[Federal Register Volume 66, Number 215 (Tuesday, November 6, 2001)]
[Notices]
[Pages 56109-56110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-27756]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0432]


Draft Guidance for Industry on the Evaluation of the Effects of 
Orally Inhaled and Intranasal Corticosteroids on Growth in Children; 
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availability of a draft guidance for industry entitled ``Evaluation of 
the Effects of Orally Inhaled and Intranasal Corticosteroids on Growth 
in Children.'' The Division of Pulmonary and Allergy Drug Products is 
providing guidance to industry regarding the design, conduct, and 
evaluation of clinical trials to evaluate the effects of orally inhaled 
and intranasal corticosteroids on growth in children. This action is 
important because of recently implemented class labeling of these 
products with regard to their impact on growth in children. An 
assessment of the available data supporting the class labeling action 
has led to recommendations that all drug products of this class be 
tested by means of a ``growth study.'' The recommendations in this 
document can provide adequate and well-controlled data that is 
consistent among drug products and can be included in product labeling.

DATES: Submit written or electronic comments on the draft guidance by 
February 4, 2002. 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Dockets Management Branch (HFA-305), Food 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access to the draft guidance document.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: Sandy Barnes, Center for Drug 
Evaluation and Research (HFD-570), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1050.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Evaluation of the Effects of Orally Inhaled and Intranasal 
Corticosteroids on Growth in Children.'' This draft guidance has been 
developed by the Division of Pulmonary and Allergy Drug Products, in 
consultation with the Division of Metabolic and Endocrine Drug 
Products, to provide guidance in the design, conduct, and evaluation of 
clinical studies to assess the effects of orally inhaled and intranasal 
corticosteroids on linear growth.
    On July 30 and 31, 1998, the Pulmonary and Allergy Drugs Advisory 
Committee and the Metabolic and Endocrine Drugs Advisory Committee were 
jointly convened to discuss the implications of findings in previous 
clinical studies that indicated that inhaled corticosteroids may, as a 
class of compounds, affect linear growth in pediatric patients. The 
joint committees agreed that data were sufficient to justify inclusion 
of a precautionary statement in the labeling for this class of 
compounds, but the data were inadequate to precisely determine the 
decrement in growth velocity resulting from the use of these drug 
products. Members of the joint committees recommended that companies 
filing new drug applications for all newly approved corticosteroid 
products conduct further studies, as post-apptoval phase 4 commitments, 
to assess the effects of nasally and orally inhaled corticosteroids on 
growth velocity in prepubertal children.
    The draft guidance provides general recommendations for the design 
and conduct of a ``growth study.'' The Division of Pulmonary and 
Allergy Drug Products endorses these recommendations to encourage the 
collection of other evidence that will consistently and accurately 
describe the effects of intranasal and orally inhaled corticosteroids 
on growth velocity in children.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115).

[[Page 56110]]

 The draft guidance, when finalized, will represent the agency's 
current thinking on evaluating the effects of orally inhaled and 
intranasal corticosteroids on growth in children. 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 
(address above) written or electronic 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

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

    Dated: October 26, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-27756 Filed 11-5-01; 8:45 am]
BILLING CODE 4160-01-S