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Federal Register · Rule · Apr 12, 2019
under section 502 of the FD&C Act (21 U.S.C. 352). … Mandates Reform Act of 1995 (Pub.
84 FR 14847Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committees; Technical Amendment
Federal Register · Rule · Mar 29, 2010
FDA has determined that notice and public comment are unnecessary because this amendment to the regulations provides only technical changes. … (c) * * * (1) A period of 30 days will be permitted for submission of nominations for that committee or subcommittee.
75 FR 15342Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 3, 1997
Although not required, FDA has in the past provided a 75- or 90-day comment period for draft ICH guidelines. … However, the comment period for this guideline has been shortened to 60 days so that comments may be received by FDA in time to be reviewed and then discussed at a July 1997 ICH meeting involving this
62 FR 16026Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted for Direct Addition to Food for Human Consumption; Sucralose
Federal Register · Rule · Apr 3, 1998
Body weight gain of females was significantly reduced in all treatment groups during this same period of time. … Comments The agency received several comments on McNeil's sucralose petition. Several comments supported amending the food additive regulations for the safe use of sucralose (Ref. 47).
63 FR 16417Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 20, 2019
In the 1990s, longer acting forms of amphetamine were introduced to the market. … During this same period, a steep increase in the diagnosis of ADHD in the United States led to a parallel increase in societal exposure to prescribed amphetamine and related stimulant products.
84 FR 49530Health and Human Services DepartmentFood and Drug AdministrationIndirect Food Additives: Paper and Paperboard Components
Federal Register · Rule · Mar 7, 1997
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. … The authority citation for 21 CFR part 176 continues to read as follows: Authority: Secs. 201, 402, 406, 409, 721 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 342, 346, 348, 379e).
62 FR 10452Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted in Feed and Drinking Water of Animals; Formic Acid
Federal Register · Rule · Feb 9, 2011
Follow the instructions for submitting comments. Written Submissions Submit written objections in the following ways: Fax: 301-827-6870. … The notice of filing provided for a 30-day comment period on the petitioner's environmental assessment. One comment was received that was not substantive. II.
76 FR 7106Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 14, 2007
the provisions of the act. … If this were not possible, they requested that the comment period remain open until commenters have the ability to look at the questionnaire materials.
72 FR 11889Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Nov 28, 1997
The proposal gave the public 30 days to submit written comments. The comment period later was reopened for an additional 2 weeks (see 61 FR 11349, March 20, 1996). … Comments relied on the recent Ninth Circuit decision, Papike, to support their interpretation of Medtronic and the scope of preemption under 521(a) of the act.
62 FR 63271Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 31, 2011
(Comment 1) FDA received several comments on the utility of the vending machine labeling provisions of section 4205 of the Affordable Care Act. … (Comment 3) Several comments argued that FDA underestimated the burden hours and costs associated with complying with the provisions of section 4205 of the Affordable Care Act.
76 FR 5380Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Feb 19, 2019
Comments on the Proposed Rule and FDA Response A. Introduction We received 12 total comments posted to the docket for the proposed rule by the close of the comment period. … The comment also noted that the FD&C Act recognizes the HPUS as “official” in 21 U.S.C. 358(b), and in the definitions at 21 U.S.C. 321, the FD&C Act defines “drug” to include articles recognized in the
84 FR 4696Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · May 31, 2002
Fairness Act of 1996 (Public Law 104-121)) and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). … Therefore, no further analysis is required under the Unfunded Mandates Reform Act.
67 FR 37988Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 2, 2008
Because the number of biotechnology product applications submitted is relatively low compared to small-molecule drugs, the pilot will have an extended submission period. … Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy.
73 FR 37972Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Apr 17, 2003
The comment stated that while a warning about the recovery period from a preceding illness may be appropriate for products used to treat, and possibly mask, the early symptoms of Reye’s syndrome, such … Analysis of Impacts FDA has examined the impacts of the final rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (2 U.S.C
68 FR 18861Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 21, 2020
Section 130(a) of the Food and Drug Administration Modernization Act of 1997 amended the FD&C Act by adding section 506B of the FD&C Act (21 U.S.C. 356b). … • Period covered by the report. • PMR/PMC update for each “Open” PMR/PMC.
85 FR 66995Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 9, 2014
Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each … Comments The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time.
79 FR 73081Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 7, 2007
Drug Administration (FDA) 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 … This notice contained an incorrect deadline for comments on the proposed collection of information in the DATES section. FDA is republishing the notice and providing a full 30-day comment period.
72 FR 10220Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 12, 1999
The comments in the docket will be periodically reviewed, and, where appropriate, the guidances will be amended. … Dotzel, Acting Associate Commissioner for Policy. [FR Doc. 99-26501 Filed 10-8-99; 8:45 am] BILLING CODE 4160-01-F
64 FR 55293Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 17, 2005
(the act) (21 U.S.C. 393(d)(2)). … The Nutrition Labeling and Education Act of 1990 (Public Law 101-535) amended the act. Section 403(r)(1)(A) of the act (21 U.S.C. 343(r)(1)(A)) was added under these amendments.
70 FR 48423Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 25, 2000
Under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Animal Drug Availability Act of 1996 (ADAA), any person intending to file a new animal drug application (NADA) or supplemental … DATES: Submit written comments on the proposed rule by November 8, 2000. Submit written comments on the information collection provisions by September 25, 2000.
65 FR 51782Health and Human Services DepartmentFood and Drug Administration
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