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Federal Register · Notice · May 28, 2020
ACTION: Notice of availability; extension of comment period SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is extending the comment period for the notice of availability that … The Agency has received a request for an extension of the comment period for 120 days.
85 FR 32040Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 27, 2020
ACTION: Notice of public meeting and request for comments; extension of comment period. … DATES: FDA is extending the comment period announced in the notice of public meeting and request for comments published October 13, 2020 (85 FR 64481).
85 FR 76081Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 21, 2011
There were an estimated 86,583 15-day Alert reports, 57,300 periodic reports, and 349 lot distribution reports submitted to FDA. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-9651 Filed 4-20-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 22401Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 2, 2009
The Food and Drug Administration Amendments Act of 2007 (FDAAA) includes a requirement that FDA identify and periodically update susceptibility test interpretive criteria for antibacterial drug products … ) • The agency revised the recommended time period for submitting revised labeling by extending the period from 60 days to 90 days.
74 FR 31740Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 27, 2011
ACTION: Notice; extension of comment period. … Interested persons were invited to submit comments by February 8, 2012. At this time, the Agency is extending the comment period until March 9, 2012, to continue to receive public comments.
76 FR 80947Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 15, 2002
ACTION: Proposed rule; reopening of the comment period. … FDA is reopening the comment period to receive comment on a footnote statement that it is proposing be required on the label when trans fat is listed.
67 FR 69171Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 1, 2020
ACTION: Notice; reopening of the comment period. … ” with a 60-day comment period.
85 FR 77220Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Revised MedWatch Forms; Availability
Federal Register · Notice · Feb 17, 2004
Background Section 303 of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) amended the Federal Food, Drug, and Cosmetic Act (the act) to require FDA to modify Forms 3500 and 3500A, the … A later comment suggested providing a 1-year interim period for industry to modify their reporting systems. FDA partially agrees with the comments.
69 FR 7490Health and Human Services DepartmentFood and Drug AdministrationDietary Supplements Containing Ephedrine Alkaloids; Availability
Federal Register · Notice · May 22, 2000
ACTION: Notice of availability; extension of comment period. … Dotzel, Acting Associate Commissioner for Policy. [FR Doc. 00-12749 Filed 5-19-00; 8:45 am] BILLING CODE 4160-01-F
65 FR 32113Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 25, 2018
The BPCI Act provides, among other things, exclusivity periods for certain biological products licensed in “stand alone” applications under section 351(a) of the PHS Act. … duration of the exclusivity period for a previously approved reference product.
83 FR 35154Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 8, 2011
ACTION: Notice; reopening of comment period. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-28875 Filed 11-7-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 69274Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 22, 1999
The agency has received several requests to extend the comment period on the draft guidance. … Hubbard, Acting Deputy Commissioner for Policy. [FR Doc. 99-10010 Filed 4-21-99; 8:45 am] BILLING CODE 4160-01-F
64 FR 19792Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Apr 29, 1998
DATES: Written comments and recommendations by August 27, 1998. … Based on an average of the estimates provided in comments to earlier rules, FDA estimates that the average redesign cost for a 1- year compliance period is $1,700 per dietary supplement label.
63 FR 23624Regulations on Statements Made for Dietary Supplements Concerning theHealth and Human Services DepartmentEffective Date of Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator
Federal Register · Proposed Rule · Jul 27, 2011
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed rule and consideration of any comments received, issue a final rule to require premarket … The FD&C 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.
76 FR 44872Health and Human Services DepartmentFood and Drug AdministrationPostmarketing Safety Reporting for Combination Products
Federal Register · Proposed Rule · Oct 1, 2009
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by November 2, 2009, (see the “Paperwork Reduction Act of 1995” section of this document). … PHS Act).
74 FR 50744Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 1, 2020
Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed … There were an estimated 169,334 15-day Alert reports, 184,265 periodic reports, and 789 lot distribution reports submitted to FDA.
85 FR 54385Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 1, 2021
ACTION: Notice; request for information and comments; extension of comment period. … Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021-21403 Filed 9-30-21; 8:45 am] BILLING CODE 4164-01-P
86 FR 54455Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 27, 2023
The guidances in List 1 of this guidance will no longer be in effect after the 180-day transition period ends. … As described in this guidance, a 180-day transition period will begin on the implementation date.
88 FR 18153Health and Human Services DepartmentFood and Drug AdministrationPostmarketing Safety Reporting for Combination Products
Federal Register · Rule · Dec 20, 2016
(Comment 15) Some commenters sought clarification of the applicability of section 227 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) concerning the reporting of malfunctions to FDA, … (Comment 16) One commenter sought clarification of whether the periodic reports addressed in proposed § 4.103(c) should be considered “expedited” reports for purposes of this rule.
81 FR 92603Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 19, 2019
Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. … These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
84 FR 42927Health and Human Services DepartmentFood and Drug Administration
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