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Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Notice · Oct 16, 1998
Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. … L. 105-115, 111 Stat. 2296 (1997)) amends section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d), allowing the agency to recognize consensus standards established by international
63 FR 55617Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 9, 2007
DATES: Submit written or electronic comments on the collection of information by September 7, 2007. … control environmental conditions and inspection result records; (4) requirements for personnel hygiene; (5) procedures for preventing contamination of equipment and products; (6) equipment adjustment, cleaning
72 FR 37235Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 29, 2012
for public comment in response to the notice. … out the provisions of the FD&C Act.
77 FR 12307Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jul 15, 2008
, sterility assurance, control of contractors, complaints, cleaning, and specifications. … or industrial cleaning agents; and product mix-ups.
73 FR 40453Health and Human Services DepartmentFood and Drug AdministrationOver-The-Counter Human Drugs; Labeling Requirements
Federal Register · Rule · Mar 17, 1999
The agency provided over 7 months for interested persons to comment on the OTC labeling proposal, which included an extension of the comment period from June 27, 1997, to October 6, 1997, published in … 505(a) of the act.
64 FR 13254Health and Human Services DepartmentFood and Drug AdministrationRequired Warnings for Cigarette Packages and Advertisements
Federal Register · Rule · Jun 22, 2011
30-day period. … (Comment 246) One comment stated that FDA's preliminary benefits analysis inappropriately excluded the effects of the rule on employer and government cleaning and maintenance costs.
76 FR 36628Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Feb 26, 2013
As an example, the comment stated that collecting a clean-catch urine sample via a catheter has a potential to cause tissue injury and/or infection and therefore has a higher degree of risk than testing … We note that given data limitations we are unable to use the same period of analysis across centers.
78 FR 12937Health and Human Services DepartmentFood and Drug AdministrationUnique Device Identification System
Federal Register · Proposed Rule · Jul 10, 2012
need for effective cleaning and sterilization before each new use providing a complicating factor. … Subpart D—FDA as an Issuing Agency § 830.200 When FDA will act as an issuing agency. (a) During any period where there is no accredited issuing agency, FDA will act as an issuing agency.
77 FR 40736Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 28, 2015
The Agency is making this information available consistent with the PHS Act. … The meropenem docket remained opened for public comment from February 27, 2012, until March 28, 2012. There were no comments submitted to the docket during that time.
80 FR 30467Health and Human Services DepartmentFood and Drug AdministrationDental Devices; Classification for Intraoral Devices for Snoring and/or Obstructive Sleep Apnea
Federal Register · Rule · Nov 12, 2002
Analysis of Comment and FDA's Response The one comment FDA received expressed concerns about the effect the guidance document would have on dental laboratories. … The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction.
67 FR 68510Health and Human Services DepartmentFood and Drug AdministrationAntiperspirant Drug Products For Over-the-Counter Human Use; Final Monograph
Federal Register · Rule · Jun 9, 2003
The second petition contended that this 10-seconds-exposure assumption was incorrect because the aluminum particles in an antiperspirant aerosol remain suspended in the air for a long period of time, and … section 505(a) of the act
68 FR 34273Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 25, 2019
In response to comments received, we have revised the draft guidance and are announcing the reissue of it elsewhere in this issue of the Federal Register to enable the public to review and comment … Air Regulatory Grp. v. EPA, 573 U.S. 302, 327 (2014) (“An agency confronting resource constraints may change its own conduct, but it cannot change the law.”)).
84 FR 57439Health and Human Services DepartmentFood and Drug AdministrationMedical Gas Regulation; Public Workshops; Request for Comments
Federal Register · Notice · Nov 17, 2017
Background On May 5, 2017, President Trump signed the Consolidated Appropriations Act, 2017 (Pub. L. 115-31). … Since the 2012 enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub.
82 FR 54353Health and Human Services DepartmentFood and Drug AdministrationFDA Modernization Act of 1997: Modifications to the List of Recognized Standards
Federal Register · Notice · Jul 12, 1999
L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d) to allow the agency to recognize consensus standards established by international and national standards … Comments Interested persons may, at any time, submit to the contact person (address above) written comments regarding this document.
64 FR 37546Health and Human Services DepartmentFood and Drug AdministrationUse of Materials Derived From Cattle in Human Food and Cosmetics
Federal Register · Rule · Apr 17, 2008
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by May 19, 2008 (see the “Paperwork Reduction Act of 1995” section of this document). … The agency will consider modifications to the current amendment to the interim final rule based on comments made during the comment period.
73 FR 20785Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 19, 2004
DATES: Submit written and electronic comments on the collection of information by April 19, 2004. … control environmental conditions and inspection result records; (4) requirements for personnel hygiene; (5) procedures for preventing contamination of equipment and products; (6) equipment adjustment, cleaning
69 FR 7755Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemption From Premarket Notification and Reserved Devices; Class I
Federal Register · Rule · Jan 14, 2000
FDA received four comments in response to the proposed rule. The following is FDA's response to those comments. 1. … FDA expects to finalize the August 9, 1999, proposed rule to make these devices class II shortly after the comment period ends on November 8, 1999.
65 FR 2296Health and Human Services DepartmentFood and Drug AdministrationPrescription Drug Products; Levothyroxine Sodium
Federal Register · Notice · Aug 14, 1997
Levothyroxine sodium is unstable in the presence of light, temperature, air, and humidity (Ref. 4). … act.
62 FR 43535Health and Human Services DepartmentFood and Drug AdministrationTobacco Products; Required Warnings for Cigarette Packages and Advertisements
Federal Register · Proposed Rule · Aug 16, 2019
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by September 16, 2019. ADDRESSES: You may submit comments as follows. … during the same period due to maternal smoking (Ref. 177).
84 FR 42754Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Dec 3, 1999
Although the March 1994 proposal provided a 60-day comment period under the Paperwork Reduction Act of 1980, and this final rule responds to the comments received, FDA is providing [[Page 67755]] an … additional opportunity for public comment under the Paperwork Reduction Act of 1995, which became effective after the expiration of the comment period and applies to this final rule.
64 FR 67720Health and Human Services DepartmentFood and Drug Administration
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