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
Type
- Notice 1,033
- Rule 70
- Proposed Rule 49
Topic
- Reporting and recordkeeping requirements 31
- Medical devices 30
- Labeling 24
- Administrative practice and procedure 19
- Drugs 15
Section
- Health & Public Welfare 1,149
- Business & Industry 1,148
- Money 2
- World 2
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Publication Date
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Agency
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Medical Devices; Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act
The Food and Drug Administration (FDA, Agency, or we) is amending certain classification regulations to reflect changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the 21st Century Cures Act (the Cures Act). The Cures Act amended the definition of a device in the FD&C Act to exclude certain software functions. FDA is taking...
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Medical Devices; Class I Surgeon's and Patient Examination Gloves
The Department of Health and Human Services (HHS or ``the Department'') issued a Notice in the Federal Register of January 15, 2021, that, among other things, identified seven types of reserved class I devices that the Department had determined no longer require premarket notification. The Department and the Food and Drug Administration (FDA or...
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Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions; Public Workshop; Request for Comments
The Food and Drug Administration (FDA or Agency) is announcing the following public workshop entitled ``Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions.'' The purpose of the workshop is to bring stakeholders together to discuss the scientific basis of morphine milligram...
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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; Withdrawal of Proposed Exemptions
The Department of Health and Human Services (HHS or ``The Department'') issued a Notice in the Federal Register of January 15, 2021, that, among other things, proposed to exempt 83 class II devices and 1 unclassified device from premarket notification. This Notice announces HHS's and the Food and Drug Administration's (FDA or ``the Agency'')...
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
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; Premarket Notification for a New Dietary Ingredient
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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Mark Reinhard: 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 Mark Reinhard 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. Reinhard was convicted of a felony under...
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice
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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Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea; Public Workshop; Request for Comments
The Food and Drug Administration (FDA, Agency, or we), the National Institute of Allergy and Infectious Diseases (NIAID), and the Centers for Disease Control and Prevention (CDC) are announcing the following public workshop entitled ``Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea.'' The purpose of the public...
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Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. The general function of the subcommittee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is...
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Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs; Reopening of the Comment Period
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice announcing a public meeting and requesting comments that appeared in the Federal Register of October 13, 2020. In that notice, FDA announced a public meeting, which was held on November 16, 2020, and requested public input on a potential revised...
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Animal Generic Drug User Fee Act; Public Meeting; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following virtual public meeting entitled ``Animal Generic Drug User Fee Act.'' The purpose of the public meeting is to invite public comment on the Animal Generic Drug User Fee Act (AGDUFA) program and suggestions regarding the features FDA should consider for the next...
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Animal Generic Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Generic Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate
The Food and Drug Administration (FDA, the Agency, or we) is issuing this notice to request that public stakeholders notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Animal Generic Drug User Fee Act (AGDUFA). The statutory authority for AGDUFA expires September 30, 2023. The Federal Food,...
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Animal Drug User Fee Act; Public Meeting; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following virtual public meeting entitled ``Animal Drug User Fee Act.'' The purpose of the public meeting is to invite public comment on the Animal Drug User Fee Act (ADUFA) program and suggestions regarding the features FDA should consider for the next reauthorization...
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Animal Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate
The Food and Drug Administration (FDA, the Agency, or we) is issuing this notice to request that public stakeholders notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Animal Drug User Fee Act (ADUFA). The statutory authority for ADUFA expires September 30, 2023. The Federal Food, Drug, and...
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Electronic Submissions; Update to the Specifications for Preparing and Submitting Postmarket Individual Case Safety Reports for Vaccines; Technical Specification
The Food and Drug Administration (FDA or Agency) Center for Biologics Evaluation and Research (CBER) is announcing the availability of version 2.2 of the Specifications for Preparing and Submitting Postmarket Individual Case Safety Reports (ICSRS) for Vaccines (Specifications). The version update is not applicable to CBER- regulated drug...
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Lavipharm Laboratories, Inc., et al.; Withdrawal of Approval of Five Abbreviated New Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of five abbreviated new drug applications (ANDAs) from multiple holders of those ANDAs. The basis for the withdrawal is that these ANDA holders have repeatedly failed to file required annual reports for those ANDAs and have failed to satisfy the requirement to have an approved risk...
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Recall Regulations
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; Food Allergen Labeling and Reporting
The Food and Drug Administration (FDA, the 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; Food Labeling; Calorie Labeling of Articles of Food in Vending Machines and Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
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.