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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Request for Information (RFI): Guidance for Prioritization of Pre-pandemic

and Pandemic Influenza Vaccine

_Printer Friendly PDF Version_ (http://aspe.hhs.gov/PIV/RFI/fulltext.pdf)

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

ACTION: Notice

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 1000 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._

(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/vaccine#vprioritization._

(http://www.pandemicflu.gov/vaccine#vprioritization)

DATES: Responses should be submitted to the U.S. Department of Health and

Human Services on or before 5:00 p.m., EDT, January 18, 2007.

ADDRESSES:

Instructions for Submitting Comments: Electronic responses are preferred and

may be addressed to _PandemicFlu.RFI@ hhs.gov_

(mailto:pandemicflu.rfi@...) . Written responses should be addressed to

U.S. Department of Health and

Human Services, Room 434E, 200 Independence Avenue, S.W., Washington, D.C.

20201, Attention: Pandemic Influenza Vaccine Prioritization RFI. A copy of this

RFI is also available on the PandemicFlu.Gov website and at

_http://www.aspe.hhs.gov/PIV/rfi_ (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, S.W., Washington, D.C.,

20201. Please call between 9:00 a.m. and 5:00 p.m. to arrange

access. The RFI and all responses will also be made available on the HHS website

at _PandemicFlu.Gov_ (http://www.pandemicflu.gov/) .

For Further Information Contact: Dr. Ben Schwartz, Office of Public Health

and Science, .

Louis N. Molino, Sr., CET

FF/NREMT-B/FSI/EMSI

Freelance Consultant/Trainer/Author/Journalist/Fire Protection Consultant

LNMolino@...

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(IFW/TFW/FSS Office)

(IFW/TFW/FSS Fax)

" A Texan with a Jersey Attitude "

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