Department of Health and Human Services May 2024 – Federal Register Recent Federal Regulation Documents
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Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Appendix 1; Extension of Comment Period
The Food and Drug Administration (FDA, we, or the Agency) is extending the comment period for a revised draft Introduction, and a revised draft Appendix 1, within a multichapter guidance for industry entitled "Hazard Analysis and Risk-Based Preventive Controls for Human Food" which were announced in the Federal Register of February 2, 2024. We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments before FDA begins work on the final guidance.
Employment and Training Services for Noncustodial Parents in the Child Support Program
In an effort to make the child support program more effective, this Notice of Proposed Rulemaking (NPRM) proposes to allow Federal financial participation (FFP) for certain optional and nonduplicative employment and training services for eligible noncustodial parents in the child support program. The proposed rule will permit states, at their discretion, to use FFP to provide any or all of the following services: job search assistance; job readiness training; job development and job placement services; skills assessments; job retention services; work supports; and occupational training and other skills training directly related to employment.
Meeting of the Advisory Committee on Infant and Maternal Mortality
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Infant and Maternal Mortality (ACIMM or Committee) has scheduled a public meeting. Information about ACIMM and the agenda for this meeting can be found on the ACIMM website at https://www.hrsa.gov/advisory-committees/infant- mortality/.
Advisory Commission on Childhood Vaccines Meeting; Correction
HRSA published a document in the Federal Register on February 26, 2024, setting forth the meeting schedule for the 2024 Advisory Commission on Childhood Vaccines (ACCV). The ACCV held two of its 2024 meetings on March 7, 2024, and March 8, 2024. The remaining two 2024 ACCV meetings originally scheduled for September 5, 2024, and September 6, 2024, are rescheduled for July 11, 2024, 12:30 p.m. ET4:30 p.m. ET, and July 12, 2024, 12:00 p.m. ET4:15 p.m. ET.
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.
Administrative Destruction
The Food and Drug Administration (FDA, Agency, or we) is issuing a regulation to implement our authority to destroy a device valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that has been refused admission into the United States by providing to the owner or consignee notice and an opportunity to appear and introduce testimony prior to the destruction. We are finalizing the change to our internal procedures for administrative destruction of drugs and devices. The notice of proposed rule making (NPRM) published in the Federal Register (October 7, 2022).
Solicitation of Nominations for Appointment to the Advisory Committee to the Director, Centers for Disease Control and Prevention; Notice of Extension
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the Advisory Committee to the Director, Centers for Disease Control and Prevention (ACD, CDC). The ACD, CDC consists of up to 15 experts knowledgeable in areas pertinent to the CDC mission, such as public health, global health, health disparities, biomedical research, and other fields, as applicable.
Proposed Collection; 60-Day Comment Request; Stakeholder Measures and Advocate Forms at the National Cancer Institute (NCI)
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health, National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Supplemental Evidence and Data Request on Peripheral Nerve Blocks for Postoperative Pain Management in Cardiothoracic Surgery
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Peripheral Nerve Blocks for Postoperative Pain Management in Cardiothoracic Surgery, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Submission for Office of Management and Budget Review; Family Violence Prevention and Services Grants to States; Native American Tribes and Alaskan Native Villages; and State Domestic Violence Coalitions (Office of Management and Budget #0970-0280)
The Family Violence Prevention and Services Act (FVPSA) program within the Office of Family Violence Prevention and Services (OFVPS) plans revised program announcements and minor changes to the previously approved Performance Progress Report for States and Tribes (Office of Management and Budget (OMB) #0970-0280; Expiration Date: May 31, 2024). Minor changes are proposed to the existing information collection.
Government-Owned Inventions; Availability for Licensing
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.
Findings of Research Misconduct
Findings of research misconduct have been made against Darrion Nguyen (Respondent), who was formerly a Laboratory Technician, Division of Pediatric Neurology and Developmental Neuroscience, Baylor College of Medicine (BCM). Respondent engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically Office of the Director (OD), National Institutes of Health (NIH), grant DP5 OD026428-01 and National Institute of Neurological Disorders and Stroke (NINDS), NIH, grant K12 NS098482-01. The questioned research was included in a PHS-funded research project progress report (RPPR), specifically DP5 OD026428-04 submitted to OD, NIH. The administrative actions, including supervision for a period of three (3) years, were implemented beginning on May 14, 2024, and are detailed below.
Advisory Committee; Science Advisory Board to the National Center for Toxicological Research; Termination; Removal From List of Standing Committees
The Food and Drug Administration (FDA or Agency) is announcing the termination of the Science Advisory Board to the National Center for Toxicological Research (NCTR). This document announces the reasons for termination and removes the Science Advisory Board to the NCTR from the Agency's list of standing advisory committees.
Tribal Consultation Meetings
Pursuant to the Head Start Act, notice is hereby given of one joint Tribal consultation session to be held between HHS/ACF ECD, OHS, and OCC leadership and the leadership of Tribal governments operating Tribal Maternal, Infant, and Early Childhood Home Visiting; Tribal Child Care and Development Fund; and Head Start and Early Head Start programs. The purpose of this consultation session is to discuss ways to better meet the needs of Tribal children and their families and issues affecting the delivery of early childhood services in their geographic locations. The consultation will also provide an opportunity for discussion on the review and promulgation of Head Start Program Performance Standards, as required under the Head Start Act. To meet this legislative requirement, one Tribal consultation will be held as part of HHS/ACF or ACF Tribal consultation sessions.
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.
Platform Technology Designation Program; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Platform Technology Designation Program for Drug Development." The purpose of this draft guidance is to provide details about the implementation of the Platform Technology Designation Program established by the PREVENT Pandemics Act. This draft guidance outlines eligibility factors for receiving a platform technology designation, potential benefits of receiving a designation, how to leverage data from designated platform technologies, how to discuss the planned designation request as part of a milestone meeting, the recommended content of a designation request submission, and the review timelines for a designation request. This draft guidance, when finalized, will represent the current thinking of FDA.
Maria Anzures-Camarena: Final Debarment Order
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Maria Anzures-Camarena from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ms. Anzures- Camarena was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Ms. Anzures-Camarena was given notice of the proposed debarment and an opportunity to request a hearing to show why she should not be debarred. As of March 6, 2024, (30 days after receipt of the notice), Ms. Anzures-Camarena has not responded. Ms. Anzures-Camarena's failure to respond and request a hearing constitutes a waiver of her right to a hearing concerning this matter.
Notice of Award of a Single Source Cooperative Agreement To Fund Universidad del Valle de Guatemala
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $5,000,000 with an expected total funding of approximately $25,000,000 over a 5-year period, to the Universidad del Valle de Guatemala. This award will build upon previously funded Global Health Security projects, and specifically surveillance activities by CDC to collaboratively work with host countries to create sustainable systems that can inform local public health policy.
Bayer HealthCare Pharmaceuticals, Inc., et al.; Withdrawal of Approval of Three New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of three new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Agency Information Collection Activities; Proposed Collection; Comment Request; De Novo Classification Process (Evaluation of Automatic Class III Designation)
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 the information collection provisions related to the De Novo Classification Process.
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; Material Threat Medical Countermeasure Product; PAXLOVID
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a material threat medical countermeasure (MCM) product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that PAXLOVID (nirmatrelvir co-packaged with ritonavir) tablets, approved on May 25, 2023, manufactured by Pfizer, Inc., meets the criteria for a material threat MCM priority review voucher.
Authorization of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for use during the COVID-19 pandemic. FDA has issued an Authorization for the drug product PEMGARDA (pemivibart) as requested by Invivyd, Inc. (Invivyd). The Authorization contains, among other things, conditions on the emergency use of the authorized product. The Authorization follows the February 4, 2020, determination by the Secretary of Health and Human Services (HHS), as amended on March 15, 2023, that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves a novel (new) coronavirus. The virus, named SARS-CoV-2, causes the illness COVID-19. On the basis of such determination, the Secretary of HHS declared on March 27, 2020, that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to the FD&C Act, subject to the terms of any authorization issued under that section. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.
Color Additive Certification; Increase in Fees for Certification Services; Extension of the Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the reopening notice entitled "Color Additive Certification; Increase in Fees for Certification Services; Reopening of the Comment Period" that appeared in the Federal Register of April 26, 2024. We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
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