[Federal Register Volume 75, Number 152 (Monday, August 9, 2010)]
[Pages 47820-47821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19537]



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.


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: mary.gross@fda.hhs.gov, 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: peter.beckerman@fda.hhs.gov.
    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 GDUFA_Meeting@fda.hhs.gov. 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.


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 
    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]