[Federal Register Volume 66, Number 78 (Monday, April 23, 2001)]
[Notices]
[Pages 20462-20465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-9928]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Program Announcement 01074]
Intervening With Children and/or Adolescents With Fetal Alcohol
Syndrome/Alcohol Related Neurodevelopmental Disorders; Notice of
Availability of Funds
A. Purpose
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 2001 funds for participation in a
collaborative research consortium for identifying, developing, and
evaluating effective strategies for Intervening with Children and/or
Adolescents with Fetal Alcohol Syndrome (FAS)/Alcohol Related
Neurodevelopmental Disorders (ARND). This program addresses the
``Healthy People 2010'' focus area(s) of Substance Abuse and Maternal,
Infant, and Child Health. The purpose of the program is to conduct
innovative research to identify and evaluate components of a systematic
intervention approach for children and/or adolescents with FAS or ARND
and their families that (1) improves developmental outcomes, (2)
prevents secondary conditions, and (3) provides education and support
to care givers and families.
B. Eligible Applicants
Applications may be submitted by public and private nonprofit
organizations and by governments and their agencies; that is,
universities, colleges, research institutions, hospitals, other public
and private nonprofit organizations, State and local governments or
their bona fide agents, and federally recognized Indian tribal
governments, Indian tribes, or Indian tribal organizations.
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 $1,200,000 is available in FY 2001 to fund
approximately 3 awards. It is expected that the average award will be
$300,000, ranging from $250,000 to $400,000. It is expected that the
awards will begin on or about September 30, 2001, and will be made for
a 12-month budget period within a project period of up to 3 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.
D. Program Requirements
In conducting activities to achieve the purpose of this program,
the recipient will be responsible for the activities under 1.
(Recipient Activities), and CDC will be responsible for the activities
listed under 2. (CDC Activities).
1. Recipient Activities
a. Develop a general approach for identifying, diagnosing,
evaluating, and intervening with children and/or adolescents with FAS
or ARND. Applicants may target a specific age group (i.e., preschoolers
or adolescents), or propose a comprehensive intervention with the
capacity of serving individuals across several ages. The approach must
include intervention components focusing on parent involvement in the
intervention as well as parent education and advocacy training or
support.
b. Develop a proposed set of diagnostic and evaluation procedures
for study participants. Describe the specific set of proposed
intervention components targeting core deficits (e.g., impaired social
skills, social communication deficits, visual-motor impairment,
behavioral issues) to intervene with the targeted population of
children and/or adolescents with FAS or ARND.
c. Develop the goals and objectives of the study, the data
collection instruments, study procedures, and evaluation plan to be
used in determining the effectiveness of intervention components.
d. Collaborate with other grantees in identification and/or
development of science-based best practices for assessment and
intervention with children and/or adolescents with FAS or ARND.
e. Develop outreach and recruitment procedures for identification
of affected children and/or adolescents from multiple sources to
maximize the possibility of ascertaining a population-based sample.
Recruit a population of at least 50 children and/or adolescents with
FAS or ARND to participate in each of the intervention and comparison
groups.
f. Develop research protocol for Institutional Review Board (IRB)
review by all cooperating institutions participating in the research
project.
g. Recruit and train appropriate staff to ensure proper
implementation of all aspects of the research and intervention.
[[Page 20463]]
h. Develop and implement a research protocol with appropriate
quality assurance procedures to assure that the research and
intervention activities are being properly implemented.
i. Compile and disseminate results of intervention program.
j. Collaborate with other grantees and CDC to develop education and
training materials derived from the intervention and research for
dissemination to a broad spectrum of potential agencies that provide
services to affected individuals.
2. CDC Activities
a. Assist in the development of a research protocol for IRB review
by all cooperating institutions participating in the research project.
b. The CDC IRB will review and approve the protocol initially and
on at least an annual basis until the research project is completed.
c. Provide technical assistance, if requested, for the overall
coordination as well as development of the intervention and evaluation
research plans.
d. Provide technical consultation and advice on all aspects of
recipient activities. Provide up-to-date, scientific information about
the intervention.
e. Facilitate collaborative efforts to compile and disseminate
program results through publications.
E. Application Content
a. General Instructions
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 25 double-spaced pages,
printed on one side, with one inch margins, and unreduced font. Do not
include any spiral or bound materials or pamphlets.
b. Specific Instructions
Abstract: A one-page single-spaced, typed abstract must be
submitted with the application. The heading should include the title of
the grant program, project title, organization name and address,
project director and telephone number. The abstract should briefly
summarize the program for which funds are requested, the activities to
be undertaken, and the applicant's organization and composition. The
abstract should follow the printed forms and precede the Program
Narrative. Program Narrative (not to exceed 25 pages) The Program
Narrative Section should address the following:
1. Background. Briefly describe:
a. Understanding of the problem of FAS and other conditions
associated with prenatal alcohol exposure, and why the applicant is
interested in participating in a project to develop and evaluate
interventions for this population.
b. Understanding of the need for targeted interventions for the
core deficits of children and/or adolescents with FAS or ARND and
understanding of the need for individualization of interventions for
affected children and/or adolescents and their families.
c. The proposed study, including purpose, objectives, and core
components with justification for their inclusion.
d. Description of the challenges, barriers, and problems associated
with developing and implementing an intervention for children and/or
adolescents with FAS or ARND.
e. Understanding of the need to include parent involvement, parent
education, and parent advocacy training or support for care givers of
children and/or adolescents with FAS or ARND.
f. Demonstration of population based approach to case ascertainment
including description of target population, size, age distribution,
race/ethnicity, care giving arrangements (e.g., adoptive families), and
other relevant sociodemographic characteristics.
g. Current patterns of service delivery to the target population,
including educational placement, auxiliary services (e.g., occupational
therapy, psychotherapy), family support services, and access to social
services (e.g., SSI, respite).
2. Organization. Briefly describe:
a. How the applicant will access intervention participants.
b. How the applicant will provide the proposed diagnostic,
evaluation, and intervention study components to study participants.
c. How the applicant proposes to evaluate the effectiveness of the
intervention study.
d. Proposed organization structure, with lines of authority, for
implementing and managing intervention and research activities. Staff
should include a principal investigator (recommend at least 15 percent
time of an individual with a Doctorate Degree with published research
to provide oversight), a project coordinator who oversees all
intervention and research activities (recommend 100 percent time of an
individual with at least a Master's Degree), diagnostic persons, parent
educator, intervention staff, and data/statistical expert. In addition,
specialized staff required for proposed intervention should be included
as appropriate.
e. Current working relationship with research, academic,
scientific, or community-based organizations with relevant expertise in
delivering services to children with FAS, ARND, or other developmental
disabilities.
f. Plans for conducting the intervention and research activities
while meeting other current clinical or research commitments.
g. The degree to which human subjects may be at risk and the
assurance that the project will be subject to initial and continuing
review by the appropriate institutional review committees.
h. The proposed plan for the inclusion of racial and ethnic
minority populations for appropriate representation.
3. Capacities. Briefly describe the capacity and experience of the
applicant and the clinical/agency site(s) in which the intervention and
research activities will be conducted, including:
a. Description of previous intervention and developmental research
conducted.
b. Description of the setting in which participants will be
recruited into the study, including provision to access potential
participants from the general population in addition to clinic-based
recruitment. In addition, the setting for conduct of diagnostic and
evaluation procedures as well as facilities for research activities.
Commitment to designate office/operating space for these activities
should be described.
c. Commitment to begin intervention and research activities by
January 1, 2002, including letters of commitment from study sites to
begin participation by this date.
4. Current Level of Service Delivery. Briefly describe data from
the past year on the following:
a. The number of individuals with FAS and ARND who are assessed
annually by the applicant (e.g., must document a population of a least
75 to 100 children or adolescents per year). Information concerning age
distribution, racial/ethic composition, and care giving situation must
be provided.
b. The proportion of clients seen in one year for initial diagnosis
and evaluation versus follow-up clients previously examined.
c. Rate of return appointments in relation to rate of loss to
follow-up.
d. Description of any other studies currently being conducted in
the proposed study site.
5. Approach. Briefly describe:
[[Page 20464]]
a. The general approach the applicant will use to develop and
implement the proposed intervention, including recruitment of
participants, diagnostic and evaluation of potential participants,
delivery of the essential components of the intervention, follow-up of
intervention participants, and quality assurance of data collection and
protocol implementation.
b. Procedures to identify, evaluate, and recruit children and/or
adolescents outside clinic referred samples.
c. The area of deficit and proposed targeted interventions to be
developed and/or implemented.
d. Research design to evaluate the effectiveness of the general
intervention approach and targeted interventions.
e. Development or implementation of parent involvement, parent
education, and parent advocacy training or support for care givers.
6. Potential Implementation Issues. Briefly describe:
Any foreseeable problems that might arise based on previous
experience with implementation of this type of intervention or
evaluation research in your selected target population, and a plan for
how these problems would be dealt with.
7. Assurances. The applicant must provide the following:
a. Assurance that study documents will be handled and stored to
ensure confidentiality and assure retention;
b. Assurance that project staff will be hired in a timely manner;
and
c. Assurance that key project personnel (or designees if the
individuals filling these positions have not been employed at the time)
will meet with CDC within 2 months of award to discuss initial
collaborative activities.
8. Budget and Line-Item Justification: This section must include a
detailed first-year budget and narrative justification with future
annual projections. The applicant should describe the program purpose
for each budget item. For contracts contained within the application
budget, applicants should name the contractor, if known; describe the
services to be performed; justify the use of a third party; and provide
a breakdown or a justification for the estimated costs of the
contracts, the kinds of organizations or parties to be selected, the
period of performance, and the method of selection. The budget should
include travel for the key study personnel to meet 3 times per year
with CDC and other grantees. Incentives for study participants may be
included in the budget.
F. Submission and Deadline
Letter of Intent (LOI)
A letter indicating intent to respond to this announcement should
be submitted. Your letter of intent should include the following
information: Name of applying organization, name of principal
investigator, address, telephone number, whether a specific age group
will be targeted by the proposed intervention, and a brief description
of core areas to be addressed as well as the general approach to
intervening in these areas. The letter of intent must be submitted on
or before May 18, 2001, to the Grants Management Specialist identified
in the ``Where to Obtain Additional Information'' section of this
announcement.
Application
Submit the original and 5 copies of PHS 398 (OMB Number 0925-0001).
Adhere to the instructions on the Errata Instruction Sheet for PHS-398.
Forms are available at the following Internet address: www.cdc.gov, or
in the application kit. On or before June 20, 2001, 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 independent review group appointed by CDC.
1. Applicant's Understanding of the Problem (20 percent)
The extent to which the applicant demonstrates an understanding of
FAS or ARND, the need for targeted interventions for this population,
and the challenges, barriers, and problems associated with developing
and implementing an intervention for this population. The applicant
should also demonstrate understanding of the need for individualization
of interventions for children and/or adolescents with FAS or ARND, as
well as the importance of care giver education and support as necessary
components to an intervention approach.
2. Description of the Intervention Target Population, Outline of
General Intervention Approach, and Area(s) of Targeted Intervention (50
Percent)
The extent to which the applicant has provided a full and
comprehensive description of the proposed intervention target
population, including recruitment procedures and methods to achieve a
generalizable sample. How the applicant will address diagnosis and
initial evaluation of potential participants should be described. The
general approach to intervening with children and/or adolescents with
FAS or ARND should be described as should implementation or development
of specific targeted areas of intervention. Methods for evaluation of
the overall intervention approach and specific targeted interventions
should be described.
Implementation, development, and/or enhancement of parent education
(including advocacy training) should be described.
The applicant must provide adequate demonstration of its ability to
access a study population of at least 50 children and/or adolescents
with FAS or ARND to participate in each of the intervention and
comparison groups. The degree to which the applicant has met the CDC
policy requirements regarding the inclusion of women, ethnic, and
racial groups in the proposed project must be demonstrated. This
includes: (a) The proposed plan for the inclusion of both sexes and
racial/ethnic minority populations for appropriate representation; (b)
The proposed justification when representation is limited or absent;
(c) A statement as to whether the design of the study is adequate to
measure differences when warranted; and (d) A statement as to whether
the plans for recruitment and outreach for intervention participants
includes the process of establishing partnerships with community(ies)
and recognition of mutual benefits.
3. Capacity To Conduct Project Activities and Begin Study Operations in
a Timely Fashion (30 Percent)
The extent to which the applicant has provided information to
support its ability to conduct the activities of
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intervention and evaluation research, including documentation of
previous intervention and research experience in behavioral science
focusing on children and/or adolescents with FAS, ARND, and/or other
developmental disabilities; documentation of institutional support for
the project; demonstrated ability to identify qualified personnel to
fill key positions (including principal investigator, project
coordinator, intervention staff, and diagnostic staff) and begin study
activities in a timely fashion; and a description of how space required
for the study will be acquired or designated.
4. Budget Justification and Adequacy of Facilities (Not Scored)
The budget will be evaluated for the extent to which it is
reasonable, clearly justified, and consistent with the intended use of
the awarded funds. The applicant shall describe and indicate the
availability of facilities and equipment necessary to carry out this
project.
5. Human Subjects Review (Not Scored)
Does the application adequately address the requirements of Title
45 CFR Part 46 for the protection of human subjects?
H. Other Requirements
Technical Reporting Requirements
Provide CDC with original plus two copies of
1. Progress reports (semi-annual);
2. Financial status report, no more than 90 days after the end of
the budget period; and
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.
The following additional requirements are applicable to this
program. For a complete description of each, see Attachment I in the
application kit.
AR-1--Human Subjects Requirements
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-14--Accounting System Requirements
AR-15--Proof of Non-Profit Status
I. Authority and Catalog of Federal Domestic Assistance Number
This program is authorized under sections 301 and 317 of the Public
Health Service Act, 42 U.S.C. 241 and 247b, as amended. The Catalog of
Federal Domestic Assistance number is 93.283.
J. Where To Obtain Additional Information
This and other CDC 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: Virginia Hall-Broadnax, Grants Management Specialist, Grants
Management Branch, Procurement and Grants Office, Centers for Disease
Control and Prevention, Room 3000, 2920 Brandywine Road, Atlanta, GA
30341-4146, Telephone number (770) 488-2710, Email address vdh2
@cdc.gov.
For program technical assistance, contact: Dr. Jacquelyn Bertrand,
(770) 488-3529: Email address: [email protected], or Connie Granoff,
(770) 488-7513; Email address: [email protected] Division of Birth Defects,
Child Development, and Disability and Health, National Center for
Environmental Health, Centers for Disease Control and Prevention, 4770
Buford Highway, (F-49), Atlanta, Georgia 30341-3724.
Dated: April 17, 2001.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention.
[FR Doc. 01-9928 Filed 4-20-01; 8:45 am]
BILLING CODE 4163-18-P