[Federal Register Volume 65, Number 95 (Tuesday, May 16, 2000)]
[Notices]
[Pages 31175-31177]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-12240]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 00046]


Integration of Viral Hepatitis Prevention Services Into Existing 
Prevention Programs; Notice of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2000 funds for a cooperative agreement 
program for integration of viral hepatitis prevention services into 
existing prevention programs. CDC is committed to achieving the health 
promotion and disease prevention objectives of ``Healthy People 2010'', 
a national activity to reduce morbidity and mortality and improve the 
quality of life. This announcement is related to the focus areas of 
Immunization and Infectious Diseases. For the conference copy of 
``Healthy People 2010'', visit the internet site http://www.health.gov/healthypeople.
    The purpose of the program is to develop strategies and guidance 
for integrating recommended viral hepatitis prevention and control 
services for persons at high risk for infection into existing settings 
that provide public health services and to improve public health 
service delivery by integrating viral hepatitis with existing 
prevention services to reach persons at high risk for disease. This 
announcement is intended to support implementation and evaluation of 
integrating currently recommended prevention activities for viral 
hepatitis (including hepatitis A and hepatitis B vaccination) into 
existing disease prevention programs, with the primary intent to 
improve delivery of established prevention services that may directly 
benefit clients served by these programs.

B. Eligible Applicants

Limited Competition

    Because of the requirement that viral hepatitis services be 
integrated with existing state or local public health programs, 
assistance will be provided only to the health departments of States or 
their bona fide agents, including the District of Columbia and the 
cities of Philadelphia, New York City, San Francisco, Los Angeles, 
Houston, Chicago, and Baltimore, the Commonwealth of Puerto Rico, the 
Virgin Islands, the Commonwealth of the Northern Mariana Islands, 
American Samoa, Guam, federally recognized Indian tribal governments, 
the Federated States of Micronesia, the Republic of the Marshall 
Islands, and the Republic of Palau. In consultation with States, 
assistance may be provided to political subdivisions of States.

C. Availability of Funds

    Approximately $800,000 is available in FY 2000 to fund 
approximately four awards. It is expected that the average award will 
be $200,000, ranging from $150,000 to $400,000. It is expected that the 
awards will begin on or about September 30, 2000, and will be made for 
a 12-month budget period within a project period of up to three 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.

Funding Preferences

    Preference will be given to programs that deliver or provide 
oversight for public health services to populations in which a high 
proportion (1000 to 3000 individuals with identifiable risk factors for 
viral hepatitis are likely to be infected with hepatitis C virus (HCV).
    Such programs include STD Clinics, HIV/AIDS counseling/testing 
sites, correctional settings and providers of services to injection 
drug users. Also to ensure geographic diversity, additional 
consideration will be given to the location of the program based on the 
region of the U.S. (Northeast, southeast, northwest, southwest, north 
central, and south central states). Finally, to ensure

[[Page 31176]]

racial and ethnic diversity of the program populations served, 
consideration will be given to gender and ethnicity of the populations 
served.

D. Program Requirements

    In conducting activities to achieve the purposes of this program, 
the recipient will be responsible for the activities under 1. 
(Recipient Activities), and CDC will be responsible for the activities 
listed under 2. (CDC Activities).

1. Recipient Activities

    a. Develop and implement protocol(s) to integrate currently 
recommended viral hepatitis prevention services into existing public 
health programs and services, as appropriate for the particular 
setting(s) proposed. Viral hepatitis prevention services may include, 
but are not limited to:
    (1) Assessing risk histories for viral hepatitis among clients;
    (2) Providing client-centered prevention counseling to patients 
with risks for infection;
    (3) Providing testing to appropriate risk groups for HCV infection 
(anti-HCV) and chronic hepatitis B virus (HBV) infection (hepatitis B 
surface antigen (HBsAg), when appropriate;
    (4) Providing hepatitis B vaccine to persons in appropriate risk 
groups (e.g., >1 sex partner in prior 6 months, history of other 
sexually transmitted diseases (STDs), men who have sex with men (MSM), 
incarcerated persons, injecting drug users);
    (5) Providing hepatitis A vaccine to persons in appropriate risk 
groups (e.g, MSM, illegal drug users);
    (6) Providing primary prevention services for anti-HCV positive and 
HBsAg-positive persons, including: (a) Counseling on how to prevent 
transmission to others, (b) Identification of partners (sex and/or 
needle-sharing) for counseling and referral services, if appropriate, 
and (c) Providing hepatitis B vaccination for at-risk (sex or needle-
sharing) partners and household contacts of HBsAg-positive persons; and
    (7) Providing, either directly or by referral, appropriate services 
to persons found to be HBsAg-positive or anti-HCV positive, including:
    (a) Alcohol and drug counseling, and (b) appropriate medical 
referral and assistance in accessing medical care for evaluation of 
chronic liver disease and possible treatment.
    b. Provide staff training regarding viral hepatitis prevention and 
control related to implementing this program.
    c. Develop and implement a monitoring and evaluation system to 
assess the feasibility, impact, and effectiveness of integrating viral 
hepatitis prevention services into existing prevention programs, 
including measurement of the cost of services and the impact of 
integration on existing disease prevention services.
    d. Conduct appropriate data analysis and interpretation.
    e. Attend and participate in an annual meeting of project managers, 
to plan and present program activities and evaluate activities.

2. CDC Activities

    a. Provide technical support for and training in the design, 
implementation, and evaluation of program activities, if requested.
    b. Assist in data management, analysis, presentation, and 
publication of project findings.
    c. Assist in the development of a research protocol for 
Institutional Review Board (IRB) review by all cooperating 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.

E. Application Content

Letter of Intent (LOI)

    In order to assist CDC in planning and executing the evaluation of 
applications submitted under this announcement, all parties intending 
to submit an application are requested to inform CDC of their intention 
to do so at least thirty (30) days prior to the application due date. 
Notification should include: (1) Name and address of institution, and 
(2) name, address, and telephone number of contact person. Notification 
should be provided by facsimile, postal mail, or E-mail, to the Grants 
Management Specialist identified in the ``Where to Obtain Additional 
Information'' section of this announcement''.

Applications

    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 
(excluding appendices), printed on one side, with one inch margins, 
unreduced (12-point) font, unbound, and unstapled. A complete index to 
the application and its appendices should be provided, and a one-page 
executive summary included.

F. Submission and Deadline

Letter of Intent (LOI)

    One original and two copies of the Letter of Intent (LOI) must be 
submitted on or before June 15, 2000. Submit the letter of intent to 
the Grants Management Specialist identified in the ``Where to Obtain 
Additional Information'' section of this announcement.

Application

    Applications should include an original and two copies of PHS 5161-
1 (OMB Number 0937-0189). Forms are in the application kit. Submit the 
application to the Grants Management Specialist identified in the 
``Where to Obtain Additional Information'' section of this announcement 
on or before July 14, 2000.
    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 prior to 
submission to the review panel. (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.)
    Late Applications: Applications which do not meet the criteria in 
(a) or (b) above are considered late applications, will not be 
considered, 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:

1. Background and Need (10 Points)

    a. Extent to which the applicant demonstrates a clear understanding 
of the subject area and of the purpose and objectives of this 
cooperative agreement (5 points).
    b. Extent to which the applicant demonstrates need based on disease 
burden of viral hepatitis (i.e., prevalence, incidence data) among high 
risk populations, as well as prevalence of risk factors for viral 
hepatitis among populations accessible to the applicant programs and 
services (5 points).

2. Capacity (40 Points)

    Extent to which the applicant provides evidence of ability to 
provide all recommended and appropriate viral hepatitis prevention and 
control activities and services annually to 1000

[[Page 31177]]

to 3000 individuals with identifiable risk factors for viral hepatitis. 
This should include:
    a. Description of adequate resources, including personnel and 
facilities (both technical and administrative), either direct or 
through collaboration, for conducting the project (10 points);
    b. Description of population served by existing program(s) and 
access to additional populations with identifiable risk factors for 
viral hepatitis (MSM, injection drug users (IDUs), sex partners of 
IDUs, heterosexuals at high risk) that may accept viral hepatitis 
prevention and control activities and services provided through an 
integrated program (10 points);
    c. Extent to which applicant documents experience of proposed 
personnel, either direct or collaborating, in providing viral hepatitis 
prevention and control activities and services (e.g., training, 
testing, counseling, vaccination, clinical services) (10 points);
    d. Evidence of existing quality assurance mechanisms to insure 
appropriate counseling and other services as recommended for the 
proposed setting, as provided by published CDC guidelines in various 
settings (e.g. STD, HIV, Drug Treatment) and the extent the applicant 
demonstrates how the planned integration activities may improve 
existing prevention services. (10 points).

3. Objectives and Technical Approach (50 Points)

    a. Extent to which the applicant describes objectives of the 
proposed project which are (1) consistent with the purpose and goals of 
this cooperative agreement program, (2) measurable and time-phased, and 
(3) consistent with published CDC guidelines on prevention and control 
of hepatitis C (MMWR 1998;47 [No. RR-19], hepatitis B (MMWR 1991;40 
[No. RR-13] and hepatitis A (MMWR 1999;48 [No. RR-12]. (15 points)
    b. Extent and quality of operational plan proposed for implementing 
the program, including maximizing the use of existing resources and 
staff to integrate viral hepatitis prevention services, which clearly 
and appropriately addresses all ``Recipient Activities'' in the 
application. (15 points)
    c. Extent to which the applicant clearly identifies specific 
assigned responsibilities of all key professional personnel. (5 points)
    d. Extent to which the applicant prioritizes resources for 
evaluation and determination of effectiveness of integrating services 
through a detailed and adequate plan for evaluating progress toward 
achieving program process and outcome objectives. This should include 
methods and instruments for evaluating progress in planning, 
implementation, and effectiveness of interventions through measurement 
of outcomes related to viral hepatitis and to impact of integrating 
these services on other prevention services offered (e.g., HIV 
counseling and testing) (10 points).
    e. The degree to which the applicant has met the CDC Policy 
requirements regarding the inclusion of women, ethnic, and racial 
groups in the proposed program. This includes: (1) The proposed plan 
for the inclusion of both sexes and racial and ethnic minority 
populations for appropriate representation; (2) The proposed 
justification when representation is limited or absent; (3) A statement 
as to whether the plans for recruitment and outreach for participants 
include the process of establishing partnerships with community(ies) 
and recognition of mutual benefits. (5 points)

4. Budget (Not Scored)

    The budget will be reviewed to determine the extent to which it is 
reasonable, clearly justified, consistent with the intended use of 
funds, and allowable.
    a. Submit line-item descriptive justification for personnel, 
travel, supplies, laboratory testing, and other services related to the 
project;
    b. For contracts, include the name of the person or firm to receive 
the contract, the method of selection, the period of performance, and a 
description of the contracted service requested, itemized budget with 
narrative justification and method of accountability.
    c. Funding levels for years two and three should be estimated.

5. Human Subjects (Not Scored)

    Does the application adequately address the requirements of Title 
45 CFR part 46 for the protection of human subjects?

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of:

1. Progress reports (semiannual);
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 the Grants Management Specialist identified in 
the ``Where to Obtain Additional Information'' section of this 
announcement.
    For descriptions of the following Other Requirements, 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-7-Executive Order 12372 Review
AR-9-Paperwork Reduction Act Requirements
AR-10-Smoke-Free Workplace Requirements
AR-11-Healthy People 2010
AR-12-Lobbying Restrictions

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under sections 301(a), and 317(k)(1) and 
317(k)(2) of the Public Health Service Act, [42 U.S.C. sections 241(a), 
and 247b(k)(1) and 247(k)(2)], as amended. The Catalog of Federal 
Domestic Assistance number is 93.283.

J. Where To Obtain Additional Information

    This and other CDC announcements can be found on the CDC home page 
Internet address--http://www.cdc.gov. Click on ``Funding'' then 
``Grants and Cooperative Agreements''.
    To obtain additional information, contact: Gladys Gissentanna, 
Grants Management Specialist, Grants Management Branch, Procurement and 
Grants Office, Centers for Disease Control and Prevention, Room 3000, 
2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone number (770) 
488-2753, Facsimile number (770) 488-2777, E-mail address [email protected].
    For program technical assistance, contact: Dr. Joanna Buffington, 
Centers for Disease Control and Prevention, National Center for 
Infectious Diseases, Division of Rickettsial Diseases, Hepatitis 
Branch, 1600 Clifton Road, NE, M/S G-37, Atlanta, GA 30333, Telephone: 
(404) 371-5460, E-mail address: [email protected].

    Dated: May 10, 2000.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 00-12240 Filed 5-15-00; 8:45 am]
BILLING CODE 4163-18-P