[Federal Register Volume 83, Number 152 (Tuesday, August 7, 2018)]
[Notices]
[Pages 38694-38696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16797]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-18-17BAN]
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 entitled Strengthening United States Response to
Resistant Gonorrhea (SURRG) 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 November 15, 2017 to obtain comments from the public and
affected agencies. CDC received one non-substantive comment on this 60
day public 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,
[[Page 38695]]
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
Strengthening U.S. Response to Resistant Gonorrhea (SURRG)--New--
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
(NCHHSTP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The purposes of Strengthening U.S. Response to Resistant Gonorrhea
(SURRG) are to: (1) Improve national capacity to detect, monitor, and
respond to emerging antibiotic-resistant gonorrhea, (2) understand
trends in, and factors contributing to antibiotic-resistant gonorrhea,
and (3) build a robust evidence base for public health action. This
information collection is important because: (1) Effective treatment of
gonorrhea is critical to gonorrhea control and prevention; (2)
untreated or inadequately treated gonorrhea can cause serious
reproductive health complications, such as infertility; (3) Neisseria
gonorrhoeae (the bacterium that causes gonorrhea) has consistently
demonstrated the ability to develop resistance to the antibiotics used
for treatment and may be developing resistance to the last remaining
treatment option recommended by the CDC; and (4) antibiotic-resistant
gonorrhea is extremely difficult to detect without enhanced
surveillance and public health activities, such as SURRG, because
healthcare providers rarely perform or have access to resistance
testing for individual patients.
SURRG will support rapid detection of resistant gonorrhea and get
actionable information into the hands of healthcare providers (to
support appropriate treatment of individual patients) and local health
departments (to support rapid public health response to slow the spread
of resistant infections).
Jurisdictions participating in SURRG applied, as part of a
competitive process, and will participate voluntarily. As an overview
of SURRG, healthcare providers at participating clinics (sexually
transmitted disease [STD] clinics affiliated with a single public
health department or other participating non-STD clinic sites) will
collect specimens for N. gonorrhoeae culture testing from men and women
seeking care for possible gonorrhea. Specimens that demonstrate N.
gonorrhoeae (called ``isolates'') will undergo antibiotic resistance
testing within several days at the local public health laboratory.
Laboratory results demonstrating resistance will be rapidly
communicated by the laboratory to the healthcare provider and
designated health department staff member, who will initiate a field
investigation. Researchers will interview the patient (from whom the
resistant specimen was collected) about risk factors and recent
contacts, and will re-test to ensure cure. The health department will
interview recent contacts and test them for gonorrhea. The
participating health departments will collect and transmit to CDC,
demographic and clinical data about persons tested for and diagnosed
with gonorrhea in the participating clinics, results of local
antibiotic resistance testing, and information about field
investigations. None of the data transmitted to CDC will contain any
personally identifiable information. CDC will use the data to monitor
resistance, understand risk factors for resistance, and identify new
approaches to prevent the spread of resistance. CDC will receive
transmitted data through its Secure Access Management Services (SAMS).
SAMS is an approved federal information technology system that provides
authorized and validated users secure and encrypted access to CDC file
transfer applications. The encrypted data will be stored in a secure
CDC server with strictly controlled and restricted access rights.
Isolates will be shipped each month to one of four Antibiotic
Resistance Regional Laboratory Network (ARLN) laboratories for
confirmatory antibiotic susceptibility testing and molecular
characterization.
Under the SURRG protocol, the local SURRG data managers from each
of the funded jurisdictions will abstract STD clinic data for patients
tested for gonorrhea, receive data from non-STD clinic healthcare sites
about persons tested for gonorrhea, receive resistance testing
laboratory results from local public health laboratories, abstract data
about field investigations, and will merge the data. Every two months,
the local SURRG data manager will clean the data, remove personally
identifiable information, and transmit the data to CDC. We estimate
these data processes will take 16 hours every two months. Annually, the
local SURRG data manager will send a final cumulative data file. Seven
data transmissions/responses will occur.
Every two months, data managers at each of the participating non-
STD clinic health centers will abstract and clean data and securely
transmit the data to the local SURRG data manager. We estimate that it
will take 3 hours each time data managers at each non-STD SURRG
location abstract, clean, and transmit SURRG data.
Microbiologists at public health laboratories from each of the nine
SURRG funded jurisdictions will conduct antibiotic resistance testing
on all N. gonorrhoeae isolates from all STD clinic sites and non-STD
clinic sites participating in SURRG. Each test takes approximately 10
minutes of staff time, and testing of control strains will also be
conducted approximately twice per week at each laboratory. On average,
each jurisdiction will conduct approximately 600 resistance tests per
year for patient care, plus 100 control strains per year for quality
assurance. Thus, each grantee will perform approximately 700 tests per
year. Every two months, a laboratory data manager will abstract test
results and securely send the data file to the local SURRG data
manager. We estimate that laboratory data managers will spend
approximately 1 hour each time they abstract, clean, and transmit
project data.
Health department staff will interview any person diagnosed with
antibiotic-resistant gonorrhea or having a case of gonorrhea of public
health significance index case, a diagnosed person's social and sexual
contacts, and the sexual contacts of the index case's sexual contacts.
On average, each jurisdiction will identify four drug-resistant
isolates each month. These isolates will spur field investigations,
which will result in six additional interviews each month. We estimate
120 interviews will occur annually at each site (annual 1,080
interviews for the nine sites). Each interview will take 30 minutes.
The total estimated annual burden hours are 2,976. Respondents
receive federal funds to participate in this project. There are no
additional costs to respondents other than their time.
[[Page 38696]]
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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Local SURRG data manager.............. Facility, Laboratory and 9 7 16
field Elements.
Data manager at non-STD clinic health Non-STD clinic Elements. 18 6 3
centers.
Public Health Laboratory Laboratory Testing...... 9 700 10/60
Microbiologist.
Public Health Laboratory Data Manager. Laboratory Elements..... 9 6 1
Gonorrhea Patients, Social and Sexual Field Investigation 1,080 1 30/60
Contacts. Elements.
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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. 2018-16797 Filed 8-6-18; 8:45 am]
BILLING CODE 4163-18-P