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Federal Register · Proposed Rule · May 1, 2015
Comment Period Because of the complexity of this proposed rule, we are providing a comment period of 180 days. … period.
80 FR 25166Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 4, 2016
Background Section 226 of the Food and Drug Administration Amendments Act of 2007 and section 614 of the Food and Drug Administration Safety and Innovation Act amended the Federal Food, Drug, and Cosmetic … Act (the FD&C Act) to add and amend section 519(f) (21 U.S.C. 360i(f)), which directs FDA to publish regulations establishing a unique device identification system for medical devices.
81 FR 94Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 17, 2003
Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed … The first reason relates to the delays in cleaning up some of the contaminated sites.
68 FR 2561Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemptions From Premarket Notification for Class I and Class II Devices
Federal Register · Rule · Dec 30, 2019
This notice shall provide at least a 60-day comment period. … After a 60-day comment period, in the Federal Register of July 11, 2017 (82 FR 31976), FDA issued a notice of final determination to exempt class II devices provided in the proposed list.
84 FR 71794Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 4, 2010
Comment No. RPT3, 1981N-0114. 11. Comment No. LET19, 1981N-0114. 12. Comment No. LET20, 1981N-0114. 13. Comment No. LET21, 1981N-0114. 14. Comment No. LET22, 1981N-0114. 15. Comment No. … Comment No. C3, 1992N-0311. 17. Comment No. C4, 1992N-0311. 18. Comment No. C1, 1992N-0311. 19. Jeanmougin, M. and J.
75 FR 9767Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 2, 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. … cosmetic product manufacturers on the following topics: • Written Procedures and Documentation—including written procedures and records for manufacturing involving personnel, raw materials, processing, cleaning
83 FR 30940Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 19, 2026
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
91 FR 7994Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 9, 2004
DATES: Fax written comments on the collection of information by April 8, 2004. … To ensure that comments on the information collection are received, OMB recommends that comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for
69 FR 11022Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 4, 2019
For promotional labeling submitted for advisory comments, including resubmissions, a submission generally includes correspondence stating that it is a request for advisory comments, a clean version of … Safety and Innovation Act (Pub.
84 FR 13302Health and Human Services DepartmentFood and Drug AdministrationNew Animal Drugs for Use in Animal Feeds; Oxytetracycline; Neomycin
Federal Register · Rule · Aug 13, 2009
sacculitis (air-sac- infection) caused by E. coli susceptible to oxytetracycline. … A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal.
74 FR 40723Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Oct 22, 2018
• What information or data can you provide about cleaning, sanitizing, and maintenance practices and procedures for equipment and tools that have wood, foam, or other porous or absorbent materials? … Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations.
83 FR 53196Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 1, 1998
Import Enforcement Over the period 1992 through 1996, there were a number of imported juice products detained for various violations of the Federal Food, Drug, and Cosmetic Act (the act). … Table 1 gives the number of shipments detained and the total dollar value of juice products detained for violations of the act for the entire period 1992 through 1996.
63 FR 24254Preliminary Regulatory Impact Analysis and Initial RegulatoryFlexibility Analysis of the Proposed Rules to Ensure the Safety ofLabeling of Diphenhydramine-Containing Drug Products for Over- the-Counter Human Use
Federal Register · Proposed Rule · Aug 29, 1997
DATES: Submit written comments by November 28, 1997. … The agency is providing a period of 90 days from the date of publication of this proposed rulemaking in the Federal Register for comments on this subject to be developed and submitted.
62 FR 45767Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 16, 1998
The comments in the docket will be periodically reviewed, and, where appropriate, the guidance will be amended. … The period for this type of monitoring usually starts with the selection of the trial sites and ends with the collection and cleaning of the last subject's data.
63 FR 49583Health and Human Services DepartmentFood and Drug AdministrationReprocessing of Reusable Medical Devices
Federal Register · Notice · Jul 28, 2011
FDA receives reports of problems in all steps of medical device reprocessing, 1 including cleaning, disinfecting, and sterilizing. … How should problems with reusable medical device reprocessing be identified, reported, and acted upon by industry and users? Dated: July 25, 2011. Nancy K.
76 FR 45268Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Feb 3, 2003
FDA believes that a 60-day comment period is appropriate in this instance. … FDA will not consider any comments submitted after the 60-day comment period closes and does not intend to grant any requests for extension of the comment period due to the Bioterrorism Act's requirement
68 FR 5428Health and Human Services DepartmentFood and Drug AdministrationBrenda Elise Edwards: Final Debarment Order
Federal Register · Notice · Mar 19, 2020
Edwards also directed Cumberland employees to take steps to make it appear that the diverted drugs were purchased from authorized sellers, such as by: (1) Cleaning pharmaceutical bottles to remove evidence … Edwards during her period of debarment, other than in connection with an audit under section 306(c)(1)(B) of the FD&C Act.
85 FR 15791Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 13, 2015
Submit a single copy of electronic comments or two paper copies of any mailed comments. Comments are to be identified with the docket number found in brackets in the heading of this document. … Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: March 9, 2015. Leslie Kux, Associate Commissioner for Policy.
80 FR 13395Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 11, 2001
for public comment in response to the notice. … Sections 800.10(a)(3) and 800.12(c) require that the label of contact lens cleaning solutions contain a prominent statement alerting consumers to the tamper-resistant feature required by § 800.12.
66 FR 36285Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Feb 20, 2002
Mercury is absorbed from many sources, including food and air. … It recommends packaging in air tight containers, and providing hazard warnings regarding mercury hygiene.
67 FR 7620Health and Human Services DepartmentFood and Drug Administration
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