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Determination of Regulatory Review Period for Purposes of Patent Extension; GARDASIL 9
Federal Register · Notice · Dec 7, 2016
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.
81 FR 88245Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 4, 2023
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 31, 2024. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
88 FR 51839Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; PREVNAR-20
Federal Register · Notice · Feb 29, 2024
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, 2024. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
89 FR 14849Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 10, 2023
Legal Authority This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)), which requires Federal Register publication of “notice[ … For the treatment of air sacculitis (air-sac disease, chronic respiratory disease) caused by Mycoplasma gallisepticum and Escherichia coli; fowl cholera caused by Pasteurella multocida; infectious
88 FR 14893Health and Human Services DepartmentFood and Drug AdministrationIrradiation in the Production, Processing and Handling of Food
Federal Register · Rule · Jul 21, 2000
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. … chemical reactions (hereinafter referred to as “radiolysis products”) depend on the chemical constituents of the food and on the conditions of irradiation (e.g., temperature and presence or absence of air
65 FR 45280Health and Human Services DepartmentFood and Drug AdministrationSafety Reporting Requirements for Human Drug and Biological Products
Federal Register · Proposed Rule · Mar 14, 2003
Unfunded Mandates Reform Act of 1995 G. References VI. Paperwork Reduction Act of 1995 A. Expedited Safety Reporting B. Periodic Safety Reports C. Other Reports D. Recordkeeping VII. … under section 505(c) of the act.
68 FR 12406Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 26, 2013
ACTION: Notification; extension of comment period. … We are extending the comment period for the draft RA for 120 days to continue to make the comment period for the draft RA conform to the comment period for the proposed preventive controls rule and the
78 FR 24693Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 28, 2015
The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to give FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public … The term “no-tobacco-sale order” refers to an order prohibiting the sale of tobacco products at a retail outlet indefinitely or for a specified period of time under section 303(f)(8) of the FD&C Act.
80 FR 52299Health and Human Services DepartmentFood and Drug AdministrationAmendment to Examination and Investigation Sample Requirements
Federal Register · Rule · Sep 25, 1998
If any significant adverse comment is received during the comment period, FDA will publish, within 30 days after the comment period ends, a document withdrawing the direct final rule. … If FDA receives no significant adverse comments during the specified comment period.
63 FR 51297Health and Human Services DepartmentFood and Drug AdministrationUniform Compliance Date for Food Regulations
Federal Register · Rule · Sep 23, 1997
The Dietary Supplement Health and Education Act of 1994 (DSHEA) amended the Federal Food, Drug, and Cosmetic Act (the act) to establish a new definition for ``dietary supplement'' in section 201(ff) of … the act (21 U.S.C. 321(ff)).
62 FR 49881Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; REPEL-CV
Federal Register · Notice · Sep 9, 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 March 8, 2011.
75 FR 54887Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Oct 23, 2009
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.
74 FR 54749Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; SAPHRIS
Federal Register · Notice · Sep 10, 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 : March 4, 1997.
75 FR 55331Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; XYZAL
Federal Register · Notice · Jun 24, 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 December 21, 2011.
76 FR 37127Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Mar 8, 1996
DATES: Written comments by June 6, 1996. … Request for Comments Interested persons may, on or before June 6, 1996, submit to the Dockets Management Branch (address above) written comments regarding this proposal.
61 FR 9373Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Mar 25, 2014
ACTION: Proposed rule; extension of comment period. … We also are extending the comment period for the information collection provisions to June 30, 2014, to make the comment period for the information collection provisions the same as the comment period
79 FR 16251Health and Human Services DepartmentFood and Drug AdministrationFood Standards; General Principles and Food Standards Modernization
Federal Register · Proposed Rule · May 20, 2005
Paperwork Reduction Act of 1995 X. Additional Public Notification XI. Comments XII. References I. … the act].
70 FR 29214Agriculture DepartmentFood Safety and Inspection ServiceFederal Register · Proposed Rule · Sep 29, 2008
The comment period for the companion proposed rule runs concurrently with the comment period of the direct final rule. … This comment period runs concurrently with the comment period for the direct final rule; any comments received will be considered as comments regarding the direct final rule.
73 FR 56529Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ULORIC
Federal Register · Notice · Sep 10, 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 : October 31, 1999.
75 FR 55332Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; FOLOTYN
Federal Register · Notice · Dec 20, 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 20, 2011.
75 FR 79381Health and Human Services DepartmentFood and Drug Administration
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