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Federal Register · Notice · Apr 1, 2016
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 … One response over a 10-year period equates to an annual frequency of response equal to 0.1.
81 FR 18861Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 13, 2020
It was envisioned at the time of publication of GFI #152 that the Agency would reassess the rankings provided in Appendix A periodically to confirm that the rankings are consistent with contemporary practices … Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020-22581 Filed 10-9-20; 8:45 am] BILLING CODE 4164-01-P
85 FR 64481Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Reclassification of the Infant Radiant Warmer
Federal Register · Rule · Jun 19, 1997
Interested persons were given until November 25, 1996, to comment on the proposed rule. … During the comment period, FDA received one comment from a manufacturer who supported the proposed reclassification and stated that the previous risks to health associated with the use of the device have
62 FR 33349Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 29, 2008
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by June 30, 2008, (see the “Paperwork Reduction Act of 1995” section of this document). … Paperwork Reduction Act of 1995 X. Federalism XI. Request for Comments XII. References Appendix I.
73 FR 30831Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Nov 7, 2017
On December 13, 2016, the 21st Century Cures Act (Pub. L. 114-255) (Cures Act) was signed into law. Section 3054 of the Cures Act amended section 510(m) of the FD&C Act. … This section requires FDA to publish in the Federal Register a notice of intent to exempt a device, or of the petition, and to provide a 60-calendar-day comment period.
82 FR 51567Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 23, 1995
DATES: Written comments by October 10, 1995. … each period, treatments, periods, treatment by period interaction error, and total.
60 FR 43910Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 6, 2011
Some comments from industry stated that the 90-day time period should be calculated per market, not per chain, and asked that we clarify when the 90-day time period begins. … These comments also stated that 90 days may not be long enough for a test market. FDA points out that the 90-day time period is a statutory requirement.
76 FR 19192Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 9, 2025
of 2002 added section 414 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350c), which requires that persons who manufacture, process, pack, hold, receive, distribute, transport, or … Existing records may be used if they contain all the required information and are retained for the required time period.
90 FR 57074Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 25, 2019
Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed … deactivate the Plan and make decisions during the emergency; (2) prioritizing the manufacturer's drug products based on medical necessity; (3) identifying actions that should be taken prior to an anticipated period
84 FR 57448Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 27, 2018
The period for public comment on the proposed order closed on February 2, 2018. FDA received and has considered 78 comments on the proposed order, as discussed in section II. II. … This commenter stated that, in addition to FDA's proposed special controls, a pre-clearance good manufacturing practices (GMP) inspection should be required under section 513(f)(5) of the FD&C Act.
83 FR 48711Health and Human Services DepartmentFood and Drug AdministrationDigoxin Products for Oral Use; Revocation of Conditions for Marketing
Federal Register · Proposed Rule · Nov 24, 2000
(the act). … Requests for Comments Interested persons may submit to the Dockets Management Branch (address above) written comments regarding this proposal by February 22, 2001.
65 FR 70538Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 12, 2017
Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying … out the provisions of the FD&C Act.
82 FR 26934Health and Human Services DepartmentFood and Drug AdministrationDelmont Laboratories, Inc.; Opportunity for Hearing on a Proposal to Revoke U.S. License No. 299
Federal Register · Notice · Feb 26, 2003
A deficient request or objection will be returned; however, the deficient submission may be supplemented and subsequently filed if submitted within the 30-day time period (§ 12.22(c)). … This notice is issued under section 351 of the Public Health Service Act (42 U.S.C. 262) and sections 201, 501, 502, 505, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 355,
68 FR 8908Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 22, 2016
FDA-2012-N-1021] Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2016 Proposed Guidance Development; Correction AGENCY: Food and Drug Administration … The document was published with the incorrect number of years in which CDRH committed to finalize, withdraw, re-open the comment period, or issue another draft guidance on the topic for 80 percent of the
81 FR 56656Health and Human Services DepartmentFood and Drug AdministrationFederal 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 9, 2002
This notice requesting comments is required by the Controlled Substances Act (CSA). DATES: Submit written or electronic comments by May 9, 2002. … This abbreviated comment period is necessary to allow sufficient time to prepare and submit the domestic information package by the deadline imposed by WHO.
67 FR 17074Health 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 · May 2, 1997
DATES: Written comments by June 16, 1997. … FDA has such authority under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., and the Public Health Service Act, 42 U.S.C. 201 et seq.
62 FR 24320Timing of Nonclinical Studies for the Conduct of Human Clinical TrialsHealth and Human Services Department
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