00-12347. Determining the Prevalence of Multiple Sclerosis in Communities Living Around Hazardous Waste Sites, Applied Research and Development; Notice of the Availability of Funds

A. Purpose

The Agency for Toxic Substances and Disease Registry (ATSDR) announces the availability of fiscal year (FY) 2000 funds for a cooperative agreement program to conduct research on Determining the Prevalence of Multiple Sclerosis (MS) in Communities Living Around Hazardous Waste Sites. This addresses the “Healthy People 2010” focus area of Environmental Health.

The purpose of this program is to determine the prevalence of MS among individuals in specific communities near sources of hazardous substances.

B. Eligible Applicants

Assistance will be provided to the health departments of States or their bona fide agents or instrumentalities. This includes the District of Columbia, American Samoa, the Commonwealth of Puerto Rico, the Virgin Islands, the Federated States of Micronesia, Guam, the Northern Mariana Islands, the Republic of the Marshall Islands, the Republic of Palau, and federally recognized Indian Tribal governments. State organizations, including State universities, State colleges, and State research institutions, must establish that they meet their respective State's legislature definition of a State entity or political subdivision to be considered to be an eligible applicant. Local health jurisdictions may apply with the concurrence of the State Health Officer.

Note:

Public Law 104-65 states that an organization described in section 501(c)(4) of the Internal Revenue Code of 1986 that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, cooperative agreement, contract, loan or any other form.

C. Availability of Funds

Approximately $140,000 is available in FY 2000 to fund up to two awards. It is expected that the average award will be $70,000, ranging from $50,000 to $90,000. It is expected the awards will begin on or about September 30, 2000, and will be made for a 12-month budget period within a project period of up to two years. Funding estimates may change.

Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and the availability of funds.

Use of Funds

Funds may be expended for reasonable program purposes, such as personnel, travel, supplies and services. Funds for contractual services may be requested; however, the primary recipient of ATSDR funds must perform a substantive role in carrying out project activities and not merely serve as a conduit for an award to another party or provide funds to an ineligible party. Equipment may be purchased with these funds, however, the equipment proposed should be appropriate and reasonable for the research activity to be conducted. Equipment may be acquired only when authorized, and the application should provide a justification of need to acquire equipment, the description, and the cost of purchase versus lease. At the completion of the project, the equipment must be returned to ATSDR.

Funding Preference

Preference will be given to the proposed projects that are conducted in more than one community where MS and hazardous substances have been identified as health concerns.

D. Program Requirements

In conducting activities to achieve the purpose of this program, the recipient will be responsible for activities under 1. (Recipient Activities), and ATSDR will be responsible for the activities listed under 2. (ATSDR Activities).

1. Recipient Activities

Applicants addressing the same research issue should be willing to participate in collaborative studies with other ATSDR-sponsored researchers, including developing and using common data collection instruments and procedures, and data management procedures, as determined in post-awarding grantee planning conferences. A study group of all recipient Principal Investigators will be convened to develop a common protocol, interview instruments and data collection procedures.

a. Develop a research project which evaluates the prevalence of MS cases in communities living around hazardous waste sites. Provide scientific information concerning hazardous substances and MS and develop a model for others to determine the prevalence of MS in communities living around hazardous waste sites.

b. Develop the research study protocols and standardized data extraction forms across sites. Develop methods to verify MS diagnosis.

c. Collaborate and share data with other collaborators to answer specific research questions.

d. Conduct data analysis with all collaborators as well as present and publish research findings.

e. Disseminate research results to community members through collaborative relationships with state health and environmental agencies.

2. ATSDR Activities

a. Provide scientific, epidemiologic, and environmental assistance.

b. Work collaboratively with investigators to help facilitate research activities across sites. Provide assistance on the development of the protocol and evaluation of the data extraction instruments.

c. Preparation and submission of materials to the CDC Internal Review Board (IRB). The CDC IRB will review and approve the protocol initially and on at least an annual basis until the research project is completed.

d. Provide assistance to awardee(s) in the design of a data management system, in the analysis of research information, and the presentation and publication of research findings.

e. Provide technical assistance to awardees (if more than one award is made) to ensure a sharing of information and methodologies, as appropriate.

f. Facilitate an annual meeting between awardee(s) and ATSDR to coordinate planned efforts and review progress.

E. Application Content

Use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections to develop the application content. Your application will be evaluated on the criteria listed so it is important to follow them in laying your program plan. The narrative should be no more than 30 pages, double-spaced, printed on one-side, with 1″ margins, and unreduced fonts (font size 12 point) on 81/2″ by 11″ paper. Do not include any spiral or bound materials or pamphlets.

1. Title Page

The heading should include the title of the cooperative agreement announcement, project title, organization, name and address, project director's name address and telephone number.

2. Abstract

A one-page, singled-spaced, typed abstract must be submitted with the application. The heading should include the title of cooperative agreement announcement, project title, organization, name and address, project director and telephone number. This abstract should include a work plan identifying activities to be developed, activities to be completed, and a time-line for completion of these activities.

3. Application Narrative

The narrative of each application must address the evaluation component, in addition to the following:

a. Briefly state the applicant's understanding of the need or problem to be addressed, the purpose, and goals over the 2 year period of the cooperative agreement.

b. Describe in detail the objectives and the methods to be used to achieve the objectives of the project. The objectives should be specific, time-phased, measurable, and achievable during each budget period. The objectives should directly relate to the program goals. Identify the steps to be taken in planning and implementing the objectives and the responsibilities of the applicant for carrying out the steps.

c. Provide the name, qualifications, and proposed time allocation of the Principal Investigator who will be responsible for administering the project. Describe staff, experience, facilities, equipment available for performance of this project, and other resources that define the applicant's capacity or potential to accomplish the requirements stated above. List the names (if known), qualifications, and time allocations of the existing professional staff to be assigned to (or recruited for) this project, the support staff available for performance of this project, and the available facilities including space.

d. Document the applicant's expertise, and extent of experience in the areas of multiple sclerosis, environmental health, and population-based epidemiologic studies.

e. Provide letters of support or other documentation demonstrating coordination with all other agencies or organizations described as participating in the project.

f. Describe how the affected communities will be involved in the proposed project.

g. Human Subjects: State whether or not Humans are subjects in this proposal. (See Human Subjects in the Evaluation Criteria and Other Requirements sections.)

h. Inclusion of women, ethnic, and racial groups: Describe how the CDC/ATSDR policy requirements will be met regarding the inclusion of women, ethnic, and racial groups in the proposed research. (See Women, Racial and Ethnic Minorities in the Evaluation Criteria and Other Requirements sections.)

4. Budget

Provide a detailed budget which indicates anticipated costs for personnel, equipment, travel, communications, supplies, postage, and the sources of funds to meet these needs. The applicant should be precise about the program purpose of each budget item. For contracts described within the application budget, applicants should name the contractor, if known; describe the services to be performed; and provide an itemized breakdown and justification for the estimated costs of the contract; the kinds of organizations or parties to be selected; the period of performance; and the method of selection. The budget narrative pages showing, in detail, how funds in each object class will be spent, should be placed directly behind form 424A and not in the body of the application.

F. Submission and Deadline

Letter of Intent (LOI)

In order to enable ATSDR to determine the level of interest in the program announcement, a non-binding letter-of-intent to apply is requested from potential applicants. The letter of intent should be submitted on or before June 15, 2000, to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Application

Submit the original and two copies of PHS 5161-1 (OMB Number 0937-0189). Forms are available on the Centers for Disease Control and Prevention Internet address, or in the application kit.

On or before July 14, 2000, submit the application to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Deadline: Applications shall be considered as meeting the deadline if they are either:

(a) Received on or before the deadline date; or

(b) Sent on or before the deadline date and received in time for submission to the independent review group. (Applicants must request a legibly dated U.S. Postal Service postmark or obtain a legibly dated receipt from a commercial carrier or U.S. Postal Service. Private metered postmarks shall not be acceptable as proof of timely mailing.

Late Applications: Applications which do not meet the criteria in (a) or (b) above are considered late applications, will not be considered, and will be returned to the applicant.

G. Evaluation Criteria

Each application will be evaluated individually against the following criteria by an objective review group appointed by ATSDR.

1. Understanding of the Problem (10 percent)

a. The applicant's understanding of the problems related to community exposures to hazardous substances and concerns regarding MS, and

b. relevance of the proposed program to these and related problems.

2. Program Personnel (10 percent)

a. Applicant's technical experience and understanding (e.g. in the areas of MS, environmental health, and population-based epidemiologic studies).

b. List the names (if known), qualifications, and time allocation of the professional staff to be assigned to (or recruited for) this project and the support staff available for performance of this project.

c. Extent to which the management staff and their working partners are clearly described.

3. Goals and Objectives (10 percent)

The extent to which the proposed goals and objectives are clearly stated and measurable.

4. Demonstrated Capacity (40 percent)

a. The degree to which the applicant demonstrates prior work conducted in communities living near hazardous waste sites concerned with MS in their area.

b. Adequacy of plan to include at least one community where MS has already been identified as health concerns.

c. The extent to which the applicant's plans include accomplishing the activities listed under Recipient Activities in this announcement.

d. The extent to which the applicant's plans and schedule proposed for accomplishing the activities to be carried out in this project are clearly stated, are realistic given the length of the funding period, and can be achieved within the proposed budget.

e. The extent to which the applicant has met 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.

5. Community Involvement and Dissemination of Results (20 percent)

a. A clear identification and description of the community(ies) to be involved in this project.

b. Adequacy of plan for recruitment and outreach for study participants including the process of establishing partnerships with community(ies) and recognition of the mutual benefits.

c. A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with communities and recognition of mutual benefits.

d. Adequacy of plans to address community concerns and create lines of communication, including letters of support.

e. Adequacy of methods to disseminate the study results to community residents, state and local public health officials, tribal governments, Indian Health Service, and to other concerned individuals and organizations.

6. Facilities and Resources (10 percent)

The adequacy of the applicant's facilities, equipment, and other resources available for performance of this project.

7. Human Subjects (Not scored)

Does the application adequately address the requirements of 45 CFR 46 for the protection of human subjects?

8. Budget Justification (Not scored)

The budget will be evaluated to the extent that it is reasonable, clearly justified, and consistent with the intended use of funds.

H. Other Requirements

Technical Reporting Requirements

Provide CDC with the original and two copies of:

1. Semi-annual progress report.

2. Financial Status Report (FSR) no more than 90 days after the end of the budget period.

3. Final financial status report and performance report, no more than 90 days after the end of the project.

Send all reports to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

The following additional requirements are applicable to this program. For a complete description of each, see Attachment 1 in the application kit.

AR-1 Human Subjects Requirements

AR-2 Requirements of Inclusion of Women and Racial and Ethnic Minorities in Research

AR-7 Executive Order 12372 Review

AR-10 Smoke-Free Workplace Requirements

AR-11 Healthy People 2010

AR-12 Lobbying Restrictions

AR-17 Peer Review and Technical Reviews of Final Reports of Health Studies—ATSDR

AR-18 Cost Recovery—ATSDR

AR-19 Third Party Agreements—ATSDR

I. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized in Sections 104(i)(1)(E) 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)(l)(E) and (15)]. The Catalog of Federal Domestic Assistance number is 93.161.

J. Where To Obtain Additional Information

Please refer to Program Announcement 00114 when you request information.

This and other ATSDR announcements can be found on the CDC home page Internet address: http://www.cdc.gov. Click on “Funding” then “Grants and Cooperative Agreements.”

To receive additional written information and to request an application kit, call 1-888-GRANTS4 (1-888 472-6874). You will be asked to leave your name and address and will be instructed to identify the Announcement number of interest.

If you have questions after reviewing the contents of all the documents, business management technical assistance may be obtained from: Nelda Y. Godfrey, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC), 2920 Brandywine Road, Suite 3000, Atlanta, Georgia 30341-4146, Telephone [phone], E-mail address: [e-mail].

For program assistance, contact: Curtis Noonan, Epidemiologist, Health Investigations Branch, Division of Health Studies, Agency for Toxic Substances and Disease Registry, 1600 Clifton Road, NE., Mail Stop E-31, Atlanta, Georgia 30333, Telephone: [phone], E-mail address: [e-mail].

Dated: May 11, 2000.

Georgi Jones,

Director, Office of Policy and External Affairs, Agency for Toxic Substances and Disease Registry.