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Briefs, oral arguments, agency decisions and the Federal Register.
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Listing of Color Additives Exempt From Certification; Calcium Phosphate
Federal Register · Rule · May 12, 2025
The panel recognized the likely need for higher recommended daily allowances of phosphorus during periods of rapid growth in children. … Section 301(ll) of the FD&C Act Our review of this petition was limited to section 721 of the FD&C Act. This order is not a statement regarding compliance with other sections of the FD&C Act.
90 FR 20097Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 24, 2020
Basis for Equivalence Determination Under section 432 of the Uruguay Round Agreements Act (URAA), Public Law 103-465, U.S. … Regarding the maintenance of equivalence, both FDA and the EC will carry out periodic onsite evaluations or audits to ensure that equivalence is maintained.
85 FR 60172Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted for Direct Addition to Food for Human Consumption; Olestra
Federal Register · Rule · May 24, 2004
Response to Comment Although section 409 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348) establishes no comment period for FAPs, and the agency generally does not solicit comments in notices … FDA received one comment on the use of olestra in microwave popcorn. The comment and the agency's response follow. A comment from an individual consumer requested that FDA deny the current petition.
69 FR 29428Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 20, 2025
Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). … Such standards are those that FDA has recognized by notice published in the Federal Register or that FDA has decided to recognize but for which recognition is pending (because a periodic notice has
90 FR 13167Health and Human Services DepartmentFood and Drug AdministrationConsumer-Directed Promotion of Regulated Medical Products; Public Hearing
Federal Register · Notice · Sep 13, 2005
Comments about the meeting or comments after the meeting should be submitted to http://www.fda.gov/dockets/ecomments . … This includes, for example, “advertisements in published journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication
70 FR 54054Health and Human Services DepartmentFood and Drug AdministrationWell-Characterized Biotechnology Products; Elimination of Establishment License Application
Federal Register · Proposed Rule · Jan 29, 1996
(PHS Act). … of the act.
61 FR 2733Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 24, 2019
Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). … Such standards are those that FDA has recognized by notice published in the Federal Register or that FDA has decided to recognize but for which recognition is pending (because a periodic notice has
84 FR 57034Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committees; Notice of Meetings
Federal Register · Uncategorized Document · Aug 16, 1994
emphasized, however, that the 1 hour time limit for an open public hearing represents a minimum rather than a maximum time for public participation, and an open public hearing may last for whatever longer period … The Federal Advisory Committee Act (FACA) (5 U.S.C. app. 2, 10(d)), permits such closed advisory committee meetings in certain circumstances.
Health and Human Services DepartmentFood and Drug AdministrationNonprescription Drug Product With an Additional Condition for Nonprescription Use
Federal Register · Proposed Rule · Jun 28, 2022
Submit comments (including recommendations) on information collection issues under the Paperwork Reduction Act of 1995 by July 28, 2022. ADDRESSES: You may submit comments as follows. … Submit comments on information collection issues under the Paperwork Reduction Act of 1995 to the Office of Management and Budget (OMB) at https://www.reginfo.gov/public/do/PRAMain.
87 FR 38313Health and Human Services DepartmentFood and Drug AdministrationIndirect Food Additives: Paper and Paperboard Components
Federal Register · Rule · Jul 24, 1997
Determination of Safety Under the so-called ``general safety clause'' of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348(c)(3)(A)), a food additive cannot be approved for a particular … No comments were received during the 30-day comment period specified in the filing notice for comments on the environmental assessment submitted with the petition. VI.
62 FR 39770Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 15, 2008
FDA received two letters in response to the notice, but the letters contained comments that were not responsive to the four PRA comment requests. … The overall program improvement cycle is a 3-year period for completion of all three management tasks. CHART 1.
73 FR 2500Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Reference Daily Intakes
Federal Register · Proposed Rule · Jan 4, 1994
During the comment period on this proposal, Congress passed, and the President signed into law, the Nutrition Labeling and Education Act of 1990 (Pub. … L. 102-571) (hereinafter referred to as the ``DS act'').
59 FR 427Health and Human Services DepartmentFood and Drug AdministrationIndirect Food Additives: Adhesives and Components of Coatings
Federal Register · Rule · Jul 10, 1998
Determination of Safety Under the so-called general safety clause of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348(c)(3)(A)), a food additive cannot be approved for a particular … No comments were received during the 30-day comment period specified in the May 10, 1990, filing notice for comments on the environmental assessment submitted with the petition. VII.
63 FR 37246Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 16, 2008
To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. … FDA intends to consider information “newly acquired” if it consists of data, analyses, or other information not previously submitted to the agency, or submitted within a reasonable time period prior to
73 FR 2848Health and Human Services DepartmentFood and Drug AdministrationListing of Color Additives Exempt From Certification; Calcium Carbonate
Federal Register · Rule · Sep 27, 2022
From the NHANES data, the petitioner determined that the U.S. population aged 2 years and older consumes two dietary supplements in a 24-hour period at the mean and five at the 90th percentile. … Section 301(ll) of the FD&C Act Our review of this petition was limited to section 721 of the FD&C Act. This final rule is not a statement regarding compliance with other sections of the FD&C Act.
87 FR 58445Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committees; Notice of Meetings
Federal Register · Notice · May 22, 1996
emphasized, however, that the 1 hour time limit for an open public hearing represents a minimum rather than a maximum time for public participation, and an open public hearing may last for whatever longer period … This notice is issued under section 10(a)(1) and (2) of the Federal Advisory Committee Act (5 U.S.C. app. 2), and FDA's regulations (21 CFR part 14) on advisory committees. Dated: May 16, 1996.
61 FR 25682Health and Human Services DepartmentFood and Drug AdministrationChange of Address; Technical Amendment
Federal Register · Rule · Feb 28, 2019
Unless granted a waiver or exemption from the requirements of section 745A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1), submissions under section 505(j) of the FD&C Act (21 … We update guidances periodically. For the most recent version of a guidance, check the FDA guidance web page at https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
84 FR 6672Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jul 5, 2000
The September 7, 1995, proposed rule also provided an opportunity for interested persons to submit comments on the proposed rule and the agency's findings. … The comment period closed January 5, 1996. FDA received one citizen petition requesting a change in the classification of the obstetrical data analyzer.
65 FR 41330Health and Human Services DepartmentFood and Drug AdministrationWithdrawal of Certain Proposed Rules and Other Proposed Actions
Federal Register · Proposed Rule · Nov 26, 2004
(the act) (21 U.S.C. 343(g)). … With regard to the specific points made in the comment regarding regulation of medical foods, the comment is correct that the act exempts medical foods from the nutrition labeling, health claim and nutrient
69 FR 68831Health and Human Services DepartmentFood and Drug AdministrationIrradiation in the Production, Processing, and Handling of Food
Federal Register · Rule · Dec 21, 2004
Follow the instructions for submitting comments. • Agency Web site: http://www.fda.gov/dockets/ecomments . Follow the instructions for submitting comments on the agency Web site. … act) (21 U.S.C. 321(s)).
69 FR 76401Health and Human Services DepartmentFood and Drug Administration
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