Notice2021-14751
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 12, 2021
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 86 Issue 130 (Monday, July 12, 2021)</title>
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[Federal Register Volume 86, Number 130 (Monday, July 12, 2021)]
[Notices]
[Pages 36556-36558]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-14751]
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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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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
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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 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.
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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
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