CDC-RFA-CK18-1804.pdf

Centers for Disease Control

National Center for Emerging and Zoonotic Infectious Diseases

Sustaining the Expansion of the Overseas Health Assessment and Management of U.S.-Bound

Refugees, Non-Immigrant Visa Applicants and other Migrant Populations

CDC-RFA-CK18-1804

Application Due Date: 09/24/2018

Sustaining the Expansion of the Overseas Health Assessment and Management of U.S.-Bound

Refugees, Non-Immigrant Visa Applicants and other Migrant Populations

CDC-RFA-CK18-1804

TABLE OF CONTENTS

Part I. Overview Information A. Federal Agency Name B. Funding Opportunity Title C. Announcement Type D. Agency Funding Opportunity Number E. Catalog of Federal Domestic Assistance (CFDA) Number F. Dates G. Executive Summary

Part II. Full Text A. Funding Opportunity Description B. Award Information C. Eligibility Information D. Application and Submission Information E. Review and Selection Process F. Award Administration Information G. Agency Contacts H. Other Information I. Glossary

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-CK18-1804. 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) / Agency for Toxic Substances and Disease Registry (ATSDR) B. Notice of Funding Opportunity (NOFO) Title:

Sustaining the Expansion of the Overseas Health Assessment and Management of U.S.-Bound Refugees, Non-Immigrant Visa Applicants and other Migrant Populations C. Announcement Type: New - Type 1 This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https ://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf.

Guidance on how CDC interprets the definition of research in the context of public health can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html (See section 45 CFR 46.102(d)).

New – Type 1

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-CK18-1804

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

93.283 F. Dates:

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

2. Due Date for Applications: 09/24/2018, 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:

The purpose of the program is to implement activities to strengthen prevention and control efforts for infectious diseases, including vaccine-preventable diseases, in U.S.-bound refugee populations, as well as U.S.-bound immigrant and non-immigrant visa (NIV) applicants (from hereto called U.S.-bound migrants) worldwide by: 1) establishing surveillance for infectious diseases ; 2) evaluating the health status of U.S.-bound migrants for the purposes of informing and improving U.S. policy regarding overseas and post-arrival health assessments; 3) preventing the importation and spread of infectious diseases into the United States; and 4) improving the health of migrants who are undergoing resettlement to the United States and protecting the health of the communities that are receiving them. The performance outcomes will have long-term benefits to U.S.-bound migrant populations and resettlement communities.

https://www.grants.gov https://www.grants.gov https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html https://www.grants.gov

This program needs to last the full 5 years in order to prevent infectious diseases from entering the U.S.

a. Eligible Applicants:

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 1

d. Total Period of Performance Funding: $25,000,000

e. Average One Year Award Amount: $5,000,000

f. Total Period of Performance Length: 5

g. Estimated Award Date: 09/19/2018

h. Cost Sharing and / or Matching Requirements: N No cost sharing requirement

Part II. Full Text A. Funding Opportunity Description

Part II. Full Text

1. Background

a. Overview Every year, millions of migrants resettle to the United States from overseas. U.S.-bound migrants are particularly vulnerable populations, marginalized from public health surveillance, preventive treatment and health care in their home countries and countries of temporary asylum. They have complex health care issues, such as low baseline vaccination rates and high rates of infectious diseases, including tuberculosis, malaria, and intestinal parasites. Understanding the varying health needs of the different populations in a timely manner is critical for developing and targeting appropriate health activities before and after arrival.

The purpose of the program is to assist in implementing activities to strengthen prevention and control efforts for infectious diseases, including vaccine-preventable diseases, in U.S.-bound migrants worldwide, by:

1) Establishing surveillance for infectious diseases

2) Evaluating the health status of U.S.-bound migrants

3) Preventing the importation and spread of infectious diseases into the United States;

4) Improving the health of migrants who are undergoing resettlement to the

United States and protecting the health of the communities that are receiving them.

b. Statutory Authorities This program is authorized under the Public Health Service Act, Sections 307 and 317(k)(1) [42 U.S.C. 242l and 247b(k)(1)], as amended.

c. Healthy People 2020 This program addresses the “Healthy People 2020” focus area of Global Health, including GH- 2: Decrease the tuberculosis (TB) case rate for foreign-born persons living in the United States.

https://www.healthypeople.gov/2020/topics-objectives/topics/global-health

d. Other National Public Health Priorities and Strategies N/A

e. Relevant Work This NOFO continues the activities in the prior funded cooperative agreement CK12-1207 “Continuing the Expansion of the Overseas Health Assessment and Management of U.S.-Bound Refugees”.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

CDC-RFA CK18-1804 Logic Model: Sustaining the Expansion of the Overseas Health Assessment and Management of U.S.-Bound Refugees, Immigrants, and Non-Immigrant Visa Applicants (NIV) Bold indicates period of performance outcome

Strategies and Activities Short-term Outcomes

Intermediate Outcomes

Long-Term Outcomes

For U.S.-bound migrants:

- Establish surveillance for infectious diseases

- Detect, investigate and control clusters and/or outbreaks of infectious diseases

- Conduct pre-departure health

Improved surveillance for infectious diseases in U.S.-bound migrants

Improved ability of lab staff to accurately and rapidly detect infectious diseases

Reduced importation of diseases into the U.S.

Decreased assessments of candidates for resettlement

- Implement vaccination campaigns before they depart for the U.S.

Assess and provide training for laboratory facilities that will supply diagnostic services.

Establish mechanisms to assure the complete and accurate documentation of all health interventions, such as presumptive treatment and vaccination, on the appropriate forms that accompany each migrant.

Improved knowledge and skills for lab staff

More rapid, accurate, and secure reporting of:

- outbreak information

- disease interventions vaccinations provided

- drugs administered

Strengthened prevention and control efforts for infectious diseases, including vaccine-preventable diseases morbidity and mortality related to infectious diseases in the U.S.

i. Purpose The purpose of the program is to assist in implementing activities to strengthen prevention and control efforts for infectious diseases, including vaccine-preventable diseases, in migrant populations worldwide.

ii. Outcomes

Improved surveillance for infectious diseases in U.S.-bound migrants Improved ability of lab staff to accurately and rapidly detect infectious diseases Strengthened prevention and control efforts for infectious diseases, including vaccine-preventable diseases

iii. Strategies and Activities For U.S.-bound migrants:

- Establish surveillance for infectious diseases

- Detect, investigate and control clusters and/or outbreaks of infectious diseases

- Conduct pre-departure health assessments of candidates for resettlement

- Implement vaccination campaigns before they depart for the U.S.

Assess and provide training for laboratory facilities that will supply diagnostic services.

Establish mechanisms to assure the complete and accurate documentation of all health interventions, such as presumptive treatment and vaccination, on the appropriate forms that accompany each migrant.

1. Collaborations

a. With other CDC programs and CDC-funded organizations:

The recipient is not expected to collaborate with other CDC funded organizations.

b. With organizations not funded by CDC:

The recipient is not expected to collaborate with other organizations not funded by CDC.

2. Target Populations U.S.-bound migrants

a. Health Disparities The populations this NOFO will address are refugees that have fled their home country because of fear of death or persecution. This makes them a vulnerable population.

iv. Funding Strategy

NA

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

PROCESS MEASURES:

Below are the strategies from the logic model and their associated process measures:

For U.S.-bound migrants:

- Establish surveillance for infectious diseases

Enhance, link, and increase analytic capability within disease reporting systems to ensure that CDC and the state health departments of resettlement communities rapidly receive pertinent information. Support the implementation of targeted surveillance of human migrant populations to support disease monitoring, assessment, and treatment.

- Detect, investigate and control clusters and/or outbreaks of infectious diseases

Establish protocols that direct regional offices to report disease clusters and monitor the situation.

Appropriate medical and epidemiologist staff should create a response team to investigate and control the outbreak in migrant populations.

- Conduct pre-departure health assessments of candidates for resettlement

Perform appropriate medical screening and treatment of infectious diseases in migrants that are resettling to the U.S.

- Implement vaccination campaigns before they depart for the U.S.

Ensure that recommended vaccines are available in country.

Develop appropriate cold chain and storage Ensure that vaccinations are properly document

Assess and provide training for laboratory facilities that will supply diagnostic services.

Strengthen local laboratories diagnostic capacity for TB, intestinal parasites, and vaccine preventable diseases

Establish mechanisms to assure the complete and accurate documentation of all health interventions, such as presumptive treatment and vaccination, on the appropriate forms that accompany each migrant.

Have protocol that includes secondary and tertiary reviews for accuracy.

OUTCOME MEASURES:

Below are the outcomes the recipient is responsible for during the period of performance and their associated outcome measures:

Improved surveillance for infectious diseases in U.S.-bound migrants

Report on awardee's efforts to inform and improve prevention and response activities in migrant populations

Improved ability of lab staff to accurately and rapidly detect infectious diseases

Report on local and regional trainings on laboratory diagnostics and medical health assessment for infectious diseases

Strengthened prevention and control efforts for infectious diseases, including vaccine-preventable diseases

Report on activities relating to vaccine procurement, cold chain implementation, and vaccine administration and documentation

ii. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the recipient will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this NOFO. At a minimum, the plan must describe:

How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement.

How key program partners will participate in the evaluation and performance measurement planning processes.

Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g., performance measures proposed by the applicant)

Plans for updating the Data Management Plan (DMP), if applicable, for accuracy throughout the lifecycle of the project. The DMP should provide a description of the data that will be produced using these NOFO funds; access to data; data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations; and archival and long-term data preservation plans.

For more information about CDC’s policy on the DMP, see https://www.cdc.gov/grants/additionalrequirements/ar-25.html.

Where the applicant chooses to, or is expected to, take on specific evaluation studies, they should be directed to:

Describe the type of evaluations (i.e., process, outcome, or both).

https://www.cdc.gov/grants/additionalrequirements/ar-25.html

Describe key evaluation questions to be addressed by these evaluations.

Describe other information (e.g., measures, data sources).

Recipients will be required to submit a more detailed Evaluation and Performance Measurement plan, including a DMP, if applicable, within the first 6 months of award, as described in the Reporting Section of this NOFO.

Measurements will be based on reports from applicant and information from U.S. resettlement communities departments of public health.

c. Organizational Capacity of Recipients to Implement the Approach Applicant must demonstrate abilities and capacity to provide medical screening and treatment of U.S.-bound immigrants and refugees. Also, applicant must perform activities based on United Nations mandate and agreement to provide services to the U.S. Department of State.

d. Work Plan Applicant must submit a work plan (sample below) that covers the first year of the five-year project period and a high level summary of activities for years 2-5.

Proposed strategies must be in alignment with the NOFO logic model.

Required elements in a work plan include strategies and their associated performance measures, as well as major activities and the title of the person/group responsible for each activity.

Period of Performance Outcome :

[from Outcomes section and/or logic model]

Outcome Measure:

[from Evaluation and Performance Measurement section]

Strategies and Activities

Process Measure [from Evaluation and Performance Measurement section]

Responsible Position / Party

Completion Date

1.

2.

3.

4.

5.

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and recipients, site visits, and recipient 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 recipient progress in achieving the desired outcomes.

Ensuring the adequacy of recipient 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 deemed necessary to monitor the award:

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

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

Working with recipients 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.

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 recipients.

Applicant will have frequent calls with CDC project officer to discuss progress. Weekly, monthly, and quarterly reports will be required. CDC will also perform multiple site visits to ensure work is being performed accurately and that funds are used as intended.

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

COOPERATIVE AGREEMENTS)

CDC DGMQ will provide commitment of personnel and/or resources, specific subject matter expertise, evaluation, performance measurement, work plan development, program planning, and capacity building assistance and training.

B. Award Information

1. Funding Instrument Type: Cooperative Agreement CDC's substantial involvement in this program appears in the CDC Program Support to Recipients Section.

2. Award Mechanism: Cooperative agr U50 Special Cooperative Health Investigations and Assessments of Control and Prevention Methods

3. Fiscal Year: 2018

4. Approximate Total Fiscal Year Funding: $5,000,000

5. Approximate Period of Performance Funding: $25,000,000

This amount is subject to the availability of funds.

Estimated Total Funding: $25,000,000

6. Approximate Period of Performance Length: 5 year(s)

7. Expected Number of Awards: 1

8. Approximate Average Award: $5,000,000 Per Budget Period

9. Award Ceiling: $5,000,000 Per Budget Period

This amount is subject to the availability of funds.

10. Award Floor: $1 Per Budget Period

11. Estimated Award Date: 09/19/2018

12. Budget Period Length: 12 month(s)

Throughout the project period, CDC will continue the award based on the availability of funds, the evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the federal government. 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 period of performance comprises the initial competitive segment and any subsequent non-competitive continuation award(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)

Additional Eligibility Category:

2. Additional Information on Eligibility Single source eligibility for International Organization for Migration (IOM)

3. Justification for Less than Maximum Competition IOM is the only qualified international/intergovernmental organization that has the technical and administrative capacity to conduct the specific set of health assessment and research activities requested to support the CDC/DGMQ disease prevention and control goals in overseas U.S.-bound migrant populations outlined under this cooperative agreement because:

IOM is uniquely positioned, in terms of legal authority, ability, track record, infrastructure and credibility throughout the world to develop and support the medical assessment for the United States Refugee Admissions Program. IOM has already established a framework for the activities from a currently funded cooperative agreement with CDC, DGMQ, to conduct the activities.

4. Cost Sharing or Matching Cost Sharing / Matching Requirement: No No cost sharing requirement

5. Maintenance of Effort Maintenance of effort is not required for this program

D. Application and Submission Information

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 at no charge.

https://www.grants.gov/ http://fedgov.dnb.com/webform/displayHomePage.do

If funds are awarded to an applicant organization that includes sub-recipients, those sub-recipients 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 a recipient. 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 can require 10 or more 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 at www.grants.gov, the official HHS E-grant Web site. Registration information is located at the "Applicant Registration" option at www.grants.gov.

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

Step System Requirements Duration Follow Up 1 Data

Universal Number System

(DUNS)

1. Click on http:// fedgov.dnb.com/ webform

2. Select Begin DUNS search/request process

3. Select your country or territory and follow the instructions to obtain your DUNS 9-digit #

4. Request appropriate staff member(s) to obtain DUNS number, verify & update information under DUNS number

1-2 Business Days

To confirm that you have been issued a new DUNS number check online at (http:// fedgov.dnb.com/ webform) or call 1-866-705-5711

2 System for Award Management

(SAM)

formerly Central Contractor Registration

(CCR)

1. Retrieve organizations DUNS number

2. Go to www.sam.gov and designate an E-Biz POC (note CCR username will not work in SAM and you will need to have an active SAM account before you can register on

3-5 Business Days but up to 2 weeks and must be renewed once a year

For SAM Customer Service Contact https://fsd.gov/ fsd-gov/ home.do Calls:

866-606-8220 https://www.sam.gov/portal/public/SAM/ https://grants.gov/ https://www.grants.gov/ http://www.grants.gov https://www.grants.gov/ http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://www.sam.gov https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do grants.gov) 3 Grants.gov 1. Set up an individual account in Grants.gov using organization new DUNS number to become an authorized organization representative (AOR)

2. Once the account is set up the E-BIZ POC will be notified via email

3. Log into grants.gov using the password the E- BIZ POC received and create new password

4. This authorizes the AOR to submit applications on behalf of the organization

Same day but can take 8 weeks to be fully registered and approved in the system (note, applicants

MUST

obtain a

DUNS

number and

SAM

account before applying on grants.gov)

Register early!

Log into grants.gov and check AOR status until it shows you have been approved

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 notice of 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 OGS staff at 770-488- 2700 or e-mail OGS ogstims@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 NOFO, it will not be processed. Office of Grants Services (OGS) 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

OGS.

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

b. Application Deadline Due Date for Applications: 09/24/2018 , 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 https://www.grants.gov https://www.grants.gov mailto:ogstims@cdc.gov business day on which grants.gov operations resume.

Date for Information Conference Call N/A

5. CDC Assurances and Certifications All applicants are required to sign and submit “Assurances and Certifications” documents indicated at http://wwwn.cdc.gov/ grantassurances/ (S(mj444mxct51lnrv1hljjjmaa)) /Homepage.aspx.

Applicants may follow either of the following processes:

Complete the applicable assurances and certifications with each application submission, name the file “Assurances and Certifications” and upload it as a PDF file with 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 to all applications submitted to CDC by the applicant within one year of the submission date.

Risk Assessment Questionnaire Requirement CDC is required to conduct pre-award risk assessments to determine the risk an applicant poses to meeting federal programmatic and administrative requirements by taking into account issues such as financial instability, insufficient management systems, non-compliance with award conditions, the charging of unallowable costs, and inexperience. The risk assessment will include an evaluation of the applicant’s CDC Risk Questionnaire, located at https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf, as well as a review of the applicant’s history in all available systems; including OMB-designated repositories of government-wide eligibility and financial integrity systems (see 45 CFR 75.205(a)), and other sources of historical information. These systems include, but are not limited to: FAPIIS (https://www.fapiis.gov/), including past performance on federal contracts as per Duncan Hunter National Defense Authorization Act of 2009; Do Not Pay list; and System for Award Management (SAM) exclusions.

CDC requires all applicants to complete the Risk Questionnaire, OMB Control Number 0920- 1132 annually. This questionnaire, which is located at https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf, along with supporting documentation must be submitted with your application by the closing date of the Notice of Funding Opportunity Announcement. If your organization has completed CDC’s Risk Questionnaire within the past 12 months of the closing date of this NOFO, then you must submit a copy of that questionnaire, or submit a letter signed by the authorized organization representative to include the original submission date, organization’s EIN and DUNS.

When uploading supporting documentation for the Risk Questionnaire into this application http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx https://www.grants.gov http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf package, clearly label the documents for easy identification of the type of documentation. For example, a copy of Procurement policy submitted in response to the questionnaire may be labeled using the following format: Risk Questionnaire Supporting Documents _ Procurement Policy.

Duplication of Efforts Applicants are responsible for reporting if this application will result in programmatic, budgetary, or commitment overlap with another application or award (i.e. grant, cooperative agreement, or contract) submitted to another funding source in the same fiscal year.

Programmatic overlap occurs when (1) substantially the same project is proposed in more than one application or is submitted to two or more funding sources for review and funding consideration or (2) a specific objective and the project design for accomplishing the objective are the same or closely related in two or more applications or awards, regardless of the funding source. Budgetary overlap occurs when duplicate or equivalent budgetary items (e.g., equipment, salaries) are requested in an application but already are provided by another source.

Commitment overlap occurs when an individual’s time commitment exceeds 100 percent, whether or not salary support is requested in the application. Overlap, whether programmatic, budgetary, or commitment of an individual’s effort greater than 100 percent, is not permitted.

Any overlap will be resolved by the CDC with the applicant and the PD/PI prior to award.

Report Submission: The applicant must upload the report in Grants.gov under “Other Attachment Forms.” The document should be labeled: "Report on Programmatic, Budgetary, and Commitment Overlap.”

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 NOFO

8. Table of Contents (There is no page limit. The table of contents is not included in the project narrative page 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 https://www.grants.gov proprietary or confidential information. Applicants must enter the summary in the "Project Abstract Summary" text box at www.grants.gov.

10. Project Narrative (Unless specified in the "H. Other Information" section, maximum of 20 pages, single spaced, 12 point font, 1-inch margins, number all pages. This includes the work plan. Content beyond the specified page number will not be reviewed.)

Applicants must submit a Project Narrative with the application forms. Applicants must name this file “Project Narrative” and upload it at www.grants.gov. The Project Narrative must include all of the following headings (including subheadings): Background, Approach, Applicant Evaluation and Performance Measurement Plan, Organizational Capacity of Applicants to Implement the Approach, and Work Plan. 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 period of performance as identified in the CDC Project Description section. Applicants should use the federal plain language guidelines and Clear Communication Index to respond to this Notice of Funding Opportunity. Note that recipients should also use these tools when creating public communication materials supported by this NOFO. Failure to follow the guidance and format may negatively impact scoring of the application.

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 public health 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, as identified in the logic model in the Approach section of the CDC Project Description.

Outcomes are the results that the program intends to achieve and usually indicate the intended direction of change (e.g., increase, decrease).

iii. Strategies and Activities Applicants must provide a clear and concise description of the strategies and activities they will use to achieve the period of performance 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 the Strategies and Activities section of the CDC Project Description.

1. Collaborations

Applicants must describe how they will collaborate with programs and organizations either internal or external to CDC. Applicants must address the Collaboration requirements as described in the CDC Project Description.

2. Target Populations and Health Disparities 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. The applicants must also address how they will include specific populations that can benefit from the program that is described in the Approach section. Applicants must address the Target Populations and Health Disparities requirements as described in the CDC Project Description.

c. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the recipient will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this NOFO. At a minimum, the plan must describe:

How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement. The Paperwork Reduction Act of 1995 (PRA): Applicants are advised that any activities involving information collections (e.g., surveys, questionnaires, applications, audits, data requests, reporting, recordkeeping and disclosure requirements) from 10 or more individuals or non-Federal entities, including State and local governmental agencies, and funded or sponsored by the Federal Government are subject to review and approval by the Office of Management and Budget. For further information about CDC’s requirements under PRA see http://www.hhs.gov/ ocio/policy/collection/.

How key program partners will participate in the evaluation and performance measurement planning processes.

Available data sources, feasibility of collecting appropriate evaluation and performance data, data management plan (DMP), and other relevant data information (e.g., performance measures proposed by the applicant).

Where the applicant chooses to, or is expected to, take on specific evaluation studies, they should be directed to:

Describe the type of evaluations (i.e., process, outcome, or both).

Describe key evaluation questions to be addressed by these evaluations.

Describe other information (e.g., measures, data sources).

Recipients will be required to submit a more detailed Evaluation and Performance Measurement plan (including the DMP elements) within the first 6 months of award, as described in the Reporting Section of this NOFO.

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

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

11. Work Plan (Included in the Project Narrative’s 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 recipient plans to carry out achieving the period of performance outcomes, strategies and activities, evaluation and performance measurement.

12. Budget Narrative Applicants must submit an itemized budget narrative. 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 could include the cost of collecting, managing, sharing and preserving data.

Indirect costs on grants awarded to foreign organizations and foreign public entities and performed fully outside of the territorial limits of the U.S. may be paid to support the costs of compliance with federal requirements at a fixed rate of eight percent of MTDC exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000.

Negotiated indirect costs may be paid to the American University, Beirut, and the World Health Organization.

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 NOFO 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 http://www.phaboard.org

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 NOFO. 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 Recipients under such a plan. Applicants must name this file “Indirect Cost Rate” and upload it at www.grants.gov.

13. Funds Tracking Proper fiscal oversight is critical to maintaining public trust in the stewardship of federal funds.

Effective October 1, 2013, a new HHS policy on subaccounts requires the CDC to set up payment subaccounts within the Payment Management System (PMS) for all new grant awards.

Funds awarded in support of approved activities and drawdown instructions will be identified on the Notice of Award in a newly established PMS subaccount (P subaccount). Recipients will be required to draw down funds from award-specific accounts in the PMS. Ultimately, the subaccounts will provide recipients and CDC a more detailed and precise understanding of financial transactions. The successful applicant will be required to track funds by P-accounts/sub accounts for each project/cooperative agreement awarded. Applicants are encouraged to demonstrate a record of fiscal responsibility and the ability to provide sufficient and effective oversight. Financial management systems must meet the requirements as described 2 CFR 200 which include, but are not limited to, the following:

Records that identify adequately the source and application of funds for federally-funded activities.

Effective control over, and accountability for, all funds, property, and other assets.

Comparison of expenditures with budget amounts for each Federal award.

Written procedures to implement payment requirements.

Written procedures for determining cost allowability.

Written procedures for financial reporting and monitoring.

14. Intergovernmental Review Executive Order 12372 does not apply to this program.

15. 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 Code of Federal Regulations (CFR) section 3.908 to the award and requires that recipients 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.

16. Copyright Interests Provisions This provision is intended to ensure that the public has access to the results and accomplishments of public health activities funded by CDC. Pursuant to applicable grant regulations and CDC’s Public Access Policy, Recipient agrees to submit into the National Institutes of Health (NIH) Manuscript Submission (NIHMS) system an electronic version of the final, peer-reviewed manuscript of any such work developed under this award upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. Also at the time of submission, Recipient and/or the Recipient’s submitting author must specify the date the final manuscript will be publicly accessible through PubMed Central (PMC). Recipient and/or Recipient’s submitting author must also post the manuscript through PMC within twelve (12) months of the publisher's official date of final publication; however the author is strongly encouraged to make the subject manuscript available as soon as possible. The recipient must obtain prior approval from the CDC for any exception to this provision.

The author's final, peer-reviewed manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process, and all graphics and supplemental material associated with the article. Recipient and its submitting authors working under this award are responsible for ensuring that any publishing or copyright agreements concerning submitted articles reserve adequate right to fully comply with this provision and the license reserved by CDC. The manuscript will be hosted in both PMC and the CDC Stacks institutional repository system. In progress reports for this award, recipient must identify publications subject to the CDC Public Access Policy by using the applicable NIHMS identification number for up to three (3) months after the publication date and the PubMed Central identification number (PMCID) thereafter.

17. Funding Restrictions

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

Recipients may not use funds for research.

Recipients may not use funds for clinical care except as allowed by law.

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

Generally, recipients 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 generally is not allowed, unless the CDC provides written approval to the recipient.

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

o 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 o 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 Additional Requirement (AR) 12 for detailed guidance on this prohibition and additional guidance on lobbying for CDC recipients.

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.

In accordance with the United States Protecting Life in Global Health Assistance policy, all non-governmental organization (NGO) applicants acknowledge that foreign NGOs that receive funds provided through this award, either as a prime recipient or subrecipient, are strictly prohibited, regardless of the source of funds, from performing abortions as a method of family planning or engaging in any activity that promotes abortion as a method of family planning, or to provide financial support to any other foreign non-governmental organization that conducts such activities. See Additional Requirement (AR) 35 for applicability (https://www.cdc.gov/grants/additionalrequirements/ar-35.html).

18. Data Management Plan As identified in the Evaluation and Performance Measurement section, applications involving data collection must include a Data Management Plan (DMP) as part of their evaluation and performance measurement plan. The DMP is the applicant’s assurance of the quality of the public health data through the data’s lifecycle and plans to deposit data in a repository to preserve and to make the data accessible in a timely manner. See web link for additional information:

https://www.cdc.gov/grants/additionalrequirements/ar-25.html

19. 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 OGS Technical Information Management Section (TIMS) staff.

http://www.cdc.gov/grants/additionalrequirements/index.html#ar12 http://www.cdc.gov/grants/documents/Anti-Lobbying_Restrictions_for_CDC_Grantees_July_2012.pdf https://www.cdc.gov/grants/additionalrequirements/ar-35.html https://www.cdc.gov/grants/additionalrequirements/ar-25.html https://www.Grants.gov https://www.Grants.gov https://www.Grants.gov https://www.Grants.gov

Applications must be submitted electronically by using the forms and instructions posted for this notice of funding opportunity at www.grants.gov. Applicants can complete the application package using Workspace, which allows forms to be filled out online or offline. All application attachments must be submitted using a PDF file format. Instructions and training for using Workspace can be found at www.grants.gov under the "Workspace Overview" option.

If Internet access is not available or if the forms cannot be accessed online, applicants may contact the OGS TIMS staff at 770- 488-2700 or by e-mail at ogstims@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 OGS 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 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…