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Briefs, oral arguments, agency decisions and the Federal Register.
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Development 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 · Notice · Nov 18, 2013
ACTION: Notice; extension of comment period. … (OMB) under the Paperwork Reduction Act of 1995 (PRA).
78 FR 69095Health 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 AdministrationRevocation of Status of Specific Products; Group A Streptococcus
Federal Register · Rule · Dec 2, 2005
The comment period for the direct final rule runs concurrently with the companion proposed rule. … We are providing a comment period on the direct final rule of 75 days after the date of publication in the Federal Register .
70 FR 72197Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 21, 1999
The agency is taking this action in response to numerous requests for an extension of the comment period. DATES: Written comments on the draft standard MOU may be submitted by August 2, 1999. … In response to numerous requests, FDA has decided to reopen the comment period on the draft standard MOU until August 2, 1999.
64 FR 33100Health and Human Services DepartmentFood and Drug AdministrationDissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices
Federal Register · Rule · Nov 20, 1998
These comments argued that FDA would use this provision to extend the 60-day time period. … Section 554(c)(2) of the act requires a manufacturer to submit periodic progress reports on its clinical studies.
63 FR 64556Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ViagraSUPTM/SUP
Federal Register · Notice · Jan 27, 1999
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: January 8, 1995.
64 FR 4115Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Mar 30, 2023
ACTION: Petition for rulemaking; extension of comment period. … We have received a request for a 60-day extension of the comment period for the color additive petition The request conveyed concern that the current 60-day comment period does not allow sufficient time
88 FR 19026Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jan 5, 2016
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, consideration of any comments received, and a meeting of a device classification … The commenter requested clarification regarding what actions will be taken should the PMA not be approved within the 180-day review period.
81 FR 364Health and Human Services DepartmentFood and Drug AdministrationDefining Small Number of Animals for Minor Use Determination; Periodic Reassessment
Federal Register · Notice · Sep 15, 2022
L. 108-282) (the MUMS Act) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to provide incentives for the development of new animal drugs for use in minor animal species and for minor uses in … In our final rule, in response to comments, we agreed that periodic reassessment of the small numbers is appropriate and that such reassessments should occur approximately every 5 years.
87 FR 56681Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 25, 2019
DATES: Electronic or written comments on the application may be submitted beginning July 25, 2019. FDA will establish a closing date for the comment period as described in section I. … FDA believes that this comment period is appropriate given the volume and complexity of the applications being posted.
84 FR 35869Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 1, 2012
DATES: Submit either electronic or written comments on the collection of information by October 1, 2012. … ADDRESSES: Submit electronic comments on the collection of information to http://www.regulations.gov .
77 FR 45619Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 29, 2000
How Can I Comment on This Proposed Rule? A. Electronic Access and Filing Address B. Written Comments VIII. How Does This Regulation Comply With the Paperwork Reduction Act of 1995? I. … FDA may not consider or include in the administrative record for the final rule comments that we receive after the close of the comment period (see the DATES section) or comments delivered to an address
65 FR 52376Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jul 10, 2008
Comments D. Conclusion V. Environmental Impact VI. Paperwork Reduction Act of 1995 VII. Federalism I. … Failure to Take Action Under proposed § 314.110(c), an applicant would be considered to agree to extend the review period under section 505(c)(1) of the act until it takes any of the actions listed in
73 FR 39588Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 7, 1995
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 promulgation of a final rule within which an application or a notice is required to be filed.
60 FR 46718Health and Human Services DepartmentFood and Drug AdministrationEffective Date of Requirement for Premarket Approval for Automated External Defibrillator Systems
Federal Register · Rule · Jan 29, 2015
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, consideration of any comments received, and a meeting of a device classification … One comment suggested that the 15-month period should be extended to 30 months, which the commenter claimed would be consistent with section 501(f)(2)(B) of the FD&C Act (21 U.S.C. 351(f)(2)(B).
80 FR 4783Health and Human Services DepartmentFood and Drug AdministrationTurtles Intrastate and Interstate Requirements
Federal Register · Proposed Rule · Jul 25, 2013
The comment period for this proposed rule runs concurrently with the comment period of the companion direct final rule. … period ends.
78 FR 44915Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 12, 1996
Comment: Six commenters recommended that ORR determine country eligibility on an annual basis instead of the proposed three-year eligibility period. … One commenter recommended that ORR allow for a 90-day application period; another commenter recommended that there be a 60-day application period or that there be fewer application requirements, Response
61 FR 36739Food and Drug AdministrationRefugee Resettlement OfficeFederal Register · Notice · Aug 19, 2011
ACTION: Notice; extension of comment period. … Interested persons were invited to submit comments by September 12, 2011. At this time the Agency is extending the comment period until October 12, 2011, to continue to receive public comments.
76 FR 51993Health and Human Services DepartmentFood and Drug AdministrationAntimicrobial Animal Drug Sales and Distribution Reporting
Federal Register · Rule · May 11, 2016
, including periodic drug experience reports under § 514.80(b)(4). … We received approximately 440 individual comments on the proposed rule by the close of the comment period, each addressing one or more topics.
81 FR 29129Health and Human Services DepartmentFood and Drug Administration
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