[Federal Register Volume 75, Number 152 (Monday, August 9, 2010)]
[Notices]
[Pages 47820-47821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19537]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0381]
Generic Drug User Fee; 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 to gather stakeholder input on the development of a generic
drug user fee program. The number of human generic drug applications
awaiting FDA action and the median review times for generic drug
applications have increased in recent years. A user fee program could
provide necessary supplemental funding, in addition to current
Congressional appropriations, to allow for the timely review of such
applications. Although the President's Fiscal Year (FY) 2011 budget
includes generic drug user fees, new legislation would be required for
FDA to establish and collect user fees under such a program. As FDA
begins negotiations with the regulated industry about generic drug user
fees, FDA will hold a public meeting to gather the public's input on
such a program.
Date and Time: The public meeting will be held on September 17,
2010, from 9 a.m. to 5 p.m.
Location: The meeting will be held at the Hilton Washington DC/
Rockville and Executive Meeting Center, 1750 Rockville Pike, Rockville,
MD 20852.
Contact Persons: Mary C. Gross, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6178, Silver Spring, MD 20993, 301-796-3519, FAX: 301-847-8753,
e-mail: [email protected], or Peter C. Beckerman, Office of
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, rm. 4238, Silver Spring, MD 20993, 301-796-4830, FAX: 301-847-3541,
e-mail: [email protected].
Registration and Requests for Oral Presentations: If you wish to
attend and/or present at the meeting, please register by September 9,
2010. Please e-mail your registration information to [email protected]. Those without e-mail access may register by
contacting one of the persons listed in the Contact Persons section of
the document. Please provide complete contact information for each
attendee, including name, title, affiliation, address, e-mail address,
and phone number. Registration is free and will be on a first-come,
first-served basis. Early registration is recommended because seating
is limited. FDA may limit the number of participants from each
organization as well as the total number of participants, based on
space limitations. Registrants will receive confirmation once they have
been accepted. Onsite registration on the day of the meeting will be
based on space availability. 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, and if the entire
meeting time is not needed for presentations, FDA reserves the right to
terminate the meeting early.
If you need special accommodations due to a disability, please
contact Mary Gross or Peter Beckerman (see Contact Persons) at least 7
days before the meeting.
Comments: Regardless of attendance at the public meeting,
interested persons may submit either electronic or written comments by
October 17, 2010. 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. 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.,
[[Page 47821]]
Monday through Friday. Submission of comments prior to the meeting is
strongly encouraged.
SUPPLEMENTARY INFORMATION:
I. Introduction
FDA is announcing its intention to hold a public meeting related to
generic drug user fees. The number of generic drug applications
awaiting FDA action and the median review time for such applications
have increased. The Agency is soliciting comment on whether to seek a
user fee program that would provide additional resources for the review
of human generic drug applications, as well as what such a program
should look like. New legislation would be required for FDA to
establish and collect user fees for generic drugs, and FDA is
initiating the process for defining the scope and structure of a
generic drug user fee program. As part of this process, FDA will hold a
public meeting to seek input from stakeholders and the public on
generic drug user fees. In addition, members of the public are
encouraged to submit written comments. FDA is particularly interested
in responses to the following questions and welcomes other pertinent
information stakeholders would like to share regarding the application
process for generic drugs:
1. How, if at all, should a generic drug user fee program differ
from FDA's existing user fee programs, including the Prescription Drug
User Fee Act (PDUFA), the Animal Drug User Fee Act (ADUFA), the Medical
Device User Fee and Modernization Act (MDUFMA) and Tobacco Product User
Fees? (Information on these programs can be found at http://www.fda.gov).
2. What should a generic drug user fee program look like or how
should a generic user fee be structured? (User fees for brand name
drugs include a one-time fee for a new drug application and annual fees
for marketed products and facilities at which these products are
produced. Should the generic drug fees follow the same structure? If
not, what are the unique aspects of the generic drug industry or market
that should be considered and how might these impact a proposed user
fee plan?)
3. Are performance goals recommended for FDA. If so, what
performance goals would you recommend for FDA? If not, why not?
4. Should all applications pay the same fees and be subject to the
same goals? (For example, should applications for more complex products
pay a higher application fee to reflect the additional regulatory
efforts they entail? Should such differences be captured through
differential goals?)
5. Including applications for which exclusivities would prevent
current marketing, and applications that are awaiting responses from
sponsors for noted deficiencies, there is a current queue of over 2,000
applications under review, and approximately 800 new applications
submitted each year. How should a generic drug user fee program address
applications currently awaiting FDA review?
6. PDUFA currently supports oversight of post-marketing safety of
drugs. What kind of support, if any, should a generic user fee provide
for post-marketing safety?
II. Why Is FDA Undertaking This Process?
An important responsibility of FDA is to assess generic drug
applications. Generic drugs currently are used to fill more than two-
thirds of all prescriptions dispensed in the United States and they
provide important cost-effective alternatives to the American public.
Nonetheless, despite increasing productivity on the part of FDA's
Office of Generic Drugs, the number of applications awaiting FDA action
has been steadily increasing, and the median time for review of such
applications has grown.
Similar to user fees for brand name human drugs, animal drugs,
generic animal drugs, and medical devices, the intent of a generic drug
user fee program would be to provide additional revenues so that FDA
can hire more staff and improve systems to support the generic drug
review process. FDA believes the supplementary revenues from generic
drug user fees would allow the Agency to review generic drug
applications in a timely manner and will provide flexibility, adequacy,
and predictability in the funding of FDA's review of generic drug
applications.
Although the President's FY 2011 budget contains a generic drug
user fee program, new legislation would be needed to put such fees into
place. At this time, generic drugs for humans are the largest category
of preapproval products regulated by FDA and generic drug applicants do
not currently pay any type of user fee. FDA believes that the
predictability, flexibility, and adequacy of a funding stream from user
fees and the accompanying ability to more efficiently review generic
drug applications would benefit the public health, FDA, and the generic
drug industry.
III. What Information Should You Know About the Meeting?
A. When and Where Will the Meeting Occur? What Format Will FDA Use?
Through this notice, we are announcing a public meeting to hear
stakeholder views on what features FDA should propose for a generic
drug user fee program. We will conduct the meeting on September 17,
2010, at the Hilton Washington DC/Rockville and Executive Meeting
Center, see Location).
In general, the meeting format will include presentations by FDA
and presentations by stakeholders and members of the public who have
registered in advance to present at the meeting. The amount of time
available for presentations will be determined by the number of people
who register to make a presentation. We will also provide an
opportunity for organizations and individuals to submit written
comments to the docket after the meeting. FDA policy issues are beyond
the scope of this initiative. Accordingly, the presentations should
focus on process and funding issues, and not focus on policy issues.
B. Will Meeting Transcripts Be Available?
Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (see Comments). A transcript will
also be 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 (HFI-35), Office of Management
Programs, Food and Drug Administration, 5600 Fishers Lane, rm. 6-30,
Rockville, MD 20857.
Dated: August 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19537 Filed 8-6-10; 8:45 am]
BILLING CODE 4160-01-S