[Federal Register Volume 82, Number 220 (Thursday, November 16, 2017)]
[Notices]
[Pages 53501-53503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24804]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-17BAN; Docket No. CDC-2017-0081]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on ``Strengthening 
United States Response to Resistant Gonorrhea (SURRG).'' The goal of 
the study is to strengthen the U.S response to resistant gonorrhea by 
enhancing state and local public health surveillance and program 
infrastructure, build capacity to support rapid detection and public 
health response to antibiotic-resistant gonorrhea, and advance the 
understanding of epidemiological factors contributing to antibiotic-
resistant gonorrhea.

DATES: Written comments must be received on or before January 16, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2017-
0081 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE., MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Leroy A. Richardson, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. 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 
submissions of responses.
    5. Assess information collection costs.

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).

[[Page 53502]]

    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 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.
    Researchers will ship isolates 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 three 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 one hour each time they abstract, clean, and transmit 
project data.
    Health department staff will interview any person diagnosed with 
antibiotic-resistant gonorrhea or have 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 9 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.

                                                           Estimate of Annualized Burden Hours
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                                                                                                                              Average
                                                                                             Number of       Number of      burden per     Total burden
              Type of  respondent                               Form name                   respondents    responses per     response          hours
                                                                                                            respondent        (hours)
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Local SURRG data manager.......................  Facility, Laboratory and field Elements               9               7              16           1,008
Data manager at non-STD clinic health centers..  Non-STD clinic Elements................              18               6               3             324
Public Health Laboratory Microbiologist........  Laboratory Testing.....................               9             700           10/60           1,050
Public Health Laboratory Data Manager..........  Laboratory Elements....................               9               6               1              54
Gonorrhea Patients, Social and Sexual Contacts.  Field Investigation Elements...........           1,080               1           30/60             540
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    Total......................................  .......................................  ..............  ..............  ..............           2,976
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[[Page 53503]]

Leroy A. Richardson,
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. 2017-24804 Filed 11-15-17; 8:45 am]
BILLING CODE 4163-18-P