Documents
Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Rule · Mar 4, 1996
A 60-day comment period, ending on August 18, 1992, was provided to allow interested persons an opportunity to submit comments on the proposed changes. … FDA believes this time period is appropriate.
61 FR 8432Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 29, 2021
Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). … Specification for additive manufacturing file format (AMF) Version 1.2 Withdrawn and replaced with newer version. 8-530 8-549 ASTM F3208-20 Standard Guide for Selecting Test Soils for Validation of Cleaning
86 FR 22678Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 17, 2013
Comment Period Because of the complexity of this proposed rule, we are providing a comment period of 180 days. … period.
78 FR 76444Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 8, 2011
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed rule and consideration of any comments received, issue a final rule to require premarket … The FD&C Act does not permit an extension of the 90-day period after issuance of a final rule within which an application or a notice is required to be filed.
76 FR 48058Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 27, 1999
The comment period for the companion proposed rule ended on August 31, 1998. FDA received significant adverse comments in response to the direct final rule and the companion proposed rule. … In addition to serving as a useful forum in which scientific disputes in general can be aired, the Medical Devices Dispute Resolution Panel will implement four provisions of the Federal Food, Drug, and
64 FR 22617Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 1, 2003
FDA agrees and will replace the term “state-of-the-art” with “appropriately fit conventional air conduction hearing aids.” … Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act
68 FR 45256Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 8, 2015
Thus, for these devices, the later of these two time periods is the 90-day period. … FDA disagrees with this comment.
80 FR 32307Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 2, 1998
Period of Agreement Upon acceptance by both parties, this agreement will become effective immediately and remain in effect for a period of three (3) years from the date of signature by authorized … The notified agency will be responsible for making any requisite contact with the submitter of the protected information and will accept full responsibility for evaluating the submitter's comments prior
63 FR 30002Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 15, 1997
The agency requests comments on the draft guidance. DATE: Written comments by September 15, 1997. General comments on agency guidance documents are welcomed at any time. … The Federal Food, Drug, and Cosmetic Act (the act) authorizes FDA to establish standards for drug product packaging, including containers and closures.
62 FR 37925Health and Human Services DepartmentFood and Drug AdministrationGuidance Documents Related to Coronavirus Disease 2019; Availability
Federal Register · Notice · Aug 3, 2020
Therefore, FDA will issue COVID-19-related guidance documents for immediate implementation without prior public comment (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) … the availability of certain COVID-19-related guidance documents that FDA issued during the relevant period, as included in Table 1.
85 FR 46641Health and Human Services DepartmentFood and Drug AdministrationGuidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability
Federal Register · Notice · Nov 29, 2010
The cleaning and disinfection instructions provided with reusable lancet devices may not be adequately validated for efficacy or followed in their entirety. … Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995
75 FR 73107Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 29, 2014
packing (e.g., sorting, cleaning or seeding) at an off-farm facility. … Corrections that generally would not require records Re-cleaning and sanitizing inadequately cleaned food contact surfaces before start up.
79 FR 58524Health and Human Services DepartmentFood and Drug AdministrationCIBA Vision Corp.; Premarket Approval of Unizyme Enzymatic Cleaner
Federal Register · Notice · Apr 8, 1997
(the act), of Unizyme Enzymatic Cleaner. … The device is a periodic cleaner and is indicated for use with (hydrogen peroxide), lens care systems in the weekly cleaning of soft (hydrophilic) contact lenses (including daily wear, extended wear, tinted
62 FR 16862Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 26, 2002
Comments at the public workshop and the written comments received on the draft guidance led FDA to revise the draft document. … Act of 1995 (44 U.S.C. 3501-3520).
67 FR 70752Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 20, 2018
The Federal Food, Drug, and Cosmetic Act (FD&C Act) prohibits the introduction into interstate commerce of any cosmetic that is adulterated or misbranded; cosmetics are also to be safe and properly labeled … FDA thanks the commenters for their comments and provides our responses below.
83 FR 58582Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 24, 2006
This should include any procedures to evaluate subcontractors who have access to laboratory space, such as cleaning personnel. B. … FDA does not guarantee to accommodate or explain SPOC comments that are received after the 60-day cutoff. 5.
71 FR 50068Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 3, 2007
This should include any procedures to evaluate subcontractors who have access to laboratory space, such as cleaning personnel. 2. … FDA does not guarantee to accommodate or explain SPOC comments that are received after the 60-day cutoff. E.
72 FR 43277Health and Human Services DepartmentFood and Drug AdministrationNatural Resources Defense Council et al.; Denial of Food Additive Petition
Federal Register · Proposed Rule · May 4, 2017
Food Additive Regulation The Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizes us to regulate “food additives” (see section 409(a) of the FD&C Act (21 U.S.C. 348(a)). … Comments on the Filing Notice We received very few comments on the petition.
82 FR 20847Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 6, 2021
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by April 5, 2022 (see the “Paperwork Reduction Act of 1995” section of this document). … Another study (Ref. 67) found that E. coli was recovered from 20 percent of air samples from an almond orchard downwind from a poultry operation and from 0.48 percent of air samples from an almond
86 FR 69120Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 6, 1999
DATES: Submit written comments on the collection of information by November 5, 1999. … All comments should be identified with the docket number found in brackets in the heading of this document.
64 FR 54334Health and Human Services DepartmentFood and Drug Administration
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