August 9, 2021 – Federal Register Recent Federal Regulation Documents

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

On May 28, 2021, the Postal Service (USPS[supreg]) filed a notice of mailing services price adjustments with the Postal Regulatory Commission (PRC), effective August 29, 2021. On June 23, 2021 USPS further filed a notice to change the maximum size limitation for presorted First-Class Mail postcards. This final rule contains the revisions to Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM[supreg]) to implement the changes coincident with the price adjustments and postcard size limitation changes.

The FAA is adopting a new airworthiness directive (AD) for all The Boeing Company Model 737-8, 737-9, and 737-8200 (737 MAX) airplanes; and certain Model 737-800 and 737-900ER series airplanes. This AD was prompted by the determination that the aft cargo compartment fire suppression capability is reduced if the airplane is dispatched or released with failed electronic flow control of air conditioning packs, as is currently allowed by these airplane models' master minimum equipment lists (MMELs). This AD prohibits the carriage of cargo in the aft cargo compartment when the airplane is dispatched or released with failed electronic flow control of air conditioning packs. The FAA is issuing this AD to address the unsafe condition on these products.

FMCSA requests that medical examiners (MEs), by September 30, 2021, submit results of physical qualification examinations conducted during the National Registry of Certified Medical Examiners (National Registry) outage from December 1, 2017, through August 13, 2018. During the outage, FMCSA encouraged MEs to continue conducting physical qualification examinations and instructed MEs to submit examination results to the National Registry when upload functionality was restored. The upload functionality was fully restored on August 13, 2018, but a significant number of healthcare professionals have not uploaded the results from examinations conducted during the National Registry outage. FMCSA requests that the examiners in question upload the information.

In compliance with the Paperwork Reduction Act of 1995, this notice announces that the Information Collection Request (ICR) abstracted below is being forwarded to the Office of Management and Budget (OMB) for review and comments. Comments are invited on whether the proposed collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; the accuracy of the Department's estimate of the burden of the proposed information collection; ways to enhance the quality, utility and clarity of the information to be collected; and ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology. A Federal Register Notice with a 60-day comment period soliciting comments on the following information collection was published on April 7, 2021.

In this candidate notice of review (CNOR), we, the U.S. Fish and Wildlife Service (Service), present an updated list of foreign plant and animal species that we regard as candidates for or have proposed for addition to the Lists of Endangered and Threatened Wildlife and Plants (Lists) under the Endangered Species Act of 1973, as amended. This document also includes our findings on resubmitted petitions and describes our progress in revising the Lists during the period October 1, 2018, through September 30, 2020. Combined with other decisions for individual species that were published separately from this CNOR in the past 2 years, the current number of foreign species that are candidates for listing is 19. Identification of candidate species can assist environmental planning efforts by providing advance notice of potential listings, and by allowing landowners, resource managers, range countries, and other stakeholders to take actions to alleviate threats and thereby possibly remove the need to list species as endangered or threatened. Even if we subsequently list a candidate species, the early notification provided here could result in more options for species management and recovery by prompting earlier candidate conservation measures to alleviate threats to the species.

We are advising the public that we added the Republic of Croatia, the Republic of Senegal, and the People's Democratic Republic of Algeria to the list of regions that the Animal and Plant Health Inspection Service considers to be affected by highly pathogenic avian influenza (HPAI). These actions follow our imposition of HPAI-related restrictions on avian commodities originating from or transiting the Republic of Croatia, the Republic of Senegal, and the People's Democratic Republic of Algeria, as a result of the confirmation of HPAI in the Republic of Croatia, the Republic of Senegal, and the People's Democratic Republic of Algeria.

The Food and Drug Administration (FDA or the Agency) is extending the period for States to decide whether to sign the final standard memorandum of understanding (MOU) entitled ``Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the [insert State Board of Pharmacy or Other Appropriate State Agency] and the U.S. Food and Drug Administration'' (final standard MOU) before FDA intends to begin enforcing the statutory 5 percent limit on distribution of compounded human drug products out of the State in which they are compounded in States that do not sign the final standard MOU. FDA is extending the period, which was scheduled to end on October 27, 2021, to October 27, 2022. States may sign the final standard MOU at any time, including after the period is scheduled to end on October 27, 2022.

This notice announces a meeting of the Fusion Energy Sciences Advisory Committee (FESAC). The Federal Advisory Committee Act requires that public notice of these meetings be announced in the Federal Register.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Development and Submission of Near Infrared Analytical Procedures.'' This guidance provides recommendations to applicants to aid the development, validation, and use of near infrared (NIR)-based analytical procedures in evaluating the identity, strength, quality, purity, and potency of drug substances and drug products. The recommendations apply to new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplemental NDAs and ANDAs for small molecule drugs. The principles in this guidance also apply to drug substances and drug products covered in Type II drug master files. This guidance finalizes the draft guidance of the same title issued on March 31, 2015.

Pursuant to Department regulations, the renewal of a U.S. passport must meet certain requirements to qualify for submission of an application by mail. The Department proposes to amend this rule by allowing qualified applicants the option of submitting renewal applications by mail or online via the Department's official website. This amendment will provide more flexibility for the renewal applicant, improve the customer experience, and eliminate the added burden, time, and cost to the customer by providing the on-line option as an alternative to the mail in process.

This notice sets forth the reasons for the denial of a petition, DP21-001, submitted by Mr. Derek Colvin to NHTSA (the ``agency'') by a letter dated November 20, 2020. The petition requests that the agency initiate a safety defect investigation into an alleged defect in the reversing light system experienced in certain Model Year (MY) 2013 Porsche 911 Carrera manual transmission vehicles (the ``subject vehicles''). As the driver shifts the gear into reverse, the reversing light fails to illuminate. After conducting a technical review of: (1) The consumer complaint submitted by the petitioner; (2) consumer complaint information in NHTSA's database; and (3) information provided by Porsche in response to our Information Request letter regarding reversing light failure to illuminate and complaints received by Porsche, NHTSA's Office of Defect Investigations (ODI) has concluded that no further investigation of the issue raised by the petition is warranted and the agency, accordingly, has denied the petition.

The Department of Commerce (Commerce) preliminarily determines that cast iron soil pipe (soil pipe) from the People's Republic of China (China) was sold in the United States at less than normal value (NV) during the period of review (POR) August 31, 2018, through April 30, 2020. We invite interested parties to comment on these preliminary results.

The Department of Commerce (Commerce) finds that all companies subject to this administrative review are part of the China-wide entity because they did not file a separate rate application (SRA) or a separate rate certification (SRC). The period of review is November 20, 2018, through June 30, 2020.

We, the U.S. Fish and Wildlife Service, announce the availability of the draft recovery plan for the Poweshiek skipperling, a butterfly species. We request review and comment on this draft recovery plan from local, State, and Federal agencies, and the public.