Notice2021-14226
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 2, 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 125 (Friday, July 2, 2021)</title>
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[Federal Register Volume 86, Number 125 (Friday, July 2, 2021)]
[Notices]
[Pages 35292-35294]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-14226]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-21-0307]
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 ``Gonococcal Isolate Surveillance Project
(GISP)'' 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 March 8,
2021 to obtain comments from the public and affected agencies. CDC did
not receive comments 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
Gonococcal Isolate Surveillance Project--Revision--National Center
for HIV/AIDS, Viral Hepatitis, STD, TB Prevention (NCHHSTP), Centers
for Disease Control and Prevention (CDC).
Background and Brief Description
The Gonococcal Isolate Surveillance Project (GISP) was created in
1986 to monitor trends in antimicrobial susceptibilities of Neisseria
gonorrhoeae strains in the United States. GISP continues to be a
collaboration between different branches of the CDC's Division of STD
Prevention, selected regional laboratories, and selected state/local
public health departments and their associated STD specialty care
clinics in the United States. National organizations, local
jurisdictions and individuals use data collected in GISP to understand,
monitor, and prevent further transmission of antibiotic resistant
strains of N. gonorrhoeae. Data from GISP are used to establish a
scientific basis for the selection of gonococcal therapies and to allow
pro-active changes to treatment guidelines before widespread resistance
and failures of treatment occur. To increase capacity to detect and
monitor resistant gonorrhea and to improve the specificity of GISP,
this revision is being submitted to include collection of remnant
nucleic acid amplification test (NAAT)
[[Page 35293]]
specimens and updated data element options for treatment received based
on the 2020 updated gonorrhea treatment recommendations.
GISP core surveillance activities sample <4% of reported male
gonorrhea cases in the United States and are limited to urethral
infections only. In 2018, enhanced GISP (eGISP) began sampling female
genital (endocervical and vaginal) and male and female extragenital
(pharyngeal and rectal) anatomic sites, in addition to the male genital
site already sampled in GISP core surveillance. Including isolates from
the pharynx and other anatomic sites, as well as from women, expands on
GISP's public health efforts to detect and respond to resistance more
quickly. GISP surveillance was also strengthened with the addition of
eGISP by identifying isolates that are culture positive for N.
gonorrhoeae, but negative by NAAT, which is a more specific diagnostic
test. This helped to ensure that non-gonococcal bacteria are excluded
from gonococcal data, strengthening the accuracy and usefulness of GISP
data, especially when clinical syndromes with other Neisseria species
are indistinguishable from gonorrhea.
To further improve and strengthen GISP surveillance, an additional
enhanced surveillance activity in the form of molecular surveillance
has been added to this revision. Participating sites already locally
performing NAATs would retain the leftover gonorrhea-positive samples
(remnant) after diagnostic results have been determined and reported as
part of standard care. The gonorrhea-positive remnant NAAT sample would
be frozen, stored, and then shipped directly to CDC on a monthly basis
for molecular characterization of known resistance-conferring gene
mutations. Remnant NAAT specimens from any anatomic site (including
from the urethra, pharynx, rectum, vagina, and cervix) of gonorrhea
positive persons will be accepted. We anticipate that 10 sites will
participate in this molecular surveillance activity and we anticipate
up to 70 positive remnant NAAT specimens per month will be sent by each
of these 10 sites to CDC for testing.
To maintain accurate collection of GISP data elements, this
revision also includes the updated weight-based dosing of ceftriaxone
and cefixime. In December 2020, CDC released the ``Update to CDC's
Treatment Guidelines for Gonococcal Infection.'' These new treatment
recommendations increased the dose of the recommended regimen and the
dose for an alternative regimen (ceftriaxone and cefixime,
respectively). These values, collected and recorded under the received
treatment data element, are being added to allow for the collection of
treatment data consistent with these updated recommendations.
Under this revision, the data collection and processes for all GISP
activities are unchanged. The increased dosages for ceftriaxone and
cefixime treatments allow for new data element options, but not a
change in the number of data elements or the current work demand to
collect them. All demographic/clinical data from the sentinel sites
will be submitted electronically directly from the sentinel sites to
the GISP data manager at CDC through; (1) a secure data portal, or (2)
through the CDC Secure Access Management Services partner portal. To
minimize burden, comma-separated values (csv) files that provide
standardized structure of the electronic data are provided to sentinel
sites and laboratories. Additionally, to further minimize burden, the
regional laboratories will be able to extract electronic data directly
from electronic laboratory information systems instead of hand entering
data. Laboratories are not required to report control strain testing
results.
This project will not collect name, social security number, or date
of birth. A Patient ID, a unique patient identifier assigned by the
site that allows for linking of multiple isolates from a single person
at a single clinic visit and across multiple clinic visits, is
requested and will be provided to CDC for purposes of enhanced
surveillance. Sensitive information such as sex of sex partners, HIV
status, sex work exposure, and injection drug use are collected.
Patient data are obtained through review of medical records by the
clinic staff and included in collection reporting of demographic/
clinical information. All personally identifiable information (PII) is
retained by the STD clinics that treated the patient and is not
recorded with data sent to CDC or regional laboratories. The electronic
GISP database is stored on the CDC mainframe computer and only approved
Division of STD Prevention (DSTDP) staff have access rights to the
data. As part of the revision, we will continue to systematically
identify the risks and potential effects of collecting, maintaining,
and disseminating PII and to examine and evaluate alternative processes
for handling that information to mitigate potential privacy risks and
risks to confidentiality.
The CDC has designated N. gonorrhoeae as one of five ``urgent''
antibiotic resistance threats in the United States. The CDC is
requesting a three-year OMB approval for this revision, which directly
responds to the National Strategy for Combating Antibiotic Resistant
Bacteria by improving and strengthening surveillance of antimicrobial
resistance through GISP. GISP data can help monitor and evaluate the
effectiveness of public health interventions conducted to support the
National Strategy for Combating Antibiotic Resistant Bacteria. There
are no costs to respondents other than their time. The estimated annual
burden is 13,056 hours.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondent Form name Number of responses per per response
respondents respondent (in hours)
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Sentinel site conducting culture-based Demographic/Clinical 20 240 11/60
core surveillance. Data.
Sentinel site conducting culture-based Demographic/Clinical 10 840 12/60
enhanced surveillance. Data.
Sentinel site conducting molecular Demographic/Clinical 10 840 12/60
enhanced surveillance. Data.
Regional laboratory................... Antimicrobial 4 3,300 40/60
Susceptibility Testing
Results.
Control Strain 48 5/60
Susceptibility Testing.
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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. 2021-14226 Filed 7-1-21; 8:45 am]
BILLING CODE 4163-18-P
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