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Federal 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 AdministrationHealth Claim; Phytosterols and Risk of Coronary Heart Disease
Federal Register · Rule · Feb 21, 2012
DATES: Submit either electronic or written comments by April 23, 2012. ADDRESSES: Submit electronic comments to http://www.regulations.gov. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2012-3940 Filed 2-17-12; 8:45 am] BILLING CODE 4160-01-P
77 FR 9842Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 14, 2011
If the participant wishes to request an opportunity to make an oral presentation during the open public comment period of the hearing, their notice of participation also must include the title of their … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-5943 Filed 3-10-11; 4:15 pm] BILLING CODE 4160-01-P
76 FR 13638Health and Human Services DepartmentFood and Drug AdministrationAdam Michael Nagy: Final Debarment Order
Federal Register · Notice · Dec 15, 2023
SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Adam Michael Nagy for a period of 15 years from importing or … 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 86906Health 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 AdministrationReview of General Biologics and Licensing Regulations
Federal Register · Uncategorized Document · Jun 3, 1994
This review is part of FDA's program to periodically review existing significant regulations. … Under Executive Order 12866, the Paperwork Reduction Act of 1980 (Pub. L. 96-511), and the Regulatory Flexibility Act (Pub.
Health and Human Services DepartmentFood and Drug AdministrationPediatric Studies of Ampicillin Conducted in Accordance With the Public Health Service Act
Federal Register · Notice · Apr 25, 2017
This notice is to announce the 30-day open public comment period on the report. DATES: Submit either electronic or written comments by May 25, 2017. … Availability of Report for Public Comment FDA is announcing the 30-day open public comment period for the report of the pediatric studies of ampicillin that were conducted in accordance with section
82 FR 19065Health 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 · May 1, 2026
FDA will review any comments submitted within the 60-day comment period and will further consider whether the exemption described in this notice should be modified prior to publication of its final determination … FDA must publish in the Federal Register a notice of its intent to exempt the device, or of the petition, and provide a 60-calendar-day period for public comment.
91 FR 23427Health 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 · Dec 12, 2017
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.
82 FR 58403Health and Human Services DepartmentFood and Drug AdministrationAn Evaluation of the Prescription Drug User Fee Act Workload Adjuster; Request for Comments
Federal Register · Notice · May 6, 2013
FDA-2013-N-0418] An Evaluation of the Prescription Drug User Fee Act Workload Adjuster; Request for Comments AGENCY: Food and Drug Administration, HHS. … SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on an assessment of the Prescription Drug User Fee Act (PDUFA) Workload Adjuster conducted by an independent
78 FR 26374Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims
Federal Register · Rule · Jul 11, 2003
FDA acknowledges concerns, expressed in response to the November 2002 notice (67 FR 69171) to reopen the comment period, about the shortness of the comment period and requests to extend the comment … period.
68 FR 41434Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 22, 2021
Administrative Detention and Banned Medical Devices OMB Control Number 0910-0114—Extension FDA has the statutory authority under section 304(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act … This written appeal could include a request for an informal hearing as defined in section 201(y) of the FD&C Act (21 U.S.C. 321(y)).
86 FR 66315Health 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 AdministrationAnimal Drug Availability Act; Veterinary Feed Directive
Federal Register · Rule · Dec 8, 2000
Fairness Act of 1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). … with a zero tolerance because of a carcinogenic concern regardless of whether a withdrawal period is required, or are a veterinary feed directive drug
65 FR 76924Health and Human Services DepartmentFood and Drug AdministrationGuidance for Industry on Bioequivalence Recommendations for Specific Products; Availability
Federal Register · Notice · Jun 11, 2010
For draft BE recommendations, the Federal Register notice will identify a comment period. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010-14036 Filed 6-10-10; 8:45 am] BILLING CODE 4160-01-S
75 FR 33311Health and Human Services DepartmentFood and Drug AdministrationGuidance for Tobacco Retailers on Tobacco Retailer Training Programs; Availability
Federal Register · Notice · Sep 5, 2013
Under each schedule, violators are subject to increasing penalties for multiple violations within prescribed time periods. … Comments Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see ADDRESSES ) or electronic comments to http://www.regulations.gov
78 FR 54657Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 5, 2022
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 report must cover the period of the preceding calendar year and include separate information for each month of the calendar year.
87 FR 26764Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Mammography Quality Standards Act of 1992; Inspection Fees
Federal Register · Notice · Jan 14, 1998
Submit written comments by March 16, 1998. … Request for Comments Although the MQSA does not require FDA to solicit comments on fee exemption, assessment and collection, FDA is inviting comments from interested persons in order to have the benefit
63 FR 2245Food and Drug Administration
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