[Federal Register Volume 71, Number 31 (Wednesday, February 15, 2006)]
[Notices]
[Pages 7977-7978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-2139]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0001] (formerly 03D-0001)


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 guidance for industry entitled ``Nonclinical Safety 
Evaluation of Pediatric Drug Products.'' This document provides 
guidance on the role and timing of animal studies in the nonclinical 
safety evaluation of therapeutics intended for the treatment of 
pediatric patients. The guidance discusses some conditions under which 
juvenile animals can be meaningful predictors of toxicity in pediatric 
patients and makes recommendations on nonclinical testing.

[[Page 7978]]


DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of this 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 guidance to the Division of Dockets Management (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 guidance document.

FOR FURTHER INFORMATION CONTACT: Karen L. Davis Bruno, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 3108, Silver Spring, MD 20993-0002, 301-
796-2290.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a 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. Recent FDA regulations have focused attention on current 
practices for evaluating drug safety in this population. Traditionally, 
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 effects may be very difficult to detect in clinical trials 
or during routine postmarketing surveillance.
    In the Federal Register of February 3, 2003 (68 FR 5301), FDA 
announced the availability of a draft version of this guidance entitled 
``Nonclinical Safety Evaluation of Pediatric Drug Products.'' 
Interested persons had the opportunity to submit comments. Based on the 
public comments received, changes to wording have been added for 
clarity and the guidance has been finalized. This document provides 
guidance on the role and timing of animal studies in the safety 
evaluation of therapeutics intended for the treatment of pediatric 
patients. It is intended to serve as a resource for general 
considerations in testing and provide specific recommendations based on 
available science and pragmatic considerations. The scope of this 
guidance is limited to safety effects that cannot be reasonably, 
ethically, and safely assessed in pediatric clinical trials.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The 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 Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. The guidance and received comments may 
be seen in the Division of Dockets Management 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: February 8, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-2139 Filed 2-14-06; 8:45 am]
BILLING CODE 4160-01-S