Part I Overview Information
United States Department of Health and Human Services (HHS)
Issuing Organization
Agency for Toxic Substances and Disease Registry (DTEM/ATSDR)
Participating Organizations
Agency for Toxic Substances and Disease Registry, Division of Toxicology (DTEM/ATSDR) http://www.atsdr.cdc.gov
Components of Participating Organizations
Division of Toxicology and Environmental Medicine (DTEM/ATSDR) at
Title:
Environmental Health and Toxicology Research Program (U01)
The policies, guidelines, terms, and conditions of the HHS
Centers for Disease Control and Prevention (CDC) stated in
this announcement might differ from those used by the HHS
National Institutes of Health (NIH). If written guidance
for completing this application is not available on the CDC
website, then CDC will direct applicants elsewhere for that
information.
Authority:
This program is authorized in Sections 104 (i) (5) (A) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendment Reauthorization Act of 1986 (SARA) [42 U.S.C. 9604 (i) (5) (A)]. The Catalog of Federal Domestic Assistance number is 93.206.
Announcement Type: This is a new announcement.
Instructions for Submission of Electronic Research Applications:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must submit electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
This FOA must be read in conjunction with the application package instructions included with this announcement on Grants.gov/Apply for Grants (hereafter referred to as, Grants.gov/Apply).
A registration process is necessary before submission, and applicants are strongly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Two steps are required for on time submission:
1) The application must be successfully received by Grants.gov no later than 5:00 p.m. Eastern Standard Time on the application submission receipt date (see “Key Dates” below).
2) Applicants must complete a verification step in the Electronic Research Administration (eRA Commons) within two business days of notification. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the eRA Commons.
Funding Opportunity Announcement (FOA) Number: RFA-TS-08-002
Catalog of Federal Domestic Assistance Number(s): The catalog of Federal Domestic Assistance umber is 93.206, Human Health Studies- Applied Research and Development.
Key
Dates
Release/Posted Date: March 17, 2008
Letter of Intent Receipt Date: April 16, 2008
Council Review Date(s): July 18, 2008
Earliest Anticipated Start Date(s): September 30, 2008
Additional Information to Be Available Date: May 1, 2008
Expiration Date: 61 days after publication
Technical assistance will be available for potential applicants during one conference call. The call for eligible applicants will be held on May 1, 2008 from 1:30 p.m. to 2:30 p.m. (Eastern Time). The conference call can be accessed by calling 1-866-704-7564, stating the conference call leader name: Dr. Benjamin R. Moore and entering the passcode: 1314492.
Due Date for E.O. 12372
Due no later than 60 days after the application receipt date.
Additional Overview Content
Executive Summary
Funding Opportunity Announcement Glossary: FOA Glossary Terminology
Table of Contents
Part I Overview Information
Part II Full Text
of Announcement
Section I.
Funding Opportunity Description
1. Research
Objectives
Section II. Award
Information
1.
Mechanism(s) of Support
2. Funds
Available
Section III.
Eligibility Information
1. Eligible
Applicants
A.
Eligible Institutions
2.Cost
Sharing or Matching
3.Other -
Special Eligibility Criteria
Section IV.
Application and Submission Information
1. Request
Application Information
2. Content
and Form of Application Submission
3. Submission
Dates and Times
A.
Receipt and Review and Anticipated Start Dates
1.
Letter of Intent
B.
Submitting an Application to CDC
C.
Application Processing
4.
Intergovernmental Review
5. Funding
Restrictions
6. Other
Submission Requirements
Section V.
Application Review Information
1. Criteria
2. Review and
Selection Process
A.
Additional Review Criteria
B.
Additional Review Considerations
C.
Sharing Research Data
D.
Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award
Administration Information
1. Award
Notices
2.
Administrative and National Policy Requirements
A.
Cooperative Agreement
1. Recipient Rights and Responsibilities
2.
HHS/CDC Responsibilities
3.
Collaborative Responsibilities
3. Reporting
Section VII.
Agency Contact(s)
1.
Scientific/Research Contact(s)
2. Peer
Review Contact(s)
3. Financial/
Grants Management Contact(s)
4. General Questions Contact(s)
Section VIII.
Other Information - Required Federal Citations
Part II - Full Text of
Announcement
Section I. Funding Opportunity Description
1. Research Objectives
BACKGROUND
The Agency for Toxic Substances and Disease Registry (ATSDR) within the Department of Health and Human Services (DHHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA). This RFA addresses the “Healthy People 2010” focus areas for Environmental Health, Health Communications, Maternal/Infant and Child Health, and Educational and Community-based Programs. Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the Agency for Toxic Substances and Disease Registry (ATSDR):
(1) Goal 2 Ascertain the relationship between exposure to toxic substances and disease: Objective 3 conduct analytic studies to increase our knowledge about the effects of toxic substances on human health; and
(2) Goal 3 Develop and provide reliable understandable information for affected communities, tribes and stakeholders: Objective 2 improve public understanding of health risks from exposures in their communities. For more information please visit, www.healthypeople.gov and http://www.atsdr.cdc.gov/
The ATSDR is directed by congressional mandate to perform specific functions concerning the effect on public health of hazardous substances in the environment. These functions include the conduct of research to fill gaps in knowledge about the human health effects from exposures to toxic substances found at hazardous waste sites. These data needs are first identified in the ATSDR Toxicological Profiles for priority hazardous substances http://www.atsdr.cdc.gov/toxpro2.html and then subjected to further evaluation and prioritized using the Agency’s Decision Guide http://www.atsdr.cdc.gov/pdns/. ATSDR facilitates research for filling the priority data needs through its partnerships with other federal agencies, universities, and industry groups. Data from the studies are expected to address the substance-specific information needs of the public and scientific community.
The “Environmental Justice Act of 2002 requires federal agencies to include achieving environmental justice in their missions through identifying and addressing in their activities any disproportionately high and adverse human health or environmental effects on minority and low-income communities” (H.R. 5637, 2002).
In addition, the 1984 Report of the Secretary's Task Force, Black and Minority Health included recommendations for a coordinated DHHS effort to address the disparity in health status between minority and non-minority populations.
In line with Departmental efforts to eliminate racial and/or ethnic disparities in health, ATSDR is interested in evaluating the role environmental factors play in these adverse health outcomes, particularly exposures to hazardous substances. Studies cited in the Healthy People 2010 report have shown a link between socioeconomic status and race and the potential for increased exposure to environmental hazards. A more recent investigation provides additional evidence that the relative risk for living within 1 mile of certain types of sites on the National Priorities list is increased for mid- to low-income neighborhoods and the population in these neighborhoods is generally characterized by a high percentage of African-American and Hispanic residents.
ATSDR is committed to serve as the lead federal agency in discerning the public health implications of hazardous waste sites, wherever they exist. Consequently, ATSDR has established a Minority Health Initiative that specifically addresses hazardous waste issues. The initiative is an integral part of ATSDR’s health assessment, health studies, health education, and toxicological programs. Areas of emphasis are directly in concert with the recommendations of the DHHS Secretary’s Task Force to improve data acquisition, research, and health information dissemination and education programs with regard to minorities; as well as supporting the goals of the Environmental Justice Act of 2002, and of Healthy People 2010. Successful applicants must have the demonstrated skills and experience to conduct research to evaluate the link between health outcomes and the excess morbidity and mortality among low-income and /or minority populations that may be linked to environmental factors.
PURPOSE
The purpose of the program is to conduct substance-specific research to address research needs identified by the ATSDR for priority hazardous substances and to apply these findings to positively affect public health and environmental medicine in low-income and/or minority communities. Focus areas include:
· Exposure, toxicologic, and epidemiologic studies to fill additional data gaps for priority hazardous substances in the environment. · Studies to evaluate exposures to environmental hazards and the potential for associated health effects; · Research to assess how environmental hazards may contribute to disparities in health among racial and/or ethnic minority populations; · The development and evaluation of health services research and health education efforts that address environmental hazards and health outcomes;
Research findings from this program will provide critical information necessary to address national environmental health concerns, support departmental efforts to eliminate racial and/or ethnic disparities in health, and help achieve departmental goals in environmental justice.
Measurable outcomes of the program will be in alignment with one or more of the following performance goals for ATSDR: to ascertain the relationship between exposure to toxic substance and disease, and to collaborate with both domestic partners to address shared priorities and achieve common goals.
GOALS AND OBJECTIVES
Overall, the ultimate goals of this program will be to
· Fill research needs for priority hazardous substances · Improve the health status for minority and disadvantaged persons, · Expand environmental health services to under-served populations, · Effect a more concentrated research effort to address minority health problemsfrom exposures to hazardous substances.
The objectives of the program are to:
· Conduct research to address gaps in scientific knowledge on hazardous substances found at waste sites and from other sources in the environment · Develop strategies to educate communities about hazardous substances and the potential for health effects when people are exposed · Evaluate the impact of past health education efforts to inform health care professionals about health outcomes associated with exposures to hazardous substances
See
Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section II. Award Information
1. Mechanism(s) of Support
This funding activity is a cooperative agreement assistance instrument (U01). Under the cooperative agreement assistance instrument, the Recipient Organization retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, and with HHS/CDC staff is substantially involved as a partner with the Recipient Organization, as described in Section VI.2.A., "Cooperative Agreement”.
2. Funds Available
The ATSDR intends to commit approximately $1,000,000 for direct and indirect cost in FY2008 to fund four to five applications individually or one consortium or partnership application. The average award amount will be $200,000 to include direct and indirect costs, not to exceed $250,000, over the first 12-month budget period for individual awards. This limitation also applies to components of applications for research within a consortium or partnership not to exceed $1,000,000 in total funding. The applicant may request a project period of up to 5-year Project Period. The approximate total project period funded amount is $1,000,000. The anticipated start date for new awards is on or before September 30, 2008.
All estimated funding amounts are subject to availability of funds.
ATSDR will not accept and review applications or components with a total budget greater than the ceiling amount stated.
Section III. Eligibility
Information
1.
Eligible Applicants
1.A. Eligible Institutions
You may submit an application(s) if your organization has any of the following characteristics:
Eligible applicants are states or state organizations and political subdivisions thereof, or their bona fide agents
· State Public nonprofit organizations · State Universities · State Colleges · State Research institutions · State Political subdivisions of States (in consultation with States)
Eligible applicants may apply either as: an individual organization, as the lead member of a consortium, or in partnership with an organization from the following list: Public nonprofit organizations; private nonprofit organizations; for profit organizations; small, minority, and women-owned businesses; universities; colleges; research institutions; hospitals; community-based organizations; faith-based organizations; federally recognized or state-recognized American Indian/Alaska Native tribal governments; American Indian/Alaska Native tribally designated organizations; Alaska Native health corporations; urban Indian health organizations; tribal epidemiology centers; state and local governments or their Bona Fide Agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau); and political subdivisions of states (in consultation with states).
A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If you are applying as a bona fide agent of a state or local government, you must provide a letter from the state or local government as documentation of your status. Attach this documentation behind the first page of your application form or for electronic applications, use a PDF file and attach as “Other Documents” and label as appropriate.
Eligible applicants are limited to states, or political subdivisions thereof, in accordance with authorization for ATSDR activities under section 104 (i)(5)(A) and (15) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA) (42 U.S.C. 9604(i)(5)(A) and (15)).
Eligible applicants in a consortium or a partnership may not also apply as an individual applicant.
Failure to meet the stated eligibility criteria by the time of the application deadline will result in the return of the application without review.
2. Cost Sharing or Matching
There is no cost-sharing or matching participation.
3. Other-Special Eligibility Criteria
Applicant institutions must be trusted and accepted health organizations to accomplish the goals and objectives of this program for applied research, health education, and other activities to address the potential health risk from exposures to hazardous substances in low-income and/or minority communities. Successful applicants must have the demonstrated cultural sensitivity, community health outreach and education, and close proximity to reach and conduct research for minority and low-income communities that may disproportionately experience adverse health outcomes related to exposures to environmental hazards. Such capabilities are necessary to overcome the barriers in conducting research to address health concerns in underserved communities.
To facilitate the conduct of research under this program, eligible applicants should demonstrate that they have the following additional capabilities to address the goals and objectives of this program by including the following in their application:
· Letters from community organizations that describe the established or existing relationships between the applicant organization and the local community or Community Based Organization. · Documentation for community health outreach and/or education programs that serve minority and/or low-income communities. · Close proximity to minority and low-income communities to facilitate the conduct of research on health outcomes related to exposures to environmental hazards. · Publications from research, data collection, etc. for ATSDR priority research needs on priority hazardous substances. · Documentation that the applicant currently has the research equipment and instrumentation necessary to conduct the proposed research. · Documentation that the applicant currently has adequate staffing available to conduct the proposed research.
Applicants should include the stated documentation in Appendix 1 of their application to demonstrate that they meet these additional eligibility criteria. ,
If your application is incomplete or non-responsive to the special requirements listed in this section, it will not enter into the review process.
Section IV. Application and Submission Information
To download a SF424 (R&R) Application Package and SF424 (R&R) Application Instructions for completing the SF424 (R&R) forms for this FOA, link to Grants.gov/Apply and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at the following:
· Grants.gov Get Registered, http://grants.gov/applicants/get_registered.jsp · eRA Commons Prepare to Apply, http://era.nih.gov/ElectronicReceipt/preparing.htm
IMPORTANT: both the applicant organization, as well as, the PD/PI must register in eRA Commons for an application to be accepted electronically. The Credentials Log-In, referenced in Section IV. 2. Content and Form of Application Submission, is obtained through Step #3 in the required actions below.
PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
The following three steps are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov Get Registered, http://www.grants.gov/applicants/get_registered.jsp
2) Organizational/Institutional Registration in the eRA Commons Prepare to Apply, http://era.nih.gov/ElectronicReceipt/preparing.htm
3) Project Director/Principal Investigator (PD/PI) Registration in the eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Note that if a PD/PI is also an HHS peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the eRA Commons. The HHS/CDC strongly encourages applicants to use the Grants.gov electronic applications process and have organizations and PD/PIs complete all necessary registrations.
1. Request Application
Information
Applicants must
download the SF424 (R&R) application forms and SF424 (R&R)
Application Guide for this FOA through
Grants.gov/Apply.
Note: Only the
forms package directly attached to a specific FOA can be
used. You will not be able to use any other SF424 (R&R)
forms (e.g., sample forms, forms from another FOA); although
some of the "Attachment" files may be useable for more than
one FOA.
For
further assistance, contact PGO TIMS: Telephone
770-488-2700, Email: PGOTIM@cdc.gov
HHS/CDC
Telecommunications for the hearing impaired: TTY
770-488-2783.
2.
Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the
SF424 (R&R) Application Guide (MS Word or PDF).The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to HHS/CDC. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by HHS/CDC (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”
Applicants in a research consortium or partnership must also use the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/Apply will include all applicable components, mandatory and optional. A completed application in response to this FOA will include the following components:
Required Components:
SF424 (R&R)
(Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key
Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
Optional Components:
PHS398 Cover
Letter File
Note: While both budget components are included in the SF424 (R&R) forms package, the CDC/ATSDR