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Federal Register · Notice · Nov 3, 1998
DATES: Comments on this list and on agency guidance documents are welcome at any time. … Marketing Act (PDMA). Development, Implementation, and Maintenance of a Do. Sample Security and Audit System Under the Prescription Drug and Marketing Act (PDMA).
63 FR 59317Health and Human Services DepartmentFood and Drug AdministrationFood Labeling; Gluten-Free Labeling of Foods
Federal Register · Proposed Rule · Jan 23, 2007
Paperwork Reduction Act of 1995 IX. Comments X. References I. Background A. … FDA requested that interested persons submit comments and any scientific data or other information relevant to the draft Thresholds Report to the docket during a 60-day comment period ending August 16,
72 FR 2795Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 11, 2021
We later extended the comment period to April 29, 2009 (Ref. 1). … The comment stated that characterizing the yogurt, e.g., by adjustment of the fat content, at the end of the process rather than the beginning, would reduce water usage for cleaning blend storage
86 FR 31117Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Oct 10, 2003
Comments mention specific types of facilities, such as rail yards, container yards, LTL truck terminals, FTL truck terminals, Customs bonded Container Freight Stations, air cargo handling agents, and air … Thus, the comment period for the registration interim final rule will open today for a period of 75 days.
68 FR 58894Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 8, 2006
Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 5 years of marketing exclusivity beginning August 10, 2006. … Withdrawal period: 3 days. Dated: August 29, 2006. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. E6-14899 Filed 9-7-06; 8:45 am] BILLING CODE 4160-01-S
71 FR 53005Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemption From Premarket Notification and Reserved Devices; Class I
Federal Register · Proposed Rule · Nov 12, 1998
Two comments expressed support for FDA's interpretation of section 510(l) of FDAMA and the agency's conclusion that devices identified in 21 CFR 874.3300(b)(1), air conduction hearing aids, meet the exemption … FDA considers this comment a section 513(g) of the act request and will respond to the submitter in an individual response. 12.
63 FR 63222Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Aug 22, 2025
Legal Authority This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.360b(i)). … Do not clean the ear canal for 30 days after administration. (2) Indications for use.
90 FR 40966Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 1, 2006
DATES: Submit written or electronic comments on this list and on any agency guidance documents at any time. … Submit electronic comments to http://www.fda.gov/dockets/ecomments .
71 FR 52125Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jun 12, 2013
Paperwork Reduction Act IX. Federalism X. Comments XI. References I. Executive Summary Purpose of the Regulatory Action Title VIII of FDASIA (Pub. … M. tuberculosis can remain in the air for several hours, depending on the environment (Ref. 65).
78 FR 35155Health and Human Services DepartmentFood and Drug AdministrationOral Dosage Form New Animal Drugs; Chlortetracycline Powder
Federal Register · Rule · Nov 14, 2007
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is amended … Control of chronic respiratory disease (CRD) and air-sac infections caused by M. gallisepticum and E. coli susceptible to chlortetracycline. ( 2 ) Limitations .
72 FR 63986Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 12, 2026
FDASIA added sections 575, 576, and 577 to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360ddd, 360ddd-1, and 360ddd-2), which created a certification process for DMGs. … Specifically, section 575 of the FD&C Act provides that oxygen, nitrogen, nitrous oxide, carbon dioxide, helium, medical air, and carbon monoxide are DMGs.
91 FR 6645Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Nutrient Content Claims; Definition of Term “Healthy”
Federal Register · Rule · Dec 27, 2024
DeBenedictis, 480 U.S. 470, 491-92 (1987) (cleaned up). … Dir., OWCP, 662 F.3d 233, 260 (3d Cir. 2011) (cleaned up).
89 FR 106064Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 27, 1995
A comments section is provided on the revised form for additional information that the manufacturer deems to be appropriate but may not be covered under other sections. … Under the Paperwork Reduction Act of 1980 (Pub.
60 FR 10592Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Laboratory Developed Tests
Federal Register · Proposed Rule · Oct 3, 2023
Smith, 538 U.S. 254, 273 (2003) (cleaned up).) … Based in part on those comments, FDA is now proposing a 1-year time period for laboratories to come into compliance with the MDR requirements.
88 FR 68006Health and Human Services DepartmentFood and Drug AdministrationIndex of Legally Marketed Unapproved New Animal Drugs for Minor Species
Federal Register · Rule · Dec 6, 2007
In response to this, in the Federal Register of October 2, 2006 (71 FR 57892), FDA extended the comment period allowing an additional 30 days of public comment. II. … In response to public comments, we have provided for a 60-day time period for industry to respond with a written request for a conference, rather than the proposed 30-day time period.
72 FR 69108Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 27, 2000
SUPPLEMENTARY INFORMATION: This project is authorized under section 301 of the Public Health Service Act (42 U.S.C 241). … This project may be supplemented over the 5 year period based on annual appropriations language. II.
65 FR 81871Health and Human Services DepartmentFood and Drug Administration21 CFR Parts 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 886, 888, 890, and 892
Federal Register · Uncategorized Document · Dec 7, 1994
Interested persons were given until October 19, 1994 to comment on the proposed rule. II. … Comments During the comment period, FDA received comments requesting that various devices be added to the list of devices that the agency was proposing be exempt from the requirement of premarket
Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Mar 26, 2010
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by April 26, 2010, (see the “Paperwork Reduction Act of 1995” section of this document). … Section 510(j)(2) of the FD&C Act requires registrants to periodically update their listing information.
75 FR 14510Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 13, 2021
(42 U.S.C. 247d(a)(2)) or sections 501(a)(2)(B), 502(f)(1), 505, or 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351(a)(2)(B), 352(f)(1), 355, and 360eee-1), which include certain … We note that the recently enacted Coronavirus Aid, Relief, and Economic Security Act (Pub. L. 116-136) added section 505G to the FD&C Act (21 U.S.C. 355g).
86 FR 56960Health and Human Services DepartmentFood and Drug AdministrationNew Animal Drugs for Use in Animal Feeds; Roxarsone; Semduramycin
Federal Register · Rule · Jul 21, 2005
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is amended … (iv) 22.7 to 45.4 Chlortetracycline 200 to 400 Growing chickens: As in paragraph (d)(1)(i) of this section; and for control of chronic respiratory disease (CRD) and air sac infection caused by
70 FR 41958Health and Human Services DepartmentFood and Drug Administration
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