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Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Notice · May 6, 2011
The public comment period closed on July 16, 2009. … Paperwork Reduction Act of 1995 This guidance refers to information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995
76 FR 26307Health and Human Services DepartmentFood and Drug AdministrationOver-the-Counter Human Drugs; Labeling Requirements; Partial Extension of Compliance Dates
Federal Register · Rule · Jun 20, 2000
Within the period specified in the final monograph. … Act of 1995 (Pub.
65 FR 38191Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 17, 2022
number of units produced, along with other data as appropriate, to appropriate values for the reporting period. … Furthermore, if a product was not compounded during a particular reporting period, no product response would be sent for that product during that reporting period.
87 FR 36507Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 28, 2010
ACTION: Notice; reopening of comment period. … The agency has considered the requests and is reopening the comment period until September 7, 2010.
75 FR 44267Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 8, 2016
ACTION: Notice; extension of the comment period. … DATES: FDA is extending the comment period for the draft guidance by an additional 30 days.
81 FR 940Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 23, 2018
ACTION: Notice of availability; extension of comment period. … The Agency has received a request for a 30-day extension of the comment period.
83 FR 3164Health and Human Services DepartmentFood and Drug AdministrationAnimal Drug User Fee Act; Public Meeting; Request for Comments
Federal Register · Notice · Feb 21, 2008
FDA agreed to review and act on submissions within shorter periods of time each fiscal year. … In general, the meeting format will include presentations by FDA and an open comment period for the public.
73 FR 9571Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 16, 2021
ACTION: Notice; reopening comment period. … DATES: FDA is reopening the comment period for the notice published July 23, 2021 (86 FR 39038). Submit either electronic or written comments by August 24, 2021.
86 FR 45738Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 4, 2016
Background In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or … Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period.
81 FR 51453Health and Human Services DepartmentFood and Drug AdministrationIrradiation in the Production, Processing, and Handling of Food
Federal Register · Rule · Aug 16, 2005
Safety Evaluation Under section 201(s) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(s)), a source of radiation used to treat food is defined as a food additive. … Additionally, the act does not authorize FDA to arbitrarily limit other safe alternatives.
70 FR 48057Health and Human Services DepartmentFood and Drug AdministrationBiological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review
Federal Register · Rule · Dec 19, 2005
Periodic Review of Product Labeling C. Improvement in the Reporting of Adverse Reactions D. Periodic Review of Product Licenses E. … Periodic review of labeling on a set schedule is unnecessary.
70 FR 75018Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 5, 2001
In addition, section 505 of the act provides several periods of marketing exclusivity ranging from 3 to 10 years (depending primarily on the nature of the innovation). … To promote product innovation, the act also gives NDA applicants several periods of “market exclusivity” ranging from 3 to 10 years (depending primarily on the nature of the innovation).
66 FR 18094Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Oct 14, 1998
, 1998, the comment period on a proposed rule that was published in the Federal Register of May 22, 1998 (63 FR 28301). … Public Health Service Act.
63 FR 55067Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 25, 2022
The number of documents received each year since the original collection period has fallen to less than 5 percent of what was received in the original collection period. … FDA expects this is because documents created within the specified period should have already been submitted.
87 FR 10800Health and Human Services DepartmentFood and Drug AdministrationPostmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements
Federal Register · Proposed Rule · Feb 14, 2018
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by March 16, 2018. ADDRESSES: You may submit comments as follows. … Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (PRA) to the Office of Management and Budget (OMB) in the following ways: • Fax to the Office of Information
83 FR 6480Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 3, 1995
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act became effective: October 10, 1986.
60 FR 39752Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; MERREMRegister I.V.
Federal Register · Notice · Feb 11, 1997
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
62 FR 6261Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 23, 2018
The number of documents received each year since the original collection period has fallen to less than 5 percent of what was received in the original collection period. … FDA expects this is because documents created within the specified period should have already been submitted.
83 FR 42664Health and Human Services DepartmentFood and Drug AdministrationRevision of the Requirements for Live Vaccine Processing
Federal Register · Rule · Oct 18, 2007
The comment period for the direct final rule runs concurrently with the companion proposed rule. … We are providing a comment period on the direct final rule of 75 days after the date of publication in the Federal Register .
72 FR 59000Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 9, 1996
Cosmetic Act (21 U.S.C. 351). … At the close of the 60-day comment period, FDA will review the comments received, make revisions as necessary to the information collection requirements, and submit the requirements to OMB for review and
61 FR 47413Health and Human Services DepartmentFood and Drug Administration
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