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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