cdc-rfa-ck15-1502 06 12 15 final.pdf

Centers for Disease Control and Prevention

National Center for Emerging and Zoonotic Infectious Diseases

Advance Molecular Detection (AMD)

CDC-RFA-CK15-1502

Application Due Date: 08/12/2015

Advance Molecular Detection (AMD)

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-CK15-1502. 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:

Advance Molecular Detection (AMD) 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-CK15-1502

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

93.064 F. Dates:

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

2. Due Date for Applications: 08/12/2015, 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:

a. Eligible Applicants:

b. FOA Type: Cooperative Agreement

c. Approximate Number of Awards: 1

d. Total Project Period Funding: $100,000

e. Average One Year Award Amount: $100,000

f. Number of Years of Award: 1

g. Estimated Award Date: 09/30/2015

h. Cost Sharing and / or Matching Requirements: N Cost sharing or matching funds are not required for this program.

Part II. Full Text A. Funding Opportunity Description

1. Background

a. Overview http://foa.grantsolutions.gov/announcementmodule/www.grants.gov http://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

The use of genetic markers to accurately determine the source of a naturally occurring infection or a bioterrorism event is important in making public health actionable decisions, especially when cases do not have clear exposures. Whole genome sequencing (WGS) with large databases to compare generated data will be a major advancement for molecular epidemiology and forensics. The establishment of public databases is essential to allow collection of data from around the world, particularly in countries that cannot share strains easily, and is needed to make rapid and effective strain comparisons. It is essential to rapidly genotype isolates and analyze results in unexplained cases to determine if it is a bioterrorism event and/or determine its potential origin. CDC plans to begin sequencing the culture collections of Bacillus anthracis, Brucella spp., and Burkholderia and the applicant will use this data to perform analysis and develop public databases in collaboration with our federal and academic partners.

b. Statutory Authorities

This program is authorized under Public Health Service Act, Section 317(k)(2), 42 U.S.C 247b(k)(2)

c. Healthy People 2020

This project contributes to the Healthy People 2020 focus areas of Global Health and Health Communication and Health Information Technology to: 1) prevent the international spread of disease; 2) protect the health of the U.S. population; 3) facilitating the meaningful use of health IT and exchange of health information among health care and public health professionals; and 4) enabling quick and informed action to health risks and public health emergencies. The purpose of this FOA is to develop the capacity for analysis and comparison of whole genome sequences of B. anthracis at CDC. This whole genome analysis is crucial for epidemiology support during a public health investigation. This data will be housed at CDC and deposited into public databases (Genebank). This FOA is in alignment with HHS/CDC/OID/NCEZID's mission to reduce illness and death associated with emerging and zoonotic infectious diseases and to protect against the unintentional and intentional spread of infectious diseases and sharing vital health information with the public and building collaborations for the benefit of global health. The link to Healthy People 2020 topics and objectives is https://www.healthypeople.gov/2020/topics-objectives/topic/global-health and https ://www.healthypeople.gov/2020/topics-objectives/topic/health-communication-and-health-information-techn ology

d. Other National Public Health Priorities and Strategies

e. Relevant Work

This FOA is in alignment with HHS/CDC/NCEZID’s aims to prevent disease, disability, and death caused by a wide range of infectious diseases. We focus on diseases that have been around for many years, emerging diseases (those that are new or just recently identified), and zoonotic diseases (those spread from animals to people) and building collaborations for the benefits of global health. This FOA builds upon the work currently underway towards developing a comprehensive internal and public B. anthracis genome database which is critical for the effort for rapid, high resolution, genotyping needed for molecular epidemiology and forensic investigations. The value of having public international databases has been clearly illustrated by the establishment of online multi-locus sequence typing databases for numerous pathogens. http://www.cdc .gov/ncezid/about-ncezid.html

2. CDC Project Description

a. Approach https://www.healthypeople.gov/2020/topics-objectives/topic/global-health https://www.healthypeople.gov/2020/topics-objectives/topic/health-communication-and-health-information-technology https://www.healthypeople.gov/2020/topics-objectives/topic/health-communication-and-health-information-technology https://www.healthypeople.gov/2020/topics-objectives/topic/health-communication-and-health-information-technology http://www.cdc.gov/ncezid/about-ncezid.html http://www.cdc.gov/ncezid/about-ncezid.html

Strategies and Activities* Short-Term Outcomes*

Intermediate Outcomes Long-Term Outcomes*

· Establish whole genome SNP pipeline

- Develop pipeline

- Optimize pipeline

- Transfer to CDC and train personnel on use of pipeline

Deposit genomes in public database/NCBI

- Trim and assemble genomes

- Perform quality control of sequencing data

- Analyze phylogenetic relationships

Increase genomes in public database

(NCBI)

Description of North American isolate diversity Increase genomes in public database

Creation of public database CDC acquiring whole genome sequencing typing capacity Description of global isolate diversity Increase genomes in public database

i. Purpose

The purpose of this program is to continue building critical capacities at the national and state levels to use AMD technologies to enhance infectious disease prevention and control.

ii. Outcomes

Increase genomes in public database (NCBI)

Providing public B. anthracis genome database that can be accessed nationally and internationally

Description of North American isolate diversity

Increase knowledge of North American isolate diversity

Creation of public database

Depositing genomes in NCBI database for national and international public use

Acquiring whole genome sequencing typing capacity

Acquiring whole genome sequencing typing capacity

Increase CDC’s typing capacity

Description of global isolate diversity

Increase knowledge of global isolate diversity

iii. Strategies and Activities

Establish whole genome SNP pipeline

- Develop pipeline

- Optimize pipeline

- Transfer to CDC and train personnel on use of pipeline

Deposit genomes in public database/NCBI

- Trim and assemble genomes

- Perform quality control of sequencing data

- Analyze phylogenetic relationships

1.Collaborations n/a

a. With CDC-funded programs:

n/a

b. With organizations external to CDC:

n/a

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

Awardee will report progress toward program outcomes on a quarterly basis. CDC will develop the specific performance measures that best meet the purpose and objective of this project as well as the timing of the performance measures. Some performance measures may be required in 1st quarter but not in succeeding quarters and others will be required in subsequent quarters only. The performance measures will be closely tied to the pertinent strategies, activities, and outcomes. Overall, reports summarizing the progress and short-term outcomes of each project will be submitted, at a minimum on a semi annual basis. Performance measure may include:

Analyze and perform quality control on genomes using developed and optimized pipeline which will improve CDC’s molecular typing capacity Deposit genomes into NCBI on semi-annual basis Provide phylogenetic relationships of isolate diversity and compare data to historically used methods

ii. Applicant Evaluation and Performance Measurement Plan

Applicants are expected to have a project monitoring plan designed to demonstrate progress in project implementation (this should include timelines, schedule for conference calls, onsite meetings, submission of progress reports, etc.).

c. Organizational Capacity of Awardees to Execute the Approach

Below is the required organizational skill set the applicant would need to have to execute this FOA:

Program Management

Planning and execution Performance management and monitoring Communication management Partnership development Reporting Workforce management

Subject Matter Expertise (not all are required)

Clinical and public health expertise in refugee health Surveillance and informatics expertise Experience establishing longitudinal studies Health education/health promotion expertise Electronic health record (EHR) expertise

Financial Planning

Budget management and tracking Budget administration Financial reporting

d. Work Plan

A detailed work plan covering the project period. This work plan should include the expected outcomes, the program strategies, associated performance measures, milestones or target dates for activity completion, and identification of person(s) responsible for those activity completions.

Below is a sample work plan for illustrative purposes only:

Expected Outcome(s) for the Project Period: XXX

Program Strategy(ies); XXX

Activity Performance Measures

Person Responsible

Target Date Activity Completion Date

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 will be substantially involved with some of the activities of this FOA and will be a fully collaborating partner with certain activities.

CDC will provide:

Technical Assistance

Collaborate with the awardee to establish priorities for the program through regular meetings and communication Collaborate with the awardee to establish goals, and objectives Provide consultation, guidance and technical assistance especially in area of whole genome sequencing Assist in evaluating program operations and the overall effectiveness of the project activities through joint program review and analysis Review and approve the awardee's work plan, detailed budget, monitoring and evaluation plan Discuss on a quarterly basis with the awardee to assess quarterly technical and financial progress reports and modify plans as necessary

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: U38

U38 Cooperative Agreements to Develop or Improve Facets of the Public Health Information

3. Fiscal Year: 2015 Estimated Total Funding: $100,000

4. Approximate Total Fiscal Year Funding: $100,000

5. Approximate Project Period Funding: $100,000

6. Total Project Period Length: 1 year(s)

7. Expected Number of Awards: 1

8. Approximate Average Award: $100,000 Per Budget Period

9. Award Ceiling: $100,000 Per Budget Period

10. Award Floor: $100,000 Per Budget Period

11. Estimated Award Date: 09/30/2015 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: 12 month(s)

13. Direct Assistance Direct Assistance (DA) is available through this FOA.

C. Eligibility Information

1. Eligible Applicants Eligibility Category: Private institutions of higher education

Other:

Private colleges and universities

2. Additional Information on Eligibility Georgia Institute of Technology is the only applicant eligible to apply.

The award ceiling for this FOA is $100,000. CDC will consider any application requesting an award higher

The award ceiling for this FOA is $100,000. 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

The project would require advanced knowledge of bioinformatics tools and pipelines to check the quality, trim and assembly genome sequence data originating from next-generation sequencers such as the Illumina Hi-Seq 2500 platform, and to perform phylogenetic analyses of hundred of bacterial strains at the whole genome level. It would be necessary to evaluate existing and develop new bioinformatics solutions/algorithms, tailored to the specific needs of the project such as the high-resolution typing of whole genome sequences. High-throughout solutions for several of the tasks that underlie the latter research objective are not publicly available. Therefore, the project would also require coding skills in PERL/PHYTHON/C++ programming languages in order to produce industry-level, ready-to-use bioinformatics pipelines for the CDC personnel to employ in future projects related to typing bacterial pathogens based on genome data (draft or complete genomes).

The project would require high-performance computing resources to deal with the massive genome data available, including at least 20Tb of disk space and a couple hundred, high-memory (>16Gb per node) computer nodes for genome data assembly, whole-genome phylogenetic analysis, and Single Nucleotide Polymorphism (SNP) detection. High-speed internet connection (e.g., 100Mp/sec) and secure FTP site for data transfer and data sharing with CDC, respectively, would be necessary for these purposes.

NCEZID/DHCPP/BSPB has partnered with the Georgia Insititute of Technology for 1 year on the Development of whole genome, single nucleotide polymorphism (SNP) based genotyping method and public database for Bacillus anthracis. Georgia Tech has evaluated methods for whole genome single nucleotide polymorphism analysis; developed and optimized bioinformatics pipeline for the SNP analysis that is being used by CDC; in the past has received up to 500 genomes to deposit in the public database;

and performed training of CDC staff on the use of these tools.

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

No

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

5. Maintenance of Effort

N/A

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 http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf 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

Internet at http:// fedgov.dnb.com/webform/displayHomePage.do. The DUNS number will be provided 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: 08/12/2015, 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 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 http://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 n/a

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://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx 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.

No collaborations with any other CDC funded programs are required.

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.

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

Applicant must address the organizational capacity requirements as described in the CDC Project Description.

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.

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.

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 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.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

(AOR) will be sent an e-mail notice of receipt when www.grants.gov receives the application. The 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 ApplicantUserGuide .pdf /ce754626 -c2aa-44bc- b701 -30a75bf428c8

d. Technical Difficulties: If technical difficulties are encountered at www.grants.gov, applicants should contact Customer Service at www.grants.gov. The www.grants.gov Contact Center is available 24 hours a day, 7 days a week, except federal holidays. The Contact Center is available by phone at 1-800-518-4726 or by e-mail at support@www.grants.gov. Application submissions sent by e-mail or fax, or on CDs or thumb drives will not be accepted. Please note that www.grants.gov is managed by

HHS.

e. Paper Submission: If technical difficulties are encountered at www.grants.gov, applicants should call the www.grants.gov Contact Center at 1-800-518-4726 or e-mail them at support@www.grants.gov for assistance. After consulting with the Contact Center, if the technical difficulties remain unresolved and electronic submission is not possible, applicants may e-mail or call CDC GMO/GMS, before the deadline, and request permission to submit a paper application. Such requests are handled on a case-by-case basis.

An applicant’s request for permission to submit a paper application must:

Include the www.grants.gov case number assigned to the inquiry1.

Describe the difficulties that prevent electronic submission and the efforts taken with the www.grants.gov Contact Center to submit electronically; and

2.

Be postmarked at least three calendar days before the application deadline. Paper applications submitted without prior approval will not be considered. If a paper application is authorized, PGO will advise the applicant of specific instructions for submitting the application (e.g., original and two hard copies of the application by U.S. mail or express delivery service).

3.

E. Review and Selection Process

1. Review and Selection Process: Applications will be reviewed in three phases.

a. Phase I Review All applications will be reviewed initially for completeness by CDC PGO staff and will be reviewed jointly http://www.Grants.gov http://www.Grants.gov http://www.Grants.gov http://www.Grants.gov http://www.grants.gov/documents/19/18243/GrantsgovApplicantUserGuide.pdf/ce754626-c2aa-44bc-b701-30a75bf428c8 http://www.grants.gov/documents/19/18243/GrantsgovApplicantUserGuide.pdf/ce754626-c2aa-44bc-b701-30a75bf428c8 http://www.Grants.gov http://www.Grants.gov mailto:support@www.grants.gov http://www.grants.gov http://www.grants.gov mailto:support@www.grants.gov

All applications will be reviewed initially for completeness by CDC PGO staff and will be reviewed jointly for eligibility by the CDC NCEZID and PGO. Incomplete applications and applications that do not meet the eligibility criteria will not advance to Phase II review. Applicants will be notified that their applications did not meet eligibility or published submission requirements.

b. Phase II Review A review panel will evaluate complete, eligible applications in accordance with the criteria below.

i. Approach

ii. Evaluation and Performance Measurement

iii. Applicant’s Organizational Capacity to Implement the Approach

Approach Maximum Points: 30

Plan (30 Points)

Is the plan adequate to carry out the proposed objectives?

Does the plan thoroughly address all project goals and awardee activities for the entire project period?

Is an adequate timeline in place?

Evaluation and Performance Measurement Maximum Points: 30

Methods (30 Points)

Are the proposed evaluation methods feasible for whole genome SNP analysis?

Are the methods describe adequate to develop and optimized bioinformatics pipeline?

Applicants Organizational Capacity to Implement the Approach Maximum Points: 40

Demonstrated Experience (20 points)

Does the organization conduct evaluation methods for SNP analysis?

Has the organization developed complete an optimized bioinformatics pipeline for SNP analysis?

Does the applicant provide evidence that suggests they possess the necessary experience?

Does the applicant demonstrate the capacity to create a 1 year plan for the services outlined in this program announcement?

Does the applicant demonstrate they have working knowledge of or have collaborative experience with SNP analysis to be able to create and complete SNP pipeline and deposit genomes in public database/NCBI?

Personnel (20 Points)

Can the organization demonstrate that its staff has the appropriate knowledge of genome/SNP analysis?

Can the organization demonstrate that its staff has the appropriate knowledge of quality control of sequencing data? Can the organization demonstrate that its staff has the appropriate knowledge of analyzing phylogenetic relationships? Does the staff have experience creating public databases?

Budget and Budget Narrative

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?

Not more than thirty days after the Phase II review is completed, applicants will be notified electronically if their application does not meet eligibility or published submission requirements.

c. Phase III Review

2. Announcement and Anticipated Award Dates

The Grants Management Officer will provide electronic communication to the successful awardees in the form of a notice of award letter. Award date is expected to be September 30, 2015.

F. Award Administration Information

1. Award Notices Awardees will receive an electronic copy of the Notice of Award (NOA) from CDC PGO. The NOA shall be the only binding, authorizing document between the awardee and CDC. The NOA will be signed by an authorized GMO and emailed to the Awardee Business Officer listed in application and the Program Director.

Any applicant awarded funds in response to this FOA will be subject to the DUNS, SAM Registration, and Federal Funding Accountability And Transparency Act Of 2006 (FFATA) requirements.

Unsuccessful applicants will receive notification of these results by e-mail with delivery receipt or by U.S.

mail.

2. Administrative and National Policy Requirements Awardees must comply with the administrative and public policy requirements outlined in 45 C.F.R. Part 74 or Part 92 and the HHS Grants Policy Statement, as appropriate.

Brief descriptions of relevant provisions are available at http://www.cdc.gov/grants/additionalrequirements/index.html

The HHS Grants Policy Statement is available at http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf.

*Note that 2 CFR 200 will supersede the administrative requirements (A-110 & A-102), cost principles (A-21, A-87 & A-122) and audit requirements (A-50, A-89 & A-133).

Applicants are advised that any activities involving information collection (i.e., surveys, questionnaires, etc.)

from 10 or more non-Federal individuals/entities are subject to OMB/PRA requirements and may require the CDC to coordinate an OMB Information Collection Clearance was not provided in FOA.

For more information on the C.F.R. visit http://www.ecfr.gov/cgi-bin/ECFR?page=browse.

3. Reporting Reporting provides continuous program monitoring and identifies successes and challenges that awardees encounter throughout the project period. Also, reporting is a requirement for awardees who want to apply for yearly continuation of funding. Reporting helps CDC and awardees because it:

Helps target support to awardees;

Provides CDC with periodic data to monitor awardee progress toward meeting the FOA outcomes and overall performance;

Allows CDC to track performance measures and evaluation findings for continuous quality and program improvement throughout the project period and to determine applicability of evidence-based http://www.cdc.gov/grants/additionalrequirements/index.html http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf http://www.ecfr.gov/cgi-bin/ECFR?page=browse program improvement throughout the project period and to determine applicability of evidence-based approaches to different populations, settings, and contexts; and Enables CDC to assess the overall effectiveness and influence of the FOA.

The table below summarizes required and optional reports. All required reports must be sent electronically to GMS listed in the “Agency Contacts” section of the FOA copying the CDC Project Officer.

Report When? Required?

Awardee Evaluation and Performance Measurement Plan

6 months into award Yes

Annual Performance Report (APR) 120 days before end of budget period.

Serves as yearly continuation application.

Yes

Data on Performance Measures CDC program determines. Only if program wants more frequent performance measure reporting than annually in APR.

No

Federal Financial Reporting Forms 90 days after end of calendar quarter in which budget period ends

Yes

Final Performance and Financial Report 90 days after end of project period. Yes

a. Awardee Evaluation and Performance Measurement Plan (required) With support from CDC, awardees must elaborate on their initial applicant evaluation and performance measurement plan.