[Federal Register Volume 68, Number 86 (Monday, May 5, 2003)]
[Notices]
[Pages 23717-23719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-10978]



[[Page 23717]]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[Program Announcement 03054]


Disease Progression in Persons Exposed to Asbestos Contaminated 
Vermiculite Ore; Notice of Availability of Funds

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 health studies of disease 
occurrence and progression in persons exposed to vermiculite ore in 
Libby, Montana (MT) or shipped from Libby to other locations for 
packaging and processing. This program addresses the ``Healthy People 
2010'' focus area of Environmental Health.
    The purpose of the program is to conduct follow-up medical 
screening programs for persons exposed to vermiculite ore in Libby, MT 
or shipped from Libby to other locations for packaging and processing, 
who had past exposures to asbestos-contaminated vermiculite ore during 
processing and/or packaging, and who underwent past medical testing for 
asbestos related diseases. The findings of the follow-up medical 
screening program will then be compared with the pre-existing medical 
data on the same group of individuals to evaluate occurrence, severity, 
and progression of asbestos-related abnormalities. (See Attachment 1 of 
the announcement, as posted on the CDC Web site.)
    Measurable outcomes of the program will be in alignment with the 
following performance goals for ATSDR:
    1. Evaluate the human health risk from toxic sites and releases, 
and take action in a timely and responsive manner.
    2. Ascertain the relationship between exposure to toxic substances 
and disease.

C. Eligible Applicants

    Applications may be submitted by state and local governments or 
their bona fide agents (this includes the District of Columbia, the 
Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of 
the Northern Mariana Islands, American Samoa, Guam, the Federated 
States of Micronesia, the Republic of the Marshall Islands, the 
Republic of Palau, and federally recognized Indian tribal governments, 
and political subdivisions of states (in consultation with states)).

    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. Funding

Availability of Funds

    Approximately $160,000 is available in FY 2003 to fund one to two 
awards. It is expected that the average award will be $80,000. It is 
expected that the awards will begin on or about July 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 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. 
Equipment may be purchased with grant funds; however, justification 
must be provided. This should include a cost comparison of a lease 
versus purchase. The title to the equipment will be retained by ATSDR.

Recipient Financial Participation

    Matching funds are not required for this program.

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. Develop a protocol, conduct an evaluation of the target 
population and prepare a final report of the project. The protocol and 
report will each undergo scientific peer review as required by ATSDR.
    b. Using an existing dataset, locate and trace individuals outside 
of Libby, MT who were exposed to vermiculite shipped from Libby. These 
individuals must have undergone previous medical screening (at least 
chest x-rays or spirometry, but optimally both chest x-rays and 
spirometry) for asbestos-related pulmonary abnormalities. Elapsed time 
should allow for latent abnormalities to become evident, e.g., minimum 
20 years latency.
    c. Recipient must have access to medical records, previous x-rays 
and spirometry records related to past screening activities conducted 
for the eligible population.
    d. Provide follow-up medical screening to the eligible population 
(as defined in b. and c. above), to include chest x-rays, spirometry, 
symptom questionnaire. The questionnaire should also ascertain details 
of potential exposures to asbestos.
    e. Compare previous records to current findings and evaluate 
occurrence, severity, and progression of abnormalities consistent with 
asbestos exposure.
    f. Provide results of testing and related education and counseling 
to the eligible population. Inform participants of actions that they 
and their health care providers can take to prevent or decrease the 
adverse impact of these potential asbestos exposure and related health 
effects, if any.
    g. Identify deceased individuals among those who originally 
underwent testing. Obtain death certificates for these deceased persons 
and evaluate causes of mortality for inclusion in the final report. 
Specific attention should be given to asbestos-related mortality (e.g., 
lung cancer, asbestosis, Mesothelioma, etc.).

2. ATSDR Activities

    a. Work closely with the recipient in the design, review and 
development of the protocol and evaluation of the data. ATSDR will 
prepare and submit materials to the CDC Institutional Review Board 
(IRB) and external peer review.
    b. Assist with the tracing and locating of individuals with past 
exposure.
    c. Work with recipient to review available medical records for the 
eligible population.

[[Page 23718]]

    d. Review data with the recipient in the evaluation of the severity 
and progression of abnormalities.
    e. Facilitate meetings between recipient and ATSDR to coordinate 
planned efforts and review progress.
    f. Assist with the preparation of final reports and fact sheets 
documenting the results of testing and related education and counseling 
materials for the eligible population.

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 20 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. The program plan timeline should 
briefly address activities to be conducted over the entire three-year 
project period.

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 June 19, 
2003. Submit the application to: Technical Information Management--
PA03054, Procurement and Grants Office, Centers for Disease 
Control and Prevention, 2920 Brandywine Rd., 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 as stated in the purpose section 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.
    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 applicant's proposal and protocol 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 as described in the purpose section of this 
announcement, and the technical merit of the methods and procedures 
(including quality assurance and quality control procedures) for the 
proposed project; (c) the proposed timeline, including clearly 
established project objectives for which progress toward attainment can 
and will be measured; and (d) the proposed method to disseminate the 
results to state and local public health officials, participants, 
community residents, and other concerned individuals and organizations.
    2. Program Personnel (30 percent). The criteria will include the 
extent to which the proposal has described (a) the qualifications, 
experience and commitment of the principal investigator (or project 
director), and his or 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 
criteria will include the extent to which the proposal 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 criteria will include 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 criteria will include the 
extent to which the application adequately addresses 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.
    Does the application adequately address 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.

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

[[Page 23719]]

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 I of the 
program announcement as posted on the CDC Web site.

AR-1--Human Subjects.
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.
AR-22--Research Integrity.

J. Where To Obtain Additional Information

    This and other CDC announcements, the necessary applications, and 
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 Rd., 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 business management and budget assistance in the territories, 
contact: Jamie Legier, Contract Specialist, Procurement and Grants 
Office, Centers for Disease Control and Prevention, 2920 Brandywine 
Rd., Atlanta, GA 30341-4146, Telephone: (770) 488-2635, E-mail address: 
[email protected].
    For program technical assistance, contact:

Dr. Vikas Kapil, Senior Medical Officer, Division of Health Studies, 
Agency for Toxic Substances and Disease Registry, 1600 Clifton Rd., 
NE., MS E-31, Atlanta, GA 30333, Telephone: (404) 498-0545, E-mail 
address: [email protected].
 0r:
Maggie Warren, Public Health Advisor, Division of Health Studies, 
Agency for Toxic Substances, 1600 Clifton Rd., NE., MS E-31, Atlanta, 
GA 30303, Telephone: (404) 498-0546, E-mail address: [email protected].

    Dated: April 30, 2003.
Sandra R. Manning,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention.
[FR Doc. 03-10978 Filed 5-2-03; 8:45 am]
BILLING CODE 4163-70-P