[Federal Register Volume 72, Number 211 (Thursday, November 1, 2007)]
[Notices]
[Pages 61886-61887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-5435]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Notice of Availability of Draft Guidance on Allocating and 
Targeting Pandemic Influenza Vaccine

AGENCY: Office of the Secretary, Health and Human Services.

ACTION: Notice of availability.

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SUMMARY: The Department of Health and Human Services (HHS) and the 
Department of Homeland Security (DHS) are seeking public comment on the 
draft Guidance on Allocating and Targeting Pandemic Influenza Vaccine. 
The draft Guidance is now available on the HHS Web site.

DATES: Submit comments on or before December 31, 2007.
    Instructions for Submitting Comments: Electronic responses are 
preferred and may be addressed to [email protected]. Written 
responses should be addressed to U.S. Department of Health and Human 
Services, Room 434E, 200 Independence Avenue, SW., Washington, DC 
20201, Attention: Pandemic Influenza Vaccine Prioritization Guidance 
Comments. A copy of the Notice and the full text of the draft Guidance 
are also available on the PandemicFlu.Gov Web site at http://www.pandemicflu.gov/vaccine/prioritization.html and at http://www.aspe.hhs.gov/panflu/vaccinepriorities.html. Please follow 
instructions for submitting responses.
    The submission of comments in response to this notice should not 
exceed 25 pages, not including appendices and supplemental documents. 
Any information you submit will be made public. Consequently, do not 
send proprietary, commercial, financial, business confidential, trade 
secret, or personal information that you do not wish to be made public.
    Public Access: Responses to this notice will be available to the 
public in the HHS Public Reading Room, 200 Independence Avenue, SW., 
Washington, DC 20201. Please call (202) 690-7453 between 9 a.m. and 5 
p.m. to arrange access.

FOR FURTHER INFORMATION CONTACT: Hui-Hsing Wong, M.D., Office of the 
Assistant Secretary for Planning and Evaluation, (202) 205-0519.

SUPPLEMENTARY INFORMATION: Influenza viruses have threatened the health 
of animal and human populations for centuries. A pandemic occurs when a 
novel strain of influenza virus emerges that has the ability to infect 
and be passed between humans. Because humans have little immunity to 
the new virus, a worldwide epidemic, or pandemic, can ensue.
    Three human influenza pandemics occurred in the 20th century. In 
the U.S., each pandemic led to illness in approximately 30 percent of 
the population and death in between 2 in 100 and 2 in 1000 of those 
infected. It is projected that a modern pandemic, absent effective 
control measures, could result in the death of 200,000 to 2 million 
people in the U.S. alone.
    A critical part of the United States Government (USG) strategy to 
control the spread of a pandemic and reduce its health and societal 
impact is through the use of vaccines. The USG is working toward a goal 
of expanding domestic influenza surge capacity to produce pandemic 
influenza vaccines for the entire population within six months of a 
pandemic declaration. However, at the beginning of a pandemic, the 
limited supply of existing pandemic influenza vaccines will require 
that their distribution and administration be prioritized.
    Accordingly, the Homeland Security Council Implementation Plan for 
the National Strategy for Pandemic Influenza required the Department of 
Health and Human Services (HHS) in coordination with the Department of 
Homeland Security (DHS) to convene a federal interagency working group 
to draft a guidance to assist State and local governments, communities, 
tribal and territorial governments, and the private sector in planning 
an effective and consistent pandemic response. The USG embarked on a 
rigorous and collaborative process to seek input from all interested 
parties in developing a strategy to emerge from a pandemic with minimal 
levels of illness, death, and disruption to our society and economy.
    The draft Guidance on Allocating and Targeting Pandemic Influenza 
Vaccine outlines the USG's goal of targeting the early production of 
pandemic vaccines to reduce the impact on health and minimize 
disruption to society and the economy and describes the scientific and 
ethical framework for how this guidance was developed. As part of the 
guidance, a tiered prioritization for vaccines in severe pandemics is 
being proposed with the following objectives considered to be the most 
important: (1) Protect those who are essential to the pandemic response 
and provide care for persons who are ill; (2) protect those who 
maintain essential community services; (3) protecting children; and (4) 
protect workers who are at greater risk of infection as a result of 
their job. Protecting those who maintain homeland and national security 
was also considered a significant Federal objective. The ultimate goal 
of pandemic vaccination is to provide vaccines to all persons in the 
United States who choose to be vaccinated by 6 months after the 
declaration of a pandemic.
    With this notice, the USG requests comment from the public and 
interested stakeholders on the draft Guidance on Allocating and 
Targeting Pandemic Influenza Vaccine.
    Specifically, the USG invites comments on the following:
    The framework for establishing pandemic influenza vaccine 
priorities, including the--
    (1) approach for defining:
    a. Target groups,
    b. The clusters of target groups in the categories,
    c. The levels within categories,
    d. The tiers across categories.
    (2) The extent to which the prioritization guidance addresses the 
stated program objectives.
    (3) The extent to which the guidance is likely to lead to fair and 
ethical allocation and targeting of pandemic influenza vaccine across 
the population.
    The text of the draft guidance is available in html and pdf formats 
through the PandemicFlu.Gov Web site at http://www.pandemicflu.gov/vaccine/prioritization.html and the HHS Web site at http://
www.aspe.hhs.gov/panflu/

[[Page 61887]]

vaccinepriorities.html. For those who may not have Internet access, a 
hard copy can be requested from the point of contact, Hui-Hsing Wong, 
Office of the Assistant Secretary for Planning and Evaluation (202) 
205-0519.

    Date: October 24, 2007.
RADM W. Craig Vanderwagen,
Assistant Secretary for Preparedness and Response.
[FR Doc. 07-5435 Filed 10-31-07; 8:45 am]
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