[Federal Register Volume 73, Number 87 (Monday, May 5, 2008)]
[Notices]
[Page 24599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-9726]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0257]


Draft Prescription Drug User Fee Act IV Drug Safety Five-Year 
Plan; Availability for Comment

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability for public comment of the draft drug safety 5-year plan 
entitled ``Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-
Year Plan.'' This plan is intended to communicate FDA's strategy for 
meeting the commitments for enhancing and modernizing the drug safety 
system within the context of the PDUFA IV program.

DATES:  Submit written or electronic comments on the draft drug safety 
5-year plan by June 19, 2008.

ADDRESSES:  Submit written requests for single copies of the draft plan 
to the Office of Executive Programs, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 6100, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist that office in processing your requests. 
Submit written comments on the draft drug safety 5-year 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.regulations.gov. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the document.

FOR FURTHER INFORMATION CONTACT:  Jayne C. Ware, Food and Drug 
Administration, Center for Drug Evaluation and Research, Office of 
Executive Programs, 10903 New Hampshire Ave., Bldg. 51, rm. 6100, 
Silver Spring, MD 20993-0002, 301-796-3200.

SUPPLEMENTARY INFORMATION:

I. Background

    On September 27, 2007, President Bush signed into law the Food and 
Drug Administration Amendments Act of 2007, which includes the 
reauthorization and expansion of PDUFA. The reauthorization of PDUFA 
will significantly broaden and modernize the agency's drug safety 
program and facilitate more efficient development of safe and effective 
new medications for the American public. During the user fee 
negotiation process leading up to the renewal of PDUFA, FDA and the 
relevant regulated industries mutually agreed to certain commitments 
that the FDA will carry out during fiscal years 2008 through 2012. 
Congress signaled its agreement with the commitments by authorizing 
PDUFA funds for them. Among those commitments is the responsibility of 
the FDA to develop and periodically update a 5-year plan describing 
activities that will lead to enhancing and modernizing FDA's drug 
safety system.
    FDA is announcing for public comment the availability of the draft 
drug safety 5-year plan entitled ``Prescription Drug User Fee Act 
(PDUFA) IV Drug Safety Five-Year Plan.'' This plan is intended to 
communicate FDA's strategy for meeting the commitments for enhancing 
and modernizing the drug safety system within the context of the PDUFA 
IV program. The plan describes the agency's strategy for achieving the 
commitments defined in section VIII, Enhancement and Modernization of 
the FDA Drug Safety System, and section IX, Review of Proprietary Names 
to Reduce Medication Errors, of the PDUFA IV Performance Goals (http://www.fda.gov/oc/pdufa4/pdufa4goals.html). At the end of the comment 
period, FDA will review the comments, update the ``PDUFA IV Drug Safety 
Five-Year Plan,'' and publish the final version.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
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. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cder/pdufa/PDUFA_IV_5yr_plan_draft.pdf.

    Dated: April 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-9726 Filed 5-2-08; 8:45 am]
BILLING CODE 4160-01-S