[Federal Register Volume 86, Number 43 (Monday, March 8, 2021)]
[Notices]
[Pages 13394-13396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04671]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-21-0307 Docket No. CDC-2021-0017]


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 ``Gonococcal Isolate Surveillance 
Project (GISP)''. The purpose of GISP is to monitor trends in 
antimicrobial resistance in N. gonorrhoeae strains in the United States 
in order to establish a scientific basis for the selection of 
gonococcal therapies and to allow proactive changes to treatment 
guidelines before widespread resistance and failures of treatment 
occur.

DATES: CDC must receive written comments on or before May 7, 2021.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0017 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: 404-639-7118; 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;

[[Page 13395]]

    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

    Gonococcal Isolate Surveillance Project (OMB Control No. 0920-0307, 
Exp. 8/31/2021)--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) 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.

[[Page 13396]]



                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondent            Form name       respondents    responses per   response  (in       hours
                                                                    respondent        hours)
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Sentinel site conducting        Demographic/                  20             240           11/60             880
 culture-based core              Clinical Data
 surveillance.                   (Attachment
                                 3a1).
Sentinel site conducting        Demographic/                  10             840           12/60           1,680
 culture-based enhanced          Clinical Data
 surveillance.                   (Attachment
                                 3a2).
Sentinel site conducting        Demographic/                  10             840           12/60           1,680
 molecular enhanced              Clinical Data
 surveillance.                   (Attachment
                                 3a2).
Regional laboratory...........  Antimicrobial                  4           3,300           40/60           8,800
                                 Susceptibility
                                 Testing Results
                                 (Attachment 3b).
                                Control Strain    ..............              48            5/60              16
                                 Susceptibility
                                 Testing.
                                                 ---------------------------------------------------------------
    Total.....................  ................              44  ..............  ..............          13,056
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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. 2021-04671 Filed 3-5-21; 8:45 am]
BILLING CODE 4163-18-P