[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
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Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
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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