[Federal Register Volume 78, Number 138 (Thursday, July 18, 2013)]
[Notices]
[Pages 42956-42957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-17263]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-13-0307]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
(404) 639-7570 or send an email to [email protected]. Send written comments 
to CDC Desk Officer, Office of Management and Budget, Washington, DC 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. 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 Form 1: Demographic/Clinical Data. The four variables to be 
removed are: (1) Total monthly number of gonococcal infections; (2) 
date of birth of the patient; (3) zip code of the patient; and (4) 
reason for visit. The variables to be removed have not proven useful at 
the federal level and removal of the variables 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 are 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 antimicrobial drugs. 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

[[Page 42957]]

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. 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. The total estimated annual burden hours are 8,628.

                                       Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
         Type of respondent                   Form name             respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Clinic.............................  Demographic Clinical Data                30             240           11/60
                                      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. 2013-17263 Filed 7-17-13; 8:45 am]
BILLING CODE 4163-18-P