Childhood Asthma and Hazardous Substances Applied Research and Development; Notice of the Availability of Funds

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[Program Announcement 99059]

Childhood Asthma and Hazardous Substances 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) 1999 funds for a

cooperative agreement program to conduct research on the impact of

hazardous substances on childhood asthma. This program addresses the

``Healthy People 2000'' priority area of Environmental Health.

The purpose of this program is to: (1) Use secondary data sources

available for asthma and evaluate the contribution of environmental

exposures to asthma morbidity among children, (2) provide generalizable

scientific information about the association between hazardous

substances and childhood asthma morbidity; and (3) develop a

methodology which could serve as a useful model for other organizations

when responding to questions concerning the health impact of air

releases of hazardous substances.

B. Eligible Applicants

Assistance will be provided to official public health agencies 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's legislature definition of a State entity or

political subdivision to be considered to be an eligible applicant.

C. Availability of Funds

Approximately $185,000 may be available in FY 1999 to fund one or

two awards. It is expected that the average award will be $100,000,

ranging from $80,000 to $105,000. The award(s) are expected to begin on

or about September 30, 1999, and will be made for a 12-month budget

period within a project period of up to three years. Funding estimates

are subject to 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 Priorities

Priority will be given to the proposed project that is conducted in

a community where a completed air pathway has already been established

for one or more hazardous substances from a particular point source(s).

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

a. Develop a research project which evaluates the contribution of

environmental exposures, from a point source using secondary data.

Provide scientific information concerning hazardous substances and

childhood asthma and develop a model for others to address the health

impact of hazardous substances.

b. Develop, field test, and revise data extraction instruments.

c. Conduct the activities. Analyze data and interpret findings.

d. Disseminate research results to community members, and publish

in written format.

e. Provide evidence of collaborate efforts with the state health

department on proposed and future community outreach activities.

f. Collaborate with ATSDR on these program activities, and meet

annually to coordinate planned efforts and review progress.

2. ATSDR Activities

a. Provide scientific, epidemiologic, and environmental assistance.

b. Collaborate on the development of the protocol and evaluation of

the data extraction instruments.

c. Collaborate with awardee(s) on data analysis and interpretation

of findings.

d. Provide technical assistance to awardees (if more than one award

is made) to ensure a sharing of information and methodologies, as

appropriate.

e. Provide assistance for the dissemination of information to

community members resulting from this project.

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 application must be developed in accordance with PHS Form 5161-1

(OMB) Number 0937-0189) information. The entire application, including

appendices, should not exceed 50 pages and the Proposal Narrative

section contained therein should not exceed 30 pages. Pages should be

clearly numbered and a complete table of contents to the application

and any appendices included. The original and each copy of the

application must be submitted unstapled and unbound. All materials must

be typewritten, double-spaced, with unreduced type (font size 12 point)

on 8\1/2\'' by 11'' paper, with at least 1'' margins, headers, and

footers, and printed on one side only. Do not include any spiral or

bound materials or pamphlets.

1. Title Page

The heading should include the title of 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 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 3 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

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asthma, environmental health, and population-based epidemiologic

studies.

e. Provide letters of support or other documentation demonstrating

coordination with the state health department and all other agencies or

organizations described as participating in the project.

f. Describe how the affected communities will be involved 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. Place the

budget narrative pages showing, in detail, how funds in each object

class will be spent, directly behind form 424A. Do not put these pages

in the body of the application. ATSDR may not approve or fund all

proposed activities.

F. Submission and Deadline

Pre-Application Letter of Intent

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 should be submitted to

Lisa Garbarino, Grants Management Officer, Attn: Nelda Godfrey, Grants

Management Branch, Procurement and Grants Office, Centers for Disease

Control and Prevention (CDC), 2920 Brandywine Road, Room 3000, Atlanta,

Georgia, 30341-4146. It should be postmarked no later than May 17,

1999. The letter should identify program announcement number 99059, and

name and phone number of contact person.

Application

The original and two copies of the application PHS Form 5161-1 must

be submitted to Lisa Garbarino, Grants Management Officer, Attn: Nelda

Y. Godfrey, Grants Management Branch, Procurement and Grants Office,

Centers for Disease Control and Prevention (CDC), 2920 Brandywine Road,

Suite 3000, Atlanta, Georgia, 30341-4146 on or before July 16, 1999.

(By formal agreement, the CDC Procurement and Grants Office will act

for and on behalf of ATSDR on this matter.)

1. 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 objective review group. (Applicants should 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.)

2. Late Applications: Applications which do not meet the criteria

in 1.a. or 1.b. above are considered late applications. 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.

Review Criteria

1. Understanding of the Problem (10 percent) Responsiveness to the

objectives of the cooperative agreement including:

a. The applicant's understanding of the problems related to

community exposures to hazardous substances and concerns regarding

morbidity from childhood asthma, and

b. Relevance of the proposed program to these and related problems.

2. Program Personnel (20 percent).

a. Applicant's technical experience and understanding (e.g. in the

areas of asthma, environmental health, and population-based

epidemiologic studies).

b. Qualifications and time allocation of the professional staff to

be assigned to 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. Study Design and Methods (30 percent).

a. Adequacy of the study design and methodology for accomplishing

the stated goals and objectives.

b. The degree to which efficient and innovative approaches are

proposed to address the problems.

c. 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.

d. Adequacy of plan for recruitment and outreach for study

participants including the process of establishing partnerships with

community(ies), the state health department, and recognition of the

mutual benefits.

5. Community Involvement and Dissemination of Results (20 percent).

Adequacy of plans to address community concerns and create lines of

communication. Adequacy of methods to disseminate the study results to

state and local public health officials, tribal governments, Indian

Health Service, community residents, and to other concerned individuals

and organizations.

6. Facilities and Resources (9 percent). The adequacy of the

applicant's facilities, equipment, and other resources available for

performance of this project.

7. Minority Populations (1 percent). 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:

a. The proposed plan for the inclusion of both sexes and racial and

ethnic minority populations for appropriate representation.

b. The proposed justification when representation is limited or

absent.

c. A statement as to whether the desgin of the study is adequate to

measure differences when warranted.

d. A statement as to whether the plans for recruitment and outreach

for study pariticpants include the process of establishing partnerships

with community (ies) and recognition of mutual benefits.

8. Human Subjects (Not scored).

Does the application adequately address the requirements of 45 CFR

46 for the protection of human subjects? ________ yes ________ no

Comments: ________ A statement must address whether or not exempt from

the Department of Health and Human

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Services (DHHS) regulations. Are procedures adequate for the protection

of human subjects? Recommendations on the adequacy of protections

include: (a) protections appear adequate, and there are no comments to

make or concerns to raise, (b) protections appear adequate, but there

are comments regarding the protocol, (c) protections appear inadequate

and the Objective Review Group has concerns related to human subjects,

or (d) disapproval of the application is recommended because the

research risks are sufficiently serious and protection against the

risks are inadequate as to make the entire application unacceptable.

9. 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 (Attachment 2)

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: Nelda Y. Godfrey, Grants Management

Specialist, Grants Management Branch, Procurement and Grants Office,

Cooperative Agreement Number: ____________, Centers for Disease Control

and Prevention (CDC), 2920 Brandywine Road, Suite 3000, Atlanta,

Georgia 30341-4146.

The following additional requirements are applicable to this

program. For 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-10 Smoke-Free Workplace Requirements

AR-11 Healthy People 2000

AR-17 Peer Review and Technical Reviews of Final

Reports of Health Studies--ATSDR

------------------------------------------------------------------------

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AR-18.................................. Cost Recovery--ATSDR.

AR-19.................................. Third Party Agreements--ATSDR.

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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 99059 when you request

information. 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 any questions after

reviewing the contents of the application kit please contact: 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].

To obtain technical assistance, contact: Sherri Berger,

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)

639-5149, E-mail address: [email protected].

See also the CDC home page on the Internet: http://www.cdc.gov.

Dated: March 12, 1999.

Georgi Jones,

Director, Office of Policy and External Affairs, Agency for Toxic

Substances and Disease Registry.

[FR Doc. 99-6712 Filed 3-18-99; 8:45 am]

BILLING CODE 4163-70-P