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