oe15-1504.pdf

Centers for Disease Control and Prevention

Center for Surveillance, Epidemiology and Laboratory Services

Domestic Laboratory Biosafety for Ebola and other Highly Infectious Diseases

CDC-RFA-OE15-1504

Application Due Date: 05/01/2015

Domestic Laboratory Biosafety for Ebola and other Highly Infectious Diseases

CDC-RFA-OE15-1504

TABLE OF CONTENTS

Part I. Overview Information

Federal Agency NameA.

Funding Opportunity TitleB.

Announcement TypeC.

Agency Funding Opportunity NumberD.

Catalog of Federal Domestic Assistance (CFDA) NumberE.

Dates F.

Executive Summary G.

Part II. Full Text

Funding Opportunity Description A.

Award Information B.

Eligibility Information C.

Required Registrations D.

Review and Selection Process E.

Award Administration Information F.

Agency Contacts G.

Other Information H.

Glossary I.

Part I. Overview Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notifications Emails" link to ensure they receive notifications of any changes to CDC-RFA-OE15-1504. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) B. Funding Opportunity Title:

Domestic Laboratory Biosafety for Ebola and other Highly Infectious Diseases C. Announcement Type: New - Type 1 This announcement is only for non-research domestic activities supported by CDC. If research is proposed, the application will not be considered Research for this purpose is defined at http://www.cdc.gov/od/science /integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf.

D. Agency Funding Opportunity Number:

CDC-RFA-OE15-1504

E. Catalog of Federal Domestic Assistance (CFDA) Number:

93.322 F. Dates:

1. Due Date for Letter of Intent (LOI): N/A

2. Due Date for Applications: 05/01/2015, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

3. Date for Informational Conference Call: N/A

G. Executive Summary:

1. Summary Paragraph:

In March of 2014, the largest ebola outbreak under record erupted in West Africa. Unlike many smaller preceding outbreaks of ebola virus, this particular outbreak spread to multiple African countries and caused (as of March 2015) nearly 25,000 suspected human cases and 10,000 deaths; the outbreak continues. This outbreak has truly demonstrated that in the modern world of travel, trade and migration, infectious diseases do not respect geopolitical boundaries. Gaps in U.S. laboratory biosafety practice were identified during the care of infected individuals in U.S. facilities. Assessments of public health and clinical laboratories across the U.S. need to be undertaken to identify gaps in biosafety practice. Strategies need to be developed and implemented to address gaps. A body of knowledge (guidances, best practices, training tools, etc) needs to be developed.

This program will be jointly led by the National Center for Emerging and Zoonotic Diseases (NCEZID) and the Center for Surveillance, Epidemiology, and Laboratory Services (CSELS).

a. Eligible Applicants: Single

b. FOA Type: Cooperative Agreement

c. Approximate Number of Awards: 1

d. Total Project Period Funding: $2,200,000

e. Average One Year Award Amount: $2,200,000 The award will be made as a one-time award for a single 36-month project and budget period.

https://foa.grantsolutions.gov/announcementmodule/www.grants.gov https://foa.grantsolutions.gov/announcementmodule/www.grants.gov http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.grants.gov

17. Funding Restrictions Restrictions that must be considered while planning the programs and writing the budget are:

Awardees may not use funds for research.

Awardees may not use funds for clinical care.

Awardees may use funds only for reasonable program purposes, including personnel, travel, supplies, and services.

Generally, awardees may not use funds to purchase furniture or equipment. Any such proposed spending must be clearly identified in the budget.

Reimbursement of pre-award costs is not allowed.

Other than for normal and recognized executive-legislative relationships, no funds may be used for:

publicity or propaganda purposes, for the preparation, distribution, or use of any material designed to support or defeat the enactment of legislation before any legislative body the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or Executive order proposed or pending before any legislative body

See http:// www.cdc.gov /grants /additional requirements /index.htm l#ar12 for detailed guidance on this prohibition and http://www.cdc.gov/grants/documents/Anti-Lobbying_Restrictions_for_CDC_Grantees_July_2012.pdf

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

No additional funding restrictions.

http://www.cdc.gov/grants/additionalrequirements/index.html#ar12 http://www.cdc.gov/grants/documents/Anti-Lobbying_Restrictions_for_CDC_Grantees_July_2012.pdf

f. Number of Years of Award: 3

g. Estimated Award Date: 05/14/2015

h. Cost Sharing and / or Matching Requirements: N Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this FOA exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

Part II. Full Text A. Funding Opportunity Description

1. Background

a. Overview

In March of 2014, the largest ebola outbreak under record erupted in West Africa. Unlike many smaller preceding outbreaks of ebola virus, this particular outbreak spread to multiple African countries and caused (as of March 2015) nearly 25,000 suspected human cases and 10,000 deaths; the outbreak continues. This outbreak has truly demonstrated that in the modern world of travel, trade and migration, infectious diseases do not respect geopolitical boundaries. Gaps in U.S. laboratory biosafety practice were identified during the care of infected individuals in U.S. facilities. Assessments of public health and clinical laboratories across the U.S. need to be undertaken to identify gaps. Strategies need to be developed and implemented to address gaps. A body of knowledge (guidances, best practices, training tools, etc) needs to be developed.

Overall, this work needs to be done in individual State, Local, and Territorial (STLT) health departments in a nationally-coordinated manner, with guidance and participation/collaboration from experienced biosafety and general laboratory system subject matter experts.

The events surrounding laboratory testing of patient specimens suspected of ebola virus infection point to a lack of biosafety programs in most U.S. clinical laboratories. For example, biosafety plans may be absent or outdated and staff charged with implementing and training additional staff on biosafety procedures may require additional education and practice to do so effectively and confidently. Some deficiencies illustrated during this event may span across many U.S. laboratories while others may only apply to some laboratories.

Individual assessments should be conducted to identify the specific gaps for each laboratory. In addition to biosafety needs, biosecurity assistance is also anticipated. Some common gaps expected to be identified by laboratories include lack of staff that are knowledgeable and practiced in safe, secure and appropriate handling and shipping of agents that are potentially life-threatening, such as ebola virus. Some laboratories may also lack necessary physical biosafety and biosecurity resources (e.g., appropriate biological safety cabinets and approved shipping containers). Standard operating procedures for specimen testing may need to be updated based on what is learned from ebola. Once assessments are complete, it is imperative that reasonable measures are taken to communicate and develop plans to address the identified biosafety and biosecurity gaps. Even a delay in shipping a specimen because of uncertainty or lack of resources may result in delayed testing, delayed treatment for the patient, and potential for population exposure.

b. Statutory Authorities

Statutory Authorities: Section 317(k)(2) of the Public Health Service Act (42 USC Sections 247B(k)(2), as amended).

c. Healthy People 2020

The achievement of many Healthy People 2020 goals and objectives hinges critically on the effectiveness, capabilities, and sustainability of state and local public health laboratories in the United States. The Healthy People 2020 goals and objectives that support this FOA are:

• Environmental Health

• Immunization and Infectious Diseases

• Occupational Safety and Health

• Preparedness

• Public Health Infrastructure

For more information, see healthypeople.gov

d. Other National Public Health Priorities and Strategies

N/A

e. Relevant Work

This FOA is closely linked to the recently released FOA# CDC-RFA-CK14-1401PPHFSUPP15: "Domestic Ebola Supplement to Epidemiology and Laboratory Capacity for Infectious Diseases (ELC) - Building and Strengthening Epidemiology, Laboratory and Health Information Systems Capacity in State and Local Health Departments." One of the ELC FOA components will provide funding and technical support to STLT health departments for building and improving laboratory biosafety capacity for ebola and other highly infectious diseases. Under the ELC Ebola Supplemental program, STLT public health departments and their clinical partners will assess and develop and implement measures to improve laboratory and biological safety practices for dealing with current and emerging infectious diseases, including ebola and other highly infectious diseases (EHIDs). This FOA# CDC-RFA-OE15-1504: “Domestic Laboratory Biosafety for Ebola and Other Highly Infectious Diseases” aims to support the Association of Public Health Laboratories (APHL) to serve as a national coordinator and technical/scientific subject matter expert for the work in the STLTs.

2. CDC Project Description

a. Approach

Strategies and Activities Short-Term Outcomes Long-Term Outcomes Strategy 1: Enhance Public Health Laboratory Biosafety Capacity

Support a coordinated national effort to improve STLT laboratory biosafety capacity.

Discuss strategies and work plans with STLTs for their emergency ebola biosafety funding.

Support and assist STLTs in their efforts

More trained staff knowledgeable in working with infectious organisms and other emerging pathogens of public health concern.* Improved biosafety practices for handling/processing Ebola and other highly infectious specimens at public health and clinical labs.* Better coordination of

Greater U.S.

national lab system capacity to respond to outbreaks and safely handle EHIDs Reduced morbidity and mortality from EHIDs due to lapses/gaps in lab biosafety practices http://www.healthypeople.gov

*Outcomes to be accomplished within the Project Period.

STLTs in their efforts to:

Update and disseminate biosafety guidelines for EHIDs Perform risk assessment(s) of public health laboratory to assure the lab can safely handle and dispose of EHID Develop, provide and/or assure access to tools (i.e., risk assessment templates or models, exercises), guidance, trainings and other educational activities for clinical laboratories and facilities Implement mitigation strategies based upon results of assessment at the public health laboratory.

Strategy 2: Improve Laboratory Coordination and Outreach

Support STLTs to coordinate and reach out to their clinical laboratory partners:

Support clinical laboratory partners to perform their own risk assessments

Better coordination of biosafety practices between public health labs and clinical partners.* Labs better equipped to serve jurisdiction in the inactivation and disposal of specimens and other laboratory waste from suspected Ebola or other highly infectious agents.* assessments Work with clinical laboratories to identify and implement mitigation strategies.

i. Purpose

The purpose is to support APHL to develop a laboratory safety program for public health and clinical laboratories that provides:

Access to subject matter experts on clinical and public health laboratory safety for infectious agents, including highly infectious agents like Ebola.

Coordination of sharing of best practices among laboratories on safe handling and testing of specimens.

Assistance to laboratories for assessment of training, facilities, and equipment for safe handling and testing of specimens for highly infectious agents like Ebola.

Training to laboratories on lab safety risk assessment and risk mitigation.

ii. Outcomes

Nationally across the U.S. laboratory system, More trained staff knowledgeable in working with infectious organisms and other emerging pathogens of public health concern.

Improved biosafety practices for handling/processing suspected ebola and other highly infectious specimens at public health and clinical labs.

Better coordination of biosafety practices between public health labs and clinical partners.

Labs better equipped to serve their jurisdiction in the inactivation and disposal of specimens and other laboratory waste from suspected ebola or other highly infectious agents.

iii. Strategies and Activities

Strategy 1: Enhance Public Health Laboratory Biosafety Capacity

Support a coordinated national effort to improve STLT laboratory biosafety capacity.

Discuss strategies and work plans with STLTs for their emergency ebola biosafety funding.

Support and assist STLTs in their efforts to:

Update and disseminate in their jurisdictions, their biosafety guidelines for ebola specimens and other highly-infectious diseases based upon CDC guidelines.

Perform risk assessment(s) of jurisdiction’s public health laboratory to assure the lab can safely handle and dispose of specimens suspected of ebola and other highly infectious agents Develop, provide or assure access to tools (i.e., risk assessment templates or models, exercises), guidance, trainings and other educational activities for clinical laboratories and facilities to maintain competent staff knowledgeable in working with infectious organisms of public health concern.

Coordinate training activities as appropriate through the existing CDC-APHL collaborative National Laboratory Training Network (NLTN).

Implement mitigation strategies based upon results of assessment at the public health laboratory.

laboratory.

Strategy 2: Improve Laboratory Coordination and Outreach

Support STLTs to coordinate and reach out to their clinical laboratory partners:

Work with their jurisdiction’s clinical laboratory partners to perform their own risk assessments andcoordinate this activity with any proposed infection control assessments performed as part of a proposed Infection Control Assessment and Promotion Program.

Work with clinical laboratories to identify and implement mitigation strategies from the clinical laboratory risk assessments.

1.Collaborations

The awardee will use or develop strategic partnerships that best suit their needs in order to maximize the use of resources and improve the sustainability of the listed activities.

a. With CDC-funded programs:

CDC’s Center for Surveillance, Epidemiology, and Laboratory Services (CSELS) (required) CDC's National Center for Emerging and Zoonotic Diseases (NCEZID) (required) Epidemiology and Laboratory Capacity for Infectious Diseases (ELC) (required) Public Health Emergency Preparedness (PHEP) and Laboratory Response Network (LRN) (required)

b. With organizations external to CDC:

Collectively and one-on-one with individual STLT public health laboratories and their clinical laboratory partners (required).

2. Target Populations

N/A

a. Inclusion

N/A

iv. Funding Strategy (for multi-component FOAs only)

N/A

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

APHL will be required to report on a small set of performance measures. APHL and CDC will jointly develop these required performance measures within 6 months of award. Following are examples of measures that may be condidered and that are consistent with the logic model and workplan for this FOA:

Outcome Measures:

Number (or % increase in number) of trained staff knowledgeable in working with infectious organisms and other emerging pathogens of public health concern.

Percent or number of labs better equipped (trained staff, implemented procedures, etc) to serve jurisdiction in the inactivation and disposal of specimens and other laboratory waste from suspected Ebola or other highly infectious agents.

Process Measures:

Strategy 1: Enhance Public Health Laboratory Biosafety Capacity

Number of consultations with with STLTs on strategies and workplans for their emergency ebola biosafety funding.

Improved STLT preparedness and performance:

Percent of STLTs that have updated and disseminated in their jurisdictions, their biosafety guidelines for Ebola specimens and other highly-infectious diseases based upon CDC guidelines.

Percent of public health labs that have compelted a risk assessment of jurisdiction’s public health laboratory to assure the lab can safely handle and dispose of specimens suspected of Ebola and other highly infectious agents.

Percent/number of STLTs that have developed, provided, and/or assured access to tools (i.e., risk assessment templates or models, exercises), guidance, trainings and other educational activities for themselves and their jurisdictional clinical laboratories/facilities to maintain competent staff knowledgeable in working with infectious organisms of public health concern.

Percent of STLTs that have implemented mitigation strategies based upon results of their assessment at the public health laboratory.

Strategy 2: Improve Laboratory Coordination and Outreach

Improved STLTs coordination and outreach to their clinical laboratory partners:

Number/percent of STLTs that have held at least one meeting/consultation with one or more clinical laboratory partners to perform their own risk assessments.

Number/percent of STLTs that have at least one clinical laboratory implement mitigation strategies from the clinical laboratory risk assessments.

ii. Applicant Evaluation and Performance Measurement Plan

APHL will be required to report on a small set of performance measures. APHL and CDC will jointly develop these required performance measures within 6 months of award. See above for examples of measures that may be condidered and that are consistent with the logic model and workplan for this FOA.

c. Organizational Capacity of Awardees to Execute the Approach

The applicant must demonstrate that:

They are an existing national organization representing STLT Public Health Laboratory Directors and other PH and clinical laboratory interests.

They have substantial experience in public health laboratory practice capacity building, program planning, training, etc., that is necessary to implement the required activities.

They have the ability to immediately and rapidly implement the required activities.

d. Work Plan

The applicant must clearly identify the outcomes they expect to achieve by the end of the 36-month project period and provide a clear and concise description and timeline of the strategies and activities they will use to achieve the project's outcomes. Describe the activities being proposed and describe what the expected outputs (e.g. milestones) will be for the length of the project.

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and awardees, site visits, and awardee reporting (including work plans, performance, and financial reporting). Consistent with applicable grants regulations and policies, CDC expects the following to be included in post-award monitoring for grants and cooperative agreements:

Tracking awardee progress in achieving the desired outcomes.

Ensuring the adequacy of awardee systems that underlie and generate data reports.

Creating an environment that fosters integrity in program performance and results.

Monitoring may also include the following activities:

Ensuring that work plans are feasible based on the budget and consistent with the intent of the award.

Ensuring that awardees are performing at a sufficient level to achieve outcomes within stated timeframes.

Working with awardees on adjusting the work plan based on achievement of outcomes, evaluation results and changing budgets.

Monitoring performance measures (both programmatic and financial) to assure satisfactory performance levels.

Other activities deemed necessary to monitor the award, if applicable.

These activities may include monitoring and reporting activities that assist grants management staff (e.g., grants management officers and specialists, and project officers) in the identification, notification, and management of high-risk grantees.

f. CDC Program Support to Awardees (THIS SECTION APPLIES ONLY TO COOPERATIVE

AGREEMENTS)

CDC staff will have substantial involvement beyond site visits and regular performance and financial monitoring during the project period. CDC staff will collaborate or participate in project or program activities. This includes the following:

Technical assistance in the following: Evaluation, performance measurement, work plan development, program planning, and specific subject matter expertise.

Assistance with national coordination of activities.

Ensuring that established agency quality standards are met for training, guidance, and technical tools, that redundant effort is eliminated, and that platforms are compatible with established agency systems and protocol.

Technical assistance in the form of guidance documents, laboratory safety data, consultation, etc.

B. Award Information

1. Funding Instrument Type: Cooperative Agreement CDC's substantial involvement in this program appears in the

CDC Program Support to Awardees Section.

2. Award Mechanism: U50

3. Fiscal Year: 2015 Estimated Total Funding: $2,200,000

4. Approximate Total Fiscal Year Funding: $2,200,000

5. Approximate Project Period Funding: $2,200,000

5. Approximate Project Period Funding: $2,200,000

6. Total Project Period Length: 3 year(s)

7. Expected Number of Awards: 1

8. Approximate Average Award: $2,200,000 Per Project Period

The award will be made as a one-time award for a single 36-month project and budget period.

9. Award Ceiling: None

There is no Award Ceiling for this FOA. The application will be considered regardless of the amount requested.

10. Award Floor: None

There is no Award Floor for this FOA. The application will be considered regardless of the amount requested.

11. Estimated Award Date: 05/14/2015 Throughout the project period, CDC will continue the award based on the availability of funds, the evidence of satisfactory progress by the awardee (as documented in required reports), and the determination that continued funding is in the best interest of the federal government. The total number of years for which federal support has been approved (project period) will be shown in the “Notice of Award.” This information does not constitute a commitment by the federal government to fund the entire period. The total project period comprises the initial competitive segment and any subsequent non-competitive continuation award(s).

12. Budget Period Length: 36 month(s)

13. Direct Assistance Direct Assistance (DA) is not available through this FOA.

C. Eligibility Information

1. Eligible Applicants Eligibility Category: Others (see text field entitled "Additional Information on Eligibility" for clarification)

2. Additional Information on Eligibility

Sole-Source to the Association of Public Health Laboratories (APHL)

The award ceiling for this FOA is $0. CDC will consider any application requesting an award higher than this amount as non- responsive and it will receive no further review. If a pre-application is required, then specify here and include it in the special eligibility requirements section. (http:// www.hhs.gov/ asfr/ ogapa/ aboutog/ hhsgps107.pdf)

3. Justification for Less than Maximum Competition http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

APHL is the only organization that can successfully accomplish the objectives of this program. As part of this Nation’s emergency response to the ongoing ebola public health threat, CDC is providing FY2015 emergency ebola funding to the health departments of all 50 states, DC, the 6 largest local jurisdictions and all U.S. territories and affiliated states. This funding is to support the STLTs and their clinical laboratory partners to rapidly assess, develop, and implement measures to improve laboratory and biological safety practices for handling, testing, and disposal of specimens and supplies/equipment for ebola and other highly-infectious diseases. In order to accomplish these activities, the STLTs will need immediate and ongoing collaboration with biosafety subject matter experts for guidance, coordination, training, risk assessment, etc. Due to the immediate public health threat posed by the ongoing ebola outbreak and the requirement for rapid identification and mitigation of gaps in U.S. public health and clinical laboratory biosafety to prevent potential future exposures to ebola, the activities in this program area must be immediately and robustly implemented. APHL is uniquely positioned to be the collaborating and coordinating subject matter expert.

APHL is the single U.S. national organization representing state and local public health laboratories. APHL’s core membership consists of the public health laboratories of all 50 states and a number of the largest local health departments and U.S. territories and affiliated states.

APHL has expertise in laboratory biosafety and a long history of working with STLTs, clinical labs, CDC and others to develop and disseminate laboratory biosafety guidance, coordination, training, etc.

No other organization has the existing relationships, abilities, capacities, etc., necessary to immediately implement this program. The nature of the public health emergency requires immediate implementation with minimal, if any, ramp up time to help assure there is no repeat of transmission of ebola or any other highly infectious disease due to insufficient laboratory biosafety capacity in the U.S. national laboratory system.

4. Cost Sharing or Matching Cost Sharing / Matching Requirement:

No

Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this FOA exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

5. Maintenance of Effort

Maintenance of effort is not required for this program.

D. Required Registrations

Additional materials that may be helpful to applicants: http://www.cdc.gov/od/pgo/funding/docs/Financial ReferenceGuide.pdf.

1. Required Registrations An organization must be registered at the three following locations before it can submit an application for funding at www.grants.gov.

a. Data Universal Numbering System: All applicant organizations must obtain a Data Universal Numbering System (DUNS) number. A DUNS number is a unique nine-digit identification number provided by Dun & Bradstreet (D&B). It will be used as the Universal Identifier when applying for federal awards or cooperative agreements.

The applicant organization may request a DUNS number by telephone at 1-866-705-5711 (toll free) or Internet at http:// fedgov.dnb.com/webform/displayHomePage.do. The DUNS number will be provided http://www.cdc.gov/od/pgo/funding/docs/FinancialReferenceGuide.pdf http://www.cdc.gov/od/pgo/funding/docs/FinancialReferenceGuide.pdf http://fedgov.dnb.com/webform/displayHomePage.do at no charge.If funds are awarded to an applicant organization that includes sub-awardees, those sub-awardees must provide their DUNS numbers before accepting any funds.

b. System for Award Management (SAM): The SAM is the primary registrant database for the federal government and the repository into which an entity must submit information required to conduct business as an awardee. All applicant organizations must register with SAM, and will be assigned a SAM number. All information relevant to the SAM number must be current at all times during which the applicant has an application under consideration for funding by CDC. If an award is made, the SAM information must be maintained until a final financial report is submitted or the final payment is received, whichever is later. The SAM registration process usually requires not more than five business days, and registration must be renewed annually. Additional information about registration procedures may be found at www.SAM.gov.

c. Grants.gov: The first step in submitting an application online is registering your organization through www.grants.gov, the official HHS E-grant website. Registration information is located at the "Get Registered" option at www.grants.gov.

All applicant organizations must register with www.grants.gov. The one-time registration process usually takes not more than five days to complete. Applicants must start the registration process as early as possible.

2. Request Application Package Applicants may access the application package at www.grants.gov.

3. Application Package Applicants must download the SF-424, Application for Federal Assistance, package associated with this funding opportunity at www.grants.gov. If Internet access is not available, or if the online forms cannot be accessed, applicants may call the CDC PGO staff at 770-488-2700 or e-mail PGO PGOTIM@cdc.gov for assistance. Persons with hearing loss may access CDC telecommunications at TTY 1-888-232-6348.

4. Submission Dates and Times If the application is not submitted by the deadline published in the FOA, it will not be processed. PGO personnel will notify the applicant that their application did not meet the deadline. The applicant must receive pre-approval to submit a paper application (see Other Submission Requirements section for additional details). If the applicant is authorized to submit a paper application, it must be received by the deadline provided by PGO.

a. Letter of Intent Deadline (must be emailed or postmarked by) N/A

b. Application Deadline Due Date for Applications: 05/01/2015, 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov. If Grants.gov is inoperable and cannot receive applications, and circumstances preclude advance notification of an extension, then applications must be submitted by the first business day on which grants.gov operations resume.

5. CDC Assurances and Certifications All applicants are required to sign and submit “Assurances and Certifications” documents indicated at http://www.cdc.gov/grants/interestedinapplying/applicationprocess.html.

Complete the applicable assurances and certifications on an annual basis, name the file “Assurances and Certifications” and upload it as a PDF file at www.grants.gov Complete the applicable assurances and certifications and submit them directly to CDC on an annual basis at http://wwwn.cdc. gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/ Homepage.aspx

Assurances and certifications submitted directly to CDC will be kept on file for one year and will apply http://fedgov.dnb.com/webform/displayHomePage.do https://www.SAM.gov http://www.Grants.gov http://www.grants.gov http://www.grants.gov http://www.grants.gov http://www.grants.gov http://www.grants.gov https://foa.grantsolutions.gov/announcementmodule/PGOTIM@cdc.gov%20 http://www.grants.gov http://www.cdc.gov/grants/interestedinapplying/applicationprocess.html http://www.grants.gov/ http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx

Assurances and certifications submitted directly to CDC will be kept on file for one year and will apply to all applications submitted to CDC by the applicant within one year of the submission date.

6. Content and Form of Application Submission Applicants are required to include all of the following documents with their application package at www.grants.gov.

7. Letter of Intent

LOI is not requested or required as part of the application for this FOA.

8. Table of Contents (No page limit and not included in Project Narrative limit): The applicant must provide, as a separate attachment, the “Table of Contents” for the entire submission package.

Provide a detailed table of contents for the entire submission package that includes all of the documents in the application and headings in the "Project Narrative" section. Name the file "Table of Contents" and upload it as a PDF file under "Other Attachment Forms" at www.grants.gov.

9. Project Abstract Summary (Maximum 1 page)

A project abstract is included on the mandatory documents list and must be submitted at www.grants.gov.

The project abstract must be a self-contained, brief summary of the proposed project including the purpose and outcomes. This summary must not include any proprietary or confidential information. Applicants must enter the summary in the "Project Abstract Summary" text box at www.grants.gov.

10. Project Narrative (Maximum of 20 pages, single spaced, Calibri 12 point, 1-inch margins, number all pages. Content beyond 20 pages will not be considered. The 20 page limit includes the work plan. For a multi-component FOA, maximum page limit is 25.)

The Project Narrative must include all of the bolded headings shown in this section. The Project Narrative must be succinct, self-explanatory, and in the order outlined in this section. It must address outcomes and activities to be conducted over the entire project period as identified in the CDC Project Description section. Applicants must submit a Project Narrative with the application forms. Applicants must name this file “Project Narrative” and upload it at www.grants.gov.

a. Background Applicants must provide a description of relevant background information that includes the context of the problem (See CDC Background).

b. Approach

i. Purpose Applicants must describe in 2-3 sentences specifically how their application will address the problem as described in the CDC Background section.

ii. Outcomes Applicants must clearly identify the outcomes they expect to achieve by the end of the project period.

Outcomes are the results that the program intends to achieve. All outcomes must indicate the intended direction of change (e.g., increase, decrease, maintain). (See the logic model in the Approach section of the CDC Project Description.)

http://www.grants.gov http://www.grants.gov http://www.grants.gov

iii. Strategies and Activities Applicants must provide a clear and concise description of the strategies and activities they will use to achieve the project period outcomes. Applicants must select existing evidence-based strategies that meet their needs, or describe in the Applicant Evaluation and Performance Measurement Plan, how these strategies will be evaluated over the course of the project period. (See CDC Project Description: Strategies and Activities section.)

1. Collaborations Applicants must describe how they will collaborate with programs and organizations either internal or external to CDC.

2. Target Populations Applicants must describe the specific target population(s) in their jurisdiction and explain how such a target will achieve the goals of the award and/or alleviate health disparities. Refer back to the CDC Project Description section – Approach: Target Population.

N/A

c. Applicant Evaluation and Performance Measurement Plan Applicants must provide an overall evaluation and performance measurement plan that is consistent with the CDC Evaluation and Performance Measurement Strategy section of the CDC Project Description of this FOA. Data collected must be used for ongoing monitoring of the award to evaluate its effectiveness, and for continuous program improvement.

The plan must:

Affirm the ability to collect the performance measures and respond to the evaluation questions specified in the CDC strategy. (For guidance regarding the Paperwork Reduction Act, please visit http://www.hhs.gov/ocio/policy/collection/infocollectfaq.html) Describe how key program partners will participate in the evaluation and performance measurement planning processes.

Describe how evaluation findings will be used for continuous program quality improvement.

Where the applicant chooses to, or is expected to, take on specific evaluation studies:

Describe the type of evaluation(s) (i.e., process, outcome, or both) to be conducted.

Describe key evaluation questions to be addressed by these evaluations.

Describe other information relevant to the evaluation (e.g., measures, data sources)

Awardees will be required to submit a more detailed evaluation and performance measurement plan within the first 6 months of the project, as outlined in the reporting section of the FOA.

d. Organizational Capacity of Applicants to Implement the Approach Applicant must address the organizational capacity requirements as described in the CDC Project Description.

11. Work Plan (Included in the Project Narrative’s 20 page limit)

Applicants must prepare a work plan consistent with the CDC Project Description Work Plan section. The work plan integrates and delineates more specifically how the awardee plans to carry out achieving the project period outcomes, strategies and activities, evaluation and performance measurement.

Applicants must name this file "Work Plan" and upload it as a PDF file at www.grants.gov.

http://www.hhs.gov/ocio/policy/collection/infocollectfaq.html

12. Budget Narrative Applicants must submit an itemized budget narrative, which may be scored as part of the Organizational Capacity of Awardees to Execute the Approach. When developing the budget narrative, applicants must consider whether the proposed budget is reasonable and consistent with the purpose, outcomes, and program strategy outlined in the project narrative. The budget must include:

Salaries and wages Fringe benefits Consultant costs Equipment Supplies Travel Other categories Contractual costs Total Direct costs Total Indirect costs

Indirect costs will not be reimbursed under grants to foreign organizations, international organizations, and foreign components of grants to domestic organizations (does not affect indirect cost reimbursement to the domestic entity for domestic activities). The CDC will not reimburse indirect costs unless the recipient has an indirect cost rate covering the applicable activities and period.

For guidance on completing a detailed budget, see Budget Preparation Guidelines at:http://www.cdc.gov/grants/interestedinapplying/applicationresources.html .

If applicable and consistent with the cited statutory authority for this announcement, applicant entities may use funds for activities as they relate to the intent of this FOA to meet national standards or seek health department accreditation through the Public Health Accreditation Board (see: http://www.phaboard.org).

Applicant entities to whom this provision applies include state, local, territorial governments (including the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau), or their bona fide agents, political subdivisions of states (in consultation with states), federally recognized or state-recognized American Indian or Alaska Native tribal governments, and American Indian or Alaska Native tribally designated organizations. Activities include those that enable a public health organization to deliver public health services such as activities that ensure a capable and qualified workforce, up-to-date information systems, and the capability to assess and respond to public health needs. Use of these funds must focus on achieving a minimum of one national standard that supports the intent of the FOA. Proposed activities must be included in the budget narrative and must indicate which standards will be addressed.

Applicants must name this file “Budget Narrative” and upload it as a PDF file at www.grants.gov. If requesting indirect costs in the budget, a copy of the indirect cost-rate agreement is required. If the indirect costs are requested, include a copy of the current negotiated federal indirect cost rate agreement or a cost allocation plan approval letter for those Grantees under such a plan. Applicants must name this file “Indirect Cost Rate” and upload it at www.grants.gov.

The budget and budget narrative must cover the entire single 36-month project and budget period.

13. Tobacco and Nutrition Policies http://www.cdc.gov/grants/interestedinapplying/applicationresources.html http://www.phaboard.org

13. Tobacco and Nutrition Policies Awardees are encouraged to implement tobacco and nutrition policies.

Unless otherwise explicitly permitted under the terms of a specific CDC award, no funds associated with this FOA may be used to implement the optional policies, and no applicants will be evaluated or scored on whether they choose to implement these optional policies.

CDC supports implementing evidence-based programs and policies to reduce tobacco use and secondhand smoke exposure, and to promote healthy nutrition. CDC encourages all awardees to implement the following optional recommended evidence-based tobacco and nutrition policies within their own organizations. The tobacco policies build upon the current federal commitment to reduce exposure to secondhand smoke, specifically The Pro-Children Act, 20 U.S.C. 7181-7184, that prohibits smoking in certain facilities that receive federal funds in which education, library, day care, health care,or early childhood development services are provided to children.

Tobacco Policies:

Tobacco-free indoors: Use of any tobacco products (including smokeless tobacco) or electronic cigarettes is not allowed in any indoor facilities under the control of the awardee.

1.

Tobacco-free indoors and in adjacent outdoor areas: Use of any tobacco products or electronic cigarettes is not allowed in any indoor facilities, within 50 feet of doorways and air intake ducts, and in courtyards under the control of the awardee.

2.

Tobacco-free campus: Use of any tobacco products or electronic cigarettes is not allowed in any indoor facilities or anywhere on grounds or in outdoor space under the control of the awardee.

3.

Nutrition Policies:

Healthy food-service guidelines must, at a minimum, align with HHS and General Services Administration Health and Sustainability Guidelines for Federal Concessions and Vending Operations.

These guidelines apply to cafeterias, snack bars, and vending machines in any facility under the control of the awardee and in accordance with contractual obligations for these services (see: http://www.gsa.gov/ graphics/pbs/Guidelines_for_ Federal_ Concessions_and_Vending _ Operations.pdf).

1.

Resources that provide guidance for healthy eating and tobacco-free workplaces are:2.

http://www.cdc.gov/ nccdphp/dnpao/hwi/ toolkits/ tobacco/index.htm http://www. thecommunityguide.org/ tobacco/index.html http:// www.cdc.gov /obesity /strategies /food-serv-guide.html

14. Health Insurance Marketplaces A healthier country is one in which Americans are able to access the care they need to prevent the onset of disease and manage disease when it is present. The Affordable Care Act, the health care law of 2010, creates new Health Insurance Marketplaces, also known as Exchanges, to offer millions of Americans affordable health insurance coverage. In addition, the law helps make prevention affordable and accessible for Americans by requiring health plans to cover certain recommended preventive services without cost sharing.

Outreach efforts will help families and communities understand these new options and provide eligible individuals the assistance they need to secure and retain coverage as smoothly as possible. For more information on the Marketplaces and the health care law, visit: www.HealthCare.gov.

15. Intergovernmental Review

Executive Order 12372 does not apply to this program.

16. Pilot Program for Enhancement of Employee Whistleblower Protections http://www.gsa.gov/graphics/pbs/Guidelines_for_Federal_Concessions_and_Vending_Operations.pdf http://www.gsa.gov/graphics/pbs/Guidelines_for_Federal_Concessions_and_Vending_Operations.pdf http://www.cdc.gov/nccdphp/dnpao/hwi/toolkits/tobacco/index.htm http://www.thecommunityguide.org/tobacco/index.html http://www.cdc.gov/obesity/strategies/food-serv-guide.html http://www.HealthCare.gov

16. Pilot Program for Enhancement of Employee Whistleblower Protections Pilot Program for Enhancement of Employee Whistleblower Protections: All applicants will be subject to a term and condition that applies the terms of 48 CFR section 3.908 to the award and requires that grantees inform their employees in writing (in the predominant native language of the workforce) of employee whistleblower rights and protections under 41 U.S.C. 4712.

17. Funding Restrictions Restrictions that must be considered while planning the programs and writing the budget are:

Awardees may not use funds for research.

Awardees may not use funds for clinical care.

Awardees may use funds only for reasonable program purposes, including personnel, travel, supplies, and services.

Generally, awardees may not use funds to purchase furniture or equipment. Any such proposed spending must be clearly identified in the budget.

Reimbursement of pre-award costs is not allowed.

Other than for normal and recognized executive-legislative relationships, no funds may be used for:

publicity or propaganda purposes, for the preparation, distribution, or use of any material designed to support or defeat the enactment of legislation before any legislative body the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or Executive order proposed or pending before any legislative body

See http:// www.cdc.gov /grants /additional requirements /index.htm l#ar12 for detailed guidance on this prohibition and http://www.cdc.gov/grants/documents/Anti-Lobbying_Restrictions_for_CDC_Grantees_July_2012.pdf

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

No additional funding restrictions.

18. Other Submission Requirements

a. Electronic Submission: Applications must be submitted electronically at www.grants.gov. The application package can be downloaded at www.grants.gov. Applicants can complete the application package off-line and submit the application by uploading it at www.grants.gov. All application attachments must be submitted using a PDF file format. Directions for creating PDF files can be found at www.grants.gov. File formats other than PDF may not be readable by PGO Technical Information Management Section (TIMS) staff.

Applications must be submitted electronically by using the forms and instructions posted for this funding opportunity at www.grants.gov.

If Internet access is not available or if the forms cannot be accessed online, applicants may contact the PGO TIMS staff at 770- 488-2700 or by e-mail at pgotim@cdc.gov, Monday through Friday, 7:30 a.m.–4:30 p.m., except federal holidays. Electronic applications will be considered successful if they are available to PGO TIMS staff for processing from www.grants.gov on the deadline date.

b. Tracking Number: Applications submitted through www.grants.gov are time/date stamped electronically and assigned a tracking number. The applicant’s Authorized Organization Representative (AOR) will be sent an e-mail notice of receipt when www.grants.gov receives the application. The http://www.cdc.gov/grants/additionalrequirements/index.html#ar12 http://www.cdc.gov/grants/documents/Anti-Lobbying_Restrictions_for_CDC_Grantees_July_2012.pdf http://www.Grants.gov http://www.Grants.gov http://www.Grants.gov http://www.Grants.gov http://www.Grants.gov http://www.Grants.gov http://www.Grants.gov http://www.Grants.gov tracking number documents that the application has been submitted and initiates the required electronic validation process before the application is made available to CDC.

c. Validation Process: Application submission is not concluded until the validation process is completed successfully. After the application package is submitted, the applicant will receive a “submission receipt” e-mail generated by www.grants.gov. A second e-mail message to applicants will then be generated by www.grants.gov that will either validate or reject the submitted application package. This validation process may take as long as two business days. Applicants are strongly encouraged to check the status of their application to ensure that submission of their package has been completed and no submission errors have occurred. Applicants also are strongly encouraged to allocate ample time for filing to guarantee that their application can be submitted and validated by the deadline published in the FOA. Non-validated applications will not be accepted after the published application deadline date.

If you do not receive a “validation” e-mail within two business days of application submission, please contact www.grants.gov. For instructions on how to track your application, refer to the e-mail message generated at the time of application submission or the Applicant User Guide, Version 1.1, page 102.

http:// www.grants.gov /documents /19/18243 /Grantsgov…