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)

Page Range		43542-43543
FR Document		2017-19748
Federal Register, Volume 82 Issue 179 (Monday, 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
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent       (in hrs.)
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------


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
43542 Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices

drawn, as in the past, in large measure information, including the validity of and coughing, but that breathing may
from the ranks of other executive branch the methodology and assumptions used; generate more airborne infectious
agencies. The board shall review and (c) Enhance the quality, utility, and material than coughing over time.
evaluate the initial appraisal of each clarity of the information to be However, this work was hampered
OGE senior executive’s performance by collected; (d) Minimize the burden of because the amounts of influenza virus
his or her supervisor, along with any the collection of information on those in almost all of the aerosol samples were
recommendations in each instance to who are to respond, including through below the limit of quantification. Thus,
the appointing authority relative to the the use of appropriate automated, CDC made the following changes to the
performance of the senior executive. electronic, mechanical, or other project:
This notice updates the membership of technological collection techniques or (1) CDC will modify the cough and
OGE’s SES Performance Review Board other forms of information technology, exhalation-aerosol collection system to
as it was most recently published at 78 e.g., permitting electronic submission of collect aerosol particles continuously
FR 76148 (December 16, 2013). responses; and (e) Assess information for 40 minutes, rather than collecting
Approved: September 13, 2017. collection costs. particles from discrete coughs and
To request additional information on exhalations as in the previous study.
David J. Apol,
the proposed project or to obtain a copy This will increase the amount of
Acting Director, U.S. Office of Government
Ethics.
of the information collection plan and influenza virus that is collected.
instruments, call (404) 639–7570 or (2) Researchers will collect a blood
The following officials have been send an email to omb@cdc.gov. Within sample from each participant to allow
appointed members of the SES 30 days of this notice, direct written testing for blood markers of influenza
Performance Review Board of the Office comments and/or suggestions regarding infection and a comparison of the levels
of Government Ethics: Shelley K. the items contained in this notice to the of these markers to the amount of
Finlayson, [Chair], Chief of Staff and Attention: CDC Desk Officer, Office of expelled influenza in aerosol particles.
Program Counsel, Office of Government Management and Budget, Washington, (3) Researchers increased the time
Ethics; Stuart Bender, Director, Office of DC 20503 or by fax to (202) 395–5806. required for participation from 63
Ethics, U.S. Department of Agriculture; minutes to 95 minutes to allow for a
Judith S. Kaleta, Deputy General Proposed Project longer aerosol collection period and for
Counsel, U.S. Department of Factors Influencing the Transmission the blood collection.
Transportation; and Shira Pavis Minton, of Influenza (OMB Control Number (4) Researchers will recruit and test an
Ethics Counsel, Office of the Ethics 0920–0888; Expired 6–30–2017)— equal number of control subjects
Counsel, Securities and Exchange Reinstatement with change—National without symptoms of respiratory illness
Commission. Institute for Occupational Safety and in addition to subjects with influenza-
[FR Doc. 2017–19835 Filed 9–15–17; 8:45 am] Health (NIOSH), Centers for Disease like illness. This will allow the
BILLING CODE 6345–03–P Control and Prevention (CDC). determination of the differences in
Background and Brief Description blood biomarker levels between healthy
and infected subjects.
The National Institute for (5) Because of the longer participation
DEPARTMENT OF HEALTH AND
Occupational Safety and Health time and because blood collection has
HUMAN SERVICES
(NIOSH) is authorized to conduct been found to be a strong disincentive
Centers for Disease Control and research to advance the health and for participation, the token of
Prevention safety of workers under Section 20(a)(1) appreciation for participating in the
of the 1970 Occupational Safety and study has been increased from $25 to
[30Day–17–0888] Health Act. Influenza continues to be a $40.
major public health concern because of The purpose of the proposed study is
Agency Forms Undergoing Paperwork
the substantial health burden from to gain a better understanding of the
Reduction Act Review
seasonal influenza and the potential for production of infectious aerosols by
The Centers for Disease Control and a severe pandemic. Although influenza patients with influenza, and to compare
Prevention (CDC) has submitted the is known to be transmitted by infectious this to the levels of biomarkers of
following information collection request secretions, these secretions can be influenza infection in the blood of these
to the Office of Management and Budget transferred from person to person in patients. To do this, researchers will
(OMB) for review and approval in many different ways, and the relative collect airborne particles produced by
accordance with the Paperwork importance of the different pathways is volunteer subjects with influenza to test
Reduction Act of 1995. The notice for not known. The likelihood of the for influenza virus. Researchers will
the proposed information collection is transmission of influenza virus by small also measure the levels of influenza
published to obtain comments from the infectious airborne particles produced infection-associated biomarkers in blood
public and affected agencies. during coughing and breathing is samples from these subjects.
Written comments and suggestions particularly unclear. The question of A test coordinator will recruit
from the public and affected agencies airborne transmission is especially volunteer adult participants by using a
concerning the proposed collection of important in healthcare facilities, where poster and flyers describing the study.
information are encouraged. Your influenza patients tend to congregate Researchers will verbally screen
comments should address any of the during influenza season, because it interested potential participants to
following: (a) Evaluate whether the directly impacts the infection control verify that they have influenza-like
sradovich on DSKBBY8HB2PROD with NOTICES

proposed collection of information is and personal protective measures that symptoms and that they do not have any
necessary for the proper performance of should be taken by healthcare workers. medical conditions that would preclude
the functions of the agency, including Work under the previous approval their participation. Researchers will also
whether the information will have showed that patients infected with recruit a matching number of healthy
practical utility; (b) Evaluate the influenza virus produce airborne control participants.
accuracy of the agencies estimate of the particles containing viable airborne Researchers will ask qualified
burden of the proposed collection of influenza virus during both breathing participants who agree to participate in

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Document Created: 2017-09-16 00:52:21
Document Modified: 2017-09-16 00:52:21
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		82 FR 43542
82 FR 43542 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

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

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