[Federal Register: May 21, 2003 (Volume 68, Number 98)]
[Notices]
[Page 27810-27813]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21my03-42]
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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: slh3@cdc.gov. 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:
alk6@cdc.gov.
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