[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]



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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

[[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