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Briefs, oral arguments, agency decisions and the Federal Register.
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Ildiko M. Knoll: Final Debarment Order
Federal Register · Notice · Aug 15, 2023
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 Ms. … FDA finds that this pattern of conduct should be accorded a debarment period of 5 years as provided by section 306(c)(2)(A)(iii) of the FD&C Act. As a result of the foregoing finding, Ms.
88 FR 55461Health and Human Services DepartmentFood and Drug AdministrationOncology Center of Excellence Listening Session; Public Meeting; Request for Comments
Federal Register · Notice · Dec 8, 2017
a period for public comment during the time that each Institute is being implemented” (section 1014 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 399g)). … This will serve as the public comment period identified under the Cures Act (section 1014(b) of the FD&C Act). II.
82 FR 58003Health and Human Services DepartmentFood and Drug AdministrationUniform Compliance Date for Food Labeling Regulations
Federal Register · Rule · Dec 21, 2006
SUPPLEMENTARY INFORMATION: FDA periodically issues regulations requiring changes in the labeling of food. … FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).
71 FR 76599Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 20, 2004
Section 505(c)(1) of the act directs FDA, within 180 days after the filing of an application under section 505(b) of the act or an additional period agreed upon by the applicant and the agency, to either … (2) For applications that are human drug applications, as defined in section 735(1)(A) and (B) of the act, or supplements to such applications, as defined in section 735(2) of the act, the 180-day period
69 FR 43351Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 11, 2001
Several comments suggest that under a recent Supreme Court decision it may be a violation of the American with Disabilities Act (“ADA”) to deny HIV-infected patients the right to use their own blood. … Description: FDA is revising the test requirements in part 610 subpart E issued under the authorities of the act and the PHS Act.
66 FR 31146Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 12, 2021
ACTION: Notice of public meeting and request for comments; reopening of the comment period. … All comments previously submitted, do not need to be resubmitted. Dated: April 6, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
86 FR 18988Health and Human Services DepartmentFood and Drug AdministrationPeriodic Review of Existing Regulations; Retrospective Review Under E.O. 13563
Federal Register · Proposed Rule · Apr 27, 2011
As part of this review, FDA also invites comment to help us review our framework for periodically analyzing existing rules. … The Food and Drug Administration Modernization Act of 1997 and, 10 years later, the Food and Drug Administration Amendments Act of 2007 (FDAAA) both modernized certain FDA programs and created new ones
76 FR 23520Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Feb 13, 1998
Period Agency: Food and Drug Administration, HHS. … Action: Proposed rule; reopening of comment period on specific data. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is reopening
63 FR 7331Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 17, 2022
Given that FDA must comply with a court order and that the public can comment both by submitting comments to the docket and by participating in the public meeting, FDA believes that a 60-day comment period … is appropriate and does not intend to grant requests for extension of the comment period.
87 FR 69032Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 6, 2023
Current Good Manufacturing Practice Regulations for Medicated Feeds—21 CFR Part 225 OMB Control Number 0910-0152—Extension Under section 501 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) ( … as to safety, and also that they meet their claimed identity, strength, quality, and purity, as required by section 501(a)(2)(B) of the FD&C Act.
88 FR 7741Health and Human Services DepartmentFood and Drug AdministrationRevisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma
Federal Register · Rule · Aug 6, 2001
FDA stated that the effective date of the direct final rule would be February 11, 2000, unless any significant adverse comment was submitted to FDA during the comment period. … Flexibility Act (5 U.S.C. 601-612) (as amended by subtitle D of the Small Business Regulatory Fairness Act of 1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4
66 FR 40886Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 25, 2026
Tobacco Retailer Training Programs OMB Control Number 0910-0745—Extension Tobacco products are governed by chapter IX of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (sections 900 through 920 … received during the 60-day comment period.
91 FR 9290Health and Human Services DepartmentFood and Drug AdministrationRevision of the Requirements for Live Vaccine Processing; Confirmation of Effective Date
Federal Register · Rule · Mar 7, 2008
FDA stated that the effective date of the direct final rule would be on March 18, 2008, 75 days after the end of the comment period, unless any significant adverse comment was submitted to FDA during the … comment period.
73 FR 12262Health and Human Services DepartmentFood and Drug AdministrationNew Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Order of Prohibition
Federal Register · Rule · Jul 3, 2008
Section 530.25 provides for a public comment period of not less than 60 days. … It also provides that the order of prohibition become effective 90 days after the date of publication, unless we revoke or modify the order, or extend the period of public comment.
73 FR 38110Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 15, 2019
3 years of the close of the comment period and for the remaining 20 percent, within 5 years. … Five years from the comment period close has not yet elapsed for the remaining guidances issued in FY 2015.
84 FR 55158Health and Human Services DepartmentFood and Drug AdministrationAnimal Generic Drug User Fee Act; Public Meeting; Request for Comments
Federal Register · Notice · Sep 20, 2011
; (3) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes; and (4) publish the comments on FDA's Web site. … In general, the meeting format will include presentations by FDA followed by an open public comment period.
76 FR 58277Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 10, 2013
Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days … This notice solicits comments on the information collection associated with the submission of periodic safety reports as described in the guidance entitled “Periodic Benefit-Risk Evaluation Report (PBRER
78 FR 74151Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 18, 2003
Another comment suggested that we limit the time during which NDA holders can submit patent information to a defined time period after we have approved their NDAs. … (Comment 19) Numerous comments challenged our proposed interpretation of the act to permit only one 30-month stay per ANDA or 505(b)(2) application.
68 FR 36676Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 23, 2016
within 3 years of the close of the comment period and for the remaining 20 percent, within 5 years. … Looking forward, in FY 2017, CDRH will strive to finalize, withdraw, or re-open the comment period for 50 percent of existing draft guidances issued prior to October 1, 2011.
81 FR 94382Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 17, 2019
(Tobacco Control Act) (Pub. … Media Tracking Survey The Media Tracking Survey consists of assessments of youth aged 13 to 17 conducted periodically during the campaign period.
84 FR 22499Health and Human Services DepartmentFood and Drug Administration
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