02-10984. 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, nursesand 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,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-1Human Subjects Requirements

AR-2Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research

AR-7Executive Order 12372 Review

AR-10Smoke-Free Workplace Requirements

AR-11Healthy People 2010

AR-12Lobbying Restrictions

AR-15Proof of Non-Profit Status

AR-22Research 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:

RenéBenyard, 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: [phone], Fax number: [phone], Email address: [e-mail].

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: [phone], Fax number: [phone], Email address: [e-mail].

Dated: April 28, 2002.

Sandra R. Manning,

Director, Procurement and Grants Office, Centers for Disease Control and Prevention.