[Federal Register Volume 83, Number 140 (Friday, July 20, 2018)]
[Notices]
[Pages 34583-34585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-15525]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30 Day-18-0307]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request Gonococcal Isolate Surveillance Project to the 
Office of Management and Budget (OMB) for review and approval. CDC 
previously published a ``Proposed Data Collection Submitted for Public 
Comment and Recommendations'' notice on February 5, 2018 to obtain 
comments from the public and affected agencies. The CDC received 2 non-
substantive comments related to the previous notice. This notice serves 
to allow an additional 30 days for public and affected agency comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (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]. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th 
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide 
written comments within 30 days of notice publication.

Proposed Project

    Gonococcal Isolate Surveillance Project (0920-0307) (Exp. Date 02/
28/2019)--Revision--National Center for HIV, Viral Hepatitis, STD, and 
TB Prevention (NCHHSTP), Centers for Disease Control and Prevention 
(CDC).

Background and Brief Description

    The Gonococcal Isolate Surveillance Project (GISP) was created in 
1986 to monitor trends in antimicrobial susceptibilities of Neisseria 
gonorrhoeae strains in the United States. GISP continues to be a 
collaboration between different branches of the CDC Division of STD 
Prevention within the National Center for HIV, Viral Hepatitis, STD, 
and TB Prevention (NCHHSTP), selected regional laboratories and 
selected state/local public health departments and their associated STD 
specialty care clinics in the U.S. National organizations, local 
jurisdictions and individuals use data collected in GISP to understand 
and prevent antibiotic resistance in N. gonorrhoeae. Data from GISP are 
used to establish a scientific basis for the selection of gonococcal 
therapies and to allow pro-active changes to treatment guidelines 
before widespread resistance and failures of treatment occur. To 
increase capacity to detect and monitor resistant gonorrhea and to 
improve the specificity of GISP, this revision is being

[[Page 34584]]

submitted to include collection of additional isolates and data 
elements.
    In the current approval period, GISP isolates are only collected 
from males and include <4% of reported male gonorrhea cases in the 
United States. This relatively limited scope likely limits the speed 
with which new resistance patterns are found and with which public 
health officials can respond. Published data suggest that resistance in 
N. gonorrhoeae might develop initially in non-genital anatomic sites, 
such as the pharynx. It has also been hypothesized that susceptibility 
patterns may be different among women. Upon receiving OMB approval of 
the revision request, CDC plans to begin including isolates from the 
pharynx and other anatomic sites, as well as from women. These changes 
are expected to support public health efforts to detect and respond to 
resistance more quickly.
    GISP surveillance can also be strengthened by ensuring that GISP 
surveillance is only being conducted on N. gonorrhoeae and not on other 
similar bacteria. Neisseria meningitidis can cause clinical syndromes 
that are indistinguishable from gonorrhea. Using nucleic acid 
amplification tests (a more specific diagnostic test) in conjunction 
with bacterial culture from all anatomic sites can ensure that non-
gonococcal bacteria are excluded from GISP data. This is expected to 
strengthen the accuracy and usefulness of GISP data.
    Historically, healthcare providers at approximately 30 
participating sentinel sites (i.e., STD clinic or multiple STD clinics 
affiliated with a single public health department) obtain urethral N. 
gonorrhoeae isolates from the first 25 men with urethral gonorrhea each 
month with occasional month-to-month variability. With this revision, 
we are now asking for a subset of sentinel sites (10 out of 30 sites) 
to conduct enhanced surveillance activities, collecting additional 
isolates (including from the pharynx, rectum, and cervix of exposed 
persons) with a limited number of additional data elements. We 
anticipate that approximately 50 additional isolates per month will be 
collected by each of these 10 sites (total of approximately 70 isolates 
per month per enhanced surveillance site). All isolates will be shipped 
each month to a regional laboratory for antimicrobial susceptibility 
testing. When isolates that appear to be bacteria other than N. 
gonorrhoeae are identified at one of the ten sentinel sites conducting 
enhanced surveillance, the isolate will be shipped to the regional 
laboratory and then to CDC. Based on informal discussions with current 
GISP sentinel sites, we anticipate that approximately 10 such isolates 
will be identified at each site per year. Sentinel sites that are not 
part of this small subset will continue to function as they already 
are.
    Under this revision, the data collection and reporting processes 
have been streamlined to minimize burden. All demographic/clinical data 
from the sentinel sites, and antimicrobial susceptibility testing 
results from the regional laboratories, will be submitted 
electronically (1) directly from the sentinel site to the GISP data 
manager at CDC through a secure data portal, (2) through a secure GISP-
web based application, or (3) through the CDC Secure Access Management 
Services partner portal. To minimize burden, comma-separated values 
(csv) files that provide standardized structure of the electronic data 
are provided to sentinel sites and laboratories. Additionally, to 
further minimize burden, the regional laboratories will be able to 
extract electronic data from electronic laboratory information systems 
instead of hand entering data and will no longer be required to report 
control strain testing results.
    This project will not collect name, social security number, or date 
of birth. A Patient ID, a unique patient identifier assigned by the 
site that allows for linking of multiple isolates from a single person 
at a single clinic visit and across multiple clinic visits, is 
requested and will be provided to CDC for purposes of enhanced 
surveillance. Sensitive information such as sex of sex partners, HIV 
status, sex work exposure, and injection drug use are collected. 
Patient data are obtained through review of medical records by the 
clinic staff and included in collection reporting of demographic/
clinical information. All personally identifiable information (PII) is 
retained by the STD clinics that treated the patient and is not 
recorded with data sent to CDC or regional laboratories. At sites where 
enhanced surveillance will not occur isolates are collected from 
patients as part of their routine care when a gonorrhea infection is 
suspected. The electronic GISP database is stored on the CDC mainframe 
computer and only approved Division of STD Prevention (DSTDP) staff 
have access rights to the data. As part of the revision, we will 
continue to systematically identify the risks and potential effects of 
collecting, maintaining, and disseminating PII and to examine and 
evaluate alternative processes for handling that information to 
mitigate potential privacy risks and risks to confidentiality.
    The CDC has designated N. gonorrhoeae as one of three ``urgent'' 
antibiotic resistance threats in the United States. The CDC is 
requesting a three-year OMB approval for this revision, which directly 
responds to the National Strategy for Combating Antibiotic Resistant 
Bacteria by improving and strengthening surveillance of antimicrobial 
resistance through GISP. This GISP data can help monitor and evaluate 
the effectiveness of public health interventions conducted to support 
the National Strategy for Combating Antibiotic-Resistant Bacteria. 
Sentinel sites and regional laboratories voluntarily apply to 
participate in the GISP cooperative agreement program. Once funded, 
participation in the GISP information collection and isolate processing 
plan is required. The total estimated annualized burden hours are 
11,376. There are no costs to respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Sentinel site conducting core           Demographic/Clinical                  20             240           11/60
 surveillance.                           Data.
Sentinel site conducting enhanced       Demographic/Clinical                  10             840           12/60
 surveillance.                           Data.
Regional laboratory...................  Antimicrobial                          4           3,300           40/60
                                         Susceptibility Testing
                                         Results.
Regional laboratory...................  Control Strain                         4              48            5/60
                                         Susceptibility Testing.
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[[Page 34585]]

Jeffrey M. Zirger,
Acting 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. 2018-15525 Filed 7-19-18; 8:45 am]
 BILLING CODE 4163-18-P