Department of Health and Human Services August 2021 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

The National Institutes of Health (NIH) announces the persons who will serve on the National Institutes of Health's Senior Executive Service 2021 Performance Review Board.

The National Heart, Lung, and Blood Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Phyxius Therapeutics, Inc., a start-up company incorporated as a C corporation under the laws of the state of Delaware, to practice the inventions covered by the patent estate listed in the Supplementary Information section of this notice. This is a first notice intended to apprise the public of a change in prospective licensee of the subject intellectual property rights in the stated field of use.

The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval for an extension with no changes to a one-time study to examine familial outcomes 8 years or more after a child's adoption from the child welfare system. The primary objective of this study is to estimate the prevalence of instability events that occur in families who have adopted children who have exited the foster care system. The second objective is to understand risk and protective factors associated with post adoption instability. Office of Management and Budget (OMB) approval expires September 30, 2021, and this request is to extend approval to allow for the completion of data collection.

This proposed rule proposes to rescind the Most Favored Nation Model interim final rule with comment period that appeared in the November 27, 2020, Federal Register.

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.

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.

Notice is hereby given of the meeting on August 30, 2021 of the Substance Abuse and Mental Health Services Administration's (SAMHSA) National Advisory Council (SAMHSA NAC). The meeting is open to the public and can only be accessed virtually. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https://www.samhsa.gov/about-us/advisory-councils/meetings. The meeting will include remarks and discussion with the new Assistant Secretary for Mental Health and Substance Use; updates on SAMHSA priorities; follow up on topics related to the previous SAMHSA NAC meeting; new grant opportunities and initiatives, and a council discussion on clinical trends and emerging national issues with SAMHSA NAC members.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces a new Order under Section 361 of the Public Health Service Act to temporarily halt residential evictions in communities with substantial or high transmission of COVID-19 to prevent the further spread of COVID-19.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

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.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the Understanding important issues in ovarian cancer survivorship (OCS) project. The OCS project aims to better understand the needs of ovarian cancer survivors and how to more effectively develop interventions targeted to this population.

The Centers for Disease Control and Prevention (CDC), a component of the Department of Health and Human Services (HHS), announces an Order to replace and supersede the Order Suspending the Right to Introduce Certain Persons from Countries Where a Quarantinable Communicable Disease Exists, issued on October 13, 2020 (``October Order''). Following an assessment of the current status of the COVID-19 public health emergency and the situation in congregate settings where noncitizens seeking to enter the United States are processed and held, CDC has determined that an Order remains appropriate at this time for all ``covered noncitizens'' as defined in the order. Unaccompanied noncitizen children, already excepted under a July 16, 2021 order, remain excepted from the order's coverage. In addition, CDC is continuing an exception for individuals on a case-by-case basis, based on the totality of the circumstances, and is incorporating an additional exception for programs approved by the U.S. Department of Homeland Security (DHS) that incorporate appropriate COVID-19 mitigation protocols as recommended by CDC.

The Division of the National Toxicology Program (DNTP) announces the availability of the Draft NTP Developmental and Reproductive Toxicity Technical Reports on 2-hydroxy-4- methoxybenzophenone and 2-ethylhexyl p-methoxycinnamate scheduled for peer review. The peer-review meeting will be held remotely and will be available to the public for veiwing. Oral and written comments will be accepted; registration is required to access the webcast and to present oral comments.

The Food and Drug Administration (FDA) is announcing the issuance of two Emergency Use Authorizations (EUAs) (the Authorizations) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for biological products for use during the COVID-19 pandemic. FDA has issued one Authorization for a biological product as requested by GlaxoSmithKline LLC and one Authorization for a biological product as requested by Genentech, Inc. The Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the February 4, 2020, determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves a novel (new) coronavirus. The virus, now named SARS-CoV- 2, causes the illness COVID-19. On the basis of such determination, the Secretary of HHS declared on March 27, 2020, that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to the FD&C Act, subject to the terms of any authorization issued under that section. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.

The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of June 24, 2021. In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled ``Remanufacturing of Medical Devices.'' The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.