy a desk clock for the DoD employee that has a market value of $120. Although each of the contributions does not exceed the $20 limit, the employee may not accept the $120 gift because it is a single gift that has a market value in excess of $20.
During a holiday party, an employee of the Department of State is given a $15 store gift card to a national coffee chain by an agency contractor. The employee may accept the card as the market value is less than $20. The employee could not, however, accept a gift card that is issued by a credit card company or other financial institution, because such a card is equivalent to a gift of cash.
(b)
An employee of the Federal Deposit Insurance Corporation (FDIC) has been dating an accountant employed by a member bank. As part of its “Work-Life Balance” program, the bank has given each employee in the accountant's division two tickets to a professional basketball game and has urged each to invite a family member or friend to share the evening of entertainment. Under the circumstances, the FDIC employee may accept the invitation to attend the game. Even though the tickets were initially purchased by the member bank, they were given without reservation to the accountant to use as she wished, and her invitation to the employee was motivated by their personal friendship.
Three partners in a law firm that handles corporate mergers have invited an employee of the Federal Trade Commission (FTC) to join them in a golf tournament at a private club at the firm's expense. The entry fee is $500 per foursome. The employee cannot accept the gift of one-quarter of the entry fee even though he and the three partners have developed an amicable relationship as a result of the firm's dealings with the FTC. As evidenced in part by the fact that the fees are to be paid by the firm, it is not a personal friendship but a business relationship that is the motivation behind the partners' gift.
A Peace Corps employee enjoys using a social media site on the internet in his personal capacity outside of work. He has used the site to keep in touch with friends, neighbors, coworkers, professional contacts, and other individuals he has met over the years through both work and personal activities. One of these individuals works for a contractor that provides language services to the Peace Corps. The employee was acting in his official capacity when he met the individual at a meeting to discuss a matter related to the contract between their respective employers. Thereafter, the two communicated occasionally regarding contract matters. They later also granted one another access to join their social media networks through their respective social media accounts. However, they did not communicate further in their personal capacities, carry on extensive personal interactions, or meet socially outside of work. One day, the individual, whose employer continues to serve as a Peace Corps contractor, contacts the employee to offer him a pair of concert tickets worth $30 apiece. Although the employee and the individual are connected through social media, the circumstances do not demonstrate that the gift was clearly motivated by a personal relationship, rather than the position of the employee, and therefore the employee may not accept the gift pursuant to paragraph (b) of this section.
(c)
(1) A reduction or waiver of the fees for membership or other fees for participation in organization activities offered to all Government employees or all uniformed military personnel by professional organizations if the only restrictions on membership relate to professional qualifications; and
(2) Opportunities and benefits, including favorable rates, commercial discounts, and free attendance or participation not precluded by paragraph (c)(3) of this section:
(i) Offered to members of a group or class in which membership is unrelated to Government employment;
(ii) Offered to members of an organization, such as an employees' association or agency credit union, in which membership is related to Government employment if the same offer is broadly available to large segments of the public through organizations of similar size; or
(iii) Offered by a person who is not a prohibited source to any group or class that is not defined in a manner that specifically discriminates among Government employees on the basis of type of official responsibility or on a basis that favors those of higher rank or rate of pay.
A computer company offers a discount on the purchase of computer equipment to all public and private sector computer procurement officials who work in organizations with over 300 employees. An employee who works as the computer procurement official for a Government agency could not accept the discount to purchase the personal computer under the exception in paragraph (c)(2)(i) of this section. Her membership in the group to which the discount is offered is related to Government employment because her membership is based on her status as a procurement official with the Government.
An employee of the Consumer Product Safety Commission (CPSC) may accept a discount of $50 on a microwave oven offered by the manufacturer to all members of the CPSC employees' association. Even though the CPSC is currently conducting studies on the safety of microwave ovens, the $50 discount is a standard offer that the manufacturer has made broadly available through a number of employee associations and similar organizations to large segments of the public.
An Assistant Secretary may not accept a local country club's offer of membership to all members of Department Secretariats which includes a waiver of its $5,000 membership initiation fee. Even though the country club is not a prohibited source, the offer discriminates in favor of higher ranking officials.
(3) An employee may not accept for personal use any benefit to which the Government is entitled as the result of an expenditure of Government funds, unless authorized by statute or regulation (
The administrative officer for a field office of U.S. Immigration and Customs Enforcement (ICE) has signed an order to purchase 50 boxes of photocopy paper from a supplier whose literature advertises that it will give a free briefcase to anyone who purchases 50 or more boxes. Because the paper was purchased with ICE funds, the administrative officer cannot keep the briefcase which, if claimed and received, is Government property.
(d)
(i) The award and any item incident to the award are not from a person who has interests that may be substantially affected by the performance or nonperformance of the employee's official duties, or from an association or other organization if a majority of its members have such interests; and
(ii) If the award or any item incident to the award is in the form of cash or an investment interest, or if the aggregate value of the award and any item incident to the award, other than free attendance to the event provided to the employee and to members of the employee's family by the sponsor of the event, exceeds $200, the agency ethics official has made a written determination that the award is made as part of an established program of recognition.
Based on a written determination by an agency ethics official that the prize meets the criteria set forth in paragraph (d)(2) of this section, an employee of the National Institutes of Health (NIH) may accept the Nobel Prize for Medicine, including the cash award which accompanies the prize, even though the prize was conferred on the basis of laboratory work performed at NIH.
A defense contractor, ABC Systems, has an annual award program for the outstanding public employee of the year. The award includes a cash payment of $1,000. The award program is wholly funded to ensure its continuation on a regular basis for the next twenty years and selection of award recipients is made pursuant to written standards. An employee of the Department of the Air Force, who has duties that include overseeing contract performance by ABC Systems, is selected to receive the award. The employee may not accept the cash award because ABC Systems has interests that may be substantially affected by the performance or
An ambassador selected by a nonprofit organization as a recipient of its annual award for distinguished service in the interest of world peace may, together with his spouse and children, attend the awards ceremony dinner and accept a crystal bowl worth $200 presented during the ceremony. However, where the organization has also offered airline tickets for the ambassador and his family to travel to the city where the awards ceremony is to be held, the aggregate value of the tickets and the crystal bowl exceeds $200, and he may accept only upon a written determination by the agency ethics official that the award is made as part of an established program of recognition.
(2)
(i) Awards have been made on a regular basis or, if the program is new, there is a reasonable basis for concluding that awards will be made on a regular basis based on funding or funding commitments; and
(ii) Selection of award recipients is made pursuant to written standards.
(3)
When the honorary degree is offered by a foreign institution of higher education, the agency may need to make a separate determination as to whether the institution of higher education is a foreign government for purposes of the Emoluments Clause of the U.S. Constitution (U.S. Const., art. I, sec. 9, cl. 8), which forbids employees from accepting emoluments, presents, offices, or titles from foreign governments, without the consent of Congress. The Foreign Gifts and Decorations Act, 5 U.S.C. 7342, however, may permit the acceptance of honorary degrees in some circumstances.
A well-known university located in the United States wishes to give an honorary degree to the Secretary of Labor. The Secretary may accept the honorary degree only if an agency ethics official determines in writing that the timing of the award of the degree would not cause a reasonable person to question the Secretary's impartiality in a matter affecting the university.
(4)
(e)
(1) Resulting from the business or employment activities of an employee's spouse when it is clear that such benefits have not been offered or enhanced because of the employee's official position;
A Department of Agriculture employee whose spouse is a computer programmer employed by a Department of Agriculture contractor may attend the company's annual retreat for all of its employees and their families held at a resort facility. However, under § 2635.502, the employee may be disqualified from performing official duties affecting her spouse's employer.
Where the spouses of other clerical personnel have not been invited, an employee of the Defense Contract Audit Agency whose spouse is a clerical worker at a defense contractor may not attend the contractor's annual retreat in Hawaii for corporate officers and members of the board of directors, even though his spouse received a special invitation for herself and the employee.
(2) Resulting from the employee's outside business or employment activities when it is clear that such benefits are based on the outside business or employment activities and have not been offered or enhanced because of the employee's official status;
The members of an Army Corps of Engineers environmental advisory committee that meets six times per year are special Government employees. A member who has a consulting business may accept an invitation to a $50 dinner from her corporate client, an Army construction contractor, unless, for example, the invitation was extended in order to discuss the activities of the advisory committee.
(3) Customarily provided by a prospective employer in connection with
An employee of the Federal Communications Commission with responsibility for drafting regulations affecting all cable television companies wishes to apply for a job opening with a cable television holding company. Once she has properly disqualified herself from further work on the regulations as required by subpart F of this part, she may enter into employment discussions with the company and may accept the company's offer to pay for her airfare, hotel, and meals in connection with an interview trip.
(4) Provided by a former employer to attend a reception or similar event when other former employees have been invited to attend, the invitation and benefits are based on the former employment relationship, and it is clear that such benefits have not been offered or enhanced because of the employee's official position.
An employee of the Department of the Army is invited by her former employer, an Army contractor, to attend its annual holiday dinner party. The former employer traditionally invites both its current and former employees to the holiday dinner regardless of their current employment activities. Under these circumstances, the employee may attend the dinner because the dinner invitation is a result of the employee's former outside employment activities, other former employees have been asked to attend, and the gift is not offered because of the employee's official position.
(5) For purposes of paragraphs (e)(1) through (4) of this section, “employment” means any form of non-Federal employment or business relationship involving the provision of personal services.
(f)
The Secretary of the Department of Health and Human
(g)
(2)
(3)
(i) The event is a widely attended gathering, as set forth in paragraph (g)(2) of this section;
(ii) The employee's attendance at the event is in the agency's interest because it will further agency programs or operations;
(iii) The agency's interest in the employee's attendance outweighs the concern that the employee may be, or may appear to be, improperly influenced in the performance of official duties; and
(iv) If a person other than the sponsor of the event invites or designates the employee as the recipient of the gift of free attendance and bears the cost of that gift, the event is expected to be attended by more than 100 persons and the value of the gift of free attendance does not exceed $375.
(4)
(i) The importance of the event to the agency;
(ii) The nature and sensitivity of any pending matter affecting the interests of the person who extended the invitation and the significance of the employee's role in any such matter;
(iii) The purpose of the event;
(iv) The identity of other expected participants;
(v) Whether acceptance would reasonably create the appearance that the donor is receiving preferential treatment;
(vi) Whether the Government is also providing persons with views or interests that differ from those of the donor with access to the Government; and
(vii) The market value of the gift of free attendance.
(5)
(6)
An aerospace industry association that is a prohibited source sponsors an industry-wide, two-day seminar for which it charges a fee of $800 and anticipates attendance of approximately 400. An Air Force contractor pays $4,000 to the association so that the association can extend free invitations to five Air Force officials designated by the contractor. The Air Force officials may not accept the gifts of free attendance because (a) the contractor, rather than the association, provided the cost of their attendance; (b) the contractor designated the specific employees to receive the gift of free attendance; and (c) the value of the gift exceeds $375 per employee.
An aerospace industry association that is a prohibited source sponsors an industry-wide, two-day seminar for which it charges a fee of $25 and anticipates attendance of approximately 50. An Air Force contractor pays $125 to the association so that the association can extend free invitations to five Air Force officials designated by the contractor. The Air Force officials may not accept the gifts of free attendance because (a) the contractor, rather than the association, provided the cost of their attendance; (b) the contractor designated the specific employees to receive the gift of free attendance; and (c) the event was not expected to be attended by more than 100 persons.
An aerospace industry association that is a prohibited source sponsors an industry-wide, two-day seminar for which it charges a fee of $800 and anticipates attendance of approximately 400. An Air Force contractor pays $4,000 in order that the association might invite any five Federal employees. An Air Force official to whom the sponsoring association, rather than the contractor, extended one of the five invitations could attend if the employee's participation were determined to be in the interest of the agency and he received a written authorization.
An employee of the Department of Transportation is invited by a news organization to an annual press dinner sponsored by an association of press organizations. Tickets for the event cost $375 per person and attendance is limited to 400 representatives of press organizations and their guests. If the employee's attendance is determined to be in the interest of the agency and she receives a written authorization from the agency designee, she may accept the invitation from the news organization because more than 100 persons will attend and the cost of the ticket does not exceed $375. However, if the invitation were extended to the employee and an accompanying guest, the employee's guest could not be authorized to attend for free because the market value of the gift of free attendance would exceed $375.
An employee of the Department of Energy (DOE) and his spouse have been invited by a major utility executive to a small dinner party. A few other officials of the utility and their spouses or other guests are also invited, as is a representative of a consumer group concerned with utility rates and her spouse. The DOE official believes the dinner party will provide him an opportunity to socialize with and get to know those in attendance. The employee may not accept the free invitation under this exception, even if his attendance could be determined to be in the interest of the agency. The small dinner party is not a widely attended gathering. Nor could the employee be authorized to accept even if the event were instead a corporate banquet to which forty company officials and their spouses or other guests were invited. In this second case, notwithstanding the larger number of persons expected (as opposed to the small dinner party just noted) and despite the presence of the consumer group representative and her spouse who are not officials of the utility, those in attendance would still not represent a diversity of views
An Assistant U.S. Attorney is invited to attend a luncheon meeting of a local bar association to hear a distinguished judge lecture on cross-examining expert witnesses. Although members of the bar association are assessed a $15 fee for the meeting, the Assistant U.S. Attorney may accept the bar association's offer to attend for free, even without a determination of agency interest. The gift can be accepted under the $20 gift exception at paragraph (a) of this section.
An employee of the Department of the Interior authorized to speak on the first day of a four-day conference on endangered species may accept the sponsor's waiver of the conference fee for the first day of the conference under § 2635.203(b)(8). If the conference is widely attended, the employee may be authorized to accept the sponsor's offer to waive the attendance fee for the remainder of the conference if the agency designee has made a written determination that attendance is in the agency's interest.
A military officer has been approved to attend a widely attended gathering, pursuant to paragraph (g) of this section, that will be held in the same city as the officer's duty station. The defense contractor sponsoring the event has offered to transport the officer in a limousine to the event. The officer may not accept the offer of transportation because the definition of “free attendance” set forth in § 2635.203(g) excludes travel, and the market value of the transportation would exceed $20.
(h)
(1) The invitation is unsolicited and is from a person who is not a prohibited source;
(2) No fee is charged to any person in attendance; and
(3) If either the sponsor of the event or the person extending the invitation to the employee is not an individual, the agency designee has made a written determination after finding that the employee's attendance would not cause a reasonable person with knowledge of the relevant facts to question the employee's integrity or impartiality, consistent with § 2635.201(b).
An employee of the White House Press Office has been invited to a social dinner for current and former White House Press Officers at the home of an individual who is not a prohibited source. The employee may attend even if she is being invited because of her official position.
(i)
(1) The market value in the foreign area of the food, refreshments or entertainment provided at the meeting or event, as converted to U.S. dollars, does not exceed the per diem rate for the foreign area specified in the U.S. Department of State's Maximum Per Diem Allowances for Foreign Areas, Per Diem Supplement Section 925 to the Standardized Regulations (GC-FA), available on the Internet at
(2) There is participation in the meeting or event by non-U.S. citizens or by representatives of foreign governments or other foreign entities;
(3) Attendance at the meeting or event is part of the employee's official duties to obtain information, disseminate information, promote the export of U.S. goods and services, represent the United States, or otherwise further programs or operations of the agency or the U.S. mission in the foreign area; and
(4) The gift of meals, refreshments, or entertainment is from a person other than a foreign government as defined in 5 U.S.C. 7342(a)(2).
A number of local business owners in a developing country are eager for a U.S. company to locate a manufacturing facility in their province. An official of the Overseas Private Investment Corporation may accompany the visiting vice president of the U.S. company to a dinner meeting hosted by the business owners at a province restaurant where the market value of the food and refreshments does not exceed the per diem rate for that country.
(j)
(k)
(l)
(1) Free attendance, course or meeting materials, transportation, lodgings, food and refreshments or reimbursements therefor incident to training or meetings when accepted by the employee under the authority of 5 U.S.C. 4111. The employee's acceptance must be approved by the agency in accordance with part 410 of this title; or
(2) Gifts from a foreign government or international or multinational organization, or its representative, when accepted by the employee under the authority of the Foreign Gifts and Decorations Act, 5 U.S.C. 7342. As a condition of acceptance, an employee must comply with requirements imposed by the agency's regulations or procedures implementing that Act.
(m)
(i) The aggregate market value of all informational materials received from any one person does not exceed $100 in a calendar year; or
(ii) If the aggregate market value of all informational materials from the same person exceeds $100 in a calendar year, an agency designee has made a written determination after finding that acceptance by the employee would not be inconsistent with the standard set forth in § 2635.201(b).
(2)
(i) Are educational or instructive in nature;
(ii) Are not primarily created for entertainment, display, or decoration; and
(iii) Contain information that relates in whole or in part to the following categories:
(A) The employee's official duties or position, profession, or field of study;
(B) A general subject matter area, industry, or economic sector affected by or involved in the programs or operations of the agency; or
(C) Another topic of interest to the agency or its mission.
An analyst at the Agricultural Research Service receives an edition of an agricultural research journal in the mail from a consortium of private farming operations concerned with soil toxicity. The journal edition has a market value of $75. The analyst may accept the gift.
An inspector at the Mine Safety and Health Administration
An employee at the Department of the Army is offered an encyclopedia on cyberwarfare from a prohibited source. The cost of the encyclopedia is far in excess of $100. The agency designee determines that acceptance of the gift would be inconsistent with the standard set out in § 2635.201(b). The employee may not accept the gift under paragraph (m) of this section.
Notwithstanding any exception provided in this subpart, other than § 2635.204(j), an employee may not:
(a) Accept a gift in return for being influenced in the performance of an official act;
(b) Use, or permit the use of, the employee's Government position, or any authority associated with public office, to solicit or coerce the offering of a gift;
(c) Accept gifts from the same or different sources on a basis so frequent that a reasonable person would be led to believe the employee is using the employee's public office for private gain;
A purchasing agent for a Department of Veterans Affairs medical center routinely deals with representatives of pharmaceutical manufacturers who provide information about new company products. Because of his crowded calendar, the purchasing agent has offered to meet with manufacturer representatives during his lunch hours Tuesdays through Thursdays, and the representatives routinely arrive at the employee's office bringing a sandwich and a soft drink for the employee. Even though the market value of each of the lunches is less than $6 and the aggregate value from any one manufacturer does not exceed the $50 aggregate limitation in § 2635.204(a) on gifts of $20 or less, the practice of accepting even these modest gifts on a recurring basis is improper.
(d) Accept a gift in violation of any statute; relevant statutes applicable to all employees include, but are not limited to:
(1) 18 U.S.C. 201(b), which prohibits a public official from, directly or indirectly, corruptly demanding, seeking, receiving, accepting, or agreeing to receive or accept anything of value personally or for any other person or entity in return for being influenced in the performance of an official act; being influenced to commit or aid in committing, or to collude in, or allow, any fraud, or make opportunity for the commission of any fraud, on the United States; or for being induced to do or omit to do any action in violation of his or her official duty. As used in 18 U.S.C. 201(b), the term “public official” is broadly construed and includes regular and special Government employees as well as all other Government officials; and
(2) 18 U.S.C. 209, which prohibits an employee, other than a special Government employee, from receiving any salary or any contribution to or supplementation of salary from any source other than the United States as compensation for services as a Government employee. The statute contains several specific exceptions to this general prohibition, including an exception for contributions made from the treasury of a State, county, or municipality;
(e) Accept a gift in violation of any Executive Order; or
(f) Accept any gift when acceptance of the gift is specifically prohibited by a supplemental agency regulation issued with the concurrence of the Office of Government Ethics, pursuant to § 2635.105.
(a) Unless a gift is accepted by an agency acting under specific statutory authority, an employee who has received a gift that cannot be accepted under this subpart must dispose of the gift in accordance with the procedures set forth in this section. The employee must promptly complete the authorized disposition of the gift. The obligation to dispose of a gift that cannot be accepted under this subpart is independent of an agency's decision regarding corrective or disciplinary action under § 2635.106.
(1)
A Department of Commerce employee received a $25 T-shirt from a prohibited source after providing training at a conference. Because the gift would not be permissible under an exception to this subpart, the employee must either return or destroy the T-shirt or promptly reimburse the donor $25. Destruction may be carried out by physical destruction or by permanently discarding the T-shirt by placing it in the trash.
To avoid public embarrassment to the seminar sponsor, an employee of the National Park Service did not decline a barometer worth $200 given at the conclusion of his speech on Federal lands policy. To comply with this section, the employee must either promptly return the barometer or pay the donor the market value of the gift. Alternatively, the National Park Service may choose to accept the gift if permitted under specific statutory gift acceptance authority. The employee may not destroy this gift, as the market value is in excess of $100.
(2)
With approval by the recipient's supervisor, a floral arrangement sent by a disability claimant to a helpful employee of the Social Security Administration may be placed in the office's reception area.
(3)
A Department of Defense employee wishes to attend a charitable event to which he has been offered a $300 ticket by a prohibited source. Although his attendance is not in the interest of the agency under § 2635.204(g), he may attend if he reimburses the donor the $300 face value of the ticket.
(4)
(b) An agency may authorize disposition or return of gifts at Government expense. Employees may use penalty mail to forward reimbursements required or permitted by this section.
(c) An employee who, on his or her own initiative, promptly complies with the requirements of this section will not be deemed to have improperly accepted an unsolicited gift. An employee who promptly consults his or her agency ethics official to determine whether acceptance of an unsolicited gift is proper and who, upon the advice of the ethics official, returns the gift or otherwise disposes of the gift in accordance with this section, will be considered to have complied with the requirements of this section on the employee's own initiative.
(d) Employees are encouraged to record any actions they have taken to
Foreign Agricultural Service and Commodity Credit Corporation (CCC), USDA.
Final rule.
This final rule makes amendments to the final rule, with request for comments, published in the
This final rule is effective November 18, 2016.
Peter W. Burr, Import Policies and Export Reporting Division, Office of Trade Programs, Foreign Agricultural Service, USDA; email:
On March 9, 2015, FAS published a final rule, with request for comments, in the
The following is a summary and discussion of the comments received relative to the Agriculture Pima Trust and the Agriculture Wool Trust programs along with the reasoning for the revisions made.
A commenter suggested that applicants not be required as noted in § 1471.1(b)(3)(iii), § 1471.1(b)(4), § 1471.10(b)(3)(iii), and § 1471.10(b)(4), to annually file IRS forms W-9 (U.S. person or resident alien) or the 1199A (direct deposit) with an application for either the Agriculture Pima Trust or Agriculture Wool Trust programs unless a change in the applicant's W-9 or 1199A information had occurred when compared to their previous year's application. This was deemed to be reasonable. Beginning in 2017, IRS forms W-9 and 1199A will only need to be filed if changes in the information have occurred.
A commenter noted that a technical correction is necessary in paragraphs (1) and (2) of § 1471.2(c) by closing the parentheticals after the word “insurance.” This correction will be made.
A commenter identified an error common to paragraphs (b)(1)(ii) and (b)(2)(ii) of § 1471.11, Payments to manufacturers of certain worsted wool fabrics. The payment formula for payments to eligible persons is provided for under this section. The payment formula mistakenly states in paragraph (ii) that payments will be calculated based on the eligible person's production in the preceding year. However, the payments are actually based on the eligible person's production of qualifying worsted wool fabric during calendar years 1999, 2000, and 2001. This correction will be made.
A commenter suggested that the scope of the monetization of the wool tariff rate quota payment as noted under § 1471.13(a)(2)(i) be expanded to include eligible entities, that are manufacturers and would otherwise be eligible for monetization payments, that import qualifying worsted wool into a free trade zone (FTZ), cut the wool and use it to make worsted wool suits for men and boys within the FTZ.
The monetization payment requires that the eligible entities receiving a monetization payment (1) import into the Customs territory of the United States the qualifying worsted wool directly or indirectly; (2) manufacture in the United States the qualifying worsted wool into worsted wool suits for men and boys; and (3) own the worsted wool at the time it's cut and manufactured.
An entity that manufactures the suits in an FTZ and does not export from the FTZ into the Customs territory of the United States the qualifying worsted wool directly or indirectly, does not qualify for this benefit because by definition the entity avoided paying the import duty on the qualifying worsted wool. However, an eligible entity that manufacturers the suits in an FTZ and exports into the Customs territory of the United States the qualifying worsted wool directly or indirectly and thus pays the import duty on the qualifying worsted wool, does qualify for this benefit. For the purpose of the monetization payment, the worsted wool suits for men and boys are manufactured in the U.S. and all environmental, worker safety, and wage protection laws, etc., would apply to this manufacturer.
USDA will also broaden the scope of eligible entities as it pertains to the wool yarn, wool fiber, and wool top compensation payment found at § 1471.14(a)(2)(i) to include those operating within a FTZ.
A commenter suggested that the definition of an eligible person found at § 1471.13(a)(2)(i) in the monetization of the wool tariff rate quota payment be modified to allow an eligible person to claim the annual dollar value and quantity of imported qualifying worsted wool fabric cut and sewn if the eligible person owned the wool at the time it was cut and sewn, whether the person actually cut and sewed the imported qualifying worsted wool or another person cut and sewed the wool on behalf of the eligible person. This was deemed reasonable and is already
USDA will also make this change as it pertains to the wool yarn, wool fiber, and wool top duty compensation payment found at § 1471.14(a)(2)(i).
A commenter suggested that applicants for the monetization of the wool tariff rate quota payment not be required to include direct imports on their annual application for this payment. The commenter's suggestion was based on their observance that countries of origin of imported qualifying worsted wool by direct importers is included on the Customs and Border Protection (CBP) form #7501, which is provided to the Secretary of Treasury every year, and thus it was redundant to also require this information to be included on the affirmation part of the annual application. Even though this information is provided to CBP each year, USDA will maintain the requirement as found at § 1471.13(d)(2)(iii)(A) and (B) that applicants for the monetization of the wool tariff rate quota payment include their direct and indirect imports on their annual application. Including direct and indirect imports on the application for this payment will make it easier for USDA to process the annual payments and to distribute them in a timely manner.
Regarding the monetization of the wool tariff rate quota payment, found at § 1471.13(a)(2), a commenter suggested that the definitions of eligible person and qualifying worsted wool, a provision eliciting specific business information, and the scope of the affirmation, be expanded to include all importers of qualifying worsted wool suitable for worsted wool suits, as opposed to importers of qualifying worsted wool that actually used the wool to make suits for men or boys. To support the commenter's position, the commenter cited statutory references to types of worsted wool fabrics categorized under the harmonized tariff schedule (HTS). However the commenter conflates statutory provisions authorizing the tariffs for HTS categories of worsted wool suitable for wool suits with defining the universe of eligible manufacturers who import qualifying worsted wool and are eligible for payments under this program. The wool tariff rate quota administered by the Secretary of Commerce, until its statutory sunset in 2014, in fact required that to benefit from the tariff reduction, the worsted wool had to be actually used for worsted wool suits. This monetization program provides payments to manufacturers who formerly benefitted from the tariff reduction. The requirement in the monetization payment that the qualifying worsted wool must be used by the manufacturer receiving the payment to make suits for men and boys will remain unchanged.
A commenter made a suggestion regarding the wool yarn, wool fiber, and wool top duty compensation payment found at § 1471.14(a)(2) that is similar to the comment above. The commenter suggested that the definitions of eligible person and qualifying wool, a provision eliciting specific business information, and the scope of the affirmation, be expanded from manufacturers that directly or indirectly imported qualifying wool and manufactured the qualifying wool, to include all importers of qualifying wool (whether or not the importer was also the manufacturer of the wool). To support this position, the commenter referred to statutory authority that did not require importers of qualifying wool to also be manufacturers of the qualifying wool. The commenter further stated that the wool duty refund program, of which only manufacturers of qualifying wool have participated, did not impose the requirement that the entity actually manufacture the qualifying wool. However the commenter is incorrect about what the statutory authority actually provides, and conflates extension of the duty suspension (that was applicable to all importers, regardless of whether they also manufactured men's and boy's wool suits) in section 5102 of the Trade Act of 2002, Public Law 107-210 and the wool duty refund payment program (that applied only to manufacturers of men's and boy's wool suits) in section 5101 of the Trade Act of 2002. The duty refund program administered by the U.S. Customs Service and by Customs and Border Protection in the Department of Homeland Security from 2002-2014 required that the importer must also be the manufacturer of the qualifying wool. The requirements in the wool yarn, wool fiber, and wool top duty compensation payment that the qualifying wool must be imported and must also be used for further manufacturing by the importing manufacturer will remain unchanged.
The Wool Duty Refund payment found at § 1471.12 was administered by the Department of Homeland Security's Customs and Border Protection (CBP) through 2015. In the Farm Bill, the Wool Duty Refund payment was established for the year 2016 through 2019 and was transferred to USDA. The Wool Duty Refund payment is open to U.S. entities that manufactured certain wool articles made with certain imported wool products during calendar years 2000, 2001 and 2002; received a 2005 payment under section 505 of the Trade and Development Act of 2000; and as of January 1st of the payment year, continues to be a manufacturer in the U.S. as provided for in Section 505(a) of the Trade and Development Act of 2000. FAS will administer the Wool Duty Refund payment for 2016-2019 exactly the same as it was administered by CBP.
This Executive Order requires careful evaluation of governmental actions that interfere with constitutionally protected property rights. This rule does not interfere with any property rights and, therefore, does not need to be evaluated on the basis of the criteria outlined in Executive Order 12630.
This final rule is issued in conformance with Executive Order 12866 and Administrative Procedure Act (5 U.S.C. 553). It has been determined to be not significant for the purposes of Executive Order 12866 and was not reviewed by OMB for this purpose. A cost-benefit assessment of this rule was not completed.
This final rule is not subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. See the notice related to 7 CFR part 3015, subpart V, published at 48 FR 29115 (June 24, 1983).
This final rule has been reviewed in accordance with Executive Order 12988. This rule would not preempt State or local laws, regulations, or policies unless they present an irreconcilable conflict with this rule. This rule would not be retroactive.
This final rule has been reviewed under Executive order 13132, “Federalism.” The policies contained in this final rule do not have any substantial direct effect on States, on the relationship between the Federal government and the States, or on the distribution of power and responsibilities among the various
This final rule has been reviewed for compliance with E.O. 13175. The policies contained in this final rule do not have tribal implications that preempt tribal law.
The Regulatory Flexibility Act does not apply to this final rule because FAS is not required by 5 U.S.C. 553 or any other law to publish a notice of proposed rulemaking with respect to the subject matter of this final rule.
No major civil rights impact is likely to result from the announcement of this final rule. It will not have a negative civil rights impact on very-low income, low income, moderate income, and minority populations.
The environmental impacts of this rule have been considered in a manner consistent with the provisions of the National Environmental Policy Act (NEPA, 42 U.S.C. 4321-4347), the regulations of the Council on Environmental Quality (40 CFR parts 1500-1508), and FAS regulations for compliance with NEPA (7 CFR part 799). FAS has determined that NEPA does not apply to this final rule and that no environmental assessment or environmental impact statement will be prepared.
This final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA). Therefore, this rule is not subject to the requirements of sections 202 and 205 of UMRA.
FAS 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, services, and for other purposes. The forms, regulations, and other information collection activities required to be utilized by a person subject to this final rule are available at:
Agricultural commodities, imports.
Accordingly, 7 CFR part 1471 is amended as follows:
Sections 501-506, Pub. L. 106-200, (114 Stat. 299-304); Section 4002, Pub. L. 108-429 (7 U.S.C. 7101 note); Section 1633, Pub. L. 109-280 (120 Stat. 1166); Section 325, Pub. L. 110-343 (122 Stat. 3875); Sections 12314 and 12315, Pub. L. 113-79 (7 U.S.C. 2101 note and 7101 note).
(b) * * *
(3) * * *
(iii) A W-9 providing the Federal tax identification number of the person (if the information required by Form W-9 has changed since the previous application).
(4) Standard Form 1199A. Every person claiming a payment must provide Standard Form 1199A, a direct deposit sign-up form, to facilitate any transfer of funds (if the information required by Form 1199A has changed since the previous application).
In addition to applicable information requirements in § 1471.1, trade associations filing a claim for a payment must electronically provide a statement which states that during the calendar year immediately preceding the payment they were, as determined by the Secretary, a domestic nationally recognized association established and operating for the promotion of pima cotton for domestic use in textile and apparel goods.
(b) * * *
(3) * * *
(iii) A W-9 providing the Federal tax identification number of the person (if the information required by Form W-9 has changed since the previous application).
(4) Every person claiming a payment must provide Standard Form 1199A, a direct deposit sign-up form, to facilitate any transfer of funds (if the information required by Form 1199A has changed since the previous application).
(b) * * *
(1) * * *
(ii)
(2) * * *
(ii)
(a)
(b)
(i) Imported eligible wool directly or indirectly; and
(ii) Used the imported wool to make men's or boy's suits; or
(iii) Further manufactured the eligible imported wool.
(2)
(a) * * *
(2) * * *
(i)
(A) Imported qualifying worsted wool fabric; and
(B) Used the imported qualifying worsted wool fabric directly or had another person use the qualifying worsted wool fabric providing the eligible person owned the qualifying worsted wool fabric at the time it was used:
(
(
(d) * * *
(3) * * *
(i) * * *
(A)
(ii) * * *
(A)
(a) * * *
(2) * * *
(i)
(A) Imported qualifying wool; and
(B) Manufactured the qualifying wool directly or had another person manufacture the qualifying wool providing the eligible person owned the qualifying wool at the time it was manufactured.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are adopting a new airworthiness directive (AD) for various aircraft equipped with a BRP-Powertrain GmbH & Co KG (formerly Rotax Aircraft Engines) 912 A series engine. This AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as a manufacturing defect found in certain carburetor floats where an in-flight engine shutdown and forced landing could occur when the affected cylinder had reduced or blocked fuel supply. We are issuing this AD to require actions to address the unsafe condition on these products.
This AD is effective December 23, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of December 23, 2016.
You may examine the AD docket on the Internet at
For service information identified in this AD, contact BRP-Powertrain GmbH & Co. KG, Welser Strasse 32, A-4623 Gunskirchen, Austria; phone: +43 7246 601 0; fax: +43 7246 601 9130; Internet:
Jim Rutherford, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4165; fax: (816) 329-4090; email:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to various aircraft equipped with a BRP-Powertrain GmbH & Co KG (formerly Rotax Aircraft Engines) 912 A series engine. The NPRM was published in the
Due to a quality escape in the manufacturing process of certain floats, Part Number (P/N) 861185, a partial separation of the float outer skin may occur during engine operation. Separated particles could lead to a restriction of the jets in the carburetor, possibly reducing or blocking the fuel supply to the affected cylinder.
This condition, if not detected and corrected, could lead to in-flight engine shutdown and forced landing, possibly resulting in damage to the aeroplane and injury to occupants.
To address this potential unsafe condition, BRP-Powertrain published Alert Service Bulletin (ASB) ASB-912-069/ASB-914-051 (single document, hereafter referred to as `the ASB' in this AD), providing instructions for identification and replacement of the affected parts.
For the reasons stated above, this AD required identification and replacement of the affected floats with serviceable parts.
This AD is republished to correct one typographical error in Table 2 of Appendix 2, and to include reference to revision 1 of the ASB in the Referenced Publications.
You may examine the MCAI on the Internet at
We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.
We reviewed the relevant data and determined that air safety and the public interest require adopting this AD as proposed except for minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
We reviewed BRP-Powertrain GmbH & CO KG Rotax Aircraft Engines BRP Alert Service Bulletin ASB-912-069R1/ASB-914-051R1 (co-published as one document), Revision 1, dated July 22, 2016. The service information describes procedures for identifying and replacing defective carburetor floats. 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 estimate that this AD will affect 65 products of U.S. registry. We also estimate that it will take about 2 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $100 per product.
Based on these figures, we estimate the cost of this AD on U.S. operators to be $17,550, or $270 per product.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
You may examine the AD docket on the Internet at
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This airworthiness directive (AD) becomes effective December 23, 2016.
None.
This AD applies to all serial numbers (S/N) of the airplanes listed in table 1 of paragraph (c) of this AD, certificated in any category, that incorporate one of the following:
(1) A BRP-Powertrain GmbH & Co KG (formerly Rotax Aircraft Engines) 912 A series engine having a serial number with a carburetor part number (P/N) and S/N listed in table 2 of paragraph (c) of this AD, installed as noted, in cylinder head position 1 through 4; or
(2) an engine that, after May 8, 2016, has had an affected float, P/N 861185, installed in service as part of the airframe. Affected floats were initially delivered between May 9, 2016, and July 17, 2016, and do not have three dots stamped on the surface, as shown in paragraph 3.3) of the Accomplishment/Instructions in Rotax Aircraft Engines BRP Alert Service Bulletin ASB-912-069R1/ASB-914-051R1 (co-published as one document), Revision 1, dated July 22, 2016. A certification document (
Air Transport Association of America (ATA) Code 73: Engine—Fuel and Control.
This AD was prompted by mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as a manufacturing defect found in certain carburetor floats. We are issuing this AD to require actions to prevent the fuel supply to the affected cylinder from becoming reduced or blocked, which could cause an in-flight engine shutdown and result in a forced landing and damage to the airplane or injury to the occupants.
Unless already done, do the following actions:
(1) Within the next 25 hours time-in-service after December 23, 2016 (the effective date of this AD) or within the next 30 days after December 23, 2016 (the effective date of this AD), whichever occurs first, replace all affected floats with a serviceable float following paragraph (3) Accomplishment/Instructions in Rotax Aircraft Engines BRP Alert Service Bulletin ASB-912-069R1/ASB-914-051R1 (co-published as one document), Revision 1, dated July 22, 2016.
(2) As of December 23, 2016 (the effective date of this AD), do not install a float, P/N 861185, that does not have three dots stamped on the surface, as shown in paragraph (3.3) of the Accomplishment/Instructions in Rotax Aircraft Engines BRP Alert Service Bulletin ASB-912-069R1/ASB-914-051R1 (co-published as one document), Revision 1, dated July 22, 2016.
The following provisions also apply to this AD:
(1)
(2)
Refer to MCAI European Aviation Safety Agency (EASA) AD No.: 2016-0144, correction dated July 25, 2016, and BRP-Powertrain GmbH & CO KG Rotax Aircraft Engines BRP Alert Service Bulletin ASB-912-069/ASB-914-051 (co-published as one document), dated July 14, 2016, for related information. You may examine the MCAI on the Internet at
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) Rotax Aircraft Engines BRP Alert Service Bulletin ASB-912-069R1/ASB-914-051R1 (co-published as one document), Revision 1, dated July 22, 2016.
(ii) Reserved.
(3) For Rotax Aircraft Engines BRP service information identified in this AD, contact BRP-Powertrain GmbH & Co. KG, Welser Strasse 32, A-4623 Gunskirchen, Austria; phone: +43 7246 601 0; fax: +43 7246 601 9130; Internet:
(4) You may view this referenced service information at the FAA, Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148. In addition, you can access this service information on the Internet at
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Bureau of Industry and Security, Commerce.
Final rule.
On March 24, 2016, the Bureau of Industry and Security (BIS) published a final rule, Temporary General License. The March 24 final rule created a temporary general license that restored, for a specified time period, the licensing requirements and policies under the Export Administration Regulations (EAR) for exports, reexports, and transfers (in-country) as of March 7, 2016, to two entities (ZTE Corporation and ZTE Kangxun) that were added to the Entity List on March 8, 2016. At this time, the U.S. Government has decided to extend the temporary general license until February 27, 2017. In order to implement this decision, this final rule revises the temporary general license to remove the expiration date of November 28, 2016, and to substitute the date of February 27, 2017. This final rule makes no other changes to the EAR.
This rule is effective November 18, 2016 through February 27, 2017. The expiration date of the final rule published on March 24, 2016 (81 FR 15633) is extended until February 27, 2017.
Chair, End-User Review Committee, Office of the Assistant Secretary, Export Administration, Bureau of Industry and Security, Department of Commerce, Phone: (202) 482-5991, Email:
On March 24, 2016, the Bureau of Industry and Security (BIS) published a final rule, Temporary General License (81 FR 15633). The March 24 final rule amended the EAR by adding Supplement No. 7 to part 744 to create a temporary general license that returned, until June 30, 2016, the licensing and other policies of the EAR regarding exports, reexports, and transfers (in-country) to Zhongxing Telecommunications Equipment (ZTE) Corporation and ZTE Kangxun to that which were in effect prior to their addition to the Entity List on March 8, 2016.
On June 28, 2016, BIS published a final rule, Temporary General License: Extension of Validity (81 FR 41799), which extended the validity of the temporary general license until August 30, 2016. On August 19, 2016, BIS published a final rule, Temporary General License: Extension of Validity (81 FR 55372), which extended, for a second time, the validity of the Temporary General License until November 28, 2016. Details regarding the scope of the listing are at 81 FR 12004 (Mar. 8, 2016), (“Additions to the Entity List”). Details regarding the Temporary General License can be found in the March 24 final rule and in Supplement No. 7 to Part 744—Temporary General License.
BIS issued the March 24 final rule, and the June 28 and August 19 extension of validity final rules, in connection with a request to remove or modify the listings. The March 24 final rule, and the June 28 and August 19 final rules, specified that the temporary general license was renewable if the U.S. Government determined, in its sole discretion, that ZTE Corporation and ZTE Kangxun were performing their undertakings to the U.S. Government in a timely manner and otherwise cooperating with the U.S. Government in resolving the matter which led to the two entities' listing.
At this time, the U.S. Government has decided to extend the temporary general license until February 27, 2017. In order to implement this U.S. Government decision, this final rule revises the temporary general license to remove the date of November 28, 2016, and substitute the date of February 27, 2017. This final rule makes no other changes to the EAR.
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, 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 has been determined to be not significant for purposes of Executive Order 12866.
2. Notwithstanding any other provision of law, no person is required to respond to or be 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 in Executive Order 13132.
4. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public comment, and a delay in effective date are inapplicable because this regulation involves a military or foreign affairs function of the United States. (
Exports, Reporting and recordkeeping requirements, Terrorism.
Accordingly, part 744 of the Export Administration Regulations (15 CFR parts 730 through 774) is amended as follows:
50 U.S.C. 4601
Federal Trade Commission.
Final rule.
The Federal Trade Commission (“FTC” or “Commission”) amends the Used Motor Vehicle Trade Regulation Rule (“Rule” or “Used Car Rule”). The Final Rule adopts the following proposals: adding a Buyers Guide statement recommending that consumers obtain a vehicle history report (“VHR”), and directing them to an FTC website for more information about VHRs and safety recalls; revising the Buyers Guide statement describing the meaning of an “As Is” sale in which a dealer offers a vehicle for sale without a warranty; adding boxes to the front of the Buyers Guide where dealers can indicate additional warranty and service contract coverage; adding a Spanish statement to the English Buyers Guide advising consumers to ask for a copy of the Buyers Guide in Spanish if the dealer is conducting the sale in Spanish (and providing a Spanish translation of the optional consumer acknowledgment of receipt of the Buyers Guide); and adding air bags and catalytic converters to the list of major defects on the back of the Buyers Guide.
This Rule is effective on January 27, 2017.
Copies of this document are available on the Commission's website,
John C. Hallerud, (312) 960-5634, Attorney, Midwest Region, Federal Trade Commission, 55 West Monroe Street, Suite 1825, Chicago, IL 60603.
The Used Car Rule requires dealers to display on used cars offered for sale a window sticker called a “Buyers Guide” containing warranty and other information. The Commission promulgated the Used Car Rule in 1984, and the Rule became effective in 1985.
In July 2008, the Commission commenced its periodic regulatory review of the Rule (“Regulatory Review”) to examine its efficacy, costs, and benefits, and to determine whether to retain, to modify, or to rescind the Rule.
In December 2012, the FTC issued a notice of proposed rulemaking (“NPRM”) with proposed changes to the Rule.
After reviewing the comments, the Commission published a supplemental notice of proposed rulemaking (“SNPRM”).
The Commission also proposed modifying the Buyers Guide statement that describes the meaning of an “As Is” sale in light of comments concerning a revision of the statement proposed in the NPRM. The “As Is” statement is meant to clarify that a dealer is offering the vehicle for sale without a warranty,
After reviewing the entire record, the Commission declines to adopt the approach proposed in the SNPRM, which would have required dealers that had obtained a VHR to check a new Buyers Guide box indicating that they had obtained a VHR and would provide a copy upon request. Instead, similar to what was proposed in the NPRM, the Commission has decided to add a statement to the Buyers Guide encouraging consumers to seek vehicle history information and directing consumers to an FTC website for more information. The Commission is aware that the marketplace for vehicle history information is changing rapidly and will continue to monitor developments in this area.
The Commission also has decided to revise the “As Is” statement proposed in the SNPRM. The revised statement in the Final Rule is:
(See Figure 1). The Commission is also adopting the revised “Implied Warranties Only” disclosure proposed in the NPRM for use in jurisdictions that prohibit “As Is” used vehicle sales.
The Commission has decided to modify the Buyers Guide in other ways proposed in the NPRM and SNPRM. The modified Buyers Guide in the Final Rule includes boxes on the front of the Buyers Guide where dealers can disclose manufacturer and other non-dealer warranties. The Commission is also reformatting the Service Contract box on the front of the Buyers Guide to make it flush with the non-dealer warranty boxes.
The Commission is adding a statement in Spanish to the front of the English Buyers Guide. The statement alerts Spanish-speaking consumers who cannot read the English Buyers Guide to ask for a Spanish Buyers Guide, if the dealer conducts the sale in Spanish. The additional Spanish statement is not intended to change the Rule's existing requirement that dealers provide a Spanish Buyers Guide if the dealer conducts a sale in Spanish.
The Commission received forty-one comments during the SNPRM comment period from groups and individuals. The Commission has considered those comments as well as the comments submitted in response to the NPRM and the 2008 Regulatory Review in promulgating the Final Rule. Commenters on the three notices include consumer advocacy groups, industry trade associations, state attorneys general (“State AGs”),
The Commission has decided to modify the Buyers Guide by adding a statement that advises consumers to obtain VHRs and to visit an FTC website for more information. The Final Rule is similar to the approach proposed in the NPRM, in which the Commission proposed a Buyers Guide containing a statement that advised consumers to obtain VHRs and directed consumers to an FTC website for more information.
The informational approach to VHRs adopted here should help reduce deception and consumer injury that could result from undisclosed or deceptive disclosure of title brands or other pieces of problematic history. It
In reaching this decision, the Commission has considered the differences in VHRs and providers, the strengths and limitations of VHRs, and the evolving development of the collection and distribution of vehicle history information. The Commission notes that consumers currently can gain access to VHRs at no cost from many dealers, automobile market websites, buying services, and other sources and can purchase VHRs at a nominal cost from commercial vendors. This approach balances the benefits to consumers of vehicle history information and the burden of requiring dealers to procure and disclose vehicle history information.
Vehicle history information is available from a variety of public and private sources. These sources include state titling agencies (
NMVTIS is a nationwide electronic database of vehicle history information created pursuant to the Anti-Car Theft Act of 1992.
Although NMVTIS is intended to be a reliable source of vehicle brand and title history, it does not contain detailed repair history and may not include significant damage history.
The NMVTIS Web site,
Title and other vehicle history information are also available in commercial reports from vendors such as CARFAX and Experian's AutoCheck. CARFAX and AutoCheck enable consumers to purchase VHRs, and some dealers distribute them to consumers free of charge. CARFAX and AutoCheck obtain data from state titling agencies, insurers, repair facilities, automobile auctions, salvage facilities, and fleet rental firms. These reports can include information on prior ownership, usage, damage, repair history, etc. They may even disclose whether a vehicle has had regular oil changes. Both CARFAX and AutoCheck offer mobile apps that allow real-time access to their reports. In addition, both CARFAX and AutoCheck offer consumers an option to pay a flat fee to receive multiple reports.
Commercial VHRs may include vehicle condition data from sources other than NMVTIS.
In the NPRM, the Commission proposed a statement on the Buyers Guide informing consumers about the availability of VHRs and advising consumers to obtain the reports. In response, many consumer advocacy groups, the State AG Group, and some NMVTIS vendors recommended that the Commission require dealers to obtain NMVTIS reports and/or adopt California Assembly Bill 1215 (“AB 1215”) (codified as Cal. Vehicle Code 11713.26), or some variation of it.
Rather than issuing a final rule based on the NPRM or AB 1215, the Commission published the SNPRM to seek comments on requiring dealers to disclose on the Buyers Guide if they had a VHR and to provide a copy of whatever report they had to requesting consumers. The SNPRM also invited public comments on several other approaches to vehicle history information proposed in the comments on the NPRM. The various approaches ranged from recommending that the Rule not address vehicle history information at all to approaches that generally fell somewhere between the NPRM's informational approach and the required disclosures of AB 1215.
The National Automobile Dealers Association (“NADA”) and the National Independent Automobile Dealers Association (“NIADA”) argue that a rule provision dealing with VHRs would exceed the Commission's authority.
Section 18 rulemakings are sometimes called Magnuson-Moss rulemakings, after the name of the bill that created section 18 of the FTC Act. But rulemakings under
NADA, but not NIADA, further argues that the Commission must use more elaborate rulemaking procedures than those specified by the Administrative Procedure Act (“APA”)
NADA and NIADA argue that the Commission lacks statutory authority to issue these Rule amendments. That argument, however, founders on the mistaken premise that the Rule rests solely on the Magnuson-Moss Warranty Act and not also on the FTC Act. As discussed in more detail below, the Rule has historically rested on
Ever since the Used Car Rule was promulgated, the Commission has made clear that the authority for the Rule “is derived from two sources”: Title I of the Magnuson-Moss Warranty Act and the FTC Act.
The dual bases of statutory authority are also reflected in the Rule's existing provisions and the procedures that the Commission used to promulgate the Rule. Some of the current provisions in the Used Car Rule deal with unfair or deceptive acts or practices that are not directly related to warranties or warranty practices.
NADA and NIADA are thus incorrect in arguing that the VHR amendments exceed the FTC's rulemaking authority.
Section 1029 of the DFA authorizes standard APA rulemaking procedures when the Commission uses its section 5 and section 18 rulemaking authority to address unfair or deceptive acts or practices by motor vehicle dealers. The DFA defines a “motor vehicle dealer” to mean someone who is (1) licensed by a State or territory to sell motor vehicles, and (2) takes title, owns, or has physical custody of them.
Section 1029(d) authorizes the FTC “to prescribe rules under sections 5 and 18(a)(1)(B) of the Federal Trade Commission Act” with respect to motor vehicle dealers that are “predominantly engaged in the sale and servicing of motor vehicles, the leasing and servicing of motor vehicles, or both.”
NADA argues that some non-franchised used car dealers are outside the scope of DFA 1029(a) because they sell but do not “service” vehicles.
That definition captures activities undertaken by essentially all used car dealers. For example, whether or not they offer
The legislative history of DFA 1029 likewise confirms that Congress intended to preserve the FTC's existing rulemaking authority over auto dealers but streamline the procedures applicable to all such dealers, not only to an arbitrarily defined subset of them. When Congress enacted section 1029 of DFA, Congress sought to achieve two ends. First, Congress was aware of and intended to preserve the FTC's existing authority over auto dealers. For example, Representative Frank said, “We are not increasing the authority that the FTC has. There is no further grant of powers other than what the FTC already has.”
Second, Congress was aware that the FTC's existing section 18 rulemaking process is time consuming and wanted to speed up the FTC's rulemaking process with respect to auto dealers. As Representative Frank explained, the reason for section 1029 was to “expedite the ability of the FTC to act responding to” concerns about dealers' unfair or deceptive acts or practices.
Congress never suggested that it intended to apply the expedited rulemaking procedures to only a subset of the car dealers who are subject to the FTC's jurisdiction. Moreover, Congress had no clear basis for requiring different rulemaking procedures for different used-car dealers depending on what types of post-sale services those dealers happened to offer. In short, NADA's argument not only conflicts with the statutory text and legislative history, but would serve no rational policy objective.
Finally, as discussed, NADA's argument about the scope of the FTC's APA rule-making authority rests on an unduly narrow interpretation of “servicing” that includes only post-sale activities and excludes pre-sale activities such as refurbishing. But NADA's members are franchised dealers who are required to offer
Some commenters raised arguments against including vehicle history information in the Buyers Guide. First,
The Commission concludes that incorporating vehicle history information into the Rule fits within the general framework of the existing Rule and would benefit consumers by reducing deception in the used car market. Encouraging consumers to obtain VHRs independently will serve to direct consumers to an additional source of pre-sale information that is not controlled by the dealer and thereby lessen the consumer's reliance on dealers for information. The incorporation of vehicle history information should help reduce deception by unscrupulous dealers, because any misrepresentations will be contradicted by information that consumers have obtained independently.
Second, NADA and CARFAX commented that including vehicle history information on the Buyers Guide is not necessary because dealers already obtain and share commercial VHRs with consumers.
Finally, some commenters expressed doubt about the reliability of vehicle history information.
A disclaimer, however, is unnecessary because the reports are typically dated and contain disclaimers about the limits of the data in them.
Some commenters approved of the informational approach proposed by the NPRM,
The Commission has decided to use an informational approach to vehicle history that reduces consumer reliance on dealers for information. The chosen approach does not endorse any type of or vendor of vehicle history information. Encouraging consumers to obtain VHRs independently will reduce deception in the marketplace by directing consumers to sources of information about the vehicles that they are considering buying that are not controlled by the selling dealer and thereby reduce the potential for consumers to rely upon misrepresentations from unscrupulous dealers.
The commenters who recommended incorporating vehicle history information into the Rule proposed several different approaches. Some favored an informational approach; some recommended a Rule that, like AB 1215, would require dealers to obtain VHRs and to disclose information about them to consumers; some suggested various approaches in between. Below, the Commission discusses why it has declined to adopt three of the alternative approaches recommended by commenters.
First, in response to the NPRM and the SNPRM, the State AG Group, other regulators, and consumer advocacy groups stated that they prefer an approach like AB 1215 along with a requirement that dealers obtain and provide consumers with NMVTIS reports.
The Commission, however, has decided that it will not adopt an amended Rule modeled on AB 1215 for the reasons already stated in the SNPRM.
Second, as an alternative to the AB 1215 approach, the State AG Group proposed a vehicle history disclosure model similar to the SNPRM with the addition of a “branded title checkbox” that the dealer would be required to check to indicate that the vehicle's title had a brand.
The “branded title check box” proposal from the State AG Group suffers from a number of practical problems if dealers are not also required to obtain either NMVTIS reports or other VHRs. Without a requirement that dealers obtain a VHR, the branded title check box could encourage dealers to forego VHRs entirely or to acquire only favorable ones. In addition, if an unchecked box, indicating that the dealer is unaware that the vehicle has a branded title, is incorporated into the contract as the dealer's affirmative representation that the vehicle in fact does not have a branded title, the dealer could face liability if a subsequent VHR shows a branded title. The lack of a checkmark could also suggest to consumers that the vehicle is in good condition when the lack of a checkmark is actually the far more limited representation that the dealer does not know whether the vehicle has a branded title.
Third, CAS commented that its preferred approach is “something of a hybrid” between AB 1215 and the State AG Group's approach.
As noted, the Commission has decided against following AB 1215 and requiring dealers to obtain NMVTIS reports.
The Commission is also not adopting the CAS approach because of the recordkeeping that it seems to necessarily entail. The CAS approach would impose new recordkeeping obligations by requiring dealers to keep copies of any reports that they view. The purpose of the CAS recordkeeping requirement is to prevent dealers from selecting favorable reports or from, for example, viewing reports online, but not printing or storing them, or obtaining information orally without ever viewing, or possessing, an actual report. But it is not clear how the Commission could construct detailed rules about when a dealer will be deemed to have viewed a report that would encompass all situations or how the Commission would enforce those rules if they could be devised.
As noted above, in the SNPRM, the Commission proposed requiring dealers who had obtained VHRs to check a box so indicating and to provide a copy of the report to consumers upon request. The SNPRM proposal also contained additional text recommending that consumers obtain a VHR, regardless of whether the box was checked, and advising that consumers visit an FTC website for information on how to obtain a VHR, how to search for safety recalls, and other topics. Many commenters criticized the SNPRM approach.
Consumer advocacy groups identified several problems with the SNPRM vehicle history approach. CAS, other consumer advocacy groups, and the State AG Group note that dealers could avoid revealing negative information in VHRs by, for example, picking and choosing among reports to select the most favorable report, discarding older (or newer) reports, selecting a report that showed the fewest problems, or selecting a vendor that generates reports showing minimal problems.
NADA further questioned the value of VHRs to consumers. NADA reiterated its earlier comments that VHRs are unreliable and of limited utility, which NADA states VHR vendors acknowledge in their own disclaimers about the accuracy, reliability, or completeness of the data in the reports.
Dealers' groups identified several additional problems with the vehicle history approach proposed in the SNPRM. NADA questioned the need for a rule about VHRs in the first instance because most franchised dealers, and potentially other dealers, already provide VHRs to consumers and because of a lack of evidence that dealers fail to disclose known title brands.
Both NADA and NIADA commented that the SNPRM does not define a VHR.
The commenters disagreed about whether dealers or consumers should be required to pay for copies of the VHRs contemplated by the SNPRM. Dealers' groups commented that dealers should be permitted to pass along their costs to consumers.
Consumer advocacy groups, the State AG Group, and other commenters would place the costs of VHRs on dealers.
The American Association of Motor Vehicle Administrators supported disclosure of vehicle history data at the point of sale. Both it and the Virginia DMV commented that the FTC should recommend or reference only VHRs that integrate NMVTIS data because NMVTIS is a congressionally mandated database.
A number of commenters urged the Commission to address safety recalls in an amended Rule. Several recommended that the Commission prohibit the sale of vehicles with open recalls.
Rather than adopt these proposals, the Commission has decided to address safety recalls by including a Buyers Guide statement directing consumers to check for open safety recalls by visiting
The Commission does note, however, that under the FTC Act's existing prohibition on deceptive acts and practices, an advertiser's claims may trigger the need for the advertiser to disclose information about open safety recalls. For example, the Commission approved for public comment proposed consent orders concerning advertising that, according to the Commission's complaints, touted the benefits of rigorous inspections of used vehicles, but failed to disclose adequately that some of the vehicles were subject to open safety recalls.
The Commission has considered the comments and entire record and has decided to adopt a final rule similar to what it initially proposed in the NPRM. Accordingly, the Commission is revising the Buyers Guide to include a statement advising consumers to obtain a VHR and directing consumers to an FTC website for more information. The Buyers Guide VHR statement appears in Figures 1 and 2. The Spanish translation appears in Figures 4 and 5.
As described above, the views expressed by the commenters include those advocating that the Rule and the Buyers Guide should not address vehicle history information at all, those favoring an informational approach, and those favoring an approach that, like AB 1215, would require dealers to obtain VHRs (specifically a NMVTIS report in the case of AB1215) and to disclose information about them to consumers, and various approaches in between.
The Final Rule incorporates an informational approach to VHRs. Revising the Buyers Guide by directing consumers to obtain a vehicle history report should help reduce consumer injury and deception that could result from undisclosed or deceptive disclosure of title brands or other pieces of problematic history. The SNPRM approach could encourage consumers to rely too much on particular VHRs and dealers for mechanical condition information to the neglect of information available from sources independent of dealers. On the other hand, specifying the source of or type of VHR that consumers consult, such as AB 1215 does, could discourage consumers from choosing VHRs that best suit their needs. Finally, an informational approach to VHR disclosures should not increase the burden on dealers much beyond what the Rule already imposes.
The Commission agrees that the SNPRM approach to VHR disclosures suffers from practical problems raised by the commenters. Among these is whether the Commission must define a VHR, or adopt a standard, such as NMVTIS, for the minimum amount of information that a VHR must contain to comply with a VHR disclosure requirement. Another question is whether the Commission would have to define what it means to obtain a report and whether the Commission can prevent dealers from viewing a report online or discarding reports. Other problematic issues also would arise, such as whether consumers or dealers should bear the cost of the reports. If dealers bear the cost, should they be required to produce reports to all requesting consumers, or should they be required to provide reports only to
In addition, requiring dealers to produce any VHRs that the dealer possesses, as proposed by the SNPRM, could reduce the availability of VHRs that dealers currently provide because of dealer liability concerns. Such a requirement would likely necessitate an extensive, and potentially unwieldy, rule defining what constitutes a VHR and when a dealer will be deemed to have obtained a VHR that would likely be difficult to apply in all situations.
Moreover, the marketplace for VHRs is evolving rapidly. Consumers currently can purchase the reports from commercial vendors for between $2 and $40 per report and can also gain access to them at no cost from many dealers, automobile market websites, buying services, etc.
The Commission is also adding language to the Buyers Guide statement directing consumers to check for open safety recalls by visiting
The existing Buyers Guide contains a box that dealers who offer to sell a used car without a warranty are required to mark to indicate that the vehicle is offered “As Is,”
After reviewing the comments that addressed the “As Is” statement, the Commission has decided to adopt the following “As Is” statement on the Buyers Guide which will appear next to a box that dealers would check in appropriate circumstances:
The statement is intended to convey nothing more than that the dealer does not intend to provide post-sale repairs under a warranty. Dealer groups strenuously objected to the Commission's SNPRM proposal to include the statement, “But you may have other legal rights and remedies for dealer misconduct.”
The existing “As Is” statement on the Buyers Guide has been part of the Buyers Guide since the Rule's promulgation in 1984. The “As Is” statement was formulated to correct consumer misunderstanding of the term “As Is.”
In the NPRM, the Commission proposed revising the Buyers Guide “As Is” statement to improve readability and to clarify the meaning of the term “As Is.” The Buyers Guide in the NPRM stated:
After reviewing the comments filed in response to the NPRM, the Commission, in the SNPRM, proposed retaining the “regardless of any oral statements about the vehicle” from the existing Rule and added “but you may have other legal rights and remedies for dealer misconduct.” Thus, the Buyers Guide in the SNPRM contains the following “As Is” statement:
THE DEALER WILL NOT PAY FOR ANY REPAIRS. The dealer does not accept responsibility to make or to pay for any repairs to this vehicle after you buy it regardless of any oral statements about the vehicle. But you may have other legal rights and remedies for dealer misconduct. (“SNRPRM `As Is' Statement”).
NCLC commented that the phrase “regardless of any oral statements” is “troubling” because “[i]t is likely to convey to consumers that the dealer has the right not to stand behind its oral statements.”
The State AG Group proposed eliminating the use of “As Is” entirely.
The Commission agrees that the description of an “As Is” sale should focus on whether the dealer is offering a warranty rather than on an affirmative statement that the dealer will not pay for repairs. Likewise, the disclosure should not focus on an affirmative statement about a consumer's likely obligation in an “As Is” sale (“you will pay all costs for any repairs.”). Accordingly, the Commission has decided to delete the affirmative statements concerning the dealer's and consumer's respective obligations. Instead, the Commission has revised the Buyers Guide to add the explanatory statement, “the dealer does not provide a warranty for any repairs after sale.”
The Commission, however, has decided to retain the term “As Is.” As noted in the 1984 rulemaking, the Uniform Commercial Code specifically identifies using “As Is” as a method to disclaim implied warranties.
To balance the potential of the “regardless of oral statements” language to insulate dealers from liability and to dissuade consumers from pursuing remedies for oral misrepresentations that may be available in some circumstances, the Commission, in the SNPRM, proposed adding “but you may
Dealers' organizations strongly objected to the proposed language. NIADA commented that “one is hard pressed not to read the third sentence as anything more than a provocation of consumers to search for dealer misconduct whether it exists or not.”
The Commission has decided against including the phrase “but you may have other legal rights and remedies for dealer misconduct,” as it had proposed in the SNPRM. The Commission agrees that the phrase may suggest that dealer misconduct exists or that consumers should look for it when none exists. Simplifying the description of an “As Is” sale to one in which the “dealer does not provide a warranty” should lessen the likelihood of consumer confusion and provide clearer guidance on whether a dealer affirmatively offers a warranty.
The Commission has decided to adopt a simplified “As Is” statement to address comments about whether the existing statement on the Buyers Guide clearly conveys that the dealer is not offering a warranty. The Commission has also considered the comments critical of various formulations of the phrase “regardless of any oral statements about the vehicle” and has decided to delete the phrase. The Commission notes that the Buyers Guide will continue to warn consumers that oral promises are difficult to enforce and to advise that consumers ask the dealer to put all promises in writing.
The proposed Buyers Guide in the SNPRM included boxes (“non-dealer warranty boxes”) that dealers could check to indicate whether an unexpired manufacturer warranty, a manufacturer used car warranty, or some other warranty applies, and whether a service contract is available. The version of the Buyers Guide proposed in the NPRM included similar boxes on the back of the Buyers Guide.
As suggested by the comments, the Commission has decided to make the non-dealer warranty boxes more prominent and accessible by moving them to the front of the Buyers Guide, as proposed in the SNPRM and shown in Figures 1 and 2. The Commission is also modifying the existing Rule's description of a service contract as proposed in the SNPRM and making the service contract box flush with the non-dealer warranty boxes.
The Commission has also decided to modify the statement that dealers may use on the Buyers Guide to disclose the applicability of an unexpired manufacturer's warranty.
The Final Rule permits dealers to use their existing stock of Buyers Guides for up to one year after the effective date of the Rule amendments. It includes a revised disclosure that dealers must use if they choose to disclose unexpired manufacturers' warranties, or other non-dealer warranties, using those Buyers Guides.
The Commission has decided to adopt the language initially proposed by CAS to disclose unexpired manufacturer's warranties because the language more accurately describes that an unexpired manufacturer's warranty typically refers to warranty coverage over some components of a used vehicle rather than the bumper-to-bumper coverage associated with a new vehicle. Accordingly, the amended Final Rule will provide dealers the ability to disclose that a “manufacturer's original warranty has not expired on some components of the vehicle.”
For the reasons discussed in the NPRM, the Commission declines to make the disclosure of non-dealer warranties mandatory on the Buyers Guide.
The Commission has decided to add a revised statement, in Spanish, to the front of the English Buyers Guide advising Spanish-speaking consumers who cannot read the English Buyers Guide to ask for a copy of the Spanish Buyers Guide if the dealer conducts the sale in Spanish. A proposed Spanish statement was included in the Buyers Guide published with the NPRM and incorporated into the SNPRM Buyers Guide.
The Rule permits dealers to add an optional signature line to the back of the Buyers Guide where consumers can acknowledge receipt of the Buyers Guide.
The Final Rule and Buyers Guide incorporate text and other modifications to the Buyers Guide that the Commission proposed in the NPRM. The Buyers Guide's statement advising consumers to ask the dealer about a mechanical inspection has been relocated above the proposed vehicle history information box to enhance its prominence.
In the NPRM, the Commission proposed adding air bags and catalytic converters, as part of the exhaust system, to the list of some major defects that may occur in used vehicles.
When the Commission promulgated the Rule in 1984, the Commission noted that it did not intend to regulate those service contracts that are “excluded from the Commission's jurisdiction by the McCarran-Ferguson Act.”
The Regulatory Flexibility Act (“RFA”)
The Commission believes that the amendments will not have a significant economic impact on small entities, although they will likely affect a substantial number of small entities. The Rule, and the amendments, apply primarily to independent used vehicle dealers and franchised new vehicle dealers, which typically also sell used vehicles, such as vehicles traded for new car purchases. Most dealers would be classified as small businesses, as explained
The amendments revise the Buyers Guide that the Rule requires dealers to display on used vehicles by changing pre-printed disclosures that appear on the Buyers Guide and adding boxes that dealers can check if they choose to disclose additional information concerning non-dealer warranties. Although the amendments will require that dealers eventually substitute the revised Buyers Guides, the amendments permit dealers to use their existing stock of Buyers Guides for up to one year after the effective date of these Rule amendments before doing so. The Rule already permits dealers to make the disclosures in the check boxes, but the check boxes will make the disclosures easier for those dealers who choose to make them. Therefore, the Commission certifies that amending the Rule will not have a significant economic impact on a substantial number of small businesses.
The Final Rule is similar to the rule proposed in the NPRM. In its Initial Regulatory Flexibility Analysis (“IRFA”), the Commission determined that the NPRM Proposed Rule was not likely to have a significant economic impact on a substantial number of small entities.
Although the Commission certifies under the RFA that the amendments will not have a significant impact on a substantial number of small entities, the Commission nonetheless has determined that publishing a final regulatory flexibility analysis (FRFA) is appropriate to ensure that the impact of the amendments is fully addressed.
The purpose of the amendments is to provide material information about vehicle histories and used car warranties to help protect consumers from dealer misrepresentations and to aid consumers in making informed choices when purchasing a used vehicle. In particular, the amendments seek to promote consumer awareness of vehicle history information, to clarify the meaning of “as is” in the sale of used vehicles without warranties, to make disclosures concerning non-dealer warranties more prominent, to improve Spanish-speaking consumers' access to the Spanish Buyers Guide during sales conducted in Spanish, and to provide additional information about defects that may be found in used vehicles.
None of the comments disputed the Initial Regulatory Flexibility Analysis in the NPRM or in the SNPRM. In the SNPRM, the Commission proposed that dealers indicate on the Buyers Guide that they had obtained a VHR and, if so, provide a copy of the VHR to consumers upon request. Commenters questioned whether the cost of providing copies of VHRs to consumers should be borne by consumers or dealers. The Final Rule does not require dealers to provide copies of VHRs to consumers, but instead a pre-printed statement on the Buyers Guide recommends that consumers visit an FTC website to learn more about obtaining VHRs. Accordingly, the amendments will not require dealers to bear the cost of providing VHRs to consumers.
The Commission did not receive any comments from the Small Business Administration Chief Counsel for Advocacy.
The Used Car Rule primarily applies to “dealers” defined as “any individual or business which sells or offers for sale a used vehicle after selling or offering for sale five (5) or more used vehicles in the previous twelve months.”
Most independent used vehicle dealers would be classified as small businesses. In 2012, the United States' 37,892 independent used vehicle dealers
The SBA would also classify many franchised new car dealers as small businesses. In 2015, the nation's 16,545 franchised new car dealers
The Used Car Rule imposes disclosure obligations on used vehicle dealers, but does not impose any reporting or recordkeeping requirements. Specifically, the Rule requires dealers to complete and to display a Buyers Guide on each used car offered for sale. Neither the existing Rule nor the Final Rule requires dealers to disclose non-dealer warranties. Under the existing Rule, dealers who choose to disclose non-dealer warranties, in particular, unexpired manufacturer's warranties, may do so by adding a statement to the Buyers Guide that is prescribed by the Rule. The Final Rule permits dealers to disclose unexpired manufacturer's warranties and other third-party warranties, but does not require that dealers make those disclosures. For those dealers who choose to disclose non-dealer warranties, the Final Rule should make the disclosure easier because dealers can make the disclosures by checking a box on the Buyers Guide rather than adding a statement prescribed by the Rule.
In other
The Commission has not proposed any specific small entity exemption or other significant alternatives because the amendments simply modify the pre-printed disclosures that dealers are already required to make in connection with offering used cars for sale.
The Commission believes that the Final Rule will help reduce potential deception by promoting consumer awareness of vehicle history information, consumer understanding of the meaning of “As Is” in used vehicle sales transactions in which a dealer disclaims warranties, and consumer awareness of warranties that may apply to a used vehicle. The revised Buyers Guide contains pre-printed statements that direct consumers to consumer-oriented websites for additional information, including live links to outside sources of information. The Rule also requires dealers to complete parts of the Buyers Guide by, among other things, listing the VIN and indicating the warranty coverage, if any, that applies to the vehicle. A downloadable, fillable version of the revised Buyers Guide is available on the Commission's Web site.
The Rule also provides that the Buyers Guide is incorporated into the sales contract. The Rule requires that dealers complete a Buyers Guide for each used vehicle offered for sale, display a physical Buyers Guide on the vehicle, and provide a copy of that Buyers Guide to consumers. Therefore, consumers are able to see the Buyers Guide disclosures upon even a casual inspection of a used vehicle that they are considering buying. Consumers likely expect to see a physical label on used cars because disclosure labels (“Monroney” stickers) are required to be affixed to new cars.
The Commission considered several different approaches to vehicle history information discussed in the comments. In the SNPRM, the Commission proposed requiring dealers who have VHRs to disclose that fact on the Buyers Guide and to provide copies of the reports to requesting consumers. In the NPRM, the Commission proposed placing a statement on the Buyers Guide that would advise consumers about the availability of vehicle history information and direct consumers to an FTC website for more information. The Commission also considered requiring dealers to obtain VHRs. such as NMVTIS reports, and requiring dealers to make disclosures similar to those required by California's AB 1215. Currently consumers can gain access to VHRs at no cost from many dealers, automobile marketplace websites, buying services, etc., and from commercial vendors at a nominal cost. Given the availability of various sources for and types of VHRs, the Commission has chosen not to require that dealers obtain reports or to designate specific types of reports or specific vendors. In doing so, the Commission sought to balance the burden placed on dealers with the goals of promoting consumer choice and access to vehicle history information.
The Commission considered comments on the Buyers Guide “As Is” statement and the various formulations of the statement proposed by the comments. The Commission chose the “As Is” statement in this Final Rule because the Commission believes that the statement clearly and accurately describes the meaning of “As Is.”
The Commission considered comments on the non-dealer warranty boxes proposed in the NPRM. In response to those comments, the Commission has moved those boxes to the front of the Buyers Guide.
Under these circumstances, the Commission does not believe a special exemption for small entities or significant compliance alternatives are necessary or appropriate to minimize the compliance burden, if any, on small entities while achieving the intended purposes of the amendments.
Under section 22 of the FTC Act, the Commission must issue a regulatory analysis for a proceeding to amend a rule only when it: (1) Estimates that the amendment will have an annual effect on the national economy of $100,000,000 or more; (2) estimates that the amendment will cause a substantial change in the cost or price of certain categories of goods or services; or (3) otherwise determines that the amendment will have a significant effect upon covered entities or upon consumers.
After careful consideration of the comments, and the record as a whole, the Commission has determined that there are no facts in the record, or other reasons to believe, that these amendments will have significant effects on the national economy, on the cost of goods or services, or on covered parties or consumers. No commenter provided a cost estimate of the amendments. Moreover, none indicated that the amendments would have an annual impact of more than $100,000,000, cause substantial change in the cost of goods or services, or otherwise have a significant effect upon covered entities or consumers.
In any event, to the extent, if any, these final rule amendments will have such effects, the Commission has explained above the need for, and the objectives of, the final amendments; the regulatory alternatives that the Commission considered; the projected benefits and adverse economic or other effects, if any, of the amendments; the reasons that the final amendments will attain their intended objectives in a manner consistent with applicable law; the reasons for the particular amendments that the agency has adopted; and the significant issues raised by public comments, including the Commission's assessment of and response to those comments on those issues.
The existing Rule contains no recordkeeping or reporting requirements, but it does contain disclosure requirements that constitute “information collection requirements” as defined by 5 CFR 1320.3(c) under the Office of Management and Budget (“OMB”) regulations that implement the Paperwork Reduction Act (“PRA”). OMB has approved the Rule's existing information collection requirements through Jan. 31, 2017 (OMB Control No. 3084-0108).
As discussed above, the Commission is retaining the requirement that dealers must display a Buyers Guide on used cars offered for sale and is updating the text of the disclosures that dealers must provide in the Buyers Guide. The Commission is also amending the Buyers Guide to provide dealers with a method to disclose optional additional information about non-dealer warranties. The amendments about non-dealer warranties do not require dealers to disclose this additional information nor do they alter the Rule's existing disclosure requirements or impose recordkeeping requirements.
The Commission has made amended Buyers Guides available on its Web site for downloading by dealers free of charge. The Commission expects that current suppliers of Buyers Guides, such as commercial vendors and dealer trade associations, will supply dealers with amended Buyers Guides. Accordingly, individual dealer cost to obtain amended Buyers Guides should increase only marginally, if at all.
As explained in the NPRM, FTC staff has estimated that dealers will make the optional disclosures on 25% of used cars offered for sale. Dealers who choose to make the optional disclosures should obtain amended Buyers Guides and complete them by checking additional boxes not appearing on the current Buyers Guide. Staff has in the past estimated that completing Buyers Guides requires approximately 2 minutes per vehicle for vehicles sold without a warranty and 3 minutes per vehicle for vehicles sold with a warranty.
Staff also anticipates that dealers can use lower level clerical staff at a mean hourly wage of $15.33 per hour
Estimating, as stated above, that dealers will make the optional disclosures on 25% of the 27,966,551 used cars offered for sale, and assuming further a cost of thirty cents per preprinted Buyers Guide, incremental purchase costs per year will total $2,097,491. Any other capital costs associated with the amendments are likely to be minimal. This analysis is consistent with the analysis provided in the NPRM, but has been updated with more recent data regarding the number of used vehicles sold and labor costs tied to making the optional disclosures for those sales. None of the comments disputed the PRA analysis in the NPRM.
Motor vehicles, Trade practices.
For the reasons set forth in the preamble, the Federal Trade Commission amends part 455 of title 16, Code of Federal Regulations, as follows:
15 U.S.C. 2309; 15 U.S.C. 41-58.
(d) * * *
(7)
(a)
(2) The capitalization, punctuation and wording of all items, headings, and text on the form must be exactly as required by this Rule. The entire form must be printed in 100% black ink on a white stock no smaller than 11 inches high by 7
(b)
(ii) If your State law limits or prohibits “as is” sales of vehicles, that State law overrides this part and this rule does not give you the right to sell “as is.” In such States, the heading “As Is—No Dealer Warranty” and the paragraph immediately accompanying that phrase must be deleted from the form, and the following heading and paragraph must be substituted as illustrated in the Buyers Guide in Figure 2. If you sell vehicles in States that permit “as is” sales, but you choose to offer implied warranties only, you must also use the following disclosure instead of “As Is—No Dealer Warranty” as illustrated by the Buyers Guide in Figure 2.
The dealer doesn't make any promises to fix things that need repair when you buy the vehicle or afterward. But
(2)
(i) Whether the warranty offered is “Full” or “Limited.” Mark the box next to the appropriate designation. A “Full” warranty is defined by the Federal Minimum Standards for Warranty set forth in section 104 of the Magnuson-Moss Act, 15 U.S.C. 2304 (1975). The Magnuson-Moss Act does not apply to vehicles manufactured before July 4, 1975. Therefore, if you choose not to designate “Full” or “Limited” for such vehicles, cross out both designations, leaving only “Warranty.”
(ii) Which of the specific systems are covered (for example, “engine, transmission, differential”). You cannot use shorthand, such as “drive train” or “power train” for covered systems.
(iii) The duration (for example, “30 days or 1,000 miles, whichever occurs first”).
(iv) The percentage of the repair cost paid by you (for example, “The dealer will pay 100% of the labor and 100% of the parts.”)
(v) You may, but are not required to, disclose that a warranty from a source other than the dealer applies to the vehicle. If you choose to disclose the applicability of a non-dealer warranty, mark the applicable box or boxes beneath “NON-DEALER WARRANTIES FOR THIS VEHICLE” to indicate: “MANUFACTURER'S WARRANTY STILL APPLIES. The manufacturer's original warranty has not expired on some components of the vehicle,” “MANUFACTURER'S USED VEHICLE WARRANTY APPLIES,” and/or “OTHER USED VEHICLE WARRANTY APPLIES.”
If, following negotiations, you and the buyer agree to changes in the warranty coverage, mark the changes on the form, as appropriate. If you first offer the vehicle with a warranty, but then sell it without one, cross out the offered warranty and mark either the “As Is—No Dealer Warranty” box or the “Implied Warranties Only” box, as appropriate.
(3)
□ SERVICE CONTRACT. A service contract on this vehicle is available for an extra charge. Ask for details about coverage, deductible, price, and exclusions. If you buy a service contract within 90 days of your purchase of this vehicle,
(a) If you conduct a sale in Spanish, the window form required by § 455.2 and the contract disclosures required by § 455.3 must be in that language. You may display on a vehicle both an English language window form and a Spanish language translation of that form. Use the translation and layout for Spanish language sales in Figures 4, 5, and 6.
(b) Use the following language for the “Implied Warranties Only” disclosure when required by § 455.2(b)(1) as illustrated by Figure 5:
El concesionario no hace ninguna promesa de reparar lo que sea necesario cuando compre el vehículo o posteriormente. Sin embargo, las
(c) Use the following language for the “Service Contract” disclosure required by § 455.2(b)(3) as illustrated by Figures 4 and 5:
CONTRATO DE MANTENIMIENTO. Con un cargo adicional, puede obtener un contrato de mantenimiento para este vehículo. Pregunte acerca de los detalles de la cobertura, los deducibles, el precio y las exclusiones. Si compra un contrato de mantenimiento dentro de los 90 días desde el momento en que compró el vehículo, las
(d) Use the following language if you choose to use the Optional Signature Line provided by § 455.2(f):
Por este medio confirmo que he recibido copia de la Guía del Comprador al momento de la compraventa.
By direction of the Commission.
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA or the Agency) is amending its current good manufacturing practice (CGMP) and labeling regulations regarding medical gases. FDA is requiring that portable cryogenic medical gas containers not manufactured with permanent gas use outlet connections have gas-specific use outlet connections that cannot be readily removed or replaced except by the manufacturer. FDA is also requiring that portable cryogenic medical gas containers and high-pressure medical gas cylinders meet certain labeling, naming, and color requirements. These requirements are intended to increase the likelihood that the contents of medical gas containers are accurately identified and reduce the likelihood of the wrong gas being connected to a gas
This rule is effective January 17, 2017. See section V of this document for the compliance date of this final rule.
J. Patrick Raulerson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6260, Silver Spring, MD 20993-0002, 301-796-3522.
On April 10, 2006, FDA issued a proposed rule to amend our regulations on CGMP to include new or revised requirements for the labeling, color, dedication, and design of medical gas containers and closures (71 FR 18039). The chief impetus for the proposed rule was a number of incidents in which a medical gas container holding a gas other than oxygen was erroneously connected to a health care facility's oxygen supply system, leading to serious injuries and deaths. In addition, FDA recognized that the regulation that conditionally exempts certain medical gases from certain otherwise-applicable prescription drug labeling regulations did not reflect either industry best practices or FDA's current regulatory expectations.
Following consideration of comments received and further internal deliberation, we are finalizing this rule as described in this document. The final rule is intended to increase the likelihood that the contents of medical gas containers are accurately identified and reduce the likelihood of the wrong gas being connected to a gas supply system or container. The final rule also modifies the medical gas conditional labeling exemption regulation such that it now largely reflects existing industry best practices and FDA's current regulatory expectations regarding the labeling of medical gases.
We received approximately 50 comments on the proposed rule. The most detailed comments were from industry trade associations. The other comments were largely from individual medical gas firms, consultants, or other industry stakeholders, and they generally expressed agreement with the trade associations' comments. We discuss all significant comments in section IV.
The final rule requires that portable cryogenic medical gas containers not manufactured with permanent gas use outlet connections have gas-specific use outlet connections that cannot be readily removed or replaced except by the manufacturer. The rule further requires that portable cryogenic medical gas containers and high-pressure medical gas cylinders meet certain labeling, naming, and color requirements. Principally, portable cryogenic medical gas containers are required to bear a 360° wraparound label identifying the contents of the container, and high-pressure medical gas cylinders are required to be colored on the shoulder of the container in the FDA-designated color or colors associated with the gas or gases held in the container. These requirements are intended to increase the likelihood that the contents of medical gas containers are accurately identified and reduce the likelihood of the wrong gas being connected to a gas supply system or container.
The final rule also revises the medical gas conditional labeling exemption regulation to add oxygen and nitrogen to the list of medical gases subject to the exemption, and to remove cyclopropane and ethylene from the list. The final rule further revises this regulation by adding new warning statement content to be included in oxygen labeling and by expanding the scope of the regulation to include medically appropriate mixtures of medical gases.
Medical gases are generally regulated as prescription drugs under sections 201(g)(1) and 503(b)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321(g)(1) and 353(b)(1)) (though oxygen may be dispensed without a prescription for certain uses specified at section 576(b)(2) of the FD&C Act (21 U.S.C. 360ddd-1(b)(2)), and are subject to regulation under section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)). Sections 575 and 576 of the FD&C Act (21 U.S.C. 360ddd and 360ddd-1) address the regulation of medical gases and designated medical gases. FDA is invoking its authority under sections 501(a)(2)(B), 502(f) (21 U.S.C. 352(f)), 576(a), and 701(a) (21 U.S.C. 371(a)) of the FD&C Act to create or modify CGMP and labeling regulations applicable to medical gases to ensure that they meet the requirements of the FD&C Act as to safety and have the identity and strength, and meet the quality and purity characteristics, that they purport or are represented to possess, and are labeled with adequate warnings and instructions for use.
The rule is expected to provide a modest net social benefit (estimated benefits minus estimated costs) to society. Costs are attributed to coloring medical gas containers, complying with the 360° wraparound label requirement for portable cryogenic containers, and requiring gas-specific use outlet connections on portable cryogenic containers to be permanently attached to the valve body (
In the
Accordingly, FDA proposed certain regulatory requirements intended to (1) reduce the likelihood of the wrong gas being attached to a gas supply system or container (and in particular to reduce the likelihood of a gas other than oxygen being connected to an oxygen supply system), (2) make the contents of medical gas containers more easily and accurately identifiable, and (3) reduce the risk of contamination of medical gases. Additionally, FDA proposed including medical air, oxygen, and nitrogen among, and excluding cyclopropane and ethylene from, the list of gases that are conditionally exempt from certain labeling requirements as described in § 201.161 (21 CFR 201.161). FDA solicited written comments on the proposed rule.
Following publication of the proposed rule, the Food and Drug Administration Safety and Innovation Act (FDASIA) was enacted (Pub. L. 112-144 (July 9, 2012)). Title XI, Subtitle B of FDASIA, “Medical Gas Product Regulation,” added new sections 575, 576, and 577 to the FD&C Act (21 U.S.C. 360ddd, 360ddd-1, and 360ddd-2), creating a new certification process for certain “designated” medical gases, including all of the gases listed at § 201.161 as amended by this rule. Section 575 of the FD&C Act defines the term “designated medical gas” to include oxygen, nitrogen, nitrous oxide, carbon dioxide, helium, carbon monoxide, and medical air that meet the standards set forth in an official compendium. Section 576 of the FD&C Act permits any person to file a request for certification of a medical gas as a designated medical gas for certain specified indications. A designated medical gas for which a certification is granted is deemed to have in effect an approved application under section 505 (New Drug Application) or 512 (New Animal Drug Application) of the FD&C Act (21 U.S.C. 355 or 360b) (
Section 576 of the FD&C Act also addresses the labeling and prescription drug status of designated medical gases. Section 576(a)(3)(A)(ii) of the FD&C Act, similar to the conditional labeling exemption at § 201.161(a), specifies how the labeling of designated medical gases may meet certain generally applicable statutory labeling requirements. Specifically, section 576(a)(3)(A)(ii) of the FD&C Act provides that the requirements of sections 503(b)(4) of the FD&C Act (regarding labeling of a drug as a prescription drug) and 502(f) of the FD&C Act (regarding inclusion of adequate directions for use and adequate warnings in drug labeling) are deemed to have been met for a designated medical gas if the labeling on the final use container for the medical gas bears: (1) The information required by section 503(b)(4); (2) a warning statement concerning the use of the medical gas as determined by the Secretary by regulation; and (3) appropriate directions and warnings concerning storage and handling. Section 576(b)(2)(B) of the FD&C Act further provides that, in the case of oxygen provided for certain uses specified at section 576(b)(2)(A), the requirements of section 503(b)(4) of the FD&C Act are deemed to have been met if the labeling bears a warning that the oxygen can be used for emergency use only and for all other medical applications a prescription is required. Finally, section 576(b) of the FD&C Act provides that designated medical gases shall generally be subject to the requirements of section 503(b)(1) of the FD&C Act (requiring that drugs meeting certain specified conditions be dispensed only upon prescription), while also providing that oxygen may be dispensed without a prescription for certain specified uses.
FDA received approximately 50 written comments on the proposed rule. Comments were submitted by trade associations representing the medical gas and home health care industries, medical gas firms, medical gas industry consultants and other industry stakeholders, and one State regulatory body.
The comments addressed the following topics, among others:
• The appropriate warning statements to be included in oxygen and medical air labeling.
• Safety issues associated with converting a gas container from industrial to medical use and how best to address them.
• The utility and appropriateness of coloring medical gas containers in whole or in part.
• The appropriate content and configuration of wraparound labeling on portable cryogenic medical gas containers.
• Estimated costs to comply with the proposed rule and whether such costs are justified under a cost-benefit analysis.
This final rule includes many of the provisions of the April 2006 proposed rule, with certain modifications described in section IV.C of this document. In particular, the final rule adds oxygen and nitrogen to, and removes cyclopropane and ethylene from, the list of medical gases in § 201.161(a) that are conditionally exempt from the labeling requirements of § 201.100(b)(2) and (3), and (c)(1). The final rule also requires that portable cryogenic medical gas containers and high-pressure medical gas cylinders meet certain labeling, naming, and coloring requirements as provided in new § 201.328. The final rule further requires that portable cryogenic medical gas containers not manufactured with permanent gas use outlet connections have gas-specific use outlet connections that cannot be readily removed or replaced except by the manufacturer by amending § 211.94 (21 CFR 211.94) through the addition of new paragraph (e).
This final rule also reflects revisions FDA is making to the April 2006 proposed rule in light of comments received. In addition to other changes discussed in section IV.C of this document, FDA is making the following significant changes to the proposed rule:
FDA is making additional revisions to § 201.161 in response to concerns raised by comments. First, in response to a comment questioning § 201.161(b)'s exclusion of gas mixtures from the scope of the § 201.161(a) conditional labeling exemptions applicable to
If the labeling on a final use container of a designated medical gas (or medically appropriate mixture of designated medical gases) includes the information required by section 503(b)(4) of the FD&C Act as well as the information required to obtain the conditional labeling exemptions provided at § 201.161(a) as revised by this rule, FDA will consider such labeling to meet the conditions set forth at section 576(a)(3)(A)(ii) of the FD&C Act, and, therefore, to have met the requirements of sections 503(b)(4) and 502(f) of the FD& C Act.
In § 211.94(e)(1) of the proposed rule, FDA proposed generally prohibiting cryogenic containers and high-pressure cylinders used to hold industrial gases from being converted to medical use to minimize the risk of contamination of medical gases by industrial contaminants or cleaning solvents. As discussed further in section IV.C of this document, FDA agrees with comments stating that such a prohibition would be unnecessarily costly, as these types of contamination incidents appear to be rare and existing regulations regarding cleaning and inspection of drug containers and closures are sufficient to address this issue. Accordingly, FDA is not finalizing this proposed requirement.
Medical gases are generally regulated as prescription drugs under sections 201(g)(1) and 503(b)(1) of the FD&C Act (though oxygen may be dispensed without a prescription for certain uses specified at section 576(b)(2) of the FD&C Act, and are subject to regulation under section 501(a)(2)(B) of the FD&C Act. Sections 575 and 576 of the FD&C Act address the regulation of medical gases and designated medical gases. Under sections 501(a)(2)(B), 502(f), and 701(a) of the FD&C Act, FDA has the authority to create and modify CGMP and labeling regulations to ensure that drugs meet the requirements of the FD&C Act as to safety and have the identity and strength, and meet the quality and purity characteristics, that they purport or are represented to possess, and are labeled with adequate warnings and instructions for use. Medical gas containers, closures, and labeling are integral parts of medical gas drug products and play a critical role in ensuring that these products are safe and have the appropriate identity, strength, quality, and purity. Medical gas mix-ups have caused deaths and serious injuries. These incidents have occurred despite current regulations and guidance addressing the safe handling of medical gases. FDA is therefore invoking the authority granted by sections 701(a), 501(a)(2)(B), 502(f), and 576(a) of the FD&C Act to issue CGMP and labeling regulations designed to facilitate the safe use of medical gases and to ensure that medical gases are labeled with adequate warnings and instructions for use. The specific requirements in these regulations will help to ensure the safety of these products.
We describe and respond to comments on the proposed rule in this section. We respond to certain comments on the Preliminary Regulatory Impact Analysis (PRIA) in the Final Regulatory Impact Analysis (see Section VI). For ease of identification, the word “Comment,” in parentheses, will appear before the comment's description, and the word “Response,” in parentheses, will appear before our response. The number assigned to each comment is purely for organizational purposes and does not signify the comment's value or importance or the order in which it was received. Many of the comments voiced the same or highly similar concerns and made the same or highly similar recommendations; these comments have been consolidated where possible.
(Comment 1) Many comments contend that FDA's proposal does not reflect the risk-based principles that have historically been enunciated in connection with recent CGMP policy. These comments state that risk-based principles focus regulation on critical areas that are likely to achieve the greatest public health impact. Thus, these comments state that because the impact of FDA's proposed rule is disproportionate to and beyond the scope of any public health risk associated with medical gases, it is inconsistent with the Agency's risk-based approach for CGMP. The comments further contend that the incidents cited in the preamble of the proposed rule do not support the number of requirements proposed, and that a single requirement in the proposed rule—requirement for secure connections on portable containers—would have prevented all but one of the fatalities cited in the preamble.
(Response 1) FDA agrees in part with these comments and has, following reanalysis of expected costs and benefits, declined to adopt certain provisions in the proposed rule and has revised other proposed provisions to more efficiently achieve public health objectives. Many of the requirements in the final rule are consistent with what we understand to be industry practices (Refs. 1-3). We continue to believe that medical gas containers and closures, such as portable cryogenic containers and high-pressure cylinders, are integral parts of the drug product and play a critical role in ensuring that the drug provided to the patient has the appropriate identity, strength, quality, and purity. Accordingly, we believe that this rule, as finalized, is fully consistent with FDA's risk-based approach to CGMP regulation.
(Comment 2) Many comments contend that FDA significantly underestimated the costs to industry imposed by the rule as proposed. These comments estimate these potential costs to be in the range of $855 million to $1.3 billion, as opposed to FDA's estimate of $950,000 to $1.2 million. These comments request that the cost assumptions and conclusions contained in the preamble to the proposed rule be critically reexamined by the Department of Health and Human Services and the Office of Management and Budget (OMB).
(Response 2) We considered these concerns, as appropriate, in preparing the Final Regulatory Impact Analysis (see Section VI).
FDA proposed adding medical air, oxygen, and nitrogen to the list of gases conditionally exempted by § 201.161(a) from the labeling requirements of § 201.100(b)(2) and (3), and (c)(1). FDA proposed these changes because, based on its years of regulatory experience with these gases, FDA believed that compliance with § 201.100(b)(2) and (3), and (c)(1) would be unnecessary if the warning statement and storage and handling directions required to obtain the conditional § 201.161(a) labeling exemptions were included in the labeling of such gases and the labeling and coloring requirements found in proposed § 211.94(e)(4) were met. FDA also proposed removing cyclopropane and ethylene from § 201.161(a), as these gases are no longer used in medical procedures because they are flammable and pose a risk of explosion or fire.
Comments support these proposed changes to the list of exempted gases. Many comments expressed concern, however, over how these proposed changes would affect the labeling of oxygen and medical air. These concerns are set forth in comments 3 and 4, followed by FDA's response.
(Comment 3) Many comments express significant concerns with FDA's proposal to add oxygen to the list of gases at § 201.161(a) without providing a warning statement specific to oxygen. The warning statement at § 201.161(a)(1) previously provided that the gas may only be used by or under the supervision of a licensed practitioner. These comments argue that requiring this statement for oxygen could eliminate the ability of first responders to administer oxygen without a prescription. These comments also note that the labeling on oxygen containers that has long been in use by the industry, which provides for use without a prescription in certain situations when administered by properly trained personnel, would no longer be acceptable and would need to be changed. These comments state that further changes are needed to address these issues.
(Comment 4) Many comments further note that the warning statement at § 201.161(a) does not include certain warnings currently included on oxygen labels. For instance, widely used oxygen labeling warns that uninterrupted use of high concentrations of oxygen over a long duration without monitoring its effect on oxygen content of arterial blood may be harmful and that oxygen should not be used on patients who have stopped breathing unless used in conjunction with resuscitative equipment.
(Response to Comments 3 and 4) FDA is further revising § 201.161(a)(1) in response to these comments.
Prior to the revisions finalized in this rule, § 201.161(a) provided that if the labeling of the medical gases listed in the rule—carbon dioxide, cyclopropane, ethylene, helium, and nitrous oxide intended for drug use—bore a specified warning statement and any needed directions concerning the conditions for storage and warnings against the inherent dangers in the handling of the specific compressed gas, those gases would be exempt from certain otherwise-applicable labeling requirements concerning the recommended or usual dosage, the drug's route of administration, and adequate directions for use. Section 201.161(b) provided that the exemption in § 201.161(a) did not apply to any mixture of the gases covered by the regulation with oxygen or with each other. In the 2006 proposed rulemaking FDA proposed adding oxygen, medical air, and nitrogen, and removing cyclopropane and ethylene, from the scope of § 201.161, but proposed no other changes to the rule.
As many comments point out, the warning statement previously specified at § 201.161(a)(1) differs significantly from the warning statement that has long been in use on oxygen labeling. FDA agrees with these comments that this oxygen-specific warning statement is more useful and appropriate for oxygen than the general warning statement previously specified at § 201.161(a)(1).
FDA further agrees with these comments that conditioning the § 201.161(a) labeling exemptions on inclusion of a warning statement limiting oxygen to prescription use would be inconsistent with the longstanding use of oxygen without a prescription in certain situations. It would also be inconsistent with new section 576(b)(2)(B) of the FD&C Act which, as discussed in section II.A of this document, provides that, in the case of oxygen provided without a prescription for certain uses specified at section 576(b)(2)(A), the requirements of section 503(b)(4) of the FD&C Act shall be deemed to have been met if the labeling bears a warning that the oxygen can be used for emergency use only and for all of other medical applications a prescription is required.
Therefore, § 201.161(a)(1)(i) of this final rule provides warning statement requirements specific to oxygen, as well as an additional warning statement requirement for oxygen that may be provided for certain uses without a prescription. FDA believes most oxygen containers currently marketed in the United States bear labeling that satisfies these new requirements (Ref. 1).
(Comment 5) Some comments express concerns with FDA's proposal to add medical air to the list of gases at § 201.161(a) without providing a warning statement specific to medical air. These comments point out that widely used medical air labeling indicates that medical air may be used without a prescription by properly trained personnel for breathing support, while for all other uses a prescription is required. These comments note that such labeling would be inconsistent with the warning statement previously specified at § 201.161(a)(1), which provided that the gas may only be used by or under the supervision of a licensed practitioner.
(Response 5) FDA acknowledges the comments that certain non-prescription uses of medical air are medically appropriate, and, accordingly, that the `prescription only' warning statement at § 201.161(a)(1)(i) as finalized by this rule is not appropriate for medical air. FDA is not finalizing the proposal to add medical air to the list of gases at § 201.161, and the question of what constitutes an appropriate warning statement for medical air remains under consideration by FDA.
(Comment 6) Many comments note that the proposed rule does not address labeling for medical gas mixtures, but rather leaves in place § 201.161(b)'s exclusion of gas mixtures from the scope of the § 201.161(a) conditional labeling exemptions. These comments recommend for the short term that § 201.161(b) remain as currently published but that FDA nonetheless permit these medical gas mixtures to be labeled consistent with industry practice, which utilizes the warning statement previously specified at § 201.161(a)(1).
(Response 6) FDA notes that, as discussed in section II.A of this document, following publication of the proposed rule new section 576(a)(3)(A)(i) was added to the FD&C Act by FDASIA. This new section provides that designated medical gases for which a certification is granted are deemed alone or in combination, as medically appropriate, with one or more other designated medical gases for which certifications have been granted to have in effect an approved application.
Accordingly, FDA is further revising § 201.161(a)(1) in response to these
(Comment 7) A comment requests that medical xenon be added to the list of exempted gases in § 201.161(a) as it is used clinically as a general anesthetic and as a diagnostic and test agent.
(Response 7) FDA disagrees that medical xenon should be added to the list of gases for which the § 201.161(a) conditional labeling exemptions are available. Xenon is not a designated medical gas and is not otherwise approved for use as a general anesthetic. Certain xenon gas radioisotopes have been approved as diagnostic agents, but these products have approved prescription drug labeling. Accordingly, it would be inappropriate to add xenon gas to the list of gases at § 201.161(a).
(Comment 8) Many comments contend that the content in proposed § 211.94(e)(4) is misplaced by being located in part 211 (21 CFR part 211, CGMP requirements) rather than part 201 (21 CFR part 201, labeling requirements). These comments recommend that any proposed labeling requirements be included in part 201.
(Response 8) FDA largely agrees with these comments and is reorganizing this content in the final rule. Specifically, the labeling content requirements in proposed § 211.94(e)(4) are being finalized under new § 201.328, while requirements that medical gas labels and coloring materials be resistant to wear and, in the case of labels, not susceptible to inadvertent removal, have been retained in § 211.94(e).
In § 211.94(e)(4) of the proposed rule (renumbered as § 201.328(a)(1) in this final rule), FDA proposed to require portable cryogenic containers to bear 360° wraparound labeling that meets naming, lettering, and placement specifications.
(Comment 9) Many comments expressed concern about the proposed requirement that the word “Medical” precede the name of the gas on the wraparound label. These comments state that there is a risk that users would focus on the “Medical” designation and ignore the more significant information,
(Response 9) FDA proposed adding the word “Medical” to the wraparound label to distinguish containers labeled with medical gases from containers holding industrial gases. This proposed requirement was intended to make the contents of the containers more readily and accurately identified by persons responsible for handling and connecting them to medical gas supply systems in hospitals or other health care facilities and thereby reduce the likelihood of medical gas mix-ups. However, FDA agrees with the comments that inclusion of the word “Medical” in the name of the gas would be inconsistent with the established names of medical gases.
Accordingly, as set forth in § 201.328(a)(2), FDA will instead require that the portable cryogenic containers bear a label (either the wraparound label or a separate label) near the top of the container but below the top seam weld that includes the phrase “For Medical Use,” “Medical Gas,” or some similar phrase that indicates the gas is for medical use in conspicuous lettering.
FDA has also reconsidered the proposed requirement that gases be identified on the wraparound label by their “standard names.” Section 502(e) of the FD&C Act provides that a drug product is misbranded unless its label bears the established name of the drug, if there is such a name. All of the gases listed at § 201.328(c) have established names. Thus, the proposed requirement regarding “standard names” is not necessary, and we are removing this concept from the final rule.
(Comment 10) A few of the parties providing comments state that while they agree with the proposed requirement at § 211.94(e)(4)(i)(E) that the label be placed “as close to the top of the container as possible but below the top weld seam”, they object to the following phrase: “. . . so that it cannot be easily detached or worn” (§ 211.94(e)(4)(i)(F)). These comments express concern that if the label is worn or detached by the user, for whatever reason, the manufacturer may be considered to be not in compliance with the proposed rule requirements, when in fact the firm may have properly placed the label.
(Response 10) FDA agrees that this proposed requirement should be revised. The key issue is that the wraparound label be affixed such that it is not susceptible to wear or to being inadvertently removed during normal use, and FDA is revising this requirement accordingly (see § 211.94(e)(2) of this final rule).
(Comment 11) Many comments note that the minimum lettering height requirement for the name of the gas on the wraparound label in the proposed rule (2
(Response 11) FDA is revising the minimum letter height requirement in consideration of these comments. The final rule states that the lettering height for the name of the gas on the label must be at least 2 inches high (see § 201.328(a)(1)(ii) of this final rule).
(Comment 12) Many comments support color-coding high-pressure cylinders, but are concerned that FDA may be placing undue emphasis on this means of identification. These comments contend that health care personnel should primarily rely on the label to identify the gas or gases in a container, and argue that reliance on color is problematic because of the variability of lighting conditions, color fading, and potential personnel colorblindness. Other comments state that reliance on color coding would appear to contradict training programs that industry and FDA have implemented to prevent mix-ups, as the consistent and fundamental themes of these training programs has been to emphasize that the label should be the primary indicator of a container's contents.
(Response 12) FDA agrees that the wording on the label should be used as the primary means of identifying a drug product. Requiring color coding of high-pressure cylinders, which we understand is already industry practice (Ref. 2), simply provides an additional safeguard to facilitate accurate identification of the drug product and
(Comment 13) Many comments recommend removing the requirement of “colored in whole” for non-aluminum high-pressure cylinders. These comments state that the current industry practice is to paint the shoulder to match the designated color for that medical gas. This is based on manufacturer recommendations that some non-aluminum high-pressure cylinders should not be painted in whole due to concerns about concealing defects.
(Response 13) FDA agrees with these comments. Thus, the final rule requires only that high-pressure medical gas cylinders be colored on the shoulder portion of the cylinder (see § 201.328(b)), which is consistent with what FDA understands to be industry practice (Ref. 2).
(Comment 14) Many comments dispute FDA's assumption that a large majority of high-pressure medical gas cylinders are already in compliance with the proposed coloring requirements. These comments note that portions of the shoulders of many cylinders are painted white to make retest information more visible, and that the upper neck portion of many cylinders are not painted a color based on the contents of the cylinder.
(Response 14) The cylinder coloring requirement in the final rule (see § 201.328(b)) would not require recoloring of cylinders colored in the manner described in the comments. As long as the cylinder shoulder is colored in the FDA-designated color or colors, the upper neck portion of the cylinder need not be that same color and use of white to make retesting information on a portion of the shoulder of the cylinder more visible is acceptable.
(Comment 15) Many comments recommend removal of the requirement that high-pressure medical gas cylinders containing mixtures of gases be painted in rough proportion to the fractions of gases contained in the mixture. These comments express concern that this method may cause the end user to ignore the label and rely on color proportions to identify the contents of a mixture. Additionally, these comments recommend that the following language be incorporated in the regulation: “when color marking consists of 2 or more colors, the pattern shall permit a portion of the colors to be seen together when viewed from the top,” which is consistent with industry practice.
(Response 15) FDA agrees with these comments. Therefore, FDA is revising the rule to require that the color for every constituent gas be visible when the cylinder is viewed from the top, and to remove the proportionality requirement.
(Comment 16) Many comments recommend removing the proposed requirement (at § 211.94(e)(4)(i)(G) in the proposed rule) that if the shoulder portion of a portable cryogenic medical gas container is colored, the color used must be the FDA-designated color of the gas held in the container. These comments point out that painting cryogenic containers with dark colors causes increased heat absorption, accelerating the rate of product venting, which could lead to unsafe conditions. These comments also note that large cryogenic containers made from carbon steel are painted in whole (including on the shoulder) in a light-reflective color, which would not necessarily correspond to the FDA-designated color or colors of the gas or gases held in the container.
(Response 16) FDA agrees with these concerns and is revising the proposed coloring requirement for portable cryogenic medical gas containers. As set forth in § 201.328(a)(1)(v) of the final rule, a portable cryogenic medical gas container may only be colored, in whole or in part, in the color or colors designated at § 201.328(c) if the gas or gases held in the container correspond to that color or those colors. The container may still be colored in a light-reflective color such as white (or some other color that is not an FDA-designated gas color), or simply not colored at all.
Finally, FDA is revising color requirements for the wraparound label such that they only apply to portable cryogenic medical gas containers that hold a single gas (see § 201.328(a)(1)(i) of this final rule). FDA believes that multiple colors on a single wraparound label—either in the lettering or in the background—may be impractical. Firms may still choose to follow the color scheme at § 201.328(a)(1)(i) for portable cryogenic medical gas containers that hold gas mixtures or blends, but will not be required to do so.
In § 211.94(e)(1) of the proposed rule, FDA proposed prohibiting cryogenic containers and high-pressure cylinders used to hold industrial gases from being converted to medical use, subject to limited exceptions.
(Comment 17) Many comments oppose any requirements to dedicate high-pressure cylinders and cryogenic containers to solely one use—industrial or medical. These comments contend that the root cause of the contamination incidents involving high-pressure cylinders discussed in the preamble to the proposed rule was the improper cleaning of cylinders, regardless of whether the cylinders previously held gases intended for medical or industrial use. These comments argue that the costs that would be associated with implementing this rule are not justified considering that the preamble to the proposed rule identified only two contamination incidents leading to injuries. According to these comments, these costs would include procuring additional containers (and associated assets), tracking individual containers over their useful life, marking containers for industrial or medical use, and increased distribution expenses. These comments further argue that FDA significantly underestimated the costs associated with this requirement in the economic analysis provided in the preamble to the proposed rule.
Many comments state that the proposed prohibition on conversion of medical gas containers from industrial to medical use is unwarranted because existing CGMP requirements, particularly § 211.94(c) (requiring cleaning of containers and closures to assure they are suitable for their intended use) and § 211.100(a) (requiring written procedures for process and production control designed to assure drug products have the identity, strength, quality, and purity they purport or are represented to possess), are adequate to prevent contamination associated with such conversion. These comments further argue that the proposed rule is inconsistent with FDA's past advice that medical gas assets can be converted from industrial to medical use and need not be dedicated to industrial use provided the items in question undergo validated cleaning procedures when converted to medical use.
(Response 17) FDA has reevaluated this proposed requirement in light of these concerns. FDA has determined that the risk of contamination associated with converting gas containers from industrial to medical use is relatively low, and can be fully addressed if the manufacturer, in compliance with §§ 211.84(a), 211.94(c), 211.100, and other applicable CGMP regulations, employs adequate, validated cleaning
(Comment 18) One comment states that the incidents dated March 20, 1998, and March 27, 1996, attributed in the proposed rule to contamination likely associated with conversion of high-pressure cylinders from industrial to medical use, could have been ignition events involving polytetraethylene seals or sealing tape. The comment suggests that a more detailed description of these events should be provided in order to make clear that the odors and compounds detected were from improper cleaning and not from ignition events.
(Response 18) As stated, FDA has reevaluated the necessity of the proposed non-conversion requirement and is removing it from the final rule.
In § 211.94(e)(3) of the proposed rule, FDA proposed to require that portable cryogenic medical gas containers not manufactured with permanent gas use outlet connections have gas-specific use outlet connections that cannot be readily removed or replaced except by the manufacturer. FDA is finalizing this provision (renumbered as § 211.94(e)(1)) with certain minor modifications explained in this document.
(Comment 19) Many comments support this requirement, as it would have a positive impact on patient safety by making medical gas mix-ups less likely. In fact, these comments recommend that the rule be extended to other outlets typically found on portable cryogenic medical gas containers, namely, the vent outlet and liquid fill/withdrawal outlet.
(Response 19) FDA is not aware of mix-up incidents involving the vent outlet valves or with liquid fill/withdrawal outlets, and such hypothetical mix-ups do not seem likely, given that the gas use outlet connection should be the only connection used to connect a portable cryogenic container to a health care facility's gas supply system. Accordingly, FDA believes that it is not necessary to extend the secure gas-specific use outlet connection requirement to vent outlets or liquid fill/withdrawal outlets.
(Comment 20) Some comments propose that the Agency slightly modify the exemption for “small cryogenic gas containers for use by individual patients” from the proposed definition of “portable cryogenic medical gas containers.” These comments note that some liquid oxygen home units designed for use by individual patients are, in fact, also used in certain situations to fill other containers for use by patients. These comments are concerned that if the exemption is not clarified, these liquid oxygen home units may be subject to the secure gas use outlet connection rule if they are used to fill other containers. Accordingly, these comments propose that the exemption be revised to include “small cryogenic gas containers
(Comment 21) Many comments propose that FDA clarify in the rule that the requirement for secure gas-specific use outlet connections is inapplicable to cryogenic containers that are too large (
(Response to Comments 20 and 21) FDA agrees that the definition of “portable cryogenic medical gas container” as used in the rule should be clarified. As such, we are clarifying in the final rule that cryogenic gas containers not designed to be connected to a medical gas supply system, including tank trucks, trailers, rail cars, and liquid oxygen home units, are exempt from the secure gas-specific use outlet connection requirement.
(Comment 22) A comment recommends that base units used to fill portable containers for use by patients in hospitals and other health care facilities, and large cryogenic containers that may be placed on trailers along with vaporizers and that are used as emergency backup when repairs are performed on the health care facility's permanent storage system, also be excluded from the rule. The comment states that because these base units and containers remain within the control of the medical gas manufacturer, and not the consumer, the risk of an improper connection is substantially reduced.
(Response 22) FDA does not agree that base units used to fill portable containers for use by patients in hospitals and other health care facilities and large cryogenic containers that may be placed on trailers along with vaporizers and that are used as emergency backup when repairs are performed on the health care facility's permanent storage system should be excluded from the rule. We believe that requiring such containers (which are designed to be connected to a medical gas supply system) to have secure gas-specific use outlet connections will help minimize the likelihood that an incorrect gas is connected to a gas distribution system or container.
(Comment 23) Many comments express concern with the discussion of records maintenance in the proposed rule. The PRIA indicated that there could be a slight increase in the medical gas industry's container closure records maintenance activities under § 211.184 if the industry chooses to use locking valves or devices to bring portable cryogenic containers into compliance with the secure gas-specific use outlet connection requirement. The proposed rule stated that under existing § 211.184(b), records of the results of any test or examination of a container closure under § 211.82(a) must be maintained, and that under existing § 211.184(c), an individual inventory record must be maintained for each container closure. FDA estimated that about 10 percent of the existing inventory of portable cryogenic containers would need to be modified to comply with the secure gas-specific use outlet connection requirement, that the industry would choose to comply through use of locking valves or devices (rather than silver brazing, which is more expensive), and that the records maintenance activities associated with this work would amount to about 2 minutes per locking device per year, resulting in an annualized records maintenance cost of about $54,000 dollars per year. The estimate of 2 minutes per locking device per year includes time associated with the initial inspection of the locking valve or device by the manufacturer (71 FR 18039 at 18048-18049).
The comments express concern that the proposed rule's reference to § 211.184(c) in particular entails a change of policy from FDA's historic application of records maintenance regulations to the medical gas industry and amounts to a new records maintenance expectation for medical gas containers and closures that would cost the industry between $376 and $665 million dollars to meet. The comments appear to reach this much higher number by assuming that it would be necessary to serialize valves and/or permanently mark all valves and connections on portable cryogenic containers to meet what they contend
(Response 23) FDA does not believe that serializing or permanently marking all valves and connections on portable cryogenic containers is necessary to satisfy the requirements of § 211.184. FDA did not intend to announce new or heightened records maintenance expectations for medical gas container closures in the proposed rule. While FDA believes that the records maintenance activities used to arrive at the estimate in the PRIA section for the records maintenance costs associated with the secure gas-specific use outlet connection requirement are appropriate, medical gas manufacturers may employ alternative records maintenance procedures to document any work performed to bring container closures into compliance with the secure gas-specific use outlet connection requirement.
As discussed in the Final Regulatory Impact Analysis (see Section VI), the estimated records maintenance costs associated with the secure gas use outlet connections requirements have been revised to range between $70 and $3,500. This reduction in estimated costs is largely driven by updated information showing that the number of portable cryogenic containers in the market is much lower than was thought at the time the proposed rule was issued.
(Comment 24) A comment requests that the final rule include a requirement that all personnel handling medical gases have documented competency training. This comment states that medical gases are USP listed and should be delivered by qualified personnel, such as respiratory therapists (who, according to this comment, are the only health care professionals specifically educated and competency-tested in all aspects of oxygen therapy).
(Response 24) In § 211.25 individuals engaged in the manufacture, processing, packing, or holding of a drug product (which would include a medical gas manufacturer's delivery personnel) are required to have the education, training, and experience necessary to perform assigned functions. Further, we are not aware that actual administration of medical gases to patients is part of the function of medical gas delivery personnel, so it is not clear why such personnel would need to be trained to administer gases to patients. We believe the existing regulation (§ 211.25) is sufficient to address any issues that may arise regarding the qualifications of a medical gas manufacturer's delivery personnel.
This rule is effective January 17, 2017. Affected firms and persons are encouraged to comply as soon as possible after the effective date. We recognize, however, that while most of the requirements of this final rule are already industry practices (Refs. 1-3), such practices are not ubiquitous. Accordingly, the compliance date is May 17, 2017. We believe it would be reasonable for affected firms and persons to fully implement this final rule in that amount of time.
(Comment 25) FDA received several comments that the 60-day time period proposed for implementation of the proposed rule is insufficient. These comments state that the proposal will impact every portable cryogenic container and request that FDA provide a reasonable transition period consistent with FDA precedents.
(Response 25) FDA agrees, and is establishing a compliance date that is 180 days after publication of the final rule in the
We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this final rule is not a significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the final rule imposes new burdens on small entities, we cannot certify that the final rule will not have a significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any 1 year.” The current threshold after adjustment for inflation is $146 million, using the most current (2015) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in an expenditure in any year that meets or exceeds this amount.
This final rule amends the CGMP and labeling regulations for medical gases. These amendments include the following: (1) Portable cryogenic medical gas containers not manufactured with permanent gas use outlet connections must have gas-specific use outlet connections that cannot be readily removed or replaced except by the manufacturer; (2) portable cryogenic medical gas containers must have a 360° wraparound label that clearly identifies the container's contents and conforms to certain placement, lettering, and other requirements; (3) high-pressure medical gas cylinders (and portable cryogenic medical gas containers, if colored) must be colored using an FDA-designated standard color (or colors in the case of gas mixtures); (4) the list of medical gases that are conditionally exempt from certain otherwise-applicable labeling requirements has been revised; and (5) the warning statements required to be on final use containers to qualify for the conditional exemption from certain otherwise-applicable labeling requirements have been modified for oxygen and medical air.
The rule is expected to provide a modest net social benefit (estimated benefits minus estimated costs) to society. Costs are attributed to coloring medical gas containers, complying with the 360° wraparound label requirement for portable cryogenic containers, and requiring gas-specific use outlet connections on portable cryogenic containers to be permanently attached to the valve body (
FDA also examined the economic implications of the rule as required by the Regulatory Flexibility Act. If a rule will have a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act requires us to analyze regulatory options that would lessen the economic effect of the rule on small entities. The rule imposes new costs to small entities. We estimate the rule's one-time costs to roughly range between 0.0001 percent and 0.13 percent of average annual revenues.
The full analysis of economic impacts is available in the docket for this final rule (Ref. 4) and at
We have determined under 21 CFR 25.30(j) and (k) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final rule contains information collection requirements that are subject to review by the OMB under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The title, description, and respondent description of the information collection provisions are shown in this section with an estimate of the third-party disclosure and recordkeeping burdens. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.
We estimate the burden for the collection of information as follows:
A gas listed at § 201.161(a) is exempt from certain labeling requirements if its labeling bears, among other things, a warning statement that conforms to § 201.161(a)(1). Section 201.161(a)(1)(i) specifies the content to be included in a warning statement for oxygen and § 201.161(a)(1)(ii) specifies the content to be included in a warning statement for nitrogen, carbon dioxide, helium, nitrous oxide, and any medically appropriate combinations of any of the gases listed in § 201.161(a). FDA believes most medical gases are already labeled in a manner that complies with § 201.161(a) as finalized. Furthermore, because § 201.161(a) provides the warning statement content to be included in medical gas labeling, the inclusion of these warning statements on medical gas labeling is not considered a “collection of information” subject to review under the PRA. See 5 CFR 1320.3(c)(2) (providing that “the public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public is not included” within the definition of “collection of information”).
Under § 201.328(a)(1), each portable cryogenic medical gas container must be conspicuously marked with a 360° wraparound label identifying its contents. The identity of the medical gas held in the container must be printed on the label in one of the following ways: Using lettering that appears in the standard color designated for the gas in § 201.328(c) and that is printed against a white background, or using lettering that appears in white against a background that is painted in the standard color for the gas as designated in § 201.328(c). The lettering for the name of the gas on the label must be at least 2 inches high; the name of the gas must be printed continuously around the label and be capable of being read around the entire container; the label must be on the sidewall of the container, as close to the top of the container as possible but below the top weld seam; and, if the shoulder portion
Under § 201.328(a)(2), the 360° wraparound label required in § 201.328(a)(1), or a separate label, must include in conspicuous lettering the phrase “For Medical Use,” “Medical Gas,” or some similar phrase that indicates the gas is for medical use. Finally, under § 211.94(e)(2), the wraparound label must be affixed to the container in a manner that does not interfere with other labeling and such that it is not susceptible to becoming worn or inadvertently detached during normal use, and the wraparound label must be reasonably resistant to fading, durable when exposed to atmospheric conditions, and not readily soluble in water.
We estimate that there are approximately 35,000 portable cryogenic containers in medical gas service that are subject to the labeling requirements at § 201.328(a). As discussed in the Economic Analysis of Impacts, FDA conservatively estimates that all manufacturers will choose to comply with § 201.328(a) by removing any existing wraparound labels from all portable cryogenic containers and replacing them with wraparound labels that meet all of the requirements at § 201.328(a). Thus, on average, each manufacturer would need to add labels to (or re-label) approximately 14 containers (35,000 ÷ 2,500). FDA estimates that approximately 6 minutes would be required to remove any existing wraparound label and attach a new wraparound label to each container. Thus, the total burden third-party disclosure burden hours associated with § 201.328(a)(1) and (2) is approximately 3,500 hours (2,500 × 14 × 0.10 hours).
Section 201.328(a)(1)(v) also provides that a portable cryogenic cylinder may only be colored in the color or colors designated in § 201.328(c) if the gas or gases held within the container correspond to that color or those colors. Alternatively, the container may be colored in a light-reflective color such as white (or some other color which is not an FDA-designated gas color), or simply not colored at all. Based on discussions with subject matter experts, we believe that few to no cryogenic containers will require recoloring as a result of this requirement, and therefore we estimate no third-party disclosure burden associated with this requirement.
Under § 201.328(b), high-pressure medical gas cylinders must be colored on the shoulder with the colors designated in § 201.328(c) for the gas contained in the cylinder, and such colors must be visible when viewed from the top of the cylinder. Under § 211.94(e)(2), the materials used for coloring medical gas containers must be reasonably resistant to fading, durable when exposed to atmospheric conditions, and not readily soluble in water. Based on information contained in the Economic Analysis of Impacts (see Section VI), we estimate that as many as 10 percent of the estimated 24.6 million high-pressure cylinders in medical service will require coloring or recoloring to comply with § 201.328(b). Thus, on average, each manufacturer would need to color 984 containers (2.46 million ÷ 2,500). We conservatively estimate that it will take an average of 6 minutes to color a cylinder. Thus, the total third-party disclosure burden hours associated with § 201.328(b) is approximately 246,000 hours (2,500 × 984 × 0.10 hours).
Section 211.94(e)(1) requires that portable cryogenic medical gas containers that are not manufactured with permanent gas use outlet connections must have gas-specific use outlet connections that are attached to the valve body so that they cannot be readily removed or replaced except by the manufacturer. A small portion of the existing inventory of portable cryogenic containers would need to be modified to comply with this requirement, and manufacturers must maintain records in accordance with § 211.184 for drug product containers. As discussed in the Economic Analysis of Impacts (see Section VI), FDA conservatively estimates that manufacturers will need to secure the gas use outlets of as many as 1,750 portable cryogenic containers to bring them into compliance with the final rule. As a result each manufacturer would incur annual recordkeeping under § 211.184 incident to bringing, on average, 0.7 containers into compliance with the secure gas use outlet connection requirement (1,750 ÷ 2,500). Consistent with our estimate in the proposed rule, this should require an average of 2 minutes (0.033 hours) per container. This results in an annual burden of 58 hours (2,500 × 0.7 × 0.033 hours) for 1,750 records.
The information collection provisions of this final rule have been submitted to OMB for review, as required by section 3507(d) of the PRA. Before the effective date of this final rule, FDA will publish a notice in the
We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.
The following reference is on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at
Drugs, Labeling, Reporting and recordkeeping requirements.
Drugs, Labeling, Laboratories, Packaging and containers, Prescription drugs, Reporting and recordkeeping requirements, Warehouses.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 201 and 211 are amended as follows:
21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360, 360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.
(a) Oxygen, nitrogen, carbon dioxide, helium, and nitrous oxide gases intended for drug use, and medically appropriate combinations of any of these gases intended for drug use, are exempted from the requirements of § 201.100(b)(2) and (3), and (c)(1), provided that, where applicable, the requirements of §§ 201.328 and 211.94(e)(2) of this chapter are met and the labeling bears, in addition to any other information required by the Federal Food, Drug, and Cosmetic Act, the following:
(1)(i) In the case of oxygen, a warning statement providing that uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful; that oxygen should not be used on patients who have stopped breathing unless used in conjunction with resuscitative equipment; and, in the case of oxygen that may be provided without a prescription for use in the event of depressurization or other environmental oxygen deficiency, or for oxygen deficiency or for use in emergency resuscitation when administered by properly trained personnel, a warning statement providing that oxygen may be used for emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation, and that for all other medical applications a prescription is required.
(ii) In the case of nitrogen, carbon dioxide, helium, nitrous oxide, and medically appropriate combinations of any of the gases listed in paragraph (a) of this section, a warning statement providing that the administration of the gas or gas combination (as applicable) may be hazardous or contraindicated; and that the gas or gas combination (as applicable) should be used only by or under the supervision of a licensed practitioner who is experienced in the use and administration of the gas or gas combination (as applicable) and is familiar with the indications, effects, dosages, methods, and frequency and duration of administration, and with the hazards, contraindications, and side effects and the precautions to be taken.
(2) Any needed directions concerning the conditions for storage and warnings against the inherent dangers in the handling of the specific compressed gas.
(b) [Reserved]
(a)
(1) Each portable cryogenic medical gas container must be conspicuously marked with a 360° wraparound label identifying its contents. Such label must meet the requirements of § 211.94(e)(2) of this chapter and the following additional requirements.
(i) If the container holds a single gas, the name of the gas held in the container must be printed on the label in one of the following ways:
(A) Using lettering that appears in the color designated for the gas in paragraph (c) of this section and that is printed against a white background, or
(B) Using lettering that appears in white against a background that is painted in the color for the gas designated in paragraph (c) of this section.
(ii) The lettering for the name of the gas on the label must be at least 2 inches high.
(iii) The name of the gas must be printed continuously around the label and be capable of being read around the entire container.
(iv) The label must be on the sidewall of the container, as close to the top of the container as possible but below the top weld seam.
(v) A portable cryogenic medical gas container may only be colored in the color or colors designated in paragraph (c) of this section if the gas or gases held within the container correspond to that color or those colors.
(2) A label on the container (either the 360° wraparound label required in paragraph (a)(1) of this section or a separate label) must include, in conspicuous lettering, the phrase “For Medical Use”, “Medical Gas,” or some similar phrase that indicates the gas is for medical use.
(b)
(c)
21 U.S.C. 321, 351, 352, 355, 360b, 371, 374; 42 U.S.C. 216, 262, 263a, 264.
(e)
(2)
(c) * * * Labeling reconciliation is also waived for 360° wraparound labels on portable cryogenic medical gas containers.
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule; correction.
This document corrects technical errors in the final rule that was placed on public inspection at the Office of the Federal Register on November 2, 2016 and scheduled for publication in the
This correcting document is effective January 1, 2017.
Terri Plumb, (410) 786-4481, Gaysha Brooks, (410) 786-9649, or Annette Brewer (410) 786-6580.
In FR Doc 2016-26668, that was placed on public inspection at the Office of the Federal Register on November 2, 2016 and scheduled for publication in the
In the CY 2017 PFS final rule, we inadvertently omitted or included language in § 410.79(b), (c)(1)(ii) and (iv), (c)(2)(i) and § 424.59(a)(1) and (5), (b)(4)(i), and (e)(2)(i).
Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), the agency is required to publish a notice of the proposed rule in the
In our view, this correcting document does not constitute a rulemaking that would be subject to these requirements. This document merely corrects technical errors in the CY 2017 PFS final rule. The corrections contained in this document are consistent with, and do not make substantive changes to, the policies and payment methodologies
Even if this were a rulemaking to which the notice and comment and delayed effective date requirements applied, we find that there is good cause to waive such requirements. Undertaking further notice and comment procedures to incorporate the corrections in this document into the CY 2017 PFS final rule or delaying the effective date of the corrections would be contrary to the public interest because it is in the public interest to ensure that the rule accurately reflects the public comment period. Further, such procedures would be unnecessary, because we are not making any substantive revisions to the final rule, but rather, we are simply correcting the
In FR Doc. 16-26668 appearing on page 80170 in the
The revisions read as follows:
(b) * * *
(c) * * *
(1) * * *
(ii) Have as of the date of attendance at the first core session a body mass index (BMI) of at least 25 if not self-identified as Asian or a BMI of at least 23 if self-identified as Asian.
(iv) Have no previous diagnosis of type 1 or type 2 diabetes (other than gestational diabetes).
(2) * * *
(i)
(a) * * *
(1) At the time of enrollment has full CDC DPRP recognition.
(5) Submits a roster of all coaches who will be furnishing MDPP services on the entity's behalf that includes the coaches' first and last names, SSN, and NPI.
(b) * * *
(4) * * *
(i) Has attended one, four or nine core sessions, or
(e) * * *
(2) * * *
(i) Become eligible to bill for MDPP services again if it meets the requirements of paragraph (a)(1) of this section, and enrolls again in Medicare as an MDPP supplier subject to paragraph (a) of this section.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; area closure and inseason adjustment.
This action closes the Georges Bank Cod Trimester Total Allowable Catch Area to Northeast multispecies common pool vessels and adjusts the Georges Bank cod possession and trip limit for common pool vessels for the remainder of Trimester 2, through December 31, 2016. The common pool fishery is projected to catch 90 percent of its Trimester 2 quota for Georges Bank cod. The closure and possession and trip limit reductions are intended to prevent an overage of the common pool's quota for this stock.
This action is effective November 15, 2016, through December 31, 2016.
Liz Sullivan, Fishery Management Specialist, (978) 282-8493.
Federal regulations at 50 CFR 648.82(n)(2)(ii) require the Regional Administrator to close a common pool Trimester Total Allowable Catch (TAC) Area for a stock when 90 percent of the Trimester TAC is projected to be caught. The closure applies to all common pool vessels fishing with gear capable of catching that stock for the remainder of the trimester.
As of November 5, 2016, the common pool fishery has caught approximately 87 percent of the Trimester 2 TAC (4.2 mt) for Georges Bank (GB) cod. We
Effective November 15, 2016, the GB Cod Trimester TAC Area is closed for the remainder of Trimester 2, through December 31, 2016, to all common pool vessels fishing with trawl gear, sink gillnet gear, and longline/hook gear. The GB Cod Trimester TAC Area consists of statistical areas 521, 522, 525, and 561. The area reopens at the beginning of Trimester 3 on January 1, 2017.
The intent of the trimester TAC area closure is to close the area where 90 percent of the catch of the stock has occurred. However, data indicate that common pool vessels have caught approximately 35 percent of the total catch in Trimester 2 from outside the statistical areas that will be affected by the closure described above. Federal regulations at § 648.86(o) authorize the Regional Administrator to adjust the possession and trip limits for common pool vessels to prevent the overharvest or underharvest of the common pool quotas. Therefore, the possession and trip limits for GB cod, are reduced as shown in Table 1, effective November 15, 2016, through December 31, 2016. This is intended to prevent the common pool from exceeding its sub-annual catch limit, but still allow for landing incidental catch of GB cod in areas not affected by the closure.
On January 1, 2017, common pool possession and trip limits for GB cod will return to the initial limits set by Framework Adjustment 55 to the Northeast Multispecies Fishery Management Plan (FMP).
If a vessel declared its trip through the Vessel Monitoring System (VMS) or the interactive voice response system, and crossed the VMS demarcation line prior to November 15, 2016, it may complete its trip within the Trimester TAC Area. Additionally, such vessels are not subject to the new possession and trip limits for that trip. A vessel that has set gillnet gear prior to November 15, 2016, may complete its trip by hauling such gear.
Any overage of the Trimester 1 or 2 TACs must be deducted from the Trimester 3 TAC. Any uncaught portion of the Trimester 1 and Trimester 2 TACs is carried over into the next trimester. If the common pool fishery exceeds its sub-ACL for the 2016 fishing year, the overage must be deducted from the common pool's sub-ACL for fishing year 2017. However, any uncaught portion of the common pool's sub-ACL may not be carried over into the following fishing year.
Weekly quota monitoring reports for the common pool fishery are on our Web site at:
This action is required by 50 CFR part 648 and is exempt from review under Executive Order 12866.
The Assistant Administrator for Fisheries, NOAA, finds good cause pursuant to 5 U.S.C. 553(b)(B) and 5 U.S.C. 553(d)(3) to waive prior notice and the opportunity for public comment and the 30-day delayed effectiveness period because it would be impracticable and contrary to the public interest.
Regulations require the Regional Administrator to close a trimester TAC area to the common pool fishery when 90 percent of the Trimester TAC for a stock has been caught. Updated catch information only recently became available indicating that the common pool fishery caught 90 percent of its Trimester 2 TAC for GB cod by November 7, 2016. The time necessary to provide for prior notice and comment, and a 30-day delay in effectiveness, prevents the immediate closure of the GB Cod Trimester 2 TAC Area and reduction of the common pool's GB cod possession and trip limits. Delaying the effective date of a closure and possession and trip limit reduction increases the likelihood that the common pool fishery will exceed its quota of GB cod to the detriment of this stock, which could undermine management objectives of the Northeast Multispecies FMP.
Additionally, an overage of the common pool quota could cause negative economic impacts to the common pool fishery as a result of overage paybacks in a future trimester or fishing year.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; directed fishery closure.
NMFS is closing the directed herring fishery in management Area 1B, limiting catch from that area to 2,000 lb (907.2 kg) per trip and prohibiting landing more than once per calendar day, because it projects that 92 percent of the 2016 annual seasonal catch limit for that area will have been caught by the effective date. This action is
Effective 0001 hr local time, November 18, 2016, through December 31, 2016.
Daniel Luers, Fishery Management Specialist, (978) 282-8457.
The reader can find regulations governing the herring fishery at 50 CFR part 648. The regulations require annual specification of the overfishing limit, acceptable biological catch, annual catch limit (ACL), optimum yield, domestic harvest and processing, U.S. at-sea processing, border transfer, and sub-ACLs for each management area. The 2016 Domestic Annual Harvest is 103,045 metric tons (mt); the 2016 sub-ACL allocated to Area 1B is 4,600 mt, and 138 mt of the Area 1B sub-ACL is set aside for research (78 FR 61828, October 4, 2013). The 2016 Area 1B sub-ACL was decreased to 2,941 mt to account for the 1,521 mt overage in 2014 catch. For management Area 1B, the catch of sub-ACL is currently allocated to the seasonal period from May 1 through December 31. There is no catch currently allocated to the seasonal period from January 1 through April 30. Therefore, under current regulations, vessels are prohibited from fishing for herring in or from Area 1B during the January 1 through April 30 period.
The regulations at § 648.201 require that when the NMFS Administrator of the Greater Atlantic Region (Regional Administrator) projects herring catch will reach 92 percent of the sub-ACL allocated in any of the four management areas designated in the Atlantic Herring Fishery Management Plan (FMP), NMFS will prohibit herring vessel permit holders from fishing for, catching, possessing, transferring, or landing more than 2,000 lb (907.2 kg) of herring per trip and landing more than once per calendar day in or from the specified management area for the remainder of the directed fishery closure period. The Regional Administrator monitors the herring fishery catch in each of the management areas based on dealer reports, state data, and other available information. NMFS publishes notification in the
The Regional Administrator has determined, based on dealer reports and other available information, that the herring fleet will catch 92 percent of the total herring sub-ACL allocated to Area 1B for the 2016 seasonal period from May 1 through December 31, 2016, by November 18, 2016. Therefore, effective 0001 hr local time, November 18, 2016, federally permitted vessels may not fish for, catch, possess, transfer, or land more than 2,000 lb (907.2 kg) of herring per trip and land more than once per calendar day, in or from Area 1B through December 31, 2016, except that vessels that have entered port before 0001 hr on November 18, 2016, may offload and sell more than 2,000 lb (907.2 kg) of herring from Area 1B from that trip after the closure. During the directed fishery closure, November 18, 2016, through December 31, 2016, a vessel may transit through Area 1B with more than 2,000 lb (907.2 kg) of herring on board, provided the vessel did not catch more than 2,000 lb (907.2 kg) of herring in Area 1B and its fishing gear is not available for immediate use as defined by § 648.2. Effective 0001 hr, November 18, 2016, federally permitted dealers may not receive herring from federally permitted herring vessels that harvest more than 2,000 lb (907.2 kg) of herring from Area 1B through 2400 hr local time, December 31, 2016, unless it is from a trip landed by a vessel that entered port before 0001 hr on November 18, 2016. Under current regulations during the seasonal period from January 1, 2017, through April 30, 2017, vessels are prohibited from fishing for, catching, possessing, transferring, or landing herring from Area 1B during this seasonal period. Vessels may transit area 1B with herring on board provided such herring were caught in an area or areas with sub-ACL available and that all fishing gear is stowed and not available for immediate use as defined in § 648.2, and the vessel is issued a permit that authorizes the amount of herring on board for the area where the herring was harvested. Beginning on May 1, 2017, the 2017 allocation for Area 1B is expected to become available.
This action is required by 50 CFR part 648 and is exempt from review under Executive Order 12866.
NMFS finds good cause pursuant to 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment because it would be contrary to the public interest and impracticable. The herring fishery opened for the 2016 fishing year on January 1, 2016, and Management Area 1B opened on May 1, 2016. Data indicating the herring fleet will have landed at least 92 percent of the 2016 sub-ACL allocated to Area 1B have only recently become available. Landings data is updated on a weekly basis, and NMFS monitors catch data on a daily basis as catch increases toward the limit for the area. Further, high-volume catch and landings in this fishery increase total catch relative to the sub-ACL quickly. This action is a required response to that recently available data and closes the directed herring fishery and imposes a 2,000-lb (907.2-kg) possession limit for Management Area 1B through December 31, 2016, under current regulations. The regulations at § 648.201(a) require such action to ensure that herring vessels do not exceed the 2016 sub-ACL allocated to Area 1B. If implementation of this closure is delayed to solicit prior public comment, the sub-ACL for Area 1B for this fishing year may be exceeded, thereby undermining the conservation objectives of the FMP. If sub-ACLs are exceeded, the excess must also be deducted from a future sub-ACL and would reduce future fishing opportunities. Also, the public had prior notice and full opportunity to comment on this process when these provisions were put in place. Based on these considerations, NMFS further finds, pursuant to 5 U.S.C. 553(d)(3), good cause to waive the 30-day delayed effectiveness period for the reasons stated above.
16 U.S.C. 1801
Office of Environment, Health, Safety and Security, U.S. Department of Energy.
Notice of proposed rulemaking.
The U.S. Department of Energy (DOE) proposes to amend the values listed in two appendices to its current occupational radiation protection regulations. The proposed amendment to appendix C would correct the derived air concentration value for any single radionuclide not listed in the appendix C table with a decay mode other than alpha emission or spontaneous fission and with radioactive half-life less than two hours, adjusted for an 8-hr work day. The proposed amendments to appendix E would correct the activity information of two radionuclides, Rh-102 and Rh-102m.
The comment period for this proposed rule will end on December 19, 2016.
You may submit comments, identified by docket number AU-RM-16-ORP, and/or Regulation Identification Number (RIN) 1992-AA51 in one of four ways (please select only one of the ways listed):
1.
2.
3.
4.
For detailed instructions on submitting comments and additional information on the rulemaking process, see Section IV of this document (Public Participation).
James Dillard, U.S. Department of Energy, Office of Environment, Health, Safety and Security, Mailstop AU-11, 1000 Independence Ave. SW., Washington, DC 20585. Telephone: 301-903-1165. Email:
The requirements in title 10, Code of Federal Regulations, part 835 (10 CFR part 835),
Title 10 CFR part 835 appendix E values were developed to ensure the proper accountability of sealed radioactive sources, as well as radioactive material posting and labeling requirements (63 FR 59662, November 4, 1998). DOE most recently amended the values of appendix E to part 835 on June 8, 2007 (72 FR 31904), using the International Commission on Radiological Protection (ICRP) Publication 60 methodology (ref. 1) and the same exposure scenarios discussed in a 1998 amendment to 10 CFR part 835 (63 FR 59662, November 4, 1998). The values were based on the more limiting of the quantity of radioactive material which results in either an external or internal whole body dose, from either inhalation or ingestion, of 100 millirems. However, the final rule incorrectly listed values for two radionuclides. This proposed amendment to appendix E would provide the correct activity values for these two radionuclides (Rh-102 and Rh-102m), calculated from internal exposure scenario derived from ICRP Publication 119 (ref. 2).
A. Appendix C—Derived Air Concentration (DAC) for Workers from External Exposure During Immersion in a Cloud of Airborne Radioactive Material. The proposed amendment would provide a correction to the derived air concentration value for any single radionuclide not listed in the Appendix C table with a decay mode other than alpha emission or spontaneous fission and with radioactive half-life less than two hours to 1E-06 µCi/mL (7E+04 Bq/m
B. Appendix E—Values for Establishing Sealed Radioactive Source Accountability and Radioactive Material Posting and Labeling Requirements. The proposed amendment would correct the activity for Rh-102 to 6.4E+05 µCi and the activity from Rh-102m to 3.0E+05 µCi.
This regulatory action has been determined not to be “not significant” under Executive Order 12866, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Accordingly, this action was not subject to review under that Executive Order by the Office of Information and Regulatory Affairs (OIRA) of the Office of Management and Budget (OMB).
The Regulatory Flexibility Act of 1980 (5 U.S.C. 601
This proposed rule would amend DOE requirements for nuclear safety and occupational radiation protection at DOE sites. The requirements of part 835 are primarily implemented by contractors who conduct work at DOE facilities. DOE considered whether these contractors are “small businesses” as the term is defined in the Regulatory Flexibility Act (5 U.S.C. 601(3)). The Regulatory Flexibility Act's definition incorporates the definition of small business concerns in the Small Business Act, which the Small Business Administration (SBA) has developed through size standards in 13 CFR part 121. The DOE contractors subject to this rule exceed the SBA's size standards for small businesses. In addition, DOE expects that any potential economic impact of this rule would be negligible because DOE activities are conducted by contractors who are reimbursed through their contracts with DOE for the costs of complying with DOE nuclear safety and radiation protection requirements, including the costs of complying with the proposed rule. For these reasons, DOE certifies that this proposed rule, if promulgated, would not have a significant economic impact on a substantial number of small entities, and therefore, no regulatory flexibility analysis has been prepared. DOE's certification and supporting statement of factual basis will be provided to the Chief Counsel of Advocacy of the SBA pursuant to 5 U.S.C. 605(b).
This proposed rule does not impose a collection of information requirement subject to the Paperwork Reduction Act (44 U.S.C. 3501
DOE has concluded that promulgation of this rule falls into a class of actions that would not individually or cumulatively have a significant impact on the human environment, as determined by DOE's regulations implementing the National Environmental Policy Act of 1969 (42 U.S.C. 4321
With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform” (61 FR 4729, February 7, 1996), imposes on Federal agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; and (3) provide a clear legal standard for affected conduct rather than a general standard and promote simplification and burden reduction. Section 3(b)(2) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect, if any, to be given to the regulation; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any, to be given to the regulation; (5) defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or it is unreasonable to meet one or more of the standards. DOE has completed the
Executive Order 13132, “Federalism” (64 FR 43255, August 4, 1999), imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have federalism implications. Agencies are required to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and carefully assess the necessity for such actions. DOE has examined this proposed rule and has determined that it would not preempt State law and would not have a substantial direct effect on the States, the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. No further action is required by Executive Order 13132.
Under Executive Order 13175 (65 FR 67249, November 6, 2000) on “Consultation and Coordination with Indian Tribal Governments,” DOE may not issue a discretionary rule that has “tribal” implications and imposes substantial direct compliance costs on Indian tribal governments. DOE has determined that the proposed rule would not have such effects and concluded that Executive Order 13175 does not apply to this proposed rule.
Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), 2 U.S.C. 1531
Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001) requires Federal agencies to prepare and submit to the OMB a Statement of Energy Effects for any proposed significant energy action. A “significant energy action” is defined as any action by an agency that promulgated or is expected to lead to promulgation of a final rule, and that: (1) Is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy, or (3) is designated by the Administrator of OIRA as a significant energy action. For any proposed significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use. This regulatory action would not have a significant adverse effect on the supply, distribution, or use of energy and is therefore not a significant energy action. Accordingly, DOE has not prepared a Statement of Energy Effects.
Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any proposed rule that may affect family well-being. The proposed rule would not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.
The Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516 note) provides for agencies to review most disseminations of information to the public under guidelines established by each agency pursuant to general guidelines issued by OMB.
OMB's guidelines were published at 67 FR 8452 (February 22, 2002), and DOE's guidelines were published at 67 FR 62446 (October 7, 2002). DOE has reviewed this proposed rule under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.
DOE will accept comments, data and information regarding this proposed rule before or after the public hearings, but no later than the date provided in the
1.
Do not submit to
DOE processes submissions made through
2.
Include contact information each time you submit comments, data, documents, and other information to DOE. If you submit via mail or hand delivery/courier, please provide all items on a CD or USB flash drive, if feasible. It is not necessary to submit printed copies. No facsimiles (faxes) will be accepted.
Comments, data, and other information submitted to DOE electronically should be provided in PDF (preferred), Microsoft Word or Excel, WordPerfect, or text (ASCII) file format. Provide documents that are not secured, that are written in English, and that are free of any defects or viruses. Documents should not contain special characters or any form of encryption and, if possible, they should carry the electronic signature of the author.
3.
It is DOE's policy that all comments may be included in the public docket, without change and as received, including any personal information provided in the comments (except information deemed to be exempt from public disclosure).
4.
The Secretary of Energy has approved publication of this proposed rule.
Federal buildings and facilities, Nuclear energy, Nuclear materials, Nuclear power plants and reactors, Nuclear safety, Occupational safety and health, Radiation protection, and Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Department of Energy proposes to amend part 835 of chapter III of title 10 of the Code of Federal Regulations as set forth below:
42 U.S.C. 2201, 7191, 50 U.S.C. 2410.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Learjet Inc. Model 36A airplanes. This proposed AD was prompted by a report indicating that an aileron cable failed on an airplane during a tension check and a determination that Model 36A airplanes were not included in AD 2005-13-36, which addresses this issue for other Learjet Inc. airplanes. This proposed AD would require a one-time inspection of the center ball of the aileron control cables for a defective
We must receive comments on this proposed AD by January 3, 2017.
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 Learjet, Inc., One Learjet Way, Wichita, KS 67209-2942; telephone 316-946-2000; fax 316-946-2220; email
You may examine the AD docket on the Internet at
Donald Ristow, Aerospace Engineer, Systems and Propulsion Branch, ACE-116W, FAA, Wichita Aircraft Certification Office (ACO), 1801 Airport Road, Room 100, Dwight D. Eisenhower National Airport, Wichita, Kansas 67209; phone: 316-946-4120; fax: 316-946-4107; 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 received a report indicating that an aileron cable failed on a Learjet Inc. Model 35A (C-21A) airplane when the cable underwent a tension check while being installed. Further investigation showed that an over-sized ball was swaged onto the cable during manufacture. Swaging an over-sized ball onto a cable allows excess material into the swaging die, which causes the ball to over-swage and then sever the cable strands. This condition, if not corrected, could result in severe weakening of the aileron cable, and consequent reduced controllability of the airplane.
The subject area on Learjet Inc. Model 36A airplanes is identical to that on the affected Model 35A (C-21A) airplane. Therefore, Model 36A airplanes may be subject to the same unsafe condition.
We previously issued AD 2005-13-36, Amendment 39-14173 (70 FR 38578, July 5, 2005) (“AD 2005-13-36”), for Learjet Inc. Model 23, 24, 24A, 24B, 24B-A, 24C, 24D, 24D-A, 24E, 24F, 24F-A, 25, 25A, 25B, 25C, 25D, 25F, 28, 29, 31, 31A, 35, 35A (C-21A), and 36 airplanes. Model 36A airplanes were inadvertently omitted from the applicability of that AD. The applicability of AD 2005-13-36 referred to Bombardier Alert Service Bulletin A35/36-27-42, dated December 23, 2002, for Model 35, 35A (C-21A), and 36 airplanes. However, Model 36A airplanes are also identified in that service information.
We reviewed Bombardier Alert Service Bulletin A35/36-27-42, dated December 23, 2002. The service information describes procedures for a one-time inspection of the center ball of the aileron control cables for a defective swage, and replacement of defective cables. 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, except as described in “Differences between this Proposed AD and the Service Information.”
Bombardier Alert Service Bulletin A35/36-27-42, dated December 23, 2002, recommends that operators accomplish the actions within 10 flight hours after receipt. This proposed AD would require that operators accomplish the actions within 100 flight hours, or 90 days after the effective date of the AD, whichever occurs first. We find that the proposed compliance time addresses the unsafe condition soon enough to maintain an adequate level of safety for the affected fleet. In developing an appropriate compliance time for this proposed AD we considered the degree of urgency associated with addressing the unsafe condition, and the maximum interval of time allowable for all affected airplanes to continue to operate without compromising safety.
We estimate that this proposed AD affects 21 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:
We estimate the following costs to do any necessary replacement that would be required based on the results of the proposed inspection. We have no way of determining the number of aircraft that might need this replacement:
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.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by January 3, 2017.
None.
This AD applies to Learjet Inc. Model 36A airplanes, certificated in any category, as identified in Bombardier Alert Service Bulletin A35/36-27-42, dated December 23, 2002.
Air Transport Association (ATA) of America Code 27, Flight controls.
This AD was prompted by a report indicating that an aileron cable failed on an airplane during a tension check. We are issuing this AD to prevent severe weakening of the aileron cable, and consequent reduced controllability of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Within 100 flight hours or 90 days after the effective date of this AD, whichever occurs first, do a detailed inspection of the center ball of the aileron control cables for a defective swage, and before further flight, replace any damaged or defective cable with a new cable, in accordance with the Accomplishment Instructions of Bombardier Alert Service Bulletin A35/36-27-42, dated December 23, 2002. For the purposes of this AD, a detailed inspection is: An intensive examination of a specific item, installation, or assembly to detect damage, failure, or irregularity. Available lighting is normally supplemented with a direct source of good lighting at an intensity deemed appropriate. Inspection aids such as mirrors, magnifying lenses, etc., may be necessary. Surface cleaning and elaborate procedures may be required.
As of the effective date of this AD, no person may install on any airplane an aileron control cable unless it has been inspected in accordance with paragraph (g) of this AD.
Although Bombardier Alert Service Bulletin A35/36-27-42, dated December 23, 2002, has procedures for submitting a report showing compliance and for returning any discrepant parts to the manufacturer, this AD does not include those requirements.
(1) The Manager, Wichita 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 (k)(1) of this AD.
(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.
(1) For more information about this AD, contact Donald Ristow, Aerospace Engineer, Systems and Propulsion Branch, ACE-116W, FAA, Wichita ACO, 1801 Airport Road, Room 100, Dwight D. Eisenhower National Airport, Wichita, Kansas 67209; phone: 316-946-4120; fax: 316-946-4107; email:
(2) For service information identified in this AD, contact Learjet, Inc., One Learjet Way, Wichita, KS 67209-2942; telephone 316-946-2000; fax 316-946-2220; email
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for all The Boeing Company Model 737-300, -400, and -500 series airplanes. This proposed AD was prompted by a report of a crack in a certain body station (BS) frame inboard chord during supplemental structural inspection document (SSID) inspections. This proposed AD would require repetitive detailed and high frequency eddy current (HFEC) inspections for any crack at the frame inboard chords, and repair if necessary. We are proposing this AD to prevent the unsafe condition on these products.
We must receive comments on this proposed AD by January 3, 2017.
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: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740; telephone: 562-797-1717; Internet:
You may examine the AD docket on the Internet at
Galib Abumeri, Aerospace Engineer, Airframe Branch, ANM 120L, FAA, Los Angeles Aircraft Certification Office (ACO), 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5324; fax: 562-627-5210; 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 indicating a crack of approximately 1.00 inch was found in the BS 616 frame inboard chord during SSID inspections. The crack was located at the lowest fastener hole of the inboard chord inboard strap below stringer S-11R. The airplane had accumulated 75,584 total flight hours and 63,570 total flight cycles. Cracking in the inboard chord is the result of fatigue caused by cyclic pressurization of the fuselage. This condition, if not corrected, could result in structural failure of the frame and possible rapid decompression.
We reviewed Boeing Alert Service Bulletin 737-53A1366, dated May 17, 2016. The service information describes procedures for repetitive detailed and HFEC inspections for cracking at the frame inboard chords, and repair. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
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, except as discussed under “Differences Between this Proposed AD and the Service Information.” For information on the procedures and compliance times, see this service information at
Boeing Alert Service Bulletin 737-53A1366, dated May 17, 2016, specifies to contact the manufacturer for certain instructions, but this proposed AD would require using repair methods, modification deviations, and alteration deviations in one of the following ways:
• In accordance with a method that we approve; or
• Using data that meet the certification basis of the airplane, and that have been approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) whom we have authorized to make those findings.
We estimate that this proposed AD affects 400 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:
We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this proposed AD.
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.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by January 3, 2017.
None.
This AD applies to all The Boeing Company Model 737-300, -400, and -500 series airplanes, certificated in any category.
Air Transport Association (ATA) of America Code 53, Fuselage.
This AD was prompted by a report of a crack in the body station (BS) 616 frame inboard chord during supplemental structural inspection document (SSID) inspections; the crack was located at the lowest fastener hole of the inboard chord inboard strap below stringer S-11R. We are issuing this AD to detect and correct any crack in the inboard chord of the BS 616 frame below stringers S-11L or S-11R, which could result in structural failure of the frame and possible rapid decompression.
Comply with this AD within the compliance times specified, unless already done.
Except as required by paragraph (i) of this AD, at the applicable times specified in table 1 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 737-53A1366, dated May 17, 2016: Do detailed and HFEC inspections for any crack at the frame inboard chords, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1366, dated May 17, 2016. Repeat the inspections thereafter at the time specified in table 1 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 737-53A1366, dated May 17, 2016.
If any crack is found during any inspection required by paragraph (g) of this AD, repair before further flight using a method approved in accordance with the procedures specified in paragraph (j) of this AD. Although Boeing Alert Service Bulletin 737-53A1366, dated May 17, 2016, specifies to contact Boeing for repair instructions, and specifies that action as “RC” (Required for Compliance), this AD requires repair as specified in this paragraph.
Where Boeing Alert Service Bulletin 737-53A1366, dated May 17, 2016, specifies a compliance time “after the original issue date of this service bulletin,” this AD requires compliance within the specified compliance time after the effective date of this AD.
(1) The Manager, Los Angeles 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 (k) 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, Los Angeles 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) Except as required by paragraph (h) of this AD: For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (j)(4)(i) and (j)(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. If a step or sub-step is labeled “RC Exempt,” then the RC requirement is removed from that step or sub-step. 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 Galib Abumeri, Aerospace Engineer, Airframe Branch, ANM 120L, FAA, Los Angeles ACO, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5324; fax: 562-627-5210; email:
(2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740; telephone: 562-797-1717; Internet:
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for Zodiac Aero Evacuation Systems fusible plugs installed on emergency evacuation equipment for various transport category airplanes. This proposed AD was prompted by reports indicating that affected fusible plugs activated (vented gas) below the rated temperature. This proposed AD would require an inspection of the fusible plugs to determine the part number, and lot number and replacement of all affected fusible plugs. We are proposing this AD to prevent the unsafe condition on these products.
We must receive comments on this proposed AD by January 3, 2017.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
You may examine the AD docket on the Internet at
Cesar Gomez, Aerospace Engineer, Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone: 516-228-7318; fax: 516-794-5531.
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 reports indicating that certain fusible plugs installed on emergency evacuation equipment activated below the rated temperature. Fusible plugs are safety devices that vent air from charged inflation systems if the inflation systems encounter excessive temperatures. Tests conducted on affected fusible plugs revealed that the plugs activated (vented gas) between 130 and 150 degrees Fahrenheit (ºF) instead of the rated temperature of 174 °F. The affected fusible plugs shipped from Air Cruisers, which is a component of Zodiac Aero Evacuation Systems, from October 1, 2008, through
We reviewed Air Cruisers Service Information Letter 25-246, Rev. No. 1, dated February 21, 2014. The service information provides information regarding affected fusible plugs and provides guidance on fusible plug replacement.
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 an inspection of the fusible plugs to determine the part number and lot number, and replacement of all affected fusible plugs. This proposed AD also would require, for affected part and lot numbers only, sending the part number identification results to Air Cruisers.
We estimate that this proposed AD affects 3,384 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:
We estimate the following costs to do any necessary replacements that would be required based on the results of the proposed inspection. We have no way of determining the number of aircraft that might need these replacements:
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 available costs in our cost estimate.
A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this AD is 2120-0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW., Washington, DC 20591, ATTN: Information Collection Clearance Officer, AES-200.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by January 3, 2017.
None.
This AD applies to Zodiac Aero Evacuation Systems fusible plugs installed on emergency evacuation equipment. These affected fusible plugs might be installed on the emergency evacuation equipment of various transport airplanes, certificated in any category, including, but not limited to, the airplanes of manufacturers specified in paragraphs (c)(1), (c)(2), (c)(3), and (c)(4) of this AD.
(1) Airbus.
(2) The Boeing Company.
(3) BAE Systems (Operations) Limited.
(4) Fokker Services B.V.
Air Transport Association (ATA) of America Code 25, Equipment/furnishings.
This AD was prompted by reports indicating that affected fusible plugs activated (vented gas) below the rated temperature. We are issuing this AD to detect and correct fusible plugs that might activate below the rated temperature, which renders the evacuation system unusable.
Comply with this AD within the compliance times specified, unless already done.
Within 30 days after the effective date of this AD: Do an inspection to determine the part number and lot number of the fusible plugs installed in the emergency evacuation equipment (including all inflation valves, reservoir and valve assemblies, and evacuation slides, slides/rafts and liferafts). A review of airplane maintenance records is acceptable to make this determination if the part number and lot number of the fusible plugs can be conclusively determined from that review. If any fusible plug has part number (P/N) B13984-3, stamped with Lot PA-21 or PA-22: Before further flight, replace the fusible plug with a new part.
Guidance can be found in the applicable component maintenance manual for the replacement. In addition, Air Cruisers Service Information Letter 25-246, Rev. No. 1, dated February 21, 2014, provides information regarding affected fusible plugs and guidance on the replacement.
If any fusible plug having P/N B13984-3, stamped with Lot PA-21 or PA-22, is identified during the inspection required by paragraph (g) of this AD: At the time specified in paragraph (h)(1) or (h)(2) of this AD, report the finding to Air Cruisers, Attention Kelly Schmidt, 1747 State Route 34, Wall Township, NJ 07727-3935; fax: 732-681-9163; email:
(1) If any affected fusible plug was identified on or after the effective date of this AD: Submit the report within 30 days after the part number identification.
(2) If any affected fusible plug was identified before the effective date of this AD: Submit the report within 30 days after the effective date of this AD.
As of the effective date of this AD, no person may install on any airplane any fusible plug having P/N B13984-3, stamped with Lot PA-21 or PA-22.
A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB Control Number. The OMB Control Number for this information collection is 2120-0056. Public reporting for this collection of information is estimated to be approximately 5 minutes per response, including the time for reviewing instructions, completing and reviewing the collection of information. All responses to this collection of information are mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn: Information Collection Clearance Officer, AES-200.
(1) The Manager, New York Aircraft Certification Office (ACO), ANE-170, 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 ACO, send it to ATTN: Program Manager, Continuing Operational Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone: 516-228-7300; fax: 516-794-5531.
(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.
For more information about this AD, contact Cesar Gomez, Aerospace Engineer, Airframe and Mechanical Systems Branch, ANE-171, FAA, New York ACO, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone: 516-228-7318; fax: 516-794-5531.
Environmental Protection Agency (EPA).
Proposed rule; extension of comment period.
On August 26, 2016, the Environmental Protection Agency (EPA) issued a proposed rule to revise provisions in the Prevention of Significant Deterioration (PSD) and title V permitting regulations applicable to greenhouse gases (GHGs) to fully conform with recent court decisions. The EPA is extending the comment period on this proposed rule that was scheduled to close on December 2, 2016. The EPA received a letter requesting the extension of the proposed rule public comment period to allow the public additional time to review the rule and supporting documentation.
The public comment period on the proposed rule published in the
Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2015-0355, at
For additional information on this action, contact Jessica Montañez, Office of Air Quality Planning and Standards, Environmental Protection Agency (C504-03), Research Triangle Park, North Carolina 27711; telephone number (919) 541-3407; fax number (919) 541-5509; email address:
After considering the request to extend the public comment period, the EPA has decided to extend the public comment period by 2 weeks, until December 16, 2016. This extension will ensure that the public has additional time to review the proposed rule and its supporting documents.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing action on the portions of six submissions from the State of Wyoming that are intended to demonstrate that the State Implementation Plan (SIP) meets certain interstate transport requirements of the Clean Air Act (Act or CAA). These submissions address the 2006 and 2012 fine particulate matter (PM
Comments must be received on or before December 19, 2016.
Submit your comments, identified by Docket ID No. EPA-R08-OAR-2016-0521 at
Adam Clark, Air Program, U.S. Environmental Protection Agency, Region 8, Mail Code 8P-AR, 1595 Wynkoop Street, Denver, Colorado 80202-1129. (303) 312-7104,
1.
2.
• Identify the rulemaking by docket number and other identifying information (subject heading,
• Follow directions and organize your comments;
• Explain why you agree or disagree;
• Suggest alternatives and substitute language for your requested changes;
• Describe any assumptions and provide any technical information and/or data that you used;
• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced;
• Provide specific examples to illustrate your concerns, and suggest alternatives;
• Explain your views as clearly as possible, avoiding the use of profanity or personal threats; and
• Make sure to submit your comments by the comment period deadline identified.
On September 21, 2006, the EPA revised the primary 24-hour NAAQS for PM
Pursuant to section 110(a)(1) of the CAA, states are required to submit SIPs meeting the applicable requirements of section 110(a)(2) within three years after promulgation of a new or revised NAAQS or within such shorter period as the EPA may prescribe. Section 110(a)(2) requires states to address structural SIP elements such as requirements for monitoring, basic program requirements, and legal authority that are designed to provide for implementation, maintenance and enforcement of the NAAQS. The SIP submission required by these provisions is referred to as the “infrastructure” SIP. Section 110(a) imposes the obligation upon states to make a SIP submission to the EPA for a new or revised NAAQS, but the contents of individual state submissions may vary depending upon the facts and circumstances.
CAA Section 110(a)(2)(D)(i)(I) requires SIPs to include provisions prohibiting any source or other type of emissions activity in one state from emitting any air pollutant in amounts that will contribute significantly to nonattainment, or interfere with maintenance, of the NAAQS in another state. The two provisions of this section are referred to as prong 1 (significant contribution to nonattainment) and prong 2 (interfere with maintenance). Section 110(a)(2)(D)(i)(II) requires SIPs to contain adequate provisions to prohibit emissions that will interfere with measures required to be included in the applicable implementation plan for any other state under part C to prevent significant deterioration of air quality (prong 3) or to protect visibility (prong 4).
The Wyoming Department of Environmental Quality (Department or WDEQ) submitted the following: A certification of Wyoming's infrastructure SIP for the 2006 PM
Each of these infrastructure certifications addressed all of the infrastructure elements including section 110(a)(2)(D)(i)(I), referred to as infrastructure element (D).
In its February 6, 2014 infrastructure submittal for the 2008 ozone NAAQS, WDEQ addressed 110(a)(2)(D)(i)(I) prongs 1 and 2 by presenting ambient monitoring and wind rose data, among other information,
WDEQ's approach to evaluating its compliance with the CAA section 110(a)(2)(D)(i)(I) as to the 2008 ozone NAAQS is incomplete for two reasons. First, transported emissions may cause an area to measure exceedances of the standard even if that area is not formally designated nonattainment by the EPA. While WDEQ considered its potential impact to the Denver nonattainment area based on general wind patterns, the State did not provide analysis showing that it did not contribute to ozone levels in the Denver nonattainment area on the particular days with measured exceedances. Moreover, while the State considered whether there were designated nonattainment areas in four of several nearby states, WDEQ did not evaluate whether it contributed to ozone levels elsewhere in Colorado or in other nearby states (
Second, WDEQ's submission does not provide any technical analysis demonstrating that the SIP contains adequate provisions prohibiting emissions that will interfere with maintenance of the 2008 ozone NAAQS in any other state (prong 2). In remanding the Clean Air Interstate Rule (CAIR) to the EPA in
The EPA developed technical information and a related analysis to assist states with meeting section 110(a)(2)(D)(i)(I) requirements for the 2008 ozone NAAQS, and used this technical analysis to support the recently finalized Cross-State Air Pollution Rule Update for the 2008 Ozone NAAQS (“CSAPR Update”).
In the technical analysis supporting the CSAPR Update, the EPA used detailed air quality analyses to determine where projected nonattainment or maintenance areas would be and whether emissions from an eastern state contribute to downwind air quality problems at those projected nonattainment or maintenance receptors.
As discussed in the CSAPR Update, the air quality modeling contained in the EPA's technical analysis (1) identified locations in the U.S. where the EPA anticipates nonattainment or maintenance issues in 2017 for the 2008 ozone NAAQS (these are identified as nonattainment and maintenance receptors), and (2) quantified the projected contributions from emissions from upwind states to downwind ozone concentrations at the receptors in 2017.
Consistent with the framework established in the original CSAPR rulemaking, the EPA's technical analysis in support of the CSAPR Update applied a threshold of one percent of the 2008 ozone NAAQS of 75 ppb (0.75 ppb) to identify linkages between upwind states and the downwind nonattainment and maintenance receptors.
As to western states, the EPA noted in the CSAPR Update that there may be geographically specific factors to consider in evaluating interstate transport, and given the near-term 2017 implementation timeframe, the EPA focused the final CSAPR Update on eastern states.
The EPA's air quality modeling as updated for the final CSAPR Update projects that for the Western U.S. (outside of California), there are no nonattainment receptors and only three maintenance receptors located in the Denver, Colorado area. Wyoming emissions are projected to contribute above one percent of the NAAQS at one of these receptors (the “Douglas County maintenance receptor”; see Table 1, below). The modeling also shows that multiple upwind states would collectively contribute to the projected Douglas County maintenance receptor in Colorado. The EPA found that the contribution to ozone concentrations from all states upwind of the Douglas County maintenance receptor in Colorado is about 9.7 percent.
As noted, the Agency has historically found that the one percent threshold is appropriate for identifying interstate transport linkages for states collectively contributing to downwind ozone nonattainment or maintenance problems because that threshold captures a high percentage of the total pollution transport affecting downwind receptors. The EPA believes contribution from an individual state equal to or above one percent of the NAAQS could be considered significant where the collective contribution of emissions from one or more upwind states is responsible for a considerable portion of the downwind air quality problem regardless of where the receptor is geographically located. In this case, three states contributing to the Douglas County maintenance receptor, including Wyoming, contribute emissions greater than or equal to one percent of the 2008 ozone NAAQS. Given these data, the EPA is proposing to find that the one percent threshold is also appropriate to determine the linkage from Wyoming to the Douglas County maintenance receptor in Colorado with respect to the 2008 ozone NAAQS.
The EPA is not necessarily determining that one percent of the NAAQS is always an appropriate threshold for identifying interstate transport linkages for all states in the West. For example, the EPA recently evaluated the impact of emissions from Arizona on two projected nonattainment receptors identified in California and concluded that even though Arizona's modeled contribution was greater than one percent of the 2008 ozone NAAQS, Arizona did not significantly contribute to nonattainment or interfere with maintenance at those receptors.
Likewise, the EPA is not determining that because Wyoming contributes above the one percent threshold, it is necessarily making a significant contribution that warrants further reductions in emissions. As noted above, the one percent threshold identifies a state as “linked,” prompting further inquiry into whether the contributions are significant and whether there are cost-effective controls that can be employed. That inquiry with regard to Wyoming's SIP submittal is provided below.
In summary, Table 1 shows the air quality modeling results from the final modeling in support of the CSAPR Update. The modeling indicates that Wyoming contributes emissions above the one percent threshold of 0.75 ppb with respect to the Douglas County maintenance receptor in the Denver, Colorado area.
Wyoming's largest contribution to any projected downwind maintenance-only site is 1.18 ppb, which is approximately 1.57% of the 2008 ozone NAAQS of 75 ppb. Thus, the final modeling in support of the CSAPR Update indicates that the contributions from Wyoming are above the one percent threshold of 0.75 ppb with respect to the Douglas County maintenance receptor in the Denver, Colorado area, and the State's emissions require further evaluation, taking into account both air quality and cost considerations, to determine what, if any, emissions reductions might be necessary to address the State's emission reduction obligation pursuant to 110(a)(2)(D)(i)(I). However, WDEQ in its SIP submittal neither identified nor included any ozone or ozone precursor emission reduction measures that the EPA could evaluate to determine whether the state has fully addressed these transport impacts. Accordingly, the EPA cannot conclude that Wyoming's SIP contains sufficient provisions to prohibit emissions that will interfere with maintenance of the 2008 ozone NAAQS in the Denver, Colorado area.
WDEQ's analysis regarding prong 1 is also incomplete as previously described, but the EPA's modeling indicates that Wyoming does not contribute above the one percent threshold to any nonattainment receptors. As discussed above, while the EPA is not necessarily determining that one percent of the NAAQS is always an appropriate threshold for identifying interstate transport linkages for all states in the West, this low level of contribution suggests that Wyoming does not contribute significantly to nonattainment of the 2008 ozone NAAQS in any other state. Thus, the EPA is proposing that the Wyoming SIP meets the 110(a)(2)(D)(i) prong 1 requirement for the 2008 ozone NAAQS.
Based on WDEQ's SIP submittal and the EPA's most recent modeling, the EPA proposes to approve prong 1 and disapprove the prong 2 portion of the February 6, 2014, 2008 ozone NAAQS infrastructure submittal. The EPA is soliciting public comments on this proposed action and will consider public comments received during the comment period.
WDEQ's analysis of potential interstate transport for the 2008 Pb NAAQS discussed the lack of sources with significant Pb emissions near the State's borders. As noted in our October 14, 2011 Infrastructure Guidance Memo, there is a sharp decrease in Pb concentrations, at least in the coarse fraction, as the distance from a Pb source increases.
Wyoming's 2010 NO
The EPA does not agree with the Wyoming's reliance on area designations for purposes of determining whether the State has met the requirements of section 110(a)(2)(D)(i)(I) with respect to the 2010 NO
Due to the State's limited technical analysis, the EPA evaluated NO
In addition to the monitored levels of NO
Based on all of these factors, EPA concurs with the State's conclusion that Wyoming does not contribute significantly to nonattainment or interfere with maintenance of the 2010 NO
In Wyoming's 2008 ozone, 2010 SO
WDEQ addressed visibility for the 2008 Pb NAAQS by pointing to the lack of significant sources of Pb in Wyoming near the State's border.
As stated in the EPA's 2013 Guidance, “[o]ne way in which prong 4 may be satisfied for any relevant NAAQS is through an air agency's confirmation in its infrastructure SIP submission that it has an approved regional haze SIP that fully meets the requirements of 40 CFR 51.308 or 51.309. 40 CFR 51.308 and 51.309 specifically require that a state participating in a regional planning process include all measures needed to achieve its apportionment of emission reduction obligations agreed upon through that process.”
On January 12, 2011 and April 19, 2012, Wyoming submitted to the EPA SIP revisions to address the requirements of the regional haze program. The EPA approved Wyoming's April 19, 2012 submittal and partially approved Wyoming's January 12, 2011 submittal in a final action published December 12, 2012. 77 FR 73926. This included EPA approval of Wyoming's BART alternative for SO
The 2013 Guidance states that section 110(a)(2)(D)(i)(II)'s prong 4 requirements can be satisfied by approved SIP provisions that the EPA has found to adequately address a state's contribution to visibility impairment in other states. The EPA interprets prong 4 to be pollutant-specific, such that the infrastructure SIP submission need only address the potential for interference with protection of visibility caused by the pollutant (including precursors) to which the new or revised NAAQS applies.
The 2013 Guidance lays out two ways in which a state's infrastructure SIP submittal may satisfy prong 4. As explained above, one way is through a state's confirmation in its infrastructure SIP submittal that it has an EPA approved regional haze SIP in place. Alternatively, in the absence of a fully approved regional haze SIP, a state can make a demonstration in its infrastructure SIP submittal that emissions within its jurisdiction do not interfere with other states' plans to protect visibility. Such a submittal should point to measures in the state's SIP that limit visibility-impairing pollutants and ensure that the resulting reductions conform to any mutually agreed emission reductions under the relevant regional haze regional planning organization (RPO) process.
WDEQ worked through its RPO, the WRAP, to develop strategies to address regional haze. To help states in establishing reasonable progress goals for improving visibility in Class I areas, the WRAP modeled future visibility conditions based on the mutually agreed emissions reductions from each state. The WRAP states then relied on this modeling in setting their respective reasonable progress goals. As a result, we consider emissions reductions from measures in Wyoming's SIP that conform with the level of emission reductions the State agreed to include in the WRAP modeling to meet the visibility requirement of CAA section 110(a)(2)(D)(i)(II).
With regard to the 2010 SO
The EPA is also proposing to approve Wyoming's prong 4 SIP submittal for the 2008 Pb NAAQS. The EPA has found that significant impacts from Pb emissions from stationary sources are expected to be limited to short distances from the source. The State noted that it does not have any major sources of Pb located near any bordering state. Further, when evaluating the extent to which Pb could impact visibility, the EPA has found Pb-related visibility impacts insignificant (
The EPA is proposing to disapprove Wyoming's prong 4 infrastructure SIP submittals for the 2006 PM
As noted, Wyoming referenced both its Regional Haze SIP and WAQSR Chapter 9, Section 2 as justification for the approvability of prong 4 for the 2008 ozone, 2010 NO
If the EPA disapproves an infrastructure SIP submission for prong 4, as we are proposing for the 2006 PM
The EPA is proposing to approve CAA section 110(a)(2)(D)(i)(I) prongs 1, 2 and 4 for the 2008 Pb NAAQS, prong 1 for the 2008 ozone NAAQS, and prong 4 for the 2010 SO
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state actions, provided that they meet the criteria of the Clean Air Act. Accordingly, this proposed action merely proposes approval of some state law as meeting federal requirements and proposes disapproval of other state law because it does not meet federal requirements; this proposed action does not propose additional requirements beyond those imposed by state law. For that reason, this proposed 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 (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 Clean Air Act; and
• Does not provide the 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 does not apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the proposed rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by Reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
42 U.S.C. 7401
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Comments regarding this information collection received by December 19, 2016 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725 17th Street NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to:
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Animal and Plant Health Inspection Service, USDA.
Notice and request for comments.
In accordance with legislation implementing the results of the Uruguay Round of negotiations under the General Agreement on Tariffs and Trade, we are informing the public of the international standard-setting activities of the World Organization for Animal Health, the Secretariat of the International Plant Protection Convention, and the North American Plant Protection Organization, and we are soliciting public comment on the standards to be considered.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
For general information on the topics covered in this notice, contact Ms. Jessica Mahalingappa, Assistant Deputy Administrator for Trade and Capacity Building, International Services, APHIS, room 1132, USDA South Building, 14th Street and Independence Avenue SW., Washington, DC 20250; (202) 799-7121.
For specific information regarding standard-setting activities of the World Organization for Animal Health, contact Dr. Michael David, Director, International Animal Health Standards Team, National Import Export Services, VS, APHIS, 4700 River Road Unit 33, Riverdale, MD 20737-1231; (301) 851-3302.
For specific information regarding the standard-setting activities of the International Plant Protection Convention, contact Dr. Marina Zlotina, PPQ's IPPC Technical Director, International Phytosanitary Standards, PPQ, APHIS, 4700 River Road Unit 130, Riverdale, MD 20737; (301) 851-2200.
For specific information on the North American Plant Protection Organization, contact Ms. Patricia Abad, PPQ's NAPPO Technical Director, International Phytosanitary Standards, PPQ, APHIS, 4700 River Road Unit 130, Riverdale, MD, 20737; (301) 851-2264.
The World Trade Organization (WTO) was established as the common international institutional framework for governing trade relations among its members in matters related to the Uruguay Round Agreements. The WTO is the successor organization to the General Agreement on Tariffs and Trade. U.S. membership in the WTO was approved by Congress when it enacted the Uruguay Round Agreements Act (Pub. L. 103-465), which was signed into law on December 8, 1994. The WTO Agreements, which established the WTO, entered into force with respect to the United States on January 1, 1995. The Uruguay Round Agreements Act amended Title IV of the Trade Agreements Act of 1979 (19 U.S.C. 2531
“International standard” is defined in 19 U.S.C. 2578b as any standard, guideline, or recommendation: (1) Adopted by the Codex Alimentarius Commission (Codex) regarding food safety; (2) developed under the auspices of the World Organization for Animal Health (OIE, formerly known as the Office International des Epizooties) regarding animal health and welfare, and zoonoses; (3) developed under the auspices of the Secretariat of the International Plant Protection Convention (IPPC) in cooperation with the North American Plant Protection Organization (NAPPO) regarding plant health; or (4) established by or developed under any other international organization agreed to by the member countries of the North American Free Trade Agreement (NAFTA) or the member countries of the WTO.
The President, pursuant to Proclamation No. 6780 of March 23, 1995 (60 FR 15845), designated the Secretary of Agriculture as the official responsible for informing the public of the SPS standard-setting activities of Codex, OIE, IPPC, and NAPPO. The United States Department of Agriculture's (USDA's) Food Safety and Inspection Service (FSIS) informs the public of Codex standard-setting activities, and USDA's Animal and Plant Health Inspection Service (APHIS) informs the public of OIE, IPPC, and NAPPO standard-setting activities.
FSIS publishes an annual notice in the
APHIS is responsible for publishing an annual notice of OIE, IPPC, and NAPPO activities related to international standards for plant and animal health and representing the United States with respect to these standards. Following are descriptions of the OIE, IPPC, and NAPPO organizations and the standard-setting agenda for each of these organizations. We have described the agenda that each of these organizations will address at their annual general sessions, including standards that may be presented for adoption or consideration, as well as other initiatives that may be underway at the OIE, IPPC, and NAPPO.
The agendas for these meetings are subject to change, and the draft standards identified in this notice may not be sufficiently developed and ready for adoption as indicated. Also, while it is the intent of the United States to support adoption of international standards and to participate actively and fully in their development, it should be recognized that the U.S. position on a specific draft standard will depend on the acceptability of the final draft. Given the dynamic and interactive nature of the standard-setting process, we encourage any persons who are interested in the most current details about a specific draft standard or the U.S. position on a particular standard-setting issue, or in providing comments on a specific standard that may be under development, to contact APHIS. Contact information is provided at the beginning of this notice under
The OIE was established in Paris, France, in 1924 with the signing of an international agreement by 28 countries. It is currently composed of 180 Members, each of which is represented by a delegate who, in most cases, is the chief veterinary officer of that country or territory. The WTO has recognized the OIE as the international forum for setting animal health standards, reporting global animal disease events, and presenting guidelines and recommendations on sanitary measures relating to animal health.
The OIE facilitates intergovernmental cooperation to prevent the spread of contagious diseases in animals by sharing scientific research among its Members. The major functions of the OIE are to collect and disseminate information on the distribution and occurrence of animal diseases and to ensure that science-based standards govern international trade in animals and animal products. The OIE aims to achieve these through the development and revision of international standards for diagnostic tests, vaccines, and the safe international trade of animals and animal products.
The OIE provides annual reports on the global distribution of animal diseases, recognizes the free status of Members for certain diseases,
The next OIE General Session is scheduled for May 21 to May 26, 2017, in Paris, France. Currently, the Chief Trade Advisor for APHIS' Veterinary Services program is the official U.S. Delegate to the OIE. The Chief Trade Advisor for APHIS' Veterinary Services program intends to participate in the proceedings and will discuss or comment on APHIS' position on any standard up for adoption. Information about OIE draft Terrestrial and Aquatic Animal Health Code chapters may be found on the Internet at
More than 26 Code chapters were amended, rewritten, or newly proposed and presented for adoption at the General Session. The following Code chapters are of particular interest to the United States:
Text was not changed in this Code chapter for the definition of “casings.” The proposal to include esophagi and stomachs in the definition of “casings” was rejected because these contain striated muscle, which is not used in the production of casings.
Text in this Code chapter was modified for clarity.
Text in this Code chapter was modified for clarity and consistency.
Text in this Code chapter was modified for clarity and consistency.
This Code chapter was deleted from the Terrestrial Code because the noted tests are included in the Terrestrial Manual.
A minor change was adopted and approved by Member Countries.
The text in this chapter was modified to clarify the therapeutic use of antimicrobial agents means the administration of antimicrobial agents to animals for treating and controlling infectious diseases.
The diagrams of the heads of animals detailing the specific locations for the use of captive bolts for the purpose of slaughtering were proposed for removal from the chapter. The diagrams are to be relocated to the OIE Web site.
References to the use of penetrating and non-penetrating captive bolts as procedures for killing adult poultry were added.
Some outcome-based measurables were added, as well as minor editorial changes.
This Code chapter includes prescriptive language regarding the housing of dairy cattle to which the United States continues to object and challenge.
This is a new Code chapter that was adopted this year. The United States noted an area of concern that will be considered by the Code Commission for future review.
The current chapter received minor updates that were adopted.
This chapter was adopted in 2015 and received minor updates to make it consistent with other vector borne diseases.
Minor changes were made to create harmonization among the vector-borne disease chapters.
A minor addition referencing the pertinent Codex Guideline was made and the chapter was adopted.
An editorial change was made to correct an error in Article 14.7.21. and the chapter was adopted.
An addition referencing the prevention of
The following Aquatic Manual chapters were revised and adopted, and are of particular interest to the United States:
• Glossary.
• Chapter 1.4., Animal health surveillance.
• Chapter 2.X., Criteria for assessing the safety of commodities.
• Chapter 4.3., Zoning and compartmentalization.
• Chapter 4.16., High Health Status Horse Subpopulation.
• Chapter 5.3., OIE procedures relevant to the WTO/SPS Agreement.
• Chapter 6.1., The role of veterinary services in food safety.
• Chapter 6.X., Prevention and control of
• Chapter 6.Y., Prevention and control of
• Chapter 7.5., Slaughter of animals.
• Chapter 8.8., Foot and mouth disease virus.
• Chapter 8.X., Infection with Mycobacterium tuberculosis complex.
• Chapter 10.4., Infection with avian influenza virus.
• Chapter 10.5., Avian mycoplasmosis (
• Chapter 11.11., Infection with lumpy skin disease.
• Chapter 12.10., Glanders.
• Chapter 15.1., Infection with African swine fever virus.
• Chapter 15.X., Infection with porcine reproductive and respiratory syndrome virus.
The IPPC is a multilateral convention adopted in 1952 for the purpose of securing common and effective action to prevent the spread and introduction of pests of plants and plant products and to promote appropriate measures for their control. The WTO has recognized the IPPC as the standard setting body for plant health. Under the IPPC, the understanding of plant protection has been, and continues to be, broad, encompassing the protection of both cultivated and non-cultivated plants from direct or indirect injury by plant pests. Activities addressed by the IPPC include the development, adoption and implementation of international phytosanitary (or plant health) standards (ISPMs), the harmonization of phytosanitary activities through emerging standards, the facilitation of the exchange of official and scientific information among countries, and the furnishing of technical assistance to developing countries that are contracting parties to the IPPC.
The IPPC is deposited with the Food and Agriculture Organization (FAO), and is an international agreement of 182 contracting parties (CPs). The Convention is implemented by national plant protection organizations (NPPOs) in cooperation with regional plant protection organizations (RPPOs), the Commission on Phytosanitary Measures (CPM), and the Secretariat of the IPPC. The IPPC has been, and continues to be, administered at the national level by plant quarantine officials whose primary objective is to safeguard plant resources from injurious pests. In the United States, the NPPO is APHIS' Plant Protection and Quarantine (PPQ) program.
The Eleventh Session of the CPM took place from April 4 to 8, 2016, at FAO Headquarters in Rome, Italy. The Deputy Administrator for APHIS' PPQ program was the U.S. delegate to the CPM. The Deputy Administrator participated in the proceedings and discussed or commented on APHIS' position on any standards up for adoption.
The following standards were adopted by the CPM at its 2016 meeting. The United States, represented by the Deputy Administrator for APHIS' PPQ program, participated in consideration of these standards. The U.S. position on each of these issues were developed prior to the CPM session and were based on APHIS' analysis, information from other U.S. Government agencies, and relevant scientific information from interested stakeholders:
• Revisions to ISPM 5: Glossary of Phytosanitary Terms
• ISPM 37: Determination of host status of fruit to fruit flies (Tephritidae)
• Annexes to ISPM 28: Phytosanitary treatments:
○ 20: Irradiation treatment for
○ 21: Vapor heat treatment for
• Annexes to ISPM 27: Diagnostic Protocols
○ 08:
○ 09: Genus
○ 10:
○ 11:
○ 12:
Other APHIS key achievements from the 2016 CPM meeting were:
• Continued development of a global electronic phytosanitary system, including to proceed with a pilot study immediately with 14 selected countries, including the United States;
• Worked towards an International Year of Plant Health (IYPH) in 2020, including the establishment of a steering committee to plan and guide the process for securing a United Nations proclamation for an IYPH and to identify and plan plant health activities and events that will occur in the lead up to and during the international year. The United States will be an active supporter of this initiative;
• Established a focus group to analyze, develop, and recommend a coherent IPPC program aimed at improving the implementation of adopted standards and to recommend an appropriate committee to oversee this new area of work at the IPPC;
• Held a special CPM session on phytosanitary risks of sea containers where the CPs agreed to temporarily suspend work on an international standard on sea containers, but consider other actions that IPPC contracting parties can take to continue addressing the sea container pathway for the introduction of plant pests; and
• Agreed on a path forward on commodity specific standards, which allows countries interested in such standards to resubmit proposals for such work.
A number of expert working group (EWG) meetings or other technical consultations took place during 2016 on the topics listed below. These standard-setting initiatives are under development and may be considered for future adoption. APHIS intends to participate actively and fully in each of these working groups. The U.S. position on each of the topics to be addressed by these various working groups will be developed prior to these working group meetings and will be based on APHIS' technical analysis, information from other U.S. Government agencies, and relevant scientific information from interested stakeholders:
• EWG on the international movement of grain
• Technical Panel on Fruit Flies
• Technical Panel for the Glossary of Phytosanitary Terms
• Technical Panel on Diagnostic Protocols
• Technical Panel on Phytosanitary Treatments
• Technical Panel on Forest Quarantine
For more detailed information on the above, contact Dr. Marina Zlotina (see
APHIS posts links to draft standards on the Internet as they become available and provides information on the due dates for comments.
NAPPO, a regional plant protection organization created in 1976 under the IPPC, coordinates the efforts among the United States, Canada, and Mexico to protect their plant resources from the entry, establishment, and spread of harmful plant pests, while facilitating
The 40th NAPPO annual meeting was held October 31 to November 3, 2016, in Montreal, Canada. The NAPPO Executive Committee meetings took place on October 31, 2016. The Deputy Administrator for PPQ is the U.S. member of the NAPPO Executive Committee.
Below is a summary of the current NAPPO work program as it relates to the ongoing development of NAPPO standards and projects. The United States (
The 2016 work program includes the following topics being worked on by NAPPO expert groups:
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Work to finalize the
Revise Annex 6,
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The PPQ Deputy Administrator, as the official U.S. delegate to NAPPO, intends to participate in the adoption of these regional plant health standards and projects, including the work described above, once they are completed and ready for such consideration.
The information in this notice contains all the information available to us on NAPPO standards under development or consideration. For updates on meeting times and for information on the expert groups that may become available following publication of this notice, visit the NAPPO Web site or contact Ms. Patricia Abad (see
Rural Business-Cooperative Service, USDA.
Notice.
This Notice announces the acceptance of applications from newly-formed Rural Business Investment Companies (RBICs) or new funds from existing RBICs who are interested in obtaining a licensed fund as non-leveraged RBICs under the Agency's Rural Business Investment Program (RBIP).
The Agency began accepting applications for non-leveraged status on August 6, 2012, and will continue to accept applications for non-leveraged status on a continuous basis until such time the Agency determines otherwise.
Detailed information on the RBIP, including application materials and instructions, can be found on the Agency's Web site at
The Paperwork Reduction Act of 1995 defines “collection of information” as a requirement for “answers to * * * identical reporting or recordkeeping requirements imposed on ten or more persons” (44 U.S.C. 3502(3)(A)). The collection requirement associated with this Notice is expected to receive less than 10 respondents and therefore the Act does not apply.
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Prior to August 6, 2012, the Agency issued licenses to qualified RBICs as leveraged RBICs only. A notice published in the
The purpose of this current Notice is to notify interested RBICs that the Agency is still accepting applications from qualified RBICs for licensing as non-leveraged RBICs under the RBIP. The Agency will continue to accept such applications until such other time the Agency determines otherwise.
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Applicants and their applications are subject to the provisions of this Notice and to the provisions of 7 CFR part 4290. In order to be eligible for non-leveraged status under this Notice, the applicant must demonstrate that one or more Farm Credit System (FCS) institution(s) will invest in the RBIC and, individually or collectively, hold 10 percent or more the applicant's total capital.
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Application materials may also be obtained via
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Contents of the initial application include RD Form 4290-1, “Rural Business Investment Program (RBIP) Application,” Part I, Management Assessment Questionnaire (MAQ), and RD Form 4290-2, “Rural Business Investment Program (RBIP) Application,” Part II, Exhibits (exhibits A, B, C, D, E, F, G, H, K, L, P, V, and Z).
Submit two complete, original hard copy sets of the RD Form 4290-1 and RD Form 4290-2 (excluding Exhibit P, which is required in electronic form only). Place each of the two original sets in a large 3-ring binder. Label the binders with the RBIC's name. Submit one complete and unbound one-sided hard copy of the MAQ and Exhibits suitable for photocopying (
Applicants must enclose in their submission a nonrefundable licensing fee of $500 in the form of a check payable to USDA.
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This section of the Notice identifies the procedures the Agency will use to process and select applicants for licensing as a non-leveraged RBIC. More information about the RBIP is available in the regulation at 7 CFR part 4290.
The Agency will review each application it receives in response to this Notice with regard to eligibility and completeness. If the application is incomplete, the Agency will notify the applicant of the information that is missing. The applicant must then provide the missing information in order for the Agency to further review the application.
The Agency will select applicants for licensing as a non-leveraged RBIC on a first-come, first-served basis. The Agency will determine the order of applications based on the date the Agency receives a complete application.
Only those applications that are eligible will be processed further for determining whether the applicant will be licensed as a non-leveraged RBIC. However, not all applications received in response to this Notice will receive this further processing. For each application that receives further processing, the Agency or its designee will focus its assessment of the application on the consistency of the newly formed RBIC's business plan with the goals of the RBIP program and on the applicant's management team's qualifications. Following this assessment, if the initial recommendation is favorable, the Agency or its designee will interview the applicant's management team.
Based on the assessment and interview, a preliminary determination will be made as to whether or not to select the applicant for non-leveraged status. If the preliminary determination is favorable, the Agency will send to the applicant a Letter of Conditions (also known as a “Green Light” letter) and the applicant will be invited to submit an updated RD Form 4290-1, Part I, Management Assessment Questionnaire, and RD Form 4290-2, Part II, Exhibits. Upon receipt of the Letter of Conditions, the applicant has 24 months to raise their private equity capital. Once a selected applicant has achieved full compliance with the regulations governing licensing as an RBIC, the Agency will issue the non-leveraged license to the RBIC.
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For further information about this Notice or for assistance with the program requirements, please contact the Specialty Programs Division, U.S. Department of Agriculture, Room 4204-S, 1400 Independence Avenue SW., Washington, DC 20250-3226. Telephone: (202) 720-1400.
In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, the USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.
Persons with disabilities who require alternative means of communication for program information (
To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at
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USDA is an equal opportunity provider, employer, and lender.
Rural Business-Cooperative Service, USDA.
Notice.
This Notice is to invite applications for grants to provide Technical Assistance for Rural Transportation (RT) systems under the Rural Business Development Grant (RBDG) program pursuant to 7 CFR part 4280, subpart E, 2 CFR chapter IV and 2 CFR part 200 for fiscal year (FY) 2017, subject to the availability of funding to provide Technical Assistance for RT systems and for RT systems to Federally Recognized Native American Tribes' (FRNAT) (collectively “Programs”) and the terms provided in such funding. This Notice is being issued before the FY 2017 appropriation has been enacted in order to allow applicants sufficient time to leverage financing, prepare and submit their applications, and give the Agency time to process applications in FY 2017. This Notice is based on the assumption that the FY 2017 appropriation will be identical to its successors. Should that not be the case, this Notice will be amended to reflect those changes. Successful applications will be selected by the Agency for
All applicants are responsible for any expenses incurred in developing their applications.
All initially capitalized terms in this Notice, other than proper names, are defined in 7 CFR 4280.403.
Completed applications must be received in the USDA Rural Development State Office no later than 4:30 p.m. (local time) on March 31, 2017. Applications received at a USDA Rural Development State Office after this date will not be considered for FY 2017 funding.
Submit applications in paper format to the USDA Rural Development State Office for the State where the Project is located. A list of the USDA Rural Development State Office contacts can be found at:
Specialty Programs Division, Business Programs, Rural Business-Cooperative Service, U.S. Department of Agriculture, 1400 Independence Avenue SW., MS 3226, Room 4204-South, Washington, DC 20250-3226, or call 202-720-1400. For further information on this Notice, please contact the USDA Rural Development State Office in the State in which the applicant's headquarters is located.
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Awards under the RBDG passenger transportation program will be made on a competitive basis using specific selection criteria contained in 7 CFR part 4280, subpart E, and in accordance with section 310B(c) of the Consolidated Farm and Rural Development Act (7 U.S.C. 1932(c)). Information required to be in the application package includes Standard Form (SF) 424, “Application for Federal Assistance;” environmental documentation in accordance with 7 CFR part 1970, “Environmental Policies and Procedures;” Scope of Work Narrative; Income Statement; Balance Sheet or Audit for previous 3 years; AD-1047, “Debarment/Suspension Certification;” AD-1048, “Certification Regarding Debarment, Suspension, Ineligibility and Voluntary Exclusion;” AD-1049, “Certification Regarding Drug-Free Workplace Requirements;” SF LLL, “Disclosure of Lobbying Activities;” RD 400-1, “Equal Opportunity Agreement;” RD 400-4, “Assurance Agreement;” and a letter providing Board authorization to obtain assistance. For the FRNAT grant, which must benefit FRNATs, at least 75 percent of the benefits of the Project must be received by members of FRNATs. The Project that scores the greatest number of points based on the RBDG selection criteria and the discretionary points will be selected for each grant.
Applicants must be qualified national Nonprofit organizations with experience in providing Technical Assistance and training to Rural communities nationwide for the purpose of improving passenger transportation service or facilities. To be considered “national,” RBS requires a qualified organization to provide evidence that it operates RT assistance programming nation-wide. There is not a requirement to use the grant funds in a multi-State area. Grants will be made to qualified national non-profit organizations for the provision of Technical Assistance and training to Rural communities for the purpose of improving passenger transportation services or facilities.
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To be considered eligible, an entity must be a qualified national Nonprofit organization serving Rural Areas as evidenced in its organizational documents and demonstrated experience, per 7 CFR part 4280, subpart E. Grants will be competitively awarded to qualified national Nonprofit organizations.
The Agency requires the following information to make an eligibility determination that an applicant is a national Nonprofit organization. These applications must include, but are not limited to, the following:
(a) An original and one copy of SF 424, “Application for Federal Assistance (For Non-construction);”
(b) Copies of applicant's organizational documents showing the applicant's legal existence and authority to perform the activities under the grant;
(c) A proposed scope of work, including a description of the proposed Project, details of the proposed activities to be accomplished and timeframes for completion of each task, the number of months duration of the Project, and the estimated time it will take from grant approval to beginning of Project implementation;
(d) A written narrative that includes, at a minimum, the following items:
(i) An explanation of why the Project is needed, the benefits of the proposed Project, and how the Project meets the grant eligible purposes;
(ii) Area to be served, identifying each governmental unit,
(iii) Description of how the Project will coordinate Economic Development activities with other Economic Development activities within the Project area;
(iv) Businesses to be assisted, if appropriate, and Economic Development to be accomplished;
(v) An explanation of how the proposed Project will result in newly created, increased, or supported jobs in the area and the number of projected new and supported jobs within the next 3 years;
(vi) A description of the applicant's demonstrated capability and experience in providing the proposed Project assistance, including experience of key staff members and persons who will be providing the proposed Project activities and managing the Project;
(vii) The method and rationale used to select the areas and businesses that will receive the service;
(viii) A brief description of how the work will be performed, including whether organizational staff or consultants or contractors will be used; and
(ix) Other information the Agency may request to assist it in making a grant award determination.
(e) The latest 3 years of financial information to show the applicant's financial capacity to carry out the proposed work. If the applicant is less than 3 years old, at a minimum, the information should include all balance sheet(s), income statement(s) and cash flow statement(s). A current audited report is required if available;
(f) Documentation regarding the availability and amount of other funds to be used in conjunction with the funds from RBDG;
(g) A budget which includes salaries, fringe benefits, consultant costs, indirect costs, and other appropriate direct costs for the Project.
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Applications will only be accepted from qualified national Nonprofit organizations to provide Technical Assistance for RT. There are no “responsiveness,” or “threshold” eligibility criteria for these grants. There is no limit on the number of applications an applicant may submit under this announcement. In addition to the forms listed under program description, Form AD-3030 “Representations Regulation Felony Conviction and Tax Delinquent Status for Corporate Applicants,” must be completed in the affirmative.
None of the funds made available may be used to enter into a contract, memorandum of understanding, or cooperative agreement with, make a grant to, or provide a loan or loan guarantee to, any corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, where the awarding agency is aware of the unpaid tax liability, unless a Federal agency has considered suspension or debarment of the corporation and has made a determination that this further action is not necessary to protect the interests of the Government.
None of the funds made available may be used to enter into a contract, memorandum of understanding, or cooperative agreement with, make a grant to, or provide a loan or loan guarantee to, any corporation that was convicted of a felony criminal violation under any Federal law within the preceding 24 months, where the awarding agency is aware of the conviction, unless a Federal agency has considered suspension or debarment of the corporation and has made a determination that this further action is not necessary to protect the interests of the Government.
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Applications will not be considered for funding if they do not provide sufficient information to determine eligibility or are missing required elements.
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For further information, entities wishing to apply for assistance should contact the USDA Rural Development State Office provided in the
Applications must be submitted in paper format. Applications submitted to a USDA Rural Development State Office must be received by the closing date and local time.
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An application must contain all of the required elements. Each application received in a USDA Rural Development State Office will be reviewed to determine if it is consistent with the eligible purposes contained in section 310B(c) of the Consolidated Farm and Rural Development Act (7 U.S.C. 1932(c)). Each selection priority criterion outlined in 7 CFR 4280.435 must be addressed in the application. Failure to address any of the criterion will result in a zero-point score for that criterion and will impact the overall evaluation of the application. Copies of 7 CFR part 4280, subpart E, will be provided to any interested applicant making a request to a USDA Rural Development State Office.
All Projects to receive Technical Assistance through these passenger transportation grant funds are to be identified when the applications are submitted to the USDA Rural Development State Office. Multiple Project applications must identify each individual Project, indicate the amount of funding requested for each individual Project, and address the criteria as stated above for each individual Project.
For multiple-Project applications, the average of the individual Project scores will be the score for that application.
The applicant documentation and forms needed for a complete application are located in the PROGRAM DESCRIPTION section of this notice, and 7 CFR part 4280, subpart E.
(a) There are no specific formats, specific limitations on number of pages, font size and type face, margins, paper size, number of copies, and the sequence or assembly requirements.
(b) The component pieces of this application should contain original signatures on the original application.
(c) Since these grants are for Technical Assistance for transportation purposes, no additional information requirements other than those described in this Notice and 7 CFR part 4280, subpart E are required.
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All applicants must have a Dun and Bradstreet Data Universal Numbering System (DUNS) number which can be obtained at no cost via a toll-free request line at (866) 705-5711 or at
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(a) Application Deadline Date: No later than 4:30 p.m. (local time) on March 31, 2017.
Explanation of Deadlines: Applications must be in the USDA Rural Development State Office by the local deadline date and time as indicated above. If the due date falls on a Saturday, Sunday, or Federal holiday, the application is due the next business day.
(b) The deadline date means that the completed application package must be received in the USDA Rural Development State Office by the deadline date established above. All application documents identified in this Notice are required.
(c) If complete applications are not received by the deadline established above, the application will neither be reviewed nor considered under any circumstances.
(d) The Agency will determine the application receipt date based on the actual date postmarked.
(e) This Notice is for RT Technical Assistance grants only and therefore, intergovernmental reviews are not required.
(f) These grants are for RT Technical Assistance grants only, no construction or equipment purchases are permitted. If the grantee has a previously approved indirect cost rate, it is permissible, otherwise, the applicant may elect to charge the 10 percent indirect cost permitted under 2 CFR 200.414(f) or request a determination of its Indirect Cost Rate. Due to the time required to evaluate Indirect Cost Rates, it is likely that all funds will be awarded by the time the Indirect Cost Rate is determined. No foreign travel is permitted. Pre-Federal award costs will only be permitted with prior written approval by the Agency.
(g) Applicants must submit applications in hard copy format as previously indicated in the APPLICATION AND SUBMISSION INFORMATION section of this notice. If the applicant wishes to hand deliver its application, the addresses for these deliveries can be located in the
(h) If you require alternative means of communication for program information (
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All eligible and complete applications will be evaluated and scored based on the selection criteria and weights contained in 7 CFR 4280.435 and will select grantees subject to the grantees' satisfactory submission of the additional items required by 7 CFR part 4280, subpart E and the USDA Rural Development Letter of Conditions. Failure to address any one of the criteria in 7 CFR 4280.435 by the application deadline will result in the application being determined ineligible, and the application will not be considered for funding. The amount of an RT grant may be adjusted, at the Agency's discretion, to enable the Agency to award RT grants to the applications with the highest priority scores in each category.
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The State Offices will review applications to determine if they are eligible for assistance based on requirements contained in 7 CFR 4280.416 and 4280.417. If determined eligible, your application will be submitted to the National Office. Funding of Projects is subject to the applicant's satisfactory submission of the additional items required by that subpart and the USDA Rural Development Letter of Conditions. The Agency reserves the right to award additional discretionary points under 7 CFR 4280.435(k).
In awarding discretionary points, the Agency scoring criteria regularly assigns points to applications that direct loans or grants to Projects based in or serving census tracts with poverty rates greater than or equal to 20 percent. This emphasis will support Rural Development's mission of improving the quality of life for Rural Americans and commitment to directing resources to those who most need them.
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Successful applicants will receive notification for funding from their USDA Rural Development State Office. Applicants must comply with all applicable statutes and regulations before the grant award will be approved. Unsuccessful applications will receive notification by mail.
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Additional requirements that apply to grantees selected for this program can be found in 7 CFR 4280.408, 4280.410, and 4280.439. Awards are subject to USDA Departmental Grant Regulations at 2 CFR Chapter IV which incorporates the new Office of Management and Budget (OMB) regulations at 2 CFR part 200.
All successful applicants will be notified by letter, which will include a Letter of Conditions, and a Letter of Intent to Meet Conditions. This letter is not an authorization to begin performance. If the applicant wishes to consider beginning performance prior to the grant being officially closed, all pre-award costs must be approved in writing and in advance by the Agency. The grant will be considered officially awarded when all conditions in the Letter of Conditions have been met and the Agency obligates the funding for the Project.
Additional requirements that apply to grantees selected for this program can be found in 7 CFR part 4280, subpart E; the Grants and Agreements regulations of the U.S. Department of Agriculture codified in 2 CFR Chapter IV, and successor regulations.
In addition, all recipients of Federal financial assistance are required to report information about first-tier sub-awards and executive compensation (see 2 CFR part 170). You will be required to have the necessary processes and systems in place to comply with the Federal Funding Accountability and Transparency Act of 2006 (Pub. L. 109-282) reporting requirements (see 2 CFR 170.200(b), unless you are exempt under 2 CFR 170.110(b)). More information on
The following additional requirements apply to grantees selected for this program:
(a) Form RD 4280-2 “Rural Business-Cooperative Service Financial Assistance Agreement.”
(b) Letter of Conditions.
(c) Form RD 1940-1, “Request for Obligation of Funds.”
(d) Form RD 1942-46, “Letter of Intent to Meet Conditions.”
(e) Form AD-1047, “Certification Regarding Debarment, Suspension, and Other Responsibility Matters-Primary Covered Transactions.”
(f) Form AD-1048, “Certification Regarding Debarment, Suspension, Ineligibility and Voluntary Exclusion-Lower Tier Covered Transactions.”
(g) Form AD-1049, “Certification Regarding a Drug-Free Workplace Requirement (Grants).”
(h) Form AD-3030, “Assurance Regarding Felony Conviction or Tax Delinquent Status for Corporate Applicants.” Must be signed by corporate applicants who receive an award under this Notice.
(i) Form RD 400-4, “Assurance Agreement.” Each prospective recipient must sign Form RD 400-4, Assurance Agreement, which assures USDA that the recipient is in compliance with Title VI of the Civil Rights Act of 1964, 7 CFR part 15 and other Agency regulations. That no person will be discriminated against based on race, color or national origin, in regard to any program or activity for which the re-lender receives Federal financial assistance. That nondiscrimination statements are in advertisements and brochures.
Collect and maintain data provided by ultimate recipients on race, sex, and national origin and ensure Ultimate Recipients collect and maintain this data. Race and ethnicity data will be collected in accordance with OMB
The applicant and the ultimate recipient must comply with Title VI of the Civil Rights Act of 1964, Title IX of the Education Amendments of 1972, Americans with Disabilities Act (ADA), Section 504 of the Rehabilitation Act of 1973, Age Discrimination Act of 1975, Executive Order 12250, Executive Order 13166 Limited English Proficiency (LEP), and 7 CFR part 1901, subpart E.
(j) SF LLL, “Disclosure of Lobbying Activities,” if applicable.
(k) Form SF 270, “Request for Advance or Reimbursement.”
3.
(a) A Financial Status Report and a Project performance activity report will be required of all grantees on a quarterly basis until initial funds are expended and yearly thereafter, if applicable, based on the Federal fiscal year. The grantee will complete the Project within the total time available to it in accordance with the Scope of Work and any necessary modifications thereof prepared by the grantee and approved by the Agency. A final Project performance report will be required with the final Financial Status Report. The final report may serve as the last quarterly report. The final report must provide complete information regarding the jobs created and supported as a result of the grant if applicable. Grantees must continuously monitor performance to ensure that time schedules are being met, projected work by time periods is being accomplished, and other performance objectives are being achieved. Grantees must submit an original of each report to the Agency no later than 30 days after the end of the quarter. The Project performance reports must include, but not be limited to, the following:
(1) A comparison of actual accomplishments to the objectives established for that period;
(2) Problems, delays, or adverse conditions, if any, which have affected or will affect attainment of overall Project objectives, prevent meeting time schedules or objectives, or preclude the attainment of particular Project work elements during established time periods. This disclosure shall be accompanied by a statement of the action taken or planned to resolve the situation;
(3) Objectives and timetable established for the next reporting period;
(4) Any special reporting requirements, such as jobs supported and created, businesses assisted, or Economic Development which results in improvements in median household incomes, and any other specific requirements, should be placed in the reporting section in the Letter of Conditions; and
(5) Within 90 days after the conclusion of the Project, the grantee will provide a final Project evaluation report. The last quarterly payment will be withheld until the final report is received and approved by the Agency. Even though the grantee may request reimbursement on a monthly basis, the last 3 months of reimbursements will be withheld until a final Project, Project performance, and financial status report are received and approved by the Agency.
For general questions about this announcement, please contact your USDA Rural Development State Office provided in the
All grants made under this Notice are subject to Title VI of the Civil Rights Act of 1964 as required by the USDA (7 CFR part 15, subpart A) and Section 504 of the Rehabilitation Act of 1973, Title VIII of the Civil Rights Act of 1968, Title IX, Executive Order 13166 (Limited English Proficiency), Executive Order 11246, and the Equal Credit Opportunity Act of 1974.
In accordance with the Paperwork Reduction Act of 1995, the information collection requirement contained in this Notice is approved by OMB under OMB Control Number 0570-0070.
All applicants, in accordance with 2 CFR part 25, must have a DUNS number, which can be obtained at no cost via a toll-free request line at (866) 705-5711 or online at
In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, the USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior
Persons with disabilities who require alternative means of communication for program information (
To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD 3027, found online at
USDA is an equal opportunity provider, employer, and lender.
In the Matter of: Luis Alberto Najera-Citalan, Inmate Number: 10656-279, FCI Beaumont Low, Federal Correctional Institution, P.O. Box 26020, Beaumont, TX 77720.
On June 9, 2015, in the U.S. District Court for the Southern District of Texas, Luis Alberto Najera-Citalan (“Najera-Citalan”), was convicted of violating Section 38 of the Arms Export Control Act (22 U.S.C. 2778 (2012)) (“AECA”). Specifically, Najera-Citalan intentionally and knowingly conspired to knowingly and willfully export, attempt to export, and cause to be exported to Mexico from the United States a defense article, that is, to wit: approximately five (5) AR-15 style rifles which were designated as defense articles on the United States Munitions List, without having first obtained from the Department of State a license for such export or written authorization for such export. Najera-Citalan was sentenced to 60 months in prison, three years of supervised release, and a $100 assessment.
Section 766.25 of the Export Administration Regulations (“EAR” or “Regulations”)
BIS has received notice of Najera-Citalan's conviction for violating the AECA, and has provided notice and an opportunity for Najera-Citalan to make a written submission to BIS, as provided in Section 766.25 of the Regulations. BIS has not received a submission from Najera-Citalan.
Based upon my review and consultations with BIS's Office of Export Enforcement, including its Director, and the facts available to BIS, I have decided to deny Najera-Citalan's export privileges under the Regulations for a period of 10 years from the date of Najera-Citalan's conviction. I have also decided to revoke all licenses issued pursuant to the Act or Regulations in which Najera-Citalan had an interest at the time of his conviction.
A. Applying for, obtaining, or using any license, License Exception, or export control document;
B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations; or
C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations.
A. Export or reexport to or on behalf of the Denied Person any item subject to the Regulations;
B. Take any action that facilitates the acquisition or attempted acquisition by the Denied Person of the ownership, possession, or control of any item subject to the Regulations that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby the Denied Person acquires or attempts to acquire such ownership, possession or control;
C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from the Denied Person of any item subject to the Regulations that has been exported from the United States;
D. Obtain from the Denied Person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or
E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by the Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by the Denied Person if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.
In the Matter of: Jorge Santana, Jr., Inmate Number: 00927-180, FCI Beaumont Low, Federal Correctional Institution, P.O. Box 26020, Beaumont, TX 77720.
On May 5, 2014, in the U.S. District Court for the Southern District of Texas, Jorge Santana, Jr. (“Santana”), was convicted of violating Section 38 of the Arms Export Control Act (22 U.S.C. 2778 (2012)) (“AECA”). Specifically, Santana knowingly and willfully attempted to export and caused to be exported from the United States to Mexico a defense article, that is, a .357 caliber magazine, two (2) 9mm magazines, a Smith & Wesson .40 caliber magazine, approximately 5,440 rounds of 7.62 caliber ammunition, 200 rounds of .40 caliber ammunition, and 400 rounds of .38 super caliber ammunition, which were designed as a defense article on the United States Munitions List, without having first obtained from the Department of State a license for such export or written authorization for such export. Santana was sentenced to 66 months in prison, three years of supervised release, 100 hours of community service, and a $100 assessment.
Section 766.25 of the Export Administration Regulations (“EAR” or “Regulations”)
BIS has received notice of Santana's conviction for violating the AECA, and has provided notice and an opportunity for Santana to make a written submission to BIS, as provided in Section 766.25 of the Regulations. BIS has not received a submission from Santana.
Based upon my review and consultations with BIS's Office of Export Enforcement, including its Director, and the facts available to BIS, I have decided to deny Santana's export privileges under the Regulations for a period of 10 years from the date of Santana's conviction. I have also decided to revoke all licenses issued pursuant to the Act or Regulations in which Santana had an interest at the time of his conviction.
A. Applying for, obtaining, or using any license, License Exception, or export control document;
B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations; or
C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations.
A. Export or reexport to or on behalf of the Denied Person any item subject to the Regulations;
B. Take any action that facilitates the acquisition or attempted acquisition by the Denied Person of the ownership, possession, or control of any item subject to the Regulations that has been
C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from the Denied Person of any item subject to the Regulations that has been exported from the United States;
D. Obtain from the Denied Person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or
E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by the Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by the Denied Person if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.
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).
Copies of the above information collection proposal can be obtained by calling or writing Jennifer Jessup, Departmental Paperwork Clearance Officer, (202) 482-0266, Department of Commerce, Room 7845, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to Jasmeet Seehra, Office of Management and Budget (OMB), by email to
On November 3, 2015, in the U.S. District Court for the District of South Carolina, Hassan Jamil Salame (“Salame”), was convicted of violating Section 38 of the Arms Export Control Act (22 U.S.C. 2778 (2012)) (“AECA”). Specifically, Salame knowingly and willfully attempted to export and caused to be exported, defense articles, that is, firearms and ammunition, including a Ruger .44 Magnum revolver, two Bushmaster .223 caliber rifles, a Ruger .45 caliber pistol, a Glock .45 caliber pistol, and a Beretta 9mm pistol from the United States to Lebanon, without first having obtained a license or written approval from the United States Department of State. Salame was sentenced to 45 months in prison, three years of supervised release, and a $300 assessment.
Section 766.25 of the Export Administration Regulations (“EAR” or “Regulations”)
BIS has received notice of Salame's conviction for violating the AECA, and has provided notice and an opportunity for Salame to make a written submission to BIS, as provided in Section 766.25 of the Regulations. BIS has not received a submission from Salame.
Based upon my review and consultations with BIS's Office of Export Enforcement, including its Director, and the facts available to BIS, I have decided to deny Salame's export privileges under the Regulations for a period of 10 years from the date of Salame's conviction. I have also decided to revoke all licenses issued pursuant to the Act or Regulations in which Salame had an interest at the time of his conviction.
Accordingly, it is hereby
A. Applying for, obtaining, or using any license, License Exception, or export control document;
B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations; or
C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations.
A. Export or reexport to or on behalf of the Denied Person any item subject to the Regulations;
B. Take any action that facilitates the acquisition or attempted acquisition by the Denied Person of the ownership, possession, or control of any item subject to the Regulations that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby the Denied Person acquires or attempts to acquire such ownership, possession or control;
C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from the Denied Person of any item subject to the Regulations that has been exported from the United States;
D. Obtain from the Denied Person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or
E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by the Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by the Denied Person if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.
On August 25, 2015, in the U.S. District Court for the Southern District of Texas, Daniel Miranda-Mendoza (“Miranda-Mendoza”), was convicted of violating Section 38 of the Arms Export Control Act (22 U.S.C. 2778 (2012)) (“AECA”). Specifically, Miranda-Mendoza intentionally and knowingly conspired to knowingly and willfully export, attempt to export, and caused to be exported from the United States to Mexico, a defense article, that is, to wit: Approximately one Kel-Tec pistol, Model PMR-30, .22 caliber, one Remington rifle, Model 7400, .30-06 caliber, and one Browning rifle, Model X-bolt, .270 caliber, which were designated as defense articles on the United States Munitions List, without having first obtained from the Department of State a license for such export or written authorization for such export. Miranda-Mendoza was sentenced to 37 months in prison and a $100 assessment.
Section 766.25 of the Export Administration Regulations (“EAR” or “Regulations”)
BIS has received notice of Miranda-Mendoza's conviction for violating the AECA, and has provided notice and an opportunity for Miranda-Mendoza to make a written submission to BIS, as provided in Section 766.25 of the Regulations. BIS has not received a submission from Miranda-Mendoza.
Based upon my review and consultations with BIS's Office of Export Enforcement, including its Director, and the facts available to BIS, I have decided to deny Miranda-Mendoza's export privileges under the Regulations for a period of 10 years from the date of Miranda-Mendoza's conviction. I have also decided to revoke all licenses issued pursuant to the Act or Regulations in which Miranda-Mendoza had an interest at the time of his conviction.
Accordingly, it is hereby
A. Applying for, obtaining, or using any license, License Exception, or export control document;
B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations; or
C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations.
A. Export or reexport to or on behalf of the Denied Person any item subject to the Regulations;
B. Take any action that facilitates the acquisition or attempted acquisition by the Denied Person of the ownership, possession, or control of any item subject to the Regulations that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby the Denied Person acquires or attempts to acquire such ownership, possession or control;
C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from the Denied Person of any item subject to the Regulations that has been exported from the United States;
D. Obtain from the Denied Person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or
E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by the Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by the Denied Person if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.
On January 13, 2015, in the U.S. District Court for the Southern District of Florida, Javier Nenos Rea (“Nenos Rea”), was convicted of violating Section 38 of the Arms Export Control Act (22 U.S.C. 2778 (2012)) (“AECA”). Specifically, Nenos Rea knowingly and willfully attempted to export defense articles, that is, AK-47 assault rifles and a .40 caliber semi-automatic pistol, from the United States to Bolivia without having first obtained a license or written approval from the United States Department of State. Nenos Rea was sentenced to 46 months in prison, two years of supervised release, and a $100 assessment.
Section 766.25 of the Export Administration Regulations (“EAR” or “Regulations”)
BIS has received notice of Nenos Rea's conviction for violating the AECA, and has provided notice and an opportunity for Nenos Rea to make a written submission to BIS, as provided in Section 766.25 of the Regulations. BIS has not received a submission from Nenos Rea.
Based upon my review and consultations with BIS's Office of Export Enforcement, including its Director, and the facts available to BIS, I have decided to deny Nenos Rea's export privileges under the Regulations for a period of 10 years from the date of Nenos Rea's conviction. I have also decided to revoke all licenses issued pursuant to the Act or Regulations in which Nenos Rea had an interest at the time of his conviction.
Accordingly, it is hereby
A. Applying for, obtaining, or using any license, License Exception, or export control document;
B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations; or
C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations.
A. Export or reexport to or on behalf of the Denied Person any item subject to the Regulations;
B. Take any action that facilitates the acquisition or attempted acquisition by the Denied Person of the ownership, possession, or control of any item subject to the Regulations that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby the Denied Person acquires or attempts to acquire such ownership, possession or control;
C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from the Denied Person of any item subject to the Regulations that has been exported from the United States;
D. Obtain from the Denied Person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or
E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by the Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by the Denied Person if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.
Bureau of Industry and Security.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before January 17, 2017.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Mark Crace, BIS ICB Liaison, (202) 482-4895,
This collection of information is needed to detect violations of the Export Administration Act and Regulations, and determine if an investigation or prosecution is necessary and to reach a settlement with violators. Voluntary
Submitted on paper.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
In the Matter of: Julio Cesar Solis-Castilleja, Inmate Number: 56152-379, FCI Victorville Medium I, Federal Correctional Institution, Correctional Institution, P.O. Box 3725, Adelanto, CA 92301.
On June 30, 2014, in the U.S. District Court for the Southern District of Texas, Julio Cesar Solis-Castilleja (“Solis-Castilleja”), was convicted of violating Section 38 of the Arms Export Control Act (22 U.S.C. 2778 (2012)) (“AECA”). Specifically, Solis-Castilleja knowingly and willfully attempted to export and caused to be exported from the United States to Mexico a defense article, that is, a Norinco MAK 90 Sporter 7.62 × 39mm caliber rifle, a Bushmaster .308 caliber rifle, a DPMS Panther .308 caliber rifle, a FN Herstal .308 caliber rifle, a PTR 91C .308 caliber rifle, four (4) 7.62 × 51mm magazines, and one (1) 7.62 × 39mm magazine, which were designated as a defense article on the United States Munitions List, without having first obtained from the Department of State a license for such export or written authorization for such export. Solis-Castilleja was sentenced to 46 months in prison, three years of supervised release, and a $100 assessment.
Section 766.25 of the Export Administration Regulations (“EAR” or “Regulations”)
BIS has received notice of Solis-Castilleja's conviction for violating the AECA, and has provided notice and an opportunity for Solis-Castilleja to make a written submission to BIS, as provided in Section 766.25 of the Regulations. BIS has not received a submission from Solis-Castilleja.
Based upon my review and consultations with BIS's Office of Export Enforcement, including its Director, and the facts available to BIS, I have decided to deny Solis-Castilleja's export privileges under the Regulations for a period of 10 years from the date of Solis-Castilleja's conviction. I have also decided to revoke all licenses issued pursuant to the Act or Regulations in which Solis-Castilleja had an interest at the time of his conviction.
A. Applying for, obtaining, or using any license, License Exception, or export control document;
B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations; or
C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations.
A. Export or reexport to or on behalf of the Denied Person any item subject to the Regulations;
B. Take any action that facilitates the acquisition or attempted acquisition by the Denied Person of the ownership, possession, or control of any item subject to the Regulations that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby the Denied Person acquires or attempts to acquire such ownership, possession or control;
C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from the Denied Person of any item subject to the Regulations that has been exported from the United States;
D. Obtain from the Denied Person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or
E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by the Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by the Denied Person if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On August 12, 2016, the Department of Commerce (the Department) published the preliminary results of the administrative review and new shipper review of the antidumping duty order on solid urea from Russia. The period of review (POR) is July 1, 2014, through June 30, 2015. For the final results of these reviews, we continue to find that subject merchandise has not been sold at less than normal value.
Effective November 18, 2016.
Michael A. Romani or Andre Gziryan, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-0198, and (202) 482-2201, respectively.
On August 12, 2016, the Department published the
The merchandise subject to the order is solid urea, a high-nitrogen content fertilizer which is produced by reacting ammonia with carbon dioxide. The product is currently classified under the Harmonized Tariff Schedules of the United States (HTSUS) item number 3102.10.0010. Previously such merchandise was classified under item number 480.3000 and 3102.10.0000 of the HTSUS. Although the HTSUS subheading is provided for convenience and customs purposes, the written description of the merchandise subject to the order is dispositive.
The Department made no changes to its calculations announced in the
The Department made no changes to its calculations announced in the
In accordance with 19 CFR 351.212 and the
For entries of subject merchandise during the period of review produced by MCC EuroChem and PhosAgro for which they did not know their merchandise was destined for the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the
We intend to issue instructions to CBP 15 days after publication of the final results of this review.
The following cash deposit requirements will be effective upon publication of the notice of final results of the administrative and new shipper reviews for all shipments of solid urea from Russia entered, or withdrawn from warehouse, for consumption on or after the date of publication as provided by section 751(a)(2) of the Act: (1) The cash deposit rate with respect to the administrative review respondent, MCC EuroChem, will be 0.00 percent, the weighted average dumping margin established in the final results of the administrative review; (2) for merchandise exported by manufacturers or exporters not covered in this administrative review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recently completed segment of this proceeding in which that manufacturer or exporter participated; (3) if the exporter is not a firm covered in this administrative review, a prior review, or the original investigation, but the manufacturer is, the cash deposit rate will be the rate established for the most recently completed segment of this proceeding for the manufacturer of subject merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be 64.93 percent, the all-others rate established in the original less-than-fair-value investigation.
With respect to PhosAgro, the new shipper respondent, the Department established a combination cash deposit rate for this company, consistent with its practice, as follows: (1) For subject merchandise produced and exported by PhosAgro, the cash deposit rate will be 0.00 percent; (2) for subject merchandise exported by PhosAgro, but not produced by PhosAgro, the cash deposit rate will be the rate for the all-others established in the less-than-fair-value investigation; and (3) for subject merchandise produced by PhosAgro but not exported by PhosAgro, the cash deposit rate will be the rate applicable to the exporter.
These cash deposit requirements, when imposed, shall remain in effect until further notice.
This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.
We are issuing and publishing these results of administrative and new shipper reviews in accordance with sections 751(a)(1) 751(a)(2)(B)(iii), 751(a)(3)and 777(i)(1) of the Act and 19 CFR 351.213(h), 351.214 and 351.221(b)(5).
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).
The final rule requires that, in order to become certified, a Person or Certified Person must submit a written attestation from an “Accredited Conformity Assessment Body” (ACAB), as defined in the final rule, that such Person has information security systems, facilities and procedures in place to protect the security of the Limited Access DMF, as required under Section 1110.102(a)(2) of the final rule. A Certified Person also must provide a new written attestation periodically for renewal of its certification as specified in the final rule. The ACAB must be independent of the Person or Certified Person seeking certification, unless it is a third party conformity assessment body which qualifies for “firewalled
The Firewalled Status Application Form collects information that NTIS will use to evaluate whether the respondent qualifies for “firewalled status” under the rule, and, therefore, can provide a written attestation in lieu of an independent ACAB's attestation. This information includes specific requirements of Section 1110.502(b) of the final rule, which the respondent ACAB must certify are satisfied, and the provision of specific information by the respondent ACAB, such as the identity of the Person or Certified Person that would be the subject of the attestation and the basis upon which the certifications were made.
This information collection request may be viewed at reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
National Technical Information Service (NTIS), Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. The purpose of this notice is to allow for 60 days of public comment.
Written comments must be submitted on or before January 17, 2017.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to John W. Hounsell, Business and Industry Specialist, Office of Product and Program Management, National Technical Information Service, Department of Commerce, 5301 Shawnee Road, Alexandria, VA 22312, email:
This notice informs the public that the National Technical Information Service (NTIS) is requesting approval of a new information collection described in Section II for use in connection with the final rule for the “Certification Program for Access to the Death Master File.” The final rule was published on June 1, 2016 (81 FR 34882), with the rule to become effective on November 28, 2016. The new information collection described in Section II, if approved, will become effective on the effective date of the final rule.
On December 30, 2014, NTIS initially described a “Limited Access Death Master File Systems Safeguards Attestation Form” in the notice of proposed rulemaking (79 FR 78314 at 78321). To accommodate the requirements of the final rule, NTIS is using both the ACAB Systems Safeguards Attestation Form and the AG or IG Systems Safeguards Attestation Form.
The ACAB Systems Safeguards Attestation Form requires an “Accredited Conformity Assessment Body” (ACAB), as defined in the final rule, to attest that a Person seeking certification or a Certified Person seeking renewal of certification has information security systems, facilities and procedures in place to protect the security of the Limited Access DMF, as required under Section 1110.102(a)(2) of the final rule. The ACAB Systems Safeguards Attestation Form collects information based on an assessment by the ACAB conducted within three years prior to the date of the Person or Certified Person's submission of a completed certification statement under Section 1110.101(a) of the final rule. This collection includes specific requirements of the final rule, which the ACAB must certify are satisfied, and the provision of specific information by the ACAB, such as the date of the assessment and the auditing standard(s) used for the assessment.
Section 1110.501(a)(2) of the final rule provides that a state or local government office of AG or IG and a Person or Certified Person that is a department or agency of the same state or local government, respectively, are not considered to be owned by a common “parent” entity under Section 1110.501(a)(1)(ii) for the purpose of determining independence, and attestation by the AG or IG is possible. The AG or IG Systems Safeguards Attestation Form is for the use of a state or local government AG or IG to attest on behalf of a state or local government department or agency Person or Certified Person. The AG or IG Systems Safeguards Attestation Form requires the state or local government AG or IG to attest that a Person seeking certification or a Certified Person seeking renewal of certification has
NTIS estimates the total annual cost to the public for both the ACAB Systems Safeguards Attestation Forms and the AG or IG Systems Safeguards Attestation Forms to be $514,500 ($465,000 for ACAB Systems Safeguards Attestation Forms + $49,500 for AG or IG Systems Safeguards Attestation Forms.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
United States Patent and Trademark Office, Department of Commerce.
Notice of public meeting; request for comments.
The Hague Conference on Private International Law (“The Hague Conference”), an international organization in the Netherlands, is sponsoring negotiations for a convention on the recognition and enforcement of foreign judgments in civil and commercial matters. In February 2016, the Council on General Affairs and Policy of The Hague Conference created a Special Commission on the Recognition and Enforcement of Foreign Judgments (“the Special Commission”) to prepare a preliminary draft text of the convention, which is subject to a formal diplomatic negotiation open to member States of The Hague Conference. At its first session in June 2016, the Special Commission produced a Preliminary Draft Convention that contains general and specific provisions that would apply to the recognition and enforcement of judgments arising from transnational intellectual property disputes. The United States Patent and Trademark Office (USPTO) seeks public comments on the June 2016 Preliminary Draft Convention (the “Preliminary
To assist the USPTO in determining the best way to address this topic, the USPTO will host a public meeting to obtain public input. The meeting will be open to the public and will provide a forum for discussion of the questions identified in this notice. Written comments in response to the questions set forth in this notice also are requested.
The public meeting will be held on January 12, 2017, beginning at 1:00 p.m. Eastern Standard Time (EST) and ending at 4:00 p.m. EST.
Event Address: The public meeting will be held in the USPTO Headquarters, Global Intellectual Property Academy (GIPA), Madison Building (East), Second Floor, 600 Dulany Street, Alexandria, Virginia 22314.
All comments received are part of the public record and will be available for public inspection without change via the USPTO's Web site at
Requests for additional information should be directed to the attention of Michael Shapiro, Senior Counsel, Office of Policy and International Affairs, USPTO, by telephone at 571-272-9300, or by email to
The Hague Conference is sponsoring negotiations for a convention on the recognition and enforcement of foreign judgments. Following preparatory work on the draft convention by a Working Group beginning in 2012, in February 2016, the Council on General Affairs and Policy of The Hague Conference established a Special Commission to prepare a preliminary draft convention on the recognition and enforcement of foreign judgments in civil and commercial matters. The first meeting of the Special Commission took place June 1-9, 2016, at The Hague, Netherlands. The second meeting of the Special Commission is scheduled to take place February 16-24, 2017, at The Hague. The text of the Preliminary Draft produced at the first session of the Special Commission, along with other documents relating to the convention is available at:
The Preliminary Draft currently contains 16 articles organized into two chapters. Chapter I (Articles 1-3) sets forth the scope and definitions for the draft treaty. Chapter II (Articles 4-16) sets forth the basic rules governing the recognition and enforcement of judgments under the treaty.
The Preliminary Draft applies to the recognition and enforcement of judgments in a Contracting State of judgments relating to civil or commercial matters in another Contracting State (Article 1). The term “judgment” means any decision on the merits, including determinations of costs or expenses related to such decisions (Article 3). Judgments related to revenue, customs, and administrative matters are excluded from the scope of the Convention (Article 1) as well as more specific subject matter such as family law matters, wills and succession, and insolvency, but judgments related to intellectual property matters (Article 2) are not excluded.
The Preliminary Draft requires that a judgment of a court in a Contracting State (the “State of origin”) be recognized and enforced in another Contracting State (the “requested State”) without reviewing its merits (Article 4). Recognition and enforcement, however, may be refused but only under the grounds set forth in the treaty. The Preliminary Draft sets forth the bases for recognition and enforcement of judgments (Article 5).
Of particular importance to the intellectual property community are paragraphs 5(1)(k) and 5(1)(l), which set forth the bases for the recognition and enforcement of judgments for infringements of a patent, trademark, design, or other similar right, and judgments on the validity or infringement of a copyright or a related right, respectively. It should also be noted (subject to Article 6, discussed below), a judgment in such an infringement case might also be enforceable if one of the other bases for recognition and enforcement of the judgment set forth in Article 5 exists (for example, the person against whom recognition or enforcement is sought brought the claim on which the judgment is based) applies.
Notwithstanding Article 5, a judgment on the registration or validity of patents, trademarks, designs, or other similar rights that are required to be deposited or registered is eligible for recognition and enforcement in a requested State “if and only if” the State of origin is the State where the deposit or registration took place, or is deemed to have taken place under an international or regional
The Preliminary Draft bars the recognition and enforcement of rulings on the registration or validity of patents, trademarks, and designs, or other similar rights that arose as a preliminary question in courts other than those with exclusive jurisdiction under Article 6 (Article 8(1)). The Explanatory Note Providing Background on the Proposed Draft Text and Identifying Outstanding Issues (Prel. Doc. No. 2) provides the following example of a preliminary question: a ruling on the validity of a patent raised as a defense to an infringement claim (Prel. Doc. No. 2, para. 111). In such instances, however, a court may refuse or postpone the recognition or enforcement of a ruling on validity only (1) where the ruling is inconsistent with a judgment or a decision of a competent authority on the matter or (2) where the proceedings on validity took place in the State with exclusive jurisdiction under Article 6 (Article 8(3)). A court may refuse to recognize a judgment “if, and to the extent that, it was based on” a ruling on registration or validity as a preliminary question by in courts other than those with exclusive jurisdiction under Article 6.
The Preliminary Draft allows the court of the requested State to refuse recognition and enforcement of judgment awarding damages if and to the extent that those damages (including exemplary or punitive damages) do not compensate a party for actual loss or harm suffered (Article 9). The Preliminary Draft does not expressly address enforcement of judgments for injunctive relief. However, the Explanatory on the Preliminary Draft notes, without expressly mentioning injunctive relief, that “non-money judgments have been included in the scope of the Proposed Draft Text” (Prel. Doc. No 2, para. 52).
The USPTO is seeking comments on the Preliminary Draft as it relates to intellectual property. Interested members of the public are invited to present written comments on any issues they believe to be relevant to protection of intellectual property or any aspect of the proposed Convention as it relates to intellectual property. Comments also are invited on any or all of the questions listed below.
As used in the Preliminary Draft, the term “intellectual property rights” includes patents, trademarks, designs, and copyrights or related rights. If your response does not apply to all of these intellectual property rights, please state the specific intellectual property right, or rights, to which your response applies. Other intellectual property rights that are outside the scope of the current text of the Preliminary Draft, such as trade secrets, are identified separately in this notice where appropriate.
With respect to these and any other issues raised by the Preliminary Draft, in your responses, please: (1) Clearly identify the matter being addressed; (2) provide examples where appropriate; (3) identify any relevant legal authorities to support your comment; (4) indicate approaches and provisions that are unacceptable; and (5) express preferences for approaches, effective solutions to specific challenges, and drafting recommendations to address the matter being addressed.
1. What are your experiences in having U.S. judgments involving intellectual property matters recognized and enforced in foreign courts?
2. What are the benefits, if any, of increasing the recognition and enforcement of U.S. judgments involving intellectual property matters in foreign courts through joining a multilateral treaty?
3. What are your experiences in having foreign judgments recognized in U.S. courts, including on the basis of comity or under state statutes?
4. What are the risks, if any, of increasing the recognition and enforcement of foreign judgments involving intellectual property matters by U.S. courts through joining a multilateral treaty?
5. Are uniform rules for international enforcement of intellectual property judgments desirable?
6. What impact, if any, would the territorial nature of intellectual property rights have on enforcing rights across borders?
7. What impact, if any, would differences in procedural practices across borders have on enforcing intellectual property rights across borders?
8. What impact, if any, would differences in substantive law have on enforcing intellectual property rights across borders?
9. Would this convention have any disproportionate effects on a particular technology sector? If so, which ones and how?
10. Please identity problems that could occur from recognizing or enforcing judgments rendered on intellectual property matters in other Contracting States that have policies or laws that are inconsistent with U.S. intellectual property laws and policies.
11. Please identify any challenges with respect to enforcement in foreign courts of U.S. judgments, or in U.S. courts of foreign judgments, involving intellectual property matters.
12. How often are U.S. nationals also foreign intellectual property owners who would then be able to use this Convention to have judgments they obtain in foreign courts enforced by U.S. courts? Would that be useful for U.S. nationals?
13. What changes, if any, to U.S. law would be needed to implement the proposed convention? Please identify any drawbacks and/or advantages to such changes.
14. What effect, if any, would the Preliminary Draft have on the enforcement of intellectual property rights in the digital environment? In particular, should the language in the Preliminary Draft be revised to take into account issues that arise in connection with infringement and enforcement of intellectual property rights on the Internet?
15. Should judgments on the validity and/or the infringements of intellectual property rights, other than copyright and related rights, be excluded from the scope of the treaty under Article 2(2)? Please identify the specific intellectual property right at issue and the specific concerns, if any, raised by including it within the scope of this convention?
16. Should judgments on the validity, ownership, subsistence, and/or the infringement of copyright and related rights be excluded from the scope of the treaty under Article 2(2)? Please state the specific concerns, if any, raised by including copyrights or related rights within the scope of this convention.
17. Should judgments on the validity or misappropriation and/or theft of trade secrets be excluded from the scope of the treaty under Article 2(2)? Please state the specific concerns, if any, raised by including judgments on the validity or misappropriation and/or theft of trade secrets within the scope of this convention.
18. Should judgments on the infringement of intellectual property rights, other than copyright and related
19. Should judgments on the infringements of plant breeders' rights be included in Article 5(1)(k)?
20. Should judgments on the infringements of service marks, trade dress, and geographical indications rights be expressly included in Article 5(1)(k)?
21. Should judgments on the validity or infringement of unregistered designs and trademarks be included in Article 5(1)(l)?
22. Should judgments on the validity or the misappropriation and/or theft of trade secrets be included in Article 5(1)(l)?
23. Should the bracketed language in Article 5(1)(l) be included?
24. Should judgments on the validity, ownership, subsistence or infringement of copyright or related rights be included in Article 5(1)(l) in cases where the right arose under the law of the State of origin?
25. Should such judgments be included in Article 5(1)(l) where the right did not arise under the law of the State of origin but where another basis for jurisdiction set forth in Article 5 is satisfied?
26. With respect to a judgment on the registration or validity of patents, trademarks, designs, or other similar rights that are required to be deposited, registered, or issued, the Preliminary Draft provides for exclusive jurisdiction of the court in the State of origin where the right issued or registration took place, or is deemed to have taken place under an international or regional instrument (Article 6). Please comment on the appropriateness of this rule.
27. Should a judgment on the registration or validity of mask works or vessel designs that are required to be deposited, registered, or issued be included in Article 6?
28. What are your experiences in having U.S. rulings on preliminary questions, or judgments based on such rulings, involving the registration or validity of patents, trademarks, and designs, or other similar rights, by courts other than those with exclusive jurisdiction recognized and enforced by a foreign court?
29. Should a judgment on the registration or validity of mask works or vessel designs that are required to be deposited, registered, or issued be included in Article 8?
30. Does Article 8 provide an appropriate framework for resolving problems, if any, related to recognition and enforcement of rulings on preliminary questions and judgments based on such rulings?
31. How much discretion should a court in the requested State have to refuse or postpone the recognition or enforcement of a ruling on the validity of a patent, trademark, design, and other similar rights raised as preliminary matter in a court in the State of origin?
Remedies
32. Article 9 provides that recognition or enforcement of a judgment may be refused if, and to the extent that, the judgment awards damages, including exemplary or punitive damages, that do not compensate a party for actual loss or harm suffered. Should the court in a requested State be allowed to recognize and enforce non-compensatory damages in judgments involving intellectual property matters?
33. Does Article 9 include the types of damages that would provide effective relief for intellectual property right owners? If not, what other types of damages or other remedies ought to be included? Why?
34. How should statutory damages for copyright infringement be treated under this Article, and should Article 9 be amended to address statutory damages expressly?
35. When a judgment for infringement of an intellectual property covered by the convention includes injunctive relief, should a court in the requested State be required to recognize and enforce the award of injunctive relief?
36. If so, should there be any limitation on the circumstances under which such awards should be recognized and enforced (for example, by specifying the limitation in Article 5)? If not, should a judgment for infringement of an intellectual property right covered by the convention that includes injunctive relief be excluded as a basis for recognition and enforcement, or whole or in part, under Article 5?
Event Registration Information: To register to attend or to request to present as a speaker, please send an email message to
Committee for Purchase From People Who Are Blind or Severely Disabled.
Proposed Deletions from the Procurement List.
The Committee is proposing to delete products previously furnished by a nonprofit agency employing persons who are blind or have other severe disabilities.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.
Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.
The following products are proposed for deletion from the Procurement List:
Committee for Purchase From People Who Are Blind or Severely Disabled.
Additions to the Procurement List.
This action adds products to the Procurement List that will be furnished by a nonprofit agency employing persons who are blind or have other severe disabilities.
Committee for Purchase From People Who Are Blind or Severely Disabled,1401 S. Clark Street, Suite 715, Arlington Virginia, 22202-4149.
Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
On 9/23/2016 (81 FR 65629-65630), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed additions to the Procurement List.
After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the products and impact of the additions on the current or most recent contractors, the Committee has determined that the products listed below are suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organization that will furnish the products to the Government.
2. The action will result in authorizing a small entity to furnish the products to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the products proposed for addition to the Procurement List.
Accordingly, the following products are added to the Procurement List:
Bureau of Consumer Financial Protection.
Notice regarding charges for certain disclosures under the Fair Credit Reporting Act.
The Bureau of Consumer Financial Protection (Bureau) announces that the ceiling on allowable charges under section 612(f) of the Fair Credit Reporting Act (FCRA) will remain unchanged at $12.00, effective for 2017. The Bureau is required to increase the $8.00 amount referred to in section 612(f)(1)(A)(i) of the FCRA on January 1 of each year, based proportionally on changes in the Consumer Price Index for All Urban Consumers (CPI-U), with fractional changes rounded to the nearest fifty cents. The CPI-U increased 49.77 percent between September 1997, when the FCRA amendments took effect, and September 2016. This increase in the CPI-U, and the requirement that any increase be rounded to the nearest fifty cents, result in a maximum allowable charge of $12.00.
Effective January 1, 2017.
Jaclyn Maier, Counsel, Office of Regulations, Consumer Financial Protection Bureau, 1700 G Street NW., Washington, DC 20552, at (202) 435-7700.
Section 612(f)(1)(A) of the Fair Credit Reporting Act (FCRA) provides that a consumer reporting agency may charge a consumer a reasonable amount for making a disclosure to the consumer pursuant to section 609 of the FCRA. Section 612(f)(1)(A)(i) of the FCRA provides that, where a consumer reporting agency is permitted to impose a reasonable charge on a consumer for making a disclosure to the consumer pursuant to section 609 of the FCRA, the charge shall not exceed $8.00 and shall be indicated to the consumer before making the disclosure. Section 612(f)(2) of the FCRA states that the Bureau shall increase the $8.00 maximum amount on
Section 612(a) of the FCRA gives consumers the right to a free disclosure upon request once every 12 months. The maximum allowable charge established by this notice does not apply to requests made under that provision. The charge does apply when a consumer who orders a file disclosure has already received a free annual disclosure and does not otherwise qualify for an additional free disclosure.
The Bureau is using the $8.00 amount set forth in section 612(f)(1)(A)(i) of the FCRA as the baseline for its calculation of the increase in the ceiling on reasonable charges for certain disclosures made under section 609 of the FCRA. Since the effective date of section 612(a) was September 30, 1997, the Bureau calculated the proportional increase in the CPI-U from September 1997 to September 2016. The Bureau then determined what modification, if any, from the original base of $8.00 should be made effective for 2017, given the requirement that fractional changes be rounded to the nearest fifty cents.
Between September 1997 and September 2016, the CPI-U increased by 49.77 percent from an index value of 161.2 in September 1997 to a value of 241.428 in September 2016. An increase of 49.77 percent in the $8.00 base figure would lead to a figure of $11.98. However, because the statute directs that the resulting figure be rounded to the nearest $0.50, the maximum allowable charge is $12.00. The Bureau therefore determines that the maximum allowable charge for the year 2017 will remain at $12.00, effective January 1, 2017.
Department of the Army, DoD.
Notice of intent.
The Department of the Army hereby gives notice of its intent to grant to Per Vivo Labs, Inc.; a corporation having its principle place of business at 2002 Brookside Lane, Kingsport, TN 37660, an exclusive license.
Written objections must be filed not later than 15 days following publication of this announcement.
Send written objections to U.S. Army Research Laboratory Technology Transfer and Outreach Office, RDRL-DPT/Thomas Mulkern, Building 321 Room 110, Aberdeen Proving Ground, MD 21005-5425.
Thomas Mulkern, (410) 278-0889, E-Mail:
The Department of the Army plans to grant an exclusive license to Per Vivo Labs, Inc., in the field of use related to physical therapy/rehabilitation resistance bands incorporating rate-actuated tethers (RATs) relative to the following:
• “Rate-Responsive, Stretchable Devices”, US Patent No.: 9,303,717, Filing Date June 26, 2013, Issue Date April 5, 2016.
• “Rate-Responsive, Stretchable Devices (Further Improvements)”, US Patent Application No.: 15/057,944, Filing Date March 1, 2016.
The prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the U.S. Army Research Laboratory receives written objections including evidence and argument that establish that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i),. Competing applications completed and received by the U.S. Army Research Laboratory within fifteen (15) days from the date of this published notice will also be treated as objections to the grant of the contemplated exclusive license.
Objections submitted in response to this notice will not be made available to the public for inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.
Department of the Army, U.S. Army Corps of Engineers, DoD.
Notice of open committee meeting.
The Department of the Army is publishing this notice to announce the following Federal advisory committee meeting of the Lake Eufaula Advisory Committee (LEAC). The meeting is open to the public.
The Committee will meet from 10:00 a.m.-12:00 p.m. on Monday, December 12, 2016.
The meeting will be held at Three Forks Harbor, 5201 Three Forks Road, Fort Gibson, OK 74434.
Mr. Jeff Knack; Designated Federal Officer (DFO) for the Committee, in writing at Eufaula Lake Office, 102 E. BK 200 Rd, Stigler, OK 74462-1829, or by email at
This meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Sunshine in the Government Act of 1976 (U.S.C. 552b, as amended) and 41 Code of the Federal Regulations (CFR 102-3.150).
Pursuant to 41 CFR 102-3.140d, the Committee is not obligated to allow a member of the public to speak or otherwise address the Committee during the meeting. Members of the public will be permitted to make verbal comments during the Committee meeting only at the time and in the manner described below. If a member of the public is interested in making a verbal comment at the open meeting, that individual must submit a request, with a brief statement of the subject matter to be addressed by the comment, at least three (3) days in advance to the Committee's Designated Federal Officer, via electronic mail, the preferred mode of submission, at the addresses listed in the
Office of the Under Secretary of Defense (Acquisition, Technology, and Logistics), Department of Defense (DoD).
Federal advisory committee meeting notice.
The Department of Defense is publishing this notice to announce the following Federal advisory committee meeting of the Government-Industry Advisory Panel. This meeting is open to the public.
The meeting will be held from 9:00 a.m. to 5:00 p.m. on Tuesday, November 29, 2016. Public registration will begin at 8:45 a.m. For entrance into the meeting, you must meet the necessary requirements for entrance into the Pentagon. For more detailed information, please see the following link:
Pentagon Library, Washington Headquarters Services, 1155 Defense Pentagon, Washington, DC 20301-1155. The meeting will be held in Room B7. The Pentagon Library is located in the Pentagon Library and Conference Center (PLC2) across the Corridor 8 bridge.
LTC Andrew Lunoff, Office of the Assistant Secretary of Defense (Acquisition), 3090 Defense Pentagon, Washington, DC 20301-3090, email:
Due to circumstances beyond the control of the Designated Federal Officer and the Department of Defense, the Government-Industry Advisory Panel is unable to provide public notification, as required by 41 CFR 102-3.150(a), for its meeting on Tuesday, November 29, 2016. Accordingly, the Advisory Committee Management Officer for the Department of Defense, pursuant to 41 CFR 102-3.150(b), waives the 15-calendar day notification requirement.
Minor changes to the agenda will be announced at the meeting. All materials will be posted to the FACA database after the meeting.
Individuals requiring special accommodations to access the public meeting or seeking additional information about public access procedures, should contact LTC Lunoff, the committee DFO, at the email address or telephone number listed in the
Department of the Navy, DoD
Notice.
Pursuant to Section 102(2)(c) of the National Environmental Policy Act of 1969 and regulations implemented by the Council on Environmental Quality (40 Code of Federal Regulations parts 1500-1508), the Department of the Navy (DoN) has prepared and filed with the U.S. Environmental Protection Agency a Draft Environmental Impact Statement (EIS) to assess the potential environmental impacts of adding up to 36 Growler aircraft at the Naval Air Station (NAS) Whidbey Island complex, and continuing and increasing Growler airfield operations. The NAS Whidbey Island complex is located in Island County, Washington, on Whidbey Island, in the northern Puget Sound region. The complex includes the main air station (Ault Field), which is in the north-central part of the island, adjacent to the city of Oak Harbor, and Outlying Landing Field (OLF) Coupeville. The OLF is approximately 10 miles south of Ault Field and is dedicated primarily to Field Carrier Landing Practice (FCLP).
With the filing of the Draft EIS, the DoN is initiating an extended public comment period of 75 days, beginning on November 10, 2016 and ending on January 25, 2017. Public meetings are scheduled to inform the public and receive comments on the environmental analysis presented in the Draft EIS. This notice announces the dates, times, and
The DoN will hold public meetings to inform the public about the Draft EIS and the proposed action and alternatives under consideration and to provide opportunities for the public to comment on the Draft EIS. Federal, state, and local agencies and officials, Native American Indian Tribes and Nations, and interested organizations and individuals are encouraged to provide comments in person at the public meetings or in writing during the 75-day public review period. Public meetings will be held at the following dates, times, and locations:
1. Monday, December 5, 2016, from 3:00 p.m. to 6:00 p.m., at the Fort Worden State Park Conference Center, USO Hall, 200 Battery Way, Port Townsend, Washington 98368.
2. Tuesday, December 6, 2016, from 4:00 p.m. to 7:00 p.m., at the Oak Harbor Elks Lodge Grande Hall, 155 NE Ernst Street, Oak Harbor, Washington 98277.
3. Wednesday, December 7, 2016, from 3:00 p.m. to 6:00 p.m., at the Lopez Center for Community and the Arts, 204 Village Road, Lopez Island, Washington 98261.
4. Thursday, December 8, 2016, from 3:00 p.m. to 6:00 p.m., at the Seafarers' Memorial Park Building, 601 Seafarers Way, Anacortes, Washington 98221.
5. Friday, December 9, 2016, from 4:00 p.m. to 7:00 p.m., at the Coupeville High School Commons, 501 South Main Street, Coupeville, Washington 98239.
The public meetings will be open house sessions with informational poster stations. Members of the public will have the opportunity to ask questions of DoN representatives and subject matter experts. Attendees will also be able to provide verbal comments to a stenographer or submit written comments during the public meetings. In addition to participating in the public meetings, members of the public may submit comments via the U.S. Postal Service using the mailing address identified in the contact information later in this notice or electronically using the project Web site (
The DoN may release the city, state, and 5-digit zip code of individuals who provide comments during the Draft EIS public review period. However, the names, street addresses, email addresses and screen names, telephone numbers, or other personally identifiable information of those individuals will not be released by the DoN unless required by law. Prior to each commenter making verbal comments to the stenographer at the public meetings the commenter will be asked whether he/she agrees to a release of their personally identifiable information. Those commenters submitting written comments, either using comment forms or via the project Web site, will be asked whether they authorize release of personally identifiable information by checking a “release” box.
EA-18G EIS Project Manager, Naval Facilities Engineering Command (NAVFAC) Atlantic, Attention: Code EV21/SS; 6506 Hampton Boulevard, Norfolk, Virginia 23508.
On September 5, 2013, the DoN published a notice of intent (NOI) in the
The DoN's proposed action is to: (1) Continue and expand existing Growler operations at Ault Field and OLF Coupeville; (2) increase capabilities to accommodate up to 36 additional aircraft, including the construction and renovation of facilities at Ault Field; (3) support flight operations of other aircraft, and (4) station additional personnel in the region.
The purpose of the proposed action is to augment the DoN's existing Electronic Attack community at NAS Whidbey Island by operating additional Growler aircraft as appropriated by Congress. The DoN needs to effectively and efficiently increase electronic attack capabilities in order to counter increasingly sophisticated threats and provide more aircraft per squadron in order to give operational commanders more flexibility in addressing future threats and missions. The need for the proposed action is to maintain and expand Growler operational readiness to support national defense requirements under Title 10, United States Code (U.S.C.), Section 5062.
In developing the proposed range of alternatives that meet the purpose of and need for the proposed action, the DoN carefully reviewed important considerations unique to the Growler community that is single-sited at NAS Whidbey Island, as well as Growler squadron training in light of Title 10 responsibilities; existing training requirements and regulations; existing DoN infrastructure; and Chief of Naval Operations guidance to support operating Naval Forces. Furthermore, the DoN evaluated past home basing decisions, reconsidered alternatives previously eliminated from analysis, and thoughtfully considered basing and training options suggested by the public during the two scoping periods. The Draft EIS explains the DoN's reasons for eliminating some alternatives and suggested options from further consideration. In addition, the Draft EIS explains why some alternatives presented in the October 10, 2014 revised NOI were not carried forward.
The action alternatives evaluated in the Draft EIS vary in terms of force structure and operations to accommodate the proposed increase in Growler aircraft. In addition, three operational scenarios (sub-alternatives) are evaluated, all of which focus on the distribution of annual FCLP airfield operations between Ault Field and OLF Coupeville.
In addition to the action alternatives, the DoN evaluated the potential environmental effects of the No Action Alternative. Under this alternative, the proposed action would not occur. Although the No Action Alternative would not meet the purpose of or need for the proposed action, the conditions associated with the No Action Alternative serve as reference points for describing and quantifying the potential environmental impacts associated with the proposed action alternatives. For this Draft EIS, the DoN is using the year 2021 for the No Action Alternative because it represents conditions when events at Ault Field affecting aircraft loading, facility and infrastructure assets, personnel levels, and number of aircraft are expected to be fully implemented and complete from previous aircraft home basing, aircraft retirement, and other related decisions.
The Draft EIS provides an analysis of the potential environmental effects of the proposed action on the following resources: Airspace and airfield operations; noise; public health and safety; air quality; land use; cultural resources; American Indian traditional resources; biological resources; water resources; socioeconomics; environmental justice; transportation;
The Draft EIS was distributed to federal, state, and local agencies and elected officials, Native American Indian Tribes and Nations, and other interested individuals and organizations. The Draft EIS is available for public electronic viewing or download at the project Web site (
To be included on the DoN's mailing list for future updates on the EIS, submit a request electronically using the project Web site or submit a written request to the address previously identified for further information. The same policy for release of personally identifiable information as identified above will be maintained by the DoN for individuals requesting to be included on the EIS mailing list.
Take notice that the following hydroelectric applications have been filed with the Commission and are available for public inspection:
a.
b.
c.
d.
For license surrender: Klamath River Renewal Corporation.
e.
Lower Klamath Project (P-14803).
f.
Lower Klamath Project—on the Klamath River in Klamath County, Oregon, and Siskiyou County, California. The project would include about 395 acres of federal lands administered by the Bureau of Land Management.
g.
h.
Michael Carrier, President, Klamath River Renewal Corporation, 423 Washington Street, 3rd Floor, San Francisco, CA 94111, (415) 820-4441,
i.
Surrender: John Mudre: (202) 502-8902,
j.
k.
l. With this notice, we are initiating informal consultation with: (a) the U.S. Fish and Wildlife Service and NOAA Fisheries under section 7 of the Endangered Species Act and the joint agency implementing regulations at 50 CFR part 402; (b) NOAA Fisheries under section 305(b) of the Magnuson-Stevens Fishery Conservation and Management Act and implementing regulations at 50 CFR 600.920; and (c) the California and Oregon State Historic Preservation Officers, as required by section 106 of the National Historic Preservation Act, and the implementing regulations of the Advisory Council on Historic Preservation at 36 CFR part 800.
m. With this notice, we are designating PacifiCorp and the Renewal
n.
o. Individuals desiring to be included on the Commission's mailing list for these proceedings should so indicate by writing to the Secretary of the Commission.
p.
In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission or FERC's) regulations, 18 Code of Federal Regulations (CFR) Part 380, the Office of Energy Projects has reviewed Northern Indiana Public Service Company's application for amendment of the license for the Norway-Oakdale Hydroelectric Project (FERC Project No. 12514-074), on the Tippecanoe River near the city of Monticello in Carroll and White Counties, Indiana, and prepared a final environmental assessment (EA) for the project. The project does not occupy any federal lands.
The final EA contains staff's analysis of the potential environmental effects of implementing the proposed modified definition of abnormal flow conditions that would be included in a revised article 403, which defines the operation of the project. Staff concludes that authorizing the amendment, with staff's recommended modification to the definition of abnormal river conditions, would not constitute a major federal action that would significantly affect the quality of the human environment.
A copy of the final EA is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
You may also register online at
For further information, contact Mark Pawlowski at 202-502-6052.
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric reliability filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests,
This is a supplemental notice in the above-referenced proceeding Lawrenceburg Power, LLC`s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is November 30, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that 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 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
This is a supplemental notice in the above-referenced proceeding Three Peaks Power, LLCs application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is November 30, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that on November 14, 2016, Midwest Generation, LLC submitted tariff filing per: Refund Report to be effective N/A, pursuant to Federal Energy Regulatory Commission's (Commission) October 11, 2016 Order.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that the following hydroelectric application has been filed with the Federal Energy Regulatory Commission and is available for public inspection:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j. Deadline for filing comments, motions to intervene, and protests is 30 days from the issuance of this notice by the Commission. The Commission strongly encourages electronic filing. Please file motions to intervene, protests, and comments using the Commission's eFiling system at
k.
l.
m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n.
o.
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate 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
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
This is a supplemental notice in the above-referenced proceeding Waterford Power, LLC`s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is November 30, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Federal Energy Regulatory Commission, DOE.
Comment request.
In compliance with the requirements of the Paperwork Reduction Act of 1995, 44 U.S.C. 3507(a)(1)(D), the Federal Energy Regulatory Commission (Commission or FERC) is submitting its information collection FERC-547 (Gas Pipeline Rates: Refund Report Requirements) to the Office of Management and Budget (OMB) for review of the information collection requirements. Any interested person may file comments directly with OMB and should address a copy of those comments to the Commission as explained below. The Commission previously issued a Notice in the
Comments on the collection of information are due by December 19, 2016.
Comments filed with OMB, identified by the OMB Control No. 1902-0084, should be sent via email to the Office of Information and Regulatory Affairs:
A copy of the comments should also be sent to the Commission, in Docket No. IC16-13-000, by either of the following methods:
• eFiling at Commission's Web site:
•
Ellen Brown may be reached by email at
The Commission uses the data to monitor refunds owed by natural gas companies to ensure that the flow-through of refunds owed by these companies are made as expeditiously as possible and to assure that refunds are made in compliance with the Commission's regulations.
This is a supplemental notice in the above-referenced proceeding Darby Power, LLC`s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is November 30, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
This is a supplemental notice in the above-referenced proceeding Pima Energy Storage System, LLC`s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is November 30, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed
This is a supplemental notice in the above-referenced proceeding Gavin Power, LLC`s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is November 30, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that on November 3, 2016 Columbia Gas Transmission, LLC (Columbia Gas), 5151 San Felipe, Suite 2500, Houston, Texas 77056 filed a prior notice request pursuant to sections 157.205 and 157.213(b) of the Commission's regulations under the Natural Gas Act for authorization to construct and operate certain natural gas storage facilities located in Jackson County, West Virginia. Specifically, Columbia proposes to construct and operate three new storage wells and related pipeline to tie the wells into existing pipelines at Columbia's Ripley Storage Field. It is estimated that the three new directional wells will provide a combined total of 15 MMcf per day of improved deliverability to the Columbia system, 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 regarding this Application should be directed to Robert D. Jackson, Manager, Certificates & Regulatory Administration, Columbia Gas Transmission, LLC, 700 Louisiana Street, Suite 700, Houston, Texas 77002, by calling (832) 320-5487, or by fax (832) 320-6487, or by email at
Any person may, within 60 days after the issuance of the instant notice by the Commission, file pursuant to Rule 214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to intervene or notice of intervention. Any person filing to intervene or the Commission's staff may, pursuant to section 157.205 of the Commission's Regulations under the NGA (18 CFR 157.205) file a protest to the request. If no protest is filed within the time allowed therefore, the proposed activity shall be deemed to be authorized effective the day after the time allowed for protest. If a protest is filed and not withdrawn within 30 days after the time allowed for filing a protest, the instant request shall be treated as an application for authorization pursuant to section 7 of the NGA.
Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.
Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenter's will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with he Commission's environmental review process. Environmental commenter's will not be required to serve copies of filed documents on all other parties. However, the non-party commentary, will not receive copies of all documents
The Commission strongly encourages electronic filings of comments, protests, and interventions via the internet in lieu of paper. See 18 CFR 385.2001(a) (1) (iii) and the instructions on the Commission's Web site (
Federal Energy Regulatory Commission, Department of Energy.
Comment request.
In compliance with the requirements of the Paperwork Reduction Act of 1995, 44 U.S.C. 3507(a)(1)(D), the Federal Energy Regulatory Commission (Commission or FERC) is submitting its information collections [FERC-511 (Transfer of Electric License), FERC-515 (Rules of Practice and Procedure: Declaration of Intention), and FERC-574 (Gas Pipeline Certificates: Hinshaw Exemption)] to the Office of Management and Budget (OMB) for review of the information collection requirements. Any interested person may file comments directly with OMB and should address a copy of those comments to the Commission as explained below. The Commission previously issued a Notice in the
Comments on the collection of information are due by December 19, 2016.
Comments filed with OMB, identified by the OMB Control No. 1902-0069 (FERC-511), 1902-0079 (FERC-515), or 1902-0116 (FERC-574) should be sent via email to the Office of Information and Regulatory Affairs:
A copy of the comments should also be sent to the Commission, in Docket No. IC16-12-000, by either of the following methods:
•
•
Ellen Brown may be reached by email at
The exemption applies to companies engaged in the transportation, sale, or resale of natural gas in interstate commerce if: (a) They receive gas at or within the boundaries of the state from another person at or within the boundaries of that state; (b) such gas is ultimately consumed in such state; (c) the rates, service and facilities of such company are subject to regulation by a State Commission; and (d) that such State Commission is exercising that jurisdiction. 18 CFR part 152 specifies the data required to be filed by pipeline companies for an exemption.
On November 9, 2016, the Federal Energy Regulatory Commission staff convened a technical conference to discuss the utilization of electric storage resources as transmission assets compensated through transmission rates, for grid support services that are compensated in other ways, and for multiple services.
All interested persons are invited to file post-technical conference comments on the topics discussed in the Supplemental Notice of Technical Conference issued in this proceeding on November 1, 2016 (Supplemental Notice), including the questions listed therein. Commenters need not respond to all topics or questions asked. Commenters should organize responses consistent with the organization of the topics and questions in the Supplemental Notice. Commenters may reference material previously filed in this docket, including the technical conference transcript, but are encouraged to submit new or additional information rather than reiterate information that is already in the record. In particular, commenters are encouraged, when possible, to provide examples in support of their answers. These comments are due within 30 days of the date of this notice.
For more information about this notice, please contact:
Environmental Protection Agency (EPA).
Notice.
In accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is issuing a notice of receipt of requests by the registrants to voluntarily cancel their registrations and to amend product registrations to terminate uses.
EPA intends to grant these requests at the close of the comment period for this announcement unless the Agency receives substantive comments within the comment period that would merit its further review of the requests, or unless the registrants withdraw its requests. If these requests are granted, any sale, distribution, or use of products listed in this notice will be permitted after the registrations have been cancelled and uses terminated only if such sale, distribution, or use is consistent with the terms as described in the final order.
Comments must be received on or before December 19, 2016.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2016-0577, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
Christopher Green, Information Technology and Resources Management Division (7502P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 347-0367; email address:
This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.
1.
2.
This notice announces receipt by EPA of requests from registrants to cancel certain pesticide products and amend product registrations to terminate certain uses. The affected products and the registrants making the requests are identified in Tables 1-3 of this unit.
Unless a request is withdrawn by the registrant or if the Agency determines that there are substantive comments that warrant further review of this request, EPA intends to issue an order in the
Table 3 of this unit includes the names and addresses of record for the registrants of the products listed in Table 1 and Table 2 of this unit, in sequence by EPA company number. This number corresponds to the first part of the EPA registration numbers of the products listed in Table 1 and Table 2 of this unit.
Section 6(f)(1) of FIFRA (7 U.S.C. 136d(f)(1)) provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled or amended to terminate one or more uses. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the
Section 6(f)(1)(B) of FIFRA (7 U.S.C. 136d(f)(1)(B)) requires that before acting on a request for voluntary cancellation, EPA must provide a 30-day public comment period on the request for voluntary cancellation or use termination. In addition, FIFRA section 6(f)(1)(C) (7 U.S.C. 136d(f)(1)(C)) requires that EPA provide a 180-day comment period on a request for voluntary cancellation or termination of any minor agricultural use before granting the request, unless:
1. The registrants request a waiver of the comment period, or
2. The EPA Administrator determines that continued use of the pesticide would pose an unreasonable adverse effect on the environment.
The registrants listed in Table 3 of Unit II have requested that EPA waive the 180-day comment period. Accordingly, EPA will provide a 30-day comment period on the proposed requests.
Registrants who choose to withdraw a request for product cancellation or use termination should submit the withdrawal in writing to the person listed under
Existing stocks are those stocks of registered pesticide products that are currently in the United States and that were packaged, labeled, and released for shipment prior to the effective date of the action. If the requests for voluntary cancellation and amendments to terminate uses are granted, the Agency intends to publish the cancellation order in the
In any order issued in response to these requests for cancellation of product registrations and for amendments to terminate uses, EPA proposes to include the following provisions for the treatment of any existing stocks of the products listed in Tables 1 and 2 of Unit II.
For voluntary product cancellations, registrants will be permitted to sell and distribute existing stocks of voluntarily canceled products for 1 year after the effective date of the cancellation, which will be the date of publication of the cancellation order in the
Once EPA has approved the product labels reflecting the requested amendments to terminate uses, registrants will be permitted to sell or distribute the products under the previously approved labeling for a period of 18 months after the date of
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-2009-0317, must be received on or before December 21, 2016.
Follow the detailed instructions provided under
Richard Dumas, Pesticide Re-Evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 308-8015; 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
Equal Employment Opportunity Commission.
Notice.
Notice is hereby given of the appointment of members to the Performance Review Board of the Equal Employment Opportunity Commission.
Traci M. DiMartini, Chief Human Capital Officer, U.S. Equal Employment Opportunity Commission, 131 M Street NE., Washington, DC 20507, (202) 663-4306.
Publication of the Performance Review Board (PRB) membership is required by 5 U.S.C. 4314(c)(4). The PRB reviews and evaluates the initial appraisal of a senior executive's performance by the supervisor, and makes recommendations to the Chair, EEOC, with respect to performance ratings, pay level adjustments and performance awards.
The following are the names and titles of executives appointed to serve as members of the SES PRB. Members will serve a 12-month term, which begins on November 29, 2016.
By the direction of the Commission.
Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this Notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing and sent within thirty days of the date of this Notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 34.6, 1601 Bryan Street, Dallas, TX 75201.
No comments concerning the termination of this receivership will be considered which are not sent within this time frame.
Federal Housing Finance Agency.
60-day notice of submission of information collection for approval from Office of Management and Budget.
In accordance with the requirements of the Paperwork Reduction Act of 1995 (PRA), the Federal Housing Finance Agency (FHFA or the Agency) is seeking public comments concerning a new information collection known as “Contractor Workforce Inclusion Good Faith Efforts.” This information collection has not yet been assigned a control number by the Office of Management and Budget (OMB). FHFA intends to submit the information collection to OMB for review and approval of a three-year control number.
Interested persons may submit comments on or before January 17, 2017.
Submit comments to FHFA, identified by “Proposed Collection; Comment Request: `Contractor Workforce Inclusion Good Faith Efforts, (No. 2016-N-11)' ” by any of the following methods:
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•
We will post all public comments we receive without change, including any personal information you provide, such as your name and address, email address, and telephone number, on the FHFA Web site at
Eric Howard, Diversity and Inclusion Principal Advisor, Office of Minority and Women Inclusion,
Section 342(a)(1)(A) of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 (the Dodd-Frank Act) requires FHFA and certain other Federal agencies each to establish an Office of Minority and Women Inclusion (OMWI) responsible for all matters of the agency relating to diversity in management, employment, and business activities.
Further, section 342(c)(3)(A) of the Dodd-Frank Act requires that each agency's standards and procedures include a procedure for determining whether an agency contractor or subcontractor has failed to make a good faith effort to include minorities and women in its workforce. If the OMWI Director determines that a contractor or subcontractor has failed to make such a good faith effort, section 342(c)(3)(B)(i) provides that the OMWI Director shall recommend to the agency administrator that the contract be terminated. Section 342(c)(3)(B)(ii) provides that, upon receipt of such a recommendation, the agency administrator may either terminate the contract, make a referral to the Office of Federal Contract Compliance Programs (OFCCP) of the
As a means of implementing the requirements of section 342(c) of the Dodd-Frank Act, FHFA developed a Minority and Women Inclusion Clause (MWI Clause) that it now includes in all Agency contracts with a dollar value greater than the “simplified acquisition threshold” (currently, $150,000) established in the Federal Acquisition Regulation (FAR).
Finally, the MWI Clause requires a contractor to provide, when requested by FHFA, documentation demonstrating that it and any covered subcontractor has made a good faith effort to ensure the fair inclusion of minorities and women in its workforce. The MWI Clause provides that such documentation may include, but is not limited to: (1) The contractor's total number of employees, and the number of minority and women employees, by race, ethnicity, and gender (
While FHFA has included the MWI Clause in all contracts with a dollar value greater than $150,000 consummated since November 7, 2013, the Agency has not, to this point, asked any contractor or covered subcontractor to provide documentation pursuant to the clause. FHFA is now developing procedures that the OMWI Director will follow in determining whether its contractors and covered subcontractors have made good faith efforts to comply with the MWI Clause. The Agency expects that, once it adopts those procedures, it will begin to request the types of documentation described in the MWI Clause from contractors and covered subcontractors.
The purpose of this information collection is to fulfill the requirements of section 342(c)(3)(B) of the Dodd-Frank Act. The collected information will allow FHFA's OMWI Director to determine whether contractors and covered subcontractors have complied with their obligations to make good faith efforts to ensure, to the maximum extent possible consistent with applicable law, the fair inclusion of minorities and women in their respective workforces.
FHFA estimates that the average annual burden imposed on all respondents by this information collection over the next three years will be 368 hours. All of the assumptions and calculations underlying the total burden estimate are described in detail below.
Because, as explained below, the amount of burden imposed upon a contractor by this information collection will differ depending upon whether the contractor has 50 or more employees, FHFA has based its total burden estimate on two separate sets of calculations—(I) one for contractors with 50 or more employees; and (II) another for contractors with fewer than 50 employees.
FHFA includes the MWI Clause in Agency contracts with a dollar value greater than $150,000. Under the MWI Clause, the FHFA may also request information about covered subcontractors' ownership status, workforce demographics, and workforce inclusion plans. Contractors would request this information from their covered subcontractors, who, because the substance of the MWI Clause would be included in their subcontracts, would have an obligation to keep records and report data as required under the MWI Clause.
FHFA data on the dollar value of contracts awarded by the Agency from the beginning of fiscal year 2013 through the third quarter of fiscal year 2016 shows that 63 contractors were subject to the MWI Clause. FHFA believes that 44 of those contractors have 50 or more employees, while 19 contractors have fewer than 50 employees. FHFA estimates that no more than two subcontracts with a dollar value of $150,000 or more were awarded by Agency contractors during that same time period. Both of those subcontractors have 50 or more employees each. Thus, over the preceding three years, a total of 65 contractors and subcontractors were subject to the MWI Clause—46 of which have 50 or more employees and 19 of which have fewer than 50 employees.
Based on these figures, FHFA estimates that, on average over the next three years, 48 contractors and subcontractors with 50 or more employees and 20 contractors or subcontractors with fewer than 50 employees will be subject to the MWI Clause at any given time. For purposes of these burden estimates, FHFA has assumed that each contractor or subcontractor will provide documentation under the MWI Clause once per year, although it is unlikely that the Agency will actually request documentation from every contractor in every year. (In the interest of brevity, the word “contractor” is intended also to include covered subcontractors in the explanation of the burden estimates that follows.)
FHFA estimates that the average annual burden on contractors with 50 or more employees will be 48 hours (0 recordkeeping hours + 48 reporting hours).
Because Federal contractors with 50 or more employees are already required to maintain the same types of records that may be requested pursuant to the MWI Clause under regulations implementing Title VII of the Civil Rights Act of 1964
With respect to reporting burden, FHFA estimates that it will take each contractor approximately one hour to retrieve and submit to the FHFA the documentation specified in the MWI Clause. Thus, the estimate of the annual burden upon contractors with 50 or more employees associated with reporting requirements under this information collection is 48 hours (48 contractors × 1 hour per contractor).
FHFA estimates that the average annual burden on contractors with fewer than 50 employees will be 320 hours (300 recordkeeping hours + 20 reporting hours).
OFCCP regulations require contractors with fewer than 50 employees to maintain records on the race, ethnicity, and gender of each employee.
In order to estimate the burden associated with creating a workforce inclusion plan, FHFA considered the OFCCP's burden estimates for the time needed to develop the written program summaries required under its regulations.
FHFA estimates that a contractor with fewer than 50 employees would spend approximately 25 hours creating a workforce inclusion plan for the first time. The Agency estimates that each contractor would then spend approximately 10 hours annually in updating and maintaining its plan. This results in an estimated average annual recordkeeping burden over the next three years on each contractor with fewer than 50 employees of 15 hours [(25 + 10 + 10)/3 years]. Thus, FHFA estimates that the average annual recordkeeping burden on all contractors with fewer than 50 employees over the next three years will be 300 hours (20 contractors × 15 hours per contractor).
FHFA estimates that it will take each contractor approximately one hour to retrieve and submit to FHFA the documentation specified in the MWI Clause. Thus, the estimate of the annual burden upon contractors with fewer than 50 employees associated with reporting requirements under this information collection is 20 hours (20 contractors × 1 hour per contractor).
FHFA requests written comments on the following: (1) Whether the collection of information is necessary for the proper performance of FHFA functions, including whether the information has practical utility; (2) the accuracy of FHFA's estimates of the burdens of the collection of information; (3) ways to enhance the quality, utility, and clarity of the information collected; and (4) 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.
The companies listed in this notice have given notice under section 4 of the Bank Holding Company Act (12 U.S.C. 1843) (BHC Act) and Regulation Y, (12 CFR part 225) to engage
Each notice is available for inspection at the Federal Reserve Bank indicated. The notice also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the question whether the proposal complies with the standards of section 4 of the BHC Act.
Unless otherwise noted, comments regarding the applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than December 13, 2016.
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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 December 1, 2016.
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to retain voting shares of Farmers Bancshares Inc., and thereby retain Independent Farmers Bank, both of Maysville, Missouri.
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 December 14, 2016.
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B. Federal Reserve Bank of New York (Ivan Hurwitz, Vice President) 33 Liberty Street, New York, New York 10045-0001. Comments can also be sent electronically to
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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 December 5, 2016.
1.
Federal Retirement Thrift Investment Board.
77 K Street NE., 10th Floor Board Room, Washington, DC 20002.
Federal Retirement Thrift Investment Board Member Meeting.
November 29, 2016, In-Person, 8:30 a.m.
Information covered under 5 U.S.C. 552b(c)(4), c(6), and (c)(9)(B).
Kimberly Weaver, Director, Office of External Affairs, (202) 942-1640.
Agency for Healthcare Research and Quality, HHS.
Notice.
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: “
Comments on this notice must be received by January 17, 2017.
Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at
Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer.
Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at
In 1999, the Institute of Medicine called for health care organizations to d