[Federal Register Volume 66, Number 87 (Friday, May 4, 2001)]
[Notices]
[Pages 22579-22582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11217]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 01049]


Prevention of the Complications of Bleeding Disorders through 
Hemophilia Treatment Centers; Notice of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2001 funds for a cooperative agreement 
program for the Prevention of the Complications of Bleeding Disorders 
through Hemophilia Treatment Centers. This program addresses the 
``Healthy People 2010'' focus areas of Access to Quality Health-
Services, Disability and Secondary Conditions, HIV, and Immunization 
and Infectious Diseases. For more information on ``Healthy People 
2010'' visit the internet site: http://www.health.gov/healthypeople.
    The purpose of the hemophilia complications prevention cooperative 
agreement program is to assist in: (1) Providing a regional network of 
comprehensive prevention services through hemophilia treatment centers 
to persons with hemophilia and related disorders including women with 
bleeding disorders to prevent complications through assessment, 
surveillance, outreach, education, consultation, and management; (2) 
maintaining a prevention evaluation network to assess the efficacy of 
these prevention services; (3) participating in blood safety monitoring 
and surveillance efforts; and (4) collaborating with lay organizations 
to deliver consistent prevention messages aimed at preventing 
complications.

B. Eligible Applicants

    Assistance will be provided only to hemophilia regional core 
centers, defined as public or private non-profit entities that provide 
regional services and support to a network of comprehensive hemophilia 
treatment centers (HTCs) within their regional catchment area. A HTC is 
defined as a specialty, prevention, diagnostic and treatment program 
with the goal of providing family-centered, state-of-the-art medical 
and psycho-social evaluation and care, dental, education, genetic, 
research, and support services for individuals and families with 
bleeding disorders.

    Note: Title 2 of the United States Code, chapter 26, section 
1611 states that an organization described in section 501(c)(4) of 
the Internal Revenue Code of 1986 that engages in lobbying 
activities is not eligible to receive Federal funds constituting an 
award, grant, cooperative agreement, contract, loan, or any other 
form.

C. Availability of Funds

    Approximately $6,700,000 is available in FY 2001 to fund 
approximately 12 awards. It is expected that the average award will be 
$400,000, ranging from $200,000 to $875,000. It is expected that the 
awards will begin on or about September 30, 2001, and will be made for 
a 12-month budget period within a project period of up to five years. 
The funding estimates 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

    One award per region will be made to support the core center and 
other collaborating HTC performance sites in the region. For the 
purposes of these awards, regional breakdowns are as follows: Region I: 
Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and 
Vermont; Region II: New Jersey, New York, Puerto Rico, and the U.S. 
Virgin Islands; Region III: Delaware, the District of Columbia, 
Maryland, Pennsylvania, Virginia, and West Virginia; Region IV-North: 
Kentucky, North Carolina, South Carolina, and Tennessee; Region IV-
South: Alabama, Florida, Georgia, and Mississippi; Region V-East: 
Indiana, Michigan, and Ohio; Region V-West: Illinois, Minnesota, North 
Dakota, South Dakota, and Wisconsin; Region VI: Arkansas, Louisiana, 
Oklahoma, and Texas; Region VII: Iowa, Kansas, Missouri, and Nebraska; 
Region VIII:

[[Page 22580]]

Arizona, Colorado, Montana, New Mexico, Utah, and Wyoming; Region IX: 
California, Hawaii, Nevada, American Samoa, Northern Mariana Islands 
and Guam; Region X: Alaska, Idaho, Oregon, and Washington.

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. On the regional level, the regional core center should:
    (1) Develop appropriate management and evaluation systems to ensure 
that HTCs within the region implement the activities of this program 
appropriately and comply with federal and other required regulations. 
Conduct program assessments, site visits, assist HTCs with problem 
solving, assess local needs and recommend support for subcontracts to a 
network of centers in their region, and provide technical assistance 
when needed;
    (2) Serve as liaison with CDC to provide input and feedback 
regarding national programs, implementation and evaluation. Coordinate 
CDC consultation when necessary;
    (3) Facilitate communication within the region to foster 
opportunities to promote the exchange of information among health care 
providers;
    (4) Increase awareness about the prevention of complications by 
promoting prevention services and programs within the region among 
community-based organizations (CBOs) and persons with bleeding 
disorders to identify new patients eligible for care, and to 
reestablish contact with patients lost to follow-up;
    (5) Facilitate collaborative program development, planning, and 
communication between the region's HTCs and chapter or other consumer 
organizations to promote referral to the centers and provide access to 
educational and support services;
    (6) Encourage expansion of HTC populations to include services to 
women with bleeding disorders and develop programs to identify under 
served populations including minorities and women;
    (7) Coordinate development of HTC program plans, goals and 
objectives, and progress tracking and reporting for HTCs in the region;
    (8) Facilitate access to appropriate training resources and 
opportunities to orient new HTC personnel, and enhance the skills of 
current HTC personnel to increase the quality of prevention services; 
and
    (9) Coordinate, annually or bi-annually, with CDC participation, a 
regional meeting for HTCs and CBOs or ad hoc consumer consultation 
committees to share information and plan programs. Regional meetings 
may be jointly sponsored with other regions that have similar needs.
    b. The regional core centers should develop and coordinate a plan 
where HTCs within the region would:
    (1) Provide comprehensive prevention services to persons with 
bleeding disorders directed at attaining and measuring specific 
outcomes to reduce complications by using a multi-disciplinary team 
approach. HTC services are provided by a multi-disciplinary team. The 
core team includes: adult or pediatric hematologist, nurse coordinator, 
social worker and physical therapist. HTC services include medical and 
psycho-social assessment and monitoring, home therapy teaching and 
monitoring, infectious disease management, physical therapy, dental 
services, rehabilitation and support services. The HTC team works 
closely with other specialists and local health care providers to meet 
specific needs of persons with bleeding disorders to increase quality 
of life from birth throughout life, and assist individuals with the 
prevention and management of complications.
    (2) Assess unmet needs and under served populations, including 
minorities and women, participate in outreach efforts to identify 
patients who can benefit from prevention services, and encourage 
patient participation in HTCs;
    (3) Develop mechanisms to deliver prevention programs, messages, 
and materials to persons with hemophilia and their family members;
    (4) Participate in CDC surveillance efforts (including the 
Universal Data Collection Program, Creutz-feldt Jakob Disease (CJD) 
Program, investigations of sero-conversions and suspected bloodborne 
agents) and other data collection and surveillance efforts by complying 
with federal and other required regulations and offering programs to 
all active eligible patients;
    (5) Advise CDC of any patients who have become infected with HIV or 
hepatitis A, B, or C viruses (HAV, HBV, or HCV), possibly as a result 
of contaminated clotting factor concentrates;
    (6) Obtain approval from local Institutional Review Board (IRB) for 
all protocols. Obtain appropriate assurances as required by Office of 
Human Research Protections (OHRP), OPHS, DHHS. Develop and maintain 
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; and
    (7) Establish mechanism for consumer input and involvement in 
planning, implementing, and assessing HTC prevention activities that 
include education and outreach by collaborating with local community 
based hemophilia consumer organizations, or ad hoc consumer 
consultation committee.

2. CDC Activities

    a. Assist in determining priority areas and long-term goals for 
prevention of complications of hemophilia as a collaborative effort by 
encouraging regional core centers to seek input from providers, CBOs 
and consumer representatives.
    b. Provide consultation, scientific and technical assistance in 
planning, implementing, and evaluating activities to prevent the 
complications of hemophilia 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 development of research protocols for IRB review 
by CDC and 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.
    d. Assist in the analysis and reporting of aggregate clinical 
outcomes data, coordinate and consolidate the transfer of tabulated 
data, analyses, and conclusions among participating HTCs.
    e. Provide follow-up and technical assistance to HTCs implementing 
changes or recommendations resulting from program evaluations, 
assessments, or activities required to meet required federal and other 
regulations;
    f. Provide information and feedback regularly via teleconference, 
email and in person meetings to regional coordinators and regional 
directors serving as liaisons to CDC and their respective regional 
HTCs.
    g. Provide technical assistance and coordinate routine annual 
testing of patient samples for HAV, HBV, HCV, and reporting of results 
back to HTCs. Provide technical assistance to designated laboratory for 
permanent storage of blood samples.

[[Page 22581]]

    h. Collaborate with HTCs and appropriate State or local health 
departments to investigate any suspected HIV, HAV, HBV, HCV 
seroconversions or other reported potential bloodborne agents.
    i. Collaborate with Regional Coordinators, National Hemophilia 
Foundation, HTC personnel, consumers, and designated training centers 
to develop and provide training resources for providers and consumers.
    j. Disseminate current information related to the development, 
implementation, and evaluation of these regional programs to the funded 
HTCs and the public as necessary and as requested.
    k. Facilitate collaborative research efforts among HTCs to enhance 
the quality of life of persons with bleeding disorders.

E. 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 20 double-spaced pages, 
printed on one side, with one-inch margins, and unreduced font.

Budgetary Information

    Include all major cost items for implementing the proposed program 
for twelve months. Submit line-item descriptive justifications for 
personnel, travel, supplies, and other services on Standard Form 424A, 
``Budget Information'', provided with PHS 5161-1 (Revised 6/99). 
Separate budgets should be submitted for the regional core center and 
each HTC performance site that is included in the regional application, 
plus a totaled budget request for the region.
    If the regional core center also serves as an HTC performance site 
providing prevention services to patients, provide a separate budget 
for related costs. For each HTC performance site request, include the 
name and address of the person and organization to receive the 
contract, as well as a detailed line-item descriptive justification.
    Each applicant must provide a brief listing of budgetary requests 
included in its FY 2001 HRSA HTC comprehensive care grant application, 
specifying personnel, service, and other costs that are anticipated to 
be funded by HRSA for the twelve-month period. A budget guidance and 
preferred format will be included in the application kit.

Supporting Materials

    1. Letters of agreement from all contracting or voluntary 
collaborating HTCs in region detailing specific roles and 
responsibilities of each party.
    2. Letters of support from local consumer organizations 
representing areas coinciding with HTCs included in application. If 
areas do not have existing consumer organizations, include letters of 
support from local consumer leaders indicating their willingness to 
collaborate in prevention programming.
    3. Copies of policies protecting the confidentiality of persons 
with hemophilia and the security of patient information and records. A 
copy of the local IRB approval letter, copy of consent form, and 
assurance information (multiple project assurance number, single 
project assurance approval letter or signed collaborative inter-
institutional amendment) for the regional core center and each 
participating HTC.

F. Submission and Deadline

    Submit the original and three copies of PHS 5161-1 (OMB Number 
0937-0189). Forms are available in the application kit and at the 
following Internet address: www.cdc.gov/od/pgo/forminfo.htm. On or 
before June 15, 2001, submit the application to the Grants Management 
Specialist identified in the ``Where to Obtain Additional Information'' 
section of this announcement.
    Deadline: Applications shall be considered as meeting the deadline 
if they are either:
    (a) Received on or before the deadline date; or
    (b) Sent on or before the deadline date and received in time for 
submission to the independent review group.
    (Applicants must request a legibly dated U.S. Postal Service 
postmark or obtain a legibly dated receipt from a commercial carrier or 
U.S. Postal Service. Private metered postmarks shall not be acceptable 
as proof of timely mailing.)
    Late Applications: Applications which do not meet the criteria in 
(a) or (b) above are considered late applications, will not be 
considered, and will be returned to the applicant.

G. Evaluation Criteria

    Each application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC.

1. Background and need (20 Points Total)

    a. The extent to which the applicant describes the regional 
hemophilia population in terms of known morbidity, demographics, 
sources of care, and experience in data collection and surveillance. 
(10 points)
    b. The extent to which the applicant identifies significant 
problems experienced by the hemophilia community, and how this regional 
network of HTCs can appropriately address the issues of the target 
community. (10 points)

2. Goals and Objectives (20 Points)

    The extent to which the applicant has included goals which are 
relevant to the purpose of the proposal and feasible to be accomplished 
during the project period, and the extent to which these are specific 
and measurable. The extent to which the applicant has included 
objectives which are feasible to be accomplished during the budget 
period, and which address all activities necessary to accomplish the 
purpose of the proposal. The extent to which the objectives are 
specific, time-phased, and measurable.

3. Methods and Activities (50 Points Total)

    The extent to which the applicant provides:
    a. A detailed description of proposed activities and methods used 
to accomplish each objective within the time frame indicated. (15 
points)
    b. A description of how proposed methods will provide valid and 
reliable outcomes needed to accomplish proposed objectives. (10 points)
    c. A description of the limitations and anticipated implementation 
barriers of the principal methods, and how these problems are expected 
to be resolved. (15 points)
    d. 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; and (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. (10 points)

4. Program Management and Evaluation (10 Points)

    The extent to which the management systems and specific plans of 
evaluation

[[Page 22582]]

were used to ensure sufficient progress towards achievement of proposed 
goals and objectives are discussed. The extent to how HTC performance 
sites were selected is discussed. The extent that the types, frequency, 
and methods of evaluation were used are described. The extent to how 
the above information will be used to improve or redirect program 
operations is explained.

5. Budget (Not Scored)

    The extent to which the applicant provides a detailed budget and 
narrative justification consistent with stated objectives and planned 
program activities.

6. Human Subjects (Not Scored)

    Does the application adequately address the requirements of Title 
45 CFR part 46 for the protection of human subjects:

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of:
    1. annual progress report, no more than 90 days after the end of 
the budget period;
    2. financial status report, no more than 90 days after the end of 
the budget period; and
    3. final financial report and performance report, no more than 90 
days after the end of the project period.
    Send all reports to the Grants Management Specialist with a copy to 
the Project Officer 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 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-8  Public Health System Reporting Requirements
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

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under sections 301(a)(42 U.S.C. 241 (a)) 
and 317(k)(2)(42 U.S.C. 247b(k)(2)) of the Public Health Service Act, 
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, Grants Management Branch, 
Procurement and Grants Office, Centers for Disease Control and 
Prevention, Room 3000, 2920 Brandywine Road, Mailstop K-75, Atlanta, GA 
30341-4146, Telephone number: 770-488-2765, E-mail: [email protected].
    For program technical assistance, contact: Sally O. Crudder, 
Director, Hemophilia Treatment Center Program, Hematologic Diseases 
Branch, National Center for Infectious Diseases, Centers for Diseases 
Control and Prevention, 1600 Clifton Road, Mailstop E-64, Atlanta, GA 
30333, Ph: 404-371-5270 or 5903, Email: [email protected]

    Dated: April 30, 2001.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 01-11217 Filed 5-3-01; 8:45 am]
BILLING CODE 4163-18-P