[Federal Register Volume 80, Number 181 (Friday, September 18, 2015)]
[Notices]
[Pages 56477-56478]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23479]


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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, [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.

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: [email protected]. 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