[Federal Register Volume 86, Number 130 (Monday, July 12, 2021)]
[Notices]
[Pages 36556-36558]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14751]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30 Day-21-1242]


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 titled Strengthening U.S. 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 
September 30, 2020 to obtain comments from the public and affected 
agencies. CDC received one non-substantive comment 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. Comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. 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) (OMB 
Control No. 0920-1242, Exp. 9/30/2021)--Revision--National Center for 
HIV/AIDS, Viral Hepatitis, STD, and TB

[[Page 36557]]

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 the emerging threat of 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 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 resistance testing for individual patients.
    SURRG supports rapid detection of resistant gonorrhea and gets 
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 in the community). Jurisdictions participating 
in SURRG applied as part of a competitive process and 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) collect specimens for N. 
gonorrhoeae culture testing from men and women seeking care for 
possible gonorrhea. Specimens that demonstrate N. gonorrhoeae (called 
``isolates'') undergo antibiotic resistance testing within several days 
at a local public health laboratory. Laboratory results demonstrating 
resistance are rapidly communicated by the laboratory staff to the 
healthcare provider and designated health department staff member, who 
initiates a field investigation. The patient (from whom the resistant 
specimen was collected) is interviewed 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 resistance, understand risk 
factors for resistance, and identify the most effective approaches to 
prevent the spread of resistance. Data are transmitted through CDC's 
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 are stored in a secure CDC server with strictly 
controlled and restricted access rights. Isolates are shipped each 
month to one of four Antibiotic Resistance Regional Laboratory Network 
(ARLN) laboratories for confirmatory antibiotic susceptibility testing 
and molecular characterization. The isolates only contain bacterial DNA 
(and not human DNA).
    Under the SURRG protocol, the local SURRG data managers from each 
of the funded jurisdictions 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 merge the data. Every two months, the 
local SURRG data manager cleans the data, removes personally 
identifiable information, and transmits 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, so a 
total of seven data transmissions/responses will occur. Every two 
months, data managers at each of the participating non-STD clinic 
health centers abstract and clean data and securely transmits 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 
eight SURRG funded jurisdictions 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 is also conducted 
approximately twice per week at each laboratory. On average, each 
jurisdiction conducts approximately 600 resistance tests per year for 
patient care, plus 100 control strains per year for quality assurance. 
Thus, a total of approximately 700 tests per year per grantee are 
performed. Every two months, a laboratory data manager abstracts test 
results and securely sends the datafile to the local SURRG data 
manager. We estimate that laboratory data managers 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, and their 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 a total of 120 
interviews will occur annually at each site, for a total across the 8 
sites of 960 interviews each year. Each interview will take 
approximately 20 minutes.
    The total estimated annual burden hours are 2,665. There are no 
additional costs to respondents other than their time.

                                        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 Data Elements..               8               7              16

[[Page 36558]]

 
Data manager at non-STD clinic health   Non-STD clinic Data                   26               6               3
 centers.                                Elements.
Public Health Laboratory                Laboratory Testing Data                8             700           10/60
 Microbiologist.                         Elements.
Public Health Laboratory Data Manager.  Laboratory Data Elements               8               6               1
Gonorrhea Patients and Sexual Contacts  Field Investigation Data             960               1           20/60
                                         Elements.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-14751 Filed 7-9-21; 8:45 am]
BILLING CODE 4163-18-P