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Federal Register · Notice · Jan 7, 2020
(Appendix A to Subpart C of 41 CFR 102-3, the Federal Advisory Committee Management Final Rule notes that the Federal Advisory Committee Act (FACA, 5 U.S.C. … Vacancies are updated periodically; therefore, one or more vacancies listed may be in the nomination process or a final appointment may have been made.
85 FR 718Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 1, 1995
Submit written comments at any time. … The comments in the docket will be periodically reviewed, and, where appropriate, the guideline will be amended.
60 FR 11264Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 8, 2013
This notice is issued under the Controlled Substances Act (the CSA). DATES: Submit either electronic or written comments by February 25, 2013. … The short time period for the submission of comments and requests for a public meeting is needed to ensure that HHS may, in a timely fashion, carry out the required action and be responsive to the United
78 FR 9397Health and Human Services DepartmentFood and Drug AdministrationRetrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidances
Federal Register · Notice · Aug 7, 2013
In addition, the GGP regulation explains that FDA will periodically review existing guidance documents to determine whether they need to be changed or withdrawn. … Comments Interested persons may submit either electronic comments regarding Agency guidance documents to http://www.regulations.gov or written comments to the Division of Dockets Management (see
78 FR 48175Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Feb 27, 2014
A withdrawal period has not been established for this product in preruminating calves. … A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal 016592 (2) Chickens.
79 FR 10976Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 12, 2016
DSHEA amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding, among other provisions: (1) Section 201(ff) (21 U.S.C. 321(ff)), which defines the term “dietary supplement” and (2) section … We gave interested parties an opportunity to submit comments by October 3, 2011. In the Federal Register of September 9, 2011 (76 FR 55927), we extended the comment period to December 2, 2011.
81 FR 53486Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 10, 2001
Act of 1996 (ADAA). … We plan to hold a public meeting on import tolerances during the comment period for this advance notice of proposed rulemaking (ANPRM) and intend to consider the comments made at the meeting and in response
66 FR 42167Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 24, 2011
Prescription Drug Advertisements—(OMB Control Number 0910)—New Section 502(n) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 352(n)) requires that manufacturers, packers, and distributors … Section 202.1 applies to advertisements published in journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication
76 FR 4117Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 29, 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 … records of compensation agreements with any compensation paid to nonemployee clinical investigators, including information showing any financial interests held by the clinical investigator, for a time period
80 FR 23803Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 7, 2000
Submit electronic comments on the collection of information on the Internet at: http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm. … In such a case the applicant may begin distribution of the drug 30 days after FDA receives a supplemental application unless the agency notifies the applicant within the 30-day period that prior approval
65 FR 54279Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 29, 2014
Control Act) (Pub. … Four commenters submitted nine comments that were PRA related.
79 FR 64394Health and Human Services DepartmentFood and Drug AdministrationEffective Date of Approval of an Abbreviated New Drug Application
Federal Register · Rule · Nov 5, 1998
Submit written comments by February 3, 1999. … For the foregoing reasons, FDA finds, for good cause, that notice and public procedure would be impracticable, unnecessary, and contrary to the public interest; therefore, a public comment period before
63 FR 59710Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Aug 28, 2000
FDA received three significant adverse comments during the comment period, and the agency has considered these comments in developing the final rule. … Flexibility Act (5 U.S.C. 601-612 (as amended by subtitle D of the Small Business Regulatory Fairness Act of 1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4)
65 FR 52016Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 22, 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 39795Health and Human Services DepartmentFood and Drug AdministrationDaylen Diaz: Final Debarment Order
Federal Register · Notice · Jun 21, 2023
Follow the instructions for submitting comments. An application submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. … Diaz during her period of debarment, other than in connection with an audit under section 306 of the FD&C Act (section 306(c)(1)(B) of the FD&C Act (21 U.S.C. 335a(c)(1)(B))).
88 FR 40275Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 30, 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 … In the Federal Register of June 14, 2010 (75 FR 33624), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
75 FR 52954Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 15, 2020
FDA will periodically review these requests, and, when appropriate, expand the list. … consideration of the comment.
85 FR 42883Health and Human Services DepartmentFood and Drug AdministrationAnalay Rico: Final Debarment Order
Federal Register · Notice · Jun 8, 2023
the FD&C Act). … Rico during her period of debarment, other than in connection with an audit under section 306(c)(1)(B) of the FD&C Act.
88 FR 37546Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 12, 1999
Biotechnological/biological products have distinguishing characteristics to which consideration should be given in any well-defined testing program designed to confirm their stability during the intended storage period … Dotzel, Acting Associate Commissioner for Policy. [FR Doc. 99-26502 Filed 10-8-99; 8:45 am] BILLING CODE 4160-01-F
64 FR 55294Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs
Federal Register · Notice · Apr 16, 2026
(FD&C Act) (21 U.S.C. 360aa, 360bb, 360cc, and 360dd), as well as related guidance and Agency forms. … FDA marketing approval for that drug for the orphan indication for a period of 7 years; and, finally, section 528 is intended to encourage sponsors to make investigational orphan drugs available for treatment
91 FR 20460Health and Human Services DepartmentFood and Drug Administration
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