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Federal 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 AdministrationFederal 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 AdministrationMicrobiology Devices; Reclassification of Herpes Simplex Virus Types 1 and 2 Serological Assays
Federal Register · Rule · Aug 25, 2009
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.
74 FR 42773Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 12, 1998
The comment period for this companion proposed rule runs concurrently with the direct final rule's comment period. … The comment period runs concurrently with the comment period for the direct final rule. Two copies of any comments are to be submitted, except that individuals may submit one copy.
63 FR 26129Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 12, 2011
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk … No comments were received on the information collection.
76 FR 2127Health and Human Services DepartmentFood and Drug AdministrationDefining Small Number of Animals for Minor Use Determination; Periodic Reassessment
Federal Register · Proposed Rule · Sep 15, 2022
30 days after the comment period ends. … The comment period for this proposed rule runs concurrently with the comment period for the companion direct final rule.
87 FR 56604Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Dec 11, 1995
Several comments stated that 10 days is too short a time period for user facilities to report adverse events properly. … FDA cannot agree because the 10-day time period is the maximum time allowed by the statute. (See section 519(b)(1)(A) of the act.)
60 FR 63578Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Feb 3, 2014
ACTION: Proposed rule; extension of comment period. … We also are extending the comment period for the information collection provisions to March 31, 2014, to make the comment period for the information collection provisions the same as the comment period
79 FR 6111Health 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 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 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 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 AdministrationFederal Register · Proposed Rule · Aug 1, 2006
ACTION: Proposed rule; reopening of the comment period. … Act (the act) (21 U.S.C. 350a).
71 FR 43392Health 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 AdministrationFood Labeling; Timeframe for Final Rules Authorizing Use of Health Claims
Federal Register · Rule · May 22, 1997
If a proposal for a health claim were ever received by the public without controversy, FDA would act rapidly to issue a final rule shortly after the comment period closed. … Consequently, the agency has modified proposed Sec. 101.70(j)(4)(ii) to provide that FDA may extend the comment period for a period of no more than 90 days.
62 FR 28230Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; SAMSCA
Federal Register · Notice · Dec 14, 2010
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 June 13, 2011.
75 FR 77879Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; MULTAQ
Federal Register · Notice · Dec 10, 2010
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 June 8, 2011.
75 FR 76991Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ONGLYZA
Federal Register · Notice · Aug 31, 2010
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 : December 8, 2001.
75 FR 53315Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; AMPYRA
Federal Register · Notice · Mar 9, 2011
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 5, 2011.
76 FR 12974Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; DEXILANT
Federal Register · Notice · Jun 23, 2011
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 FD&C Act) (21 U.S.C. 355(i)) became effective: July 2, 2004.
76 FR 36929Health and Human Services DepartmentFood and Drug Administration
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