Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
1.40s
Medical Devices; Laboratory Developed Tests
Federal Register · Proposed Rule · Oct 3, 2023
Smith, 538 U.S. 254, 273 (2003) (cleaned up).) … Based in part on those comments, FDA is now proposing a 1-year time period for laboratories to come into compliance with the MDR requirements.
88 FR 68006Health and Human Services DepartmentFood and Drug AdministrationAmendments to Registration of Food Facilities
Federal Register · Rule · Jul 14, 2016
(Comment 75) Comments oppose shortening the time period for registration updates. … Some comments state that, given the potential for criminal penalties for committing prohibited acts under the FD&C Act, the shortened time period does not provide a reasonable amount of time for compliance
81 FR 45912Health and Human Services DepartmentFood and Drug AdministrationNew Animal Drugs for Use in Animal Feeds; Roxarsone; Semduramycin
Federal Register · Rule · Jul 21, 2005
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is amended … (iv) 22.7 to 45.4 Chlortetracycline 200 to 400 Growing chickens: As in paragraph (d)(1)(i) of this section; and for control of chronic respiratory disease (CRD) and air sac infection caused by
70 FR 41958Health and Human Services DepartmentFood and Drug AdministrationSunscreen Drug Products for Over-the-Counter Human Use
Federal Register · Proposed Rule · Feb 26, 2019
Comment Period We are providing a comment period of 90 days (see DATES ). … Fresh water is clean drinking water that meets the standards in 40 CFR part 141. The pool and air temperature and the relative humidity must be recorded. (i) Water resistance (40 minutes).
84 FR 6204Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Feb 3, 2003
FDA believes that a 60-day comment period is appropriate in this instance. … FDA will not consider any comments submitted after the 60-day comment period closes and does not intend to grant any requests for extension of the comment period due to the Bioterrorism Act's requirement
68 FR 5378Health and Human Services DepartmentFood and Drug AdministrationForeign Establishment Registration and Listing
Federal Register · Rule · Nov 27, 2001
The comment period for the proposed rule was originally scheduled to end on July 28, 1999. … The request arrived too late for FDA to announce an extension of the comment period, so FDA published a document in the Federal Register of August 9, 1999 (64 FR 43114), reopening the comment period
66 FR 59138Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Uncategorized Document · Aug 23, 1994
Interested persons were invited to submit comments by December 8, 1976. Reply comments in response to comments filed in the initial comment period could be submitted by January 7, 1977. … The product delivers in each 800 milliliters of air 0.40 to 0.50 milligrams of propylhexedrine.
Health and Human Services DepartmentFood and Drug AdministrationNew Animal Drugs; Change of Sponsor
Federal Register · Rule · Feb 27, 2014
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 524, 526 … For beginning treatment of acute ocular inflammations place 1 or 2 drops in the conjunctival sac 3 to 6 times during a 24 hour period.
79 FR 10965Health and Human Services DepartmentFood and Drug AdministrationCritical Path Manufacturing Sector Research Initiative (U01)
Federal Register · Notice · Jul 13, 2011
This includes development of components for more reliable delivery of pharmaceuticals to the most desirable site of action, for example, controlling the air plume of inhaled products. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-17515 Filed 7-12-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 41266Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 15, 2013
Submit electronic comments by email: standards@cdrh.fda.gov. … L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d).
78 FR 2998Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 7, 2023
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. … (Response) FDA appreciates the comment in response to the 60-day notice.
88 FR 7983Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 29, 1995
to correct a deficiency in the 1906 Food and Drugs Act (the 1906 act). … FDA usually grants permits for a period not to exceed 15 months. However, with good reason, the agency may provide for a longer initial test market.
60 FR 67492Health and Human Services DepartmentFood and Drug AdministrationSecondary Direct Food Additives Permitted in Food for Human Consumption
Federal Register · Rule · Jun 26, 2001
No new information or comments have been received that would affect the agency’s previous determination that there is no significant impact on the human environment and that an environmental impact statement … It is produced commercially by passing electrical discharges or ionizing radiation through air or oxygen.
66 FR 33829Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 4, 2017
ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before February 2, 2018. … One difference between the preamendments female condom (product code OBY) and the postamendments female condom (product code MBU) is that the preamendments female condom is indicated to be cleaned at the
82 FR 57174Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 31, 2006
Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d … Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy.
71 FR 16313Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 24, 2018
FDA will periodically review these requests, and, when appropriate, expand the list. … full consideration of the comment.”
83 FR 42904Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 18, 2004
DATES: Submit written or electronic comments concerning this document at any time. … Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d
69 FR 34176Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 8, 2009
Submit electronic comments by e-mail: standards@cdrh.fda.gov . … Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d
74 FR 46203Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jan 6, 2017
The validated processes are designed to remove soil and contaminants by cleaning and to inactivate microorganisms by disinfection or sterilization. … (Comment 1) Several comments supported reclassification of urogynecologic surgical mesh instrumentation, with some comments supporting reclassification into class II and others supporting reclassification
82 FR 1598Health and Human Services DepartmentFood and Drug AdministrationSunscreen Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph
Federal Register · Proposed Rule · Aug 27, 2007
(3) Periodic measurement . … Fresh water is clean drinking water that meets the standards in 40 CFR part 141. The pool and air temperature and the relative humidity shall be recorded.
72 FR 49070Health and Human Services DepartmentFood and Drug Administration
Ask Donna what matters in the record.
She can read the source against your case and show you exactly where the answer came from.