January 30, 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry.'' The guidance provides sponsors of retroviral vector-based human gene therapy products recommendations regarding the testing for replication competent retrovirus (RCR) during the manufacture of retroviral vector-based gene therapy products, and during follow-up monitoring of patients who have received retroviral vector-based gene therapy products. Recommendations include the identification and amount of material to be tested, and general testing methods. In addition, recommendations are provided on monitoring patients for evidence of retroviral infection after administration of retroviral vector-based gene therapy products. The guidance supersedes the document entitled ``Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors,'' dated November 2006. The guidance announced in this notice finalizes the draft guidance of the same title dated July 2018.

The National Science Foundation (NSF) is announcing plans to establish this collection. In accordance with the requirements of the Paperwork Reduction Act of 1995, we are providing opportunity for public comment on this action. After obtaining and considering public comment, NSF will prepare the submission requesting Office of Management and Budget (OMB) clearance of this collection for no longer than 3 years.

The Department of Commerce (Commerce) preliminarily determines that Pidilite Industries Limited (Pidilite), a producer/exporter of carbazole violet pigment 23 (CVP 23) from India, did not sell subject merchandise at prices below normal value (NV) during the period of review (POR) December 1, 2017 through November 30, 2018.

This notice announces the availability of the Black Abalone (Haliotis cracherodii) Draft Recovery Plan (Plan) for public review. NMFS is soliciting review and comment from the public and all interested parties on the Plan, and will consider all substantive comments received during the review period before submitting the Plan for final approval.

The Acting Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to extend the temporary schedule I status of cyclopentyl fentanyl (N-(1- phenethylpiperidin-4-yl)-N-phenylcyclopentanecarboxamide), isobutyryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylisobutyramide), para- chloroisobutyryl fentanyl (N-(4-chlorophenyl)-N-(1-phenethylpiperidin- 4-yl)isobutyramide), para-methoxybutyryl fentanyl (N-(4-methoxyphenyl)- N-(1-phenethylpiperidin-4-yl)butyramide), and valeryl fentanyl (N-(1- phenethylpiperidin-4-yl)-N-phenylpentanamide) including their isomers, esters, ethers, salts, and salts of isomers, esters and ethers. The schedule I status of cyclopentyl fentanyl, isobutyryl fentanyl, para- chloroisobutyryl fentanyl, para-methoxybutyryl fentanyl, and valeryl fentanyl currently is in effect until February 1, 2020. This temporary order will extend the temporary scheduling of cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para- methoxybutyryl fentanyl, and valeryl fentanyl for one year, or until the permanent scheduling action for these substances is completed, whichever occurs first.

The Drug Enforcement Administration proposes placing cyclopentyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- phenylcyclopentanecarboxamide), isobutyryl fentanyl (N-(1- phenethylpiperidin-4-yl)-N-phenylisobutyramide), para-chloroisobutyryl fentanyl (N-(4-chlorophenyl)-N-(1-phenethylpiperidin-4- yl)isobutyramide), para-methoxybutyryl fentanyl (N-(4-methoxyphenyl)-N- (1-phenethylpiperidin-4-yl)butyramide), and valeryl fentanyl (N-(1- phenethylpiperidin-4-yl)-N-phenylpentanamide), including their isomers, esters, ethers, salts, and salts of isomers, esters and ethers whenever the existence of such isomers, esters, ethers and salts is possible, in schedule I of the Controlled Substances Act. If finalized, this action would make permanent the existing regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle cyclopentyl fentanyl, isobutyryl fentanyl, para-chloroisobutyryl fentanyl, para- methoxybutyryl fentanyl, and valeryl fentanyl.

The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Fine Particulate Matter (PM2.5) National Ambient Air Quality Standards (NAAQS) State Implementation Plan (SIP) Requirements Rule (EPA ICR Number 2258.05, OMB Control Number 2060-0611), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed renewal of the existing ICR for the PM2.5 NAAQS State Implementation Plan (SIP) Requirements Rule, which is currently approved through January 31, 2020. Public comments were previously requested via the Federal Register on October 1, 2019, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. 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.

In accordance with the Paperwork Reduction Act of 1995, we, the National Park Service (NPS) are proposing to renew an information collection.

In accordance with the Paperwork Reduction Act of 1995, we, the National Park Service (NPS) are proposing to renew an information collection.

The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the proposed collection of information; Development Disabilities State Plan Information Collection.

The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NSPS for Phosphate Rock Plants (EPA ICR Number 1078.12, OMB Control Number 2060-0111), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through March 31, 2020. Public comments were previously requested via the Federal Register on May 6, 2019 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may neither conduct nor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

In this document, the Federal Communications Commission clarifies its interpretation of the VoIP Symmetry Rule, finding that the 2015 Declaratory Ruling was misguided in its interpretation of the VoIP Symmetry Rule and holding that a LEC providing retail service with a VoIP provider partner provides the functional equivalent of end office switching and thus may assess end office switched access charges only if either the LEC or its VoIP partner provides a physical connection to the last-mile facilities used to serve the end user. By adopting this interpretation of the VOIP Symmetry Rule, the Commission reduces intercarrier disputes and uncertainty and promotes competition.

The Federal Emergency Management Agency, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on a revision of a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning the collection of Public Assistance customer satisfaction survey responses and information for assessment and improvement of the delivery of disaster assistance to States, Local and Tribal governments, and eligible non-profit organizations.

As part of the Administration's commitment to improving customer service delivery, the Department of Agriculture, has under OMB review the following proposed Information Collection Request ``Improving Customer Experience (OMB Circular A-11, Section 280 Implementation)'' for approval under the Paperwork Reduction Act (PRA).