Department of Health and Human Services – Federal Register Recent Federal Regulation Documents
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Notice of Supplemental Funding; Rural Health and Economic Development Analysis Program
HRSA provided supplemental funds to the sole award recipient of the Rural Health and Economic Development Analysis Program to support a research project that quantifies the relationships between health care and economic factors in rural communities.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project (new): "The AHRQ Safety Program for Healthcare Associated Infection Prevention."
Determination That FORTESTA (Testosterone) Gel, 10 Milligrams/0.5 Gram Actuation, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that FORTESTA (testosterone) gel, 10 milligrams (mg)/0.5 gram (gm) actuation, was not withdrawn from sale for reasons of safety or effectiveness.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 this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Notice of Supplemental Funding; National Rural Health Information Clearinghouse Program
HRSA provided supplemental funds to the National Rural Health Information Clearinghouse Program recipient, University of North Dakota, to develop toolkits and other resources that address strategies to promote rural community health and support the improvement of health care in rural areas.
Prospective Grant of Exclusive License, Inter-Institutional Agreement-Institution Lead: Peptides and Peptide Microarrays for Detection and Differentiation of Antibody Responses to Ebola Virus and Other Pathogens.
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive, sublicensable patent license to The Trustees of Columbia University in the City of New York, Columbia Technology Ventures, located in New York, New York to practice the inventions embodied in the patent applications listed in the SUPPLEMENTARY INFORMATION section of this notice.
Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Cue Health, Inc., for the Cue COVID-19 Test, and Cue COVID-19 Test for Home and Over The Counter (OTC) Use. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document.
Miguel Angel Montalvo Villa: Final Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Miguel Angel Montalvo Villa 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 Mr. Montalvo Villa was convicted of multiple felonies under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product. Mr. Montalvo Villa was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of September 19, 2024 (30 days after receipt of the notice), Mr. Montalvo Villa has not responded. Mr. Montalvo Villa's failure to respond and request a hearing constitutes a waiver of Mr. Montalvo Villa's right to a hearing concerning this matter.
Per- and Polyfluoroalkyl Substances in Seafood; Request for Information
The Food and Drug Administration (FDA or we) is requesting information to help fill data gaps that remain regarding per- and polyfluoroalkyl substances (PFAS) in seafood. The purpose of this request is to help increase our understanding of the potential for PFAS exposure from seafood. We intend to use the information submitted in response to this request to help inform future activities to reduce dietary exposure to PFAS that may pose a health concern.
Submission for Office of Management and Budget (OMB) Review; Sexual Risk Avoidance Education Program Performance Analysis Study-Extension (OMB #0970-0536).
The Office of Planning, Research, and Evaluation (OPRE) and the Family and Youth Services Bureau in the Administration for Children and Families (ACF) request an extension without changes of a currently approved information collection activity as part of the Sexual Risk Avoidance Education (SRAE) Program Performance Analysis Study (PAS). The goal of the study is to collect, analyze, and report on performance measures data for the SRAE program (OMB Control No. 0970-0536; expiration date January 31, 2025). The purpose of the requested extension is to continue the ongoing data collection and submission of the performance measures by SRAE grant recipients. Minor updates were identified to incorporate into the OMB-approved versions of instruments.
Agency Information Collection Activities: Proposed Collection; 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 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.
National Committee on Vital and Health Statistics
Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee meeting. This meeting is open to the public. Name: National Committee on Vital and Health Statistics (NCVHS) Meeting.
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled "Bioequivalence Recommendations for Specific Products" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.
Determination That IC-GREEN (Indocyanine Green), 25 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that IC-GREEN (indocyanine green), 25 milligrams (mg)/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for IC-GREEN (indocyanine green), 25 mg/vial, if all other legal and regulatory requirements are met.
Notice of Supplemental Funding; National Rural Health Policy, Community, and Collaboration Program
HRSA provided supplemental funds to the sole award recipient of the National Rural Health Policy, Community, and Collaboration Program to enhance rural health state partnerships, support ongoing work with technical assistance recipients, and work to support a toolkit designed to assist rural health networks.
Determination That NOXAFIL (Posaconazole) Delayed-Release Tablets, 100 Grams Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on October 16, 2024. The document announced that NOXAFIL (posaconazole) delayed-release tablets, 100 grams (g), was not withdrawn from sale for reasons of safety or effectiveness. The document incorrectly listed the dosage strength as 100 g. The correct strength is 100 milligrams (mg). This notice corrects that error.
Statement of Organization, Functions, and Delegations of Authority
The Food and Drug Administration's (FDA), Office of the Commissioner (OC), Office of Digital Transformation (ODT) has modified their organizational structure. The new organizational structure was approved by the Secretary of Health and Human Services on September 20, 2024.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Rural Health Care Services Outreach Program Measures
In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Frequently Asked Questions-Developing Potential Cellular and Gene Therapy Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled "Frequently asked QuestionsDeveloping Potential Cellular and Gene Therapy Products." The draft guidance document provides industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy (CGT) products. The FAQs represent common questions directed to the Agency and span multiple disciplines, including regulatory review; chemistry, manufacturing, and controls (CMC); pharmacology/toxicology; clinical; and clinical pharmacology.
Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications
The Drug Enforcement Administration (DEA) in concert with the Department of Health and Human Services (HHS) is issuing a third extension of telemedicine flexibilities for the prescribing of controlled medications, through December 31, 2025.
Kevin Sheng Hsiang Fang: Final Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Kevin Sheng Hsiang Fang for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Fang was convicted of a felony count under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Fang was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of July 1, 2024 (30 days after receipt of the notice), Mr. Fang has not responded. Mr. Fang's failure to respond and request a hearing constitutes a waiver of Mr. Fang's right to a hearing concerning this matter.
Determination That HYDROCORTONE (Hydrocortisone Sodium Phosphate) Injection, Equivalent to 50 Milligrams Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that HYDROCORTONE (hydrocortisone sodium phosphate) injection, equivalent to (EQ) 50 milligrams (mg) base/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for HYDROCORTONE (hydrocortisone sodium phosphate) injection, EQ 50 mg base/mL, if all other legal and regulatory requirements are met.
Determination That JESDUVROQ (daprodustat) Tablets, 1 Milligram, 2 Milligrams, 4 Milligrams, 6 Milligrams, and 8 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that JESDUVROQ (daprodustat) tablets, 1 milligram (mg), 2 mg, 4 mg, 6 mg, and 8 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for JESDUVROQ (daprodustat) tablets, 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg, if all other legal and regulatory requirements are met.
Pfizer, Inc., et al.; Withdrawal of Approval of 26 New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 26 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.
Ivette Maria Portela Martinez: Final Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Ivette Maria Portela Martinez 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. Portela Martinez was convicted of two felonies under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product. Ms. Portela Martinez was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of September 14, 2024 (30 days after receipt of the notice), Ms. Portela Martinez has not responded. Ms. Portela Martinez's failure to respond and request a hearing constitutes a waiver of Ms. Portela Martinez's right to a hearing concerning this matter.
Submission for Office of Management and Budget Review; Child Care and Development Fund Plan for Tribes for Fiscal Year 2026-2028 (ACF-118A) (Office of Management and Budget #0970-0198)
The Administration for Children and Families (ACF) Office of Child Care (OCC) is requesting a 3-year extension of the form ACF-118A: Child Care and Development Fund for Tribes (Office of Management and Budget (OMB) #0970-0198, expiration April 30,2025) for Federal Fiscal Year (FFY) 2026-2028. There are changes proposed to the form to improve formatting, streamline questions, and reduce burden.
Determination of Regulatory Review Period for Purposes of Patent Extension; AGILI-C
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AGILI-C and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Establishment of the National Advisory Committee on the Trafficking of Children and Youth in the United States
The National Advisory Committee on the Trafficking of Children and Youth in the United States (Committee) was established on November 7, 2024, to build on the work of the previous National Advisory Committee on the Sex Trafficking of Children and Youth in the United States, authorized pursuant to section 121 of the Preventing Sex Trafficking and Strengthening Families Act. The Committee advises on practical and general policies concerning improvements in the Nation's response to the human trafficking of children and youth in the United States, including the cooperation of Federal, State, local, and Tribal governments; child welfare agencies; social service providers; physical health and mental health providers; victim service providers; Federal, State, and local police; juvenile detention centers; State or local courts with responsibility for conducting or supervising proceedings related to child welfare or social services for children and their families; runaway and homeless youth programs; schools; technology, gaming and entertainment industry; and businesses and organizations that provide services to youth. While addressing the response to the trafficking of children and youth, the Committee shall consider recommendations related to the intersection of sex trafficking and labor trafficking among children and youth in the United States. Note that this Federal Register Notice of the Charter filing should have been published 15 days in advance.
Agency Information Collection Request; 60-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.
Submission for Office of Management and Budget Review; Fiscal Responsibility Act-Temporary Assistance for Needy Families Work Outcomes Measures (New Collection)
The Administration for Children and Families (ACF) is proposing to collect data for new Temporary Assistance for Needy Families (TANF) work outcomes measures required by the Fiscal Responsibility Act (FRA) of 2023. Information collections include the Work Outcomes of TANF Exiters Report, Secondary School Diploma or its Recognized Equivalent Rate, and the Supplemental Work Outcomes Report.
Medicaid and Children's Health Insurance Program (CHIP) Generic Information Collection Activities: Proposed Collection; Comment Request
On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the "generic" clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are "usually voluntary, low-burden, and uncontroversial collections," do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit 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.
Solicitation of Nominations for Appointment to the Advisory Committee on Breast Cancer in Young Women
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 on Breast Cancer in Young Women (ACBCYW). The ACBCYW consists of up to 15 experts in fields associated with breast cancer, disease prevention, early detection, diagnosis, public health, social marketing, genetic screening and counseling, treatment, rehabilitation, palliative care, and survivorship in young women, or in related disciplines with a specific focus on young women.
Supplemental Evidence and Data Request on Dietary Total Fat Intake and Dietary Polyunsaturated Fatty Acid Intake and Child Growth and Development Outcomes: A Systematic Review
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 Dietary Total Fat Intake and Dietary Polyunsaturated Fatty Acid Intake and Child Growth and Development Outcomes: A Systematic Review, 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.
Increase Flexibility for Tribes in Child Care and Development Fund (CCDF) Eligibility
This final rule amends the Child Care and Development Fund (CCDF) regulations to provide all Indian Tribes and Tribal Organizations operating CCDF programs the flexibility, at their discretion, to establish and use eligibility criteria regardless of family income or assets.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 National Notifiable Diseases Surveillance System. This data collection provides the official source of statistics in the United States for nationally notifiable conditions.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 National Concussion Surveillance System. This data collection is designed to allow CDC to calculate the prevalence and incidence of traumatic brain injuries (TBI) for both adults and children, and the circumstances related to TBIs occurring in the preceding year.
Notice of Meeting for the Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC)
The Secretary of Health and Human Services (Secretary) announces a meeting of the Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC). The ISUDCC is open to the public and members of the public can attend the meeting via telephone or webcast only, and not in person. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https://www.samhsa.gov/ about-us/advisory-councils/meetings.
Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug User Fee Program
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 information collection associated with FDA's Prescription Drug User Fee program.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Generic Information Collection Request for Health Resources and Services Administration Hotlines, Chatlines, and Online Portals
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Submission for Office of Management and Budget Review; Administration of Psychotropic Medication to Unaccompanied Children (New Collection)
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services is inviting public comment on the proposed collection. The request consists of two forms that will allow the Unaccompanied Children (UC) Bureau to obtain informed consent from authorized consenters and informed assent or agreement from unaccompanied children for the administration of psychotropic medication.
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