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Public Health Research Accreditation Project; Notice of Availability of Funds

Document Details

Information about this document as published in the Federal Register.

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Start Preamble

Application Deadline: August 1, 2003.

A. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under sections 301 and 317(k)(2) of the Public Health Service Act, [42 U.S.C. 241 and 247b(k)(2)], as amended. The Catalog of Federal Domestic Assistance number is 93.993.

B. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2003 funds for a grant to assess the role of accreditation in enhancing the protection of participants in public health research. This program addresses the “Healthy People 2010” focus area 23 Public Health Infrastructure.

The purpose of the program is to assess the role of accreditation of human research protection programs to enhance protections afforded to persons involved in the full range of public health research programs, e.g., epidemiologic research, health services research, and social and behavioral intervention research, as well as traditional biomedical research and clinical trials. Voluntary accreditation is one component of a national oversight system for protection of human subjects. The National Bioethics Advisory Commission (2001) and the Institute of Medicine (2001, 2002) recommended that a voluntary system for accreditation of human research protection programs be initiated and evaluated over the next several years.

This project will result in the development of pilot measures that can be used to assess the improvement of the ability of the public health infrastructure (such as state and local public health departments, schools of public health, and other public health research partners) to assess and monitor research involving human subjects. In year two, the pilot measures will be implemented in several locations, such as state or local health departments, schools of public health, or community-based organizations that engage in public health research, and will be evaluated for utility and feasibility in the public health setting. In year three, the measures will be refined and made available to public health research partners to document and evaluate the impact of accreditation as a process to improve protection of human subjects in public health research.

Measurable outcomes of the program will be in alignment with the performance goals for the CDC Office of Science Policy and Technology Transfer.

C. Eligible Applicants

Limited Eligibility

Assistance will be provided only to a public, private, for-profit, or non-profit organization that is currently actively engaged in the process of accrediting human research protection programs that represent the full range of activities, Start Printed Page 39573which are applicable to state, and local public health departments.

Note:

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

D. Funding

Availability of Funds

Approximately $100,000 is available in FY 2003 to fund one award. It is expected that the award will begin on or about August 1, 2003 and will be made for a 12-month budget period within a project period of up to three years. Funding estimates 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.

Recipient Financial Participation

Matching funds are not required for this program.

Funding Priority

Public comments on the proposed Funding Priority are not being solicited due to insufficient time prior to the funding date.

E. Program Requirements

In conducting activities to achieve the purpose of this program, the recipient will be responsible for the following activities:

Phase 1—Develop measures for key indicators of accreditation's effectiveness and seek agreement from stakeholders on the measures' appropriateness with particular emphasis on their use in the public health setting. The public health setting here would include state and local health departments, schools of public health, and other public health research partners, including community-based organizations or other non-traditional research partners. Methods might include such strategies as:

1. Prepare a summary of the relevant literature on accreditation and quality improvement, bioethics, and biomedical, social science, and public health research to identify potential measures of effectiveness.

2. Convene a steering committee consisting of persons with appropriate expertise in human subject research protections, public health research, and state or local health department activities. This group could also contain liaison representatives from other government agencies or departments with interest or expertise in the role of accreditation in improving human research protection programs.

Phase 2—Develop evaluation methods and data collection instruments to examine the impact of the accreditation process in public health settings. Phase 2 activities will be largely dependent upon the measures generated in Phase 1. Evaluation methods should include plan for a longitudinal activity in which organizations that seek accreditation are evaluated over time as well as a comparison of accredited and non-accredited organizations.

Phase 3—Pilot test the evaluation methods and validate the proposed set of outcome measures in a small number of settings. These settings should be generally representative of the types of public health settings noted above.

Phase 4—Refine the initial set of outcome measures and evaluation methods and make them accessible to a range of interested parties for potential implementation.

Phases 1 and 2 should be undertaken in Year one, with a general outline of Phases 3 and 4 provided for Year two and three.

F. Content

Letter of Intent (LOI)

A LOI is not required for this program.

Applications

The Program Announcement title and number must appear in the application. 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 pages, double-spaced, printed on one side, with one-inch margins, and unreduced 12-point font.

The narrative should consist of a plan to achieve the full purpose of project for the three-year project period, a description of the qualifications and background of key personnel, a defined set of measurable objectives for year one activities, the proposed methods for achieving the objectives, a projected timeline to monitor progress, a plan for evaluation of project activities, and a proposed budget.

G. Submission and Deadline

Application Forms

Submit the signed original and two copies of PHS form 398. (OMB Number 0925-0001); adhere to the instructions on the Errata Instruction Sheet for PHS 398. Forms are available at the following Internet address: http://www.cdc.gov/​od/​pgo/​forminfo.htm.

If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) at: 770-488-2700. Application forms can be mailed to you.

Submission Date, Time, and Address

The application must be received by 4 p.m. Eastern Time August 1, 2003. Submit the application to: Technical Information Management—PA#03157, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146.

Applications may not be submitted electronically.

CDC Acknowledgement of Application Receipt

A postcard will be mailed by PGO-TIM, notifying you that CDC has received your application.

Deadline

Applications shall be considered as meeting the deadline if they are received before 4 p.m. Eastern Time on the deadline date. Any applicant who sends their application by the United States Postal Service or commercial delivery services must ensure that the carrier will be able to guarantee delivery of the application by the closing date and time. If an application is received after closing due to (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, CDC will upon receipt of proper documentation, consider the application as having been received by the deadline.

Any application that does not meet the above criteria will not be eligible for competition, and will be discarded. The applicant will be notified of their failure to meet the submission requirements.

H. Evaluation Criteria

Application

Applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the grant. Measures of effectiveness must relate to the performance goals stated in the purpose section of this announcement. Measures must be objective and quantitative and must measure the intended outcome. These measures of effectiveness must be submitted with the application and will be an element of evaluation. Start Printed Page 39574

An independent review group appointed by CDC will evaluate each application against the following criteria:

1. Plan to achieve the purpose of the program: 25 points.

2. Background and qualifications of staff: 20 points.

3. Measurable objectives: 15 points.

4. Adequacy of methods to achieve objectives: 15 points.

5. Evaluation plan: 15 points.

6. Timeline: 10 points.

7. Budget (reviewed, but not scored).

I. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two copies of:

1. Interim progress report, no less than 90 days before the end of the budget period. The progress report will serve as your non-competing continuation application, and must contain the following elements:

a. Current Budget Period Activities Objectives.

b. Current Budget Period Financial Progress.

c. New Budget Period Program Proposed Activity Objectives.

d. Detailed Line-Item Budget and Justification.

e. Additional Requested Information.

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.

Additional Requirements

The following additional requirements are applicable to this program. For a complete description of each, see Attachment I of the program announcement, as posted on the CDC Web site.

AR-10 Smoke-Free Workplace Requirements

AR-12 Lobbying Restrictions

AR-15 Proof of Non-Profit Status

Executive Order 12372 does not apply to this program.

J. Where To Obtain Additional Information

This and other CDC announcements, the necessary applications, and associated forms can be found on the CDC Web site, Internet address: http://www.cdc.gov. Click on “Funding” then “Grants and Cooperative Agreements”.

For general questions about this announcement, contact: Technical Information Management, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-2700.

For business management and budget assistance, contact: James Masone, Contracts Specialist, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-2736, E-mail address: zft2@cdc.gov.

For program technical assistance, contact: John R. Livengood, M.D. M. Phil., Deputy Associate Director for Science, Office of Science Policy and Technology Transfer, Centers for Disease Control and Prevention, MS D-50, 1600 Clifton Road, NE., Atlanta, GA 30333, Telephone: 404-639-7260, E-mail address: JRL1@cdc.gov.

Start Signature

Dated: June 26, 2003.

Edward Schultz,

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

End Signature End Preamble

[FR Doc. 03-16680 Filed 7-1-03; 8:45 am]

BILLING CODE 4163-18-P