02-14728. 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.

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.

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.

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: [phone], E-Mail address: [e-mail].

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: [phone], E-Mail address: [e-mail].

Dated: June 6, 2002.

Edward Schultz,

Acting Director, Procurement and Grants Office, Centers for Disease Control and Prevention.