Documents
Briefs, oral arguments, agency decisions and the Federal Register.
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Prescription Drug User Fee Act (PDUFA); Public Meeting
Federal Register · Notice · Nov 19, 2001
The Federal Food, Drug, and Cosmetic Act (the act) encourages FDA to consult with stakeholders, as appropriate, in carrying out agency responsibilities. … If you wish to make an oral presentation during the open public comment period of the meeting, you must specify on your registration you wish to make a presentation.
66 FR 57967Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 28, 2004
An annual financial status report (FSR) is due 90 days after the end of each budget period. The final FSR is due 90 days after the end of the project period. … FDA does not guarantee that we will accommodate or explain SPOC comments that are received after the 60-day cutoff. B.
69 FR 36091Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Apr 7, 2000
One comment objected that OTC drugs of abuse test kits are not medical devices under section 201(h) of the act (21 U.S.C. 321(h)). … Fairness Act of 1996 (Public Law 104-121), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).
65 FR 18230Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 24, 2014
The Agency is making this information available consistent with the PHS Act. … The sodium nitroprusside docket remained opened for public comment from October 3, 2012, through November 2, 2012.
79 FR 4167Health and Human Services DepartmentFood and Drug AdministrationInvestigational New Drug Applications and New Drug Applications
Federal Register · Proposed Rule · Sep 8, 1995
DATES: Written comments by December 7, 1995. … The General Accounting Office (GAO) conducted a larger study of drugs approved during the period 1988 through 1991, and found similar proportions.
60 FR 46794Health and Human Services DepartmentFood and Drug AdministrationEmergency Permit Control Regulations; Technical Amendments
Federal Register · Proposed Rule · Sep 22, 2015
For additional information on submitting comments, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this document. … Additional Information Regarding Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets
80 FR 57137Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committees; Notice of Meetings
Federal Register · Uncategorized Document · Oct 18, 1994
If necessary, comments may be limited to 5 minutes. Open committee discussion. … This notice is issued under section 10(a)(1) and (2) of the Federal Advisory Committee Act (5 U.S.C. app. 2), and FDA's regulations (21 CFR part 14) on advisory committees.
Health and Human Services DepartmentFood and Drug AdministrationDisqualification of a Clinical Investigator
Federal Register · Proposed Rule · Apr 13, 2011
Paperwork Reduction Act of 1995 X. Federalism XI. Request for Comments XII. References I. … It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments.
76 FR 20575Health and Human Services DepartmentFood and Drug AdministrationIrradiation in the Production, Processing, and Handling of Food
Federal Register · Rule · Apr 13, 2011
Objections and Requests for a Hearing Section 409(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348(f)(1)) provides that, within 30 days after publication of an order relating … The report was made available to the public for comment in the Federal Register of March 27, 1981 (46 FR 18992).
76 FR 20509Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 10, 2006
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 … In the Federal Register of November 24, 2004 (69 FR 68381), FDA published a notice of availability with a 60-day comment period requesting public comment on the collection of information in FDA's draft
71 FR 7048Health and Human Services DepartmentFood and Drug AdministrationRequirements for Additional Traceability Records for Certain Foods: Compliance Date Extension
Federal Register · Proposed Rule · Aug 7, 2025
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. … Effects of the Proposed Rule [Millions of 2024 dollars] Category Primary estimate Low estimate High estimate Units Year dollars Discount rate (%) Period
90 FR 38084Health and Human Services DepartmentFood and Drug AdministrationOver-the-Counter Drug Products Containing Colloidal Silver Ingredients or Silver Salts
Federal Register · Proposed Rule · Oct 15, 1996
DATES: Written comments by January 13, 1997; written comments on the agency's economic impact determination by January 13, 1997. … The agency is providing a period of 90 days from the date of publication of this proposed rule for comments on this subject to be developed and submitted.
61 FR 53685Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities; Submission for OMB Review; Comment Request
Federal Register · Notice · Mar 25, 1998
DATES: Submit written comments on the collection of information by April 24, 1998. … The regulations contain no periodic reporting requirements.
63 FR 14468Health and Human Services DepartmentFood and Drug AdministrationEstablishment Registration and Product Listing for Tobacco Products
Federal Register · Proposed Rule · Jun 29, 2026
DATES: Either electronic or written comments on the proposed rule must be submitted by September 14, 2026. ADDRESSES: You may submit comments as follows. … Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m.
91 FR 39168Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 10, 2022
Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). … Such standards are those that FDA has recognized by notice published in the Federal Register or that FDA has decided to recognize but for which recognition is pending (because a periodic notice has
87 FR 48671Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Mar 6, 2002
Introduction IRBs are boards, committees, or other groups formally designated by an institution to review, approve the initiation of, and conduct periodic review of biomedical research involving human … (While section 520(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(g)) refers to “institutional review committees” rather than IRBs, FDA considers institutional review committees to be IRBs
67 FR 10115Health and Human Services DepartmentFood and Drug AdministrationOver-The-Counter Human Drugs; Labeling Requirements; Final Rule; Technical Amendment
Federal Register · Rule · Jan 3, 2000
Submit written comments by March 18, 2000. … Therefore, under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 201, 341, and 369 are amended
65 FR 7Health and Human Services DepartmentFood and Drug AdministrationExocrine Pancreatic Insufficiency Drug Products for Over-The- Counter Human Use
Federal Register · Rule · Apr 24, 1995
Interested persons were invited to submit comments by April 21, 1980. Reply comments in response to comments filed in the initial comment period could be submitted by May 21, 1980. … (the act) (21 U.S.C. 321(p)).
60 FR 20162Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 14, 2004
We seek comments on this interpretation. … FDA invites public comment on this proposed rule. The agency will consider modifications to this proposed rule based on comments made during the comment period.
69 FR 42275Health and Human Services DepartmentFood and Drug AdministrationFDA Regulation of Combination Products; Public Hearing
Federal Register · Notice · Oct 28, 2002
If you wish to make an oral presentation during the open public comment period of the hearing, you must state your intention on your registration form or with the registration contact person listed ( … In accordance with section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 353(g)(l)), the agency is required to assign premarket review responsibility for combination products
67 FR 65801Health and Human Services DepartmentFood and Drug Administration
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