[Federal Register Volume 71, Number 225 (Wednesday, November 22, 2006)]
[Notices]
[Page 67622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-19689]


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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Draft Guidance for Industry on Sinusitis: Designing Clinical 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availability of a draft guidance for industry entitled ``Sinusitis: 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DATES: Submit written or electronic comments on the draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Division of Dockets Management (HFA-305), 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access to the draft guidance document.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    FDA is announcing the availability of a draft guidance for industry 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]
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