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

In compliance with the Paperwork Reduction Act of 1995, HRSA has 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 have been 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 withdrawing approval of 10 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

The Food and Drug Administration (FDA) is correcting a notice entitled ``Qualification Process for Drug Development Tools; Guidance for Industry; Availability'' that appeared in the Federal Register of November 25, 2020. The document announced the availability of a final guidance for industry and FDA staff that met the 21st Century Cures Act's requirement to issue guidance on this qualification process and elaborated on the new qualification process and transparency requirements and discusses the taxonomy for biomarkers and other drug development tools. The document was published with incorrect information in the Paperwork Reduction Act of 1995 section. This document corrects that error.

The Food and Drug Administration (FDA or Agency) is announcing the availability of three device-specific final guidance documents for the Safety and Performance Based Pathwayspecifically, ``Spinal Plating SystemsPerformance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff,'' ``Orthopedic Non-Spinal Metallic Bone Screws and Washers Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff,'' and ``Magnetic Resonance (MR) Receive-only CoilPerformance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff.'' The device-specific guidances identified in this notice were developed in accordance with the final guidance entitled ``Safety and Performance Based Pathway.''

This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Centers for Disease Control and Prevention (CDC)/Health Resources and Services Administration (HRSA) Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through November 25, 2022.

The Food and Drug Administration (FDA or we) is announcing that a temporary permit has been issued to Bongards Creameries (the applicant) to market test several pasteurized standardized cheeses that deviate from the U.S. standards of identity for cheese products. The temporary permit will allow the applicant to evaluate commercial viability of the products and to collect data on consumer acceptance of the products.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Food and Drug Administration (FDA) is announcing the names of the members who will serve on its fiscal year (FY) 2020 Performance Review Board (PRB). The purpose of the PRB is to provide fair and impartial review of Senior Executive Service (SES), Senior Professional, 21st Century Cures Act, and Title 42(f) (SES Equivalents) performance appraisals, bonus recommendations, and pay adjustments.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate or any other aspect of the ICR.

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection pertaining to Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products.'' FDA is issuing this draft guidance to help sponsors develop human nonprescription drug product proprietary names. This draft guidance describes best practices to help minimize medication errors and otherwise avoid adoption of proprietary names that contribute to violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations. The draft guidance also describes the framework FDA uses in evaluating proposed proprietary names for nonprescription drug products, which is available to sponsors to use before marketing a nonprescription drug product bearing a particular proprietary name. This draft guidance is issued in response to industry stakeholders' requests to specifically address the approaches for naming of human nonprescription drug products.

The Administration for Children and Families (ACF) is requesting a revision to the Social Services Block Grant (SSBG) Post- Expenditure Report, Pre-Expenditure Report, and Intended Use Plan (OMB #0970-0234), previously titled, ``Social Services Block Grant (SSBG) Post-Expenditure Report''). ACF is proposing to expand the information collection to include the collection of states' Intended Use Plans and retitle the information collection to clarify the role of the Pre- Expenditure Report.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces a webinar entitled, ``CDC STI Treatment Guidelines Update''. The purpose of the webinar is for CDC to receive comments from potential users on the proposed updated guidelines. This webinar is an opportunity for all interested parties to ask questions and provide feedback, but is specifically directed toward clinicians, such as medical doctors, nurse practitioners, and physician's assistants. CDC will consider comments made during the webinar prior to finalizing the updated STI Treatment Guidelines for publication.

ACF/OPRE announces the intent to award a grant in the amount of $499,514 to the University of Maryland in College Park, Maryland. The purpose of this award is to develop alternative statistical methods for adjusting Temporary Assistance for Needy Families (TANF) caseload data to account for states' programmatic differences and examine the relative effectiveness of state programs.

HRSA is seeking nominations of qualified candidates to be considered for appointment as members of the National Advisory Council on Migrant Health (NACMH). The NACMH consults with and makes recommendations to the HHS Secretary concerning the organization, operation, selection, and funding of migrant health centers (MHC) and other entities funded under grants and contracts under section 330(g) of the Public Health Service (PHS) Act. HRSA is seeking nominations to fill up to three positions on the NACMH.

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) 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 DANYELZA (naxitamab-gqgk) manufactured by Y-mAbs Therapeutics, Inc., (Cato Research LLC., US Agent) meets the criteria for a priority review voucher.

Statement of Organization, Functions, and Delegations of Authority. The Administration for Children and Families (ACF) has reorganized the Office of Child Support Enforcement. This reorganization realigns the functions of the Office of Child Support Enforcement. It eliminates the Division of Performance and Statistical Analysis and moves the functions to the Division of Federal Systems.

This document corrects technical and typographical errors in the final rule that appeared in the September 18, 2020 issue of the Federal Register titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Final Policy Changes and Fiscal Year 2021 Rates; Quality Reporting and Medicare and Medicaid Promoting Interoperability Programs Requirements for Eligible Hospitals and Critical Access Hospitals''.

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.