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Federal 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 AdministrationOrtho-phthlates for Food Contact Use; Request for Information
Federal Register · Notice · May 20, 2022
, the Poultry Products Inspection Act, or the Meat Inspection Act. … The term “prior sanction” derives from section 201(s)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(s)(4)), which excepts from the definition of a food additive any substance
87 FR 31090Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jan 16, 2025
In response to a written request submitted to the docket, we extended the comment period to May 18, 2023 (88 FR 19026, March 30, 2023). … Section 721(b)(5)(c)(i) of the FD&C Act states that any person who will be adversely affected by a proposal if placed into effect may request, within the specified time period, that the petition or order
90 FR 4628Health and Human Services DepartmentFood and Drug AdministrationNonproprietary Naming of Biological Products; Guidance for Industry; Availability
Federal Register · Notice · Jan 13, 2017
be licensed under section 351 of the PHS Act on March 23, 2020 (section 7002(e)(2) through (e)(4) of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act)). … This estimate for submission of the requested information is based on the average number of responses per respondent and the average burden per response over a 3-year period.
82 FR 4345Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 2, 2024
On April 13, 2017, we published a notice announcing the extension of the comment period to June 19, 2017 (82 FR 17844). … Moreover, section 740(d)(4)(B) of the Federal Food, Drug, and Cosmetic Act uses this term (21 U.S.C. 379j-12(d)(4)(B)).
89 FR 35832Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 16, 2011
These procedures may include, but are not limited to, review of records and manufacturing deviations and defects, and periodic audits. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-6055 Filed 3-15-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 14405Health 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 · Mar 5, 2014
Background Under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 201 et seq. ) and section 351 of the Public Health Service Act (42 U.S.C. 262), CBER is responsible for receiving, reviewing, … Comments Persons who have questions or wish further information concerning CBER's move to the FDA White Oak campus in Silver Spring, MD, may access the FDA Web site at http://www.fda.gov/AboutFDA/
79 FR 12506Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 16, 2000
Section 702 of the act (21 U.S.C. 372) authorizes investigational powers to FDA for enforcement of the act. … As both the 3500 instructions and 3500A instructions can be updated periodically based on questions/comments from stakeholders and statutory/regulatory changes, changing the forms themselves is not seen
65 FR 69314Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 28, 1996
The agency is also inviting comments on the guidance. DATES: Written comments by August 26, 1996. … The products are subject to licensure as biological products under section 351 of the Public Health Service Act (42 U.S.C. 262).
61 FR 26523Health and Human Services DepartmentFood and Drug AdministrationPrivacy Act, Exempt Record System; Implementation
Federal Register · Rule · Jul 1, 2013
The comment period was open through November 13, 2012. The Agency received three comments regarding the exemptions. One comment was positive and in favor of the exemptions. … Reform Act of 1995 (Pub.
78 FR 39184Health and Human Services DepartmentFood and Drug AdministrationElectronic Study Data Submission; Data Standard Support End Date
Federal Register · Notice · Jan 28, 2013
(FD&C Act), added by section 1136 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public Law 112-144), requires electronic submission of drug and biologic applications beginning … The final guidance, to be issued under section 745A of the FD&C Act following public notice and opportunity for comment, will specify the format required for such electronic submissions.
78 FR 5816Health and Human Services DepartmentFood and Drug AdministrationBottled Water: Monitoring Requirements
Federal Register · Notice · Aug 6, 1998
Under the SDWA Amendments (section 410(b)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 349(b)(1)), for contaminants covered by a standard of quality regulation promulgated by FDA … Because FDA received significant adverse comment about monitoring requirements for these nine contaminants, FDA is unable to promulgate monitoring requirements for the nine contaminants by August 6, 1998
63 FR 42199Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 19, 2015
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 … A source previously found to contain E. coli will be considered negative for E. coli after five samples collected over a 24 hour period from the same sampling site are tested and found to be
80 FR 63228Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 8, 2000
Subsequently, FDA extended the comment period to March 8, 1999, in response to an extension request. FDA received one comment on the proposed rule from a non-profit trade association. III. … FDA disagrees with the comment.
65 FR 36324Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 1, 2021
Therefore, designated countries may respond to our periodic requests by submitting information to confirm their designations remain appropriate. … Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021-06706 Filed 3-31-21; 8:45 am] BILLING CODE 4164-01-P
86 FR 17156Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 19, 2007
Public Health Service Act. … These procedures may include, but are not limited to, review of records and manufacturing deviations and defects, and periodic audits.
72 FR 65034Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 25, 2013
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 … A source previously found to contain E. coli will be considered negative for E. coli after five samples collected over a 24-hour period from the same sampling site are tested and found to be
78 FR 17932Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 2, 2024
FDA has the authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to approve new animal drugs. … maintain records showing the name and post office address of the expert or expert organization to whom it is shipped and the date, quantity, and batch or code mark of each shipment and delivery for a period
89 FR 35838Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 9, 1997
This report is mandated by the Nutrition Labeling and Education Act of 1990 (the 1990 amendments). DATES: Comments may be submitted at any time. … SUPPLEMENTARY INFORMATION: The 1990 amendments amended the Federal Food, Drug, and Cosmetic Act (the act) to require, among other things, that under section 403(q)(4) of the act (21 U.S.C. 343(q)(4)),
62 FR 25635Health and Human Services DepartmentFood and Drug Administration
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