Department of Health and Human Services – Federal Register Recent Federal Regulation Documents
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Willis Reed: 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 Willis Reed 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. Reed was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Reed was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of February 10, 2024 (30 days after receipt of the notice), Mr. Reed has not responded. Mr. Reed's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Revocation of Six Authorizations of Emergency Use of In Vitro Diagnostic Device 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 Life Technologies Corp. (a legal entity of Thermo Fisher Scientific, Inc.), for the TaqPath COVID-19 Pooling Kit; Bio-Rad Laboratories, Inc., for the Reliance SARS-CoV-2 RT-PCR Assay Kit; Revvity, Inc., (on behalf of Revvity Omics (a Revvity, Inc. company that was a rebranding of PerkinElmer Genomics)), for the PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit; bioM[eacute]rieux SA for the VIDAS SARS-CoV-2 IgM kit; bioM[eacute]rieux SA for the VIDAS SARS- CoV-2 IgG kit; and Luminex Corp. for the xMAP SARS-CoV-2 Multi-Antigen IgG Assay. 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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Total Product Life Cycle Advisory Program Pilot
The Food and Drug Administration (FDA, the Agency, or we) 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collections associated with Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot.
Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products.'' FDA is issuing this draft guidance as part of a series of guidance documents under its Real-World Evidence (RWE) Program and to satisfy, in part, a mandate under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to issue guidance about the use of RWE in regulatory decision-making. The draft guidance provides recommendations to sponsors who are considering submitting a non- interventional study, also referred to as an observational study, to FDA to contribute to a demonstration of substantial evidence of effectiveness and/or evidence of safety of a drug. This draft guidance was developed in response to stakeholders' growing interest in the potential use of non-interventional studies to contribute to a demonstration of the effectiveness or safety of a drug.
Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed Directive
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 reporting, recordkeeping, and third-party disclosure burden associated with the veterinary feed directive regulations.
Eli Lilly and Company; Withdrawal of Approval of SARAFEM (Fluoxetine Hydrochloride) Capsules, Equivalent to 10 Milligrams Base and Equivalent to 20 Milligrams Base, Including the Premenstrual Dysphoric Disorder Indication Approved Under New Drug Application 018936
The Food and Drug Administration (FDA or Agency) is withdrawing approval of SARAFEM (fluoxetine hydrochloride (HCl)) capsules, equivalent to (EQ) 10 milligrams (mg) base and EQ 20 mg base, including the premenstrual dysphoric disorder (PMDD) indication, approved under new drug application (NDA) 018936. This NDA is held by Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285 (Lilly). Lilly notified the Agency in writing that SARAFEM (fluoxetine HCl) capsules, EQ 10 mg base and EQ 20 mg base, indicated for the treatment of PMDD, was no longer marketed and requested that the approval of SARAFEM (fluoxetine HCl) capsules, including the PMDD indication, be withdrawn.
Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations Under the Federal Import Milk Act
The Food and Drug Administration (FDA, Agency, or we) 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 reporting and recordkeeping requirements of our regulations implementing the Federal Import Milk Act (FIMA).
Reorganization of the Office of Safety, Security and Asset Management
CDC has modified its structure. This notice announces the reorganization of the Office of Safety, Security and Asset Management (OSSAM). OSSAM retitled a component.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Prospective Grant of an Exclusive Patent License: Manufacturing of Anti-Malaria Monoclonal Antibody L9LS in Transgenic Cows and Sheep
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 Patent License to practice inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Taurgen Malaria, Inc. (``Taurgen''), headquartered in Logan, UT. Taurgen Malaria, Inc. is a wholly-owned subsidiary of Taurgen Therapeutics, LLC, which is also headquartered in Logan, UT.
Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration is proposing to establish criteria for the lists of drug products or categories of drug products that present demonstrable difficulties for compounding (Demonstrable Difficulties for Compounding Lists or DDC Lists) under certain sections of the Federal Food, Drug, and Cosmetic Act. Additionally, the Agency is proposing to identify the first three categories of drug products on both DDC Lists. Drug products or categories of drug products that appear on the DDC Lists cannot qualify for certain statutory exemptions, and therefore may not be compounded under, either section 503A or section 503B, respectively.
Air Products and Chemicals, Inc.; Withdrawal of Approval of a New Drug Application and New Animal Drug Application for Helium, USP
The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) 205864 and the new animal drug application (NADA) 141-395 for the designated medical gas Helium, USP held by Air Products and Chemicals, Inc., 1940 Air Products Blvd., Allentown, PA 18106-5500 (Air Products). Air Products notified the Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.
Notice of Award of a Sole Source Cooperative Agreement To Fund International Union Against Tuberculosis and Lung Disease (The Union)
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $500,000, for Year 1 funding to The Union. The award will continue developing and updating Tuberculosis (TB) scientific and programmatic resources, disseminating TB best practices, and building TB capacity. Funding amounts for years 2-5 will be set at continuation.
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. The public is welcome to attend in person or to obtain the link to attend this meeting by following the instructions posted on the Committee website: https://ncvhs.hhs.gov/meetings/full-committee-meeting-16/. Name: National Committee on Vital and Health Statistics (NCVHS) Meeting.
Notice of Award of a Sole Source Cooperative Agreement To Fund Ministry of Health of Mozambique (MISAU)
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award(s) of approximately $10,000,000, for Year 1 funding to MISAU. The(se) award(s) will support the GRM through MISAU to continue to address Tuberculosis (TB) and human immunodeficiency virus (HIV) as a public health problem through the expansion of access to quality HIV prevention, care, and treatment services to reduce remaining gaps among children, adolescents, key populations (KP) and men. Funding amounts for years 2-5 will be set at continuation.
Notice of Award of a Sole Source Cooperative Agreement To Fund National Health Laboratory Service (NHLS)
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award(s) of approximately $5,000,000, for Year 1 funding to NHLS. The(se) award(s) will strengthen laboratory systems for improved access to sustainable delivery of quality laboratory services and promote rational use of diagnostic services in South Africa through above site interventions. Funding amounts for years 2-5 will be set at continuation.
Notice of Award of a Sole Source Cooperative Agreement To Fund Rwanda Biomedical Center (RBC)
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $17,500,000, for Year 1 funding to RBC. The award will support a sustainable, affordable, integrated, and country- led HIV/AIDS clinical and public health program in Rwanda. Funding amounts for years 2-5 will be set at continuation.
Notice of Award of a Sole Source Cooperative Agreement To Fund World Health Organization (WHO)
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $20,000,000, for Year 1 funding to WHO. This award will support the development of global guidelines and provide technical assistance through WHO to aid PEPFAR-supported countries to meet the 95-95-95 targets and achieve program sustainability by 2030. Funding amounts for years 2-5 will be set at continuation.
Notice of Award of a Sole Source Cooperative Agreement To Fund National Tuberculosis Control Program (NTCP)
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award(s) of approximately $3,000,000, for Year 1 funding to NTCP. The award will improve the capacity of the health system at national, regional, district, and facility levels to provide an effective public health response for Tuberculosis (TB) and human immunodeficiency virus (HIV) co-infection in Cameroon, reduce disease burden, and contribute to achieving and sustaining epidemic control. Funding amounts for years 2-5 will be set at continuation.
Solicitation for Nominations for Appointment to the Board of Scientific Counselors, National Institute for Occupational Safety and Health
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 Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH). The BSC, NIOSH consists of 15 experts in fields associated with occupational safety and health.
Proposed Information Collection Activity; Annual Report on Children in Foster Homes and Children in Families Receiving Payments in Excess of the Poverty Income Level From a State Program Funded Under Part A of Title IV of the Social Security Act (Office of Management and Budget #: 0970-0004)
The Office of Family Assistance (OFA), Administration for Children and Families (ACF) is requesting a three-year extension of the form ACF-4125: Annual Report on Children in Foster Homes and Children in Families Receiving Payment in Excess of the Poverty Income Level from a State Program Funded Under Part A of Title IV of the Social Security Act (Office of Management and Budget #: 0970-0004, expiration 6/30/2024). There are no changes requested to the form.
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.
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.
Early Alzheimer's Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
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. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938-1148 (CMS-10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. 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.
Bayer HealthCare Pharmaceuticals Inc.; Withdrawal of Approval of New Drug Application for ALIQOPA (Copanlisib) for Injection, 60 Milligrams per Vial
The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) for ALIQOPA (copanlisib) for injection, 60 milligrams (mg)/vial, held by Bayer HealthCare Pharmaceuticals Inc., 100 Bayer Blvd., Whippany, NJ 07981- 0915. Bayer HealthCare Pharmaceuticals Inc. (Bayer) has voluntarily requested that FDA withdraw approval of this application and has waived its opportunity for a hearing.
Request for Information: Office of Head Start Tribal Programs
Prioritizing and directing resources to American Indian and Alaskan Native (AI/AN) programs to implement, expand, and/or enhance their Head Start services to tribal children and families is critical for meeting federal trust responsibility; preserving, and promoting Native language, culture, and traditions; and addressing the impact of historical trauma on Native Americans. As part of the Administration for Children and Families' (ACF) commitment to partnering with tribal nations to provide high-quality Head Start programming, in addition to regular tribal consultations, the Office of Head Start (OHS) invites public comment on the rules, regulations, and available training and technical assistance (TTA) supports impacting the AI/AN Head Start community. This Request for Information (RFI) seeks input on topics including eligibility; program options; quality environments; child health and safety; tribal language preservation, maintenance, revitalization, and restoration; family and community engagement; workforce; training and technical assistance; partnerships with state systems; facilities; fiscal operations; early childhood systems; and others, to improve the quality of Head Start services in areas of great need and affirm the federal government's commitment to protect Native communities.
Controlled Correspondence Related to Generic Drug Development; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Controlled Correspondence Related to Generic Drug Development.'' This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA requesting information related to generic drug development and the Agency's process for providing communications related to such correspondence. This guidance also describes the process by which generic drug manufacturers and related industry can submit requests to clarify ambiguities in FDA's controlled correspondence response and the Agency's process for responding to those requests. This guidance finalizes the draft guidance of the same title issued on December 22, 2022. This guidance replaces the guidance ``Controlled Correspondence Related to Generic Drug Development'' issued on December 17, 2020.
Manufacture of Batches in Support of Original New Animal Drug Applications, Abbreviated New Animal Drug Applications, and Conditional New Animal Drug Applications; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #285 entitled ``Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs.'' This draft guidance is intended to provide recommendations for the primary batches of drug product manufactured to support the approval or conditional approval of new animal drug products. This guidance is applicable to all original new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs), and their associated investigational new animal drug files (INADs) and generic investigational new animal drug files, respectively, as well as applications for conditional approval of new animal drugs (CNADAs).
Pharmacokinetics in Patients With Impaired Renal Function-Study Design, Data Analysis, and Impact on Dosing; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Pharmacokinetics in Patients with Impaired Renal FunctionStudy Design, Data Analysis, and Impact on Dosing.'' In general, drug development programs should be conducted so that when products are approved, the labeling provides appropriate dosing recommendations for patients with renal impairment. This guidance is intended to assist sponsors in the design and analysis of studies that assess the influence of impaired renal function on the pharmacokinetics (PK) and/ or pharmacodynamics (PD) of an investigational drug and addresses how such information can inform the labeling. This guidance finalizes the draft guidance ``Pharmacokinetics in Patients with Impaired Renal FunctionStudy Design, Data Analysis, and Impact on Dosing'' issued on September 4, 2020.
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