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Radiology Devices; Reclassification of Digital Breast Tomosynthesis System
Federal Register · Proposed Rule · Aug 10, 2026
ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. … (viii) Validated methods and instructions for cleaning and disinfection of any reusable patient-contacting components. Grace R.
91 FR 51406Health and Human Services DepartmentFood and Drug AdministrationFood; Current Good Manufacturing Practice Regulations; Public Meetings
Federal Register · Rule · May 21, 2004
The meetings are also intended to fulfill part of the outreach requirement of the Small Business Regulatory Enforcement Fairness Act of 1996. … of hazards that may be present during the production or warehousing of food: Physical hazards (such as the presence of glass fragments in food), chemical hazards (such as the unintended presence of a cleaning
69 FR 29220Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 31, 2006
A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. … A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal.
71 FR 16223Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 28, 2013
FDA-2013-N-0134] Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements AGENCY: Food and Drug Administration, HHS. … This notice solicits comments on the estimated reporting, recordkeeping, and third-party disclosure burden associated with the Mammography Quality Standards Act requirements.
78 FR 13681Health and Human Services DepartmentFood and Drug AdministrationFood; Current Good Manufacturing Practice Regulations; Public Meetings
Federal Register · Rule · Jul 2, 2004
The meetings are also intended to fulfill part of the outreach requirement of the Small Business Regulatory Enforcement Fairness Act of 1996. … of hazards that may be present during the production or warehousing of food: Physical hazards (such as the presence of glass fragments in food), chemical hazards (such as the unintended presence of a cleaning
69 FR 40312Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Anesthesiology Devices; Oxygen Pressure Regulators and Oxygen Conserving Devices
Federal Register · Proposed Rule · Feb 27, 2007
To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. … This time period would allow manufacturers an opportunity to make any necessary design changes, test products, and modify labeling.
72 FR 8643Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 13, 2026
FDA-2025-N-4942] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mammography Standards Quality Act Requirements AGENCY: Food and … Mammography Quality Standards Act Requirements—21 CFR Part 900 OMB Control Number 0910-0309—Extension The Mammography Quality Standards Act (Pub.
91 FR 12427Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jul 2, 2014
review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries under the Freedom of Information Act (FOIA). … A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal.
79 FR 37617Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 14, 2015
L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). … Submission of Comments and Effective Date Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets
80 FR 48871Health and Human Services DepartmentFood and Drug AdministrationRequirements for Liquid Medicated Animal Feed and Free-Choice Medicated Animal Feed
Federal Register · Rule · May 27, 2004
Analysis of Impacts FDA has examined the impacts of this final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public … New animal drugs intended for use in free-choice feed must be approved for such use under section 512 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(b)), as: (1) An original new
69 FR 30194Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 3, 2007
after FDA has: (1) Received a recommendation from a device classification panel (an FDA advisory committee); (2) published the panel's recommendation for comment, along with a proposed regulation classifying … FDA agrees that variations in the technology of impedance plethysmographs and air displacement plethysmographs for body composition analysis warrant FDA's assigning air displacement plethysmographs for
72 FR 36468Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 20, 2022
The comments stated that the use of these chemicals could result in the contamination of soil, air, and drinking water. … To the extent that the comments suggested that environmental effects can be a basis for withdrawing a food additive petition, we are unaware of any such authority under the FD&C Act and the comments did
87 FR 31066Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 19, 2019
FDA-2013-N-0134] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mammography Quality Standards Act Requirements AGENCY: Food and … Mammography Quality Standards Act Requirements—21 CFR Part 900 OMB Control Number 0910-0309—Extension The Mammography Quality Standards Act (Pub.
84 FR 42931Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 2, 2010
Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period. … PROGEL PLEURAL AIR LEAK SEALANT January 14, 2010 P060040/S005 FDA-2010-M-0078 Thoratec Corp.
75 FR 38532Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 20, 2013
FDA's CGMP regulations at 21 CFR part 212 are intended to ensure that PET drug products meet the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) regarding safety, identity, strength … We estimate that recording maintenance and cleaning information would take approximately 5 minutes a day for each piece of equipment, with a total recordkeeping burden of approximately 40,237 hours.
78 FR 17215Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 26, 2000
Agenda: The committee will conduct a review and comment on the scope of work for the sixth and final round of examinations of the Air Force Health Study. … Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: September 14, 2000. Linda A. Suydam, Senior Associate Commissioner.
65 FR 57820Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 1, 2019
FDA-2013-N-0134 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements.” … Mammography Quality Standards Act Requirements—21 CFR Part 900 OMB Control Number 0910-0309—Extension The Mammography Quality Standards Act (Pub.
84 FR 18548Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 4, 2004
Bioterrorism Act, which is a provision relating to the “period of detention.” … (Comment 105) One comment discusses the shelf life of air freighted fish and fish products.
69 FR 31660Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 8, 2016
This notice solicits comments on the estimated reporting, recordkeeping, and third-party disclosure burden associated with the Mammography Quality Standards Act requirements. … FDA-2013-N-0134 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements.”
81 FR 36924Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 27, 2000
Agenda: The committee will provide final comments and recommendations on the scope of work for the physical examinations and final report preparation for the sixth and final round of the Air Force Health … Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: December 15, 2000. Linda A. Suydam, Senior Associate Commissioner.
65 FR 81876Health and Human Services DepartmentFood and Drug Administration
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