Academic Partners for Excellence in Environmental Public Health Tracking, 21794-21799 [05-8398]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Academic Partners for Excellence in
Environmental Public Health Tracking
Announcement Type: New.
Funding Opportunity Number: RFA
EH–05074.
Catalog of Federal Domestic
Assistance Number: 93.283.
Key Dates:
Letter of Intent (LOI) Deadline: May
27, 2005.
Pre-Application Conference Calls:
May 16, 2005.
Application Deadline: June 27, 2005.
I. Funding Opportunity Description
Authority: This program is authorized
under section 301 of the Public Health
Service Act, [42 U.S.C. section 241], as
amended.
Purpose: The purpose of the program
is to provide expertise and support to
the National Environmental Public
Health Tracking Program (NEPHTP) in
the development and utilization of the
National Environmental Public Health
Tracking Network (NEPHTN).
Additional information about the
NEPHTN and funded activities at state
and local government levels is provided
at https://www.cdc.gov/nceh/tracking.
This program addresses the ‘‘Healthy
People 2010’’ focus areas of
Environmental Health and Public
Health Infrastructure.
Measurable outcomes of the program
will be in alignment with the following
performance goal for the National
Center for Environmental Health
(NCEH): Increase the understanding of
the relationship between environmental
exposures and health effects.
This announcement contains two
separate parts: Part I and Part II in order
to accommodate the range of specialty
activities needed to support the
development of the NEPHTN. Each
applicant can only apply for one part.
Please indicate in your abstract and in
the research plan which component
your application is directed to. These
projects will move the nation toward
improved environmental public health
surveillance and response capacity for
development of the NEPHTN. Detailed
description of each project is included
under ‘‘Activities.’’
Research Objectives:
• Nature of the research problem
The environment plays an important
role in human development and health.
Researchers have linked exposures to
some environmental hazards with
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specific diseases. Currently, no systems
exist at the state or national level to
track many of the exposures and health
effects that may be related to
environmental hazards. In most cases,
existing environmental hazard,
exposure, and disease tracking systems
are not linked together. Because existing
systems are not linked, it is difficult to
study and monitor relationships among
hazards, exposures, and health effects.
CDC is developing a National
Environmental Public Health Tracking
Network that integrates data about
environmental hazards and exposures
with data about diseases that are
possibly linked to the environment.
However, to develop this Network,
methods for data collection, data
linkage, and data analysis will need to
be improved and evaluated. Information
from this network should guide
etiologic research into the relationship
between environmental factors and
human health. Ultimately, state and
local public health agencies must have
a trained workforce capable of operating
and utilizing an EPHT network to
provide substantial public health
impact.
• Scientific knowledge to be achieved
through research supported by this
program
Increased understanding of: (1) The
relationship between environmental
hazards, exposures and health effects;
(2) the methods required to collect,
integrate, analyze, and interpret data;
and (3) effective techniques for
dissemination of information to protect
and improve health.
• Objectives of this research program
(1) Innovative, cost-effective data
collection strategies that state and local
health departments can use to obtain
valid, high quality data on
environmental health effects, exposures,
and hazards.
(2) Data linkage methods for
combined analysis of health and
environmental data that could be
utilized by state and local
environmental public health programs
in building an EPHTN.
(3) Statistical algorithms that could be
used by state and local environmental
public health programs to analyze
trends and detect patterns of health
effects occurrence, population exposure,
or hazard levels in the environment that
may indicate a problem.
(4) Greater understanding of the
relationship between particular health
effects and environmental exposures
and/or hazards.
(5) Effective training tools for all areas
critical to the development, operation,
maintenance, and utilization of an
EPHTN.
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• Identify the types of research and
experimental approaches that are being
sought to achieve the objectives
Research to support these objectives
includes public health surveillance
methods evaluation, epidemiological
studies, and training effectiveness
evaluations.
Activities: In conducting activities to
achieve the purpose of this program, the
awardee will be responsible for the
activities under Awardee Activities, and
CDC will be responsible for the
activities listed under CDC Activities.
Awardee activities for this program are
as follows:
Awardee Activities: Recipients under
Part I must develop and submit a
research plan to address recipient
activities a–h.
Part I Recipient Activities: Provide
lead expertise in the development of
public health surveillance methods.
These should, at a minimum, include:
(a) Evaluating current surveillance
methodology and developing
innovative, cost-effective data collection
strategies (including consideration of
non-traditional data sources) that state
and local health departments can use to
obtain valid, high quality data on
environmental health effects, exposures,
and hazards.
(b) Developing data linkage methods
for combined analysis of health and
environmental data that could be
utilized by state and local
environmental public health programs
in building an EPHTN.
(c) Developing statistical algorithms
that could be used by state and local
environmental public health programs
to analyze trends and detect patterns of,
and relationships between, health
effects occurrence, population exposure,
or hazard levels in the environment; and
generating alerts when unusual
occurrences of health effect, exposure,
or hazard are detected.
(d) Conduct an epidemiology study
examining the relationship between a
health effect and an environmental
exposure and/or hazard in collaboration
with environmental public health
tracking program partners and CDC.
This study should utilize data from a
state or local environmental public
health tracking program, as well as other
summary or secondary data sources in
the design and/or analysis phase. This
may require the development of a
research protocol for Institutional
Review Board (IRB) review by all
cooperating institutions participating in
the research project. Where CDC
scientists are involved, the CDC IRB will
initially review and approve the
protocol, with a minimum of an annual
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review until the research project is
completed.
(e) Provide training for the nation’s
future Environmental Public Health
workforce through the provision of
student academic tracks in the areas of
environmental epidemiology, public
health surveillance methods, and/or
internship opportunities.
(f) Build capacity at the state and local
level through the communication of
project accomplishments, barriers, and
lessons learned with EPHT
(surveillance) Program partners and
other critical stakeholders at CDCsponsored seminars, stakeholder
meetings, quarterly conference calls,
and by posting information to an EPHT
web forum.
(g) Participate in workgroups with
EPHT Program partners. Applicant will
also be required to work in conjunction
with the CDC Environmental Public
Health Tracking Program’s Standards
and Network Development workgroup
and other relevant workgroups and
activities critical to the development of
the EPHTN.
(h) Collaborate with the relevant
academic partners for excellence
involved with the EPHT Program on
training activities to promote the
dissemination of knowledge from this
focus area to other program partners.
Recipients under Part II must develop
and submit a research plan to address
recipient activities a–h.
Part II Recipient Activities:
(a) Develop training tools and provide
training to state and local health
department partners participating in the
NEPHT Program, in collaboration with
CDC and other funded academic
partners involved with the EPHT
program. Training should include, but
not be limited to, all areas critical to the
development, operation, maintenance,
and utilization and dissemination of
information from the Network. These
should include public health
surveillance methods, GIS, spatial
statistics and other environmental
assessment methods, and risk
communication.
(b) Collaborate with other funded
academic partners to identify and
develop focus areas for continuous
training.
(c) Develop and conduct at least two
regional and one annual training
workshop for Environmental Public
Health Tracking grantees covering
public health surveillance methods,
environmental epidemiology, risk
communication, Geographic
Information Systems, (GIS), spatial
statistics and other assessment methods,
prevention effectiveness, program
evaluation and other subjects critical to
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the development, maintenance,
utilization, and dissemination of
information from an EPHTN.
(d) Conduct an assessment of: (1) The
key issues that influence perceptions
concerning the risk posed by
environmental hazards or exposures;
and (2) techniques to communicate
information on environmental hazards,
exposures, or risk most likely to
promote protective actions. This
assessment could include
comprehensive literature reviews,
review of state and local public health
communications activities, risk
perception surveys, convening a panel
of communications experts, or other
assessment strategies. As a product of
this assessment, develop written
guidance on methods to disseminate
information from an EPHTN that would
most effectively communicate this
information to a variety of audiences
representing diverse social and cultural
backgrounds, including policy makers,
healthcare providers, and community
representatives.
(e) Develop, test, disseminate, and
evaluate communication strategies for
health effects, exposure and hazard
information from a surveillance network
(EPHTN) that take into account risk
perception differences among various
audiences. Collaborate with CDC to
promote the dissemination of
knowledge from this focus area to other
program partners.
(f) Provide training for the nation’s
future Environmental Public Health
workforce through the provision of
student academic tracks in the areas of
environmental epidemiology, public
health surveillance methods, and risk
communication strategies and/or
internship opportunities.
(g) Build capacity at the state and
local level through the communication
of project accomplishments, barriers,
and lessons learned with Environmental
Public Health Tracking (surveillance)
Program partners and other critical
stakeholders at CDC-sponsored
seminars, stakeholder meetings,
quarterly conference calls, and by
posting information to an EPHT web
forum.
(h) Participate in workgroups with
EPHT Program partners.
CDC Activities: In a cooperative
agreement, CDC staff is substantially
involved in the program activities,
above and beyond routine grant
monitoring. CDC Activities for this
program are as follows:
a. Foster relationships among
academic partners and state and local
health departments by assisting in the
sharing of information through an EPHT
Web site, seminars, an annual
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stakeholder meeting, quarterly
conference calls, and other direct
interactions.
b. Convene workgroups to foster the
development of the NEPHTN.
c. Participate in designing,
developing, and evaluating surveillance
methods.
d. Participate in the development of
statistical algorithms to analyze trends
and detect patterns of health effects
occurrence, population exposure, or
hazard levels in the environment that
may indicate a problem.
e. Participate in the protocol
development, study implementation,
data analysis, interpretation of results,
and dissemination of epidemiology
study findings including report writing
and oral presentation. When involved in
a scientific study, the CDC IRB will
initially review and approve the
protocol, with a minimum annual
review until the research project is
completed.
f. Provide assistance in development
of training materials on surveillance
methods, evaluation, risk
communication, and other topics for
state and local agencies and other EPHT
Program partners, including the
dissemination of information about
strategies for communicating health
effect, exposure, and hazard information
from an EPHT network.
II. Award Information
Type of Award: Cooperative
Agreement. CDC involvement in this
program is listed in the Activities
Section above.
Mechanism of Support: U19—
Research Programs (Cooperative
Agreements).
Fiscal Year Funds: 2005.
Approximate Total Funding:
$2,000,000 (This amount is an estimate,
and is subject to availability of funds.)
Approximate Number of Awards: Five.
Approximate Average Award:
$400,000 (This amount is for the first
12-month budget period.)
Floor of Award Range: $350,000.
Ceiling of Award Range: $450,000.
(This ceiling is for the first 12-month
budget period.)
Anticipated Award Date: August 1,
2005.
Budget Period Length: 12 months.
Project Period Length: Five (5) years.
Throughout the project period, CDC’s
commitment to continuation of awards
will be conditioned on the availability
of funds, evidence of satisfactory
progress by the recipient (as
documented in required reports), and
the determination that continued
funding is in the best interest of the
Federal Government.
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III. Eligibility Information
III.1. Eligible Applicants
Assistance will be provided to United
States Schools of Public Health,
accredited by the Council on Education
of Public Health, which are associated
with or have access to programs in
environmental epidemiology,
environmental sciences, health
education, health/risk communication,
clinical medicine, and medical
informatics. Eligibility is open to these
applicants because they provide: (1) The
technical expertise in the wide range of
disciplines needed to further develop
the theoretical and scientific base for
environmental public health tracking
(surveillance), and develop and test for
new methodology essential to support
state and local programs; and (2) a
training ground for the nation’s future
environmental public health workforce.
This wide range of disciplines and
expertise is often unavailable or difficult
to access by state or local public health
agencies yet will be required for an
environmental public health tracking
network to fulfill all the critical
functions of a public health surveillance
system.
III.2. Cost Sharing or Matching
Matching funds are not required for
this program.
III.3. Other
If you request a funding amount
greater than the ceiling of the award
range, your application will be
considered non-responsive, and will not
be entered into the review process. You
will be notified that your application
did not meet the submission
requirements.
Special Requirements: If your
application is incomplete or nonresponsive to the requirements listed in
this section, it will not be entered into
the review process. You will be notified
that your application did not meet
submission requirements.
• Late applications will be considered
non-responsive. See section ‘‘IV.3.
Submission Dates and Times’’ for more
information on deadlines.
• All documentation submitted as
evidence of eligibility as outlined in
Section III.1 above should be placed
directly behind the face page (first page)
of your application. Applications that
fail to submit evidence requested above
will be considered non-responsive and
returned without review.
• Note: Title 2 of the United States Code
Section 1611 states that an organization
described in Section 501(c)(4) of the Internal
Revenue Code that engages in lobbying
activities is not eligible to receive Federal
funds constituting an award, grant, or loan.
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Individuals Eligible To Become
Principal Investigators: Any individual
with the skills, knowledge, and
resources necessary to carry out the
proposed research is invited to work
with their institution to develop an
application for support. Individuals
from under-represented racial and
ethnic groups as well as individuals
with disabilities are always encouraged
to apply for CDC programs.
IV. Application and Submission
Information
IV.1. Address To Request Application
Package
To apply for this funding opportunity,
use application form PHS 398 (OMB
number 0925–0001 rev. 9/2004). Forms
and instructions are available in an
interactive format on the CDC Web site,
at the following Internet address:
https://www.cdc.gov/od/pgo/
forminfo.htm.
Forms and instructions are also
available in an interactive format on the
National Institutes of Health (NIH) Web
site at the following Internet address:
https://grants.nih.gov/grants/funding/
phs398/phs398.html.
If you do not have access to the
Internet, or if you have difficulty
accessing the forms on-line, you may
contact the CDC Procurement and
Grants Office Technical Information
Management Section (PGO–TIM) staff
at: 770–488–2700. Application forms
can be mailed to you.
IV.2. Content and Form of Application
Submission
Letter of Intent (LOI): Your LOI must
be written in the following format:
• Maximum number of pages: Two
• Font size: 12-point unreduced
• Double spaced
• Paper size: 8.5 by 11 inches
• Page margin size: One inch
• Printed only on one side of page
• Written in plain language, avoid
jargon
Your LOI must contain the following
information:
• Descriptive title of the proposed
application
• Component of this announcement,
Part I or II, you wish to be considered
for
• Name, address, E-mail address,
telephone number, and fax number of
the Principal Investigator
• Names of other key personnel
• Participating institutions
• Number and title of this
Announcement
Application: Follow the PHS 398
application instructions for content and
formatting of your application. For
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further assistance with the PHS 398
application form, contact PGO–TIM staff
at 770–488–2700, or contact GrantsInfo,
Telephone 301–435–0714, E-mail:
GrantsInfo@nih.gov.
Your research plan should address
activities to be conducted over the
entire project period.
You are required to have a Dun and
Bradstreet Data Universal Numbering
System (DUNS) number to apply for a
grant or cooperative agreement from the
Federal government.
Your DUNS number must be entered
on line 11 of the face page of the PHS
398 application form. The DUNS
number is a nine-digit identification
number, which uniquely identifies
business entities. Obtaining a DUNS
number is easy and there is no charge.
To obtain a DUNS number, access
https://www.dunandbradstreet.com or
call 1–866–705–5711.
For more information, see the CDC
Web site at: https://www.cdc.gov/od/pgo/
funding/pubcommt.htm.
This announcement uses the nonmodular budgeting format.
Additional requirements that may
require you to submit additional
documentation with your application
are listed in section ‘‘VI.2.
Administrative and National Policy
Requirements.’’
V.3. Submission Dates and Times
LOI Deadline Date: May 27, 2005.
CDC requests that you send a LOI if
you intend to apply for this program.
Although the LOI is not mandatory, not
binding, and does not enter into the
review of your subsequent application,
the LOI will be used to gauge the level
of interest in this program, and to allow
CDC to plan the application review.
Application Deadline Date: June 27,
2005.
Explanation of Deadlines: LOIs and
Applications must be received in the
CDC Procurement and Grants Office by
4 p.m. Eastern Time on the deadline
date. If you submit your LOI or
application by the United States Postal
Service or commercial delivery service,
you must ensure that the carrier will be
able to guarantee delivery by the closing
date and time. If CDC receives your
submission after closing due to: (1)
Carrier error, when the carrier accepted
the package with a guarantee for
delivery by the closing date and time, or
(2) significant weather delays or natural
disasters, you will be given the
opportunity to submit documentation of
the carriers guarantee. If the
documentation verifies a carrier
problem, CDC will consider the
submission as having been received by
the deadline.
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This announcement is the definitive
guide on LOI and application content,
submission address, and deadline. It
supersedes information provided in the
application instructions. If your
application does not meet the deadline
above, it will not be eligible for review,
and will be discarded. You will be
notified that you did not meet the
submission requirements.
CDC will not notify you upon receipt
of your submission. If you have a
question about the receipt of your LOI
or application, first contact your courier.
If you still have a question, contact the
PGO-TIM staff at: 770–488–2700. Before
calling, please wait two to three days
after the submission deadline. This will
allow time for submissions to be
processed and logged.
IV.4. Intergovernmental Review of
Applications
Your application is subject to
Intergovernmental Review of Federal
Programs, as governed by Executive
Order (EO) 12372. This order sets up a
system for state and local governmental
review of proposed federal assistance
applications. You should contact your
state single point of contact (SPOC) as
early as possible to alert the SPOC to
prospective applications, and to receive
instructions on your state’s process.
Click on the following link to get the
current SPOC list: https://
www.whitehouse.gov/omb/grants/
spoc.html.
IV.5. Funding Restrictions
Restrictions, which must be taken into
account while writing your budget, are
as follows:
• Funds relating to the conduct of
research will not be released until the
appropriate assurances and Institutional
Review Board approvals are in place.
• Reimbursement of pre-award costs
is not allowed.
If you are requesting indirect costs in
your budget, you must include a copy
of your indirect cost rate agreement. If
your indirect cost rate is a provisional
rate, the agreement should be less than
12 months of age.
IV.6. Other Submission Requirements
LOI Submission Address: Submit your
LOI by express mail, delivery service,
fax, or e-mail to: Scientific Review
Administrator, Attn: Kathleen Shaver
Madden, Ph.D., CDC/Office of Public
Health Research, One West Court
Square, Suite 7000, Rm 7018, Mailstop
D–72, Decatur, GA 30030, Tel: 404–371–
5253, Fax: 404–371–5215, E-mail:
kmn0@cdc.gov.
Application Submission Address:
Submit the original and one hard copy
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of your application by mail or express
delivery service to: Technical
Information Management—RFA EH–
05074, CDC Procurement and Grants
Office, 2920 Brandywine Road, Atlanta,
GA 30341.
At the time of submission, four
additional copies of the application, and
all appendices must be sent to:
Scientific Review Administrator, Attn:
Kathleen Shaver Madden, Ph.D. (RFA
EH–05074), CDC/Office of Public Health
Research, One West Court Square, Suite
7000, Rm 7018, Mailstop D–72, Decatur,
GA 30030, Tel: 404–371–5253, Fax:
404–371–5215, E-mail: kmn0@cdc.gov.
V. Application Review Information
V.1. Criteria
Applicants are required to provide
measures of effectiveness that will
demonstrate the accomplishment of the
various identified objectives of the
cooperative agreement. Measures of
effectiveness must relate to the
performance goals stated in the
‘‘Purpose’’ section of this
announcement. Measures must be
objective and quantitative, and must
measure the intended outcome. These
measures of effectiveness must be
submitted with the application and will
be an element of evaluation.
The goals of CDC-supported research
are to advance the understanding of
biological systems, improve the control
and prevention of disease and injury,
and enhance health. In the written
comments, reviewers will be asked to
evaluate the application in order to
judge the likelihood that the proposed
research will have a substantial impact
on the pursuit of these goals.
The scientific review group will
address and consider each of the
following criteria equally in assigning
the application’s overall score,
weighting them as appropriate for each
application. The application does not
need to be strong in all categories to be
judged likely to have major scientific
impact and thus deserve a high priority
score. For example, an investigator may
propose to carry out important work
that by its nature is not innovative, but
is essential to move a field forward.
The review criteria are as follows:
Significance: Does this study address
an important problem? If the aims of the
application are achieved, how will
scientific knowledge be advanced? What
will be the effect of these studies on the
concepts or methods that drive this
field?
Approach: Are the conceptual
framework, design, methods, and
analyses adequately developed, wellintegrated, and appropriate to the aims
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of the project? Does the project scope
reflect a clear understanding of the
purpose and requirements of the
cooperative agreement and the
conceptual framework, intent, and
challenges of implementing a National
Environmental Public Health Tracking
Network? Are the project scope, key
objectives, project milestones, products,
and performance measures clearly
described and appropriate for the
project? Are the strategy, schedule, and
resources appropriate for timely
completion of the project? Does the
applicant acknowledge potential
problem areas and consider alternative
tactics and provide plans for mitigating
project risk?
Innovation: Does the project employ
novel concepts, approaches or methods?
Are the aims original and innovative?
Does the project challenge existing
paradigms or develop new
methodologies or technologies?
Investigator: Is the investigator
appropriately trained and well suited to
carry out this work? Is the work
proposed appropriate to the experience
level of the principal investigator and
other researchers (if any)? Are the
resumes/curricula vita of key personnel
included? If there are several
researchers involved, is this there a
clear description of how the principal
investigator will manage the project
team and, if necessary, coordinate with
other academic departments or groups
participating in this endeavor? Are all
researcher and staff roles and
responsibilities clearly described and
linked to project activities and
milestones?
Environment: Does the scientific
environment in which the work will be
done contribute to the probability of
success? Do the proposed experiments
take advantage of unique features of the
scientific environment or employ useful
collaborative arrangements? Is there
evidence of institutional support?
Additional Review Criteria: In
addition to the above criteria, the
following programmatic priorities will
be considered in the determination of
scientific merit and priority score:
1. Collaborative Relationships: The
extent to which the applicant identifies
key partners to carry out proposed
activities and provides evidence that
these organizations/agencies support,
and will be actively involved in,
carrying out the project. Letters of
Support from appropriate personnel,
such as department chairs, must be
provided if applicant is utilizing
affiliate institutions to provide expertise
in environmental epidemiology,
environmental sciences, health
education, health communication,
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clinical medicine, or medical
informatics. The extent to which the
applicant describes past and current
collaborations with Federal agencies,
state and local health and
environmental agencies, professional
organizations, community-based
organizations, and other relevant
organizations will be considered.
Protection of Human Subjects from
Research Risks: Does the application
adequately address the requirements of
Title 45 CFR Part 46 for the protection
of human subjects? The involvement of
human subjects and protections from
research risk relating to their
participation in the proposed research
will be assessed.
Inclusion of Women and Minorities in
Research: Does the application
adequately address the CDC Policy
requirements regarding the inclusion of
women, ethnic, and racial groups in the
proposed research? This includes: (1)
The proposed plan for the inclusion of
both sexes and racial and ethnic
minority populations for appropriate
representation; (2) The proposed
justification when representation is
limited or absent; (3) A statement as to
whether the design of the study is
adequate to measure differences when
warranted; and (4) A statement as to
whether the plans for recruitment and
outreach for study participants include
the process of establishing partnerships
with community (ies) and recognition of
mutual benefits.
Care and Use of Vertebrate Animals:
If vertebrate animals are to be used in
the project, the five items described
under Section f. of the PHS 398 research
grant application instructions will be
assessed.
Budget: The reasonableness of the
proposed budget and the requested
period of support in relation to the
proposed research.
V.2. Review and Selection Process
Applications will be reviewed for
completeness by the Procurement and
Grants Office (PGO) and for
responsiveness by the National Center
for Environmental Health (NCEH).
Incomplete applications and
applications that are non-responsive to
the eligibility criteria will not advance
through the review process. Applicants
will be notified that their application
did not meet submission requirements.
Applications that are complete and
responsive to the announcement will be
evaluated for scientific and technical
merit by an appropriate peer review
group or charter study section convened
by the NCEH in accordance with the
review criteria listed above. As part of
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the initial merit review, all applications
may:
• Undergo a process in which only
those applications deemed to have the
highest scientific merit by the review
group, generally the top half of the
applications under review, will be
discussed and assigned a priority score.
• Receive a written critique.
• Receive a second programmatic
level review by the NCEH, Office of
Science.
Award Criteria: Criteria that will be
used to make award decisions during
the programmatic review include:
• Scientific merit (as determined by
peer review)
• Availability of funds
• Programmatic priorities
• Preference may be given to the
establishment of academic partnerships
in different geographic areas of the
United States.
V.3. Anticipated Announcement and
Award Dates
It is anticipated that notification of
awards will go out to successful
applicants on or before August 31, 2005
with a projected start date on or before
October 1, 2005.
VI. Award Administration Information
VI.1. Award Notices
Successful applicants will receive a
Notice of Award (NoA) from the CDC
Procurement and Grants Office. The
NoA shall be the only binding,
authorizing document between the
recipient and CDC. The NoA will be
signed by an authorized Grants
Management Officer, and mailed to the
recipient fiscal officer identified in the
application.
Unsuccessful applicants will receive
notification of the results of the
application review by mail.
VI.2. Administrative and National
Policy Requirements
45 CFR Part 74 and Part 92
For more information on the Code of
Federal Regulations, see the National
Archives and Records Administration at
the following Internet address: https://
www.access.gpo.gov/nara/cfr/cfr-tablesearch.html.
The following additional
requirements apply to this project:
• AR–1 Human Subjects
Requirements
• AR–2 Requirements for Inclusion
of Women and Racial and Ethnic
Minorities in Research
• AR–7 Executive Order 12372
• AR–8 Public Health System
Reporting Requirements
• AR–9 Paperwork Reduction Act
Requirements
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• AR–10 Smoke-Free Workplace
Requirements
• AR–11 Healthy People 2010
• AR–12 Lobbying Restrictions
• AR–22 Research Integrity
• AR–24 Health Insurance
Portability and Accountability Act
Requirements
Additional information on these
requirements can be found on the CDC
web site at the following Internet
address: https://www.cdc.gov/od/pgo/
funding/ARs.htm.
VI.3. Reporting
You must provide CDC with an
original, plus two hard copies of the
following reports:
1. Interim progress report, (use form
PHS 2590, OMB Number 0925–0001,
rev. 9/2004 as posted on the CDC
website) no less than 90 days before the
end of the budget period. The progress
report will serve as your non-competing
continuation application, and must
contain the following elements:
a. Current Budget Period Activities
Objectives.
b. Current Budget Period Financial
Progress.
c. New Budget Period Program
Proposed Activity Objectives.
d. Budget.
e. Measures of Effectiveness.
f. Additional Requested Information.
2. Financial status report, no more
than 90 days after the end of the budget
period.
3. Final financial and performance
reports, no more than 90 days after the
end of the project period.
These reports must be mailed to the
Grants Management Specialist listed in
the ‘‘Agency Contacts’’ section of this
announcement.
VII. Agency Contacts
We encourage inquiries concerning
this announcement.
For general questions, contact:
Technical Information Management
Section, CDC Procurement and Grants
Office, 2920 Brandywine Road, Atlanta,
GA 30341, Telephone: 770–488–2700.
For scientific/research issues, contact:
Mildred Williams-Johnson, Ph.D.,
Scientific Program Administrator, CDC/
ATSDR, 1600 Clifton Road, NE,
Mailstop E17, Atlanta, GA 30333,
Telephone: 404–498–0639, E-mail:
MWilliams-Johnson@cdc.gov. or Judy
Qualters, Ph.D; Scientific Program
Collaborator, 1600 Clifton Road, NE;
M/S E–19, Atlanta, GA 30333,
Telephone: 404–498–1270, E-mail:
epht@cdc.gov.
For questions about peer review,
contact: Kathleen Shiver Madden, Ph.D.,
Scientific Review Administrator, CDC/
E:\FR\FM\27APN1.SGM
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Federal Register / Vol. 70, No. 80 / Wednesday, April 27, 2005 / Notices
Office of Public Health Research, One
West Court Square, Suite 7000, Rm
7018, Mailstop D–72, Decatur, GA
30030, Telephone: 404–371–5253, Email: Kmn0@cdc.gov.
For financial, grants management, or
budget assistance, contact: Edna Green,
Grants Management Specialist, CDC
Procurement and Grants Office, 2920
Brandywine Road, Atlanta, GA 30341,
Telephone: 770–488–2743, E-mail:
EGreen@cdc.gov.
VIII. Other Information
This and other CDC funding
opportunity announcements can be
found on the CDC Web site, Internet
address: https://www.cdc.gov. Click on
‘‘Funding’’ then ‘‘Grants and
Cooperative Agreements.’’ Additional
Information about the Environmental
Public Health Tracking Program and
current activities of the academic
partners can be found at https://
www.cdc.gov/nceh/tracking.
Dated: April 21, 2005.
William P. Nichols,
Director, Procurement and Grants Office,
Centers for Disease Control and Prevention.
[FR Doc. 05–8398 Filed 4–26–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Cellular, Tissue and Gene Therapies
Advisory Committee (Formerly
Biological Response Modifiers
Advisory Committee); Notice of
Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of Committee: Cellular, Tissue
and Gene Therapies Advisory
Committee (formerly Biological
Response Modifiers Advisory
Committee).
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on May 20, 2005, from 2 p.m. to
approximately 4 p.m.
Location: 5515 Security Lane, rm.
1113, Rockville, MD. This meeting will
be held by teleconference. The public is
welcome to attend the meeting at the
VerDate jul<14>2003
16:41 Apr 26, 2005
Jkt 205001
specified location. A speakerphone will
be provided at this location for public
participation in the meeting.
Contact Person: Gail Dapolito or
Rosanna L. Harvey, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852,
301–827–0314, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512389. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: The committee will receive
an update on individual research
programs in the Division of Therapeutic
Proteins, Center for Drug Evaluation and
Research.
Procedure: On May 20, 2005, from 2
p.m. to approximately 4 p.m., the
meeting is open to the public. Interested
persons may present data, information,
or views, orally or in writing, on issues
pending before the committee. Written
submissions may be made to the contact
person by May 13, 2005. Oral
presentations from the public will be
scheduled between approximately 3
p.m. and 4 p.m. Time allotted for each
presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person before May 13, 2005, and submit
a brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation.
Closed Committee Deliberations: On
May 20, 2005, from approximately 4
p.m. to 4:30 p.m., the meeting will be
closed to permit discussion where
disclosure would constitute a clearly
unwarranted invasion of personal
privacy (5 U.S.C. 552b(c)(6)). The
committee will discuss a review of
individual FDA research programs.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Gail Dapolito
at least 7 days in advance of the
meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
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21799
Dated: April 18, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–8353 Filed 4–26–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel A T32
Application.
Date: June 14, 2005.
Time: 5 p.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Wyndham City Center Hotel, 1143
New Hampshire Ave., NW., Washington, DC
20037.
Contact Person: Raymond A. Petryshyn,
PhD, Scientific Review Administrator,
Resources and Training Review Branch,
Division of Extramural Activities, National
Cancer Institute, National Institutes of
Health, 6116 Executive Blvd., 8th Fl., Room
8109, Bethesda, MD 20892, 301/594–1216,
petryshr@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: April 19, 2005.
LaVerne Y. Stringfield,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–8414 Filed 4–26–05; 8:45 am]
BILLING CODE 4140–01–M
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Agencies
[Federal Register Volume 70, Number 80 (Wednesday, April 27, 2005)]
[Notices]
[Pages 21794-21799]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-8398]
[[Page 21794]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Academic Partners for Excellence in Environmental Public Health
Tracking
Announcement Type: New.
Funding Opportunity Number: RFA EH-05074.
Catalog of Federal Domestic Assistance Number: 93.283.
Key Dates:
Letter of Intent (LOI) Deadline: May 27, 2005.
Pre-Application Conference Calls: May 16, 2005.
Application Deadline: June 27, 2005.
I. Funding Opportunity Description
Authority: This program is authorized under section 301 of the
Public Health Service Act, [42 U.S.C. section 241], as amended.
Purpose: The purpose of the program is to provide expertise and
support to the National Environmental Public Health Tracking Program
(NEPHTP) in the development and utilization of the National
Environmental Public Health Tracking Network (NEPHTN). Additional
information about the NEPHTN and funded activities at state and local
government levels is provided at https://www.cdc.gov/nceh/tracking. This
program addresses the ``Healthy People 2010'' focus areas of
Environmental Health and Public Health Infrastructure.
Measurable outcomes of the program will be in alignment with the
following performance goal for the National Center for Environmental
Health (NCEH): Increase the understanding of the relationship between
environmental exposures and health effects.
This announcement contains two separate parts: Part I and Part II
in order to accommodate the range of specialty activities needed to
support the development of the NEPHTN. Each applicant can only apply
for one part. Please indicate in your abstract and in the research plan
which component your application is directed to. These projects will
move the nation toward improved environmental public health
surveillance and response capacity for development of the NEPHTN.
Detailed description of each project is included under ``Activities.''
Research Objectives:
Nature of the research problem
The environment plays an important role in human development and
health. Researchers have linked exposures to some environmental hazards
with specific diseases. Currently, no systems exist at the state or
national level to track many of the exposures and health effects that
may be related to environmental hazards. In most cases, existing
environmental hazard, exposure, and disease tracking systems are not
linked together. Because existing systems are not linked, it is
difficult to study and monitor relationships among hazards, exposures,
and health effects.
CDC is developing a National Environmental Public Health Tracking
Network that integrates data about environmental hazards and exposures
with data about diseases that are possibly linked to the environment.
However, to develop this Network, methods for data collection, data
linkage, and data analysis will need to be improved and evaluated.
Information from this network should guide etiologic research into the
relationship between environmental factors and human health.
Ultimately, state and local public health agencies must have a trained
workforce capable of operating and utilizing an EPHT network to provide
substantial public health impact.
Scientific knowledge to be achieved through research
supported by this program
Increased understanding of: (1) The relationship between
environmental hazards, exposures and health effects; (2) the methods
required to collect, integrate, analyze, and interpret data; and (3)
effective techniques for dissemination of information to protect and
improve health.
Objectives of this research program
(1) Innovative, cost-effective data collection strategies that
state and local health departments can use to obtain valid, high
quality data on environmental health effects, exposures, and hazards.
(2) Data linkage methods for combined analysis of health and
environmental data that could be utilized by state and local
environmental public health programs in building an EPHTN.
(3) Statistical algorithms that could be used by state and local
environmental public health programs to analyze trends and detect
patterns of health effects occurrence, population exposure, or hazard
levels in the environment that may indicate a problem.
(4) Greater understanding of the relationship between particular
health effects and environmental exposures and/or hazards.
(5) Effective training tools for all areas critical to the
development, operation, maintenance, and utilization of an EPHTN.
Identify the types of research and experimental approaches
that are being sought to achieve the objectives Research to support
these objectives includes public health surveillance methods
evaluation, epidemiological studies, and training effectiveness
evaluations.
Activities: In conducting activities to achieve the purpose of this
program, the awardee will be responsible for the activities under
Awardee Activities, and CDC will be responsible for the activities
listed under CDC Activities. Awardee activities for this program are as
follows:
Awardee Activities: Recipients under Part I must develop and submit
a research plan to address recipient activities a-h.
Part I Recipient Activities: Provide lead expertise in the
development of public health surveillance methods. These should, at a
minimum, include:
(a) Evaluating current surveillance methodology and developing
innovative, cost-effective data collection strategies (including
consideration of non-traditional data sources) that state and local
health departments can use to obtain valid, high quality data on
environmental health effects, exposures, and hazards.
(b) Developing data linkage methods for combined analysis of health
and environmental data that could be utilized by state and local
environmental public health programs in building an EPHTN.
(c) Developing statistical algorithms that could be used by state
and local environmental public health programs to analyze trends and
detect patterns of, and relationships between, health effects
occurrence, population exposure, or hazard levels in the environment;
and generating alerts when unusual occurrences of health effect,
exposure, or hazard are detected.
(d) Conduct an epidemiology study examining the relationship
between a health effect and an environmental exposure and/or hazard in
collaboration with environmental public health tracking program
partners and CDC. This study should utilize data from a state or local
environmental public health tracking program, as well as other summary
or secondary data sources in the design and/or analysis phase. This may
require the development of a research protocol for Institutional Review
Board (IRB) review by all cooperating institutions participating in the
research project. Where CDC scientists are involved, the CDC IRB will
initially review and approve the protocol, with a minimum of an annual
[[Page 21795]]
review until the research project is completed.
(e) Provide training for the nation's future Environmental Public
Health workforce through the provision of student academic tracks in
the areas of environmental epidemiology, public health surveillance
methods, and/or internship opportunities.
(f) Build capacity at the state and local level through the
communication of project accomplishments, barriers, and lessons learned
with EPHT (surveillance) Program partners and other critical
stakeholders at CDC-sponsored seminars, stakeholder meetings, quarterly
conference calls, and by posting information to an EPHT web forum.
(g) Participate in workgroups with EPHT Program partners. Applicant
will also be required to work in conjunction with the CDC Environmental
Public Health Tracking Program's Standards and Network Development
workgroup and other relevant workgroups and activities critical to the
development of the EPHTN.
(h) Collaborate with the relevant academic partners for excellence
involved with the EPHT Program on training activities to promote the
dissemination of knowledge from this focus area to other program
partners.
Recipients under Part II must develop and submit a research plan to
address recipient activities a-h.
Part II Recipient Activities:
(a) Develop training tools and provide training to state and local
health department partners participating in the NEPHT Program, in
collaboration with CDC and other funded academic partners involved with
the EPHT program. Training should include, but not be limited to, all
areas critical to the development, operation, maintenance, and
utilization and dissemination of information from the Network. These
should include public health surveillance methods, GIS, spatial
statistics and other environmental assessment methods, and risk
communication.
(b) Collaborate with other funded academic partners to identify and
develop focus areas for continuous training.
(c) Develop and conduct at least two regional and one annual
training workshop for Environmental Public Health Tracking grantees
covering public health surveillance methods, environmental
epidemiology, risk communication, Geographic Information Systems,
(GIS), spatial statistics and other assessment methods, prevention
effectiveness, program evaluation and other subjects critical to the
development, maintenance, utilization, and dissemination of information
from an EPHTN.
(d) Conduct an assessment of: (1) The key issues that influence
perceptions concerning the risk posed by environmental hazards or
exposures; and (2) techniques to communicate information on
environmental hazards, exposures, or risk most likely to promote
protective actions. This assessment could include comprehensive
literature reviews, review of state and local public health
communications activities, risk perception surveys, convening a panel
of communications experts, or other assessment strategies. As a product
of this assessment, develop written guidance on methods to disseminate
information from an EPHTN that would most effectively communicate this
information to a variety of audiences representing diverse social and
cultural backgrounds, including policy makers, healthcare providers,
and community representatives.
(e) Develop, test, disseminate, and evaluate communication
strategies for health effects, exposure and hazard information from a
surveillance network (EPHTN) that take into account risk perception
differences among various audiences. Collaborate with CDC to promote
the dissemination of knowledge from this focus area to other program
partners.
(f) Provide training for the nation's future Environmental Public
Health workforce through the provision of student academic tracks in
the areas of environmental epidemiology, public health surveillance
methods, and risk communication strategies and/or internship
opportunities.
(g) Build capacity at the state and local level through the
communication of project accomplishments, barriers, and lessons learned
with Environmental Public Health Tracking (surveillance) Program
partners and other critical stakeholders at CDC-sponsored seminars,
stakeholder meetings, quarterly conference calls, and by posting
information to an EPHT web forum.
(h) Participate in workgroups with EPHT Program partners.
CDC Activities: In a cooperative agreement, CDC staff is
substantially involved in the program activities, above and beyond
routine grant monitoring. CDC Activities for this program are as
follows:
a. Foster relationships among academic partners and state and local
health departments by assisting in the sharing of information through
an EPHT Web site, seminars, an annual stakeholder meeting, quarterly
conference calls, and other direct interactions.
b. Convene workgroups to foster the development of the NEPHTN.
c. Participate in designing, developing, and evaluating
surveillance methods.
d. Participate in the development of statistical algorithms to
analyze trends and detect patterns of health effects occurrence,
population exposure, or hazard levels in the environment that may
indicate a problem.
e. Participate in the protocol development, study implementation,
data analysis, interpretation of results, and dissemination of
epidemiology study findings including report writing and oral
presentation. When involved in a scientific study, the CDC IRB will
initially review and approve the protocol, with a minimum annual review
until the research project is completed.
f. Provide assistance in development of training materials on
surveillance methods, evaluation, risk communication, and other topics
for state and local agencies and other EPHT Program partners, including
the dissemination of information about strategies for communicating
health effect, exposure, and hazard information from an EPHT network.
II. Award Information
Type of Award: Cooperative Agreement. CDC involvement in this
program is listed in the Activities Section above.
Mechanism of Support: U19--Research Programs (Cooperative
Agreements).
Fiscal Year Funds: 2005.
Approximate Total Funding: $2,000,000 (This amount is an estimate,
and is subject to availability of funds.) Approximate Number of Awards:
Five.
Approximate Average Award: $400,000 (This amount is for the first
12-month budget period.)
Floor of Award Range: $350,000.
Ceiling of Award Range: $450,000. (This ceiling is for the first
12-month budget period.)
Anticipated Award Date: August 1, 2005.
Budget Period Length: 12 months.
Project Period Length: Five (5) years. Throughout the project
period, CDC's commitment to continuation of awards will be conditioned
on the availability of funds, evidence of satisfactory progress by the
recipient (as documented in required reports), and the determination
that continued funding is in the best interest of the Federal
Government.
[[Page 21796]]
III. Eligibility Information
III.1. Eligible Applicants
Assistance will be provided to United States Schools of Public
Health, accredited by the Council on Education of Public Health, which
are associated with or have access to programs in environmental
epidemiology, environmental sciences, health education, health/risk
communication, clinical medicine, and medical informatics. Eligibility
is open to these applicants because they provide: (1) The technical
expertise in the wide range of disciplines needed to further develop
the theoretical and scientific base for environmental public health
tracking (surveillance), and develop and test for new methodology
essential to support state and local programs; and (2) a training
ground for the nation's future environmental public health workforce.
This wide range of disciplines and expertise is often unavailable or
difficult to access by state or local public health agencies yet will
be required for an environmental public health tracking network to
fulfill all the critical functions of a public health surveillance
system.
III.2. Cost Sharing or Matching
Matching funds are not required for this program.
III.3. Other
If you request a funding amount greater than the ceiling of the
award range, your application will be considered non-responsive, and
will not be entered into the review process. You will be notified that
your application did not meet the submission requirements.
Special Requirements: If your application is incomplete or non-
responsive to the requirements listed in this section, it will not be
entered into the review process. You will be notified that your
application did not meet submission requirements.
Late applications will be considered non-responsive. See
section ``IV.3. Submission Dates and Times'' for more information on
deadlines.
All documentation submitted as evidence of eligibility as
outlined in Section III.1 above should be placed directly behind the
face page (first page) of your application. Applications that fail to
submit evidence requested above will be considered non-responsive and
returned without review.
Note: Title 2 of the United States Code Section 1611
states that an organization described in Section 501(c)(4) of the
Internal Revenue Code that engages in lobbying activities is not
eligible to receive Federal funds constituting an award, grant, or
loan.
Individuals Eligible To Become Principal Investigators: Any
individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from under-represented
racial and ethnic groups as well as individuals with disabilities are
always encouraged to apply for CDC programs.
IV. Application and Submission Information
IV.1. Address To Request Application Package
To apply for this funding opportunity, use application form PHS 398
(OMB number 0925-0001 rev. 9/2004). Forms and instructions are
available in an interactive format on the CDC Web site, at the
following Internet address: https://www.cdc.gov/od/pgo/forminfo.htm.
Forms and instructions are also available in an interactive format
on the National Institutes of Health (NIH) Web site at the following
Internet address: https://grants.nih.gov/grants/funding/phs398/
phs398.html.
If you do not have access to the Internet, or if you have
difficulty accessing the forms on-line, you may contact the CDC
Procurement and Grants Office Technical Information Management Section
(PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to
you.
IV.2. Content and Form of Application Submission
Letter of Intent (LOI): Your LOI must be written in the following
format:
Maximum number of pages: Two
Font size: 12-point unreduced
Double spaced
Paper size: 8.5 by 11 inches
Page margin size: One inch
Printed only on one side of page
Written in plain language, avoid jargon
Your LOI must contain the following information:
Descriptive title of the proposed application
Component of this announcement, Part I or II, you wish to
be considered for
Name, address, E-mail address, telephone number, and fax
number of the Principal Investigator
Names of other key personnel
Participating institutions
Number and title of this Announcement
Application: Follow the PHS 398 application instructions for
content and formatting of your application. For further assistance with
the PHS 398 application form, contact PGO-TIM staff at 770-488-2700, or
contact GrantsInfo, Telephone 301-435-0714, E-mail: GrantsInfo@nih.gov.
Your research plan should address activities to be conducted over
the entire project period.
You are required to have a Dun and Bradstreet Data Universal
Numbering System (DUNS) number to apply for a grant or cooperative
agreement from the Federal government.
Your DUNS number must be entered on line 11 of the face page of the
PHS 398 application form. The DUNS number is a nine-digit
identification number, which uniquely identifies business entities.
Obtaining a DUNS number is easy and there is no charge. To obtain a
DUNS number, access https://www.dunandbradstreet.com or call 1-866-705-
5711.
For more information, see the CDC Web site at: https://www.cdc.gov/
od/pgo/funding/pubcommt.htm.
This announcement uses the non-modular budgeting format.
Additional requirements that may require you to submit additional
documentation with your application are listed in section ``VI.2.
Administrative and National Policy Requirements.''
V.3. Submission Dates and Times
LOI Deadline Date: May 27, 2005.
CDC requests that you send a LOI if you intend to apply for this
program. Although the LOI is not mandatory, not binding, and does not
enter into the review of your subsequent application, the LOI will be
used to gauge the level of interest in this program, and to allow CDC
to plan the application review.
Application Deadline Date: June 27, 2005.
Explanation of Deadlines: LOIs and Applications must be received in
the CDC Procurement and Grants Office by 4 p.m. Eastern Time on the
deadline date. If you submit your LOI or application by the United
States Postal Service or commercial delivery service, you must ensure
that the carrier will be able to guarantee delivery by the closing date
and time. If CDC receives your submission after closing due to: (1)
Carrier error, when the carrier accepted the package with a guarantee
for delivery by the closing date and time, or (2) significant weather
delays or natural disasters, you will be given the opportunity to
submit documentation of the carriers guarantee. If the documentation
verifies a carrier problem, CDC will consider the submission as having
been received by the deadline.
[[Page 21797]]
This announcement is the definitive guide on LOI and application
content, submission address, and deadline. It supersedes information
provided in the application instructions. If your application does not
meet the deadline above, it will not be eligible for review, and will
be discarded. You will be notified that you did not meet the submission
requirements.
CDC will not notify you upon receipt of your submission. If you
have a question about the receipt of your LOI or application, first
contact your courier. If you still have a question, contact the PGO-TIM
staff at: 770-488-2700. Before calling, please wait two to three days
after the submission deadline. This will allow time for submissions to
be processed and logged.
IV.4. Intergovernmental Review of Applications
Your application is subject to Intergovernmental Review of Federal
Programs, as governed by Executive Order (EO) 12372. This order sets up
a system for state and local governmental review of proposed federal
assistance applications. You should contact your state single point of
contact (SPOC) as early as possible to alert the SPOC to prospective
applications, and to receive instructions on your state's process.
Click on the following link to get the current SPOC list: https://
www.whitehouse.gov/omb/grants/spoc.html.
IV.5. Funding Restrictions
Restrictions, which must be taken into account while writing your
budget, are as follows:
Funds relating to the conduct of research will not be
released until the appropriate assurances and Institutional Review
Board approvals are in place.
Reimbursement of pre-award costs is not allowed.
If you are requesting indirect costs in your budget, you must include a
copy of your indirect cost rate agreement. If your indirect cost rate
is a provisional rate, the agreement should be less than 12 months of
age.
IV.6. Other Submission Requirements
LOI Submission Address: Submit your LOI by express mail, delivery
service, fax, or e-mail to: Scientific Review Administrator, Attn:
Kathleen Shaver Madden, Ph.D., CDC/Office of Public Health Research,
One West Court Square, Suite 7000, Rm 7018, Mailstop D-72, Decatur, GA
30030, Tel: 404-371-5253, Fax: 404-371-5215, E-mail: kmn0@cdc.gov.
Application Submission Address: Submit the original and one hard
copy of your application by mail or express delivery service to:
Technical Information Management--RFA EH-05074, CDC Procurement and
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
At the time of submission, four additional copies of the
application, and all appendices must be sent to: Scientific Review
Administrator, Attn: Kathleen Shaver Madden, Ph.D. (RFA EH-05074), CDC/
Office of Public Health Research, One West Court Square, Suite 7000, Rm
7018, Mailstop D-72, Decatur, GA 30030, Tel: 404-371-5253, Fax: 404-
371-5215, E-mail: kmn0@cdc.gov.
V. Application Review Information
V.1. Criteria
Applicants are required to provide measures of effectiveness that
will demonstrate the accomplishment of the various identified
objectives of the cooperative agreement. Measures of effectiveness must
relate to the performance goals stated in the ``Purpose'' section of
this announcement. Measures must be objective and quantitative, and
must measure the intended outcome. These measures of effectiveness must
be submitted with the application and will be an element of evaluation.
The goals of CDC-supported research are to advance the
understanding of biological systems, improve the control and prevention
of disease and injury, and enhance health. In the written comments,
reviewers will be asked to evaluate the application in order to judge
the likelihood that the proposed research will have a substantial
impact on the pursuit of these goals.
The scientific review group will address and consider each of the
following criteria equally in assigning the application's overall
score, weighting them as appropriate for each application. The
application does not need to be strong in all categories to be judged
likely to have major scientific impact and thus deserve a high priority
score. For example, an investigator may propose to carry out important
work that by its nature is not innovative, but is essential to move a
field forward.
The review criteria are as follows:
Significance: Does this study address an important problem? If the
aims of the application are achieved, how will scientific knowledge be
advanced? What will be the effect of these studies on the concepts or
methods that drive this field?
Approach: Are the conceptual framework, design, methods, and
analyses adequately developed, well-integrated, and appropriate to the
aims of the project? Does the project scope reflect a clear
understanding of the purpose and requirements of the cooperative
agreement and the conceptual framework, intent, and challenges of
implementing a National Environmental Public Health Tracking Network?
Are the project scope, key objectives, project milestones, products,
and performance measures clearly described and appropriate for the
project? Are the strategy, schedule, and resources appropriate for
timely completion of the project? Does the applicant acknowledge
potential problem areas and consider alternative tactics and provide
plans for mitigating project risk?
Innovation: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
Investigator: Is the investigator appropriately trained and well
suited to carry out this work? Is the work proposed appropriate to the
experience level of the principal investigator and other researchers
(if any)? Are the resumes/curricula vita of key personnel included? If
there are several researchers involved, is this there a clear
description of how the principal investigator will manage the project
team and, if necessary, coordinate with other academic departments or
groups participating in this endeavor? Are all researcher and staff
roles and responsibilities clearly described and linked to project
activities and milestones?
Environment: Does the scientific environment in which the work will
be done contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? Is there
evidence of institutional support?
Additional Review Criteria: In addition to the above criteria, the
following programmatic priorities will be considered in the
determination of scientific merit and priority score:
1. Collaborative Relationships: The extent to which the applicant
identifies key partners to carry out proposed activities and provides
evidence that these organizations/agencies support, and will be
actively involved in, carrying out the project. Letters of Support from
appropriate personnel, such as department chairs, must be provided if
applicant is utilizing affiliate institutions to provide expertise in
environmental epidemiology, environmental sciences, health education,
health communication,
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clinical medicine, or medical informatics. The extent to which the
applicant describes past and current collaborations with Federal
agencies, state and local health and environmental agencies,
professional organizations, community-based organizations, and other
relevant organizations will be considered.
Protection of Human Subjects from Research Risks: Does the
application adequately address the requirements of Title 45 CFR Part 46
for the protection of human subjects? The involvement of human subjects
and protections from research risk relating to their participation in
the proposed research will be assessed.
Inclusion of Women and Minorities in Research: Does the application
adequately address the CDC Policy requirements regarding the inclusion
of women, ethnic, and racial groups in the proposed research? This
includes: (1) The proposed plan for the inclusion of both sexes and
racial and ethnic minority populations for appropriate representation;
(2) The proposed justification when representation is limited or
absent; (3) A statement as to whether the design of the study is
adequate to measure differences when warranted; and (4) A statement as
to whether the plans for recruitment and outreach for study
participants include the process of establishing partnerships with
community (ies) and recognition of mutual benefits.
Care and Use of Vertebrate Animals: If vertebrate animals are to be
used in the project, the five items described under Section f. of the
PHS 398 research grant application instructions will be assessed.
Budget: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
V.2. Review and Selection Process
Applications will be reviewed for completeness by the Procurement
and Grants Office (PGO) and for responsiveness by the National Center
for Environmental Health (NCEH). Incomplete applications and
applications that are non-responsive to the eligibility criteria will
not advance through the review process. Applicants will be notified
that their application did not meet submission requirements.
Applications that are complete and responsive to the announcement
will be evaluated for scientific and technical merit by an appropriate
peer review group or charter study section convened by the NCEH in
accordance with the review criteria listed above. As part of the
initial merit review, all applications may:
Undergo a process in which only those applications deemed
to have the highest scientific merit by the review group, generally the
top half of the applications under review, will be discussed and
assigned a priority score.
Receive a written critique.
Receive a second programmatic level review by the NCEH,
Office of Science.
Award Criteria: Criteria that will be used to make award decisions
during the programmatic review include:
Scientific merit (as determined by peer review)
Availability of funds
Programmatic priorities
Preference may be given to the establishment of academic
partnerships in different geographic areas of the United States.
V.3. Anticipated Announcement and Award Dates
It is anticipated that notification of awards will go out to
successful applicants on or before August 31, 2005 with a projected
start date on or before October 1, 2005.
VI. Award Administration Information
VI.1. Award Notices
Successful applicants will receive a Notice of Award (NoA) from the
CDC Procurement and Grants Office. The NoA shall be the only binding,
authorizing document between the recipient and CDC. The NoA will be
signed by an authorized Grants Management Officer, and mailed to the
recipient fiscal officer identified in the application.
Unsuccessful applicants will receive notification of the results of
the application review by mail.
VI.2. Administrative and National Policy Requirements
45 CFR Part 74 and Part 92
For more information on the Code of Federal Regulations, see the
National Archives and Records Administration at the following Internet
address: https://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
The following additional requirements apply to this project:
AR-1 Human Subjects Requirements
AR-2 Requirements for Inclusion of Women and Racial and
Ethnic Minorities in Research
AR-7 Executive Order 12372
AR-8 Public Health System Reporting Requirements
AR-9 Paperwork Reduction Act Requirements
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
AR-22 Research Integrity
AR-24 Health Insurance Portability and Accountability Act
Requirements
Additional information on these requirements can be found on the
CDC web site at the following Internet address: https://www.cdc.gov/od/
pgo/funding/ARs.htm.
VI.3. Reporting
You must provide CDC with an original, plus two hard copies of the
following reports:
1. Interim progress report, (use form PHS 2590, OMB Number 0925-
0001, rev. 9/2004 as posted on the CDC website) no less than 90 days
before the end of the budget period. The progress report will serve as
your non-competing continuation application, and must contain the
following elements:
a. Current Budget Period Activities Objectives.
b. Current Budget Period Financial Progress.
c. New Budget Period Program Proposed Activity Objectives.
d. Budget.
e. Measures of Effectiveness.
f. Additional Requested Information.
2. Financial status report, no more than 90 days after the end of
the budget period.
3. Final financial and performance reports, no more than 90 days
after the end of the project period.
These reports must be mailed to the Grants Management Specialist listed
in the ``Agency Contacts'' section of this announcement.
VII. Agency Contacts
We encourage inquiries concerning this announcement.
For general questions, contact: Technical Information Management
Section, CDC Procurement and Grants Office, 2920 Brandywine Road,
Atlanta, GA 30341, Telephone: 770-488-2700.
For scientific/research issues, contact: Mildred Williams-Johnson,
Ph.D., Scientific Program Administrator, CDC/ATSDR, 1600 Clifton Road,
NE, Mailstop E17, Atlanta, GA 30333, Telephone: 404-498-0639, E-mail:
MWilliams-Johnson@cdc.gov. or Judy Qualters, Ph.D; Scientific Program
Collaborator, 1600 Clifton Road, NE; M/S E-19, Atlanta, GA 30333,
Telephone: 404-498-1270, E-mail: epht@cdc.gov.
For questions about peer review, contact: Kathleen Shiver Madden,
Ph.D., Scientific Review Administrator, CDC/
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Office of Public Health Research, One West Court Square, Suite 7000, Rm
7018, Mailstop D-72, Decatur, GA 30030, Telephone: 404-371-5253, E-
mail: Kmn0@cdc.gov.
For financial, grants management, or budget assistance, contact:
Edna Green, Grants Management Specialist, CDC Procurement and Grants
Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-
2743, E-mail: EGreen@cdc.gov.
VIII. Other Information
This and other CDC funding opportunity announcements can be found
on the CDC Web site, Internet address: https://www.cdc.gov. Click on
``Funding'' then ``Grants and Cooperative Agreements.'' Additional
Information about the Environmental Public Health Tracking Program and
current activities of the academic partners can be found at https://
www.cdc.gov/nceh/tracking.
Dated: April 21, 2005.
William P. Nichols,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention.
[FR Doc. 05-8398 Filed 4-26-05; 8:45 am]
BILLING CODE 4163-18-P