Department of Health and Human Services April 2023 – Federal Register Recent Federal Regulation Documents

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 purpose of this Request for Information (RFI) is to solicit public input on proposed changes to the peer review of Ruth L. Kirschstein National Research Service Award (NRSA) fellowship applications that would restructure the review criteria and modify some sections of the Public Health Service (PHS) Fellowship Supplemental Form within the application. The goal of this effort is to facilitate the mission of NRSA fellowship peer review: to identify the most promising trainees and the excellent, individualized training programs that will help them become the outstanding scientists of the next generation. The proposed changes will allow peer reviewers to better evaluate the applicant's potential and the quality of the scientific training plan without undue influence of the sponsor's or institution's reputation; and ensure that the information provided in the application is aligned with the restructured criteria and targeted to the fellowship candidate's specific training needs.

The Food and Drug Administration (FDA, the Agency, or we), in cosponsorship with the Duke-Margolis Center for Health Policy, is announcing a public workshop entitled ``Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches.'' This workshop will address innovative manufacturing technologies for drug and biological products and will include a discussion of potential best practices, case studies from previous submissions, potential barriers to adoption, corresponding regulatory strategies, and the Advanced Manufacturing Technologies Designation Program.

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.

OCSE proposes to eliminate the non-Federal share of program expenditures requirement for Tribal child support enforcement programs including the 90/10 and 80/20 cost sharing rates. Based upon the experiences of and consultations with Tribes and Tribal organizations, we have determined that the non-Federal share requirement limits growth, causes disruptions, and creates instability.

The Substance Abuse and Mental Health Services Administration (SAMHSA) within the Department of Health and Human Services (HHS), is soliciting nominations from qualified organizations to be considered for non-voting liaison representative positions on a subcommittee of the Advisory Committee for Women's Services (ACWS) focused on maternal mental health.

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 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 use of rapid response surveys to obtain data on safety information that supports quick turnaround decision making about potential safety problems or risk management solutions.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment.'' The purpose of this draft guidance is to provide information and recommendations to assist sponsors and other interested parties in the development of drugs to prevent or treat acute radiation syndrome (ARS) caused by exposure to ionizing radiation from accidental or deliberate events. Generally, drugs developed for such indications will require approval under the regulations commonly referred to as the Animal Rule.

The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ accepted a notification of proposed voluntary relinquishment from the Emergency Medical Error Reduction Group PSO, PSO number P0235, of its status as a PSO, and has delisted the PSO accordingly.