[Federal Register Volume 76, Number 182 (Tuesday, September 20, 2011)]
[Notices]
[Pages 58279-58281]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-24082]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0656]


Animal Drug User Fee Act; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting on the Animal Drug User Fee Act (ADUFA). FDA invites public 
comment on the ADUFA program and suggestions regarding the features FDA 
should propose for the next ADUFA program.
    Date and Time: The meeting will be held on November 7, 2011, from 9 
a.m. to 12 noon.
    Location: The meeting will be held at the Food and Drug 
Administration, 7519 Standish Pl., 3d floor, Rm. A, Rockville, MD 
20855. If you require special accommodations, please contact Patricia 
Arnwine (see Contact Person) at least 7 days before the meeting.
    Contact Person: Donal Parks, Food and Drug Administration, Center 
for Veterinary Medicine, 7519 Standish Pl., Rockville, MD 20855, 240-
276-8688, FAX: 240-276-9744, [email protected], or Patricia 
Arnwine, Food and Drug Administration, Center for Veterinary Medicine, 
7519 Standish Pl., Rockville, MD 20855, 240-276-9724, FAX: 240-276-
9744, [email protected].
    Comments: Regardless of attendance at the meeting, interested 
persons may submit either electronic or written comments regarding this 
document. 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. Identify comments with the docket number found in 
brackets in the heading of this document. Comments received by October 
26, 2011, will be taken into consideration before the public meeting.
    Transcripts: Transcripts of the meeting will be available for 
review at the Division of Dockets Management and on the Internet at 
http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm042891.htm approximately 30 days after the meeting.

SUPPLEMENTARY INFORMATION:

I. Introduction

    FDA is announcing its intention to hold a public meeting on ADUFA. 
The authority for ADUFA expires September 30, 2013. Without new 
legislation, FDA will no longer have the authority to collect user fees 
to fund the new animal drug review process. Prior to beginning 
negotiations with the regulated industry on ADUFA reauthorization, 
section 740A(d)(2) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 379j-13) requires FDA to: (1) Publish a notice in 
the Federal Register requesting public input on the reauthorization; 
(2) hold a public meeting at which the public may present its views on 
the reauthorization including specific suggestions for changes to the 
goals referred to in section 740A(a) of the FD&C Act; (3) provide a 
period of 30 days after the public meeting to obtain written comments 
from the public suggesting changes; and (4) publish the comments on 
FDA's Web site. FDA is holding a public meeting to gather information 
on what FDA should consider including in the reauthorization of ADUFA. 
FDA is interested in responses from the public on the following two 
general questions and welcomes other pertinent information that 
stakeholders would like to share:
    1. What is your assessment of the overall performance of the ADUFA 
program thus far?
    2. What aspects of ADUFA should be retained, changed, or 
discontinued to further strengthen and improve the program?
    The following information is provided to help potential meeting 
participants better understand the history and evolution of ADUFA, and 
its current status.

II. What is ADUFA? What does it do?

    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 that were to be dedicated to expediting the review of animal drug 
applications in accordance with certain performance goals. The 
implementation of ADUFA I provided a significant funding increase for 
the new animal drug application review process, and enabled FDA to

[[Page 58280]]

increase the number of staff dedicated to the new animal drug 
application review process by 30 percent since 2003.
    Under ADUFA I, the industry agreed to pay user fees that are 
available to FDA, in addition to appropriated funds, to spend on the 
new animal drug application review process. Moreover, FDA's authority 
to collect user fees is contingent on a certain level of spending from 
appropriated funds, as adjusted for inflation.
    As part of ADUFA I, FDA established review performance goals that 
have been phased in over a 5-year period. These performance goals set 
from FY 2004 to FY 2008 were intended to achieve progressive, yearly 
improvements in the time for review of new animal drug applications. By 
the 5th and final year of ADUFA ending on September 30, 2008, FDA 
agreed to review and act on 90 percent of the following submission 
types within specified times:
     New animal drug applications and reactivations of such 
applications within 180 days after submission date.
     Nonmanufacturing supplemental new animal drug applications 
(that is, supplemental new animal drug applications for which safety or 
effectiveness data are required) and reactivations of such supplemental 
applications within 180 days after submission date.
     Manufacturing supplemental new animal drug applications 
and reactivations of such supplemental applications within 120 days 
after submission date.
     Investigational new animal drug study submissions within 
180 days after submission date.
     Investigational new animal drug submissions consisting of 
protocols, that FDA and the sponsor consider to be an essential part of 
making the decision to approve or not approve a new animal drug 
application or supplemental new animal drug application, without 
substantial data, within 60 days after submission date.
     Administrative new animal drug applications submitted 
after all scientific decisions have been made in the investigational 
new animal drug process (that is, prior to submission of the animal 
drug application) within 60 days after submission date.
    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 time frames. In addition, 
FDA agreed to the following program enhancements to reduce review 
cycles and improve communications during reviews:
     Incorporating an ``end-review amendment'' (ERA) process to 
amend pending submissions to achieve a complete review decision sooner 
and reduce the number of review cycles.
     Developing an electronic submission tool that allows 
industry to submit drug applications electronically.
     Participating with industry in public workshops on 
mutually agreed-upon topics.
     Improving communications by enhancing the timeliness and 
predictability of foreign pre-approval inspections.
    FDA has published a number of reports that provide useful 
background on ADUFA I and ADUFA II. ADUFA-related Federal Register 
notices, guidances, legislation, performance reports, and financial 
reports and plans can be found at: http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm.

III. What information should you know about the meeting?

A. When and where will the meeting occur? What format will FDA use?

    Throughout this document, FDA has been announcing a public meeting 
to hear stakeholders' views on what FDA should consider for the ADUFA 
III program. FDA will conduct the meeting on November 7, 2011, at 7519 
Standish Pl., 3rd floor, Rm. A, Rockville, MD 20855. (see Comments). In 
general, the meeting format will include presentations by FDA followed 
by an open public comment period. Registered speakers for the open 
public comments will be grouped and invited to speak in the order of 
their affiliation and time of registration (scientific and academic 
experts/veterinary professionals, representatives of consumer advocacy 
groups, and the regulated industry). FDA presentations are planned from 
9 a.m. until 10 a.m. The open public comment portion of the meeting for 
registered speakers is planned to begin at 10 a.m. An opportunity for 
public comments from meeting attendees will commence following the 
registered presentations, if time permits.
    FDA policy issues are beyond the scope of these reauthorization 
discussions. Accordingly, the presentations should focus on process 
enhancements and funding issues, not on policy issues.
    The docket will remain open for either electronic or written 
comments through December 7, 2011.

B. What questions would FDA like the public to consider?

    Please consider the following questions for this meeting:
    1. What is your assessment of the overall performance of the ADUFA 
II program thus far?
    2. What aspects of ADUFA should be retained, changed, or 
discontinued to further strengthen and improve the program?

C. How do you register for the meeting or submit comments?

    If you wish to attend and/or present at the meeting, please 
register by email to [email protected] by October 26, 
2011. Your e-mail should contain complete contact information for each 
attendee--name, title, affiliation, address, e-mail, and phone number. 
Also, please self-identify as a member of one of the following 
stakeholder categories: Scientific or academic experts; veterinary 
professionals; patient and consumer advocacy groups; or the regulated 
industry. Registration is free and will be on a first-come, first-
served basis. Early registration is recommended since seating is 
limited. FDA may limit the number of participants from each 
organization based on space constraints. Registrants will receive 
confirmation once their registrations are accepted. Onsite registration 
on the day of the public meeting will be based on space availability. 
FDA will try to accommodate all persons who wish to make a 
presentation. The time allotted for presentations may depend on the 
number of persons who wish to speak. If you need special 
accommodations, please contact Patricia Arnwine (see Contact Person) at 
least 7 days before the meeting.
    In addition, interested persons may submit either electronic or 
written comments to the Division of Dockets Management (see Comments). 
It is only necessary to send one set of comments. It is no longer 
necessary to send two copies of mailed 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. To ensure 
consideration before the public meeting, all comments must be received 
by October 26, 2011.

D. Will meeting transcripts be available?

    Please be advised that as soon as the transcript is available, it 
will be accessible at http://www.fda.gov/ForIndustry/UserFees/

[[Page 58281]]

AnimalDrugUserFeeActADUFA/ucm042891.htm. It may be viewed at the 
Division of Dockets Management (see Comments). A transcript will also 
be made available in either hard copy or on CD-ROM, after submission of 
a Freedom of Information request. Written requests are to be sent to 
Division of Freedom of Information (ELEM-1029), Food and Drug 
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.

    Dated: September 13, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-24082 Filed 9-19-11; 8:45 am]
BILLING CODE 4160-01-P