[Federal Register Volume 72, Number 48 (Tuesday, March 13, 2007)]
[Notices]
[Pages 11369-11370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-4452]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0069]


Animal Drug User Fee Act; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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

    The Food and Drug Administration (FDA) is announcing a public 
meeting on the Animal Drug User Fee Act of 2003 (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 April 24, 2007, 
beginning at 9 a.m.
    Location: The public meeting will be held at the Food and Drug 
Administration, 7519 Standish Pl., third floor, rm. A, Rockville, MD 
20855. There is parking near the building. Photo identification is 
required to clear building security.
    Contact: Aleta Sindelar, Office of the Director (HFV-3), Center for 
Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-276-9004, FAX 240-276-9020, e-mail: 
[email protected].
    Registration and Requests for Oral Presentations: Registration is 
not required to attend the meeting. Requests to make an oral 
presentation at the meeting must be submitted by April 17, 2007, to the 
contact person. Your request to make a presentation should include the 
following information: Name, title, firm name, address, telephone, fax 
number, and e-mail address. We will try to accommodate all persons who 
wish to make a presentation. The time allotted for

[[Page 11370]]

presentations may depend on the number of persons who wish to speak.
    If you require special accommodations due to a disability, please 
contact Aleta Sindelar at least 7 days in advance of the meeting.
    Comments: Interested persons may submit to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852, written or electronic comments. 
Electronic comments may be submitted to the docket at the following 
site: http://www.fda.gov/dockets/ecomments. Submit a single copy of 
electronic comments or two paper copies of mailed 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 seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday. The docket 
will remain open for written or electronic comments through May 24, 
2007.

SUPPLEMENTARY INFORMATION:

I. Background

    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 provide greater public health 
protection by ensuring that animal drug products that are approved to 
be safe and effective are readily available for both companion animals 
and animals intended for food consumption.
    The FDA 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 four fees: (1) A sponsor fee, (2) an establishment 
fee, (3) a product fee, and (4) an application fee. ADUFA also provides 
for specific waivers and exemptions from fees. FDA prepared guidance 
for the industry regarding the fees, billings and submission of fees, 
as well as waivers and exemptions (http://www.fda.gov/cvm/adufa.htm).
    The total amounts authorized for collection were: $5 million for FY 
2004; $8 million in FY 2005; and $10 million in each FY 2006 through 
2008, subject to annual inflation and workload adjustments after 2004. 
ADUFA provided for four types of fees to be assessed each fiscal year, 
with each fee type expected to raise 25 percent of the annual amount 
collected. Thus, in FY 2004, we expected to receive $1.25 million from 
sponsor fees, establishment fees, product fees, and application fees, 
for a total of $5 million dollars. 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.

II. Agenda

    In the language authorizing ADUFA, 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 
we should consider to include in the reauthorization of ADUFA (http://www.fda.gov/cvm/adufa.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?
    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://www.fda.gov/cvm/adufa.htm.

III. Meeting Format

    In general, the meeting format will include presentations by FDA 
followed by the 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 10:30 a.m. The open public comment portion of the meeting 
for registered speakers is planned to begin at 10:30 a.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 or electronic comments through May 24, 
2007.

IV. Transcripts

    Meeting transcripts will be made available on the CVM Website 
(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 between 9 a.m. and 4 
p.m. Monday through Friday.

    Dated: March 6, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-4452 Filed 3-12-07; 8:45 am]
BILLING CODE 4160-01-S