U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention (CDC)
Gonococcal Isolate Surveillance Project (GISP) Regional Laboratories
Announcement Type: New – Limited Competition - Type 1
Funding Opportunity Number: CDC-RFA-PS09- 901
Catalog of Federal Domestic Assistance Number: 93.977
Preventive Health Services-Sexually Transmitted Diseases Control Grants
Key Dates:
Letter of Intent Deadline: August 5, 2008
Application Deadline: September 4, 2008
Executive Summary: NA
This announcement contains the following information:
Authority: Sections 317 (k) (2) and 318 of the Public Health Service Act [42 U.S.C. Sections 247b(k) (2) and 247c], as amended.
Background: Approximately 700,000 persons require treatment for gonorrhea each year, and it is essential these patients receive effective therapy in order to prevent serious sequelae (e.g., pelvic inflammatory disease, infertility, and ectopic pregnancy), to prevent increased sexual transmission of HIV, and to prevent the further transmission of gonorrhea. However, effective gonococcal therapy is complicated by the ability of Neisseria gonorrhoeae to develop resistance to antimicrobial therapies.
The Gonococcal Isolate Surveillance Project (GISP) was created in 1986 to address the problem of changing resistance patterns in N. gonorrhoeae and has been a unique national sentinel surveillance system to monitor trends in antimicrobial susceptibilities of strains of N. gonorrhoeae in the United States. Data provided by GISP from the GISP regional laboratories and sentinel sites assists in establishing a rational basis for the selection of gonococcal therapies. These data have directly contributed to CDC’s Sexually Transmitted Diseases (STD) Treatment Guidelines in 1993, 1998, 2002, and 2006. Most recently, increased prevalence of fluoroquinolone-resistant N. gonorrhoeae (QRNG) as seen in GISP data from 2005 to June 2006, prompted CDC to release a Morbidity and Morality Weekly Report (MMWR) article which states that fluoroquinolones were no longer the recommended treatment for gonococcal infections in the U.S.
Purpose: The purpose of the program is to establish GISP regional laboratories to provide timely antimicrobial susceptibility testing on all isolates from GISP sentinel sites using the GISP protocol and to serve as expert/ technical consultants to GISP. (The GISP protocol can be found at http://www.cdc.gov/std/gisp/default.htm under GISP protocol)
This program addresses the “Healthy People 2010” focus area 25, Sexually Transmitted Diseases.
Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the Coordinating Center for Infectious Diseases (CCID), National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP): 1) Reduction of Pelvic Inflammatory Disease (PID); and 2) Elimination of syphilis.
This announcement is only for non-research activities supported by HHS/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:
In a cooperative agreement, HHS/CDC staff is substantially involved in the program activities, above and beyond routine grant monitoring.
HHS/CDC activities for this program are as follows:
Type of Award: Cooperative Agreement
HHS/CDC’s involvement in this program is listed in the Activities Section above.
Award Mechanism: H25 Venereal Disease Control Cooperative Agreement
Fiscal Year Funds: 2009
Approximate Current Fiscal Year Funding: $ 600,000
Approximate Total Project Period Funding: $ 3,000,000 (This amount is an estimate, and is subject to availability of funds, and includes both direct and indirect costs.)
Approximate Number of Awards: Up to 5
Approximate Average Award: $ 120,000 (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: $160,000 (This ceiling is for the first 12-month budget period only, and includes both direct and indirect costs.)
Anticipated Award Date: January 1, 2009
Budget Period Length: 12 months
Project Period Length: 5 years
Throughout the project period, HHS/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:
·
Nonprofit with 501C3 IRS status (other than institution of highereducation)
·
Nonprofit without 501C3 IRS status (other than institution of highereducation)
·
For-profit organizations (other than small business)·
Small, minority, and women-owned businesses·
Universities·
Colleges·
Research institutions·
Hospitals·
Community-based organizations·
Faith-based organizations·
Federally recognized or state-recognized American Indian/AlaskaNative tribal governments
·
American Indian/Alaska native tribally designated organizations·
Alaska Native health corporations·
Urban Indian health organizations·
Tribal epidemiology centers·
State and local governments or their Bona Fide Agents (this includesthe 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. Attach with “Other Attachment Forms” when submitting via www.grants.gov.
For the proposed program, eligible participants must be located in the United States and must have the necessary infrastructure in place to perform the activities required for this national surveillance program. In addition, participants must have the expertise and experience needed to successfully complete the required functions.
Participants must have a laboratory director with known expertise in the field of Neisseria gonorrhoeae who has had previous experience in the area of surveillance and epidemiology of antimicrobial resistant Neisseria gonorrhoeae. In addition, the laboratory must be located in the United States and have the demonstrated capacity to perform antimicrobial susceptibility testing on specific antibiotics as directed by the GISP protocol using the agar dilution method on a minimum of 1,500 isolates per year from multiple GISP sentinel sites and the capacity to increase testing, if needed. Furthermore, laboratory personnel must have had previous experience in the culturing, handling, and storage of gonococcal isolates; and the willingness to collaborate and disseminate results electronically in a timely manner to CDC, GISP sites, and to state/local public health authorities.
III.2. Cost Sharing or Matching
Cost sharing or matching funds are not required for this program.
III.3. 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 submission requirements.
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.
IV.1. Address to Request Application Package
To apply for this funding opportunity use the application forms package posted in Grants.gov.
Electronic Submission:
HHS/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 Registered” 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 Registered,” the one-time registration process will take three to five days to complete; however, as part of the Grants.gov registration process, registering your organization with the Central Contractor Registry (CCR) annually, could take an additional one to two 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.
IV.2. Content and Form of Submission
Letter of Intent (LOI):
Prospective applicants are asked to submit a letter of intent that includes the following information:
Application:
A Project Abstract must be submitted with the application forms. All electronic project abstracts must be uploaded in a PDF file format when submitting via Grants.gov. The abstract must be submitted in the following format, if submitting a paper application:
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. All electronic narratives must be uploaded in a PDF file format when submitting via Grants.gov. The narrative must be submitted in the following format, if submitting a paper application:
The narrative should address activities to be conducted over the entire project period and must include the following items in the order listed:
Additional information may be included in the application appendices. The appendices will not be counted toward the narrative page limit. This additional information includes:
Additional information submitted via Grants.gov should be uploaded in a PDF file format, and should be named:
No more than 10 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 the Dun and Bradstreet website or call 1-866-705-5711.
Additional requirements that may request submission of additional documentation with the application are listed in section “VI.2. Administrative and National Policy Requirements.”
Letter of Intent (LOI) Deadline Date: August 5, 2008
Application Deadline Date: September 4, 2008
Explanation of Deadlines: LOIs and Applications must be received in the CDC Procurement and Grants Office by 5:00 p.m. Eastern Time on the deadline date.
Applications must be submitted electronically at www.Grants.gov. Applications completed on-line through Grants.gov are considered formally submitted when the applicant organization’s Authorizing Organization Representative (AOR) electronically submits the application to www.Grants.gov. Electronic applications will be considered as having met the deadline if the application has been successfully submitted electronically by the applicant organization’s AOR to Grants.gov on or before the deadline date and time.
When submission of the application is done electronically through Grants.gov (http://www.grants.gov), the application will be electronically time/date stamped and a tracking number will be assigned, which will serve as receipt of submission. The AOR will receive an e-mail notice of receipt when HHS/CDC receives the application.
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. The application face page will be returned by HHS/CDC with a written explanation of the reason for non-acceptance. The applicant will be notified the application did not meet the submission requirements.
IV.4. Intergovernmental Review of Applications
The application is subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (EO) 12372. This order sets up a system for state and local governmental review of proposed federal assistance applications. Contact the state single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications and to receive instructions on the State’s process. Visit the following Web address to get the current SPOC list:
IV.5. Funding Restrictions
Restrictions, which must be taken into account while writing the budget, are as follows:
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 indirect cost rate agreement should be uploaded as a PDF file with “Other Attachment Forms” when submitting via Grants.gov.
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
LOI Submission Address: Submit the LOI by express mail, delivery service, fax, or E-mail to:
Eileen Yee, MD
CDC/NCHHSTP/DSTDP/ESB
For express/overnight delivery:10 Corporate Square Blvd,
Room 2422, Atlanta, GA 30329
For regular mail: 1600 Clifton Rd, Mailstop E-02, Atlanta, GA 30333
Telephone: 404-639-8373
Fax: 404-639-8610
EYee@cdc.gov
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CDC Program staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed in Section IV.3.A.
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 support@grants.gov 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 prior to the closing date 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.
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:
Principal Investigator Expertise/Experience: (25 points total)
·
(10 points) Is the principal investigator (PI), a known expert in the field of Neisseria gonorrhoeae, as demonstrated in part by publication records and with a minimal of 5 year experience in this field? Does the PI also have experience in the areas such as surveillance and epidemiology of STDs, specifically with antimicrobial resistant N. gonorrhoeae?·
(5 points) Has the PI participated either in GISP in the past or has demonstrated significant participation in a similar antimicrobial resistant N. gonorrhoeae surveillance system? Documentation must be provided.·
(5 points) Does the PI have the appropriate scientific oversight in the area of antimicrobial resistant N. gonorrhoeae necessary to fulfill the program requirements?·
(5 points) Is the PI, a laboratory director, for a laboratory capable of culturing, performing antimicrobial susceptibilities to penicillin, tetracycline, spectinomycin, cefixime, ceftriaxone, ciprofloxacin, azithromycin, and other antibiotics as needed for N. gonorrhoeae isolates using the agar dilution method? And is the laboratory capable of testing for ß-lactamase production by the Nitrocefin test, as directed by the GISP protocol? CV for the PI must be provided with documentation of publications within the field of N. gonorrhoeae.
Laboratory Personnel Expertise/Experience: (20 points total)
·
(10 points) Do the laboratory personnel have appropriate background and experience working directly with culturing, performing antimicrobial susceptibilities to penicillin, tetracycline, spectinomycin, cefixime, ceftriaxone, ciprofloxacin, and azithromycin on N. gonorrhoeae isolates using the agar dilution method, and testing for ß-lactamase production by the Nitrocefin test, as directed by the GISP protocol?·
(2 points) Is the grantee willing to run a set of control strain with each run as directed by the GISP protocol?·
(2 points) Does the grantee demonstrate the capability and willingness to provide the technical support and resources necessary to improve or optimize the quality of GISP isolates submitted by GISP sites?·
(2 points) Does the grantee have documented experience with specimen storage and transport? Is the grantee familiar with DOT regulations for shipping infectious agents and have they been specifically trained to meet such regulations?·
(2 points) Is there a commitment from the grantee to disseminate results to GISP sites, local/state public health authorities, and to CDC in a timely manner?·
(2 points) Will the grantee be willing to participate in a CDC administered external quality assessment test for N. gonorrhoeae antimicrobial susceptibility testing twice a year?
Laboratory Capacity: (20 points total)
·
(5 points) Has the grantee demonstrated willingness and capacity to perform antimicrobial susceptibility testing using the methods as directed by the GISP protocol on at least 1,500 N. gonorrhoeae isolates submitted each year? Does the laboratory have the capacity and willingness to increase testing for up to 2,500 isolates a year?·
(5 points) Does the grantee have capacity to receive, handle, store, and transport N. gonorrhoeae isolates as directed by the GISP protocol?·
(5 points) Can the grantee provide duplicate or triplicate copies of N. gonorrhoeae isolates when requested by CDC?·
(5 points) Does the grantee demonstrate the capacity to perform appropriate confirmatory testing on isolates that exhibit atypical colonial morphologic characteristics or aberrant susceptibility patterns?
Collaboration: (15 points total)
·
(5 points) Has the grantee demonstrated ability to successfully collaborate with CDC, state/local public health departments, and publicly-funded STD clinics?·
(5 points) Is the grantee willing to participate actively on GISP conference calls and at the GISP PI annual meeting?·
(5 points) Is the grantee willing to collaborate directly in the publication and dissemination of project findings?
Timeliness: (10 points total)
·
(5 points) Does the grantee have the electronic capacity and willingness to disseminate monthly results from the project in a timely manner to CDC, GISP sites, and local/state public health authorities?·
(5 points) Has the grantee demonstrated its capacity to communicate, in a timely manner, results of isolates with an alert value MIC and/or problems with improper shipping, non-viability, or contamination to CDC, GISP sites, and local/state public health authorities?
Timeline: (4 points total)
·
(2 points) Has the grantee proposed an achievable timeline for these activities?·
(2 points) Has the grantee documented its ability to implement the proposed project within 1 – 4 months of the start of the project period?
Sustainability: (2 points total) What extent has the grantee demonstrated that activities can continue as ongoing surveillance activities?
Objectives/Plan: (2 points total) Does the grantee have a clear objective of the project and does the project adhere to the GISP protocol?
Data Security: (2 points total) Does the grantee meet or exceed CDC HIV/STD surveillance data security and confidentiality guidelines and will not provide CDC with any GISP participants’ identifying information (i.e. name or contact information)?
Budget (SF 424A) and Budget Narrative (Reviewed, but not scored) Is the budget reasonable, clearly justified, and consistent with the intended use of funds and itemized into categories for annual testing of a minimum of 1,500 isolates?
V.2. Review and Selection Process
Applications will be reviewed for completeness by the Procurement and Grants Office (PGO) for responsiveness jointly by NCHHSTP/DSTDP 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 if 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.
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.
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:
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.
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
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 annual interim progress report via www.grants.gov:
1. The interim progress report is due no less than 90 days before the end of the budget period. The 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, the applicant must provide CDC with an original, plus two hard copies of the following reports:
2. Annual progress report, due 90 days after the end of the budget period. 3. Financial status report and annual progress report, no more than 90 days after the end of the budget period.These reports must be submitted to the attention of the Grants Management Specialist listed in “VII. Agency Contacts” section of this announcement.
CDC encourages inquiries concerning this announcement.
For general questions, contact:
CDC Procurement and Grants Office
2920 Brandywine Road, MS E-14
Atlanta, GA 30341
Telephone: 770-488-2700
For program technical assistance, contact:
Eileen Yee, MD, Project Officer
NCHHSTP/DSTDP/ESB
For regular mail: 1600 Clifton Rd, Mailstop E-02, Atlanta, GA 30333
For express/overnight delivery: 10 Corporate Square Blvd,
Room 2422, Atlanta, GA 30329
Telephone: 404-639-8373
Fax: 404-639-8610
E-mail: EYee@cdc.gov
For financial, grants management, or budget assistance, contact:
Cheryl Pressley, Grants Management Specialist
CDC Procurement and Grants Office
2920 Brandywine Road, MS E-15
Telephone: 404-639-8164
E-mail: CAM6@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.
GISP protocol and annual reports can be found at: http://www.cdc.gov/std/gisp/default.htm
Applicants may access the application process and other awarding documents using the Electronic Research Administration System (eRA Commons). A one-time registration is required for interested institutions/organizations at http://era.nih.gov/ElectronicReceipt/preparing.htm
Program Directors/Principal Investigators (PD/PIs) should work with their institutions/organizations to make sure they are registered in the eRA Commons.
1. Organizational/Institutional Registration in the eRA Commons
2. Project Director/Principal Investigator (PD/PI) Registration in the eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Note that if a PD/PI is also an HHS peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should check with their business official to determine whether their organization/institution is already registered in the eRA Commons. HHS/CDC strongly encourages applicants to register to utilize these helpful on-line tools when applying for funding opportunities.
CDC Home Page: http://www.cdc.gov
CDC Funding Web Page: http://www.cdc.gov/od/pgo/funding/FOAs.htm
CDC Forms Web Page:
http://www.cdc.gov/od/pgo/funding/grants/app_and_forms.shtm