Department of Health and Human Services 2025 – Federal Register Recent Federal Regulation Documents

Results 101 - 150 of 191
Meeting of the Advisory Commission on Childhood Vaccines
Document Number: 2025-00389
Type: Notice
Date: 2025-01-10
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Commission on Childhood Vaccines (ACCV) has scheduled a public meeting. Information about ACCV and the agenda for this meeting can be found on the ACCV website at https:// www.hrsa.gov/advisory-committees/vaccines/.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2025-00386
Type: Notice
Date: 2025-01-10
Agency: Department of Health and Human Services, National Institutes of Health
Announcement of the Advisory Panel on Outreach and Education (APOE) Virtual Meeting
Document Number: 2025-00385
Type: Notice
Date: 2025-01-10
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the next meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace[supreg],\1\ Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2025-00382
Type: Notice
Date: 2025-01-10
Agency: Department of Health and Human Services, Office of the Secretary
National Antimicrobial Resistance Monitoring System 2026-2030 Strategic Plan; Request for Comments
Document Number: 2025-00342
Type: Notice
Date: 2025-01-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or Agency) is soliciting comments from the public regarding the National Antimicrobial Resistance Monitoring System (NARMS) 2026-2030 Strategic Plan. Comments received will help inform the development of a draft 2026-2030 Strategic Plan, to be discussed at a public meeting in spring 2025. Specific questions and information requests are included in this notice to help guide input from interested parties.
Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; ALYFTREK (vanzacaftor, tezacaftor, and deutivacaftor)
Document Number: 2025-00341
Type: Notice
Date: 2025-01-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that the application for ALYFTREK (vanzacaftor, tezacaftor, and deutivacaftor), approved December 20, 2024, meets the criteria for redeeming a priority review voucher.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; CRENESSITY (crinecerfont)
Document Number: 2025-00340
Type: Notice
Date: 2025-01-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that CRENESSITY (crinecerfont), approved on December 13, 2024, manufactured by Neurocrine Biosciences, Inc., meets the criteria for a priority review voucher.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2025-00399
Type: Notice
Date: 2025-01-10
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.
Advisory Committee; Antimicrobial Drugs Advisory Committee; Renewal
Document Number: 2025-00357
Type: Notice
Date: 2025-01-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the renewal of the Antimicrobial Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Antimicrobial Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the October 7, 2026, expiration date.
Meeting of the Advisory Committee on Immunization Practices
Document Number: 2025-00349
Type: Notice
Date: 2025-01-10
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 of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment.
Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee
Document Number: 2025-00310
Type: Notice
Date: 2025-01-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC) in the Center for Devices and Radiological Health. Nominations will be accepted for current and upcoming vacancies effective January 1, 2025, with this notice. FDA seeks to include the views of women and men, 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.
Organization, Functions, and Delegations of Authority; Part G; Indian Health Service Headquarters, Office of the Director
Document Number: 2025-00183
Type: Notice
Date: 2025-01-08
Agency: Department of Health and Human Services, Indian Health Service
Part G of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (HHS) is hereby amended to reflect a reorganization of the Indian Health Service (IHS). The purpose of this reorganization is to revise the current approved structure for the IHS, Office of the Director, Intergovernmental Affairs functions in Chapter GA (GAA-GAC), as provided for herein.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Maternal, Infant, and Early Childhood Home Visiting Program Model Eligibility Review Survey
Document Number: 2025-00129
Type: Notice
Date: 2025-01-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
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. Specifically, HRSA is inviting public comment on its proposed survey to identify evidence-based service delivery models that funding recipients may use to provide services under HRSA's MIECHV Program.
Yong Sheng Jiao; Denial of Hearing; Final Debarment Order
Document Number: 2025-00126
Type: Notice
Date: 2025-01-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Yong Sheng Jiao, also known as Yongsheng Jiao and Wilson Jiao (Jiao), and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jiao for 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Jiao was convicted of a felony under Federal law for conduct relating to the importation into the United States of any drug or controlled substance under the FD&C Act. In determining the appropriateness and period of Jiao's debarment, FDA considered the relevant factors listed in the FD&C Act. Jiao submitted a request for hearing but failed to file with the Agency information and analyses sufficient to create a basis for a hearing.
Withdrawal of Food and Drug Administration Notice Regarding Yong Sheng Jiao; Denial of Hearing; Final Debarment Order
Document Number: 2025-00125
Type: Notice
Date: 2025-01-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing this notice to withdraw the December 5, 2024, Federal Register notice entitled "Yong Sheng Jiao; Denial of Hearing; Final Debarment Order" because the document provided the incorrect bases for debarment and omitted edited language. A corrected notice document is published elsewhere in this Federal Register.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2025-00166
Type: Notice
Date: 2025-01-08
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 The Greater Access and Impact with NAT (GAIN) Study: Improving HIV Diagnosis, Linkage to Care, and Prevention Services with HIV Point- of-Care Nucleic Acid Tests (NATs). This study will identify facilitators and barriers with implementation of HIV point-of-care (POC) nucleic acid tests (NATs) in clinical settings, estimate the sensitivity and specificity of the HIV POC NAT, and assess the impact of the test in decreased time to receipt of HIV prevention and care.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2025-00165
Type: Notice
Date: 2025-01-08
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 and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Pathogens of High Consequence, which assesses the incidence and prevalence of select high consequence pathogens of public health importance in acute care hospitals. In addition to the nine diseases approved for collection, the following three additional diseases are being added to the form: Influenza A (H5), Marburg, and Oropouche.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2025-00164
Type: Notice
Date: 2025-01-08
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 Combating Antimicrobial Resistant Gonorrhea and Other STIs (CARGOS). CARGOS is a comprehensive strategy designed to streamline and improve the coordination of Antimicrobial Resistance (AR) surveillance and preparedness and response activities focused on Neisseria gonorrhoeae (GC) and expand capacity to include other STIs with emerging AR in the United States.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2025-00163
Type: Notice
Date: 2025-01-08
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 National Program of Cancer Registries Cancer Surveillance System. This information collection creates a Cancer Registry that provides useful data on cancer incidence, trends, and outcomes.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2025-00162
Type: Notice
Date: 2025-01-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2025-00161
Type: Notice
Date: 2025-01-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2025-00160
Type: Notice
Date: 2025-01-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2025-00159
Type: Notice
Date: 2025-01-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Center for Indigenous Innovation and Health Equity Tribal Advisory Committee; Solicitation of Nominations for Delegates
Document Number: 2025-00210
Type: Notice
Date: 2025-01-08
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH) hereby gives notice that OMH is accepting nominations of candidates to serve as primary and alternate delegates for the Center for Indigenous Innovation and Health Equity Tribal Advisory Committee (CIIHE TAC).
Establishing a Road Map for Accelerated Diagnosis and Treatment of HCV Infection in the United States
Document Number: 2025-00204
Type: Notice
Date: 2025-01-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) announces a two-day convening hosted and facilitated by the Association of Public Health Laboratories (APHL) to discuss hepatitis C diagnostics. Leaders from public health, laboratory, medical, academic, and industry sectors will have the opportunity to provide individual input, without building a consensus, on accelerating the diagnosis of current hepatitis C virus (HCV) infection. Members of the public with interest and expertise in diagnosing HCV infection are also invited to provide individual input. Specifically, the convening will focus on how to leverage the following hepatitis C diagnostic methods: same-day diagnosis and treatment, and viral-first testing. The goal of the convening will be for each person to give their individual input, and not to build consensus. No discussions, recommendations, or advice to CDC will occur or be provided at the meeting. Day 1 will focus on the utility of point-of- care (POC) testing for accelerating same-day HCV diagnosis and rapid treatment i.nitiation. Day 2 will focus on the utility of viral-first testing strategies for accelerating HCV diagnosis and treatment initiation in the United States. Following the meeting, APHL will prepare a meeting report summarizing the discussion and public comment received through regulations.gov, developed and documented as individual input to ensure thorough and complete input from partners. CDC and APHL will disseminate the APHL-prepared report as a reference for partners and industry to follow in developing and implementing future hepatitis C testing strategies. The final report will be added to docket CDC-2025-0002 once it is available.
Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction; Draft Guidance for Industry; Availability
Document Number: 2025-00237
Type: Notice
Date: 2025-01-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction." This draft guidance provides recommendations to industry regarding the development of drugs and biological products regulated within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance of body weight in patients with obesity or overweight. This draft guidance revises and replaces the draft guidance for industry "Developing Products for Weight Management" issued in February 2007.
Developing Drugs for Optical Imaging; Draft Guidance for Industry; Availability
Document Number: 2025-00213
Type: Notice
Date: 2025-01-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Developing Drugs for Optical Imaging." The purpose of this guidance is to provide recommendations to sponsors regarding clinical trial design features that support development and approval of optical imaging drugs that are used in conjunction with imaging devices and intended as intraoperative aids for the detection of pathology such as tumors or to enhance the conspicuity of normal anatomical structures.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2025-00105
Type: Notice
Date: 2025-01-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2025-00104
Type: Notice
Date: 2025-01-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2025-00103
Type: Notice
Date: 2025-01-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2025-00102
Type: Notice
Date: 2025-01-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2025-00101
Type: Notice
Date: 2025-01-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2025-00100
Type: Notice
Date: 2025-01-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2025-00099
Type: Notice
Date: 2025-01-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2025-00111
Type: Notice
Date: 2025-01-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2025-00110
Type: Notice
Date: 2025-01-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting
Document Number: 2025-00109
Type: Notice
Date: 2025-01-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2025-00108
Type: Notice
Date: 2025-01-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2025-00107
Type: Notice
Date: 2025-01-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2025-00106
Type: Notice
Date: 2025-01-07
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: C1-2024-30444
Type: Notice
Date: 2025-01-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway; Draft Guidance for Industry; Availability
Document Number: 2024-31527
Type: Notice
Date: 2025-01-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway." For drugs granted accelerated approval, sponsors conduct confirmatory studies that must be completed postapproval to verify and describe the anticipated effect on irreversible morbidity or mortality or other clinical benefit. This draft guidance describes FDA's interpretation of the term "underway" and discusses policies for implementing this requirement, including factors FDA intends to consider when determining whether a confirmatory trial is underway prior to accelerated approval.
Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2024-31526
Type: Notice
Date: 2025-01-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Evaluation of Sex- Specific and Gender-Specific Data in Medical Device Clinical Studies." This document provides guidance on the study and evaluation of sex- and/or gender-specific data in clinical investigations or research involving one or more subjects to determine the safety or effectiveness of a device. The purpose of this guidance is to encourage science- driven consideration of sex and/or gender, as appropriate for both the scientific question being addressed and the intended use of the device, when designing medical device clinical studies and reporting data from such studies in accordance with legal requirements. This draft guidance is not final nor is it for implementation at this time.
Food and Drug Administration Animal Food Ingredient Consultation; Guidance for Industry; Availability
Document Number: 2024-31525
Type: Notice
Date: 2025-01-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry #294 entitled "Animal Food Ingredient Consultation (AFIC)." This guidance describes FDA's interim AFIC process and explains one way FDA will work with firms that are developing animal food ingredients now that the Memorandum of Understanding (MOU) with the Association of American Feed Control Officials (AAFCO) expired on October 1, 2024, and while FDA evaluates the animal Food Additive Petition and Generally Recognized as Safe (GRAS) Notification programs. The AFIC process provides an additional way for engagement with FDA regarding ingredients for which firms may otherwise have used the AAFCO ingredient definition process. AFIC will help FDA identify any potential safety concerns associated with such ingredients. The AFIC process also allows for public awareness of and input on such ingredients. In addition, this guidance describes FDA's enforcement policy for certain ingredients assessed using the AFIC process.
Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry; Availability
Document Number: 2024-31524
Type: Notice
Date: 2025-01-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance document entitled "Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)." This draft guidance document includes general information on determining eligibility for donors of HCT/Ps. In addition, FDA intends to issue separate guidance documents with recommendations regarding reducing the risk of transmission of specific communicable disease agents and diseases for donors of HCT/Ps. These guidance documents are intended to update an existing guidance.
Draft Guidances Relating to Recommendations To Reduce the Risk of Transmission of Relevant Communicable Disease Agents and Diseases by Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidances for Industry; Availability
Document Number: 2024-31523
Type: Notice
Date: 2025-01-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of three specific draft guidances for industry entitled "Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps);" "Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps);" and "Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)." These draft guidances are intended to update existing guidances and to assist establishments making donor eligibility determinations in understanding the requirements for determining donor eligibility, including donor screening and testing, for donors of HCT/Ps. These draft guidances are also intended to provide establishments making donor eligibility determinations with recommendations to reduce the risk of transmission of specific communicable disease agents and diseases, specifically, hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV), by HCT/Ps.
Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2024-31522
Type: Notice
Date: 2025-01-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency." The draft guidance describes general recommendations for the validation of in vitro diagnostic devices (IVDs) for emerging pathogens during an applicable declaration of public health emergency. This guidance and the associated template include the recommendations that apply to test data and information submitted in a pre-Emergency Use Authorization (EUA), an EUA request, or to a test offered as described in an applicable enforcement discretion policy. This draft guidance is not final nor is it for implementation at this time.
Notifying the Food and Drug Administration of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2024-31547
Type: Notice
Date: 2025-01-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act." This guidance updates the previous version of the guidance, of the same title, issued on November 17, 2023, and finalizes the concurrently issued draft guidance entitled "Select Updates for the 506J Guidance: 506J Device List and Additional Notifications." This guidance finalizes a list of device product codes for which a manufacturer of such devices is required to notify FDA in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) (hereafter referred to as the "506J Device List") and clarifies that manufacturers may submit voluntary notifications regarding supply chain issues at any time, unrelated to the declaration or potential declaration of a public health emergency (PHE).
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
Document Number: 2024-31546
Type: Notice
Date: 2025-01-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act." This guidance describes FDA's interim policy concerning compounding by human drug product compounders that are not outsourcing facilities using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under the applicable section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance finalizes the draft guidance of the same title issued in December 2023 and replaces the final guidance of the same title issued in January 2017.
Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
Document Number: 2024-31545
Type: Notice
Date: 2025-01-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act." This guidance describes FDA's interim regulatory policy concerning compounding by outsourcing facilities using bulk drug substances while FDA develops the list of bulk drug substances that outsourcing facilities can use in compounding under the applicable section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance finalizes the draft guidance of the same title issued in December 2023 and replaces the final guidance of the same title issued in January 2017.
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