Improving the Quality of Genetic Testing and Assuring Its Appropriate Integration Into Clinical and Public Health Practice

Announcement Type: New.

Funding Opportunity Number: 04137.

Catalog of Federal Domestic Assistance Number: 93.064.

Application Deadline: June 14, 2004.

Executive Summary: The number of genetic tests available to the clinical and public health communities is increasing, as is the number of tests being ordered. For many genetic tests, significant concerns exist related to test ordering, analytical and clinical validation, quality control, result reporting, and use of test results in medical decision making. Surveys carried out previously have indicated variability and gaps in each of these areas with potentially significant implications for the delivery of genetic testing services to the public. Initially, to address these issues, the scope of work for this project will include a technology and practice assessment linked to development of a program to improve one, or more aspects of the genetic testing process.

The goals of this program are (1) to conduct a technology and practice assessment within the scope of genetic testing laboratory services in the United States that will evaluate elements important for assuring the quality, appropriate use, and to what extent an understanding of benefits and limitations are applied; (2) to conduct a pilot study to test concepts potentially useful for improving the quality of the genetic testing process; and (3) to compare relevant international activities (those occurring outside the United States) to efforts undertaken in this project. The focus will be on one, or more health conditions and/or group of technologies that can provide insights into a broader spectrum of genetic testing issues. The target audiences for the assessment are laboratories performing genetic tests and users of genetic laboratory services (i.e. clinical and public health practitioners who order and use genetic tests and results). Important factors to consider include technologies employed, methods used for test validation and quality control, and pre- and post-analytic factors pertinent to the collection and use of patient/population-based information and the use of test results for health-care decision-making. This program is also expected to recognize international efforts that address similar issues and their potential impact on practices within the U.S. As such, a review of relevant international efforts will be undertaken as part of this project proposed.

I. Funding Opportunity Description

Authority: This program is authorized under section 317(k)(2) of the Public Health Service Act, 42 U.S.C. section 247b(k)(2), as amended.

Purpose: The purpose of the program is to improve the quality of laboratory genetic testing practices relevant to clinical and public health settings.

This program will assess current practices and the impact of technology on the provision of genetic testing services within the U.S. The project will take a quality systems approach in which technical and management aspects of each component of the system is recognized as contributing to the overall quality of testing and its potential impact on clinical and public health decision making. The initial part of this project must include a U.S. technology and practice assessment. The proposed assessment can be undertaken in several formats. It may be general in nature with the intent to capture data covering a broad spectrum of topics or focused on a subset of health conditions and/or technologies that can serve as models reflective of broader genetic testing issues. The assessment will be used to document variability in practices and expected to be helpful in identifying opportunities to address shortcomings and improve the quality of genetic testing and laboratory practices. This assessment should not be duplicative of past efforts but build upon them, or be novel in the areas explored and approaches taken.

Conclusions made from the assessment should be relevant to the broader community that performs genetic testing or uses genetic test results. Relevant issues can include test validation, quality assurance, quality control, proficiency testing, and the methods by which laboratories communicate with clinical and public health care providers, payers, policy makers, and others toward assuring appropriate use of their services. As such, it is also important to consider both the laboratories and users of their services (i.e. clinical/public health professionals) as target populations for the assessment and follow up efforts. The latter part of this program requires that the applicant propose a study or pilot program to test concepts that can potentially improve the quality of laboratory practice related to one or more of the issues documented during the assessment. Efforts can include developing and evaluating novel quality assurance practices, developing educational/training programs to improve the knowledge and competencies among laboratory and health care professionals (i.e., in the use and communication of genetic tests and results), or undertaking studies useful for informing professional groups and regulatory bodies toward the development, implementation, and evaluation of guidelines, standards, and/or regulatory requirements. As a final component to this program, a review of international efforts relevant to the work undertaken will be performed. The intent for this final requirement is to take a broader look at what is happening in other parts of the world relevant to the work undertaken in this program and comment upon opportunities that may benefit both U.S. practices as well as those in other countries. Less guidance is provided in addressing this part of the program since the nature of the work will depend on the direction the applicant proposes for earlier aims and their connectivity with the international community. This program addresses the “Healthy People 2010” focus area(s) of “Access to Quality Health Services” and “Public Health Infrastructure.”

Measurable outcomes of the program will be in alignment with the following performance goals for the Public Health Practice Program Office: Increase the number of frontline public health workers at the state and local level that are competent and prepared to respond to bioterrorism, other infectious disease outbreaks, and other public health threats and emergencies and prepare frontline state and local health departments and laboratories to respond to current and emergency health threats.

Activities: This project requires several activities be undertaken and as such it is vital that the applicant clearly state what is intended to be accomplished each year, or part thereof, of the three-year proposal. Funding for years two and three are dependent on the availability of funds and progress made.

Awardee activities for this program are as follows:

a. Develop and conduct assessments of laboratory practices which gather specific information related to technology assessment, test validation, quality assurance practices, personnel competencies, and ways in which tests are ordered and results are reported and used for medical and public health decision making. The recipient is expected to provide an analysis of the data that is potentially broadly applicable to genetic testing in clinical and/or public health practice settings.

b. Conduct a pilot project to test and evaluate a process for improving the quality of laboratory testing that is based upon findings from the assessment described above.

c. Where appropriate, educational efforts should be conducted for laboratory staff and/or health care professionals as a component of the research or pilot project proposed. An evaluation of the educational activity should be undertaken to assess its usefulness and broader applicability. Particular emphasis should be placed upon the clinical/laboratory interface and/or public health laboratory setting.

d. Develop and implement a comparative analysis between U.S. and non-U.S. practices and policies relevant to the project proposed.

e. Convene advisory group(s) (comprised of knowledgeable and experienced persons), as appropriate, to develop recommendations useful for carrying out the work proposed.

In a cooperative agreement, CDC staff is substantially involved in the program activities, above and beyond routine grant monitoring.

CDC Activities for this program are as follows:

a. Serve in an advisory capacity to the awardee in the development of data collection instruments and not otherwise be involved in the collection, use, or ownership of the data.

b. Assist in collaborating with other organizations, government entities, CDC staff, and others in carrying out program activities.

c. Assist in preparing training and education programs.

d. Assist forming expert focus groups, which may be composed of national and international experts, to develop strategies and recommendations.

II. Award Information

Type of Award: Cooperative Agreement.

CDC involvement in this program is listed in the Activities Section above.

Fiscal Year Funds: 2004.

Approximate Total Funding: $225,000.

Approximate Number of Awards: One.

Approximate Average Award: $225,000 (This amount is for the first 12-month budget period, and includes both direct and indirect costs).

Floor of Award Range: None.

Ceiling of Award Range: $225,000 (This ceiling is for the first 12-month budget period.)

Anticipated Award Date: September 1, 2004.

Budget Period Length: 12 months.

Project Period Length: Three years.

Throughout the 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.

III. Eligibility Information

III.1. Eligible Applicants

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-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).

A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If you are applying as a bona fide agent of a state or local government, you must provide a letter from the state or local government as documentation of your status. Place this documentation behind the first page of your application form.

III.2. Cost Sharing or Matching

Matching funds are not required for this program.

III.3. Other

If you request a funding amount greater than the ceiling of the award range, your application will be considered non-responsive, and will not be entered into the review process. You will be notified that your application did not meet the submission requirements.

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.

IV. Application and Submission Information

IV.1. Address To Request Application Package

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: 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) staff at: 770-488-2700. Application forms can be mailed to you.

IV.2. Content and Form of Submission

Application: You must submit a project narrative with your application forms. The narrative must be submitted in the following format:

• Maximum number of pages: 25.
• If your narrative exceeds the page limit, only the first pages, which are within the page limit, will be reviewed.
• Font size: 12 point unreduced.
• Paper size: 8.5 by 11 inches.
• Page margin size: One inch.
• Printed only on one side of page.
• Held together only by rubber bands or metal clips; not bound in any other way.
• Single spaced.

Your narrative should address activities to be conducted over the entire project period, and must include the following items in the order listed:

The narrative should consist of goals and objectives, methods and technical approach, project management and staffing, evaluation plan, and proposed budget for carrying out the recipient activities consistent with the evaluation criteria listed section “H”. The budget justification will be counted in the stated page limit. Additional information may be included in the application appendices. The appendices will not be counted toward the narrative page limit. This additional information includes:

• Curriculum Vitaes
• Letters of Support

You are required to have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal government. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access http://www.dunandbradstreet.com or call 1-866-705-5711.

For more information, see the CDC Web site at: http://www.cdc.gov/od/pgo/funding/pubcommt.htm.

If your application form does not have a DUNS number field, please write your DUNS number at the top of the first page of your application, and/or include your DUNS number in your application cover letter.

Additional requirements that may require you to submit additional documentation with your application are listed in section “VI.2. Administrative and National Policy Requirements.”

IV.3. Submission Dates and Times

Application Deadline Date: June 14, 2004.

Explanation of Deadlines: Applications must be received in the CDC Procurement and Grants Office by 4 p.m. Eastern Time on the deadline date. If you send your application by the United States Postal Service or commercial delivery service, you must ensure that the carrier will be able to guarantee delivery of the application by the closing date and time. If CDC receives your application 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, you will be given the opportunity to submit documentation of the carriers guarantee. If the documentation verifies a carrier problem, CDC will consider the application as having been received by the deadline.

This announcement is the definitive guide on application submission address and deadline. It supersedes information provided in the application instructions. If your application does not meet the deadline above, it will not be eligible for review, and will be discarded. You will be notified that your application did not meet the submission requirements.

CDC will not notify you upon receipt of your application. If you have a question about the receipt of your application, first contact your courier. If you still have a question, contact the PGO-TIM staff at: 770-488-2700. Before calling, please wait two to three days after the application deadline. This will allow time for applications to be processed and logged.

IV.4. Intergovernmental Review of Applications

Executive Order 12372 does apply to this program.

IV.5. Funding Restrictions

Restrictions, which must be taken into account while writing your budget, are as follows:

• None.

If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement. If your indirect cost rate is a provisional rate, the agreement should be less than 12 months of age.

Awards will not allow reimbursement of pre-award costs.

Guidance for completing your budget can be found on the CDC Web site, at the following Internet address: http://www.cdc.gov/od/pgo/funding/budgetguide.htm.

IV.6. Other Submission Requirements

Application Submission Address: Submit the original and two hard copies of your application by mail or express delivery service to: Technical Information Management-PA# 04137, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.

Applications may not be submitted electronically at this time.

V. Application Review Information

V.1. Criteria

You are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement. 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.

Your application will be evaluated against the following criteria:

1. Methods and Technical Approach (30 points)

a. Does applicant clearly and succinctly describe the steps to be taken in the planning and implementation of the proposed cooperative agreement?

b. Are the methods used to carry out the responsibilities of the proposed cooperative agreement must be feasible and explained in sufficient detail?

2. Project Management and Staffing (30 points)

a. Does the applicant describe a project management and staffing plan, and must demonstrate sufficient knowledge, expertise, and other resources required to perform the responsibilities in this project?

b. Does the applicant describe the staff qualifications and time allocations of key personnel to be assigned to this project, facilities and equipment, and other resources available for performance of this project?

3. Goals and Objectives (20 points)

a. Does the applicant clearly describe an understanding of the objectives of this project and the relevance of the proposal to the stated objectives?

b. Are the goals and objectives measurable, specific, and achievable?

4. Evaluation Plan (20 points)

Does the applicant describe the schedule for accomplishing the activities to be carried out in this project and methods for evaluating the accomplishments?

5. Budget (Reviewed, but not Scored)

The proposed budget must be reasonable, clearly justified, and consistent with the intended use of funds.

6. Performance Measures (Reviewed, but not Scored)

The application should be consistent with the Government Performance and Results Act of 1993.

V.2. Review and Selection Process

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.

VI. Award Administration Information

VI.1. Award Notices

Successful applicants will receive a Notice of Grant Award (NGA) from the CDC Procurement and Grants Office. The NGA shall be the only binding, authorizing document between the recipient and CDC. The NGA will be signed by an authorized Grants Management Officer, and mailed to the recipient fiscal officer identified in the application.

Unsuccessful applicants will receive notification of the results of the application review by mail.

VI.2. Administrative and National Policy Requirements

45 CFR Part 74 and Part 92

For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.

The following additional requirements apply to this project:

• AR-10 Smoke-Free Workplace Requirements
• AR-11 Healthy People 2010
• AR-12 Lobbying Restrictions
• AR-15 Proof of Non-Profit Status

Additional information on these requirements can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

VI.3. Reporting Requirements

You must provide CDC with an original, plus two hard copies of the following reports:

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. Budget.

e. Additional Requested Information.

f. Measures of Effectiveness.

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.

These reports must be mailed to the Grants Management or Contract Specialist listed in the “Agency Contacts” section of this announcement.

VII. Agency Contacts

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: Ira Lubin, Ph.D., Centers for Disease Control and Prevention, PHPPO, DLS, 4770 Buford HWY, MSG23, Telephone: 770-488-8070, Fax: 770-488-8278, E-mail: ilubin@cdc.gov.

For financial, grants management, or budget assistance, contact: Sharon Robertson, Grants Management Specialist, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2748, E-mail: sqr2@cdc.gov.

VIII. Other Information

For information about the Centers for Disease Control and Prevention see http://wwww.cdc.gov.

For information about the genetic activities within the Division sponsoring this cooperative agreement, see http://www.phppo.cdc.gov/dls/genetics/default.asp.