October 2, 2017 – Federal Register Recent Federal Regulation Documents

This notice amends the notice of a major disaster declaration for the State of Iowa (FEMA-4334-DR), dated August 27, 2017, and related determinations.

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) is announcing support for version 1.1 of Clinical Data Interchange Standards Consortium (CDISC), Analysis Data Model Implementation Guide (ADaM IG V1.1), an update to the FDA Data Standards Catalog (Catalog). (See https://www.fda.gov/forindustry/ datastandards/studydatastandards/default.htm). ADaM IG V1.1 has been available from CDISC (www.cdisc.org) since February 12, 2016. FDA is encouraging sponsors and applicants to use ADaM IG V1.1 in investigational study data provided in regulatory submissions to CDER.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57); Draft Guidance for Industry and Food and Drug Administration Staff.'' When finalized, this guidance describes FDA's policy with respect to certain LIPs that comply with International Electrotechnical Commission (IEC) standards during laser product classification under the Electronic Product Radiation Control provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that apply to electronic products. When finalized, this document will supersede the ``Immediately in Effect Guidance Document: Classification and Requirements for Laser Illuminated Projectors (LIPs); Guidance for Industry and Food and Drug Administration Staff,'' issued February 18, 2015. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Marketing Clearance of Diagnostic Ultrasound Systems and Transducers; Draft Guidance for Industry and Food and Drug Administration Staff.'' This draft guidance provides detailed information recommended for manufacturers seeking marketing clearance of diagnostic ultrasound systems and transducers. This draft guidance is not final nor is it in effect at this time.

Section 106 of the Department of Housing and Urban Development Reform Act of 1989 (the HUD Reform Act) requires HUD to publish quarterly Federal Register notices of all regulatory waivers that HUD has approved. Each notice covers the quarterly period since the previous Federal Register notice. The purpose of this notice is to comply with the requirements of section 106 of the HUD Reform Act. This notice contains a list of regulatory waivers granted by HUD during the period beginning on April 1, 2017, and ending on June 30, 2017.

The best available scientific and commercial data indicate that threats to Astragalus desereticus (Deseret milkvetch) identified at the time of listing in 1999 are not as significant as originally anticipated and are being adequately managed. Therefore, the species no longer meets the definition of an endangered or threatened species under the Endangered Species Act of 1973, as amended (Act). Consequently, we, the U.S. Fish and Wildlife Service (Service), propose to remove (delist) Astragalus desereticus from the Federal List of Endangered and Threatened Plants (List). This determination is based on a thorough review of all available information, which indicates that this species' population is much greater than was known at the time of listing in 1999 and that threats to this species have been sufficiently minimized. This document also serves as the 12-month finding on a petition to remove this species from the List. We are seeking information, data, and comments from the public on the proposed rule to remove the Astragalus desereticus from the List.

The Federal Open Market Committee (``Committee'') is finalizing its interim final rule amending the Committee's regulations under the Freedom of Information Act (``FOIA''). The FOIA Improvement Act of 2016 (``Improvement Act'') amended the FOIA and required each federal agency to review its FOIA regulations and to issue certain revisions by December 27, 2016. Substantive revisions to the Committee's Rules Regarding Availability of Information (``Rules'') were made to conform to the Improvement Act, and the Committee made other technical changes to the Rules in order to clarify the existing procedures for requesting information and to update contact information. The interim final rule became effective on December 27, 2016. This rulemaking finalizes the interim rule with minor edits for consistency and clarification.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Stratford Avenue Bridge across the Pequonnock River, mile 0.1 at Bridgeport, Connecticut. This deviation is necessary to facilitate a planned inspection and will allow the owner to temporarily close the draw for five days from 7:30 a.m. to 5:00 p.m. daily.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the SR 156/Benjamin Harrison Memorial Bridge which carries SR 156 across the James River, mile 65.0, at Hopewell, VA. The deviation is necessary to facilitate bridge maintenance. This deviation allows the bridge to remain in the closed- to-navigation position.

The Department of Commerce (the Department) preliminarily determines that countervailable subsidies are being provided to producers and exporters of 100- to 150-seat large civil aircraft (aircraft) from Canada. The period of investigation is January 1, 2016, through December 31, 2016.

Before a Federal agency can collect certain information from the public, it must receive approval from the Office of Management and Budget (OMB). Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatement of previously approved collections. This document describes a collection of information for which NHTSA intends to seek OMB approval.

The Federal Financial Institutions Examination Council (FFIEC or Council) is adopting as a final rule the interim final rule published July 3, 2017. The interim final rule announced revisions and additions to the Council's information disclosure regulations under the Freedom of Information Act (FOIA Regulations). The interim final rule also replaced the interim final rule published on December 27, 2016. The revisions in the interim final rule implement recent statutory amendments to the FOIA that are mandated by the FOIA Improvement Act of 2016, as well as update the language of the Council's regulations to more closely mirror the language of the FOIA and to reflect the Council's current FOIA procedures.

The National Institute of Drug Abuse, an institute of the National Institutes of Health, Department of Health and Human Services is contemplating the modification of grant of an Exclusive Patent License to EncepHeal Therapeutics, Inc., located in Winston-Salem, North Carolina, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC), announces the following meeting for the Subcommittee on Procedures Review (SPR) of the Advisory Board on Radiation and Worker Health (ABRWH). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the teleconference at the USA toll- free, dial-in number at 1-866-659-0537; the pass code is 9933701. The conference line has 150 ports for callers.

In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA) as amended, notification is hereby given that NMFS has issued an incidental harassment authorization (IHA) to the Navy to incidentally harass, by Level B harassment only, marine mammals during construction activities associated with the pier replacements project at Naval Base Point Loma.

NMFS is reallocating the projected unused amount of the 2017 Atka mackerel incidental catch allowance (ICA) for the Bering Sea subarea and Eastern Aleutian district (BS/EAI) to the Amendment 80 cooperative allocations in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to allow the 2017 total allowable catch of Atka mackerel in the BSAI to be fully harvested.

On September 30, 2017, the Department of Labor (DOL) will submit the Employee Benefits Security Administration (EBSA) sponsored information collection request (ICR) titled, ``Suspension of Pension Benefits Pursuant to Regulations 29 CFR 2530.203-3,'' to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.

NMFS is prohibiting directed fishing for pollock in Statistical Area 610 in the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the C season apportionment of the 2017 total allowable catch of pollock for Statistical Area 610 in the GOA.

In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.