[Federal Register Volume 67, Number 113 (Wednesday, June 12, 2002)]
[Notices]
[Pages 40303-40306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-14728]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 02165]


Population-based Research in Attention-Deficit Hyperactivity 
Disorder; Notice of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2002 funds for cooperative agreements 
for population-based research projects on Attention-Deficit 
Hyperactivity Disorder (ADHD) that describe prevalence, treated 
prevalence, select comorbid conditions, secondary conditions, and 
health risk behaviors.

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    The purpose of this program is to support research in ADHD and the 
exploration of other health conditions and health risk behaviors to 
children and adolescents with the disorder.
    This program consists of two types of research (Type I and Type 
II):

Type I--Research Targeting Children With ADHD Ages 4 to 10

    The purpose of Type I funding is to determine the prevalence or 
treated prevalence of children with ADHD in a defined community; to 
identify rates of select comorbid or secondary conditions in children 
with ADHD in a defined community; to identify types and rates of health 
risk behaviors in children with ADHD; and to describe current and 
previous receipt of treatment in children with ADHD. Type I awardees 
will work in collaboration with other grantees and CDC to develop 
adequate measures and inform methodologic decisions. Wherever possible, 
Type I grantees will use identical case identification methods as in 
Type II projects.

Type II--Research Targeting Adolescents With ADHD Ages 11 to 17

    Similar to Type I, the purpose of Type II funding is to describe 
the prevalence or treated prevalence of ADHD in adolescents in a 
defined community; to identify rates of comorbidity and secondary 
conditions in adolescents with ADHD in the defined community; to 
identify rates of health risk behaviors in adolescents with ADHD; and 
to describe current and previous receipt of treatment in adolescents 
with ADHD. Type II awards will work in collaboration with CDC to 
develop adequate measures and inform analytic decisions. Wherever 
possible, Type II grantees will use identical case identification 
methods as in Type I projects.
    Quantifiable outcomes of the cooperative agreement will be measured 
against the following performance goal: To find causes and risk factors 
for birth defects and developmental disabilities in order to develop 
prevention strategies.

B. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under Sections 301, 311 and 317(C) of 
the Public Health Service Act, (42 U.S.C. Sections 241, 243, and 247b-
4) as amended. The Catalog of Federal Domestic Assistance number is 
93.283.

C. Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations and by governments and their agencies; that is, 
universities, colleges, technical schools, research institutions, 
hospitals, other public and private nonprofit organizations, community-
based organizations, faith-based organization, State and local 
governments or their bona fide agents, including the District of 
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the 
Commonwealth of the Northern Mariana Islands, American Samoa, Guam, the 
Federated States of Micronesia, the Republic of the Marshall Islands, 
and the Republic of Palau, federally recognized Indian tribal 
governments, Indian tribes, or Indian tribal organizations.
    Only one application from each organization may be submitted for 
this announcement. The applicant can apply for only one Type (Type I or 
Type II).
    To be eligible for Type I or Type II awards, applicants must 
document a population of at least 5,000 youths either aged 4 to 10 or 
aged 11 to 17 from which screening for ADHD will be conducted. The 
minimum study population was determined to ensure a robust study sample 
and is based on ADHD prevalence estimates of 5 to 7 percent of school-
age children. Applicants who are unable to document the minimum study 
population requirement will be determined ineligible. The applicant 
must include this information as part of the abstract. If it is not 
included, then the application will be determined as non-responsive and 
returned without review.

    Note: Title 2 of the United States Code section 1611 states that 
an organization described in section 501(c)(4) of the Internal 
Revenue Code that engages in lobbying activities is not eligible to 
receive Federal funds constituting an award, grant or loan.

D. Availability of Funds

    Approximately $500,000 is available in FY 2002 to fund 
approximately two awards. It is expected that the awards will average 
$250,000. It is expected that the awards will begin on or about 
September 1, 2002, 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 the approved project period will be 
made on the basis of satisfactory progress, submission of required 
reports, and the availability of funds.

Funding Preferences

    Funding preference will include: (1) Geographic balance; and (2) 
racial/ethnic diversity of target populations, relative to and 
consistent with the technical merit of the application.
    Matching funds are not required for this program.

E. Program Requirements

    In conducting activities to achieve the purposes of this program 
announcement under both types of award, the recipient will be 
responsible for activities under 1. Recipient Activities, and CDC will 
be responsible for activities listed under 2. CDC Activities.

1. Recipient Activities

    a. Develop or enhance a population-based (in the community or area 
defined by the applicant) epidemiologic survey to identify prevalence 
or treated prevalence rates of ADHD in children (Type I) or adolescents 
(Type II). The recipient will clearly describe a population-based 
method for the study.
    b. Identify methodology for ascertaining an ADHD case. Method 
should reflect the current diagnostic criteria for ADHD as seen in the 
Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition 
(DSM-IV), American Psychiatric Association, 1994.
    c. Identify select comorbid conditions to be included in the 
survey. Applicants will focus on the presence of common conditions 
often comorbid with ADHD. These may include but are not limited to the 
following: Oppositional-defiant disorder; depression; learning 
disorders; anxiety; and conduct disorder. Comorbid conditions may be 
investigated based on the interest and capabilities of the applicant 
organization.
    d. Identify specific health risk behaviors to be included in the 
survey. For Type I studies, health risk behaviors among 4 to 10 year 
old children will be assessed. These may include but are not limited to 
the following examples: Unintentional injury, fighting/bullying; drug 
or alcohol use; smoking; truancy; delinquency; and early sexual 
activity. For Type II studies, health risk behaviors among 11 to 17 
year old youth will be assessed. These may include but are not limited 
to the following examples: Unintentional injury due to automobile 
collisions; bicycle or sports related injuries; fighting/bullying; drug 
use; alcohol use; smoking; sexual activity; teen-age pregnancy or 
paternity; self-injurious behaviors; truancy; and criminality.
    e. Develop a survey module to collect other descriptive and 
demographic data on the study participants including current and 
previous treatment for ADHD and comorbid cases. Emergency medical care 
utilization should also be assessed for the reason and frequency of 
care.

[[Page 40305]]

    f. Develop valid and reliable survey data collection instruments 
and protocols.
    g. Establish or enhance collaborative relationships with 
appropriate stakeholders, i.e. schools, school districts, local 
officials, professionals, or local organizations.
    h. Develop and implement quality assurance procedures to ensure 
that study protocols are followed and that data is not compromised.
    i. Develop research questions or survey modules in areas related 
to, but distinct from those already specified in the announcement. 
Recipient initiated research questions and methods will be clearly 
described.
    j. Collaborate with other grantees to design and develop a common 
protocol for all recipients to implement and evaluate.

2. CDC Activities

    a. Participate in designing, developing, and evaluating 
methodologies and approaches for using standardized case definitions 
for the grantees. Provide final approval of case identification and 
study methods.
    b. Participate in the development and planning of the survey 
instrument and study protocol. Provide final approval of survey 
instrument.
    c. Provide current information on survey methods including 
technical information on ADHD, selected comorbid conditions, and health 
risk behaviors.
    d. Assist the recipient in the development of quality assurance 
procedures.
    e. Participate in the development of an evaluation plan for the 
completeness and validity of data from the survey.
    f. Assist in the analysis and reporting of aggregate survey data 
collected from grantees, and coordinate the transfer of data among 
grantees.
    g. Facilitate communication/coordination among recipients to 
enhance collaborative activities, to improve the overall quality of the 
research, and ensure data quality.
    h. Assist recipients in the evaluation and dissemination of the 
findings.

F. Content

Letter of Intent

    A non-binding letter of intent is requested from prospective 
applicants. The letter should not exceed two pages. It should identify 
the announcement number, name the proposed project director, denote the 
intent to submit a Type I or Type II application (applicants are only 
permitted to submit a proposal for one type of award), and indicate the 
funding level being requested. This letter will allow CDC to determine 
the amount of interest in the announcement, to plan the review more 
efficiently, and to ensure that each applicant receives timely and 
relevant information prior to the application submission date.

Application

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop the 
application content. The application will be evaluated on the criteria 
listed, so it is important to follow them in laying out your program 
plan.

G. Submission and Deadline

Letter of Intent (LOI)

    On or before June 28, 2002, submit the LOI to the Official 
Designated for Program Technical Assistance identified in the ``Where 
to Obtain Additional Information'' section of this announcement.

Application

    Submit the original and two copies of Form 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: 
http://www.cdc.gov/od/pgo/forminfo.htm
    On or before 5 p.m. Eastern Time, August 2, 2002, submit the 
application to: Technical Information Management-PA02165 Procurement 
and Grants Office, Centers for Disease Control and Prevention, 2920 
Brandywine Rd, Room 3000, Atlanta, GA 30341-4146.
    Deadline: Applications will be considered as meeting the deadline 
if they are received before 5 p.m. Eastern Time on the deadline date. 
Applicants sending applications by the United States Postal Service or 
commercial delivery services must ensure that the carrier will be able 
to guarantee delivery of the application by the closing date and time. 
If an application is received after closing due to: (1) Carrier error, 
when the carrier accepted the package with a guarantee for delivery by 
the closing date and time, or (2) significant weather delays or natural 
disaster, CDC will upon receipt of proper documentation, consider the 
application as having been received by the deadline.
    Applications that do not meet the above criteria will not be 
eligible for competition and will be discarded. Applicants will be 
notified of their failure to meet the submission requirements.

H. Evaluation Criteria

    Applicants are required to provide measures of effectiveness that 
will demonstrate the accomplishment of the various identified 
objectives of the cooperative agreement. Measures of effectiveness must 
relate to the performance goal as stated in section ``A. Purpose'' of 
this announcement. Measures must be objective/quantitative and must 
measure the intended outcome. These measures of effectiveness shall be 
submitted with the application and shall be an element of evaluation.
    Applications will be evaluated individually against the following 
criteria by an independent review group appointed by CDC:

1. Description of Program and Methodology (30 Points)

    a. Extent to which applicant describes the methods they will use 
to: (1) Identify and clearly define the population for the proposed 
research, including the size of the community, demographic 
characteristics of the study area, and methods for screening or 
administering the survey in this population; (2) develop case 
definitions for ADHD, the selected comorbid conditions, and measures of 
health risk behaviors using valid and reliable measurement tools; (3) 
train study staff on case ascertainment methods and survey delivery as 
appropriate; (4) develop and implement quality assurance procedures and 
an evaluation plan for the study; and (5) develop an analytic and 
dissemination plan, and prepare manuscripts.
    b. Extent to which applicant describes proposed investigator-
initiated survey questions or modules, including specific questions or 
types of questions, existing scales or inventories, and why these 
additions are relevant and important to the intent of this 
announcement.

2. Collaborative Efforts (20 Points)

    a. Extent to which applicant demonstrates the ability to access 
multiple data sources as necessary for the proposed study. For 
instance, school systems, local officials, parent groups, or others for 
the purpose of case ascertainment (include written assurances).
    b. Extent to which recipient identifies possible collaborative 
relationships with existing ADHD research programs that may enhance 
recipients' future research activities.
    c. Extent to which collaborative efforts with other relevant 
stakeholders are documented.

[[Page 40306]]

3. Goals and Objectives (15 Points)

    a. Extent to which applicant clearly describes the short-term and 
long-term goals and measurable objectives of the project.
    b. Extent to which applicant's goals and objectives are realistic, 
time-bounded, and consistent with the stated goals and purpose of this 
announcement and the proposed program methodology.
    c. The degree to which applicant has met the CDC policy 
requirements regarding the inclusion of women, ethnic and racial groups 
in the proposed research. This includes:
    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.
    3. A statement as to why and in what ways the design of the study 
is adequate to establish the rates and descriptive data required by the 
recipient.
    4. A statement as to whether the plans for recruitment and outreach 
for study participants include the process of establishing partnerships 
with the community(ies) and recognition of mutual benefits.

4. Staffing and Management (15 Points)

    a. Extent to which key personnel have qualifications, skills and 
experience in epidemiologic methods, ADHD specific surveys or similar 
large population-based surveys, data management and analysis to develop 
and implement population-based surveys and analytic studies in ADHD and 
other related disorders.
    b. Extent to which applicant has the ability to manage and 
coordinate the proposed research.
    c. Extent to which there is appropriate dedicated staff time to 
develop and implement the project.
    d. Extent to which applicant provides an appropriate time line and 
includes activities and personnel responsibilities.
    e. Extent to which applicant demonstrates an organizational 
structure (include an organizational chart) and facilities/space/ 
equipment that are adequate to carry out the activities of the program.

5. Understanding the Problem (10 Points)

    a. Extent to which applicant has a clear, concise understanding of 
the requirements and purpose of the cooperative agreement.
    b. Extent to which applicant understands the issues, challenges, 
and barriers associated with developing and implementing population-
based surveys on ADHD and the complexity of epidemiologic study in ADHD 
and related disorders.
    c. Extent to which applicant understands the issues, challenges, 
and barriers associated with case ascertainment for ADHD.
    d. Extent to which applicant describes the need for population-
based study of ADHD and related disorders in their community or State.

6. Evaluation Plan (10 Points)

    a. Extent to which applicant describes an evaluation plan that will 
monitor the reliability, progress, timeliness, and completeness of the 
objectives and activities of the project.
    b. Extent to which applicant describes a method to evaluate the 
completeness of ascertainment of cases for the survey aspects of the 
study.

7. Budget Justification (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 cooperative agreement funds. The applicant shall describe and 
indicate the availability of the facilities and equipment necessary to 
carry out this project.

8. Human Subjects Review (Not Scored)

    The extent to which the applicant adequately address the 
requirements of Title 45 CFR Part 46 for the protection of human 
subjects. (Not scored; however, an application can be disapproved if 
the research risks are sufficiently serious and protection against 
risks are so inadequate as to make the entire application 
unacceptable.)

I. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of:
    1. Semi-Annual progress reports to include:
    a. A brief project description.
    b. A comparison of the actual accomplishments to the goals and 
objectives established for the period.
    c. In the case that established goals and objectives may not be 
accomplished or are delayed, documentation of both the reason for the 
deviation and the anticipated corrective action or a request for 
deletion of the activity from the project.
    d. Other pertinent information, including preliminary findings from 
the analysis of available data.
    e. Financial recap of obligated dollars to date as a percentage of 
total available funds.
    f. A data requirement that demonstrates measures of effectiveness 
as related to the performance goal stated in section ``A. Purpose'' of 
this announcement.
    2. Financial status report, no more than 90 days after the end of 
the budget period.
    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 II of the 
application kit.

AR-1  Human Subjects Requirements
AR-2  Requirements for Inclusion of Women and Racial Minorities in 
Research
AR-9  Paperwork Reduction Act Requirements
AR-10  Smoke-Free Workplace Requirements
AR-11  Healthy People 2010
AR-12  Lobbying Restrictions
AR-22  Research Integrity

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 go to 
Grants and Cooperative Agreements.
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from: Sheryl Heard, Grants Management Specialist, Assistance and 
Acquisition Branch B, Procurement and Grants Office, Centers for 
Disease Control and Prevention (CDC), Program Announcement 02165, 2920 
Brandywine Road, Room 3000, Atlanta, Georgia 30341-4146, Telephone: 
770-488-2723, E-Mail address: [email protected].
    For program technical assistance, contact: William K. Ramsey, 
Project Officer, National Center on Birth Defects and Developmental 
Disabilities, CDC, 4770 Buford Highway, MS F-15, Atlanta, Georgia 
30341, Telephone: 770-488-7282, E-Mail address: [email protected].

    Dated: June 6, 2002.
Edward Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 02-14728 Filed 6-11-02; 8:45 am]
BILLING CODE 4163-18-P