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Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Proposed Rule · Mar 30, 2023
ACTION: Petition for rulemaking; extension of comment period. … We have received a request for a 60-day extension of the comment period for the color additive petition The request conveyed concern that the current 60-day comment period does not allow sufficient time
88 FR 19026Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; QUADRAMETRegister
Federal Register · Notice · Jul 17, 1998
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) became effective (21 U.S.C. 355): June 16, 1989.
63 FR 38656Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; PREVICOX
Federal Register · Notice · Mar 26, 2007
Submit electronic comments to http://www.fda.gov/dockets/ecomments . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
72 FR 14119Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ONYX LES
Federal Register · Notice · Mar 26, 2007
Submit electronic comments to http://www.fda.gov/dockets/ecomments . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
72 FR 14120Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ZUBRIN
Federal Register · Notice · Jul 28, 2005
Submit electronic comments to http://www.fda.gov/dockets/ecomments . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
70 FR 43701Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ZILMAX
Federal Register · Notice · Jun 1, 2007
Submit electronic comments to http://www.fda.gov/dockets/ecomments . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
72 FR 30594Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; LEVEMIR
Federal Register · Notice · Feb 22, 2007
Submit electronic comments to http://www.fda.gov/dockets/ecomments . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
72 FR 7999Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; NAMENDA
Federal Register · Notice · Jun 5, 2007
Submit electronic comments to http://www.fda.gov/dockets/ecomments. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
72 FR 31075Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 21, 2007
Submit electronic comments to http://www.fda.gov/dockets/ecomments . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
72 FR 28498Health and Human Services DepartmentFood and Drug AdministrationDissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices
Federal Register · Rule · Nov 20, 1998
These comments argued that FDA would use this provision to extend the 60-day time period. … Section 554(c)(2) of the act requires a manufacturer to submit periodic progress reports on its clinical studies.
63 FR 64556Health and Human Services DepartmentFood and Drug AdministrationDefining “Small Number of Animals” for Minor Use Designation
Federal Register · Rule · Aug 26, 2009
An additional comment suggested periodic reevaluation of the small numbers based on the potential for an increase in the cost of drug development. … Just as the agency could not ignore a statutory restriction in response to the previous comment, FDA cannot exclude “agribusiness” from the MUMS Act provisions in response to this comment when such a restriction
74 FR 43043Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 20, 2013
DATES: The FDA is extending the comment period for the proposed rule referenced in the Summary. … Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by November 22, 2013 (see the “Paperwork Reduction Act of 1995” section).
78 FR 69604Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 16, 2024
The Consolidated Appropriations Act of 2022 (the Appropriations Act), that was enacted on March 15, 2022, amended the definition of the term “tobacco product” in section 201(rr) of the FD&C Act to include … Additionally, the Appropriations Act includes a transition period for premarket review requirements, directing companies to submit premarket tobacco product applications (PMTAs) for NTN products by May
89 FR 57907Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 28, 1996
: (1) The applicable legal authorities in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act; (2) FDA's approach to the regulation of human cord blood stem cells intended for transplantation … Accordingly, FDA is extending the original comment period by 90 days, to July 26, 1996.
61 FR 26473Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 10, 2024
DATES: Submit either electronic or written comments on the application beginning May 10, 2024. FDA will establish a closing date for the comment period as described in section I. … FDA believes that this comment period is appropriate given the volume and complexity of information in the MRTPA that has not already been available for public comment as part of the previously authorized
89 FR 40488Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 3, 2015
(Comment 28) Many comments supported the 6-month expiration period. … Some comments recommended expiration periods of 21 and 30 days.
80 FR 31708Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Uncategorized Document · Jul 22, 1994
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 512(j) of the Federal Food, Drug, and Cosmetic Act became effective: July 14, 1982.
Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 11, 2000
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … period.
65 FR 7023Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Zemplar
Federal Register · Notice · Mar 1, 1999
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: May 6, 1995.
64 FR 10003Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 13, 1998
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … period.
63 FR 54719Health and Human Services DepartmentFood and Drug Administration
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