CDC-RFA-EH17-1704.pdf

Centers for Disease Control

National Center for Environmental Health

Lead Exposure Registry of Flint Residents - Michigan

CDC-RFA-EH17-1704

Application Due Date: 06/28/2017

CDC-RFA-EH17-1704

TABLE OF CONTENTS

Part I. Overview Information A. Federal Agency Name B. Funding Opportunity Title C. Announcement Type D. Agency Funding Opportunity Number E. Catalog of Federal Domestic Assistance (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 "Send Me Change Notifications Emails" link to ensure they receive notifications of any changes to CDC-RFA-EH17-1704. 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. Funding Opportunity Title:

Lead Exposure Registry of Flint Residents - Michigan 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 http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-healt h-research-nonresearch.pdf.

D. Agency Funding Opportunity Number:

CDC-RFA-EH17-1704

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

93.197 F. Dates:

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

2. Due Date for Applications: 06/28/2017, 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 Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2017 funds of approximately $3.6 million to support the City of Flint, MI, and the State of Michigan to build their capacity to: 1) identify communication and training strategies for a registry of residents exposed to lead-contaminated water from the Flint Water System (FWS) during April 25, 2014–October 15, 2015; 2) develop the registry to identify eligible residents; 3) recruit and enroll eligible residents, collect their baseline information, and refer them to services; 4) ensure a referral process to link registrants to comprehensive, coordinated services to mitigate the effects of lead exposure; and 5) select appropriate measures and frequency of follow-up to collect data on exposure, health, and developmental milestones along with choices of interventions, services, and enrichment activities undertaken during the project period.

To maximize the public health benefit to the residents of the City of Flint, MI, the CDC 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 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 https://www.grants.gov recommends that the registry be designed to examine whether registrants’ choice of referred interventions might be related to better health outcomes and developmental milestones. The registry design should enable important policy and administrative decisions and recommendations for the City of Flint and for the State of Michigan.

a. Eligible Applicants: Single

b. FOA Type: Grant

c. Approximate Number of Awards: 1

d. Total Project Period Funding: $14,400,000

e. Average One Year Award Amount: $3,600,000

f. Total Project Period Length: 4

g. Estimated Award Date: 08/01/2017

h. Cost Sharing and / or Matching Requirements: N Cost sharing or matching funds are not required for this program.

Part II. Full Text A. Funding Opportunity Description

Part II. Full Text

1. Background

a. Overview During April 25, 2014–October 15, 2015, approximately 99,000 residents of the City of Flint, MI, were exposed to lead when the water source was switched from the Detroit Water Authority to the FWS. Because the FWS did not use corrosion control, the lead levels in Flint tap water increased above the EPA action level of 15 ppb as required by the Lead and Copper Rule. In children, lead exposure can result in serious effects on cognitive and physiological development.

Lead can reduce kidney function and increase risk of hypertension and essential tremor among adults. Data from the Michigan Department of Health and Human Services showed an increase in blood lead levels ≥5 µg/dL (CDC reference value) among Flint children, under 5 years of age, after the source water change. Support is needed to assist the City of Flint and the State of Michigan to build their capacity to establish a public health registry.

The Centers for Disease Control and Prevention (CDC) announces the availability of FY2017 funds of approximately $3.6 million to support the City of Flint, MI, and the State of Michigan to build their capacity to: 1) identify communication and training strategies for a registry of residents exposed to lead-contaminated water from the Flint River during April 25, 2014– October 15, 2015; 2) develop the registry to identify eligible residents; 3) recruit and enroll eligible residents, collect their baseline information, and refer them to services; 4) ensure a referral process to link registrants to comprehensive, coordinated services to mitigate the effects of lead exposure; and 5) select appropriate measures and frequency of follow-up to collect data on exposure, health, and developmental milestones along with choices of interventions, services, and enrichment activities undertaken during the 4 year project period.

This grant requires close collaboration with community leaders, clinical partners and educators, stakeholders, and various entities that serve Flint residents. The applicant, with the network of collaborators, should strive for timely registry planning and development; accurate registrant identification and enrollment; appropriate referral to services; and the collection of both baseline and follow-up information from registrants. Although this NOFO is not intended to fund case-management services for registrants, the applicant should design, establish, and manage a public health registry that links registrants’ data about exposure, health, and developmental milestones with their participation in intervention activities and services through a voluntary referral network of external collaborators. This joint effort of shared state and community resources should provide evidence of outcomes for registrants who choose interventions through available health, educational, environmental, and community services for Flint residents.

This non-research NOFO supports state and local capacity to establish a registry to prevent or control disease or injury resulting from exposure to the lead-contaminated FWS. This registry should be used for quality improvement of state and local public health programs and services for residents with lead exposure. Generally, the results and accomplishments from federally-funded grants should be made available to the public. Thus, the ideal applicant should implement a data management plan (DMP) to maximize the utility of the registry data to inform policy and administrative decisions for the benefit of Flint residents and the State of Michigan.

b. Statutory Authorities This program is authorized under Section 2203(b) of Public Law 114-322, the Water Infrastructure Improvements for the Nation (WIIN) Act of 2016; 42 U.S.C. Section 300j-27(b).

c. Healthy People 2020 The CDC is committed to achieving the objectives of “Healthy People 2020” found at https ://www.healthypeople.gov/. This NOFO is committed to the Healthy People 2020 lead-related goals of reducing: 1) blood lead levels in children aged 1-5 years; 2) mean blood lead levels in children; 3) exposure to lead in the population as measured by blood and urine concentrations;

and 4) the proportion of persons who have elevated blood lead concentrations from work exposures. This NOFO also addresses the Healthy People 2020 focus areas of Maternal, Infant, and Child Health.

d. Other National Public Health Priorities and Strategies The President’s Task Force on Environmental Health Risks and Safety Risks to Children reports on “Key Federal Programs to Reduce Childhood Lead Exposures and Eliminate Associated Health Impacts” and “Eliminating Childhood Lead Poisoning: A Federal Strategy Targeting Lead Paint Hazards.” See https:// ptfceh.niehs.nih.gov/ features/ featured-resource/index.htm.

The Occupational Safety and Health Administration (OSHA) Directive No. CPL 03-00-009:

National Emphasis Program (NEP) on Lead. See https:// www.osha.gov/ ;OshDoc/ Directive_pdf https://www.healthypeople.gov/ https://www.healthypeople.gov/ https://ptfceh.niehs.nih.gov/features/featured-resource/index.htm https://www.osha.gov/OshDoc/Directive_pdf/CPL_03-00-0009.pdf

/ CPL_03-00-0009.pdf.

e. Relevant Work On December 14, 2015, lead contamination in the FWS was declared a state of emergency. By January 2016, CDC, led by the Department of Health and Human Services, assisted the City of Flint and the State of Michigan to develop a response and recovery plan. The CDC Emergency Operation Center was activated from February 1, 2016 to March 11, 2016, to coordinate the 2016 Flint Water Contamination Response.

At CDC, NCEH funds 35 childhood lead poisoning prevention programs under NOFO No.

CDC-RFA-EH14-1408PPHF14, and the National Institute for Occupational Safety and Health (NIOSH) Adult Lead Epidemiology and Surveillance (ABLES) Program partners with 28 states.

2. CDC Project Description

a. Approach

Bold indicates project period outcome.

The overall NOFO approach is depicted in the following “high-level” logic model, which is elaborated in the sections that follow. A graphic of the full logic model is available in the supporting documents.

CDC-RFA-EH17-1704

https://www.osha.gov/OshDoc/Directive_pdf/CPL_03-00-0009.pdf

i. Purpose

The purpose of the NOFO is to build local and state capacity to establish a public health registry for residents who were exposed to lead-contaminated water from the FWS during April 25, 2014–October 15, 2015. The registry should include community, tribal, and stakeholder outreach and training; registrant enrollment and baseline data collection; referral of registrants to services to reduce or control lead exposure effects; measurement of registrants’ exposure, health, and developmental milestones with their interventions, services, and enrichment activities.

ii. Outcomes

The awardee is expected to achieve the following short-term and intermediate outcomes during the project period:

Short-Term Outcomes Intermediate Outcomes

Community and Providers have:

Increased awareness of registry goals and scope

Increased awareness of eligibility criteria for registry

Community, Providers, and Workforce have increased knowledge of:

Adverse health and developmental outcomes from lead exposure

Blood lead testing and reporting requirements

Medical management recommendations Environmental lead exposure sources and reduction methods Modifiable factors for lead exposure reduction Available preventive referral services and interventions to reduce the impact of lead exposure

Registry Protocol enables metrics for:

Increased registrant referral to services over baseline

Target number of registry follow-ups achieved per registrant

Registrants:

Use preventive services Reduce environmental lead exposures where they live, work, and play Have lower blood lead levels Have better health and fewer developmental delays

Registry data collection leads to:

Increased quality and quantity of data to inform lead poisoning prevention policy and program administration

Increased knowledge about the effectiveness of the number of prevention services leading to improved outcomes

Increased knowledge about the effectiveness of different types of prevention services leading to improved outcomes

Increased knowledge about acute and long-term impacts of lead exposure

iii. Strategies and Activities This NOFO supports the following strategies and activities during this four-year program period.

Strategy 1 - Identify communication and training strategies for a registry of residents exposed to lead-contaminated water from the FWS during April 25, 2014–October 15, 2015.

Engaging the public, partners, and stakeholders about lead-related issues will be a key strategy to maximize the public’s interest, to promote the registry, and to serve the needs of the registrants.

The strategies used by the awardee should be culturally appropriate and include an understanding of the unique demographics and the anticipated challenges of recruiting from targeted Flint neighborhoods and from applicable tribes and tribal members, and the establishment of a community advisory board early in the registry development process. Strategies should also include a commitment to utilize established community social networks and trusted intermediaries to build community, tribal, and audience trust in the registry process.

Techniques such as audience segmentation and social marketing strategies may be used to reach key audiences such as the residents of Flint, including tribal members; health care, educational, and other providers of referral services; the lead prevention workforce; community and agency partners, tribal leaders and tribal public health organizations, and other stakeholders. A robust community outreach plan may use the many communication channels currently available.

Effective strategies may also include organizing regular meetings with partners, tribes, stakeholders, and programs (e.g., early childhood education programs, social services, school systems, tribal public health organizations, etc.) that provide services to mitigate the effects of high blood lead levels.

Effective health education and training among partners and public health professionals is another key to link lead-exposed residents to recommended services. Professional education and training will enhance the provision of state and local technical support and subject matter expertise to systems that identify, refer, provide services to, and follow lead-exposed residents.

Strategy 2 - Develop the registry to identify eligible residents.

The awardee is responsible for developing a registry protocol specifying the methods and materials including strategies, activities, and timeline for the registry and the eligibility criteria for registrants, including potentially affected tribal members.

In developing the registry protocol, the awardee is encouraged to apply the key principles of registry design, operation, and evaluation; and to address common challenges encountered in registry implementation. An example of structured guidelines and recommendations are available in the Agency for Healthcare Research and Quality (AHRQ) “Registries for Evaluating Patient Outcomes: A User's Guide (3rd Edition)” (see general guidelines in the full report at https :// www.ncbi.nlm.nih.gov/ books/NBK208616/ and specific guidelines in Chapter 22 “Quality Improvement Registries” at https:// ;www.ncbi.nlm.nih.gov/ books/ NBK208630/). The awardee is also encouraged to consider principles of a primary, secondary, or tertiary prevention models in the registry framework, activities, and metrics to assess the impact of registry activities at the individual registrant level and at the population level.

The awardee should ensure the protocol adheres to all federal, state, tribal, and local data security and privacy protection requirements; and ensure it complies with State of Michigan, tribal, and https://www.ncbi.nlm.nih.gov/books/NBK208616/ https://www.ncbi.nlm.nih.gov/books/NBK208616/ https://www.ncbi.nlm.nih.gov/books/NBK208630/ local laws for lead poisoning prevention. The protocol should also describe how and by whom hardcopy and electronic registry records for community and tribal members will be collected, stored, and transmitted.

Prior to implementation, the awardee should have the registry protocol, data collection tools, consent forms, data quality management plan, data security plan, and data management plan finalized and approved by required state, tribal, and local authorities. It is recommended that the protocol clearly list all investigators, their institutions, and their roles and responsibilities, and describe the key partnerships required to implement this registry through the community advisory board and through the referral network and its shared resources.

This activity is funded under a non-research grant; therefore, research activities must not be proposed under this NOFO. The awardee must be aware of and commit to prepare and implement a DMP according to CDC requirements and to describe how and with whom the data will or may be shared. The awardee may choose to allow information from this non-research registry to be used for research by requesters as an additional way to maximize the utility of the registry data in the future. If so, the awardee’s consent forms and DMP should reflect this long-term goal beyond the program period.

Strategy 3 - Recruit and enroll eligible residents, collect their baseline information, and refer them to services.

Collection of pertinent registrant information is necessary to accomplish the goals of the registry.

The awardee should develop data collection tools that align with the stated goals of the protocol.

At enrollment, it is recommended that baseline information be used to establish the registrant’s demographics, exposure metrics, health and developmental milestones, housing characteristics, occupational exposures, and other co-factors for lead exposure. Accurate baseline information about the registrants’ access to and use of services and diagnosed conditions prior to joining the registry will be needed to track the impact of their referral services sought before and after enrollment and to properly identify registrants who are in need of additional types or increased frequency of select interventions after baseline.

Strategy 4 - Ensure a referral process to link registrants to comprehensive, coordinated services to mitigate the effects of lead exposure.

In a quality improvement registry framework, the awardee should establish the referral network as a vital component of the registry protocol. Active partnership, in the form of support and subject matter expertise, may be the key to including all systems and programs that identify, refer, provide services to, and follow lead-exposed residents. The collaboration with partners, stakeholders, and programs (e.g., early childhood education programs, social services, school systems, etc.) is important to establish because they may provide services to families and households that need to mitigate the effects of high blood lead levels. These partners may be involved in conducting education and outreach to parents and providers of eligible lead-exposed residents.

Along with the provision of services to the registrant, the referral network will be a key source of data about the type of services, about the frequency of service visits, and about changes in health conditions or developmental milestones achieved for each registrant. The referral network should be aware of and agree whether, or under what conditions, their network data linked to the registrant’s records may be shared with key partners to inform policy and administrative decisions, released to the public, or potentially released to researchers in the future. Plans for data release or sharing, including that from the referral network, should be described in the awardee DMP. The CDC is not endorsing any particular mitigation service or providing entity that may be made available to the registrant.

Strategy 5 - Select appropriate measures and frequency of follow-up to collect data on exposure, health, and developmental milestones along with choices of interventions, services, and enrichment activities undertaken during the project period.

The registry protocol should include methods for follow-up data collection from each registrant.

Follow-ups are important as results from early vs. later interventions after exposure, or after exposure mitigation, may demonstrate how type of, timing of, and frequency of services result in measurable improvements in health and developmental outcomes.

Data collections in this registry should be designed to inform ways to improve state and local public health programs and referral services for these residents with lead exposure. Therefore, careful consideration of measures of registrants’ exposure, health, and developmental milestones is recommended. In addition, measures of registrants’ choices of intervention activities and services through the established referral network should be carefully considered. A careful choice of measures of the impact of services on registrants’ outcomes will make registry data highly useful to inform policy and administrative decisions for the City of Flint, MI, and the State of Michigan.

1. Collaborations

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

The applicant should engage other CDC-funded programs in its jurisdiction, particularly those with a focus on child health and/or environmental health; and leverage opportunities to reach targeted populations, share databases, deliver services, and achieve outcomes expected under this NOFO. Examples of other CDC-funded programs include, but are not limited to:

Healthy Homes and Lead Poisoning Prevention Program https://www.cdc.gov/ nceh/ information/ healthy_homes_lead.htm

Environmental Public Health Tracking Program http://www.cdc.gov/ nceh/ tracking/ National Center for Birth Defects and Developmental Disabilities (NCBDDD) programs and registries National Institute of Occupational Safety and Health’s Adult Blood Lead Epidemiology

Program (ABLES) https://www.cdc.gov/ niosh/ topics/ ;ables/ Pediatric Environmental Health Specialty Unit (PEHSU) State and local immunization programs and registries

b. With organizations not funded by CDC:

The applicant should work with relevant organizations external to CDC that could extend its reach to targeted populations, interface with other databases, and help facilitate activities under this NOFO. Letters of support, memorandums of understanding (MOU), and memorandums of agreement (MOA) stating agreed upon area of collaboration from state relevant officials and others should be included in the application.

https://www.cdc.gov/nceh/information/healthy_homes_lead.htm https://www.cdc.gov/nceh/information/healthy_homes_lead.htm http://www.cdc.gov/nceh/tracking/ https://www.cdc.gov/niosh/topics/ables/

Examples of such organizations are:

Agency for Healthcare Research and Quality (AHRQ) Local health departments Michigan Department of Health and Human Services Centers for Medicare and Medicaid Services (CMS) Special Supplemental Nutrition Program for Women, Infants and Children (WIC) Environmental Protection Agency (EPA) Health Resources and Services Administration (HRSA) Title V grantees HRSA Federal Home Visiting Program Healthy Start Association Maternal and child health programs State of Michigan Department of Education Academic institutions Community-based, nonprofit and/or faith-based organizations community organizations State and local health and housing agencies Private and public laboratories Hospitals and healthcare systems Indian Health Service (IHS) Tribes and tribal groups located in Michigan (e.g., Little River Band of Ottawa Indians) Tribal organizations (e.g., Inter-Tribal Council of Michigan, National Indian Health

Board, or others) Flint Kids – The Community Foundation of Greater Flint Ruth Mott Foundation C.S. Mott Foundation Community Education Initiative Tides Foundation (Justice for Flint) Michigan Health Endowment Fund Community Foundation of Greater Flint Great Lake Health Connect Flint Now Foundation Annenberg Foundation American Association of Pediatrics Michigan Chapter National Basketball Players Association Michigan Fitness Foundation Robert Wood Johnson Foundation Hagerman Foundation

Strategies should be implemented for leveraging resources that include funds from other allowable federally funded programs and/or state, local, charity, nonprofit or for-profit entities, or internal agency resources. The applicant is expected to partner with a referral network of national, state, or local systems and programs that identify, refer, provide services to, and follow lead-exposed residents. The partnership is important because the referral network provides services to families and households that need to mitigate the effects of lead exposure to contaminated water from the FWS.

The applicant is expected to create a capacity-building mechanism, with partners, that will provide training, education, technical support, mobilization, and consensus to improve the Flint community’s ability to detect lead sources and identify risks and provide appropriate and timely interventions.

2. Target Populations The target population for this program is residents of the City of Flint, MI, who were exposed to lead-contaminated water from the Flint Water System (FWS) during the period April 25, 2014– October 15, 2015. Eligible residents may include Native Americans who are citizens of sovereign tribes.

a. Health Disparities The applicant should consider underserved populations, including tribal, disabled, and English speakers of other languages (ESOL), as well as other populations that may experience disparities in blood lead levels based on age, race, ethnicity and gender to ensure they benefit from the applicant’s activities.

iv. Funding Strategy

NA

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy This section provides measures CDC will use to monitor awardee progress on achieving the project outputs, products, and outcomes. These performance measures and evaluation findings will be used by CDC for continuous program quality improvement during the program period.

Database management will be a continuous process during the program period.

CDC Process Evaluation

Budget Year 1 - By 3 months after award Outputs

Finalize public health goals for the registry Finalize organizational structure of registry and referral network Finalize definition of eligible residents Estimate number of eligible residents and compile data sources for recruitment

Budget Year 2 - By end of Quarter 2

Establish community advisory board, including key representatives from community groups, tribal membership, and stakeholder organizations

Finalize scope, methods, and materials for the registry protocol Community outreach, health education, and training to target audiences begins and continues as needed during the program period

Products

Community outreach, health education, and training materials for target audiences are prepared, distributed, and tracked as needed during the program period

Budget Year 2 - By end of Quarter 3

Obtain state and local authority approval for protocol

Products

Registry protocol finalized

Target - Data collection is approved to begin

Budget Year 2 – By end of Quarter 4

Implement registry strategies for community and stakeholder outreach and communication plan

Implement registry recruitment, enrollment, and baseline data collection Implement DMP, and update as required during program period

Budget Year 3 – By end of Quarter 4

Recruitment, enrollment, and baseline data collection is complete Follow-up data collection continues

During Budget Years 2, 3, and part of 4

Outputs - continue registry recruitment, enrollment, and baseline and follow-up data collection

Budget Year 4 - By end of Quarter 2

Registry data collection is completed Registry database is prepared for data analysis Preliminary data analysis begins

CDC Outcome Measurement

Short-term Outcomes for Community and Providers:

Increased awareness of registry goals and scope Increased awareness of eligibility criteria for registry

Measured by:

Number of attendees (by type - community, tribe, professional) who attend outreach events

Percent of attendees of community outreach events (by type) have increased awareness of registry goals, scope, and eligibility criteria

Number of or percent of registrants who enroll after attending outreach events

Target: At least 80 percent of residents who are contacted for eligibility screening and enrollment report attending at least one outreach event, receiving outreach materials, or hearing about the registry in the media.

Short-term Outcomes for Community, Providers, and Workforce:

Increased knowledge of adverse health and developmental outcomes from lead exposure Increased knowledge of blood lead testing and reporting requirements Increased knowledge of medical management recommendations Increased knowledge of environmental lead exposure sources and reduction methods Increased knowledge of modifiable factors for lead exposure reduction Increased knowledge of available preventive referral services and interventions to reduce the impact of lead exposure

Measured by:

Number of attendees (by type – community, tribe, provider, lead workforce, or stakeholder) who attend education and training events)

Percent of attendees of education and training events

Reasons for attendance at education and training events Number of or percent of registrants who enroll after attending education and training events

Target: At least 80 percent of registry investigators and collaborators (e.g., public health professionals, lead prevention workforce, partners, and other stakeholders) attend or participate in lead poisoning prevention and intervention training programs.

Short-term Outcomes for Registry Implementation

Increased registrant referral to services over baseline Target number of registry follow-ups achieved per registrant

Measured by:

Number of types and frequency of services previously accessed and used is recorded at baseline

Number of types and frequency of referred services accessed and used after baseline is recorded at repeated follow-up

Percent of increase in use of services by type and frequency

Target:

At least a 30 percent increase in number of registrant referrals to recommended services over baseline.

At least a 30 percent increase in number of registrants who use referral services over baseline.

At least 75 percent of registrants have completed the targeted number of registry follow-ups.

Intermediate Outcomes for Registrants:

Use preventive services Reduce their environmental lead exposures where they live, work, and play Have lower blood lead levels over time Have better health and fewer developmental delays

Measured by:

Number and percent of registrants who use follow-up care and referral services (by type of service)

Reasons that registrants seek or do not seek care from provider and from referral services (by type of service)

Number and percent of registrants who reduce environmental lead exposures (by type of environmental intervention)

Reasons that registrants seek or do not seek environmental lead exposures (by type of environmental intervention)

Number and percent of registrants with lower blood lead levels during follow-up (by type of service, by type of environmental intervention)

Number and percent of registrants who have better health and fewer developmental delays (by type of service, by type of environmental intervention)

Target:

At least 85 percent of registrants use preventive services.

At least 85 percent of registrants take steps to reduce environmental lead exposures.

At least 60 percent of registrants have lower blood lead levels at their last follow-up.

At least 60 percent of registrants have better health and fewer developmental delays at their last follow-up.

Intermediate Outcomes for Registry Data:

Increased quality and quantity of data to inform lead poisoning prevention policy and program administration

Increased knowledge about the effectiveness of the number of prevention services leading to improved outcomes

Increased knowledge about the effectiveness of different types of prevention services leading to improved outcomes

Increased knowledge about the acute and long-term impacts of lead exposure

Measured by:

Data endpoints to assess if lead poisoning prevention policies or procedures should be updated.

Data endpoints to analyze effectiveness of frequency and type of prevention services on improved outcomes.

Data endpoints to assess if registrants who seek referral services earlier have more favorable outcomes (by lead exposure category).

Target: At least three types of referral services have led to better health and fewer developmental delays at registrants’ last follow-up through objective measures and reports by providers in the referral network.

ii. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the awardee 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).

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

Data Management Plan (DMP): CDC requires the awardee to develop and submit a DMP for each collection or generation of public health data for federally funded projects and programs.

For purposes of this announcement, “public health data” means digitally recorded factual material commonly accepted in the scientific community as a basis for public health findings, conclusions, and implementation. The DMP will be required to be evaluated and approved prior to initiation of the data collection.

The DMP may be outlined in a narrative format or as a checklist. In addition to the minimum requirements outlined above, the DMP should include:

Mechanisms for providing access to and sharing of the data (including collecting provisions for protection of privacy, confidentiality, security, intellectual property, or other rights), including a description of how data for Native American registrants will be managed, including any agreements reached with Tribes;

Use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use; and

Plans for archival and long-term preservation of the data, or explaining why long-term preservation and access cannot be justified.

The applicant who contends that the public health data collected or generated are not appropriate for release must justify that contention in the DMP submitted with the application for CDC funds (for example, privacy and confidentiality considerations, https://www.cdc.gov/grants/additionalrequirements/ar-25.html embargo issues).

The DMP should be maintained as a living document that will be updated and revised, as needed, throughout the lifecycle of the data collected within the funding period. Any changes from the original DMP, such as changes to the initial data collection plan, challenges with data collection, and recent data collected, should be justified. The awardee should update the DMP to reflect progress or issues with planned data collections and submit as required for each reporting period.

CDC requires that mechanisms for, and cost of, public health data sharing be included in grants.

The cost of sharing or archiving public health data may also be included as part of the total budget requested for first-time or continuation awards. Fulfilling the data-sharing requirement must be documented in the DMP that is developed during the project planning phase prior to the initiation of data collection or generation. Funding restrictions may be imposed, pending submission and evaluation of a DMP.

The awardee who fails to release public health data in a timely fashion will be subject to procedures normally used to address lack of compliance (for example, reduction in funding, restriction of funds, or award termination) consistent with 45 CFR 74.62 or other authorities as appropriate. For further information, please see: http://www.cdc.gov/ grants/ additionalrequi rements/ index.html for revised AR-25.

c. Organizational Capacity of Awardees to Implement the Approach The organizational capacity statement should describe how the applicant agency is organized to carry out the requirements of this announcement, the nature and scope of its work, and/or its capabilities. The applicant should include a detailed description of the institution’s experience, program management components, collection and data reporting requirements, and readiness to establish working agreements, as well as letters of support, MOUs/MOAs, or contracts with collaborating or partner entities. Although this NOFO is not intended to fund referral, follow-up, and case-management of registrants, the applicant should seek to collaborate with other government and non-governmental agencies that will provide preventive, case management, enrichment, educational, or public health services. The applicant must demonstrate that collaborators are willing to provide registrant data. This collaboration is necessary to link registrants’ data about exposure, health, and developmental milestones with their participation in intervention activities and services through this voluntary referral network.

Project Management: Key personnel must have the level of education, experience, and/or skills necessary to successfully implement and complete the project. This section should include a clear delineation of the roles and responsibilities of program staff and their qualifications.

Specify who will have day-to-day responsibility for key tasks such as: leadership of project;

monitoring of project’s ongoing progress; management and storage of the data repository, preparation of reports; program evaluation; and communication with other partners and CDC;

qualifications, experience, leadership ability, and description of how staff will be used to accomplish the work; and percentage of time the project staff will commit to the project.

Additional information should be provided in the application appendices and labeled as separate appendices (i.e., curriculum vitae, letters of support, MOU/MOA, etc.). The appendices will not be counted toward the narrative page limit.

Additional information includes the following:

http://www.cdc.gov/grants/additionalrequirements/index.html%20for%20revised%20AR-25 http://www.cdc.gov/grants/additionalrequirements/index.html%20for%20revised%20AR-25

Organizational chart (including voluntary network of collaborators) Curriculum vitae for existing key personnel (or job descriptions for planned key personnel) Indirect cost rate agreements Letters of support and/or MOU/MOA

The applicant must create a separate file for the noted items and must name the file "Organizational Chart,” “CVs/Resumes," “Indirect Cost Rate Agreements,” “Letters of Support,” and/or “MOU/MOA” and upload to www.grants.gov.

d. Work Plan The applicant must provide a detailed work plan for the first year of the project and a high-level work plan for subsequent years. No specific work plan template is required as long as it is clear how the components in the work plan crosswalk to the strategies and activities, outcomes, and evaluation performance measures presented in the logic model and the narrative sections of this

NOFO.

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 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 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.

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.

CDC and the awardee will have 6 months after award to finalize the performance monitoring and accountability approach.

B. Award Information

1. Funding Instrument Type: Grant

2. Award Mechanism: Grant UE2–Studies of Emergency and Environmental Health Services - Grant

3. Fiscal Year: 2017

4. Approximate Total Fiscal Year Funding: $3,600,000

5. Approximate Project Period Funding: $14,400,000

This amount is subject to the availability of funds.

Estimated Total Funding: $14,400,000

6. Total Project Period Length: 4 year(s)

7. Expected Number of Awards: 1

8. Approximate Average Award: $3,600,000 Per Budget Period

9. Award Ceiling: $6,000,000 Per Budget Period

This amount is subject to the availability of funds.

10. Award Floor: $1,200,000 Per Budget Period

11. Estimated Award Date: 08/01/2017

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 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).

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)

Additional Eligibility Category:

2. Additional Information on Eligibility This is a single source eligibility NOFO. Funding is limited to Michigan State University.

The award ceiling for this NOFO is $6,000,000. CDC will consider any application requesting an award higher than this amount as nonresponsive and it will receive no further review.

3. Justification for Less than Maximum Competition During April 25, 2014–October 15, 2015, approximately 99,000 residents of the City of Flint, MI, were exposed to lead when their water source was switched from the Detroit Water Authority to the Flint Water System (FWS). Because the FWS did not use corrosion control, the lead levels in Flint tap water increased above the EPA action level of 15 ppb as required by the Lead and Copper Rule. In children, lead exposure can result in serious effects on cognitive and physiological development. Lead can reduce kidney function and increase risk of hypertension and essential tremor among adults. Data from the Michigan Department of Health and Human Services showed an increase in blood lead levels ≥5 µg/dL (CDC reference value) among Flint children, under 5 years of age, after the source water change. Immediate support is needed to assist the City of Flint and the State of Michigan to build their capacity to establish a public health registry.

Michigan State University (MSU) is already building a registry to support Flint residents. In January of 2017, the Michigan Department of Health and Human Services awarded a one-year grant of $500,000 to MSU College of Human Medicine for the planning of a registry for Flint residents. MSU’s plan to build a registry is divided into two phases:

Phase I of registry planning: clarify registry scope, definition(s), goals and objectives, stakeholders/partners, advisory structure, priorities (by tier) and deliverables.

Phase II of registry planning: identify and begin to develop infrastructure required for the registry as well as the case management/resource linkages; develop processes for linkage of pre-existing cohorts and environmental data sets; develop guidelines for how registry data will be protected and utilized once operationalized; and develop process for ongoing registry operation and maintenance.

MSU’s registry plan supports and builds upon activities contained in this grant. The matrix below provides a comparison of MSU’s current registry plan and the activities contained in the CDC registry grant:

MSU Registry Plan to Support Flint Residents

CDC Grant Activities CDC-RFA-

EH17-1704

Phase I: Clarify registry scope, definition(s), goals and objectives, stakeholders/partners, advisory structure, priorities (by tier) and

Activity: Develop a public health registry of residents who were exposed to lead-contaminated water from the Flint Water System during deliverables. the period April 25, 2014 - October 15, 2015

Phase II: Identify and begin to develop infrastructure required for the registry as well as the case management/resource linkages

Activity: Implement systems and policies that link lead-exposed residents to comprehensive, coordinated services to mitigate the effects of lead exposure.

Phase I: Clarify registry scope, definition(s), goals and objectives, stakeholders/partners, advisory structure, priorities (by tier) and deliverables

Requirement: This work requires close collaboration with community leaders, partners, stakeholders and various entities serving residents to ensure timely and accurate data collection, and a comprehensive system of referral, follow up and evaluation.

This grant requires close collaboration and work with community leaders, partners, stakeholders and various entities serving residents to ensure timely and accurate data collection;

and a comprehensive system of referral, follow up, and evaluation of lead-exposed residents. MSU currently has the relationships needed to make this grant successful.

4. Cost Sharing or Matching Cost Sharing / Matching Requirement: No Cost sharing or matching funds are not required for this program.

5. Maintenance of Effort Maintenance of effort is not required for this program.

D. Application and Submission Information

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

a. Data Universal Numbering System:

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

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

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

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

https://www.grants.gov/ http://fedgov.dnb.com/webform/displayHomePage.do

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.