[Federal Register Volume 62, Number 109 (Friday, June 6, 1997)]
[Notices]
[Pages 31104-31108]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14784]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Announcement Number 762]


Hemophilia Prevention Education and Peer Support

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1997 funds for a cooperative agreement 
program to enhance the national hemophilia prevention program by 
supporting community-based peer support and educational programs 
delivered at the local, regional and national levels. For the purposes 
of this announcement, the term hemophilia includes all congenital 
bleeding disorders.
    CDC is committed to achieving the health promotion and disease 
prevention objectives of Healthy People 2000, a national activity to 
reduce morbidity and mortality and improve the quality of life. This 
announcement is related to the priority areas of Immunization and 
Infectious Diseases and Diabetes and Chronic Disabling Conditions. (For 
ordering a copy of Healthy People 2000, see the Section Where to Obtain 
Additional Information.)

Authority

    This program is authorized under Section 317 of the Public Health 
Service Act, as amended (42 U.S.C. 247b). Applicable program 
regulations are found in 42 CFR 51b--Project Grants for Preventive 
Health Services.

Smoke-Free Workplace

    CDC strongly encourages all grant recipients to provide a smoke-
free workplace and to promote nonuse of all tobacco products, and 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities that receive Federal funds in which education, 
library, day care, health care, and early childhood development 
services are provided to children.

Eligible Applicants

    Assistance will be provided only to a national nonprofit 
organization that has

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a current working relationship with the hemophilia community and can 
provide an established network and ability to provide technical 
assistance to lay level hemophilia groups such as local chapters and 
foundations, as well as national hemophilia consumer networking 
organizations and hemophilia treatment center provider groups.
    Since the purpose of this program is to enhance the national 
hemophilia prevention program, only organizations that can perform the 
above listed activities can be considered eligible applicants. The 
applicant must include evidence of 501(c)(3) nonprofit status and 
summarize their eligibility status in the Abstract of their application 
(see Application Content).

    Note: Effective January 1, 1996, Public Law 104-65 states that 
an organization described in section 501(c)(4) of the Internal 
Revenue Code of 1986 which engages in Lobbying activities shall not 
be eligible for the receipt of Federal funds constituting an award, 
grant (cooperative agreement), contract, loan, or any other form.

Availability of Funds

    Approximately $2.8 million is available in FY 1997 to fund 
approximately one award. It is expected that the award will begin on or 
about September 30, 1997, for a 12-month budget period within a project 
period of up to 5 years. Funding estimates may vary and are subject to 
change. Continuation awards within the project period will be made on 
the basis of satisfactory programmatic progress and the availability of 
funds.

Use of Funds

Restrictions on Lobbying

    Applicants should be aware of restrictions on the use of HHS funds 
for lobbying of Federal or State legislative bodies. Under the 
provisions of 31 U.S.C. Section 1352 (which has been in effect since 
December 23, 1989), recipients (and their subtier contractors) are 
prohibited from using appropriated Federal funds (other than profits 
from a Federal contract) for lobbying Congress or any Federal agency in 
connection with the award of a particular contract, grant, cooperative 
agreement, or loan. This includes grants/cooperative agreements that, 
in whole or in part, involve conferences for which Federal funds cannot 
be used directly or indirectly to encourage participants to lobby or to 
instruct participants on how to lobby.
    In addition, the FY 1997 HHS Appropriations Act, which became 
effective October 1, 1996, expressly prohibits the use of 1997 
appropriated funds for indirect or ``grass roots'' lobbying efforts 
that are designed to support or defeat legislation pending before State 
legislatures. This new law, Section 503 of Pub. L. No. 104-208, 
provides as follows:

    Sec. 503(a) No part of any appropriation contained in this Act 
shall be used, other than for normal and recognized executive-
legislative relationships, for publicity or propaganda purposes, for 
the preparation, distribution, or use of any kit, pamphlet, booklet, 
publication, radio, television, or video presentation designed to 
support or defeat legislation pending before the Congress, * * * 
except in presentation to the Congress or any State legislative body 
itself.
    (b) No part of any appropriation contained in this Act shall be 
used to pay the salary or expenses of any grant or contract 
recipient, or agent acting for such recipient, related to any 
activity designed to influence legislation or appropriations pending 
before the Congress or any State legislature.

    Department of Labor, Health and Human Services, and Education, and 
Related Agencies Appropriations Act, 1997, as enacted by the Omnibus 
Consolidated Appropriations Act, 1997, Division A, Title I, Section 
101(e), Pub. L. No. 104-208 (September 30, 1996).

Background

    The primary congenital bleeding disorders consist of hemophilia A 
and B which affect approximately 1 in 7,500 males, and von Willebrand's 
Disease which affects approximately 1 in 100 persons (both male and 
female). Hemophilia A and B are bleeding disorders that result from 
congenital deficiencies of blood clotting factors VIII and IX, 
respectively. These deficiencies can result in both spontaneous 
internal bleeding and bleeding following injuries or surgical 
procedures. Bleeding episodes can result in severe joint damage, 
neurologic damage, and damage to other organ systems that are 
compromised by the hemorrhage and in rare cases, death. The treatment 
of bleeding episodes involves the prompt and proper use of clotting 
factor concentrates. Properly trained patients under the guidance of 
competent health care providers can use clotting factor concentrates to 
treat bleeding episodes on individualized self treatment programs to 
prevent most of these seriously disabling and fatal conditions 
(similarly to diabetes patients). However, inappropriate, misdirected, 
inadequate or delayed treatment often leads to premature death or a 
life coupled with pain and disability due to progressive joint and/or 
neurologic crippling, and, in many cases, loss of employment.
    The HIV epidemic has had a devastating impact on the health and 
welfare of hemophilia patients and their families. As many as 65 
percent of all persons with hemophilia in the United States were 
infected with HIV by 1985 as a direct result of receiving HIV-
contaminated clotting factor products recommended to treat hemophilia. 
Universal screening and deferral of HIV-infected plasma donors, heat 
treatment of blood products, and the use of recombinant factor 
concentrates have virtually eliminated the transmission of HIV through 
contaminated blood products. However, transmission of other blood borne 
viruses through blood products remains a serious concern of the 
community and transmission of HIV and hepatitis from infected patients 
with hemophilia to their sex partners and offspring has remained an 
issue of public health concern. Although blood product therapy has 
improved the quality of life for persons with hemophilia, complications 
include the transmission of viral agents and diseases, development of 
inhibitors, liver disease, joint disease, and psychosocial issues 
related to coping with a chronic disorder are of paramount concern.
    The cost of hemophilia care has escalated rapidly in the last 
decade, mainly due to increases in the cost of clotting factor. The 
annual product cost per patient with severe hemophilia can now reach 
$150,000. Although the annual costs of treating preventable 
complications of hemophilia have not been well documented, they could 
be as high as annual product costs. The economic burden of these costs 
rests with individuals with hemophilia who are reaching their lifetime 
maximum insurance benefits (for those able to get insurance), and on 
State programs that pay for hemophilia services such as Medicare, 
Medicaid, or other special State programs. New health care systems may 
prevent access to specialized care needed to improve the quality of 
life for persons with bleeding disorders.
    Certain subgroups of the target population have been traditionally 
under or unserved due to the rarity of the disorder and socioeconomic, 
cultural, and geographical barriers. These groups include minorities, 
women, and adolescents. Access to information and services is often 
limited among these groups.
    In response to the CDC's Congressional mandate, the CDC's National 
Hemophilia Program has adopted the primary mission to reduce or prevent 
complications of hemophilia and other bleeding and clotting disorders. 
This national prevention program is directed toward achieving

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outcome-based goals to accomplish this mission. The complications of 
immediate concern are blood safety and prevention of joint disease. 
These complications were selected as a result of surveillance 
activities and consultation with representatives from all facets of the 
hemophilia community. The national program is organized in the 
functional units of surveillance, coordinated prevention intervention 
activities for the health care provider and lay populations, education, 
and epidemiologic and laboratory research directed towards providing 
the basis for translation into specific prevention focused 
interventions. Currently, there are several prevention messages and 
behaviors persons with bleeding disorders should engage in to improve 
their quality of life. As outcome data is analyzed, new messages will 
be developed by CDC. The prevention issues are:
    1. Universal precautions when handling blood and blood products.
    2. Vaccination for hepatitis A and B.
    3. Comprehensive evaluation at least annually from hemophilia 
specialists such as that which exists in Hemophilia Treatment Centers.
    4. Serum sample storage for blood safety monitoring and evaluation.
    5. Early adequate treatment of bleeding episodes.
    6. Development of strong, musculo-skeletal systems through regular 
physical exercise.

Purpose

    The purpose of this award is to support consumer-based, peer-led 
prevention activities to increase knowledge about proven prevention 
strategies so that persons with bleeding disorders can make informed 
decisions regarding their care and engage in behaviors to reduce or 
eliminate the complications of hemophilia. This is best accomplished by 
a national program designed to strengthen and utilize local, regional, 
and national consumer-organized activities.

Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities under A., below, 
and the CDC will be responsible for conducting activities under B., 
below:

A. Recipient Activities

    1. Obtain information from representatives from the hemophilia 
community to determine knowledge, attitudes, beliefs and behaviors of 
families with bleeding disorders to guide prevention programming 
development. Solicit input from a representative sample of the 
community, including those who are unserved or under served and/or who 
may have limited or no access to prevention and support programs.
    2. In collaboration with CDC, provide information to the public 
about prevention peer programming directed toward reducing or 
eliminating complications of bleeding disorders.
    3. Evaluate effectiveness of current educational programs and 
materials, identify gaps, and propose strategies to improve the 
availability of educational resources and information for prevention.
    4. Maintain communication network and develop effective mechanisms 
to deliver prevention messages, provide information, referral, and 
updates on significant medical advances, hemophilia related policies, 
and blood safety issues to families with congenital bleeding disorders 
through a variety of educational forums and media.
    5. Participate in a formalized network of communication with the 
CDC and the Food and Drug Administration (FDA) when blood safety issues 
arise.
    6. Expand and enhance peer-based prevention and educational 
activities by coordinating a system to support programs at the local 
level. Provide technical assistance and financial support in the areas 
of program planning, development, implementation, evaluation, and 
public health education to local peer-led activities for the purpose of 
delivering prevention messages.
    7. Obtain input from consumer and provider representatives to 
explore mechanisms and develop strategies for increasing collaboration 
between local chapters and hemophilia treatment centers (HTCs) to 
enhance prevention programs.
    8. Provide opportunities for hemophilia care providers to receive 
state of the art prevention information and training by utilizing 
prevention messages and educational materials developed by this 
cooperative agreement.
    9. Disseminate any educational or promotional materials, with the 
exception of regularly distributed newsletters, that are developed with 
funds from this cooperative agreement. These materials must be reviewed 
and approved by a program review panel prior to finalization.
    10. Report any program income generated from fees or other charges 
in the Financial Status Report (FSR) as additive income (see Technical 
Reporting Requirements). This income should be available to be used to 
forward the goals of this cooperative agreement.
    11. Provide semiannual reports of the progress toward achievement 
of the goals of this cooperative agreement (see Technical Reporting 
Requirements).

B. CDC Activities

    1. Provide current scientific and public health information 
regarding the prevention of complications of hemophilia and other 
bleeding disorders including technical review of educational and 
promotional materials developed with funds from this cooperative 
agreement.
    2. Provide consultation and technical assistance in the areas of 
program planning, development, implementation, and evaluation.
    3. As requested, provide consultation and input to committees or 
working groups whose operations may impact the programs funded through 
this cooperative agreement.
    4. Collaborate in the presentation and dissemination of information 
resulting from these activities.
    5. Provide coordination between the recipient and Regional 
Hemophilia Treatment Center Programs to provide appropriate mechanisms 
of provider involvement and collaboration with consumer program 
activities.
    6. Participate in the grantees meetings of consumer organizations 
to provide information and solicit input, as requested.

Technical Reporting Requirements

    An original and two copies of progress reports must be submitted to 
CDC semiannually. The first progress report will cover the six-month 
period from the date of the award. Subsequent progress reports are 
required 30 days after the end of each successive six-month period and 
must include the following: (1) A comparison of actual accomplishments 
to the objectives established for the progress period, (2) the reasons 
for failing to meet any established objectives, (3) description and 
explanation of any modification of program activities and protocols, 
(4) other pertinent information such as key staffing changes or reasons 
for unexpectedly high or low costs for performance, and (5) these 
reports should keep the CDC appraised of significant activities of this 
program or decisions to be made that may impact the progress of the 
programs funded through this cooperative agreement.
    An annual financial status report (FSR) and two copies are required 
no later than 90 days after the end of each budget period. A final FSR 
is due no later than 90 days after the end of the

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project period. All reports or other correspondence will be submitted 
to: Sharron P. Orum, Grants Management Officer, Grants Management 
Branch, Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 255 East Paces Ferry Road, NE., Mailstop E-18, Room 
300, Atlanta, Georgia 30305.

Application Content

    Applicants should describe their ability to address the purpose and 
required activities of this announcement in a collaborative manner with 
CDC. Applicants must develop their applications in accordance with (1) 
the required activities stipulated in the Program Requirements section 
of this announcement, (2) Public Health Service (PHS) Form 5161-1 
(Revised 7/92, OMB number 0937-0189), and (3) the content area provided 
below. The applicant should provide a detailed description of first-
year activities and a brief overview of subsequent four year plan.

Content areas

A. Abstract (Maximum 3 pages)
    Summarize the Eligible Applicant requirements, background, needs, 
capacity, goals, objectives, methods, and evaluation plan of the 
proposal.
B. Narrative (Maximum 30 pages)
    1. Background and need. Describe current status of prevention 
education and support programming in existence, target populations, and 
areas of need for expansion. Identify source of needs assessment and 
assumptions and age of data. Identify potential barriers and 
facilitators to the delivery of a prevention program in this 
population.
    2. Capacity. Discuss the scope and magnitude of previous 
experiences in prevention education and support programming. 
Characterize the unique capabilities of the applicant to accomplish (a) 
the hemophilia prevention program and recipient activities as proposed 
in this announcement, and (b) specific goals and objectives as 
proposed. Define the roles and responsibilities of participating 
organizations, and their type of relationship--contractual or voluntary 
collaboration. Describe roles, responsibilities, and level of expertise 
of all staff positions to implement this program by providing 
descriptions for all key project personnel.
    3. Goals and Objectives. Identify one or more goals of the 
prevention program as related to the recipient activities. List and 
briefly describe specific, measurable, realistic, and time-phased 
objectives designed to achieve stated goals.
    4. Methods and Activities. Describe the types of activities and 
methods used to accomplish each objective within the time frame 
indicated. Discuss how proposed methods will provide valid and reliable 
outcomes needed to accomplish proposed objectives. Explain the 
limitations and anticipated implementation barriers of the principal 
methods, and how these problems are expected to be resolved.
    5. Program Management and Evaluation. Discuss the management 
systems and specific plans of evaluation used to ensure sufficient 
progress towards achievement of proposed goals and objectives. Describe 
the types, frequency, and methods of evaluation used. Explain how the 
above information will be used to improve or redirect program 
operations.
C. Budget
    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 7/92). For 
each staff position for which funding is requested, submit name of 
person, title, annual salary, percent time spent on this effort, 
percent of salary requested from this cooperative agreement, and total 
dollars requested for each position and total personnel. For applicants 
requesting funding for contracts, include the name of the person or 
organization to receive the contract, the method of selection, the 
period of performance, and a description of the contracted service 
requested.
D. Supporting Materials (Appendices)
    1. Letters of agreement from all contracting or voluntary 
collaborating entities detailing specific roles and responsibilities of 
each party.
    2. Letters of support from other organizations with which the 
applicant will be collaborating in the development and/or 
implementation of activities.
    3. Curriculum vitae and job descriptions of all project staff.

Format

    Applicants are required to submit an original application and two 
copies. The original and two copies of the applications should be 
unstapled and unbound. Pages must be clearly numbered, and a complete 
index to the application and its appendices must be included. Begin 
each separate section on a new page. All materials must be typewritten, 
single-spaced and with unreduced type on 8\1/2\'' by 11'' paper. All 
pages should be printed on one side only, with at least 1'' margins, 
headers, and footers. The application narrative must be limited to 30 
pages, excluding abstract, budget, and appendices. Materials that 
should be part of the basic plan will not be accepted if placed in the 
appendices.

Evaluation Criteria

    Applications will be reviewed and evaluated according to the 
following criteria: (Total 100 points)
    1. The applicant must have a working relationship with a majority 
of the current local hemophilia organizations, and the ability to 
provide technical assistance to the local chapters. The applicant 
should demonstrate commitment to the national goal of preventing the 
complications of hemophilia through the provision of strong and 
effective consumer based programs. (25 points)
    2. Project personnel are well qualified by training and/or 
experience to manage, coordinate, and evaluate a national program 
involving multiple local peer organizations and HTCs. Project personnel 
have the expertise and capability to provide accurate information from 
national sources and efficiently disseminate hemophilia related 
prevention messages and information to families affected by bleeding 
disorders, lay leadership, and treatment providers. (20 points)
    3. The applicant organization has adequate facilities and manpower 
including a mechanism for obtaining input from people with bleeding 
disorders and related family members representing the demographics of 
the community. (15 points)
    4. The proposed activities support the CDC goals to reduce or 
eliminate the complications of hemophilia through community leadership; 
and, the capability to mobilize persons with bleeding disorders and 
their family members to engage in, design, and evaluate community-based 
prevention activities. (40 points)
    5. The estimated cost to the Government of the project is 
reasonable; the budget justifiable and consistent with the intended use 
of the cooperative agreement funds. (not scored)

Executive Order 12372 Review

    The program is not subject to the Executive Order 12372 review.

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Public Health System Reporting Requirement

    The program is not subject to the Public Health System Reporting 
Requirements.

Catalog of Federal Domestic Assistance Number

    The Catalog of Federal Domestic Assistance number is 93.283, 
Centers for the Control and Prevention (CDC)--Investigations and 
Technical Assistance.

Other Requirements

Paperwork Reduction Act

    Projects that involve collection of information from 10 or more 
individuals and funded by cooperative agreements will be subject to 
review by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act.

HIV/AIDS Requirements

    Recipients must comply with the document entitled ``Content of 
AIDS-Related Written Materials, Pictorials, Audiovisuals, 
Questionnaires, Survey Instruments, and Educational Sessions'' (June 
15, 1992), a copy of which is included in the application kit. In 
complying with the requirements for a program review panel, recipients 
are encouraged to use an existing program review panel such as the one 
created by the State health department's HIV/AIDS prevention program. 
If the recipient forms its own program review panel, at least one 
member must be an employee (or a designated representative) of a 
government health department consistent with the content guidelines. 
The names of the review panel members must be listed on the Assurance 
of Compliance form CDC 0.1113, which is also included in the 
application kit. The recipient must submit the program review panel's 
report that indicates all materials have been reviewed and approved, 
this includes conference agendas.

Application Submission and Deadline

    The original and two copies of the application PHS Form 5161-1 (OMB 
number 0937-0189) must be submitted to Sharron Orum, Grants Management 
Officer, Grants Management Branch, Procurement and Grants Office, 
Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry 
Road, NE., Room 300, Mailstop E-18, Atlanta, Georgia 30305, on or 
before July 25, 1997.
    1. 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 objective 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.)
    2. Late Applications: Applications which do not meet the criteria 
in 1.a. or 1.b. above are considered late applications. Late 
applications will not be considered and will be returned to the 
applicant.

Where To Obtain Additional Information

    A complete program description and information on application 
procedures are contained in the application package.
    Business management technical assistance may be obtained from Locke 
Thompson, Grants Management Specialist, Grants Management Branch, 
Procurement and Grants Office, Centers for Disease Control and 
Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, Mailstop E-
18, Atlanta, Georgia 30305, telephone (404) 842-6595; or by Internet or 
CDC WONDER electronic mail at: [email protected]. Programmatic technical 
assistance may be obtained from Sally Crudder, Hematologic Diseases 
Branch, Division of AIDS, STD, and TB Laboratory Research, National 
Center for Infectious Diseases, Centers for Disease Control and 
Prevention (CDC), 1600 Clifton Road, NE., Mailstop E-64, Atlanta, 
Georgia 30333, telephone (404) 639-4036; or by Internet or CDC WONDER 
electronic mail at: [email protected].
    You may obtain this and other CDC announcements from one of two 
Internet sites: CDC's homepage at: http://www.cdc.gov or the Government 
Printing Office homepage (including free on-line access to the Federal 
Register at: http://www.access.gpo.gov).
    Please refer to Announcement Number 762 when requesting information 
and submitting an application.
    Potential applicants may obtain a copy of Healthy People 2000 (Full 
Report, Stock No. 017-001-00474-0) or Healthy People 2000 (Summary 
Report, Stock No. 017-001-00473-1) referenced in the Introduction 
through the Superintendent of Documents, Government Printing Office, 
Washington, DC 20402-9325, telephone (202) 512-1800.

    Dated: June 2, 1997.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 97-14784 Filed 6-5-97; 8:45 am]
BILLING CODE 4163-18-P