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Federal Register · Notice · May 31, 2017
Voluntary Cosmetic Registration Program—21 CFR Parts 710 and 720 OMB Control Number 0910-0027—Extension The Federal Food, Drug, and Cosmetic Act (the FD&C Act) provides us with the authority to regulate … Cosmetic products that are adulterated under section 601 of the FD&C Act (21 U.S.C. 361) or misbranded under section 602 of the FD&C Act (21 U.S.C. 362) may not be distributed in interstate commerce.
82 FR 24977Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 9, 2005
FDA is providing a period of 90 days, from the date of publication of this proposed rule in the Federal Register , to develop and submit comments on this subject. … section 505(a) of the act
70 FR 73178Health and Human Services DepartmentFood and Drug AdministrationFederal 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 AdministrationFederal Register · Notice · Oct 19, 1998
Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. … Received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday.
63 FR 55873Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 10, 2003
Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act … To ensure that comments on the information collection are received, OMB recommends that comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for
68 FR 63799Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 10, 2003
Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act … To ensure that comments on the information collection are received, OMB recommends that comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for
68 FR 63801Health and Human Services DepartmentFood and Drug AdministrationDevelopment and Regulation of Abuse-Deterrent Formulations of Opioid Medications; Public Meeting
Federal Register · Notice · Sep 23, 2014
• Much of the focus in developing abuse-deterrent formulations has been on extended-release and long-acting (ER/LA) opioids. … Please comment.
79 FR 56810Health 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 · 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 · Rule · Jun 1, 2000
Two comments stated that the informed consent process may encourage potential study participants to act responsibly and make their own risk-benefit analysis. … Such precautions include pregnancy testing, use of a highly effective method of birth control, and entry after a confirmed menstrual period.
65 FR 34963Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Oct 29, 2008
The notice of filing provided for a 60-day comment period on the petitioner's environmental information. No comments have been received. II. … Flynn, Acting Director, Center for Veterinary Medicine. [FR Doc. E8-25719 Filed 10-28-08; 8:45 am] BILLING CODE 4160-01-S
73 FR 64197Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 14, 2002
The May 10, 1999, proposed rule also provided an opportunity for interested persons to submit comments on the proposed rule and the agency's proposed findings. … The comment period closed August 9, 1999. FDA received no petitions requesting a change in the classification of glans sheath devices. FDA received no comments on the proposed rule. II.
67 FR 40848Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 4, 1998
DATES: Submit written comments on the collection of information by October 5, 1998. … Statutory authority for the collection of this information is provided by section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262).
63 FR 47299Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted in Feed and Drinking Water of Animals; Feed Grade Sodium Formate
Federal Register · Rule · Sep 30, 2016
The Agency will review this copy, including the claimed confidential information, in its consideration of comments. … The notice of petition provided for a 30-day comment period on the petitioner's request for categorical exclusion from preparing an environmental assessment or environmental impact statement.
81 FR 67153Health 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 AdministrationFederal Register · Proposed Rule · Jan 7, 2022
proposed rule entitled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water,” which was issued under the FDA Food Safety Modernization Act … These meetings will be held during the formal comment period on the proposed rule.
87 FR 913Health 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 AdministrationFederal Register · Notice · Feb 18, 2004
After the close of the comment period, written or electronic comments may be submitted at any time to the contact persons listed in this document. … Gill, Acting Deputy Director, Center for Devices and Radiological Health. [FR Doc. 04-3412 Filed 2-17-04; 8:45 am] BILLING CODE 4160-01-S
69 FR 7650Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · May 26, 1999
FDA received one comment in response to the notice. … during the culture period, and that the filtration step in the purification process would remove any viable production organisms from the final product (Ref. 7).
64 FR 28358Health and Human Services DepartmentFood and Drug Administration
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