Draft Guidance for Industry on Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment; Availability, 67622 [E6-19689]

Download as PDF 67622 Federal Register / Vol. 71, No. 225 / Wednesday, November 22, 2006 / Notices regulations governing premarket approval applications (21 CFR part 814, OMB control number 0910–0231). The labeling provisions addressed in the guidance have been approved by OMB under OMB control number 0910–0485. V. 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. Dated: October 26, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 06–9325 Filed 11–17–06; 4:30 pm] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D–0463] Draft Guidance for Industry on Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment; Availability AGENCY: Food and Drug Administration,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. pwalker on PROD1PC61 with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment.’’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 DATES: Submit written or electronic comments on the draft guidance by January 22, 2007.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 ADDRESSES: Submit written requests for single copies of the draft guidance to the VerDate Aug<31>2005 22:25 Nov 21, 2006 Jkt 211001 Division of Drug Information (HFD– 240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one selfaddressed 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 https:// 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 PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 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 https://www.fda.gov/cder/guidance/ index.htm or https://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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Children’s Hospitals Graduate Medical Education Payment Program (CHGME PP) Health Resources and Services Administration, HHS. ACTION: Notice of Children’s Hospitals Graduate Medical Education Payment Program (CHGME PP) Conference Call. AGENCY: SUMMARY: This document announces a scheduled CHGME PP conference call for Federal fiscal year (FY) 2007. The purpose of this conference call is to discuss new annual reporting requirements as required under Public Law (Pub. L.) 109–307 for children’s hospitals participating in the CHGME PP. The conference call will be held on Wednesday, December 6, 2006, from 2 p.m. to 4 p.m. EST. DATES: E:\FR\FM\22NON1.SGM 22NON1

Agencies

[Federal Register Volume 71, Number 225 (Wednesday, November 22, 2006)]
[Notices]
[Page 67622]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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 https://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 https://www.fda.gov/cder/guidance/index.htm or https://
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
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