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Federal Register · Notice · Oct 9, 1998
FQPA amended both the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the Federal Food, Drug, and Cosmetic Act (FFDCA). … If EPA were writing on a clean slate, it perhaps would classify coloring differently.
63 FR 54532Legal and Policy Interpretation of the Jurisdiction Under the FederalFood, Drug, and Cosmetic Act of the Food and Drug Administration andFederal Register · Proposed Rule · Nov 16, 2000
of the Federal Food, Drug, and Cosmetic Act (the act) which apply to drugs (21 U.S.C. 201 et seq .). … Act of 1995 (the PRA) (44 U.S.C. 3501-3520).
65 FR 69378Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 5, 2003
(the act). … FDA is providing a period of 90 days from the date of publication of this proposed rule in the Federal Register for comments on this subject to be developed and submitted.
68 FR 46133Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 27, 2005
FDA is publishing this document in accordance with section 701(e)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 371(e)(1)), which directs the Secretary of Health and Human Services … FDA is publishing this document in accordance with section 701(e)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C 371(e)(1)), which directs the Secretary of Health and Human Services
70 FR 56409Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 28, 2007
Several provisions of this act affect the PMA process, such as section 515(d)(6) of the act. … Thus, FDA estimates that the periodic reporting burden required by this section will take 340 hours.
72 FR 35494Health and Human Services DepartmentFood and Drug AdministrationPilot Project Program Under the Drug Supply Chain Security Act; Request for Comments
Federal Register · Notice · Jul 20, 2017
FDA-2016-N-0407 for “Pilot Project Program under the Drug Supply Chain Security Act; Request for Comments.” … Each pilot project is expected to be completed within the proposed duration time period. This time period does not include an additional 30-days for completion of a final report (see section G.
82 FR 33497Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 6, 2007
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 … Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy.
72 FR 37027Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 12, 2015
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, including each proposed … Under § 314.80(c)(2), applicants must provide periodic reports of adverse drug experiences.
80 FR 13009Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 19, 2011
We are requesting that OMB extend approval for the information in this collection, as described below, which will continue to be submitted to FDA during this multi-year period. … David Dorsey, Acting Associate Commissioner for Policy and Planning. [FR Doc. 2011-32397 Filed 12-16-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 78668Health and Human Services DepartmentFood and Drug AdministrationFood Labeling; Health Claims; Dietary Noncariogenic Carbohydrate Sweeteners and Dental Caries
Federal Register · Rule · Sep 17, 2007
Baseline plaque pH was measured over a 15 minute period following a 3 minute period of chewing paraffin. … FDA invites public comment on this interim final rule. The agency will consider modifications to this interim final rule based on comments made during the comment period.
72 FR 52783Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 29, 2023
of the FD&C Act. … No comments were received.
88 FR 42080Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 9, 2017
Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine business practice. … Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine business practice.
82 FR 52055Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 25, 2009
for public comment in response to the notice. … The quality of pregnancy registry data is enhanced by enrollment of women early in their pregnancy and by complete follow up of all enrolled pregnancies to the end of the registry study period.
74 FR 42901Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted for Direct Addition to Food for Human Consumption; Advantame
Federal Register · Rule · May 21, 2014
Comments IV. Conclusion V. Public Disclosure VI. Environmental Impact VII. Paperwork Reduction Act of 1995 VIII. Section 301( ll ) of the FD&C Act IX. Objections X. References I. … Comments We received two comments in response to the advantame food additive petition.
79 FR 29078Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jan 16, 2018
Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. … These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
83 FR 2057Health and Human Services DepartmentFood and Drug AdministrationKnickerbocker Biologicals, Inc.; Revocation of U.S. License No. 458-001
Federal Register · Notice · Jun 19, 1998
The notice provided other interested persons with 60 days to submit written comments on the proposed revocation. … No comments were received from any other parties within the 60-day time period.
63 FR 33680Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 23, 2018
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 … Panel members will be asked to participate in up to eight experimental and observational studies over the 3-year panel commitment period.
83 FR 53485Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 21, 2000
DATES: Submit written comments by June 5, 2000. … Dotzel, Acting Associate Commissioner for Policy. [FR Doc. 00-9942 Filed 4-20-00; 8:45 am] BILLING CODE 4160-01-F
65 FR 21446Health and Human Services DepartmentFood and Drug AdministrationRevision of the Requirements for Live Vaccine Processing; Companion to Direct Final Rule
Federal Register · Proposed Rule · Oct 18, 2007
The comment period for this companion proposed rule runs concurrently with the comment period for the direct final rule. … response in a notice-and-comment process in accordance with section 553 of the Administrative Procedure Act (5 U.S.C. 553).
72 FR 59041Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 25, 2011
FDA now intends to complete the notice and comment rulemaking process for the Patient Protection and Affordable Care Act of 2010 (hereinafter “section 4205”) before initiating enforcement activities based … , in part, on extensive comments on the draft guidance submitted to the Agency.
76 FR 4360Health and Human Services DepartmentFood and Drug Administration
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