[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.
                                                                                         ---------------------------------------------------------------
    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]
BILLING CODE 4163-18-P