[Federal Register: October 14, 2003 (Volume 68, Number 198)]
[Page 59191]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[[Page 59191]]



Food and Drug Administration

[Docket No. 2003N-0429]

Prescription Drug User Fee Act III Five-Year Plan; 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 the ``PDUFA III 
Five-Year Plan'' (the plan). The plan to achieve PDUFA (Prescription 
Drug User Fee Act) III goals for the drug review process takes into 
account changes in the law under PDUFA III and projects revenue and 
spending in fiscal year (FY) 2003 through FY 2007.

DATES: Submit written or electronic comments on the plan at any time. 
These comments will be considered as the agency makes annual 
adjustments to the plan each fiscal year.

ADDRESSES: Submit written requests for single copies of this plan to 
the Office of Management and Systems, Attn: Frank Claunts (see FOR 
FURTHER INFORMATION CONTACT). Send a self-addressed adhesive label to 
assist that office in processing your requests. Submit written comments 
on the plan to the Division of Dockets Management (HFA 305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 

FOR FURTHER INFORMATION CONTACT: Frank Claunts, Office of Management 
and Systems (HF-20), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4427.


I. Background

    FDA is announcing the availability of an internal planning document 
entitled ``PDUFA III Five-Year Plan.'' PDUFA was amended and extended 
through the year 2007 by the Prescription Drug User Fee Amendments of 
2002 (PDUFA III). PDUFA III authorizes appropriations and fees that 
will provide FDA with resources to sustain the drug review staff 
developed through FY 2002 and to achieve the even more stringent new 
goals through FY 2007.
    The plan begins with a statement of purpose, provides background 
information on PDUFA along with a summary of the new goals, and the 
plan documents the 10 major assumptions on which it is based. The plan 
summarizes individual plans of agency components with major PDUFA 
responsibilities and also provides a consolidated agency summary. The 
plan to achieve PDUFA III goals for the drug review process is based on 
projected revenue and spending projections through FY 2007. Appendix A 
of the plan is entitled the ``PDUFA III Information Technology Five-
Year Plan.''
    We (FDA) are making this plan available to interested individuals. 
We welcome comments, and we will consider all comments in the future as 
annual adjustments are made to the plan.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments. Submit a single copy of 
electronic comments or two paper copies of any mailed comments, except 
that individuals may submit one paper copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. The plan and received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

III. Electronic Access

    Copies of this document are available on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/pdufa3/2003plan/default.htm

    Dated: October 7, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-25965 Filed 10-8-03; 4:06 pm]