[Federal Register Volume 67, Number 87 (Monday, May 6, 2002)]
[Notices]
[Pages 30388-30391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-11116]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 02086]


Prevention of Viral Hepatitis Among High-Risk Youth Through 
Integrating Prevention Services Into Existing Programs; Notice of 
Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2002 funds for a cooperative agreement 
program for Prevention of Viral Hepatitis among High-Risk Youth Through 
Integrating Prevention Services into Existing Programs. This program 
addresses the ``Healthy People 2010'' focus area of Immunization and 
Infectious Diseases.
    The purpose of the program is to evaluate the feasibility and 
effectiveness of integrating activities to prevent infection with 
Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), and Hepatitis C Virus 
(HCV) into existing programs that serve high-risk adolescents 
populations.
    High-risk adolescents are youth aged 11-19 years who engage or are 
at risk for engaging in behaviors shown to be associated with 
transmission of infection with hepatitis viruses or other blood borne 
virus infections such as Human Immunodeficiency Virus (HIV/AIDS), 
injecting or non-injecting drug

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use, male homosexual activity, sexual activity with multiple partners, 
and behaviors leading to incarceration.
    Prevention of infection with hepatitis viruses is achieved through 
immunization (HAV, HBV) and risk reduction intervention (HCV) to 
prevent injection drug use and high risk sexual practices. For adults, 
activities to prevent viral hepatitis have been effectively integrated 
into other prevention programs. However, the feasibility of providing 
such services for high-risk youth, and the effectiveness of these 
prevention services in reducing all types of viral hepatitis in this 
population has not been evaluated. This announcement is intended to 
support the formative, operational and evaluation research required to 
determine the most effective means of integrating viral hepatitis 
prevention activities into existing disease prevention and health 
promotion programs.

B. Eligible Applicants

    Applications may be submitted by public and private non-profit 
organizations and by governments and their agencies; that is, 
universities, colleges, research institutions, hospitals, other public 
and private nonprofit organizations, State and local governments or 
their bona fide agents, including the District of Columbia, the 
Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of 
the Northern Mariana Islands, American Samoa, Guam, the Federated 
States of Micronesia, the Republic of the Marshall Islands, and the 
Republic of Palau, federally recognized Indian Tribal Governments, 
Indian Tribes, or Indian Tribal Organizations. Faith-based 
Organizations are eligible to apply.
    Eligible applicants are required to have a minimum of two years of 
experience in developing and implementing public health prevention or 
promotion activities in addition to having access to the at risk 
adolescent population to be served.

    Note: Title 2 of the United States Code section 1611 states that 
an organization described in section 501(c)(4) of the Internal 
Revenue Code that engages in lobbying activities is not eligible to 
receive Federal funds constituting an award, grant or loan.

A. Availability of Funds

    Approximately $150,000 is available in FY 2002 to fund one award. 
It is expected that the award will begin on or about September 1, 2002 
and will be made for a 12 month budget period within a project period 
up to five 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 population based programs that deliver 
or provide oversight for public health services to large adolescent 
populations (1000 to 3000 individuals served per year) in which a high 
proportion have risk factors for infection with hepatitis viruses. Such 
community-based programs should attempt to identify and follow cohorts 
of youth through indicators of risk and specific programs, including: 
demographic characteristics and health disparities which identify high-
risk youth, correctional settings, residential community programs, 
court mandated programs, job corps, drug detoxification and 
rehabilitation programs, homeless and runaway shelters, HIV/AIDS 
prevention services, and Sexually Transmitted Disease (STD) prevention 
and treatment programs.

B. Program Requirements

    In conducting activities to achieve the purpose 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 adolescents in the 
particular setting(s) proposed. Viral hepatitis prevention services may 
include, but are not limited to:
    (1) Providing hepatitis B vaccination.
    (2) Assessing risk histories for viral hepatitis among clients.
    (3) Providing client-centered prevention counseling to patients 
with risks for infection.
    (4) Providing testing to appropriate risk groups for HCV infection 
(anti-HCV), and chronic or past hepatitis B virus (HBV) infection, 
hepatitis B surface antigen, (HbsAg) or anti-HBc, when appropriate.
    (5) Providing hepatitis A vaccine to persons in appropriate risk 
groups (e.g., men having sex with men (MSM) and, illegal drug users).
    (6) Providing secondary prevention services for anti-HCV positive 
and HBsAg-positive persons, including: (1) Counseling on how to prevent 
transmission to others, (2) identification of partners (sex and/or 
needle sharing) for counseling and referral services, if appropriate, 
and (3) providing hepatitis B vaccination for at-risk (sex or needle 
sharing) partners and household contacts of HBsAg-positive persons.
    (7) Providing, either directly or by referral, appropriate services 
to persons found to be HBsAg-positive or anti-HCV positive, including: 
(1) Alcohol and drug counseling, and (2) 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 protocols, data collection and analytic 
systems to assess the feasibility, impact, and effectiveness of 
integrating viral hepatitis prevention services into existing programs 
for high-risk youth. Areas of analysis could include prevention of 
infections, completion of hepatitis B vaccine series, determining cost 
effectiveness of interventions, and defining the determinants of 
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. 
This includes training on participation in the Vaccine for Children 
(VFC) Program on how to acquire vaccine for eligible adolescents.
    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. Content

Letter of Intent (LOI)

    An LOI is optional for this program. The narrative should be no 
more than five double spaced pages, printed on one side, with one inch 
margins, and unreduced font. Your letter of intent will be used to plan 
and execute the evaluation of applications, and should include the 
following information: (1) Name and address of institution, and (2) 
name, address, and telephone number of a contact person.

[[Page 30390]]

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, 
printed on one side, with one inch margins, and unreduced fonts.
    The narrative should consist of, at a minimum, a Plan, Objectives, 
Methods, and Evaluation. The Budget should contain a line item 
descriptive justification for personnel, travel, supplies, laboratory 
testing, and other services related to the project. Contracts should 
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. Funding levels for years 
two and three should be estimated. A one page executive summary and a 
complete index to the application and its appendices should be 
provided.

F. Submission and Deadline

Letter of Intent (LOI)

    On or before June 1, 2002, submit the LOI to the Grants Management 
Specialist identified in the ``Where to Obtain Additional Information'' 
section of this announcement.

Application

    Submit the original and five copies of PHS-398 (OMB Number 0925-
0001) (adhere to the instructions on the Errata Instruction Sheet for 
PHS 398). Forms are available in the application kit and at the 
following Internet address: www.cdc.gov/od/pgo/forminfo.htm
    On or before July 1, 2002, submit the application to the Technical 
Information Management Section 2920 Brandywine Road, Suite 3000, 
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 independent 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).
    Late: Applications which do not meet the criteria in 1. or 2. above 
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 total points)
    a. The 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. The extent to which the applicant demonstrates need based on 
disease burden of viral hepatitis (i.e., prevalence, incidence data) 
among adolescent 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 total points)

    The 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 to 3000 adolescents 
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 (heterosexuals at high risk, MSM, injection drug users 
(IDUs), sex partners of IDUs), that may accept viral hepatitis 
prevention and control activities and services provided through an 
integrated program. (10 points)
    c. The extent to which the 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 (45 total points)

    a. The 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. The extent and quality of an 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. (10 points)
    c. The extent to which the applicant clearly identifies specific 
assigned responsibilities of all key professional personnel. (5 points)
    d. The 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. (4) A statement 
as to whether the plans for recruitment and outreach for participants 
include the process of establishing partnerships with community or 
communities and recognition of mutual benefits. (5 points)

4. Measures of Effectiveness

    The extent the applicant provide Measures of Effectiveness that 
will demonstrate the accomplishment of the purpose of the cooperative 
agreement. The measures must be objective/quantitative and must 
adequately

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measure the intended outcome? (5 points)

5. 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.

6. 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. Semiannual progress reports.
    2. Financial status report, no more than 90 days after the end of 
the budget period.
    3. Final financial 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.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment I of the 
announcement.

AR-1  Human Subjects Requirements
AR-2  Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR-3  Animal Subjects Requirements
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
AR-15  Proof of Non-Profit Status
AR-22  Research Integrity

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under Sections 301(a) and 317(k)(2) of 
the Public Health Service Act [42 U.S.C. Sections 241(a) and 
247b(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.''
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from:
    Renee Benyard, Grants Management Specialist, Acquisition and 
Assistance, Branch B, Procurement and Grants Office, Centers for 
Disease Control and Prevention, 2920 Brandywine Road, Room 3000, 
Atlanta, GA 30341-4146, Telephone number: (770)488-2722, Fax number: 
(770)488-2777, email address: [email protected].
    For program technical assistance, contact: Joanna Buffington, 
Program Management Official, Division of Viral Hepatitis, National 
Center for Infectious Diseases, Centers for Disease Control and 
Prevention, 1600 Clifton Road, NE, Mailstop G-37, Atlanta, GA 30333, 
Telephone number: (404)371-5460, Fax number: (404) 371-5488, e-mail 
address: [email protected].

    Dated: April 30, 2002.
Sandra R. Manning,
CGFM, Director, Procurement and Grants Office, Center for Disease 
Control and Prevention.
[FR Doc. 02-11116 Filed 5-3-02; 8:45 am]
BILLING CODE 4163-18-P