Approaches To Estimating the Waterborne Disease Outbreak Burden in the United States: Uses and Limitations of the Waterborne Disease Outbreak Surveillance System; External Review Draft, 54481-54482 [E6-15335]
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Federal Register / Vol. 71, No. 179 / Friday, September 15, 2006 / Notices
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and Toxics
[FR Doc. E6–15339 Filed 9–14–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–8220–2; EPA–HQ–Docket ID No. EPA–
ORD–2006–0666]
Approaches To Estimating the
Waterborne Disease Outbreak Burden
in the United States: Uses and
Limitations of the Waterborne Disease
Outbreak Surveillance System;
External Review Draft
Environmental Protection
Agency (EPA).
ACTION: Notice of public comment
period.
jlentini on PROD1PC65 with NOTICES
AGENCY:
SUMMARY: EPA is announcing a 30-day
public comment period for the draft
document titled, Approaches To
Estimating the Waterborne Disease
Outbreak Burden in the United States:
Uses and Limitations of the Waterborne
Disease Outbreak Surveillance System
(EPA/600/R–06/069). The document
was prepared by the National Center for
Environmental Assessment (NCEA)
within EPA’s Office of Research and
Development.
EPA is releasing this draft document
solely for the purpose of predissemination peer review under
applicable information quality
guidelines. This document has not been
formally disseminated by EPA. It does
not represent and should not be
construed to represent any Agency
policy or determination. EPA will
consider any public comments
submitted in accordance with this
notice when revising the document.
DATES: The 30-day public comment
period begins September 15, 2006, and
ends October 16, 2006. Technical
comments should be in writing and
VerDate Aug<31>2005
16:50 Sep 14, 2006
Jkt 208001
must be received by EPA by October 16,
2006.
ADDRESSES: The draft Approaches To
Estimating the Waterborne Disease
Outbreak Burden in the United States:
Uses and Limitations of the Waterborne
Disease Outbreak Surveillance System
(EPA/600/R–06/069) is available
primarily via the Internet on the
National Center for Environmental
Assessment’s home page under the
Recent Additions and Publications
menus at https://www.epa.gov/ncea. A
limited number of paper copies are
available from Ms. Donna Tucker,
Technical Information Manager, NCEACincinnati; telephone: 513–569–7257;
facsimile: 513–569–7916; e-mail:
tucker.donna@epa.gov. If you are
requesting a paper copy, please provide
your name, your mailing address, and
the document title, Approaches To
Estimating the Waterborne Disease
Outbreak Burden in the United States:
Uses and Limitations of the Waterborne
Disease Outbreak Surveillance System
(EPA/600/R–06/069).
Comments may be submitted
electronically via EPA’s E-Docket, by
mail, by facsimile, or by hand delivery/
courier. Please follow the detailed
instructions provided in the
Supplementary Information section of
this notice.
FOR FURTHER INFORMATION CONTACT: For
information on the public comment
period, contact the Office of
Environmental Information Docket;
telephone: 202–566–1752; facsimile:
202–566–1753; or e-mail:
ORD.Docket@epa.gov.
For technical information, contact
Glenn Rice, NCEA; telephone: 513–569–
7813; facsimile: 513–487–2539; or email: rice.glenn@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Information About the Project/
Document
Information about waterborne disease
outbreaks (WBDOs) in the United States
is voluntarily reported by State,
territorial and local public health
agencies to the Centers for Disease
Control and Prevention (CDC). CDC and
EPA jointly maintain a WBDO database.
The database describes outbreak
attributes including, among other
things, the drinking water system
deficiency, the etiologic agent, and the
number of individuals who became ill.
Underreporting of such events is
assumed but the magnitude of
underreporting is unknown.
This draft document presents an
approach for estimating the
epidemiologic and economic burden of
disease associated with 665 WBDOs
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
54481
reported in the U.S. between 1971 and
2000. The term disease burden broadly
refers to the magnitude of the impact
incurred by society as a consequence of
disease in the community (e.g.,
decrements in a population’s health or
the associated economic effects) and
there are various metrics that can be
employed by analysts to quantify
burden. In order to capture some of the
benefits of drinking water regulations,
EPA has typically expressed waterborne
disease impacts in terms of
epidemiologic and monetary measures;
this WBDO burden analysis employs
those same measures. Because not all
WBDOs in the United States and
associated cases of illness are reported,
the WBDO database on which this draft
document is based is not
comprehensive. The extent to which
WBDOs are not recognized is unknown
and is not examined in this analysis.
This draft report develops several
quantitative sensitivity analyses to
characterize some of the uncertainty in
the burden estimates but does not
provide an evaluation of the potential
impact of under- or overreporting of
WBDOs or their associated severity
characteristics. The draft report includes
recommendations for the collection and
reporting of additional outbreak
information that would improve the
usefulness of the WBDO database for
future disease burden estimates.
II. How To Submit Technical Comments
to EPA’s E-Docket
Submit your comments, identified by
Docket ID No. EPA-ORD–2006–0666 by
one of the following methods:
• www.regulations.gov: Follow the
on-line instructions for submitting
comments.
• E-mail: ORD Docket@epa.gov.
• Fax: 202–566–1753.
• Mail: Office of Environmental
Information (OEI) Docket (Mail Code:
2822T), U.S. Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. The phone
number is 202–566–1752.
If you provide comments by mail,
please submit one unbound original
with pages numbered consecutively,
and three copies. For attachments,
provide an index, number pages
consecutively with the comments, and
submit an unbound original and three
copies.
• Hand Delivery: The OEI Docket is
located in the Headquarters EPA Docket
Center, EPA/DC; EPA West Building,
1301 Constitution Ave., NW.,
Washington, DC. The EPA Docket
Center Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal
E:\FR\FM\15SEN1.SGM
15SEN1
jlentini on PROD1PC65 with NOTICES
54482
Federal Register / Vol. 71, No. 179 / Friday, September 15, 2006 / Notices
holidays. The telephone number for the
Public Reading Room is 202–566–1744.
Such deliveries are only accepted
during the Docket’s normal hours of
operation, and special arrangements
should be made for deliveries of boxed
information.
Instructions: Direct your comments to
Docket ID No. EPA–ORD–2006–0666.
EPA’s policy is that all comments
received will be included in the public
docket without change and may be
made available online at
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through www.regulations.gov
or e-mail. The www.regulations.gov Web
site is an ‘‘anonymous access’’ system,
which means EPA will not know your
identity or contact information unless
you provide it in the body of your
comment. If you send an e-mail
comment directly to EPA without going
through www.regulations.gov, your email address will be automatically
captured and included as part of the
comment that is placed in the public
docket and made available on the
Internet. If you submit an electronic
comment, EPA recommends that you
include your name and other contact
information in the body of your
comment and with any disk or CD–ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, any form
of encryption, and be free of any defects
or viruses. For additional information
about EPA’s public docket visit the EPA
Docket Center homepage at https://
www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket
are listed in the www.regulations.gov
index. Although listed in the index,
some information is not publicly
available, e.g., CBI or other information
whose disclosure is restricted by statute.
Certain other material, such as
copyrighted material, will be publicly
available only in hard copy. Publicly
available docket materials are available
either electronically in
www.regulations.gov or in hard copy at
the OEI Docket in the EPA Headquarters
Docket Center.
Note: The EPA Docket Center suffered
damage due to flooding during the last week
of June 2006. The Docket Center is
continuing to operate. However, during the
VerDate Aug<31>2005
14:51 Sep 14, 2006
Jkt 208001
cleanup, there will be temporary changes to
Docket Center telephone numbers, addresses,
and hours of operation for people who wish
to make hand deliveries or visit the Public
Reading Room to view documents. Consult
EPA’s Federal Register notice at 71 FR 38147
(July 5, 2006) or the EPA Web site at
www.epa.gov/epahome/dockets.htm for
current information on docket operations,
locations and telephone numbers. U.S. mail
and the procedures for submitting comments
to www.regulations.gov are not affected by
the flooding and will remain the same.
Dated: September 7, 2006.
Peter W. Preuss,
Director, National Center for Environmental
Assessment.
[FR Doc. E6–15335 Filed 9–14–06; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
International Development of H5N1
Influenza Vaccines; Funding
Opportunity
Office of the Secretary, Office
of Public Health Emergency
Preparedness.
ACTION: Notice.
AGENCY:
Funding Opportunity Title:
International Development of H5N1
Influenza Vaccines.
Announcement Type: Single-Source
Cooperative Agreement.
Catalog of Federal Domestic
Assistance Number: The Office of
Management and Budget (OMB) Catalog
of Federal Domestic Assistance number
is 93.019.
SUMMARY: The objective of this project is
to mitigate any potential global shortage
of influenza vaccines and the
manufacturing of this vaccine in the
event of an influenza pandemic. The
Office of Public Health Emergency
Preparedness (OPHEP) requires the
World Health Organization (WHO) to
perform activities related to pandemic
influenza preparedness and planning,
particularly in the international
development of H5N1 human vaccines
(and other pandemic influenza vaccine
candidates) and influenza vaccine
manufacturing infrastructure building in
countries where resources for vaccine
acquisition and manufacturing may be
limited. The specific countries in which
the WHO Secretariat will carry out these
activities are Argentina, Brazil, India,
Indonesia, Mexico, Romania, Russia,
South Africa, and Tunisia. Activities
include pre-clinical safety and
immunogenicity testing, toxicology
testing, clinical vaccine lot
manufacturing, scale-up and process
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
development, analytical lot release
assay development and validation, and
clinical immunogencity assay
development and validation.
DATES: To receive consideration,
applications must be received no later
than 5 p.m., Eastern Time, on
September 29, 2006.
ADDRESSES: The Office of Grants
Management within the Office of Public
Health and Science of the U.S.
Department of Health and Human
Services, located at 1101 Wootten
Parkway, Rockville, MD 20857, must
receive all applications.
SUPPLEMENTARY INFORMATION: In the last
century, three influenza pandemics
have struck the United States and the
world, and viruses from birds
contributed to all of them. In 1918, the
first pandemic infected one-third of the
U.S. population, killed over half a
million Americans, reduced American
life expectancy by 13 years, and killed
more than 20 million people worldwide.
Following the 1918 outbreak, influenza
pandemics in 1957 and 1968 also killed
tens of thousands of Americans and
millions across the world. The recent
limited outbreak of Severe Acute
Respiratory Syndrome (SARS) in 2003
suggests the danger that a modern
pandemic would present.
The H5N1 strain of avian influenza
has become the most threatening
influenza virus in the world, and any
large scale outbreak of this disease
among humans would have grave
consequences for global public health.
Influenza experts have warned that the
reassortment of different H5N1 viruses
over the past seven years greatly
increases the potential for the viruses to
be transmitted more easily from person
to person. Medical practitioners have
also discovered several other, new avian
viruses that can be transmitted to
humans.
The U.S. Government is concerned
that a new influenza virus could become
efficiently transmissible among humans.
Now spreading through bird
populations across Asia, reaching into
Europe, the Middle East and, most
recently, Africa, the H5N1 strain has
infected domesticated birds, such as
ducks and chickens, and long range
migratory birds. In 1997, the first
recorded H5N1 outbreak in humans
took place in Hong Kong. H5N1 struck
again in late 2003, and has, as of August
17, 2006, resulted in 239 confirmed
cases and 140 deaths world-wide, a 59
percent mortality rate. As of now, the
H5N1 avian influenza is primarily an
animal disease; H5N1 infection in
humans has been the result of contact
with sick poultry. Unless people come
E:\FR\FM\15SEN1.SGM
15SEN1
Agencies
[Federal Register Volume 71, Number 179 (Friday, September 15, 2006)]
[Notices]
[Pages 54481-54482]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-15335]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[FRL-8220-2; EPA-HQ-Docket ID No. EPA-ORD-2006-0666]
Approaches To Estimating the Waterborne Disease Outbreak Burden
in the United States: Uses and Limitations of the Waterborne Disease
Outbreak Surveillance System; External Review Draft
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of public comment period.
-----------------------------------------------------------------------
SUMMARY: EPA is announcing a 30-day public comment period for the draft
document titled, Approaches To Estimating the Waterborne Disease
Outbreak Burden in the United States: Uses and Limitations of the
Waterborne Disease Outbreak Surveillance System (EPA/600/R-06/069). The
document was prepared by the National Center for Environmental
Assessment (NCEA) within EPA's Office of Research and Development.
EPA is releasing this draft document solely for the purpose of pre-
dissemination peer review under applicable information quality
guidelines. This document has not been formally disseminated by EPA. It
does not represent and should not be construed to represent any Agency
policy or determination. EPA will consider any public comments
submitted in accordance with this notice when revising the document.
DATES: The 30-day public comment period begins September 15, 2006, and
ends October 16, 2006. Technical comments should be in writing and must
be received by EPA by October 16, 2006.
ADDRESSES: The draft Approaches To Estimating the Waterborne Disease
Outbreak Burden in the United States: Uses and Limitations of the
Waterborne Disease Outbreak Surveillance System (EPA/600/R-06/069) is
available primarily via the Internet on the National Center for
Environmental Assessment's home page under the Recent Additions and
Publications menus at https://www.epa.gov/ncea. A limited number of
paper copies are available from Ms. Donna Tucker, Technical Information
Manager, NCEA-Cincinnati; telephone: 513-569-7257; facsimile: 513-569-
7916; e-mail: tucker.donna@epa.gov. If you are requesting a paper copy,
please provide your name, your mailing address, and the document title,
Approaches To Estimating the Waterborne Disease Outbreak Burden in the
United States: Uses and Limitations of the Waterborne Disease Outbreak
Surveillance System (EPA/600/R-06/069).
Comments may be submitted electronically via EPA's E-Docket, by
mail, by facsimile, or by hand delivery/courier. Please follow the
detailed instructions provided in the Supplementary Information section
of this notice.
FOR FURTHER INFORMATION CONTACT: For information on the public comment
period, contact the Office of Environmental Information Docket;
telephone: 202-566-1752; facsimile: 202-566-1753; or e-mail:
ORD.Docket@epa.gov.
For technical information, contact Glenn Rice, NCEA; telephone:
513-569-7813; facsimile: 513-487-2539; or e-mail: rice.glenn@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Information About the Project/Document
Information about waterborne disease outbreaks (WBDOs) in the
United States is voluntarily reported by State, territorial and local
public health agencies to the Centers for Disease Control and
Prevention (CDC). CDC and EPA jointly maintain a WBDO database. The
database describes outbreak attributes including, among other things,
the drinking water system deficiency, the etiologic agent, and the
number of individuals who became ill. Underreporting of such events is
assumed but the magnitude of underreporting is unknown.
This draft document presents an approach for estimating the
epidemiologic and economic burden of disease associated with 665 WBDOs
reported in the U.S. between 1971 and 2000. The term disease burden
broadly refers to the magnitude of the impact incurred by society as a
consequence of disease in the community (e.g., decrements in a
population's health or the associated economic effects) and there are
various metrics that can be employed by analysts to quantify burden. In
order to capture some of the benefits of drinking water regulations,
EPA has typically expressed waterborne disease impacts in terms of
epidemiologic and monetary measures; this WBDO burden analysis employs
those same measures. Because not all WBDOs in the United States and
associated cases of illness are reported, the WBDO database on which
this draft document is based is not comprehensive. The extent to which
WBDOs are not recognized is unknown and is not examined in this
analysis. This draft report develops several quantitative sensitivity
analyses to characterize some of the uncertainty in the burden
estimates but does not provide an evaluation of the potential impact of
under- or overreporting of WBDOs or their associated severity
characteristics. The draft report includes recommendations for the
collection and reporting of additional outbreak information that would
improve the usefulness of the WBDO database for future disease burden
estimates.
II. How To Submit Technical Comments to EPA's E-Docket
Submit your comments, identified by Docket ID No. EPA-ORD-2006-0666
by one of the following methods:
www.regulations.gov: Follow the on-line instructions for
submitting comments.
E-mail: ORD Docket@epa.gov.
Fax: 202-566-1753.
Mail: Office of Environmental Information (OEI) Docket
(Mail Code: 2822T), U.S. Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460. The phone number is 202-
566-1752.
If you provide comments by mail, please submit one unbound original
with pages numbered consecutively, and three copies. For attachments,
provide an index, number pages consecutively with the comments, and
submit an unbound original and three copies.
Hand Delivery: The OEI Docket is located in the
Headquarters EPA Docket Center, EPA/DC; EPA West Building, 1301
Constitution Ave., NW., Washington, DC. The EPA Docket Center Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal
[[Page 54482]]
holidays. The telephone number for the Public Reading Room is 202-566-
1744. Such deliveries are only accepted during the Docket's normal
hours of operation, and special arrangements should be made for
deliveries of boxed information.
Instructions: Direct your comments to Docket ID No. EPA-ORD-2006-
0666. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or e-mail.
The www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through www.regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at https://www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the OEI Docket in the EPA
Headquarters Docket Center.
Note: The EPA Docket Center suffered damage due to flooding
during the last week of June 2006. The Docket Center is continuing
to operate. However, during the cleanup, there will be temporary
changes to Docket Center telephone numbers, addresses, and hours of
operation for people who wish to make hand deliveries or visit the
Public Reading Room to view documents. Consult EPA's Federal
Register notice at 71 FR 38147 (July 5, 2006) or the EPA Web site at
www.epa.gov/epahome/dockets.htm for current information on docket
operations, locations and telephone numbers. U.S. mail and the
procedures for submitting comments to www.regulations.gov are not
affected by the flooding and will remain the same.
Dated: September 7, 2006.
Peter W. Preuss,
Director, National Center for Environmental Assessment.
[FR Doc. E6-15335 Filed 9-14-06; 8:45 am]
BILLING CODE 6560-50-P