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New Animal Drug Applications
Federal Register · Proposed Rule · Oct 23, 2009
If FDA receives any significant adverse comments, the agency will publish a document withdrawing the direct final rule within 30 days after the comment period ends. … The comment period for this companion proposed rule runs concurrently with the comment period for the direct final rule.
74 FR 54771Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; IXIARO
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 54888Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; ACTEMRA
Federal Register · Notice · May 31, 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 November 28, 2011.
76 FR 31349Health and Human Services DepartmentFood and Drug Administration
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E
Federal Register · Rule · Mar 18, 2019
(FD&C Act) (21 U.S.C. 342). … subject to the longer compliance period.
84 FR 9706Health and Human Services DepartmentFood and Drug Administration
Beverages: Bottled Water; Companion Document to Direct Final Rule
Federal Register · Proposed Rule · May 11, 1998
The comment period for the companion proposed rule runs concurrently with the comment period of the direct final rule. … The comment period for this companion proposed rule runs concurrently with the comment period for the direct final rule.
63 FR 25789Health and Human Services DepartmentFood and Drug Administration
National Environmental Policy Act; Food Contact Substance Notification System
Federal Register · Rule · May 11, 2000
The comment period for the direct final rule runs concurrently with the comment period of the companion proposed rule. … This comment period runs concurrently with the comment period for the companion proposed rule. Two copies of any comment are to be submitted, except that individuals may submit one copy.
65 FR 30352Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; AUBAGIO-Patent No. 5,679,709
Federal Register · Notice · Apr 15, 2015
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … 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.
80 FR 20227Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; KYNAMRO
Federal Register · Notice · Apr 24, 2015
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … 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.
80 FR 23035Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; STIVARGA
Federal Register · Notice · May 22, 2015
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … 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.
80 FR 29723Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; COMETRIQ
Federal Register · Notice · Apr 22, 2015
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … 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.
80 FR 22528Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; HALAVEN
Federal Register · Notice · May 3, 2012
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: April 30, 2003.
77 FR 26288Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; NATROBA
Federal Register · Notice · Apr 6, 2012
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 3, 2012.
77 FR 20829Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; ORTHO-EVRA
Federal Register · Notice · Feb 6, 2004
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: May 31, 1996.
69 FR 5859Health and Human Services DepartmentFood and Drug Administration
Sunscreen Drug Products for Over-the-Counter Human Use; Request for Data and Information Regarding Dosage Forms; Extension of Comment Period
Federal Register · Proposed Rule · Sep 14, 2011
The comment period for that ANPRM will end on September 15, 2011. This document extends the comment period to October 17, 2011. … FDA is extending the comment period to end on October 17, 2011. A total comment period of 4 months is sufficient for the public to submit comments to the ANPRM. III.
76 FR 56682Health and Human Services DepartmentFood and Drug Administration
Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents
Federal Register · Rule · Aug 28, 1996
Clean for household products, and the Peanuts characters for life insurance. … period.
61 FR 44396Regulations Restricting the Sale and Distribution of Cigarettes andHealth and Human Services Department
Medical Devices; 30-Day Notices and 135-Day PMA Supplement Review; Companion Document to Direct Final Rule
Federal Register · Proposed Rule · Apr 27, 1998
The comment period for this companion proposed rule runs concurrently with the direct final rule's comment period. … This 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 20558Health and Human Services DepartmentFood and Drug Administration
Modified Risk Tobacco Product Application: Application for the IQOS 3 System Holder and Charger Submitted by Philip Morris Products S.A.
Federal Register · Notice · May 14, 2021
DATES: Electronic or written comments on the application may be submitted beginning May 14, 2021. FDA will establish a closing date for the comment period as described in section I. … FDA believes that this comment period is appropriate given the relatively low volume of information in the MRTPA that has not already been available for public comment as part of the previously authorized
86 FR 26530Health and Human Services DepartmentFood and Drug Administration
Privacy Act, Exempt Record System
Federal Register · Rule · Aug 28, 2012
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.
77 FR 51910Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; Arctic Front Cryocatheter System
Federal Register · Notice · Jun 12, 2014
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … 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 33762Health and Human Services DepartmentFood and Drug Administration
Determination of Regulatory Review Period for Purposes of Patent Extension; IMMITICIDERegister
Federal Register · Notice · Mar 18, 1996
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.- A regulatory review period consists of two periods of time: … period.
61 FR 11054Health and Human Services DepartmentFood and Drug Administration

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