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Federal Register · Notice · Dec 19, 2003
FDA received one comment. FDA considered the comment and revised the guidance document for clarity. II. … 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
68 FR 70816Health and Human Services DepartmentFood and Drug AdministrationMammography Quality Standards Act
Federal Register · Rule · Mar 10, 2023
The comment period for the proposed rule closed on June 26, 2019. … Cleaning of Mammography Equipment (Comment 123) A comment recommends that the MQSA regulations be more specific regarding when and how mammography equipment should be cleaned.
88 FR 15126Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 20, 2018
The Federal Food, Drug, and Cosmetic Act (FD&C Act) prohibits the introduction into interstate commerce of any cosmetic that is adulterated or misbranded; cosmetics are also to be safe and properly labeled … FDA thanks the commenters for their comments and provides our responses below.
83 FR 58582Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 26, 2002
Comments at the public workshop and the written comments received on the draft guidance led FDA to revise the draft document. … Act of 1995 (44 U.S.C. 3501-3520).
67 FR 70752Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 2, 2000
Background Reuse of SUD's is the practice of cleaning, disinfecting, sterilizing, and reusing medical devices that are intended for only one use. … Reuse has raised concerns regarding patient safety, informed consent, and equitable regulation of reuse under the Federal Food, Drug and Cosmetic Act.
65 FR 4985Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 26, 2026
(FD&C Act). … conditions: (i) Storage stability testing must demonstrate the real time stability and dynamics of the device formulation within the expiration date (shelf life) of the unopened product and within a use period
91 FR 38504Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 25, 2005
FDA does not guarantee to accommodate or explain SPOC comments that are received after the 60-day cutoff. 5. … Periodic site visits with officials of the grantee organization may also occur.
70 FR 30121Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 1, 2014
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 … FDA cautions that, under section 515(d)(1)(B)(i) of the FD&C Act, the Agency may not enter into an agreement to extend the review period for a PMA beyond 180 days unless the Agency finds that “. . . the
79 FR 24642Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 13, 2005
Paperwork Reduction Act of 1995 VIII. Environmental Impact IX. Federalism X. Request for Comments XI. Proposed Effective Date XII. References I. Background A. … The authors measured blood pressure over a 7-hour period after the subjects took ephedrine.
70 FR 40237Health and Human Services DepartmentFood and Drug AdministrationCIBA Vision Corp.; Premarket Approval of Unizyme Enzymatic Cleaner
Federal Register · Notice · Apr 8, 1997
(the act), of Unizyme Enzymatic Cleaner. … The device is a periodic cleaner and is indicated for use with (hydrogen peroxide), lens care systems in the weekly cleaning of soft (hydrophilic) contact lenses (including daily wear, extended wear, tinted
62 FR 16862Health and Human Services DepartmentFood and Drug AdministrationPilot Program for Medical Device Reporting on Malfunctions
Federal Register · Notice · Aug 18, 2015
For purposes of the pilot, “quarterly basis” is defined as a three (3) month period. … Currently use or are willing to use eMDR to submit summary malfunction reports to the FDA during the pilot period. 4.
80 FR 50010Health and Human Services DepartmentFood and Drug AdministrationDietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting
Federal Register · Notice · Oct 20, 2004
, and Cosmetic Act (the act). … Method of drying—air or heat. h. Processing information—hand or machine sorted, chopped or milled. 4.
69 FR 61680Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 10, 2021
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. … FDA is responsible for enforcing the FD&C Act as well as related statutes, including the Public Health Service Act.
86 FR 30960Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; List of Premarket Approval Actions
Federal Register · Notice · Dec 30, 1998
In accordance with section 515(d)(3) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(3)), notification of an order approving, denying, or withdrawing approval of a PMA will continue … There were no denial actions during this period.
63 FR 71930Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 16, 2022
Paperwork Reduction Act of 1995 This guidance contains no collection of information. … Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) is not required. III.
87 FR 29753Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Mar 10, 2005
In the Federal Register of May 16, 1988 (53 FR 17227), FDA extended the comment period of the proposed rule from 60 days to 90 days in response to a letter from a medical trade association requesting … In this notice, FDA issued its tentative findings on BPAC's recommendation and requested from the public comments on BPAC's recommendation. The comment period closed August 13, 2001.
70 FR 11887Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 16, 2003
) (MDUFMA section 302(b), the act section 510(o)). … One of MDUFMA's provisions requires the submission of validation data specified in the statute for certain reprocessed SUDs (as identified by FDA) such as cleaning and sterilization data, and functional
68 FR 70019Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 7, 2008
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 … The draft guidance recommends “periodic” testing of finished product, such as weekly, monthly, or quarterly.
73 FR 7293Health and Human Services DepartmentFood and Drug AdministrationRegulatory Clean Up Initiative
Federal Register · Rule · Nov 16, 2020
Rulemaking Procedure Under the Administrative Procedure Act (5 U.S.C. 553(b)), an agency may waive publication in the Federal Register of a notice of proposed rulemaking and opportunity for comment … As authorized by 5 U.S.C. 553(b)(3)(B), HHS finds good cause to waive notice and opportunity for comment on these amendments, as notice and opportunity for comment are unnecessary.
85 FR 72899Health and Human Services DepartmentOffice of the SecretaryFederal Register · Proposed Rule · Jan 23, 2017
Topics discussed in the draft guidance include: • General Sprout Production; • Buildings, Tools, and Equipment; • Cleaning and Sanitizing; • Agricultural Water in Sprouting Operations; • Seeds for … Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each
82 FR 7751Health and Human Services DepartmentFood and Drug Administration
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