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Federal Register · Notice · Oct 30, 2015
The comment period closed on April 7, 2014. … drug definition in section 201(g)(1)(B) or (C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321(g)(1)(B) or (C)).
80 FR 66907Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 17, 1997
If FDA does not initiate such a proceeding, section 515(b)(3) of the act provides that FDA shall, after the close of the comment period on the proposed rule and consideration of any comments received, … The act does not permit an extension of the 90-day period after issuance of a final rule within which an application or a notice is required to be filed.
62 FR 38231Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 25, 2021
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. … After the initial outreach, we will request updates to the information periodically to keep the data current and accurate.
86 FR 28116Health and Human Services DepartmentFood and Drug AdministrationGuidance for Industry on Monoclonal Antibodies Used as Reagents in Drug Manufacturing; Availability
Federal Register · Notice · Mar 29, 2001
All comments received during the comment period have been carefully reviewed and incorporated in this revised guidance where appropriate. … As a result of public input during the comment period, the final guidance is clearer and more concise than the draft version.
66 FR 17184Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 22, 1999
DATES: Submit written comments by October 20, 1999; written comments on the agency's economic impact determination by October 20, 1999. … The agency considered but rejected several labeling alternatives: (1) A shorter implementation period, and (2) an exemption from coverage for small entities.
64 FR 39452Health and Human Services DepartmentFood and Drug AdministrationSherrie R. McCain: Final Debarment Order
Federal Register · Notice · Feb 19, 2026
In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that the Agency considered applicable to Ms. … FDA finds that the offense should be accorded a debarment period of 5 years as provided by section 306(c)(2)(A)(iii) of the FD&C Act. As a result of the foregoing finding, Ms.
91 FR 8003Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 24, 2003
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 … In the Federal Register of July 28, 2003 (68 FR 44341), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.
68 FR 65937Health and Human Services DepartmentFood and Drug AdministrationAnimal Generic Drug User Fee Act; Public Meeting; Request for Comments
Federal Register · Notice · Dec 5, 2012
FDA-2011-N-0655] Animal Generic Drug User Fee Act; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meeting; request for comments. … AGDUFA Achievements AGDUFA I established increasingly stringent review performance goals over a 5-year period from FY 2009 through FY 2013.
77 FR 72359Health and Human Services DepartmentFood and Drug AdministrationBiological Products; Reporting of Errors and Accidents in Manufacturing
Federal Register · Proposed Rule · Sep 23, 1997
Reporting Period FDA is proposing to amend Sec. 600.14(a) to replace the term ``promptly'' with a reporting period of ``as soon as possible but not to exceed 45 calendar days.'' … Request for Comments Interested persons may, on or before December 22, 1997, submit to the Dockets Management Branch (address above) written comments regarding this proposal, except that comments
62 FR 49642Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 6, 2017
During the open comment period following this first panel, we will specifically invite comment about whether there are any considerations specific to certain classes or types of ingredients that should … The topics discussed at the public meeting, both during the panel discussions and during open public comment periods, as well as written comments submitted after the meeting, will help us determine how
82 FR 42098Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 27, 2020
Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine business practice. … Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine business practice.
85 FR 23367Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 13, 2021
In order to be considered during the preparation of the draft EIS, all comments must be received prior to the close of the public scoping period. … See FDA's website for periodic updates, available at https://www.fda.gov/drugs/guidance-compliance-regulatory-information and search for Environmental Impact Statement.
86 FR 26224Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Medical Device Data Systems
Federal Register · Rule · Feb 15, 2011
A few comments suggested that the comment period for the proposed rule should be extended. … FDA is finalizing this rule without a public meeting based on the substantial substantive and constructive comments received during the comment period.
76 FR 8637Health and Human Services DepartmentFood and Drug AdministrationDraft Guidance for Industry; Consumer-Directed Broadcast Advertisements; Availability
Federal Register · Notice · Aug 12, 1997
The agency requests comments on this draft guidance. DATES: Written comments may be submitted on the draft guidance document by October 14, 1997. … Statutory and Regulatory Requirements Section 502(n) (21 U.S.C. 352(n)) of the Federal Food, Drug, and Cosmetic [[Page 43172]] Act (the act) requires that advertisements for prescription drugs for
62 FR 43171Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 5, 2001
One letter of comment was received in response to the 60-day notice. … The comment stated that the requirements for written procedures represent ongoing, not one-time, costs, in part because written procedures must be periodically reviewed and updated.
66 FR 1138Health and Human Services DepartmentFood and Drug AdministrationEligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products
Federal Register · Rule · May 25, 2004
The comment period for that proposed rule closed on December 29, 1999. On April 18, 2000, we reopened the comment period for an additional 90 days. … We received two requests for an extension of the comment period.
69 FR 29786Health and Human Services DepartmentFood and Drug AdministrationPlasma Derivatives and Other Blood-Derived Products; Requirements for Tracking and Notification
Federal Register · Proposed Rule · Aug 19, 1999
provisions of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 351-353, 355-360, and 371-374)), FDA has the authority to issue regulations designed to protect the public from unsafe or ineffective … For example, the patient may have moved or may be away from his or her home for an extended period of time.
64 FR 45383Health and Human Services DepartmentFood and Drug AdministrationProgram Priorities in the Center for Food Safety and Applied Nutrition; Request for Comments
Federal Register · Notice · Sep 1, 1999
Comments are also requested on those additional activities that should be worked on during the 9- month period, but not necessarily completed by the end of the fiscal year (i.e., the ``B'' list activities … Dotzel, Acting Associate Commissioner for Policy. [FR Doc. 99-22678 Filed 8-31-99; 8:45 am] BILLING CODE 4160-01-F
64 FR 47845Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 24, 2008
Submit written or electronic comments by December 23, 2008. … The treatment period lasted 14 days.
73 FR 63491Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 13, 2023
Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. … Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this guidance.
88 FR 9296Health and Human Services DepartmentFood and Drug Administration
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