Legal Status
This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the official electronic version on GPO’s govinfo.gov.
The documents posted on this site are XML renditions of published Federal Register documents. Each document posted on the site includes a link to the corresponding official PDF file on govinfo.gov. This prototype edition of the daily Federal Register on FederalRegister.gov will remain an unofficial informational resource until the Administrative Committee of the Federal Register (ACFR) issues a regulation granting it official legal status. For complete information about, and access to, our official publications and services, go to About the Federal Register on NARA's archives.gov.
The OFR/GPO partnership is committed to presenting accurate and reliable regulatory information on FederalRegister.gov with the objective of establishing the XML-based Federal Register as an ACFR-sanctioned publication in the future. While every effort has been made to ensure that the material on FederalRegister.gov is accurately displayed, consistent with the official SGML-based PDF version on govinfo.gov, those relying on it for legal research should verify their results against an official edition of the Federal Register. Until the ACFR grants it official status, the XML rendition of the daily Federal Register on FederalRegister.gov does not provide legal notice to the public or judicial notice to the courts.
Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the Nation's food supply, cosmetics, and products that emit radiation. FDA is also responsible for advancing the public health by accelerating innovations to make medicines more effective and providing the public with accurate, science-based information on medicines and food to improve their health. FDA plays a significant role in addressing the Nation's counterterrorism capability and ensuring the security of the food supply.
- Agency URL:
- http://www.fda.gov/
- Parent Agency
- Health and Human Services Department
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Securing Updated and Necessary Statutory Evaluations Timely
Editorial Note: The Office of the Federal Register made technical corrections to this document after it was posted for public display. It will remain on display through the close of business on January 19, 2021.
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Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods; Correction
The Food and Drug Administration (FDA or we) is correcting a final rule that published in the Federal Register of August 13, 2020. The final rule establishes requirements concerning ``gluten-free'' labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients.
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Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods
The Food and Drug Administration (FDA or we) is issuing a final rule to establish requirements concerning ``gluten-free'' labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. These requirements f are needed to help ensure that individuals with celiac disease are not misled and receive truthful...
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Laboratory Accreditation for Analyses of Foods; Extension of Comment Period
The Food and Drug Administration (FDA or we) is extending for a second time the comment period for the proposed rule, and for the information collection related to the proposed rule, entitled ``Laboratory Accreditation for Analyses of Foods'' that appeared in the Federal Register of November 4, 2019. We are taking this action in response to a...
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Premarket Tobacco Product Applications and Recordkeeping Requirements; Reopening of the Comment Period
The Food and Drug Administration (FDA or the Agency) is reopening the comment period only for the agency information collection activity associated with proposed rulemaking entitled ``Premarket Tobacco Product Applications and Recordkeeping Requirements,'' which appeared in the Federal Register of September 25, 2019. FDA is not reopening the...
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Laboratory Accreditation for Analyses of Foods; Extension of Comment Period
The Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule, and for the information collection related to the proposed rule, entitled ``Laboratory Accreditation for Analyses of Foods'' that appeared in the Federal Register of November 4, 2019. We are taking this action in response to a request for an...
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Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date
As required by an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule (``Tobacco Products; Required Warnings for Cigarette Packages and Advertisements''), which published on March 18, 2020. The new effective date is January 14, 2022.
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TG United Inc., et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 27 abbreviated new drug applications (ANDAs) 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.
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Patient-Focused Drug Development for Vitiligo; Public Meeting; Request for Comments
In the Federal Register notice published on March 19, 2020, the Food and Drug Administration (FDA, Agency, or we) announced the cancellation of the public meeting entitled ``Patient-Focused Drug Development for Vitiligo'' originally scheduled to occur on March 30, 2020, as announced in the Federal Register on February 12, 2020. FDA is announcing...
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Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards; Public Meeting; Request for Comments
The Food and Drug Administration (FDA or Agency) is announcing the following virtual public meeting entitled ``Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.'' The purpose of the virtual public meeting and the request for comments is to fulfill FDA's commitment to seek stakeholder input related to data...
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Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices From Premarket Notification Requirements; Request for Information, Research, Analysis, and Public Comment on Opportunities for Further Science and Evidence-Based Reform of Section 510(k) Program
To provide Americans with expanded access to certain medical devices to respond to the COVID-19 Public Health Emergency, FDA issued guidance documents providing numerous regulatory flexibilities, including a temporary waiver of premarket notification requirements under section 510(k) of the Food, Drug, and Cosmetic Act. For seven class I devices...
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey of Drug Product Manufacturing, Processing, and Packing Facilities
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Extralabel Drug Use in Animals
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
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Agency Information Collection Activities; Proposed Collection; Comment Request; 513(g) Request for Information
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,...