Documents
Briefs, oral arguments, agency decisions and the Federal Register.
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Food Labeling: Health Claims; Oats and Coronary Heart Disease
Federal Register · Rule · Jan 23, 1997
Body weights were maintained at a constant level throughout the treatment period. … period.
62 FR 3584RuleHealth and Human Services DepartmentFederal Register · Notice · Jul 12, 2013
Section 1271.200(e) requires documentation of all equipment maintenance, cleaning, sanitizing, calibration, and other activities. … and section 351 of the PHS Act (42 U.S.C. 262), that have registered and listed with FDA.
78 FR 41934Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 1, 2004
The types of validation data to be submitted include cleaning, sterilization, and functional performance data. … The guidance represents the agency's current thinking on validation data regarding the cleaning, sterilization, and functional performance of reprocessed SUDs, as well as the procedures and review times
69 FR 30943Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Aug 16, 2000
The comment period closed on June 12, 2000. … (c) Conveyance means any land or air carrier, or any vessel as defined in paragraph (h) of this section.
65 FR 49906Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 2, 2011
Additionally, there has been an evolution towards more complex reusable medical device designs that are more difficult to clean and disinfect or sterilize. … Paperwork Reduction Act of 1995 This draft guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act
76 FR 24494Health and Human Services DepartmentFood and Drug AdministrationGeneral Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device
Federal Register · Proposed Rule · Nov 7, 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 January 8, 2018. … (2) Validation of cleaning and disinfection instructions must demonstrate that the device can be safely and effectively reprocessed after use per the recommended cleaning and disinfection protocol in
82 FR 51585Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 30, 2024
However, the Federal Food, Drug, and Cosmetic Act (FD&C Act) does not preclude FDA from using performance criteria to facilitate this comparison. … Act (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)).
89 FR 79615Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 17, 2018
Once the comment period ends, we will consider the comments and publish in the Federal Register a final action classifying such suitable accessories into class I. II. … apparatus accessory (FYD) Supplementary device that is intended to be used with an air-handling apparatus for a surgical operating room.
83 FR 41023Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 14, 2005
We also considered different implementation periods before proposing a 12-month implementation period. … We have learned through industry and trade association comments submitted in response to proposed OTC drug rules that the OTC drug industry can accommodate a 12-month implementation period without undue
70 FR 69102Health and Human Services DepartmentFood and Drug AdministrationCurrent Good Manufacturing Practice for Positron Emission Tomography Drugs
Federal Register · Proposed Rule · Sep 20, 2005
Proposed § 212.70(e) would allow the 30-hour period to be exceeded in certain cases, such as weekends or holidays, provided it is shown that the extended period will not affect the stability or viability … (c) Record retention period .
70 FR 55038Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 7, 2016
Section 1271.200(e) requires documentation of all equipment maintenance, cleaning, sanitizing, calibration, and other activities. … and section 351 of the PHS Act (42 U.S.C. 262), that have registered and listed with FDA.
81 FR 61685Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 31, 2017
DATES: Fax written comments on the collection of information by May 1, 2017. … and section 351 of the PHS Act (42 U.S.C. 262), that have registered and listed with FDA.
82 FR 16040Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 5, 2019
Section 1271.200(e) requires documentation of all equipment maintenance, cleaning, sanitizing, calibration, and other activities. … and section 351 of the PHS Act (42 U.S.C 262), that have registered and listed with FDA.
84 FR 66673Health and Human Services DepartmentFood and Drug AdministrationTesting Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products
Federal Register · Proposed Rule · Dec 27, 2024
Submit written comments (including recommendations) on information collection issues under the Paperwork Reduction Act of 1995 by January 27, 2025. … Thus, FDA estimates a period of up to 3 years from the time the record was created to when FDA may request the record.
89 FR 105490Health and Human Services DepartmentFood and Drug AdministrationOphthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device
Federal Register · Rule · May 20, 2024
The period for public comment on the proposed order closed on November 26, 2018. FDA received and has considered comments on the proposed order, as discussed in Section II of this document. II. … If the device contains reusable eye-contact components, the validation tests must demonstrate adequate cleaning and reprocessing of these components.
89 FR 43743Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 2, 2003
The first reason relates to the delays in cleaning up some of the contaminated sites. … In the Federal Register of January 17, 2003 (68 FR 2561), the agency requested comments on the proposed collections of information. The agency received no comments to the notice.
68 FR 16059Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 23, 2014
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk … and section 351 of the PHS Act (42 U.S.C 262), that have registered and listed with FDA.
79 FR 3822Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 17, 2015
Additionally, there has been an evolution towards more complex medical device designs that are more difficult to clean, disinfect, and sterilize. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
80 FR 13864Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 11, 2016
(Response) As required under the Paperwork Reduction Act (PRA), FDA provided 60 days for respondents to submit comment in response to the December 29, 2015, notice. … Any specific estimates submitted by PET drug producers and facilities subsequent to the comment period provided for under the PRA will be reviewed and considered by FDA for future renewals of this information
81 FR 44876Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 7, 2014
Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. … Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES
79 FR 830Health and Human Services DepartmentFood and Drug Administration
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