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Federal Register · Notice · Dec 17, 2012
The basis for the proposal is that the sponsors have repeatedly failed to file required periodic reports for these applications. … Any other interested person may also submit comments on this notice.
77 FR 74672Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Health Claims; D-tagatose and Dental Caries
Federal Register · Rule · Jul 3, 2003
Comments from seven consumers were sent to this docket during the comment period, none of which were relevant to this rulemaking. … No comments from State or local government entities were received.
68 FR 39831Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 13, 2002
Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each … During that 4-year period, an average of five antimicrobial NADAs (including original and major supplements) were approved in food-producing animals per year.
67 FR 58058Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 9, 2014
Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each … Comments The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time.
79 FR 73081Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities: Proposed Collection; Comment Request
Federal Register · Notice · Apr 8, 1998
Statutory authority for this collection of information is found in section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262). … In the interim period, the old Form FDA 356h and the new Form FDA 356h were to be acceptable alternatives for NDA's, ANDA's, AADA's, and BLA's.
63 FR 17183Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 20, 2017
Section 301(a) of the FD&C Act (21 U.S.C. 331(a)) prohibits the introduction or delivery for introduction into interstate commerce of adulterated food. … The records of processing information are periodically reviewed during factory inspections by FDA to verify fulfillment of the requirements in parts 113 or 114.
82 FR 28069Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 12, 1999
The comments in the docket will be periodically reviewed, and, where appropriate, the guidances will be amended. … Dotzel, Acting Associate Commissioner for Policy. [FR Doc. 99-26501 Filed 10-8-99; 8:45 am] BILLING CODE 4160-01-F
64 FR 55293Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 20, 2024
Legal Authority FDA is taking this action under the general administrative provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). … of Benefits, Costs and Distributional Effects of Proposed Rule Category Primary estimate Low estimate High estimate Units Year dollars Discount rate (%) Period
89 FR 77062Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 1, 2019
Implants are medical devices that are placed into a surgically or naturally formed opening of the human body and are intended to remain there after the procedure for an extended period of time (typically … Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: September 25, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy.
84 FR 52111Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 19, 2015
After the comment period is closed, nominations to add or remove bulk drug substances from the list may be submitted to FDA by citizen petition under § 10.30 (21 CFR 10.30). … Follow the instructions for submitting comments.
80 FR 28622Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 9, 2025
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. … In the Federal Register of August 7, 2025 (90 FR 38151) FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
90 FR 57067Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 27, 2014
The comment stated that the Food Safety Modernization Act (FSMA) gave FDA authority “to require producers to implement prevention based food safety standards.” … The comment also noted the periodic scheduling of audits and inspections of hospitals by the regulator.
79 FR 4350Health and Human Services DepartmentFood and Drug AdministrationYong Sheng Jiao: Denial of Application for Termination of Debarment
Federal Register · Notice · Oct 1, 2025
ADDRESSES: Submit comments electronically at https://www.regulations.gov. … Jiao of its proposal to issue an order under section 306(b)(1)(D) of the FD&C Act debarring him for a period of 5 years from importing or offering to import any drug into the United States.
90 FR 47312Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 23, 1997
The comment noted that the period to use labels that state ``manufactured for'' and ``distributed by'' could be easily as long. … FDA is persuaded by the majority of the comments that it is appropriate to have the effective date of this final rule be 18 months from the date of its publication, consistent with the time period allowed
62 FR 49859Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 28, 2012
FDA seeks comment on the following issues related to section 918(a)(2) of the FD&C Act: 2.1. … FDA seeks comment on the following issues related to section 918(a)(3) of the FD&C Act: 3.1.
77 FR 70955Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 16, 2004
Therefore, the physician who elects to use isocarboxazid for extended periods should periodically evaluate the long-term usefulness of the drug for the individual patient. 3. … Any other interested person may also submit comments on this proposal to withdraw approval.
69 FR 20632Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 12, 2023
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 … Therefore, designated countries may respond to our periodic requests by submitting information to confirm their designations remain appropriate.
88 FR 70676Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 4, 2013
Follow the instructions for submitting comments. … FDA cannot guarantee that all drugs nominated during the nomination period will be considered for inclusion on the next published bulk drugs list.
78 FR 72838Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 29, 2023
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. … ) 1 1 1 30 30 Subpart E—Postapproval Requirements: Postapproval requirements (814.82(a)(9)) 121 1 121 135 16,335 Periodic reports (814.84(b)) 764 1 764 10
88 FR 18552Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 11, 2013
Evaluation of FDA's General Market Youth Tobacco Prevention Campaigns—(OMB Control Number 0910-New) The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. … As the cohort will be aging over this time period, the data collected throughout the study will reflect information from youth aged 11 to 18.
78 FR 55725Health and Human Services DepartmentFood and Drug Administration
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