[Federal Register Volume 75, Number 160 (Thursday, August 19, 2010)]
[Notices]
[Pages 51269-51270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-20569]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day 10-0307]


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, CDC Reports Clearance Officer, 1600 
Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to 
[email protected].
    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 exp. 3/31/2011)--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. Monitoring antibiotic susceptibility is 
critical since Neisseria gonorrhoeae has demonstrated the consistent 
ability to gain antibiotic resistance. GISP was established in 1986 as 
a voluntary surveillance project and now involves 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 clinics to CDC.
    During 1986-2009, GISP has demonstrated the ability to effectively 
achieve its objectives. The emergence of resistance in the United 
States to penicillin, tetracyclines, and fluoroquinolones among 
Neisseria gonorrhoeae isolates was identified through GISP. Increased 
prevalence of fluoroquinolone-resistant N. gonorrhoeae (QRNG), as 
documented by GISP data, prompted CDC to update treatment 
recommendations for gonorrhea in CDC's Sexually Transmitted Diseases 
Treatment Guidelines, 2006 and to release an MMWR article stating that 
CDC no longer recommended fluoroquinolones for treatment of gonococcal 
infections.
    Under the GISP protocol, each of the 30 clinics submit an average 
of 20 isolates per clinic per month (i.e., 240 times per year) recorded 
on Form 1. The estimated time for clinical personnel to abstract data 
for Form 1 is 11 minutes per response.
    Each of the 5 Regional laboratories receives and processes an 
average of 20 isolates from 6 different clinics per month (i.e., 120 
isolates per regional laboratory per month) using Form 2. For Form 2, 
the annual frequency of responses per respondent is 1,440 (120 isolates 
x 12 months). Based on previous laboratory experience, 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 patient's isolate, gathering and maintaining the data needed, and 
completing and reviewing the collection of information. For Form 3, a 
``response'' is defined as the processing and recording of Regional 
laboratory data for a set of 7 control strains. It takes approximately 
12 minutes to process and record the Regional laboratory data on Form 3 
for one set of 7 control strains, of which there are 4 sets. The number 
of responses per respondent is 48 (4 sets x 12 months). There is no 
cost to the respondents other than their time.

                                                           Estimate of Annualized Burden Hours
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                                                                                                        Number of      Average burden     Total annual
              Type of respondent                            Form name                 Number of       responses per   per response (in     burden (in
                                                                                     respondents       respondent          hours)            hours)
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Clinic........................................  Form 1..........................                30               240             11/60             1,320
Laboratory....................................  Form 2..........................                 5             1,440                 1             7,200

[[Page 51270]]

 
                                                Form 3..........................                 5                48             12/60                48
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    Total.....................................  ................................                40  ................  ................             8,568
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Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2010-20569 Filed 8-18-10; 8:45 am]
BILLING CODE 4163-18-P