Department of Health and Human Services November 19, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
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.
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.
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