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Public Meeting on Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products
Federal Register · Notice · Oct 6, 2016
See section 505(j)(2)(A) and (j)(4) of the FD&C Act. … Topics for discussion during the open public comment period on Day 1 and by the panel: • Based on any testing you have attempted to perform or performed in accordance with the March 2016 draft guidance
81 FR 69532Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 16, 2026
• the requirement under section 505G(b)(2) of the FD&C Act to provide for a public comment period on a proposed order; and • the requirement under section 505G(b)(4) of the FD&C Act, addressing certain … expedited safety orders, to provide for a public comment period on an interim final order.
91 FR 43647Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 26, 1999
One of the incentives for orphan drug development is to obtain exclusive approval for the pioneer product for a period of 7 years during which no approval will be given to a subsequent sponsor of the same … Dotzel, Acting Associate Commissioner for Policy. [FR Doc. 99-18928 Filed 7-23-99; 8:45 am] BILLING CODE 4160-01-F
64 FR 40381Health and Human Services DepartmentFood and Drug AdministrationHassan Tahsildar; Denial of Hearing; Final Debarment Order
Federal Register · Notice · Feb 8, 2023
and period of his debarment, as discussed below. … Tahsildar during his period of debarment (section 306(c)(1)(B) of the FD&C Act). Dated: February 2, 2023. Namandjé N. Bumpus, Chief Scientist.
88 FR 8292Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 3, 1999
DATES: Submit written comments on the collection of information by October 4, 1999. … in the donor's blood (a so-called ``window'' period).
64 FR 42132Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 3, 2018
Medical Device Recall Authority OMB Control Number 0910-0432—Extension This collection of information implements section 518(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360h( … FDA issued part 810 to implement the provisions of section 518 of the FD&C Act.
83 FR 38151Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 6, 2011
Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. … FDA intends to determine what constitutes a reasonable period of time on a case-by-case basis.
76 FR 789Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Dec 7, 1998
Comment No. C190, Docket No. 78N-036L, Dockets Management Branch. 2. Comment No. LET176, Docket No. 78N-036L, Dockets Management Branch. 3. Comment No. … of information'' under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
63 FR 67399Health and Human Services DepartmentFood and Drug AdministrationBulk Drug Substances To Be Used in Pharmacy Compounding; Request for Nominations
Federal Register · Notice · Apr 7, 1998
FDA cannot guarantee that all drugs nominated during the comment period will be considered for inclusion on the first published bulk drugs list. … Nominations received during the comment period that are supported by the most complete and relevant information, as set forth previously, will likely be evaluated first.
63 FR 17011Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 9, 2002
Background Section 403(r)(4)(A)(iii) of the Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 343(r)(4)(A)(iii)), provides that any person may petition the Secretary of Health and Human Services … If FDA fails to notify the petitioner of its decision to grant or deny the petition within the 100-day period, the petition shall be considered to be granted.
67 FR 72963Health and Human Services DepartmentFood and Drug AdministrationGuidance for Industry: Food Contact Substance Notification System; Availability
Federal Register · Notice · Apr 11, 2002
Background The FDAMA amended section 409 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348) to establish the FCN process as the primary method for authorizing new uses of food additives … The comment period for these two draft guidance documents closed on February 14, 2000.
67 FR 17703Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 28, 1999
Advisory Opinions--21 CFR 10.85 (OMB Control Number 0910-0193-- Extension) Section 10.85 (21 CFR 10.85), issued under section 701(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C … The burden estimate for this collection of information is based on an average for the period 1996 through 1998 with each advisory opinion requiring an estimated 16 hours of preparation time.
64 FR 52329Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities: Proposed Collection; Comment Request; Extension
Federal Register · Notice · Nov 4, 1996
DATES: Submit written comments on the collection of information by January 3, 1997. … There are 39 national and international organizations with one report each reporting --------------------------------------------------------------------------- period. Dated: October 29, 1996.
61 FR 56685Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 21, 2005
DATES: Fax written comments on the collection of information by August 22, 2005. … Information collection is a statutory requirement under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
70 FR 42068Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 25, 2000
Section 510(h) of the act (21 U.S.C. 360(h)) requires that condom manufacturers as device manufacturers be inspected at least once in a 2-year period. … In the Federal Register of June 23, 2000 (65 FR 39150), the agency requested comments on the proposed collection of information. No comments were received.
65 FR 57617Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 31, 2006
Administrative Detention and Banned Medical Devices—(OMB Control Number 0910-0114)—Extension FDA has the statutory authority under section 304(g) of the Federal Food, Drug, and Cosmetic Act (the act … These recordkeeping requirements for administrative detentions allow FDA to trace devices for which the detention period expired before a seizure is accomplished or injunctive relief is obtained.
71 FR 63764Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted for Direct Addition to Food for Human Consumption; Aspartame
Federal Register · Rule · Jun 28, 1996
Under section 409(b)(5) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348(b)(5)), FDA is required to announce the filing of a food additive petition. … Although public notice of a petition is required, the act is silent with respect to public comment on a petition.
61 FR 33654Health and Human Services DepartmentFood and Drug AdministrationDavid J. Brancato: Grant of Special Termination; Final Order Terminating Debarment
Federal Register · Notice · Jul 20, 2015
ADDRESSES: Comments should reference Docket No. … Under section 306(d)(4)(D) of the FD&C Act, the period of debarment of an individual who qualifies for special termination may be limited to less than permanent but to no less than 1 year. Dr.
80 FR 42826Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 4, 2023
On June 15, 2023, the committee will meet in open session to discuss and make recommendations on the selection of strain(s) to be included in the periodic updated COVID-19 vaccines for the 2023-2024 vaccination … Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: April 27, 2023. Lauren K. Roth, Associate Commissioner for Policy.
88 FR 28563Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 17, 2024
In the Federal Register of September 9, 2011 (76 FR 55927), we extended the comment period to December 2, 2011. We received numerous comments on the 2011 draft guidance. … In the Federal Register of October 4, 2016 (81 FR 68434), we extended the comment period to December 12, 2016.
89 FR 2957Health and Human Services DepartmentFood and Drug Administration
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