
[Federal Register Volume 79, Number 174 (Tuesday, September 9, 2014)]
[Notices]
[Pages 53430-53431]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21227]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1049]


Exploring the Expansion of Conditional Approval to Appropriate 
Categories of New Animal Drugs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
is beginning the exploration process described in a stated performance 
goal in the Animal Drug User Fee Amendments of 2013 (ADUFA III) goals 
letter. Consistent with the performance goal, the FDA is inviting 
comments in regard to the Agency exploring the use of statutory changes 
to expand the use of conditional approval

[[Page 53431]]

beyond new animal drugs intended for minor species or for minor uses in 
major species to additional categories of new animal drugs as 
appropriate.

DATES: Although you can comment on this document at any time, to ensure 
that the Agency considers your comment before finalizing work on the 
exploration process described in this document, submit either 
electronic or written comments by March 9, 2015.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Matthew Lucia, Center for Veterinary 
Medicine, Food and Drug Administration, 7500 Standish Pl., Rm. E444, 
Rockville, MD 20855, 240-402-0811, matthew.lucia@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA considers the timely review of the safety and effectiveness of 
new animal drugs to be central to the Agency's mission to protect and 
promote the public health. Before 2004, the timeliness and 
predictability of the new animal drug review program was a concern. The 
Animal Drug User Fee Act enacted in 2003 (Pub. L. 108-130; hereinafter 
referred to as ``ADUFA I''), authorized FDA to collect user fees for 5 
years--fiscal year (FY) 2004 to FY 2008--that were to be dedicated to 
expediting the review of new animal drug applications according to 
certain performance goals and to expand and modernize the new animal 
drug review program. The Agency agreed to meet a comprehensive set of 
performance goals established to show significant improvement in the 
timeliness and predictability of the new animal drug review process. 
The implementation of ADUFA I provided a significant funding increase 
that enabled FDA to increase the number of staff dedicated to the new 
animal drug application review process.
    In 2008, before ADUFA I expired, Congress passed the Animal Drug 
User Fee Amendments of 2008 (Pub. L. 110-316; hereinafter referred to 
as ``ADUFA II'') which included an extension of ADUFA for an additional 
5 years--FY 2009 to FY 2013. ADUFA II performance goals were 
established based on ADUFA I FY 2008 review timeframes. In addition, 
FDA provided program enhancements to reduce review cycles and improve 
communications during reviews.
    In 2013, before ADUFA II expired, Congress passed the Animal Drug 
User Fee Amendments of 2013 (Pub. L. 113-14; hereinafter referred to as 
ADUFA III), which was signed by the President on June 13, 2013. Like 
its predecessors, ADUFA III included its own comprehensive set of 
performance goals. One such goal, as stated in the ADUFA III goals 
letter, was: ``Beginning in early FY 2014, the Agency agrees to 
explore, in concert with industry, the feasibility of pursuing 
statutory revisions, consistent with the Agency's mission to protect 
and promote the public health, that may expand the use of conditional 
approvals to other appropriate categories of new animal drug 
applications and develop recommendations by September 30, 2015.''
    The conditional approval provisions are found in section 571 of the 
Federal Food, Drug and Cosmetic Act (the FD&C Act). These provisions 
allow an applicant to market a new animal drug intended for a minor 
species or a minor use in a major species after the applicant has 
demonstrated that the drug is safe and can be manufactured according to 
standards applicable to approval of applications under section 
512(b)(1) of the FD&C Act (21 U.S.C. 360b(b)(1)), but before meeting 
the full requirements for demonstrating effectiveness by providing 
``substantial evidence'' that the drug is effective. Instead, the 
applicant seeking conditional approval must demonstrate a ``reasonable 
expectation of effectiveness'' and has up to 5 years to meet the 
requirements for demonstrating ``substantial evidence'' of 
effectiveness and receive complete approval of an application filed 
under section 512(b) of the FD&C Act.
    Today, FDA is announcing that it is beginning the exploration 
process described in the ADUFA III goals letter. With this document, 
FDA is requesting comments in regard to the Agency exploring the use of 
statutory changes to expand the use of conditional approval to 
appropriate categories of new animal drugs beyond those intended for 
use either in minor species or for minor uses in major species. FDA is 
opening a public docket to receive comments on the issue. In 
particular, FDA is inviting comments on the following specific 
questions:
    1. Which categories of new animal drugs, if any, beyond those 
intended for minor species or minor uses in major species, should be 
considered by FDA for conditional approval in accordance with the 
current conditional approval process and why?
    2. How would expanding conditional approval positively or 
negatively affect animal health?
    FDA will be reviewing the docket and considering comments submitted 
as it moves forward with this process. The docket will remain open for 
180 days following publication of this document in the Federal 
Register.

II. Comments

    Interested persons may submit electronic comments regarding this 
document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: September 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21227 Filed 9-8-14; 8:45 am]
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