[Federal Register Volume 69, Number 99 (Friday, May 21, 2004)]
[Notices]
[Pages 29311-29312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11528]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-04-54]


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 (404) 498-1210.
    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 [email protected]. 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.

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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
                   Respondent                       respondents    responses per   response  (in    (in hours)
                                                                    respondent        hours)
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Laboratory......................................               5           1,296               1           6,480
Clinic..........................................              28             228           11/60           1,170
                                                 -----------------
    Total.......................................              33  ..............  ..............           7,650
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[[Page 29312]]

    Dated: May 17, 2004.
Alvin Hall,
Director, Management Analysis and Services Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-11528 Filed 5-20-04; 8:45 am]
BILLING CODE 4163-18-P