oe11-1103 foa final 3.15.11.doc

Table of Contents

Part 1. Overview Information Part 2. Full Text of the Announcement Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

PART 1. OVERVIEW INFORMATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Agency Name: Federal Centers for Disease Control and Prevention (CDC)

Funding Opportunity Title: Improving Rapid Influenza Testing Practices in Outpatient Settings: Evidence- Based Solutions Announcement Type: - New - Type 1

Agency Funding Opportunity Number: CDC-RFA-OE11-1103 Catalog of Federal Domestic Assistance Number: 93.064 Key Dates:

Application Deadline Date: April 14, 2011, 5:00pm Eastern Standard Time Executive Summary:

Various CDC studies have retrospectively assessed the role of diagnostic testing in the clinical management of influenza and especially 2009 influenza A (H1N1). Findings support benefit of positive rapid influenza diagnostic test (RIDT) results for patient management, but in some cases the use of the tests adversely affected infection control and medical management, particularly with negative RIDT results. For example: 1) Ongoing transmission of illness among campers and at schools may have occurred due to persons resuming activities after negative RIDT results; 2) Delayed implementation of infection control precautions, complicated contact investigations for healthcare-associated cases of influenza; 3) Delayed antiviral treatment or respiratory support measures; 4) Failure to prescribe antiviral treatment for obstetric and gynecologic patients with pandemic H1N1 in California [RIDTs were falsely negative in 38% of those tested (58 of 153)]. Of eight fatal cases in the report, none received antiviral treatment and six had rapid test results that were falsely negative. Given these and other collective findings, it is imperative for public health and for response planning that CDC develops sector-specific guidance and effective outreach to the clinicians on appropriate use of RIDT in their practices.

Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the Office of Surveillance, Epidemiology, and Laboratory Services (proposed): Increase the number of communities with the capacity to prevent, detect, and control infectious diseases including those caused by drug-resistant organisms; increase the number of healthcare settings that comply with evidence-based guidelines for disease identification, and management; and increase the numbers of healthcare settings that protect patients and healthcare workers against adverse events, including therapeutic adverse events and development of drug-resistant infections.

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be reviewed. For the definition of research, please see the CDC Web site at the following Internet address: http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-onresearch.pdf.

PART 2. FULL TEXT

I. FUNDING OPPORTUNITY DESCRIPTION

Statutory Authority

Section 317(k)(2) of the Public Health Service Act [42 U.S.C. Section 247b(k)(2)].

Background

Influenza epidemics usually cause an average of >200,000 hospitalizations and 36,000 deaths per year in the U.S. Respiratory illnesses caused by influenza viruses are not easily differentiated from other respiratory infections based solely on symptoms, and influenza viruses may adversely affect different subpopulations. For example, seasonal influenza is more threatening to younger children (<5 years old) and the elderly (>65 years old). Conversely the effects of H1N1 pandemic were relatively mild among the elderly population, but were disproportionately morbid among pregnant women. Also, seasonal influenza generally peaks in the winter, whereas the H1N1 virus initially manifested in the spring. Differences in the circulating types of influenza among the population at different times of year requires adjustment and changes in laboratory testing practices as well as the interpretation of test results. The prevalence and type of circulating influenza, and the relative risk of morbidity and mortality in different sectors of the population, are important factors that must be considered in test interpretation. Current evidence suggests that these factors are not well understood among all outpatient providers. Thus it is critical for CDC and professional medical organizations to reach out and educate clinicians about appropriate influenza testing practices and expectations expeditiously whenever an outbreak, epidemic or pandemic occurs. Results from the current CDC influenza testing projects have consistently confirmed that rapid influenza test usage is increasing in outpatient settings to diagnose influenza and to inform treatment decisions, particularly the use of antiviral therapies. We have learned that clinicians favor rapid tests because they are easily accessible and provide results within 30 minutes. More than a dozen rapid tests have been approved by the U.S. Food and Drug Administration and are commercially available. Several of these rapid tests are waived from federal requirements for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) thus permitting their widespread use in non-traditional laboratory (outpatient) settings such as nursing homes, clinics, and physician’s offices. However, the reliability of rapid influenza tests is influenced by the individual test product used and the setting. Reported sensitivities range from 10-75%; while the median specificities reported are 90-95%. A recent study presented at the 2010 annual meeting of the American Public Health Laboratory Association reported specificities as low as 40% in one state. Other factors influencing accuracy are the stage (or duration) of illness when the diagnostic specimen is collected, type and adequacy of the specimen collected, variability in user technique for specimen collection or assay performance, and disease activity in the community.

Purpose

The purpose of the program is to evaluate and improve the use of influenza rapid tests in the differential diagnosis of respiratory disease, to determine how influenza rapid test usage has changed in outpatient settings since H1N1, to inform the development and dissemination of influenza testing guidelines, and to improve access to and utilization of influenza testing guidelines, given the epidemiology and prevalence of influenza at any given time and location. The project will provide critical information to evaluate how rapid tests for influenza are being used and the impact of the H1N1 pandemic on rapid test volume and practices in outpatient medical settings such as .community clinics, solo and group practice physician offices, and clinical laboratories doing testing for hospital emergency rooms across the United States. This evaluation will include a determination and comparison of the scope of rapid influenza test use, the types of tests in use and how they are selected, the personnel performing testing, the extent to which good laboratory practices and testing guidelines are being followed, how results are reported and interpreted, how results are used for patient care and antiviral and antibiotic prescribing practices, and the presence of linkages between these outpatient settings and the public health system. Connectivity with public health is critical in the case of pandemic influenza, as was proven in the H1N1 pandemic of 2009. The results of comparative analysis of the data already available, and the new post-H1N1 data will be shared with federal partners and stakeholders, to inform the improvement of influenza testing guidelines, to improve practices associated with influenza testing, and to improve the understanding and utilization of recommendations among clinicians. This should result in more cases correctly identified, fewer cases missed, faster diagnosis and treatment, and decreased morbidity and mortality of influenza.

This program addresses the “Healthy People 2020” focus area(s) of Access to Quality Health Services, Health Communication, Immunization and Infectious Diseases, Public Health Infrastructure and Respiratory Diseases.

Program Implementation

Recipient Activities

· Utilizing data from current and previous influenza seasons, develop a nationwide program for rapid influenza test utilization in outpatient medical settings, including community clinics, solo and group practice physician offices, hospital emergency rooms, and clinical laboratories that do testing for these facilities.

· Evaluate the nationwide program for influenza rapid testing practices among clinical laboratories that do testing for outpatient facilities including the specific clinical laboratories that performed testing for emergency departments that responded to surveys in 2008 and 2010, and a representative sample of U.S. clinical laboratories. Evaluation may include the following items: demographics of sites and clinical laboratories, specific tests and selection criteria use, title/type of personnel performing tests, testing volume (annual and/or seasonal), patient populations, testing purpose, laboratory’s interaction with emergency departments, effect of test on patient care and treatment, etc.

· Integrate the outpatient health delivery system, such as: (1) the methods used for specimen collection and handling; (2) test performance; (3) results interpretation and reporting; (4) therapeutic decision-making; (5) and other follow-up actions.

· Compare use or misuse of RIDT for detecting H1N1 and for treatment selection.

· Compare perceptions of laboratory testing personnel regarding advantages and disadvantages of using these tests.

· Assess quality assurance practices (i.e., proficiency testing participation, personnel training and competency, etc.)

· Assess the degree to which testing practices, interpretation, and utilization have affected the diagnosis of influenza.

· Share the information with partners and stakeholders; facilitate meetings and discussions to collect input for the purpose clarifying and disseminating existing guidelines to improve relevancy and uptake in clinical practice.

· Assess the extent to which the laboratories servicing outpatient facilities are linked in to local or state public health systems for disease reporting and specimen referral.

· Recommend specific interventions that could improve the utilization and quality of testing when using rapid influenza tests.

· Based upon previously collected data and newly collected evidence, develop instructional materials targeting clinicians (i.e., physicians, physician’s assistants, and nurses) performing rapid tests in outpatient facilities addressing diagnostic and treatment issues for each of the high risk groups. (Access CDC guidelines at http://www.cdc.gov/flu/professionals/diagnosis/clinician_guidance_ridt.htm.)

· Convene a Technical Advisory Panel (TAP), consisting of members of salient professional organizations, to evaluate the curriculum and materials developed under this agreement.

· Develop web-based, continuing educational training for physicians and healthcare workers to optimize specimen collection procedures for influenza testing, including rapid influenza testing.

· Based upon previously collected and newly collected evidence, develop hard copy and electronic tool kits for rapid testing and influenza diagnostics, targeting clinicians (physicians, nurses, and physicians’ assistants, etc. ) in outpatient facilities such as physician’s offices, community health centers, and emergency departments, and laboratories performing testing for these types of facilities. Instructions will include the proper use of influenza rapid tests in the diagnostic and treatment decision making process for individuals with influenza-like illness and especially among high-risk patients such as pregnant women, people 65 or older, children under 5, and especially <2 yrs. old, people with underlying chronic conditions, etc. (http://www.cdc.gov/flu/about/disease/high_risk.htm). (Kits may contain items such as pocket sized algorithms, wall posters, etc.)

· Integrate tools and materials with resources consistent with CDC guidelines and guidelines developed by other professional organizations. Coordinate access and use through professional clinical organizations such as physicians’ organizations, nurses’ organizations, clinical laboratory organizations, organizations representing outpatient facilities, and organizations representing healthcare workers.

· Assess the utility of electronic applications (APPs) and other electronic devices among the targeted outpatient providers (physicians, nurses, physicians’ assistants, healthcare workers, etc). Electronic tools may be piloted by members of these groups.

· Develop a sustainability and accessibility plan for updating and disseminating tools/materials, as necessary.

· Improve the understanding and application of the guidelines and updated information that CDC and professional organizations provide, particularly among outpatient facilities, to promote in more accurate and appropriate use of influenza rapid testing, more correctly diagnosed and correctly treated cases, and ultimately to decrease morbidity due to influenza.

· Broadly disseminate developed materials via all available formats (i.e., websites, streaming videos, mail, etc.), making them available and easily accessible to clinicians (physicians, nurses, physicians’ assistants, health-care workers, etc. ) in outpatient facilities such as physician’s offices, community health centers, emergency departments, and laboratories performing testing for these types of facilities. Materials will describe the proper use of influenza rapid tests in the diagnostic and treatment decision making process for individuals with influenza-like illness and especially with high-risk patients such as pregnant women, people 65 or older, children under 5, and especially <2 yrs. old, people with underlying chronic conditions, etc. (http://www.cdc.gov/flu/about/disease/high_risk.htm).

· Pursue and obtain linkages among TAP representatives and other professional organizations representing physicians, nurses, physicians’ assistants, healthcare workers, and laboratorians on their websites to assist with continued dissemination and updating of materials as experiences with influenza testing and diagnosis evolve.

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

CDC Activities

· Specify the types of analysis and information that is needed

· Specify the types of educational materials and tools that will be developed at a minimum, incorporating plans and ideas from the recipient

· Work with the awardee in identifying content for educational tools

· Provide background information on accepted practices and guidelines for testing and reporting.

· Provide technical assistance with the development of collection instruments.

· Identify subject matter experts on influenza testing and promote collaboration.

· Attend and provide leadership in holding meetings with federal partners and stakeholders to share information and collect their input.

· Attend and provide technical input and ideas in meetings with the technical advisory panel (TAP).

· Work with the awardee to identify potential systematic interventions to promote quality improvement and connectivity with public health.

· Collaborate in analyzing the data and information collected and in preparing written or oral summaries.

· Collaborate in the preparation of manuscripts for peer-reviewed publications.

II. AWARD INFORMATION

Type of Award: Cooperative Agreement - CDC substantial involvement in this program appears in the Activities Section above.

Award Mechanism: U47 Fiscal Year Funds: 2011 Approximate Current Fiscal Year Funding: $ 300,000 Approximate Total Project Period Funding: $ 600,000 (This amount is an estimate, and is subject to availability of funds.) Includes both direct and indirect costs. Approximate Number of Awards: 1 Approximate Average Award: $ 300,000 (This amount is for the first 12-month budget period, and includes both direct and indirect costs.)

Floor of Individual Award Range: $250,000

Ceiling of Individual Award Range: $300,000 (This ceiling is for the first 12-month budget period.) This is total cost.

Anticipated Award Date: April 29, 2011 Budget Period Length: 12 months

Project Period Length: 2 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

Eligible Applicants Eligible applicants that can apply for this funding opportunity are limited to non-profits with 501C3 IRS status (other than institutions of higher education).

The LEJ is limited to non-profits with 501C3 IRS status organizations that has the following:

· Major accrediting body in the U.S. and accredits hospitals, outpatient clinical treatment facilities, and laboratories;

· National accrediting body for community health centers, and user of influenza rapid tests;

· Assessed influenza rapid testing practices in outpatient facilities during the 2009 influenza season, including the H1N1 season;

· Identify laboratories that performed testing for emergency departments that participated in the previous studies (in 2008 and 2009) and in the assessment of rapid influenza testing practices in those outpatient facilities during the 2009 influenza season, including the H1N1 season;

· Facilitate collection of necessary data within the current influenza season and within the same year as the as the post- H1N1 data;

· Active listserv that reaches over 70,000 subscribers, professional clinical associations and other preferred communication streams proven to reach clinical facilities nationwide;

· Two or more years experience in gathering and analyzing data on influenza rapid test practice and use in a representative sample of outpatient facilities;

· Collected data from a representative sample of outpatient clinical facilities to determine how practices and utilization trends have changed since H1N1; and

· Experience and expertise communicating and providing guidance documents to all types of hospitals, outpatient clinical treatment facilities (community health centers and clinical laboratories); and through professional clinical organizations, and others representing outpatient clinicians.

Required Registrations

Registering your organization through www.Grants.gov, the official agency-wide E-grant website, is the first step in submitting an application online. Registration information is located on the “Get Registered” screen of www.Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes. The “one-time” registration process will take three to five days to complete. However, the Grants.gov registration process also requires that you register your organization with the Central Contractor Registry (CCR). The CCR registration can require an additional one to two days to complete. You are required to maintain a current registration in CCR.

Central Contractor Registration and Universal Identifier Requirements

All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the Central Contractor Registry (CCR) and maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later. CCR is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient. Additional information about registration procedures may be found at the CCR internet site at www.ccr.gov.

If an award is granted, the grantee organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its DUNS number to the grantee organization.

Cost Sharing or Matching

Cost sharing or matching funds are not required for this program.

Other

If a funding amount greater than the ceiling of the award range is requested, the application will be considered non-responsive and will not be entered into the review process. The applicant will be notified that the application did not meet the eligibility 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 a grant, loan, or an award.

Maintenance of Effort

Maintenance of Effort is not required for this program.

IV. Application and Submission Information

Address to Request Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity from Grants.gov. If access to the Internet is not available or if the applicant encounters difficulty in accessing the forms on-line, contact the HHS/CDC Procurement and Grant Office Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 for further instruction. CDC Telecommunications for the hearing impaired or disabled is available at: TTY 1-888-232-6348.

If the applicant encounters technical difficulties with Grants.gov, the applicant should contact Grants.gov Customer Service. The Grants.gov Contact Center is available 24 hours a day, 7 days a week, with the exception of all Federal Holidays. The Contact Center provides customer service to the applicant community. The extended hours will provide applicants support around the clock, ensuring the best possible customer service is received any time it’s needed. You can reach the Grants.gov Support Center at 1-800-518-4726 or by email at support@grants.gov. Submissions sent by e-mail, fax, CD’s or thumb drives of applications will not be accepted.

Content and Form of Application Submission

Unless specifically indicated, this announcement requires submission of the following information:

Table of Contents

CDC Assurances and Certifications can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm A letter of intent is not applicable to this funding opportunity announcement.

A Project Abstract must be completed in the Grants.gov application forms. The Project Abstract must contain a summary of the proposed activity suitable for dissemination to the public. It should be a self-contained description of the project and should contain a statement of objectives and methods to be employed. It should be informative to other persons working in the same or related fields and insofar as possible understandable to a technically literate lay reader. This abstract must not include any proprietary/confidential information.

A Project Narrative must be submitted with the application forms. The project narrative must be uploaded in a PDF file format when submitting via Grants.gov. The narrative must be submitted in the following format:

· Maximum number of pages: 30 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, Times New Roman

Double spaced

· Page margin size: One inch

· Number all narrative pages; not to exceed the maximum number of pages.

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

· Purpose and Need

· Goals and Objectives

· Methods and Technical Approach/Plan

· Project Management and Staffing Plan (including % of time spent for each of key personnel)

· Timeline

· Evaluation Plan

· Performance Measures

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 Vitae, Resumes

· Organizational Charts

· Indirect Cost Rate Agreement

· Letters of Agreement for any contractors that may be used in the work

· Letters of Support

Additional information submitted via Grants.gov should be uploaded in a PDF file format, and should be named:

· Curriculum vitae or Resumes

· Organizational Chart

· Letters of Support

· Contractor’s Letter of Agreement

· Indirect Cost Rate Agreement

No more than 10 attachments should be uploaded per application.

Additional requirements for additional documentation with the application are listed in Section VII. Award Administration Information, subsection entitled “Administrative and National Policy Requirements.”

Submission Dates and Times This announcement is the definitive guide on Letter of Intent (LOI) and application content, submission, and deadline. It supersedes information provided in the application instructions. If the application submission does not meet the deadline published herein, it will not be eligible for review and the applicant will be notified the application did not meet the submission requirements.

Application Deadline Date: April 14, 2011, 5:00pm Eastern Standard Time.

Intergovernmental Review

Executive Order 12372 does not apply to this program.

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

· Recipients may not use funds for research.

· Recipients may not use funds for clinical care.

· Recipients may only expend funds for reasonable program purposes, including personnel, travel, supplies, and services, such as contractual.

· Awardees may not generally use HHS/CDC/ATSDR funding for the purchase of furniture or equipment. Any such proposed spending must be identified in the budget.

· The direct and primary recipient in a cooperative agreement program must perform a substantial role in carrying out project objectives and not merely serve as a conduit for an award to another party or provider who is ineligible.

· Recipients may not use funds for construction.

· Reimbursement of pre-award costs is not allowed.

Other Submission Requirements

Application Submission

Submit the application electronically by using the forms and instructions posted for this funding opportunity on www.Grants.gov. If access to the Internet is not available or if the applicant encounters difficulty in accessing the forms on-line, contact the HHS/CDC Procurement and Grant Office Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 for further instruction.

Note: Application submission is not concluded until successful completion of the validation process. After submission of your application package, applicants will receive a “submission receipt” email generated by Grants.gov. Grants.gov will then generate a second e-mail message to applicants which will either validate or reject their submitted application package. This validation process may take as long as two (2) business days. Applicants are strongly encouraged check the status of their application to ensure submission of their application package is complete and no submission errors exists. To guarantee that you comply with the application deadline published in the Funding Opportunity Announcement, applicants are also strongly encouraged to allocate additional days prior to the published deadline to file their application. Non-validated applications will not be accepted after the published application deadline date.

In the event that you do not receive a “validation” email within two (2) business days of application submission, please contact Grants.gov. Refer to the email message generated at the time of application submission for instructions on how to track your application or the Application User Guide, Version 3.0 page 57.

Electronic Submission of Application

Applications must be submitted electronically at www.Grants.gov. Electronic applications will be considered as having met the deadline if the application has been successfully made available to CDC for processing from Grants.gov on the deadline date. The application package can be downloaded from www.Grants.gov. Applicants can complete the application package off-line, and then upload and submit the application via the Grants.gov Web site. The applicant must submit all application attachments using a PDF file format when submitting via Grants.gov. Directions for creating PDF files can be found on the Grants.gov Web site. Use of file formats other than PDF may result in the file being unreadable by staff.

Applications submitted through Grants.gov (http://www.grants.gov), are electronically time/date stamped and assigned a tracking number. The AOR will receive an e-mail notice of receipt when Grants.gov receives the application. The tracking number serves to document submission and initiate the electronic validation process before the application is made available to CDC for processing.

If the applicant encounters technical difficulties with Grants.gov, the applicant should contact Grants.gov Customer Service. The Grants.gov Contact Center is available 24 hours a day, 7 days a week, with the exception of all Federal Holidays. The Contact Center provides customer service to the applicant community. The extended hours will provide applicants support around the clock, ensuring the best possible customer service is received any time it’s needed. You can reach the Grants.gov Support Center at 1-800-518-4726 or by email at support@grants.gov. Submissions sent by e-mail, fax, CD’s or thumb drives of applications will not be accepted.

Organizations that encounter technical difficulties in using www.Grants.gov to submit their application must attempt to overcome those difficulties by contacting the Grants.gov Support Center (1-800-518-4726, support@grants.gov). After consulting with the Grants.gov Support Center, if the technical difficulties remain unresolved and electronic submission is not possible to meet the established deadline, organizations may submit a request prior to the application deadline by email to GMO/GMS for permission to submit a paper application. An organization's request for permission must: (a) include the Grants.gov case number assigned to the inquiry, (b) describe the difficulties that prevent electronic submission and the efforts taken with the Grants.gov Support Center (c) be submitted to the GMO/GMS at least 3 calendar days prior to the application deadline. Paper applications submitted without prior approval will not be considered.

If a paper application is authorized, the applicant will receive instructions from PGO TIMS to submit the original and two hard copies of the application by mail or express delivery service.

V. Application Review Information

Eligible applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the CDC-RFA-OE11-1103. Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement. Measures of effectiveness must be objective, quantitative and measure the intended outcome of the proposed program. The measures of effectiveness must be included in the application and will be an element of the evaluation of the submitted application.

Criteria Eligible applications will be evaluated against the following criteria:

Methods and Technical Approach/Plan (30 Points)

a. Does the applicant’s project plan and technical approach include utilizing the data already collected by the CDC and others to implement the plan?

b. Does the technical approach include identifying and assessing the specific clinical laboratories that performed influenza rapid testing for the emergency departments identified through previous surveys in 2008 and 2009? Does the technical approach address any potential legal or procedural barriers to collecting this information? Can the applicant identify these specific laboratories? Does the technical approach specifically state how this will be done?

c. Does the technical approach reflect the ability to identify representative samples in the U.S. of outpatient facilities and clinical laboratories that do testing for those outpatient facilities?

d. Does the project plan and technical approach reflect the ability to commence the project without significant start-up time due to learning curves, training newly hired staff or any other factors that would delay start-up? Does the plan reflect administering the clinical laboratory survey within eight weeks of the current influenza season and within the same year as the previously-collected post- H1N1 data?

e. How will the Technical Advisory Panel members be selected and informed about the project? Does the plan include utilization of technical advisors that are familiar with the data and outcomes of the previous CDC rapid influenza testing projects? What is the level of participation of panel members in previous CDC influenza projects? Is there evidence that each proposed panel member has knowledge and experience that is key to the project? Is there evidence that the proposed panel members agree to participate and support the goals of the project?

How will the TAP members be engaged in the design and implementation of the training?

f. Does the applicant clearly and succinctly describe the steps to be taken in the planning and implementation of the proposed cooperative agreement? Is the applicant sufficiently familiar with the results of previous CDC influenza testing projects (especially those done in 2008 and 2009 among outpatient facilities) sufficient to commence the project without delay?

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

Project Management and Staffing (30 points)

a. Which staff is responsible for overall project management? Do the project director and the project manager have specific expertise with collecting, analyzing and interpreting influenza rapid testing data from all types of outpatient facilities? Does the management staff have previous experience in accreditation of outpatient facilities, and access to accreditation data bases sufficient to identify representative U.S. samples of outpatient facilities and clinical laboratories that do testing for these facilities, and sufficient to collect enough data from various outpatient facilities and laboratories to be statistically meaningful? Are the management staff familiar with the influenza rapid testing data that has been previously collected during the 2008 and 2009 influenza seasons, including the H1N1 influenza season?

b. Which staff will design the clinical laboratory survey? Is this staff familiar with the influenza rapid testing data that has been previously collected during the 2008 and 2009 influenza seasons, including the H1N1 influenza season sufficient to design a meaningful and complimentary survey? Does the staff have knowledge and experience in clinical testing practices sufficient to design a meaningful clinical laboratory survey? Does the staff have knowledge and experience in influenza testing and rapid testing data? Does the staff have experience in outpatient treatment center testing practices and patient management?

c. Which staff will perform statistical analysis? Is this staff familiar with the influenza rapid testing data that has been previously collected during the 2008 and 2009 influenza seasons, including the H1N1 influenza season?

d. Which staff will design the training curriculum? Does this staff have knowledge and experience in outpatient practices for testing and patient management? Does this staff demonstrate experience in training clinical personnel in outpatient facilities? Is this staff familiar with the influenza rapid testing data that has been previously collected by the CDC sufficient to use that data in designing training materials? Is the staff familiar with influenza testing guidelines from CDC and professional organizations representing clinicians working in outpatient centers?

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

f. Are the staff roles clearly defined and does the applicant describe qualifications and time allocations of key personnel and other resources to be assigned to this project? Are CVs of all key personnel provided?

g. As described, can the management and staff of the applicant accomplish the program goals no loss of time due to hiring requirements, start-up, and learning curve sufficiently to accomplish the goals of the project, including administering the clinical laboratory assessment within eight weeks of the current (2011) influenza season?

Goals and Objectives (20 points)

a. Does the applicant describe how the clinical laboratory sites will be identified and targeted for the follow-up clinical laboratory assessment? Can the applicant identify the specific laboratories that did testing for the emergency departments that participated in the two previous CDC influenza rapid testing assessments?

b. Are there plans to implement the goals and activities described in the “project plan” of this FOA and for the “recipient activities” described in the FOA?

c. How will the TAP members be engaged in accomplishing goals?

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

e. Are the stated objectives specific, measurable, time-phased and achievable?

Evaluation Plan and Timeline (20 points)

a. Does the timeline reflect immediate start-up so as to capture data from clinical laboratories relevant to the current influenza season?

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

c. What specifically is the evaluation plan for success and uptake of the training? If professional organizations help sponsor or present the training, is there a plan for those organizations to evaluate success and share those outcomes with the CDC and the applicant?

d. Does the plan include a quantitative process and specific outcome measures?

e. Is there a plan for handling potential problems or delays?

Budget (SF 424A) and Budget Narrative (Reviewed, but not scored)] Although the budget is not scored applicants should consider the following in development of their budget. Is the itemized budget for conducting the project, and justification reasonable and consistent with stated objectives and planned program activities?

If the applicants requests indirect costs in the budget, a copy of the indirect cost rate agreement is required. If the indirect cost rate is a provisional rate, the agreement should be less than 12 months of age. The indirect cost rate agreement should be uploaded as a PDF file with “Other Attachment Forms” when submitting via Grants.gov.

The applicant can obtain guidance for completing a detailed justified budget on the CDC website, at the following Internet address:

http://www.cdc.gov/od/pgo/funding/budgetguide.htm.

Review

All eligible applications will be initially reviewed for completeness by the Procurement and Grants Office (PGO) staff. In addition, eligible applications will be jointly reviewed for responsiveness by Office of Surveillance Epidemiology and Laboratory Services and PGO. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will be notified the application did not meet eligibility and/or published submission requirements.

An objective review panel will evaluate complete and responsive applications according to the criteria listed in Section VI. Application Review Information, subsection entitled “Evaluation Criteria”. The objective review process will follow the policy requirements as stated in the GPD 2.04 at http://198.102.218.46/doc/gpd204.doc. CDC employees will review the applications.

Selection

Applications will be funded in order by score and rank determined by the review panel.

VI. Award Administration Information

Award Notices

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

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration and Transparency Act requirements.

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

Administrative and National Policy Requirements

Successful applicants must comply with the administrative requirements outlined in 45 Code of Federal Regulations (CFR) Part 74 or Part 92, as appropriate. The following additional requirements apply to this project:

· AR-9

Paperwork Reduction Act Requirements

· AR-10

Smoke-Free Workplace Requirements

· AR-11

Healthy People 2020

· AR-12

Lobbying Restrictions

· AR-15

Proof of Non-Profit Status

· AR-21

Small, Minority, and Women-Owned Business

· AR-23

States and Faith-Based Organizations

· AR-25

Release and Sharing of Data

· AR-26

National Historic Preservation Act of 1966

(Public Law 89-665, 80 Stat. 915)

· AR-27

Conference Disclaimer and Use of Logos

· AR-29

Compliance with E.O. 13513 Federal Leadership on Reducing

Text Messaging While Driving, October 1, 2009

· AR-30

Information Letter 10-006. – Compliance with Section 508 of the

Rehabilitation Act of 1973

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

Federal Funding Accountability And Transparency Act Of 2006 (FFATA): Public Law 109-282, the Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), requires full disclosure of all entities and organizations receiving Federal funds including grants, contracts, loans and other assistance and payments through a single publicly accessible Web site, www.USASpending.gov. The Web site includes information on each Federal financial assistance award and contract over $25,000, including such information as:

1. The name of the entity receiving the award

2. The amount of the award

3. Information on the award including transaction type, funding agency, etc.

4. The location of the entity receiving the award

5. A unique identifier of the entity receiving the award; and

6. Names and compensation of highly-compensated officers (as applicable)

Compliance with this law is primarily the responsibility of the Federal agency. However, two elements of the law require information to be collected and reported by recipients: 1) information on executive compensation when not already reported through the Central Contractor Registry; and 2) similar information on all sub-awards/subcontracts/consortiums over $25,000.

For the full text of the requirements under the Federal Funding Accountability and Transparency Act of 2006, please review the following website:

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_cong_bills&docid=f:s2590enr.txt.pdf .

Each funded applicant must provide CDC with an annual Interim Progress Report submitted via www.grants.gov:

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

a. Standard Form (“SF”) 424S Form.

b. SF-424A Budget Information-Non-Construction Programs.

c. Budget Narrative.

d. Indirect Cost Rate Agreement.

e. Project Narrative.

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

2. Quarterly Progress Report, 30 days after the end of each quarter. The progress report must contain the following contents:

a. Quarterly Budget Period Activities Objectives

b. Quarterly Budget Period Financial Progress

c. Next Quarter Proposed Activity Objectives

d. Measures of Effectiveness

3. Progress Report, due at the end of the budget period. Annual progress report, due 90 days after the end of the budget period. The report must contain the following contents:

a. Background Information

b. Methodological Approach Used

c. Results Obtained

d. Discussion of Findings and Future Direction

4. Financial Status Report* (SF 269) and annual progress report, no more than 90 days after the end of the budget period.

5. Final performance and Financial Status Reports*, no more than 90 days after the end of the project period.

*Disclaimer: As of February 1, 2011, current Financial Status Report (FSR) requirements will be obsolete. Existing practices will be updated to reflect changes for implementation of the new Federal Financial Reporting (FFR) requirements.

These reports must be submitted to the attention of the Grants Management Specialist listed in the Section VII below entitled “Agency Contacts”.

VII. Agency Contacts

CDC encourages inquiries concerning this announcement.

For programmatic technical assistance, contact:

Laurina Williams, PhD, MPH - Project Officer

Department of Health and Human Services

Centers for Disease Control and Prevention

1600 Clifton Rd., MS G-25

Atlanta, GA 30333

Telephone: 404-498-2267 (office); 404-512-1589 (blackberry)

E-mail: low1@cdc.gov

For financial, grants management, or budget assistance, contact:

Ebony Holt, Grants Management Specialist

CDC Procurement and Grants Office

2920 Brandywine Road, MS K-69

Atlanta, GA 30341

Telephone: 770-488-5872

E-mail: gvl2@cdc.gov For assistance with submission difficulties, contact:

Grants.gov Contact Center Phone: 1-800-518-4726.

Hours of Operation: 24 hours a day, 7 days a week. Closed on federal holidays.

For submission questions, contact:

Technical Information Management Section

CDC Procurement and Grants Office

2920 Brandywine Road, MS E-14

Atlanta, GA 30341

Telephone: 770-488-2700

Email:

pgotim@cdc.gov

CDC Telecommunications for the hearing impaired or disabled is available at: TTY 770-488-2783.

VIII. Other Information

Other CDC funding opportunity announcements can be found at www.grants.gov.

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