[Federal Register Volume 85, Number 198 (Tuesday, October 13, 2020)]
[Notices]
[Pages 64475-64476]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22489]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-21-0888; Docket No. CDC-2020-0102]


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 Factors Influencing the 
Transmission of Influenza. This proposed collection is intended to 
further our understanding of how respiratory viruses like influenza are 
transmitted from person to person.

DATES: CDC must receive written comments on or before December 14, 
2020.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0102 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

[[Page 64476]]

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

    Factors Influencing the Transmission of Influenza (OMB Control No. 
0920-0888, Exp. 2/28/2021)--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 
(expiring February 28, 2021) because the ongoing COVID-19 pandemic has 
temporarily halted the study 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 costs to 
respondents other than their time.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent       (in hrs.)       (in hrs.)
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Potential participant.........  Initial verbal               180               1            3/60               9
                                 screening.
Qualified participant.........  Informed consent              90               1           15/60              23
                                 form.
Qualified participant.........  Health                        90               1            5/60               8
                                 questionnaire.
Qualified participant.........  Medical testing.              90               1           72/60             108
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             148
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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. 2020-22489 Filed 10-9-20; 8:45 am]
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