[Federal Register Volume 65, Number 146 (Friday, July 28, 2000)]
[Notices]
[Pages 46465-46466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-19046]


-----------------------------------------------------------------------

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 2000 
Update; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of an internal planning document entitled ``PDUFA II Five-
Year Plan: FY 2000 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 and FY 1999 and updated projections 
for FY 2000 through 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: 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 Office of 
Management and Systems (HF-20), Attention: Frank P. Claunts (HF-20), 
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, Office of Management 
Systems (HF-20), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4427.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of an 
internal planning document entitled ``PDUFA II Five-Year Plan--FY 2000 
Update.'' 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 FY 2000 updated 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 second 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 it 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 and FY 1999 and updated projections for FY 2000 
through FY 2002. Attachments include: The Federal Register notice of 
December 28, 1999 (64 FR 72669) establishing prescription drug user fee 
rates for FY 2000, 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 who have an interest. We 
welcome comments and will consider them in the future as annual 
adjustments are made to the plan.

[[Page 46466]]

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the plan. 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 21, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-19046 Filed 7-27-00; 8:45 am]
BILLING CODE 4160-01-F