[Federal Register Volume 67, Number 111 (Monday, June 10, 2002)]
[Notices]
[Pages 39725-39727]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-14452]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[Program Announcement 02134]


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.

[[Page 39726]]

    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 8\1/2\ 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.

[[Page 39727]]

    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 (770) 488-2743, E-mail 
address: [email protected].
    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: (404) 498-0571, E-
mail Address: [email protected].
    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 (404) 498-0546, E-mail 
Address: [email protected].

    Dated: June 3, 2002.
Edward Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 02-14452 Filed 6-7-02; 8:45 am]
BILLING CODE 4163-70-P