07-5435. Notice of Availability of Draft Guidance on Allocating and Targeting Pandemic Influenza Vaccine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.

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of Health and Human Services (HHS) and the Department of Homeland Security (DHS) are seeking public comment on the draft Guidance on Allocating and Targeting Pandemic Influenza Vaccine. The draft Guidance is now available on the HHS Web site.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 [e-mail]. 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 A copy of the Notice and the full text of the draft Guidance are also available on the PandemicFlu.Gov Web site at http://www.pandemicflu.gov/​vaccine/​prioritization.html and at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 [phone] 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, [phone].

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/​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 [phone].

Date: October 24, 2007.

RADM W. Craig Vanderwagen,

Assistant Secretary for Preparedness and Response.