[Federal Register Volume 67, Number 112 (Tuesday, June 11, 2002)]
[Notices]
[Pages 39991-39994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-14582]


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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

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 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.

B. 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.

C. 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.

D. 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.

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
Level I
    a. 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.
    b. Develop study protocol for approval of project implementation to 
include methods for data collection, data management, and data 
analysis.
    c. Establish cooperative relationships with medical care providers 
in the area(s) to be studied.
    d. Collaborate and share data with other recipients to answer 
specific research questions and present and publish research findings.
    e. Collaborate with other recipients in a pooled anonymized data 
set. Data analysis will be conducted at the state and federal levels.
    f. Disseminate research results to community members through 
collaborative relationships with community groups and state health and 
environmental agencies.
Level II
    a. Responsible for all Level I activities.
    b. Expand existing MS prevalence project to include ALS, additional 
communities, and/or the collection of incidence data.
2. ATSDR Activities
    a. Provide scientific, epidemiologic, and environmental assistance.
    b. 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.
    c. Facilitate external peer review of the protocol and the final 
report(s).
    d. 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.
    e. Provide assistance to awardees in the analysis of research 
information and the presentation and publication of findings.
    f. Provide technical assistance to awardees to ensure a sharing of 
information and methodologies, as appropriate.
    g. Facilitate an annual meeting between awardees and ATSDR to 
coordinate planned efforts and review progress.

F. 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:
    a. 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.
    b. 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.
    c. 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.
    d. Document the applicant's expertise, and extent of experience in 
the areas of MS, ALS, environmental health, and chronic disease 
surveillance.
    e. Provide letters of support or other documentation demonstrating 
coordination with all other agencies or organizations described as 
participating in the project.
    f. 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.

G. 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.

H. 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)
    a. 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.
    b. Adequacy of the plan to include at least one community where 
neurodegenerative disease has already been identified as a health 
concern.
    c. The extent to which the applicant's plans include accomplishing 
the activities listed under Recipient Activities in this announcement.
    d. 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.
    e. 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)
    a. A clear identification and description of the community(ies) to 
be involved in this project.
    b. 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.
    c. 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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    d. Adequacy of plans to address community concerns and create lines 
of communication, including letters of support.
    e. 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)
    a. The applicant's understanding of the problems related to 
community exposures to hazardous substances and concerns regarding MS 
and ALS.
    b. The relevance of the proposed program to these and related 
problems.
5. Program Personnel (10 percent)
    a. Applicant's technical experience and understanding (e.g. in the 
areas of MS and ALS, environmental health, and chronic disease 
surveillance).
    b. 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.
    c. 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.

I. 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

J. 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: 
[email protected].
    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: [email protected].

    Dated: June 5, 2002.
Edward Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 02-14582 Filed 6-10-02; 8:45 am]
BILLING CODE 4163-70-P