[Federal Register Volume 61, Number 79 (Tuesday, April 23, 1996)]
[Notices]
[Pages 17896-17900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9936]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Announcement Number 614]
Surveillance of the Complications of Hemophilia
Introduction
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1996 funds to continue a cooperative
agreement program to conduct active surveillance for hemophilia A and B
(henceforth referred to as hemophilia) and their complications. The
international classification of diseases (ICD) code definition of
hemophilia A is congenital factor VIII disorder and hemophilia B is
congenital factor IX disorder. Applicant's programs must be targeted to
individuals with hemophilia who receive their care both within and
outside hemophilia treatment centers and comprehensive care centers.
Such individuals should include: persons who do not access traditional
hemophilia treatment services and may receive inadequate care (and are
possibly over-represented by persons who are economically
disadvantaged), persons who live in rural areas or inner cities; or,
persons who are members of one of four federally recognized minority
groups: (1) Black; African-American or Caribbean; (2) Hispanic; Central
American, South American, Mexican American, Dominican, Cuban, or Puerto
Rican; (3) Asian/Pacific Islander, or (4) American Indian or Alaskan
Native.
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
[[Page 17897]]
[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 non-use 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 the official public health
agencies of States or their bona fide agents. This includes the
District of Columbia, American Samoa, the Commonwealth of Puerto Rico,
the Virgin Islands, the Federated States of Micronesia, Guam, the
Northern Mariana Islands, the Republic of the Marshall Islands, the
Republic of Palau, and federally recognized Indian tribal governments.
The low prevalence of hemophilia limits competition to the official
public health agencies of States. This project requires experience in
conducting statewide, active surveillance programs for hemophilia, and
experience in collaboration with organizations having the ability to
reach a wide variety of demographically distinct populations, including
traditionally under served populations. Since only State health
agencies can perform the required project activities, competition is
limited accordingly.
Funding preference will be given to competitive continuation
applications of States who have currently established statewide
hemophilia surveillance systems (HSS); and, who have demonstrated
collaboration between health departments, hemophilia treatment centers,
and/or university schools of public health, in hemophilia surveillance
activities.
Availability of Funds
Approximately $2,500,000 is available in FY 1996 to fund
approximately 6 awards. The average award will be $350,000, ranging
from $250,000 to $450,000. It is expected that the funds will be
awarded on or about September 30, 1996, and will be made for a 12-month
budget period within a project period of up to 3 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 cooperative agreement program is to
assist recipients in characterizing the statewide epidemiology of
hemophilia and its complications, and determining its impact among
three populations: (1) Those who access traditional hemophilia
treatment and comprehensive care services, (2) those who receive care
outside traditional hemophilia care centers, and (3) those who receive
inadequate care. The latter population category may be over-represented
by persons who are economically disadvantaged, or who live in rural
areas, or inner cities. Inadequate care would include less than prompt
treatment, treatment from improperly trained personnel, or poor access
to comprehensive care. The data collected through a Hemophilia
Surveillance System (HSS) can assist hemophilia treatment providers and
States in developing, implementing, and evaluating education and
prevention programs to reduce the morbidity, mortality, and costs of
hemophilia and its complications.
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 the activities under B.
below:
A. Recipient Activities
All recipients must conduct activities in collaboration and
coordination with the CDC.
Required Activities for All Recipients
1. Meet with representatives from CDC to: (a) Assure continuation
of optimal surveillance methods, such as the use of standardized HSS
protocols and data collection form, and (b) amend previous HSS
protocols with any new activities or procedures.
2. Use standard surveillance protocols as a basis to design,
implement, and evaluate statewide surveillance programs for adult,
adolescent, and pediatric cases of hemophilia and its complications.
3. Update data abstractors, as necessary, in methods of active
surveillance, use of the HSS data abstraction form, techniques of
reviewing medical records, and other methods of surveillance as
appropriate and provided for in the HSS Manual.
4. Maintain appropriate management and evaluation systems that
ensure data abstractors conduct active surveillance, and use data
collection methods according to the HSS Manual.
5. Maintain secure databases of all reported cases of hemophilia
and its complications.
6. 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.
7. Using the standardized format, prepare and submit progress
reports on a quarterly basis that address the achievements of HSS
activities, program goals and objectives for the previous quarter.
8. Upon request, assist State or regional programs in the use of
data to develop or improve hemophilia care programs.
Surveillance of Hemophilia: Specific Required Activities
1. Promote and maintain liaison with potential reporting sources
both within and outside of the traditional hemophilia treatment system.
These potential reporting sources include, but are not limited to,
State or regional hemophilia chapters or associations, hospitals,
emergency care centers, hematology clinics, private physicians,
organizations that provide home- infusion therapy, distributors of
home-infusion factor concentrates, and others.
2. In accordance with HSS protocols, implement active hemophilia
surveillance among reporting sources outside of the traditional
hemophilia care system, and in the collaborative network of hemophilia
treatment centers to determine the statewide prevalence of hemophilia.
3. In accordance with standard HSS protocols, redirect current
surveillance activities as indicated through critical review of data
and evaluation of yield from various surveillance activities. Initiate
additional methods of surveillance for hemophilia, as appropriate.
4. Augment surveillance through the use of at least one alternate
database (e.g., death certificates, State hospital-discharge summaries,
State reimbursement programs). Document these methods, results, and if
appropriate, the redirection of surveillance activities in the
quarterly progress report.
5. Through death certificate review and active surveillance,
collect data on deaths attributed to hemophilia to calculate State
hemophilia-specific mortality rates. Collect epidemiologic data that
could be used to determine the sensitivity of death certificates in
[[Page 17898]]
documenting deaths attributed to hemophilia.
6. Collect Universal Data Collection (UDC) forms from designated
hemophilia treatment centers, and enter into the CDC-provided UDC
software for transmission to the CDC on a regular basis. Document this
activity in the quarterly progress report.
Surveillance of Hemophilia-Related Complications: Specific Required
Activities
1. Through medical record review or other methods proposed by the
applicant, describe the source, frequency, and type of preventive and
medical care among persons with hemophilia, and determine the
prevalence of the following hemophilia-related complications:
Joint disease
Liver disease
Inhibitors
HIV/AIDS
Blood-borne infections
Sampling methods, if used, will be developed in collaboration with
CDC to insure sufficient representation of persons of different race/
ethnicity, age, HIV status, severity of hemophilia, and source of care.
2. Conduct longitudinal follow-up of persons with hemophilia-
related joint disease to relate the source, frequency, and type of
preventive and medical care to health outcome (e.g., severity of joint
disease, degree of disability). In addition to joint disease,
applicants are encouraged to propose and conduct longitudinal follow-up
of persons with other hemophilia-related complications.
B. CDC Activities
1. Provide programmatic consultation, scientific and technical
assistance in planning, implementing, and evaluating hemophilia
surveillance activities. Assistance includes the implementation of
standardized HSS protocols, and the use of the HSS data abstraction
form, progress report forms, and HSS database software.
2. Plan, coordinate, and facilitate periodic meetings with
recipients to exchange operational experiences, and to provide
consultation and assistance in the modification of standard
surveillance protocols as needed.
3. Provide programmatic coordination of surveillance initiatives
among the recipients.
4. Assist with the analysis and reporting of aggregate surveillance
data collected from funded initiatives by coordinating and
consolidating the transfer of tabulated data, analyses, and conclusions
from the recipients.
5. Assist National, State, or regional programs in the use of data
to develop or improve hemophilia care programs.
Evaluation Criteria
Applications will be reviewed and evaluated according to the
following criteria: (Total 100 points)
A. Capacity
1. The capacity of the applicant to access the medical records of
hemophilia patients who receive care both within and outside of the
traditional hemophilia treatment system. The capacity to access these
records is measured by (a) the extent that the applicant incorporates
shared responsibility between hemophilia treatment centers and State
health departments as delineated in letters of agreement, and (b) the
extent of collaboration among these entities and with other
organizations involved in the delivery of care to persons with
hemophilia. (25 points)
2. The scope and magnitude of previous cooperative efforts between
regional or State hemophilia treatment centers and State or local
health departments that propose to collaborate in this application. (5
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. (5 points)
B. Goals and Objectives
The extent to which the applicant's proposed goals and objectives
meet the required activities specified under Program Requirements
section A. Recipient Activities of this announcement, and that are
measurable, specific, time-phased, and realistic. (20 points)
C. Methods and Activities
1. The quality of the applicant's plan for conducting program
activities and the extent to which surveillance methods proposed are:
(a) Appropriate to accomplish stated goals and objectives; (b)
adaptable to a variety of health care settings, multiple complications
of hemophilia, and the collection of longitudinal data; (c) accurate to
produce valid and reliable data, and (d) feasible within programmatic
and fiscal restrictions. (25 points)
2. The applicant's documented ability to (a) identify optimal
surveillance methods, (b) develop standardized HSS protocols, HSS data
collection instruments, progress report forms, and HSS database
software, (c) modify proposed methods and activities to conform to
standardized protocols, and (d) ensure that women and racial and ethnic
minority populations are appropriately represented in applications for
research involving human subjects. (10 points)
D. Program Management and Evaluation
The extent to which the proposed management system, including the
type, frequency, and methods of evaluation, will be used to assure
valid and reliable data. (10 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 Research
Whether or not exempt from DHHS regulations, are the procedures
adequate for the protection of human subjects? Recommendations on the
adequacy of protections include: (1) Protections appear adequate and
there are no comments to make or concerns to raise, or (2) protections
appear adequate, but there are comments regarding the protocol, or (3)
protections appear inadequate and the objective review group (ORG) has
concerns related to human subjects; or (4) 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)
Executive Order 12372 Review
Applications are subject to Intergovernmental Review of Federal
Programs as governed by Executive Order (E.O.) 12372, which sets up a
system for State and local government review of proposed Federal
assistance applications. Applicants (other than federally recognized
Indian tribal governments) should contact their state Single Point of
Contact (SPOC) early as possible to alert them to the prospective
applications and receive any necessary instructions on the State
process. Indian tribes are strongly encouraged to request tribal
government review of the approved application. A current list of SPOCs
is included in the application kit. If SPOCs (or tribal governments)
have any State (or tribal) process recommendations on applications
submitted to CDC, they should reference this announcement number (614)
and forward recommendations to Sharron Orum, Grants Management Officer,
Grants Management Branch, Procurement and Grants Office, Centers
[[Page 17899]]
for Disease Control and Prevention (CDC), 255 East Paces Ferry Road,
NE., Room 300, Mailstop E-18, Atlanta, Georgia 30305, no later than 60
days after the application deadline date. CDC does not guarantee to
``accommodate or explain'' State process recommendations it receives
after that date.
Public Health System Reporting Requirement
This program is not subject to the Public Health System Reporting
Requirement.
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
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 to demonstrate that the project
will be subject to initial and continuing review by an appropriate
institutional review committee. In addition to other applicable
committees, Indian Health Service (IHS) institutional review committees
must review the project if any component of IHS will be involved or
will support the research. If any American Indian community is
involved, its tribal government must also approve that portion of the
project applicable to it. The applicant will be responsible for
providing evidence of this assurance in accordance with the appropriate
guidelines and forms provided in the application kit.
Confidentiality
All information obtained in connection with this surveillance
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 program may be disclosed: (1) in
summary, statistical, or other form, or (2) for clinical or research
purposes, but only if the identity of the individual under such program
is not disclosed.
HIV/AIDS Requirement
Recipients must comply with the document entitled ``Content of
AIDS-Related Written Materials, Pictorials, Audiovisuals,
Questionnaires, Survey Instruments, and Educational Sessions'' (June
1992), a copy of which is included in the application kit. To meet 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, including 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, Friday,
September 15, 1995, pages 47947-47951.
Application Submission and Deadline
The original and two copies of the application PHS Form 5161-1
(Revised 7/92, 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 June 24, 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 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 Robert Cicatello, Public Health Advisor, telephone (404)
639-4034, or by Internet or CDC WONDER electronic mail at
[email protected], Hematologic Diseases Branch, National Center
for Infectious Diseases, Centers for Disease Control and Prevention
(CDC), 1600 Clifton Road, NE., Mailstop D-02, Atlanta, Georgia 30333.
Please refer to Announcement Number 614 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,
[[Page 17900]]
Washington, DC 20402-9325, telephone (202) 512-1800.
Dated: April 17, 1996.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for
Disease Control and Prevention (CDC).
[FR Doc. 96-9936 Filed 4-22-96; 8:45 am]
BILLING CODE 4163-18-P