PKG00259841-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

CDC-RFA-EH20-2003

Application Due Date: 05/15/2020

National Public Health Surveillance for Chemical and Radiologic Exposures and Emerging

Drug Threats

CDC-RFA-EH20-2003

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- EH20-2003. 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 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-EH20-2003

E. Assistance Listings (CFDA) Number:

93.070 F. Dates:

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

2. Due Date for Applications: 05/15/2020, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

3. Date for Informational Conference Call:

May 05, 2020 3:00 - 4:00 PM Eastern Time

(855) 644-0229, (Dial-in Conference Region) Conference ID: 9827483

G. Executive Summary:

1. Summary Paragraph:

The purpose of this NOFO is to facilitate the partnership between CDC/National Center for Environmental Health/Division of Environmental Health Science and Practice (DEHSP), the CDC/National Center for Injury Prevention and Control/Division of Overdose Prevention (DOP), and the recipient to facilitate development, implementation, and continuous improvement of a system for receiving and compiling data from US poison centers (PCs) that 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 can be used for public health surveillance of toxic exposures at the national level. This NOFO will fund several important activities including 1) providing DEHSP scientists’ access to the national system of US PC call data; 2) maintaining the technologic functioning of this system;

3) supporting a team of toxicologists who review specific alerts generated by this system; 4) development and implementation of enhancements to this system to improve public health surveillance capabilities; and 5) collaboration with PCs and public health to conduct a needs assessment to identify both technical and process enhancements that would benefit local infrastructure and surveillance and to develop success stories and related dissemination products. This system is used to: improve surveillance for toxic exposures based on data collected from US PCs; identify early markers of public health emergencies so appropriate, rapid public health response can be launched; and improve situational awareness about ongoing or emerging chemical or radiological exposures.

a. Eligible Applicants: Single

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 1

d. Total Period of Performance Funding: $7,500,000

e. Average One Year Award Amount: $1,500,000

f. Total Period of Performance Length: 5

g. Estimated Award Date: 08/14/2020

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 facilitate the partnership between CDC/National Center for Environmental Health/Division of Environmental Health Science and Practice (DEHSP), the CDC/National Center for Injury Prevention and Control/Division of Overdose Prevention (DOP), and the recipient to facilitate development, implementation, and continuous improvement of a system for receiving and compiling data from US poison centers (PCs) that can be used for public health surveillance of toxic exposures at the national level. Data collected from callers to PCs is uploaded to a national system every 4-10 minutes, 24 hours a day. DEHSP Scientists can use this system to conduct national surveillance for toxic exposures. PC data collected in this national system the only source of near real-time data for toxicosurveillance in the US. This system of national PC data will be used to quickly identify exposures to 64 high priority exposures and illnesses for the purpose of public health surveillance.

DEHSP scientists examine PC data anomalies to identify clusters of illness of potential public health importance and create case-based definitions of public health events to facilitate case finding. DEHSP will works closely with the recipient to provide both funding and guidance for system development, as well as epidemiologic and toxicological expertise during public health incidents. Anomalies in call volume, clinical effects (signs and symptoms), and in case-based definitions are generated automatically. A member of a team of toxicologists will be on-call 24/7 to review anomalies and notify DEHSP if a public health threat is identified.

In 2019, CDC’s National Center for Injury Prevention and Control (NCIPC) joined this partnership to better understand how drug poisonings and overdose captured in PC data could complement or enhance ongoing drug overdose surveillance activities.

The recipient will also increase state and local capacity to respond to chemical, biological, and radiological incidents. A national protocol for state health department notification ensures that state epidemiologists are aware of all incidents identified by the surveillance system for prompt public health response. Moreover, state health departments can utilize PC data for agent-specific surveillance activities using state-specific PC data from their own jurisdictions. A 2013 survey revealed that around 80% of state health departments use PC data for surveillance in some capacity and 95% of state health departments believe PC data is important for public health activities.

This NOFO will fund several important activities including 1) providing DEHSP scientists’ access to the national system of US PC call data; 2) maintaining the technologic functioning of this system; 3) supporting a team of toxicologists who review specific alerts generated by this system; 4) development and implementation of enhancements to this system to improve public health surveillance capabilities; and 5) collaboration with PCs and public health to conduct a needs assessment to identify both technical and process (e.g., communication between partners who use the system) enhancements that would benefit local infrastructure and surveillance and to develop success stories and related dissemination products.

b. Statutory Authorities This program is authorized under Sect 301 PHS Act (42 U.S.C. Sect 241 and 247), as amended Section 301 (a) [42 U.S.C. 241a)] of the Public Health Service Act, and Section 391 (a) [42 U.S.C. 280 b (a)] of the Public Health Service Act. Additional authority is found in the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, Public Law 115-271 (October 24, 2018).

c. Healthy People 2030 This program addresses the "Healthy People 2030" focus area(s) 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. This funding opportunity also supports Healthy People 2030 topic areas of injury and violence prevention, opioids, and substance abuse.

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) o The Homeland Security Presidential Directive ? 21 (HSPD-21) (http://www.dhs.gov/xabout/laws/gc_121926396144 9.shtm).

o HHS Five-Point Opioid Strategy (https://www.hhs.gov/opioids/about-the-epide mic/hhs-response/index.html) o President’s Commission on Combating Drug Addiction and the Opioid Crisis Recommendations (https://www.whitehouse.gov/ondcp/presidents-commission) o President Donald J. Trump’s Initiative to Stop Opioid Abuse and Reduce Drug Supply and Demand (https://www.whitehouse.gov/briefings-statements/president -donald-j-trumps-initiative-stop-opioid-abuse-reduce-drug-supply-demand-2/)

e. Relevant Work 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 natural and human-induced disasters. AAPCC’s NPDS is the system created following many years of partnership with DEHSP and currently funded by the NOFO CDC-RFA-EH15-1506 and is the cornerstone of DEHSP surveillance activities, allowing our scientists to conduct national surveillance for and report on exposure events of potential public health significance.

Public Health and Poison Centers Collaborations Community of Practice (CoP) facilitates communications between and among state departments of health (DOH) and PCs, facilitate relationship building between PCs and state DOHs, and promote the use of PC data for state preparedness and response activities. The CoP has over 240 members from public health agencies and poison centers. It is recognized and supported by AAPCC, the Council of State and Territorial Epidemiologists (CSTE), and the North American Congress of Clinical Toxicology (NACCT).

DEHSP works with PCs serving areas affected by hurricanes to examine the risk factors for and messages about carbon monoxide exposures after storms. NPDS and PCs were integral to situational awareness activities during Hurricanes Irma, Harvey, and Maria. This information was used at the CDC Emergency Operations Center to guide national public health response activities.

DOP leads the agency’s drug overdose surveillance program within the Overdose Data to Action funding announcement (OD2A; CDC-RFA-CE-19-1904). AAPCC NPDS surveillance activities on drug overdose surveillance complement the strategies currently being implemented by funded OD2A health departments.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

http://www.govtrack.us/congress/bill.xpd?bill=s109-3678 http://www.govtrack.us/congress/bill.xpd?bill=s109-3678 https://www.hhs.gov/opioids/about-the-epidemic/hhs-response/index.html https://www.hhs.gov/opioids/about-the-epidemic/hhs-response/index.html https://www.whitehouse.gov/ondcp/presidents-commission https://www.whitehouse.gov/briefings-statements/president-donald-j-trumps-initiative-stop-opioid-abuse-reduce-drug-supply-demand-2/ https://www.whitehouse.gov/briefings-statements/president-donald-j-trumps-initiative-stop-opioid-abuse-reduce-drug-supply-demand-2/

Approach:

Outcomes Major Activities

Short Intermediate Long

Provide DEHSP scientists’ access to the national system of US PC call data

Maintain the technologic functioning of the national system

Support a team of toxicologists to review specific alerts generated by this system

Improved situational awareness and ability to investigate incidents of public health significance

Collaborate with poison centers and public health to conduct a needs assessment to identify both technical and process (e.g., communication between partners who use the system) enhancements that would benefit local infrastructure and surveillance and to develop success stories and related dissemination products

Increased collaboration of PCs, state and local public health agencies, healthcare systems, and emergency management agencies

Enhanced surveillance capacity of state and local public health agencies and public health professionals

Development and Implementation enhancements to this system to improve public health surveillance capabilities

Improved surveillance capabilities and overall functionality of NPDS for public health surveillance

Enhanced technical capacity of the national system of US PC data for preparedness and response activities

Increased federal, state, and local public health capacity for identifying, addressing, and reducing morbidity and mortality from chemical, radiological, and other threats

i. Purpose The purpose of this NOFO is to facilitate public health surveillance at the national level for chemical and radiological exposures and other threats using data collected at U.S. PCs. The recipient will collaborate with scientists at DEHSP to establish and maintain case-based and syndromic surveillance definitions, along with other surveillance parameters to conduct near-real time public health surveillance using PC data. Additionally, this NOFO will facilitate collaboration with DOP to help improve alerting tools for drug exposures and surveillance for emerging drug threats.

ii. Outcomes Short term outcome - Improved situational awareness and ability to investigate incidents of public health significance: the immediate outcome of this activity is the improvement of situational awareness through access to near real-time PC data. PC data are collected in a timely manner which allows for prompt identification of incidents of public health significance and prompt notification to state health departments for appropriate public health action.

Short term outcome - Increased collaboration of PCs, state and local public health agencies, healthcare systems, and emergency management agencies: another immediate outcome is improved collaboration amongst stakeholders through regular communications of incidents that spur from DEHSP surveillance activities or investigation into drug exposure clusters and emerging drug threats by local public health epidemiologists using PC data. Improved collaboration will increase response capacity for future incidents.

Short term outcome - Improved surveillance capabilities and overall functionality of NPDS for public health surveillance: another immediate outcome is improved functionality of the system that stores national PC data to identify incidents of public health significance. Improved functionality includes improving the sensitivity and specificity of the system in identifying incidents, and providing a more user- friendly interface for federal, state, and local public health users of the system Intermediate term outcome - Enhanced surveillance capacity of state and local public health agencies and public health professionals: the intermediate outcome of this cooperative agreement is an overall improvement of state and local public health to conduct surveillance.

PC data constitutes one of the major data sources for identification of chemical and radiological incidents, as well as emerging drug exposure threats, and continued maintenance and improvement of this system will allow for improved capacity.

Intermediate term outcome - Enhanced technical capacity of using PC data for preparedness and response activities: the intermediate outcome of this agreement is improved technical capacity of using PC data, which includes improving the data’s usefulness, flexibility, and acceptability among state and local users. As the technical capacity improves, so does the ability for federal, state, and local public health to identify incidents of importance.

iii. Strategies and Activities

- Provide DEHSP scientists’ access to the national system of US PC call data The recipient will provide DEHSP scientists with access to the national system of US PC data for the purposes of conducting national surveillance for chemical and radiological exposures by being able to identifying early markers of a larger public health threat (sentinel event surveillance). Additionally, the recipient will collaborate with DOP scientists related to efforts to improve alerting for drugs of abuse.

The recipient will provide DEHSP scientists with access to the national system for the purpose of increasing situational awareness about known public health emergencies and for identifying emerging public health threats. Additionally, the recipient will work collaboratively with DOP in responding to emerging drug threats.

- Maintaining the technologic functioning of this system The recipient will ensure continual operation and functionality of the national system of US PC data by maintaining information technology, data management, and public health surveillance capabilities.

- Support a team of toxicologists who review specific alerts generated by this system The recipient will maintain a toxicosurveillance team of approximately 5 to 8 toxicologists from member PCs to investigate data anomalies generated by the system. Investigation of these anomalies may include contacting the originating PC for more information about the exposure.

Within 48 hours, the toxicosurveillance team will make a determination of whether a data anomaly escalates to an incident of public health significance. The toxicosurveillance team will notify DEHSP about incidents they identify as public health significance.

The recipient will maintain a toxicosurveillance team to investigate case-based data anomalies.

These anomalies identify individual cases that meet pre-specified criteria, including high priority exposures such as cases potentially related to weapons of mass destruction, CDC category A and category B bioterrorism agents, and marine toxins. Within six hours, the toxicosurveillance team will make a determination of whether a case-based data anomaly indicates an exposure of public health significance and notify DEHSP.

- Collaborate with poison centers and public health to conduct a needs assessment to identify both technical and process (e.g., communication between partners who use the system) enhancements that would benefit local infrastructure and surveillance and to develop success stories and related dissemination products The recipient will improve emerging drug threat surveillance capabilities by assessing needs of state and local partners using the system; evaluating these needs; implementing changes and dissemination products as identified. Some examples of this may include: training materials for users, improved organization and querying of generic and product codes, building new case

- Develop and implement enhancements to the system to improve public health surveillance capabilities The recipient will make improvements to the national system in order to maintain the system’s utility for national public health surveillance. These improvements may include but are not limited to those listed below:

1. Technical: the collection, transmission, and analysis of data that occurs in the background of the system

2. Surveillance: the surveillance methodologies and case-definitions used to identify data anomalies

3. Data quality: the consistency and reliability of information collected by PCs

The recipient will conduct monthly meetings (one technical call, one surveillance call) with DEHSP and DOP to discuss potential improvements to the system. These suggested improvements will also inform DEHSP and DOP of future funding initiatives. The recipient leadership will meet monthly by teleconference with DEHSP and DOP leadership to discuss broader issues associated with the system and to introduce ideas for new different strategies and activities to achieve the purpose of this activity.

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:

Collaborations with the Council of State and Territorial Epidemiologists and the North American Congress of Clinical Toxicology is highly recommended (but considered optional) as a part of the work highlighted in this NOFO.

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 U.S. population through the rapid identification of and response to chemical and radiological exposures and other incidents of public health significance.

a. Health Disparities The recipient will ensure that underserved populations (e.g., tribal, rural, and ESOL populations, and people with disabilities) are included and reached through this project.

iv. Funding Strategy N/A

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

- Major Activity 1: Provide DEHSP scientists’ access to the national system of US PC call data DEHSP scientists are able to access the national system with no down time during business hours throughout the period of performance.

Measure – The recipient will allow at least five DEHSP users unfettered access to the national system

- Major Activity 2: Support a team of toxicologists who review specific alerts generated by this system Measure - The recipient’s toxicosurveillance team follows up data anomalies within 48 hours of detection.

Measure - The recipient’s toxicosurveillance team follows up on high-priority data anomalies within 6 hours of detection.

The recipient will create ad-hoc temporary codes for ongoing situational awareness when deemed necessary.

- Major Activity 3: Maintain the technologic functioning of this system DEHSP scientists are able to access the national system with no down time during business hours throughout the period of performance.

Measure – The recipient will allow at least five DEHSP users unfettered access to the national system

- Major Activity 4: Collaborate with PCs and public health to identify both technical and process (e.g. communication between partners who use the system) enhancements that would benefit local infrastructure and surveillance and to develop success stories and related dissemination products.

Within 6 months, the recipient will assess needs of state and local public health partners through a systematic needs assessment of the following: 1) how PC data are currently used for surveillance of and response to emerging drug threats; 2)what some of the barriers are to its use;

and 3) areas of improvement to help inform state and local utility for overdose surveillance and response efforts. The recipient will develop a plan to address barriers to using PC data at the state and local level, identifying enhancements that will improve the usage of PC data for state and local surveillance and response within 3 months of assessment and begin implementation of this plan within 6 months of award.

The recipient will develop and disseminate additional training materials as identified as needed, including success stories.

Performance measures will demonstrate the value, in terms of timeliness, accuracy, and scope, of PC data for national public health surveillance. Performance measures will be used by CDC to review and improve surveillance processes so that PC data continue to be valuable for national toxicosurveillance. Information about performance measures and decisions made based on them will be shared with stakeholders (e.g., PC directors).

Measure – have a completed assessment report of state and local health partner needs within six months.

- Major activity 5: Develop and implement enhancements to the system to improve public health surveillance capabilities Measure - The recipient will gather requirements for technical improvements within 6 months of identifying the improvement.

The recipient will implement improvements to NPDS surveillance capacity within 6 months of gathering requirements.

Outcome measure for improved surveillance capabilities and overall functionality of NPDS for public health surveillance : The recipient will ensure the system will have less than 1% downtime where DEHSP scientists will not be able to access PC data. This outcome measure can be calculated by total downtime for period of performance divided by total period of performance Outcome Measure for improved situational awareness and ability to investigate incidents of public health significance: The recipient will ensure over 80% of anomalies reviewed by the toxicosurveillance team occur within 48 hours of anomaly detection Outcome measure for increased collaboration of PCs, state and local public health agencies, healthcare systems, and emergency management agencies: the recipient will ensure at least 80% of state health departments have at least some collaborative capacity with appropriate PCCs.

Outcome measure for enhanced surveillance capacity of state and local public health agencies and public health professionals: the recipient will ensure at least 50% of state health departments have access to state-based poison center data on a near real-time basis.

Outcome measure for enhanced technical capacity of the national system of US PC data for preparedness and response activities : The recipient will ensure that the following variables will be less than 5% incomplete in records uploaded to the system during the period of performance: time, location, age, sex, call type, clinical effects, and medical outcome.

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. In addition to process measures to demonstrate the validity of the data, the recipient should routinely provide an analysis of data anomalies and evaluate surveillance data for information collection improvements.

c. Organizational Capacity of Recipients to Implement the Approach In order 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 U.S. and is expected to have existing relationships in place with PC in order to meet the requirements of this NOFO. The recipient must demonstrate membership in the Public Health and Poison Centers Collaborations Community of Practice as well as relationships with CSTE and NACCT.

d. Work Plan Period of Performance Outcome:

[from Outcomes section and/or logic model]

Outcome Measure:

[from Evaluation and Performance Measurement section]

Strategies and Process Measure Responsible Position /

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

Activities [from Evaluation and Performance Measurement section]

Party Date

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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.

DEHSP and DOP will monitor the progress of performance measures during 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.

DEHSP, DOP, and the recipient will meet annually, in person or by available technology, to review program progress, challenges, successes and next steps.

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 DEHSP scientists’ access to the national system of US PC call data DEHSP scientists will consult with the recipient when there are access issues and how to address issues with access to national PC data.

- Strategy 2: Support a team of toxicologists who review specific alerts generated by this system DEHSP will consult with the recipient on the particular criteria needed to choose the team of toxicologists. DESHP scientists will also hold monthly meetings with this team of toxicologists to provide guidance on the types of incidents that will constitute an incident of public health significance.

- Strategy 3: Maintain the technologic functioning of this system DEHSP and DOP will consult with the recipient on ways to ensure optimal technologic functioning of the system. DEHSP will hold monthly technical meetings with the recipient to ensure constant communication about the health of the system.

Additionally, DOP will consult with the recipient to develop appropriate guidance for state and local partners using PC data to monitor for anomalous drugs of abuse events and also conduct surveillance for emerging drug threats.

- Strategy 4: Collaborate with PCs and public health to identify both technical and process (e.g.

communication between partners who use the system) enhancements that would benefit local infrastructure and surveillance and to develop success stories and related dissemination products.

DEHSP and DOP will facilitate discussion with state and local partners about their needs related to surveillance and response activities for drugs of abuse using PC data and provide subject matter expertise related to national drug overdose surveillance and response activities.

- Strategy 5: Develop and implement enhancements to the system to improve public health surveillance capabilities DEHSP and DOP scientists will consult with the recipient monthly to discuss suitable enhancements to the system that would build federal, state, and local capacity for surveillance of chemical and radiologic threats and emerging drugs.

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: $1,500,000

5. Approximate Period of Performance Funding: $7,500,000

This amount is subject to the availability of funds.

Estimated Total Funding: $7,500,000

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

7. Expected Number of Awards: 1

8. Approximate Average Award: $1,500,000 Per Budget Period

9. Award Ceiling: $2,000,000 Per Budget Period

This amount is subject to the availability of funds.

10. Award Floor: $0 Per Budget Period

11. Estimated Award Date: 08/14/2020

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 American Association of Poison Control Centers (AAPCC) 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 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/

1 Data Universal Number System

(DUNS)

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

2. Select Begin DUNS search/request process

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

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

1-2 Business Days

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

2 System for Award Management

(SAM)

formerly Central Contractor Registration

(CCR)

1. Retrieve organizations DUNS number

2. Go to 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 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: 05/15/2020 , 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 May 05, 2020 3:00 - 4:00 PM Eastern Time

(855) 644-0229, (Dial-in Conference Region) Conference ID: 9827483

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 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 will apply to all applications submitted to CDC by the applicant within one year of the submission date.

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

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

When uploading supporting documentation for the Risk Questionnaire into this application 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 https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf

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…