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.
- Documents
- Public Inspection
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Section
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Agency
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Regulatory Clean Up Initiative; Correction
The Department of Health and Human Services is correcting a final rule that appeared in the Federal Register on November 16, 2020. This document had incorrectly designated footnotes and typographical errors.
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Regulatory Clean Up Initiative
The U.S Department of Health and Human Services (HHS) is amending its regulations to make miscellaneous corrections, including correcting references to other regulations, misspellings and other typographical errors. This document is necessary to inform the public of these non-substantive changes to HHS's regulations.
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Blood Products Advisory Committee Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Blood Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarket Surveillance
The Food and Drug Administration (FDA) 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; Medical Device: Current Good Manufacturing Practice Quality System Regulations
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information including each...
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requests for Clinical Laboratory Improvement Amendments Categorization
The Food and Drug Administration (FDA) 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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Determination That AQUAMEPHYTON (Phytonadione) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were 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 these drug products, and it...
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Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Medical Device Fellowship Program
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each...
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications
The Food and Drug Administration (FDA) 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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Antimicrobial Drugs Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
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Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods; Draft Guidance for Industry; Extension of Comment Periods
The Food and Drug Administration (FDA or we) is extending the comment periods for the Draft Guidance entitled, ``Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods'' that appeared in the Federal Register of June 2, 2016. In the notice, we requested...
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New Animal Drugs for Use in Animal Feed; Category Definitions
The Food and Drug Administration (FDA, the Agency, we) proposes to amend the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. The proposed revision will preserve the availability of medicated feeds...
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Good Laboratory Practice for Nonclinical Laboratory Studies
The Food and Drug Administration (FDA) is proposing to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach, referred to as a GLP Quality System, when safety and toxicity studies support or are intended to support applications or submissions for products...
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Medical Devices; Foreign Letters of Approval
The Food and Drug Administration (FDA) 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; Mammography Quality Standards Act Requirements
The Food and Drug Administration (FDA) 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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Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is issuing a final rule that amends and clarifies the criteria in our regulations for when the use of a substance in food for humans or animals is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) because the substance is generally recognized...
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Calorie Labeling of Articles of Food in Vending Machines: Guidance for Industry; Small Entity Compliance Guide; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Calorie Labeling of Articles of Food in Vending Machines--Small Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled ``Food Labeling; Calorie...
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Calorie Labeling of Articles of Food in Vending Machines; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry, entitled ``Calorie Labeling of Articles of Food in Vending Machines.'' The draft guidance, when finalized, will help covered vending machine operators and industry to better understand and comply with the final rule entitled ``Food...
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Regulatory Hearing Before the Food and Drug Administration; General Provisions; Technical Amendment
The Food and Drug Administration (FDA) is amending its regulations to correct an error in the lists of statutory and regulatory provisions that provide an opportunity for an informal hearing so that the lists correctly reference the statutory and regulatory provisions that provide such an opportunity in connection with a ban of a device. This...
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New Animal Drug Applications; Contents of Notice of Opportunity for a Hearing; Correction
The Food and Drug Administration (FDA, the Agency, or we) is making technical corrections to its regulations for hearing procedures for denial of approval or withdrawal of approval of new animal drug applications. The Agency is taking this action to harmonize terminology and to improve the organization and clarity of the regulations.