[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]
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