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

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