November 6, 2017 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and the guidance entitled ``Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act.''

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Having completed our review of the application materials for corrosion-inhibited copper shot, the U.S. Fish and Wildlife Service (hereinafter Service or we) approves the shot for hunting waterfowl and coots. We have concluded that this type of shot left in terrestrial or aquatic environments is unlikely to adversely affect fish, wildlife, or their habitats. Approving this shot formulation would increase the nontoxic shot options for hunters.

NMFS announces the availability of the ``Draft Environmental Assessment (EA) on the Effects of Issuing an Incidental Take Permit (ITP) (No. 21293) to Mr. Jack Rudloe, Gulf Specimen Marine Laboratories, Inc. (GSML), pursuant to the Endangered Species Act of 1973, as amended (ESA). Publication of this notice begins the official public comment period for this draft EA. Per the National Environmental Policy Act (NEPA), the purpose of the draft EA is to evaluate the potential direct, indirect, and cumulative impacts caused by the issuance of Permit No. 21293 to GSML for the incidental take of Gulf sturgeon (Acipenser oxyrinchus desotoi) or loggerhead (Caretta caretta Northwest Atlantic Ocean Distinct Population Segment), green (Chelonia mydas North Atlantic Distinct Population Segment), Kemp's ridley (Lepidochelys kempii) and leatherback sea turtles (Dermochelys coriacea) associated with the otherwise lawful trawling activities in Florida state waters of Bay, Gulf, Franklin, and Wakulla Counties to harvest marine organisms for the purpose of supplying entities conducting scientific research and educational activities. All comments received will become part of the public record and will be available for review. An electronic copy of the revised application and proposed conservation plan may be obtained by contacting NMFS Office of Protected Resources (see FOR FURTHER INFORMATION CONTACT) or visiting the internet at www.nmfs.noaa.gov/pr/permits/esa_review.htm.

Due to the receipt of an adverse comment, the Environmental Protection Agency (EPA) is withdrawing the September 6, 2017 direct final rule approving a State Implementation Plan (SIP) revision submitted by the State of New Hampshire. New Hampshire's SIP revision establishes emission standards and operating practices for incinerators and wood waste burners that are not regulated pursuant to federal incinerator standards. This action is being taken in accordance with the Clean Air Act.

This regulation establishes an exemption from the requirement of a tolerance for residues of formaldehyde, polymer with 1,3- benzenediol, ethers with polyethylene glycol mono-Me ether (CAS Reg. No. 1998118-32-3) when used as an inert ingredient in a pesticide chemical formulation. Eco Verde Technologies, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether on food or feed commodities.

In accordance with the Federal Advisory Committee Act, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory Council (NAC). This Committee reports to the NAC. The meeting will be held for the purpose of soliciting, from the scientific community and other persons, scientific and technical information relevant to program planning.

The Food and Drug Administration (FDA or we) 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.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled ``Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food.'' The guidance announces that we do not intend to take enforcement action against a receiving facility that is a co-manufacturer and that is not in compliance with certain supply-chain program requirements in the ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food'' and ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals'' regulations (preventive controls regulations) for food manufactured for the brand owner, under certain circumstances, until November 6, 2019. Furthermore, we do not intend to take enforcement action under the Foreign Supplier Verification Programs (FSVP) regulation against an importer whose supply-chain program is subject to enforcement discretion under the preventive controls regulations until November 6, 2019.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry and review staff entitled ``Formal Dispute Resolution: Sponsor Appeals Above the Division Level.'' This guidance provides recommendations for industry and review staff on the procedures in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for resolving scientific and/or medical disputes between CDER or CBER and sponsors that cannot be resolved at the division level. This guidance describes the formal dispute resolution procedures for sponsors that wish to appeal a scientific and/or medical issue to the office or center level and provides a structured process for resolving disputes. This guidance finalizes the revised draft guidance entitled ``Formal Dispute Resolution: Appeals Above the Division Level'' issued September 9, 2015, and replaces the guidance of the same name issued February 2000.

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The Government of the United States received a request from the Government of Morocco on October 10, 2017, on behalf of MODALINE HOLDING to initiate consultations under Article 4.3.3 of the USMFTA. The Government of Morocco is requesting that the United States and Morocco (``the Parties'') consider revising the rules of origin for certain pants, skirts, and jackets to address availability of supply of certain woven fabrics in the territories of the Parties. The President of the United States may proclaim a modification to the USMFTA rules of origin for textile and apparel products after the United States reaches an agreement with the Government of Morocco on a modification under Article 4.3.6 of the USMFTA to address issues of availability of supply of fibers, yarns, or fabrics in the territories of the Parties. CITA hereby solicits public comments on this request, in particular with regard to whether certain woven fabrics can be supplied by the U.S. domestic industry in commercial quantities in a timely manner.

The United States Mint, a bureau of the Department of the Treasury, invites the general public and other Federal agencies to take this opportunity to comment on currently approved information collection 1525-0012, as required by the Paperwork Reduction Act of 1995, The United States Mint is soliciting comments on the United States Mint customer satisfaction and opinion surveys, and focus group interviews.

The Sonoma County Water Agency, acting as administrator for the North Bay Water Reuse Authority and the lead State agency, and the Bureau of Reclamation, the lead Federal agency, will prepare a joint Environmental Impact Report/Environmental Impact Statement for Phase 2 of the North Bay Water Recycling Program. The purpose of the Phase 2 Program is to build upon the existing regional wastewater reuse network developed under the Program's Phase 1 to provide additional opportunities for recycled water for agricultural, urban, and environmental uses as an alternative to discharging treated wastewater to San Pablo Bay.

The Department of Commerce (the Department) is conducting an administrative review of the antidumping duty order on utility scale wind towers (wind towers) from the Socialist Republic of Vietnam (Vietnam). This review covers respondent CS Wind Group. The period of review (POR) is February 1, 2016, through January 31, 2017. We preliminarily find no evidence of any shipments of subject merchandise by CS Wind Group during the POR, and are therefore issuing a preliminary no shipments determination.

The Department of Commerce (the Department) preliminarily determines that countervailable subsidies are being provided to producers and exporters of fine denier polyester staple fiber (fine denier PSF) from India. The period of investigation is January 1, 2016, through December 31, 2016.