[Federal Register Volume 80, Number 175 (Thursday, September 10, 2015)]
[Notices]
[Pages 54529-54530]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22730]


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 DEPARTMENT OF COMMERCE

International Trade Administration


Request for Comments On World Health Organization Pandemic 
Influenza Preparedness Framework

AGENCY: International Trade Administration, U.S. Department of 
Commerce.

ACTION: Notice and Request for Comments.

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SUMMARY: The International Trade Administration 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 will be used to support the five-year review of the WHO PIP-FW 
in 2016.

DATES: Written comments must be submitted on or before October 7, 2015. 
Comments should be no more than 15 pages. Business-confidential 
information should be clearly identified as such.

ADDRESSES: Submissions should be made via the Internet at 
www.regulations.gov docket number ITA-2015-0003. For alternatives to 
on-line submissions please contact Jennifer Boger at (202) 482-3360. 
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 Jennifer Boger at (202) 482-3360, 
[email protected], or Bijou Mgbojikwe at (202) 482-1722, 
[email protected].

SUPPLEMENTARY INFORMATION: 
    Background: 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.
    The key goals of PIP 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 Global 
Influenza Surveillance and Response System (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.
    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). 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 Commerce 
seeks comments on the following points:
    (1) Experiences, best practices, opportunities, and challenges in 
advancing the PIP-FW over the past five years.
    (2) Experiences relating to the status and process of concluding 
Standard Material Transfer Agreements (SMTA2).
    (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.
    (5) 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 Commerce in 
the interagency process to prepare for United States participation for 
the five-

[[Page 54530]]

year 2016 review of the PIP-FW. Upon receipt of the written submission, 
representatives from the U.S. Department of Commerce will consider them 
and share them, as needed, with other interested U.S. Government 
agencies and departments engaging in the five-year review process.
    The Department of Commerce invites comments from civil society 
organizations as well as pharmaceutical and medical technology 
industries and other interested members of the public on a number of 
issues regarding pandemic influenza preparedness and response. Entities 
making submissions may be contacted for further information or 
explanation and, in some cases, meetings with submitters may be 
requested.

    Dated: September 3, 2015.
Jennifer Boger,
Health Team Director, Office of Health and Information Technologies.
[FR Doc. 2015-22730 Filed 9-9-15; 8:45 am]
 BILLING CODE 3510-DR-P