02-14452. Exposure to Tremolite Asbestos in Vermiculite Ore; Notice of Availability of Funds

A. 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 conduct site-specific health activities for Exposure to Tremolite Asbestos in Vermiculite Ore. This program addresses the “Healthy People 2010” focus area of Environmental Health.

The purpose of the program is to conduct site-specific health activities related to human exposure to contaminated vermiculite ore at sites identified by the Environmental Protection Agency (EPA) as receiving and/or processing ore.

Measurable outcomes of the program will be in alignment with the following performance goals for ATSDR:

1. Evaluate human health risks from toxic sites and take action in a timely and responsive public health manner.

2. Ascertain the relationship between exposure to toxic substances and disease.

B. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under section 104(i)(1)(E),(6), (7), (14) and (15) of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) of 1980 as amended by the Superfund Amendments and Reauthorization Act (SARA) of 1986 [42 U.S.C. 9604 (i)(1)(E),(6),(7),(14), and (15)]. The Catalog of Federal Domestic Assistance number is 93.161.

C. Eligible Applicants

Assistance will be provided only to the health departments of States or their bona fide agents or instrumentalities. State organizations, including State universities, must establish that they meet their respective State legislature's definition of a State entity or political subdivision to be considered an eligible applicant.

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.

D. Availability of Funds

Approximately $400,000 is available in FY 2002 to fund approximately one to four awards. It is expected that the awards will range from $10,000 to $400,000 ($10,000 per site evaluated for the conduct of health statistics reviews, $75,000 for mesothelioma surveillance, and a maximum of $400,000 for epidemiologic investigations.) It is expected that 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 grantee, as the direct and primary recipient of PHS grant 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. Funds may not be used to purchase equipment.

Funding Preference

For the mesothelioma surveillance, preference will be given to states with at least 100 cases of mesothelioma per year and at least eight sites that received the asbestos contaminated ore.

E. 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

a. Health Statistics Reviews. Analyze existing health outcome data of select asbestos-related diseases. Mortality data will be the most readily available data for asbestos-related diseases such as mesothelioma, lung cancer, and asbestosis, although cancer registry data should be utilized where available. Using disease rates by site, determine if there is any excess in disease that would require additional follow-up in Years two and three.

b. Epidemiologic Investigations. After demonstrating an increase of asbestos related disease at a specific site (e.g, through a health statistics review) develop a protocol, conduct the investigation and prepare a final report of the study. This protocol and report will undergo scientific peer review as required by ATSDR.

c. Mesothelioma Surveillance.

Determine if a particular site which received Libby ore is contributing to the mesothelioma burden in the state. Develop a protocol, conduct the recommended investigation and prepare a final report of the project. This protocol and report will undergo scientific peer review as required by ATSDR.

d. Provide proof by citing a State code or regulation or other State pronouncement under authority of law, that medical information obtained pursuant to the agreement will be protected from disclosure when the consent of the individual to release identifying information is not obtained.

e. If a demonstrated excess of disease is found, develop a mechanism for ongoing interaction with, and education of the affected community.

2. ATSDR Activities

a. Health Statistics Review.

(1) Provide a standard protocol to use to analyze existing health outcome data of select asbestos-related diseases.

(2) Provide scientific and epidemiologic assistance.

b. Epidemiologic Investigations. Provide consultation and assist in monitoring the data; participate in the study analysis and collaborate in interpreting the study findings.

c. Mesothelioma Surveillance.

(1) Provide a standard protocol and questionnaire to be used to trace, interview cases of mesothelioma, and analyze the risk of environmental exposure to asbestos contaminated vermiculite ore from Libby, MT, and link it to the cases of mesothelioma.

(2) Provide scientific and epidemiologic assistance.

d. Conduct technical and peer review.

F. Content

In a narrative form, the application should include a discussion of areas under the “Evaluation Criteria” section of this announcement as they relate to the proposed program. These criteria serve as the basis for evaluating the application, therefore, omissions or incomplete information may affect the rating of the application. This program does not require in-kind support or matching funds, however, the applicant should describe any in-kind support in the application.

The narrative should be no more than 30 pages, double-spaced, printed on one side, with one-inch margins, and unreduced 12 point font on 81/2 by 11 inch paper. The pages must be clearly numbered, and a complete index to the application and its appendices must be included. The original and two copies of the application must be submitted unstapled and unbound.

G. Submission and Deadline

Application

Submit the original and two copies of PHS 5161-1 (OMB Number 0937-0189). Forms are available at the following Internet address: www.cdc.gov/​od/​forminfo.htm.

On or before July 15, 2002, submit the application to: Technical Information Management—PA 02134, 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 in above are considered late applications, will not be considered, and will be returned to the applicant.

H. Evaluation Criteria

The applicant is 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 independent review group appointed by ATSDR.

1. Proposed Program (50 percent)

The extent to which the application addresses (a) the approach, feasibility, adequacy, and rationale of the proposed project design; (b) the technical merit of the proposed project, including the degree to which the project can be expected to yield results that meet the program objective, and the technical merit of the methods and procedures (including quality assurance and quality control procedures) for the proposed project; (c) the proposed project timeline, including clearly established project objectives towards which progress can and will be measured; (d) the proposed community involvement strategy; (e) the proposed method to disseminate the results to State and local public health officials, community residents, and other concerned individuals and organizations; and (f) the degree 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 the proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation.

2. Program Personnel (30 percent)

The extent to which the application has described (a) the qualifications, experience, and commitment of the principal investigator (or project director) and his/her ability to devote adequate time and effort to provide effective leadership; and (b) the competence of associates to accomplish the proposed activity, their commitment, and the time they will devote.

3. Applicant Capability and Coordination Efforts (20 percent)

The extent to which the application has described (a) the capability of the applicant's administrative structure to foster successful scientific and administrative management of a study; (b) the capability of the applicant to demonstrate an appropriate plan for interaction with the community; (c) the suitability of facilities and (d) equipment available or to be purchased for the project.

4. Program Budget (not scored)

The extent to which the budget is reasonable, clearly justified, and consistent with intended use of cooperative agreement/grant funds.

5. Human Subjects (not scored)

The extent to which the application adequately addresses the requirements of Title 45 CFR Part 46 for the protection of human subjects.

I. Other Requirements

Technical Reporting Requirements

Provide CDC and ATSDR with original plus two copies of:

1. Semi-annual progress reports. The progress report will include:

a. A brief program description.

b. A listing of program goals and objectives accompanied by a comparison of the actual accomplishments related to the goals and objectives established for the period.

c. If established goals and objectives to be accomplished were delayed, describe both the reason for the deviation and anticipated corrective action or deletion of the activity from the project.

d. Other pertinent information, including the status of the program.

e. Measures of effectiveness data requirement.

f. Financial recap of obligated dollars to date as a percentage of total available funds.

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.

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 III in the application kit.

AR-1 Human Subjects Requirements

AR-2 Requirements for 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 and Technical Reviews of Final Reports of Health Studies—ATSDR

AR-18 Cost Recovery—ATSDR

AR-19 Third Party Agreements—ATSDR

J. Where To Obtain Additional Information

A complete copy of the announcement may be downloaded from CDC's home page at: 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, Acquisition and Assistance Branch B, Procurement and Grants Office, Centers for Disease Control and Prevention, Announcement 02134, 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-4146, Telephone number [phone], E-mail address: [e-mail].

For program technical assistance, contact:

Kevin Horton, Epidemiologist, Division of Health Studies, Agency for Toxic Substances and Disease Registry, Executive Park, Building 4, Suite 2300, MS E-31, Atlanta, GA 30305, Telephone: [phone], E-mail Address: [e-mail].

  or

Maggie Warren, Public Health Advisor, Division of Health Studies, Agency for Toxic Substances and Disease Registry, 1600 Clifton Rd., NE., MS E-31, Atlanta, GA 30333, Telephone [phone], E-mail Address: [e-mail].

Dated: June 3, 2002.

Edward Schultz,

Acting Director, Procurement and Grants Office, Centers for Disease Control and Prevention.