[Federal Register Volume 67, Number 105 (Friday, May 31, 2002)]
[Notices]
[Pages 38115-38118]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-13632]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 02172]


Surveillance and Epidemiologic Research of Duchenne and Becker 
Muscular Dystrophy and Other Single Gene Disorders; 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 a cooperative agreement 
program on surveillance and epidemiologic research of (1) Duchenne and 
Becker Muscular Dystrophy (DBMD) and other single gene disorders, and 
(2) genetic and other disorders identified through tandem mass 
spectrometry and other newborn screening technologies. This program 
addresses the ``Healthy People 2010'' priority areas for Disability and 
Secondary Conditions.
    The purpose of the program is to: (1) Develop and/or expand 
surveillance systems to characterize the epidemiology of DBMD and other 
single gene disorders and their complications; and (2) develop long-
term follow-up tracking of children identified through tandem mass 
spectrometry and other newborn screening technologies.
    This program consists of two types of projects (Type I and Type 
II):

Type I: Surveillance and Tracking of DBMD and Other Single Gene 
Disorders Without Universal Screening Programs

    The purpose of Type I funding is to determine the prevalence of 
DBMD and other single gene disorders that are not detected through 
newborn screening programs and that therefore require active case 
finding activities. 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 the 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.

Type II: Surveillance and Tracking of Conditions With Universal 
Screening Programs

    The purpose of Type II funding is to determine the prevalence of 
single gene or other conditions identified using existing or potential 
newborn screening programs, and to conduct population-based long-term 
follow-up research to describe the history of treated and/or untreated 
cases. Potential newborn screening programs include, but are not 
limited to, newborn blood spot screening using tandem mass 
spectrometry.
    Quantifiable outcomes of the cooperative agreement will be measured 
against the following Government Performance Results Act 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. 241, 243, and 247b-4 as 
amended]. The Catalog of Federal Domestic Assistance number is 93.184.

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.
    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 a 
contiguous area comprising a combination of States, based on U.S. 
Census Data. 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.
    If an applicant chooses to apply for both a Type I and a Type II 
award, a separate complete application must be submitted for each type.

    Note: Title 2 of the United States Code, Section 1611 states 
that an organization

[[Page 38116]]

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 $1,600,000 is available in FY 2002 funding to fund up 
to five awards. It is expected that up to three Type I awards will be 
made, ranging from $350,000 to $450,000, and that up to two Type II 
awards will be made, ranging from $100,000 to $150,000. It is expected 
that the award will begin on or about September 1, 2002, and will be 
made for a 12-month budget period within a three 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.
    Funding preference will include: (1) Geographic balance, (2) Type I 
programs that target DBMD, and (3) Type II programs that target fatty 
acid oxidation and/or organic acid disorders.

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 for Type I projects or 2. Recipient Activities for Type II 
projects. CDC will be responsible for the activities listed under 3. 
CDC Activities.

1. Recipient Activities for Type I Projects

    a. Develop, implement and evaluate methods and approaches that 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 other single gene disorders and their complications.
    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 Type I funded recipients to design and 
develop one common protocol for all recipients to implement and 
evaluate.
    d. Implement active case ascertainment of DBMD and other genetic 
condition(s) 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 and other genetic condition(s), 
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 and other genetic condition(s) 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 genetic conditions and other 
family members.
    i. Evaluate and disseminate the findings.

2. Recipient Activities for Type II Projects

    a. Collaborate with other Type II funded recipients to design and 
develop one common protocol for all recipients to implement and 
evaluate.
    b. Describe the source, frequency, type of and access to preventive 
and medical care among persons with the genetic condition(s), and 
determine the prevalence of related complications.
    c. Conduct population-based long-term follow-up of persons with 
genetic condition(s) to relate health outcomes to the source, 
frequency, type of, and access to preventive and therapeutic care, 
including both primary and specialty care settings.
    d. Assess the option of obtaining buccal samples or other 
biologics, as agreed upon by awardees, from children with the genetic 
condition(s) and other family members.
    e. Evaluate and disseminate the findings.

3. CDC Activities

    a. Participate in designing, developing, and evaluating 
methodologies and approaches used for population-based surveillance of 
genetic conditions.
    b. Participate in the collection, management, and analysis of 
surveillance data related to genetic conditions.
    c. Participate in the development and planning of the study 
protocol. Provide final approval for the study protocol.
    d. Assist 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. Assist national, state, or regional programs in the use of data 
to develop or improve care programs for genetic conditions.
    f. Assist recipients in developing a plan for the collection, 
storage and access of biologic samples.
    g. Assist recipients in the evaluation and dissemination of the 
findings.

F. Content

Letter of Intent (LOI)

    A LOI is requested for this program. The LOI will not be used to 
eliminate potential applicants, but it will enable CDC to determine the 
level of interest and plan the review more efficiently. The LOI should 
be no more than two, double-spaced pages, printed on one side, with 
one-inch margins and 12 point font. The LOI should denote the intent to 
submit a Type I or Type II application, and 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.

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 proposal narrative (excluding budget narrative and any 
appendices) should be no more than 35 double-spaced pages, printed on 
one side, with one inch margins, and 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. Type of request (I or II).
    b. Amount of federal assistance requested.
    c. Existing capacity.

[[Page 38117]]

    d. 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 Narrative.
    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

Letter of Intent

    On or before June 28, 2002, submit the LOI to the Program Officer 
listed as the point of contact for programmatic technical assistance 
identified in the Where to Obtain Additional Information section of 
this announcement.

Application

    On or before 5:00 p.m. Eastern Time August 2, 2002, submit the 
original and two copies of PHS-5161 (OMB Number 0920-0428). Forms are 
available at the following Internet address: www.cdc.gov/od/pgo/forminfo.htm.
    Submit the application to: Technical Information Management-
PA02172, Procurement and Grants Office, Centers for Disease Control and 
Prevention, 2920 Brandywine Rd, Room 3000, Atlanta, GA 30341-4146.
    Deadline: Applications shall be considered as meeting the deadline 
if they are received before 5:00 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 goals 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.
    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)

    a. 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.
    b. 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.

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. Semiannual progress reports which should include:
    a. Brief project description.
    b. Comparison of the actual accomplishments to the goals and 
objectives established for the period.
    c. Data requirement that demonstrates measures of effectiveness. 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.

[[Page 38118]]

    e. Financial recap of obligated dollars to date as a percentage of 
total available funds.
    2. Financial status report, no more than 90 days after the end of 
the budget period.
    3. Final financial status 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 in the 
Application Kit.
AR-1--Human Subjects Requirements
AR-2--Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
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
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 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 L. Heard, Grants Management Specialist, Acquisition and 
Assistance Branch B, Centers for Disease Control and Prevention, 
Announcement 02172, 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-
4146, Telephone: (770) 488-2723, Email address: [email protected].
    Programmatic technical assistance may be obtained from: William 
Ramsey, National Center on Birth Defects and Developmental 
Disabilities, Centers for Disease Control and Prevention, 4770 Buford 
Highway N.E. MailStop F-15, Atlanta, GA 30341-3724, Telephone: (770) 
488-7226, Email address: [email protected].

Sandra R. Manning,
CGFM, Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 02-13632 Filed 5-30-02; 8:45 am]
BILLING CODE 4163-18-P