Documents
Briefs, oral arguments, agency decisions and the Federal Register.
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Uniform Compliance Date for Food Labeling Regulations
Federal Register · Rule · Dec 8, 2008
SUPPLEMENTARY INFORMATION: FDA periodically issues regulations requiring changes in the labeling of food. … FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).
73 FR 74349Health and Human Services DepartmentFood and Drug AdministrationPostmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements
Federal Register · Rule · Jul 29, 2020
Summary of Comments to the Proposed Rule We received two comment letters on the proposed rule by the close of the comment period, each containing one or more comments on one or more issues. … (a) of the FD&C Act.
85 FR 45505Health and Human Services DepartmentFood and Drug AdministrationStatus of Certain Additional Over-the-Counter Drug Category II Active Ingredients
Federal Register · Proposed Rule · Jun 19, 2008
FDA requests comment on this issue. … FDA requests comment on this issue. VI. Paperwork Reduction Act of 1995 This proposed rule contains no collections of information.
73 FR 34895Health 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 · Jul 2, 2014
The comment period on the draft guidance ended on February 3, 2014. … Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES
79 FR 37742Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 17, 1999
The comments added that the implementation period for the new rule must ensure that label integrity is not compromised or done haphazardly. … Comment No. C25, Docket No. 77N-094W, Dockets Management Branch. Dated: March 11, 1999. William K. Hubbard, Acting Deputy Commissioner for Policy.
64 FR 13066Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 12, 2006
The public comment period closed on March 5, 2004. A number of comments were received, which the agency considered carefully as it finalized the guidance and made appropriate changes. … The Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of
71 FR 2057Health and Human Services DepartmentFood and Drug AdministrationPermanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products
Federal Register · Rule · Jul 8, 2015
Reduction in notification period for “good cause.” … (Comment 33) One comment recommended that FDA require manufacturers to provide periodic updates on actions they are taking to bring drugs that are in shortage back to the market.
80 FR 38915Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Medical Device Reporting; Companion to Direct Final Rule
Federal Register · Proposed Rule · Feb 28, 2005
If we receive any significant adverse comment regarding the direct final rule, we will withdraw the direct final rule within 30 days after the comment period ends and proceed to respond to all of the comments … The comment period for this companion proposed rule runs concurrently with the direct final rule's comment period.
70 FR 9558Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 8, 2016
ACTION: Notice; extension of the comment period. … DATES: FDA is extending the comment period for the draft guidance by an additional 30 days.
81 FR 940Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 23, 2018
ACTION: Notice of availability; extension of comment period. … The Agency has received a request for a 30-day extension of the comment period.
83 FR 3164Health and Human Services DepartmentFood and Drug AdministrationAnimal Generic Drug User Fee Act; Public Meeting; Request for Comments
Federal Register · Notice · Sep 30, 2022
FDA-2011-N-0655 for “Animal Generic Drug User Fee Act; Public Meeting; Request for Comments.” … Section 742(d)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379j-13(d)(4)) requires that, after holding negotiations with regulated industry and periodic consultations with stakeholders
87 FR 59441Health 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 · Notice · Jun 17, 2022
number of units produced, along with other data as appropriate, to appropriate values for the reporting period. … Furthermore, if a product was not compounded during a particular reporting period, no product response would be sent for that product during that reporting period.
87 FR 36507Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 12, 2013
(Comment 9) One comment questioned why the preamble to the proposed rule identified change in dosage form as an example of “inappropriate `evergreening' of exclusive approval periods” (76 FR 64868 at 64870 … Congress would not have prescribed a definite period of exclusivity and at the same time provided for means to indefinitely extend that period.
78 FR 35117Health and Human Services DepartmentFood and Drug AdministrationRadiology Devices; Reclassification of Medical Image Analyzers
Federal Register · Rule · Jan 22, 2020
The comment period on the proposed order closed on August 3, 2018. II. … a professional society by the close of the comment period, each containing one or more comments on one or more issues.
85 FR 3545Health and Human Services DepartmentFood and Drug AdministrationDevelopment of Hazard Analysis Critical Control Points for the Food Industry; Request for Comments
Federal Register · Uncategorized Document · Aug 4, 1994
In particular, FDA will meet with the food industry, consumer groups, and other interested parties during the comment period on this advance notice of proposed rulemaking. … Request for Comments Under the act, the food industry has the primary responsibility for ensuring the safety of the food it produces and distributes.
Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 23, 1996
1996, the comment period on the proposed rule that published in the Federal Register of July 9, 1996 (61 FR 36154). … The agency is taking this action in response to a request for an extension of the comment period.
61 FR 49714Health and Human Services DepartmentFood and Drug AdministrationAnimal Drug User Fee Act; Public Meeting; Request for Comments
Federal Register · Notice · Nov 21, 2022
FDA-2011-N-0656 for “Animal Drug User Fee Act; Public Meeting; Request for Comments.” … Section 740A(d)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-13(d)(4)) requires that, after holding negotiations with regulated industry and periodic consultations with stakeholder, and
87 FR 70833Health 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 Administration
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