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Federal Register · Notice · Mar 6, 2001
the LM Working Group for an extension of the comment period, FDA and FSIS are extending the comment period until May 21, 2001. … , FDA and FSIS are extending the comment period until May 21, 2001.
66 FR 13545Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 23, 2021
ACTION: Notice; extension of comment period. … DATES: FDA is extending the comment period on the notice published June 15, 2021 (86 FR 31722). Submit either electronic or written comments by August 30, 2021.
86 FR 39047Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 25, 2023
ACTION: Notice; reopening of the comment period. … Therefore, we are reopening the comment period to allow interested parties additional time to submit comments.
88 FR 47886Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Safe Handling Statements: Labeling of Shell Eggs
Federal Register · Proposed Rule · May 5, 2005
We solicit comment on this issue. … Mandates Reform Act of 1995 (Public Law 104-4).
70 FR 23813Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Oct 11, 2000
FDA solicited comments concerning the DFR for a 75-day period ending July 25, 2000. … FDA stated that the effective date of the DFR would be on August 24, 2000, 30 days after the end of the comment period, unless any significant adverse comment was submitted to FDA during the comment period
65 FR 60359Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 26, 2006
Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each … Description : Devices subject to premarket approval under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) are also subject to periodic reports imposed by the premarket approval
71 FR 62595Health and Human Services DepartmentFood and Drug AdministrationOversight of Laboratory Developed Tests; Public Meeting; Reopening of the Comment Period
Federal Register · Notice · Aug 19, 2010
ACTION: Notice; reopening of the comment period. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010-20489 Filed 8-18-10; 8:45 am] BILLING CODE 4160-01-S
75 FR 51280Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 29, 2012
There were five comments received: (Comment 1) Jane Public commented that she does not see the usefulness of the study. … (Comment 4) FMI believes the proposed study fails to meet FDA's Information Quality Guidelines and the requirements of the Data Quality Act because its structure will not provide information of utility
77 FR 65555Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 28, 2026
Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. … The previously approved collections of information are subject to review by Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
91 FR 47247Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 17, 2012
ACTION: Notification; extension of comment period. … SUMMARY: The Food and Drug Administration (FDA) is extending the comment period pertaining to information collection issues under the Paperwork Reduction Act of 1995 (the PRA) associated with the proposed
77 FR 57055Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; VITREON; Amendment
Federal Register · Notice · Mar 17, 2003
Submit electronic comments to http://www.fda.gov/dockets/ecomments . … Any interested person may petition FDA, on or before September 15, 2003, for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period.
68 FR 12707Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 13, 2009
Period AGENCY: Food and Drug Administration, HHS. … ACTION: Notice; reopening of the comment period.
74 FR 52495Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 4, 1998
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … period.
63 FR 24557Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 10, 2013
This notice solicits comments on the collection of health documents that were created during the period of June 23, 2009, through December 31, 2009. … The number of documents received each year since the original collection period has fallen to less than 5 percent of the number received in the original collection period.
78 FR 21379Health and Human Services DepartmentFood and Drug AdministrationLatex Condoms; User Labeling; Expiration Dating
Federal Register · Rule · Sep 26, 1997
Section 510(h) of the act, requires that condom manufacturers, as device manufacturers, be inspected at least once in a 2-year period. … The agency received one comment on the Paperwork Reduction Act statement of the proposed rule.
62 FR 50497Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Feb 3, 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.
80 FR 5674Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 4, 1998
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
63 FR 41580Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 7, 1998
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
63 FR 42405Health and Human Services DepartmentFood and Drug AdministrationFramework for a Real-World Evidence Program; Availability; Reopening of the Comment Period
Federal Register · Notice · Feb 15, 2019
ACTION: Notice of availability; reopening of the comment period. … Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019-02561 Filed 2-14-19; 8:45 am] BILLING CODE 4164-01-P
84 FR 4475Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 16, 2020
ACTION: Notice; reopening of the comment period. … Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020-22969 Filed 10-15-20; 8:45 am] BILLING CODE 4164-01-P
85 FR 65819Health and Human Services DepartmentFood and Drug Administration
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