[Federal Register Volume 78, Number 217 (Friday, November 8, 2013)]
[Notices]
[Pages 67147-67148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26787]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day-14-0888]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-7570 or 
send comments to Kimberly Lane, 1600 Clifton Road, MS-D74, Atlanta, GA 
30333 or send an email to [email protected].
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Persistence of Viable Influenza Virus in Aerosols (0920-0888, 
Expiration 05/31/2014)--Revision--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)

[[Page 67148]]

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. The purpose of 
this study is to measure the amount of viable influenza virus in 
airborne particles that are produced by patients when they cough, and 
the size and quantity of the particles carrying the virus. A better 
understanding of the amount of potentially infectious material released 
by patients and the size of the particles carrying the virus will 
assist in determining the possible role of airborne transmission in the 
spread of influenza and in devising measures to prevent it.
    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. 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, two nasopharyngeal 
swabs and one oropharyngeal swab will be collected from the 
participant. They then will be asked to cough repeatedly into an 
aerosol particle collection system, and the airborne particles produced 
by the participant during coughing will be collected and tested. The 
sounds produced during coughing will also be recorded for analysis and 
comparison to the amount of virus expelled. The study will require 60 
volunteer test subjects each year for 3 years, for a total of 180 test 
participants.
    The following revisions have been made to the previous approved 
information collection request:
    (1) Initially, potential participants will be screened verbally 
rather than through the health questionnaire.
    (2) The number of potential participants has been increased from 
132 to 360. In a previous similar study, the number of potential 
participants who agree to join the study was 50%, which was lower than 
anticipated. The increase will allow the study to recruit 180 
participants.
    (3) The number of qualified participants has been increased from 
120 to 180. This is necessary to provide a sufficient number of cough 
aerosol samples with detectable amounts of viable influenza and is 
based on a previous study, where 10% of aerosol samples had culturable 
virus.
    (4) The Informed consent form has been substantially revised to 
make it easier to read and understand. As a result of the revisions, 
the burden per response for that form has been reduced from 20 to 15 
minutes.
    (5) Because of the increases in the number of potential and 
qualified participants, the total burden hours has increased from 51 to 
78 hours.
    (6) The title of the ICR has been changed to ``Factors Influencing 
the Transmission of Influenza'' in order to reflect the new focus of 
the project on influenza viability and to match the title of the human 
subjects protocol approved by the Institutional Review Board.
    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               360               1            3/60              18
                                 screening.
Qualified participant.........  Informed consent             180               1           15/60              45
                                 form.
Qualified participant.........  Health                       180               1            5/60              15
                                 questionnaire.
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    Total.....................  ................  ..............  ..............  ..............              78
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Kimberly S. Lane,
Deputy Director, Office of Scientific Integrity, Office of the 
Associate Director for Science, Office of the Director, Centers for 
Disease Control and Prevention.
[FR Doc. 2013-26787 Filed 11-7-13; 8:45 am]
BILLING CODE 4163-18-P