[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