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Federal Register · Notice · Nov 29, 2016
The Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information that 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 85976Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 12, 2008
(the PHS Act) (42 U.S.C. 264). … Since the Expedited Reports and Periodic Reports draft guidances were issued, the agency has received ICSRs for HCT/Ps regulated under section 361 of the PHS Act.
73 FR 33436Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; CONVENIA
Federal Register · Notice · Apr 29, 2011
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 FD&C Act became effective: July 17, 2000.
76 FR 24034Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 5, 2006
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.
71 FR 38170Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; NEUTERSOL
Federal Register · Notice · Jul 7, 2004
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by January 3, 2005.
69 FR 40944Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; SURPASS
Federal Register · Notice · Feb 3, 2006
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 subsection 512(j) of the act became effective : March 6, 1998.
71 FR 5859Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 7, 2006
Postmarketing Adverse Drug Experience Reporting—21 CFR 310.305 and 314.80 (OMB Control Number 0910-0230)—Extension Sections 201, 502, 505, and 701 of the Federal Food, Drug, and Cosmetic Act (the act) … Concerning periodic reports, the comment said the annual frequency per response (an estimate the comment assumed to be the average number of periodic reports submitted per company) is estimated by FDA
71 FR 6281Health and Human Services DepartmentFood and Drug AdministrationMedical Device User Fee and Modernization Act; Public Meeting
Federal Register · Notice · Apr 18, 2007
After the public meeting and the close of the 30-day comment period, we will undertake a careful review of all the public comments we receive on these proposed recommendations. II. … We propose to publish draft guidance by the end of FY 2008 and allow for a 90-day public comment period. We propose to issue a final guidance within one year of the close of the comment period. 5.
72 FR 19528Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 20, 1996
FDA is reopening the comment period for 30 days for the sole purpose of inviting public comments on the information being added to the administrative record. … FDA believes that 30 days to comment is ample in this case, as the agency is specifically limiting its reopening of the comment period to comments on the statements being added.
61 FR 11419Health and Human Services DepartmentFood and Drug AdministrationRegulation of Flavors in Tobacco Products; Extension of Comment Period
Federal Register · Proposed Rule · Jun 8, 2018
ACTION: Advance notice of proposed rulemaking; extension of comment period. … Prevention and Tobacco Control Act.
83 FR 26618Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; AvaproRegister
Federal Register · Notice · Nov 19, 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) (21 U.S.C. 355) became effective: April 30, 1993.
63 FR 64268Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 31, 2015
.; Reopening of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of the comment period. … The comment period on these originally-filed applications closed on February 23, 2015.
80 FR 45661Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; NPLATE
Federal Register · Notice · Aug 11, 2009
Submit electronic comments to http://www.regulations.gov . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
74 FR 40205Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; PREVNAR
Federal Register · Notice · Apr 28, 2003
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by October 27, 2003.
68 FR 22389Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; PAYLEAN
Federal Register · Notice · Feb 28, 2002
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by August 27, 2002.
67 FR 9298Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; TYSABRI
Federal Register · Notice · Mar 16, 2006
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by September 12, 2006.
71 FR 13604Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 28, 2010
ACTION: Proposed rule; reopening of the comment period. … The agency has considered the requests and is reopening the comment period until September 7, 2010.
75 FR 44172Health and Human Services DepartmentFood and Drug AdministrationAnimal Generic Drug User Fee Act; Public Meeting; Request for Comments
Federal Register · Notice · Oct 5, 2017
FDA-2011-N-0655 for “Animal Generic Drug User Fee Act; Public Meeting; Request for Comments.” … Section 742(d)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379j-22(d)(4)) requires that, after holding negotiations with regulated industry and periodic consultations with
82 FR 46506Health and Human Services DepartmentFood and Drug AdministrationIrradiation in the Production, Processing and Handling of Food
Federal Register · Rule · Aug 22, 2008
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. … Over the same storage period, coliforms remained below the level of detection in irradiated samples (Ref. 56).
73 FR 49593Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; EMEND FOR INJECTION
Federal Register · Notice · Oct 5, 2009
Submit electronic comments to http://www.regulations.gov . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
74 FR 51159Health and Human Services DepartmentFood and Drug Administration
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