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

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that NULIBRY (fosdenopterin), manufactured by Origin Biosciences, Inc., meets the criteria for a priority review voucher.

In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of the re-establishment of a computer matching program between CMS and the Department of Homeland Security (DHS)/United States Citizenship and Immigration Services (USCIS), ``Verification of United States Citizenship and Immigration Status Data for Eligibility Determinations.''

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 a reinstatement of a currently approved data collection titled ``Development of CDC's Let's Stop HIV Together Social Marketing Campaign for Consumers''. The purpose of this data collection is to inform the development of messages, concepts, and materials for CDC's Let's Stop HIV Together social marketing campaign for the general public and subpopulations at increased risk for HIV acquisition or transmission in support of the U.S. Department of Health and Human Services' Ending the HIV Epidemic.

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is withdrawing approval of five abbreviated new drug applications (ANDAs) from multiple holders. Akorn Inc. (Akorn), Mylan ASI LLC (Mylan), Pfizer Inc. (Pfizer), X-GEN Pharmaceuticals, Inc. (X-GEN), and Fresenius Kabi USA, LLC (Fresenius) have requested withdrawal of approval of their respective applications and have waived their opportunity for a hearing.

In accordance with the Presidential directive as expressed in the memorandum of January 20, 2021, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Freeze Pending Review,'' this action proposes, following a 5-day public comment period, to further delay until July 20, 2021, the effective date of the rule entitled ``Implementation of Executive Order on Access to Affordable Life-saving Medications'' published in the Federal Register on December 23, 2020. That final rule is currently scheduled to take effect on March 22, 2021, after an initial delay from its original effective date of January 22, 2021. HHS seeks comments on this proposed delay of the effective date to July 20, 2021, which would allow it additional opportunity for review and consideration of the new rule. HHS will take comments about issues of fact, law, and policy raised by rule into account as the rule is reviewed during the delay period.

This final notice announces our decision to approve the request from Solutions Medical Consulting, LLC d/b/a Serenity Springs Hospital for an exception to the prohibition on expansion of facility capacity.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Department of Health and Human Services (the Department) is extending the comment period for the proposed rule entitled ``Proposed Rulemaking (NPRM) to modify the Standards for the Privacy of Individually Identifiable Health Information (Privacy Rule) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act),'' published in the Federal Register on January 21, 2021. The comment period for the proposed rule, which would end March 22, 2021, is extended to May 6, 2021.

The Administration on Children, Youth and Families, Family and Youth Services Bureau plans to extend data collection for the Family Violence Prevention and Services Program (OMB #0970-0280; Expiration Date: March 31, 2021). No changes are proposed to the existing information collection.

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 a reinstatement of a currently approved data collection titled ``Formative Research to Develop HIV Social Marketing Campaigns for Healthcare Providers.'' The purpose of this data collection is to understand healthcare providers' interpretation and understanding of existing and emergent HIV prevention science; understand how providers use guidance or evidence-based approaches in their practices generally and with populations that have been largely overlooked (e.g., transgender individuals, people who inject drugs (PWID)); and to inform the development and/or revision of messages, concepts and materials for healthcare providers designed to support patient-provider communication about HIV testing, prevention, and care in support of the U.S. Department of Health and Human Services' Ending the HIV Epidemic.