[Federal Register Volume 72, Number 43 (Tuesday, March 6, 2007)]
[Notices]
[Pages 9951-9952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-3807]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2001D-0432]


Guidance for Industry on Orally Inhaled and Intranasal 
Corticosteroids: Evaluation of the Effects 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 guidance for industry entitled ``Orally Inhaled and 
Intranasal Corticosteroids: Evaluation of the Effects on Growth in 
Children.'' This guidance provides recommendations regarding the 
design, conduct, and evaluation of clinical trials to assess the 
effects of orally inhaled and intranasal corticosteroids on growth in 
children. For this class of drug products, measurement of growth is 
considered a sensitive surrogate of, and an important sentinel for, the 
potential to cause systemic effects. Growth studies designed and 
carried out following the recommendations in this guidance can provide 
adequate and well-controlled data that are consistent among drug 
products and can be included in product labeling. This guidance 
finalizes the draft guidance published on November 6, 2001.

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:  Peter Starke, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 22, rm. 3300, Silver Spring, MD 20993-0002, 
301-796-2300.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Orally Inhaled and Intranasal Corticosteroids: Evaluation of 
the Effects on Growth in Children.'' This guidance provides 
recommendations for the design, conduct, and evaluation of clinical 
studies to assess the effects of orally inhaled and intranasal 
corticosteroids on linear growth (``growth study''). The guidance was 
developed by the Division of Pulmonary and Allergy Products in 
consultation with the Division of Metabolism and Endocrinology Products 
and the Office of Biostatistics to encourage the collection of evidence 
that can consistently and accurately describe the effects of intranasal 
and orally inhaled corticosteroids on growth velocity in children.
    In July 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 can, as a class of 
drug products, affect linear growth in pediatric patients. The joint 
committee concluded that data were sufficient to justify inclusion of a 
precautionary statement in the labeling for this class of drug 
products, 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 committee recommended that companies 
filing new drug applications for all newly approved corticosteroid 
products conduct further studies, as post-approval phase 4 commitments, 
to assess the effects of nasally and orally inhaled corticosteroids on 
growth velocity in prepubertal children. On November 6, 2001 (66 FR 
56109), FDA published for comment in the Federal Register a draft of 
this guidance.
    Comments received from industry, professional societies, and 
consumer groups on the draft guidance have been taken into 
consideration in finalizing this guidance. Changes are based on 
thorough review of all comments received, growth studies submitted 
since publication of the draft guidance, and previously submitted 
growth data. Changes or updates were made to all sections of the 
guidance, and are briefly summarized here.
    A new overview section and updated background and data analysis 
sections include a more thorough discussion of the objective of and the 
appropriate statistical comparisons for a growth study. These changes 
will affect future labeling for such studies. Recommendations for 
sample size calculations and primary and secondary ``sensitivity'' 
analyses have been reviewed and modified based on review of growth 
studies submitted since publication of the draft guidance as well as 
previously submitted data. The general study recommendations and 
protocol design sections include a discussion of the appropriate 
patient populations to be studied and modifications to recommendations 
for the inclusion and exclusion criteria, assessments of adherence, and 
spacer use.
    This 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 the evaluation of 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 Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft guidance. 
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 draft guidance and received 
comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

[[Page 9952]]

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 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-3807 Filed 3-5-07; 8:45 am]
BILLING CODE 4160-01-S