[Federal Register Volume 72, Number 124 (Thursday, June 28, 2007)]
[Notices]
[Pages 35490-35491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-12505]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[60 Day-07-0307]


 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 [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)--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
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                                                                                      Average
                                                     Number of       Number of      burden  per    Total burden
                 Types of forms                     respondents    responses per   response  (in    (in hours)
                                                                    respondent        hours)
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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
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[[Page 35491]]

    Dated: June 22, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
 [FR Doc. E7-12505 Filed 6-27-07; 8:45 am]
BILLING CODE 4163-18-P