November 29, 2017 – Federal Register Recent Federal Regulation Documents

Reader Aids
Document Number: FR-2017-11-29-ReaderAids
Type: Reader Aids
Date: 2017-11-29
Delegation of Authority Under the Foreign Aid Transparency and Accountability Act of 2016
Document Number: 2017-25845
Type: Administrative Order
Date: 2017-11-29
Agency: Executive Office of the President
Sunshine Act Meeting
Document Number: 2017-25830
Type: Notice
Date: 2017-11-29
Agency: National Transportation Safety Board, Agencies and Commissions
Government in the Sunshine Act Meeting Notice
Document Number: 2017-25825
Type: Notice
Date: 2017-11-29
Agency: International Trade Commission, Agencies and Commissions
Government in the Sunshine Act Meeting Notice
Document Number: 2017-25824
Type: Notice
Date: 2017-11-29
Agency: International Trade Commission, Agencies and Commissions
Product Change-Priority Mail Express and Priority Mail Negotiated Service Agreement
Document Number: 2017-25777
Type: Notice
Date: 2017-11-29
Agency: Postal Service, Agencies and Commissions
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
U.S. Army Installation Command
Document Number: 2017-25776
Type: Notice
Date: 2017-11-29
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is giving notice that by petition dated March 16, 2017, as supplemented on April 10, May 21, June 25, July 24, August 16, August 18, October 11, October 12, October 15, and October 16, 2017, Dr. Michael Reimer (the petitioner) has requested that the NRC take action with regard to depleted uranium (DU) from the M101 spotting rounds licensed at the Pohakuloa Training Area (PTA) under source materials license SUC-1593. The petitioner's requests that have been accepted for evaluation are included in the SUPPLEMENTARY INFORMATION section of this document.
Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2017-25775
Type: Notice
Date: 2017-11-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.'' FDA has developed this draft guidance to implement a section of the 21st Century Cures Act (Cures Act) that requires FDA to revise ``V. Demonstrating Insignificant Risk of an Erroneous Result Accuracy'' of the guidance ``Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices'' (``2008 CLIA Waiver Guidance'') that was issued on January 30, 2008. This draft guidance updates FDA's thinking regarding the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy. This draft guidance is not final nor is it in effect at this time.
Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments Waiver by Application Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2017-25774
Type: Notice
Date: 2017-11-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application Studies.'' It describes study designs for generating data that supports both 510(k) clearance and CLIA waived categorization. Use of the Dual 510(k) and CLIA Waiver by Application pathway is optional; however, FDA believes this pathway is in many instances the least burdensome and fastest approach for manufacturers to obtain a CLIA waived categorization in addition to 510(k) clearance for new In Vitro Diagnostic (IVD) devices. FDA believes increased use of this pathway will speed up the process of bringing simple and accurate IVD devices to CLIA waived settings, which will better serve patients and providers. This draft guidance is not final nor is it in effect at this time.
Determination of Regulatory Review Period for Purposes of Patent Extension; SOLX SYSTEM
Document Number: 2017-25773
Type: Notice
Date: 2017-11-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SOLX SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; REXULTI
Document Number: 2017-25772
Type: Notice
Date: 2017-11-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for REXULTI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Roxane Laboratories, Inc.; Withdrawal of Approval of a New Drug Application for ROXICODONE (Oxycodone Hydrochloride) Sustained-Release Tablets, 10 Milligrams and 30 Milligrams
Document Number: 2017-25771
Type: Notice
Date: 2017-11-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of new drug application (NDA) 020932 for ROXICODONE (oxycodone hydrochloride (HCl)) Sustained-Release Tablets, 10 milligrams (mg) and 30 mg, held by Roxane Laboratories, Inc. (Roxane). Roxane requested withdrawal of this application and waived its opportunity for a hearing.
Determination of Regulatory Review Period for Purposes of Patent Extension; XURIDEN
Document Number: 2017-25770
Type: Notice
Date: 2017-11-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XURIDEN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Product Change-Priority Mail Negotiated Service Agreement
Document Number: 2017-25769
Type: Notice
Date: 2017-11-29
Agency: Postal Service, Agencies and Commissions
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Certain Tool Chests and Cabinets From the People's Republic of China: Final Affirmative Countervailing Duty Determination
Document Number: 2017-25768
Type: Notice
Date: 2017-11-29
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (the Department) determines that countervailable subsidies are being provided to producers and exporters of certain tool chests and cabinets (tool chests) from the People's Republic of China (PRC). The period of investigation is January 1, 2016, through December 31, 2016. For information on the estimated subsidy rates, see the ``Final Determination'' section of this notice.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle
Document Number: 2017-25767
Type: Notice
Date: 2017-11-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
New England Fishery Management Council; Public Meeting
Document Number: 2017-25766
Type: Notice
Date: 2017-11-29
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The New England Fishery Management Council's Scientific and Statistical Committee will hold a webinar to review the 2017 Plan B Operational Assessment for Atlantic Halibut. Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
Pacific Fishery Management Council; Public Meeting (Webinar)
Document Number: 2017-25765
Type: Notice
Date: 2017-11-29
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Pacific Fishery Management Council's (Pacific Council) Ad hoc Ecosystem Workgroup (EWG) will hold a meeting via webinar to discuss the work associated with the Climate Change and Communities Initiative. The meeting is open to the public.
Importation of Fresh Mango Fruit From Vietnam Into the Continental United States
Document Number: 2017-25764
Type: Rule
Date: 2017-11-29
Agency: Department of Agriculture, Animal and Plant Health Inspection Service
We are amending the regulations to allow the importation of fresh mango fruit from Vietnam into the continental United States. As a condition of entry, fresh mango fruit from Vietnam will be subject to a systems approach that includes orchard or packinghouse requirements, irradiation treatment, and port of entry inspection. The fruit will also be required to be imported in commercial consignments and accompanied by a phytosanitary certificate issued by the national plant protection organization of Vietnam with an additional declaration stating that the consignment was inspected and found free of Macrophoma mangiferae and Xanthomonas campestris pv. mangiferaeindicae. This action will allow for the importation of fresh mango fruit from Vietnam while continuing to provide protection against the introduction of plant pests into the continental United States.
Metropolitan Planning Organization Coordination and Planning Area Reform
Document Number: 2017-25762
Type: Rule
Date: 2017-11-29
Agency: Federal Highway Administration, Department of Transportation, Federal Transit Administration
This rulemaking rescinds certain transportation planning regulations pertaining to the establishment of the metropolitan planning area (MPA) boundaries, the designation of metropolitan planning organizations (MPO), and the coordination among MPOs. The amendments contained in this rule carry out the statutory mandate to rescind the final rule published on December 20, 2016, on this topic.
Determination of Regulatory Review Period for Purposes of Patent Extension; VELTASSA
Document Number: 2017-25761
Type: Notice
Date: 2017-11-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VELTASSA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
18-Month Extension of Transition Period and Delay of Applicability Dates; Best Interest Contract Exemption (PTE 2016-01); Class Exemption for Principal Transactions in Certain Assets Between Investment Advice Fiduciaries and Employee Benefit Plans and IRAs (PTE 2016-02); Prohibited Transaction Exemption 84-24 for Certain Transactions Involving Insurance Agents and Brokers, Pension Consultants, Insurance Companies, and Investment Company Principal Underwriters (PTE 84-24)
Document Number: 2017-25760
Type: Rule
Date: 2017-11-29
Agency: Employee Benefits Security Administration, Department of Labor
This document extends the special transition period under sections II and IX of the Best Interest Contract Exemption and section VII of the Class Exemption for Principal Transactions in Certain Assets between Investment Advice Fiduciaries and Employee Benefit Plans and IRAs for 18 months. This document also delays the applicability of certain amendments to Prohibited Transaction Exemption 84-24 for the same period. The primary purpose of the amendments is to give the Department of Labor the time necessary to consider public comments under the criteria set forth in the Presidential Memorandum of February 3, 2017, including whether possible changes and alternatives to these exemptions would be appropriate in light of the current comment record and potential input from, and action by, the Securities and Exchange Commission and state insurance commissioners. The Department is granting the delay because of its concern that, without a delay in the applicability dates, consumers may face significant confusion, and regulated parties may incur undue expense to comply with conditions or requirements that the Department ultimately determines to revise or repeal. The former transition period was from June 9, 2017, to January 1, 2018. The new transition period ends on July 1, 2019, rather than on January 1, 2018. The amendments to these exemptions affect participants and beneficiaries of plans, IRA owners and fiduciaries with respect to such plans and IRAs.
Fisheries of the Exclusive Economic Zone Off Alaska; Several Groundfish Species in the Bering Sea and Aleutian Islands Management Area
Document Number: 2017-25759
Type: Rule
Date: 2017-11-29
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS apportions amounts of the non-specified reserve to the initial total allowable catch (ITAC) of Aleutian Islands (AI) Greenland turbot, AI ``other rockfish,'' Bering Sea (BS) sablefish, Bering Sea and Aleutian Islands (BSAI) Alaska plaice, BSAI northern rockfish, BSAI ``other flatfish,'' BSAI shortraker rockfish, BSAI sculpin, BSAI skates, and Central and Western Aleutian Islands (CAI/WAI) blackspotted/rougheye rockfish in the BSAI management area. This action is necessary to allow the fisheries to continue operating. It is intended to promote the goals and objectives of the fishery management plan for the BSAI management area.
City Water and Light Plant of the City of Jonesboro; Notice of Filing
Document Number: 2017-25758
Type: Notice
Date: 2017-11-29
Agency: Department of Energy, Federal Energy Regulatory Commission
Western Area Power Administration; Notice of Filing
Document Number: 2017-25757
Type: Notice
Date: 2017-11-29
Agency: Department of Energy, Federal Energy Regulatory Commission
Southern Star Central Gas Pipeline, Inc.; Notice of Request Under Blanket Authorization
Document Number: 2017-25756
Type: Notice
Date: 2017-11-29
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings #1
Document Number: 2017-25755
Type: Notice
Date: 2017-11-29
Agency: Department of Energy, Federal Energy Regulatory Commission
Notice of Public Meeting of the Arizona Advisory Committee
Document Number: 2017-25754
Type: Notice
Date: 2017-11-29
Agency: Commission on Civil Rights
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Arizona Advisory Committee (Committee) to the Commission will be held at 12:00 p.m. (Mountain Time) Friday, December 1, 2017. The purpose of the meeting is for the Committee to discuss logistics for March briefing on voting rights.
Notice of Permit Modification Received Under the Antarctic Conservation Act of 1978
Document Number: 2017-25753
Type: Notice
Date: 2017-11-29
Agency: National Science Foundation, Agencies and Commissions
The National Science Foundation (NSF) is required to publish a notice of requests to modify permits issued to conduct activities regulated and permits issued under the Antarctic Conservation Act of 1978. NSF has published regulations under the Antarctic Conservation Act in the Code of Federal Regulations. This is the required notice of a requested permit modification and permit issued.
Safety Zone, Savannah River, Savannah, GA
Document Number: 2017-25751
Type: Rule
Date: 2017-11-29
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is establishing a temporary safety zone for navigable waters around the M/V SWAN during its transit from the Savannah River entry point to Garden City Terminal in Savannah, GA and during cargo operations. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by the transport and offloading of oversized cranes. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port (COTP) Savannah or a designated representative.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Health Professions Student Loan (HPSL) Program and Nursing Student Loan (NSL) Program Administrative Requirements (Regulations and Policy). OMB No. 0915-0047-Revision
Document Number: 2017-25750
Type: Notice
Date: 2017-11-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Safety Zone; Delaware River, Marcus Hook, PA
Document Number: 2017-25749
Type: Rule
Date: 2017-11-29
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is establishing a temporary safety zone on the waters of the Delaware River between Marcus Hook Range and Tinicum Range. The safety zone will temporarily restrict vessel traffic from transiting or anchoring in portions of the Delaware River while rock blasting, dredging, and rock removal operations are being conducted to facilitate the Main Channel Deepening project for the Delaware River. The safety zone is needed to protect personnel, vessels, and the marine environment from hazards created by rock blasting, dredging, and rock removal operations. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the COTP or his designated representatives.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: NURSE Corps Scholarship Program, OMB No. 0915-0301-Revision
Document Number: 2017-25748
Type: Notice
Date: 2017-11-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Notice of Public Meeting of the Indiana Advisory Committee to the U.S. Commission on Civil Rights
Document Number: 2017-25746
Type: Notice
Date: 2017-11-29
Agency: Commission on Civil Rights
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Indiana Advisory Committee (Committee) will hold a meeting on Wednesday December 13, 2017, at 2:00 p.m. EST for the purpose of preparing for its public meeting on voting rights issues in the state.
Prospective Grant of Exclusive Patent Commercialization License: N6, A Novel, Broad, Highly Potent HIV-Specific Antibody
Document Number: 2017-25745
Type: Notice
Date: 2017-11-29
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Allergy and Infectious Diseases (NIAID), an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent commercialization license to GlaxoSmithKline Intellectual Property Development Ltd (GSK) located at 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.
Prospective Grant of an Exclusive Patent License: Concatenated L2 Peptide Based Human Papillomavirus Vaccines
Document Number: 2017-25744
Type: Notice
Date: 2017-11-29
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to BravoVax Co., Ltd located in Wuhan, China.
Prospective Grant of Exclusive Patent License: T-Cells Transduced with HLA A11 Restricted CT-RCC HERV-E Reactive T-Cell Receptors for the Treatment of Renal Cell Carcinoma
Document Number: 2017-25743
Type: Notice
Date: 2017-11-29
Agency: Department of Health and Human Services, National Institutes of Health
The National Heart, Lung, and Blood Institute (``NHLBI''), an institute of the National Institutes of Health; an agency within the Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to commercialize the invention(s) embodied in the intellectual property estate stated in the Summary Information section of this notice to T-Cure Bioscience, Inc. located in Thousand Oaks, California and incorporated under the laws of Delaware.
Impact of the Implementation of the Chemical Weapons Convention (CWC) on Legitimate Commercial Chemical, Biotechnology, and Pharmaceutical Activities Involving “Schedule 1” Chemicals (Including Schedule 1 Chemicals Produced as Intermediates) Through Calendar Year 2017
Document Number: 2017-25742
Type: Notice
Date: 2017-11-29
Agency: Department of Commerce, Bureau of Industry and Security
The Bureau of Industry and Security (BIS) is seeking public comments on the impact that implementation of the Chemical Weapons Convention (CWC), through the Chemical Weapons Convention Implementation Act (CWCIA) and the Chemical Weapons Convention Regulations (CWCR), has had on commercial activities involving ``Schedule 1'' chemicals during calendar year 2017. The purpose of this notice of inquiry is to collect information to assist BIS in its preparation of the annual certification to Congress on whether the legitimate commercial activities and interests of chemical, biotechnology, and pharmaceutical firms are being harmed by such implementation. This certification is required under Condition 9 of Senate Resolution 75, April 24, 1997, in which the Senate gave its advice and consent to the ratification of the CWC.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-25739
Type: Notice
Date: 2017-11-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute on Aging; Notice of Closed Meeting
Document Number: 2017-25734
Type: Notice
Date: 2017-11-29
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2017-25733
Type: Notice
Date: 2017-11-29
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2017-25732
Type: Notice
Date: 2017-11-29
Agency: Department of Health and Human Services
National Center for Advancing Translational Sciences; Notice of Meetings
Document Number: 2017-25731
Type: Notice
Date: 2017-11-29
Agency: Department of Health and Human Services, National Institutes of Health
Claims Procedure for Plans Providing Disability Benefits; 90-Day Delay of Applicability Date
Document Number: 2017-25729
Type: Rule
Date: 2017-11-29
Agency: Employee Benefits Security Administration, Department of Labor
This document delays for ninety (90) daysthrough April 1, 2018the applicability of a final rule amending the claims procedure requirements applicable to ERISA-covered employee benefit plans that provide disability benefits (Final Rule). The Final Rule was published in the Federal Register on December 19, 2016, became effective on January 18, 2017, and was scheduled to become applicable on January 1, 2018. The delay announced in this document is necessary to enable the Department of Labor to carefully consider comments and data as part of its effort, pursuant to Executive Order 13777, to examine regulatory alternatives that meet its objectives of ensuring the full and fair review of disability benefit claims while not imposing unnecessary costs and adverse consequences.
Certain Road Construction Machines and Components Thereof; Institution of Investigation
Document Number: 2017-25728
Type: Notice
Date: 2017-11-29
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on October 26, 2017, under section 337 of the Tariff Act of 1930, as amended, on behalf of Caterpillar Inc. of Peoria, Illinois and Caterpillar Paving Products, Inc. of Minneapolis, Minnesota. A supplement was filed on November 9, 2017. The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain road construction machines and components thereof by reason of infringement of one or more of U.S. Patent No. 7,140,693 (``the '693 patent''); U.S. Patent No. 9,045,871 (``the '871 patent''); and U.S. Patent No. 7,641,419 (``the '419 patent''). The complaint further alleges that an industry in the United States exists, or is in the process of being established, as required by the applicable Federal Statute. The complainants request that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and a cease and desist order.
Notice of Electric Quarterly Report Users Group Meeting
Document Number: 2017-25726
Type: Notice
Date: 2017-11-29
Agency: Department of Energy, Federal Energy Regulatory Commission
Occidental Energy Marketing, Inc. v. BridgeTex Pipeline Company, LLC; Notice of Complaint
Document Number: 2017-25724
Type: Notice
Date: 2017-11-29
Agency: Department of Energy, Federal Energy Regulatory Commission
Blue Mountain Midstream LLC; Notice of Application
Document Number: 2017-25723
Type: Notice
Date: 2017-11-29
Agency: Department of Energy, Federal Energy Regulatory Commission