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Briefs, oral arguments, agency decisions and the Federal Register.
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New Animal Drugs for Minor Use and Minor Species
Federal Register · Proposed Rule · Nov 15, 2010
The comment period for the companion proposed rule runs concurrently with the comment period of the direct final rule. … If we receive any significant adverse comments, we will withdraw the direct final rule within 30 days after the comment period ends and proceed to respond to all of the comments under this companion proposed
75 FR 69614Health and Human Services DepartmentFood and Drug AdministrationMedical Gloves; Draft Guidance Manual; Availability; Extension of Comment Period
Federal Register · Notice · Oct 28, 1999
The agency is taking this action to harmonize the comment period for the draft guidance with the extension of the comment period for the proposed rule on the reclassification of surgeon's and patient examination … Received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday. Dated: October 21, 1999. Margaret M. Dotzel, Acting Associate Commissioner for Policy.
64 FR 58070Health 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 · Proposed Rule · Jul 28, 2010
ACTION: Proposed rule; reopening of the comment period. … The agency has considered the requests and is reopening the comment period until September 7, 2010.
75 FR 44172Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 27, 2012
ACTION: Proposed rule; reopening of comment period on specific data. … The proposed rule provided a 90-day period for public comment. The comment period closed June 28, 2010.
77 FR 4273Health and Human Services DepartmentFood and Drug AdministrationUniform Compliance Date for Food Labeling Regulations
Federal Register · Rule · Dec 27, 1996
SUPPLEMENTARY INFORMATION: FDA periodically issues regulations requiring changes in the labeling of food. … FDA has examined the economic implications of this final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601- 612).
61 FR 68145Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 27, 2021
The comment period on this proposed order affords an opportunity for the public to submit information that has become available since the closure of the comment period on the 2019 Proposed Rule. … FDA will consider all comments that were submitted to the public docket for the 2019 Proposed Rule within its comment period to be constructively submitted as comments on the proposed order being issued
86 FR 53322Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 14, 2008
ACTION: Notice; reopening of comment period. … The Controlled Substances Act (21 U.S.C. 811 et seq. ) (Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970) provides that when WHO notifies the United States under Article
73 FR 60705Health and Human Services DepartmentFood and Drug AdministrationPerformance Standards for Ionizing Radiation Emitting Products; Fluoroscopic Equipment; Correction
Federal Register · Proposed Rule · Apr 13, 2015
If FDA receives any significant adverse comments regarding the direct final rule, we will withdraw it within 30 days after the comment period ends. … The comment period for this companion proposed rule runs concurrently with the direct final rule's comment period.
80 FR 19589Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 20, 1998
The comment period for this companion proposed rule runs concurrently with the comment period for the direct final rule. … This comment period runs concurrently with the comment period for the direct final rule. Two copies of any comments are to be submitted, except that individuals may submit one copy.
63 FR 19431Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 12, 2015
FSMA amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish the foundation of a modernized, prevention-based food safety system. … The NOI asked for public comment by November 15, 2013, and FDA later extended the deadline for the comment period to April 18, 2014 (79 FR 13593; March 11, 2014).
80 FR 1478Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Humanitarian Use of Devices
Federal Register · Rule · Nov 3, 1998
FDA stated that if the agency received any significant adverse comment regarding the direct final rule, FDA would publish a document withdrawing the direct final rule within 30 days after the comment period … Proposed Sec. 814.126(b)(2) has been modified, in response to a comment, to require HDE holders to retain records for a time period specified in the approval order, rather than an unlimited time period
63 FR 59217Health and Human Services DepartmentFood and Drug AdministrationGuidance for Industry on Classifying Resubmissions in Response to Action Letters; Availability
Federal Register · Notice · May 14, 1998
After the comment period, comments may be submitted to one of the centers at the address below. FOR FURTHER INFORMATION CONTACT: Murray M. … However, the agency wishes to solicit comment from the public and is providing a 90-day comment period and establishing a docket for the receipt of comments.
63 FR 26808Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 29, 2008
period ends. … The comment period for the direct final rule runs concurrently with that of the companion proposed rule.
73 FR 56487Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ERTACZO
Federal Register · Notice · May 12, 2005
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: July 3, 1996.
70 FR 25091Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; T-Scan 2000
Federal Register · Notice · Jan 24, 2002
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by July 23, 2002.
67 FR 3501Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Starlix
Federal Register · Notice · Feb 27, 2003
Submit electronic comments to http://www.fda.gov/dockets/ecomments . … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
68 FR 9091Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 10, 1999
(the act) (21 U.S.C. 201 et seq.) and the Public Health Service Act (42 U.S.C. 262 and 264), FDA is required to ensure the marketing of only those biological products that are shown to be safe and effective … In developing the reproposal, FDA will also consider comments submitted in response to the proposed rule of October 27, 1994, regarding periodic adverse experience reports.
64 FR 11920Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 30, 2021
&C Act (21 U.S.C. 355) (NDAs or ANDAs). … Section 760(e) of the FD&C Act also requires that responsible persons maintain records of nonprescription drug adverse event reports, whether the event is serious or not, for a period of 6 years.
86 FR 34759Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 8, 2013
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 … Act of 1995 (PRA) (44 U.S.C. 3501-3520).
78 FR 20926Health and Human Services DepartmentFood and Drug Administration
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