Prevention of Complications in Hemophilia; Notice of Availability of Funds

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 99024]

Prevention of Complications in Hemophilia; Notice of Availability

of Funds

A. Purpose

The Centers for Disease Control and Prevention (CDC) announces the

availability of fiscal year (FY) 1999 funds for a cooperative agreement

program for Prevention of Complications in Hemophilia. This program

addresses the ``Healthy People 2000'' priority area of Diabetes and

Chronic Disabling Conditions. The purpose of this program is to assist

eligible Hemophilia Treatment Centers (HTC) in determining the

prospective incidence and risk factors of central venous access device

(CVAD) infections in patients with Hemophilia and to assist in the

design of interventions to prevent this complication in the future.

B. Eligible Applicants

Assistance will be provided only to comprehensive hemophilia

treatment centers (HTCs), defined as public or private, nonprofit

entities that provide directly or through contract: (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 Services Administration (HRSA) to fund a grant

program.

Because of the low prevalence and degree of specialization required

in the treatment of hemophilia, competition is limited to hemophilia

treatment centers (HTCs) that routinely provide comprehensive health

care to two thirds of persons with hemophilia in the United States.

HTCs are the only health care facilities administering to the number of

persons with hemophilia required for this study.

Note: Pub. L. 104-65 states that an organization described in

section 501(c)(4) of the Internal Revenue Code of 1986 that engages

in lobbying activities is not eligible to receive Federal funds

constituting an award, grant, cooperative agreement, contract, loan

or any other form.

C. Availability of Funds

Approximately $500,000 is available in FY 1999 to fund

approximately two awards. It is expected that the average award will be

$250,000, ranging from $250,000 to $500,000. It is expected that the

awards will begin on or about July 15, 1999, and will be made for a 12-

month budget period within a project period of up to two years. The

funding estimate may change.

Continuation awards within an approved project period will be made

on the basis of satisfactory progress as evidenced by required reports

and the availability of funds.

D. Program Requirements

In conducting activities to achieve the purpose of this program,

the recipient will be responsible for the activities under 1. below,

and CDC will be responsible for conducting activities under 2. below:

1. Recipient Activities

a. Develop standardized study protocols, data collection

instruments, and questionnaires to be used across collaborating sites.

b. Train study coordinators and medical personnel in methods of

data collection and patient assessment in the use of standard data

abstraction instruments, in techniques of reviewing medical records,

and in other methods of data collection as appropriate and provided for

in the study protocols. It will be the responsibility of the recipient

to ensure uniform training of study personnel at all data collection

sites and to ensure that the data is collected in a uniform manner at

all locations.

c. Develop appropriate management and evaluation systems to ensure

that study personnel use data collection and interview instruments

according to standard study protocols.

d. Collect and edit all data from all sites.

e. Develop clinical specimen laboratory testing for successful

completion of the research.

f. Publish the results of the study.

2. CDC Activities

a. Provide consultation, scientific and technical assistance in

planning and implementing the study protocol, as requested. This

assistance may include the development of study protocols, data

abstraction instruments, interview quesstionnaires, consent forms,

support in statistical and epidemiologic methods to conduct data

analysis, development of the clinical laboratory specimen testing, and

in publication of the results.

b. Assist in the development of a research protocol for

Institutional Review Board (IRB) review by all institutions

participating in the research project. The CDC IRB will review and

approve the protocol initially and on at least an annual basis until

the research project is completed.

c. Collaborate in the planning, coordination, and facilitation of

initial and periodic meetings with recipients to exchange operational

experiences.

E. Application Content

Use the information in the Program Requirements, Other

Requirements, and Evaluation Criteria sections to develop the

application content. Your application will be evaluated on the criteria

listed, so it is important to follow them in laying out your program

plan. The narrative should be no more than 20 double-spaced pages,

printed on one side, with one inch margins, and unreduced font.

Noncompeting Continuation Applications

For noncompeting continuation applications submitted within the

project period need only include:

1. A brief progress report that describes the accomplishments of

the previous budget period.

2. Any new or significantly revised items or information

(objectives, scope of activities, operational methods, evaluation),

that is, not included in year 01 or subsequent continuation

applications.

3. An annual budget and justification. Existing budget items that

are unchanged from the previous budget period do not need

rejustification. Simply list the items in the budget and indicate that

they are continuation items.

F. Submission and Deadline

Application

Submit the original and two copies of PHS-5161 (OMB Number 0937-

0189). Forms are in the application kit. On or before May 3, 1999,

submit the application to: Locke Thompson, Grants Management

Specialist, Grants Management Branch, Procurement and Grants Office,

Announcement 99024, Centers for Disease Control and Prevention (CDC),

2920 Brandywine Road, Mailstop E-18, Atlanta, Georgia 30341.

Deadline: Applications shall be considered as meeting the deadline

if they are either:

1. Received on or before the deadline date.

2. 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

[[Page 5660]]

postmarks shall not be acceptable as proof of timely mailing).

Late applications: Applications that do not meet the criteria in

(a) or (b) above are considered late applications. Late applications

will not be considered in the current competition and will be returned

to the applicant.

G. Evaluation Criteria

Each application will be evaluated individually against the

following criteria by an independent review group appointed by CDC

(Total 100 points).

1. Background and Need

The extent to which the applicant presents data that central venous

access devices (CVADs) are utilized in persons with hemophilia and risk

factors identified in the literature. The extent to which the applicant

compares the experience in persons with hemophilia with other persons

with CVADs and the complications they experience, especially infection.

The extent to which the applicant discusses the long-term consequences

of CVAD and blood stream infections. Does the applicant propose an

experimental rationale that would explain why persons with hemophilia

would be more susceptible to develop infections with CVADs, especially

those with inhibitors? (10 points)

2. Goals and Objectives

The extent to which the applicant's proposed goals and objectives

meet the required activities specified under the ``Recipient

Activities'' section of this announcement, and that are measurable,

specific, time-phased, and realistic. (15 points)

3. Capacity (Total 30 Points)

a. The capacity of the applicant to accrue 380 persons with CVADs

currently in place or placed during the first year of the study. Each

participating HTC must be able to enroll a minimum of 20-30 patients

who meet the above criteria. The capacity to accrue patients to this

study will be measured by (1) the number of patients who are seen

annually at each HTC, and (2) the average number of CVADs placed in

each HTC 3 years prior to the start of the study. (15 points)

b. Qualifications of proposed staff to meet stated objectives and

goals, and the availability of facilities to be used during the project

period. The applicant should provide evidence that there is experience

in collaborating in multi-site studies. (15 points)

4. Methods and Activities (Total 30 Points)

a. The quality of the applicant's plan for conducting program

activities and the extent to which the study design proposed is: (1)

appropriate to accomplish stated goals and objectives; (2) acceptable

to the needs of the patient population (e.g., likely to produce

compliance); (3) feasible within programmatic and fiscal restrictions.

(20 points)

b. The recipient should demonstrate a basic knowledge and describe

how they will implement their protocol at various HTCs; (1) develop

progress report forms: (2) and collect and edit the data. (10 points)

5. Program Management and Evaluation

The recipient should demonstrate the ability to design information

management systems to ensure that valid and reliable data are collected

to achieve the proposed goals and objectives. The applicant should

present specific plans to evaluate data periodically, quality assurance

measures to be used and operations will be changed based on the above

information. The recipient should demonstrate adequate biostatistical

support for protocol design, study implementation and data management.

The degree to which the applicant has met the CRC Policy requirements

regarding the inclusion of women, ethnic, and racial groups in the

proposed research. This includes: (a) the proposed plan for the

inclusion of both sexes, racial and ethnic minority populations for

appropriate representation, (b) the proposed justification when

representation is limited or absent, (c) a statement as to whether the

design of the study is adequate to measure differences when warranted,

and (d) a statement as to whether the plans for recruitment and

outreach for study participants include the process of establishing

partnerships with community(ies) and recognition of mutual benefits.

(15 points)

6. Budget

The extent to which the budget is reasonable and consistent with

the intended use of the cooperative agreement funds. (Not Scored)

7. Human Subjects Requirements

Does the application adequately address the requirements of Title

45 CFR Part 46 for the protection of human subjects? (not scored)

______Yes ______No

Comments:--------------------------------------------------------------

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two copies of

1. Progress reports (annual);

2. Financial status report, no more than 90 days after the end of

the budget period; and

3. Final financial status and performance reports, no more than 90

days after the end of the project period.

Send all reports to: Locke Thompson, Grants Management Specialist,

Grants Management Branch, Procurement and Grants Office, Centers for

Disease Control and Prevention (CDC), 2920 Brandywine Road, Mailstop E-

18, Atlanta, Georgia 30341.

The following additional requirements are applicable to this

program. For the complete description of each, see Attachment I, in the

application kit.

AR-1 Human Subjects Requirements

AR-2 Requirements for Inclusion of Women and Racial and Ethnic

Minorities in Research

AR-8 PHS Reporting Requirements

AR-9 Paperwork Reduction Act Requirements

AR-10 Smoke-Free Workplace Requirements

AR-11 Healthy People 2000

AR-12 Lobbying Restrictions

AR-15 Proof of Non-Profit Status

I. Authority and Catalog of Federal Domestic Assistance Number

(CFDA)

This program is authorized under the Public Health Service Act

Sections 301(a) [42 U.S.C. 241(a)], 317(k)(1) [42 U.S.C. 247b(k)(1)],

317(k)(2) [42 U.S.C. 247b(k)(2)], as amended. The Catalog of Federal

Domestic Assistance number is 93.283.

J. Where To Obtain Additional Information

To receive additional written information and to request an

application kit, call 1-888-GRANTS4 (1-888-472-6874). You will be asked

to leave your name and address and will be instructed to identify the

Announcement number of interest.

If you have any questions after reviewing the contents of all the

documents, business management technical assistance may be obtained

from: Locke Thompson, Grants Management Specialist, Grants Management

Branch, Procurement and Grants Office, Announcement 99024, Centers for

Disease Control and Prevention (CDC), 2929 Brandywine Road, Mailstop E-

18, Atlanta, Georgia 30341, telephone (404) 842-6595, Email address

[email protected]

[[Page 5661]]

See also the CDC home page on the Internet: http://www.cdc.gov

For program technical assistance, contact Lisa Richardson, MD, 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) 639-4025, e-mail address

[email protected].

John L. Williams,

Director, Procurement and Grants Office, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 99-2635 Filed 2-3-99; 8:45am]

BILLING CODE 4163-18-M