[Federal Register Volume 67, Number 90 (Thursday, May 9, 2002)]
[Notices]
[Pages 31337-31339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-11562]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 02088]


Prevention of Complications of Thalassemia; 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 for Prevention of Complications of Thalassemia. This program 
addresses the ``Healthy People 2010'' focus area(s) Access to Quality 
Health Services and Disability and Secondary Conditions.
    The purpose of the program is to assist in: (1) Providing 
comprehensive healthcare services through a network of thalassemia 
treatment and prevention centers to prevent complications through 
assessment, surveillance, outreach, education, consultation, and 
management; (2) participating in blood safety monitoring and 
surveillance efforts; (3) maintaining a prevention evaluation network 
to assess the efficacy of prevention services; and (4) collaborating 
with lay organizations to deliver consistent prevention messages aimed 
at preventing complications.
    Measurable outcomes of this program will be in alignment with one 
or more of the following performance goals for the National Center for 
Infectious Diseases (NCID):
    1. Protect Americans from priority infectious diseases.
    2. Apply scientific findings to prevent and control infectious 
diseases.

B. Eligible Applicants

    Assistance will be provided only to specialized thalassemia 
treatment and prevention centers that provide comprehensive treatment 
and prevention services to patients with thalassemia.
    A thalassemia treatment and prevention center is a specialty, 
prevention, diagnostic and treatment program. Their goal is to provide 
family-centered, state-of-the-art medical and psycho-social evaluation 
and care, dental, educational, nutritional, genetic, research, and 
support services for individuals and families affected by thalassemia 
including beta thalassemia major, beta thalassemia intermedia, 
Hemoglobin H (Hb H) disease, Hb H Constant Spring or another variant.
    Applicants must serve a minimum of 25 regularly transfused 
thalassemia patients (thalassemia major) and be able to demonstrate 
experience in providing multi-disciplinary treatment and prevention 
services to patients with thalassemia.


    Note: Title II 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.

C. Availability of Funds

    Approximately $1,000,000 is available in FY 2002 to fund 
approximately six awards. It is expected that the average award will be 
$150,000, ranging from $100,000 to $200,000. 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 five years. The 
funding estimate may change.
    Continuation awards within an approved project period will be made 
on the basis of satisfactory progress as evidenced by required reports 
and the availability of funds.

Funding Preference

    Preference will be given to applicants with a minimum of 25 
patients with severe forms of thalassemia who require chronic blood 
product transfusion therapy (thalassemia major).

D. Program Requirements

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

1. Recipient Activities

    a. The thalassemia treatment and prevention center applicant should 
develop and coordinate a plan in which a treatment center network 
within their catchment area would:
    (1) Provide comprehensive prevention services to persons with 
thalassemia directed at attaining and measuring specific outcomes to 
prevent or reduce complications by using a multi-disciplinary team 
approach. The treatment center should work closely with other 
specialists and local health care providers to meet specific needs of 
persons with thalassemia to increase quality of life from birth 
throughout life. It should also assist individuals with the prevention 
and management of complications.
    (2) Assess unmet needs and under-served populations. Participate in 
outreach efforts to identify patients who can benefit from treatment 
and prevention services and encourage patient participation in 
treatment center programs.
    (3) Participate in development and implementation of CDC 
surveillance efforts (including the Thalassemia Universal Data 
Collection Program, investigations of sero-conversions, suspected 
blood-borne agents, and suspected bacterial contamination), other data 
collection and surveillance efforts by complying with federal and other 
required regulations, and offering programs to all active eligible 
patients to obtain informed consent or refusal.
    (4) Identify any patients who have become infected with HIV or 
hepatitis A, B, C viruses (HAV, HBV, or HCV), new variant Creutzfeld-
Jakob Disease (nvCJD), or bacterial contamination possibly as a result 
of contaminated blood products.
    (5) Obtain appropriate assurances as required by the Office of 
Human Research Protections (OHRP), the Department of Health and Human 
Services (DHHS). Develop and maintain

[[Page 31338]]

strict policies on protecting the confidentiality of patients, and 
ensure the security of databases and other records through controlled 
access to areas with confidential information, database password 
protection, locking file cabinets, and other security features.
    (6) Establish a mechanism for consumer input and involvement in 
planning, implementing, and assessing center prevention activities that 
include education and outreach by collaborating with local and national 
consumer organizations, or ad hoc consumer consultation committee.
    b. If subcontracting with satellite centers, the applicant should 
develop appropriate management and evaluation systems to ensure that 
subcontractors implement the recipient activities of this program 
appropriately (as outlined in section ``D. Program Requirements''), and 
comply with federal and other required regulations. The applicant 
should conduct program assessments, site visits, assist treatment 
centers with problem solving, assess local needs, and provide technical 
assistance when needed.
    c. For all activities, develop and implement an evaluation plan 
which measures the effectiveness of the activities involved, and 
document lessons learned.

2. CDC Activities

    a. Assist in determining priority areas and long term goals for 
prevention of complications of thalassemia as a collaborative effort. 
Encourage treatment and prevention centers to seek input from 
providers, Community Based Organizations (CBOs), and consumer 
representatives.
     b. Provide consultation, scientific and technical assistance in 
planning, implementing, and evaluating activities to prevent the 
complications of thalassemia by using surveillance data to develop 
interventions and assess their effectiveness. Coordinate the 
development, implementation, and evaluation of prevention intervention 
protocols.
    c. Assist in the analysis and reporting of aggregate clinical 
outcomes data, coordinate and consolidate the transfer of tabulated 
data, analyses, and conclusions among participating treatment and 
prevention centers, as needed.
    d. Provide necessary follow-up and technical assistance, as needed, 
to treatment and prevention centers implementing changes or 
recommendations resulting from program evaluations, assessments, or 
activities required to meet federal and other regulations.
    e. Provide technical assistance and coordinate routine annual 
testing of patient samples for HAV, HBV, HCV, HIV, and other clinically 
significant tests and reporting of results back to treatment centers. 
Provide technical assistance to designated laboratory for permanent 
storage of blood samples.
    f. Collaborate with treatment centers and appropriate State or 
local health departments to investigate any suspected HIV, HAV, HBV, 
HCV seroconversions, nvCJD, bacterial contaminant or other reported 
potential blood borne agents.
    g. Ensure that surveillance data systems developed through this 
program will adhere to the National Electronic Disease Surveillance 
System (NEDSS) Standards as they become available to increase the 
interoperability of systems and the exchange of data among the users of 
these systems.
    h. Assist in the development of a research protocol for 
Institutional Review Board (IRB) review by all cooperating institutions 
participating in the research project. The CDC IRB will review and 
approve the protocol initially and on at least an annual basis until 
the research project is completed.

E. Content

Letter of Intent (LOI)

    A LOI is optional for this program. The narrative should be no more 
than three single-spaced pages, printed on one side, with one inch 
margins, and unreduced font. Your letter of intent will be used to 
enable CDC to plan for the review, and should include the following 
information: (1) The program announcement number 02088, (2) name and 
address of institution, (3) name, address, and telephone number of a 
contact person. Notification can be provided by facsimile, postal mail, 
or electronic mail (e-mail).

Applications

    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 narrative should be no more than 25 double-spaced pages, 
printed on one side, with one inch margins, and unreduced font.
    The application should include:
1. Background, Unmet Need, and Capacity
    Describe the need for blood safety monitoring, data collection, 
education, outreach, and treatment and prevention services and 
programs. Explain the basis for providing such programs, expected 
outcomes and the relevance to preventing complications among people 
with thalassemia. Describe applicant's experience in providing 
treatment and prevention services to this population and other 
activities related to, but not supported by, the cooperative agreement.
2. Objectives
    Establish long-term (five year) and short-term (one year) 
objectives for programmatic plans. Objectives should be specific, 
measurable, time-phased and realistic.
3. Operational Plan
    Describe the methods by which the objectives will be achieved, 
including their sequence. Address CDC policy requirements as described 
in the evaluation criteria.
4. Evaluation Plan
    Describe the plans to monitor the progress of the program, as well 
as to evaluate the outcomes of the proposed activities.
5. Program Management
    Describe the roles and responsibilities of all project staff in the 
proposed project, regardless of their funding source. The description 
should include their titles, qualifications, and experience, as well as 
the percentage of time each will devote to the project, and the 
portions of their salaries to be paid by the cooperative agreement.
6. Budget
    A detailed first year's budget and budget justification for the 
cooperative agreement with projections for the next four additional 
years. Separate detailed budgets with line-item descriptive 
justifications should be submitted for each sub-grantee if requested. 
For each performance site (applicant and sub-grantees), include the 
name and address of the person and organization to receive the 
contract.

F. Submission and Deadline

Letter of Intent (LOI)

    On or before June 15, 2002, submit the LOI to the Grants Management 
Specialist identified in the ``Where to Obtain Additional Information'' 
section of this announcement.

Application

    Submit the original and two copies of PHS 5161-1 (OMB Number 0920-
0428). Forms are available in the application kit and at the following 
Internet address: www.cdc.gov/od/pgo/forminfo.htm.

[[Page 31339]]

    On or before July 15, 2002, submit the application to: Technical 
Information Management-PA02088, 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 on or before the deadline date.
    Late: Applications which do not meet the criteria above will be 
returned to the applicant.

G. 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 (or goals) as stated in section ``A. 
Purpose'' of this announcement.
    Each application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC.

1. Background and need (20 points)

    The extent to which the applicant understands the needs, problems, 
objectives and complexities of the project. Rationale for selection of 
the targeted community and documentation of health needs and risk 
factors.

2. Objectives (15 points)

    The degree to which the proposed objectives are clearly stated, 
realistic, time-phased, and related to the purpose of the project.

3. Operational Plan (Total 35 points)

    a. The adequacy of the operational plans for carrying out the 
various initiatives involved in the project. (30 points)
    b. The degree to which the 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 whether the design of the study is adequate to measure 
differences when warranted. (4) A statement as to whether the plans for 
recruitment and outreach for study participants include the process of 
establishing partnerships with community(ies) and recognition of mutual 
benefits. (5 points)

4. Collaboration (10 points)

    The extent of community sanction/liaison. Evidence of access to, 
interaction with, and participation of collaborative interactions among 
all project participants. Demonstration of effective communication 
channels among researchers.

5. Staff Qualifications (5 points)

    The extent to which professional personnel proposed to be involved 
in this project are qualified, including evidence of past achievements 
appropriate to this project and capacity to fulfill program goals and 
objectives.

6. Evaluation Plan (10 points)

    The quality and feasibility of the evaluation plan for the various 
initiatives involved in the project.

7. Measures of Effectiveness (5 points)

    The extent to which the applicant provide measures of effectiveness 
that will demonstrate the accomplishment of the various identified 
objectives of the cooperative agreement. The extent to which the 
measures are objective/quantitative and adequately measure the intended 
outcome.

8. Human Subjects (Not Scored)

    The extent to which the application adequately address the 
requirements of Title 45 CFR part 46 for the protection of human 
subjects.

9. Budget (Not scored)

    The extent to which the applicant provides justification for budget 
expenditures as well as appropriateness of activities proposed in their 
application.

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with the original plus two copies of:
    1. Semiannual progress reports (the progress report will include a 
data requirement that demonstrates measures of effectiveness).
    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 I of the 
announcement 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-15  Proof of Non-Profit Status
AR-22  Research Integrity

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under sections 301(a), and 317(k)(1) and 
317(k)(2) of the Public Health Service Act, (42 U.S.C. sections 241(a), 
and 247b(k)(1) and 247(k)(2)), as amended. The Catalog of Federal 
Domestic Assistance number is 93.283.

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.''
    To obtain business management technical assistance, contact: Merlin 
Williams, Grants Management Specialist, Acquisition and Assistance, 
Branch B, Procurement and Grants Office, Centers for Disease Control 
and Prevention, 2920 Brandywine Road, Room 3000, MS K75, Atlanta, GA 
30341-4146.
    Telephone Number: 770-488-2765.
    E-mail Address: [email protected].
    For program technical assistance, contact: Sally O. Crudder, Acting 
Deputy Chief, Hematologic Diseases Branch, National Center for 
Infectious Diseases, Centers for Disease Control and Prevention, 1600 
Clifton Road, MS E64,Atlanta, GA 30333.
    Telephone Number: 404-371-5270.
    E-mail Address: [email protected].

    Dated: May 4, 2002.
Sandra R. Manning,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 02-11562 Filed 5-8-02; 8:45 am]
BILLING CODE 4163-18-P