[Federal Register Volume 64, Number 53 (Friday, March 19, 1999)]
[Notices]
[Pages 13583-13586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6712]


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

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,

[[Page 13584]]

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

[[Page 13585]]

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

[[Page 13586]]

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