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Federal Register · Notice · Dec 20, 2006
The interim final rule established a 75-day comment period. … notice system, FDA reopened the comment period for 30 days on April 14, 2004 (69 FR 19763), and for an additional 60 days on May 18, 2004 (69 FR 28060), for a total of 165 days.
71 FR 76344Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 22, 2026
We considered all comments on the draft guidance received during the comment period in finalizing the guidance. … Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995
91 FR 30318Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 12, 2008
The Food and Drug Administration Amendments Act of 2007 (FDAAA) includes a requirement that FDA identify and periodically update susceptibility test interpretive criteria for antibacterial drug products … Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each
73 FR 33438Health and Human Services DepartmentFood and Drug AdministrationYong Sheng Jiao; Denial of Hearing; Final Debarment Order
Federal Register · Notice · Jan 8, 2025
In determining the appropriateness and period of Jiao's debarment, FDA considered the relevant factors listed in the FD&C Act. … FDA has considered the applicable factors listed in section 306(c)(3) of the FD&C Act and determined that a debarment period of 5 years is appropriate.
90 FR 1505Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 15, 2018
DATES: Submit either electronic or written comments on the proposed rule by July 16, 2018. ADDRESSES: You may submit comments as follows. … Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 16, 2018.
83 FR 22428Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 19, 2019
Section 130(a) of the Food and Drug Administration Modernization Act (Pub. … L. 105-115) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding a new provision (section 506B of the FD&C Act (21 U.S.C. 356b)) requiring reports of postmarketing studies for approved
84 FR 49310Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 16, 2005
Section 702 of the act (21 U.S.C. 372) authorizes investigational powers to FDA for enforcement of the act. … During this transition period FDA will accept both the newly effective Form FDA 3500A and the prior version of the form.
70 FR 48157Health and Human Services DepartmentFood and Drug AdministrationSecondary Direct Food Additives Permitted in Food for Human Consumption
Federal Register · Rule · Apr 3, 2002
Technical Corrections Act of 1998. … In the notice of filing, FDA gave interested parties an opportunity to submit comments on the petitioner's environmental assessment. FDA received no comments in response to that notice.
67 FR 15719Health and Human Services DepartmentFood and Drug AdministrationSkin Bleaching Drug Products For Over-the-Counter Human Use; Proposed Rule
Federal Register · Proposed Rule · Aug 29, 2006
Paperwork Reduction Act of 1995 VI. Environmental Impact VII. Federalism VIII. Request for Comments IX. Proposed Effective Date X. References I. … Comment No. LET2. 11. Comment No. MM1. 12. Comment No. RPT3. 13. Comment No. RPT5. 14. Comment No. MM2. 15. Comment No. MM3. 16. Comment No. LET16. 17. Comment No. C24. 18. Cullison D., D.
71 FR 51146Health and Human Services DepartmentFood and Drug AdministrationAnimal Drug Availability Act; Veterinary Feed Directive
Federal Register · Proposed Rule · Jul 2, 1999
)(6) of the act. … comment period.
64 FR 35966Health and Human Services DepartmentFood and Drug AdministrationJustin Insprucker: Final Debarment Order
Federal Register · Notice · Feb 19, 2026
SUMMARY: The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Justin Insprucker for a period of 5 years from importing … In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that the Agency considered applicable to Mr.
91 FR 8006Health and Human Services DepartmentFood and Drug AdministrationGuidance Documents Related to Coronavirus Disease 2019; Availability
Federal Register · Notice · Sep 9, 2020
Therefore, FDA will issue COVID-19-related guidance documents for immediate implementation without prior public comment (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) … the availability of certain COVID-19-related guidances FDA issued during the relevant period, as included in table 1.
85 FR 55678Health and Human Services DepartmentFood and Drug AdministrationGuidance Documents Related to Coronavirus Disease 2019 (COVID-19); Availability
Federal Register · Notice · Oct 16, 2020
Therefore, FDA will issue COVID-19-related guidances for immediate implementation without prior public comment (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C … availability of certain COVID-19-related guidances that FDA issued during the relevant period, as included in table 1.
85 FR 65820Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 31, 2019
(FD&C Act) (21 U.S.C. 355-1(e)(4))). … We define an additional fill as a second prescription fill for an opioid analgesic in a short period after the first fill.
84 FR 25283Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 11, 2018
Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed … Under § 314.80(c)(2), applicants must provide periodic reports of adverse drug experiences.
83 FR 32132Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jun 19, 2013
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 … For intra-aortic balloon and control system devices, the preamendments class III devices that are the subject of this proposal, the later of these two time periods is the 90-day period.
78 FR 36702Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 3, 2012
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by February 2, 2012, (see section “VI. Paperwork Reduction Act of 1995” of this document). … The 180-day period is not to be extended for any reason, including any determination made under section 505(q)(1)(A) of the FD&C Act regarding delay of approval of an application, the submission of comments
77 FR 25Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 18, 2012
Background Section 409 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348) establishes a premarket approval requirement for “food additives;” section 201(s) of the FD&C Act (21 … In the Federal Register of December 28, 2010 (75 FR 81536) (the GRAS reopener), FDA announced the reopening of the comment period for the 1997 proposed rule.
77 FR 2552Health and Human Services DepartmentFood and Drug AdministrationHarpreet Singh: Final Debarment Order
Federal Register · Notice · Mar 13, 2025
SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Harpreet Singh for a period of 10 years from importing or offering … In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that it considered applicable to Mr.
90 FR 11986Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 12, 2018
Paperwork Reduction Act of 1995 I. … When FDA conducts rulemaking, it normally does so using notice-and-comment procedures established under the Administrative Procedure Act (APA) and FDA regulations.
83 FR 46104Health and Human Services DepartmentFood and Drug Administration
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