[Federal Register Volume 68, Number 108 (Thursday, June 5, 2003)]
[Notices]
[Pages 33701-33704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14127]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[Program Announcement 03079]


Exposure to Tremolite Asbestos in Vermiculite Ore; Notice of 
Availability of Funds

    Application Deadline: July 21, 2003.

[[Page 33702]]

A. 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.

B. Purpose

    The Agency for Toxic Substances and Disease Registry (ATSDR) 
announces the availability of fiscal year (FY) 2003 funds for a 
cooperative agreement program to conduct site-specific health 
activities due to 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 from the mine in Libby, 
Montana.
    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.

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 501c(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. Funding

Availability of Funds

    Approximately $250,000 is available in FY 2003 to fund 
approximately one to four awards. It is expected that the awards will 
range from $10,000 to $250,000 ($10,000 per site evaluated for the 
conduct of health statistics reviews; $100,000 for mesothelioma 
surveillance; and a maximum of $250,000 for epidemiologic 
investigations.) It is expected that the awards will begin on or about 
September 1, 2003, 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 ATSDR 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.

Recipient Financial Participation

    Matching funds are not required for this program.

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 the activities listed in 1. 
Recipient Activities, and ATSDR will be responsible for the activities 
listed in 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. (Please see 
Attachment 1 of this announcement as posted on the CDC Web site for 
information about vermiculite ore from Libby, Montana). Identify cases 
of mesothelioma in the State and interview the cases and next-of-kin. 
Provide information to ATSDR to combine with other State information. 
Prepare a final report of the project. This 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 and 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

Applications

    The Program Announcement title and number must appear in the 
application. 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.
    The narrative should consist of, at a minimum, a Plan, Objectives, 
Methods, Evaluation and Budget.

[[Page 33703]]

G. Submission and Deadline

Application Forms

    Submit the signed original and two copies of PHS 5161-1 (OMB 0920-
0428). Forms are available at the following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm. 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) at: 770-488-2700. Application forms can be 
mailed to you.

Submission Date, Time, and Address

    The application must be received by 4 p.m. Eastern Time July 21, 
2003. Submit the application to: Technical Information Management--
PA03079, CDC Procurement and Grants Office, 2920 Brandywine 
Road, Atlanta, GA 30341-4146.
    Applications may not be submitted electronically.

CDC Acknowledgement of Application Receipt

    A postcard will be mailed by PGO-TIM, notifying you that CDC has 
received your application.

Deadline

    Applications shall be considered as meeting the deadline if they 
are received before 4 p.m. Eastern Time on the deadline date. Any 
applicant who sends their application by the United States Postal 
Service or commercial delivery services must ensure that the carrier 
will be able to guarantee delivery of the application by the closing 
date and time. If an application is received 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, CDC will upon receipt of proper 
documentation, consider the application as having been received by the 
deadline.
    Any application that does not meet the above criteria will not be 
eligible for competition, and will be discarded. The applicant will be 
notified of their failure to meet the submission requirements.

H. Evaluation Criteria

Application

    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 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.
    An independent review group appointed by ATSDR will evaluate each 
application against the following criteria:
    1. Proposed Program (50 percent)
    The criteria will include 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 criteria will include 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 and (b) 
the capability of the applicant to demonstrate an appropriate plan for 
interaction with the community.
    4. Program Budget--(not scored)
    The extent to which the budget is reasonable, clearly justified, 
and consistent with intended use of cooperative agreement funds.
    5. Human Subjects (not scored)
    Does the application adequately address the requirements of Title 
45 CFR part 46 for the protection of human subjects? Not scored; 
however, an application can be disapproved if the research risks are 
sufficiently serious and protection against risks is so inadequate as 
to make the entire application unacceptable.

I. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of:
    1. Interim progress report, 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 elements:
    a. Current Budget Period Activities Objectives.
    b. Current Budget Period Financial Progress.
    c. New Budget Period Program Proposed Activity Objectives.
    d. Detailed Line-Item Budget and Justification.
    e. Additional Requested Information.
    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.

Additional Requirements

    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment II of the 
program announcement, as posted on the CDC web site.
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

    This and other CDC announcements, the necessary applications, and

[[Page 33704]]

associated forms can be found on the CDC Web site, Internet address: 
http://www.cdc.gov.
    Click on ``Funding'' then ``Grants and Cooperative Agreements''.
    For general questions about this announcement, contact: Technical 
Information Management, CDC Procurement and Grants Office, 2920 
Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-2700.
    For business management and budget assistance, contact: Edna Green, 
Grants Management Specialist, Procurement and Grants Office, Centers 
for Disease Control and Prevention, 2920 Brandywine Road, Room 3000, 
Atlanta, GA 30341-4146, Telephone: (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: May 30, 2003.
Edward Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 03-14127 Filed 6-4-03; 8:45 am]
BILLING CODE 4163-70-P