Department of Health and Human Services September 7, 2022 – Federal Register Recent Federal Regulation Documents

OPRE and the Family and Youth Services Bureau (FYSB) request an extension without changes to a currently approved information collection activity as part of the Sexual Risk Avoidance Education Performance Analysis Study (SRAE PAS) (OMB Control No. 0970-0536; expiration date October 31, 2022). The goal of the study is to collect, analyze, and report on performance measures data for the SRAE program.

HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the Advisory Commission on Childhood Vaccines (ACCV). The ACCV advises the Secretary of HHS (Secretary) on issues related to implementation of the National Vaccine Injury Compensation Program (VICP). HRSA is seeking nominations of qualified candidates to fill vacancies on the ACCV.

The Office of Planning, Research and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), proposes survey and focus group data collection activities for the Sexual Risk Avoidance Education National Evaluation (SRAENE) Nationwide Study (NWS) of the National Descriptive Study (NDS).

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 Monitoring and Reporting for the Overdose Data to Action (OD2A) Co-Operative Agreement. Information will be collected to provide data to CDC for program monitoring and budget tracking, to improve timely CDC-recipient communications, and to inform technical assistance and guidance documents produced by CDC to support program implementation among funded jurisdictions.

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 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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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 ZTALMY (ganaxolone), manufactured by Marinus Pharmaceuticals, Inc., meets the criteria for a priority review voucher.