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Federal Register · Notice · Dec 17, 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 69632Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 30, 2023
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, 1 consideration of any comments received, and a meeting of a device classification … The 30-month time period to file for a PMA is dictated by statute (section 501(f)(2)(B) of the FD&C Act).
88 FR 18990Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 19, 2016
The Paperwork Reduction Act of 1995 These guidances refer to previously approved collections of information found in FDA regulations. … These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520).
81 FR 46938Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; PRECEDEX
Federal Register · Notice · Mar 19, 2003
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.
68 FR 13314Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Rapamune
Federal Register · Notice · Feb 13, 2003
Submit electronic comments to http://www.fda/dockets/ecomments. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
68 FR 7382Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; AciphexTM
Federal Register · Notice · Mar 7, 2001
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 : August 21, 1991.
66 FR 13770Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Provigil
Federal Register · Notice · Mar 9, 2001
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 : July 30, 1993.
66 FR 14153Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Detrol
Federal Register · Notice · Jul 10, 2001
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(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective : October 7, 1994.
66 FR 35989Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; RAPLON
Federal Register · Notice · Jun 6, 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 31331Health and Human Services DepartmentFood and Drug AdministrationInvestigational New Drug Application Annual Reporting
Federal Register · Proposed Rule · Dec 9, 2022
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (PRA) by January 9, 2023. ADDRESSES: You may submit comments as follows. … 371) and under section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262).
87 FR 75551Health and Human Services DepartmentFood and Drug AdministrationNew Animal Drugs for Minor Use and Minor Species
Federal Register · Rule · Nov 15, 2010
30 days after the comment period on this direct final rule ends. … The comment period for this direct final rule runs concurrently with the comment period of the companion proposed rule.
75 FR 69586Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 1, 2016
One comment expressed concern about being unable to submit a product report within the required 30-day reporting period because of the extensive amount of time to create a product report, especially for … Furthermore, if a product was not compounded during a particular reporting period, no SPL response needs be sent for that product during that reporting period.
81 FR 50523Health 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 AdministrationAdministrative Practices and Procedures; Internal Review of Agency Decisions
Federal Register · Rule · Jun 16, 1998
FDA is providing a period of 75 days for comment on this direct final rule, to run concurrently with the comment period for the companion proposed rule. … This comment period begins on June 16, 1998, and ends on August 31, 1998.
63 FR 32733Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted for Direct Addition to Food for Human Consumption; Sucrose Oligoesters
Federal Register · Rule · Aug 20, 2003
Submit electronic comments to http://www.fda.gov/dockets/ecomments. FOR FURTHER INFORMATION CONTACT: Martha D. … Paperwork Reduction Act 1995 This final rule contains no collection of information.
68 FR 50069Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 19, 2004
of 1984 and the Animal Drug and Patent Term Restoration Act of 1988 (35 U.S.C. 156). … used to calculate that period.
69 FR 51468Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 18, 2013
ACTION: Notice; extension of comment period. … (OMB) under the Paperwork Reduction Act of 1995 (PRA).
78 FR 69095Health and Human Services DepartmentFood and Drug AdministrationRevocation of Status of Specific Products; Group A Streptococcus
Federal Register · Rule · Dec 2, 2005
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 .
70 FR 72197Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 3, 2015
FD&C Act) (21 U.S.C. 341). … The aging period for cheese manufactured from unpasteurized milk was presumed to act as a control measure to reduce the risk that pathogens would be present when the cheese was consumed.
80 FR 46023Health 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 Administration
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