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Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Notice · Jun 8, 2010
This meeting and written comments submitted to the docket have provided critical input as the Agency prepares for reauthorization discussions. … Notification of Intent to Participate in Periodic Consultation Meetings If you intend to participate in continued periodic stakeholder consultation meetings regarding PDUFA Reauthorization, please provide
75 FR 32483Health and Human Services DepartmentFood and Drug AdministrationPadam C. Bansal; Grant of Special Termination; Final Order Terminating Debarment
Federal Register · Notice · Mar 11, 1997
Under section 306(d)(4)(D) of the 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. … Bansal's period of debarment has lasted more than 1 year.
62 FR 11212Health and Human Services DepartmentFood and Drug AdministrationGuidance for Industry: Computerized Systems Used in Clinical Trials; Availability
Federal Register · Notice · May 10, 1999
Upon petition, FDA extended the comment period for an additional 60 days. FDA received more than 500 comments from 24 respondents. … Hubbard, Acting Deputy Commissioner for Policy. [FR Doc. 99-11582 Filed 5-7-99; 8:45 am] BILLING CODE 4160-01-F
64 FR 25048Health and Human Services DepartmentFood and Drug AdministrationGuidance for Industry on Changes to an Approved NDA or ANDA; Availability
Federal Register · Notice · Nov 23, 1999
Section 116 of the Modernization Act amended the Food, Drug, and Cosmetic Act (the act) by adding section 506A (21 U.S.C. 356a), which provides requirements for making and reporting manufacturing changes … All comments received during the comment period have been carefully reviewed and incorporated in this revised guidance, where appropriate.
64 FR 65716Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Feb 21, 2002
Request for Comments and Proposed Dates Interested persons may submit to the Dockets Management Branch (address above) written or electronic comments regarding this proposed rule by April 22, 2002. … 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.
67 FR 7982Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 1, 2024
FDA is establishing the electronic format requirements described in this guidance under the Federal Food, Drug, and Cosmetic Act (FD&C Act). … The collections of information for submitting periodic adverse drug experience reports have been approved under OMB control number 0910-0230.
89 FR 22410Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 8, 2008
of 2002 (the Bioterrorism Act) added section 414 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350c), which requires that persons who manufacture, process, pack, hold, receive, distribute … Existing records may be used if they contain all of the required information and are retained for the required time period.
73 FR 7564Health and Human Services DepartmentFood and Drug AdministrationGuidance for Industry: Validation of Analytical Procedures for Type C Medicated Feeds; Availability
Federal Register · Notice · Nov 8, 2005
Paperwork Reduction Act of 1995 According to the Paperwork Reduction Act of 1995, a collection of information must display a valid OMB control number. … FDA periodically will review the comments in the docket, and where appropriate, will amend the guidance.
70 FR 67725Health and Human Services DepartmentFood and Drug AdministrationSeafood HACCP Transition Guidance; Availability
Federal Register · Notice · Feb 2, 2000
(the act). … As noted by the comment, the 180-day period is the maximum permitted tentative response time.
65 FR 4984Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities: Proposed Collection; Comment Request
Federal Register · Notice · Mar 26, 1997
Under the Paperwork Reduction Act of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, and to allow 60 days for public comment … Most of the questions asked are identical to ones asked in a 1992-1993 survey so that changes over this time period can be assessed.
62 FR 14432Health and Human Services DepartmentFood and Drug AdministrationPrescription Drug User Fee Act (PDUFA) II Five-Year Plan Revision; Availability
Federal Register · Notice · Aug 27, 1999
This revised plan updates FDA's anticipated prescription drug user fee revenues and planned expenditures of the fee revenues over the 5-year period from 1998 to 2002. … 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.
64 FR 46918Health and Human Services DepartmentFood and Drug AdministrationPublic Meeting on Section 406(b) of the FDA Modernization Act of 1997
Federal Register · Notice · Aug 20, 1998
of 1997 (FDAMA) to discuss how FDA can best meet its statutory obligations under the Federal Food, Drug, and Cosmetic Act (the act). … Comments Written comments should be identified with the docket number found in brackets in the heading of this document and should be submitted by September 11, 1998, to the Dockets Management Branch
63 FR 44628Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 8, 2021
FDA is reopening the 60-day comment period in order to satisfy PRA requirements. No changes have been made to the information collection. Dated: January 4, 2021. Lauren K. … Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021-00120 Filed 1-7-21; 8:45 am] BILLING CODE 4164-01-P
86 FR 1504Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 16, 2013
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 … Periodic drug experience reports and special drug experience reports must be accompanied by a completed Form FDA 2301, “Transmittal of Periodic Reports and Promotional Material for New Animal Drugs” (see
78 FR 3433Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 25, 2011
All comments should be identified with the OMB control number 0910-New and title “FDA Food Safety Modernization Act: Economic Hardship Fee Reduction Guidance.” … FDA will review the comments (comment period closes on November 30, 2011) and then develop the proposed set of guidelines; these will likely be implemented in fiscal year (FY) 2013.
76 FR 72712Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 15, 2009
On January 31, 2005 (70 FR 4857), FDA announced the availability of the draft revision for public comment. The comment period closed on May 2, 2005. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
74 FR 34359Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 7, 2011
It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-8360 Filed 4-6-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 19311Agriculture DepartmentFood Safety and Inspection ServiceFederal Register · Notice · Nov 25, 1998
This amendment implements changes made by the Food and Drug Administration Modernization Act of 1997 (FDAMA) to section 519(f) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360i(f)). … During that period of time, no reports of corrections or removals were submitted by distributors.
63 FR 65210Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 15, 2010
In terms of the detail provided, the questionnaire, which provided extensive detail about the exact questions proposed, was available upon request during the first comment period and will continue to be … available during the second comment period.
75 FR 78252Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 30, 2009
comment in response to the notice. … Were there any other foods or products given to the animal during this period of time?
74 FR 69106Health and Human Services DepartmentFood and Drug Administration
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