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Federal Register / Vol. 71, No.

179 / Friday, September 15, 2006 / Notices 54481

For information on access, or services must be received by EPA by October 16, reported in the U.S. between 1971 and
for individuals with disabilities, please 2006. 2000. The term disease burden broadly
contact John Alter at (202) 564–9891 or ADDRESSES: The draft Approaches To refers to the magnitude of the impact
e-mail npptac.oppt@epa.gov. To request Estimating the Waterborne Disease incurred by society as a consequence of
accommodation of a disability, please Outbreak Burden in the United States: disease in the community (e.g.,
contact John Alter, preferably at least 10 Uses and Limitations of the Waterborne decrements in a population’s health or
days prior to the meeting, to give EPA Disease Outbreak Surveillance System the associated economic effects) and
as much time as possible to process (EPA/600/R–06/069) is available there are various metrics that can be
your request. primarily via the Internet on the employed by analysts to quantify
National Center for Environmental burden. In order to capture some of the
List of Subjects benefits of drinking water regulations,
Assessment’s home page under the
Environmental protection, NPPTAC, Recent Additions and Publications EPA has typically expressed waterborne
Pollution prevention, toxics, Toxic menus at http://www.epa.gov/ncea. A disease impacts in terms of
chemicals, and Chemical health and limited number of paper copies are epidemiologic and monetary measures;
safety. available from Ms. Donna Tucker, this WBDO burden analysis employs
Dated: September 8, 2006. Technical Information Manager, NCEA- those same measures. Because not all
Ann E. Goode, Cincinnati; telephone: 513–569–7257; WBDOs in the United States and
facsimile: 513–569–7916; e-mail: associated cases of illness are reported,
Acting Director, Office of Pollution Prevention
and Toxics tucker.donna@epa.gov. If you are the WBDO database on which this draft
requesting a paper copy, please provide document is based is not
[FR Doc. E6–15339 Filed 9–14–06; 8:45 am]
your name, your mailing address, and comprehensive. The extent to which
BILLING CODE 6560–50–S
the document title, Approaches To WBDOs are not recognized is unknown
Estimating the Waterborne Disease and is not examined in this analysis.
Outbreak Burden in the United States: This draft report develops several
ENVIRONMENTAL PROTECTION
Uses and Limitations of the Waterborne quantitative sensitivity analyses to
AGENCY
Disease Outbreak Surveillance System characterize some of the uncertainty in
[FRL–8220–2; EPA–HQ–Docket ID No. EPA– (EPA/600/R–06/069). the burden estimates but does not
ORD–2006–0666] provide an evaluation of the potential
Comments may be submitted
electronically via EPA’s E-Docket, by impact of under- or overreporting of
Approaches To Estimating the WBDOs or their associated severity
Waterborne Disease Outbreak Burden mail, by facsimile, or by hand delivery/
courier. Please follow the detailed characteristics. The draft report includes
in the United States: Uses and recommendations for the collection and
Limitations of the Waterborne Disease instructions provided in the
Supplementary Information section of reporting of additional outbreak
Outbreak Surveillance System; information that would improve the
External Review Draft this notice.
FOR FURTHER INFORMATION CONTACT: For
usefulness of the WBDO database for
AGENCY: Environmental Protection information on the public comment future disease burden estimates.
Agency (EPA). period, contact the Office of II. How To Submit Technical Comments
ACTION: Notice of public comment Environmental Information Docket; to EPA’s E-Docket
period. telephone: 202–566–1752; facsimile: Submit your comments, identified by
202–566–1753; or e-mail: Docket ID No. EPA-ORD–2006–0666 by
SUMMARY: EPA is announcing a 30-day ORD.Docket@epa.gov.
public comment period for the draft one of the following methods:
For technical information, contact • www.regulations.gov: Follow the
document titled, Approaches To Glenn Rice, NCEA; telephone: 513–569–
Estimating the Waterborne Disease on-line instructions for submitting
7813; facsimile: 513–487–2539; or e- comments.
Outbreak Burden in the United States: mail: rice.glenn@epa.gov. • E-mail: ORD Docket@epa.gov.
Uses and Limitations of the Waterborne SUPPLEMENTARY INFORMATION: • Fax: 202–566–1753.
Disease Outbreak Surveillance System • Mail: Office of Environmental
(EPA/600/R–06/069). The document I. Information About the Project/
Information (OEI) Docket (Mail Code:
was prepared by the National Center for Document
2822T), U.S. Environmental Protection
Environmental Assessment (NCEA) Information about waterborne disease Agency, 1200 Pennsylvania Ave., NW.,
within EPA’s Office of Research and outbreaks (WBDOs) in the United States Washington, DC 20460. The phone
Development. is voluntarily reported by State, number is 202–566–1752.
EPA is releasing this draft document territorial and local public health If you provide comments by mail,
solely for the purpose of pre- agencies to the Centers for Disease please submit one unbound original
dissemination peer review under Control and Prevention (CDC). CDC and with pages numbered consecutively,
applicable information quality EPA jointly maintain a WBDO database. and three copies. For attachments,
guidelines. This document has not been The database describes outbreak provide an index, number pages
formally disseminated by EPA. It does attributes including, among other consecutively with the comments, and
not represent and should not be things, the drinking water system submit an unbound original and three
construed to represent any Agency deficiency, the etiologic agent, and the copies.
policy or determination. EPA will number of individuals who became ill. • Hand Delivery: The OEI Docket is
consider any public comments Underreporting of such events is located in the Headquarters EPA Docket
submitted in accordance with this assumed but the magnitude of Center, EPA/DC; EPA West Building,
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notice when revising the document. underreporting is unknown. 1301 Constitution Ave., NW.,
DATES: The 30-day public comment This draft document presents an Washington, DC. The EPA Docket
period begins September 15, 2006, and approach for estimating the Center Public Reading Room is open
ends October 16, 2006. Technical epidemiologic and economic burden of from 8:30 a.m. to 4:30 p.m., Monday
comments should be in writing and disease associated with 665 WBDOs through Friday, excluding legal

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54482 Federal Register / Vol. 71, No. 179 / Friday, September 15, 2006 / Notices

holidays. The telephone number for the cleanup, there will be temporary changes to development, analytical lot release
Public Reading Room is 202–566–1744. Docket Center telephone numbers, addresses, assay development and validation, and
Such deliveries are only accepted and hours of operation for people who wish clinical immunogencity assay
during the Docket’s normal hours of to make hand deliveries or visit the Public development and validation.
Reading Room to view documents. Consult
operation, and special arrangements EPA’s Federal Register notice at 71 FR 38147 DATES: To receive consideration,
should be made for deliveries of boxed (July 5, 2006) or the EPA Web site at applications must be received no later
information. www.epa.gov/epahome/dockets.htm for than 5 p.m., Eastern Time, on
Instructions: Direct your comments to current information on docket operations, September 29, 2006.
Docket ID No. EPA–ORD–2006–0666. locations and telephone numbers. U.S. mail ADDRESSES: The Office of Grants
EPA’s policy is that all comments and the procedures for submitting comments Management within the Office of Public
received will be included in the public to www.regulations.gov are not affected by
Health and Science of the U.S.
docket without change and may be the flooding and will remain the same.
Department of Health and Human
made available online at Dated: September 7, 2006. Services, located at 1101 Wootten
www.regulations.gov, including any Parkway, Rockville, MD 20857, must
Peter W. Preuss,
personal information provided, unless receive all applications.
the comment includes information Director, National Center for Environmental
Assessment. SUPPLEMENTARY INFORMATION: In the last
claimed to be Confidential Business century, three influenza pandemics
Information (CBI) or other information [FR Doc. E6–15335 Filed 9–14–06; 8:45 am]
BILLING CODE 6560–50–P
have struck the United States and the
whose disclosure is restricted by statute. world, and viruses from birds
Do not submit information that you contributed to all of them. In 1918, the
consider to be CBI or otherwise first pandemic infected one-third of the
protected through www.regulations.gov DEPARTMENT OF HEALTH AND
U.S. population, killed over half a
or e-mail. The www.regulations.gov Web HUMAN SERVICES
million Americans, reduced American
site is an ‘‘anonymous access’’ system, life expectancy by 13 years, and killed
which means EPA will not know your International Development of H5N1
Influenza Vaccines; Funding more than 20 million people worldwide.
identity or contact information unless Following the 1918 outbreak, influenza
you provide it in the body of your Opportunity
pandemics in 1957 and 1968 also killed
comment. If you send an e-mail AGENCY: Office of the Secretary, Office tens of thousands of Americans and
comment directly to EPA without going of Public Health Emergency millions across the world. The recent
through www.regulations.gov, your e- Preparedness. limited outbreak of Severe Acute
mail address will be automatically Respiratory Syndrome (SARS) in 2003
ACTION: Notice.
captured and included as part of the suggests the danger that a modern
comment that is placed in the public Funding Opportunity Title: pandemic would present.
docket and made available on the International Development of H5N1 The H5N1 strain of avian influenza
Internet. If you submit an electronic Influenza Vaccines. has become the most threatening
comment, EPA recommends that you Announcement Type: Single-Source influenza virus in the world, and any
include your name and other contact Cooperative Agreement. large scale outbreak of this disease
information in the body of your Catalog of Federal Domestic among humans would have grave
comment and with any disk or CD–ROM Assistance Number: The Office of consequences for global public health.
you submit. If EPA cannot read your Management and Budget (OMB) Catalog Influenza experts have warned that the
comment due to technical difficulties of Federal Domestic Assistance number reassortment of different H5N1 viruses
and cannot contact you for clarification, is 93.019. over the past seven years greatly
EPA may not be able to consider your SUMMARY: The objective of this project is increases the potential for the viruses to
comment. Electronic files should avoid to mitigate any potential global shortage be transmitted more easily from person
the use of special characters, any form of influenza vaccines and the to person. Medical practitioners have
of encryption, and be free of any defects manufacturing of this vaccine in the also discovered several other, new avian
or viruses. For additional information event of an influenza pandemic. The viruses that can be transmitted to
about EPA’s public docket visit the EPA Office of Public Health Emergency humans.
Docket Center homepage at http:// Preparedness (OPHEP) requires the The U.S. Government is concerned
www.epa.gov/epahome/dockets.htm. World Health Organization (WHO) to that a new influenza virus could become
Docket: All documents in the docket perform activities related to pandemic efficiently transmissible among humans.
are listed in the www.regulations.gov influenza preparedness and planning, Now spreading through bird
index. Although listed in the index, particularly in the international populations across Asia, reaching into
some information is not publicly development of H5N1 human vaccines Europe, the Middle East and, most
available, e.g., CBI or other information (and other pandemic influenza vaccine recently, Africa, the H5N1 strain has
whose disclosure is restricted by statute. candidates) and influenza vaccine infected domesticated birds, such as
Certain other material, such as manufacturing infrastructure building in ducks and chickens, and long range
copyrighted material, will be publicly countries where resources for vaccine migratory birds. In 1997, the first
available only in hard copy. Publicly acquisition and manufacturing may be recorded H5N1 outbreak in humans
available docket materials are available limited. The specific countries in which took place in Hong Kong. H5N1 struck
either electronically in the WHO Secretariat will carry out these again in late 2003, and has, as of August
www.regulations.gov or in hard copy at activities are Argentina, Brazil, India, 17, 2006, resulted in 239 confirmed
the OEI Docket in the EPA Headquarters Indonesia, Mexico, Romania, Russia, cases and 140 deaths world-wide, a 59
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Docket Center. South Africa, and Tunisia. Activities percent mortality rate. As of now, the
Note: The EPA Docket Center suffered include pre-clinical safety and H5N1 avian influenza is primarily an
damage due to flooding during the last week immunogenicity testing, toxicology animal disease; H5N1 infection in
of June 2006. The Docket Center is testing, clinical vaccine lot humans has been the result of contact
continuing to operate. However, during the manufacturing, scale-up and process with sick poultry. Unless people come

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