[Federal Register Volume 67, Number 134 (Friday, July 12, 2002)]
[Notices]
[Pages 46196-46197]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-17513]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Pediatric Oncology Drug Development; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing a public 
workshop, cosponsored with the American Academy of Pediatrics (AAP), 
regarding pediatric oncology drug development. The public workshop is 
intended to provide information for and perspective from advocacy 
groups, interested health care providers, academia, and industry 
organizations on various aspects of drug development in pediatric 
oncology, including prioritization of new and emerging therapeutic 
alternatives, clinical trial design, and access to new therapeutic 
agents. The input from this public workshop will be used in developing 
topics for discussion at future meetings of the Pediatric Subcommittee 
of the Oncologic Drugs Advisory Committee (the subcommittee).
    Date and Time: The public workshop will be held on Thursday, July 
18, 2002, from 8 a.m. to 4 p.m.
    Location: The public workshop will be held in the Center for Drug 
Evaluation and Research Advisory Committee Conference Room, rm. 1066, 
5630 Fishers Lane, Rockville, MD 20857. Seating is limited and 
available only on a first-come, first-served basis. Please note there 
is very limited parking in the vicinity of 5630 Fishers Lane, but it is 
near the Twinbrook Metro station. Please bring picture identification 
in order to clear building security.
    Contact: Steven I. Hirschfeld, Center for Drug Evaluation and 
Research (HFD-150), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1532, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop, 
cosponsored with the AAP, regarding pediatric oncology drug 
development. On January 4, 2002, the President signed into law the Best 
Pharmaceuticals for Children Act (Public Law 107-109). Section 15 of 
the Best Pharmaceuticals for Children Act (Section 15) relates to the 
subcommittee.
    Section 15 directs the subcommittee, in carrying out ``the mission 
of reviewing and evaluating the data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in the treatment of pediatric cancers,'' to:
     Evaluate and, to the extent practicable, prioritize new 
and emerging therapeutic alternatives available to treat pediatric 
cancer;
     Provide recommendations and guidance to help ensure that 
children with cancer have timely access to the most promising new 
cancer therapies; and
     Advise on ways to improve consistency in the availability 
of new therapeutic agents.
    The agency is seeking public input to inform its future 
decisionmaking in regard to Section 15.
    The agency encourages individuals, patient advocates, industry, 
consumer groups, health care professionals, researchers, and other 
interested persons to attend this public workshop.
    Requests to Make Oral Presentations: The public workshop agenda 
allows opportunities for oral presentations from interested persons. If 
you desire to make a formal oral presentation, please notify the 
contact person (see the Contact section of this document) before July 
17, 2002, and provide your name,

[[Page 46197]]

address, telephone number, fax number, e-mail address, title, business 
affiliation (if applicable), the sponsor of the presentation (e.g., the 
organization paying travel expenses or fees), a brief summary of the 
presentation, and the approximate amount of time requested for the 
presentation. Presentation times may be limited. Persons or groups 
having similar interests are encouraged to consolidate their 
presentations and present them through a single representative.
    Persons needing a sign language interpreter or other special 
accommodations should notify the contact person by July 17, 2002.
    Transcripts: Transcripts of the public workshop will be available 
for review at the Dockets Management Branch Public Reading Room, Food 
and Drug Administration, rm. 1061, 5630 Fishers Lane, Rockville, MD 
20852 and on the Internet at http://www.fda.gov/ohrms/dockets/ac/cder02.htm or you may request a transcript of the public workshop from 
the Freedom of Information Staff (HFI-35), Food and Drug 
Administration, rm. 12A-16, 5600 Fishers Lane, Rockville, MD 20857, 
approximately 20 working days after the public workshop, at a cost of 
10 cents per page.

    Dated: July 8, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-17513 Filed 7-11-02; 8:45 am]
BILLING CODE 4160-01-S