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Federal Register · Notice · Nov 13, 2009
FDA-2008-N-0488] Medical Devices: Ophthalmic Devices; Laser-Assisted In Situ Keratomileusis (LASIK) Devices; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. … Jeffrey Shuren, Acting Director, Center for Devices and Radiological Health. [FR Doc. E9-27222 Filed 11-12-09; 8:45 am] BILLING CODE 4160-01-S
74 FR 58640Health and Human Services DepartmentFood and Drug AdministrationRevising the Announcement Procedures for Approvals and Denials of Premarket Approval Applications
Federal Register · Rule · Jan 30, 1998
Interested persons were given until September 25, 1997, to comment on the proposed regulation. … Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period.
63 FR 4571Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 14, 2011
(the FD&C Act). … Because FDA may request additional information from the applicant during the review period, we have also included in this estimate time to prepare any additional information.
76 FR 13629Health and Human Services DepartmentFood and Drug AdministrationSami Anwar; Denial of Hearing; Final Debarment Order
Federal Register · Notice · Feb 2, 2023
Follow the instructions for submitting comments. An application submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. … For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389
88 FR 7093Health and Human Services DepartmentFood and Drug AdministrationRahim Shafa; Denial of Hearing; Final Debarment Order
Federal Register · Notice · Aug 31, 2026
Shafa is subject to mandatory debarment under section 306(a)(2)(B) of the FD&C Act and permissive debarment under section 306(b)(3)(C) of the FD&C Act, FDA then must determine the debarment period for … Shafa during his period of debarment (section 306(c)(1)(B) of the FD&C Act). Additionally, as a result of the foregoing findings, Dr.
91 FR 55886Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 23, 2015
What issues did the comments raise? What are FDA's responses to the comments? We invited public comment on the proposed rule. The comment period closed on July 1, 2013. … This will allow the industry to make any needed reformulations and label changes to their infant formula products in the 12-month period that the comment identified as cost effective and timely for needed
80 FR 35834Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 8, 2011
(the FD&C Act) (21 U.S.C. 379g and 379h). … Because FDA may request additional information from the applicant during the review period, we have also included in this estimate time to prepare any additional information.
76 FR 40375Health and Human Services DepartmentFood and Drug AdministrationDefinition of the Term “Biological Product”
Federal Register · Proposed Rule · Dec 12, 2018
Act, subject to certain exceptions during a 10-year transition period ending on March 23, 2020 (see sections 7002(e)(1) through (3) and (e)(5) of the BPCI Act). … History of the Rulemaking On October 5, 2010, the Agency published a notice of public hearing and request for comments concerning implementation of the BPCI Act (75 FR 61497).
83 FR 63817Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 21, 2022
The comment period closed on September 10, 2021. FDA received no comments on the draft guidance. The Agency made minor editorial changes to the guidance to improve clarity. … Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information.
87 FR 36864Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 24, 2020
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. … Specifically, we are including Form FDA 766 “Application for Authorization to Relabel or to Perform Other Action of the Federal Food, Drug, and Cosmetic Act and Other Related Acts” (currently approved
85 FR 23048Health and Human Services DepartmentFood and Drug AdministrationUse of Materials Derived From Cattle in Human Food and Cosmetics
Federal Register · Rule · Jul 14, 2004
FDA invites public comment on this interim final rule. The comment period on this interim final rule will be 90 days. … The agency will consider modifications to this interim final rule based on comments made during the comment period.
69 FR 42256Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 12, 2021
The meeting and written comments submitted to the docket will provide critical input as the Agency prepares for reauthorization discussions. … Notification of Intent To Participate in Periodic Stakeholder Consultation Meetings If you intend to participate in continued periodic stakeholder consultation meetings regarding AGDUFA reauthorization
86 FR 18987Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 12, 2021
The meeting and written comments submitted to the docket will provide critical input as the Agency prepares for reauthorization discussions. … Notification of Intent To Participate in Periodic Stakeholder Consultation Meetings If you intend to participate in continued periodic stakeholder consultation meetings regarding ADUFA reauthorization
86 FR 18991Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 13, 2018
(OPEN Government Act) and the FOIA Improvement Act of 2016 (FOIA Improvement Act). … 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 November 13, 2018.
83 FR 46437Health and Human Services DepartmentFood and Drug AdministrationCrabmeat; Amendment of Common or Usual Name Regulation
Federal Register · Proposed Rule · Apr 23, 1998
(the act) (21 U.S.C. 343(b)). … Comments Interested persons may on or before July 7, 1998, submit to the Dockets Management Branch (address above) written comments regarding this proposal.
63 FR 20148Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 8, 2013
FDA-2013-N-0196] Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for Comments AGENCY: Food and Drug Administration, HHS. … The comment period will remain open for 60 days following the publication of this notice. After consideration of public comments, FDA will finalize the plan.
78 FR 15019Health and Human Services DepartmentFood and Drug AdministrationWojciech Lesniak: Final Debarment Order
Federal Register · Notice · Feb 27, 2023
SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Wojciech Lesniak for a period of 5 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.
88 FR 12381Health and Human Services DepartmentFood and Drug AdministrationMedical Device Warning Letter Draft Pilot; Availability
Federal Register · Notice · Aug 27, 1998
The draft pilot includes eligibility criteria and procedures for the issuance of warning letters and will not be implemented until after the public comment period has expired. … This draft pilot will be evaluated by FDA at the end of the 18- month period.
63 FR 45821Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 24, 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. … of the FD&C Act.
86 FR 11303Health and Human Services DepartmentFood and Drug AdministrationMedical Device De Novo Classification Process
Federal Register · Proposed Rule · Dec 7, 2018
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by January 7, 2019. ADDRESSES: You may submit comments as follows. … • An investigation period description to assist FDA in assessing whether the clinical investigation period is applicable to the target population.
83 FR 63127Health and Human Services DepartmentFood and Drug Administration
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