Grants and cooperative agreements; availability, etc.: Multiple sclerosis and amyotrophic lateral sclerosis in communities living around hazardous waste sites,

[Federal Register: June 11, 2002 (Volume 67, Number 112)]

[Notices]

[Page 39991-39994]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr11jn02-85]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[Program Announcement 02154]

Determining the Prevalence of Multiple Sclerosis and Amyotrophic Lateral Sclerosis in Communities Living Around Hazardous Waste Sites; Notice of the Availability of Funds

1. Purpose

   The Agency for Toxic Substances and Disease Registry (ATSDR) announces the availability of fiscal year (FY) 2002 funds for a cooperative agreement program to Determine the Prevalence of Multiple Sclerosis (MS) and Amyotrophic Lateral Sclerosis (ALS), 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 conduct research to determine the prevalence of MS and ALS among individuals in specific communities near sources of hazardous substances.

   Measurable outcomes of the program will be in alignment with the following performance goals for ATSDR: (1) Develop and provide reliable, understandable information for people in affected communities and tribes and for stakeholders; and (2) Build and enhance effective partnerships.

2. Authority and Catalog of Federal Domestic Assistance Number

   This program is authorized in sections 104(i)(1)(E), (7) 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) and (15)). The Catalog of Federal Domestic Assistance number is 93.206.

3. 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,

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   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 legislature's definition of a State entity or political subdivision to be considered to be an eligible applicant.

   Two levels of cooperative agreements will be awarded:

   Level I: Eligible applicants for Level I funding are those States or State entities that: (1) Have identified a community or communities concerned about MS and ALS and hazardous substances; and (2) do not have an existing program for determining MS and ALS prevalence in a given community.

   Level II: Eligible applicants for Level II funding are those States or State entities that: (1) Have an existing program for determining MS or ALS prevalence in specific areas; and (2) have identified additional communities with concerns of these diseases and hazardous substances, or have identified an additional health concern in the communities in which they are currently working (e.g., previous work focused on MS, but the applicant would now like to expand surveillance to ALS).

   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.

4. Availability of Funds

   Approximately $450,000 is available in FY 2002 to fund up to six awards. It is expected that up to three awards will be made to Level I applicants. The average award will be $100,000, ranging from $90,000 to $110,000. It is expected that up to three awards will be made to Level II applicants. The average award will be $75,000, ranging from $50,000 to $90,000. It is expected the awards will begin on or about September 1, 2002, and will be made for a 12-month budget period within a project period of up to three 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. To the greatest extent practicable, all equipment and products purchased with CDC/ATSDR funds should be American made. ATSDR retains the right to request return of all equipment purchased (in operable condition) with grant funds at the conclusion of the project period.

   Funding Preference

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

   Matching funds are not required for this program.

5. 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 Level I

   1. Participate in collaborative planning conferences with other recipients and ATSDR to develop or refine a common set of research questions, and to develop and implement complementary research protocols.

   2. Develop study protocol for approval of project implementation to include methods for data collection, data management, and data analysis.

   3. Establish cooperative relationships with medical care providers in the area(s) to be studied.

   4. Collaborate and share data with other recipients to answer specific research questions and present and publish research findings.

   5. Collaborate with other recipients in a pooled anonymized data set. Data analysis will be conducted at the state and federal levels.

   6. Disseminate research results to community members through collaborative relationships with community groups and state health and environmental agencies. Level II

   1. Responsible for all Level I activities.

   2. Expand existing MS prevalence project to include ALS, additional communities, and/or the collection of incidence data. 2. ATSDR Activities

   1. Provide scientific, epidemiologic, and environmental assistance.

   2. 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.

   3. Facilitate external peer review of the protocol and the final report(s).

   4. Prepare and submit materials to the CDC Institutional 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.

   5. Provide assistance to awardees in the analysis of research information and the presentation and publication of findings.

   6. Provide technical assistance to awardees to ensure a sharing of information and methodologies, as appropriate.

   7. Facilitate an annual meeting between awardees and ATSDR to coordinate planned efforts and review progress.

6. 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 out your program plan. The narrative should be no more than 30 pages, double-spaced, printed on one side, with one-inch margins, and unreduced 12 point font. Do not include any spiral or bound materials or pamphlets.

   Cover Letter: Include a one-page cover letter stating whether applying for Level I funding or Level II funding. If applying for Level II funding, applicant must explain how they fulfill eligibility requirements. Narrative 1. Title Page

   The heading should include the title of the cooperative agreement announcement, project title, organization, name and address, project

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   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 the 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:

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

   2. 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.

   3. 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.

   4. Document the applicant's expertise, and extent of experience in the areas of MS, ALS, environmental health, and chronic disease surveillance.

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

   6. Describe how the affected communities will be involved in the proposed project.34. 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.

7. 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 state whether the applicant plans to apply for Level I funding or Level II funding. The letter of intent should be submitted on or before June 30, 2002, 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 in the application kit and at the following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm

   On or before July 30, 2002, submit the application to: Technical Information Management--PA 02154, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-4146.

   Deadline: Applications shall be considered as meeting the deadline if they are received on or before the deadline date.

   Late Applications: Applications which do not meet the criteria above will be returned to the applicant.

8. Evaluation Criteria

   Applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement. Measures of effectiveness must relate to the performance goals as stated in section ``A. Purpose'' of this announcement. Measures must be objective and quantitative and must measure the intended outcome. These measures of effectiveness shall be submitted with the application and shall be an element of evaluation.

   Each application will be evaluated individually against the following criteria by an objective review group appointed by ATSDR: 1. Demonstrated Capacity (40 percent)

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

   2. Adequacy of the plan to include at least one community where neurodegenerative disease has already been identified as a health concern.

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

   4. 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.

   5. 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.

      (3) A statement as to whether the design of the study is adequate to measure differences when warranted.

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

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

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

   3. 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.

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

   5. 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. 3. Facilities and Resources (10 percent)

      The adequacy of the applicant's facilities, equipment, and other resources available for performance of this project. 4. Understanding of the Problem (10 percent)

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

   2. The relevance of the proposed program to these and related problems. 5. Program Personnel (10 percent)

   1. Applicant's technical experience and understanding (e.g. in the areas of MS and ALS, environmental health, and chronic disease surveillance).

   2. 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.

   3. Extent to which the management staff and their working partners are clearly described. 6. Goals and Objectives (10 percent)

      The extent to which the proposed goals and objectives are clearly stated and measurable. 7. Human Subjects (Not scored)

      Not scored, however, an application can be disapproved if the research risks are sufficiently serious and protection against risks are so inadequate as to make the entire application unacceptable. 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.

      1. 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.

      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-9 Paperwork Reduction Act Requirements 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 AR-22 Research Integrity

10. Where To Obtain Additional 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.''

    If you have questions after reviewing the contents of all the documents, business management technical assistance may be obtained from:Edna Green, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC), Announcement 02154, 2920 Brandywine Road, Suite 3000, Atlanta, Georgia 30341-4146, Telephone (770) 488-2743, E-mail address: ecg4@cdc.gov.

    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: (404) 498- 0588, E-mail address: cen9@cdc.gov.

    Dated: June 5, 2002. Edward Schultz, Acting Director, Procurement and Grants Office, Centers for Disease Control and Prevention.

    [FR Doc. 02-14582Filed6-10-02; 8:45 am]

    BILLING CODE 4163-70-P