[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)
----------------------------------------------------------------------------------------------------------------
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