Department of Health and Human Services May 19, 2023 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.

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 Administration on Children, Youth and Families, Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is requesting approval for a revision of a currently approved information collection, the Center for States Evaluation Ancillary Data 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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Management Information System for Comprehensive Cancer Control Programs''. The CDC will use annual key informant interviews and biennial NCCCP survey to monitor program outcomes and report progress to CDC yearly.

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 Workplans for Regional Centers to Enhance Public Health Preparedness and Response. This data collection is designed to support regional centers' creation of a five-year workplan which addresses focus areas that would benefit from use of new or enhanced evidence- based strategies (EBSI), existing and needed approaches to meet regional emergency preparedness and EBSI needs, proposed measures to ensure strategies and interventions are effectively implemented, and regional sustainability of evidence-based practice beyond the five-year workplan.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled ``Requirements for Additional Traceability Records for Certain Foods: What You Need to Know About the FDA Regulation: Guidance for Industry Small Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled ``Requirements for Additional Traceability Records for Certain Foods.''