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Centers for Disease Control and Prevention

National Center for Environmental Health

National Public Health Surveillance for Chemical and Radiologic Exposures

CDC-RFA-EH15-1506

Application Due Date: 05/29/2015

National Public Health Surveillance for Chemical and Radiologic Exposures

CDC-RFA-EH15-1506

TABLE OF CONTENTS

Part I. Overview Information

Federal Agency NameA.

Funding Opportunity TitleB.

Announcement TypeC.

Agency Funding Opportunity NumberD.

Catalog of Federal Domestic Assistance (CFDA) NumberE.

Dates F.

Executive Summary G.

Part II. Full Text

Funding Opportunity Description A.

Award Information B.

Eligibility Information C.

Required Registrations D.

Review and Selection Process E.

Award Administration Information F.

Agency Contacts G.

Other Information H.

Glossary I.

Part I. Overview Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notifications Emails" link to ensure they receive notifications of any changes to CDC-RFA-EH15-1506. 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) B. Funding Opportunity Title:

National Public Health Surveillance for Chemical and Radiologic Exposures C. Announcement Type: New - Type 1 This announcement is only for non-research domestic activities supported by CDC. If research is proposed, the application will not be considered Research for this purpose is defined at http://www.cdc. gov/od/ science / integrity/ docs/cdc- policy- distinguishing- public- health- research- nonresearch. pdf.

D. Agency Funding Opportunity Number:

CDC-RFA-EH15-1506

E. Catalog of Federal Domestic Assistance (CFDA) Number:

93.070 F. Dates:

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

2. Due Date for Applications: 05/29/2015, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

3. Date for Informational Conference Call: N/A

G. Executive Summary:

1. Summary Paragraph:

The purpose of this FOA is to facilitate the partnership between CDC/National Center for Environmental Health/Health Studies Branch (HSB) and the American Association of Poison Control Centers (AAPCC). Since 2002, HSB and AAPCC have worked together to develop, implement, and continuously improve 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. HSB's National Chemical and Radiological Surveillance Program (NCRSP) uses AAPCC's system, the National Poison Data System (NPDS) to 1) improve surveillance for toxic exposures based on data collected from US PCs; 2) identify early markers of public health emergencies so appropriate, rapid public health response can be launched; and 3) improve situational awareness about ongoing or emerging chemical or radiological exposures.

This FOA will fund several important activities including 1) providing HSB scientists access to NPDS; 2) maintaining the technologic functioning of NPDS; 3) supporting AAPCC's team of toxicologists who review specific alerts generated by NPDS; and 4) development and implementation of enhancements to NPDS to improve CDC's surveillance capabilities.

The purpose of this FOA is to provide additional information and amend the original FOA. Changes were made to sections Part 1 G.d. ( to adjust the total project period funding), Part G.e. (to adjust the average 1-year amount), Part 1 G.g (to adjust the estimated award date), and A.2.111.1. (to clarify collaborations).

The summary of specific changes can be found on page 31.

https://foa.grantsolutions.gov/announcementmodule/www.grants.gov https://foa.grantsolutions.gov/announcementmodule/www.grants.gov http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.grants.gov

a. Eligible Applicants: Single

b. FOA Type: Cooperative Agreement

c. Approximate Number of Awards: 1

d. Total Project Period Funding: $7,500,000

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

f. Number of Years of Award: 5

g. Estimated Award Date: 09/15/2015

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

Part II. Full Text A. Funding Opportunity Description

1. Background

a. Overview

Since 2002, HSB and AAPCC have worked together to develop, implement, and continuously improve a system to use data from poison centers for public health surveillance. The collaboration resulted in NPDS, which receives and compiles data from US poison centers (PCs). AAPCC wholly owns and operates the National Poison Data System (NPDS), which holds all information and exposure phone calls received by US PCs. Data collected from callers to PCs is uploaded to NPDS every 4-10 minutes, 24 hours a day. CDC/HSB’s National Chemical and Radiological Surveillance Program (NCRSP) uses AAPCC’s NPDS to conduct national surveillance for toxic exposures. It is the only source of near real-time data for toxicosurveillance in the US.

NPDS currently runs 13 national case-based surveillance definitions used to identify 59 high priority exposures and illnesses for the purpose of public health surveillance.

HSB scientists examine NPDS data anomalies to identify clusters of illness of potential public health importance and create case-based definitions during public health events to facilitate case finding. CDC works closely with AAPCC and provides both funding and guidance for system development, as well as epidemiologic and toxicologic 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 AAPCC’s Toxicology Team is on-call 24/7 to review anomalies and notify CDC if a public health threat is identified. NPDS is often the only surveillance system able to provide timely and meaningful information for emergency response and public health decision-making.

NPDS increases state and local capacity to respond to chemical, biological, and radiological incidents.

NCEH’s national state health department notification protocol 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 NPDS for agent-specific surveillance activities using state-specific PC data from their own jurisdictions. A recent survey revealed that around 80% of state health departments use poison center data for surveillance in some capacity and 95% of state health departments believe poison center data is important for public health activities.

This program facilitates the long-standing partnership and collaboration between CDC/HSB and AAPCC to maintain and enhance the National Poison Data System (NPDS) for public health surveillance. This will fund

1) maintaining the technologic functioning of NPDS; 2) providing access for HSB scientists to NPDS; 3) AAPCC’s team of toxicologists who review specific alerts generated by NPDS; and 4) enhancements to NPDS to improve CDC’s surveillance capabilities.

b. Statutory Authorities

Section 317(k)(2) of the Public Health Service Act (42 USC 247b)

c. Healthy People 2020

This program addresses the "Healthy People 2020" focus areas of Environmental Health (http://www.healthypeople.gov/2020/topicsobjectives2020/overview.aspx?topicid=12) and Public Health Infrastructure (http://www.healthypeople.gov/2020/topicsobjectives2020/overview.aspx?topicid=35) in addition to CDC's Vision of "Health Protection....Health Equity" 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 program addresses the "Healthy People 2020" focus area(s) of Environmental Health (http://www.healthypeople.gov/2020/topicsobjectives2020/overview.aspx?topicid=12) and Public Health Infrastructure (http://www.healthypeople.gov/2020/topicsobjectives2020/overview.aspx?topicid=35) in addition to CDC's Vision of "Health Protection....Health Equity" 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

NCEH/ATSDR protects people's health from environmental hazards that can be present in the air we breathe, the water we drink, and the world that sustains us. We do this by investigating the relationship between environmental factors and health, developing guidance, and building partnerships to suppport healthy decision-making. The goals and strategies outlined in the NCEH Strategic Plan are specifically supported and aligned with the work outlined in this FOA. http://www.cdc.gov/nceh/infor mation/mission_vision_goals.htm

The Pandemic and All-Hazards Preparedness Act (SB 3678) (http://www.govtrack.us/congress/bill.xpd?bill=s109-3678) amended the Public Health Service Act to improve situational awareness in public health emergencies. The Act recommended establishing near real-time electronic nationwide public health capacity for situational awareness using a network of existing systems to enhance early detection of, rapid response to, and management of public health emergencies.

The Homeland Security Presidential Directive – 21 (HSPD-21) mandates the US Department of Health and Human Services establish a nationwide biosurveillance system built upon and integrated with state and local capabilities (http://www.dhs.gov/xabout/laws/gc_1219263961449.shtm).

CDC/OPHPR’s Preparedness Objective of advance surveillance, epidemiology, and laboratory science and service practice provides direction in health monitoring and surveillance by “…Increasing surveillance… tools.”

(http://www.cdc.gov/phpr/publications/2011/A_Natl_Strategic_Plan_for_Preparedness_20110901A.pdf, p.

5).

This announcement is consistent with priorities and strategies in the Department of Health and Human Services, U.S. Environmental Protection Agency , National Aeronautics and Space Administration (http://www.cdc.gov/nceh/tracking/partners.htm), and other CDC programs including the National Asthma Control Program, the Climate and Health Program, and ATSDR's Program to Promote Localized Efforts to http://www.cdc.gov/nceh/information/mission_vision_goals.htm http://www.cdc.gov/nceh/information/mission_vision_goals.htm

Reduce Environmental Exposure (http://www.cdc.gov/nceh/tracking/related.htm). These programs address core public health areas such as environmental health, chronic disease, and health communication that contribute to prevention and health promotion efforts utilizing Tracking data.

e. Relevant Work

NCEH/HSB 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 man-made disasters. AAPCC’s NPDS is the cornerstone of HSB’s NCRSP, allowing our scientists to conduct national surveillance for and report on exposure events of potential public health significance.

Adverse effects of e-cigarette usage: E-cigarette use has increased drastically in the past 3 years and public health authorities have struggled to fully understand the scope of the problem in part due to a lack of information. NPDS identified over 1,300 e-cigarette exposures in four years (2010 to 2013). NPDS is the only system that had data – from calls to poison centers – that described e-cigarette exposures. An MMWR article was published and FDA is considering regulating sales of e-cigarettes.

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

(NACCT).

Hurricane Sandy: HSB’s NCRSP is working with PCs serving areas affected by Hurricane Sandy to examine the risk factors for and messages about carbon monoxide exposure after the storm. This information will help public health preparedness professionals improve communications about the risks of carbon monoxide poisoning.

2. CDC Project Description

a. Approach

Bold font indicates outcomes to be completed within the project period.

CDC-RFA EH15-1506 National Public Health Surveillance for Chemical and Radiologic Exposures Approach: Conduct national public health surveillance for incidents of chemical or radiological exposures using US poison center (PC) data. Facilitate communications among poison centers and State public health agencies to improve response to and preparedness for chemical/radiation events. Facilitate system and process improvements to enhance surveillance capabilities and overall functionality.

Period of Performance: Five years Inputs Strategies and

Activities Outputs Short Intermediate Long

Funding from

CDC/HHS

Conduct surveillance for chemical and radiological exposures using data from US Poison Centers (PCs)

Identification of incidents of public health significance and situational awareness during known chemical or radiation events

Increased timeliness of response to a chemical or radiological event

Increased state and local preparedness and response capacity

Decreased morbidity and mortality from chemical or radiological events of public health significance

Partners: Regional Poison Centers, American Association of Poison Control Centers, State public health agencies, Council of State and Territorial Epidemiologists, International Society for Disease Surveillance, National American Congress of Clinical Toxicology, CDC/HHS

Facilitate communication between PCs and State public health agencies

Robust and responsive surveillance system with the ability to quickly identify trends in specific data elements

Increased collaboration of PCCs, State public health agencies, healthcare systems, public health and emergency management

Enhanced technical capacity of state/local public health professionals and their jurisdictions

Data from regional PCs

Maintain current system functionality

Increased awareness of poison center activities in the public health community

Improved community resilience and response to public health emergencies and potential incidents of public health significance

Identify and implement technologic improvements to the system to enhance surveillance capabilities and overall functionality

i. Purpose

The purpose of this cooperative agreement is to facilitate public health surveillance at the national level for chemical and radiological exposures using data collected at US PCs. AAPCC toxicologists and epidemiologists collaborate with scientists at CDC’s National Center for Environmental Health’s Health Studies Branch (CDC/NCEH/HSB) to establish and maintain case-based and syndromic surveillance definitions, along with other surveillance parameters (call volume, clinical effect data, and specific substance data) to conduct near-real time public health surveillance.

ii. Outcomes

The immediate outcome of this cooperative agreement will be increased timeliness of federal and/or state response to a chemical or radiological event as a result of ongoing near-real time national surveillance and improved situational awareness. Other short-term outcomes include improved communications among CDC, state DOHs, and PCs; and increased collaboration among public health, emergency preparedness and response, and health care; and increased awareness of the public health community about poison center roles and activities during an emergency. Longer term outcomes include increased state and local preparedness and response capacity and ultimately, decreased morbidity and mortality from chemical or radiological events of public health significance.

iii. Strategies and Activities

Conduct surveillance for chemical and radiological exposures using data from US Poison Centers (PCs)

The applicant will provide NCEH/HSB scientists access to NPDS for the purposes of conducting national surveillance for chemical and radiological exposures. The applicant will maintain a toxicosurveillance team -toxicologists from member poison centers - to investigate data anomalies generated by NPDS. Investigation of these anomalies may include contacting the originating poison center 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 NCEH/HSB about incidents they identify as public health significance.

Identify early markers of a larger public health threat (sentinel event surveillance)

The applicant will provide NCEH/HSB scientists access to NPDS for the purposes of identifying early markers of a larger public health threat (sentinel event surveillance). The applicant 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 2 hours, the toxicosurveillance team will make a determination of whether a case-based data anomaly indicates an exposure of public health significance and notify NCEH/HSB.

Situational awareness (surveillance after a known event)

The applicant will provide NCEH/HSB scientists access to NPDS for the purpose of increasing situational awareness about known public health emergencies, and for identifying emerging public health threats that are not detected by the methods described in strategies 1 and 2.

Known public health emergencies: Poison centers receive calls during almost any type of public health emergency. Situational awareness activities (identification of relevant cases, aggregation and analysis of related case records, and prompt dissemination of information for public health action) conducted by NCEH/HSB with assistance by the applicant through access of near real-time data provide a timely snapshot of the types of exposures and the severity of exposures in the affected area, demographics of the impacted population, and can help target communications to the public. During the response phase of a public health emergency, the applicant will create ad-hoc temporary codes to be used by PCs in order to ensure that calls related to the public health emergency are captured and are easily identified by that code.

Emerging public health threats: The applicant will provide NCEH/HSB scientists access to NPDS for the purpose of monitoring exposure trends (e.g., number of cases, number of calls, geographic area, demographics of cases). Poison centers receive calls about exposures to products and substances. Data from these calls may identify new dangers not yet in the purview of public health. For example, analysis of data in NPDS helped identify risks associated with exposure to laundry pods and to electronic cigarettes.

Once a specific substance or product is identified as an exposure of interest, the applicant will create ad-hoc temporary codes to be used by PCs in order to ensure that calls related to the product or substance are captured and are easily identified by that code.

Facilitate communication between PCs and State Public Health Agencies

Participate in the CDC-led Poison Center and Public Health Collaborations Community of Practice (CoP)

Promote and encourage PC participation in and contribution to regular meetings and information exchanges of the PC/DOH CoP.

Present success stories about CDC/applicant collaboration; in particular, successes related to specific poison centers (e.g., Hurricane Sandy, e-cigarette), to exemplify value of poison center data for surveillance.

Maintain current system functionality

Ensure continual operation and functionality of NPDS by maintaining information technology and toxicology capabilities.

Identify and implement technologic improvements to the system to enhance surveillance capabilities and overall functionality

The applicant will make improvements to NPDS in order to maintain the system’s utility for national public health surveillance. These improvements may include but are not limited to:

Technical: the data collection, transmission, and analysis that occur in the background of NPDS Surveillance: the surveillance methodologies and case-definitions used to identify data anomalies Data quality: the consistency and reliability of information collected by PCs

The applicant will conduct monthly meetings (one technical call, one surveillance call) with NCEH/HSB to discuss potential improvements to the system. These suggested improvements will also inform NCEH/HSB of future funding initiatives. The applicant leadership will meet monthly by teleconference with NCEH/HSB 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 CDC-funded programs:

There are no required collaborations. The applicant is encouraged to continue working with current CDC programs (e.g. NCEZID's Flu on Call, NCEH's Public Health Tracking Network) to the extent possible.

b. With organizations external to CDC:

Collaboration with the Council of State and Territorial Epidemiologists, the International Society for Disease Surveillance, and the National American Congress of Clinical Toxicology is highly recommended (but considered optional) as a part of the work highlighted in this FOA.

2. Target Populations

US population-anyone who calls a poison control center in the United States.

a. Inclusion

Not applicable

iv. Funding Strategy (for multi-component FOAs only)

Not applicable

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

Strategy 1: Conduct national surveillance (routine surveillance)

NCEH/HSB/NCRSP scientists are able to access NPDS daily.

The applicant's toxicosurveillance team follows up data anomalies within 48 hours of detection.

Strategy 2: Identify early markers of a larger public health threat (sentinel event surveillance)

NCEH/HSB/NCRSP scientists are able to access NPDS daily.

The applicant's toxicosurveillance team follows up high-priority data anomalies within 2 hours of detection.

Strategy 3: Situational awareness

NCEH/HSB/NCRSP scientists are able to access NPDS daily.

Create ad-hoc temporary codes when determined necessary

Strategy 4: Improvements to NPDS for public health surveillance

Gather requirements for technical improvements within 1 year of identifying the improvement.

Implement improvements to surveillance definitions within 6 months of identifying the improvement.

To conduct the strategies, the applicant and NCEH/HSB use data regularly collected by poison centers and uploaded into NPDS. Data collection methods are in place and routinely used by poison centers.

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

ii. Applicant Evaluation and Performance Measurement Plan

The applicant 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 applicant should routinely provide an analysis of data anomalies and evaluate surveillance data for information collection improvements.

c. Organizational Capacity of Awardees to Execute the Approach

In order to implement the activities described in the FOA, a certain level of organizational capacity is required. The organization 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 organization must demonstrate relevant experience and capacity (management, administrative, and technical) to implement the activities and achieve the project outcomes. The applicant must have access to poison control center data across the US and is expected to have existing relationships in place with poison control centers in order to meet the requirements of this FOA. The applicant must demonstrate membership in the Public Health and Poison Centers Collaborations for Surveillance Community of Practice as well as relationships with CSTE, ISDS and

NACCT.

d. Work Plan

Project Period Outcome: Increased state and local preparedness and response capacity

Outcome Measure: Identification of incidents of public health significance.

Outcome Measure: ability to quickly identify trends in specific data elements.

Strategies/Activities Process Measure: NCEH/HSB/NCRSP scientists are able to access NPDS data daily.

Increased collaboration of PCCs, State public health agencies, CDC/HHS

Process Measure: AAPCC toxicosurveillance team follows up data anomalies within 48 hours of detection.

Improvements to NPDS for public health surveillance

Process Measure: Requirements for technical improvements are developed within one year of identification of needed technical improvement.

Outcome Measure: Implement improvements to surveillance definition within 6 months of identification of needed improvement.

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and awardees, site visits, and awardee 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 awardee progress in achieving the desired outcomes.

Ensuring the adequacy of awardee 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:

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

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

Working with awardees 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.

Other activities deemed necessary to monitor the award, if applicable.

These activities may include 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 grantees.

NCEH/HSB 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 AAPCC is performing at a level sufficient to achieve outcomes within stated timeframes, and to adjust the work plan based on achievement of outcomes, evaluation results and changing budgets.

NCEH/HSB and AAPCC staff will meet annually, in person or by conference call or webinar, to review program progress, challenges, success, and next steps.

AAPCC will submit a mid-year and final report summarizing work performed for each strategy and whether and how performance measures were met.

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

AGREEMENTS)

AAPCC’s NPDS is the cornerstone of CDC/NCEH/HSB’s National Chemical and Radiological Surveillance Program (NCRSP), using the system to conduct public health surveillance for chemical and radiological exposures. CDC/NCEH/HSB will provide AAPCC with expertise in surveillance, epidemiology, and general public health. NCEH/HSB’s contributions to each strategy are shown below.

Strategy 1: Conduct national surveillance (routine surveillance)

Scientists at CDC/HSB’s NCRSP will be notified by AAPCC’s toxicosurveillance team about anomalies in call volume or clinical effects data that may indicate an incident of public health significance. Upon access to the case information via NPDS and review of the information collected by the toxicosurveillance team, HSB scientists will decide whether to contact the poison center where the data originated along with the state epidemiologist to ensure they are aware of the incident and to enhance situational awareness about the incident. NCEH/HSB will access NPDS to analyze data related to exposures of interest, and evaluate the public health importance of the incident to make a determination whether to notify the appropriate state epidemiologist of the incident.

Strategy 2: Identify early markers of a larger public health threat (sentinel event surveillance)

Scientists at CDC/HSB’s NCRSP will be notified by AAPCC’s toxicosurveillance team about anomalies in case-based definitions. Upon access to the case information via NPDS and review of the information collected by the toxicosurveillance team, HSB scientists will decide whether to contact the poison center where the data originated along with the state epidemiologist to ensure they are aware of the incident and to enhance situational awareness about the incident. NCEH/HSB will access the system to analyze data related to exposures of interest, evaluate the public health importance of the incident to make a determination whether to notify the appropriate state epidemiologist of the incident.

Strategy 3: Situational awareness – acute events and emerging threats

Known public health emergencies: In the event of a public health emergency (an acute event such as a hurricane, chemical spill, detonation of an improvised nuclear device), scientists at CDC/HSB’s NCRSP will use NPDS to review data from callers in the affected geographic region to obtain critical information and increase CDC’s situational awareness; that is, CDC’s understanding and knowledge about the scope and extent of the impact of the event.

CDC/HSB/NCRSP epidemiologists will aggregate data from calls related to the event, analyze it, and disseminate results to stakeholders (e.g., federal, state and local public health and emergency response teams; poison centers).

Emerging public health threats: For public health issues that are more slowly evolving (such as illnesses from exposure to contaminated dietary supplements, illness and death from using tainted recreational drugs), scientists at NCEH/HSB’s NCRSP will use NPDS to identify a previously unknown threat, and to monitor trends in data variables such as number of cases, number of calls, geographic area, demographics of cases.

NCEH/HSB/NCRSP epidemiologists will aggregate data from calls about the exposure of interest, analyze it, and disseminate results to stakeholders (e.g., federal, state and local public health and emergency response teams; poison centers).

Strategy 4: Improvements to NPDS for public health surveillance

CDC/NCEH/HSB will evaluate the quality of NPDS data for surveillance purposes.

Epidemiologists and toxicologists at NCEH/HSB NCRSP will make recommendations to AAPCC for technical, surveillance, data quality improvements during regularly scheduled topic-specific conference calls.

Additional Support:

NCEH/HSB scientists will facilitate communication and collaborations between state health departments and regional poison centers through the "Poison Center and Public Health Collaborations Community of Practice", led and managed by HSB's National Chemical and Radiation Surveillance Program (NCRSP).

B. Award Information

1. Funding Instrument Type: Cooperative Agreement CDC's substantial involvement in this program appears in the

CDC Program Support to Awardees Section.

2. Award Mechanism:

3. Fiscal Year: 2015 Estimated Total Funding: $1,500,000

4. Approximate Total Fiscal Year Funding: $1,500,000

5. Approximate Project Period Funding: $7,500,000

6. Total Project Period Length: 5 year(s)

7. Expected Number of Awards: 1

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

9. Award Ceiling: $1,500,000 Per Budget Period

10. Award Floor: $1,000,000 Per Budget Period

11. Estimated Award Date: 09/15/2015 Throughout the project period, CDC will continue the award based on the availability of funds, the evidence

Throughout the project period, CDC will continue the award based on the availability of funds, the evidence of satisfactory progress by the awardee (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 project period comprises the initial competitive segment and any subsequent non-competitive continuation award(s).

12. Budget Period Length: 12 month(s)

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

C. Eligibility Information

1. Eligible Applicants Eligibility Category: Others (see text field entitled "Additional Information on Eligibility" for clarification)

2. Additional Information on Eligibility

This is a single eligibility FOA. Single Source Award: American Association for Poison Control Centers

(AAPCC)

The award ceiling for this FOA is $1,500,000. CDC will consider any application requesting an award higher than this amount as non- responsive and it will receive no further review. If a pre-application is required, then specify here and include it in the special eligibility requirements section. (http:// www.hhs.gov/ asfr/ ogapa/ aboutog/ hhsgps107.pdf)

3. Justification for Less than Maximum Competition

AAPCC is the sole source for data collected by US poison centers from callers to their centers reporting potentially harmful exposures. Data from these calls is entered into the poison center systems, and uploaded regularly from the poison centers to the National Poison Data System (NPDS). AAPCC wholly owns and operates NPDS, and poison centers own the data they collect and upload to that system. No other organization has access to data collected by US poison centers, entered into a single data system, with the flexibility to analyze both standardized case definitions and other established analytical protocols and specific data variables as needed. AAPCC is the only organization that receives and manages data collected by national poison centers.

Poison center data is the cornerstone of NCEH/Health Studies Branch's National Chemical and Radiation Surveillance Program (NCRSP). Data from poison centers uploaded to NPDS allows CDC/NCEH/HSB to conduct surveillance for harmful exposures and adverse health effects on a national basis. NCRSP and AAPCC staff use data in NPDS to: 1) improve surveillance for toxic exposures based on data collected from US PCs; 2) identify early markers of public health emergencies so appropriate, rapid public health response can be launched; and 3) improve situational awareness about ongoing or emerging chemical or radiological exposures. Without access to NPDS and poison center data, this critical national surveillance capacity would be lost.

AAPCC and CDC/NCEH/HSB have been working together since 2002 to effectively use poison center data to conduct national surveillance for chemical and radiological exposures, using single eligibility/sole-source contract and cooperative agreement mechanisms.

4. Cost Sharing or Matching http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

Cost Sharing / Matching Requirement:

No

Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this FOA 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 FOA.

D. Required Registrations

Additional materials that may be helpful to applicants: http://www.cdc.gov/od/pgo/funding/docs/Financial ReferenceGuide.pdf.

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-awardees, those sub-awardees 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 an awardee. 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 usually requires not more than five business days, and registration must be renewed annually. Additional information about registration procedures may be found at www.SAM.gov.

c. Grants.gov: The first step in submitting an application online is registering your organization through www.grants.gov, the official HHS E-grant website. Registration information is located at the "Get Registered" option at www.grants.gov.

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

2. Request Application Package Applicants may access the application package at www.grants.gov.

3. Application Package http://www.cdc.gov/od/pgo/funding/docs/FinancialReferenceGuide.pdf http://www.cdc.gov/od/pgo/funding/docs/FinancialReferenceGuide.pdf http://www.grants.gov http://fedgov.dnb.com/webform/displayHomePage.do https://www.SAM.gov http://www.Grants.gov http://www.grants.gov http://www.grants.gov

3. Application Package Applicants must download the SF-424, Application for Federal Assistance, package associated with this funding opportunity at www.grants.gov. If Internet access is not available, or if the online forms cannot be accessed, applicants may call the CDC PGO staff at 770-488-2700 or e-mail PGO PGOTIM@cdc.gov for assistance. Persons with hearing loss may access CDC telecommunications at TTY 1-888-232-6348.

4. Submission Dates and Times If the application is not submitted by the deadline published in the FOA, it will not be processed. PGO 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 PGO.

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

b. Application Deadline Due Date for Applications: 05/29/2015, 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.

5. CDC Assurances and Certifications All applicants are required to sign and submit “Assurances and Certifications” documents indicated at http://www.cdc.gov/grants/interestedinapplying/applicationprocess.html.

Complete the applicable assurances and certifications on an annual basis, name the file “Assurances and Certifications” and upload it as a PDF file 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.

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

A Letter of Intent is not requested or required as part of the application for this FOA.

8. Table of Contents (No page limit and not included in Project Narrative 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 http://www.grants.gov https://foa.grantsolutions.gov/announcementmodule/PGOTIM@cdc.gov%20 http://www.grants.gov http://www.cdc.gov/grants/interestedinapplying/applicationprocess.html http://www.grants.gov/ http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://www.grants.gov http://www.grants.gov enter the summary in the "Project Abstract Summary" text box at www.grants.gov.

10. Project Narrative (Maximum of 20 pages, single spaced, Calibri 12 point, 1-inch margins, number all pages. Content beyond 20 pages will not be considered. The 20 page limit includes the work plan. For a multi-component FOA, maximum page limit is 25.)

The Project Narrative must include all of the bolded headings shown in this section. 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 project period as identified in the CDC Project Description section. Applicants must submit a Project Narrative with the application forms. Applicants must name this file “Project Narrative” and upload it at www.grants.gov.

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

b. Approach

i. Purpose Applicants must describe in 2-3 sentences specifically how their application will address the 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.

Outcomes are the results that the program intends to achieve. All outcomes must indicate the intended direction of change (e.g., increase, decrease, maintain). (See the logic model in the Approach section of the CDC Project Description.)

iii. Strategies and Activities Applicants must provide a clear and concise description of the strategies and activities they will use to achieve the project period 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 CDC Project Description: Strategies and Activities section.)

1. Collaborations Applicants must describe how they will collaborate with programs and organizations either internal or external to CDC.

There are no required collaborations. The applicant is encouraged to continue working with current CDC programs (e.g. NCEZID's Flu on Call, NCEH's Public Health Tracking Network) to the extent possible.

2. Target Populations 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. Refer back to the CDC Project Description section – Approach: Target Population.

c. Applicant Evaluation and Performance Measurement Plan

c. Applicant Evaluation and Performance Measurement Plan Applicants must provide an overall evaluation and performance measurement plan that is consistent with the CDC Evaluation and Performance Measurement Strategy section of the CDC Project Description of this FOA. Data collected must be used for ongoing monitoring of the award to evaluate its effectiveness, and for continuous program improvement.

The plan must:

Affirm the ability to collect the performance measures and respond to the evaluation questions specified in the CDC strategy. (For guidance regarding the Paperwork Reduction Act, please visit http://www.hhs.gov/ocio/policy/collection/infocollectfaq.html) Describe how key program partners will participate in the evaluation and performance measurement planning processes.

Describe how evaluation findings will be used for continuous program quality improvement.

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

Describe the type of evaluation(s) (i.e., process, outcome, or both) to be conducted.

Describe key evaluation questions to be addressed by these evaluations.

Describe other information relevant to the evaluation (e.g., measures, data sources)

Awardees will be required to submit a more detailed evaluation and performance measurement plan within the first 6 months of the project, as outlined in the reporting section of the FOA.

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

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

11. Work Plan (Included in the Project Narrative’s 20 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 awardee plans to carry out achieving the project period outcomes, strategies and activities, evaluation and performance measurement.

Applicants must name this file "Work Plan" and upload it as a PDF file at www.grants.gov.

Applicant must address the organizational capacity requirements as described in the CDC Project Description.

12. Budget Narrative Applicants must submit an itemized budget narrative, which may be scored as part of the Organizational Capacity of Awardees to Execute the Approach. When developing the budget narrative, applicants must consider whether the proposed budget is reasonable and consistent with the purpose, outcomes, and program strategy outlined in the project narrative. The budget must include:

Salaries and wages Fringe benefits Consultant costs Equipment Supplies Travel Other categories Contractual costs http://www.hhs.gov/ocio/policy/collection/infocollectfaq.html

Total Direct costs Total Indirect costs

Indirect costs will not be reimbursed under grants to foreign organizations, international organizations, and foreign components of grants to domestic organizations (does not affect indirect cost reimbursement to the domestic entity for domestic activities). The CDC will not reimburse indirect costs unless the recipient has an indirect cost rate covering the applicable activities and period.

For guidance on completing a detailed budget, see Budget Preparation Guidelines at:http://www.cdc.gov/grants/interestedinapplying/applicationresources.html .

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 FOA 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…

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