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Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments
Federal Register · Notice · Oct 30, 2020
In addition, FDA will provide a period of 30 days after the public meeting for the public to submit written comments. … BsUFA was originally enacted in 2012 as the Biosimilar User Fee Act under the Food and Drug Administration Safety and Innovation Act (FDASIA, Pub. L. 112-144) for a period of 5 years.
85 FR 68886Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Apr 24, 2019
Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C)(i)) and § 10.115(g)(2)). … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
84 FR 17081Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 24, 2021
OMB Control Number 0910-0850—Extension Section 2011 of the 21st Century Cures Act of 2016 (Pub. … , the Genetic Information Nondiscrimination Act, the Privacy Act, the Federal Policy for the Protection of Human Subjects (“Common Rule”), etc.) regarding protected health information, patient privacy,
86 FR 11300Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 3, 2005
Postmarketing Adverse Drug Experience Reporting—21 CFR 310.305 and 314.80 (OMB Control Number 09109-0230)—Extension Sections 201, 502, 505, and 701 of the Federal Food, Drug, and Cosmetic Act (the act … Under § 314.80(c)(2) applicants must provide periodic reports of adverse drug experiences.
70 FR 22882Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 25, 2002
Postmarketing Adverse Drug Experience Reporting—21 CFR 310.305 and 314.80 (OMB Control No. 0910-0230)—Extension Sections 201, 502, 505, and 701 of the Federal Food, Drug, and Cosmetic Act (the act) (21 … Under § 314.80(c)(2) applicants must provide periodic reports of adverse drug experiences.
67 FR 8545Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 9, 2021
The report must cover the period of the preceding calendar year and include separate information for each month of the calendar year. … Animal drug manufacturers are already required to maintain distribution records for their animal drug products to comply with FDA's current good manufacturing regulations for periodic drug reports under
86 FR 62178Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 3, 1999
The period for public comment on the proposed regulations closed on September 13, 1999, and FDA is currently reviewing the comments and preparing a final rule. … The comment period for the draft guidance closed on August 27, 1999, and FDA has considered these comments when preparing the guidance that is the subject of this request for emergency processing.
64 FR 59776Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Apr 28, 1995
(the act) (21 U.S.C. 321(m)). … current technology and to evaluate this information in light of comments received during the extended comment period.
60 FR 20897Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 17, 1997
If FDA does not initiate such a proceeding, 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, … 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.
62 FR 38231Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 25, 2021
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. … After the initial outreach, we will request updates to the information periodically to keep the data current and accurate.
86 FR 28116Health and Human Services DepartmentFood and Drug AdministrationGuidance for Industry on Monoclonal Antibodies Used as Reagents in Drug Manufacturing; Availability
Federal Register · Notice · Mar 29, 2001
All comments received during the comment period have been carefully reviewed and incorporated in this revised guidance where appropriate. … As a result of public input during the comment period, the final guidance is clearer and more concise than the draft version.
66 FR 17184Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 22, 1999
DATES: Submit written comments by October 20, 1999; written comments on the agency's economic impact determination by October 20, 1999. … The agency considered but rejected several labeling alternatives: (1) A shorter implementation period, and (2) an exemption from coverage for small entities.
64 FR 39452Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 28, 2006
This document provides the preliminary results of the agency's review and requests stakeholder comments to fulfill the act's requirement for stakeholder consultation prior to the agency's final determination … During this period, FDA has continued to classify and assign many new products not specifically covered by the ICAs.
71 FR 56988Health and Human Services DepartmentFood and Drug AdministrationSherrie R. McCain: Final Debarment Order
Federal Register · Notice · Feb 19, 2026
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 Ms. … FDA finds that the offense 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.
91 FR 8003Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 24, 2003
To ensure that comments on the information collection are received, OMB recommends that comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for … In the Federal Register of July 28, 2003 (68 FR 44341), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.
68 FR 65937Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Apr 28, 2014
Summary of Comments and Agency's Responses We invited comments on the proposed rule. The comment period closed on February 11, 2008. We received 19 comments, each containing one or more issues. … We agree with the comments requesting a transition period.
79 FR 23262Health and Human Services DepartmentFood and Drug AdministrationAnimal Generic Drug User Fee Act; Public Meeting; Request for Comments
Federal Register · Notice · Dec 5, 2012
FDA-2011-N-0655] Animal Generic Drug User Fee Act; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meeting; request for comments. … AGDUFA Achievements AGDUFA I established increasingly stringent review performance goals over a 5-year period from FY 2009 through FY 2013.
77 FR 72359Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Mar 19, 2019
The comment period on both installments of the draft guidance is open until July 5, 2019, for comments to be considered before work in begun on a final guidance. 1 1 Under FDA's Good Guidance … The meeting will be held during the comment period on the draft guidance.
84 FR 9987Health and Human Services DepartmentFood and Drug AdministrationBiological Products; Reporting of Errors and Accidents in Manufacturing
Federal Register · Proposed Rule · Sep 23, 1997
Reporting Period FDA is proposing to amend Sec. 600.14(a) to replace the term ``promptly'' with a reporting period of ``as soon as possible but not to exceed 45 calendar days.'' … Request for Comments Interested persons may, on or before December 22, 1997, submit to the Dockets Management Branch (address above) written comments regarding this proposal, except that comments
62 FR 49642Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 6, 2017
During the open comment period following this first panel, we will specifically invite comment about whether there are any considerations specific to certain classes or types of ingredients that should … The topics discussed at the public meeting, both during the panel discussions and during open public comment periods, as well as written comments submitted after the meeting, will help us determine how
82 FR 42098Health and Human Services DepartmentFood and Drug Administration
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