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Federal Register · Notice · Oct 11, 2011
Background In Title I of the Food and Drug Administration Amendments Act of 2007 (Pub. … After the close of the public comment period, FDA intends to publish a draft guidance describing the best test methods for proprietary name evaluation. II.
76 FR 62813Health and Human Services DepartmentFood and Drug AdministrationTimothy Baxter; Final Order Announcing Termination Date of Debarment
Federal Register · Notice · Feb 29, 2024
ADDRESSES: Submit comments electronically at https://www.regulations.gov. … Timothy Baxter pursuant to section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C. 335a(b)(2)(B)(i)(I)) for a period of 5 years from providing services in any capacity to a person with an approved or pending
89 FR 14861Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Ingredient Labeling of Dietary Supplements That Contain Botanicals
Federal Register · Rule · Aug 28, 2003
If FDA receives no significant adverse comments within the specified comment period, the agency intends to publish a document in the Federal Register confirming the effective date of this direct final … This comment period runs concurrently with that for the companion proposed rule.
68 FR 51693Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 31, 2006
DATES: Fax written comments on the collection of information by November 30, 2006. … 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 Officer
71 FR 63768Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 19, 2026
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 … The regulations were issued under FDA's statutory authority to regulate food safety, including section 402(a)(1) and (4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) and (4)).
91 FR 8010Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments
Federal Register · Notice · Feb 6, 2026
FDA will review any comments submitted within the 60-day comment period and will consider whether the list of class II devices should be modified prior to publication of its final determination in the … Additionally, FDA must provide at least a 60-day comment period for any such notice published under section 510(m)(1)(A) of the FD&C Act.
91 FR 5485Health and Human Services DepartmentFood and Drug AdministrationColor Additive Certification; Increase in Fees for Certification Services
Federal Register · Rule · Nov 8, 2024
Summary of Comments to the Proposed Rule The proposed rule provided a 60-day comment period. … Based on a request from stakeholders, we re-opened the comment period for an additional 45 days (88 FR 4117 (January 24, 2023)).
89 FR 88635Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 23, 1999
DATES: Submit written comments on the collection of information by August 23, 1999. … In the Federal Register of March 4, 1999 (64 FR 10470), the agency requested comments on the proposed collections of information. No comments were received.
64 FR 40008Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Oct 3, 2005
The interim final rule responded to comments from the public on the proposed rule, and established a 75-day comment period on a limited set of issues identified in the interim final rule and also set out … system, FDA reopened the comment period on the same limited set of issues for 30 days on April 14, 2004 (69 FR 19766).
70 FR 57505Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 27, 2004
(the act) designed to assure the adequate labeling of prescription (Rx) drugs. … Under section 502(a) of the act (21 U.S.C. 352(a)), a drug product is misbranded if its labeling is false or misleading in any particular, and under section 201(n) of the act (21 U.S.C. 321(n)), a drug's
69 FR 3921Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 28, 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. … The annual frequency per response and total annual responses shown are based on the number of MDRs reported during the same period.
86 FR 40593Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 29, 2019
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 … In the Federal Register of September 4, 2019 (84 FR 46544), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
84 FR 65820Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 12, 2018
This figure (4,000 applications) includes labeling for approximately 800 applications submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 505(b)) or section … 351 of the Public Health Service Act (42 U.S.C. 262), 1,200 applications submitted under section 505(j) of the FD&C Act, and 2,000 revised drug product labeling from repackagers and relabelers for approximately
83 FR 6036Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 24, 2014
Application for FDA Approval To Market a New Drug—(OMB Control Number 0910-0001)—Extension Under section 505(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(a)), a new drug … Other interested persons may also submit comments on the notice.
79 FR 16003Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 6, 1999
The Unfunded Mandates Reform Act of 1995 (Pub. … The Small Business Regulatory Enforcement Fairness Act of 1996 (Pub.
64 FR 36516Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 16, 2014
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 … for public comment in response to the notice.
79 FR 62160Health and Human Services DepartmentFood and Drug AdministrationMedical Device User Fee Amendments; Public Meeting; Request for Comments
Federal Register · Notice · Apr 7, 2022
Following discussions with the device industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (FD&C Act) directs FDA to publish the recommendations for the … This notice, the 30-day comment period, and the public meeting will satisfy parts of these requirements. After the public meeting, we will revise the recommendations as necessary.
87 FR 20436Health and Human Services DepartmentFood and Drug AdministrationFinal Determination Regarding Partially Hydrogenated Oils
Federal Register · Notice · Jun 17, 2015
The notice must allow a period of 60 days for comment. … period.
80 FR 34650Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 25, 2023
Subsequent to the close of the 60-day notice public comment period, additional comments were received from internal and external stakeholders through our solicitation of feedback external to the PRA public … comment opportunity.
88 FR 73347Health and Human Services DepartmentFood and Drug AdministrationLabeling of Diphenhydramine-Containing Drug Products for Over-the-Counter Human Use
Federal Register · Rule · Dec 6, 2002
Analysis of Impacts 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 … The agency considered but rejected several alternatives: (1) A shorter or longer implementation period, and (2) an exemption from coverage for small entities.
67 FR 72555Health and Human Services DepartmentFood and Drug Administration
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