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Notice

Notice of Availability of Draft Guidances To Assist in Preparation for an Influenza Pandemic

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Information about this document as published in the Federal Register.

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AGENCY:

Office of the Secretary, Health and Human Services.

ACTION:

Notice of Availability.

SUMMARY:

The Department of Health and Human Services (HHS) is seeking public comment on three draft guidances: Interim Guidance on the Use and Purchase of Facemasks and Respirators by Individuals and Families for Pandemic Influenza Preparedness; Proposed Guidance on Antiviral Drug Use during an Influenza Pandemic; and Proposed Considerations for Antiviral Drug Stockpiling by Employers In Preparation for an Influenza Pandemic. The draft Guidances are now available on the HHS Web site http://aspe.hhs.gov/​panflu/​antiviral-n-masks.htm

DATES:

Submit comments on or before July 3, 2008.

ADDRESSES:

Instructions for Submitting Comments: Electronic responses are preferred. Comments on the Facemask and Respirator guidance may be addressed to Panflucomments1@hhs.gov. Comments on the Antiviral Use guidance may be addressed to Panflucomments2@hhs.gov. Comments on the Employer Antiviral Stockpiling guidance may be addressed to Panflucomments3@hhs.gov. 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 Masks Comments, Attention: Pandemic Influenza Antiviral Comments, or Attention: Pandemic Influenza Employer Antiviral Comments, respectively. A copy of this Notice and the full text of the draft Guidances are available on the HHS Web site at http://aspe.hhs.gov/​panflu/​antiviral-n-masks.htm and the PandemicFlu.Gov Web site at http://www.pandemicflu.gov. Please follow instructions for submitting responses.

The submission of comments in response to this notice should not exceed 25 pages for each guidance, not including appendices and supplemental documents. Any information you submit will be made public. Consequently, please do not send any 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.

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FOR FURTHER INFORMATION CONTACT:

Ms. Julie Schafer, Office of the Assistant Secretary for Preparedness and Response, (202) 205-2882.

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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 easily passed between humans. Because humans have little immunity to the new virus, many people may become ill and a worldwide epidemic, or pandemic, can ensue. Three human influenza pandemics occurred in the 20th century. In the United States (US) 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 based on this historical experience and given the current U.S. population, a pandemic today, absent effective control measures, could result in the deaths of 200,000 to 2 million people in the U.S. alone.

The U.S. Government (USG) has developed a comprehensive strategy to prepare for and respond to an influenza pandemic, including developing and Start Printed Page 31691acquiring vaccine and antivirals to prevent and treat illness, planning for use of measures to reduce the spread of the disease by asking ill persons to stay home, voluntary quarantine of household members who live with an ill person, closure of child care facilities and dismissal of students from schools, decreasing the frequency and duration of close contact among people to slow transmission of infection (social distancing), recommending hygiene measures, and advising the use of personal protective equipment in certain situations. HHS has developed a number of guidances to assist government agencies, businesses, community organizations, and the public in their preparedness efforts, utilizing these strategies. The three guidance documents available for public comment are part of this series and should be reviewed as part of an overall approach to pandemic preparedness.

With this notice, the USG requests comment from the public and interested stakeholders on three draft guidances: Interim Guidance on the Use and Purchase of Facemasks and Respirators by Individuals and Families for Pandemic Influenza Preparedness; Proposed Guidance on Antiviral Drug Use during an Influenza Pandemic; and Proposed Considerations for Antiviral Drug Stockpiling by Employers In Preparation for an Influenza Pandemic. The text of these draft guidances is available in HTML and PDF formats through the HHS Web site at http://aspe.hhs.gov/​panflu/​antiviral-n-masks.htm and the PandemicFlu.Gov Web site at http://www.pandemicflu.gov. For those who may not have Internet access, a hard copy can be requested from the point of contact, Ms. Julie Schafer, Office of the Assistant Secretary for Preparedness and Response, (202) 205-2882.

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Dated: May 23, 2008.

W. Craig Vanderwagen,

Assistant Secretary for Preparedness and Response.

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[FR Doc. E8-12357 Filed 6-2-08; 8:45 am]

BILLING CODE 4151-04-P