[Federal Register Volume 85, Number 109 (Friday, June 5, 2020)]
[Notices]
[Pages 34636-34637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12242]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-20-20OT; Docket No. CDC-2020-0063]


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 ``Mycoplasma genitalium Treatment 
Failure Registry.'' The purpose of the collection is to determine which 
second-line antibiotics are in use for M. genitalium treatment failure 
and monitor antibiotic resistance patterns for treatment failure cases 
throughout the United States.

DATES: CDC must receive written comments on or before August 4, 2020.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0063 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: 404-639-7570; 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;
    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

    Mycoplasma genitalium Treatment Failure Registry--New--National 
Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), 
Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    The Centers for Disease Control and Prevention (CDC), Division of 
STD Prevention requests a three-year approval of an information 
collection request for the Mycoplasma genitalium Treatment Failure 
Registry, which will entail use of a standardized Case Report Form.
    The primary goal of this activity is to establish a registry to 
monitor cases of Mycoplasma genitalium (M. genitalium) treatment 
failure in the United States. The project objectives are as follows: 
(1) Using existing clinical data, describe demographic and behavioral 
factors among patients with documented Mycoplasma genitalium who fail 
current CDC-recommended treatment. (2) Using existing clinical data, 
describe antibiotic regimens utilized among patients with Mycoplasma 
genitalium treatment failure, including documentation of clinical and 
microbiologic cure. (3) Using existing laboratory specimens, monitor 
genetic mutations associated with macrolide or fluroquinolone 
antibiotic resistance. Data captured on the standardized Case Report 
Form will be analyzed to determine outcomes from usage of second-line 
antibiotic therapy for M.

[[Page 34637]]

gentialium. These data may inform future CDC STD Treatment Guidelines.
    There are an estimated 100 respondents (anticipated to report once 
per year) who will be clinicians in private and public health care 
settings. The data collection is necessary as there are no current 
national recommendations for patients who fail current CDC-recommended 
therapy for M. genitalium. Each case report form is anticipated to take 
up to 60 minutes to complete.
    This data collection provides CDC with information to determine 
which second-line treatments are most clinically effective, as well as 
determining antibiotic resistance patterns of M. genitalium throughout 
the US. There are no costs to respondents other than their time. The 
estimated annualized burden hours for this data collection are 100 
hours.

                                        Estimated Annualized Burden Hours
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                                                                      Number      Average burden
      Type of respondent            Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
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Physician or Nurse              M. genitalium                100               1               1             100
 Practitioner.                   Treatment
                                 Failure
                                 Registry Case
                                 Report Form.
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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. 2020-12242 Filed 6-4-20; 8:45 am]
 BILLING CODE 4163-18-P