Surveillance of the Complications of Hemophilia

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

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[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

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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,

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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