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Reauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Comments
Federal Register · Notice · Aug 24, 2021
This notice, the 30-day comment period, and the public meeting will satisfy some of these requirements. … PDUFA was originally enacted in 1992 as the Prescription Drug User Fee Act (Pub. L. 102-571) for a period of 5 years.
86 FR 47316Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 28, 2020
Comment Period AGENCY: Food and Drug Administration, HHS. … ACTION: Notice of availability; extension of comment period.
85 FR 84347Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 15, 2011
Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-23491 Filed 9-14-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 57056Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 1, 2011
ACTION: Notice; reopening of the comment period. … The Agency has considered the requests and is reopening the comment period until May 2, 2011. III.
76 FR 18227Health 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 · Oct 22, 2024
ACTION: Notice of availability; extension of comment period. … The Agency has received a request for an extension of the comment period.
89 FR 84352Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 26, 2018
ACTION: Notice of availability; extension of comment period. … The Agency has received a request for a 60-day extension of the comment period.
83 FR 3740Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 16, 2021
ACTION: Notice of availability; reopening of the comment period. … FDA has considered the request and is reopening the comment period until June 14, 2021.
86 FR 14454Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jun 28, 2023
ACTION: Notification of petition; extension of comment period. … We have received requests for a 60-day extension of the comment period for the color additive petition.
88 FR 41870Health 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 AdministrationWhite Chocolate; Proposal to Establish a Standard of Identity
Federal Register · Proposed Rule · Mar 10, 1997
For small firms the cost of relabeling ranges from $12,750 with a 6-month compliance period to $1,550 with a 24-month compliance period. … The agency requests comments on the impact of the compliance period on small chocolate producers and suggestions for minimizing the impact of this proposed rule on small businesses. VI.
62 FR 10781Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 1, 2011
ACTION: Notice; reopening of the comment period. … The Agency has received a request for an extension of the comment period for this notice.
76 FR 67465Health 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 AdministrationFederal Register · Notice · Aug 26, 2021
ACTION: Notice; request for comments; extension of comment period. … The Agency has received a request for a 60-day extension of the comment period.
86 FR 47647Health and Human Services DepartmentFood and Drug AdministrationExport Requirements for Medical Devices; Reopening of Comment Period
Federal Register · Proposed Rule · Jan 7, 1997
comment period for a proposed rule that appeared in the Federal Register of November 27, 1995 (60 FR 58308). … During this comment period and FDA's review of the comments, FDA will issue export permits under section 801(e)(2) of the act using current CDRH procedures.
62 FR 953Health and Human Services DepartmentFood and Drug AdministrationSugars That Are Metabolized Differently Than Traditional Sugars; Extension of Comment Period
Federal Register · Notice · Dec 18, 2020
ACTION: Notification; extension of comment period. … We have concluded that it is reasonable to extend the comment period for 60 days.
85 FR 82489Health and Human Services DepartmentFood and Drug AdministrationFood Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease
Federal Register · Proposed Rule · Dec 8, 2010
Paperwork Reduction Act of 1995 XI. Federalism XII. Comments XIII. References I. Background The Nutrition Labeling and Education Act of 1990 (NLEA) (Pub. … After the comment period had closed, the agency received two requests to extend the comment period.
75 FR 76526Health and Human Services DepartmentFood and Drug AdministrationNew Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food
Federal Register · Rule · Jul 11, 2019
(Comment 15) One comment suggests that “the availability of advanced methods that improve upon the practicable method necessarily means that the tolerance, withdrawal period, and the need for use restrictions … Other Comments (Comment 25) One comment to the 2012 proposed rule expresses concern that an unintended consequence of this rule is that it would have the effect of acting as a “non-tariff trade barrier
84 FR 32982Health and Human Services DepartmentFood and Drug AdministrationMedical Device Classification Procedures; Extension of Comment Period
Federal Register · Proposed Rule · Jun 12, 2014
FDA-2013-N-1529] Medical Device Classification Procedures; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; extension of comment period. … The Agency has received requests for an extension of the comment period for the proposed rule.
79 FR 33711Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 25, 1998
The comment period for this companion proposed rule runs concurrently with the comment period for the direct final rule. … If timely significant adverse comments regarding the rule are received, FDA will publish a document withdrawing the direct final rule within 30 days after the comment period ends.
63 FR 51322Health and Human Services DepartmentFood and Drug Administration
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