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Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Rule · Jan 21, 2016
A detailed summary of the adverse events and effectiveness outcomes from the clinical performance testing; (ii) Detailed instructions on how to fit the device to the patient; (iii) Instructions for periodic … cleaning of any reusable components; (iv) Information related to electromagnetic compatibility; and (v) Patient labeling that includes: (A) A patient card that identifies if a patient has been fitted
81 FR 3325Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 9, 1997
DATES: Written comments by June 23, 1997. … The period for this type of monitoring usually starts with the selection of the study sites and ends with the collection and cleaning of the last subject's data.
62 FR 25712Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 31, 1998
Public Meeting FDA intends to hold a public workshop during the comment period of this proposed rule to discuss the BLA/biologics license scheme. … (a) * * * (3) A lot may be subdivided into clean, sterile vessels. Each subdivision shall constitute a sublot.
63 FR 40858Health and Human Services DepartmentFood and Drug AdministrationLabeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use
Federal Register · Rule · Jun 17, 2011
All of the requests to extend the comment period were submitted before the November 28, 2007 Federal Register notice in which we extended the comment period of the 2007 proposed rule (72 FR 67264). … In that notice, we extended the close of the comment period from November 26, 2007, to December 26, 2007. We have not received any more requests to extend the comment period since December 2007.
76 FR 35620Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Mar 29, 2010
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by April 28, 2010, (see section “VI. Paperwork Reduction Act of 1995” of this document). … We will provide an opportunity for public comment on the results of the analyses either during the existing comment period or through reopening the comment period if necessary. II.
75 FR 15376Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 13, 2013
FDA: Sherri Dennis, Acting Director, Division of Risk Assessment, Office of Analytics and Outreach, FDA/CFSAN, HFS-005, 5100 Paint Branch Parkway, College Park, Maryland 20740; Telephone: (240) 402 … including product-to-slicers, gloves-to-display cases, and utensils-to-gloves); • Incorporates employee behaviors that contribute either to the spread or inactivation of L. monocytogenes ( e.g., cleaning
78 FR 27939Agriculture DepartmentFood Safety and Inspection ServiceQuality Mammography Standards; General Preamble and Proposed Alternative Approaches
Federal Register · Proposed Rule · Apr 3, 1996
(the PHS Act)(42 U.S.C. 263b(f)). … Costs were determined for a 10-year analysis period.
61 FR 14856Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 18, 2013
Act) regarding safety, identity, strength, quality, and purity. … 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 42960Health and Human Services DepartmentFood and Drug AdministrationSunlamp Products; Proposed Amendment to Performance Standard
Federal Register · Proposed Rule · Dec 22, 2015
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by January 21, 2016. … requiring a period of 3 to 4 weeks.
80 FR 79505Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted for Direct Addition to Food for Human Consumption; Olestra
Federal Register · Rule · Jan 30, 1996
period. … The comment added that the comment period was too brief a time for review of transcripts and other data to prepare a thoughtful and complete postmeeting comment.
61 FR 3118Food Additives Permitted for Direct Addition to Food for HumanHealth and Human Services DepartmentFederal Register · Rule · Aug 2, 2012
The comment period closed on June 24, 2010. II. Overview of the Final Rule A. Significant Changes to the Proposed Rule FDA made no significant changes to the proposed rule. B. … The comment questioned whether the Bioterrorism Act would require the revocation of the exemption and whether the U.S.
77 FR 45927Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 25, 2014
30-day period before its effective date) and to be consistent with the Tobacco Control Act. … Indoor Air, 23(1):25-31, 2013.] 108. Memorandum from B. J.
79 FR 23142Health and Human Services DepartmentFood and Drug AdministrationRequirements To Submit Prior Notice of Imported Food; Technical Amendments
Federal Register · Rule · Mar 30, 2017
The Administrative Procedure Act Publication of this document constitutes final action of these changes under the Administrative Procedure Act (APA) (5 U.S.C. 553). … For these reasons we have determined that publishing a notice of proposed rulemaking and providing opportunity for public comment is unnecessary.
82 FR 15627Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 17, 2008
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by October 17, 2008 (see the “Paperwork Reduction Act of 1995” section of this document). … Executive Order 12866 and Regulatory Flexibility Act A. Preliminary Economic Impact Analysis B. Small Entity Analysis VIII. Paperwork Reduction Act of 1995 IX. Federalism X. Comments XI.
73 FR 53775Health and Human Services DepartmentFood and Drug AdministrationWithdrawing Rule on Securing Updated and Necessary Statutory Evaluations Timely
Federal Register · Rule · May 27, 2022
The comment period on the Withdrawal NPRM closed on December 28, 2021, and HHS received approximately 80 comments. … Comment: Multiple comments objected to the length of the comment period for the SUNSET proposed rule.
87 FR 32246Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Reclassification of 38 Preamendments Class III Devices into Class II
Federal Register · Proposed Rule · Mar 15, 1999
FDA guidances are periodically updated as new information becomes available. … Consensus standards are periodically updated as new information becomes available.
64 FR 12774Health and Human Services DepartmentFood and Drug AdministrationForeign Supplier Verification Programs for Importers of Food for Humans and Animals
Federal Register · Proposed Rule · Jul 29, 2013
Comments VIII. … Consistent with section 805(d) of the FD&C Act, proposed § 1.510(d) would require importers to maintain all records for a period of at least 2 years, but the start of the 2-year period would differ depending
78 FR 45730Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 26, 2025
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). … Such standards are those that FDA has recognized by notice published in the Federal Register or that FDA has decided to recognize but for which recognition is pending (because a periodic notice has
90 FR 27312Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 20, 2007
DATES: Fax written comments on the collection of information by October 22, 2007. … 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
72 FR 53774Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 10, 2020
A transcript will also be made available in either hardcopy or on CD-ROM, in response to a Freedom of Information Act request. … International Organization for Standardization, “ISO 10312:2019(en) Ambient air—Determination of asbestos fibres—Direct transfer transmission electron microscopy method.”
85 FR 1317Health and Human Services DepartmentFood and Drug Administration
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