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Federal Register · Proposed Rule · Apr 4, 2013
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, consideration of any comments received, and a meeting of a device classification … For the preamendments class III devices that are the subject of this proposal, the later of these two time periods is the 90-day period.
78 FR 20268Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 24, 2026
L. 103-417) added section 402(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342(g)), which provides, in part, that the Secretary of Health and Human Services may, by regulation, … records pertaining to: (1) personnel; (2) sanitation; (3) calibration of instruments and controls; (4) calibration, inspection, or checks of automated, mechanical, or electronic equipment; (5) maintaining, cleaning
91 FR 8886Health and Human Services DepartmentFood and Drug AdministrationBeverages: Bottled Water; Companion Document to Direct Final Rule
Federal Register · Proposed Rule · Mar 3, 2003
The comment period for the companion proposed rule runs concurrently with the comment period of the direct final rule. … Instead, FDA will publish a confirmation notice, after the comment period ends, to confirm the effective date of the direct final rule.
68 FR 9955Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemptions From Premarket Notification: Class II Devices
Federal Register · Notice · Jul 11, 2017
Interested persons were given until May 15, 2017, to comment on the proposed list of class II devices. … Handling, Bench FZG 878.5070 Apparatus, Air Handling, Room FZH 878.5070 Apparatus, Air Handling, Enclosure FZI 880.5580 Locator, Acupuncture Point BWJ 880.5580
82 FR 31976Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 14, 2022
L. 103-417) added section 402(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342(g)), which provides, in part, that the Secretary of Health and Human Services may, by regulation, … records pertaining to: (1) personnel; (2) sanitation; (3) calibration of instruments and controls; (4) calibration, inspection, or checks of automated, mechanical, or electronic equipment; (5) maintaining, cleaning
87 FR 62429Health and Human Services DepartmentFood and Drug AdministrationNew Drug Applications; Drug Master Files
Federal Register · Rule · Jan 12, 2000
Based on comments and FDA's own evaluation, the agency has concluded [[Page 1779]] that the proposed implementation period is inadequate, particularly for foreign firms seeking approval where Type I … Therefore, under the Regulatory Flexibility Act, no further analysis is required.
65 FR 1776Health and Human Services DepartmentFood and Drug AdministrationGeneral and Plastic Surgery Devices; Classification of Silicone Sheeting
Federal Register · Rule · Aug 9, 2004
FDA invited interested persons to comment on the proposed rule by June 18, 2003. II. Summary of the Comments and FDA's Response FDA received two comments on the proposed rule. … This device is used in conjunction with other standard scar care treatments and provides a physical barrier between the scar and the environment, keeping the scar moist and clean, thus contributing to
69 FR 48146Health and Human Services DepartmentFood and Drug AdministrationReprocessing of Reusable Medical Devices; Public Workshop
Federal Register · Notice · May 2, 2011
This workshop includes a public comment session. … How should problems with reusable medical device reprocessing be identified, reported, and acted upon by industry and users? III.
76 FR 24495Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 24, 2022
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.
87 FR 64232Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 2, 2013
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—(OMB Control Number 0910-0309)—Extension The Mammography Quality Standards Act (Pub.
78 FR 39731Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Uncategorized Document · May 19, 1994
The exclusivity period for this application expires on June 6, 1994. … FDA could only review NDA 20-242 as an application submitted under section 505(b)(1) of the act because until the exclusivity period of Eldepryl expires, no application submitted under section 505(b)(2
Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Reclassification of Suction Lipoplasty System for Aesthetic Body Contouring
Federal Register · Notice · Nov 13, 1996
DATES: Written comments by February 11, 1997. … Eleven deaths and nine nonfatal serious complications over a 5-year period (an estimated 100,000 cases) were documented (Ref. 12).
61 FR 58195Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 5, 2019
L. 103-417) added section 402(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342(g)), which provides, in part, that the Secretary of Health and Human Services may, by regulation, … records pertaining to: (1) Personnel; (2) sanitation; (3) calibration of instruments and controls; (4) calibration, inspection, or checks of automated, mechanical, or electronic equipment; (5) maintaining, cleaning
84 FR 66678Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 4, 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 59240Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 19, 2016
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.
81 FR 55463Health 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 AdministrationUnique Device Identification System
Federal Register · Rule · Sep 24, 2013
The July 10, 2012, proposed rule provided a liberal comment period ending November 7, 2012, and the November 19, 2012, amended proposed rule provided an additional comment period ending December 19, 2012 … Furthermore, section 519(f) of the FD&C Act, as amended by FDASIA, requires FDA to “finalize the proposed regulations not later than 6 months after the close of the comment period . . . .” and FDA has
78 FR 58786Health 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 · 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 AdministrationFederal Register · Rule · Mar 3, 2003
If FDA receives no significant adverse comments during the specified comment period, the agency will publish a document in the Federal Register no later than June 11, 2003, confirming the effective … The comment period for the direct final rule runs concurrently with that of the companion proposed rule.
68 FR 9873Health and Human Services DepartmentFood and Drug Administration
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