2010-22881. 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.

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: [e-mail].

Fax: [phone] (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 [phone] or Andrea Cornwell at [phone].

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 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 [e-mail]. 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.