[Federal Register Volume 71, Number 240 (Thursday, December 14, 2006)]
[Notices]
[Pages 75252-75253]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-21282]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Request for Information (RFI): Guidance for Prioritization of 
Pre-pandemic and Pandemic Influenza Vaccine

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

ACTION: Notice.

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SUMMARY: 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 lack 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 1,000 of those infected. It is projected that 
a modern pandemic, absent effective control measures, could result in 
the deaths of 200,000 to 2 million people in the United States alone. 
Extensive information on Federal government strategic and 
implementation plans for pandemic flu is available at http://www.pandemicflu.gov.
    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 U. S. Government is working 
toward a goal of expanding domestic influenza vaccine surge capacity 
for the production of pandemic influenza vaccines for the entire 
population within six months of a pandemic declaration. However, at the 
beginning of a pandemic, the scarcity of pre-pandemic influenza vaccine 
and pandemic influenza vaccine (which could include up to two doses) 
will require that the limited supply be prioritized for distribution 
and administration. Pre-pandemic vaccine refers to influenza vaccine 
that is produced against a virus strain that is believed to have 
pandemic potential and is maintained in a national stockpile. Depending 
on what influenza strain actually causes the pandemic, stockpiled pre-
pandemic vaccine may provide some protection. Total quantities of pre-
pandemic vaccines will be limited.
    Accordingly, the Federal government has initiated a process to 
provide guidance to assist State and local governments, communities, 
tribal and territorial governments, and the private sector in defining 
groups that should be considered for priority access to scarce vaccine. 
Guidance will be drafted by a Federal interagency task force that will 
seek information and advice from relevant individual stakeholders, a 
public engagement process in selected communities across the country, 
and through this Request for Information (RFI). The Federal government 
plans to issue draft guidance resulting from this process for public 
comment before finalization.
    With this RFI, the Department of Health and Human Services (HHS) 
requests input from the public on considerations in developing guidance 
for prioritization of the distribution and administration of both pre-
pandemic and pandemic influenza vaccines based on various pandemic 
severity and vaccine supply scenarios. Specifically, HHS is seeking 
input on pandemic influenza vaccine prioritization considerations from 
all interested and affected parties, including but not limited to 
public health and health care individuals and organizations, as well as 
those from other sectors of the economy including, for example, travel 
and transportation, commerce and trade, law enforcement, emergency 
management and responders, other critical infrastructure sectors and 
the general public. Previous reports relating to pandemic influenza 
vaccine prioritization issues are available at http://www.pandemicflu.gov.

DATES: Responses should be submitted to the Department of Health and 
Human Services on or before 5 p.m., EDT, January 18, 2007.

ADDRESSES: 
    Instructions for Submitting Comments: Electronic responses are 
preferred and may be addressed to PandemicFlu.RFI@ hhs.gov. Written 
responses should be addressed to Department of Health and Human 
Services, Room 434E, 200 Independence Avenue, SW., Washington, DC 
20201, Attention: Pandemic Influenza Vaccine Prioritization RFI. A copy 
of this RFI is also available on the PandemicFlu.Gov Web site and at 
http://www.aspe.hhs.gov/PIV/rfi. Please follow instructions for 
submitting responses.
    The submission of written materials in response to the RFI should 
not exceed 25 pages, not including appendices and supplemental 
documents. Responders may submit other forms of electronic materials to 
demonstrate or exhibit concepts of their written responses. 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 RFI 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. The RFI and all responses will also be made 
available on the HHS Web site at PandemicFlu.Gov.

FOR FURTHER INFORMATION CONTACT: Dr. Ben Schwartz, Office of Public 
Health and Science, (404) 639-8953.

[[Page 75253]]


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 lack 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 1,000 of those infected. 
Extrapolating from experience in prior pandemics, it is projected that 
a modern pandemic, absent effective control measures, could result in 
the deaths of 200,000 to 2 million people in the United States alone.
    The goals of the Federal response to an influenza pandemic include 
to: (1) Stop, slow, or otherwise limit the spread of the pandemic to 
the United States; (2) limit the domestic spread of the pandemic and 
mitigate the disease, suffering, and death; and (3) sustain 
infrastructure and mitigate impact to the economy and functioning of 
society.
    A critical part of the U.S. Government strategy to control the 
spread of a pandemic and reduce its health and societal impact is 
through the use of vaccines. The U.S. Government is working toward a 
goal of expanding domestic influenza vaccine surge capacity to ensure 
the production of pandemic vaccines for the entire population within 
six months of a pandemic declaration. However, at the beginning of a 
pandemic, the scarcity of pre-pandemic and pandemic influenza vaccine 
will require that the limited supply be prioritized for distribution 
and administration.
    The Homeland Security Council Implementation Plan for the National 
Strategy for Pandemic Influenza requires that HHS in coordination with 
the Department of Homeland Security (DHS) shall identify lists of 
personnel and high-risk groups who should be considered for priority 
access to medical countermeasures, including pre-pandemic and pandemic 
influenza vaccine. Priority recommendations will reflect the pandemic 
response goals of limiting mortality and severe morbidity; maintaining 
critical infrastructure and societal function; diminishing economic 
impacts; and maintaining national security. Limiting transmission may 
also be an objective.
    To accomplish this task a Federal interagency working group has 
been established to: (1) Recommend priority groups for pandemic 
influenza vaccination as guidance for State, local, and tribal pandemic 
planning; and (2) recommend priority groups for vaccination with pre-
pandemic vaccine as guidance for State, local, and tribal pandemic 
planning. The working group is co-chaired by HHS and DHS and includes 
members representing other Federal agencies. The working group is 
soliciting information from individual stakeholders in a series of 
meetings. In addition, a series of public engagement meetings will be 
held across the country to gather further information. This RFI 
provides an additional opportunity to inform the pandemic vaccine 
priority development process. In addition, the interagency working 
group's draft guidance and recommendations will be published in the 
Federal Register for a public comment period before being finalized.
    Priorities for vaccine use will vary based on pandemic severity as 
well as the vaccine supply. In a situation where a very limited vaccine 
supply exists, it will be necessary to narrowly target and efficiently 
use the available vaccine. With greater availability, it may be 
feasible to expand priority groups and consider strategies to limit 
disease transmission. With respect to pre-pandemic vaccines, 
prioritization must consider the limited available supply and the 
likelihood that protection will only be partial, depending on how close 
the pre-pandemic vaccine matches the circulating pandemic virus. 
Because no single priority list is appropriate for all scenarios and 
because significant uncertainty is involved, Federal guidance will be 
developed for multiple contingencies.

Information Requested

    For the purpose of developing pandemic influenza vaccine 
prioritization guidance, HHS requests input from the public on 
priorities for allocation of both pre-pandemic and pandemic influenza 
vaccines based on various pandemic severity and vaccine supply 
scenarios. HHS is interested in receiving comments on factors that 
should be considered in order to provide guidance on priority groups 
for pre-pandemic and pandemic vaccines to best achieve national 
pandemic response goals. As described earlier, the goals of the Federal 
response to an influenza pandemic include to: (1) Stop, slow, or 
otherwise limit the spread of the pandemic to the United States; (2) 
limit the domestic spread of the pandemic and mitigate the disease, 
suffering, and death; and (3) sustain infrastructure and mitigate 
impact to the economy and functioning of society. HHS is particularly 
interested in receiving responses to the following questions:
     What objectives, principles, strategies, criteria, 
assumptions and rationales should be considered in pandemic vaccine 
prioritization determinations?
     What is the relative importance of the three goals 
described above and what are the associated implications for vaccine 
prioritization?
     Which population group(s) should have priority for 
receiving pre-pandemic vaccine? Which should have priority for 
receiving pandemic vaccine? What is the rationale?
     How can fairness, equity, efficiency and related 
principles be reflected in the determination of priority groupings for 
receipt of pre-pandemic or pandemic vaccine?
     For priority groups, how should vaccine be allocated, 
distributed and administered? Who (Federal, State or local authorities) 
should determine when and how the vaccine is distributed and 
administered?

Potential Responders

    HHS invites input from a broad range of individuals and 
organizations that have interests in pre-pandemic and pandemic vaccine 
prioritization. Some examples of these organizations include but are 
not limited to the following:
     State and local governments
     Advocacy groups and public interest organizations
     State and local public health departments
     Vaccine manufacturing industry, distributors and related 
organizations
     Health care professional societies and organizations
     Police, law enforcement, and public safety organizations
     Trade and labor organizations
     Emergency management and first responder organizations
     Chambers of Commerce and other business representatives
     Public utilities
     Other critical infrastructure sectors
     General Public

    Dated: December 11, 2006.
John O. Agwunobi,
Assistant Secretary for Health, Office of Public Health and Science, 
Department of Health and Human Services.
[FR Doc. E6-21282 Filed 12-13-06; 8:45 am]
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