[Federal Register Volume 65, Number 120 (Wednesday, June 21, 2000)]
[Notices]
[Pages 38564-38565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-15629]


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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Draft Guidance for Industry: Pediatric Oncology Studies in 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availability of a draft guidance for industry entitled ``Pediatric 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 The draft guidance 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 The draft guidance 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DATES: Submit written comments on the draft guidance to ensure their 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 Submit written comments on the draft guidance to the Dockets 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: [email protected], 
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: [email protected].

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]
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