[Federal Register Volume 63, Number 132 (Friday, July 10, 1998)]
[Notices]
[Page 37401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18401]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0495]


Prescription Drug User Fee Act, ``PDUFA II Five-Year Plan;'' 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of an internal planning document entitled ``PDUFA II Five-
Year Plan.'' This plan is intended to show FDA's anticipated 
prescription drug user fee revenues and planned expenditures of the fee 
revenues over the 5-year period from 1998 through 2002. The plan is 
designed to assist in achieving the new goals for the drug review 
process under the Prescription Drug User Fee Act of 1992 (PDUFA), which 
was amended and extended through the year 2002 by the Food and Drug 
Administration Modernization Act of 1997 (FDAMA). The amended and 
extended PDUFA is referred to as PDUFA II.

DATES: Written comments my be provided at any time and will be 
considered as the agency makes annual adjustments to the plan in the 
second quarter of each fiscal year.

ADDRESSES: Copies of this document are available on the Internet at 
``www.fda.gov/oc/pdufa2/5yrplan.html''. For those without Internet 
access, single copies of this plan may be obtained from the Division of 
Management Systems and Policy (HFA-300), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857. Please send a self-addressed 
adhesive label to assist that office in processing your request. Submit 
written comments on the plan to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Frank P. Claunts, Division of 
Management Systems and Policy (HFA-300), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-827-5501.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of an 
internal planning document entitled ``PDUFA II Five-Year Plan.'' PDUFA 
was amended and extended through the year 2002 by FDAMA. The amended 
and extended PDUFA is referred to as PDUFA II. PDUFA II authorizes 
appropriations and fees that will provide FDA with resources to sustain 
the drug review staff developed in the last 5 years and to achieve the 
even more stringent new goals.
    The plan begins with a statement of purpose, provides background 
information on PDUFA and a summary of the new goals, and discusses the 
10 major assumptions on which the plan is based. Included is the 
assumption that this plan is dynamic and will be reassessed each fiscal 
year through 2002. The individual plans of agency components with major 
PDUFA responsibilities are summarized, followed by a summary of 
associated expenditures and an agency summary.
    In our continuing efforts to maximize the availability and clarity 
of information about our review processes and plans, we are sharing 
this plan with all who have an interest and making it available on the 
Internet. We welcome comments and will consider them in the future as 
annual adjustments are made to the plan.
    Interested persons, may at any time, submit written comments to the 
Dockets Management Branch (address above). Two copies of any comments 
are to be submitted, except that individuals may submit one copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. The guidance document and received 
comments may be seen in the office above between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: July 3, 1998.
 William K. Hubbard,
 Associate Commissioner for Policy Coordination.
[FR Doc. 98-18401 Filed 7-9-98; 8:45 am]
BILLING CODE 4160-01-F