cdc-rfa-ts16-1601 amend 4.pdf

Centers for Disease Control and Prevention

Agency for Toxic Substances and Disease Registry

Biomonitoring Legacy and Emerging Great Lakes Contaminants in Susceptible Great Lakes Populations

CDC-RFA-TS16-1601

Application Due Date: 03/31/2016

Biomonitoring Legacy and Emerging Great Lakes Contaminants in Susceptible Great Lakes Populations

CDC-RFA-TS16-1601

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-TS16-1601. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Agency for Toxic Substances and Disease Registry (ATSDR) B. Funding Opportunity Title:

Biomonitoring Legacy and Emerging Great Lakes Contaminants in Susceptible Great Lakes Populations C. Announcement Type: New - Type 1 This announcement is only for non-research domestic activities supported by ATSDR. 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-TS16-1601

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

93.161 F. Dates:

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

2. Due Date for Applications: 03/31/2016, 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Date for Informational Conference Call: 03/10/2016 An informational conference call will be held on Thursday, March 10, 2016, at 2:30PM (Eastern).

Call in number: 1-866-692-3158; Passcode: 81253953 The questions and answers from the call will be published on Grants.gov (as an amendment to this FOA) approximately a week after the call.

G. Executive Summary:

1. Summary Paragraph:

The purposes of this FOA is for the awardee to conduct a biomonitoring program to assess body burden of legacy and emerging contaminants in susceptible Great Lakes populations in areas not monitored under CDC-RFA-TS10-1001 and CDC-RFA-TS13-1302 cooperative agreement programs. Determining which contaminants get into human populations informs public health officials and guides environmental public health action throughout the Great Lakes restoration process.

Awardee will conduct the following activities during the project period: 1) conduct a biomonitoring program to assess exposure to legacy and emerging contaminants in a susceptible population(s) in the Great Lakes basin, particularly in those who are at higher exposure risk, 2) use the results to develop a plan guiding and advancing public health actions and safeguarding people from harmful exposure, 3) conduct multi-level communication and outreaches to high-risk populations, key audiences and stakeholders, and general populations to communicate the risks and benefits of Great Lakes fish consumption, and, to promote healthy fish consumption choices that minimize the risk of contaminant exposure, 4) establish and strengthen collaborations and coordination in biomonitoring activities and projects.

ATSDR anticipates the following outcomes during the project period: 1) improved and expanded knowledge about Great Lakes-specific environmental chemical exposures, 2) increased use of high-quality biomonitoring results as bases for public health actions in the Great Lakes region, 3) increased awareness about chemical exposures and risk and benefit of fish consumption in target population, 4) increased awareness of exposure assessment using biomonitoring to guide public health actions, 5) increased ability at the state and local level to monitor and track Great Lakes-specific exposures, 6) strong collaborations for biomonitoring activities and projects.

The purpose of this amendment is to include Q & A's from the informational conference call on March 10, 2016.

a. Eligible Applicants: Limited

b. FOA Type: Cooperative Agreement

c. Approximate Number of Awards: 1

d. Total Project Period Funding: $1,600,000

e. Average One Year Award Amount: $800,000 ATSDR anticipates funding one award at up to $895,000 for FY2016 and up to $705,000 for FY2017. The total project period is two years. The total funding level for the project period (FY2016 and FY2017) is approximately $1,600,000. This amount is subject to the availability of funds.

f. Number of Years of Award: 2

g. Estimated Award Date: 07/01/2016

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 Over the past century, careless practices have resulted in contamination of the Great Lakes ecosystem with countless chemical products and byproducts of modern life 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.grants.gov

1. Background

a. Overview Over the past century, careless practices have resulted in contamination of the Great Lakes ecosystem with countless chemical products and byproducts of modern life

Over the past century, careless practices have resulted in contamination of the Great Lakes ecosystem with countless chemical products and byproducts of modern life entering into the air, water, land, and biota, and even into people's bodies. People's health in the Great Lakes area can be at risk because the environment/ecosystem is contaminated with these harmful contaminants. It is difficult for public health agencies and others to take effective action unless they know the extent and characteristics of exposure. Biomonitoring is the direct measurement of environmental chemicals, or their products, in people’s blood and urine. Biomonitoring measurement represents the amount of chemical that enters the body from all environmental sources, and is the most direct approach on assessing people’s exposure.

The purpose of this project is for the awardee to conduct a biomonitoring program to assess body burden of legacy contaminants and chemicals of emerging concern in susceptible Great Lakes populations with potential high exposure to contaminants from Great Lakes fish consumption in areas not monitored previously. This awardee is also required to develop a plan to use the biomonitoring study results to help guide and advance public health actions and safeguard the health of the people in their jurisdiction.

b. Statutory Authorities This program is authorized by Section 104(i)(15) of the Comprehensive Environmental Response, Compensation and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act (SARA) [42 U.S.C. 9604(i)15]; additionally, the EPA is authorized to transfer funds to ATSDR for the purpose of undertaking this activity by the Consolidated Appropriations Act, 2014 (P.L. 113-76).

c. Healthy People 2020 This program addresses the “Healthy People 2020” focus area related to Environmental Health; Objective EH-20, “Reduce exposure to selected environmental chemicals in the population, as measured by blood and urine concentrations of the substances or their metabolites.” http://www.healthypeople.gov/2020/topics-objec tives/topic/environmental-health/objectives

d. Other National Public Health Priorities and Strategies In 2009, President Obama’s Administration announced the Great Lakes Restoration Initiative (GLRI) to protect, restore and maintain the Great Lakes ecosystem. In 2010, GLRI was launched with unprecedented federal agency coordination. A task force of federal agencies developed milestones and outcome measures to make the five-year GLRI Action Plan a national success during FY2010-2014. In 2015, federal agencies developed the GLRI Action Plan II, which summarizes the actions that federal agencies plan to implement during FY15-19 and outlines the next phase of work on Great Lakes environmental problems and associated human health issues ( http://greatlakesrestoration.us/actionplan/pdfs/glri-action-plan-2.pdf).

The GLRI Action Plan II identifies objectives, commitments, measures of progress for five focus areas—Toxic Substances and Areas of Concern; Invasive Species;

Nonpoint Source Pollution Impacts on Nearshore Health; Habitats and Species; and, Foundations for Future Restoration Actions. Biomonitoring is a valuable tool to assess human exposure to environmental contaminants. Biomonitoring results provide unique exposure information than can guide public health efforts to reduce exposure of human populations to specific chemicals. EPA is funding the ATSDR, in accordance with the Consolidated Appropriations Act, 2014 (P.L. 113-76), to implement the “Biomonitoring Legacy and Emerging Great Lakes Contaminants in Susceptible Great Lakes Populations” program as part of the Focus Area 1, Toxic Substances and Areas of Concern, of the GLRI.

In reference to the Great Lakes Action Plan II, this project directly supports the Focus Area 1 (Toxic Substances and Areas of Concern), Objective 1.2 (Increase knowledge about contaminants in Great Lakes fish and wildlife), Commitment 1.2.1 (Reduce human exposure to contaminants from Great Lakes fish consumption).

Activities under this project support Measures of Progress 1.2.1 (Number of people provided information on the risks and benefits of Great Lakes fish consumption by GLRI-funded projects).

e. Relevant Work This project will provide public health information to supplement the CDC-RFA-TS10-1001 and CDC-RFA-TS13-1302 cooperative agreement programs that were initiated in FY2010 and FY2013, respectively.

As part of CDC-RFA TS10-1001, the ATSDR awarded funds to the Michigan Department of Community Health (MDCH), the Minnesota Department of Health (MDH), and the New York State Department of Health (NYS DOH) to conduct non-research studies of human exposures to select environmental contaminants in order to advance jurisdiction-specific public health actions. This public health effort focuses on vulnerable or susceptible subpopulations with the potential for increased risk of exposure to persistent contaminants common to the Great Lakes watersheds and ecosystems. The health departments in these states targeted four types of susceptible populations in six areas of concerns (AOCs): MDCH – shoreline anglers on the Detroit River AOC; MDH – American Indians near the St. Louis River AOC; and NYS DOH – licensed anglers and immigrants from Burma and their family members living in four Lake Ontario and Lake Erie AOCs. The NYS areas included the Rochester Embayment AOC, the Eighteenmile Creek AOC, and the AOCs along the Niagara and Buffalo Rivers.

As part of CDC-RFA TS13-1302, the ATSDR awarded funds to the New York State Department of Health (NYS DOH) to conduct a second biomonitoring program in Syracuse, NY. In this program, NYS DOH targets urban low-income minority anglers and refugees and immigrants from Burma and Bhutan who consume fish from Onondaga Lake and its tributaries (Seneca River, Oswego River AOC) and Lake Ontario.

2. CDC Project Description

a. Approach

Bold indicates project period outcome.

The logic model below describes the program framework for this FOA. Note that the bolded components are those that are expected to be accomplished during the http://www.healthypeople.gov/2020/topics-objectives/topic/environmental-health/objectives http://www.healthypeople.gov/2020/topics-objectives/topic/environmental-health/objectives http://greatlakesrestoration.us/actionplan/pdfs/glri-action-plan-2.pdf

Over the past century, careless practices have resulted in contamination of the Great Lakes ecosystem with countless chemical products and byproducts of modern life entering into the air, water, land, and biota, and even into people's bodies. People's health in the Great Lakes area can be at risk because the environment/ecosystem is contaminated with these harmful contaminants. It is difficult for public health agencies and others to take effective action unless they know the extent and characteristics of exposure. Biomonitoring is the direct measurement of environmental chemicals, or their products, in people’s blood and urine. Biomonitoring measurement represents the amount of chemical that enters the body from all environmental sources, and is the most direct approach on assessing people’s exposure.

The purpose of this project is for the awardee to conduct a biomonitoring program to assess body burden of legacy contaminants and chemicals of emerging concern in susceptible Great Lakes populations with potential high exposure to contaminants from Great Lakes fish consumption in areas not monitored previously. This awardee is also required to develop a plan to use the biomonitoring study results to help guide and advance public health actions and safeguard the health of the people in their jurisdiction.

b. Statutory Authorities This program is authorized by Section 104(i)(15) of the Comprehensive Environmental Response, Compensation and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act (SARA) [42 U.S.C. 9604(i)15]; additionally, the EPA is authorized to transfer funds to ATSDR for the purpose of undertaking this activity by the Consolidated Appropriations Act, 2014 (P.L. 113-76).

c. Healthy People 2020 This program addresses the “Healthy People 2020” focus area related to Environmental Health; Objective EH-20, “Reduce exposure to selected environmental chemicals in the population, as measured by blood and urine concentrations of the substances or their metabolites.” http://www.healthypeople.gov/2020/topics-objec tives/topic/environmental-health/objectives

d. Other National Public Health Priorities and Strategies In 2009, President Obama’s Administration announced the Great Lakes Restoration Initiative (GLRI) to protect, restore and maintain the Great Lakes ecosystem. In 2010, GLRI was launched with unprecedented federal agency coordination. A task force of federal agencies developed milestones and outcome measures to make the five-year GLRI Action Plan a national success during FY2010-2014. In 2015, federal agencies developed the GLRI Action Plan II, which summarizes the actions that federal agencies plan to implement during FY15-19 and outlines the next phase of work on Great Lakes environmental problems and associated human health issues ( http://greatlakesrestoration.us/actionplan/pdfs/glri-action-plan-2.pdf).

The GLRI Action Plan II identifies objectives, commitments, measures of progress for five focus areas—Toxic Substances and Areas of Concern; Invasive Species;

Nonpoint Source Pollution Impacts on Nearshore Health; Habitats and Species; and, Foundations for Future Restoration Actions. Biomonitoring is a valuable tool to assess human exposure to environmental contaminants. Biomonitoring results provide unique exposure information than can guide public health efforts to reduce exposure of human populations to specific chemicals. EPA is funding the ATSDR, in accordance with the Consolidated Appropriations Act, 2014 (P.L. 113-76), to implement the “Biomonitoring Legacy and Emerging Great Lakes Contaminants in Susceptible Great Lakes Populations” program as part of the Focus Area 1, Toxic Substances and Areas of Concern, of the GLRI.

In reference to the Great Lakes Action Plan II, this project directly supports the Focus Area 1 (Toxic Substances and Areas of Concern), Objective 1.2 (Increase knowledge about contaminants in Great Lakes fish and wildlife), Commitment 1.2.1 (Reduce human exposure to contaminants from Great Lakes fish consumption).

Activities under this project support Measures of Progress 1.2.1 (Number of people provided information on the risks and benefits of Great Lakes fish consumption by GLRI-funded projects).

e. Relevant Work This project will provide public health information to supplement the CDC-RFA-TS10-1001 and CDC-RFA-TS13-1302 cooperative agreement programs that were initiated in FY2010 and FY2013, respectively.

As part of CDC-RFA TS10-1001, the ATSDR awarded funds to the Michigan Department of Community Health (MDCH), the Minnesota Department of Health (MDH), and the New York State Department of Health (NYS DOH) to conduct non-research studies of human exposures to select environmental contaminants in order to advance jurisdiction-specific public health actions. This public health effort focuses on vulnerable or susceptible subpopulations with the potential for increased risk of exposure to persistent contaminants common to the Great Lakes watersheds and ecosystems. The health departments in these states targeted four types of susceptible populations in six areas of concerns (AOCs): MDCH – shoreline anglers on the Detroit River AOC; MDH – American Indians near the St. Louis River AOC; and NYS DOH – licensed anglers and immigrants from Burma and their family members living in four Lake Ontario and Lake Erie AOCs. The NYS areas included the Rochester Embayment AOC, the Eighteenmile Creek AOC, and the AOCs along the Niagara and Buffalo Rivers.

As part of CDC-RFA TS13-1302, the ATSDR awarded funds to the New York State Department of Health (NYS DOH) to conduct a second biomonitoring program in Syracuse, NY. In this program, NYS DOH targets urban low-income minority anglers and refugees and immigrants from Burma and Bhutan who consume fish from Onondaga Lake and its tributaries (Seneca River, Oswego River AOC) and Lake Ontario.

2. CDC Project Description

a. Approach

Bold indicates project period outcome.

The logic model below describes the program framework for this FOA. Note that the bolded components are those that are expected to be accomplished during the http://www.healthypeople.gov/2020/topics-objectives/topic/environmental-health/objectives http://www.healthypeople.gov/2020/topics-objectives/topic/environmental-health/objectives http://greatlakesrestoration.us/actionplan/pdfs/glri-action-plan-2.pdf

The logic model below describes the program framework for this FOA. Note that the bolded components are those that are expected to be accomplished during the project period.

Strategies and Activities Short-term Outcomes Intermediate Outcomes Long-term Outcomes

Biomonitoring

Identify target populations Develop study protocol, questionnaire, sampling strategy, data collection system, etc.

Designate labs with high quality biomonitoring capabilities Recruit study participants Conduct data collection and biological sample collection Conduct laboratory measurements to determine levels of environmental chemicals in participants Produce written assessment Produce data use plan

Communication and Outreach

Develop communication and outreach plan Communicate data & findings to key audiences Conduct outreach activities on the risk and benefit of fish consumption through multiple channels

Collaboration

Engage stakeholders and establish Advisory Committee Collaborate with state, tribal, local, and other federal partners in biomonitoring activities and projects

Biomonitoring

Accurate assessment of exposure in Great Lakes populations More current data on Great Lakes-specific environmental chemical exposures Strong plan for use of findings Increased use of high-quality biomonitoring results as bases for public health actions

Communication and Outreach

Increased awareness about chemical exposures, and risk and benefit of fish consumption in target population Increased awareness of the value of biomonitoring as a tool for exposure assessment among federal and state governments, policymakers, and stakeholders Improved and expanded knowledge about Great Lakes chemical exposures among the scientific community

Collaboration

Improved ability of Advisory Committee to promote biomonitoring and implement activities Strong collaborations for biomonitoring activities and projects

Findings used by the state and local government to guide public health action to reduce and prevent harmful chemical exposures

Increased ability at the state and local level to monitor and track Great Lakes-specific exposures

Increased awareness of environmental contamination and chemical exposure among the general Great Lakes population

Increased awareness about risk and benefit of fish consumption among the general Great Lakes population

Changes in behavior among susceptible populations to reduce exposure to harmful Great Lakes contaminants

Reduced exposure to harmful Great Lakes contaminants among susceptible Great Lakes populations

Improved health outcomes in susceptible Great Lakes

Improved Great Lakes ecosystem

i. Purpose The purpose of the current announcement is to evaluate body burden levels of legacy contaminants and chemicals of emerging concern in susceptible Great Lakes populations in an area that was not addressed in the FY2010 CDC-RFA TS10-1001 and FY2013 CDC-RFA TS13-1302 cooperative agreement programs. The susceptible populations include those with potential high exposure to contaminants from Great Lakes fish consumption (e.g. subsistence anglers who tend to be low income minority), and/or those who are susceptible to the potential health effect of such chemical exposure (e.g. children, adolescents and elderly).

ii. Outcomes During the project period, awardees will achieve the following outcomes:

Short-term outcomes Biomonitoring

• Accurate assessment of exposure in Great Lakes populations

• More current data on Great Lakes-specific environmental chemical exposures

• Strong plan for use of findings

• Increased use of high-quality biomonitoring results as bases for public health actions Communication and Outreach

• Increased awareness about chemical exposures, and risk and benefit of fish consumption in target population

• Increased awareness of the value of biomonitoring as a tool for exposure assessment among federal and state governments, policymakers, and stakeholders

• Improved and expanded knowledge about Great Lakes chemical exposures among the scientific community Collaboration

The logic model below describes the program framework for this FOA. Note that the bolded components are those that are expected to be accomplished during the project period.

Long-term Outcomes

Changes in behavior among susceptible populations to reduce exposure to harmful Great Lakes contaminants

Reduced exposure to harmful Great Lakes contaminants among susceptible Great Lakes

Improved health outcomes in susceptible Great Lakes

Improved Great Lakes ecosystem

i. Purpose The purpose of the current announcement is to evaluate body burden levels of legacy contaminants and chemicals of emerging concern in susceptible Great Lakes populations in an area that was not addressed in the FY2010 CDC-RFA TS10-1001 and FY2013 CDC-RFA TS13-1302 cooperative agreement programs. The susceptible populations include those with potential high exposure to contaminants from Great Lakes fish consumption (e.g. subsistence anglers who tend to be low income minority), and/or those who are susceptible to the potential health effect of such chemical exposure (e.g. children, adolescents and elderly).

ii. Outcomes During the project period, awardees will achieve the following outcomes:

Short-term outcomes Biomonitoring

• Accurate assessment of exposure in Great Lakes populations

• More current data on Great Lakes-specific environmental chemical exposures

• Strong plan for use of findings

• Increased use of high-quality biomonitoring results as bases for public health actions Communication and Outreach

• Increased awareness about chemical exposures, and risk and benefit of fish consumption in target population

• Increased awareness of the value of biomonitoring as a tool for exposure assessment among federal and state governments, policymakers, and stakeholders

• Improved and expanded knowledge about Great Lakes chemical exposures among the scientific community Collaboration

• Improved ability of Advisory Committee to promote biomonitoring and implement activities

• Strong collaborations for biomonitoring activities and projects Intermediate outcomes

• Findings used by the state and local government to guide public health action to reduce and prevent harmful chemical exposures

• Increased ability at the state and local level to monitor and track Great Lakes-specific exposures

iii. Strategies and Activities Awardee will conduct the following activities:

Biomonitoring

1. Identify target populations

• Identify environmental exposure concerns in their jurisdiction presented by Great Lakes pollutants

• Identify past and current activities related to identification, control and prevention of potential adverse human health effects associated with Great Lakes pollutants

• Identify, specify, and describe target population(s) with regard to potential exposure risk, social economic status, geographic location, and other relevant information and justification as deemed necessary.

2. Develop study protocol, questionnaire, sampling strategy, data collection system, etc. in collaboration with ATSDR

• Develop a study protocol that follows CDC guidelines: http://www.cdc.gov/niosh/nas/mining/pdfs/Protocol%20Checklist.pdf .

• Develop a biomonitoring questionnaire interview in collaboration with ATSDR using questionnaire items similar to the FY2010 TS10-1001 and FY2013 TS13-1302 cooperative agreement program.

• Establish a statistically valid sampling strategy in collaborate with ATSDR to ensure that the selection of participants is representative of the targeted, susceptible subpopulation.

• Develop standardized protocols for the collection and analysis of biological specimens, including proficiency-testing, quality assurance, and quality control, established in collaboration with or consistent with the Centers for Disease Control and Prevention’s Environmental Health Laboratory.

• Develop an appropriate personal interview component, e.g., computer-assisted personal interview (CAPI), for the questionnaire interview

• Establish quality assurance mechanisms for data collection and management, to provide complete and quality data. Awardees may need to provide certification and accreditation of their data collection system that meets federal Privacy Act standards for protecting the privacy of individuals, including secure electronic storage, to the extent possible, of all collected data.

• Establish a data collection system to collect, synthesize, and manage program data. Develop and maintain the capability to securely export data.

3. Designate labs with high quality biomonitoring capabilities

• Designate a laboratory to be responsible for the processing, analysis and storage of biological specimens.

• The laboratory must provide documentation of Clinical Laboratory Improvement Act of 1988 (CLIA) certification, as well as documentation of the mechanism (e.g., contract) under which they perform clinical measurements (i.e. triglycerides, cholesterol, etc.).

• The laboratory must also provide documentation of participation in an external proficiency testing program(s).

• Describe the laboratory’s past and current biomonitoring activities, if any.

4. Recruit study participants

• Follow the established statistically valid sampling strategy, pre-screen the target population regarding established inclusion criteria

• Conduct sampling and recruitment

• Collect biological specimens, conduct clinical screenings and questionnaire interviews

• Train staff, clinic staff and interviewers.

5. Conduct data collection and biological sample collection

• Use the established personal interview component to conduct interview and administer questionnaire.

• Follow the quality assurance mechanisms for data collection and management, to provide complete and quality data.

• Collect, store, and transport biological samples, e.g., blood and urine, from the consenting participants following the standardized protocols for biological specimen collection, storage, and transport.

6. Conduct laboratory measurements to determine levels of environmental chemicals in participants

• Measure the following chemicals in biological samples: PCBs (congeners 28, 52, 101, 105, 118, 138, 153, 180), mercury, lead, mirex, hexachlorobenzene, DDT/DDE, and perfluorinated compounds (perfluorooctanoic acid or PFOA, and, perfluorooctane sulfonate or PFOS).

• Identify additional emerging contaminants that may be included in the study, and provide justification for such selection. Emerging contaminants of concern found in the Great Lakes, including but not limited to, brominated flame retardants (BFRs), polycyclic aromatic hydrocarbons (PAHs), and alkylphenols, are examples of contaminants that may be selected. Because these chemicals of emerging concerns can come from many sources other than consuming fishes from the Great Lakes, appropriate considerations must be taken when designing and conducting the biomonitoring program.

• The designated laboratory or laboratories process and analyze biological specimens for required and optional environmental chemicals or biomarkers, following established analytical, quality assurance, and quality control protocols.

• The laboratory must provide documentation of participation in an external proficiency testing program(s) covering the period of laboratory measurements.

• Provide feedback, e.g., result letters, to participants

7. Produce written assessment

• Analyze data to assess human exposure to environmental chemicals.

• Produce and disseminate a written assessment of the biomonitoring study results. Results should include an assessment of analytes based on percentile levels in study participants relative to NHANES data and other appropriate population-based study results; and, an assessment of the potential influence of exposure parameters collected in the biomonitoring questionnaire interview.

• Provide de-identified data of established quality to ATSDR via secure transfer.

http://www.cdc.gov/niosh/nas/mining/pdfs/Protocol%20Checklist.pdf

• Improved ability of Advisory Committee to promote biomonitoring and implement activities

• Strong collaborations for biomonitoring activities and projects Intermediate outcomes

• Findings used by the state and local government to guide public health action to reduce and prevent harmful chemical exposures

• Increased ability at the state and local level to monitor and track Great Lakes-specific exposures

iii. Strategies and Activities Awardee will conduct the following activities:

Biomonitoring

1. Identify target populations

• Identify environmental exposure concerns in their jurisdiction presented by Great Lakes pollutants

• Identify past and current activities related to identification, control and prevention of potential adverse human health effects associated with Great Lakes pollutants

• Identify, specify, and describe target population(s) with regard to potential exposure risk, social economic status, geographic location, and other relevant information and justification as deemed necessary.

2. Develop study protocol, questionnaire, sampling strategy, data collection system, etc. in collaboration with ATSDR

• Develop a study protocol that follows CDC guidelines: http://www.cdc.gov/niosh/nas/mining/pdfs/Protocol%20Checklist.pdf .

• Develop a biomonitoring questionnaire interview in collaboration with ATSDR using questionnaire items similar to the FY2010 TS10-1001 and FY2013 TS13-1302 cooperative agreement program.

• Establish a statistically valid sampling strategy in collaborate with ATSDR to ensure that the selection of participants is representative of the targeted, susceptible subpopulation.

• Develop standardized protocols for the collection and analysis of biological specimens, including proficiency-testing, quality assurance, and quality control, established in collaboration with or consistent with the Centers for Disease Control and Prevention’s Environmental Health Laboratory.

• Develop an appropriate personal interview component, e.g., computer-assisted personal interview (CAPI), for the questionnaire interview

• Establish quality assurance mechanisms for data collection and management, to provide complete and quality data. Awardees may need to provide certification and accreditation of their data collection system that meets federal Privacy Act standards for protecting the privacy of individuals, including secure electronic storage, to the extent possible, of all collected data.

• Establish a data collection system to collect, synthesize, and manage program data. Develop and maintain the capability to securely export data.

3. Designate labs with high quality biomonitoring capabilities

• Designate a laboratory to be responsible for the processing, analysis and storage of biological specimens.

• The laboratory must provide documentation of Clinical Laboratory Improvement Act of 1988 (CLIA) certification, as well as documentation of the mechanism (e.g., contract) under which they perform clinical measurements (i.e. triglycerides, cholesterol, etc.).

• The laboratory must also provide documentation of participation in an external proficiency testing program(s).

• Describe the laboratory’s past and current biomonitoring activities, if any.

4. Recruit study participants

• Follow the established statistically valid sampling strategy, pre-screen the target population regarding established inclusion criteria

• Conduct sampling and recruitment

• Collect biological specimens, conduct clinical screenings and questionnaire interviews

• Train staff, clinic staff and interviewers.

5. Conduct data collection and biological sample collection

• Use the established personal interview component to conduct interview and administer questionnaire.

• Follow the quality assurance mechanisms for data collection and management, to provide complete and quality data.

• Collect, store, and transport biological samples, e.g., blood and urine, from the consenting participants following the standardized protocols for biological specimen collection, storage, and transport.

6. Conduct laboratory measurements to determine levels of environmental chemicals in participants

• Measure the following chemicals in biological samples: PCBs (congeners 28, 52, 101, 105, 118, 138, 153, 180), mercury, lead, mirex, hexachlorobenzene, DDT/DDE, and perfluorinated compounds (perfluorooctanoic acid or PFOA, and, perfluorooctane sulfonate or PFOS).

• Identify additional emerging contaminants that may be included in the study, and provide justification for such selection. Emerging contaminants of concern found in the Great Lakes, including but not limited to, brominated flame retardants (BFRs), polycyclic aromatic hydrocarbons (PAHs), and alkylphenols, are examples of contaminants that may be selected. Because these chemicals of emerging concerns can come from many sources other than consuming fishes from the Great Lakes, appropriate considerations must be taken when designing and conducting the biomonitoring program.

• The designated laboratory or laboratories process and analyze biological specimens for required and optional environmental chemicals or biomarkers, following established analytical, quality assurance, and quality control protocols.

• The laboratory must provide documentation of participation in an external proficiency testing program(s) covering the period of laboratory measurements.

• Provide feedback, e.g., result letters, to participants

7. Produce written assessment

• Analyze data to assess human exposure to environmental chemicals.

• Produce and disseminate a written assessment of the biomonitoring study results. Results should include an assessment of analytes based on percentile levels in study participants relative to NHANES data and other appropriate population-based study results; and, an assessment of the potential influence of exposure parameters collected in the biomonitoring questionnaire interview.

• Provide de-identified data of established quality to ATSDR via secure transfer.

http://www.cdc.gov/niosh/nas/mining/pdfs/Protocol%20Checklist.pdf

8. Produce data use plan

• Develop a plan to use the biomonitoring data to identify, control and prevent potential adverse exposures associated with Great Lakes pollutants, and, to guide public health actions to advance the protection of people in their jurisdiction who are at increased exposure risks to Great Lakes contaminants.

Communication and Outreach

9. Develop communication and outreach plan for the target or at risk populations, key audiences and stakeholder, and general populations.

• Produce study brochures and outreach materials

10. Communicate data & findings to key audiences as outlined in the communication and outreach plan

11. Conduct outreach activities on the risk and benefit of fish consumption during both data collection and result dissemination phases, through multiple channels, including but not limited to website, mail-outs, community meetings, and health fairs.

Collaboration

12. Engage stakeholders and establish advisory committee

• The awardee will establish an advisory committee to assist with consensus building, cooperation, and planning for the state biomonitoring program. Representatives may include intrastate agencies, tribes, universities, and public or nonprofit private agencies, institutions, organizations in their geographic region and others deemed appropriate. (Note: This advisory committee will not be established or utilized by ATSDR or any other component of the federal government.)

• The advisory committee, or a sub-committee if necessary, should also provide guidance on ethical issues that arise from biomonitoring studies such as informed consent in the use of newly collected and archived samples, individual notification of results, interpretation and dissemination of results to the affected subpopulation and plans for action.

13. Collaborate with state, tribal, local, and other federal partners in biomonitoring activities and projects.

Note: In accordance with the Paperwork Reduction Act, ATSDR must obtain approval from the White House Office of Management and Budget (OMB) prior to initiating any program related data collection activities.

1.Collaborations Applicants are expected to use or develop strategic partnerships that best suit their needs in order to carry out all required activities required. Some state health departments and/or tribal entities may not have all of the technical expertise to conduct a biomonitoring project on this scale. Hence, this cooperative agreement allows for and encourages eligible applicants to partner with other organizations, including universities, non-profit and for-profit organizations, and faith-based organizations, to carry out all planned activities.

Applicants must file the MOU or MOA, as appropriate, name the file “MOUs/MOAs”, and upload it as a PDF file at www.grants.gov.

Applicants must file letters of support, as appropriate, name the file “Letters of Support”, and upload it as a PDF file at www.grants.gov.

Letters of support need to be provided for collaborations with intrastate agencies, tribes, universities, and public or nonprofit private agencies, institutions, organizations in your geographic region and others deemed appropriate.

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

Applicants are encouraged to collaborate with states previously or currently funded by ATSDR’s Great Lakes Biomonitoring cooperative agreements (New York, Michigan, and Minnesota) to share expertise and learn about program challenges and successes.

Applicants may also consider collaborating with state programs that receive funding through:

• ATSDR’s State Cooperative Agreement Program to build capacity to assess and respond to site-specific issues involving human exposure to hazardous substances in communities in the U.S.

• CDC’s State-Based Public Health Laboratory Biomonitoring Programs to increase the capability and capacity of state public health laboratories to conduct high-quality biomonitoring science and assess human exposure to environmental chemicals.

• CDC’s Environmental Health Tracking Program to develop a state network to track and report environmental hazards and related health problems.

b. With organizations not funded by CDC:

The awardee is required to establish an advisory committee to assist with consensus building, cooperation, collaboration, planning, communication and outreach for the Great Lakes state biomonitoring program. Representatives may include intrastate agencies, tribes, academic institutions, professional organizations, non-profit organizations, advocacy groups, and community groups in their geographic region, and others deemed appropriate.

The advisory committee, or a sub-committee if necessary, should also provide guidance on ethical issues that arise when conducting biomonitoring studies such as informed consent in the use of newly collected and archived samples, individual notification of results, interpretation and dissemination of results to the affected subpopulation and plans for action.

This advisory committee will not be established or utilized by ATSDR or any other component of the federal government.

2. Target Populations The target populations include those with potential high exposure to contaminants from Great Lakes fish consumption (e.g. subsistence anglers who tend to be low income minority), and/or those who are susceptible to the potential health effect of such chemical exposure (e.g. children, adolescents, women of child-bearing age, and elderly). A subpopulation identified to be at increased risk of exposure to Great Lakes contaminants include racial or ethnic groups with traditional fishing and fish consumption customs, sport anglers and urban poor. Applicants are required to use data, such as social determinant data to identify a subpopulation within their jurisdiction that is at increased risk of exposure to Great Lakes contaminants. The target population must be large enough to recruit a target sample of at least 350 people. The exposure pathway is primarily consumption of locally caught fish, but lifestyles associated with contaminated waters/sediments/soil will also be considered.

a. Inclusion N/A

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

b. Evaluation and Performance Measurement

8. Produce data use plan

• Develop a plan to use the biomonitoring data to identify, control and prevent potential adverse exposures associated with Great Lakes pollutants, and, to guide public health actions to advance the protection of people in their jurisdiction who are at increased exposure risks to Great Lakes contaminants.

Communication and Outreach

9. Develop communication and outreach plan for the target or at risk populations, key audiences and stakeholder, and general populations.

• Produce study brochures and outreach materials

10. Communicate data & findings to key audiences as outlined in the communication and outreach plan

11. Conduct outreach activities on the risk and benefit of fish consumption during both data collection and result dissemination phases, through multiple channels, including but not limited to website, mail-outs, community meetings, and health fairs.

Collaboration

12. Engage stakeholders and establish advisory committee

• The awardee will establish an advisory committee to assist with consensus building, cooperation, and planning for the state biomonitoring program. Representatives may include intrastate agencies, tribes, universities, and public or nonprofit private agencies, institutions, organizations in their geographic region and others deemed appropriate. (Note: This advisory committee will not be established or utilized by ATSDR or any other component of the federal government.)

• The advisory committee, or a sub-committee if necessary, should also provide guidance on ethical issues that arise from biomonitoring studies such as informed consent in the use of newly collected and archived samples, individual notification of results, interpretation and dissemination of results to the affected subpopulation and plans for action.

13. Collaborate with state, tribal, local, and other federal partners in biomonitoring activities and projects.

Note: In accordance with the Paperwork Reduction Act, ATSDR must obtain approval from the White House Office of Management and Budget (OMB) prior to initiating any program related data collection activities.

1.Collaborations Applicants are expected to use or develop strategic partnerships that best suit their needs in order to carry out all required activities required. Some state health departments and/or tribal entities may not have all of the technical expertise to conduct a biomonitoring project on this scale. Hence, this cooperative agreement allows for and encourages eligible applicants to partner with other organizations, including universities, non-profit and for-profit organizations, and faith-based organizations, to carry out all planned activities.

Applicants must file the MOU or MOA, as appropriate, name the file “MOUs/MOAs”, and upload it as a PDF file at www.grants.gov.

Applicants must file letters of support, as appropriate, name the file “Letters of Support”, and upload it as a PDF file at www.grants.gov.

Letters of support need to be provided for collaborations with intrastate agencies, tribes, universities, and public or nonprofit private agencies, institutions, organizations in your geographic region and others deemed appropriate.

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

Applicants are encouraged to collaborate with states previously or currently funded by ATSDR’s Great Lakes Biomonitoring cooperative agreements (New York, Michigan, and Minnesota) to share expertise and learn about program challenges and successes.

Applicants may also consider collaborating with state programs that receive funding through:

• ATSDR’s State Cooperative Agreement Program to build capacity to assess and respond to site-specific issues involving human exposure to hazardous substances in communities in the U.S.

• CDC’s State-Based Public Health Laboratory Biomonitoring Programs to increase the capability and capacity of state public health laboratories to conduct high-quality biomonitoring science and assess human exposure to environmental chemicals.

• CDC’s Environmental Health Tracking Program to develop a state network to track and report environmental hazards and related health problems.

b. With organizations not funded by CDC:

The awardee is required to establish an advisory committee to assist with consensus building, cooperation, collaboration, planning, communication and outreach for the Great Lakes state biomonitoring program. Representatives may include intrastate agencies, tribes, academic institutions, professional organizations, non-profit organizations, advocacy groups, and community groups in their geographic region, and others deemed appropriate.

The advisory committee, or a sub-committee if necessary, should also provide guidance on ethical issues that arise when conducting biomonitoring studies such as informed consent in the use of newly collected and archived samples, individual notification of results, interpretation and dissemination of results to the affected subpopulation and plans for action.

This advisory committee will not be established or utilized by ATSDR or any other component of the federal government.

2. Target Populations The target populations include those with potential high exposure to contaminants from Great Lakes fish consumption (e.g. subsistence anglers who tend to be low income minority), and/or those who are susceptible to the potential health effect of such chemical exposure (e.g. children, adolescents, women of child-bearing age, and elderly). A subpopulation identified to be at increased risk of exposure to Great Lakes contaminants include racial or ethnic groups with traditional fishing and fish consumption customs, sport anglers and urban poor. Applicants are required to use data, such as social determinant data to identify a subpopulation within their jurisdiction that is at increased risk of exposure to Great Lakes contaminants. The target population must be large enough to recruit a target sample of at least 350 people. The exposure pathway is primarily consumption of locally caught fish, but lifestyles associated with contaminated waters/sediments/soil will also be considered.

a. Inclusion N/A

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

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy ATSDR will evaluate program planning, implementation, start-up and progress to assess whether program performance adheres to the guidelines in the FOA plan.

Performance measures will be used to guide continuous program improvement and evaluate the success of this FOA to implement a biomonitoring study in a well-defined, at risk target subpopulation of residents in the Great Lakes Basin and assess human exposure to Great Lakes contaminants within their jurisdictions.

The evaluation component will examine whether the program 1) plans the appropriate activities, 2) meets scheduled project milestones and deadlines, and 3) completes the program within the project period. These measures will align closely to the activities and outputs depicted in the logic model and the elaboration of these in the work plan section.

Key evaluation questions and metrics of performance throughout the project period will include:

• Does the awarded program establish effective advisory committees and…