Department of Health and Human Services April 5, 2024 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2024-07202
Type: Notice
Date: 2024-04-05
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Notice of Meetings
Document Number: 2024-07295
Type: Notice
Date: 2024-04-05
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group (IRG) Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will be closed to the public.
Submission for Office of Management and Budget Review; Proposed Information Collection Activity; Tribal Early Childhood Facilities Combined Application Guide (New Collection)
Document Number: 2024-07292
Type: Notice
Date: 2024-04-05
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Early Childhood Development (ECD), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting Office of Management and Budget (OMB) approval of the Tribal Early Childhood Facilities Combined Application Guide for joint applications for construction and major renovation projects using both Head Start and Child Care and Development Fund (CCDF) resources.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2024-07289
Type: Notice
Date: 2024-04-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 Assisted Reproductive Technology (ART) Program Reporting System. This study is designed to collect information on ART cycles to publish information on pregnancy success rates as required under Section 2(a) of the Federal Clinic Success Rate and Certification Act (FCSRCA).
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2024-07288
Type: Notice
Date: 2024-04-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 Documenting outcomes associated with Persistent Tic Disorders (including Tourette Syndrome) in Children, Adolescents, and Young Adults through Surveillance. This study will collect data on the public health impact of persistent tic disorders from children and adolescents with tic disorders and their parents, as well as young adults with tic disorders.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2024-07287
Type: Notice
Date: 2024-04-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 DFWED National Hypothesis Generation and Investigation Module. The proposed data collection will define a core set of standardized data elements and forms used for outbreak investigations and surveillance activities for a variety of enteric illnesses.
Request for Nominations on Device Good Manufacturing Practice Advisory Committee
Document Number: 2024-07261
Type: Notice
Date: 2024-04-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is requesting that any industry organization interested in participating in the selection of a nonvoting industry representative to serve on the Device Good Manufacturing Practice Advisory Committee (DGMPAC) in the Center for Devices and Radiological Health notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative to fill an upcoming vacancy on DGMPAC. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for an upcoming vacancy effective with this notice.
Request for Nominations for Voting Members for the Patient Engagement Advisory Committee
Document Number: 2024-07254
Type: Notice
Date: 2024-04-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is requesting nominations for voting members, excluding consumer and industry representatives, to serve on the Patient Engagement Advisory Committee (the Committee) in the Center for Devices and Radiological Health. Nominations will be accepted for upcoming vacancies effective with this notice. FDA seeks to include the views of members of all gender groups, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-General Topic
Document Number: 2024-07273
Type: Notice
Date: 2024-04-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Robert Lance Shuffert: Final Debarment Order
Document Number: 2024-07271
Type: Notice
Date: 2024-04-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Robert Lance Shuffert for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Shuffert was convicted of one felony count under Federal law for, with the intent to defraud and mislead, causing a drug to be misbranded while it was held for sale after shipment in interstate commerce. The factual basis supporting Mr. Shuffert's conviction, as described below, is conduct relating to the importation into the United States of any drug or controlled substance. Mr. Shuffert was given notice of the proposed debarment and an opportunity to request a hearing to show why he should not be debarred. As of March 4, 2024 (30 days after receipt of the notice), Mr. Shuffert had not responded. Mr. Shuffert's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Determination That GLUCOTROL (Glipizide) Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2024-07268
Type: Notice
Date: 2024-04-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that GLUCOTROL (glipizide) tablets, 5 milligrams (mg) and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to these products as long as they meet relevant legal and regulatory requirements.
Advisory Board on Radiation and Worker Health
Document Number: 2024-07301
Type: Notice
Date: 2024-04-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the renewal of the charter of the Advisory Board on Radiation and Worker Health (ABRWH).
Board of Scientific Counselors, National Center for Injury Prevention and Control
Document Number: 2024-07300
Type: Notice
Date: 2024-04-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC). This meeting is closed to the public.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2024-07279
Type: Notice
Date: 2024-04-05
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2024-07278
Type: Notice
Date: 2024-04-05
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. to achieve expeditious commercialization of results of federally-funded research and development.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2024-07277
Type: Notice
Date: 2024-04-05
Agency: Department of Health and Human Services, National Institutes of Health
Final Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)
Document Number: 2024-07082
Type: Notice
Date: 2024-04-05
Agency: Department of Health and Human Services, National Institutes of Health
This notice sets forth final changes to NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) as initially outlined in a Federal Register notice issued on August 10, 2023. Following solicitation of public comments, the NIH is amending the NIH Guidelines to include specific considerations and requirements for conducting research involving gene drive modified organisms (GDMOs) in contained research settings. NIH is updating the NIH Guidelines to clarify minimum containment requirements, provide considerations for performing risk assessments, and define additional institutional responsibilities regarding Institutional Biosafety Committees (IBCs) and Biological Safety Officers (BSOs).
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