Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
0.52s
Refuse To Accept Procedures for Premarket Tobacco Product Submissions
Federal Register · Proposed Rule · Aug 8, 2016
The comment period for this companion proposed rule runs concurrently with the comment period for the direct final rule. … a certain percentage of RTA determinations made within a defined period of time, and with the percentage rising over time. B.
81 FR 52371Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 26, 2024
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. … After the initial outreach, we will request updates to the information periodically to keep the data current and accurate.
89 FR 32437Health and Human Services DepartmentFood and Drug AdministrationGood Laboratory Practice for Nonclinical Laboratory Studies
Federal Register · Proposed Rule · Dec 21, 2010
DATES: Submit either electronic or written comments by February 22, 2011. ADDRESSES: You may submit comments, identified by the Docket No. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010-31888 Filed 12-20-10; 8:45 am] BILLING CODE 4160-01-P
75 FR 80011Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 28, 2012
Background Section 409 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348) establishes a premarket approval requirement for “food additives;” section 201(s) of the FD&C Act (21 … In the Federal Register of December 28, 2010 (75 FR 81536) (the GRAS reopener), FDA announced the reopening of the comment period for the 1997 proposed rule.
77 FR 38638Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Nutrient Content Claims, Expansion of the Nutrient Content Claim “Lean”
Federal Register · Proposed Rule · Nov 25, 2005
(Nestlé) under the Federal Food, Drug, and Cosmetic Act (the act). … Paperwork Reduction Act of 1995 X. Comments XI. References I. Background On November 8, 1990, President George H.W.
70 FR 71041Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Nov 20, 1996
The authority for Sec. 101.3 is section 403(c) of the act. … The cost of label inventory loss depends on average label inventory and the length of the compliance period.
61 FR 58991Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 20, 2019
Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act … Panel members will be asked to participate in up to eight experimental and observational studies over the 3-year panel commitment period.
84 FR 22862Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 4, 2017
This figure (4,000 applications) includes labeling for approximately 800 applications submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 505(b)) or section … 351 of the Public Health Service Act (42 U.S.C. 262), 1,200 applications submitted under section 505(j) of the FD&C Act, and 2,000 revised drug product labeling from repackagers and relabelers for approximately
82 FR 46248Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 15, 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 27509Health and Human Services DepartmentFood and Drug AdministrationKimberly Schaff Kiehl: Final Debarment Order
Federal Register · Notice · Apr 23, 2026
SUMMARY: The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Kimberly Schaff Kiehl for a period of 10 years from … In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that the Agency considered applicable to Ms.
91 FR 21823Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 26, 2006
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 … The regulations were issued under FDA's statutory authority to regulate food safety, including section 402(a)(1) and (a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) and (a)(4)),
71 FR 56154Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 23, 2022
Accordingly, an ophthalmic dispenser that meets the definition of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(h)) and that is packaged together with an … As part of this notice, FDA is soliciting feedback from stakeholders as to whether a 12-month period is sufficient for affected stakeholders to develop and implement the policies and procedures necessary
87 FR 16391Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 7, 2011
It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-13950 Filed 6-6-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 32863Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 6, 2026
In the Federal Register of March 7, 2023 (88 FR 14170), FDA extended the comment period for the guidance to May 19, 2023. … Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information.
91 FR 50860Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 26, 2010
DATES: Fax written comments on the collection of information by March 29, 2010. … ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk
75 FR 8957Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 11, 2003
1999 proposal (November 2002 reopening of the comment period) to solicit comments on a proposed footnote statement that would be used in place of a % DV for trans fat on the nutrition label. … A few comments to the November 2002 reopening of the comment period supported the proposed footnote statement, “Intake of trans fat should be as low as possible,” with or without some modification
68 FR 41507Health and Human Services DepartmentFood and Drug AdministrationInfusion Pumps; Public Meeting; Request for Comments
Federal Register · Notice · Apr 26, 2010
During the period from January 1, 2005, to December 31, 2009, FDA received over 56,000 medical device reports associated with the use of external infusion pumps. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010-9208 Filed 4-23-10; 8:45 am] BILLING CODE 4160-01-S
75 FR 21641Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 22, 2019
FDA-2019-N-0305] Agency Information Collection Activities; Proposed Collection; Comment Request; Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act AGENCY: Food and … This notice solicits comments on the information collection “Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act).”
84 FR 16673Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 19, 2015
Most commenters on the 2013 draft 503A guidance said this period was too short, but did not recommend a specific alternative. … The Agency is providing a 120-day comment period.
80 FR 8874Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jan 5, 2009
(Comment) One comment requested that FDA not consider cochineal extract and carmine to be major allergens under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). … According to this comment, we said there were 14 adverse events over a 10-year period, and we assumed that only one percent of adverse events are reported.
74 FR 207Health 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.