Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
6.17s
Food Labeling: Health Claims; Soluble Dietary Fiber From Certain Foods and Coronary Heart Disease
Federal Register · Rule · Dec 23, 2005
Section 403(r)(7) of the act authorizes us to make proposed regulations issued under section 403(r) of the act effective upon publication pending consideration of public comment and publication of a final … FDA invites public comment on this interim final rule. The agency will consider modifications to this interim final rule based on comments made during the comment period.
70 FR 76150Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 10, 2014
(f) * * * (4) Records, in accordance with § 106.30(f), on equipment cleaning, sanitizing, and maintenance that show the date and time of such cleaning, sanitizing, and maintenance and the production aggregate … number of each infant formula processed between equipment startup and shutdown for cleaning, sanitizing, and maintenance.
79 FR 33057Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 30, 2020
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). … Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device ASTM F3276-19.
85 FR 17584Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Oct 29, 2013
facilities; air quality, temperature and ventilation; lighting; equipment; personal hygiene; cleaning; maintenance; pest control; waste; drains; storage; transport; and training. … (g) Compressed air or other gases mechanically introduced into animal food or used to clean animal food-contact surfaces or equipment must be treated in such a way that animal food is not contaminated
78 FR 64736Health and Human Services DepartmentFood and Drug AdministrationPrevention of Salmonella Enteritidis in Shell Eggs During Production
Federal Register · Proposed Rule · Sep 22, 2004
Paperwork Reduction Act of 1995 XI. Comments XII. … (Comment 6) One comment recommended that food handlers be periodically tested for Salmonella , Listeria, and Escherichia coli . (Response) We disagree with this comment.
69 FR 56824Health and Human Services DepartmentFood and Drug AdministrationStandards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
Federal Register · Rule · Nov 27, 2015
of mechanisms for introducing air include passive diffusion and mechanical means (such as blowers that suction air from the composting materials or blow air into the composting material using positive … Examples of mechanisms for introducing air include passive diffusion and mechanical means (such as blowers that suction air from the composting materials or blow air into the composting material using
80 FR 74354Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 4, 2004
In the guidance, table 1 entitled “Air Classifications,” which summarizes clean area air classifications and recommended microbiological action levels, has been modified to acknowledge that alternate … 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
69 FR 59258Health and Human Services DepartmentFood and Drug AdministrationGastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices
Federal Register · Rule · Jul 25, 2014
Regarding the comments relating to the testing and labeling of compatible cleaning and disinfecting agents, FDA agrees that an alternative to printing contraindicated disinfecting agents directly on the … (E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device.
79 FR 43241Health and Human Services DepartmentFood and Drug AdministrationGastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices
Federal Register · Proposed Rule · Jun 28, 2013
The proposed rule provided for a comment period that was open until September 18, 2012. FDA received three comments that suggested modifications to the proposed Special Controls Guidance Document. … Air leakage testing and liquid leakage testing must be conducted. f.
78 FR 38867Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 16, 2013
Proper ventilation, e.g., over powder dumping operations, and proper operation of fans and other air-blowing equipment are essential to prevent the transfer of allergens via dust in air currents. … Proper ventilation, e.g., over powder dumping operations, and proper operation of fans and other air-blowing equipment are essential to prevent the transfer of allergens via dust in air currents.
78 FR 3646Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 6, 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 47703Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 29, 2014
The comment period did not close until March 31, 2014; we are still actively reviewing the comments. C. … (e) Compressed air or other gases mechanically introduced into animal food or used to clean animal food-contact surfaces or equipment must be used in such a way that animal food is not contaminated.
79 FR 58476Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids
Federal Register · Rule · Aug 17, 2022
We received more than 1,000 comments on the proposed rule by the close of the comment period, which was January 18, 2022. … (Comment 2) Many comments urged FDA: to clarify that the definition of OTC hearing aids under section 520(q)(1)(A) of the FD&C Act is synonymous with the identification for self-fitting air-conduction
87 FR 50698Health and Human Services DepartmentFood and Drug AdministrationDental Devices; Endodontic Dry Heat Sterilizer
Federal Register · Rule · Jan 21, 1997
The comment period closed August 7, 1995. [[Page 2901]] FDA received one comment in response to the proposed rule. … Benefit of the Device The endodontic dry heat sterilizer is used to decontaminate endodontic instruments during a procedure on a single patient provided the instruments are properly cleaned to remove
62 FR 2900Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 4, 2007
The comment period for the companion proposed rule runs concurrently with the comment period of the direct final rule. … This comment period runs concurrently with the comment period for the direct final rule.
72 FR 68113Health and Human Services DepartmentFood and Drug AdministrationAmendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
Federal Register · Rule · Dec 4, 2007
This change will clarify that the act of cleaning is done for a particular purpose, to prevent the introduction of contaminants, and must be done unless such cleaning is not necessary to prevent such an … If any significant adverse comments are received during the comment period, FDA will publish, within 30 days after the close of the comment period, a notice of significant adverse comment and will withdraw
72 FR 68064Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 22, 2018
Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. … L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d).
83 FR 53264Health and Human Services DepartmentFood and Drug AdministrationRequirements for Tobacco Product Manufacturing Practice
Federal Register · Proposed Rule · Mar 10, 2023
ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. … Use of fans and other air-blowing equipment can maintain air ventilation to minimize odors and vapors (including steam and noxious fumes) in areas where they may contaminate product or otherwise render
88 FR 15174Health and Human Services DepartmentFood and Drug AdministrationAmendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
Federal Register · Rule · Sep 8, 2008
The comment period for the direct final rule closed on February 19, 2008. … (Comment 20) One comment stated that many current biotech processes include component additions and deletions in a continuous or periodic manner over long periods of time.
73 FR 51919Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 15, 2025
air through a permeable surface and separating plant material by size (Ref. 8). … Information about any processes, such as initial inspection, cleaning or separation of plant parts, mixing, crushing, blending, treatments such as heating or washing, drying, cleaning of equipment, cleaning
90 FR 3873Health 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.