03-25965. 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://www.fda.gov/​dockets/​ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the plan.

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.

SUPPLEMENTARY INFORMATION:

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://www.fda.gov/​oc/​pdufa3/​2003plan/​default.htm.

Dated: October 7, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.