[Federal Register: February 15, 2006 (Volume 71, Number 31)]
[Notices]
[Page 7977-7978]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15fe06-89]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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