04-11528. 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 the CDC Reports Clearance Officer on [phone].

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. Send comments to Sandra Gambescia, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-E11, Atlanta, GA 30333 or send an e-mail to [e-mail]. Written comments should be received within 60 days of this notice.

Proposed Project

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

CDC is requesting OMB approval for a 3-year extension of the Gonococcal Isolate Surveillance Project (GISP), OMB Control No. 0920-0307. The objectives of GISP are to: (1) Monitor trends in antimicrobial susceptibility of strains of Neisseria gonorrhoeae in the U.S. and (2) characterize resistant isolates. GISAP provides critical surveillance for antimicrobial resistance, allowing for informed treatment recommendations. GISP was begun in 1986 as a voluntary surveillance project and has involved 5 regional laboratories and 28 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 clinics to CDC.

During 1986-2003, GISP has demonstrated the ability to effectively achieve its objectives. The emergence of resistance in the U.S. to fluoroquinolones, commonly used therapies for gonorrhea was identified through GISP and makes ongoing surveillance critical. Emergence of decreased susceptibility to fluoroquinolones among the men having sex with men (MSM) population in the U.S. was also identified through GISP in 2003. Data gathered through GISP were used to change the treatment for gonorrhea for the MSM population in April, 2004.

Under the GISP protocol, clinics are asked to provide 25 isolates per month. However, due to low volume at some site, clinics submit an average of 19 isolates per clinic per month, providing an average of 108 isolates per laboratory per month. For this data collection, a “response” is defined as the laboratory processing and data collection/processing associated with an individual gonococcal isolate from an individual patient. Based on previous laboratory experience in analyzing the gonococcal isolates, the estimated burden for each participating laboratory is 1 hour per response. This time estimate includes the time to record control strain data. We estimate 108 gonococcal isolates per laboratory each month (total number of responses per 5 laboratories is 1,296). The estimated time for clinical personnel to abstract data is 11 minutes per response (19 isolates per clinic per month). The estimated annualized burden for this data collection is 7,650 hours. There is no cost to respondents.

Respondent	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden (in hours)
Laboratory	5	1,296	1	6,480
Clinic	28	228	11/60	1,170
Total	33			7,650

Dated: May 17, 2004.

Alvin Hall,

Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.