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Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Notice · May 16, 2002
DATES: Submit written comments on the collection of information by June 17, 2002. … In the Federal Register of February 7, 2002 (67 FR 5825), the agency requested comments on the proposed collection of information. There were no comments received.
67 FR 34939Health and Human Services DepartmentFood and Drug AdministrationEffective Date of Requirement for Premarket Approval for Blood Lancets
Federal Register · Proposed Rule · Mar 3, 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 … FDA cautions that under section 515(d)(1)(B)(i) of the FD&C Act, the Agency may not enter into an agreement to extend the review period for a PMA beyond 180 days unless the Agency finds that “. . . the
81 FR 11151Health and Human Services DepartmentFood and Drug AdministrationGeneral and Plastic Surgery Devices; Reclassification of Blood Lancets
Federal Register · Proposed Rule · Mar 3, 2016
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (PRA) by April 4, 2016, (see the “Paperwork Reduction Act of 1995” section of this document). … , and consideration of comments to a public docket.
81 FR 11140Health and Human Services DepartmentFood and Drug AdministrationUse of Ozone-Depleting Substances; Removal of Essential-Use Designations; Public Meeting
Federal Register · Proposed Rule · Jul 9, 2007
Background Under the Clean Air Act, FDA, in consultation with the EPA, is required to determine whether an FDA-regulated product that releases an ODS is an essential use of the ODS. … Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one copy. Comments are to be identified with Docket No. 2006N-0454.
72 FR 37137Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Oct 7, 2022
Failure to use the proper solution to keep contact lenses clean and moist can lead to infections. … We do not, therefore, consider impacts related to shipments via commercial air, land, and seaports.
87 FR 60947Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 30, 2003
L. 107-250), amended the Federal Food, Drug, and Cosmetic Act (the act) by adding section 510(o) (21 U.S.C. 360(o)), which provided new regulatory requirements for reprocessed SUDs. … Comments You may submit written or electronic comments on these lists to the Dockets Management Branch (see ADDRESSES ).
68 FR 23139Health and Human Services DepartmentFood and Drug AdministrationProcedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products
Federal Register · Rule · Dec 18, 1995
The agency received several written requests for an extension of the comment period. … The comments either agreed with a 1-year implementation period or requested a longer period of 2 years or more.
60 FR 65096Procedures for the Safe and Sanitary Processing and Importing of FishHealth and Human Services DepartmentFederal Register · Rule · Jan 19, 2001
(Comment 53) One comment requested that FDA require processors to monitor for water and cleaning solution contamination. … (The terms “cleaning” and “culling” are discussed below in the response to comment 132.)
66 FR 6138Health and Human Services DepartmentFood and Drug AdministrationNatural Resources Defense Council et al.; Filing of Food Additive Petition
Federal Register · Proposed Rule · Mar 16, 2015
We are requesting comments on the petition and establishing a comment period of 60 days from the date of publication of this notice. … Pursuant to § 189.1(c), we are requesting comments on the petition and establishing a comment period of 60 days from the date of publication of this notice. II.
80 FR 13508Health and Human Services DepartmentFood and Drug AdministrationSurgeon's and Patient Examination Gloves; Reclassification
Federal Register · Proposed Rule · Jul 30, 1999
period. … period.
64 FR 41710Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 24, 1998
FDA has the authority under section 701(a) of the act (21 U.S.C. 371(a)) to issue regulations for the efficient enforcement of the act regarding CGMP procedures for manufacturing, processing, and holding … Thereafter, SOP's need to be periodically updated. A combined estimate is provided below for routine maintenance of SOP's.
63 FR 71291Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Dec 27, 2016
After medication, move birds to clean ground or to a clean house. If disease recurs, use 0.05 percent in feed again for 2 days. Do not treat chickens or turkeys within 10 days of slaughter for food. … After medication, move birds to clean ground or to a clean house. If disease recurs, use 0.05 percent in feed again for 2 days. Do not treat chickens or turkeys within 10 days of slaughter for food.
81 FR 94991Health and Human Services DepartmentFood and Drug AdministrationPrevention of Salmonella Enteritidis in Shell Eggs During Production; Extension of Comment Period
Federal Register · Proposed Rule · Jun 8, 2005
ACTION: Proposed rule; extension of comment period. … FDA reopened the comment period to receive comment and other information regarding industry practices and programs that prevent SE-monitored chicks from becoming infected by SE during the period of pullet
70 FR 33404Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 7, 2014
Follow the instructions for submitting comments. … 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
79 FR 765Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 10, 1997
sections: (1) Introduction; (2) General Information; (3) Water Systems, including discussions of General Description of Water System, Validation Summary and Routine Monitoring; (4) Heating, Ventilation and Air … Conditioning Systems; and (5) Contamination/Cross Contamination Issues, including discussions of Cleaning Procedures and Validation and Containment Features.
62 FR 1460Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 19, 2007
ACTION: Notice; reopening of comment period. … One of the respondents' comments was received after the 60-day comment period closed and is not addressed.
72 FR 39623Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 25, 2006
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.
71 FR 55748Health and Human Services DepartmentFood and Drug AdministrationPer- and Polyfluoroalkyl Substances in Seafood; Request for Information
Federal Register · Notice · Nov 20, 2024
air, water, and food (Refs. 10 through 12). … The White House, “Fact Sheet: Biden-Harris Administration Combatting PFAS Pollution to Safeguard Clean Drinking Water for All Americans, June 2022.” Accessed June 14, 2024.
89 FR 91765Health and Human Services DepartmentFood and Drug AdministrationPediculicide Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph
Federal Register · Proposed Rule · May 10, 2002
Individuals submitting written comments or anyone submitting electronic comments may submit one copy. … section 505(a) of the act.
67 FR 31739Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Apr 14, 2004
the comment period for an additional 30 days in March 2004, coinciding with the issuance of the plan by FDA and CBP relating to timeframes. … Comments Elsewhere in this issue of the Federal Register , we are reopening the comment period on the prior notice IFR.
69 FR 19765Health and Human Services DepartmentFood and Drug Administration
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