[Federal Register Volume 68, Number 22 (Monday, February 3, 2003)]
[Notices]
[Pages 5301-5302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-2376]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03D-0001]


Draft Guidance for Industry on Nonclinical Safety Evaluation of 
Pediatric Drug Products; 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availability of a draft guidance for industry entitled ``Nonclinical 
Safety Evaluation of Pediatric Drug Products.'' The draft guidance 
provides recommendations on the role and timing of animal studies in 
the safety evaluation of therapeutics intended for the treatment of 
pediatric patients.

DATES: Submit written or electronic comments on the draft guidance by 
May 5, 2003. General comments on agency guidance documents are welcome 
at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. 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on the draft guidance to the Dockets Management Branch (HFA-305), Food 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. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Karen Davis Bruno, Center for Drug 
Evaluation and Research (HFD-580), Food and Drug Administration, 5600

[[Page 5302]]

Fishers Lane, Rockville, MD 20857, 301-827-6430.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Nonclinical Safety Evaluation of Pediatric Drug Products.'' 
Many therapeutics marketed in the United States and used in pediatric 
patients lack adequate information in the labeling for use in that 
population. In most cases to date, safety data from clinical studies in 
adults, supported by nonclinical studies in adult animals, have been 
used to support the use of a drug in pediatric patients. These studies 
may not always assess possible drug effects on developmental processes 
specific to pediatric age groups. Some drug effects also may be 
difficult to detect in clinical trial or during routine postmarketing 
surveillance.
    The draft guidance provides recommendations on the role and timing 
of animal studies in the safety evaluation of therapeutics intended for 
the treatment of pediatric patients. It describes how juvenile animal 
studies can be useful in monitoring, timing, and phasing of trials for 
initial enrollment in pediatric clinical studies. The draft guidance is 
intended to serve as a resource for general considerations in animal 
testing and to provide recommendations based on the available science 
and pragmatic considerations. The scope of animal studies is limited to 
safety effects that cannot be reasonably, ethically, and safely 
assessed in pediatric clinical trials.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance 
represents the agency's current thinking on ``Nonclinical Safety 
Evaluation of Pediatric Drug Products.'' 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 statutes and regulations.

II. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments or two hard copies of any written comments, except 
that individuals may submit one hard 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 may be seen in 
the Dockets Managment Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: January 21, 2003.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 03-2376 Filed 1-31-03; 8:45 am]
BILLING CODE 4160-01-S