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Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease
Federal Register · Rule · Oct 26, 1999
This new law amended the Federal Food, Drug, and Cosmetic Act (the act) in a number of important ways. … before January 1, 1958, in conformance with Sec. 201(s) of the act.
64 FR 57700Final RuleHealth and Human Services DepartmentSubstances Affirmed as Generally Recognized as Safe: Menhaden Oil
Federal Register · Rule · Jun 5, 1997
FDA received three comments, two from manufacturers and one from a government agency. All of the comments supported the affirmation of GRAS status for use of the oils in food. … studies that used 3 g/d EPA plus DHA for 6 weeks (Ref. 42) and 2.7 g/d EPA plus DHA for 8 weeks (Ref. 43) found only transient increases in blood glucose halfway through their respective supplementation periods
62 FR 30751Health and Human Services DepartmentFood and Drug AdministrationCenter for Devices and Radiological Health Radiation Sterilization Master File Pilot Program
Federal Register · Notice · Apr 12, 2023
The Radiation Pilot Program participants may comment on and discuss their experiences with the Center. II. … Paperwork Reduction Act of 1995 This notice refers to previously approved collections of information found in FDA regulations.
88 FR 22040Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Mar 3, 2014
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by April 2, 2014, (see the “Paperwork Reduction Act of 1995” section of this document). … Paperwork Reduction Act of 1995 VII. Federalism VIII. Comments IX.
79 FR 11990Health and Human Services DepartmentFood and Drug AdministrationHuman Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing
Federal Register · Rule · Jan 19, 2001
under the act and/or section 351 of PHS Act. … One comment noted that it is unlikely that the components processed by individual laboratories will change greatly over a 12-month period.
66 FR 5447Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Quality System Regulation Amendments
Federal Register · Proposed Rule · Feb 23, 2022
Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 (PRA) by March 25, 2022. … 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 May 24, 2022.
87 FR 10119Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 3, 2026
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets … On June 30, 2022, Vanda requested an opportunity for a hearing under 21 CFR 314.110(b)(3) on whether there are grounds under section 505(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C
91 FR 33174Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Health Claims; Soluble Fiber from Certain Foods and Coronary Heart Disease
Federal Register · Proposed Rule · May 22, 1997
This new law amended the Federal Food, Drug, and Cosmetic Act (the act) in a number of important ways. … Comments Interested persons may, on or before August 5, 1997, submit to the Dockets Management Branch (address above) written comments regarding this proposal.
62 FR 28234Health and Human Services DepartmentFood and Drug AdministrationGrocery Manufacturers Association; Denial of Food Additive Petition
Federal Register · Proposed Rule · May 21, 2018
be safely used (section 409(b)(1) of the FD&C Act). … Seven comments expressed opposition to the petition, one comment was about labeling of PHOs, one comment did not pertain to the petition, and one comment was a duplicate submission.
83 FR 23382Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 4, 1997
Submission of Comments Interested persons may, on or before December 3, 1997, submit to the Dockets Management Branch (address above) written comments regarding this proposal. … Two copies of any comments are to be submitted except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document.
62 FR 46686Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 16, 2005
FDA's authority to enter into grants and cooperative agreements is detailed under title XVII of the Public Health Service Act (42 U.S.C. 300u-1) or the Radiation Control for Health and Safety Act of 1968 … FDA does not guarantee to accommodate or explain SPOC comments that are received after the 60-day cutoff. 5. Funding Restrictions See section IV.2.B of this document. 6.
70 FR 35103Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3
Federal Register · Rule · Aug 12, 2014
Follow the instructions for submitting comments. … We have not received any new information or comments that would affect our previous determination. VI. Paperwork Reduction Act of 1995 This final rule contains no collection of information.
79 FR 46993Health and Human Services DepartmentFood and Drug AdministrationMicro-Tracers, Inc.; Response to Objections and Requests for a Public Hearing
Federal Register · Rule · Aug 5, 2026
(FD&C Act) (21 U.S.C. 371(e)(2)) as of February 18, 2025. … However, because these comments, dated November 13, 2023, were submitted after the comment period closed on May 18, 2023 (88 FR 19026, March 30, 2023), they were not included in the docket.
91 FR 50475Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 10, 2000
501(a)(2)(C) of the act (21 U.S.C. 351(a)(2)(C)) (i.e., that comply with United States Pharmacopeia (USP) PET compounding standards and monographs) for a period of 4 years after the date of enactment … However, the act does not prohibit the voluntary submission and FDA review of applications before these time periods expire.
65 FR 12999Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 1, 1995
DATES: Written comments by January 2, 1996. … ``You ought to change it periodically.
60 FR 61670Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 31, 2020
4) and (5) of the FD&C Act. 4 Section 503B(d)(4)(C) of the FD&C Act. … rationale for such proposal; (2) providing a period of not less than 60 calendar days for comment on the notice; and (3) publishing a notice in the Federal Register designating bulk drug substances
85 FR 46126Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 28, 1995
Comments are requested on this tentative conclusion. … Comments are requested on the placement of this heading.
60 FR 67194Health and Human Services DepartmentHealth and Human Services DepartmentFederal Register · Notice · Sep 13, 2022
SUMMARY: As required by the 21st Century Cures Act (Cures Act), the Food and Drug Administration (FDA, Agency, or we) is finalizing a list of alternative or streamlined mechanisms for complying with the … In December 2016, the Cures Act (Pub. L. 114-255) was signed into law.
87 FR 56066Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 5, 2019
ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. … 1—Summary of Benefits, Costs, and Distributional Effects of the Proposed Rule Category Primary estimate Low estimate High estimate Units Year dollars Discount rate Period
84 FR 46688Health and Human Services DepartmentFood and Drug AdministrationListing of Color Additives Exempt From Certification; Haematococcus Algae Meal
Federal Register · Rule · Jul 6, 2000
Paperwork Reduction Act of 1995 This final rule contains no collections of information. … Kitahara, T., “Carotenoids in the Pacific Salmon During the Marine Period,” Comprehensive Biochemistry and Physiology , 78B:859-862, 1984. 4. Mori, T., K. Makabe, K. Yamaguchi, S.
65 FR 41581Health and Human Services DepartmentFood and Drug Administration
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