80_FR_56658 80 FR 56477 - Submission for OMB Review; 30-Day Comment Request; United States and Global Human Influenza Surveillance in At-Risk Settings (NIAID) [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication."> [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication." /> [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication." />

80 FR 56477 - Submission for OMB Review; 30-Day Comment Request; United States and Global Human Influenza Surveillance in At-Risk Settings (NIAID)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 181 (September 18, 2015)

Page Range56477-56478
FR Document2015-23479

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on April 9, 2015, page 19090 and allowed 60-days for public comment. One comment was received. However, it was not applicable to this data collection. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.

Federal Register, Volume 80 Issue 181 (Friday, September 18, 2015)
[Federal Register Volume 80, Number 181 (Friday, September 18, 2015)]
[Notices]
[Pages 56477-56478]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-23479]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; United States 
and Global Human Influenza Surveillance in At-Risk Settings (NIAID)

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Institutes of Health, has submitted 
to the Office of Management and Budget (OMB) a request for review and 
approval of the information collection listed below. This proposed 
information collection was previously published in the Federal Register 
on April 9, 2015, page 19090 and allowed 60-days for public comment. 
One comment was received. However, it was not applicable to this data 
collection. The purpose of this notice is to allow an additional 30 
days for public comment. The National Institute of Allergy and 
Infectious Diseases (NIAID), National Institutes of Health, may not 
conduct or sponsor, and the respondent is not required to respond to, 
an information collection that has been extended, revised, or 
implemented on or after October 1, 1995, unless it displays a currently 
valid OMB control number.
    Direct Comments to OMB: Written comments and/or suggestions 
regarding the item(s) contained in this notice, especially regarding 
the estimated public burden and associated response time, should be 
directed to the: Office of Management and Budget, Office of Regulatory 
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, 
Attention: NIH Desk Officer.
    Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 30 days 
of the date of this publication.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments, or request more information on the 
proposed project, contact: Dr. Diane Post, Program Officer, Respiratory 
Diseases Branch, NIAID, NIH, 5601 Fishers Lane, Bethesda, MD or call 
non-toll-free number at 240-627-3348 or email your request, including 
your address to: postd@niaid.nih.gov. Formal requests for additional 
plans and instruments must be requested in writing.
    Proposed Collection: United States and Global Human Influenza 
Surveillance in at-Risk Settings, 0925--NEW, National Institute of 
Allergies and Infectious Diseases (NIAID), National Institutes of 
Health (NIH).
    Need and Use of Information Collection: These studies will identify 
individuals with or at risk for influenza through focused surveillance 
in at-risk settings within the United States and internationally, 
rapidly identify circulating influenza strains to identify those with 
pandemic potential and create an invaluable bank of human samples from 
influenza patients to allow the characterization of the determinants of 
influenza transmission to and among humans, the immune response to 
influenza, and the basis of severe disease--critical knowledge gaps 
impacting effectiveness of decision-making around patient care and

[[Page 56478]]

pandemic preparedness. These studies will provide insight into viral 
and host determinants that may be contributing to the transmission of 
influenza, immune response to influenza, and severity of influenza and 
associated morbidity and mortality.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours for the entire 3 year request are 17334.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                            Estimates of hour burden
                               ---------------------------------------------------------------------------------
      Type of respondents                            Number of     Frequency of    Average time     Annual hour
                                    Form name       respondents      response      per response       burden
----------------------------------------------------------------------------------------------------------------
Hospital/care setting patients  Informed Consent            1600               1           10/60             267
                                 Form.
                                Form 1a           ..............               1           10/60             267
                                 Screening and
                                 enrollment log
                                 (Attachment 3).
                                Form 2a           ..............               1           10/60             267
                                 Eligibility
                                 Checklist
                                 (Attachment 4).
                                Form 3a Subject   ..............               1           10/60             267
                                 Identification
                                 (Attachment 5).
                                Form 4a           ..............               1           10/60             267
                                 Demographic and
                                 Exposure
                                 Information
                                 (Attachment 6).
                                Form 5a Current   ..............               1           10/60             267
                                 Symptoms
                                 (Attachment 7).
                                Form 6a Medical   ..............               1           10/60             267
                                 History
                                 (Attachment 8).
                                Form 8a Follow    ..............               4           10/60           1,067
                                 Up Assessment
                                 (Attachment 10).
Human Animal-interface          Informed Consent             900               1           10/60             150
 patients.                       Form.
                                Form 1a           ..............               1           10/60             150
                                 Screening and
                                 enrollment log
                                 (Attachment 3).
                                Form 2a           ..............               1           10/60             150
                                 Eligibility
                                 Checklist
                                 (Attachment 4).
                                Form 3a Subject   ..............               1           10/60             150
                                 Identification
                                 (Attachment 5).
                                Form 4a           ..............               1           10/60             150
                                 Demographic and
                                 Exposure
                                 Information
                                 (Attachment 6).
                                Form 5a Current   ..............              25           10/60           3,750
                                 Symptoms
                                 (Attachment 7).
                                Form 6a Medical   ..............               1           10/60             150
                                 History
                                 (Attachment 8).
                                Form 8a Follow    ..............              25           10/60           3,750
                                 Up Assessment
                                 (Attachment 10).
Household Surveillance          Informed Consent             500               1           10/60              83
 patients.                       Form.
                                Form 1a           ..............               1           10/60              83
                                 Screening and
                                 enrollment log
                                 (Attachment 3).
                                Form 2a           ..............               1           10/60              83
                                 Eligibility
                                 Checklist
                                 (Attachment 4).
                                Form 3a Subject   ..............               1           10/60              83
                                 Identification
                                 (Attachment 5).
                                Form 4a           ..............               1           10/60              83
                                 Demographic and
                                 Exposure
                                 Information
                                 (Attachment 6).
                                Form 5a Current   ..............               6           10/60             500
                                 Symptoms
                                 (Attachment 7).
                                Form 6a Medical   ..............               1           10/60              83
                                 History
                                 (Attachment 8).
                                Form 8a Follow    ..............               6           10/60             500
                                 Up Assessment
                                 (Attachment 10).
Study Staff...................  Informed Consent               5             600           10/60             500
                                 Form.
                                Form 7a           ..............             600           10/60             500
                                 Enrollment
                                 Specimen
                                 Collection
                                 (Attachment 9).
                                Form 9a ED Chart  ..............             600           10/60             500
                                 Review
                                 (Attachment 11).
                                Form 10a Chart    ..............             600           10/60             500
                                 Review--Inpatie
                                 nt
                                 Hospitalization
                                 (Attachment 12).
                                Form 11a Subject  ..............             600           10/60             500
                                 Withdrawal Form
                                 (Attachment 13).
                                Form 12a Subject  ..............             600           10/60             500
                                 checklist
                                 (Attachment 14).
                                Form 13A          ..............             600           10/60             500
                                 Enrollment
                                 Report
                                 (Attachment 15).
                                Form 14A 10%      ..............             600           10/60             500
                                 Data accuracy
                                 report
                                 (Attachment 16).
                                Form 15A--QC      ..............             600           10/60             500
                                 Checklist
                                 (Attachment 17).
                                                 ---------------------------------------------------------------
    Totals....................  ................           3,005  ..............  ..............          17,334
----------------------------------------------------------------------------------------------------------------


    Dated: September 10, 2015.
Dione Washington,
Project Clearance Liaison, NIAID, NIH.
[FR Doc. 2015-23479 Filed 9-17-15; 8:45 am]
BILLING CODE 4140-01-P



                                                                          Federal Register / Vol. 80, No. 181 / Friday, September 18, 2015 / Notices                                           56477

                                              be available at http://ntp.niehs.nih.gov/               DEPARTMENT OF HEALTH AND                              collection was previously published in
                                              go/ivive-wksp-2016.                                     HUMAN SERVICES                                        the Federal Register on April 9, 2015,
                                                 Meeting and Registration: This                                                                             page 19090 and allowed 60-days for
                                                                                                      National Institutes of Health                         public comment. One comment was
                                              workshop is open to the public, free of
                                              charge, with attendance limited only by                                                                       received. However, it was not applicable
                                                                                                      National Institute on Aging; Notice of                to this data collection. The purpose of
                                              the space available. Registration is                    Closed Meeting                                        this notice is to allow an additional 30
                                              required to attend both the webinars
                                                                                                        Pursuant to section 10(d) of the                    days for public comment. The National
                                              and the workshop. Those persons                                                                               Institute of Allergy and Infectious
                                              attending the workshop should plan to                   Federal Advisory Committee Act, as
                                                                                                      amended (5 U.S.C. App.), notice is                    Diseases (NIAID), National Institutes of
                                              participate in all four webinars.                                                                             Health, may not conduct or sponsor,
                                                                                                      hereby given of the following meeting.
                                              However, viewing the webinars does not                    The meeting will be closed to the                   and the respondent is not required to
                                              require attendance at the workshop.                     public in accordance with the                         respond to, an information collection
                                              Individuals who plan to attend the                      provisions set forth in sections                      that has been extended, revised, or
                                              workshop must register at http://                       552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,            implemented on or after October 1,
                                              ntp.niehs.nih.gov/go/ivive-wksp-2016 by                 as amended. The grant applications and                1995, unless it displays a currently valid
                                              February 5, 2016. Individuals who plan                  the discussions could disclose                        OMB control number.
                                              to participate in the webinars must                     confidential trade secrets or commercial                 Direct Comments to OMB: Written
                                              register at http://ntp.niehs.nih.gov/go/                property such as patentable material,                 comments and/or suggestions regarding
                                              ivive-wksp-2016 two business days prior                 and personal information concerning                   the item(s) contained in this notice,
                                              to the webinar date to ensure access.                   individuals associated with the grant                 especially regarding the estimated
                                              Please visit this Web page for the most                 applications, the disclosure of which                 public burden and associated response
                                              current information about the webinars                  would constitute a clearly unwarranted                time, should be directed to the: Office
                                              and workshop. For those who register,                   invasion of personal privacy.                         of Management and Budget, Office of
                                              information about how to access the                       Name of Committee: National Institute on
                                                                                                                                                            Regulatory Affairs, OIRA_submission@
                                              webinar will be emailed within two                      Aging Special Emphasis Panel; Aging of the            omb.eop.gov or by fax to 202–395–6974,
                                              business days of each webinar.                          Lung.                                                 Attention: NIH Desk Officer.
                                                                                                        Date: October 20, 2015.                                Comment Due Date: Comments
                                                 Individuals with disabilities who                      Time: 3:00 p.m. to 7:00 p.m.                        regarding this information collection are
                                              need accommodation to participate in                      Agenda: To review and evaluate grant                best assured of having their full effect if
                                              these events should contact Dr.                         applications.                                         received within 30 days of the date of
                                              Elizabeth Maull at phone: (919) 316–                      Place: National Institute on Aging,                 this publication.
                                              4668 or email: maull@niehs.nih.gov.                     Gateway Building, 2C212, 7201 Wisconsin
                                                                                                      Avenue, Bethesda, MD 20892, (Telephone                FOR FURTHER INFORMATION CONTACT: To
                                              TTY users should contact the Federal                                                                          obtain a copy of the data collection
                                                                                                      Conference Call).
                                              TTY Relay Service at (800) 877–8339.                      Contact Person: Maurizio Grimaldi, MD,              plans and instruments, or request more
                                              Requests should be made at least five                   Ph.D., Scientific Review Officer, National            information on the proposed project,
                                              business days in advance of the event.                  Institute on Aging, National Institutes of            contact: Dr. Diane Post, Program Officer,
                                              Visitor and security information for                    Health, 7201 Wisconsin Avenue, Room                   Respiratory Diseases Branch, NIAID,
                                              those attending the workshop can be                     2c218, Bethesda, MD 20892, 301–496–9374,              NIH, 5601 Fishers Lane, Bethesda, MD
                                              found at http://www2.epa.gov/                           grimaldim2@mail.nih.gov.
                                                                                                                                                            or call non-toll-free number at 240–627–
                                              aboutepa/about-epas-campus-research-                    (Catalogue of Federal Domestic Assistance             3348 or email your request, including
                                              triangle-park-rtp-north-carolina.                       Program Nos. 93.866, Aging Research,
                                                                                                      National Institutes of Health, HHS)
                                                                                                                                                            your address to: postd@niaid.nih.gov.
                                                 Background Information on                                                                                  Formal requests for additional plans and
                                                                                                        Dated: September 14, 2015.                          instruments must be requested in
                                              NICEATM: NICEATM conducts data
                                                                                                      Melanie J. Gray,                                      writing.
                                              analyses, workshops, independent
                                              validation studies, and other activities                Program Analyst, Office of Federal Advisory              Proposed Collection: United States
                                                                                                      Committee Policy.                                     and Global Human Influenza
                                              to assess new, revised, and alternative
                                              test methods and strategies. NICEATM
                                                                                                      [FR Doc. 2015–23388 Filed 9–17–15; 8:45 am]           Surveillance in at-Risk Settings, 0925—
                                                                                                      BILLING CODE 4140–01–P                                NEW, National Institute of Allergies and
                                              also provides support for the
                                                                                                                                                            Infectious Diseases (NIAID), National
                                              Interagency Coordinating Committee on
                                                                                                                                                            Institutes of Health (NIH).
                                              the Validation of Alternative Methods                   DEPARTMENT OF HEALTH AND                                 Need and Use of Information
                                              (ICCVAM). The ICCVAM Authorization                      HUMAN SERVICES                                        Collection: These studies will identify
                                              Act of 2000 (42 U.S.C. 285l–3) provides                                                                       individuals with or at risk for influenza
                                              authority for ICCVAM and NICEATM in                     National Institutes of Health                         through focused surveillance in at-risk
                                              the development of alternative test                                                                           settings within the United States and
                                              methods. Information about NICEATM                      Submission for OMB Review; 30-Day
                                                                                                                                                            internationally, rapidly identify
                                              and ICCVAM is found at http://                          Comment Request; United States and
                                                                                                                                                            circulating influenza strains to identify
                                              ntp.niehs.nih.gov/go/niceatm and                        Global Human Influenza Surveillance
                                                                                                                                                            those with pandemic potential and
                                              http://ntp.niehs.nih.gov/go/iccvam,                     in At-Risk Settings (NIAID)
                                                                                                                                                            create an invaluable bank of human
                                              respectively.                                           SUMMARY:   Under the provisions of                    samples from influenza patients to
tkelley on DSK3SPTVN1PROD with NOTICES




                                                Dated: September 14, 2015.                            Section 3507(a)(1)(D) of the Paperwork                allow the characterization of the
                                                                                                      Reduction Act of 1995, the National                   determinants of influenza transmission
                                              John R. Bucher,
                                                                                                      Institutes of Health, has submitted to the            to and among humans, the immune
                                              Associate Director, National Toxicology                 Office of Management and Budget                       response to influenza, and the basis of
                                              Program.                                                (OMB) a request for review and                        severe disease—critical knowledge gaps
                                              [FR Doc. 2015–23386 Filed 9–17–15; 8:45 am]             approval of the information collection                impacting effectiveness of decision-
                                              BILLING CODE 4140–01–P                                  listed below. This proposed information               making around patient care and


                                         VerDate Sep<11>2014   18:47 Sep 17, 2015   Jkt 235001   PO 00000   Frm 00041   Fmt 4703   Sfmt 4703   E:\FR\FM\18SEN1.SGM   18SEN1


                                              56478                              Federal Register / Vol. 80, No. 181 / Friday, September 18, 2015 / Notices

                                              pandemic preparedness. These studies                                    severity of influenza and associated                                          estimated annualized burden hours for
                                              will provide insight into viral and host                                morbidity and mortality.                                                      the entire 3 year request are 17334.
                                              determinants that may be contributing                                     OMB approval is requested for 3
                                              to the transmission of influenza,                                       years. There are no costs to respondents
                                              immune response to influenza, and                                       other than their time. The total

                                                                                                                     ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                 Estimates of hour burden
                                                    Type of respondents                                                                                                Number of                 Frequency of               Average time              Annual hour
                                                                                                                     Form name                                        respondents                  response                 per response                burden

                                              Hospital/care setting patients               Informed Consent Form ...............................                                     1600                             1                   10/60               267
                                                                                           Form 1a Screening and enrollment log (At-                                 ........................                         1                   10/60               267
                                                                                              tachment 3).
                                                                                           Form 2a Eligibility Checklist (Attachment 4)                              ........................                         1                  10/60                267
                                                                                           Form 3a Subject Identification (Attachment                                ........................                         1                  10/60                267
                                                                                              5).
                                                                                           Form 4a Demographic and Exposure Infor-                                   ........................                         1                   10/60               267
                                                                                              mation (Attachment 6).
                                                                                           Form 5a Current Symptoms (Attachment 7)                                   ........................                         1                  10/60                 267
                                                                                           Form 6a Medical History (Attachment 8) .....                              ........................                         1                  10/60                 267
                                                                                           Form 8a Follow Up Assessment (Attach-                                     ........................                         4                  10/60               1,067
                                                                                              ment 10).
                                              Human Animal-interface pa-                   Informed Consent Form ...............................                                       900                            1                  10/60                150
                                                tients.
                                                                                           Form 1a Screening and enrollment log (At-                                 ........................                         1                   10/60               150
                                                                                              tachment 3).
                                                                                           Form 2a Eligibility Checklist (Attachment 4)                              ........................                         1                  10/60                150
                                                                                           Form 3a Subject Identification (Attachment                                ........................                         1                  10/60                150
                                                                                              5).
                                                                                           Form 4a Demographic and Exposure Infor-                                   ........................                         1                   10/60               150
                                                                                              mation (Attachment 6).
                                                                                           Form 5a Current Symptoms (Attachment 7)                                   ........................                       25                   10/60               3,750
                                                                                           Form 6a Medical History (Attachment 8) .....                              ........................                        1                   10/60                 150
                                                                                           Form 8a Follow Up Assessment (Attach-                                     ........................                       25                   10/60               3,750
                                                                                              ment 10).
                                              Household Surveillance pa-                   Informed Consent Form ...............................                                       500                           1                   10/60                  83
                                                tients.
                                                                                           Form 1a Screening and enrollment log (At-                                 ........................                         1                   10/60                 83
                                                                                              tachment 3).
                                                                                           Form 2a Eligibility Checklist (Attachment 4)                              ........................                         1                  10/60                  83
                                                                                           Form 3a Subject Identification (Attachment                                ........................                         1                  10/60                  83
                                                                                              5).
                                                                                           Form 4a Demographic and Exposure Infor-                                   ........................                         1                   10/60                 83
                                                                                              mation (Attachment 6).
                                                                                           Form 5a Current Symptoms (Attachment 7)                                   ........................                         6                  10/60                500
                                                                                           Form 6a Medical History (Attachment 8) .....                              ........................                         1                  10/60                 83
                                                                                           Form 8a Follow Up Assessment (Attach-                                     ........................                         6                  10/60                500
                                                                                              ment 10).
                                              Study Staff .............................    Informed Consent Form ...............................                                           5                     600                      10/60               500
                                                                                           Form 7a Enrollment Specimen Collection                                    ........................                    600                      10/60               500
                                                                                              (Attachment 9).
                                                                                           Form 9a ED Chart Review (Attachment 11)                                   ........................                     600                    10/60                500
                                                                                           Form 10a Chart Review—Inpatient Hos-                                      ........................                     600                    10/60                500
                                                                                              pitalization (Attachment 12).
                                                                                           Form 11a Subject Withdrawal Form (At-                                     ........................                     600                     10/60               500
                                                                                              tachment 13).
                                                                                           Form 12a Subject checklist (Attachment 14)                                ........................                     600                    10/60                500
                                                                                           Form 13A Enrollment Report (Attachment                                    ........................                     600                    10/60                500
                                                                                              15).
                                                                                           Form 14A 10% Data accuracy report (At-                                    ........................                     600                     10/60               500
                                                                                              tachment 16).
                                                                                           Form 15A—QC Checklist (Attachment 17) ..                                  ........................                     600                    10/60                500

                                                    Totals .............................   .......................................................................                  3,005       ........................   ........................         17,334
tkelley on DSK3SPTVN1PROD with NOTICES




                                                Dated: September 10, 2015.
                                              Dione Washington,
                                              Project Clearance Liaison, NIAID, NIH.
                                              [FR Doc. 2015–23479 Filed 9–17–15; 8:45 am]
                                              BILLING CODE 4140–01–P




                                         VerDate Sep<11>2014       18:47 Sep 17, 2015       Jkt 235001        PO 00000        Frm 00042        Fmt 4703        Sfmt 9990      E:\FR\FM\18SEN1.SGM               18SEN1



Document Created: 2015-12-15 09:27:59
Document Modified: 2015-12-15 09:27:59
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
DatesComments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
ContactTo obtain a copy of the data collection plans and instruments, or request more information on the proposed project, contact: Dr. Diane Post, Program Officer, Respiratory Diseases Branch, NIAID, NIH, 5601 Fishers Lane, Bethesda, MD or call non-toll-free number at 240-627-3348 or email your request, including
FR Citation80 FR 56477 

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