[Federal Register: December 28, 2005 (Volume 70, Number 248)]
[Page 76851-76852]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0488]

Animal Drug User Fee Act; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.


SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting on the Animal Drug User Fee Act (ADUFA) to seek public comments 
relative to the program's overall performance and reauthorization as 
directed by Congress.
    Date and Time: The public meeting will be held on February 24, 
2006, from 9 a.m. to 5 p.m. Requests to make a presentation at the 
meeting must be received by February 10, 2006. Written comments 
regarding this meeting may be made by March 26, 2006, to the Division 
of Dockets Management (see Addresses).
    Location: The meeting will be held at the DoubleTree Hotel, Plaza 
II and III, 1750 Rockville Pike, Rockville, MD 20852. Registration is 
not required to attend the meeting. Parking is limited, so we recommend 
arriving by subway (Metro rail) if possible. The DoubleTree Hotel is 
accessible from the Metro rail's red line at the Twinbrook station.

ADDRESSES: You may submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 Follow the instructions for submitting 


FOR FURTHER INFORMATION CONTACT: Aleta Sindelar, Center for Veterinary

[[Page 76852]]

Medicine (CVM) (HFV-3), Food and Drug Administration, 7519 Standish 
Pl., Rockville, MD 20855, 240-276-9004, FAX: 240-276-9020, e-mail: 

    Transcripts: Meeting transcripts will be made available on CVM's 
Web site (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm/adufa.htm) approximately 30 working 

days after the meeting. The transcript will also be available for 
public examination at the Division of Dockets Management (see 
ADDRESSES), between 9 a.m. and 4 p.m., Monday through Friday.


I. Background

    In the language authorizing the Animal Drug User Fee Act, Congress 
directed the Secretary of Health and Human Services (the Secretary) to 
consult with the Committee on Energy and Commerce of the House of 
Representatives, the Committee on Health, Education, Labor and Pensions 
of the Senate, appropriate scientific and academic experts, veterinary 
professionals, representatives of consumer advocacy groups, and the 
regulated industry in developing recommendations to Congress for the 
reauthorization of ADUFA and for the goals and plans for meeting the 
goals associated with the process for review of animal drug 
applications. As directed by Congress, FDA is holding a public meeting 
to gather information on what features we should propose to include in 
the ADUFA program (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm/4218.htm) and hear 

stakeholder views on this subject.
    We are offering the following two general questions for 
consideration, and we are interested in responses to these questions 
and any other pertinent information stakeholders would like to share:
    1. What is your assessment of the overall performance of the ADUFA 
program thus far?
    2. What suggestions or changes would you make relative to the 
reauthorization of ADUFA?
    ADUFA, amended the Federal Food, Drug, and Cosmetic Act (the act) 
and authorized FDA to collect fees for certain animal drug 
applications, establishments, products, and sponsors in support of the 
review of animal drugs. These additional resources support FDA's 
responsibilities under the act to ensure that new animal drug products 
are safe and effective for animals as well as for the public with 
respect to animals intended for food consumption.
    FDA's animal drug user fee program was authorized in 2003 and 
implemented in 2004. A significant part of the preparations for the 
program included determining the fee levels for fiscal year (FY) 2004. 
ADUFA provides for the following four fees: (1) A sponsor fee, (2) an 
establishment fee, (3) a product fee, and (4) an application fee. The 
act also provides for specific waivers and exemptions from fees. FDA 
prepared guidance for the industry regarding the fees, billings and 
submission of fees, and waivers and exemptions (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm/adufa.htm

    The total amounts of monies expected for collection were as 
follows: $5 million for FY 2004; $8 million in FY 2005; and, $10 
million in each FY 2006 through 2008. Each fee type was expected to be 
25 percent of the total amount collected. Thus, in FY 2006, we expect 
to receive $2,500,000 from sponsor fees, establishment fees, product 
fees, and application fees, for a total of $10,000,000 dollars (figures 
are subject to inflation and workload adjustments). The user fees are 
used to achieve shorter, more predictable review times by increasing 
the review staff at FDA and building better management systems. As a 
result, we anticipate substantial savings to the industry in regulatory 
review and developmental expenses.
    FDA's animal drug premarket review program is making continual and 
substantial improvements in the animal drug review process as a result 
of user fees. This helps ensure an adequate supply of safe and 
effective therapeutic and production animal drugs.
    We have published a number of reports that may help inform the 
public about the ADUFA program. Key documents such as ADUFA-related 
guidance, legislation, performance reports, and financial reports, can 
be found at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm/adufa.htm.

II. Meeting

    FDA will conduct the meeting on February 24, 2006, at the 
DoubleTree Hotel (see Location). In general, the meeting format will 
include presentations by FDA and a series of panels representing 
different stakeholder interest groups (scientific and academic experts, 
veterinary professionals, representatives of consumer advocacy groups, 
and the regulated industry). FDA and panel presentations are planned 
from 9 a.m. until 12 noon. The open public comment portion of the 
meeting for registered speakers is planned to begin at 1 p.m. An 
opportunity for public comments from meeting attendees will commence 
following the registered presentations, if time permits. The docket 
will remain open for written comments through March 26, 2006, 30 days 
following the meeting.
    If you wish to reserve time to make a presentation at the meeting, 
please contact Aleta Sindelar (see FOR FURTHER INFORMATION CONTACT) by 
February 10, 2006. Your request to make a presentation should include 
the following information: Name, company, company address, company 
phone number, and e-mail address. We 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 require special accommodations due to a disability, please 
contact the DoubleTree Hotel (see Location) at least 7 days in advance 
of the meeting.

III. Comments

    If you would like to submit written comments to the docket 
regarding ADUFA, please send your comments to the Division of Dockets 
Management (See ADDRESSES). Submit a single copy of electronic comments 
or two paper copies of any written comments, except that individuals 
may submit one paper copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. 
Received comments may be reviewed in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 20, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5-7876 Filed 12-27-05; 8:45 am]