[Federal Register: November 22, 2006 (Volume 71, Number 225)]
[Notices]
[Page 67622]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22no06-84]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0463]
Draft Guidance for Industry on Sinusitis: Designing Clinical
Development Programs of Nonantimicrobial Drugs for Treatment;
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availability of a draft guidance for industry entitled ``Sinusitis:
Designing Clinical Development Programs of Nonantimicrobial Drugs for
Treatment.'' Sinusitis is a common disease affecting an estimated 16
percent of the adult U.S. population annually. At present, other than
antimicrobials, the treatment options for sinusitis are limited. This
guidance is intended to assist the pharmaceutical industry in designing
clinical development programs for nonantimicrobial drug products for
the treatment of sinusitis.
DATES: Submit written or electronic comments on the draft guidance by
January 22, 2007. 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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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on the draft guidance to the Division of Dockets Management (HFA-305),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access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Dr. Badrul A. Chowdhury, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 3316, Silver Spring, MD 20993-0002, 301-
796-2300.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Sinusitis: Designing Clinical Development Programs of
Nonantimicrobial Drugs for Treatment.'' Sinusitis is a disease
characterized by inflammation of one or more of the paranasal sinuses.
It is one of the most commonly diagnosed diseases in the United States
affecting an estimated 16 percent of the adult population annually. At
present, other than antimicrobials, some of which have a label
indication of acute bacterial sinusitis, the treatment options for
sinusitis are limited. There is an interest within the pharmaceutical
industry in the development of new drugs, including drugs other than
antimicrobials, for the treatment of sinusitis.
This guidance focuses on the development of nonantibiotic drugs for
the treatment of acute sinusitis as well as the development of drugs
for other types of sinusitis. This guidance also focuses on the
assessment of efficacy in phase 3 clinical studies of sinusitis. In
addition, this guidance addresses chemistry, manufacturing, and
controls issues and pharmacology and toxicology issues, because some of
the products for sinusitis are developed for nasal delivery, and there
are nuances to nasal route of delivery that should be considered for
appropriate clinical study design.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on designing
clinical development programs of nonantimicrobial drugs for the
treatment of sinusitis. 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. 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: November 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-19689 Filed 11-21-06; 8:45 am]
BILLING CODE 4160-01-S