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 366
- Rule 21
- Proposed Rule 17
Topic
- Reporting and recordkeeping requirements 12
- Labeling 9
- Administrative practice and procedure 6
- Drugs 6
- Food labeling 6
Section
- Health & Public Welfare 402
- Business & Industry 401
- Money 2
- World 1
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Publication Date
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Agency
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Morton Grove Pharmaceuticals Inc. et al.; Withdrawal of Approval of Seven Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of seven 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
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Data Standards; Requirement Begins for the Clinical Data Interchange Standards Consortium Version 1.1 of the Standard for Exchange of Nonclinical Data Developmental and Reproductive Toxicology Implementation Guide and Version 1.6 of the Study Data Tabulation Model; Clarification to Food and Drug Administration Data Standards
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is announcing the date that support will begin for version 1.1 of the Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data Developmental and Reproductive Toxicology Implementation Guide (SENDIG- DART) and...
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Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications
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...
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Canned Tuna Deviating From the Standard of Identity; Amendment of Temporary Marketing Permit
The Food and Drug Administration (FDA or we) is amending StarKist Seafood Company's temporary permit to market test canned tuna. The temporary permit is amended to add three additional manufacturing locations and to increase the amount of test product. This amendment will allow the applicant to continue to test market the test product and...
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Agency Information Collection Activities; Proposed Collection; Comment Request; Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use
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,...
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Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Food Labeling; Declaration of Certified and Non-Certified Color Additives
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...
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Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Obtaining Information To Understand and Challenges and Opportunities Encountered by Compounding Outsourcing Facilities
The Food and Drug Administration (FDA or Agency) is announcing that a collection of information entitled ``Obtaining Information to Understand and Challenges and Opportunities Encountered by Compounding Outsourcing Facilities'' has been approved by the Office of Management and Budget (OMB) 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; Study of Multiple Indications in Direct-to-Consumer Television Advertisements
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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Request for Nominations on Device Good Manufacturing Practice Advisory Committee
The Food and Drug Administration (FDA or Agency) is requesting that any industry organization interested in participating in the selection of a nonvoting industry representative to serve on the Device Good Manufacturing Practice Advisory Committee (DGMPAC) in the Center for Devices and Radiological Health notify FDA in writing. FDA is also...
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Determination That BELVIQ (Lorcaserin Hydrochloride) Tablets, 10 Milligrams, and BELVIQ XR (Lorcaserin Hydrochloride) Extended-Release Tablets, 20 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that BELVIQ (lorcaserin hydrochloride) tablets, 10 milligrams (mg), and BELVIQ XR (lorcaserin hydrochloride) extended- release tablets, 20 mg, were withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications...
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Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice for Manufacturing, Processing, Packing, and Holding of Finished Pharmaceuticals, Including Medical Gases, and Active Pharmaceutical Ingredients
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 extension of an existing...
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Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration's Study of How Consumers Use Flavors To Make Inferences About Electronic Nicotine Delivery System Product Qualities and Intentions To Use (Phase 2)
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 and to allow...
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Proposal To Refuse To Approve a New Drug Application for Sotagliflozin Oral Tablets, 200 Milligrams and 400 Milligrams; Opportunity for a Hearing
The Director of the Center for Drug Evaluation and Research (Center Director) of the Food and Drug Administration (FDA or Agency) is proposing to refuse to approve a new drug application (NDA) submitted by Lexicon Pharmaceuticals, Inc. (Lexicon) for sotagliflozin oral tablets, 200 milligrams (mg) and 400 mg, in its present form. This notice...
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Michael Gurry: Final Debarment Order
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Michael Gurry 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. Gurry was convicted of a felony...
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PolyMedica Industries Inc., et al.; Proposal To Withdraw Approval of Three New Drug Applications; Opportunity for a Hearing
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of three new drug applications (NDAs) and is announcing an opportunity for the NDA holders to request a hearing on this proposal. The basis for the proposal is that the NDA holders have repeatedly failed to file...
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Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 054
The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 054''...
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Lawrence B. Ryan: Final Debarment Order
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Lawrence B. Ryan 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. Ryan was convicted of a...
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Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices 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; Generic Clearance for Data To Support Cross-Center Collaboration for Social Behavioral Sciences Associated With Disease Prevention, Treatment, and the Safety, Efficacy, and Usage of Food and Drug Administration Regulated Products
The Food and Drug Administration (FDA or Agency) 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 (PRA).
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Agency Information Collection Activities; Proposed Collection; Comment Request; Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices
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...