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)

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.

[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]


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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.

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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 
[email protected]. 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]]

[email protected], or Robert Sorenson at (202) 647 4689, 
[email protected].

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 [email protected] three days prior to each meeting. Persons 
who need special accommodations should also contact Dr. Ruscio at 
[email protected] 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