80_FR_10532 80 FR 10494 - Submission for OMB Review; Emergency Clearance Request Human Influenza Surveillance of Health Care Centers in the United States and Taiwan [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer."> [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer." /> [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer." />

80 FR 10494 - Submission for OMB Review; Emergency Clearance Request Human Influenza Surveillance of Health Care Centers in the United States and Taiwan

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 38 (February 26, 2015)

Page Range10494-10495
FR Document2015-04069

In accordance with Section 3507(j) of the Paperwork Reduction Act of 1995, the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for emergency review and processing of this information collection by March 7, 2015. NIAID is requesting emergency processing of this information collection, pursuant to 5 CFR 1320.13, because NIAID cannot reasonably comply with the normal clearance procedures which would cause a delay and likely prevent or substantially disrupt the collection of information. A delay in starting the information collection would hinder the agency in accomplishing its mission to the detriment of the public good. Public harm could result through the loss of critically needed information to understand the causes of severity of influenza and associated morbidity and mortality during the Northern hemisphere 2014-15 influenza season. The 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. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. 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.

Federal Register, Volume 80 Issue 38 (Thursday, February 26, 2015)
[Federal Register Volume 80, Number 38 (Thursday, February 26, 2015)]
[Notices]
[Pages 10494-10495]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-04069]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; Emergency Clearance Request Human 
Influenza Surveillance of Health Care Centers in the United States and 
Taiwan

SUMMARY: In accordance with Section 3507(j) of the Paperwork Reduction 
Act of 1995, the National Institute of Allergy and Infectious Diseases 
(NIAID), the National Institutes of Health (NIH), has submitted to the 
Office of Management and Budget (OMB) a request for emergency review 
and processing of this information collection by March 7, 2015. NIAID 
is requesting emergency processing of this information collection, 
pursuant to 5 CFR 1320.13, because NIAID cannot reasonably comply with 
the normal clearance procedures which would cause a delay and likely 
prevent or substantially disrupt the collection of information. A delay 
in starting the information collection would hinder the agency in 
accomplishing its mission to the detriment of the public good. Public 
harm could result through the loss of critically needed information to 
understand the causes of severity of influenza and associated morbidity 
and mortality during the Northern hemisphere 2014-15 influenza season. 
The 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. Written 
comments and/or suggestions from the public and affected agencies are 
invited on one or more of the following points: (1) Whether the 
proposed collection of information is necessary for the proper 
performance of the function of the agency, including whether the 
information will have practical utility; (2) The accuracy of the 
agency's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) Ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) Ways to minimize the

[[Page 10495]]

burden of the collection of information on those who are to respond, 
including the use of appropriate automated, electronic, mechanical, or 
other technological collection techniques or other forms of information 
technology.
    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.

DATES: Comment due date: Comments regarding this information collection 
are best assured of having their full effect if received within 7 days 
of the date of this publication.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, 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

SUPPLEMENTARY INFORMATION: 
    Proposed Collection: Human Influenza Surveillance of Health Care 
Centers in the United States and Taiwan, (NIAID), 0925--NEW, National 
Institute of Allergy and Infectious Diseases (NIAID), National 
Institutes of Health (NIH).
    Need and Use of Information Collection: This study will identify 
individuals with influenza through focused surveillance in key regions 
of the United States and Taiwan, rapidly identify circulating influenza 
strains to identify those with pandemic potential and create an 
invaluable bank of human samples from patients with influenza to 
characterize the basis of severe disease--a critical knowledge gap 
impacting effectiveness of decision-making around patient care. The 
2014-15 influenza season is unique because the dominant circulating 
strain is an H3N2 strain that is not sensitive to the immunity induced 
by the influenza vaccine formulation administered to the general 
public. Our study will provide insight into viral determinants that may 
be contributing to the severity of influenza and associated morbidity 
and mortality this season. Capturing samples from this influenza season 
is essential for understanding the public health implications the virus 
may have in the future, and discerning the reasons behind the severity 
of the disease it causes.
    OMB approval is requested for 6 months. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 500.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                  Number of      Average burden
             Type of respondent                  Number of      responses per     per response     Total burden
                                                respondents       respondent       (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Patients....................................             500                2            30/60              500
----------------------------------------------------------------------------------------------------------------


    Dated: February 20, 2015.
Dione Washington,
Project Clearance Liaison, NIAID, NIH, NIAID, NIH.
[FR Doc. 2015-04069 Filed 2-25-15; 8:45 am]
BILLING CODE 4140-01-P



                                               10494                       Federal Register / Vol. 80, No. 38 / Thursday, February 26, 2015 / Notices

                                               Monday through Friday, and will be                         Agenda: The Committee will hear                    Room 17W65, Rockville, MD 20857;
                                               posted to the docket at http://                         presentations, including those on the                 telephone (301) 443–1127.
                                               www.regulations.gov.                                    following topics: Kidney Paired                       Jackie Painter,
                                                 Transcripts: As soon as a transcript is               Donation; Vascularized Composite                      Director, Division of the Executive Secretariat.
                                               available, FDA will post it at http://                  Allografts; Donor Management
                                                                                                                                                             [FR Doc. 2015–03929 Filed 2–25–15; 8:45 am]
                                               wwww.fda.gov/NewsEvents/                                Research; Living Donation; and the
                                                                                                                                                             BILLING CODE 4165–15–P
                                               MeetingsConferencesWorkshops/                           Affordable Care Act and
                                               ucm433552.htm.                                          Transplantation. Agenda items are
                                                 Dated: February 20, 2015.                             subject to change as priorities indicate.             DEPARTMENT OF HEALTH AND
                                               Leslie Kux,                                                After Committee discussions,                       HUMAN SERVICES
                                               Associate Commissioner for Policy.                      members of the public will have an
                                               [FR Doc. 2015–03974 Filed 2–25–15; 8:45 am]             opportunity to comment. Because of the                National Institutes of Health
                                               BILLING CODE 4164–01–P                                  Committee’s full agenda and timeframe                 Submission for OMB Review;
                                                                                                       in which to cover the agenda topics,                  Emergency Clearance Request Human
                                                                                                       public comment will be limited. All                   Influenza Surveillance of Health Care
                                               DEPARTMENT OF HEALTH AND                                public comments will be included in                   Centers in the United States and
                                               HUMAN SERVICES                                          the record of the ACOT meeting.                       Taiwan
                                                                                                       Meeting summary notes will be posted
                                               Health Resources and Services                                                                                 SUMMARY:    In accordance with Section
                                               Administration                                          on the Department’s organ donation
                                                                                                       Web site at http://www.organdonor.gov/                3507(j) of the Paperwork Reduction Act
                                                                                                                                                             of 1995, the National Institute of Allergy
                                               Advisory Committee on Organ                             legislation/advisory.html#meetings.
                                                                                                                                                             and Infectious Diseases (NIAID), the
                                               Transplantation; Notice of Meeting                         The draft meeting agenda will be                   National Institutes of Health (NIH), has
                                                                                                       posted on www.blsmeetings.net/ACOT.                   submitted to the Office of Management
                                                  In accordance with section 10(a)(2) of               Those participating on this meeting                   and Budget (OMB) a request for
                                               the Federal Advisory Committee Act                      should pre-register by visiting                       emergency review and processing of this
                                               (Pub. L. 92–463), notice is hereby given                www.blsmeetings.net/ACOT. The                         information collection by March 7,
                                               of the following meeting:
                                                                                                       deadline to pre-register for this meeting             2015. NIAID is requesting emergency
                                                  Name: Advisory Committee on Organ                                                                          processing of this information
                                                                                                       is Wednesday, March 11, 2015.
                                               Transplantation (ACOT).                                                                                       collection, pursuant to 5 CFR 1320.13,
                                                                                                       Registration will be confirmed on site.
                                                  Date and Time: March 12, from 8:30                                                                         because NIAID cannot reasonably
                                                                                                       For all logistical questions and
                                               a.m. to 4:30 p.m. Eastern Standard                                                                            comply with the normal clearance
                                                                                                       concerns, please contact Anita Allen,
                                               Time. March 13, from 8:30 a.m. to 12:30                                                                       procedures which would cause a delay
                                                                                                       Seamon Corporation at 301–658–3442
                                               p.m. Eastern Standard Time.                                                                                   and likely prevent or substantially
                                                                                                       or send an email to aallen@
                                                  Place: Health Resources and Services                                                                       disrupt the collection of information. A
                                               Administration, 5600 Fishers Lane,                      seamoncorporation.com.
                                                                                                                                                             delay in starting the information
                                               Room 05W11, Rockville, MD 20857.                           Public Comment: It is preferred that               collection would hinder the agency in
                                                  Status: The meeting will be open to                  persons interested in providing an oral               accomplishing its mission to the
                                               the public.                                             presentation email a written request,                 detriment of the public good. Public
                                                  Purpose: Under the authority of 42                   along with a copy of their presentation,              harm could result through the loss of
                                               U.S.C. Section 217a, Section 222 of the                 to Patricia Stroup, MBA, MPA,                         critically needed information to
                                               Public Health Service Act, as amended,                  Executive Secretary, Healthcare Systems               understand the causes of severity of
                                               and 42 CFR 121.12 (2000), ACOT was                      Bureau, Health Resources and Services                 influenza and associated morbidity and
                                               established to assist the Secretary in                  Administration, at pstroup@hrsa.gov.                  mortality during the Northern
                                               enhancing organ donation, ensuring that                 Requests should contain the name,                     hemisphere 2014–15 influenza season.
                                               the system of organ transplantation is                  address, telephone number, email                      The National Institutes of Health may
                                               grounded in the best available medical                  address, and any business or                          not conduct or sponsor, and the
                                               science, and assuring the public that the               professional affiliation of the person                respondent is not required to respond
                                               system is as effective and equitable as                 desiring to make an oral presentation.                to, an information collection that has
                                               possible, thereby increasing public                     Groups having similar interests are                   been extended, revised, or implemented
                                               confidence in the integrity and                         requested to combine their comments                   on or after October 1, 1995, unless it
                                               effectiveness of the transplantation                    and present them through a single                     displays a currently valid OMB control
                                               system. ACOT is composed of up to 25                    representative.                                       number. Written comments and/or
                                               members including the Chair. Members                                                                          suggestions from the public and affected
                                               serve as Special Government Employees                      The allocation of time may be                      agencies are invited on one or more of
                                               and have diverse backgrounds in fields                  adjusted to accommodate the level of                  the following points: (1) Whether the
                                               such as organ donation, health care                     expressed interest. Persons who do not                proposed collection of information is
                                               public policy, transplantation medicine                 file an advance request for a                         necessary for the proper performance of
                                               and surgery, critical care medicine, and                presentation, but desire to make an oral              the function of the agency, including
                                               other medical specialties involved in                   statement, may request it during the                  whether the information will have
                                               the identification and referral of donors,              public comment period. Public                         practical utility; (2) The accuracy of the
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                                               non-physician transplant professions,                   participation and ability to comment                  agency’s estimate of the burden of the
                                               nursing, epidemiology, immunology,                      will be limited to time as it permits. FOR            proposed collection of information,
                                               law and bioethics, behavioral sciences,                 FURTHER INFORMATION CONTACT: Patricia                 including the validity of the
                                               economics and statistics, as well as                    Stroup, MBA, MPA, Executive                           methodology and assumptions used; (3)
                                               representatives of transplant candidates,               Secretary, Healthcare Systems Bureau,                 Ways to enhance the quality, utility, and
                                               transplant recipients, organ donors, and                Health Resources and Services                         clarity of the information to be
                                               family members.                                         Administration, 5600 Fishers Lane,                    collected; and (4) Ways to minimize the


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                                                                                     Federal Register / Vol. 80, No. 38 / Thursday, February 26, 2015 / Notices                                                                   10495

                                               burden of the collection of information                                    instruments, contact Dr. Diane Post,                            disease—a critical knowledge gap
                                               on those who are to respond, including                                     Program Officer, Respiratory Diseases                           impacting effectiveness of decision-
                                               the use of appropriate automated,                                          Branch, NIAID, NIH 5601 Fishers Lane,                           making around patient care. The 2014–
                                               electronic, mechanical, or other                                           Bethesda, MD or call non-toll-free                              15 influenza season is unique because
                                               technological collection techniques or                                     number at 240–627–3348 or email your                            the dominant circulating strain is an
                                               other forms of information technology.                                     request, including your address to:                             H3N2 strain that is not sensitive to the
                                                 Direct Comments to OMB: Written                                          postd@niaid.nih.gov                                             immunity induced by the influenza
                                               comments and/or suggestions regarding                                      SUPPLEMENTARY INFORMATION:                                      vaccine formulation administered to the
                                               the item(s) contained in this notice,                                        Proposed Collection: Human                                    general public. Our study will provide
                                               especially regarding the estimated                                         Influenza Surveillance of Health Care                           insight into viral determinants that may
                                               public burden and associated response                                      Centers in the United States and                                be contributing to the severity of
                                               time, should be directed to the: Office                                    Taiwan, (NIAID), 0925—NEW, National                             influenza and associated morbidity and
                                               of Management and Budget, Office of                                        Institute of Allergy and Infectious
                                               Regulatory Affairs, OIRA_submission@                                                                                                       mortality this season. Capturing samples
                                                                                                                          Diseases (NIAID), National Institutes of                        from this influenza season is essential
                                               omb.eop.gov or by fax to 202–395–6974,                                     Health (NIH).
                                               Attention: NIH Desk Officer.                                                                                                               for understanding the public health
                                                                                                                            Need and Use of Information
                                               DATES: Comment due date: Comments
                                                                                                                                                                                          implications the virus may have in the
                                                                                                                          Collection: This study will identify
                                               regarding this information collection are                                                                                                  future, and discerning the reasons
                                                                                                                          individuals with influenza through
                                               best assured of having their full effect if                                                                                                behind the severity of the disease it
                                                                                                                          focused surveillance in key regions of
                                               received within 7 days of the date of                                      the United States and Taiwan, rapidly                           causes.
                                               this publication.                                                          identify circulating influenza strains to                          OMB approval is requested for 6
                                               FOR FURTHER INFORMATION CONTACT: To                                        identify those with pandemic potential                          months. There are no costs to
                                               request more information on the                                            and create an invaluable bank of human                          respondents other than their time. The
                                               proposed project or to obtain a copy of                                    samples from patients with influenza to                         total estimated annualized burden hours
                                               the data collection plans and                                              characterize the basis of severe                                are 500.

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

                                               Patients ............................................................................................................         500              2               30/60              500



                                                 Dated: February 20, 2015.                                                  Name of Committee: Center for Scientific                        Date: March 23–24, 2015.
                                               Dione Washington,                                                          Review Special Emphasis Panel,                                    Time: 8:00 a.m. to 5:00 p.m.
                                                                                                                          Fellowships: Risk, Prevention, and Health                         Agenda: To review and evaluate grant
                                               Project Clearance Liaison, NIAID, NIH,                                     Behavior Overflow.
                                               NIAID, NIH.                                                                                                                                applications.
                                                                                                                            Date: March 18, 2015.                                           Place: Embassy Suites at the Chevy Chase
                                               [FR Doc. 2015–04069 Filed 2–25–15; 8:45 am]                                  Time: 8:00 a.m. to 5:00 p.m.
                                                                                                                            Agenda: To review and evaluate grant                          Pavilion, 4300 Military Road, NW.,
                                               BILLING CODE 4140–01–P
                                                                                                                          applications.                                                   Washington, DC 20015.
                                                                                                                            Place: National Institutes of Health, 6701                      Contact Person: Martha M. Faraday, Ph.D.,
                                                                                                                          Rockledge Drive, Bethesda, MD 20892,                            Scientific Review Officer, Center for
                                               DEPARTMENT OF HEALTH AND
                                                                                                                          (Virtual Meeting).                                              Scientific Review, National Institutes of
                                               HUMAN SERVICES                                                               Contact Person: Lee S. Mann, Ph.D.,                           Health, 6701 Rockledge Drive, Room 3110,
                                                                                                                          Scientific Review Officer, Center for                           MSC 7808, Bethesda, MD 20892, (301) 435–
                                               National Institutes of Health                                              Scientific Review, National Institutes of                       3575, faradaym@csr.nih.gov.
                                                                                                                          Health, 6701 Rockledge Drive, Room 3224,
                                               Center for Scientific Review; Notice of                                    MSC 7808, Bethesda, MD 20892, 301–435–                          (Catalogue of Federal Domestic Assistance
                                               Closed Meetings                                                            0677, mannl@csr.nih.gov.                                        Program Nos. 93.306, Comparative Medicine;
                                                                                                                            Name of Committee: Center for Scientific                      93.333, Clinical Research, 93.306, 93.333,
                                                 Pursuant to section 10(d) of the                                         Review Special Emphasis Panel, Innate/                          93.337, 93.393–93.396, 93.837–93.844,
                                               Federal Advisory Committee Act, as                                         Adaptive Immunology and Vaccine                                 93.846–93.878, 93.892, 93.893, National
                                               amended (5 U.S.C. App.), notice is                                         Development.                                                    Institutes of Health, HHS)
                                               hereby given of the following meetings.                                      Date: March 19–20, 2015.
                                                                                                                            Time: 8:30 a.m. to 5:00 p.m.                                    Dated: February 20, 2015.
                                                 The meetings will be closed to the                                         Agenda: To review and evaluate grant                          Anna Snouffer,
                                               public in accordance with the                                              applications.                                                   Deputy Director, Office of Federal Advisory
                                               provisions set forth in sections                                             Place: Hilton Washington/Rockville, 1750                      Committee Policy.
                                               552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,                                 Rockville Pike, Rockville, MD 20852.
                                                                                                                            Contact Person: Patrick K. Lai, Ph.D.,                        [FR Doc. 2015–03936 Filed 2–25–15; 8:45 am]
                                               as amended. The grant applications and
                                               the discussions could disclose                                             Scientific Review Officer, Center for                           BILLING CODE 4140–01–P
rmajette on DSK2VPTVN1PROD with NOTICES




                                                                                                                          Scientific Review, National Institutes of
                                               confidential trade secrets or commercial
                                                                                                                          Health, 6701 Rockledge Drive, Room 2215,
                                               property such as patentable material,                                      MSC 7812, Bethesda, MD 20892, 301–435–
                                               and personal information concerning                                        1052, laip@csr.nih.gov.
                                               individuals associated with the grant                                        Name of Committee: Center for Scientific
                                               applications, the disclosure of which                                      Review Special Emphasis Panel,
                                               would constitute a clearly unwarranted                                     Fellowships: Risk, Prevention and Health
                                               invasion of personal privacy.                                              Behavior.



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Document Created: 2015-12-18 13:05:43
Document Modified: 2015-12-18 13:05:43
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
ContactTo request more information on the proposed project or to obtain a copy of the data collection plans and instruments, 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 10494 

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