To improve the quality of laboratory genetic testing practices relevant to clinical and public health settings and to determine standardized approaches to quality assurance in pathology and laboratory medicine that can be applied in multiple, diverse settings (e.g.

community hospitals, academic

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medical centers, and independent laboratories) that demonstrate measurable and sustainable improvements over time.

None.

Uses and Use Restrictions

None.

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Eligibility Requirements

Applicant Eligibility

Applications may be submitted by public and private nonprofit organizations and by governments and their agencies, such as: Public nonprofit organizations, private nonprofit organizations, universities, colleges, research institutions, hospitals, community and faith based organizations, State and local governments or their Bona Fide Agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau).

Beneficiary Eligibility

Applicants must have experience in the administration and evaluation of standardized quality assurance programs in multiple, diverse laboratory sites (including community hospitals and academic medical centers). This experience is required for an applicant to be able to assess the effectiveness of these quality assurance programs and to determine best practices.

Credentials/Documentation

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. For all other nonprofit grantees, costs will be determined in accordance with HHS Regulations 45 CFR 74, Subpart Q. For-profit organizations' costs are determined in accordance with the Federal Acquisition Regulations, 48 CFR 31.

Aplication and Award Process

Preapplication Coordination

This program is excluded from coverage under Executive Order 12372.

Application Procedures

To apply for this funding opportunity use application form PHS 5161. Application forms and instructions are available on the CDC web site, at the following Internet address: 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) staff at: Telephone: (770) 488-2700. Application forms can be mailed to you.

Award Procedures

Applications will be reviewed for completeness by the Procurement and Grants Office (PGO) staff, and for responsiveness by the PHPPO. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will be notified that their application did not meet submission requirements. An objective review panel will evaluate complete and responsive applications according to the criteria listed in the "V.1. Criteria" section above. In addition, the following factors may affect the funding decision: Preference may be given to organizations that routinely provide and/or utilize clinical or public health genetic testing laboratory services. Preference may also be given to organizations that have contributed to the development, or use of quality assurance programs for genetic testing, have engaged in research or assessment of new technologies and their implications for clinical and public health practice, have participated in activities relevant to the translation of research findings to clinical and public health applications, and/or participated in efforts to develop domestic and international genetic testing policies. Preferences may be given to organizations that have expertise in heritable human conditions of public health significance that can be applied to the efforts described in this program announcement in such a way that results will be broadly applicable to other areas of genetic testing. Lastly, preferences will be given to applications demonstrating collaboration among clinical and public health entities in developing and carrying out the work proposed. Entities can include clinical and public health academic departments, state and local public health organizations, professional organizations that focus on clinical and/or public health issues, and other such groups.

Deadlines

None.

Authorization

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

Range of Approval/Disapproval Time

From two to three months.

Appeals

None.

Renewals

Throughout the three year project period, CDC's commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal Government.

Assistance Considerations

Formula and Matching Requirements

This program has no statutory formula or matching requirements.

Length and Time Phasing of Assistance

Financial assistance is provided for a 12 month budget period, with project periods of up to three years.

Post Assistance Requirements

Reports

Interim progress report, no less than 90 days before the end of the budget period.

1) The progress report will serve as your non-competing continuation application, and must contain the following elements: current budget period activities objectives, current budget period financial progress, new Budget period program proposed activity objectives, budget, additional requested information, measures of effectiveness; 2) Financial status report, no more than 90 days after the end of the budget period and; 3)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 from Federal audit requirements for that year, except as noted in Circular No. A-133. In addition, grants and cooperative agreements are subject to inspection and audits by DHHS and other Federal governments officials.

Records

Financial records, including documents to support entries on accounting records and to substantiate charges to each grant, must be kept readily available for review by personnel authorized to examine PHS grant accounts. Records must be maintained for three years after the end of a budget period. If questions still remain, such as those raised as a result of audit, related records should be retained until the matter is completely resolved.

Financial Information

Account Identification

75-0943-0-1-550.

Obigations

(Grants) FY 07 $1,405,000; FY 08 $2,644,196; and FY 09 est $2,400,000.

Range and Average of Financial Assistance

$100,000 to $500,000; $250,000.

Regulations, Guidelines, and Literature

42 CFR 52; basic grant administration policies of DHHS and PHS are also applicable, 45 CFR 74 and 45 CFR 92; PHS Grants Policy Statement, DHHS publication No. (OASH) 94-50,000, (Rev.) April 1, 1994.

Information Contacts

Regional or Local Office

For general questions about this announcement, contact: Technical Information Management Section, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: 770-488-2700. For program technical assistance, contact: Charlene Beach, Centers for Disease Control and Prevention, NCPDCID, DLS, 1600 Clifton Road, MS G25. Telephone: (404) 718-1039, Fax: (404) 718-1095, E-mail: CHO1@cdc.gov. For financial, grants management, or budget assistance, contact: Sharron Orum, Grants Management Specialist, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: (770) 488-2716, E-mail: spo2@cdc.gov.

Headquarters Office

Program POC: Charlene Beach, Telephone: (404) 718-1039; Email: CHO1@cdc.gov. Grants Management Officer contact is Sharron Orum. Telephone: (404) 488-2716, Grants Management Officer, Procurement and Grants Office, Centers for Disease Control and Prevention, Department of Health and Human Services, 2920 Brandywine Road, Suite 3000, Atlanta, GA 30341.

Criteria for Selecting Proposals

Applications will be evaluated based upon best practices in quality assurance methods for addressing pre-analytic components of laboratory testing, including the test requisition, quality assurance methods for addressing post-analytic components of laboratory testing, including the test report, assessments of laboratory practices which gather specific information related to technology assessment. This requires the development of specific and measurable objectives and a sound operational plan that includes laboratory genetic testing practices relevant to clinical and public health settings and standardized approaches to quality assurance in pathology and laboratory medicine that can be applied in multiple, diverse settings, demonstrate measurable and sustainable improvements over time.