September 2019 – Federal Register Recent Federal Regulation Documents

This Order withdraws, subject to valid existing rights, approximately 43.32 acres of Federal lands from settlement, sale, location, and entry under the general land laws, including the United States mining laws, mineral leasing laws, and geothermal leasing laws, for a period of 3 years for use by the Department of the Army for border security purposes. This withdrawal also transfers administrative jurisdiction of the lands to the Department of the Army.

This Order withdraws, subject to valid existing rights, approximately 228 acres of Federal lands from settlement, sale, location, and entry under the general land laws, including the United States mining laws, mineral leasing laws, and geothermal leasing laws, for a period of 3 years for use by the Department of the Army for border security purposes. This withdrawal also transfers administrative jurisdiction of the lands to the Department of the Army.

This Order withdraws, subject to valid existing rights, approximately 68 acres of Federal lands from settlement, sale, location, and entry under the general land laws, including the United States mining laws, mineral leasing laws, and geothermal leasing laws, for a period of 3 years for use by the Department of the Army for border security purposes. This withdrawal also transfers administrative jurisdiction of the lands to the Department of the Army.

This notice announces a meeting of the Research, Engineering, and Development Advisory Committee (REDAC).

The Environmental Protection Agency (EPA) Science Advisory Board (SAB) Staff Office announces a public meeting of the SAB's All- Ages Lead Model (AALM) Panel. The Panel will meet to conduct a peer review the EPA's AALM External Review Draft Version 2.0, comprising the model's software, technical documentation, and user manual (hereafter referred to collectively as AALM 2.0). The AALM 2.0 was developed by EPA's Office of Research and Development.

The Department of Veterans Affairs (VA), Office of Geriatrics and Extended Care, is seeking nominations of qualified candidates to be considered for appointment as a member of the Geriatrics and Gerontology Advisory Committee (herein-after in this section referred to as ``the Committee''). The Committee advises the VA Secretary and the Under Secretary for Health on all matters pertaining to geriatrics and gerontology.

The Food and Drug Administration (FDA, Agency, or we) has determined that ATROPINE SULFATE ANSYR PLASTIC SYRINGE (atropine sulfate solution) intravenous, intramuscular, subcutaneous, and endotracheal, 0.5 milligram (mg)/5 milliliters (mL) (0.1 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for atropine sulfate solution intravenous, intramuscular, subcutaneous, and endotracheal, 0.5 mg/5 mL (0.1 mg/mL), if all other legal and regulatory requirements are met.

Notice is hereby given, pursuant to CBP regulations, that Laboratory Service, Inc. (Carteret, NJ), has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of January 17, 2018.

The Food and Drug Administration (FDA) is establishing a public docket to collect comments related to the post-marketing pediatric-focused safety reviews of products posted between April 12, 2019, and September 23, 2019, on FDA's website but not presented at the September 26 or 27, 2019, Joint Pediatric Advisory Committee (PAC) and Drug Safety and Risk Management (DSaRM) Advisory Committee meeting. These reviews are intended to be available for review and comment by members of the PAC, interested parties (such as academic researchers, regulated industries, consortia, and patient groups), and the general public.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

Notice is hereby given, pursuant to CBP regulations, that AmSpec LLC (Gonzales, LA), has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of April 11, 2019.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Wholesale Distributor Verification Requirement for Saleable Returned Drug ProductCompliance Policy.'' This guidance describes FDA's intention regarding enforcement of the Drug Supply Chain Security Act (DSCSA) provision requiring wholesale distributors to verify a product identifier prior to further distributing returned product beginning on November 27, 2019. Given concerns expressed by stakeholders and to minimize possible disruptions in the pharmaceutical distribution supply chain, FDA does not intend to take action against wholesale distributors who do not, prior to November 27, 2020, verify a product identifier prior to further distributing returned product as required under the DSCSA. This represents a 1-year delay in enforcement of this DSCSA requirement.

Notice is hereby given, pursuant to CBP regulations, that AmSpec LLC (La Porte, TX), has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of April 10, 2019.

Notice is hereby given, pursuant to CBP regulations, that AmSpec LLC (Kenai, AK), has been approved to gauge petroleum and certain petroleum products for customs purposes for the next three years as of April 11, 2019.

The Environmental Protection Agency is planning to submit an information collection request (ICR), ``Procedures for Implementing the National Environmental Policy Act and Assessing the Environmental Effects Abroad of EPA Actions'' (EPA ICR No. 2243.08, OMB Control No. 2020-0033) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. Before doing so, the EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through January 31, 2020. An Agency may not conduct, or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the 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. Currently, the IRS is soliciting comments concerning the collection of information related to the disclosure requirements with respect to prohibited tax shelter transactions.

As a result of this expedited sunset review, the Department of Commerce (Commerce) finds that revocation of the countervailing duty order on oil country tubular goods (OCTG) from India would be likely to lead to continuation or recurrence of countervailable subsidies as indicated in the ``Final Results of Sunset Review'' section of this notice.

The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the 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. Currently, the IRS is soliciting comments concerning the collection of information required to obtain the benefit of using revisions to FHA loan limits to determine average area purchase prices.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment.'' The guidance provides FDA's current thinking on the clinical development program and clinical trial designs for drugs to support an indication for the treatment of amyotrophic lateral sclerosis (ALS). The guidance addresses the clinical development of drugs intended to treat the main motor aspects of ALS, i.e., muscle weakness and its direct consequences, including shortened life expectancy. It does not address in detail the development of drugs to treat other symptoms that may arise in ALS, such as muscle cramps, spasticity, sialorrhea, pseudobulbar affect, and others. This guidance finalizes the draft guidance of the same name issued on February 16, 2018.