[Federal Register: November 6, 2001 (Volume 66, Number 215)]
[Notices]
[Page 56109-56110]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06no01-63]
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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Draft Guidance for Industry on the Evaluation of the Effects of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availability of a draft guidance for industry entitled ``Evaluation of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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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on the draft guidance to the Dockets Management Branch (HFA-305), Food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://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access to the draft guidance document.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://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: 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