[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]


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

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

[[Page 20465]]

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