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Federal Register · Notice · Feb 18, 2010
On September 15, 2009 (74 FR 47257), FDA published a notice correcting the length of the comment period, keeping it open until October 1, 2009. … On October 13, 2009 (74 FR 52495), FDA published a notice reopening the comment period until October 26, 2009.
75 FR 7269Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 1, 2025
The statutory authority to collect this information is provided under sections 351 and 361 of the PHS Act (42 U.S.C. 262 and 264) and the provisions of the Federal Food, Drug, and Cosmetic Act that apply … These characteristics include long latency periods and the ability to establish persistent infections.
90 FR 18669Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 29, 2014
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 … FDA received one comment; however, this comment did not address the information collection.
79 FR 64392Health and Human Services DepartmentFood and Drug AdministrationAnimal Drug User Fee Act; Public Meeting; Request for Comments
Federal Register · Notice · Nov 21, 2022
FDA-2011-N-0656 for “Animal Drug User Fee Act; Public Meeting; Request for Comments.” … Section 740A(d)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-13(d)(4)) requires that, after holding negotiations with regulated industry and periodic consultations with stakeholder, and
87 FR 70833Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 10, 2004
Third-party reviews should maintain records of their 510(k) reviews and a copy of the 510(k) for a reasonable period of time, usually a period of 3 years. … In the Federal Register of August 10, 2004 (69 FR 48508), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.
69 FR 65201Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 18, 1998
Section 515(b)(3) of the act provides that FDA shall, after the close of the comment period on the proposed rule and consideration of any comments received, issue a final rule to require premarket approval … Interested persons were given until September 16, 1997, to comment on the proposed rule. During the comment period, the agency received no comments on the proposed rule.
63 FR 44177Health and Human Services DepartmentFood and Drug AdministrationDesignation of New Animal Drugs for Minor Uses or Minor Species
Federal Register · Rule · Jul 26, 2007
In response to this, in the Federal Register of December 28, 2005 (70 FR 76732), FDA reopened the comment period allowing an additional 30 days of public comment. II. … Also in a Federal Register of December 28, 2005, FDA published a notice reopening the comment period for the proposed rule to allow interested persons additional time to comment.
72 FR 41010Health and Human Services DepartmentFood and Drug AdministrationEffective Date of Requirement for Premarket Approval for Four Class III Preamendments Devices
Federal Register · Proposed Rule · Aug 25, 2010
Section 515(b)(3) of the act provides that FDA shall, after the close of the comment period on the proposed rule and consideration of any comments received, issue a final rule to require premarket approval … The act does not permit an extension of the 90-day period after issuance of a final rule within which an application or a notice is required to be filed.
75 FR 52294Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jul 23, 1996
Comments also objected to requiring that the reporter certify all reportable events have been filed on the basis that such a requirement was not specifically required in the act, and that potential liability … The Administrative Procedure Act (Pub.
61 FR 38346Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Oct 26, 2011
We will not consider comments received during the reply comment period that do not identify the specific issue(s) raised during the initial comment period on which the reply comment is based. … It is the Agency's intent to comply with Executive Order 13563 as quickly as possible, so we will not look favorably on requests for extensions of the comment period.
76 FR 66235Health and Human Services DepartmentFood and Drug AdministrationPhibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Opportunity for Hearing
Federal Register · Notice · Apr 12, 2016
Comments Submitted by Other Interested Parties: For all comments submitted by other interested parties you may submit comments as follows: Electronic Submissions Submit electronic comments in the … approved 70-day withdrawal period for carbadox in NADA 092-955.
81 FR 21559Health and Human Services DepartmentFood and Drug AdministrationUniform Compliance Date for Food Labeling Regulations
Federal Register · Rule · Nov 25, 2016
SUPPLEMENTARY INFORMATION: We periodically issue regulations requiring changes in the labeling of food. … We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub.
81 FR 85156Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 20, 2025
Under section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360) and part 807, subparts A through D (21 CFR part 807, subparts A through D), medical device establishment owners … We attribute this adjustment to a decrease in the number of submissions we received over the last approval period. Dated: June 13, 2025. Grace R.
90 FR 26304Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 29, 2017
FDA-2017-N-3199] Program for Enhanced Review Transparency and Communication for Original 351(k) Biologics License Applications in Biosimilar User Fee Act II AGENCY: Food and Drug Administration, … DATES: FDA is providing a period of 30 days for public comment on the statement of work before beginning the assessment.
82 FR 29569Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jan 12, 1999
SUPPLEMENTARY INFORMATION: FDA solicited comments concerning the direct final rule for a 75-day period ending on December 14, 1998. … the comment period.
64 FR 1762Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 17, 2016
Because the cohort aged over the study period, data have been collected from youth aged 11 to 18. … Media Tracking Survey The media tracking survey consists of assessments of youth aged 13 to 18 conducted periodically during the campaign period.
81 FR 39675Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 22, 2018
Background In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing … Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period.
83 FR 23686Health and Human Services DepartmentFood and Drug AdministrationEffective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices
Federal Register · Proposed Rule · Jan 18, 2013
Paperwork Reduction Act of 1995 X. Proposed Effective Date XI. Comments XII. References I. … Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, consideration of any comments received, and a meeting of a device classification
78 FR 4094Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 22, 2016
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, consideration of any comments received, and a meeting of a device classification … The comment period for the proposed rule closed on November 7, 2011.
81 FR 3751Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 19, 2016
The statutory basis for FDA conducting this study is derived from the Public Health Service Act (PHS Act) (42 U.S.C. 243, section 311(a)). … The sample for each data collection period is evenly distributed among Specialists.
81 FR 64168Health and Human Services DepartmentFood and Drug Administration
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