[Federal Register Volume 65, Number 96 (Wednesday, May 17, 2000)]
[Notices]
[Pages 31325-31327]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-12347]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[Program Announcement 00114]


Determining the Prevalence of Multiple Sclerosis in Communities 
Living Around Hazardous Waste Sites, Applied Research and Development; 
Notice of the Availability of Funds

A. Purpose

    The Agency for Toxic Substances and Disease Registry (ATSDR) 
announces the availability of fiscal year (FY) 2000 funds for a 
cooperative agreement program to conduct research on Determining the 
Prevalence of Multiple Sclerosis (MS) 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 determine the prevalence of MS 
among individuals in specific communities near sources of hazardous 
substances.

B. 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, 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's legislature definition of a State entity or political 
subdivision to be considered to be an eligible applicant. Local health 
jurisdictions may apply with the concurrence of the State Health 
Officer.

    Note: Public Law 104-65 states that an organization described in 
section 501(c)(4) of the Internal Revenue Code of 1986 that engages 
in lobbying activities is not eligible to receive Federal funds 
constituting an award, grant, cooperative agreement, contract, loan 
or any other form.

C. Availability of Funds

    Approximately $140,000 is available in FY 2000 to fund up to two 
awards. It is expected that the average award will be $70,000, ranging 
from $50,000 to $90,000. It is expected the awards will begin on or 
about September 30, 2000, and will be made for a 12-month budget period 
within a project period of up to two 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. At the completion 
of the project, the equipment must be returned to ATSDR.

Funding Preference

    Preference will be given to the proposed projects that are 
conducted in more than one community where MS and hazardous substances 
have been identified as health concerns.

D. 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

    Applicants addressing the same research issue should be willing to 
participate in collaborative studies with other ATSDR-sponsored 
researchers, including developing and using common data collection 
instruments and procedures, and data management procedures, as 
determined in post-awarding grantee planning conferences. A study group 
of all recipient Principal Investigators will be convened to develop a 
common protocol, interview instruments and data collection procedures.
    a. Develop a research project which evaluates the prevalence of MS 
cases in communities living around hazardous waste sites. Provide 
scientific information concerning hazardous substances and MS and 
develop a model for others to determine the prevalence of MS in 
communities living around hazardous waste sites.
    b. Develop the research study protocols and standardized data 
extraction forms across sites. Develop methods to verify MS diagnosis.
    c. Collaborate and share data with other collaborators to answer 
specific research questions.
    d. Conduct data analysis with all collaborators as well as present 
and publish research findings.
    e. Disseminate research results to community members through 
collaborative relationships with state health and environmental 
agencies.

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. Preparation and submission of materials to the CDC Internal 
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.
    d. Provide assistance to awardee(s) in the design of a data 
management system, in the analysis of research information, and the 
presentation and publication of research findings.
    e. Provide technical assistance to awardees (if more than one award 
is made) to ensure a sharing of information and methodologies, as 
appropriate.
    f. Facilitate an annual meeting between awardee(s) and ATSDR to 
coordinate planned efforts and review progress.

E. Application 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 your program plan. 
The narrative should be no more than 30 pages, double-spaced, printed 
on one-side, with 1" margins, and unreduced fonts (font size 12 point) 
on 8\1/2\" by 11" paper. Do not include any spiral or bound materials 
or pamphlets.

1. Title Page

    The heading should include the title of the cooperative agreement 
announcement, project title, organization, name and address, project 
director's name address and telephone number.

2. Abstract

    A one-page, singled-spaced, typed abstract must be submitted with 
the

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application. The heading should include the title of 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 2 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 multiple sclerosis, environmental health, and population-
based epidemiologic studies.
    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.
    g. Human Subjects: State whether or not Humans are subjects in this 
proposal. (See Human Subjects in the Evaluation Criteria and Other 
Requirements sections.)
    h. Inclusion of women, ethnic, and racial groups: Describe how the 
CDC/ATSDR policy requirements will be met regarding the inclusion of 
women, ethnic, and racial groups in the proposed research. (See Women, 
Racial and Ethnic Minorities in the Evaluation Criteria and Other 
Requirements sections.)

4. 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.

F. 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 be 
submitted on or before June 15, 2000, 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 on the Centers for Disease Control and 
Prevention Internet address, or in the application kit.
    On or before July 14, 2000, submit the application to the Grants 
Management Specialist identified in the ``Where to Obtain Additional 
Information'' section of this announcement.
    Deadline: Applications shall be considered as meeting the deadline 
if they are either:
    (a) Received on or before the deadline date; or
    (b) Sent on or before the deadline date and received in time for 
submission to the independent review group. (Applicants must request a 
legibly dated U.S. Postal Service postmark or obtain a legibly dated 
receipt from a commercial carrier or U.S. Postal Service. Private 
metered postmarks shall not be acceptable as proof of timely mailing.
    Late Applications: Applications which do not meet the criteria in 
(a) or (b) above are considered late applications, will not be 
considered, and will be returned to the applicant.

G. Evaluation Criteria

    Each application will be evaluated individually against the 
following criteria by an objective review group appointed by ATSDR.

1. 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
    b. relevance of the proposed program to these and related problems.

2. Program Personnel (10 percent)

    a. Applicant's technical experience and understanding (e.g. in the 
areas of MS, environmental health, and population-based epidemiologic 
studies).
    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.

3. Goals and Objectives (10 percent)

    The extent to which the proposed goals and objectives are clearly 
stated and measurable.

4. 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 in their area.
    b. Adequacy of plan to include at least one community where MS has 
already been identified as health concerns.
    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:

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    (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.

5. 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 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.
    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.

6. Facilities and Resources (10 percent)

    The adequacy of the applicant's facilities, equipment, and other 
resources available for performance of this project.

7. Human Subjects (Not scored)

    Does the application adequately address the requirements of 45 CFR 
46 for the protection of human subjects?

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.

H. 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. For a complete description of each, see Attachment 1 in the 
application kit.

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-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

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized in Sections 104(i)(1)(E) 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)(l)(E) and (15)]. The Catalog of Federal 
Domestic Assistance number is 93.161.

J. Where To Obtain Additional Information

    Please refer to Program Announcement 00114 when you request 
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.''
    To receive additional written information and to request an 
application kit, call 1-888-GRANTS4 (1-888 472-6874). You will be asked 
to leave your name and address and will be instructed to identify the 
Announcement number of interest.
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from: Nelda Y. Godfrey, Grants Management Specialist, Grants Management 
Branch, Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 2920 Brandywine Road, Suite 3000, Atlanta, Georgia 
30341-4146, Telephone (770) 488-2722, 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) 639-5150, E-mail 
address: [email protected].

    Dated: May 11, 2000.
Georgi Jones,
Director, Office of Policy and External Affairs, Agency for Toxic 
Substances and Disease Registry.
[FR Doc. 00-12347 Filed 5-16-00; 8:45 am]
BILLING CODE 4163-70-P