Department of Health and Human Services February 16, 2024 – 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.

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 (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 Administration for Children and Families (ACF), Office of Family Assistance (OFA), is requesting an extension with changes to its approved collection and reporting of performance measures about program operations, services, and clients served through the Healthy Marriage (HM) and Responsible Fatherhood (RF) grant programs. In an effort to gain a great understanding of how HMRF programs influence program participants and staff at an individual level, ACF proposes to add one open field to the quarterly narrative reports to capture information about the experiences of HMRF participants and/or staff. ACF is requesting to extend approval, with the implementation of this change, for 3 years.

The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) intends to request approval from the Office of Management and Budget (OMB) to establish a new umbrella generic clearance to request information while engaging individuals and groups who could provide valuable information to inform ACF programs and work, including but not limited to those who are served or have been served by ACF, those with expertise in ACF program areas, and individuals invested in the outcomes of ACF research and evaluation. These engagement activities often need to be conducted quickly, to allow for sufficient time to inform project direction and decision-making. Additionally, planning for engagement activities is most often on a quick timeline and the standard timeline to comply with a full request under the Paperwork Reduction Act (PRA) often inhibits the ability to collect information to inform these activities. Therefore, an umbrella generic is necessary to allow for quick turnaround requests for similar information collections related to these activities.