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Determination of Regulatory Review Period for Purposes of Patent Extension; ULTIVASUPTM
Federal Register · Notice · Feb 12, 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 6549Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 21, 1997
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … period.
62 FR 44477Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 8, 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 512(j) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(j)) became effective: June 22, 1990.
63 FR 36922Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 27, 2004
The comment period closed on December 3, 2004. … Food, Drug, and Cosmetic Act (21 U.S.C. 350b(a)(2)).
69 FR 77258Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 24, 2013
Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES … under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
78 FR 44573Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 27, 2012
ACTION: Proposed rule; reopening of comment period on specific data. … The proposed rule provided a 90-day period for public comment. The comment period closed June 28, 2010.
77 FR 4273Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Feb 23, 2016
ACTION: Proposed rule; reopening of the comment period. … The period for comments regarding information collection issues under the Paperwork Reduction Act of 1995 remains unchanged, where comments were to be submitted until February 22, 2016 (see 81 FR 3751,
81 FR 8869Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · May 21, 1998
One comment requested that sodium phosphates oral solution products bear a warning against consuming more than 45 mL in a 24-hour period unless directed by a physician. … The agency agrees with the comment that the labeling for sodium phosphates oral solution should include a warning not to ingest more than the recommended dose in a 24-hour period.
63 FR 27836Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 14, 2008
ACTION: Notice; reopening of comment period. … The Controlled Substances Act (21 U.S.C. 811 et seq. ) (Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970) provides that when WHO notifies the United States under Article
73 FR 60705Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Dec 19, 2011
Submit comments on the information collection requirements under the Paperwork Reduction Act of 1995 by January 3, 2012 (see the “Paperwork Reduction Act of 1995” section of this document). … Act of 1995 (Pub.
76 FR 78530Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 17, 2019
This notice solicits comments on electronic drug product reporting for human drug compounding outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). … 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.
84 FR 34184Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Bapten®
Federal Register · Notice · Feb 2, 2000
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 act became effective: June 11, 1982.
65 FR 4982Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 10, 2010
Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d … It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments.
75 FR 32943Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 12, 2010
Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010-8231 Filed 4-9-10; 8:45 am] BILLING CODE 4160-01-S
75 FR 18504Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 14, 2014
L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). … It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document.
79 FR 2453Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; MycobutinSUPTM
Federal Register · Uncategorized Document · Apr 15, 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 505(i) of the Federal Food, Drug, and Cosmetic Act became effective: March 23, 1986.
Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Rotashield®
Federal Register · Notice · Feb 2, 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 4983Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; CELLCEPTRegister
Federal Register · Notice · Dec 7, 1995
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.
60 FR 62865Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; VERLUMASUPTM/SUP
Federal Register · Notice · Jul 10, 1998
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 351 of the Public Health Service Act became effective: June 11, 1987.
63 FR 37397Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; PATANOLSUPTM/SUP
Federal Register · Notice · May 29, 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 29143Health and Human Services DepartmentFood and Drug Administration
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