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Signature Date

Centers for Disease Control and Prevention

OFFICE OF THE DIRECTOR, CENTERS FOR DISEASE CONTROL & PREVENTION

Increasing Public Awareness and Provider Education About Primary Immunodeficiency Disease

CDC-RFA-CD-23-0057

05/22/2023

Table of Contents 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

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- CD-23-0057. 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:

Increasing Public Awareness and Provider Education About Primary Immunodeficiency Disease 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)).

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-CD-23-0057

E. Assistance Listings Number:

93.135 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.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

F. Dates:

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

05/22/2023

2. Due Date for Applications:

05/22/2023 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Due Date for Informational Conference Call:

N/A

G. Executive Summary:

1. Summary Paragraph The purpose of the program is to strengthen the nation’s capacity to carry out public health activities in the area of primary immunodeficiency diseases (PID) by increasing and improving physician education and public health awareness for/of primary immunodeficiency diseases. The objective is to disseminate educational information on a national level to health care providers, educators, third-party payers, impacted families, and others who may help expedite clinical recognition and improve health outcomes for Americans with primary immunodeficiency diseases.

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

G (Grant)

c. Approximate Number of Awards

d. Total Period of Performance Funding:

$15,000,000

e. Average One Year Award Amount:

$3,000,000

f. Total Period of Performance Length:

5 year(s)

g. Estimated Award Date:

July 01, 2023

h. Cost Sharing and / or Matching Requirements:

No Part II. Full Text

A. Funding Opportunity Description

1. Background

a. Overview https://www.grants.gov/

Primary Immunodeficiency Diseases (PID) are a group of primarily single-gene disorders of the immune system. Primary denotes the genetic nature of the defects, differentiating them from secondary or acquired immunodeficiencies caused by malnutrition, infection, chemotherapy, or other external agents. The defining characteristics of primary immunodeficiency diseases make them candidates for a public health intervention approach. Although the clinical manifestations and underlying genetic defects are diverse, primary immunodeficiency diseases share the common feature of increased susceptibility to infection and collectively result in substantial morbidity and shortened life spans. However prompt diagnosis and treatment can be lifesaving and may result in marked improvements in the quality and length of life. The heterogeneity of primary immunodeficiency diseases and the limited understanding of the relation between genotype and phenotype also hinder intervention efforts. Additional obstacles include the difficulty of diagnosis in the absence of a high index of suspicion and the lack of awareness of health care providers and the public which impedes the timely recognition of affected person by using a combination of clinical suspicion and diagnostic testing.

b. Statutory Authorities This program is authorized under section 317(k)(2) of the Public Health Service Act, (42 U.S.C 247b(k)(2): Project grants for preventive health services).

c. Healthy People 2030 This program addresses the “Healthy People 2030” topic(s):

Children (https://health.gov/healthypeople/objectives-and-data/browse-objectives/children)

Child and Adolescent Development (https://health.gov/healthypeople/objectives-and-data/browse-objectives/child-and-adolescent-development)

Health Communication (https://health.gov/healthypeople/objectives-and-data/browse-objectives/health-communication)

Community (https://health.gov/healthypeople/objectives-and-data/browse-objectives/community)

d. Other National Public Health Priorities and Strategies CDC Key National Priority: Better at preventing illness, injury, disability and death (http://www.cdc.gov /about/organization/strategic-framework/index.html )

CDC CORE Health Equity Science and Intervention Strategy (https://www.cdc.gov/healthequity/core/)

e. Relevant Work This opportunity builds on the previous grant, CDC Increasing Public Awareness and Provider Education about Primary Immunodeficiency Disease CDC-RFA-OE-17-1702 (https://www.grants.gov/web/grants/view-opportunity.html?oppId=327486) https://health.gov/healthypeople/objectives-and-data/browse-objectives/children https://health.gov/healthypeople/objectives-and-data/browse-objectives/children https://health.gov/healthypeople/objectives-and-data/browse-objectives/child-and-adolescent-development https://health.gov/healthypeople/objectives-and-data/browse-objectives/child-and-adolescent-development https://health.gov/healthypeople/objectives-and-data/browse-objectives/health-communication https://health.gov/healthypeople/objectives-and-data/browse-objectives/health-communication https://health.gov/healthypeople/objectives-and-data/browse-objectives/community https://health.gov/healthypeople/objectives-and-data/browse-objectives/community http://www.cdc.gov/about/organization/strategic-framework/index.html http://www.cdc.gov/about/organization/strategic-framework/index.html https://www.cdc.gov/healthequity/core/ https://www.grants.gov/web/grants/view-opportunity.html?oppId=327486

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Strategies and Activities

Short-term Outcomes

Intermediate Outcomes

Long-Term Outcomes

Provide financial assistance for planning, design, and implementation of materials and displays

Disseminate educational information on a national level to health care providers, educators, third-party payers, impacted families, and others

Form partnerships with the health care community

Conduct evaluation and quality improvement processes

Improved awareness of primary immunodeficiency diseases among providers and the public

Improved provider participation and engagement in educational opportunities offered

Increased skills and knowledge of the healthcare workforce on primary immunodeficiency diseases

Increased use of evaluation results and quality improvement processes to guide actions

Improved integration of primary immunodeficiency prevention into clinical care

Expedited clinical recognition of primary immunodeficiency diseases

Increased community and health care provider knowledge of primary immunodeficiency diseases

Increased number of people appropriately diagnosed with primary immunodeficiency diseases

Increased access to care for people with primary immunodeficiency diseases

Improved health outcomes - for full & independent lives for people with primary immunodeficiency diseases

i. Purpose The purpose of the program is to strengthen the nation’s capacity to carry out public health activities in the area of primary immunodeficiency diseases (PID) by increasing and improving physician education and public health awareness for/of PID. The intent is to disseminate educational information on a national level to health care providers, educators, third-party payers, impacted families, and others who may help expedite clinical recognition and improve health outcomes for Americans with primary immunodeficiency diseases.

ii. Outcomes The intended outcomes of the grant include:

Development of materials and implementation of displays Providers engage in education opportunities Skills and knowledge of healthcare providers about primary immunodeficiency diseases increases Improve integration of primary immunodeficiency diseases prevention into clinical care Expedited clinical recognition of primary immunodeficiency diseases Increase community and provider knowledge of primary immunodeficiency diseases Increase the number of people appropriately diagnosed with primary immunodeficiency diseases Increase access to care for people with primary immunodeficiency diseases.

Improve health outcomes for people with primary immunodeficiency diseases to live full

& independent lives

iii. Strategies and Activities

1. Provide financial assistance for planning, design, and implementation of materials and displays.

2. Disseminate educational information on a national level to public and private health care providers, educators, third-party payers, impacted families, and others.

3. Form partnerships with health care community.

4. The recipient will conduct evaluation and quality improvement efforts.

1. Collaborations

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

Recipient is required to collaborate with CDC programs and CDC funded programs including state public health departments. Specifically, CDC funded programs focused on newborn screening, healthy childhood development, and efforts dedicated to ensuring that children thrive should be included where appropriate.

Applicants must demonstrate collaborative efforts through the documentation of MOUs, letters of support, etc. Applicants must name these files "MOU" or "LOS" and upload it at www.grants.gov.

b. With organizations not funded by CDC:

The recipient should consider collaboration with organizations not funded by CDC when such mutual partnership opportunities can advance the stated goals of the grant.

2. Target Populations Target populations will include young children and their families who are at risk for developing primary immunodeficiency diseases.

Target populations for physician education efforts would include a wide array of health care providers including but not limited to, physicians, physicians' assistants, and nurses.

Recipient should describe their plan to include underserved populations such as, but not limited to, tribal, English to Speakers of Other Languages (ESOL), and disabled populations.

a. Health Disparities Recipient efforts will include a focus on populations at risk who may face a greater impact from primary immunodeficiency diseases because of issues involving health disparities and reduced access to quality health care. Early diagnosis and quality and follow-up health care are critical determinants of better health outcomes for children with primary immunodeficiency diseases.

iv. Funding Strategy

NA

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

Strategy 1: Provide financial assistance for planning, design, and implementation of materials and displays. Process measure: materials and displays funded and implemented.

Strategy 2: Disseminate educational information on a national level to public and private health care providers, educators, third-party payers, impacted families, and others. Process measure: educational information disseminated on a national level to intended audience.

Strategy 3: Form partnerships with health care community. Process measure:

working collaborations formed to facilitate communication messages and materials which support the goals of the campaigns.

Strategy 4: The recipient will conduct evaluation and quality improvement efforts.

Process measure: evaluation conducted of completed work and documented efforts to improve the operations and effectiveness of the grant activities in an ongoing fashion.

Short Term Outcome 1: Development of materials and implementation of displays.

Outcome measure: Primary immunodeficiency materials developed and displayed on a national scale.

Short Term Outcome 2: Providers engage in education opportunities. Outcome measure: On a national scale, health care providers reached with appropriate messages about identifying patients with primary immunodeficiency diseases.

Short Term Outcome 3: Skills and knowledge of healthcare providers about primary immunodeficiency diseases increases. Outcome measure: As a result of the recipient's work, the knowledge of healthcare providers about primary immunodeficiency diseases increases.

Short Term Outcome 4: Findings of evaluation and quality improvement processes are used to guide action. Outcome measure: Recipient conducts annual evaluation efforts - and as data and information becomes available - engages in a continual effort to improve the quality of the grant activities.

Medium Term Outcome 5: Improve integration of primary immunodeficiency diseases prevention into clinical care. Outcome measure: As a result of the recipient's work, diagnostic procedures and follow-up for primary immunodeficiency diseases are more integrated into clinical care on a national scale.

Medium Term Outcome 6: Expedited clinical recognition of primary immunodeficiency diseases. Outcome measure: As a result of the recipient's work, clinical recognition of primary immunodeficiency diseases occurs more rapidly and more often than it did previously - on a national scale.

Medium Term Outcome 7: Increase community and provider knowledge of primary immunodeficiency diseases. Outcome measure: As a result of the recipient's work, general community/public and healthcare provider knowledge of primary immunodeficiency diseases increases on a national scale.

Long Term Outcome 8: Increase the number of people appropriately diagnosed with primary immunodeficiency diseases. Outcome measure: As a result of the recipient's work, the annual rate of children identified/diagnosed with primary immunodeficiency diseases increases.

Long Term Outcome 9: Increase access to care for people with primary immunodeficiency diseases. Outcome measure: As a result of the recipient's work, more health care systems and providers across the nation are knowledgeable of the signs of primary immunodeficiency diseases and thus more people have access to health care where primary immunodeficiency disease is understood and considered for diagnosis.

Long Term Outcome 10: Improve health outcomes for people with primary immunodeficiency diseases to live full & independent lives. Outcome measure: As a result of the recipient's work, more people - especially children - have improved health outcomes from earlier detection and follow-up care than before.

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 the 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) as new pertinent information becomes available. If applicable, throughout the lifecycle of the project. Updates to DMP should be provided in annual progress reports. 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/additional-requirements/ar-25.html.

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

Since this NOFO does not involve the generation or collection of public health data, a Data Management Plan is not required for this NOFO.

c. Organizational Capacity of Recipients to Implement the Approach The ideal applicant will have experience in conducting effective physician education and public awareness campaigns for primary immunodeficiency diseases, collaborating effectively with health care and public health partners, and maximizing resources dedicated to campaign materials development and distribution to meet outcome goals. CVs and organizational charts must be uploaded. Recipients must name this file "CVs/Resumes" or "Organizational Charts" and upload it at www.grants.gov.

The recipient will provide the following:

Demonstrate expertise with primary immunodeficiency disease activities contained in the announcement.

Ensure adequate staffing and oversight to accomplish the program goals and provide clearly defined staff roles.

Provide a staffing plan that defines the roles, responsibilities and qualifications of the team and the expected contributions of the key/collaborative partners.

Demonstrate awareness of primary immunodeficiency diseases among providers and the public

Describe provider participation and engagement in educational opportunities offered Describe skills and knowledge of the healthcare workforce on primary immunodeficiency diseases

d. Work Plan Applicants must include a work plan that allows the CDC Project Officer to monitor implementation of activities and progress on period of performance outcomes. The work plan should be detailed and should focus on the first year of the period of performance with only a high-level plan for subsequent years. Work plans should demonstrate alignment among the outcomes, strategies, activities, timelines, and staffing/collaborations.

Additional information on performance measures and data sources can also be included.

Applicants must provide a work plan for the proposed activities. Applicants must construct logical, step wise work plans that include:

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

Work plans must demonstrate alignment between activities (with appropriate performance measures or milestones for accomplishing tasks) and achievement of the NOFO period of performance outcomes shown in the logic model.

Sample Work Plan

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.

CDC will collect recipient financial and progress reporting data annually through the end of the period of performance. CDC will collect recipient financial and progress reporting data quarterly through the end of the period of performance.

CDC will collect recipient financial and progress reporting data annually through the end of the period of performance.

CDC will also conduct a virtual compliance visit after six months, but before the end of the first year, from date of the award. The virtual compliance visit will be a telephone call and/or video conference to ensure the recipient’s compliance with using the funding for the approved activities and to identify technical assistance needs. CDC may conduct additional in-person site or virtual visits as needed to best facilitate grants management and oversight duties.

B. Award Information

1. Funding Instrument Type:

G (Grant)

2. Award Mechanism:

E11 - Increasing Public Awareness and Provider Education About Primary Immunodeficiency Disease

3. Fiscal Year:

4. Approximate Total Fiscal Year Funding:

$3,000,000

5. Total Period of Performance Funding:

$15,000,000 This amount is subject to the availability of funds.

Estimated Total Funding:

$15,000,000

6. Total Period of Performance Length:

5 year(s) year(s)

7. Expected Number of Awards:

8. Approximate Average Award:

$3,000,000 Per Budget Period

9. Award Ceiling:

$3,000,000 Per Budget Period

This amount is subject to the availability of funds.

10. Award Floor:

$1,000,000 Per Budget Period

11. Estimated Award Date:

July 01, 2023

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.

If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR part 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

C. Eligibility Information

1. Eligible Applicants

Eligibility Category:

00 (State governments)

01 (County governments)

02 (City or township governments)

04 (Special district governments)

05 (Independent school districts)

06 (Public and State controlled institutions of higher education)

07 (Native American tribal governments (Federally recognized))

08 (Public housing authorities/Indian housing authorities)

11 (Native American tribal organizations (other than Federally recognized tribal governments))

12 (Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education)

13 (Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education)

20 (Private institutions of higher education)

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

2. Additional Information on Eligibility

3. Justification for Less than Maximum Competition

4. Cost Sharing or Matching

Cost Sharing / Matching Requirement:

No

5. Maintenance of Effort

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.

PLEASE NOTE: Effective April 4, 2022, applicants must have a Unique Entity Identifier (UEI) at the time of application submission (SF-424, field 8c). The UEI is generated as part of SAM.gov registration. Current SAM.gov registrants have already been assigned their UEI and can view it in SAM.gov and Grants.gov. Additional information is available on the GSA website, SAM.gov, and Grants.gov- Finding the UEI.

a. Unique Entity Identifier (UEI):

All applicant organizations must obtain a Unique Entity Identifier (UEI) number by registering in SAM.gov prior to submitting an application. A UEI number is a unique twelve-digit identification number assigned to the registering organization.

If funds are awarded to an applicant organization that includes sub-recipients, those sub-recipients must provide their UEI numbers before accepting any funds.

https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-management/integrated-award-environment-iae/iae-systems-information-kit/unique-entity-identifier-update https://sam.gov/content/home https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/ https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/

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 and a Unique Entity Identifier (UEI). 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 SAM.gov and the SAM.gov Knowledge Base.

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

System for Award Management

(SAM)

1. Go to SAM.gov and designate an E-Biz POC (You will need to have an active SAM account before you can register on grants.gov). The UEI is generated as part of your registration.

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

2 Grants.gov

1. Set up an individual account in Grants.gov using organization's new UEI 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

It takes one day (after you enter the EBiz POC name and EBiz POC email in SAM) to receive a UEI (SAM) which will allow you to register with Grants.gov and apply for federal funding.

Register early!

Applicants can register within minutes.

https://sam.gov/content/home https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fsd.gov%2Fgsafsd_sp%3Fid%3Dgsa_kb_view2%26kb_id%3Df66d8e6cdb76d4100d73f81d0f9619c6&data=04%7C01%7Ccshifflett%40dminc.com%7C8eee7a2adab549a3b3c008d925e9a364%7Cdb7ac9ef779d46e59bca00509580ad6b%7C0%7C0%7C637582507851821018%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=UrR%2B%2FM2wWF2fZG05Z8O6JS2C3FXXSl%2F7B3%2FB45XHRrg%3D&reserved=0 https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fsd.gov%2Fgsafsd_sp%3Fid%3Dgsa_kb_view2%26kb_id%3Df66d8e6cdb76d4100d73f81d0f9619c6&data=04%7C01%7Ccshifflett%40dminc.com%7C8eee7a2adab549a3b3c008d925e9a364%7Cdb7ac9ef779d46e59bca00509580ad6b%7C0%7C0%7C637582507851821018%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=UrR%2B%2FM2wWF2fZG05Z8O6JS2C3FXXSl%2F7B3%2FB45XHRrg%3D&reserved=0 https://grants.gov/ https://www.grants.gov/ http://www.grants.gov/ https://www.grants.gov/ https://sam.gov/content/home https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do submit applications on behalf of the organization

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)

Number Of Days from Publication 45

05/22/2023

b. Application Deadline

Number Of Days from Publication 45

05/22/2023 11:59 pm U.S. Eastern 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.

Due Date for Information Conference Call N/A

5. Pre-Award Assessments

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 https://www.grants.gov/ https://www.grants.gov/ https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf

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 UEI.

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 https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf

(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

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 https://www.grants.gov/

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).

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

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.

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 http://www.phaboard.org/ 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 45 CFR 75 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. 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.

15. 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.

16. 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.

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