[Federal Register Volume 80, Number 237 (Thursday, December 10, 2015)]
[Notices]
[Pages 76690-76692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31104]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-16-0307]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted
the
[[Page 76691]]
following information collection request to the Office of Management
and Budget (OMB) for review and approval in accordance with the
Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (a)
Evaluate whether the proposed collection of information is necessary
for the proper performance of the functions of the agency, including
whether the information will have practical utility; (b) Evaluate the
accuracy of the agencies estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (c) Enhance the quality, utility, and clarity of
the information to be collected; (d) Minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to [email protected]. Written comments and/or
suggestions regarding the items contained in this notice should be
directed to the Attention: CDC Desk Officer, Office of Management and
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written
comments should be received within 30 days of this notice.
Proposed Project
The Gonococcal Isolate Surveillance Project (GISP, OMB No. 0920-
0307 exp. 08/31/2016) - 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 antibiotic
resistance of Neisseria gonorrhoeae strains in the United States and
(2) to characterize resistant specimens. Surveillance of N. gonorrhoeae
antibiotic resistance is important because: (1) Nearly all gonococcal
infections are treated empirically (meaning that healthcare providers
have to decide how to treat their patients without having resistance
testing results for individual patients upon which to base clinical
decision-making) and susceptibility/resistance testing data are not
routinely available in clinical practice; (2) N. gonorrhoeae has
consistently demonstrated the ability to develop resistance to the
antibiotics 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 national, regional,
and site-specific gonococcal antibiotic resistance information. 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 the ability of the specimens
to resist the effects of 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 1986-2015, GISP has demonstrated the ability to effectively
achieve its objectives. GISP has tracked penicillin and tetracycline
resistance and identified the emergence of fluoroquinolone resistance.
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. Information from GISP thus allowed public health officials
to change treatment recommendations before resistance became
widespread, ensuring that patients were able to be successfully
treated. 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 5 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. For Form
2: Antimicrobial Susceptibility Testing, the annual frequency of
responses per respondent is 1452 (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 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).
The total estimated annual burden hours are 8,628. Respondents
receive federal funds to participate in this project. There are no
additional costs to respondents other than their time.
[[Page 76692]]
Estimate of Annualized Burden Hours
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Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
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Clinic................................ Demographic Clinical 30 240 11/60
Data Form 1.
Laboratory............................ Antimicrobial 5 1,452 1
Susceptibility Testing
Form 2.
Control Strain 5 48 12/60
Susceptibility Testing
Form 3.
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Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2015-31104 Filed 12-9-15; 8:45 am]
BILLING CODE 4163-18-P