[Federal Register: July 12, 2002 (Volume 67, Number 134)]
[Notices]
[Page 46196-46197]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12jy02-70]
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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: HIRSCHFELDS@CDER.FDA.GOV.
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