[Federal Register Volume 75, Number 177 (Tuesday, September 14, 2010)]
[Notices]
[Pages 55776-55777]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22881]


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 DEPARTMENT OF COMMERCE

International Trade Administration


Request for Comments on Vaccine Production and Additional 
Planning for Future Possible Pandemic Influenza

AGENCY: International Trade Administration, 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 vaccine production 
and additional planning for future possible pandemic influenza.

DATES: Written comments must be submitted on or before October 1, 2010. 
Comments should be no more than 15 pages. Business-confidential 
information should be clearly identified as such.

ADDRESSES: You may submit comments by any of the following methods:
    E-mail: <a href="/cdn-cgi/l/email-protection#63350200000a0d064d200c0e0e060d17102317110207064d040c15"><span class="__cf_email__" data-cfemail="4016212323292e256e032f2d2d252e34330034322124256e272f36">[email protected]</span></a>.
    Fax: (202) 482-1975 (Attn.: Jane Earley).
    Mail or Hand Delivery/Courier: Jane Earley, U.S. Department of 
Commerce, Office of Health and Consumer Goods, Room 1015, 1401 
Constitution Avenue, NW., Washington, DC 20230.

FOR FURTHER INFORMATION CONTACT: For questions on the submission of 
comments, please contact Jane Earley by phone at (202) 482-2561 or 
Andrea Cornwell at (202) 482-0998.

SUPPLEMENTARY INFORMATION: Written comments are sought in light of the 
announced end of the H1N1 influenza pandemic (see World Health 
Organization announcement of August 10, 2010) and the need to plan for 
future pandemics. The facts and information obtained from written 
submissions will be used to inform the participation of the United 
States Department of Commerce in the interagency process to prepare for 
United States participation in international meetings and negotiations 
on pandemic planning, such as the meeting of the World Health 
Organization (WHO) Pandemic Influenza Preparedness Open Ended Working 
Group (PIP-OEWG) December 13-17, 2010.
    The Department of Commerce invites comments from the pharmaceutical 
and medical technology industries and interested members of the public 
on a number of issues regarding vaccine production for pandemic 
influenza.
    The Department of Commerce invites written submissions on the 
following topics:
    1. Manufacturers' experiences during the 2009 H1N1 pandemic. What 
issues could have been better handled by industry, governments and the 
WHO? What is realistic and unrealistic to expect from governments, 
vaccine manufacturers, the WHO and others during a mild pandemic such 
as the 2009 H1N1 pandemic? How might expectations be different for a 
more severe pandemic?
    2. The emergency response process. Based on the H1N1 pandemic 
experience, what changes in operational procedures or practices should 
be made to prepare for the next influenza pandemic? What additional 
consultation and decisional processes (within industry and among 
governments and the WHO) for pandemic preparedness are needed? What are 
the most critical deficiencies that need to be overcome in the present 
system to mount a more effective and robust response to pandemic 
influenza?
    3. Improving availability for developing countries. How can we 
support and stimulate demand for seasonal flu vaccine in middle and 
lower income countries? Are there other

[[Page 55777]]

mechanisms to increase pandemic influenza vaccine manufacturing 
capacity or otherwise improve global availability of pandemic influenza 
vaccine? Have manufacturers discussed recent proposals by WHO member 
countries to implement ``mandatory'' mechanisms regarding participation 
in the Global Influenza Surveillance Network? What options to current 
proposals have been considered?
    4. Other matters that are related to the substance contained in 1-
3, above.
    Please submit by October 1, 2010, a written submission of 15 pages 
or less with facts and information on the issues described above. 
Comments should be submitted electronically to 
<a href="/cdn-cgi/l/email-protection#c197a0a2a2a8afa4ef82aeacaca4afb5b281b5b3a0a5a4efa6aeb7"><span class="__cf_email__" data-cfemail="d284b3b1b1bbbcb7fc91bdbfbfb7bca6a192a6a0b3b6b7fcb5bda4">[email protected]</span></a>. Business-confidential information should be 
clearly identified.
    Upon receipt of the written submission, representatives from the 
Department of Commerce and other federal agencies and departments will 
consider the information. In doing so, entities submitting the 
information may be contacted for further information or explanation 
and, in some cases, meetings with individual submitters may be 
requested.

    Dated: September 8, 2010.
Skip Jones,
Deputy Assistant Secretary, Trade Agreements and Compliance, Market 
Access and Compliance, International Trade Administration, U.S. 
Department of Commerce.
[FR Doc. 2010-22881 Filed 9-13-10; 8:45 am]
BILLING CODE 3510-DA-P


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