Public Health Research Accreditation Project

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.

Agency - Department of Health and Human Services

The Department of Health and Human Services is the Federal government's principal agency for protecting the health of all Americans and providing essential human services, especially to those who are least able to help themselves.

Website Address

http://www.cdc.gov



Program Accomplishments

None.

Uses and Use Restrictions

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.

Eligibility Requirements

Applicant Eligibility

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

Beneficiary Eligibility

Public, private, for-profit, or nonprofit organization that is currently actively engaged in the process of accrediting human research protection programs that represent the full- range of activities, which are applicable to State, and local public health departments.

Credentials/Documentation

Applicants should document the need for assistance, state the objectives of the project, present their approach to meeting the objectives, and outline the methods of operating. Costs will be determined in accordance with HHS Regulations 45 CFR 74, Subpart Q. For-profit organizations' cost are determined in accordance with the Federal Acquisition Regulations, 48 CFR 31.

Aplication and Award Process

Preapplication Coordination

Preapplication coordination is desired for research grants, but not required.

This program is excluded from coverage under E.O.

12372.

Application Procedures

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. Submit the application to: Technical Information Management, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146. Applications may not be submitted electronically.

Award Procedures

Approved grants are funded based on a priority score ranking from an independent review group as well as availability of funds, secondary review and such other significant programmatic factors deemed necessary and appropriate by the agency. Initial award provides funds for the first budget period (usually 12 months) and Notice of Grant Award (Form PHS 5152-1) indicates support recommended for remainder of project period (usually three to five years), allocations for Federal funds by budget categories, and special conditions, if any.

Deadlines

Applications shall be considered as meeting the deadline if they are received before 4:00 p.m. Eastern Time on the deadline date.

Authorization

Sections 301 and 317(k)(2) of the Public Health Service Act, 42 U.S.C. Section 241 and 247b(k)(2), as amended.

Range of Approval/Disapproval Time

From 90 to 120 days.

Appeals

None.

Renewals

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.

Assistance Considerations

Formula and Matching Requirements

None.

Length and Time Phasing of Assistance

Financial assistance is provided for a 12-month budget period with project periods of up to three years subject to the availability of funds and satisfactory progress of the grantee.

Post Assistance Requirements

Reports

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: (1) Current Budget Period Activities Objectives; (2) Current Budget Period Financial Progress; (3) New Budget Period Program Proposed Activity Objectives; (4) Detailed Line-Item Budget and Justification; and (5) Additional Requested Information.

Financial status report, no more than 90 days after the end of the budget period.

Final financial and performance reports, no more than 90 days after the end of the project period.

Audits

In accordance with the provisions of OMB Circular No. A-133 (Revised, June 27, 2003), "Audits of States, Local Governments, and Nonprofit organizations," nonfederal entities that expend financial assistance of $500,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $500,000 a year in Federal awards are exempt for Federal audit requirements for that year, except as noted in Circular No. A-133. In addition, these grants are subject to inspection and audits by DHHS and other Federal officials.

Records

Financial records, supporting documents, statistical records, and all other records pertinent to the project must be kept readily available to review by personnel authorized to examine PHS grant accounts. Records must be maintained for a minimum of 3 years after the end of a budget period. If questions still remain, such as those raised as a result of an audit, records must be retained until completion or resolution of any audit in process or pending resolution. Property records must be retained until the matter is completely resolved.

Financial Information

Account Identification

75-0943-0-1-550.

Obigations

FY 07 $0; FY 08 $0; and FY 09 est not reported.

Range and Average of Financial Assistance

Not applicable.

Regulations, Guidelines, and Literature

None.

Information Contacts

Regional or Local Office

Not applicable.

Headquarters Office

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: Mattie Jackson, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: (770) 488-2696, E-mail: MJackson2@cdc.gov . For program technical assistance, Contact: Marylin Radke, MD, MPH, Office of the Chief Science Officer, Centers for Disease Control and Prevention, MS D-50, 1600 Clifton Road, N.E., Atlanta, GA 30333; Telephone: (404) 639-7260, E-mail: mzr4@cdc.gov.

Criteria for Selecting Proposals

Applications will be evaluated based upon the applicant's ability to identify a plan that will achieve the purpose of the program, background and qualifications of staff, measurable objectives, adequacy of methods to achieve objectives, Evaluation plan, timeline and the overall budget.



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