05-9373. 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 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 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://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 [phone], E-mail: [e-mail].

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 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.

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: [phone]. E-mail address: [e-mail].

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.

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: [phone].

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: [phone]. E-mail: [e-mail]; or Sharon Campolucci, RN, MSN, Scientific Collaborator, CDC/ATSDR, 1600 Clifton Road, NE, MailStop E31, Atlanta, GA 30333. Telephone: [phone]. E-mail: [e-mail].

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: [phone]. E-mail: [e-mail].

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: [phone]. E-mail: [e-mail].

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.