[Federal Register: June 21, 2000 (Volume 65, Number 120)]
[Notices]
[Page 38564-38565]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21jn00-84]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1336]


Draft Guidance for Industry: Pediatric Oncology Studies in
Response to a Written Request; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Pediatric
Oncology Studies in Response to a Written Request.'' The draft guidance
document provides assistance to applicants intending to respond to a
written request from FDA for pediatric studies for a drug that may show
potential health benefits in children with cancer. The draft guidance
discusses the kind of information applicants should include in their
pediatric studies, which, if responsive to a written request, may make
the applicant's drug eligible to qualify for an additional 6 months of
marketing exclusivity. This guidance is part of the agency's pediatric
initiative to generate new knowledge to assist practitioners in the
care of children with cancer and to help provide pediatric patients
early access to emerging new drugs.

DATES: Submit written comments on the draft guidance to ensure their
adequate consideration in preparation of the final document by
September 18, 2000. General comments on agency guidance documents are
welcome at any time.

ADDRESSES: Submit written requests for single copies of ``Pediatric
Oncology Studies in Response to a Written Request'' to the Drug
Information Branch (HFD-210), Center for Drug Evaluation and Research,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857;
or the Manufacturers Assistance and Communications Staff (HFM-42),
Center for Biologics Evaluation and Research, Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 208521448. Send one
self-addressed adhesive label to assist that office in processing your
requests. Submit written comments on the draft guidance to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. See the SUPPLEMENTARY INFORMATION
section of this document for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT:
    Terrie L. Crescenzi, Center for Drug Evaluation and Research (HFD-
104), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-594-7337, FAX 301-827-2520, e-mail: crescenzit@cder.fda.gov,
or
    Elaine C. Esber, Center for Biologics Evaluation and Research (HFM-
30), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD
20852, 301-827-0641, FAX 301-827-0644, e-mail: esber@cber.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Pediatric Oncology Studies in Response to a Written
Request.'' Section 111 of the Food and Drug Administration
Modernization Act of 1997 (the Modernization Act), signed into law by
President Clinton on November 21, 1997, created section 505A of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355a), which
permits certain marketing applications to obtain an additional 6 months
of marketing exclusivity if the sponsor submits requested information

[[Page 38565]]

relating to the use of the drug in the pediatric population. The
statute permits the agency to issue a written request for pediatric
studies under section 505A(a) or (c) of the act. A written request is a
specific document in which the agency requests submission of certain
studies. The studies are designed to provide information on the health
benefits of a drug in the pediatric population.
    Because the study of oncology drugs in pediatric populations merits
special consideration, the agency is publishing this guidance to assist
sponsors who wish to undertake pediatric oncology studies.
    This draft guidance is being issued consistent with FDA's good
guidance practices (62 FR 8961, February 27, 1997). The draft guidance
represents the agency's current thinking on pediatric oncology studies.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statute, regulations, or both.

II. Comments

    Interested persons may submit to the Dockets Management Branch
(address above) written comments on the draft guidance. Two copies of
any comments are to be submitted, except that individuals may submit
one copy. Comments are to be identified with the docket number found in
brackets in the heading of this document. The draft guidance and
received comments are available for public examination in the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Copies of this draft guidance for industry are available on the
Internet at http://www.fda.gov/cder/guidance/index.htm, http://
www.fda.gov/cder/pediatrics, and at http://www.fda.gov/cber/
guidelines.htm.

    Dated: June 14, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-15629 Filed 6-20-00; 8:45 am]
BILLING CODE 4160-01-F