81 FR 17535 - Request for Comments on World Health Organization Pandemic Influenza Preparedness Framework Review
DEPARTMENT OF STATE Federal Register Volume 81, Issue 60 (March 29, 2016)
Federal Register Volume 81, Issue 60 (March 29, 2016)
| Page Range | 17535-17536 | |
| FR Document | 2016-07069 |
[Federal Register Volume 81, Number 60 (Tuesday, March 29, 2016)] [Notices] [Pages 17535-17536] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-07069] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF STATE [Public Notice: 9495] Request for Comments on World Health Organization Pandemic Influenza Preparedness Framework Review AGENCY: International Health and Biodefense, U.S. Department of State. ACTION: Notice and request for comments. ----------------------------------------------------------------------- SUMMARY: The U.S. Department of State invites submission of comments from the public and relevant industries on influenza surveillance and response, related to the implementation of the World Health Organization (WHO) Pandemic Influenza Preparedness Framework (PIP-FW) (http://apps.who.int/gb/ebwha/pdf_files/WHA64/A64_8-en.pdf). Comments are specifically requested on the PIP-FW Review areas of virus sharing and benefits sharing, and on governance and linkages with other international programs or instruments. DATES: Written comments on PIP-FW virus sharing and benefits sharing must be submitted on or before April 10, 2016, and written comments on PIP-FW governance and linkages must be submitted before May 25, 2016. Comments should be no more than 15 pages with single spaced text. ADDRESSES: Submissions should be made via the Internet at www.regulations.gov docket number DOS-2016-0016. For alternatives to online submissions please contact Bruce Ruscio at (202) 647-3017 or ruscioba@state.gov. Note that relevant comments submitted to regulations.gov will be posted without editing and will be available to the public; therefore, business-confidential information should be clearly identified as such and submitted by email. The public is strongly encouraged to file submissions electronically rather than by facsimile or mail. FOR FURTHER INFORMATION CONTACT: Questions regarding the submission of comments should be directed to Bruce Ruscio (202) 647-3017, [[Page 17536]] ruscioba@state.gov, or Robert Sorenson at (202) 647 4689, sorensonra@state.gov. SUPPLEMENTARY INFORMATION: In 2007, the Sixtieth World Health Assembly passed a resolution calling on the Director-General to convene an intergovernmental meeting to develop mechanisms to ensure the continued sharing of potential pandemic influenza viruses, and the fair and equitable sharing of benefits arising from such sample sharing. For four years, WHO member states met as an Intergovernmental Mechanism, as well as informally, to negotiate the Pandemic Influenza Preparedness Framework (PIP-FW). The PIP-FW came into effect on May 24, 2011 when it was unanimously adopted by the Sixty-fourth World Health Assembly. At the core of the PIP-FW is a robust Global Influenza Surveillance and Response System (GISRS, previously called the Global Influenza Surveillance Network or GISN). The key goals of the PIP-FW are to improve and strengthen global influenza pandemic preparedness by: (1) Ensuring the global sharing of influenza viruses with human pandemic potential for continuous global monitoring and assessment of risks, and for the development of safe and effective countermeasures. The PIP-FW provides a transparent mechanism for sharing virus samples, based on two Standard Material Transfer Agreements (SMTAs) that specify the conditions for samples passed within and outside of the GISRS, and a traceability mechanism to monitor the movement of samples. (2) Increasing countries' access to vaccines and other pandemic related resources. Two innovative and complementary benefit-sharing mechanisms pool monetary and in-kind contributions from entities that use the GISRS to enhance pandemic influenza preparedness and response capacity for countries in need and at risk of pandemic influenza: The annual partnership contribution and the SMTA-2. Section 7.4.2 of the PIP-FW provides that: ``The Framework and its Annexes will be reviewed by 2016 with a view to proposing revisions reflecting development as appropriate, to the World Health Assembly in 2017, through the Executive Board.'' It is in anticipation of the 2016 review that the U.S. Department of State seeks comments on the following points: (1) Perspectives on the PIP-FW efforts in advancing global pandemic influenza preparedness, including inter-pandemic surveillance, and capacity to respond. (2) Experiences relating to the status and process of concluding Standard Material Transfer Agreements (SMTA-2). (3) Use of partnership contributions and WHO efforts to strengthen the GISRS and overall global preparedness and response capability/ capacity. (4) How changing technology has impacted or has the ability to impact the existing PIP-FW, specifically as regards genetic sequence data. (5) Potential linkages with other instruments, including the Nagoya Protocol. (6) Other matters related to prevention, planning and response whose resolution will be integral for the effective operation of a global influenza pandemic response. The facts and information obtained from written submissions will be used to inform the participation of the U.S. Department of State in the interagency process to prepare for United States participation for the five-year 2016 review of the PIP-FW. Upon receipt of the written submission, representatives from the Department of State will consider them and share them, as appropriate, with other interested U.S. Government agencies and departments engaging in the five-year review process. The Department of State invites comments from civil society organizations as well as pharmaceutical and medical technology industries and other interested members of the public. Entities making submissions may be contacted for further information or explanation. Two meetings are planned in association with this request for written submissions. Time and Date: The meetings will begin at 2:00 p.m. EDT on Monday, May 2, 2016, and Thursday, June 16, 2016. Both meetings will continue until 4:30 p.m. each day. Place: Both meetings will be held at the U.S. State Department's Harry S. Truman Building, 2201 C Street NW., Washington, DC 20520. Please use the 23rd Street entrance, and plan to arrive at least twenty minutes prior to the start of the meeting to allow for ID verification and escorting requirements. Status: The meeting will be open to the public. Persons planning on attending must provide their full name and organization to Dr. Bruce Ruscio at ruscioba@state.gov three days prior to each meeting. Persons who need special accommodations should also contact Dr. Ruscio at ruscioba@state.gov or (202) 647-3017 seven days before each meeting. Requests made after that time will be considered, but might not be possible to accommodate. Personal data is requested pursuant to Public Law 99-399 (Omnibus Diplomatic Security and Antiterrorism Act of 1986), as amended; Public Law 107-56 (USA PATRIOT Act); and E.O. 13356. The purpose of the collection is to validate the identity of individuals who enter 1033 Department facilities. The data will be entered into the Visitor Access Control System (VACS-D) database. Please see the Security Records System of Records Notice (State-36) at https://foia.state.gov/_docs/SORN/State-36.pdf for additional information. Dated: March 24, 2016. Jonathan A Margolis, Deputy Assistant Secretary for Science Space and Health, Acting Bureau of Oceans International Environmental and Scientific Affairs. [FR Doc. 2016-07069 Filed 3-28-16; 8:45 am] BILLING CODE 4710-09-P
![Federal Register / Vol. 81, No. 60 / Tuesday, March 29, 2016 / Notices 17535
operative delay and designates the business days between the hours of All other information in the original
proposal operative upon filing.16 10:00 a.m. and 3:00 p.m. Copies of the declaration remains unchanged.
At any time within 60 days of the filing also will be available for (Catalog of Federal Domestic Assistance
filing of the proposed rule change, the inspection and copying at the principal Numbers 59002 and 59008)
Commission summarily may office of the Exchange. All comments
temporarily suspend such rule change if received will be posted without change; James E. Rivera,
it appears to the Commission that such the Commission does not edit personal Associate Administrator for Disaster
action is necessary or appropriate in the identifying information from Assistance.
public interest, for the protection of submissions. You should submit only [FR Doc. 2016–06967 Filed 3–28–16; 8:45 am]
investors, or otherwise in furtherance of information that you wish to make BILLING CODE 8025–01–P
the purposes of the Act. If the available publicly. All submissions
Commission takes such action, the should refer to File Number SR–NYSE–
Commission shall institute proceedings 2016–25 and should be submitted on or DEPARTMENT OF STATE
to determine whether the proposed rule before April 19, 2016. [Public Notice: 9495]
change should be approved or For the Commission, by the Division of
disapproved. Trading and Markets, pursuant to delegated Request for Comments on World
IV. Solicitation of Comments authority.17 Health Organization Pandemic
Brent J. Fields, Influenza Preparedness Framework
Interested persons are invited to Secretary. Review
submit written data, views, and
[FR Doc. 2016–06991 Filed 3–28–16; 8:45 am]
arguments concerning the foregoing, AGENCY: International Health and
BILLING CODE 8011–01–P Biodefense, U.S. Department of State.
including whether the proposed rule
change is consistent with the Act. ACTION: Notice and request for
Comments may be submitted by any of comments.
the following methods: SMALL BUSINESS ADMINISTRATION
SUMMARY: The U.S. Department of State
Electronic Comments [Disaster Declaration # 14637 and # 14638]
invites submission of comments from
• Use the Commission’s Internet Oregon Disaster Number OR–00080 the public and relevant industries on
comment form (http://www.sec.gov/ influenza surveillance and response,
rules/sro.shtml); or AGENCY: U.S. Small Business related to the implementation of the
• Send an email to rule-comments@ Administration. World Health Organization (WHO)
sec.gov. Please include File Number SR– ACTION: Amendment 2. Pandemic Influenza Preparedness
NYSE–2016–25 on the subject line. Framework (PIP–FW) (http://
SUMMARY: This is an amendment of the apps.who.int/gb/ebwha/pdf_files/
Paper Comments Presidential declaration of a major WHA64/A64_8-en.pdf). Comments are
• Send paper comments in triplicate disaster for Public Assistance Only for specifically requested on the PIP–FW
to Secretary, Securities and Exchange the State of Oregon (FEMA–4258–DR), Review areas of virus sharing and
Commission, 100 F Street NE., dated 02/17/2016. benefits sharing, and on governance and
Washington, DC 20549–1090. Incident: Severe Winter Storms, linkages with other international
All submissions should refer to File Straight-line Winds, Flooding, programs or instruments.
Number SR–NYSE–2016–25. This file Landslides, and Mudslides. DATES: Written comments on PIP–FW
number should be included on the Incident Period: 12/06/2015 through virus sharing and benefits sharing must
subject line if email is used. To help the 12/23/2015. be submitted on or before April 10,
Commission process and review your Effective Date: 03/21/2016. 2016, and written comments on PIP–FW
comments more efficiently, please use Physical Loan Application Deadline governance and linkages must be
only one method. The Commission will Date: 04/18/2016. submitted before May 25, 2016.
post all comments on the Commission’s Economic Injury (EIDL) Loan Comments should be no more than 15
Internet Web site (http://www.sec.gov/ Application Deadline Date: 11/17/2016. pages with single spaced text.
rules/sro.shtml). Copies of the ADDRESSES: Submit completed loan ADDRESSES: Submissions should be
submission, all subsequent applications to: U.S. Small Business made via the Internet at
amendments, all written statements Administration, Processing and www.regulations.gov docket number
with respect to the proposed rule Disbursement Center, 14925 Kingsport DOS–2016–0016. For alternatives to
change that are filed with the Road, Fort Worth, TX 76155. online submissions please contact Bruce
Commission, and all written FOR FURTHER INFORMATION CONTACT: A Ruscio at (202) 647–3017 or
communications relating to the Escobar, Office of Disaster Assistance, ruscioba@state.gov. Note that relevant
proposed rule change between the U.S. Small Business Administration, comments submitted to regulations.gov
Commission and any person, other than 409 3rd Street SW., Suite 6050, will be posted without editing and will
those that may be withheld from the Washington, DC 20416. be available to the public; therefore,
public in accordance with the SUPPLEMENTARY INFORMATION: The notice business-confidential information
provisions of 5 U.S.C. 552, will be of the President’s major disaster should be clearly identified as such and
available for Web site viewing and declaration for Private Non-Profit submitted by email. The public is
mstockstill on DSK4VPTVN1PROD with NOTICES
printing in the Commission’s Public organizations in the State of OREGON, strongly encouraged to file submissions
Reference Room, 100 F Street NE., dated 02/17/2016, is hereby amended to electronically rather than by facsimile or
Washington, DC 20549 on official include the following areas as adversely mail.
affected by the disaster. FOR FURTHER INFORMATION CONTACT:
16 For purposes only of waiving the 30-day
operative delay, the Commission has considered the Primary Counties: Clackamas. Questions regarding the submission of
proposed rule’s impact on efficiency, competition, comments should be directed to Bruce
and capital formation. See 15 U.S.C. 78c(f). 17 17 CFR 200.30–3(a)(12). Ruscio (202) 647–3017,
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![17536 Federal Register / Vol. 81, No. 60 / Tuesday, March 29, 2016 / Notices
ruscioba@state.gov, or Robert Sorenson Material Transfer Agreements (SMTA– Diplomatic Security and Antiterrorism
at (202) 647 4689, sorensonra@state.gov. 2). Act of 1986), as amended; Public Law
SUPPLEMENTARY INFORMATION: In 2007, (3) Use of partnership contributions 107–56 (USA PATRIOT Act); and E.O.
the Sixtieth World Health Assembly and WHO efforts to strengthen the 13356. The purpose of the collection is
passed a resolution calling on the GISRS and overall global preparedness to validate the identity of individuals
Director-General to convene an and response capability/capacity. who enter 1033 Department facilities.
intergovernmental meeting to develop (4) How changing technology has The data will be entered into the Visitor
mechanisms to ensure the continued impacted or has the ability to impact the Access Control System (VACS–D)
sharing of potential pandemic influenza existing PIP–FW, specifically as regards database. Please see the Security
viruses, and the fair and equitable genetic sequence data. Records System of Records Notice
sharing of benefits arising from such (5) Potential linkages with other (State-36) at https://foia.state.gov/_docs/
sample sharing. For four years, WHO instruments, including the Nagoya SORN/State-36.pdf for additional
member states met as an Protocol. information.
Intergovernmental Mechanism, as well (6) Other matters related to
prevention, planning and response Dated: March 24, 2016.
as informally, to negotiate the Pandemic Jonathan A Margolis,
Influenza Preparedness Framework whose resolution will be integral for the
effective operation of a global influenza Deputy Assistant Secretary for Science Space
(PIP–FW). The PIP–FW came into effect and Health, Acting Bureau of Oceans
on May 24, 2011 when it was pandemic response.
The facts and information obtained International Environmental and Scientific
unanimously adopted by the Sixty- Affairs.
fourth World Health Assembly. At the from written submissions will be used
to inform the participation of the U.S. [FR Doc. 2016–07069 Filed 3–28–16; 8:45 am]
core of the PIP–FW is a robust Global
Department of State in the interagency BILLING CODE 4710–09–P
Influenza Surveillance and Response
System (GISRS, previously called the process to prepare for United States
Global Influenza Surveillance Network participation for the five-year 2016
or GISN). review of the PIP–FW. Upon receipt of DEPARTMENT OF TRANSPORTATION
The key goals of the PIP–FW are to the written submission, representatives
improve and strengthen global influenza from the Department of State will Federal Highway Administration
pandemic preparedness by: consider them and share them, as [FHWA Docket No. FHWA–2016–0005]
(1) Ensuring the global sharing of appropriate, with other interested U.S.
influenza viruses with human pandemic Government agencies and departments Notice of Funding Opportunity for the
potential for continuous global engaging in the five-year review process. Advanced Transportation and
monitoring and assessment of risks, and The Department of State invites Congestion Management Technologies
for the development of safe and effective comments from civil society Deployment Program
countermeasures. The PIP–FW provides organizations as well as pharmaceutical
and medical technology industries and AGENCY: Federal Highway
a transparent mechanism for sharing
virus samples, based on two Standard other interested members of the public. Administration (FHWA), Department of
Material Transfer Agreements (SMTAs) Entities making submissions may be Transportation (DOT).
that specify the conditions for samples contacted for further information or ACTION: Notice of funding opportunity.
passed within and outside of the GISRS, explanation.
Two meetings are planned in SUMMARY: The Fixing America’s Surface
and a traceability mechanism to monitor
the movement of samples. association with this request for written Transportation (FAST) Act directs the
(2) Increasing countries’ access to submissions. DOT to establish an advanced
vaccines and other pandemic related Time and Date: The meetings will transportation and congestion
resources. Two innovative and begin at 2:00 p.m. EDT on Monday, May management technologies deployment
complementary benefit-sharing 2, 2016, and Thursday, June 16, 2016. (ATCMTD) initiative. The initiative
mechanisms pool monetary and in-kind Both meetings will continue until 4:30 provides grants to eligible entities to
contributions from entities that use the p.m. each day. develop model deployment sites for
GISRS to enhance pandemic influenza Place: Both meetings will be held at large scale installation and operation of
preparedness and response capacity for the U.S. State Department’s Harry S. advanced transportation technologies to
countries in need and at risk of Truman Building, 2201 C Street NW., improve safety, efficiency, system
pandemic influenza: The annual Washington, DC 20520. Please use the performance, and infrastructure return
partnership contribution and the 23rd Street entrance, and plan to arrive on investment. The ATCMTD program
SMTA–2. at least twenty minutes prior to the start is funded for fiscal years (FY) 2016
Section 7.4.2 of the PIP–FW provides of the meeting to allow for ID through 2020 at $60 million per FY from
that: ‘‘The Framework and its Annexes verification and escorting requirements. amounts authorized under sections
will be reviewed by 2016 with a view Status: The meeting will be open to 6002(a)(1), 6002(a)(2), and 6002(a)(4) of
to proposing revisions reflecting the public. Persons planning on the FAST Act. This notice is the first of
development as appropriate, to the attending must provide their full name annual solicitations for the ATCMTD
World Health Assembly in 2017, and organization to Dr. Bruce Ruscio at program and seeks applications from
through the Executive Board.’’ It is in ruscioba@state.gov three days prior to eligible entities to establish the initial
anticipation of the 2016 review that the each meeting. Persons who need special set of model technology deployment
mstockstill on DSK4VPTVN1PROD with NOTICES
U.S. Department of State seeks accommodations should also contact Dr. sites. The DOT intends for these model
comments on the following points: Ruscio at ruscioba@state.gov or (202) technology deployments to help
(1) Perspectives on the PIP–FW efforts 647–3017 seven days before each demonstrate how emerging
in advancing global pandemic influenza meeting. Requests made after that time transportation technologies, data, and
preparedness, including inter-pandemic will be considered, but might not be their applications, which also link to
surveillance, and capacity to respond. possible to accommodate. Beyond Traffic 2045, can be effectively
(2) Experiences relating to the status Personal data is requested pursuant to deployed and integrated with existing
and process of concluding Standard Public Law 99–399 (Omnibus systems to provide access to essential
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Document Created: 2016-03-30 08:29:46
Document Modified: 2016-03-30 08:29:46
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice and request for comments. | |
| Dates | Written comments on PIP-FW virus sharing and benefits sharing must be submitted on or before April 10, 2016, and written comments on PIP-FW governance and linkages must be submitted before May 25, 2016. Comments should be no more than 15 pages with single spaced text. | |
| Contact | Questions regarding the submission of comments should be directed to Bruce Ruscio (202) 647-3017, [email protected], or Robert Sorenson at (202) 647 4689, [email protected] | |
| FR Citation | 81 FR 17535 |
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