[Federal Register Volume 85, Number 190 (Wednesday, September 30, 2020)]
[Notices]
[Pages 61750-61752]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21621]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-20-1242; Docket No. CDC-2020-0099]


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 the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled Strengthening U.S. Response to 
Resistant Gonorrhea, which is to intended to enhance U.S. state and 
local public health surveillance and program infrastructure, build 
capacity to support rapid detection and public health response to 
antibiotic-resistant gonorrhea (an urgent public health threat), and 
advance the understanding of epidemiological factors contributing to 
antibiotic-resistant gonorrhea. CDC is requesting a three-year 
approval.

DATES: CDC must receive written comments on or before November 30, 
2020.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0099 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, 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 Jeffrey M. Zirger, 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) (OMB 
Control No. 0920-1242, Exp. 9/30/

[[Page 61751]]

2021)--Revision--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 this Revision request for Strengthening U.S. 
Response to Resistant Gonorrhea (SURRG) are to: (1) Improve national, 
state, and local capacity to rapidly detect, monitor, and respond to 
emerging antibiotic-resistant gonorrhea (and get actionable information 
to local health departments), (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 
antibiotic resistance and may be developing resistance to the last 
remaining treatment option recommended by the Centers for Disease 
Control and Prevention (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 culture and resistance testing for individual 
patients.
    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 collect specimens 
for N. gonorrhoeae culture testing. Specimens that demonstrate N. 
gonorrhoeae (called ``isolates'') rapidly undergo antibiotic resistance 
testing at the local public health laboratory. Detection of resistance 
is rapidly communicated by laboratory staff to the healthcare provider 
and health department. The patient (from whom the resistant specimen 
was collected) is interviewed by local health department staff about 
risk factors and recent contacts, and will be re-tested to ensure that 
they were cured. Recent contacts are interviewed by the health 
department (contact tracing) and tested for gonorrhea. The 
participating health departments 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 contains any 
personally identifiable information. These data are used by CDC to 
monitor and better understand resistance and identify effective 
approaches to prevent resistance spread. Data are transmitted to CDC 
through a secure encrypted file transfer application and stored in a 
secure CDC server with strictly controlled and restricted access 
rights.
    In processes that take approximately 16 hours every two months 
(plus an annual cumulative datafile), local SURRG data managers 
abstract STD clinic data for patients tested for gonorrhea and field 
investigation data, receive gonorrhea data from non-STD clinic 
healthcare sites and resistance testing results from local public 
health laboratories, and clean and transmit data to CDC.
    Other data managers at each participating non-STD clinic health 
center abstract, clean, and transmit data (approximately three hours 
every two months). Microbiologists at public health laboratories from 
each funded jurisdiction conduct resistance testing on ~700 N. 
gonorrhoeae isolates each year (600 clinical isolates and 100 control 
strains; each test ~10 minutes). Laboratory data managers take about 
one hour every two months to abstract, clean, and transmit 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, and their sexual contacts. On average, 
each jurisdiction will identify four drug-resistant isolates each 
month; these isolates will spur field investigations and six additional 
interviews monthly. We estimate a total of 120 interviews annually at 
each site, for a total across the eight sites of 960 interviews each 
year. Each interview will take ~20 minutes.
    The total estimated annual burden hours are 2,665. This burden 
represents a decrease from the burden of the initial submission. The 
number of jurisdictions decreased from nine to eight. So the number of 
local data managers decreased from nine to eight (and the burden hours 
decreased from 1008 to 896), the number of public health 
microbiologists decreased from nine to eight (burden hours decreased 
from 1050 to 933), the number of lab data managers decreased from nine 
to eight (burden hours decreased from 54 to 48), and the number of 
gonorrhea and contacts decreased from 1080 to 960 (burden hours 
decreased from 540 to 480). The number of clinic sites will increase 
from 18 to 26. Respondents receive federal funds to participate in this 
project. There are no additional costs to respondents other than their 
time.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent        (hours)          hours
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Local SURRG data manager......  STD Clinic                     8               7              16             896
                                 Facility Data
                                 Elements.
Data manager at non-STD clinic  Non-STD Clinic                26               6               3             468
 health centers.                 Facility Data
                                 Elements.
Public Health Laboratory        Laboratory Data                8             700           10/60             933
 Microbiologist.                 Elements.
Public Health Laboratory Data   Laboratory                     8               6               1              48
 Manager.                        Testing Data
                                 Elements.
Gonorrhea Patients, Social and  Investigation                960               1            0.33             320
 Sexual Contacts.                Data Elements.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           2,665
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[[Page 61752]]

Jeffery M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2020-21621 Filed 9-29-20; 8:45 am]
 BILLING CODE 4163-18-P