Source: http://www.law.cornell.edu/cfr/text/21/514.201
Timestamp: 2014-07-23 03:47:36
Document Index: 672128053

Matched Legal Cases: ['art 514', '§ 514', 'art 12', 'art 514', 'art 514', 'arts 514', 'art 514']

21 CFR 514.201 - Procedures for hearings. | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter E › Part 514 › Subpart C › Section 514.201 21 CFR 514.201 - Procedures for hearings.
There is 1 rule appearing in the Federal Register for 21 CFR 514. View below or at eCFR (GPOAccess)
§ 514.201
Procedures for hearings.
Hearings relating to new animal drugs under section 512(d) and (e) of the act shall be governed by part 12 of this chapter.
[64 FR 63204, Nov. 19, 1999]
Title 21 published on 2013-04-01The following are only the Rules published in the Federal Register after the published date of Title 21.For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.2014-03-17; vol. 79 # 51 - Monday, March 17, 201479 FR 14609 - New Animal Drug Applications; Confidentiality of Data and Information in a New Animal Drug Application File
typeregulations.gov FR Doc.2014-05430 RIN Docket No.FDA-2014-N-0108 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Direct final rule. This rule is effective July 30, 2014. Submit either electronic or written comments by June 2, 2014. If FDA receives no significant adverse comments within the specified comment period, the Agency will publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, the Agency will publish a document in the Federal Register withdrawing this direct final rule before its effective date. 21 CFR Part 514 SummaryThe Food and Drug Administration (FDA) is amending its regulation regarding the confidentiality of data and information in and about new animal drug application files to change when certain approval-related information will be disclosed by the Agency. This change will ensure that the Agency is able to update its list of approved new animal drug products within the statutory timeframe. It will also permit more timely public disclosure of approval-related information, increasing the transparency of FDA decision making in the approval of new animal drugs.
Title 21 published on 2013-04-01The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 514 after this date.2014-03-17; vol. 79 # 51 - Monday, March 17, 201479 FR 14609 - New Animal Drug Applications; Confidentiality of Data and Information in a New Animal Drug Application File
79 FR 14630 - New Animal Drug Applications; Confidentiality of Data and Information in a New Animal Drug Application File
typeregulations.gov FR Doc.2014-05432 RIN Docket No.FDA-2014-N-0108 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments by June 2, 2014. If FDA receives any significant adverse comments, the Agency will publish a document in the Federal Register withdrawing the direct final rule within 30 days after the comment period ends. FDA will then proceed to respond to comments under this proposed rule using the usual notice and comment procedures. 21 CFR Part 514 SummaryThe Food and Drug Administration (FDA or Agency) is proposing to amend its regulation regarding the confidentiality of data and information in and about new animal drug application files to change when certain approval-related information would be disclosed by the Agency. This change would ensure that the Agency is able to update its list of approved new animal drug products within the statutory timeframe. It would also permit more timely public disclosure of approval-related information, increasing the transparency of FDA decision making in the approval of new animal drugs.
2013-12-12; vol. 78 # 239 - Thursday, December 12, 201378 FR 75515 - Veterinary Feed Directive
typeregulations.gov FR Doc.2013-29696 RIN0910-AG95 Docket No.FDA-2010-N-0155 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on the proposed rule by March 12, 2014. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by January 13, 2014, (see the “Paperwork Reduction Act of 1995” section). 21 CFR Parts 514 and 558 SummaryThe Food and Drug Administration (FDA) is proposing to amend its animal drug regulations regarding veterinary feed directive (VFD) drugs. FDA&apos;s VFD regulation, which became effective on January 8, 2001, established requirements relating to the distribution and use of VFD drugs and animal feeds containing such drugs. This proposed amendment is intended to improve the efficiency of FDA&apos;s VFD program.
2013-09-26; vol. 78 # 187 - Thursday, September 26, 201378 FR 59308 - Antimicrobial Animal Drug Sales and Distribution Annual Summary Report Data Tables
typeregulations.gov FR Doc.2013-23488 RIN Docket No.FDA-2012-N-0447 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification; request for comments. Submit electronic or written comments by November 25, 2013. 21 CFR Part 514 SummaryThe Food and Drug Administration (FDA) is seeking comment on a proposal regarding the content and format of data tables for the Agency&apos;s annual summary report of sales and distribution data collected from sponsors of antimicrobial new animal drugs in accordance with the new animal drug records and reporting provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Animal Drug User Fee Amendments of 2008 (ADUFA).