E7-12505. Centers for Disease Control and Prevention; Proposed Data Collections Submitted for Public Comment and Recommendations

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 or send comments to Maryam Daneshvar, Acting CDC Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email to [e-mail].

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice.

Proposed Project

The Gonococcal Isolate Surveillance Project (GISP) (OMB No. 0920-0307)—Extension—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The objectives of GISP are: (1) To monitor trends in antimicrobial susceptibility of strains of Neisseria gonorrhoeae in the United States and (2) to characterize resistant isolates. GISP provides critical surveillance for antimicrobial resistance, allowing for informed treatment recommendations. GISP was established in 1986 as a voluntary surveillance project and now involves 5 regional laboratories and 30 publicly funded sexually transmitted disease 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 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 recommended fluoroquinolones for treatment of gonococcal infections (CDC, MMWR, Vol. 56, No. 14, 332-336).

Under the GISP protocol, clinics are asked to provide 25 isolates per month. However, due to low volume at some sites, clinics submit an average of 20 isolates per clinic per month, providing an average of 121 isolates per laboratory per month. For Forms 1 and 2, a “response” is defined as the laboratory processing and data collection/processing associated with an individual gonococcal isolate from an individual patient. The estimated time for clinical personnel to abstract data for Form 1 is 11 minutes per response (20 isolates per clinic per month; the total number of responses per 30 clinics is 240). Based on previous laboratory experience in analyzing the gonococcal isolates, the estimated burden for each participating laboratory for Form 2 is 1 hour per response, which includes the time required for laboratory processing of the client's isolate, gathering and maintaining the data needed, and completing and reviewing the collection of information. We estimate 121 gonococcal isolates per laboratory each month (total number of responses per 5 laboratories is 1,452). For Form 3, a “response” is defined as the laboratory processing and recording of laboratory data for a set of 7 control strains. It takes approximately 12 minutes to process and record the laboratory data on Form 3 for one set of 7 control strains, of which there are 4 sets (total number of responses per 5 laboratories is 48). There is no cost to respondents other than their time.

Estimate of Annualized Burden Hours

Types of forms	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden (in hours)
Clinic:
Form 1	30	240	11/60	1,320
Laboratory:
Form 2	5	1,452	1	7,260
Form 3	5	48	12/60	48
Total				8,628

Dated: June 22, 2007.

Maryam I. Daneshvar,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.