E7-23633. Agency Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at [phone] or send an e-mail to [e-mail]. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to [phone]. Written comments should be received within 30 days of this notice.

Proposed Project

Gonococcal Isolate Surveillance Project (GISP)—Revision—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

CDC is requesting a 3-year revision with change for this project. The objectives of GISP are to monitor trends in antimicrobial susceptibility of strains of Neisseria gonorrhoeae in the U.S. and characterize resistant isolates. GISP provides critical surveillance for antimicrobial resistance, allowing for informed treatment recommendations.

This project began in 1986 as a voluntary surveillance project and has involved 5 regional laboratories and 30 publicly-funded, sexually transmitted disease (STD) clinics around the country. The STD clinics submit up to 25 gonococcal isolates per month to the regional laboratories, which measure susceptibility to a panel of antibiotics. Limited demographic and clinical information corresponding to the isolates are submitted directly by the STD clinics to CDC.

During 1986-2006, GISP has demonstrated the ability to effectively achieve its objectives. The emergence of resistance in the United States to penicillin, tetracyclines, and now fluoroquinolones was identified through GISP and makes ongoing surveillance critical. Increased prevalence of fluoroquinolone-resistant N. gonorrhoeae (QRNG) as seen in GISP data has prompted the CDC to update the treatment recommendations for gonorrhea in the CDC's Sexually Transmitted Diseases Treatment Guidelines, 2006 and to release an MMWR article stating the CDC no longer recommends fluoroquinolones for treatment of gonococcal infections (CDC, MMWR, Vol.56, No.14, 332-336). Respondents are paid by Federal funds through the CDC Comprehensive STD Prevention Systems, Prevention of STD-Related Infertility, and Syphilis Elimination Grant (CSPS), for their participation in GISP network. The estimated annualized burden for this data collection is 8,628 hours.

Estimated Annualized Burden Hours

Type of respondent	Form name	No. of respondents	No. of responses per respondent	Avg. burden per response (in hours)
Clinic	Form 1	30	240	11/60
Laboratory	Form 2	5	1,452	1
	Form 3	5	48	12/60
Total		40

Dated: November 28, 2007.

Maryam I. Daneshvar,

Acting Reports Clearance Officer.