Submission for OMB Review; 30-Day Comment Request; United States and Global Human Influenza Surveillance in At-Risk Settings (NIAID), 56477-56478 [2015-23479]
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Dated: September 14, 2015.
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[FR Doc. 2015–23386 Filed 9–17–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Aging of the
Lung.
Date: October 20, 2015.
Time: 3:00 p.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 2C212, 7201 Wisconsin
Avenue, Bethesda, MD 20892, (Telephone
Conference Call).
Contact Person: Maurizio Grimaldi, MD,
Ph.D., Scientific Review Officer, National
Institute on Aging, National Institutes of
Health, 7201 Wisconsin Avenue, Room
2c218, Bethesda, MD 20892, 301–496–9374,
grimaldim2@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: September 14, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–23388 Filed 9–17–15; 8:45 am]
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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)
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
SUMMARY:
PO 00000
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56477
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 decisionmaking around patient care and
E:\FR\FM\18SEN1.SGM
18SEN1
56478
Federal Register / Vol. 80, No. 181 / Friday, September 18, 2015 / Notices
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
Form name
Hospital/care setting patients
Human Animal-interface patients.
Household Surveillance patients.
Study Staff .............................
tkelley on DSK3SPTVN1PROD with NOTICES
Totals .............................
Number of
respondents
Frequency of
response
Informed Consent Form ...............................
Form 1a Screening and enrollment log (Attachment 3).
Form 2a Eligibility Checklist (Attachment 4)
Form 3a Subject Identification (Attachment
5).
Form 4a Demographic and Exposure Information (Attachment 6).
Form 5a Current Symptoms (Attachment 7)
Form 6a Medical History (Attachment 8) .....
Form 8a Follow Up Assessment (Attachment 10).
Informed Consent Form ...............................
1600
........................
1
1
10/60
10/60
267
267
........................
........................
1
1
10/60
10/60
267
267
........................
1
10/60
267
........................
........................
........................
1
1
4
10/60
10/60
10/60
267
267
1,067
900
1
10/60
150
Form 1a Screening and enrollment log (Attachment 3).
Form 2a Eligibility Checklist (Attachment 4)
Form 3a Subject Identification (Attachment
5).
Form 4a Demographic and Exposure Information (Attachment 6).
Form 5a Current Symptoms (Attachment 7)
Form 6a Medical History (Attachment 8) .....
Form 8a Follow Up Assessment (Attachment 10).
Informed Consent Form ...............................
........................
1
10/60
150
........................
........................
1
1
10/60
10/60
150
150
........................
1
10/60
150
........................
........................
........................
25
1
25
10/60
10/60
10/60
3,750
150
3,750
500
1
10/60
83
Form 1a Screening and enrollment log (Attachment 3).
Form 2a Eligibility Checklist (Attachment 4)
Form 3a Subject Identification (Attachment
5).
Form 4a Demographic and Exposure Information (Attachment 6).
Form 5a Current Symptoms (Attachment 7)
Form 6a Medical History (Attachment 8) .....
Form 8a Follow Up Assessment (Attachment 10).
Informed Consent Form ...............................
Form 7a Enrollment Specimen Collection
(Attachment 9).
Form 9a ED Chart Review (Attachment 11)
Form 10a Chart Review—Inpatient Hospitalization (Attachment 12).
Form 11a Subject Withdrawal Form (Attachment 13).
Form 12a Subject checklist (Attachment 14)
Form 13A Enrollment Report (Attachment
15).
Form 14A 10% Data accuracy report (Attachment 16).
Form 15A—QC Checklist (Attachment 17) ..
........................
1
10/60
83
........................
........................
1
1
10/60
10/60
83
83
........................
1
10/60
83
........................
........................
........................
6
1
6
10/60
10/60
10/60
500
83
500
5
........................
600
600
10/60
10/60
500
500
........................
........................
600
600
10/60
10/60
500
500
........................
600
10/60
500
........................
........................
600
600
10/60
10/60
500
500
........................
600
10/60
500
........................
600
10/60
500
.......................................................................
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]
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Average time
per response
Annual hour
burden
]]>Agencies
[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]
-----------------------------------------------------------------------
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
