82 FR 12360 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 82, Issue 40 (March 2, 2017)

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, 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 data collection project will help examine the amount of influenza virus in airborne particles produced by subjects with influenza and it relationship to biomarkers in the blood.

[Federal Register Volume 82, Number 40 (Thursday, March 2, 2017)]
[Notices]
[Pages 12360-12361]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-04045]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-17RT; Docket No. CDC-2017-0013]


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 efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, 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 data collection project will help 
examine the amount of influenza virus in airborne particles produced by 
subjects with influenza and it relationship to biomarkers in the blood.

DATES: Written comments must be received on or before May 1, 2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2017-
0013 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, 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. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

    Please note:  All public comment should be submitted 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 the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; 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 OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    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; (d) ways to 
minimize the

[[Page 12361]]

burden of the collection of information on respondents, including 
through the use of automated collection techniques or other forms of 
information technology; and (e) estimates of capital or start-up costs 
and costs of operation, maintenance, and purchase of services to 
provide information. Burden means the total time, effort, or financial 
resources expended by persons to generate, maintain, retain, disclose 
or provide information to or for a Federal agency. This includes the 
time needed to review instructions; to develop, acquire, install and 
utilize technology and systems for the purpose of collecting, 
validating and verifying information, processing and maintaining 
information, and disclosing and providing information; to train 
personnel and to be able to respond to a collection of information, to 
search data sources, to complete and review the collection of 
information; and to transmit or otherwise disclose the information.

Proposed Project

    Factors Influencing the Transmission of Influenza--New--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.
    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. 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 swabs and five 
milliliters of blood will be collected. The participant 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 study will require 40 volunteer test subjects each year for 
three years, for a total of 120 test participants. NIOSH intends to 
seek a three-year OMB approval to conduct this information collection. 
There are no costs to respondents other than their time.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response  (in     (in hrs.)
                                                                    respondent         hrs.)
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Potential participant.........  Initial Verbal               240               1            3/60              12
                                 Screening.
Qualified participant.........  Informed consent             120               1           15/60              30
                                 form.
Qualified participant.........  Health                       120               1            5/60              10
                                 questionnaire.
Qualified participant.........  Medical Testing.             120               1           40/60              80
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             132
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Leroy A. 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. 2017-04045 Filed 3-1-17; 8:45 am]
 BILLING CODE 4163-18-P