[Federal Register Volume 86, Number 125 (Friday, July 2, 2021)]
[Notices]
[Pages 35292-35294]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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

    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
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondent                    Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
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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[[Page 35294]]

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