[Federal Register Volume 64, Number 166 (Friday, August 27, 1999)]
[Notices]
[Pages 46918-46919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22311]


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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 
Revision; 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 1999 Revision.'' This revised plan updates FDA's 
anticipated prescription drug user fee revenues and planned 
expenditures of the fee revenues over the 5-year period from 1998 to 
2002. The revised plan to achieve 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, takes into account changes in 
revenue projections and work load based on actual revenue and 
application receipts in fiscal year (FY) 1998. The amended and extended 
PDUFA is referred to as PDUFA II.

DATES: Written comments on the revised plan may be submitted at any 
time and will be considered as the agency makes annual adjustments to 
the revised plan in the second quarter of each FY.

ADDRESSES: Copies of this revised plan are available on the Internet at 
``www.fda.gov/oc/pdufa2/5yrplan.html''. For those without Internet 
access, single copies of this revised plan may be obtained from the 
Office of Management and Systems (HFA-20), Attention: Frank P. Claunts, 
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 revised 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 (HFA-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 1999 
Revision.'' PDUFA was amended and

[[Page 46919]]

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 revised 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 revised plan is based 
and how those assumptions have changed since the original plan was 
issued last year. Included is the assumption that this revised plan is 
dynamic, and it will be reassessed each FY through 2002. This is the 
first revision of the plan since it was initially published last year. 
The individual plans of agency components with major PDUFA 
responsibilities are summarized, followed by a summary of associated 
expenditures and an agency summary. Attachments include: Estimates of 
PDUFA fees and revenues, the Federal Register notice of December 22, 
1998, establishing prescription drug user fee rates for FY 1999, and 
the revised ``PDUFA II Information Management Five-Year Plan.''
     In FDA's continuing efforts to maximize the availability and 
clarity of information about the agency's review processes and plans, 
FDA is sharing this revised plan with all who have an interest, and the 
agency is making it available on the Internet. The agency welcomes 
comments, and it will consider them in the future as annual adjustments 
are made to the plan.
     Interested persons may submit written comments on the revised plan 
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 revised plan and received 
comments may be seen in the office above between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: August 20, 1999.
 Margaret M. Dotzel,
 Acting Associate Commissioner for Policy.
[FR Doc. 99-22311 Filed 8-26-99; 8:45 am]
BILLING CODE 4160-01-F