PKG00258651-instructions.pdf

Centers for Disease Control and Prevention

National Center for Immunization and Respiratory Diseases

Immunization Barriers in the United States: Targeting Medicaid Partnerships

CDC-RFA-IP20-2001

Application Due Date: 04/28/2020

Immunization Barriers in the United States: Targeting Medicaid Partnerships

CDC-RFA-IP20-2001

TABLE OF CONTENTS

Part I. Overview Information A. Federal Agency Name B. Funding Opportunity Title C. Announcement Type D. Agency Funding Opportunity Number E. Assistance Listings (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 "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA- IP20-2001. 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:

Immunization Barriers in the United States: Targeting Medicaid Partnerships 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-IP20-2001

E. Assistance Listings (CFDA) Number:

93.268 F. Dates:

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

2. Due Date for Applications: 04/28/2020, 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:

Despite the availability of Medicaid benefits and Vaccines for Children (VFC) vaccine in the United States, immunization rates for children and pregnant women in poverty or with Medicaid coverage remain lower than those above the poverty line or with private insurance. The purpose of this funding announcement is to help CDC address and reduce income-based disparities in immunization rates. Recipient collaboration with Medicaid programs in states can help CDC better understand barriers to immunization for children and pregnant women with Medicaid coverage and improve immunization rates. Such collaborations also support state immunization programs and Medicaid programs to use mutual resources to improve sustainability of immunization information systems. Recipient(s) will communicate national immunization program goals to state Medicaid program leadership, identify and share best practices among Medicaid programs, and engage Medicaid program leadership to identify solutions to 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 immunization gaps. Recipient(s) will also assist CDC and state immunization leaders to better understand how to work effectively with Medicaid leadership in states, and make progress toward immunization program goals by identifying shared priorities and strategies.

a. Eligible Applicants: Open Competition

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 2

d. Total Period of Performance Funding: $1,200,000

e. Average One Year Award Amount: $200,000

f. Total Period of Performance Length: 3

g. Estimated Award Date: 09/28/2020

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

Part II. Full Text A. Funding Opportunity Description

Part II. Full Text

1. Background

a. Overview Almost half of children and approximately half of pregnant women in the United States are covered by Medicaid. In 1994, the Vaccines for Children (VFC) Program was created, which included providing vaccine at no cost to children enrolled in Medicaid. Despite the availability of Medicaid benefits and VFC vaccine, estimated rates with recommended childhood immunizations are persistently lower for children in poverty than those above the poverty level. Interruptions in insurance coverage are associated with lower immunization rates, and children with Medicaid coverage are more likely than those with private insurance to have these interruptions in coverage. For pregnant women, estimated Tdap and influenza vaccination rates of those with Medicaid coverage is lower than rates among pregnant women with private insurance. Reasons for lower immunization rates among these Medicaid-covered populations may include limited access to transportation, childcare responsibilities, work responsibilities, and more. However, some barriers may be barriers that could be addressed by Medicaid programs, such as avoiding missed opportunities for immunization, and providing for immunization of pregnant women in OB/GYN offices.

Immunization Information Systems (IIS) are centralized registries of immunization records in a jurisdiction. Use of IIS has been found to raise immunization rates and has the potential to prevent patients from receiving unnecessary extra doses of vaccine. Federal Medicaid funding is available to states at the 90 percent matching rate for state expenditures on certain activities to promote health information exchange (HIE) and encourage the adoption of certified Electronic Health Record (EHR) technology by certain Medicaid providers (HITECH funding).

Collaborations among Medicaid and Immunization programs in states can increase sustainability of IISs through use of these matching funds, however, few jurisdictions are currently accessing this resource.

Recipient collaboration with Medicaid programs in states can help CDC better understand barriers to immunization for children and pregnant women with Medicaid coverage and improve immunization rates. Such collaborations by recipient(s) also can support state immunization programs and Medicaid programs to use mutual resources to improve sustainability of immunization information systems. Recipient(s) will communicate national immunization program goals to state Medicaid program leadership, identify and share best practices among Medicaid programs, and engage Medicaid program leadership to identify solutions to immunization gaps. Recipient(s) will also assist CDC and state immunization leaders to better understand how to work effectively with Medicaid leadership in states and make progress toward immunization program goals by identifying shared priorities and strategies. Partnerships between immunization programs and Medicaid programs could contribute to accelerate the reduction of income-based disparities in immunization rates.

https://www.cdc.gov/vaccines/programs/iis/resources-refs/sustainability-resources.html

b. Statutory Authorities Authorized under section 317(k)(1) of the Public Health Service Act [42 U.S.C. 247b(k)(1)], as amended

c. Healthy People 2030 Healthy People 2020 focus area of Immunization and Infectious Diseases https://www.healthypeo ple.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases/objectives

d. Other National Public Health Priorities and Strategies This NOFO supports various other national public health strategies/ priorities for infectious disease and other conditions.

e. Relevant Work This NOFO builds on CDC’s NOFO-CDC-RFA-IP17-1704 titled “Immunization Barriers in the United States: Targeting Medicaid Partnerships”, which supported two recipients to address and reduce income-based disparities. In addition, it supports NOFO CDC-RFA-IP19-1901 titled “Immunization and Vaccines for Children (VFC) Program.” The VFC program allows vulnerable children access to lifesaving vaccines as a part of routine preventive care, focusing on children without insurance, those eligible for Medicaid, and American Indian/Alaska Native children. The Immunization Program also provides funding to support scientific and programmatic expertise to further develop, enhance, and maintain IIS.

2. CDC Project Description

a. Approach https://www.cdc.gov/vaccines/programs/iis/resources-refs/sustainability-resources.html https://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases/objectives https://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases/objectives

Bold indicates period of performance outcome.

Strategies and Activities Short-term Outcomes Intermediate Outcomes Long-Term Outcomes

Facilitate open communications between CDC Immunization Program and state Medicaid Programs to advance mutual immunization priorities Include:

-Immunization-related topics in ongoing communications vehicles (e.g., newsletters, electronic communications) -Utilize steering committees or sub-committees of Medicaid program leaders to explore possible mutual efforts in immunization Identify and share best practices to increase immunization in Medicaid programs Identify state-level opportunities to increase IIS sustainability

Increased state opportunities to facilitate vaccination of children living in poverty

Increased state opportunities to facilitate vaccination of pregnant women living in poverty Increased state opportunities to facilitate improvements in IIS (e.g. create infrastructure enabling eligibility for HITECH funding)

Increased vaccination of children living in poverty

Increased vaccination of pregnant women living in poverty

Improved sustainability of IIS in multiple jurisdictions

Reduction in vaccine preventable diseases

Decreased immunization program costs for redundant vaccinations

i. Purpose The purpose NOFO is to help address and reduce income-based disparities in immunization rates.

Collaboration with Medicaid programs in states will increase our understanding of barriers to immunization for children and pregnant women with Medicaid coverage and improve immunization rates.

ii. Outcomes The logic model for this project identifies short-, intermediate, and long-term outcomes. Overall, the long-term outcomes for this project are reduction in vaccine-preventable diseases and decreased immunization program costs for redundant vaccinations.

The recipient is expected to show progress on all of the short-term outcomes during the period of performance:

Increased state opportunities to facilitate vaccination of children living in poverty Increased state opportunities to facilitate vaccination of pregnant women living in poverty Increased state opportunities to facilitate improvements in IIS (e.g. create infrastructure enabling eligibility for HITECH funding) The applicant can also propose activities that will demonstrate progress on intermediate or long-term outcomes as described in the logic model.

iii. Strategies and Activities The applicant’s proposed activities should be designed to specifically and efficiently achieve outcomes during the period of performance . The applicant will propose a set of strategies and activities that will yield the short-term outcomes and also help address immunization barriers and identify solutions. The applicant is expected to address the following strategies and activities:

Facilitate open communications between CDC Immunization Program and state Medicaid programs to advance mutual immunization priorities;

Include immunization-related topics in ongoing communications vehicles (e.g., newsletters, electronic communications);

Utilize steering committees or sub-committees of Medicaid program leaders to explore possible mutual efforts in immunization;

Identify and share best practices to increase immunization in Medicaid programs;

Identify state-level opportunities to increase IIS sustainability.

1. Collaborations

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

N/A

b. With organizations not funded by CDC:

Applicants must demonstrate existing relationships with Medicaid program leadership in at least 20 states. This may be demonstrated through a membership list, meeting attendee list, letters of support, MOU or MOA.

Applicants are encouraged to collaborate with national organizations or agencies working in the area of public health administration and practice, and state affiliates of those organizations where applicable, to assist applicant in identifying opportunities for collaboration between Medicaid programs and immunization programs on the state and national level. Applicant should provide documentation demonstrating evidence of collaboration. This may be in the form of an MOU, MOA, or letter of support.

Applicants must file the MOU or MOA, as appropriate, name the file “MOUs/MOAs”, and upload it as a PDF file at www.grants.gov].

CDC will consider any application that does not provide documentation of its participants or https://www.grants.gov/ member list as non-responsive and it will receive no further review.

2. Target Populations Children and pregnant women covered by Medicaid.

a. Health Disparities This NOFO is intended to reduce poverty-based disparities in immunization rates for recommended vaccines for children and pregnant women.

iv. Funding Strategy N/A

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy The CDC strategy for monitoring and evaluating program and recipient performance will include several activities, spanning both process and outcomes evaluation, and will be consistent with the logic model and approach presented earlier.

Proposed process/output measures will include:

Number of communications to state Medicaid program leadership to inform programs about vaccine-related issues

Number of surmountable barriers to immunization that are identified Number of best practices to increase immunization that are identified Number of state best practices identified that facilitate improvements and sustainability of

IIS

Proposed outcome measures will include:

At least one-two states create additional opportunities to facilitate vaccination of children living in poverty

At least one-two states create additional opportunities to facilitate vaccination of pregnant women living in poverty

At least one-two states create additional opportunities to facilitate improvements in IIS (e.g. create infrastructure enabling eligibility for HITECH funding)

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).

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.

c. Organizational Capacity of Recipients to Implement the Approach Applicant must demonstrate a national/regional presence among states and capacity for direct communication with state Medicaid program leadership. Applicant must have a track record of 5 years or greater in representing and/or collaborating with state Medicaid organizations and personnel demonstrated through existing relationships. This may be demonstrated through a membership list, meeting attendee list, letters of support, MOU or MOA.

Applicant must demonstrate an ability to convene Medicaid program leadership and advance information sharing across state programs.

Applicant should have experience with program evaluation, performance monitoring, financial reporting, budget management and administration.

Applicant should demonstrate relevant experience and capacity to implement the activities and achieve the project outcomes, implement the evaluation plan, and a staffing plan and project management structure sufficient to achieve the project outcomes and which clearly defines staff roles.

Applicant should demonstrate ability to manage the required procurement efforts, including the ability to write and award contracts in accordance with applicable grants regulations.

Applicant is required to provide CVs/Resumes of key staff who will work on the project and a https://www.cdc.gov/grants/additionalrequirements/ar-25.html current organizational chart.

The Applicants must name this file "CVs/Resumes" or "Organizational Charts" and upload it at www.grants.gov.

d. Work Plan Applicants must provide a detailed work plan for the first year of the project and a high-level work plan for subsequent years. Applicants must identify and address the activities under this NOFO in 10 pages or less.

Include specific details on how the proposed strategies will achieve this program’s outcomes.

CDC will provide feedback and technical assistance to recipient(s) to finalize the work plan after award.

Applicants should consider the following when preparing a work plan:

For each selected activity, a descriptive plan, process and timeline with milestones/measures for efforts related to each short-term outcome in the logic model, for the year-one detailed work plan. A high-level work plan for years two and three should address how progress will continue;

A description of the staff and administrative roles and functions to support the project work plan and outcomes. Applicants should identify and assign staff, contractors, and/or consultants, sufficient in number and expertise, to carry out the activities of this NOFO;

A description of administrative and assessment processes to ensure successful implementation, reporting and quality assurance;

A description of organizational capacity to successfully achieve the project outcomes, including demonstrated experience leading to collective action;

A description of capacity and plans to successfully implement sustainable practices that result in the improved immunization rates of the target population.

The following is a sample work plan the applicant may use in its approach to this section

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.

6.

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.

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

COOPERATIVE AGREEMENTS)

CDC will provide technical assistance in identifying disparities in immunization, setting program priorities, work plan development, and subject matter expertise. CDC will share information, practices, lessons learned, and evaluation results through meetings, conference calls, and electronic communication. CDC will monitor the recipient's performance of program activities and progress toward program goals. CDC will establish and facilitate coordination with the U.S.

Centers for Medicare and Medicaid Services to contribute to the success of this project.

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: U66

3. Fiscal Year: 2020

4. Approximate Total Fiscal Year Funding: $400,000

5. Approximate Period of Performance Funding: $1,200,000

This amount is subject to the availability of funds.

Estimated Total Funding: $1,200,000

6. Approximate Period of Performance Length: 3 year(s)

7. Expected Number of Awards: 2

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

9. Award Ceiling: $200,000 Per Budget Period

This amount is subject to the availability of funds.

10. Award Floor: $150,000 Per Budget Period

11. Estimated Award Date: 09/28/2020

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 NOFO.

C. Eligibility Information

1. Eligible Applicants

Eligibility Category: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

Additional Eligibility Category:

2. Additional Information on Eligibility However, under statutory authority of PHS Act 317 for profit organizations are not eligible entities.

The award ceiling for this NOFO is $200,000. CDC will consider any application requesting an award higher than this amount as non-responsive and it will receive no further review.

Applicants must provide documentation of existing relationships with Medicaid program leadership in at least 20 states. This may be demonstrated through a membership list, meeting attendee list, letters of support, MOU or MOA. CDC will consider any application that does not provide documentation of its membership list, meeting attendee list, letters of support, MOU or MOA as non responsive and it will receive no further review.

3. Justification for Less than Maximum Competition N/A

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

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

D. 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.

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 https://www.sam.gov/SAM/.

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

1. Retrieve organizations DUNS number

2. Go to https://www.sam.gov/SAM/ and designate an E-Biz POC (note CCR username will not work in SAM and you

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

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

866-606-8220 http://fedgov.dnb.com/webform/displayHomePage.do https://www.sam.gov/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 https://www.sam.gov/SAM/ https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do

Registration

(CCR)

will need to have an active SAM account before you can register on grants.gov) once a year

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.

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: 04/28/2020 , 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.

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 https://www.grants.gov 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 https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf representative to include the original submission date, organization’s EIN and DUNS.

When uploading supporting documentation for the Risk Questionnaire into this application 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 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.

https://www.grants.gov

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 https://www.cdc.gov/od/science/integrity/reducePublicBurden/.

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).

https://www.cdc.gov/od/science/integrity/reducePublicBurden/

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.

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 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.

Vital records data, including births and deaths, are used to inform public health program and policy decisions. If applicable and consistent with the cited statutory authority for this NOFO, applicant entities are encouraged to collaborate with and support their jurisdiction’s vital records office (VRO) to improve vital records data timeliness, quality and access, and to advance public health goals. Recipients may, for example, use funds to support efforts to build VRO capacity through partnerships; provide technical and/or financial assistance to improve vital records timeliness, quality or access; or support vital records improvement efforts, as approved by CDC.

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 http://www.phaboard.org 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.