[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
