PKG00262435-instructions.pdf

Centers for Disease Control and Prevention

National Center for Environmental Health

National Public Health Surveillance for Chemical and Radiologic Exposures and Emerging

Drug Threats - COVID-19 Supplemental

CDC-RFA-EH20-20030101SUPP20

Application Due Date: 08/19/2020

National Public Health Surveillance for Chemical and Radiologic Exposures and Emerging

Drug Threats - COVID-19 Supplemental

CDC-RFA-EH20-20030101SUPP20

TABLE OF CONTENTS

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

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

Part I. Overview Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA- EH20-20030101SUPP20. 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:

National Public Health Surveillance for Chemical and Radiologic Exposures and Emerging Drug Threats - COVID-19 Supplemental C. Announcement Type: New - Type 1 This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https ://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf.

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

New-Type 1

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-EH20-20030101SUPP20

E. Assistance Listings (CFDA) Number:

93.070 F. Dates:

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

2. Due Date for Applications: 08/19/2020, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

3. Date for Informational Conference Call:

Not Applicable.

G. Executive Summary:

1. Summary Paragraph:

The purpose of this NOFO is to enhance CDC’s COVID-19 surveillance and response activities by increasing CDC/National Center for Environmental Health (NCEH) and partnering COVID- 19 response task forces' access to information about calls received by U.S. poison centers (PCs) related to COVID-19 pandemic not currently captured by routine National Poison Data System (NPDS) access. This NOFO will fund the following activities: 1) access to a subset of PC records, including call notes, for calls related to COVID-19 illness and clinical management (e.g., treatment, medication use, adverse events) and/or exposure calls related to potentially harmful actions taken by individuals to prevent, treat, or cure COVID-19 (e.g., vitamin and herbal supplement use); and 2) coordination with American Association of Poison Control Centers (AAPCC) and regional PCs to conduct follow-up studies regarding of COVID-19 and https://www.grants.gov https://www.grants.gov https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html https://www.grants.gov related exposure calls. While CDC/NCEH has access within NPDS to basic information related to the purpose of the calls, gaining expanded access to call notes and potential follow-up of COVID-19 and related exposure calls can describe caller concerns, needs, and specific medical details. CDC will not require or collect caller identifiers as part of this NOFO. This additional information will enhance CDC and state health department COVID-19 response activities including messaging and advice as well as improved situational awareness and preparedness for potential future outbreaks.

a. Eligible Applicants: Single

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 1

d. Total Period of Performance Funding: $2,250,000

e. Average One Year Award Amount: $750,000

f. Total Period of Performance Length: 3

g. Estimated Award Date: 09/02/2020

h. Cost Sharing and / or Matching Requirements: N No cost sharing requirement. Cost sharing or matching funds are not required for this program.

Although no statutory matching requirement for this NOFO exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

Part II. Full Text A. Funding Opportunity Description

Part II. Full Text

1. Background

a. Overview This NOFO will enhance surveillance and response activities by increasing CDC/NCEH and partnering COVID-19 response task forces’ access to information about calls received by U.S.

PCs related to the COVID-19 pandemic not currently captured by routine NPDS access.

Currently, the 55 U.S. PCs are receiving thousands of COVID-19 calls from concerned citizens as well as from medical professionals. In many states, PCs partnered with their state health departments (HDs) to serve as COVID-19 hotlines to help reduce burden on state and local HD staff. As a known reputable source of medical information, PCs have an important and unique role of providing sound public health and medical advice to the public and healthcare providers.

As of 3 May 2020, US PCs have received more than 313,000 calls coded as related to COVID- 19, ~60% of which were received in March. In addition, PCs are seeing a marked increase in the number of calls related to cleaners and disinfectants since the beginning of March 2020 compared to previous years. With the media attention of possible medications used to prevent and/or treat for COVID-19 (e.g., chloroquine, hydroxychloroquine, remdesivir) and other medicines that have been linked to COVID-19 treatment (e.g., antivirals and immune modulating medications), there are concerns that the public may attempt to divert/self-medicate and about off-label prescribing by physicians. CDC has observed potential recent increases in these exposures within NPDS. However, while CDC/NCEH has access within NPDS to basic information related to the purpose of these calls, demographic characteristics of the callers, and outcome of the call, these data are limited. Expanded access to call notes and potential follow-up of COVID-19 and related exposure calls can detail caller concerns, needs, and specific medical details. CDC will not require or collect caller identifiers as part of this NOFO. This additional information will enhance CDC and state health department COVID-19 response activities including messaging and advice as well as improved situational awareness and preparedness for potential future outbreaks.

This NOFO will fund the following activities: 1) access to a subset of PC records, including call notes, for calls related to COVID-19 illness and clinical management (e.g., treatment, medication use, adverse events) and/or exposure calls related to potentially harmful actions taken by individuals to prevent, treat, or cure COVID-19 (e.g., vitamins and herbal supplement use, exposure to cleaning products); and 2) coordination with AAPCC and regional PCs to conduct follow-up studies regarding COVID-19 and related exposure calls.

b. Statutory Authorities This activity is authorized by Section 301 of the Public Health Service Act [42 U.S.C. Section 241]; Section 392 of the Public Health Service Act [42 U.S.C. Section 280b-0]; and by The Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020 [Public Law 116-123].

c. Healthy People 2030 This program addresses the Healthy People 2030 focus area of Environmental Health and Public Health Infrastructure by collaborating with partners to create the expertise, information, and tools that people and communities need to protect their health-through health promotion, prevention of disease, injury and disability, and preparedness for new health threats.

d. Other National Public Health Priorities and Strategies This NOFO also supports the following national public health priorities and strategies:

o The Pandemic and All-Hazards Preparedness Act (SB 3678) (http://www.govtr ack.us/congress/bill.xpd?bill=s109-3678)

e. Relevant Work NCEH’s Division of Environmental Health Science and Practice (DEHSP) studies environmental exposures that may be harmful to people and develops strategies for preventing human exposure to environmental hazards and mitigating the effects of disasters and emergencies. The National Poison Data System (NPDS), owned and operated by AAPCC and currently funded by CDC-RFA-EH15-1506, is the cornerstone of DEHSP’s National Chemical and Radiological Surveillance Program (NCRSP). On a routine basis, DEHSP conducts surveillance for emerging threats of potential public health significance using NPDS. DEHSP also uses the system to monitor for potential harmful exposures and health outcomes during http://www.govtrack.us/congress/bill.xpd?bill=s109-3678 http://www.govtrack.us/congress/bill.xpd?bill=s109-3678 public health emergencies, such as the COVID-19 pandemic and other disasters and emergencies (e.g., Hurricanes Harvey, Irma, Maria, Florence, Michael, etc.; Fukushima earthquake and tsunami; Deepwater Horizon oil spill). For example, DEHSP works with PCs serving areas affected by hurricanes to examine the risk factors for and messages about carbon monoxide exposures after storms. NPDS data are integral to situational awareness activities during disasters and are used at the CDC Emergency Operations Center (EOC) to guide national public health response activities. Currently, NPDS data related to the COVID-19 pandemic are reported weekly to the CDC EOC. In addition, CDC and PCs collaborated to publish an MMWR article in March 2020 warning the public about potentially harmful exposures to cleaners and disinfectants (https://www.cdc.gov/mmwr/volumes/69/wr/mm6916e1.htm).

Previous enhanced NPDS activities using call notes and/or follow-up surveys include the characterization of carbon monoxide exposure during Hurricane Sandy and subsequent nor’easter (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5708145/) and characterizing risk factors for pediatric lamp oil product exposures (https://www.ncbi.nlm.nih.gov/pubmed/24066 734).

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Approach:

Outcomes Major Activities

Short Intermediate Long

Provide NCEH who work with partnering EOC task forces with access to records, including call notes, for agreed upon PC calls related to COVID-19 pandemic

Conduct follow-up studies to better understand COVID-19 related calls and exposures captured in

NPDS

Improved situational awareness and understanding of needs, concerns, and medical outcomes related to the COVID-19 pandemic

Improved capacity to respond to the COVID- 19 pandemic through tailored messaging and advice

Increased capacity for identifying, addressing, and reducing morbidity and mortality from potential future pandemics

i. Purpose

The purpose of this NOFO is to enhance CDC’s COVID-19 surveillance and response activities by increasing CDC/NCEH access to information about calls received by U.S. PCs that is not https://www.cdc.gov/mmwr/volumes/69/wr/mm6916e1.htm https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5708145/ https://www.ncbi.nlm.nih.gov/pubmed/24066734 https://www.ncbi.nlm.nih.gov/pubmed/24066734 currently captured by NCEH’s NPDS access. The recipient will collaborate with scientists and subject matter experts at NCEH to provide or obtain enhanced, detailed information for a subset of calls related to COVID-19 illness and management and/or exposure calls related to potentially harmful, actions taken by individuals to prevent, treat, or cure COVID-19.

ii. Outcomes Short-term outcome: Improved situational awareness and understanding of needs, concerns, and medical outcomes related to the COVID-19 pandemic. The short-term outcome of this activity(ies) is the improved situational awareness and understanding of the current COVID-19 pandemic. Detailed records, call notes, and/or follow-up studies can provide vital information to help describe caller concerns, needs, and specific medical details. This additional, detailed information will enhance CDC and state/local HD response activities including messaging and advice as well as improved situational awareness Intermediate-term outcome: Improved capacity to respond to the COVID-19 pandemic through tailored messaging and advice. The immediate-term outcome is the improved capacity to respond to the COVID-19 pandemic through tailored messaging and advice. With detailed information about the specific medical treatment and outcomes, public needs, and concerns/questions from callers, CDC, state and local HDs, and PCs can tailor messages and advice related to the pandemic.

Long-term outcome: Increased capacity for identifying, addressing, and reducing risk factors for morbidity and mortality from potential future pandemics. The long-term outcome is the increased capacity for identifying, addressing, and reducing morbidity and mortality from potential future pandemics. CDC, state and local HDs, and PCs will be able to adapt information gleaned and lessons learned from the enhanced COVID-19 surveillance and response activities to better prepare for and respond to future pandemics and other related public health emergencies and proactively implement interventions to reduce morbidity and mortality.

iii. Strategies and Activities Strategy 1: Provide NCEH and partnering COVID-19 response task forces’ with access to records, including call notes for agreed upon PC calls related to COVID-19 pandemic The recipient will provide NCEH call available records, including call notes, for a subset of PC calls related to COVID-19 and related exposure calls (e.g., medications, COVID-19, disinfectants) using agreed upon parameters. The notes will be provided to NCEH in an agreed upon format and on an agreed upon timeline. NCEH will work with partnering COVID-19 task forces to analyze, interpret, and disseminate findings.

Strategy 2: Conduct follow-up studies to better understand COVID-19 related calls and exposures captured in NPDS The recipient will collaborate with CDC and regional PCs to follow up on calls related to a specific exposure or set of exposures. The PCs will recontact callers to ask an agreed upon set up questions to obtain additional information about the exposure(s) of interest. The PCs will record the callers’ responses and provide the responses to NCEH in an agreed upon format and on an agreed upon timeline. Calls will be identified using agreed upon parameters within NPDS.

1. Collaborations

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

There are no required collaborations. The applicant is encouraged to continue working with current CDC programs to the extent possible.

b. With organizations not funded by CDC:

There are no required collaborations.

2. Target Populations No particular target population has been identified as the beneficiary of the outcomes of this project. The work conducted under this NOFO will benefit the entire US population through the enhanced information related to the COVID-19 pandemic.

a. Health Disparities The recipient will ensure that underserved populations (e.g., tribal, rural, and English to Speakers of Other Languages (ESOL) populations, and people with disabilities) are included and reached through this project. PCs provide 24/7 coverage to all members of the public, and do not refuse calls from any underserved populations. Follow-up activities will represent those individuals and populations who called in to the PCs.

iv. Funding Strategy N/A

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy Major Activity 1: Provide NCEH with access to records, including call notes, for agreed upon PC calls related to COVID-19 pandemic NCEH scientists received records, including call notes, for all identified PCs calls on exposure(s) of interest defined using the agreed upon search parameters and format (e.g., Excel) and within the agreed upon timeline.

Measure – The recipient will provide 100% of requested records, including call notes

Major Activity 2: Conduct follow-up studies to better understand COVID-19 related calls and exposures captured in NPDS Measure – The recipient will work with PCs to track all follow-up calls made and the resulting outcome (e.g., completed, number of attempts, no answer, refused). The recipient will provide caller responses to NCEH for 100% of completed calls in the agreed upon format (e.g., Excel) and within the agreed upon timeline.

ii. Applicant Evaluation and Performance Measurement Plan

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

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

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

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

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

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

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

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

Describe key evaluation questions to be addressed by these evaluations.

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

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

The recipient will affirm their ability to collect the required data and will develop performance metrics to demonstrate the timeliness, accuracy, and scope of PC data and NPDS public health surveillance data.

c. Organizational Capacity of Recipients to Implement the Approach To implement the activities described in the NOFO, a certain level of organizational capacity of the recipient is required. The recipient is expected to have personnel with the scientific and program management skills so that performance measures are met and the administrative aspects of the program (e.g., budget and finance, communications) are maintained. The recipient must demonstrate relevant experience and capacity (management, administrative, technical) to implement the activities and achieve the project outcomes. The recipient must have access to PC data across the US and is expected to have existing relationships in place with PC.

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

Period of Performance Outcome:

[from Outcomes section and/or logic model]

Outcome Measure:

[from Evaluation and Performance Measurement section]

Strategies and Activities

Process Measure [from Evaluation and Performance Measurement section]

Responsible Position / Party

Completion Date

1.

2.

3.

4.

5.

6.

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and recipients, site visits, and recipient reporting (including work plans, performance, and financial reporting).

Consistent with applicable grants regulations and policies, CDC expects the following to be included in post-award monitoring for grants and cooperative agreements:

Tracking recipient progress in achieving the desired outcomes.

Ensuring the adequacy of recipient systems that underlie and generate data reports.

Creating an environment that fosters integrity in program performance and results.

Monitoring may also include the following activities deemed necessary to monitor the award:

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

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

Working with recipients on adjusting the work plan based on achievement of outcomes, evaluation results and changing budgets.

Monitoring performance measures (both programmatic and financial) to assure satisfactory performance levels.

Monitoring and reporting activities that assist grants management staff (e.g., grants management officers and specialists, and project officers) in the identification, notification, and management of high-risk recipients.

NCEH will monitor the progress of performance measures during existing monthly calls with different teams (i.e., technical team, the toxicosurveillance team, and the leadership team) about specific topics to ensure that the recipient is performing at a level that is responsive and sufficient to achieve outcomes and evaluation results within stated time frames, and to adjust the work plan based on achievement of outcomes, evaluation results and shifting priorities. The recipient will submit a final report annually summarizing work performed specific to each strategy, including whether and how performance measures were met.

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

COOPERATIVE AGREEMENTS)

Strategy 1: Provide NCEH and partnering COVID-19 response task forces’ with access to records, including call notes, for agreed upon PC calls related to COVID-19 pandemic NCEH and partnering COVID-19 response task forces’ scientists will consult with the recipient on particular criteria/parameters needed to pull the records, including call notes, from NPDS and when/if there are access issues or incomplete call notes and how to address issues to these data Strategy 2: Conduct follow-up studies to better understand COVID-19 related calls and exposures captured in NPDS NCEH scientists and partnering COVID-19 response task forces will consult with the recipient on particular criteria for identifying calls that would be included in any potential follow-up studies. NCEH and partnering COVID-19 response task forces will work with recipients to design the scope and nature of the follow-up studies, including questionnaire design, data collection format, and method of providing data.

B. Award Information

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

2. Award Mechanism: UE1 UE1 Studies of Environmental Hazards and Health Effects

3. Fiscal Year: 2020

4. Approximate Total Fiscal Year Funding: $750,000

5. Approximate Period of Performance Funding: $2,250,000

This amount is subject to the availability of funds.

Estimated Total Funding: $2,250,000

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

7. Expected Number of Awards: 1

8. Approximate Average Award: $750,000 Per Budget Period

9. Award Ceiling: $750,000 Per Budget Period

This amount is subject to the availability of funds.

10. Award Floor: $0 Per Budget Period

11. Estimated Award Date: 09/02/2020

12. Budget Period Length: 12 month(s)

Throughout the project period, CDC will continue the award based on the availability of funds, the evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the federal government. The total number of years for which federal support has been approved (project period) will be shown in the “Notice of Award.” This information does not constitute a commitment by the federal government to fund the entire period. The total period of performance comprises the initial competitive segment and any subsequent non-competitive continuation award(s).

13. Direct Assistance Direct Assistance (DA) is not available through this NOFO.

C. Eligibility Information

1. Eligible Applicants Eligibility Category: Others (see text field entitled "Additional

Information on Eligibility" for clarification)

Additional Eligibility Category:

2. Additional Information on Eligibility Single Source Eligibility:

AAPCC is the non-profit member organization of the poison control centers in the U.S.

AAPCC wholly owns and operates the National Poison Data System. No other organization exists that has a comprehensive, real-time database that contains information on all calls made to all U.S. poison control centers. AAPCC is the only organization that receives, manages, and disseminates data collected by all poison control centers.

Use of the National Poison Data System is the cornerstone of CDC/NCEH's National Chemical and Radiation Surveillance Program (NCRSP) to detect chemical and radiological incidents for prompt public health response. NCEH has received funding from CDC's Center for Preparedness and Response (CPR) to work with AAPCC since 2001 to develop and implement a national, real-time database to improve surveillance for chemical and radiological exposures and other poisonings based on data collected from US Poison Control Centers. Without the system, CDC's crucial national chemical and radiological surveillance capacity would be lost.

AAPCC has been a CDC contractor and grantee for more than 17 years. The previous cooperative agreements and contracts with AAPCC were all single eligibility or sole source procurements, because AAPCC is the only organization with access to data collected by all poison control centers.

American Association for Poison Control Centers (AAPCC).

3. Justification for Less than Maximum Competition AAPCC is the non-profit member organization of the 55 poison control centers (PCCs) in the United States. AAPCC is the only organization that receives and manages PCC data. AAPCC wholly owns and operates the National Poison Data System (NPDS), the sole repository for real-time poison exposure data received from all U.S. PCCs.

In response to congressional mandate following the September 11 terrorist attacks, NCEH has received funding from CDC's Center for Preparedness and Response (CPR) since 2001 to work with AAPCC to develop and implement a national, real-time database to improve surveillance for chemical and radiological exposures and other poisonings using PCC data.

AAPCC identifies and reviews data anomalies that may represent public health threats and to notify appropriate state public health authorities and the corresponding PCC about the threat for prompt public health response/action. This data is used to educate the public on poison safety and allows PCCs to identify the specific poison topics and populations of greatest need in their geographic area. PCCs may apply this data when answering close to three million calls a year, centers save countless lives and millions of tax dollars.

In 2015, CDC entered into a cooperative agreement (single source) with AAPCC to reflect the collaborative nature of the partnership and surveillance activities. Without this ongoing partnership, much of the national, state, and local public health capacity to conduct surveillance for chemical and radiological incidents would be lost. Without access to the NPDS data, AAPCC will not be able to detect and review data anomalies and notify state public health departments of potential threats. Subsequently, state public health departments' awareness of and response to potential threats will be severely delayed, putting the population's health at risk. A sole source competition cooperative agreement between CDC and AAPCC will ensure continuation of a Congressionally-mandated, vital public health surveillance system that brings nationwide benefit to the U.S. population and that CDC's over $30M investment throughout a 17-year CDC-AAPCC partnership is put to maximum use to protect the American people.

4. Cost Sharing or Matching Cost Sharing / Matching Requirement: No

No cost sharing requirement. 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 NOFO.

D. Application and Submission Information

1. Required Registrations An organization must be registered at the three following locations before it can submit an application for funding at www.grants.gov.

a. Data Universal Numbering System:

All applicant organizations must obtain a Data Universal Numbering System (DUNS) number.

A DUNS number is a unique nine-digit identification number provided by Dun & Bradstreet (D&B). It will be used as the Universal Identifier when applying for federal awards or cooperative agreements.

The applicant organization may request a DUNS number by telephone at 1-866-705-5711 (toll free) or internet at http:// fedgov.dnb. com/ webform/ displayHomePage.do. The DUNS number will be provided at no charge.

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

b. System for Award Management (SAM):

The SAM is the primary registrant database for the federal government and the repository into which an entity must submit information required to conduct business as a recipient. All applicant organizations must register with SAM, and will be assigned a SAM number. All information relevant to the SAM number must be current at all times during which the applicant has an application under consideration for funding by CDC. If an award is made, the SAM information must be maintained until a final financial report is submitted or the final payment is received, whichever is later. The SAM registration process can require 10 or more business days, and registration must be renewed annually. Additional information about registration procedures may be found at https://www.sam.gov/SAM/.

c. Grants.gov:

The first step in submitting an application online is registering your organization at www.grants.gov, the official HHS E-grant Web site. Registration information is located at the "Applicant Registration" option at www.grants.gov.

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

Step System Requirements Duration Follow Up 1 Data 1. Click on http:// 1-2 To confirm that 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

Universal Number System

(DUNS)

fedgov.dnb.com/ webform

2. Select Begin DUNS search/request process

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

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

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

2 System for Award Management

(SAM)

formerly Central Contractor Registration

(CCR)

1. Retrieve organizations DUNS number

2. Go to 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://fsd.gov/ fsd-gov/ home.do Calls:

866-606-8220

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

Applicants may access the application package at www.grants.gov.

3. Application Package Applicants must download the SF-424, Application for Federal Assistance, package associated with this notice of funding opportunity at www.grants.gov.

4. Submission Dates and Times If the application is not submitted by the deadline published in the NOFO, it will not be processed. Office of Grants Services (OGS) personnel will notify the applicant that their application did not meet the deadline. The applicant must receive pre-approval to submit a paper application (see Other Submission Requirements section for additional details). If the applicant is authorized to submit a paper application, it must be received by the deadline provided by

OGS.

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

b. Application Deadline Due Date for Applications: 08/19/2020 , 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov. If Grants.gov is inoperable and cannot receive applications, and circumstances preclude advance notification of an extension, then applications must be submitted by the first business day on which grants.gov operations resume.

Date for Information Conference Call Not Applicable.

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

Applicants may follow either of the following processes:

Complete the applicable assurances and certifications with each application submission, name the file “Assurances and Certifications” and upload it as a PDF file with at www.grants.gov

Complete the applicable assurances and certifications and submit them directly to CDC on an annual basis at http://wwwn.cdc.gov/ grantassurances/ (S(mj444mxct51lnrv1hljjjmaa))/ Homepage.aspx

Assurances and certifications submitted directly to CDC will be kept on file for one year and will apply to all applications submitted to CDC by the applicant within one year of the submission date.

Risk Assessment Questionnaire Requirement https://www.grants.gov https://www.grants.gov https://www.grants.gov http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx https://www.grants.gov http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx

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.

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.”

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

6. Content and Form of Application Submission Applicants are required to include all of the following documents with their application package at www.grants.gov.

7. Letter of Intent LOI is not requested or required as part of the application for this NOFO.

8. Table of Contents (There is no page limit. The table of contents is not included in the project narrative page limit.): The applicant must provide, as a separate attachment, the “Table of Contents” for the entire submission package.

Provide a detailed table of contents for the entire submission package that includes all of the documents in the application and headings in the "Project Narrative" section. Name the file "Table of Contents" and upload it as a PDF file under "Other Attachment Forms" at www.grants.gov.

9. Project Abstract Summary (Maximum 1 page) A project abstract is included on the mandatory documents list and must be submitted at www.grants.gov. The project abstract must be a self-contained, brief summary of the proposed project including the purpose and outcomes. This summary must not include any proprietary or confidential information. Applicants must enter the summary in the "Project Abstract Summary" text box at www.grants.gov.

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

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

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

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

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

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

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

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

Describe key evaluation questions to be addressed by these evaluations.

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

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:

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

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 http://www.phaboard.org negotiated federal indirect cost rate agreement or a cost allocation plan approval letter for those Recipients under such a…