[Federal Register Volume 66, Number 100 (Wednesday, May 23, 2001)]
[Notices]
[Page 28528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13069]


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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--FY 2001 
Update; 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--FY 2001 Update.'' The updated plan to achieve PDUFA II goals 
for the drug review process takes into account changes in revenue 
projections and workload based on actual revenue and application 
receipts in fiscal year (FY) 1998, FY 1999, and FY 2000 and updated 
projections for FY 2001 and FY 2002.

DATES: Submit written comments on the plan at any time. Comments will 
be considered as the agency makes annual adjustments to the plan in the 
second quarter of each FY.

ADDRESSES: Submit written requests for single copies of this plan to 
the Office of Management and Systems (HF-300), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, Attn: Frank 
Claunts. Send a self-addressed adhesive label to assist that office in 
processing your requests. 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. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the plan.

FOR FURTHER INFORMATION CONTACT: Frank Claunts, Office of Management 
Systems (HF-300), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4427.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of an internal planning document 
entitled ``PDUFA II Five-Year Plan--FY 2001 Update.'' The Prescription 
Drug User Fee Act of 1992 (PDUFA) was amended and extended through the 
year 2002 by the Food and Drug Administration Modernization Act of 
1997. 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 through FY 1997 
and to achieve the even more stringent new goals.
    The updated FY 2001 plan begins with a statement of purpose, 
provides background information on PDUFA and a summary of the new 
goals, and updates the 10 major assumptions on which the plan is based. 
This is the third update of the plan since it was initially published 
in July 1998. The updated plan summarizes individual plans of agency 
components with major PDUFA responsibilities and also provides a 
consolidated agency summary. The updated plan to achieve PDUFA II goals 
for the drug review process takes into account changes in revenue 
projections and workload based on actual revenue and application 
receipts in FY 1998, FY 1999, and FY 2000 and updates projections for 
FY 2001 and FY 2002. Attachments include the Federal Register notice of 
December 18, 2000 (65 FR 79107), establishing prescription drug user 
fee rates for FY 2001, updated 5-year estimates of PDUFA fees and 
revenues, and the revised PDUFA II Information Management Five-Year 
Plan.
    We are making this plan available to all that have an interest. We 
welcome comments and will consider them in the future as annual 
adjustments are made to the plan.

II. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the plan at any time. 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 FY 2001 update and 
received comments are available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/oc/pdufa2/5yrplan.html.

    Dated: May 17, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-13069 Filed 5-22-01; 8:45 am]
BILLING CODE 4160-01-S