Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
0.34s
Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3
Federal Register · Rule · Jan 5, 2023
We have not received any new information or comments that would affect our previous determination. VII. Paperwork Reduction Act of 1995 This final rule contains no collection of information. … Section 301(ll) of the Federal Food, Drug, and Cosmetic Act Our review of this petition was limited to section 409 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348).
88 FR 745Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 3, 2005
Meetings covered by this notice will be supported under sections 1701-1706 (42 USC 300u-300u-5) of the Public Health Service Act. … The FDA does not guarantee availability to accommodate or explain SPOC comments that are received after the 60-day cut-off.
70 FR 22889Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Oct 23, 1998
The Agency's Conclusions on the Comments A. Comments to the TFM 1. … Section 502(f) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 352(f)) states that a drug shall be deemed misbranded: ``Unless its labeling bears (1) adequate directions for use; and (
63 FR 56802Health and Human Services DepartmentFood and Drug AdministrationListing of Color Additives Exempt from Certification; Canthaxanthin
Federal Register · Rule · Mar 27, 1998
The petition was filed under section 721(d) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379e(d)). II. … FDA received one comment on the petition. This comment endorsed the petitioned use of canthaxanthin. III. Stability FDA finds that canthaxanthin is relatively unstable.
63 FR 14814Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 20, 2000
SUPPLEMENTAL INFORMATION: This project is authorized under section 301 of the Public Health Service Act (the PHS Act) (42 U.S.C. 241). … A final FSR (SF-269), Program Progress Report and Invention Statement, must be submitted within 90 days after the expiration of the project period, as noted on the Notice of Grant Award.
65 FR 45083Health and Human Services DepartmentFood and Drug AdministrationExocrine Pancreatic Insufficiency Drug Products
Federal Register · Notice · Apr 28, 2004
(the act) should submit a citizen petition. … Interested persons were invited to submit comments on the proposed rulemaking.
69 FR 23410Health and Human Services DepartmentFood and Drug AdministrationListing of Color Additives Exempt From Certification; Synthetic Iron Oxide
Federal Register · Rule · Mar 20, 2015
Follow the instructions for submitting comments. … We have not received any new information or comments that would affect our previous determination. VIII. Paperwork Reduction Act of 1995 This final rule contains no collection of information.
80 FR 14839Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jan 4, 1994
The comment invited FDA to join the supplement industry in seeking an amendment to section 411 of the act that will remedy this problem. … Further, the comment noted that an enforcement moratorium would avoid the relabeling problem that would arise if FDA disapproves and then reapproves use of the term within a short period of time.
59 FR 354Health and Human Services DepartmentFood and Drug AdministrationFoods, Infant Formulas, and Dietary Supplements; Technical Amendments
Federal Register · Rule · Mar 30, 2001
FDA has determined that notice and public comment are unnecessary because these amendments are merely correcting nonsubstantive errors. … Witt, Acting Associate Commissioner for Policy. [FR Doc. 01-7980 Filed 3-29-01; 8:45 am] BILLING CODE 4160-01-S
66 FR 17356Health and Human Services DepartmentFood and Drug AdministrationProduct Tracing Systems for Food; Public Meeting
Federal Register · Notice · Nov 3, 2009
(21 U.S.C. 642), the Poultry Products Inspection Act (21 U.S.C. 460(b)), and the Egg Products Inspection Act (21 U.S.C. 1040). … Sections 642 of the Federal Meat Inspection Act (21 U.S.C. 601 et seq. ), 460(b) of the Poultry Products Inspection Act (21 U.S.C. 451 et seq. ), and 1040 of the Egg Products Inspection Act (21
74 FR 56843Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted for Direct Addition to Food for Human Consumption; 1,3-Butylene Glycol
Federal Register · Rule · May 13, 1997
FDA received no comments in response to that notice. After the petition was filed, the petitioner amended the petition to limit the scope of the requested GRAS affirmation. … (the act) (21 U.S.C. 348).
62 FR 26225Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 9, 2014
L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). … Submission of Comments and Effective Date Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets
79 FR 38910Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 16, 2007
FDA did not receive any comments in response to that notice. … in effective date is required by the Administrative Procedure Act (5 U.S.C. 553(d)).
72 FR 12560Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jan 4, 2011
Section 801 of FDAAA amends the Public Health Service Act (the PHS Act) to require the Secretary, acting through the Director of NIH, to expand the existing clinical trial registry databank established … Other comments stated that the rule should not require re-consent of enrolled participants. One comment requested a 6-month grace period for compliance after the rule takes effect.
76 FR 256Health 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 · Notice · Jan 23, 2017
Background In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. … Gastrointestinal Diseases: To tide the patient over a critical period of the disease in: Ulcerative colitis; regional enteritis.
82 FR 7837Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 Bakers Yeast
Federal Register · Rule · Aug 29, 2012
Follow the instructions for submitting comments. Written Submissions Submit written objections in the following ways: • FAX: 301-827-6870. … The IOM considers the UL as the highest usual intake level of a nutrient that poses no risk of adverse effects when the nutrient is consumed over long periods of time.
77 FR 52228Health and Human Services DepartmentFood and Drug AdministrationFinal Decision on the Proposal To Refuse To Approve a New Drug Application for ITCA 650
Federal Register · Notice · Aug 23, 2024
Panel members commented on the moving testimonies during the open public hearing. [T2DM] is a devastating disorder to live with. … In this context, reliability is the probability that the device will perform satisfactorily for a specified period of time for the intended use.
89 FR 68168Health and Human Services DepartmentFood and Drug AdministrationAmendments to Sterility Test Requirements for Biological Products
Federal Register · Rule · May 3, 2012
The Paperwork Reduction Act of 1995 I. … Act of 1996 (Pub.
77 FR 26162Health 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 Administration
Ask Donna what matters in the record.
She can read the source against your case and show you exactly where the answer came from.