Billing Code: 4163-18-P
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Evaluation of the Use of Rapid Testing For Influenza in Outpatient Medical Settings
Announcement Type: New
Funding Opportunity Number: CDC-CI07-711
Catalog of Federal Domestic Assistance Number: 93.064
Application Deadline: August 6, 2007
Authority: This program is authorized under section 317(k)(2) of the Public Health Service Act [42 USC 247b(k)(2)], as amended.
Background: Influenza epidemics usually occur during the winter months causing an average of 36,000 deaths per year. Respiratory illnesses caused by influenza viruses are not easily differentiated from other respiratory infections based solely on symptoms. Rapid influenza tests are increasingly used as an aid to diagnosis, particularly in physician offices because they provide results in 30 minutes or less compared to the three to ten days required for viral culture results. Currently more than 15 rapid tests approved by the U.S. Food and Drug Administration are commercially available. Eight of these rapid tests are waived from federal requirements for laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) which permits their widespread use in non-traditional laboratory settings such as nursing homes, clinics, and physician’s offices. The reliability of rapid influenza tests is influenced by variables such as: the individual test product used (median sensitivities are 70-75%; median specificities are 90-95%), the stage of illness when the specimen is collected, type and adequacy of the specimen collected, and disease activity in the community. When disease prevalence is lower (the beginning or end of the influenza season), false-positive results are more likely to occur and negative results are more likely to be true negatives. When influenza prevalence is high, positive test results are more likely to be correct and false-negative results are more likely to occur.
Rapid screening tests are beneficial during outbreaks and aid in diagnosis and treatment of respiratory illness; however, they do not address the essential public health need for new clinical isolates. Isolates of influenza virus circulating in the community are needed for comparison with the current season’s vaccine and for the selection of future vaccine strains.
Purpose: The purpose of this project is to evaluate how rapid tests for influenza are being implemented and used in clinical practice in outpatient medical settings such as community clinics, solo and group practice physician offices, and hospital emergency rooms across the United States. This evaluation will include a determination 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. Additionally, this project may identify potential opportunities to provide guidance to assist sites in making decisions on the appropriate use of these tests and ways to enhance the connectivity with the public health system. Connectivity with public health is especially important in light of the possibility of an influenza pandemic.
This project will identify and evaluate practices used in outpatient settings related to processes such as specimen collection, testing, reporting and referral for influenza. This program addresses the “Healthy People 2010” focus areas of Access to Quality Health Services, Health Communication, Immunization and Infectious Diseases, Public Health Infrastructure, and Respiratory Diseases.
Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the National Center for Preparedness, Detection and Control of Infectious Diseases (NCPDCID): 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/regs/hrpp/researchDefinition.htm.
Activities:
Awardee activities for this program are as follows:
Provide leadership in developing a program to determine the national scope of rapid influenza test utilization in outpatient medical settings, including the community clinics, solo and group practice physician offices, and hospital emergency rooms. Information to be collected includes: demographics of sites using these tests, the specific tests used and how they are selected, the personnel who perform the testing, testing volume (annual and/or seasonal), patient populations, the purposes for testing, effect on patient care and treatment, and other characteristics related to the sites where rapid influenza testing is being conducted.
Evaluate how these tests are integrated into the outpatient health delivery system such as the methods used for specimen collection and handling, test performance, results interpretation and reporting, therapeutic decision-making and other follow up actions. Also, evaluate perceptions of clinicians and testing personnel as to the advantages and disadvantages of using these tests.
Assess the practices used to assure quality such as quality assurance, proficiency testing participation, and personnel training and competency assessment.
Identify issues negatively impacting testing such as test performance, false negative and false positive results, and personnel turnover.
Assess the extent to which the outpatient testing sites are linked into local or state public health systems for disease reporting and specimen referral.
Recommend specific interventions such a practice guidelines or training that could improve the utilization and quality of testing using rapid influenza tests.
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:
Assist the awardee in identifying outpatient sites using rapid influenza tests.
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.
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.
Assist in the preparation of manuscripts for peer-reviewed publications.
Type of Award: Cooperative Agreement
CDC’s involvement in this program is listed in the Activities Section above.
Award Mechanism: U47
Fiscal Year Funds: 2007
Approximate Current Fiscal Year Funding: $200,000.
Approximate Total Project Period Funding: $600,000. (This amount is an estimate, and is subject to availability of funds. The stated amount includes both direct and indirect costs.)
Approximate Number of Awards: 1
Approximate Average Award: $200,000. (This amount is for the first 12-month budget period, and includes both direct and indirect costs.)
Floor of Individual Award Range: None
Ceiling of Individual Award Range: $200,000 (This total-cost ceiling is for the first 12-month budget period.)
Anticipated Award Date: August 31, 2007
Budget Period Length: 12 months
Project Period Length: 3 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.1. Eligible Applicants
Eligible applicants that can apply for this funding opportunity are listed below:
Public nonprofit organizations
Private nonprofit organizations
Small, minority, women-owned businesses
Universities
Colleges
Research institutions
Hospitals or Medical Centers
Community-based organizations
Faith-based organizations
Federally recognized Indian tribal governments
Indian tribes
Indian tribal 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)
Political subdivisions of States (in consultation with States)
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 applying as a bona fide agent of a state or local government, a letter from the state or local government as documentation of the status is required. Place this documentation behind the first page of the application form.
III.2. Cost Sharing or Matching
Matching funds are not required for this program.
III.3. Other
CDC will accept and review application with budget greater than the ceiling of the award range.
Special Requirements:
If the application is incomplete or non-responsive to the special requirements listed in this section, it will not be entered into the review process. The applicant will be notified the application did not meet submission requirements.
Late applications will be considered non-responsive. See section “IV.3. Submission Dates and Times” for more information on deadlines.
Your application should indicate the extent of your experience in working with clinical laboratory services and infectious disease testing, and should additionally provide letters of support – both in an application appendix.
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.
IV.1. Address to Request Application Package
To apply for this funding opportunity use application form PHS 5161-1.
Electronic Submission:
CDC strongly encourages the applicant to submit the application electronically by utilizing the forms and instructions posted for this announcement on www.Grants.gov, the official Federal agency wide E-grant Web site. Only applicants who apply on-line are permitted to forego paper copy submission of all application forms.
Registering your organization through www.Grants.gov is the first step in submitting applications online. Registration information is located in the “Get Started” screen of www.Grants.gov. While application submission through www.Grants.gov is optional, we strongly encourage you to use this online tool.
Please visit www.Grants.gov at least 30 days prior to filing your application to familiarize yourself with the registration and submission processes. Under “Get Started,” the one-time registration process will take three to five days to complete. We suggest submitting electronic applications prior to the closing date so if difficulties are encountered, you can submit a hard copy of the application prior to the deadline.
Paper Submission:
Application forms and instructions are available on the CDC Web site, at the following Internet address: http://www.cdc.gov/od/pgo/funding/forms.htm.
If access to the Internet is not available, or if there is difficulty accessing the forms on-line, contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) staff at 770-488-2700 and the application forms can be mailed.
IV.2. Content and Form of Submission
Application:
A Project Abstract must be submitted with the application forms. The abstract must be submitted in the following format:
Maximum of one page.
Font size: 12 point unreduced, Times New Roman
Single spaced
Paper size: 8.5 by 11 inches
Page margin size: One inch
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 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.
Paper size: 8.5 by 11 inches
Page margin size: One inch
Number all pages of the application sequentially from page 1 (Application Face Page) to the end of the application, including charts, figures, tables, and appendices.
Printed only on one side of page.
Held together only by rubber bands or metal clips; not bound in any other way.
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
Performance Measures and Timeline
Evaluation Plan
Required Resources with Budget and Justification
Note: the section entitled “Required Resources with Budget and Justification” will not count toward 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 Vitae, Resumes, and Organizational Charts
Letters of Support
References
Additional information submitted via Grants.gov should be labeled:
CVs
Organizational Structure
Supporting Letters
References
Other Supporting Materials
No more than five electronic attachments should be uploaded per application.
The agency or organization is 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.
Additional requirements that may request submittal of additional documentation with the application are listed in section “VI.2. Administrative and National Policy Requirements.”
Application Deadline Date: August 6, 2007
Explanation of Deadlines: Applications must be received in the CDC Procurement and Grants Office by 4:00 p.m. Eastern Time on the deadline date.
Applications may be submitted electronically at www.Grants.gov. Applications completed on-line through Grants.gov are considered formally submitted when the applicant organization’s Authorizing Official electronically submits the application to www.Grants.gov. Electronic applications will be considered as having met the deadline if the application has been submitted electronically by the applicant organization’s Authorizing Official to Grants.gov on or before the deadline date and time.
If submittal of the application is done electronically through Grants.gov (http://www.grants.gov), the application will be electronically time/date stamped, which will serve as receipt of submission. Applicants will receive an e-mail notice of receipt when HHS/CDC receives the application.
If submittal of the application is by the United States Postal Service or commercial delivery service, the applicant must ensure that the carrier will be able to guarantee delivery by the closing date and time. The applicant will be given the opportunity to submit documentation of the carrier’s guarantee, if HHS/CDC receives the submission after the closing date 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. If the documentation verifies a carrier problem, HHS/CDC will consider the submission as having been received by the deadline.
If a hard copy application is submitted, HHS/CDC will not notify the applicant upon receipt of the submission. If questions arise on the receipt of the application, the applicant should first contact the carrier. If the applicant still has questions, contact the PGO-TIM staff at (770) 488-2700. The applicant should wait two to three days after the submission deadline before calling. This will allow time for submissions to be processed and logged.
This announcement is the definitive guide on LOI and application content, submission address, and deadline. It supersedes information provided in the application instructions. If the application submission does not meet the deadline above, it will not be eligible for review, and will be discarded by HHS/CDC. The applicant will be notified the application did not meet the submission requirements.
IV.4. Intergovernmental Review of Applications
Executive Order 12372 does not apply to this program.
IV.5. 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.
Reimbursement of pre-award costs is not allowed.
Reimbursement of construction costs is not allowed.
If requesting 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 recommended guidance for completing a detailed justified 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:
Electronic Submission:
HHS/CDC strongly encourages applicants to submit applications electronically at www.Grants.gov. The application package can be downloaded from www.Grants.gov. Applicants are able to complete it off-line, and then upload and submit the application via the Grants.gov Web site. E-mail submissions will not be accepted. If the applicant has technical difficulties in Grants.gov, customer service can be reached by E-mail at http://www.grants.gov/CustomerSupport or by phone at 1-800-518-4726 (1-800-518-GRANTS). The Customer Support Center is open from 7:00a.m. to 9:00p.m. Eastern Time, Monday through Friday.
HHS/CDC recommends that submittal of the application to Grants.gov should be early to resolve any unanticipated difficulties prior to the deadline. Applicants may also submit a back-up paper submission of the application. Any such paper submission must be received in accordance with the requirements for timely submission detailed in Section IV.3. of the grant announcement. The paper submission must be clearly marked: “BACK-UP FOR ELECTRONIC SUBMISSION.” The paper submission must conform to all requirements for non-electronic submissions. If both electronic and back-up paper submissions are received by the deadline, the electronic version will be considered the official submission.
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.
OR
Paper Submission:
Applicants should submit the original and two hard copies of the application by mail or express delivery service to:
2920 Brandywine Road
Atlanta, GA 30341
V.1. Criteria
Applicants 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. The measures of effectiveness must be submitted with the application and will be an element of evaluation.
The application will be evaluated against the following criteria:
Methods and Technical Approach/Plan (30 Points)
Does the applicant clearly and succinctly describe the steps to be taken in the planning and implementation of the proposed cooperative agreement?
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)
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?
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?
As described, will the staff be sufficient to accomplish the program goals?
Goals and Objectives (20 points)
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?
Are the stated objectives specific, measurable, time-phased and achievable?
Evaluation Plan and Timeline (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?
Does the plan include a quantitative process and specific outcome measures?
Required resources with budget and justification – Reviewed, but not scored
V.2. Review and Selection Process
Applications will be reviewed for completeness by the Procurement and Grants Office (PGO) staff, and for responsiveness jointly by NCPDCID 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 submission requirements.
An objective review panel will evaluate complete and responsive applications according to the criteria listed in the “V.1. Criteria” section above. The objective review panel will consist of CDC employees from outside the funding division who will evaluate the technical merit of the application for the purpose of advising the awarding official. As part of the review process, the application will:
Receive a written Summary Statement of the findings of the Objective Review Panel.
Receive a vote of approval or disapproval and an approval score.
Receive a second programmatic level review by Division senior staff.
Applications will be funded in order by score and rank determined by the review panel.
CDC will provide justification for any decision to fund out of rank order.
V.3. Anticipated Announcement Award Dates
August 31, 2007
VI.1. 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 emailed to the program director and a hard copy 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
Successful applicants must comply with the administrative requirements outlined in 45 CFR Part 74 and Part 92, as appropriate. The following additional requirements apply to this project:
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
AR-14 Accounting System Requirements
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
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.
VI.3. Reporting Requirements
The applicant must provide CDC with an original, plus two hard copies of the following reports:
1. Interim Quarterly Progress Report, due no more than 30 days after the end of each quarter. The progress report must contain the following elements:
a. Quarterly Budget Period Activities Objectives.
b. Quarterly Budget Period Financial Progress.
c. Next Quarter Proposed Activity Objectives.
d. Measures of Effectiveness.
e. Additional Requested Information.
2. Final Report, due 90 days after the end of the budget period to include:
a. Background Information,
b. Methodological Approach Used
c. Results Obtained
d. Discussion of Findings and Future Direction
Final Performance and Financial Status Report, no more than 90 days after the end of the project period.
The reports must be mailed to the Grants Management Specialist listed in the “Agency Contacts” section of this announcement.
CDC encourages inquiries concerning this announcement.
For general questions, contact:
CDC Procurement and Grants Office
2920 Brandywine Road
Atlanta, GA 30341
Telephone: 770-488-2700
For program technical assistance, contact:
Devery A. Howerton, Ph.D., Project Officer
Department of Health and Human Services
CDC/CCID/NCPDCID/DLS
1600 Clifton Road, N.E., Mailstop G-23
Atlanta, GA 30333
Telephone: 404-718-1016
Fax: 404-718-1080
E-mail: dxh7@cdc.gov
For financial, grants management, or budget assistance, contact:
Yolanda Sledge, Grants Management Specialist
CDC Procurement and Grants Office
2920 Brandywine Road, Mail stop: E-14
Telephone: (770) 488-2787
E-mail: yiso@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 on the CDC Web site, Internet address: http://www.cdc.gov/od/pgo/funding/FOAs.htm.
CDC Home Page: http://www.cdc.gov
CDC Funding Web Page: http://www.cdc.gov/od/pgo/funding/funding.htm
CDC Forms Web Page: http://www.cdc.gov/od/pgo/forminfo.htm