[Federal Register Volume 73, Number 107 (Tuesday, June 3, 2008)]
[Notices]
[Pages 31690-31691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-12357]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


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

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) 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 [email protected]. Comments on the Antiviral Use 
guidance may be addressed to [email protected]. Comments on the 
Employer Antiviral Stockpiling guidance 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 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.

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

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

[[Page 31691]]

acquiring 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.

    Dated: May 23, 2008.
W. Craig Vanderwagen,
Assistant Secretary for Preparedness and Response.
 [FR Doc. E8-12357 Filed 6-2-08; 8:45 am]
BILLING CODE 4151-04-P