CDC-RFA-CK21-2107 rev1.pdf

Centers for Disease Control and Prevention

National Center for Emerging and Zoonotic Infectious Diseases

Globally coordinated safety monitoring for COVID-19 vaccines

CDC-RFA-CK21-2107

04/16/2021

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- CK21-2107. 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:

Globally coordinated safety monitoring for COVID-19 vaccines 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

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-CK21-2107

E. Assistance Listings Number:

93.344 F. Dates:

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

NA

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

2. Due Date for Applications:

04/16/2021 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 nCoV Novel Coronavirus (COVID-19) pandemic has disrupted life across the globe. To provide a lasting defense against the spread of the pandemic, public health authorities worldwide are planning for safe and effective COVID-19 vaccines to be made available to their populations. As countries prepare for national COVID-19 immunization programs, the ability to monitor the safety of these vaccines in a timely manner is critical. Many countries rely on passive vaccine safety surveillance systems; however, these systems have limitations in their ability to detect and evaluate adverse events following immunization and assess risk. Active surveillance addresses many of the limitations of passive surveillance. Countries with access to quality electronic health records can perform near-real time monitoring that allows for signal detection and evaluation. On a larger scale, a multi-site, multi-country active vaccine safety surveillance data system allows for increased statistical power to detect associations of COVID- 19 vaccines with very rare outcomes, the ability to refine and evaluate signals observed in a country or region to another setting, and increased geographic diversity as well as population heterogeneity. This three-year project will be sole sourced to a project and data coordinating center with an established relationship with data partners from at least 10 countries over 6 continents. For the purposes of this NOFO, the project and data coordinating center will be referred to as a DCC. This DCC, will coordinate and lead efforts to establish globally harmonized surveillance of adverse events following COVID-19 vaccination to address this need in order to inform national COVID-19 immunization policies.

a. Eligible Applicants:

Single

b. Funding Instrument Type:

G (Grant)

c. Approximate Number of Awards

d. Total Period of Performance Funding:

$ 5,665,726

e. Average One Year Award Amount:

$ 5,665,726

f. Total Period of Performance Length:

g. Estimated Award Date:

April 21, 2021

h. Cost Sharing and / or Matching Requirements:

No https://www.grants.gov/

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

1. Background

a. Overview The COVID-19 pandemic has disrupted life across the globe and caused nearly 60 million infections and 1.4 million deaths as of late November 2020. It has been argued that the only way to adequately address the pandemic is through the development and deployment of safe and effective vaccines. There are multiple vaccines for COVID-19 being distributed. These vaccines were developed in less than a year, a significantly shorter timeframe for vaccine development than ever before. Because of the expedited nature of the development of these vaccines, it will be of extreme importance to track vaccine safety, especially potential adverse events that might occur in tandem with vaccine distribution and administration.

With the limited size and duration of clinical trials, if a rare or delayed onset vaccine safety issue exists with any of the candidate COVID-19 vaccines, it is likely to be detected post-introduction, when millions of persons have been vaccinated and followed for longer periods. While many countries rely on passive safety surveillance, during the post-introduction period near-real time monitoring and response to safety signals are critical. Having a global, centralized surveillance process involving multiple complimentary systems among countries with the vaccine safety infrastructure to monitor COVID-19 vaccines is essential as it offers geographic diversity and population heterogeneity. In addition, a coordinated global pharmacovigilance system allows for organized tracking of potential adverse events following COVID-19 vaccination. This system would provide the ability to compare the various COVID-19 vaccines using common protocols, as well as increase statistical power to assess rare outcomes due to a larger combined sample size from many different data sources. The system’s ability to refine and evaluate safety signals observed in a single country and across countries or programs can provide important comparisons of diverse socio-ecological systems.

The purpose of this grant is to fund a sole source as a DCC to manage and to work with global data partners that have experience in the analyses of vaccine safety surveillance using electronic databases and experience with vaccine safety evaluation using individual medical record review to evaluate possible cases of adverse events. The coordinating center will conduct all combined data analyses for this effort. Global data partners will provide de-identified aggregate data or output generated from analytic programs (SAS, R, etc) to the coordinating center so a sequential method will be employed among all provided data. These include near real-time sequential monitoring techniques such as MaxSPRT and sequential tree-based scan statistics, which are standardized methods the Centers for Disease Control and Prevention (CDC) Vaccine Safety Datalink developed and has used since the early 2000's to assess post-licensure vaccine safety in the United States.

b. Statutory Authorities

This program is authorized under Public Health Service Act sections 301(a), 307 and 317, as amended [42 U.S.C. sections 241(a), 242l, and 247b]. Authority may also stem from an applicable emergency supplemental appropriation; such appropriation and any requirements and/or limitations associated with that emergency supplemental will be added to the notice of award.

Possible applicable supplemental appropriations include, but may not be limited to:

P.L. 116-123 - Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 [March 6, 2020] P.L 116–136 - Coronavirus Aid, Relief, and Economic Security Act (CARES Act) [ March 27, 2020] P.L. 116-139 – Paycheck Protection Program and Healthcare Enhancement Act [April 24, 2020] Consolidated Appropriations Act and the Coronavirus Response and Relief Supplement Appropriations Act, 2021 (P.L. 116-260) [December 27, 2020].

c. Healthy People 2030 Vaccination https://health.gov/healthypeople/objectives-and-data/browse-objectives/vaccination Infectious Disease https://health.gov/healthypeople/objectives-and-data/browse-objectives/infectious-disease

HP2030 has a goal to increase immunization rates and reduce preventable infectious diseases.

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

e. Relevant Work Since the 1990s, CDC has been monitoring the safety of vaccines. The two main systems include the Vaccine Adverse Event System (VAERS) and the Vaccine Safety Datalink (VSD). These two systems serve as the backbone of the United States’ vaccine safety infrastructure and serve as a model for other countries. More information on these two systems can be found here:

https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vaers/index.html https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html

2. CDC Project Description

a. Approach Bold indicates period of performance outcome.

CDC-RFA-CK21-2107 Logic Model: Globally coordinated safety monitoring for COVID-19 vaccines Bold indicates period of performance outcome

Strategies Short-term Output Intermediate Outcome Long-term Outcomes https://health.gov/healthypeople/objectives-and-data/browse-objectives/vaccination https://health.gov/healthypeople/objectives-and-data/browse-objectives/infectious-disease https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vaers/index.html https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html

Support readiness of methods for a globally harmonized post-introduction monitoring of COVID- 19 vaccines

Support country readiness for globally coordinated active vaccine safety surveillance upon roll-out of COVID-19 vaccine in the general public

Enhance ability to evaluate safety monitoring of COVID- 19 vaccines post-introduction

Approvals of data agreements secured

Common protocols developed to support and to initiate global COVID-19 vaccine surveillance at partner sites Enhanced ability to evaluate vaccine exposure

Enhanced ability to conduct chart review Case report summaries available on an interactive dashboard, located and managed by the data coordinating center

Frequent scans of data for adverse events using rapid cycle techniques for each vaccine and aggregate rates across vaccine technologies

Identification of unanticipated adverse events using data mining techniques

Rates of vaccine failure through identification of vaccine-mediated enhanced disease reported

Comparisons of vaccine uptake and safety profiles of various types of Covid19 vaccines

Completed cohort and case- based COVID- 19 vaccine safety surveillance

Increase studies using electronic health care databases both in-country and across countries/regions completed

Increase follow-up studies to evaluate rare events using chart review, when applicable

Active surveillance for COVID-19 initiated

Develop guidance based on COVID- 19 vaccine pharmacovigilance findings that may impact national immunization policies

Public confidence in COVID-19 vaccines maintained through surveillance findings

i. Purpose This NOFO will create a DCC with associated data partners in order to implement a globally harmonized post-introduction monitoring of the safety of COVID-19 vaccines. This NOFO will support a DCC that will facilitate the implementation of a multi-site, multi-country surveillance system. The recipient is expected to work with participating data partners to ensure they follow protocol to monitor and conduct activities as it relates to monitoring and evaluating adverse events following COVID-19 vaccines. The findings from these surveillance efforts will provide guidance on COVID-19 vaccine pharmacovigilance that may impact national immunization policies.

ii. Outcomes Provide guidance based on COVID-19 vaccine pharmacovigilance findings that may impact national immunization policies. As countries introduce COVID-19 vaccines into their population, there will be a review of the safety of any and all authorized and approved vaccines to inform nation COVID-19 vaccination policies. Regular reports from surveillance systems are an integral component to ensure safety. At any time, a potential adverse event is detected in any system through a statistical signal, it is imperative to rapidly evaluate the signal to determine if it there is a true association with one of the authorized or approved COVID-19 vaccines. The intent of this grant is to provide additional data on a larger scale than a single country product, increasing the assessed sample size of a population that has received a COVID-19 vaccine. This global vaccine safety surveillance system will also provide support in signal evaluation to confirm or refute any statistical signal detected. The findings from this surveillance system can be used not only for global advisory committees, such as the World Health Organization (WHO) Global Advisory Committee for Vaccine Safety (GACVS) and CDC’s Advisory Committee on Immunization Practices (ACIP), but also for public health and regulatory agencies in individual countries that are reviewing the safety of COVID-19 vaccines and the policies each country recommends.

Maintain public confidence in COVID-19 vaccines. Ensuring that COVID-19 vaccines are safe is a critical component of any national immunization program. The global vaccine safety surveillance activity funded through this grant will develop, enhance and allow for regular reporting of the monitoring of COVID-19 vaccines both within a country and across countries. As any concerns arise, data generated from this global surveillance effort will provide additional data to countries globally. Like any immunization program, timely and transparent reporting on safety data will assist in maintaining public confidence.

iii. Strategies and Activities Strategy A: Support the readiness of methods for a globally harmonized post-introduction monitoring of COVID-19 vaccines. Through this, the recipient will:

Draft protocols of activities for vaccine safety monitoring.

Form agreements with data partners/sites that allow for the execution of all the activities set out in this global surveillance program.

Strategy B: Support country readiness for a globally coordinated active vaccine safety surveillance system upon roll-out of COVID-19 vaccine in the general public. Through this, the recipient will:

Perform inventory of ongoing activities at partner sites.

Assess and describe site capacity and data sources Create common protocols to assess vaccine safety and perform active surveillance.

Conduct adverse events background rates studies.

Strategy C: Conduct safety monitoring after COVID-19 vaccine post-introduction. Through this, the recipient will:

Create monthly reports/summaries of vaccine safety as the staggered roll out of vaccines occurs through the use of the dashboard established and managed by the DCC.

Perform case report assessments of potential adverse events.

Conduct active surveillance of adverse events using rapid cycle techniques and tree-base scan statistics.

1. Collaborations

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

The CDC’s Immunization Safety Office’s Vaccine Safety Datalink (VSD) may be a contributing data partner. The VSD will conduct near real time safety monitoring of COVID-19 vaccines.

b. With organizations not funded by CDC:

The funded recipient is expected to develop collaborations with data partners pertinent to the purpose of this Notice of Funding Opportunity (NOFO). Data partners for this global vaccine safety effort should have experience conducting active surveillance with the availability of electronic health care databases and existing infrastructure. Some of these data partners may be funded through the recipient. These data partners should have a working relationship with the recipient in furtherance of the purpose of this NOFO. These relationships should be evidenced by letters of support, memoranda of understanding, or an agreement detailing the nature and extent of the ability to conduct the proposed work. Any documents i.e letter of support shall be uploaded to www.grants.gov as a pdf and labeled CK212107SupportingDoc. The recipient is required to follow procurement procedures outlined in 2 CFR 200 or 45 CFR 75 and follow CDC guidelines to insure subrecipient contract mechanisms include: scope of work, method of accountability, budget, and period of contract that aligns with this funding.

2. Target Populations COVID-19 vaccines are yet to be licensed; however, some have been approved in some countries for use. Depending on the availability of vaccine, initial vaccination may occur in high priority groups such as health care workers or those most affected by the COVID-19 disease. Eventually, the target population that will benefit from the outcomes of this activity will be the general public. Vaccine safety monitoring is critical to maintain public confidence among participating countries as well as globally.

a. Health Disparities N/A

iv. Funding Strategy This award will be fully funded for the three-year period of performance at the time of initial award.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy http://www.grants.gov

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/additionalrequirements/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.

c. Organizational Capacity of Recipients to Implement the Approach The applicant should describe its internal organizational structure and capabilities to operate as a coordinating center to implement a multi-site, multi-country COVID-19 vaccine safety surveillance system. Please provide a staffing plan and project management structure that clearly defines staff roles and an organizational chart. Applicants are encouraged to name upload the staffing plan and organizational as a PDF on www.grants.gov and name the file [CDC-RFA- CK21-2107_Staffing]. At a minimum to meet the objectives of the NOFO, the staffing should be adequate to manage data, conduct analyses, and to respond to signals, if appropriate.

d. Work Plan General Work Plan Guidance: Recipient must develop and submit a high-level work plan that addresses the proposed activities and strategies. The plans and activities should align with the https://www.cdc.gov/grants/additionalrequirements/ar-25.html http://www.grants.gov/ program strategies in the logic model and describe the expected output (e.g., milestones) over the three years of the period of performance. The high-level plan should reflect the strategies, outcomes, evaluation, and performance measures described in the NOFO. Recipient must provide at least one proposed long-term outcome. The proposed short-term and intermediate outcomes should directly relate to the expected results of completing the planned activity.

Planned activities must be associated with functions or objectives related to the program strategy(ies).

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.

B. Award Information

1. Funding Instrument Type:

G (Grant)

2. Award Mechanism:

E11 To provide grants to public or nonprofit organizations for planning, development, demonstration,

3. Fiscal Year:

4. Approximate Total Fiscal Year Funding:

$ 5,665,726

5. Total Period of Performance Funding:

$ 5,665,726 This amount is subject to the availability of funds.

Estimated Total Funding:

$ 5,665,726

6. Total Period of Performance Length:

3 year(s)

7. Expected Number of Awards:

8. Approximate Average Award:

$ 5,665,726 Per Project Period

9. Award Ceiling:

$ 5,665,726 Per Project Period

This amount is subject to the availability of funds.

10. Award Floor:

$ 75,000 Per Project Period

11. Estimated Award Date:

April 21, 2021

12. Budget Period Length:

36 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.

N/A

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:

25 (Others (see text field entitled "Additional Information on Eligibility" for clarification))

2. Additional Information on Eligibility Auckland UniServices Limited

3. Justification for Less than Maximum Competition The Auckland UniServices Limited is the coordinating site for the Global Vaccine Data Network (GVDN). The GVDN is an existing network of 21 study sites representing 13 countries (Argentina, Australia, Canada, China, Denmark, Finland, France, India, New Zealand, Taiwan, UK, US, and South Africa) across six continents. It is the largest known international big data collaboration using large-linked databases to examine the impact of biologics on populations.

Each of the GVDN sites has experience in conducting vaccine safety studies using electronic databases. In addition, most sites have prior vaccine safety evaluation experience using individual medical record review to evaluate possible cases of adverse events following immunization. There is no other existing organization that has the geographic diversity, population heterogeneity, breadth of subject matter expertise, and database robustness of the GVDN. These qualities will be especially important for the COVID-19 response.

Active surveillance of COVID-19 vaccines is essential, especially in the early months of the distribution, since the development was expedited and will be distributed under Emergency Use Authorization agreements. The GVDN sites will perform vaccine safety surveillance using rapid cycle techniques and sequential tree-based scan statistics, which are methods the CDC Vaccine Safety Datalink developed and have used since the early 2000's to assess post-licensure vaccine safety in the United States.

Without this funding opportunity, there will be no centralized global public health surveillance network monitoring COVID-19 vaccine safety and synthesizing data. While there may be ad hoc surveillance, collaborative surveillance provides the opportunity for an organized tracking of potential adverse events after vaccination. This network system will have the ability to compare the various COVID-19 vaccines using a common protocol. Additionally, it will increase statistical power to assess outcomes due to the larger combined sample size, and the ability to test and evaluate any safety signal observed in a single country or program in other settings, which can provide important comparisons across diverse socio-ecological systems.

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.

StepSystem Requirements Duration Follow Up

Data Universal Number

1. Click on http:// fedgov.dnb.com/ webform 1-2 Business Days

To confirm that you have been issued a new https://www.grants.gov/ 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

System

(DUNS)

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

DUNS number check online at (http:// fedgov.dnb.com/ webform) or call 1-866-705-

System for Award Management

(SAM)

formerly Central Contractor Registration

(CCR)

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

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

For SAM Customer Service Contact https://fs d.gov/ fsd-gov/ home.do Calls: 86 6-606-8220

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 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 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)

NA

b. Application Deadline

Due Date for Applications 04/16/2021 04/16/2021 11:59 pm 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.

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 Management (SAM) exclusions.

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

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

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

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 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.

https://www.grants.gov/ https://www.grants.gov/

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

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

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

b. Approach

i. Purpose

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

ii. Outcomes

Applicants must clearly identify the outcomes they expect to achieve by the end of the project period, as identified in the logic model in the Approach section of the CDC Project Description.

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

iii. Strategies and Activities

Applicants must provide a clear and concise description of the strategies and activities they will use to achieve the period of performance outcomes. Applicants must select existing evidence-based strategies that meet their needs, or describe in the Applicant Evaluation and Performance Measurement Plan how these strategies will be evaluated over the course of the project period.

See the Strategies and Activities section of the CDC Project Description.

1. Collaborations

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

2. Target Populations and Health Disparities Applicants must describe the specific target population(s) in their jurisdiction and explain how such a target will achieve the goals of the award and/or alleviate health disparities. The applicants must also address how they will include specific populations that can benefit from the program that is described in the Approach section. Applicants must address the Target Populations and Health Disparities requirements as described in the CDC Project Description.

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

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

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

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

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

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

Describe key evaluation questions to be addressed by these evaluations.

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

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

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

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

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 http://www.phaboard.org/ 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 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).