[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]
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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.
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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