Department of Health and Human Services July 17, 2023 – Federal Register Recent Federal Regulation Documents
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Healthcare Infection Control Practices Advisory Committee (HICPAC)
In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Healthcare Infection Control Practices Advisory Committee (HICPAC). This is a virtual meeting. The public is welcomed to listen to the meeting via Zoom; 500 teleconference lines are available. Time will be available for public comment. Registration is required.
Agency Father Generic Information Collection Request: 30-Day Public Comment Request
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.
Agency Father Generic Information Collection Request: 30-Day Public Comment Request
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.
Privacy Act of 1974; Matching Program
In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of the re-establishment of a matching program between CMS and the Social Security Administration (SSA), ``Determining Enrollment or Eligibility for Insurance Affordability Programs Under the Patient Protection and Affordable Care Act.''
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
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) 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 ELEVIDYS (delandistrogene moxeparvovec-rokl), manufactured by Sarepta Therapeutics, Inc., meets the criteria for a priority review voucher.
Submission for Office of Management and Budget Review; Mother and Infant Home Visiting Program Evaluation: Long-Term Follow-Up, Third Grade Data Collection (Office of Management and Budget #0970-0402)
The Administration for Children and Families (ACF), in partnership with the Health Resources and Services Administration, both of the U.S. Department of Health and Human Services (HHS), is proposing to collect data as part of the elementary school phase of the Mother and Infant Home Visiting Program Evaluation (MIHOPE). MIHOPE is a longitudinal study of the effects of Maternal, Infant, and Early Childhood Home Visiting (MIECHV)-funded home visiting on child and family outcomes. The purpose of the MIHOPE Long-Term Follow-Up, Third grade (MIHOPE-3G) data collection, which will focus on children when they are in approximately third grade, is to assess the long-term effects of MIECHV-funded home visiting on families and children when participating children are in elementary school.
Proposed Information Collection Activity; Title V State Sexual Risk Avoidance Education (Office of Management and Budget #0970-0551)
The Family and Youth Services Bureau (FYSB) within the Administration on Children, Youth and Families (ACYF) is accepting mandatory formula grant applications and state plans from states and territories for the development of and implementation for Title V State Sexual Risk Avoidance Education (SRAE) Program. The Title V State SRAE Notice of Funding Opportunity (NOFO) sets forth the application requirements for recipients. This request is to extend Office of Management and Budget (OMB) approval of the request for information. No changes are proposed.
Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications
The Food and Drug Administration (FDA or Agency) 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 reporting requirements contained in existing FDA regulations governing temporary marketing permit applications.
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