U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention (CDC)

STD Surveillance Network (SSuN)

Announcement Type: New – Type 1

Funding Opportunity Number: CDC-RFA-PS08-865

Catalog of Federal Domestic Assistance Number: 93.977

Key Dates:

Letter of Intent Deadline: June 13, 2008

Application Deadline: July 14, 2008

Executive Summary: The STD Surveillance Network (SSuN) is a dynamic network of state and local health department-based STD prevention and control programs following common protocols to address surveillance and program evaluation issues of national, state, and local interest. Such issues include monitoring behavioral and clinical trends in STDs, HIV, and viral hepatitis, identification of emerging STD/HIV issues, evaluation of public health interventions, and improvement of surveillance capacity.

In Part A, this announcement intends to fund up to 12 STD project areas to participate in the SSuN Surveillance Platform over a five-year period. Participating project areas will be expected to conduct SSuN activities through the county or state health department as well as within at least one STD clinic. Sites will be expected to maintain STD clinic data in an electronic format that can be queried by CDC and collaborating sites for a wide variety of analyses. Examples of initial multisite STD clinic activities might include: monitoring STD and HIV prevalence in men who have sex with men (MSM), assessing how burden of genital wart disease is affected by HPV vaccine implementation, and evaluating HIV testing coverage. SSuN Surveillance Platform sites are also expected to conduct population-based gonorrhea surveillance in counties. Sites are expected to be able to rapidly modify surveillance and information management activities at the STD clinic or county level as needed to respond to STD trends and public health priorities.

Through Part B, this announcement intends to fund up to 6 SSuN Surveillance Platform sites to participate in a laboratory component over a five-year period. Participating sites would be expected to have high quality laboratory and clinical capacity in one or more STD clinics to implement a broad range of surveillance activities such as monitoring antimicrobial susceptibilities of causative agents of STDs, serological biomarkers for STDs, and etiological diagnoses of STD clinical syndromes. The initial proposed activity of Part B would be to establish routine surveillance of Trichomonas vaginalis resistance or other sexually transmitted pathogens of public health importance, and additional activities would be expected as indicated by public health need and availability of funding.

This announcement contains the following information:

I. Funding Opportunity Description

Authority: Sections 317 (k) (2) and 318 of the Public Health Service Act [42 U.S.C. Sections 427b (k) (2) and 247c], as amended.

Background: A dynamic, national STD surveillance network, comprised of local enhanced STD surveillance systems following common protocols, is critical for filling several important gaps in the existing national STD surveillance system. National STD morbidity surveillance data, reported through the National Electronic Telecommunication Surveillance System (NETSS), currently includes a limited number of demographic data elements (e.g. age, race/ethnicity, sex, and county) collected from all states for a limited number of sexually transmitted diseases (chancroid, chlamydia, gonorrhea, and syphilis). Weekly reporting through NETSS is insufficient for rapid identification of many trends in other diseases, and does not support the collection and reporting of data on relevant STD behavioral and clinical information. Furthermore, even if trends in disease or risk behaviors are identified, the national STD morbidity surveillance infrastructure comprised of NETSS reporting from all states has limited capacity to be easily and rapidly modified. Although many states have greater surveillance capacity and flexibility than evidenced by their NETSS data, the wide variability between states in terms of data systems and standards make timely ad hoc collaborations and analyses difficult.

In the past, CDC has relied on separate supplemental activities such as prevalence monitoring projects and special studies to enhance STD surveillance at a national level. A current example of such an activity is the Men who have Sex with Men (MSM) Prevalence Monitoring Project.

The STD Surveillance Network (SSuN) was established in 2005 to create a standing network of collaborating sites with the capacity to implement a wide variety of surveillance activities, the flexibility to rapidly modify the activities over time as trends dictated, and the ability to use surveillance data to guide programmatic action. SSuN’s initial activities were to conduct:

1.) Enhanced population-based gonorrhea surveillance,

2.) Gonorrhea surveillance in STD clinics, and

3.) Monitoring of the burden and epidemiology of genital warts among patients attending STD clinics.

However, ability to generalize data from SSuN was limited by the small number of sites (six) funded, and the first phase of SSuN did not attempt to integrate other ongoing surveillance activities, such as the MSM Prevalence Monitoring Project, into the SSuN surveillance platform. Furthermore, SSuN activities were limited to three discrete areas of surveillance; due to limited funding, it was unable to fully establish locally the substantial human capacity and information technology (IT) infrastructure necessary to manage large numbers of analyses and multiple areas of surveillance.

In Part A, the current proposal is intended to expand and strengthen the network to include a greater number of sites, and further strengthen the human capacity and IT infrastructure at both the STD clinic and project area level. Furthermore, Part A intends to integrate and consolidate, where feasible, ongoing surveillance projects such as the MSM Prevalence Monitoring Project. By integrating systems, duplicative efforts can be eliminated, common systems and protocols can be developed, and personnel capacity and training can be combined for more efficient use of local resources. It is intended that SSuN continue to expand its scope of monitoring activities to promote integrated surveillance with HIV, viral hepatitis, and tuberculosis programs, as well as expand evaluation of public health interventions.

The intent of Part B to establish network composed of a subset of SSuN sites with high quality STD clinic laboratory and clinical capacity to implement a broad range of surveillance activities such as monitoring antimicrobial susceptibilities, serological biomarkers of STDs, and etiological diagnoses of STD clinical syndromes. The initial proposed activity of Part B would be to establish routine surveillance of Trichomonas vaginalis resistance or other sexually transmitted pathogens of public health importance. Additional activities would be expected as indicated by public health need and availability of funding.

Purpose: The purpose of Part A is to strengthen and expand the existing SSuN platform to establish an integrated network of STD clinics and health departments that serve a diverse population, have a strong clinical as well as analytic capacity, and follow common protocols to implement surveillance activities. The SSuN Project is intended to improve the capacity of national, state, and local STD programs to detect, monitor, and respond rapidly, with flexibility, and with greater effectiveness to established and emerging trends in STDs and related risk behaviors, and evaluate the effectiveness of public health interventions to reduce STD morbidity.

The purpose of Part B is to expand the capacity of the SSuN Surveillance Platform to allow the collection of STD biomarkers in a subset of STD clinics. This would require laboratory specimen collection and processing. As the initial activity, participating sites would be expected to collaborate with CDC to conduct trichomonas resistance monitoring or monitoring of other sexually transmitted pathogens of public health importance, and be flexible enough to implement other future activities as indicated.

This program addresses the “Healthy People 2010” overarching goals to increase quality and years of healthy life, and eliminate health disparities. It also addresses the focus areas of: Access to Quality Health Services, Cancer, HIV Infection, Immunization and Infectious Diseases, Maternal, Infant, and Child Health, Public Health Infrastructure, and Sexually Transmitted Diseases. This program addresses the CDC Health Protection Goals of: healthy people in every stage of life, and healthy people in healthy places.

Measurable outcomes of the program will be in alignment with one (or more) of the following performance goals for the Coordinating Center for Infectious Diseases (CCID), National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP): (1) Reduce the rates of non-HIV sexually transmitted diseases in the United States; (2) Reduce the rate of new HIV infections in the United States; (3) Reduce rates of viral hepatitis in the United States. Furthermore, this program supports the NCHHSTP programmatic imperatives of program collaboration and service integration, and reduction of health disparities.

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:

Part A - Required awardee activities for Part A of this program are as follows:

Provide the human and technical resources necessary for collection, analysis, interpretation, and dissemination of enhanced surveillance data at the STD clinic and project area level.
- Participating sites must demonstrate that the equivalent of at least 0.5 FTE is dedicated to STD clinic SSuN data management, collection, and/or analysis activities either through the funding in this cooperative agreement or through matching funds.
- In addition, participating sites must demonstrate that the equivalent of at least 0.5 FTE is dedicated to population level SSuN data management, collection, and/or analysis activities either through the funding in this cooperative agreement or through matching funds.
Plan to use or build upon currently existing electronic information systems for the collection, integration, analysis, and reporting of SSuN surveillance data at both the STD clinic and project area level.
- Sites are expected to have the capacity to quickly and efficiently generate an electronic line-listed SAS data set, and translate or recode a broad range of data on all STD clinic patients for use locally, by CDC, and collaborating sites for a wide variety of analyses.
  - Such data should include: demographics, risk behavior, medical history, clinical exam findings, laboratory test results, treatment information, and other services (e.g. vaccination, counseling, referrals).
  - Sites should be able to compile line-listed SAS datasets of STD clinic visits with unique individual and event codes within 1 month of patient visit. Sites must also be able to transform any identifiable information such that information transmitted to CDC does not allow identification of individuals, yet allows CDC to maintain a person-based data set. Sites are expected to have data confidentiality and security protections in place.
- Sites should demonstrate that they have the capacity to collect and manage enhanced data collected on patients at the project area level in an electronic format that can be used locally, by CDC, and by collaborating sites for a wide variety of analyses.
  - Such data may include: demographics, risk behavior, clinical history, laboratory test results, treatment information, other services (e.g. partner management, counseling, referrals).
  - Sites should be able to compile line-listed SAS datasets of case reports with unique individual and event codes within 1 month of report date. Sites must be able to link case reports with additional data such as that described above. Sites must also be able to transform any identifiable information such that information transmitted to CDC does not allow identification of individuals, yet allows CDC to maintain a person-based data set. Sites are expected to have data confidentiality and security protections in place.
  - In addition to conducting enhanced population-based surveillance on gonorrhea, sites should also have adequate capacity at the project area level to be able to work with other STDs as necessary.
  - In addition to working with STD clinics, sites should also have adequate capacity at the project area level to work with other facility types and data sources (e.g. hospital emergency departments, managed care organizations) as necessary.
Ensure that STD clinic and project area personnel work collaboratively so that STD clinic and wider project area data are shared with the STD clinic and project area and translated into broader public health action wherever possible.
Work collaboratively with other awardees and CDC to standardize surveillance protocols and data elements. Examples of surveillance protocols and data elements used in prior SSuN (#AA055) and MSM Prevalence Monitoring Project (#99000-E) cooperative agreements can be found at: www.stdpreventiononline.org (after logging in, click on “Groups” and go to “STD Surveillance Network Information Site” or “MSM Prevalence Monitoring Project Information Site”).
Be willing to share standardized STD clinic and project area surveillance data with CDC and other SSuN collaborating sites via a data warehouse or other electronic data storage format for collaboratively identified analyses.
Electronically transmit standardized data from STD surveillance activities to CDC on a monthly basis as a SAS file through secure mechanisms.
Develop data quality standards with CDC and participate in ongoing assessments and improvement of data quality.
Maintain a secure environment to protect the security and confidentiality of data obtained during this surveillance activity.
Participate in at least monthly conference calls and annual collaboration meetings by working with other sites to develop or revise common enhanced surveillance activity protocols and reporting preliminary data and the status of ongoing activities.
Perform routine analyses of local and multisite surveillance data, and evaluate the effectiveness of different methods of analysis in improving STD surveillance and program activities.
Establish mechanisms by which STD enhanced and routine surveillance data and relevant protocols are shared with stakeholders and translated into program action.
Participate in the following core STD clinic collaborative activities:
- Monitor the prevalence of STDs, HIV, viral hepatitis, and risk behaviors in MSM.
- Assess trends in the burden of genital wart disease in patients attending STD clinics.
- Monitor HIV testing coverage in patients attending STD clinics.
Implement a core population-based surveillance activity:
- Conduct brief interviews to collect demographic, clinical, and behavioral information annually on a representative sample of at least 120 men and 120 women with gonorrhea in the county or counties in which the participating STD clinic(s) is/are located.
Collaborate with CDC and other awardees on an ongoing basis to identify and implement surveillance of other STDs and sexual health issues of public health importance (eg: resistant Trichomonas vaginalis, LGV, hepatitis A and B vaccine coverage, resistant gonorrhea, Mycoplasma genitalium, resistant syphilis, increased illicit drug use, management of pelvic inflammatory disease, implementation of expedited partner therapy, hepatitis C serology monitoring) as they emerge. Activities may be implemented using the existing STD clinic platform or the project area platform. Activities that will be prioritized are those that are likely to lead to improved STD, HIV, and hepatitis prevention and control.

Part B - Required awardee activities for Part B of this program are as follows:

· Provide the human and technical resources necessary for the collection, processing, data management, analysis, interpretation, and dissemination of laboratory surveillance activities.

o Clinical specimens are expected to come from patients from the same, or a subset of the same, STD clinics involved in the SSuN Surveillance Platform.

o Participating laboratories should demonstrate close communication with the project area STD program.

o Participating laboratories should have the capacity to conduct a broad range of basic and more complex STD tests.

§ At a minimum, laboratories should have the capacity to conduct testing for Trichomonas vaginalis and Neisseria gonorrhoeae, nucleic acid amplification testing for urogenital gonorrhea and chlamydia, wet preps for bacterial vaginosis and trichomoniasis, syphilis treponemal and non-treponemal test capacity. For T. vaginalis and N. gonorrhoeae this should include the ability to do culture-based testing as documented by current practice, or by capacity to initiate such clinically approved approaches.

§ Participating laboratories are expected to be flexible, willing, and have sufficient capacity to implement new or additional STD test technology.

§ Laboratories should be willing to conduct routine quality assurance and quality control of all tests involved in SSuN activities.

o Laboratories are expected to have the capacity to prepare, store, and ship specimens to CDC for SSuN activities.

o Participating sites are expected to have currently existing electronic information systems with the capacity to quickly and efficiently generate an electronic line-listed data set.

· As the initial proposed activity, awardees will be expected to outline a plan for the collection of vaginal specimens positive by culture for T. vaginalis in a representative sample of 50 women that can be tested for resistance to metronidazole and tinidazole.

· Participating laboratories are expected to work collaboratively with CDC and other participating laboratories to identify priority activities, develop common protocols, and implement new multi-site activities over time as public health needs and availability of funds evolve.

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

CDC activities for both Part A and Part B are as follows:

· Coordinate annual collaboration meetings and at least monthly conference calls to review and plan program activities.

· Coordinate the development of common protocols, standardization of data elements, and definition of data reporting formats through collaboration with awardees.

· Facilitate, where possible, and assist with the electronic transmission of data to CDC.

· Work with grantees to assess and improve SSuN data quality.

· Manage SSuN data warehouse or other central data store to support data provisioning for collaborative analyses.

· Ensure that analysis and dissemination of SSuN project findings and experiences are conducted by both CDC and participating sites.

· Lead collaborative discussions to identify emerging trends in STDs, HIV, hepatitis B, and sexual health issues that merit further investigation by the STD surveillance network.

In addition to the activities listed above, for Part B CDC will:

· Perform susceptibility testing for T. vaginalis specimens, or support for other Part B activities that can not be implemented in local laboratories.

· Provide guidance and technical support for quality assurance and quality control of other SSuN laboratory component activities.

II. Award Information

Part A:

Type of Award: Cooperative Agreement. CDC’s involvement in this program is listed in the Activities Section above.

Award Mechanism: H25 – Venereal Disease Control

Fiscal Year Funds: 2008

Approximate Current Fiscal Year Funding: $1,400,000

Approximate Total Project Period Funding: $7,000,000 (This amount is an estimate, is subject to availability of funds, and includes both direct and indirect costs.)

Approximate Number of Awards: 12

Approximate Average Award: $120,000 (This amount is for the first 12-month budget period only, and includes both direct and indirect costs.)

Floor of Individual Award Range: None

Ceiling of Individual Award Range: $150,000 (This ceiling is for the total cost over the first 12-month budget period, and includes both direct and indirect costs.)

Anticipated Award Date: September 30, 2008

Budget Period Length: 12 months

Project Period Length: 5 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.

Part B:

Type of Award: Cooperative Agreement. CDC’s involvement in this program is listed in the Activities Section above.

Award Mechanism: H25 – Venereal Disease Control

Fiscal Year Funds: 2008

Approximate Current Fiscal Year Funding: $450,000

Approximate Total Project Period Funding: $2,250,000 (This amount is an estimate, is subject to availability of funds, and includes both direct and indirect costs.)

Approximate Number of Awards: 6

Approximate Average Award: $75,000 (This amount is for the first 12-month budget period only, and includes both direct and indirect costs.)

Floor of Individual Award Range: None.

Ceiling of Individual Award Range: $100,000 (This ceiling is for the total cost over the first 12-month budget period only, and includes both direct and indirect costs.)

Anticipated Award Date: September 30, 2008

Budget Period Length: 12 months

Project Period Length: 5 years

III. Eligibility Information

III.1. Eligible Applicants

Part A: Limited competition. Only the 65 state, county, city, and territorial health departments that are current recipients of Comprehensive STD Prevention Systems grants may apply for this program because participation in an STD surveillance network requires the participating entity to have the legal and programmatic capacity to collect and monitor health data, as well as the programmatic capacity to respond to emerging trends in disease and risk behaviors.

Part B: Limited competition. Only the applicants that apply for part A are eligible for Part B.

Applicants may apply for Part A only, or Part A and Part B. Applicants who submit applications for Part A and part B should clearly identify in the application whether they still choose to be considered for Part A alone if, after review, they are not selected for Part B.

III.2. Cost Sharing or Matching

Cost sharing or matching funds are not required for these programs.

III.3. Other

CDC will accept and review applications with budgets 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.

Part A:

Late applications will be considered non-responsive. See section “IV.3. Submission Dates and Times” for more information on deadlines.
Letters of intent are requested.
Project area awardees that are not state health departments must have a letter of support from their state health department.
Awardees must have a letter of support that demonstrates the cooperation of at least one STD clinic that diagnosed at least 100 patients with gonorrhea in 2006 or 20 patients with primary or secondary syphilis in 2006.
Awardees must ensure that they have identified the county or counties that they intend to work such that the targeted area had at least 400 reported cases of gonorrhea or 50 cases of syphilis in 2006.
Active participation in the STD Surveillance Network (SSuN) cooperative agreement #AA055 or the MSM Prevalence Monitoring Project cooperative agreement #99000-E is useful, but not required, for meeting the requirements of this activity. If not a former SSuN or MSM participant, the applicant should demonstrate in the narrative that they have significant experience conducting other types of enhanced STD surveillance, analyzing enhanced STD surveillance data, and disseminating findings to stakeholders.
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.

Part B: In addition to the special requirements for Part A:

Awardees must be funded for Part A to receive funding for Part B.
Awardees must have a letter of support from the participating laboratory.

IV. Application and Submission Information

IV.1. Address to Request Application Package

To apply for this funding opportunity use the application forms package posted in Grants.gov.

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 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.

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/grants/app_and_forms.shtm

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-TIMS) staff at 770-488-2700 and the application forms can be mailed.

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:

Descriptive title of proposed project.
Name, address, and telephone number of the Principal Investigator/Project Director at the project area.
Name of participating project area, counties, STD clinics, and any other institutions.
Whether applicant intends to apply for Part A only or for both Part A and Part B.
Number and title of this funding opportunity.

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:

Maximum of 3 paragraphs.

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 Part A, and Part B if applicable) 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 separate project narrative for each part must be submitted with the application forms. Include separate budgets and attachments for Part A and for Part B if the application is proposing to implement both activities, as Part A and Part B applications will be reviewed by different objective review panels. 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:

Maximum number of pages: Part A: (20), and Part B: (6), if either of your narratives 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 narrative pages; not to exceed the maximum number of pages.
For paper submissions:
- Printed only on one side of page.
- Held together only by rubber bands or metal clips; not bound in any other way.

The narrative for each part should address activities to be conducted over the entire project period and must include the following items in the order listed: Summary, Background/Need, Objectives, Plan, Method, Experience, Capacity, Timeline, Evaluation Plans, and Sustainability. The budget and budget justification will be included as a separate attachment not to be counted in the narrative page limit. Additional information may be included in the application appendices, with no more than 15 appendices for Part A, and 10 for Part B. The appendices will not be counted toward the narrative page limit. This additional information includes:

Curriculum Vitas
Organizational Charts
Letters of Support
Indirect Cost Rate Agreement

Additional information submitted via Grants.gov should be uploaded in a PDF file format, and should be named as listed above to reflect content (i.e. “Curriculum vitas, Letters of Support, Indirect cost rate agreement, etc.).

No more than 25 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.”

IV.3. Submission Dates and Times

Letter of Intent (LOI) Deadline Date: June 13, 2008

Application Deadline Date: July 14, 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 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 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.

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 received 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 verified 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 PGOTIMS 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. 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:

http://www.whitehouse.gov/omb/grants/spoc.html

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.
Funds may not be used for construction.
When federal funds are used to develop or purchase STD health education materials (including HIV/AIDS), they shall contain medically accurate information regarding the effectiveness or lack of effectiveness of condoms in preventing the STD the materials are designed to address.

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:

Dr. Lori M. Newman

Division of STD Prevention

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention

Centers for Disease Control and Prevention

Mailstop E-02

1600 Clifton Road NE

Atlanta, GA 30333

(404) 639-6183 (telephone)

(404) 639-8610 (fax)

Len4@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.

Paper Submission:

Applicants should submit the original and two hard copies of the application by mail or express delivery service to:

Technical Information Management – CDC-RFA-PS08-865 (SSuN)

Department of Health and Human Services

CDC Procurement and Grants Office

2920 Brandywine Road, MS E-14

Atlanta, GA 30341

V. Application Review Information

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:

Part A

Summary: (Reviewed but not scored)

Does the applicant provide a less than one page summary of the proposed activities, including the name and scope of the project area, the name of the principal project collaborator, the name of the principal STD clinic collaborator, the name of the collaborating STD clinic(s), and which activities they plan to implement?

Capacity: (28 points total)
- Is the proposed staff capacity sufficient (at least 0.5 FTE) to conduct enhanced data collection, entry, cleaning, analysis, evaluation, and dissemination at the STD clinic level? Does the project staff have the appropriate background, experience, and time to perform the proposed work? (6 points)
- Is the proposed staff capacity sufficient (at least 0.5 FTE) to conduct enhanced data collection, entry, cleaning, analysis, evaluation, and dissemination at the project area level? Does the project staff have the appropriate background, experience, and time to perform the proposed work? (6 points)
- Does the applicant have existing information management systems at the STD clinic level with the capacity to merge or integrate electronic data from providers, laboratories, and other data sources? Does the applicant have a database that can be queried, can generate line listed clinic visit/patient data, and can easily be modified to incorporate new data elements or to generate electronic data extracts? Has the applicant clearly outlined how staff will create STD clinic datasets? Does the applicant demonstrate that they have the capacity to maintain the data in a safe and confidential environment? (6 points)
- Does the applicant have existing information management systems at the project area level with the capacity to merge or integrate electronic data from case reports, laboratories, STD clinics, and other data sources? Does the applicant have a database that can be queried, can generate line listed patient data, and can easily be modified to incorporate new data elements? Has the applicant clearly outlined how staff will create datasets using data from population-based surveillance activities? Does the applicant demonstrate that they have the capacity to maintain the data in a safe and confidential environment? (6 points)
- Has the applicant demonstrated that the STD clinic(s) have professional staff with the ability to recognize, correctly diagnose, and treat emerging STDs and sexual issues? (4 points)
Objectives/Plan: (18 points total)
- What is the quality of the proposed plan to participate in an enhanced surveillance network to conduct core activities? Consider clarity of objectives and soundness of the applicant’s approach. Does it include initiation of the proposed core activities within the first year of the project? (6 points)
- Does the applicant demonstrate an understanding of the potential utility of enhanced STD surveillance at both the local and national level? (2 points)
- Does the applicant indicate willingness and the capacity to collaborate with other grantees funded for this project, and adhere to common standard protocols? (2 points)
- Does the applicant indicate a willingness and capacity to be flexible and modify their individual and collaborative activities in the future as necessary to adapt to trends in disease and public health needs? (2 points)
- To what extent does the applicant demonstrate their ability and intent to disseminate and translate the data into programmatic action in their project area? (4 points)
- Does the applicant demonstrate a willingness and capacity to promote integrated surveillance with HIV and viral hepatitis programs? (2 points)
Experience: (18 points total)
- Did the applicant participate in previous STD Surveillance Network (SSuN) cooperative agreement #AA055 or the MSM Prevalence Monitoring Project cooperative agreement #99000-E and demonstrate the ability to successfully conduct enhanced surveillance and work collaboratively with other sites? OR Does the applicant demonstrate that they have significant experience conducting other types of enhanced STD surveillance, analyzing enhanced STD surveillance data, and disseminating findings to stakeholders (as documented by surveillance reports, presentations, or peer-reviewed publications)? (10 points)
- Does the applicant demonstrate experience collaborating with other grantees and adhering to common standardized protocols? (4 points)
- Does the applicant demonstrate experience being flexible and able to modify collaborative activities as necessary to adapt to trends in disease and public health needs? (4 points)
Methods: (16 points total)
- Has the applicant included letters from collaborating STD clinics and county health departments that demonstrate their support? If the application is from a county or a city health department, does the application include a letter of support from the state? (4 points)
- To what extent does the applicant demonstrate that methods for STD clinic-based surveillance, information management, and disease investigation and response are robust, flexible, and can be adapted for other types of enhanced surveillance and evaluation? (8 points)
- Does the applicant indicate clearly how they will identify, contact, and interview a representative sample of reported gonorrhea in the county or counties of interest? (4 points)
Background/Need: (8 points total)
- To what extent does the STD clinic(s) have a large and varied clientele (with regard to gender, race, ethnicity, and sexual orientation) who experience a range of STDs? (Note: It is required that the STD clinic have seen at least 100 patients diagnosed with gonorrhea in 2006 or 20 patients diagnosed with primary and secondary syphilis in 2006.) (4 points)
- How well has the applicant described the population under surveillance and justified the need for this program within the population? Is the STD morbidity in the targeted counties sufficient to merit enhanced surveillance and subsequent interventions? (Note: Awardees must identify a county or set of counties to work in that had at least 400 reported cases of gonorrhea or 50 cases of primary and secondary syphilis in 2006.) (4 points)
Timeline: (4 points total)

Has the applicant proposed an achievable timeline? Has the applicant documented their ability to implement the four core STD clinic activities and enhanced population-based gonorrhea surveillance within the first year of the project period?

Evaluation Plans: (4 points total)

Has the applicant set forth clear performance goals that suggest that the data will be used locally for disease prevention and program improvement? Has the applicant outlined outcome measures that are objective, quantitative, and adequately measure the intended outcome?

Sustainability: (4 points total)

To what extent has the applicant demonstrated that SSuN activities have improved or could improve project area capacity and have been or could be institutionalized as ongoing surveillance activities?

Budget (SF 424A) and Budget Narrative: (Reviewed, but not scored.)

Is the budget reasonable, clearly justified, and consistent with the intended use of funds?

Part B

Summary: (Reviewed but not scored)

Does the applicant provide a less than one page summary of the proposed activities that includes a description of Part B, including the name of the proposed collaborating laboratory?

Capacity: (30 points total)

o Is the proposed staff capacity sufficient to collect, process, manage data, analyze, interpret, and disseminate data on a minimum set of in-house STD tests (testing for Trichomonas vaginalis and Neisseria gonorrhoeae, nucleic acid amplification testing for urogenital gonorrhea and chlamydia, wet preps for bacterial vaginosis and trichomoniasis, syphilis treponemal and non-treponemal test capacity? For T. vaginalis and N. gonorrhoeae this should include the ability to do culture-based testing as documented by current practice, or by capacity to initiate such clinically approved approaches. (10 points)

o Is the proposed staff capacity sufficient to collect, process, manage data, analyze, interpret, and disseminate data a broad range of STD test technology beyond the minimum set of STD tests? (10 points)

Does the applicant have existing information management systems in the laboratory with the capacity to manage laboratory data? Can the database be queried and generate line listed data? (10 points)

Objectives/Plan: (22 points total)
- What is the quality of the proposed plan to participate in an enhanced laboratory network? (8 points)
- Does the applicant indicate willingness and the capacity to collaborate with other grantees funded for this project, and adhere to common standard protocols? (8 points)
- Does the applicant indicate a willingness and capacity to be flexible and modify their individual and collaborative activities in the future as necessary to adapt to trends in disease and public health needs? (6 points)
Experience: (20 points total)
- Does the applicant demonstrate that they have significant experience conducting the minimum required STD tests? (5 points)
- Does the applicant demonstrate that they have experience interpreting and disseminating laboratory data (as documented by surveillance reports, presentations, or peer-reviewed publications)? (5 points)
- Does the applicant demonstrate experience collaborating with other grantees and adhering to common standardized protocols? (5 points)
- Does the applicant demonstrate experience being flexible and able to modify collaborative activities as necessary to adapt to trends in disease and public health needs? (5 points)
Methods: (16 points total)
- Has the applicant included a letter from the collaborating laboratory that demonstrates its support? (8 points)
- Does the applicant indicate clearly how they could implement surveillance for resistant T. vaginalis from a representative sample of at least 50 women in participating STD clinics? (8 points)
Background/Need: (4 points total)
- To what extent does the laboratory serve STD clinic(s) with a large and varied clientele (with regard to gender, race, ethnicity, and sexual orientation) who experience a range of STDs? Has the STD clinic diagnosed at least 50 women with trichomoniasis in 2006?
Timeline: (4 points total)

Has the applicant proposed an achievable timeline to implement monitoring of resistant T. vaginalis in the first budget period?

Evaluation Plans: (4 points total)

Has the applicant set forth clear plans for how they intend to ensure ongoing quality control and quality assurance?

Budget (SF 424A) and Budget Narrative: (Reviewed, but not scored.)

Is the budget reasonable, clearly justified, and consistent with the intended use of funds?

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 NCHHSTP 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. Separate objective review panels will review Part A applications and Part B applications.

In addition, the following factors may affect the funding decision:

The need for geographic diversity.
The importance of covering high STD morbidity areas.
The importance of including populations disproportionately affected by STDs such as men who have sex with men African Americans, or adolescents.

CDC will provide justification for any decision to fund out of rank order.

V.3. Anticipated Announcement Award Dates

September 30, 2008

VI. Award Administration Information

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-4 HIV/AIDS Confidentiality Provisions
AR-6 Patient Care
AR-7 Executive Order 12372
AR-9 Paperwork Reduction Act Requirements
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-14 Accounting System Requirements
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.

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.