[Federal Register: May 11, 2005 (Volume 70, Number 90)]
[Notices]
[Page 24797-24801]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11my05-54]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
Applied Research for Populations Around Hazardous Waste Sites
Announcement Type: New.
Funding Opportunity Number: RFA TS05-110.
Catalog of Federal Domestic Assistance Number: 93.161.
Key Dates: Letter of Intent Deadline: June 10, 2005.
Application Deadline: June 27, 2005.
I. Funding Opportunity Description
Authority: This program is authorized in sections 104(i) (1)(E),
(7), (9), and (15) of the Comprehensive Environmental Response,
Compensation, and Liability Act (CERCLA) as amended by the Superfund
Amendments and Reauthorization Act (SARA) [42 U.S.C. 9604(i)(1)(E),
(7), (9), and (15)].
Background
Agency for Toxic Substances and Disease Registry (ATSDR) has the
responsibility under Comprehensive Environmental Response,
Compensation, and Liability Act (CERCLA), as amended, to evaluate the
relationship between exposures to hazardous substances and adverse
human health effects. However, this relationship between exposures to
hazardous substances and adverse health effects is complicated and
difficult to evaluate. Many factors can generate the appearance or hide
the presence of a relationship between exposure to hazardous substances
and adverse health effects. The presence of environmental contamination
and an adverse health effect does not automatically demonstrate
evidence of a causal relationship. Beginning in 1992, ATSDR developed a
research agenda to address some of these questions. Research under this
agenda continues to be conducted, but additional research is needed.
Therefore, projects conducted under this program announcement will
focus on those questions that have the greatest relevance toward
determining the relationship of adverse health effects among persons
exposed to hazardous substances.
Examples of relevant ATSDR activities are presented below:
Evaluation of Persons Exposed to Tremolite Asbestos Contaminated
Vermiculite
Asbestos contaminated vermiculite ore was mined and processed in
Libby, Montana, from the early 1920s until 1990. ATSDR has completed a
medical screening program, a mortality review and a Public Health
assessment in Libby. Based on these studies and additional evaluation
conducted by ATSDR, EPA and the State of Montana, people who worked in
the Libby mine or processing facilities and people who lived in the
Libby community were exposed to asbestos-contaminated vermiculite.
Nearly eighteen percent of medical screening participants had
radiographic pleural abnormalities consistent with asbestos exposure.
Mortality due to lung cancer and asbestosis was also found to be
elevated in Libby. ATSDR has also implemented a Tremolite Asbestos
Registry (TAR) of exposed persons and has funded the State of Montana
to conduct additional periodic medical surveillance for eligible
persons.
Additionally, records indicate that the vermiculite ore from Libby
was shipped to over 200 locations around the U.S. for handling and/or
processing into various commercial and consumer products. Twenty-eight
``Phase 1 Sites'' have been identified based on a variety of factors
such as tonnage of ore received, population density, numbers of
workers, etc. Health statistics reviews (to evaluate mortality and
cancer registry data) are currently being completed in sixteen states
and mesothelioma surveillance has been initiated in three states (New
York, Wisconsin and New Jersey). In addition, ATSDR has funded a
comprehensive community exposure assessment project in a community
receiving the ore. This work addresses the priority health conditions
of lung and respiratory disease.
Exposure to Contaminants From Collapse of World Trade Center Towers on
September 11, 2001
The World Trade Center Health Registry is a joint effort of ATSDR
and the New York City Department of Health and Mental Hygiene
(NYCDOHMH). It was designed to track the health of people who were most
directly exposed to the disaster on September 11, 2001 and in the
months that followed. Registrants will be followed to attempt to
determine if their exposure to smoke, dust, and airborne substances
from the collapse of the towers and subsequent fires has a long term
impact on their health. Questions regarding their physical and mental
health were asked
[[Page 24798]]
in a structured interview of approximately 30 minutes. Data collection
was completed over approximately 15 months and over 71,000 people
enrolled in the registry. Environmental monitoring information
indicates that possible exposure to asbestos, particulate matter,
manmade vitrious fibers, silica, Polycyclic Aromatic Hydrocarbons
(PAHs), and other caustic material may have occurred. Several of these
materials are associated with short- and long-term health effects. Some
preliminary follow-up studies of people in lower Manhattan have found
some associations between those exposures and respiratory health
problems. Additional research is needed to better clarify the exposure
and dose relationship. In addition, research is needed to determine the
possible future occurrence of adverse health effects. This work
addresses the priority health conditions of lung and respiratory
disease.
Purpose: The purpose of this program is to fill gaps in knowledge
by conducting applied research studies related to human exposure to
hazardous substances at hazardous waste sites and adverse health
outcomes, including health outcomes as prioritized by ATSDR. 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 ATSDR:
Determine human health effects associated with exposures
from hazardous waste sites to Superfund-related priority hazardous
substances.
Hazardous substances, as applies to this announcement, are those as
defined by the Comprehensive Environmental, Response, Compensation, and
Liability Act (CERCLA).
The list of priority hazardous substances found at CERCLA sites can
be found at http://www.atsdr.cdc.gov/clist.html.
Research Objectives: Studies may be conducted in the following
areas:
Identification, validation, and development of biomarkers
of exposure, susceptibility, and effect;
Further evaluation of the link or lack of linkage between
specific chemicals and specific health effects and
Development of research projects to further investigate
outcomes found in data previously collected by ATSDR or its grantees.
Activities: Awardee activities for this program are as follows:
Applications must propose studies which will address one or more of
the following ATSDR Priority Health Conditions: (in alphabetic order)
Birth defects and reproductive disorders;
Cancers (selected anatomic sites);
Immune function disorders;
Kidney dysfunction;
Liver dysfunction
Lung and respiratory diseases; and
Neurotoxic disorders.
Applicants must propose studies/projects in one or more of any of
the following areas of investigation:
Identify risk factors for adverse health effects in
populations that have either potential or known exposures to hazardous
substances (as defined by CERCLA) from hazardous waste sites and
releases.
Evaluate potentially impacted populations exposed to the
events of the collapse of the World Trade Center Towers on 9/11 and/or
exposed to ore from the Libby, MT mine to identify linkages between
exposure and adverse health effects and those risk factors which may be
impacted by prevention actions. See summaries of these ATSDR activities
under the Background section of this RFA.
Develop methods to identify adverse health effects in
populations that are potentially exposed to hazardous substances from
hazardous waste sites in their environment. This includes medical
research to evaluate currently available biological tests (biomarkers)
and disease occurrence in potentially impacted populations such as
individuals exposed to vermiculite contaminated with asbestos from the
Libby, MT mine. See summary of this ATSDR activity under the Background
section of this RFA.
Disseminate research findings upon satisfactory completion
of peer and public review. Findings should be disseminated through
presentations at scientific meetings, participation in stakeholder or
state sponsored meetings, and/or journal publications.
II. Award Information
Type of Award: Grant.
Mechanism of Support: R01.
Fiscal Year Funds: 2005.
Approximate Total Funding: $500,000. (This amount is an estimate,
and is subject to availability of funds.)
Approximate Number of Awards: One.
Approximate Average Award: $500,000. (This amount is for the first
12-month budget period.)
Floor of Award Range: None.
Ceiling of Award Range: $500,000. (This ceiling is for the first
12-month budget period.)
Anticipated Award Date: August 31, 2005.
Budget Period Length: 12 Months.
Project Period Length: Three (3) 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.
III. Eligibility Information
III.1. Eligible Applicants
Assistance will be provided only to state supported United States
Schools of Public Health who are currently accredited by the Council on
Education of Public Health that are associated with or have access to
programs in environmental epidemiology, environmental sciences,
clinical medicine, and medical informatics. Applicants must
affirmatively establish that they meet their respective State's
legislative definition of a State entity or political subdivision to be
considered an eligible applicant. Eligibility is limited 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 necessary for this research and to 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 range of disciplines and expertise is often unavailable
or difficult to access by state or local public health agencies.
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.
Note: Title 2 of the United States Code Section 1611
states that an
[[Page 24799]]
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 underrepresented
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: http: //http://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: http://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 research
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.
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 http://www.dunandbradstreet.com or
call 1-866-705-5711. For more information, see the CDC Web site at:
http://www.cdc.gov/od/pgo/funding/pubcommt.htm.
This announcement uses the modular budgeting as well as non-modular
budgeting formats. See: http://grants.nih.gov/grants/funding/modular/modular.htm
for additional guidance on modular budgets. Specifically,
if you are submitting an application with direct costs in each year of
$250,000 or less, use the modular budget format. Otherwise, follow the
instructions for non-modular budget research grant applications.
Additional requirements that may require you to submit additional
documentation with your application are listed in section ``VI.2.
Administrative and National Policy Requirements.''
IV.3. Submission Dates and Times
LOI Deadline Date: June 10, 2005.
CDC requests that you send a LOI if you intend to apply for this
program. Although the LOI is not required, 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: 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 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.
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 about your
application, contact the PGO-TIM staff at: 770-488-2700. If you still
have a question about your LOI, contact OPHR staff at: 404-371-5253.
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: http://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.
Funds may not be used for projects in the area of asthma-
related research.
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.
[[Page 24800]]
IV.6. Other Submission Requirements
LOI Submission Address: Submit your LOI by express mail, delivery
service, fax, or E-mail to: Mary Lerchen, DrPH, Scientific Review
Administrator, CDC/Office of Public Health Research, One West Court
Square, Suite 7000, Mailstop D-72, Decatur, GA 30030. Telephone Number:
404-371-5277. Fax: 404-371-5215. E-mail address: Mlerchen@cdc.gov.
Application Submission Address: Submit the original and one copy of
your application by mail or express delivery service to: Technical
Information Management-RFA TS05-110, CDC Procurement and Grants Office,
2920 Brandywine Road, Atlanta, GA 30341.
At the time of submission, four additional copies of the
applications, and all appendices must be sent to: Mary Lerchen, DrPH,
Scientific Review Administrator, CDC/Office of Public Health Research,
One West Court Square, Suite 7000, Mailstop D-72, Decatur, GA 30030.
Applications may not be submitted electronically at this time.
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 grant. 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/ATSDR 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? The study should include the rationale for selecting a
community and population to be the subject of the proposed
investigation and the relevance to exposures to hazardous substances at
hazardous waste sites and adverse health outcomes.
Approach: Does the applicant provide a sound rationale for the
specific approach and scientific method to conduct the study? Are the
conceptual framework, design, methods, and analyses adequately
developed, well-integrated, and appropriate to the aims of the project?
Does the applicant acknowledge potential problem areas and consider
alternative tactics? Is there (a) an adequate rationale for the design
of the proposed study; (b) identification of a target (exposed/
diseased) population; (c) identification of an appropriate comparison
group (if warranted); (d) consideration of sample size; (e) a plan for
linking environmental exposure to hazardous substances and health
outcome data; and (f) detailed plan for analysis of the data included.
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)?
Environment: Does the scientific environment in which the work will
be done contribute to the probability of success? Do the proposed
studies take advantage of unique features of the scientific environment
or employ useful collaborative arrangements? Is there evidence of
adequate institutional support? Are there letters of support, if
appropriate?
Additional Review Criteria: In addition to the above criteria, the
following items will be considered in the determination of scientific
merit and priority score:
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.
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 Office of Public
Health Research. 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 ATSDR 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 conducted by
the Scientific Program Administrator in the Office of the Associate
Director for 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
V.3. Anticipated Announcement and Award Dates
The anticipated award date will be on or before August 31, 2005.
[[Page 24801]]
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: http://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-9 Paperwork Reduction Act Requirements
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
AR-14 Accounting System Requirements
AR-17 Peer and Technical Reviews of Final Reports of Health
Studies--ATSDR
AR-18 Cost Recovery--ATSDR
AR-19 Third Party Agreements--ATSDR
AR-22 Research Integrity
Additional information on these requirements can be found on the
CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm
.
VI.3. Reporting
You must provide ATSDR 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 additional elements:
a. Progress toward Measures of Effectiveness.
b. Additional Information Requested by Program.
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. Final performance reports should
include a scientific report that summarizes the complete project, the
analyses and the final results, and/or a manuscript suitable for
publication in a peer review journal. Additionally, the Program office
requests that all data sets generated under this project be provided to
ATSDR in electronic format.
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 Sharon Campolucci, RN, MSN, Scientific
Collaborator, CDC/ATSDR, 1600 Clifton Road, NE, MailStop E31, Atlanta,
GA 30333. Telephone: 404-498-0105. E-mail: ssc1@cdc.gov.
For questions about peer review, contact: Mary Lerchen, DrPH,
Scientific Review Administrator, CDC/Office of Public Health Research,
One West Court Square, Suite 7000, Mailstop D-72, Atlanta, GA 30030.
Telephone: 404-498-5277. E-mail: MLerchen@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: http://www.cdc.gov. Click on
``Funding'' then ``Grants and Cooperative Agreements.''
Dated: May 5, 2005.
William P. Nichols,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention.
[FR Doc. 05-9373 Filed 5-10-05; 8:45 am]
BILLING CODE 4163-70-P