[Federal Register Volume 86, Number 34 (Tuesday, February 23, 2021)]
[Notices]
[Pages 10969-10970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03556]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30-Day-21-0888]


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 Factors Influencing the Transmission of 
Influenza 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 October 
13, 2020 to obtain comments from the public and affected agencies. CDC 
received two 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

[[Page 10970]]

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

    Factors Influencing the Transmission of Influenza (OMB Control No. 
0920-0888, Exp. 2/28/21)--Extension--National Institute for 
Occupational Safety and Health (NIOSH), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    The National Institute for Occupational Safety and Health (NIOSH) 
is authorized to conduct research to advance the health and safety of 
workers under Section 20(a)(1) of the 1970 Occupational Safety and 
Health Act. NIOSH is requesting an extension to an existing ICR 
(Expiration Date: February 28, 2021) because the ongoing COVID-19 
pandemic temporarily halted the study in 2020 due to staff safety 
concerns and an inability to access healthcare facilities in order to 
recruit test subjects.
    Influenza continues to be a major public health concern because of 
the substantial health burden from seasonal influenza and the potential 
for a severe pandemic. Although influenza is known to be transmitted by 
infectious secretions, these secretions can be transferred from person 
to person in many different ways, and the relative importance of the 
different pathways is not known. The likelihood of the transmission of 
influenza virus by small infectious airborne particles produced during 
coughing and breathing is particularly unclear. The question of 
airborne transmission is especially important in healthcare facilities, 
where influenza patients tend to congregate during influenza season, 
because it directly impacts the infection control and personal 
protective measures that should be taken by healthcare workers.
    The purpose of this study is to gain a better understanding of the 
production of infectious aerosols by patients with influenza, and to 
compare this to the levels of biomarkers of influenza infection in the 
blood of these patients. To do this, airborne particles produced by 
volunteer subjects with influenza will be collected and tested for 
influenza virus, and the levels of influenza infection-associated 
biomarkers will be measured in blood samples from these subjects.
    Volunteer adult participants will be recruited by a test 
coordinator using a poster and flyers describing the study. Interested 
potential participants will be screened verbally to verify that they 
have influenza-like symptoms and that they do not have any medical 
conditions that would preclude their participation. A matching number 
of healthy control participants will also be recruited. Qualified 
participants who agree to participate in the study will be asked to 
read and sign an informed consent form, and then to complete a short 
health questionnaire. After completing the forms, the participant's 
oral temperature will be measured and two nasopharyngeal mucus samples 
and five ml of blood will be collected. The participant then will be 
asked to don an elastomeric mask and breathe and cough normally for 40 
minutes into an aerosol particle collection system. The total time from 
initial verbal screening to completion will be about 95 minutes. The 
study will require 90 volunteer test subjects each year for three 
years, for a total of 270 test participants. There are no changes to 
data collection instruments, methodology, or burden estimates. OMB 
approval is requested for three years. Participation is voluntary and 
there are no costs to respondents other than their time. The total 
estimated annualized burden hours are 148.

                                        Estimated Annualized Burden Hours
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                                                                                     Number of      Avg. burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent       (in hrs.)
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Potential participant.................  Initial verbal screening             180               1            3/60
Qualified participant.................  Informed consent form...              90               1           15/60
Qualified participant.................  Health questionnaire....              90               1            5/60
Qualified participant.................  Medical testing.........              90               1           72/60
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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. 2021-03556 Filed 2-22-21; 8:45 am]
BILLING CODE 4163-18-P