Source: https://www.law.cornell.edu/cfr/text/21/part-514
Timestamp: 2017-10-24 05:36:09
Document Index: 300251583

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

CFR › Title 21 › Chapter I › Subchapter E › Part 514
Subpart A - General Provisions (§§ 514.1 - 514.15)
Subpart B - Administrative Actions on Applications (§§ 514.80 - 514.121)
Subpart C - Hearing Procedures (§§ 514.200 - 514.201)
Subpart F - Judicial Review (§ 514.235)
21 U.S.C. 321, 331, 351, 352, 354, 356a, 360b, 360ccc, 371, 379e, 381.
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 514 after this date.
81 FR 52995 - New Animal Drug Applications; Contents of Notice of Opportunity for a Hearing; Correction
FR Doc. 2016-18809
Docket No. FDA-2016-N-1943
This rule is effective August 11, 2016.
81 FR 29129 - Antimicrobial Animal Drug Sales and Distribution Reporting
FR Doc. 2016-11082
RIN 0910-AG45
This rule is effective July 11, 2016. For the applicable compliance dates, please see section V, “Effective and Compliance Dates” in SUPPLEMENTARY INFORMATION .
The Food and Drug Administration (FDA or we) is issuing a final rule to require that the sponsor of each approved or conditionally approved new animal drug product that contains an antimicrobial active ingredient submit an annual report to us on the amount of each such ingredient in the drug product that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. This final rule codifies the reporting requirements established in section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA). The final rule also includes an additional reporting provision intended to enhance our understanding of antimicrobial new animal drug sales intended for use in specific food-producing animal species and the relationship between such sales and antimicrobial resistance.
FR Doc. 2015-13393
RIN 0910-AG95
21 CFR Parts 514 and 558
The Food and Drug Administration (FDA) is amending its animal drug regulations regarding veterinary feed directive (VFD) drugs. FDA&apos;s current VFD regulation established requirements relating to the distribution and use of VFD drugs and animal feeds containing such drugs. This amendment is intended to improve the efficiency of FDA&apos;s VFD program while protecting human and animal health.
80 FR 28863 - Antimicrobial Animal Drug Sales and Distribution Reporting
FR Doc. 2015-12081
Submit either electronic or written comments on the proposed rule by August 18, 2015. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by June 19, 2015 (see the “Paperwork Reduction Act of 1995” section of this document).
The Animal Drug User Fee Amendments of 2008 (ADUFA) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require that sponsors of approved or conditionally approved applications for new animal drugs containing an antimicrobial active ingredient submit an annual report to the Food and Drug Administration (FDA or Agency) on the amount of each such ingredient in the drug that is sold or distributed for use in food-producing animals, and further requires FDA to publish annual summary reports of the data it receives from sponsors. At this time, FDA is issuing proposed regulations for the administrative practices and procedures for animal drug sponsors who must report under this law. This proposal also includes an additional reporting provision intended to enhance FDA&apos;s understanding of antimicrobial animal drug sales intended for use in specific food-producing animal species.
79 FR 37175 - New Animal Drug Applications; Confidentiality of Data and Information in a New Animal Drug Application File; Confirmation of Effective Date
FR Doc. 2014-15209
Effective date of final rule published in the Federal Register of March 17, 2014 (79 FR 14609) confirmed: July 30, 2014.
The Food and Drug Administration (FDA) is confirming the effective date of July 30, 2014, for the final rule that appeared in the Federal Register of March 17, 2014. The direct final rule amends the 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 ensures that the Agency is able to update its list of approved new animal drug products within the statutory timeframe. It also permits more timely public disclosure of approval-related information, increasing the transparency of FDA decisionmaking in the approval of new animal drugs. This document confirms the effective date of the direct final rule.
79 FR 14609 - New Animal Drug Applications; Confidentiality of Data and Information in a New Animal Drug Application File
FR Doc. 2014-05430
FR Doc. 2014-05432
78 FR 75515 - Veterinary Feed Directive
FR Doc. 2013-29696
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).
The 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.
78 FR 59308 - Antimicrobial Animal Drug Sales and Distribution Annual Summary Report Data Tables
FR Doc. 2013-23488
The 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).
77 FR 59156 - Antimicrobial Animal Drug Sales and Distribution Reporting; Extension of Comment Period
FR Doc. 2012-23740
FR Doc. 2012-18366