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

In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the final guidance entitled ``Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions.'' This guidance outlines FDA's policies and regulatory review expectations after the COVID-19 public health emergency (PHE) for certain limited modifications affecting the safety and effectiveness of a device required to have an approved PMA or the safety and probable benefit of a device required to have an approved HDE. This guidance has been implemented without prior comment, but it remains subject to comment in accordance with the Agency's good guidance practices.

The Administration for Children and Families' (ACF) Office of Child Support Services (OCSS) is requesting a 3-year extension for the Advance Planning Document (APD) process (OMB #0970-0417). No changes are proposed.

The National Center for Advancing Translational Sciences, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this Notice to Platform Pharmaceuticals, Inc. (``Platform Pharma''), headquartered in New York, NY.

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its prior notice regulations to add a requirement that the prior notice for articles of food arriving by international mail include the name of the mail service and a mail tracking number and add a requirement that prior notice and food facility registration information be submitted within a certain timeframe, after certain notices of refusal or hold have been issued (``post-refusal'' and ``post-hold'' submission). We are also proposing certain technical changes, including those that reflect expanded capabilities of the Automated Broker Interface/Automated Commercial Environment/ International Trade Data System (ABI/ACE/ITDS) and the Prior Notice Systems Interface (PNSI). These amendments, if finalized, will improve program efficiency and better enable FDA to protect the U.S. food supply and public health.

HRSA published a notice in the Federal Register of October 12, 2023, concerning a meeting of the Advisory Committee on Infant and Maternal Mortality. The document contained incorrect location information. The notice originally stated that the meeting would be held in person at HRSA Headquarters (5600 Fishers Lane, Room 5W07, Rockville, Maryland, 20857) and virtually via webinar. The meeting will now be fully virtual via webinar and not held in person. The webinar link and log-in information will be available at the Committee's website before the meeting: https://www.hrsa.gov/advisory-committees/ infant-mortality/.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting a supplement in scope of the original award to the Community-Based, Advocacy-Focused, Data-Driven, Coalition-Building Association (CADCA) recipient funded in FY 2019 under the National Anti-Drug Coalitions Training and Workforce Development Grant Program (Short Title: Coalitions Training Grant), Notice of Funding Opportunity (NOFO) SP-19- 002. The recipient may receive up to $562,500. The supplemental funding will extend the project period by 10-months until September 29, 2024 and will: leverage existing resources and conference support to expand SAMHSA's scope and capacity; and provide training and technical assistance to state and community prevention leaders, including members of anti-drug community coalitions from around the country who are committed to addressing the evolving needs of the behavioral health field. The training and workforce development activities supported through this grant include SAMHSA's Prevention Day and SAMHSA's participation in the annual National Leadership Forum and annual Mid- Year Training Institute of CADCA.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Healthcare Delivery of Clinical Preventive Services for People with Disabilities, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.

The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) granting special termination of the debarment of David Winne with an effective date of August 18, 2024. FDA bases this order on a finding that Mr. Winne provided substantial assistance in the investigations or prosecutions of offenses relating to a matter under FDA's jurisdiction, and that special termination of Mr. Winne's debarment serves the interest of justice and does not threaten the integrity of the drug approval process.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Omegaven and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide an opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) Office of Intramural Training & Education (OITE) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.