[Federal Register: June 3, 2008 (Volume 73, Number 107)]
[Notices]
[Page 31690-31691]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03jn08-42]
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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 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.
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