[Federal Register Volume 68, Number 98 (Wednesday, May 21, 2003)]
[Notices]
[Pages 27810-27813]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-12708]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 03070]


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.

[[Page 27811]]

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

[[Page 27812]]

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 (770) 488-
2700. 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.

[[Page 27813]]

    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: 770-488-2700.
    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: (770) 488-2723, 
Email address: [email protected].
    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: (404) 498-3039, Email address: 
[email protected].

    Dated: May 14, 2003.
Sandra R. Manning,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention.
[FR Doc. 03-12708 Filed 5-20-03; 8:45 am]
BILLING CODE 4163-18-P