82_FR_12400 82 FR 12360 - Proposed Data Collection Submitted for Public Comment and Recommendations

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)

Page Range12360-12361
FR Document2017-04045

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 Issue 40 (Thursday, March 2, 2017)
[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response  (in     (in hrs.)
                                                                    respondent         hrs.)
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------


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



                                                12360                                  Federal Register / Vol. 82, No. 40 / Thursday, March 2, 2017 / Notices

                                                level and any faculty changes. Sponsors                                 and organizations throughout the                                              our service to courses, the effectiveness
                                                who elect to have their approval                                        country voluntarily submit applications                                       of the program changes implemented
                                                renewed for an additional 5 year period                                 and materials to become course                                                since 2005, and the usefulness of
                                                submit a renewal application and                                        sponsors and carry out training.                                              potential Program enhancements.
                                                supporting documentation for review by                                  Submissions are required for NIOSH to
                                                                                                                                                                                                        The annualized figures slightly over-
                                                NIOSH staff to ensure the course                                        evaluate a course and determine
                                                                                                                                                                                                      estimate the actual burden, due to
                                                curriculum meets all current standard                                   whether it meets the criteria in the
                                                                                                                        Standard and whether technicians will                                         rounding of the number of respondents
                                                requirements.
                                                  Approved courses that elect to offer                                  be adequately trained as mandated                                             for even allocation over the three-year
                                                NIOSH-Approved Spirometry Refresher                                     under the Standard. NIOSH will                                                clearance period. The estimated annual
                                                Courses must submit a separate                                          disseminate a one-time customer                                               burden to respondents is 159 hours.
                                                application and supporting documents                                    satisfaction survey to course directors                                       There will be no cost to respondents.
                                                for review by NIOSH staff. Institutions                                 and sponsor representatives to evaluate

                                                                                                                       ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                                  Average
                                                                                                                                                                                                    Number of
                                                                                                                                                                         Number of                                              burden per              Total burden
                                                          Type of respondents                                                Form name                                                            responses per
                                                                                                                                                                        respondents                                              response                (in hours)
                                                                                                                                                                                                    respondent                   (in hours)

                                                Potential Sponsors ............................          Initial Application ..............................                                3                           1                       8                  24
                                                                                                         Annual Report ..................................                                 30                           1                   30/60                  15
                                                                                                         Report for course changes ..............                                         24                           1                   30/60                  12
                                                                                                         Renewal Application .........................                                    13                           1                       6                  78
                                                                                                         Refresher Course Application ..........                                           3                           1                       8                  24
                                                                                                         One-time Customer Satisfaction ......                                            32                           1                   12/60                   6
                                                                                                         Survey ..............................................

                                                     Total ...........................................   ...........................................................   ........................   ........................   ........................            159



                                                Leroy A. Richardson,                                                    collection project titled ‘‘Factors                                           the information collection plan and
                                                Chief, Information Collection Review Office,                            Influencing the Transmission of                                               instruments, contact the Information
                                                Office of Scientific Integrity, Office of the                           Influenza.’’ This data collection project                                     Collection Review Office, Centers for
                                                Associate Director for Science, Office of the                           will help examine the amount of                                               Disease Control and Prevention, 1600
                                                Director, Centers for Disease Control and                               influenza virus in airborne particles                                         Clifton Road NE., MS–D74, Atlanta,
                                                Prevention.                                                             produced by subjects with influenza                                           Georgia 30329; phone: 404–639–7570;
                                                [FR Doc. 2017–04047 Filed 3–1–17; 8:45 am]                              and it relationship to biomarkers in the                                      Email: omb@cdc.gov.
                                                BILLING CODE 4163–18–P                                                  blood.                                                                        SUPPLEMENTARY INFORMATION: Under the
                                                                                                                        DATES: Written comments must be                                               Paperwork Reduction Act of 1995 (PRA)
                                                                                                                        received on or before May 1, 2017.                                            (44 U.S.C. 3501–3520), Federal agencies
                                                DEPARTMENT OF HEALTH AND
                                                                                                                        ADDRESSES: You may submit comments,                                           must obtain approval from the Office of
                                                HUMAN SERVICES
                                                                                                                        identified by Docket No. CDC–2017–                                            Management and Budget (OMB) for each
                                                Centers for Disease Control and                                         0013 by any of the following methods:                                         collection of information they conduct
                                                Prevention                                                                • Federal eRulemaking Portal:                                               or sponsor. In addition, the PRA also
                                                                                                                        Regulations.gov. Follow the instructions                                      requires Federal agencies to provide a
                                                [60Day–17–17RT; Docket No. CDC–2017–                                                                                                                  60-day notice in the Federal Register
                                                0013]                                                                   for submitting comments.
                                                                                                                          • Mail: Leroy A. Richardson,                                                concerning each proposed collection of
                                                                                                                        Information Collection Review Office,                                         information, including each new
                                                Proposed Data Collection Submitted
                                                                                                                        Centers for Disease Control and                                               proposed collection, each proposed
                                                for Public Comment and
                                                                                                                        Prevention, 1600 Clifton Road NE., MS–                                        extension of existing collection of
                                                Recommendations
                                                                                                                        D74, Atlanta, Georgia 30329.                                                  information, and each reinstatement of
                                                AGENCY: Centers for Disease Control and                                   Instructions: All submissions received                                      previously approved information
                                                Prevention (CDC), Department of Health                                  must include the agency name and                                              collection before submitting the
                                                and Human Services (HHS).                                               Docket Number. All relevant comments                                          collection to OMB for approval. To
                                                ACTION: Notice with comment period.                                     received will be posted without change                                        comply with this requirement, we are
                                                                                                                        to Regulations.gov, including any                                             publishing this notice of a proposed
                                                SUMMARY:   The Centers for Disease                                      personal information provided. For                                            data collection as described below.
                                                Control and Prevention (CDC), as part of                                access to the docket to read background                                          Comments are invited on: (a) Whether
                                                its continuing efforts to reduce public                                 documents or comments received, go to                                         the proposed collection of information
                                                burden and maximize the utility of                                      Regulations.gov.                                                              is necessary for the proper performance
                                                government information, invites the                                                                                                                   of the functions of the agency, including
sradovich on DSK3GMQ082PROD with NOTICES




                                                general public and other Federal                                          Please note: All public comment should be                                   whether the information shall have
                                                agencies to take this opportunity to                                    submitted through the Federal eRulemaking                                     practical utility; (b) the accuracy of the
                                                                                                                        portal (Regulations.gov) or by U.S. mail to the
                                                comment on proposed and/or                                              address listed above.
                                                                                                                                                                                                      agency’s estimate of the burden of the
                                                continuing information collections, as                                                                                                                proposed collection of information; (c)
                                                required by the Paperwork Reduction                                     FOR FURTHER INFORMATION CONTACT:    To                                        ways to enhance the quality, utility, and
                                                Act of 1995. This notice invites                                        request more information on the                                               clarity of the information to be
                                                comment on a proposed information                                       proposed project or to obtain a copy of                                       collected; (d) ways to minimize the


                                           VerDate Sep<11>2014       16:13 Mar 01, 2017        Jkt 241001      PO 00000         Frm 00026        Fmt 4703       Sfmt 4703       E:\FR\FM\02MRN1.SGM                02MRN1


                                                                                       Federal Register / Vol. 82, No. 40 / Thursday, March 2, 2017 / Notices                                                                                                 12361

                                                burden of the collection of information                                  (NIOSH) is authorized to conduct                                              influenza virus, and the levels of
                                                on respondents, including through the                                    research to advance the health and                                            influenza infection-associated
                                                use of automated collection techniques                                   safety of workers under Section 20(a)(1)                                      biomarkers will be measured in blood
                                                or other forms of information                                            of the 1970 Occupational Safety and                                           samples from these subjects.
                                                technology; and (e) estimates of capital                                 Health Act.                                                                     Volunteer adult participants will be
                                                or start-up costs and costs of operation,                                   Influenza continues to be a major                                          recruited by a test coordinator using a
                                                maintenance, and purchase of services                                    public health concern because of the                                          poster and flyers describing the study.
                                                to provide information. Burden means                                     substantial health burden from seasonal
                                                the total time, effort, or financial                                                                                                                   Interested potential participants will be
                                                                                                                         influenza and the potential for a severe                                      screened verbally to verify that they
                                                resources expended by persons to                                         pandemic. Although influenza is known
                                                generate, maintain, retain, disclose or                                                                                                                have influenza-like symptoms and that
                                                                                                                         to be transmitted by infectious                                               they do not have any medical
                                                provide information to or for a Federal                                  secretions, these secretions can be
                                                agency. This includes the time needed                                                                                                                  conditions that would preclude their
                                                                                                                         transferred from person to person in                                          participation. Qualified participants
                                                to review instructions; to develop,                                      many different ways, and the relative
                                                acquire, install and utilize technology                                                                                                                who agree to participate in the study
                                                                                                                         importance of the different pathways is
                                                and systems for the purpose of                                                                                                                         will be asked to read and sign an
                                                                                                                         not known. The likelihood of the
                                                collecting, validating and verifying                                                                                                                   informed consent form, and then to
                                                                                                                         transmission of influenza virus by small
                                                information, processing and                                                                                                                            complete a short health questionnaire.
                                                                                                                         infectious airborne particles produced
                                                maintaining information, and disclosing                                                                                                                After completing the forms, the
                                                                                                                         during coughing and breathing is
                                                and providing information; to train                                      particularly unclear. The question of                                         participant’s oral temperature will be
                                                personnel and to be able to respond to                                   airborne transmission is especially                                           measured and two nasopharyngeal
                                                a collection of information, to search                                   important in healthcare facilities, where                                     swabs and five milliliters of blood will
                                                data sources, to complete and review                                     influenza patients tend to congregate                                         be collected. The participant then will
                                                the collection of information; and to                                    during influenza season, because it                                           be asked to cough repeatedly into an
                                                transmit or otherwise disclose the                                       directly impacts the infection control                                        aerosol particle collection system, and
                                                information.                                                             and personal protective measures that                                         the airborne particles produced by the
                                                Proposed Project                                                         should be taken by healthcare workers.                                        participant during coughing will be
                                                                                                                                                                                                       collected and tested.
                                                  Factors Influencing the Transmission                                      The purpose of this study is to gain
                                                of Influenza—New—National Institute                                      a better understanding of the production                                        The study will require 40 volunteer
                                                for Occupational Safety and Health                                       of infectious aerosols by patients with                                       test subjects each year for three years,
                                                (NIOSH), Centers for Disease Control                                     influenza, and to compare this to the                                         for a total of 120 test participants.
                                                and Prevention (CDC).                                                    levels of biomarkers of influenza                                             NIOSH intends to seek a three-year
                                                                                                                         infection in the blood of these patients.                                     OMB approval to conduct this
                                                Background and Brief Description                                         To do this, airborne particles produced                                       information collection. There are no
                                                  The National Institute for                                             by volunteer subjects with influenza                                          costs to respondents other than their
                                                Occupational Safety and Health                                           will be collected and tested for                                              time.

                                                                                                                        ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                                   Average
                                                                                                                                                                                                     Number of
                                                                                                                                                                          Number of                                              burden per              Total burden
                                                          Type of respondents                                                 Form name                                                            responses per
                                                                                                                                                                         respondents                                              response                 (in hrs.)
                                                                                                                                                                                                     respondent                    (in hrs.)

                                                Potential participant        ..........................   Initial Verbal Screening ....................                                   240                           1                     3/60                 12
                                                Qualified participant        ..........................   Informed consent form .....................                                     120                           1                    15/60                 30
                                                Qualified participant        ..........................   Health questionnaire ........................                                   120                           1                     5/60                 10
                                                Qualified participant        ..........................   Medical Testing ................................                                120                           1                    40/60                 80

                                                     Total ...........................................    ...........................................................   ........................   ........................   ........................            132



                                                Leroy A. Richardson,                                                     DEPARTMENT OF HEALTH AND                                                      the proposed information collection is
                                                Chief, Information Collection Review Office,                             HUMAN SERVICES                                                                published to obtain comments from the
                                                Office of Scientific Integrity, Office of the                                                                                                          public and affected agencies.
                                                Associate Director for Science, Office of the                            Centers for Disease Control and                                                  Written comments and suggestions
                                                Director, Centers for Disease Control and                                Prevention                                                                    from the public and affected agencies
                                                Prevention.
                                                                                                                                                                                                       concerning the proposed collection of
                                                [FR Doc. 2017–04045 Filed 3–1–17; 8:45 am]                               [30Day–17–16AJE]                                                              information are encouraged. Your
                                                BILLING CODE 4163–18–P
                                                                                                                         Agency Forms Undergoing Paperwork                                             comments should address any of the
                                                                                                                         Reduction Act Review                                                          following: (a) Evaluate whether the
                                                                                                                                                                                                       proposed collection of information is
sradovich on DSK3GMQ082PROD with NOTICES




                                                                                                                           The Centers for Disease Control and                                         necessary for the proper performance of
                                                                                                                         Prevention (CDC) has submitted the                                            the functions of the agency, including
                                                                                                                         following information collection request                                      whether the information will have
                                                                                                                         to the Office of Management and Budget                                        practical utility; (b) Evaluate the
                                                                                                                         (OMB) for review and approval in                                              accuracy of the agencies estimate of the
                                                                                                                         accordance with the Paperwork                                                 burden of the proposed collection of
                                                                                                                         Reduction Act of 1995. The notice for                                         information, including the validity of


                                           VerDate Sep<11>2014       16:13 Mar 01, 2017         Jkt 241001      PO 00000         Frm 00027        Fmt 4703       Sfmt 4703       E:\FR\FM\02MRN1.SGM                02MRN1



Document Created: 2017-03-02 00:09:31
Document Modified: 2017-03-02 00:09:31
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice with comment period.
DatesWritten comments must be received on or before May 1, 2017.
ContactTo 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]
FR Citation82 FR 12360 

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR