[Federal Register Volume 67, Number 86 (Friday, May 3, 2002)]
[Notices]
[Pages 22432-22434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-10984]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 02047]


Evaluate the Long-Term Protection From Hepatitis A and B Vaccine 
Among Multiple Cohorts of Alaska Natives Vaccinated and Study the 
Natural History of Chronic Hepatitis C Among Alaska Natives; 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 to Evaluate the Long Term Protection from Hepatitis A and B 
Vaccine Among Multiple Cohorts of Alaska Natives Vaccinated and Study 
the Natural History of Chronic Hepatitis C Among Alaska Natives. This 
program addresses the ``Healthy People 2010'' focus area of 
Immunization and Infectious Diseases.
    The purpose of the program is to (1) Evaluate the persistence of an 
antibody and the long term protection afforded by hepatitis A vaccine 
among Alaska Natives who received the primary vaccine series in three 
different age groups: as infants, young children and adults. (2) 
Evaluate the long term protection afforded by plasma-derived and 
recombinant hepatitis B vaccines among Alaska Natives who received the 
primary vaccine series in three different age groups: as infants 
(beginning at birth), young children and adults. (3) Study the natural 
history of chronic hepatitis C in a cohort of Alaska Natives followed 
over time.

B. Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations and by governments and their agencies; that is, 
universities, colleges, research institutions, hospitals, other public 
and private non-profit 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 must have experienced research clinicians, 
nurses

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and data management personnel and have close linkages and 
collaborations with an Alaska Native Tribal Health Consortium (ANTHC) 
or similar organization that provides for and manages statewide health 
services for Alaska Area Natives.

    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.

C. Availability of Funds

    Approximately $300,000 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 
of 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 programs that have immediate access to 
sufficiently large cohorts of Alaska Native infants, young children and 
adults who received complete hepatitis A and hepatitis B vaccine 
series. These cohorts should include a minimum of one cohort in each 
age category, for hepatitis A vaccination and hepatitis B vaccination 
(i.e., a total of six cohorts), in which response to vaccination was 
verified by post-vaccination serologic testing.

D. 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. Identify and recruit persons who constitute the study 
population.
    b. Develop and implement research study protocol(s) and consent 
forms required for the study.
    c. Obtain appropriate approvals from required Institutional Review 
Board(s) (IRB), tribal review committees, and other relevant 
cooperating institutions participating in the research project.
    d. Provide serum samples to CDC, as appropriate.
    e. Collect and enter data into an appropriate statistical database 
for analysis.
    f. Collaborate with CDC in conducting appropriate data analysis and 
interpretation.

2. CDC Activities

    a. Provide technical support for the design, implementation, and 
evaluation of program activities.
    b. Collaborate on 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 fonts. Your letter of intent will be used to plan 
the evaluation of applications, and should include the following 
information: (1) Name and address of institution, and (2) Name, 
address, and telephone number of contact person.
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 ten double spaced pages, 
printed on one side, with one inch margins, and unreduced font. 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)
    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 one or two 
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 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 a need based on a 
disease burden of viral hepatitis (i.e., prevalence, incidence data) 
among high risk populations. (5 points)

2. Objectives and Technical Approach (40 points)

    a. The extent to which the applicant describes a research plan for 
long term follow up of the specified cohorts that is (1) Consistent 
with the purpose and goals of this cooperative agreement program. (2) 
Measurable and time-phased. (3) Consistent with published Advisory 
Committee on Immunization Practices (ADID)recommendations. (15 points)
    b. The extent and quality of the operational plan proposed for 
implementing the program, including maximizing the use of existing 
resources and staff 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 data 
collection, data analysis and reporting. (5 points)
    e. The degree to which the applicant has met the CDC Policy 
requirements regarding the inclusion of women,

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ethnic, and racial groups in the proposed research. 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 design of the study is adequate to measure 
differences when warranted. (4) A statement as to whether the plans for 
recruitment and outreach for study participants include the process of 
establishing partnerships with community. (5 points)

3. Capacity (45 Points)

    a. The extent to which the applicant provides evidence of ability 
to access the following cohorts and perform the following activities:
    (1) To identify at least 100 Alaska Native infants who received 
hepatitis A vaccine beginning at less than two years of age and who had 
serologic testing after vaccination to determine response to 
vaccination. To follow these children every other year with serologic 
testing for an antibody to hepatitis A virus and clinical chart review.
    (2) To identify at least 50 children and adults who received 
hepatitis A vaccine greater than five years ago and had post 
vaccination serologic testing for immune response. To follow these 
adults and children with follow-up serologic testing.
    (3) To identify at least 400 predominantly Alaska Native children 
who received hepatitis B vaccine starting at birth and who are 
currently aged four to six years (~200) and 12-14 years (~200). To 
obtain specimens for serologic testing, administer a hepatitis B 
vaccine booster dose, and obtain a follow-up specimen.
    (4) To identify Alaska Natives who received hepatitis B vaccination 
greater than 15 years ago and who have had periodic follow-up serologic 
testing. To obtain specimens for serologic testing, administer 
hepatitis B vaccine as appropriate, and obtain follow-up specimens.
    (5) To identify at least 500 Alaska Natives with chronic hepatitis 
C and/or other types of chronic liver disease, including clinical and 
risk factor information and serologic specimens.
    a. Description of adequate resources, includingpersonnel and 
facilities (both technical and administrative), either direct or 
through collaboration, for conducting the project. (10 points)
    b. The extent to which the applicant describes currently available 
cohorts and access to additional populations. (20 points)
    c. The extent to which the applicant documents experience of 
proposed personnel, either directly or collaborating, in successfully 
completing studies among Alaska Natives related to hepatitis prevention 
and hepatitis vaccines. (15 points)

4. Measures of Effectiveness (5 points)

    The extent the applicant provides Measures of Effectiveness that 
will demonstrate the accomplishment of the various identified 
objectives of the grant. Measures must be objective/quantitative and 
must measure the intended outcome.

5. Budget (Not Scored)

    The budget will be reviewed to determine if the budget is 
reasonable, clearly justified and 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 semiannual progress reports; financial status report, no more 
than 90 days after the end of the budget period; and 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-7  Executive Order 12372 Review
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)(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.''
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from:
    ReneBenyard, 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: Beth Bell, M.D., 
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) 371-5221, Email address: [email protected].

    Dated: April 28, 2002.
Sandra R. Manning,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention.
[FR Doc. 02-10984 Filed 5-2-02; 8:45 am]
BILLING CODE 4163-18-P