[Federal Register Volume 64, Number 23 (Thursday, February 4, 1999)]
[Notices]
[Pages 5659-5661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-2635]



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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

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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].

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    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