
[Federal Register Volume 76, Number 182 (Tuesday, September 20, 2011)]
[Notices]
[Pages 58277-58279]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24083]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0655]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

    The Food and Drug Administration (FDA) is announcing a public 
meeting on the Animal Generic Drug User Fee Act (AGDUFA). FDA invites 
public comment on the AGDUFA program and suggestions regarding the 
features FDA should propose for the next AGDUFA program.
    Date and Time: The meeting will be held on November 7, 2011, from 1 
p.m. to 4 p.m.
    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, Donal.Parks@fda.hhs.gov; or Patricia 
Arnwine, Food and Drug Administration, Center for Veterinary Medicine, 
7519 Standish Pl., Rockville, MD 20855, 240-276-9724, FAX: 240-276-
9744, Patricia.Arnwine@fda.hhs.gov.

[[Page 58278]]

    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/AnimalGenericDrugUserFeeActAGDUFA/ucm270232.htm approximately 30 days 
after the meeting.

SUPPLEMENTARY INFORMATION: 

I. Introduction

    FDA is announcing its intention to hold a public meeting on AGDUFA. 
The authority for AGDUFA expires September 30, 2013. Without new 
legislation, FDA will no longer have the authority to collect user fees 
to fund the generic animal drug review process. Prior to beginning 
negotiations with the regulated industry on AGDUFA reauthorization, 
section 740A(d)(2) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 379j-13(d)(2)) 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 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 AGDUFA. 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 AGDUFA 
program thus far?
    2. What aspects of AGDUFA 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 AGDUFA, and 
its current status.

II. What is AGDUFA? What does it do?

    The Animal Generic Drug User Fee Act enacted in 2008 (Public Law 
110-316; hereinafter referred to as ``AGDUFA I'') amended the FD&C Act 
to authorize the FDA's first-ever generic animal drug user fee program. 
AGDUFA provides FDA with additional funds to enhance the performance of 
the generic animal drug review process. Furthermore, the authorization 
of AGDUFA enables FDA's continued assurance that generic animal drug 
products are safe and effective, and enables FDA's continued support 
for lower-cost alternatives to brand drugs for consumers. Under AGDUFA, 
FDA agreed to meet review performance goals for certain submissions 
over 5 years from fiscal year (FY) 2009 through FY 2013. These review 
performance goals strive to expedite the review of abbreviated new 
animal drug applications (ANADAs) and reactivations, supplemental 
ANADAs, and generic investigational new animal drug (JINAD) 
submissions.
    Under AGDUFA, the industry agreed to pay user fees that are 
available to FDA, in addition to appropriated funds, to spend on the 
generic animal drug 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.
    AGDUFA established increasingly-stringent review performance goals 
over a 5-year period from FY 2009 through FY 2013. By the final year of 
AGDUFA, FDA agreed to review and act on 90 percent of the following 
submission types within the specified time frames:
     Original ANADAs and reactivations within 270 days of the 
submission date.
     Administrative ANADAs (ANADAs submitted after all 
scientific decisions have been made during the JINAD process, i.e., 
prior to the submission of the original ANADAs) within 100 days after 
the submission date.
     Manufacturing supplemental ANADAs and reactivations within 
270 days after the submission date.
     JINAD study submissions within 270 days after the 
submission date.
     JINAD protocol submissions within 100 days after 
submission date. JINAD protocol submissions consist of protocols 
without substantial data that FDA and the sponsor consider to be an 
essential part of the basis for making the decision to approve or not 
approve an ANADA or supplemental ANADA.
    The additional resources provided under AGDUFA I enabled FDA to 
completely eliminate the backlog of ANADA and JINAD submissions by 
August 2010.
    FDA has published a number of reports that provide useful 
background on AGDUFA. AGDUFA-related Federal Register notices, 
guidances, legislation, performance reports, and financial reports and 
plans can be found at: http://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/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 AGDUFA 
II program. 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 1 p.m. until 2 p.m. The open public comment portion of the 
meeting for registered speakers is planned to begin at 2 p.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 AGDUFA 
program thus far?
    2. What aspects of AGDUFA should be retained, changed, or 
discontinued to further strengthen and improve the program?

[[Page 58279]]

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 e-mail to AGDUFAReauthorization@fda.hhs.gov 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 viewed 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/AnimalGenericDrugUserFeeActAGDUFA/ucm270232.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. 2011-24083 Filed 9-19-11; 8:45 am]
BILLING CODE 4160-01-P


