Documents
Briefs, oral arguments, agency decisions and the Federal Register.
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Supplements and Other Changes to an Approved Application
Federal Register · Proposed Rule · Jun 28, 1999
DATES: Written comments by September 13, 1999. Comments on the collection of information by July 28, 1999. … Request for Comments Interested persons may, on or before September 13, 1999, submit to the Dockets Management Branch (address above) written comments regarding this proposal.
64 FR 34608Health 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 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 · Notice · Jul 2, 2014
Follow the instructions for submitting “comments.” … Individuals and organizations will be able to comment on nominated substances after the nomination period has closed or petition FDA to make additional list amendments after the list is published, in accordance
79 FR 37747Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 28, 2015
(the FD&C Act). … How frequently should metrics be reported and/or segmented within the reporting period ( e.g., annually, semiannually, or quarterly)? C.
80 FR 44973Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted in Feed and Drinking Water of Animals; Selenium Yeast
Federal Register · Rule · Jul 19, 2007
Follow the instructions for submitting comments. • Agency Web site: http://www.fda.gov/dockets/ecomments . Follow the instructions for submitting comments on the agency Web site. … The notice of filing provided for a 60-day comment period on the petitioner's environmental assessment. No substantive comments have been received. II.
72 FR 39560Health 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 AdministrationMedical Devices; Exemption From Premarket Notification for Certain Classified Devices
Federal Register · Rule · Jul 28, 1995
During the comment period, FDA received comments that questioned the appropriateness of the proposed exemptions for a small number of the devices. … FDA disagrees with this comment.
60 FR 38896Health 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 AdministrationFederal Register · Rule · Jan 20, 1995
If a serious error is not detected for a long period, the resulting product could pose a threat to public health and safety. … Therefore, under the Regulatory Flexibility Act, no further analysis is required.
60 FR 4087Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Apr 30, 1997
Before marketing could begin, the comment period for the proposal must have ended [[Page 23351]] and another Federal Register notice must have been published setting forth the agency's determination … The comment requested that the agency do the following for an initial period of at least 2 years: (1) Restrict the general use of avobenzone- containing OTC sunscreen drug products to use by adults with
62 FR 23350Health and Human Services DepartmentFood and Drug AdministrationPlascon, Inc.; Opportunity for Hearing on a Proposal to Revoke U.S. License No. 572-003
Federal Register · Notice · Nov 17, 1995
Plascon, Inc., did not respond to FDA's letter within the specified response period. … This notice is issued under the Public Health Service Act (sec. 351 (42 U.S.C. 262)) and the Federal Food, Drug, and Cosmetic Act (secs. 201, 501, 502, 505, 701 (21 U.S.C. 321, 351, 352, 355, 371)) and
60 FR 57719Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemptions From Premarket Notification; Class II Devices; Vascular Tunnelers
Federal Register · Rule · Mar 3, 2000
This section requires FDA to publish in the Federal Register a notice of intent to exempt a device, or of the petition, and to provide a 30-day comment period. … In the Federal Register of November 17, 1999 (64 FR 62678), FDA published a notice announcing that this petition had been received and providing an opportunity for interested persons to submit comments
65 FR 11466Health 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 AdministrationFood Additives Permitted in Feed and Drinking Water of Animals; Formaldehyde
Federal Register · Rule · Nov 21, 2003
The notice of filing provided for a 60-day comment period on the petitioner's environmental assessment. No substantive comments have been received. … (iii) To assure the safe use of the additive, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act (the act), the label and labeling of the dried mixture shall bear
68 FR 65632Health and Human Services DepartmentFood and Drug AdministrationRegulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
Federal Register · Rule · May 17, 1999
In the Federal Register of January 5, 1999 (64 FR 457), FDA reopened until February 12, 1999, the comment period on the medical imaging draft guidance. … In the Federal Register of February 16, 1999 (64 FR 7561), the agency further extended the comment period to April 14, 1999.
64 FR 26657Health and Human Services DepartmentFood and Drug AdministrationToll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products
Federal Register · Proposed Rule · Apr 22, 2004
(the act) (21 U.S.C. 355). … FDA requests comment on this assumption.
69 FR 21778Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 24, 2024
Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA-regulated products in carrying out … the provisions of the FD&C Act.
89 FR 84889Health and Human Services DepartmentFood and Drug AdministrationDrug Labeling; Sodium Labeling for Over-the-Counter Drugs
Federal Register · Rule · Nov 29, 2004
FDA considered but rejected several labeling alternatives: (1) A longer implementation period and (2) an exemption from coverage for small entities. … A longer time period would unnecessarily delay the benefit of the new labeling to consumers who self-medicate with these products.
69 FR 69278Health and Human Services DepartmentFood and Drug AdministrationWithdrawal of Certain Proposed Rules and Other Proposed Actions
Federal Register · Proposed Rule · Dec 12, 2008
Background In 1990, the Food and Drug Administration (FDA) began the process of conducting periodic, comprehensive reviews of its regulations process that included reviewing the backlog of ANPRMs, notices … Should we decide to undertake such rulemakings in the future, we will re-propose the actions and provide new opportunities for comment.
73 FR 75625Health and Human Services DepartmentFood and Drug Administration
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