Department of Health and Human Services May 2023 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of the final decision withdrawing approval of MAKENA (hydroxyprogesterone caproate injection, 250 milligrams (mg) per milliliter (mL), once weekly), under the new drug application (NDA) 021945, held by Covis Pharma Group/Covis Pharma GmbH (Covis), and the eight abbreviated new drug applications (ANDAs) from multiple ANDA holders that reference NDA 021945. The Commissioner of Food and Drugs (the Commissioner) and the Chief Scientist jointly issued the decision following an October 2022 public hearing.

HRSA will provide supplemental funding to UMass, a current Regional AETC Program award recipient, for a 1-year period of performance and 1-year budget period to support a program designed to train internal and family medicine residents to specialize in HIV treatment and care management. This training program is critically needed, as it will help increase the number of primary HIV care providers available to diagnose, treat, and medically manage people with HIV and address urgent needs stemming from the HIV care workforce shortage.

This notice announces continuation of the May 4, 2023, meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC) on May 16, 2023. The BSC is a federally chartered, external advisory group composed of scientists from the public and private sectors. During a public meeting on May 4, the BSC considered a report from its Working Group containing proposed recommendations on whether NTP authors sufficiently addressed internal and external scientific comments on NTP's systematic review to evaluate the neurobehavioral health effects from exposure to fluoride during development, as set forth in NTP's Draft State of the Science Monograph and Draft Meta- Analysis Manuscript. After deliberation and discussion, the BSC voted to accept the Working Group's report in full, with the exception of one paragraph on page 323 related to an IQ statistic that the BSC asked the Working Group to verify or correct. The Working Group has reexamined the text, and the BSC will discuss and deliberate the Working Group's updated input at the meeting on May 16. This is a virtual meeting and open to the public. This notice is being published less than 15 days prior to the meeting due to scheduling difficulties.

The Administration for Children and Families' (ACF) Office of Planning, Research, and Evaluation (OPRE) requests Office of Management and Budget (OMB) approval for an overarching generic clearance to collect data on programs serving youth transitioning out of foster care as part of the Chafee Strengthening Outcomes for Transition to Adulthood (Chafee SOTA) Project. The generic mechanism will allow ACF to conduct rapid-cycle evaluations that would not otherwise be feasible under the timelines associated with the Paperwork Reduction Act of 1995. The purpose of the data collections submitted under the generic will be to inform ACF programming by building the evidence about what works to improve outcomes for the target population and to identify innovative learning methods that address common evaluation challenges.

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a 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 IC Extension solicits comments on the information collection requirements relating to the Annual SMP/SHIP/MIPPA National Training Conference Survey.

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published in the 3-month period, relating to the Medicare and Medicaid programs and other programs administered by CMS.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry.'' The guidance document provides blood establishments that collect blood or blood components, including Source Plasma, with FDA's revised donor deferral recommendations for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection. FDA is also recommending that these blood establishments make corresponding revisions to donor educational materials, donor history questionnaires and accompanying materials, along with revisions to donor requalification and product management procedures. The guidance announced in this notice finalizes the draft guidance of the same title issued January 2023. This guidance also supersedes the guidance entitled ``Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry'' dated April 2020 and updated August 2020.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institute of General Medical Sciences (NIGMS) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

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 information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Noise Exposures and Hearing Loss in the Oil and Gas Extraction Industry. This information collection is designed to evaluate oil and gas extraction workers' noise and chemical exposures and hearing.

In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to comment on the information collection titled, ``Indian Health Service Medical Staff Credentials Application,'' OMB Control Number 0917-0009, which expires August 31, 2023.