ps11-1111 final 03.22.11.doc

Table of Contents

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

PART 1. OVERVIEW INFORMATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES

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

Funding Opportunity Title: Addressing Global TB And Domestic TB Of All Forms Including TB/HIV In All Populations And In All Settings To Prevent, Control TB And Other Programmatic Activities Involved In Eliminating TB Announcement Type: New Agency Funding Opportunity Number: CDC-RFA-PS11-1111 Catalog of Federal Domestic Assistance Number: 93.947 Key Dates:

Application Deadline Date: April 25, 2011, 5:00 PM U.S. Eastern Time Executive Summary: The United States (U.S.) Civilian Research and Development Foundation (CRDF) will provide fiduciary support to the CDC's Division of TB Elimination in initiating and managing a diverse portfolio of Tuberculosis (TB)-related programmatic activities in up to 35 countries worldwide. These activities will include all aspects of TB control. CRDF will serve as a fiduciary and administrative agent to (1) liaise with foreign government agencies and non-governmental organizations for the purpose of securing formal approvals and authorizations, (2) set up management systems and logistical procedures, and (3) disburse funds to foreign governmental and non-governmental organizations and individuals, and U.S. domestic non-governmental organizations (sub-recipients) or individuals according to DTBE's requirements. In turn, the sub-recipients in collaboration with CDC will implement TB control-related activities. Based on protocols and work plans developed jointly by CDC, U.S. domestic partners and international counterparts, CRDF will liaise with foreign governments and organizations to obtain all necessary governmental, legal, and organizational authorizations and establish mechanisms to administer project funds and disburse project funds as required by the project's budget. Specific individual projects will be initiated by the foreign counterpart or U.S. domestic partner in cooperation with CDC/DTBE, funded by CDC/DTBE through this FOA and conducted in the U.S. or in a foreign country. Total amount awarded: 3 M for Year 1 Total of 15 million for 5 years. This FOA has met the sole source requirement.

Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for CDC. Measureable outcomes of the program will be in alignment with the following performance goal for the NCHHSTP: Global Protection Systems Strengthening.

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be reviewed.

PART 2. FULL TEXT

I. FUNDING OPPORTUNITY DESCRIPTION

Statutory Authority This program is authorized under the Public Health Service Act, Section 317(a)317E, 42 U.S.C. 247b-b(a), as amended; and section 301(a) and 307 of the Public Health Service Act, [42 U.S.C. sections 241 (a) and 242l] as amended.

Purpose

Tuberculosis is a global health emergency. While both preventable and curable, TB remains one of the world’s major causes of illness and death, causing an estimated 9 million new TB cases and approximately 1.8 million deaths each year. More than one-third of the world’s population or two billion people are thought to be infected with latent TB. TB is found in almost every country in the world. Two drug resistant forms of TB threaten to undermine recent progress in controlling the disease. First, multidrug-resistant (MDR) TB is defined as TB with resistance to both isoniazid and rifampin and first-line anti-TB drugs. Second, extensively drug-resistant (XDR) TB has shown additional resistance to fluoroquinolone and at least one of three injectable second-line drugs (capreomycin, kanamycin, and amikacin). The TB epidemic is further compounded by its complex interaction with HIV/AIDS; of the 1.8 million annual TB deaths, approximately 500,000 are among people living with HIV. The TB epidemic is further compounded by its complex interaction with HIV/AIDS.

The purpose of the Cooperative Agreement with the United States (U.S.) Civilian Research and Development Foundation (CRDF) is to provide fiduciary support to the CDC's Division of Tuberculosis Elimination (DTBE) in initiating and managing a diverse portfolio of Tuberculosis (TB)-related programmatic activities in up to 35 countries worldwide. These activities will include all aspects of TB control. CRDF will serve as a fiduciary and administrative agent to (1) liaise with foreign government agencies and non-governmental organizations for the purpose of securing formal approvals and authorizations, (2) set up management systems and logistical procedures, and (3) disburse funds to foreign governmental and non-governmental organizations and individuals, and U.S. domestic non-governmental organizations (sub-recipients) or individuals according to DTBE's requirements. In turn, the sub-recipients in collaboration with CDC will implement TB control-related activities. Based on protocols and work plans developed jointly by CDC, U.S. domestic partners and international counterparts, CRDF will liaise with foreign governments and organizations to obtain all necessary governmental, legal, and organizational authorizations and establish mechanisms to administer project funds and disburse project funds as required by the project's budget.

This program addresses the “Healthy People 2020” focus area will be to strengthen international TB control activities to reduce morbidity and mortality due to TB among vulnerable populations (such as persons with or at risk of drug-resistant TB, people living with HIV and children), improve infection control practices to prevent TB transmission and the capacity and quality of TB Programs internationally.

The program also supports efforts to improve the health of populations disproportionately affected by HIV/AIDS, viral hepatitis, sexually transmitted diseasess (STDs) and TB by maximizing the health impact of public health services, reducing disease prevalence, and promoting health equity consistent with the National HIV/AIDS Strategy.

Health disparities in HIV, viral Hepatitis, STDs, and TB are inextricably linked to a complex blend of social determinants that influence which populations are most severely affected by these diseases. Health equity is a desirable goal that entails special efforts to improve the health of those who have experienced social or economic disadvantage. See Appendix one for definitions of health disparity, social determinants of health and health equity.

Programs should use data, including social determinants data, to identify communities within their jurisdictions that are disproportionately affected by HIV, viral hepatitis, STDs and TB and related diseases and conditions, and plan activities to help eliminate health disparities. In collaboration with partners and appropriate sectors of the community, programs should consider social determinants of health in the development, implementation, and evaluation of program specific efforts and use culturally appropriate interventions that are tailored for the communities for which they are intended.

Program Implementation

Recipient Activities CRDF will provide fiduciary support to the CDC's Division of Tuberculosis Elimination in initiating and managing a diverse portfolio of Tuberculosis (TB)-related programmatic activities in up to 35 countries worldwide. These activities will include all aspects of TB control. CRDF will serve as a fiduciary and administrative agent to (1) liaise with foreign government agencies and non-governmental organizations for the purpose of securing formal approvals and authorizations, (2) set up management systems and logistical procedures, and (3) disburse funds to foreign governmental and non-governmental organizations and individuals, and U.S. domestic non-governmental organizations (sub-recipients) or individuals according to DTBE's requirements. In turn, the sub-recipients in collaboration with CDC will implement TB control-related activities. Based on protocols and work plans developed jointly by CDC, U.S. domestic partners and international counterparts, CRDF will liaise with foreign governments and organizations to obtain all necessary governmental, legal, and organizational authorizations and establish mechanisms to administer project funds and disburse project funds as required by the project's budget. Additionally, CRDF will procure equipment, materials, and supplies, including tax-exempt importation and customs clearance when and where possible, and support related logistics such as travel, meetings, training, shipping, and communications. CRDF will coordinate receipt, review, and award of proposals for individual projects; obtain all necessary foreign approvals, and manage business and logistical aspects of the projects. CDC/DTBE works in up to 35 different countries in all regions of the world. CRDF will provide support to any or all of 35 countries.

CDC/DTBE will be an active partner in providing technical support to the diverse portfolio of Tuberculosis (TB)-related programmatic activities in up to 35 countries worldwide. The sub-recipients will be responsible for specific projects with the active involvement of CDC. Examples include, but are not limited to: implementing and evaluating strategies for rapid diagnosis, numerous trainings, improved measures to detect and prevent institutional transmission of TB, improve TB treatment and strengthen case detection, surveillance and reporting. Other measures include: addressing TB in foreign born populations, vulnerable populations such as people living with HIV/AIDS (PLWHIV), children, the elderly, persons with drug-resistant TB, institutionalized populations and those living in poverty. Reduce TB transmission by promoting and implementing a three-tier hierarchy of infection control measures: administrative controls, environmental controls and personal protective equipment (respirators).

As a fiduciary agent, CRDF will be responsible for developing sub-contracts/ cooperative agreements with foreign governmental and non-governmental organizations and individuals and U.S. domestic non-governmental organizations and individuals (sub-recipients). The sub-recipients, in collaboration with CDC/DTBE, will implement public health programs and projects. Projects in the sub-contracts/cooperative agreements will focus on improving tuberculosis (TB) control internationally and among the foreign-born in the United States. Specific individual projects will be initiated by the foreign counterpart or U.S. domestic partner in cooperation with CDC/DTBE, funded by CDC/DTBE through this FOA and conducted in the U.S. or in a foreign country.

CRDF, the recipient will have the primary responsibility for the following:

· Provide oversight of management and administrative aspects of projects, including resources and specific aspects of operations.

· Fulfill required and appropriate legal, regulatory, and political authorizations and approvals.

· Set up efficient administrative mechanisms for managing project funds.

· Procure and distribute (including shipping & importation) of project-related material.

· Organize and provide logistical support to travel, trainings, and meetings related to supported projects.

· Collaborate with local senior researchers, HHS/CDC researchers and community-based organizations or similar community liaison for the duration of project period on project management and administrative activities.

· Participate in conference calls with HHS/CDC project officer(s) and project team.

· Collaborate with HHS/CDC scientists and Administrative Project Officers to meet the objectives of this agreement.

The objectives for the specific individual projects, fulfilled by sub-recipients in collaboration with CDC/DTBE, will be to strengthen international and domestic TB control activities to reduce morbidity and mortality due to TB among vulnerable populations (such as persons with or at risk of drug-resistant TB, people living with HIV and children), improve infection control practices to prevent TB transmission and the capacity and quality of TB Programs internationally and domestically.

The sub-recipients will respond to focus areas and activities below as directed by CDC/DTBE. CDC/DTBE will work closely with CRDF to select the sub-recipients and determine and implement the required objectives and activities for the sub-recipients. The sub-recipients and CRDF must consult and reach an agreement with CDC/DTBE when selecting the objectives and projects that will be performed and implemented.

The sub-recipients will support the following focus areas and activities in collaboration with CRDF and CDC/DTBE under the agreed upon sub-contracts/cooperative agreements as deemed appropriate:

1: Strengthen TB control programs to improve and expand services related to drug-resistant TB through technical assistance, training, implementation, and evaluation

· Implement cost-effective strategies for case detection and diagnosis that incorporate new, rapid diagnostic technologies

· Conduct drug resistance surveys and improve routine surveillance for drug resistant TB in multiple countries

· Implement new treatment strategies for patients with drug-resistant TB

· Implement strategies for screening and preventive treatment of contacts of patients with TB, including contacts of patients with drug-resistant TB

· Implement and evaluate information management strategies that support the foregoing activities

· Develop and produce training materials on TB with emphasis on Drug Resistant Tuberculosis (DR-TB).

2: To reduce the impact of HIV on TB prevalence and mortality.

· Implement effective approaches for TB screening and diagnosis in people living with HIV and populations with high HIV prevalence (e.g., urban slums, drug users), including implementation and evaluation of new TB diagnostic tests in people with HIV.

· Implement more effective treatments for latent TB infection to prevent TB disease among people with HIV and ways to improve the uptake of isoniazid preventive therapy (IPT).

· Determine more effective approaches for addressing TB and TB/HIV in children, such as improving TB diagnosis in children, identifying ways to ensure that children receive appropriate care, developing and evaluating family-centered, integrated approaches to TB and TB/HIV, and identifying opportunities to ensure that women and children are mainstreamed into the National TB Program (NTP) and TB/HIV collaborative activities.

3: To reduce the impact of TB and/or HIV on reproductive health, maternal health, and perinatal transmission.

· Implement effective approaches for TB screening and diagnosis in women living with HIV, in women with high risk of HIV, and in pregnant women, both in clinical and community settings (drug users, young women living and working on the streets)

· Integrate effective contraception, specifically long-acting reversible contraception, into TB and/or HIV clinical care settings.

· Determine more effective approaches for addressing TB and TB/HIV in orphans and street youth, such as improving TB diagnosis in high risk youth, identifying ways to ensure that such youth receive appropriate care, developing and evaluating family-centered, integrated approaches to TB and TB/HIV, and TB/HIV/family planning, while identifying opportunities to ensure that women and high risk youth in need of clinical care and unintended pregnancy prevention services are mainstreamed into TB/HIV collaborative activities.

4: To improve the quality of TB Programs internationally

· Identify sustainable TB control methods for resource constrained settings

· To implement and evaluate promising new TB diagnostics

5: To improve infection control practices to prevent TB transmission and provide a safer environment in health facilities, prisons, homeless shelters, congregate settings and other community settings:

· Implement, monitor and evaluate TB infection control measures and interventions: administrative controls, environmental controls and personal respirators

· Conduct facility assessments.

· Conduct evaluation of the efficacy of various TB Infection Control (IC) interventions and their impact of TB transmission.

· Develop additional TB IC consultants, conduct trainings on TB IC, establish new training centers and critique prior trainings and trainees.

6: To strengthen laboratories to provide timely, accurate diagnosis of TB and drug resistance:

· Implement and evaluate phenotypic methods for detection, identification, and drug susceptibility testing of mycobacteria based on liquid culture media and other novel alternatives to conventional solid media and methods.

· Implement and evaluate novel molecular methods for detection, identification, and drug resistance testing of mycobacteria.

· Evaluate the effectiveness of interferon-gamma release assays in detection and diagnosis of active and latent TB infection

· Assess and implement TB laboratory services: lab structure, performance and the cost of the current network of laboratory service providers and users.

· Encourage a systems approach to improving laboratory services and using quality-improvement principles to evaluate laboratory performance.

7: Prevent the introduction and spread of infectious diseases into the United States and to prevent morbidity and mortality among immigrants, refugees, migrant workers, international travelers and foreign born populations. Support in building quarantine and migration health systems.

8: Contribute to the global targets for reducing the burden of TB that have been set for 2015 within the context of the Millennium Development Goal and by the World Health Organization’s (WHO) Stop TB Partnership: Halt and begin to reverse the incidence of tuberculosis (TB) by 2015 and reduce by 50% TB prevalence and death rates by 2015 compared with their levels in 1990.

9: Provide support to the Global Health Initiative (GHI), including GHI Plus countries. The core principles of the initiative emphasize country ownership; a gender-equity approach; and integration, coordination, and innovation, among other themes.

Description of Non-research Activities That May Be Supported through this FOA:

Non-research activities will be performed collaboratively by the CDC/DTBE and the sub-recipients. The activities include technical assistance to National TB Programs in other countries in partnership with international partners (for example, World Health Organization (WHO)), United States Government (USG) and Ministries of Health to reduce TB prevalence and mortality globally and among foreign born persons in the U.S. through international and domestic collaborations.

Specific activities may include, but not limited to the following:

· Collaborate with the World Health Organization to assist in developing activities and guidelines for international TB control.

· Provide support to the international scale-up of diagnosis, treatment and prevention of drug-resistant TB.

· Provide technical assistance for TB/HIV to Ministries of Health in countries supported by the President’s Emergency Plan for AIDS Relief to scale-up high-quality collaborative TB/HIV activities.

· Collaborate with World Health Organization to develop and improve international guidelines for TB/HIV in adults and children.

· Provide assistance to national TB programs in surveillance, monitoring and evaluation, TB prevalence surveys and drug resistance surveys.

· Develop and promote international guidelines, policies, standards, and norms.

· Expand Directly Observed Therapy Short Course (DOTS).

· Improve the diagnosis of TB in children.

· Improve TB case finding in special populations (e.g., prisons, drug users and residents of urban slums).

· Establish model programs for social support of TB patients to promote and facilitate ambulatory care.

· Develop TB infection control specialists to address TB IC issues internationally.

· Support CDC and international partners in TB IC issues.

· Conduct specialized TB IC trainings domestically and internationally.

· Provide support to foreign born populations as it relates to global migration and quarantine.

· Expand infection control trainings to prevent the transmission of TB in clinics, healthcare and community settings.

· Provide support to Supranational TB Reference Laboratory Networks.

· Develop consensus guidelines for external quality assurance for line-probe assays.

· Participate in training courses to roll out standardized laboratory tools for quality assured smear microscopy and drug susceptibility testing.

· Increase scale-up of liquid culture, emerging diagnostic techniques and bio-safety assessments.

· Conduct training courses on the fundamental concepts of all forms of TB.

· Create training modules on all forms of TB.

· Conduct technical assistance (TA) and trainings for international partners at regional, national, and local levels, for a variety of audiences.

CDC/DTBE may also provide support to activities and objectives that may not be listed in the FOA, but are related to all forms of TB. This Cooperative Agreement will support any and all of those unforeseeable activities, priorities or objectives which may occur in the future and are not identified in the FOA or the application.

On a project-by project basis, CDC, CRDF, and the sub-recipients will negotiate specific intellectual property rights as part of the process of evaluating sub-recipients’ applications before awarding funds to sub-recipients. In general, sub-recipents may have the opportunity to share custody of and rights to data, software, and other intellectual property developed under these awards, subject to government rights of access consistent with current DHHS, PHS, and CDC policies.

CDC Activities

CDC employees have substantial programmatic involvement during the planning and performance of the activities that is above and beyond the normal stewardship role in awards, as described below:

· Collaborate, as needed, to establish priorities, plans and structure for the development and implementation of the recipient and sub-recipients activities, both among and within each of the outlined focus areas, objectives and proposed activities through regular meetings and communication.

· Provide technical assistance to CRDF and the sub-recipients by linking them with other national and international agencies that might provide additional technical or material assistance.

· Collaborate, as needed, with key partners, USG agencies, CRDF and sub-recipients by providing technical assistance, advice and coordination in support of activities implemented under this agreement.

· Provide budget and administrative oversight on all activities conducted and managed by CRDF and sub-recipients as necessary.

· Collaborate with CRDF and the sub-recipients in developing goals, objectives, effective and innovative strategies and methodologies.

· Providing consultation and guidance, as needed, in support of activities implemented under this agreement.

· Coordinate among CDC units internally to minimize coordination burden for CRDF and sub-recipients as necessary.

· Collaborate with local senior officers, HHS/CDC officers and community-based organizations or similar community liaisons for the duration of project periods on several project management and administrative activities, such as the development of data-collection instruments, specimen-collection protocols, and data-management procedures.

II. AWARD INFORMATION

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

Award Mechanism: U01 Cooperative Agreement. The Recipient Organization retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, and HHS/CDC is substantially involved as a partner with the Recipient Organization, as described in Section VI.2.A., "Cooperative Agreement.

Fiscal Year Funds: 2011 Approximate Current Fiscal Year Funding: $3 million Approximate Total Project Period Funding: $15 Million This amount is an estimate, and is subject to availability of funds and includes direct costs.

Approximate Number of Awards: 1 Approximate Average Award: $3 million (This amount is for the first 12 month and includes direct costs and indirect costs). Subject to availability of funds.

Floor of Individual Award Range: $3 million (per year) Ceiling of Individual Award Range: $3 million (per year) Anticipated Award Date: September 1, 2011 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.

III. ELIGIBILITY INFORMATION

Eligible Applicants The eligible applicant that can apply for this funding opportunity is The U.S. Civilian Research and Development Foundation (CRDF). HHS/CDC will only provide funding for CRDF. CRDF is the only appropriate and qualified organization to fulfill the requirements set forth in this announcement.

The U.S. Civilian Research and Development Foundation (CRDF) is the only organization that can meet all the requirements cited below in each of the 30 plus countries that CDC provides technical TB support and assistance.

· CRDF is a nonprofit organization authorized by the U.S. Congress and established in 1995 by the National Science Foundation. This unique organization promotes international scientific and technical collaboration through grants, technical resources, and training. CRDF is based in Arlington, Virginia with offices in Moscow, Russia; Kyiv, Ukraine; Almaty, Kazakhstan; Baku, Azerbaijan (opening 2010), and Amman, Jordan (opening 2010). CRDF actively promotes science and technology collaboration in more than 30 countries.

· CDC, OGAC, DOE, DOD, HHS and other departments have a long standing working relationship with CRDF. CDC has worked closely and effectively with CRDF in Russia and countries in the former Soviet Union to help translate health promotion and disease prevention techniques into improved health for all people. CRDF, given its political and historical knowledge, is the only organization with the ability to navigate the administrative complexities of the Russian government while ensuring all projects adhere to US and Russian laws. The Russian Ministry of Health and the Ministry of Science and Technology trust and support CDC and CRDF’s partnership in public health.

· CRDF is the only organization which facilitates the host country authorization between U.S. government and Russia. This involves ensuring that the Russian governmental review process is completed and has received all necessary authorizations. CRDF contacts and obtains required information from institutions, which is often difficult and time intensive. CRDF enacts a Project Agreement which requires the grantees to review and sign before the project is initiated and considered active. The projects are assigned unique numbers. The Project Agreement outlines the terms and conditions of the project administration under the CRDF Grant Assistance Program. CRDF is the only organization capable of managing all relevant up-to-date agreements between all institutions in Russia and the US. CRDF is the only organization which ensures no human subjects research is planned for each project as appropriate.

· CRDF is the only organization which monitors grantees to determine whether Intellectual Property is anticipated to be developed or whether commercial development or products are associated with this work or are likely to result from it, and if royalties or other commercial benefits are expected during the course of this project.

· Since the inception of the partnership, CRDF had provided meticulous oversight and completing transparent accounting of all funds. Once the Project Agreement is executed, CRDF authorizes project payments upon receipt of a duly completed invoice according to the schedule specified in the Project Agreement. CRDF provides an invoice template, which is used for requesting payment. All project payments are subject to sponsor approval and availability of project funds at CRDF. This also includes administering budget reviews, personnel modifications, no cost extensions and budget allocations. The grantees provide expenditures and invoices to CRDF. CRDF is the only organization capable of serving as a reliable and credible existing institutional structure to pay individual team members (its employees) and make equipment and travel payments on behalf of the projects in Russia and U.S. CRDF has an extensive knowledge of US government regulations.

· CRDF manages and processes equipment, supplies, travel, training and services. CRDF makes direct payment to a selected vendor or service provided on behalf of the grantee using the funds budgeted under “Materials and Services” in accordance with the approved project budget. CRDF monitors individual advance or reimbursement and manages imports into the Russian Federation which adhere to import certification requirements. CRDF is the only organization which ensures that vendors must be legally-recognized entities licensed or otherwise certified to provide the goods and services requested. All Russian vendors must have Russian State Registration Number, which confirms that this vendor is included in the Russian State list of enterprises. Equipment purchased utilizing funds are recorded and tracked to ensure proper use and to avoid loss or theft.

CDC/DTBE will not solicit any other applications.

Required Registrations

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

Central Contractor Registration and Universal Identifier Requirements

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

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

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

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

Maintenance of Effort

Maintenance of Effort is not required for this program.

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

Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting a grant, loan, or an award.

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

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

Content and Form of Application Submission 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 Letter of Intent (LOI):

A letter of intent is not applicable to this funding opportunity announcement.

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

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

· Maximum number of pages: 40. 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

· Page margin size: One inch

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

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

Purpose/ Objectives

Description of Need

Work plan/activities/methods

Timeline

Performance Measures

Description of staff who will implement the activities

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. The appendices will not be counted toward the narrative page limit.

Additional information includes:

· Curriculum Vitas, Resumes, Organizational Charts, Letters of Support, etc.

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

· Curriculum vitae, Letters of Support, Indirect Cost Rate Agreement, etc.).

No more than 20 electronic attachments should be uploaded per application.

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

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

Letter of Intent (LOI) Deadline Date: N/A Application Deadline Date: April 25, 2011, 5:00 PM U.S. Eastern Time Intergovernmental Review Executive Order 12372 does not apply to this program.

Funding Restrictions

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

· Recipients may not use funds for research.

· Recipients may not use funds for clinical care.

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

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

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

· Reimbursement of pre-award costs is not allowed.

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

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

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

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

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

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

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

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

V. Application Review Information Eligible applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of CDC-RFA-PS11-1111. Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement. Measures of effectiveness must be objective, quantitative and measure the intended outcome of the proposed program. The measures of effectiveness must be included in the application and will be an element of the evaluation of the submitted application.

Criteria Eligible applications will be evaluated against the following criteria:

Plan (30 Points) Is the plan adequate to carry out the proposed objectives? How complete and comprehensive is the plan for the entire project period? Does the plan include quantitative process and outcome measures?

Methods (20 Points) Are the proposed methods feasible? To what extent will they accomplish the program goals?

Personnel (30 Points) Do the staff members have appropriate experience? Are the staff roles clearly defined? As described, will the staff be sufficient to accomplish the program goals?

Need (20 Points) To what extent does the applicant justify the need for this program within the target community?

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

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

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

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

Review and Selection Process

Review

All eligible applications will be initially reviewed for completeness by the Procurement and Grants Office (PGO) staff. In addition, eligible applications will be jointly reviewed for responsiveness by CDC/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 eligibility and/or published submission requirements.

An objective review panel will evaluate complete and responsive applications according to the criteria listed in Section VI. Application Review Information, subsection entitled “Evaluation Criteria”.

Selection

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.

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

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

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

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

· AR-4

HIV/AIDS Confidentiality Provisions

· AR-5

HIV Program Review Panel Requirements

· AR-6

Patient Care

· AR-8

Public Health System Reporting Requirements

· AR-10

Smoke-Free Workplace Requirements

· AR-11

Healthy People 2010

· AR-12

Lobbying Restrictions

· AR-14

Accounting System Requirement

· AR-25

Release and Sharing of Data

· AR-29 Compliance with EO13513 “Federal Leadership on reducing Text Messaging while driving.

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

For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html Reporting Federal Funding Accountability And Transparency Act Of 2006 (FFATA): Public Law 109-282, the Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), requires full disclosure of all entities and organizations receiving Federal funds including grants, contracts, loans and other assistance and payments through a single publicly accessible Web site, USASpending.gov. The Web site includes information on each Federal financial assistance award and contract over $25,000, including such information as:

1. The name of the entity receiving the award

2. The amount of the award

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

4. The location of the entity receiving the award

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

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

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

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

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

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

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

a. Standard Form (“SF”) 424S Form.

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

c. Budget Narrative.

d. Indirect Cost Rate Agreement.

e. Project Narrative.

2. Annual progress report, due 90 days after the end of the budget period.

3. Financial status report, due no more than 90 days after the end of the budget period;

4. Final financial status and progress reports, due no more than 90 days after the end of the project period. Recipients must mail the reports to the Grants Management or Contract Specialist listed in the 'Agency…