[Federal Register Volume 61, Number 118 (Tuesday, June 18, 1996)]
[Notices]
[Pages 30902-30906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15381]



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[[Page 30903]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Announcement Number 620]


Prevention of the Complications of Hemophilia through Hemophilia 
Treatment Centers

Introduction

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1996 funds for a cooperative agreement 
program to prevent the complications of congenital bleeding disorders, 
particularly hemophilia A and B (henceforth referred to as hemophilia).
    The 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 area of 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 Sections 301(a) and 317(k)(2) of 
the Public Health Service Act, as amended [42 U.S.C. 241(a) and 
247b(k)(2)]. Applicable program regulations are found in 42 CFR Part 
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 comprehensive hemophilia 
treatment centers (HTCs), defined as public or private entities that 
provide: 1) regional services to support hemophilia comprehensive 
treatment centers or 2) diagnostic and treatment services to persons 
with hemophilia and other congenital blood disorders. This definition 
of HTCs is currently used by the Health Resources and Services 
Administration (HRSA) to fund a grant program for comprehensive 
hemophilia treatment centers for the provision of prevention and care 
services to persons with hemophilia and other congenital bleeding 
disorders. The definition is also used by HRSA to determine eligibility 
of HTCs to receive Public Health Pricing under the Veterans Health Care 
Act.
    Because of the degree of specialization required in the treatment 
of hemophilia, competition is limited to HTCs as defined above.
    This project requires experience in providing comprehensive 
outreach, diagnostic, treatment, and preventive services to patients 
with hemophilia which can only be provided by HTCs.
    One award per region will be made to support the core HTC and other 
contracting or collaborating HTCs 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: 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.

Availability of Funds

    Approximately $5,700,000 is available in FY 1996 to fund 
approximately 12 awards. It is expected that the awards will range from 
$200,000 to $750,000. One award will be made for each of the following 
Regions: I, II, III, VI, VII, VIII, IX, and X; two awards will be made 
for each Region IV and V. It is expected that the awards will begin on 
or about September 30, 1996, and will be made 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.

Purpose

    The purpose of the hemophilia complications prevention cooperative 
agreement program is to assist recipients in (1) providing 
comprehensive prevention services to persons with hemophilia or related 
disorders to prevent the complications of their bleeding disorder, (2) 
developing a prevention evaluation network to assess the efficacy of 
these prevention services and make refinements as necessary, and (3) 
building their capacity to serve as public health prevention centers in 
the hemophilia community.

Program Requirements

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

A. Recipient Activities

    1. Implement and evaluate prevention interventions directed at 
attaining specific outcomes of reduced complications.
    a. Implement mechanisms for clinical outcomes evaluation including 
evaluation of prevention strategies.
    b. Work collaboratively with specified sites to collect 
standardized clinical outcomes data.
    c. Develop appropriate management and evaluation systems to ensure 
that other HTCs within the region implement the activities of this 
program appropriately and use clinical outcomes data collection 
instruments.
    d. Analyze, present, and publish local, State, or regional 
hemophilia prevention outcomes.
    e. Develop and maintain strict policies on protecting the 
confidentiality of persons with hemophilia, 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.
    f. Recipients are encouraged to propose and conduct longitudinal 
clinical prevention studies of persons with hemophilia-related 
complications.
    2. Prioritize targets for interventions, including, but not limited 
to, prevention of joint disease in persons with hemophilia and 
prevention of infections due to unsafe blood and blood products or 
unsafe practices related to treatment of persons with hemophilia.
    3. Implement intervention strategies for reducing complications of 
hemophilia.
    a. Implement prevention guidelines as they are developed and as 
appropriate for providing proper prevention services to persons with 
hemophilia. Develop mechanisms for appropriate delivery of prevention 
protocols, messages, and materials to persons with hemophilia and their 
family members (consumers of hemophilia care and prevention services, 
or consumers).

[[Page 30904]]

    b. Make available appropriate training resources and opportunities, 
including attending local, regional, or national trainings as 
necessary.
    c. Provide persons with hemophilia and their family members with 
appropriate and up-to-date prevention messages and notice of training 
opportunities. Prevention messages include those directed at preventing 
transmission of HIV from infected persons with hemophilia to their 
sexual partners, offspring, or other contacts, as well as preventing 
other complications of hemophilia such as joint disease and viral 
diseases.
    (1) Utilize these consumers as possible in delivering prevention 
messages through mechanisms of peer-led prevention education, outreach, 
and support.
    (2) Review home infusion, home safety, and infection control 
practices with each patient and/or family as applicable at least yearly 
at comprehensive clinic visit or every other year for patients on 
biennial comprehensive visit schedules.
    d. Establish mechanism for consumer input and involvement in 
planning, implementing, and assessing HTC prevention activities. Work 
collaboratively and regularly with local hemophilia consumer 
organization or ad hoc consumer consultation committee to solicit this 
input.
    e. Work collaboratively with other HTCs in the region to 
effectively disseminate information to HTC personnel and clients.
    4. Advise CDC of any patients who have become newly infected with 
HIV or hepatitis A, B, or C viruses (HAV, HBV, or HCV), potentially as 
a result of contaminated clotting factor concentrates.
    a. Collect sera and/or cells from patients with hemophilia and ship 
these to a central, specified laboratory for testing and reporting 
results. This central laboratory will be determined through a contract 
with CDC.
    5. Serve as liaison with all HTCs in the defined region, their 
clients, the Hemophilia Program at the Maternal and Child Health 
Bureau, and CDC. As a liaison be responsible for coordination of 
activities of the region, including contracting or collaborating HTCs. 
Those responsibilities should include:
    a. Coordinate prevention and programmatic activities of HTCs in 
region and promote collaboration of HTCs within the region;
    b. Promote collaboration of HTCs with their local consumer 
organization or ad hoc consumer consultation committee;
    c. Coordinate technical assistance to HTCs, including conducting 
program assessments, site visits, and necessary implementation of 
findings. Coordinate CDC consultation when necessary;
    d. Coordinate assessments of training needs of HTC personnel and 
clients and work with CDC and designated training center as necessary 
to assist HTC personnel and clients in locating appropriate resources 
to meet defined training needs. These designated training centers will 
be determined by contract with CDC.
    e. Coordinate development of HTC program plans, goals and 
objectives, and progress tracking and reporting for HTCs in the region; 
and
    f. Coordinate, annually or bi-annually, and with CDC participation, 
a regional meeting for HTCs and consumer organizations or ad hoc 
consumer consultation committees in the region for the purposes of 
information sharing and program planning. Regional meetings may be 
joint with other regions with similar needs.

B. CDC Activities

    1. Assist in setting priority areas for prevention of complications 
of hemophilia as a collaborative effort with the participating HTCs. 
Provide consultation, scientific and technical assistance in planning, 
implementing, and evaluating activities to prevent the complications of 
hemophilia. This assistance includes the development of standard 
instruments to evaluate prevention protocols and accompanying software.
    2. Assist hemophilia programs in the implementation of prevention 
guidelines developed through a collaborative effort.
    3. Provide programmatic coordination of prevention protocol 
development, including evaluation of the effectiveness of prevention 
protocols and other studies to determine the efficacy of the 
guidelines.
    4. Assist in the analysis and reporting of aggregate clinical 
outcomes data collected from funded programs; coordinate and 
consolidate the transfer of tabulated data, analyses, and conclusions 
among recipients.
    5. Provide or locate necessary follow-up and technical assistance 
to implement any noted changes or recommendations resulting from 
programmatic evaluations or assessments.
    6. Collaborate with HTCs and appropriate State or local health 
departments to investigate any suspect HIV, HAV, HBV, HCV or parvovirus 
seroconversions that are reported by HTCs.
    7. Provide technical assistance to coordinate routine annual 
testing of patient samples for HAV, HBV, HCV, and parvovirus and 
reporting of results back to HTC. Provide technical assistance to 
designated laboratory for permanent storage of blood samples. These 
laboratories will be determined by contract with CDC.
    8. Collaborate with the National Hemophilia Foundation and other 
consumer organizations to provide appropriate mechanisms of consumer 
involvement in program activities as required in Recipient Activity 
number 3.
    9. Participate in regional meetings of HTCs and consumer 
organizations.
    10. Collaborate with Regional Coordinators, HTC personnel, 
consumers, and designated training centers to provide appropriate 
training resources to providers and consumers.
    11. 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.

Evaluation Criteria

    All applications will be reviewed and evaluated according to the 
following criteria: (Total 100 points).

A. Capacity (30 Points Maximum)

    1. The capacity of the applicant to access persons with hemophilia 
in the region to provide prevention services. The applicant must 
demonstrate the ability to work cooperatively with all HTCs in the 
region when the funds are awarded. This is regardless of whether other 
HTCs in the defined region submit an application to be the coordinating 
HTC for the region. The capacity to access the hemophilia community is 
measured by (a) the extent that this proposal incorporates shared 
responsibility between participating HTCs to serve the patients in the 
defined catchment area, and (b) the extent to which this collaboration 
is evidenced by included letters of support from contracting or 
voluntary collaborating HTCs. (15 points)
    2. The scope and magnitude of previous experiences in treatment of 
hemophilia, in prevention of disease complications, in hemophilia-
related epidemiologic or clinical studies, and in management and 
coordination of a regional network of HTCs. (7 points)
    3. The allocation of time, number, and qualifications of proposed 
staff to meet stated objectives and goals; and, the availability of 
facilities to be used during the project period. (8 points)

[[Page 30905]]

B. Goals and Objectives (15 Points Maximum)

    The extent to which the applicant's proposed goals and objectives 
meet the required activities specified under ``A. Recipient 
Activities,'' part 1. Required activities for all recipients in the 
Program Requirements section of this announcement, and are measurable, 
specific, time-phased, and realistic. (15 points)

C. Methods and Activities (50 Points Maximum)

    1. The quality of the applicant's plan for conducting program 
activities and the extent to which prevention methods proposed are: (a) 
Appropriate to accomplish stated goals and objectives, and (b) feasible 
within programmatic and fiscal restrictions. (14 points)
    2. The extent to which the proposal incorporates gathering and 
using input from persons with hemophilia, their family members, and 
local consumer organizations; and the applicant's willingness to 
cooperate with consumers in the development and implementation of 
prevention services. (18 points)
    3. The applicant's willingness to cooperate with CDC and other 
funded applicants to (a) collect a unified set of clinical outcomes 
data, as defined by CDC, to assess the efficacy of prevention 
activities, and (b) develop and implement prevention protocols and 
guidelines. (18 points)

D. Program Management and Evaluation (5 Points Maximum)

    The extent to which management systems, including the types, 
frequency, and methods of evaluation, are used to assure appropriate 
implementation of the activities of this program, including 
implementation of program activities in contracting and voluntary 
collaborating HTCs; and, assurance that women, racial and ethnic 
minority populations are appropriately represented in applications for 
research involving human subjects. (5 points)

E. Budget

    The extent to which the budget is reasonable and consistent with 
the intended use of the cooperative agreement funds. (not scored)

F. Human Subjects

    Whether or not exempt from the DHHS regulations, are procedures 
adequate for the protection of human subjects? Recommendations on the 
adequacy of protections include: (a) Protections appear adequate and 
there are no comments to make or concerns to raise, or (b) protections 
appear adequate, but there are comments regarding the protocol, or (c) 
protections appear inadequate and the Objective Review Group has 
concerns related to human subjects; or (d) disapproval of the 
application is recommended because the research risks are sufficiently 
serious and protection against the risks are inadequate as to make the 
entire application unacceptable. (Not scored)

Funding Preference

    In order to maximize the utility of a service provision 
infrastructure, one award will be made per region (two awards for 
Regions IV and V) and funding preference will take into consideration 
geographic location.

Executive Order 12372 Review

    Applications are subject to Intergovernmental Review of Federal 
Programs as governed by Executive Order 12372. E.O. 12372 sets up a 
system for State and local government review of proposed Federal 
assistance applications. Applicants should contact their State Single 
Point of Contacts (SPOCs) as early as possible to alert them to the 
prospective applications and receive any necessary instructions on the 
State process. For proposed projects serving more than one State, the 
applicant is advised to contact the SPOC for each affected State. A 
current list of SPOCs is included in the application kit. If SPOCs have 
any State process recommendations on applications submitted to CDC, 
they should reference this announcement number (620) and forward 
recommendations 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. The due date for State process 
recommendations is 30 days after the application deadline date for new 
awards (the appropriation for these awards was received late in the 
fiscal year and would not allow for an application receipt date which 
would accommodate the 60 day State recommendation process within FY 
1996). CDC does not guarantee to ``accommodate or explain'' State 
process recommendations it receives after that date.

Public Health System Reporting Requirements

    This program is subject to the Public Health System Reporting 
Requirements. Under these requirements, all community-based 
nongovernmental applicants must prepare and submit the items identified 
below to the head of the appropriate State and/or local health 
agency(s) in the program area(s) that may be impacted by the proposed 
project no later than the receipt date of the Federal application. The 
appropriate State and/or local health agency is determined by the 
applicant. The following information must be provided:
    a. A copy of the face page of the application (SF 424)
    b. A summary of the project that should be titled ``Public Health 
System Impact Statement'' (PHSIS), not to exceed one page, and include 
the following:
    (1) A description of the population to be served;
    (2) A summary of the services to be provided;
    (3) A description of the coordination plans with the appropriate 
State and/or local health agencies.
    If the State and/or local health official should desire a copy of 
the entire application, it may be obtained from the State Single Point 
of Contact (SPOC) or directly from the applicant.

Catalog of Federal Domestic Assistance Number

    The Catalog of Federal Domestic Assistance number is 93.283, 
Centers for Disease 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.

Human Subjects Requirement

    If the proposed project involves research on human subjects, the 
applicant must comply with the Department of Health and Human Services 
Regulations (45 CFR Part 46) regarding the protection of human 
subjects. Assurance must be provided which demonstrate that the project 
will be subject to initial and continuing review by an appropriate 
institutional review committee. The applicant will be responsible for 
providing evidence of this assurance in accordance with the appropriate 
guidelines and forms provided in the application kit.
    All information obtained in connection with this program shall not, 
without such individual's consent, be disclosed except as may be 
necessary to provide services to him or her or as may be required by a 
law of a State or political subdivision of a State. Information derived 
from any such

[[Page 30906]]

program may be disclosed: (1) In summary, statistical, or other form, 
or (2) for clinical or research proposed, but only if the identity of 
the individuals under such program is not disclosed.

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.

Women, Racial and Ethnic Minorities

    It is the policy of the Centers for Disease Control and Prevention 
(CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) 
to ensure that individuals of both sexes and the various racial and 
ethnic groups will be included in CDC/ATSDR-supported research projects 
involving human subjects, whenever feasible and appropriate. Racial and 
ethnic groups are those defined in OMB Directive No. 15 and include 
American Indian, Alaskan Native, Asian, Pacific Islander, Black and 
Hispanic. Applicants shall ensure that women, racial and ethnic 
minority populations are appropriately represented in applications for 
research involving human subjects. Where clear and compelling rationale 
exist that inclusion is inappropriate or not feasible, this situation 
must be explained as part of the application. This policy does not 
apply to research studies when the investigator cannot control the 
race, ethnicity and/or sex of subjects. Further guidance to this policy 
is contained in the Federal Register, Vol. 60, No. 179, pages 47947-
47951, dated Friday, September 15, 1995.

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 August 5, 1996.
    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 in the current competition 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, (404) 842-6595; or by Internet or CDC 
WONDER electronic mail at: [email protected]. Programmatic 
technical assistance may be obtained from Sarah Wiley, MPH, 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) 639-4026; or by Internet or CDC WONDER 
electronic mail at: [email protected].
    Please refer to Announcement Number 620 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.
    There may be delays in mail delivery and difficulty in reaching the 
CDC Atlanta offices during the 1996 Summer Olympics. Therefore, CDC 
suggests using Internet, following all instructions in this 
announcement and leaving messages on the contact person's voice mail 
for more timely responses to any questions.

    Dated: June 11, 1996.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 96-15381 Filed 6-17-96; 8:45 am]
BILLING CODE 4163-18-P