Department of Health and Human Services July 25, 2023 – Federal Register Recent Federal Regulation Documents

ACF, ORR, Division of Refugee Health (DRH) announces the intent to award supplements in the aggregate amount of up to $466,563 to nine grant recipients under Notice of Funding Opportunity: Direct Services for Survivors of Torture, HHS-2022-ACF-ORR-ZT-0051. The purpose of the awards is to ensure that the 222 Nicaraguan Humanitarian Parolees (NHP) who were brought to the United States will have access to holistic care and services. This supplement will enable the identified grant recipients in California, Florida, Georgia, Maryland, Minnesota, Texas, and Virginia to provide access to medical, mental health, social, and legal services to NHP within their geographic service areas, and coordinate with The Center for Victims of Torture in Minnesota and other providers to serve NHP outside their service areas. The goal of these services is to help the NHP improve their health, find employment and stable housing, and regularize their immigration status.

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 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 these 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 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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk'' (M7(R2) Guidance) and two supplemental documents entitled ``M7(R2) Addendum: Application of the Principles of the ICH M7 Guidance to Calculation of Compound-Specific Acceptable Intakes'' (M7(R2) Addendum) and ``M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk Questions and Answers'' (M7(R2) Questions and Answers). The M7(R2) Guidance, M7(R2) Addendum, and M7(R2) Questions and Answers were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance and supplemental documents are intended to harmonize the considerations for assessment and control of DNA reactive (mutagenic) impurities. The M7(R2) Guidance and M7(R2) Addendum replace the guidance for industry entitled ``M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk,'' issued on March 14, 2018. The M7(R2) Guidance, M7(R2) Addendum, and M7(R2) Questions and Answers, also finalize the draft guidances for industry entitled ``M7(R2) Addendum: Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes'' and ``M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk Questions and Answers'' issued on April 7, 2022, and September 29, 2020, respectively.

The Food and Drug Administration (FDA or we) is reopening the comment period for the notice entitled ``Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Quantitative Research on Front of Package Labeling on Packaged Foods,'' published in the Federal Register of June 15, 2023, to allow interested parties additional time to submit comments. We are taking this action due to technical difficulties experienced on the final two days of the comment period that may have prevented some interested parties from submitting comments.