Document ID: FDA-2014-N-0108-0003
Agency: fda
Document Type: Rule
Title: New Animal Drug Applications; Confidentiality of Data and Information
in a New Animal Drug Application File; Confirmation of Effective Date
Posted Date: 2014-07-01T04:00Z

[Federal Register Volume 79, Number 126 (Tuesday, July 1, 2014)]
[Rules and Regulations]
[Page 37175]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15209]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 514

[Docket No. FDA-2014-N-0108]

New Animal Drug Applications; Confidentiality of Data and 
Information in a New Animal Drug Application File; Confirmation of 
Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; confirmation of effective date.

-----------------------------------------------------------------------

SUMMARY: 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.

DATES: Effective date of final rule published in the Federal Register 
of March 17, 2014 (79 FR 14609) confirmed: July 30, 2014.

FOR FURTHER INFORMATION CONTACT: Scott Fontana, Center for Veterinary 
Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0656.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 17, 2014 
(79 FR 14609), FDA solicited comments concerning the direct final rule 
for a 75-day period ending June 2, 2014. FDA stated that the effective 
date of the direct final rule would be on July 30, 2014, 30 days after 
the end of the comment period, unless any significant adverse comment 
was submitted to FDA during the comment period. FDA did not receive any 
significant adverse comments.

    Authority: 21 U.S.C. 321, 331, 351, 352, 356a, 360b, 371, 379e, 
381.

    Accordingly, the amendments issued thereby are effective.

    Dated: June 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15209 Filed 6-30-14; 8:45 am]
BILLING CODE 4164-01-P