[Federal Register Volume 78, Number 59 (Wednesday, March 27, 2013)]
[Notices]
[Pages 18600-18601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-07059]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-13-0307]
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 404-639-7570 or
send comments to Ron Otten, 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 exp. 12/31/2013--Revision--National Center for HIV/AIDS, Viral
Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The purpose of this request is to obtain Office of Budget and
Management (OMB) approval to revise the data collection for the
Gonococcal Isolate Surveillance Project (GISP) (OMB No. 0920-0307,
expires 12/31/2013). CDC seeks a three-year approval to conduct the
GISP project. Revisions to this ICR consist of removing 4 variables
from the approved Form 1: Demographic and Clinical Data. The variables
to be removed have not proven useful in the past and will not increase
or decrease the burden. 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. Surveillance of N. gonorrhoeae antimicrobial resistance is
important because: (1) Nearly all gonococcal infections are treated
empirically and susceptibility testing data is not routinely available
in clinical practice; (2) N. gonorrhoeae has consistently demonstrated
the ability to develop resistance to the antimicrobials used for
treatment; (3) effective treatment of gonorrhea is a critical component
of gonorrhea control and prevention; and (4) untreated or inadequately
treated gonorrhea can cause serious reproductive health complications.
GISP is the only source in the United States of critical national,
regional, and site-specific gonococcal antimicrobial resistance data.
GISP provides information to support informed and scientifically-based
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 (STD) clinics around the country. The STD
clinics submit up to 25 gonococcal specimens (or isolates) per month to
the regional laboratories, which measure susceptibility of the isolates
to multiple antibiotics. Limited demographic and clinical information
corresponding to the isolates (and that do not allow identification of
the patient) are submitted directly by the clinics to CDC.
During 1986-2012, GISP has demonstrated the ability to effectively
achieve its objectives. The emergence of resistance in the United
States to penicillin, tetracyclines, and fluoroquinolones among N.
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.
Recently, GISP isolates demonstrated increasing minimum inhibitory
concentrations of cefixime, which can be an early warning of impending
resistance. This worrisome trend prompted CDC to again update treatment
recommendations and no longer recommend the use of cefixime as first-
line treatment for 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: Demographic/Clinical Data. The estimated time for clinical
personnel to abstract data for Form 1: Demographic/Clinical Data is 11
minutes per response.
Each of the five Regional laboratories receives and processes
approximately 20 isolates from each referring clinic per month (i.e.,
121 isolates per regional laboratory per month [based on 2011 specimen
volume]) using Form 2: Antimicrobial Susceptibility Testing.
[[Page 18601]]
For Form 2: Antimicrobial Susceptibility Testing, the annual frequency
of responses per respondent is 1,452 (121 isolates x 12 months). Based
on previous laboratory experience, the estimated burden of completing
Form 2 for each participating laboratory 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: Control Strain
Susceptibility Testing, a ``response'' is defined as the processing and
recording of Regional laboratory data for a set of seven control
strains. It takes approximately 12 minutes to process and record the
Regional laboratory data on Form 3 for one set of seven control
strains, of which there are 4 sets. The number of responses per
respondent is 48 (4 sets x 12 months). There are no additional costs to
respondents.
Estimate of Annualized Burden Hours
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Number of Avg. burden Total annual
Type of respondent Form name Number of responses per per response burden (in
respondents respondent (in hours) hours)
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Clinic......................................... Demographic Clinical Data Form 1....... 30 240 11/60 1,320
Laboratory..................................... Antimicrobial Susceptibility Testing 5 1,452 1 7,260
Form 2.
Control Strain Susceptibility Testing 5 48 12/60 48
Form 3.
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Total...................................... ....................................... 40 .............. .............. 8,628
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Dated: March 21, 2013.
Ron A. Otten,
Director, Office of Scientific Integrity, Office of the Associate
Director for Science, Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2013-07059 Filed 3-26-13; 8:45 am]
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