03-12708. Surveillance and Epidemiologic Research of Duchenne and Becker Muscular Dystrophy; Notice of Availability of Funds

Application Deadline: July 21, 2003.

A. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under Sections 301, 311 and 317C of the Public Health Service Act [42 U.S.C. 241, 243, and 247b-4 as amended]. The Catalog of Federal Domestic Assistance number is 93.184.

B. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2003 funds for a cooperative agreement program on surveillance and epidemiologic research of Duchenne and Becker Muscular Dystrophy (DBMD). This Program addresses the “Healthy People 2010” focus areas for Disability and Secondary Conditions.

The purpose of the program is to support (1) the development and/or expansion of active case ascertainment surveillance systems to characterize the epidemiology of DBMD and it's complications; and (2) the participation of the state DBMD surveillance system in the Collaborative DBMD Project. Long-term population-based follow-up research activities will be planned to describe history of treated and/or untreated cases, and to determine factors that affect outcome of the condition among three populations: (a) Those who access care at specialty clinics (e.g., Muscular Dystrophy Association (MDA) or other muscular dystrophy clinics), (b) those who receive their care elsewhere, and (c) those who are not receiving care or are undiagnosed. See Attachment I for Background and Definitions. All attachments referenced in this announcement are posted with the announcement on the CDC Web site.

Measurable outcomes of this program will be in alignment with the following performance goal for the National Center for Birth Defects and Developmental Disabilities (NCBDDD): to find causes and risk factors for birth defects and developmental disabilities in order to develop prevention strategies.

C. Eligible Applicants

Assistance will be provided only to the health departments of States 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, the Republic of Palau, and federally recognized Indian tribal governments.

Recipients funded under CDC Program Announcement 02172, (Surveillance and Epidemiologic Research of Duchenne and Becker Muscular Dystrophy and Other Single Gene Disorders) currently involved in type 1 projects are not eligible. See Attachment II for a list of the States currently funded.

To be eligible, applicants must document a study population of at least 30,000 live births per year within a State, a contiguous area of a State (such as the catchment of a local health agency), or an area comprising a combination of States, based on U.S. Census Data. In addition, a copy of the state Legislation that allows the authority for state Health Departments to collect information on birth defects, genetic diseases or related conditions needs to be included.

This information should be placed directly behind the face page of the application. Applications that fail to submit the evidence requested above will be considered 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. Funding

Availability of Funds

Approximately $1,000,000 is available in FY 2003 to fund up to two awards. It is expected that up to two awards will be made, ranging from $400,000 to $500,000. It is expected that the award will begin on or about September 1, 2003, and will be made for a 12-month budget period within a two-year project period. Funding estimates may change.

Continuation awards within the project period will be made on the basis of satisfactory programmatic progress and the availability of funds.

Recipient Financial Participation

Matching funds are not required for this program.

Funding Preference

Relative to and consistent with the technical merit of the application, funding preference will be given to applicants who complement the existing funded programs by balancing the geographic and racial/ethnic diversity of the multi-state collaborative effort.

E. Program Requirements

In conducting activities to achieve the purpose of this program, the recipient will be responsible for the activities under 1. Recipient Activities. CDC will be responsible for the activities listed under 2. CDC Activities.

1. Recipient Activities:

a. Develop, implement and evaluate methods and approaches which will improve or expand the capacity of the applicant's existing surveillance system to ascertain cases and generate timely population-based data of DBMD and its complications. Make any necessary modifications to the surveillance system to comply with the Collaborative DBMD Project case definitions. The Collaborative DBMD Project case definitions and other information developed by the current grantees may be obtained from the programmatic technical assistance point-of-contact in the “Where to Obtain Additional Information” section.

b. Establish or enhance collaborative relationships with appropriate stakeholders, i.e., specialty treatment centers (e.g., MDA clinics, other muscular dystrophy clinics), state or regional chapters or associations related to genetic conditions, hospitals, emergency care centers, private physicians, managed care organizations, clinical and diagnostic laboratories that provide diagnosis of genetic conditions (e.g., creatine kinase measurements, muscle biopsy analysis, genetic analysis, etc.), and others.

c. Collaborate with other funded recipients to design and develop one common protocol for all recipients to implement and evaluate as described in Attachment III. The Collaborative DBMD Project current draft protocol and other information developed by the current grantees may be obtained from the programmatic technical assistance point-of-contact in the “Where to Obtain Additional Information” section.

d. Implement active case ascertainment of DBMD among reporting sources to determine the prevalence of the genetic condition(s) in the defined geographic area, including a complete count of all prevalent cases, including ages birth to 21 years, and supplemented in later years by newly diagnosed cases.

e. Describe the source, frequency, and type of preventive and medical care among persons with DBMD among three populations: (a) Those who access care at specialty clinics (e.g., MDA or other muscular dystrophy clinics), (b) those who receive their care elsewhere, and (c) those who are not receiving care or are undiagnosed.

f. Determine the prevalence of related complications.

g. Conduct population-based long-term follow-up of persons with DBMD to relate health outcomes to the source, frequency, and type of preventive and therapeutic care.

h. Obtain buccal samples or other biologics, as agreed-upon by awardees, from children with DBMD and other family members.

i. Evaluate and disseminate the findings.

2. CDC Activities:

a. Provide technical assistance in designing, developing, and evaluating methodologies and approaches used for population-based surveillance of genetic conditions.

b. Provide technical assistance in the collection, management, and analysis of surveillance data related to genetic conditions.

c. Provide technical assistance in the development and planning of the study protocol. Provide final approval for the study protocol.

d. Provide technical assistance in the analysis and reporting of aggregate surveillance data collected from funded initiatives; coordinate and consolidate the transfer of tabulated data, analyses, and conclusions among recipients.

e. Provide technical assistance to national, state, or regional programs in the use of data to develop or improve care programs for genetic conditions.

f. Provide technical assistance to recipients in developing a plan for the collection, storage and access of biologic samples.

g. Provide technical assistance to recipients in the evaluation and dissemination of the findings.

F. Content

Letter of Intent (LOI)

A LOI is requested for this program. The Program Announcement title and number must appear in the LOI. The narrative should be no more than two, double-spaced pages, printed on one side, with one inch margins and 12 point font. The LOI will not be used to eliminate potential applicants, but it will enable CDC to determine the level of interest in this announcement, and plan the review more efficiently. The LOI should include the following information: Program announcement number; applicant's name and address; project director's name, phone number, and e-mail address; a brief description of the number of births in the defined geographic region and a brief description of the planned cooperative agreement activities.

Applications

The Program Announcement title and number must appear in the application. 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 program plan should include activities to be conducted over the entire two year project period. The application's narrative (excluding budget narrative and any appendices) should be no more than 40 double-spaced pages, printed on one side, with one inch margins, and no smaller than 12-point font. Number each page consecutively and provide a complete table of contents.

The application should contain the following:

1. Executive Summary (one-page, may be single spaced):

This section should briefly summarize:

a. amount of federal assistance requested

b. existing capacity

c. key objectives and activities

2. Proposal Narrative

a. introduction, statement of need, proposed goals and objectives

b. existing program and capacity

c. proposed methods and activities

d. project management and project staff

e. proposed methods to evaluate the attainment of objectives

3. Budget and Budget Justification—Provide a detailed budget which indicates the anticipated costs. Please provide a copy of the appropriate indirect rate agreement letter or cost allocation plan.

4. Human Subjects

5. Appendices, which may include letters of commitment from key collaborators (including specialty clinics such as MDA clinics and other muscular dystrophy clinics), resumes of key staff, brief summary reports of analyses of surveillance data for other genetic conditions.

G. Submission and Deadline

LOI Submission

On or before June 20, 2003, submit the LOI to the Program Technical Assistance contact, at the address designated for programmatic technical assistance identified in the “Where to Obtain Additional Information” section of this announcement.

Application Forms

Submit the signed original and two copies of PHS-5161 (OMB Number 0920-0428) Forms are available at the following Internet address: http://www.cdc.gov/​od/​pgo/​forminfo.htm. If you do not have access to the internet, or if you have difficulty accessing the forms on-line, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) at telephone number [phone]. Application forms can be mailed to you.

Submission Date, Time, and Address

The application must be received by 4 p.m. Eastern Time on July 21, 2003. Submit the application to: Technical Information Management—PA #03070, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Rd., Atlanta, GA 30341-4146.

Applications may not be submitted electronically.

CDC Acknowledgment of Application Receipt

A postcard will be mailed by PGO-TIM, notifying you that CDC has received your application.

Deadline

Letters of intent and applications will be considered as meeting the deadline if they are received before 4 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 disasters, CDC will upon receipt of proper documentation, consider the application as having been received by the deadline.

Applications which 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 goals as stated in section “B. 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.

Each application will be evaluated and scored individually by an objective review panel. Evaluations and scoring will be conducted according to the following criteria:

1. Methods and Activities (30 points):

a. The quality of the applicant's plan for conducting program activities and the extent to which surveillance methods proposed are: (1) Appropriate to accomplish stated goals and objectives; (2) adaptable to a variety of health care settings, and to the collection of longitudinal data; (3) accurate to produce valid and reliable data, and (4) feasible within programmatic and fiscal restrictions.

b. The applicant's willingness to cooperate with CDC and other funded applicants to (1) identify optimal surveillance methods, (2) develop standardized surveillance protocols, data collection instruments, interview questionnaires, progress report forms, and database software, and (3) modify proposed methods and activities to conform to standardized protocols.

2. Capacity (20 points):

The extent to which the applicant can access the state or regional community with genetic conditions that is receiving care within and outside of the specialty clinics (e.g., MDA and other muscular dystrophy clinics), as measured by (1) the extent that this proposal incorporates shared responsibility between specialty clinics and state or local health departments as delineated in letters of agreement, and (2) the extent of collaboration obtained from these entities with other organizations involved in the delivery of care and/or services to persons with genetic conditions.

3. Goals and objectives (20 points):

The extent to which the project goals and objectives are relevant, specific, achievable, measurable, time-linked and can be addressed through the proposed methods.

4. Management and Staffing (20 points):

a. The extent to which the scientific resources for project planning and data management/analysis are demonstrated within the applicant's organization or through collaboration with universities or other agencies.

b. The extent to which proposed staffing, staff qualifications and experience, and project organization indicates ability to accomplish the active case findings and other objectives of the program.

5. Evaluation (10 points):

The degree to which the applicant includes plans to evaluate the attainment of proposed objectives and to evaluate the quality of the data collected.

6. Human Subjects (not scored):

Does the application 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.)

7. Budget (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.

I. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two copies of:

1. Interim progress report, no less than 90 days before the end of the budget period. The interim progress report will serve as your non-competing continuation application and must include the following elements:

a. Current Budget Period Activities Objectives.

b. Current Budget Period Financial Progress.

c. New Budget Period Proposed Activity Objectives.

d. Detailed Line-Item Budget and Justification.

e. Additional Requested Information.

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.

Additional Requirements

The following additional requirements are applicable to this program. For a complete description of each, see Attachment IV of the program announcement as posted on the CDC web site.

AR-1 Human Subjects Requirements

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

J. Where to Obtain Additional Information

This and other CDC announcements, the necessary applications, and associated forms can be found on the CDC home page Internet address: http://www.cdc.gov. Click on “Funding” then “Grants and Cooperative Agreements.”

For general questions about this announcement, contact: Technical Information Management, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: [phone].

For business management and budget assistance, contact: Sheryl L. Heard, Grants Management Specialist, Procurement and Grants Office, Centers for Disease Control and Prevention, Announcement 03070, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: [phone], Email address: [e-mail].

For program technical assistance contact: Aileen Kenneson, National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, 1600 Clifton Road, MailStop F-35, Atlanta, GA 30333, Telephone: [phone], Email address: [e-mail].

Dated: May 14, 2003.

Sandra R. Manning,

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