82 FR 43542 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 82, Issue 179 (September 18, 2017)

[Federal Register Volume 82, Number 179 (Monday, September 18, 2017)]
[Notices]
[Pages 43542-43543]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-19748]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-17-0888]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (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 or send an email to [email protected]. Within 30 days of this 
notice, direct written comments and/or suggestions regarding the items 
contained in this notice to the Attention: CDC Desk Officer, Office of 
Management and Budget, Washington, DC 20503 or by fax to (202) 395-
5806.

Proposed Project

    Factors Influencing the Transmission of Influenza (OMB Control 
Number 0920-0888; Expired 6-30-2017)--Reinstatement with change--
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. 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.
    Work under the previous approval showed that patients infected with 
influenza virus produce airborne particles containing viable airborne 
influenza virus during both breathing and coughing, but that breathing 
may generate more airborne infectious material than coughing over time. 
However, this work was hampered because the amounts of influenza virus 
in almost all of the aerosol samples were below the limit of 
quantification. Thus, CDC made the following changes to the project:
    (1) CDC will modify the cough and exhalation-aerosol collection 
system to collect aerosol particles continuously for 40 minutes, rather 
than collecting particles from discrete coughs and exhalations as in 
the previous study. This will increase the amount of influenza virus 
that is collected.
    (2) Researchers will collect a blood sample from each participant 
to allow testing for blood markers of influenza infection and a 
comparison of the levels of these markers to the amount of expelled 
influenza in aerosol particles.
    (3) Researchers increased the time required for participation from 
63 minutes to 95 minutes to allow for a longer aerosol collection 
period and for the blood collection.
    (4) Researchers will recruit and test an equal number of control 
subjects without symptoms of respiratory illness in addition to 
subjects with influenza-like illness. This will allow the determination 
of the differences in blood biomarker levels between healthy and 
infected subjects.
    (5) Because of the longer participation time and because blood 
collection has been found to be a strong disincentive for 
participation, the token of appreciation for participating in the study 
has been increased from $25 to $40.
    The purpose of the proposed 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, researchers will collect 
airborne particles produced by volunteer subjects with influenza to 
test for influenza virus. Researchers will also measure the levels of 
influenza infection-associated biomarkers in blood samples from these 
subjects.
    A test coordinator will recruit volunteer adult participants by 
using a poster and flyers describing the study. Researchers will 
verbally screen interested potential participants to verify that they 
have influenza-like symptoms and that they do not have any medical 
conditions that would preclude their participation. Researchers will 
also recruit a matching number of healthy control participants.
    Researchers will ask qualified participants who agree to 
participate in

[[Page 43543]]

the study to read and sign an informed consent form, and then to 
complete a short health questionnaire. After completing the forms, 
researchers will measure the participant's oral temperature and collect 
two nasopharyngeal mucus samples and five ml of blood. The researchers 
will then ask the participants to don elastomeric masks, 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 3 
years, totaling 270 test participants. There are no costs to 
respondents other than their time. The total number of annual burden 
hours are 148.

                                        Estimated Annualized Burden Hours
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                                                                                     Number of    Average 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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Leroy Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2017-19748 Filed 9-15-17; 8:45 am]
 BILLING CODE 4163-18-P