[Federal Register Volume 85, Number 239 (Friday, December 11, 2020)]
[Notices]
[Pages 80106-80107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27326]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-21-20OT]


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 ``Mycoplasma genitalium Treatment Failure 
Registry'' 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 June 5, 
2020 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

    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

[[Page 80107]]

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.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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                                                                                                  Average burden
          Type of respondent                    Form name             No. of       No. responses   per response
                                                                    Respondents   per respondent    (in hours)
----------------------------------------------------------------------------------------------------------------
Physician or Nurse Practitioner.......  M. genitalium Treatment              100               1               1
                                         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. 2020-27326 Filed 12-10-20; 8:45 am]
BILLING CODE 4163-18-P