[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