October 21, 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by our Agency. Under the Paperwork Reduction Act of 1995 (the 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. This notice solicits comments on the collection of information associated with adverse event reporting and recordkeeping for dietary supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA).

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.

On October 13, 2015, the Department of Commerce published notice in the Federal Register of a final negative countervailing duty determination in connection with the subject investigation (80 FR 61365). Accordingly, the countervailing duty investigation concerning certain welded line pipe from Korea (Investigation No. 701-TA-524 (Final)) is terminated.

The Small Business Administration (SBA) intends to request approval, from the Office of Management and Budget (OMB) for the collection of information described below. The Paperwork Reduction Act (PRA) of 1995, 44 U.S.C Chapter 35 requires federal agencies to publish a notice in the Federal Register concerning each proposed collection of information before submission to OMB, and to allow 60 days for public comment in response to the notice. This notice complies with that requirement.

Notice is hereby given of the appointment of new members to the General Services Administration Senior Executive Service Performance Review Board. The Performance Review Board assures consistency, stability, and objectivity in the performance appraisal process.

The Commission hereby gives notice of the scheduling of the final phase of antidumping duty investigation No. 731-TA-1269 (Final) pursuant to the Tariff Act of 1930 (``the Act'') to determine whether an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of silicomanganese from Australia, provided for in subheading 7202.30.00 of the Harmonized Tariff Schedule of the United States, preliminarily determined by the Department of Commerce to be sold at less-than-fair-value.\1\

In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.

In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Health Administration (VHA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and includes the actual data collection instrument.

In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.

In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Office of Management (OM), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.

The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revision of a currently approved collection, and allow 60 days for public comment in response to the notice. The Pre-Discharge Compensation Claim is used by service members to file claims under the Benefits Delivery at Discharge or Quick Start programs under Title 38 U.S.C. 5101(a). Without this information, VA would be unable to effectively administer this law.

The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revision of a currently approved collection, and allow 60 days for public comment in response to the notice. VA Form 21-0304 is used to gather information necessary to determine eligibility for a monetary allowance for a child born with Spina Bifida or certain birth defects who is a natural child of a Vietnam Veteran.

The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revision of a currently approved collection, and allow 60 days for public comment in response to the notice. VA Form 26-8937 solicits comments on information needed for lenders to determine they have evidence from VA that there is no debt, or if a debt exists, an acceptable repayment plan has been agreed to by the veteran, or payments under a plan already in effect are current.

The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revision of a currently approved collection, and allow 60 days for public comment in response to the notice. The holder of a vendee account which has been guaranteed by the Department of Veterans Affairs (VA) may request VA to repurchase a loan as provided in 38 CFR 36.4600(d).

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the 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 Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Administrative Practices and Procedures; Formal Evidentiary Public Hearing'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Manufacturing Site Change Supplements: Content and Submission''. This draft guidance describes the decision-making steps that FDA recommends to determine whether a premarket approval application (PMA) supplement should be submitted when a manufacturer intends to change the manufacturing site (including a change to the processing, packaging, or sterilization site) of its legally marketed PMA-approved device. This guidance also discusses the general factors FDA intends to consider to determine whether a preapproval inspection is necessary before approval of the PMA supplement. This draft guidance is not final nor is it in effect at this time.

FMCSA delays the effective and compliance dates for its August 23, 2013, Unified Registration System (URS) final rule. Because FMCSA changes the effective date (the actual date when the regulatory text that appears in the Code of Federal Regulations (CFR) will be changed) and makes technical corrections and conforming amendments to the 2013 regulatory text, the Agency has determined that it is in the best interest of the regulated entities, our State partners and the general public to present the full text of the sections affected. The 2013 URS final rule was issued to improve the registration process for motor carriers, property brokers, freight forwarders, Intermodal Equipment Providers (IEPs), hazardous materials safety permit (HMSP) applicants and cargo tank facilities required to register with FMCSA, and streamline the existing Federal registration processes to ensure the Agency can more efficiently track these entities. Today's final rule delays the implementation of the 2013 final rule in order to allow FMCSA additional time to complete the information technology (IT) systems work required to fully implement that rule.

This document provides notice of substantive rules issued by the Coast Guard that were made temporarily effective between January 2015 and March 2015 but expired before they could be published in the Federal Register. This notice lists temporary safety zones, security zones, special local regulations, drawbridge operation regulations and regulated navigation areas, all of limited duration and for which timely publication in the Federal Register was not possible.

This document announces U.S. Customs and Border Protection's (CBP's) plan to modify the National Customs Automation Program (NCAP) test concerning the Entry Summary, Accounts and Revenue (ESAR) test program in the Automated Commercial Environment (ACE) to allow importers and brokers to file electronically entry summary data for entry types 51 and 52, in addition to entry types 01, 03, and 11 that are already available for electronic filing, for merchandise arriving by truck, rail, vessel, and air, as well as arriving by mail, pedestrian, and passenger (hand-carried).

This regulation establishes tolerances for residues of pyrimethanil in or on multiple commodities which are identified and discussed later in this document. Interregional Research Project Number 4 (IR-4) requested the tolerances associated with pesticide petition number (PP 4E8302), and Bayer CropScience requested the tolerances associated with PP 4F8291, under the Federal Food, Drug, and Cosmetic Act (FFDCA).

The U.S. Small Business Administration (SBA) is seeking comments on this Advance Notice of Proposed Rulemaking (ANPRM) regarding the Immediate Disaster Assistance Program (IDAP), the Expedited Disaster Assistance Program (EDAP), and the Private Disaster Assistance Program (PDAP). Specifically, SBA is seeking comments on the development of proposed regulations for PDAP and EDAP and potential revisions to the existing regulations for IDAP. These programs were authorized by the Small Business Disaster Response and Loan Improvements Act of 2008. The purpose of this ANPRM is to request feedback from potential participants and the public in order to implement these programs in a way that will encourage and enable private sector lenders to participate with SBA to fund loans to disaster survivors.

The Otis Pike Fire Island High Dunes Wilderness Act, Public Law 96-585, December 23, 1980, designated approximately 1,360 acres as wilderness in the Fire Island National Seashore. Due to existing boardwalks and a pit toilet, this Act also designated approximately 18 acres of potential wilderness within Fire Island National Seashore that could be re-designated as wilderness upon elimination of these non- conforming uses. The National Park Service (NPS) described the wilderness and potential wilderness areas on maps entitled ``Wilderness PlanFire Island National Seashore,'' dated December 1980. In November 1983, the NPS adopted the ``Wilderness Management Plan, Fire Island National Seashore'' which also contained the legal description of the wilderness boundaries and a map showing the wilderness and the potential wilderness areas. On October 12, 1999, 17 acres of potential wilderness were re-designated as wilderness (see Federal Register Vol. 64, No. 196). On October 29, 2012, Hurricane Sandy moved through Fire Island National Seashore, destroying the boardwalk nature trail west of the Wilderness Visitor Center, the boardwalk dune crossing, and pit toilet at Old Inlet. The footprint of the two boardwalks and pit toilet is infrastructure that existed within the boundaries of the remaining one acre (more or less) of potential wilderness, entirely in Federal ownership. Upon destruction, the non-conforming uses of this potential wilderness addition were eliminated. Section (C) of the Otis Pike Fire Island High Dunes Wilderness Act authorized the Secretary of the Interior to designate administratively as wilderness any lands previously designated as potential wilderness upon publication in the Federal Register of a notice that all uses thereon that are inconsistent with the Wilderness Act of 1964 (Pub. L. 88-577) have ceased. Accordingly, this notice hereby converts the one acre of potential wilderness in the Otis Pike Fire Island High Dune Wilderness, within Fire Island National Seashore, to designated wilderness. The one acre (more or less) shall be added to the 1,379 acres of designated wilderness within the Otis Pike Fire Island High Dune Wilderness, and managed in accordance with the Wilderness Act of 1964. The maps and legal description are on file at the headquarters of the Fire Island National Seashore, 120 Laurel Street, Patchogue, NY 11772, and at the Office of the Director, 1849 C Street NW., Washington, DC 20240.