PKG00248173-instructions.pdf

Centers for Disease Control

National Center for Environmental Health

State-Based Public Health Laboratory Biomonitoring Programs

CDC-RFA-EH19-1901

Application Due Date: 04/26/2019

State-Based Public Health Laboratory Biomonitoring Programs

CDC-RFA-EH19-1901

TABLE OF CONTENTS

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

Part II. Full Text A. Funding Opportunity Description B. Award Information C. Eligibility Information D. Required Registrations 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-EH19-1901. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) B. Notice of Funding Opportunity (NOFO) Title:

State-Based Public Health Laboratory Biomonitoring Programs C. Announcement Type: New - Type 1 This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https ://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf.

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

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-EH19-1901

E. Assistance Listings (CFDA) Number:

93.070 F. Dates:

1. Due Date for Letter of Intent (LOI): 03/15/2019 Is a LOI: Recommended but not Required

2. Due Date for Applications: 04/26/2019, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

3. Date for Informational Conference Call: 02/19/2019 Informational conference calls covering identical content will be held on Tuesday, February 19, 2019, 10:00-11:00 a.m. EST and Thursday, February 21, 2019, 4:30-5:30 p.m. EST. Join by phone 770-488-3600 or (855) 644-0229; conference ID: 5661594 Join Skype Meeting

G. Executive Summary:

1. Summary Paragraph:

The purpose of this notice of funding opportunity is to increase the capability and capacity of state public health laboratories to conduct high-quality biomonitoring science and assess human exposure to environmental chemicals within their jurisdictions. Improved exposure assessment will enable states to reduce or eliminate exposure to certain environmental chemicals by helping to identify at-risk population groups and assess the effectiveness of interventions to reduce harmful exposures.

Applicants may propose biomonitoring activities based on one or all of the following strategies:

state-wide population surveillance, targeted investigations, and rapid response. Recipient activities will include biomonitoring to assess exposures of concern, enhancement of laboratory https://www.grants.gov https://www.grants.gov https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html https://www.grants.gov https://webconf.cdc.gov/iop2/YC0LZ74J capability/expertise, coordination/collaboration with partners to improve exposure investigations, and reporting of findings to key audiences.

As a result of recipient activities, CDC anticipates the following outcomes during the period of performance: increased use of biomonitoring to track state-specific exposures and reduce harmful chemical exposures, improved nationwide biomonitoring capacity and capability, greater efficiency and stronger collaborations in conducting biomonitoring, increased awareness of the value of biomonitoring among the general population and scientific community, and improved quality of chemical exposure assessment across the U.S.

a. Eligible Applicants: Open Competition

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 6

d. Total Period of Performance Funding: $25,000,000

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

Component A and/or B: $350,000 - $1,000,000 Component C: not to exceed $400,000

f. Number of Years of Award: 5

g. Estimated Award Date: 09/01/2019

h. Cost Sharing and / or Matching Requirements: N

Part II. Full Text A. Funding Opportunity Description

1. Background

a. Overview Every day people are exposed to potentially harmful chemicals in their environment from the air, water, soil, food and consumer products. Biomonitoring is the direct measurement of environmental chemicals, or their products, in people's blood and urine. Biomonitoring measurements are the most health-relevant assessments of people's exposure, representing the amount of chemical that enters the body from all environmental sources.

The National Biomonitoring Program at the Centers for Disease Control and Prevention (CDC) develops unique, high-quality biomonitoring methods to measure synthetic and naturally occurring environmental chemicals. CDC also conducts the most comprehensive, ongoing assessment of the U.S. population's exposure to environmental chemicals using biomonitoring of participants in the National Health and Nutrition Examination Survey (NHANES). CDC publishes findings and national reference ranges in peer-reviewed literature and in a periodically updated summary report, the National Report on Human Exposure to Environmental Chemicals.

CDC's biomonitoring data are nationally representative and do not provide exposure information by specific state or locality. The purpose of this notice of funding opportunity (NOFO) is to increase the capability and capacity of state public health programs to conduct high-quality biomonitoring science, assess human exposure to environmental chemicals within their jurisdictions, and provide biomonitoring data to inform actions that reduce or eliminate human exposure to harmful environmental chemicals.

As a result of recipient activities, CDC anticipates the following outcomes during the period of performance: increased use of biomonitoring to track state-specific exposures and reduce harmful chemical exposures, improved nationwide biomonitoring capacity and capability, greater efficiency and stronger collaborations in conducting biomonitoring, increased awareness of the value of biomonitoring among the general population and scientific community, and improved quality of chemical exposure assessment across the U.S.

Applicants must demonstrate substantial integration in the public health system. Biomonitoring investigations involve community engagement and results reporting to participants. Collaboration with epidemiologists to develop detailed communication plans and community engagement are important in establishing successful biomonitoring programs. Therefore, this NOFO places considerable emphasis on strong collaborations between the laboratory and epidemiologists.

Applicants have the opportunity to develop biomonitoring activities using existing laboratory infrastructure to assess environmental exposures through a multi-component level approach.

Applicants can select one or both of the following components: Component A, programs conducting state-wide population surveillance; Component B, programs conducting targeted investigations and/or emergency response. Applicants may apply for an optional Component C to purchase analytical equipment to support biomonitoring methods.

Component A: State-wide Population Surveillance supports biomonitoring investigations that establish reference exposure levels or monitor trends in exposure for chemicals of concern based on a state-wide representative sample of the population within the state and territorial jurisdictions.

Component B: Targeted Investigations support assessment of population exposures in response to a community health concern or discovery of chemical contamination. Rapid Response supports urgent biomonitoring analysis in response to emergencies such as ingestion of contaminated food, uncontrolled releases to air and water, or chemical spills at work or in the community.

(Optional) Component C: Equipment funding for recipients to purchase analytical biomonitoring equipment. This limited funding for Component C is based on availability of funds and the laboratory demonstrating a bona fide need for equipment.

b. Statutory Authorities Section 317 of the Public Health Service Act, [42 U.S.C. Section 247b], as amended.

c. Healthy People 2020 This NOFO directly addresses the Healthy People 2020 theme of Infrastructure and Surveillance in the Environmental Health topic area. Funding to support state biomonitoring activities will increase national capacity for investigating and responding to disease, monitoring hazards, and educating the public. For more information, see http://healthypeople.gov/2020/topicsobjective s2020/objectiveslist.aspx?topicId=12 http://healthypeople.gov/2020/topicsobjectives2020/objectiveslist.aspx?topicId=12 http://healthypeople.gov/2020/topicsobjectives2020/objectiveslist.aspx?topicId=12

d. Other National Public Health Priorities and Strategies n/a

e. Relevant Work This activity builds on previous, successful CDC-funded programs to establish and expand national capacity to conduct high-quality biomonitoring science in state public health laboratories. In 2001, CDC launched a grant program to support biomonitoring capacity-building in state public health laboratories. CDC awarded funding via PA 01072, Public Health Laboratory Biomonitoring Planning Grant (http://www.gpo.gov/fdsys/pkg/FR-2001-05-04/html/01-11215 .htm), to 22 individual states and 11 states in consortium to develop plans for implementing or expanding biomonitoring programs at the state level. In 2003, CDC funded two individual states (New York and New Hampshire) and six states in consortium (Montana, Wyoming, Utah, Colorado, Arizona, and New Mexico) to implement those biomonitoring program plans via PA 03034, Public Health Laboratory Biomonitoring Implementation Program (http://www.gpo.gov /fdsys/pkg/FR-2003-04-03/html/03-8062.htm). In 2009, CDC awarded five-year funding to three additional individual states (California, New York, and Washington, http://www.cdc.gov/biomo nitoring/state_grants.html) via CDC-RFA-EH09-902, State-Based Public Health Laboratory Biomonitoring Programs. In 2014, CDC awarded five-year funding to six recipients including five individual states and one consortium via CDC-RFA-EH14-1402, State-Based Public Health Laboratory Biomonitoring Programs. The states funded include California, New Hampshire, Massachusetts, New Jersey, Virginia, and the 4 Corners States Biomonitoring Consortium (Utah, Colorado, New Mexico, Arizona). Through this NOFO, recipients are expected to further increase use of biomonitoring to track state-specific exposures and reduce harmful chemical exposures.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

The following high-level logic model is a visual representation of the program approach and demonstrates how the strategies and outcomes are related. In the Strategies and Activities section, the strategies apply to both Components A and B, unless noted as an activity for a specific component. The short-term outcomes focus on building laboratory capacity and developing effective biomonitoring approaches. The intermediate outcomes are capabilities that are expected to enhance biomonitoring data impact. The long term outcomes are to improve quality of chemical exposure assessment across the US. This logic model applies to both Component A and B activities.

CDC-RFA-EH19-1901 Logic Model: State-Based Public Health Laboratory Biomonitoring Programs Bold indicates period of performance outcome

Strategies and Short-term Outcomes Intermediate Outcomes Long-Term Outcomes http://www.gpo.gov/fdsys/pkg/FR-2001-05-04/html/01-11215.htm http://www.gpo.gov/fdsys/pkg/FR-2001-05-04/html/01-11215.htm http://www.gpo.gov/fdsys/pkg/FR-2003-04-03/html/03-8062.htm http://www.gpo.gov/fdsys/pkg/FR-2003-04-03/html/03-8062.htm http://www.cdc.gov/biomonitoring/state_grants.html http://www.cdc.gov/biomonitoring/state_grants.html

Activities

Biomonitoring

Develop measures on state-specific environmental chemical exposures

Enhanced data on state-specific environmental chemical exposures

Improved response to exposures above a known toxicity threshold

Increased use of high-quality laboratory methods for biomonitoring

High quality and interpretable data to inform actions to reduce harmful chemical exposures

Increased ability to track state-specific exposures

Increased use of biomonitoring to asses harmful environmental chemical exposures

Improved quality of chemical exposure assessment across the US

Reduction or elimination of human exposure to harmful environmental chemicals

Capability/Expertise

Develop quality data collection for biomonitoring activities

Increased capability, capacity, and expertise in biomonitoring sciences

CLIA

compliance for new and existing biomonitoring laboratory methods

Improved nationwide biomonitoring capacity

High-quality biomonitoring techniques used nationwide

Coordination/Collaboration

Develop and maintain results driven partnerships that enhance

Stronger and improved collaborations for biomonitoring

A network of programs to advance the science and activities activities quality of biomonitoring

Reporting

Communicate results with participants

Publish interpretable results to inform policy

Increased awareness about environmental chemical exposures in states

Improved knowledge about chemical exposures among the scientific community

Increased awareness of the value of biomonitoring among the general population

i. Purpose The purpose of this notice of funding opportunity is to increase the capability and capacity of state public health programs to conduct high-quality biomonitoring science and assess human exposure to environmental chemicals within their jurisdictions. Improved exposure assessment will enable states to reduce or eliminate exposure to certain environmental chemicals by helping to identify at-risk population groups and assess the effectiveness of interventions to reduce harmful exposures.

ii. Outcomes During the period of performance, a successful recipient will execute the strategies and activities to improve assessment of harmful chemical exposures. Recipients conducting biomonitoring investigations should work toward the bolded short-term and intermediate outcomes outlined in the logic model. The long-term outcomes will contribute to reducing the US populations' exposure to harmful environmental chemicals. The short-term and intermediate outcomes for the first period of performance include:

Short-Term

Enhanced data on state-specific environmental chemical exposures Improved response to exposures above a known toxicity threshold Increased capability, capacity, and expertise in biomonitoring sciences Increased use of high-quality laboratory methods for biomonitoring Clinical Laboratory Improvement Act (CLIA) compliance for new and existing biomonitoring laboratory methods Stronger collaborations between the laboratory, epidemiologists, and environmental health stakeholders

Increased awareness about environmental chemical exposures in targeted populations

Intermediate

High quality and interpretable data to inform actions to reduce harmful chemical exposures

iii. Strategies and Activities Recipients are expected to implement the strategies and activities below through developing biomonitoring approaches, laboratory methods, laboratory analysis, reporting results and collaborating with key stakeholders. The strategies and activities apply to both Components A and B, unless otherwise noted.

Biomonitoring: Activities to improve measurements on state-specific environmental chemical exposures through high quality laboratory methods and well-designed biomonitoring approaches.

Determine levels of environmental chemicals in people and potential sources of exposure through laboratory analyses

Use laboratory data to assess exposures in targeted populations, population-based surveillance, or emergency response

Monitor exposure over time and track trends Follow guidance on best biomonitoring practices developed by key stakeholders (Component A) Use laboratory data to assess exposure in population-based surveillance (Component B) Use laboratory data to assess exposure in targeted populations (Component B) Use laboratory data to assess exposure in emergency response

Capability/Expertise: Activities to improve operational capacity and ensure quality data collection for biomonitoring approaches.

Build state workforce capabilities/capacity/competency in biomonitoring sciences Participate in CDC-sponsored biomonitoring training/technical assistance CLIA compliant for all biomonitoring methods Share laboratory methods during development for CDC technical input

Coordination/Collaboration: Activities to build and maintain results driven partnerships that enhance biomonitoring approaches

Use existing collaborations to investigate exposures Collaborate with state epidemiologists or health department Collaborate with other award recipients to ensure quality practices Establish & use advisory panel Participate in the Association of Public Health Laboratories' (APHL) National

Biomonitoring Network

Reporting: Activities to communicate results with participants and publish interpretable results to inform policy changes.

Develop and implement a Data Management Plan Develop risk communication plans for reporting data back to biomonitoring participants Communicate data & findings to key audiences Track public health impact of biomonitoring

1. Collaborations Applicants are expected to use or develop strategic partnerships in order to maximize the use of resources, improve the sustainability of state biomonitoring programs, and ensure appropriate expertise toward planning biomonitoring investigations, interacting with communities, and reporting meaningful biomonitoring results. Collaborations should be used to streamline exposure assessment by making use of previously collected, suitable samples or other existing groundwork for biomonitoring investigations.

Applicants can apply as consortia to share resources for biomonitoring activities. Applicants must provide letters of support, a memorandum of understanding (MOU), memorandum of agreement (MOA), or other formal documentation for established collaborations, including a direct or administrative partnership with each state health department they plan to work with.

When uploading supporting documentation for collaborations into this application package, clearly label the documents for easy identification of the type of documentation. For example, an MOA with the state public health department may be labeled using the following format: Collaboration Supporting Documents _ MOA with SPHD.

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

Applicants are encouraged to collaborate with CDC-funded programs at the state level to support high quality biomonitoring approaches. Examples of such programs include:

The Agency for Toxic Substances and Disease Registry's (ATSDR) State Cooperative Agreement Program which builds capacity to assess and respond to site-specific issues involving human exposure to hazardous substances in communities in the U.S.

CDC's Environmental Health Tracking Program which develops a state network to track and report environmental hazards and related health problems.

CDC's Public Health Emergency Preparedness program and Laboratory Response Network (LRN) which builds and strengthens the ability to respond to public health incidents.

b. With organizations not funded by CDC:

Applicants may consider collaboration with existing state biomonitoring programs funded by states (not currently funded by CDC) to share expertise and program challenges and successes.

Applicants may also consider appropriate collaboration with and support from biomonitoring stakeholders to accomplish diverse activities. Potential collaborators may include, but are not limited to: academic institutions, professional organizations, non-profit organizations, advocacy groups, community groups, and public health or environmental officials. Engagement with organizations external to CDC will confirm stakeholder support to implement and sustain a state biomonitoring program.

Applicants must have or propose an advisory committee to assist with planning, collaborations, communication and outreach for biomonitoring programs. Representatives on the committee may include academic institutions, professional organizations, community groups, tribes, health providers, and others deemed appropriate.

The Association of Public Health Laboratories' (APHL) convenes the National Biomonitoring Network (NBN), which may be helpful for recipients to join. This network is a collaboration of federal, regional, state and local laboratories that conduct biomonitoring for use in public health practice and in response to environmental emergencies. To join the NBN, laboratories must apply through APHL's website and undergo a laboratory evaluation and review.

2. Target Populations The target populations for this NOFO are based on Components A & B. The NOFO provides funding to develop biomonitoring activities for one or both target populations under these two components:

Component A and B address populations and communities within the applicants' jurisdiction:

Component A: State-wide population surveillance - This activity involves assessing exposure of the state-wide population to environmental chemicals and toxic substances using a systematic approach.

Component B: Targeted Investigations & Rapid Response -These activities involve assessing exposures in response to a community health concern or discovery of chemical contamination, or support urgent biomonitoring analysis in response to emergencies.

Applicants should identify which component strategy the program will conduct for each biomonitoring approach. The programs proposal should include strategies and activities that will help to achieve the outcomes of the biomonitoring investigations.

a. Health Disparities N/A

iv. Funding Strategy (for multi-component NOFOs only) This NOFO is to support programs who can demonstrate the capability and capacity to measure environmental biomarkers of exposure within their jurisdictions. Applicants apply for NOFO components A, B, and C to directly support biomonitoring activities throughout the duration of the five-year cooperative agreement. Applicants should submit one project and budget narrative that will include all activities for either one or all Components A, B, and C. The applicant should describe each biomonitoring approach as either component A or B in the project narrative.

Component A (state-wide population surveillance) activities involves a complex biomonitoring approach to assess biomarkers of exposure across an entire state, region or jurisdiction. The strategies associated with this approach will require additional funding to support the programs activities and outcomes to conduct state-wide biomonitoring.

Component B (targeted investigations or rapid response) activities involve a complex biomonitoring approach but may not assess exposure across an entire state, region or jurisdiction. The strategies involved with this approach are unique to a single community, demographic, or exposure site.

Component C (equipment purchases) is based on availability of funds and a bona fide need.

Applicants can apply for additional funding under component C to purchase laboratory equipment in years 1 & 2 of the cooperative agreement.

This funding opportunity will use a two-part strategy to award recipients based on funding availability:

Funding Strategy 1: Funding under this strategy is to award recipients for either one or both components A and B. Applications submitted under this funding opportunity will be reviewed objectively as described in the Review and Selection Process section of this NOFO. Recipients will receive funding based on the size and the complexity of the biomonitoring sampling approach, sample collection strategies, sample analysis, and results reporting for state-wide population surveillance, targeted investigations and/or rapid response. Applicants will not be penalized for selecting only one component category. Applicants should develop activities based on the organizational capacity and capability to complete project outcomes.

Funding Strategy 2: Funding under this strategy is to award recipients for component C. To strengthen laboratory capability and capacity, applicants funded under Funding Strategy 1 will have the opportunity to receive funding to enhance infrastructure through the purchase of analytical equipment for analysis of clinical biomonitoring samples. The objective review panel during the initial NOFO merit review will select the Year 1 and Year 2 recipients of Component C funding.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy CDC's evaluation and performance measurement strategy will evaluate recipient's achievement of desired outcome success during the period of performance. Performance measures will be used to guide continuous program improvement and evaluate the success of this notice of funding opportunity.

Recipients will report on the following specific performance measures on key strategies and activities related to biomonitoring; capability/expertise; coordination/collaboration; and reporting from the logic model.

Biomonitoring Performance Measures:

Number of biomonitoring laboratory methods developed and validated for measuring environmental chemicals reported in NHANES

Developed and implemented systematic biomonitoring approach for sample collection in the recipients jurisdiction

Number of references by key stakeholders for guidance on best biomonitoring practices to develop biomonitoring activities

(Component A) Number of sub-state regions included in the state-wide biomonitoring surveillance approach

(Component B) Developed and implemented relevant biomonitoring approach for specific targeted investigations

(Component B) Reasonable response time for emergency response activities

Capability/Expertise Performance Measures:

Number of appropriate staff supporting biomonitoring activities Number of appropriate trainings for biomonitoring staff Number of highly complex analytical instruments maintained and used for biomonitoring analysis Number of laboratory methods shared with CDC for quality review CLIA compliance and certification for all biomonitoring methods

Coordination/Collaboration Performance Measures:

Developed an integrated collaboration with the state health department for biomonitoring activities

Developed integrated collaborations with federal and non-federal partners Participation in recipient activities held by CDC or key stakeholders Number of advisory board meetings held and summary of recommendations for biomonitoring activities Participation in the Association of Public Health Laboratories' (APHL) National

Biomonitoring Network

Reporting Performance Measures:

Developed and implemented a Data Management Plan (DMP) Developed and implemented a risk communication plan for reporting data back to biomonitoring participants Number of different communication approaches on biomonitoring activities with key audiences Developed tracking plan to evaluate the public health impact of biomonitoring in the recipients jurisdiction

Outcome Measures Recipients must submit outcome performance measures throughout the five-year period of performance related to the short-term outcomes from the logic model.

Enhanced data on state-specific environmental chemical exposures. Program Measure: Number of previously unavailable biomonitoring results measured during the period of performance

Improved response to exposures above a known toxicity threshold. Program Measure:

Development of risk communication plan for exposure to chemicals with a known toxicity threshold

Clinical Laboratory Improvement Act (CLIA) compliance for new and existing biomonitoring laboratory methods. Program Measure: Successful CLIA surveys for all validated biomonitoring methods

Stronger collaborations between the laboratory, epidemiologists, and environmental health stakeholder. Program Measure: Number of integrated collaborations between the laboratory, epidemiologists, and environmental health stakeholders

Increased awareness about environmental chemical exposures in targeted population. Program Measure: Development and implementation of biomonitoring communication plan for targeted populations

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

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

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

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

Plans for updating the Data Management Plan (DMP), if applicable, for accuracy throughout the lifecycle of the project. The DMP should provide a description of the data that will be produced using these NOFO funds; access to data; data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations; and archival and long-term data preservation plans. For more information about CDC’s policy on the DMP, see https://www.cdc.gov/grants/additionalrequirements/ar-25.html.

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

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

Describe key evaluation questions to be addressed by these evaluations.

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

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

c. Organizational Capacity of Recipients to Implement the Approach Applicants must have an active public health laboratory and demonstrate legal authority to conduct biomonitoring investigations. Applicants must demonstrate existing laboratory https://www.cdc.gov/grants/additionalrequirements/ar-25.html infrastructure to conduct biomonitoring including: equipment, laboratory space, staff with appropriate technical and administrative expertise, and collaborative partnerships. Applicants must provide documentation of Clinical Laboratory Improvement Act of 1988 (CLIA) certification. If a bona fide agent conducts biomonitoring analyses, then the bona fide agent must provide CLIA documentation as well as documentation of the mechanism (e.g., contract) under which they perform measurements for the state.

Organizational capacity provides an opportunity for applicants to demonstrate their ability to execute the biomonitoring strategies and activities and achieve its outcomes. Applicants should have adequate infrastructure, communication systems, and workforce capacity and competence to execute the award.

d. Work Plan Applicants must construct a logical, stepwise work plan including a detailed plan that covers the first year of the period of performance and a high level plan for subsequent years. The work plan must demonstrate alignment between activities (with appropriate performance measures or milestones for accomplishing tasks) and achievement of the NOFO period of performance outcomes shown in the logic model. Applicants must designate the appropriate component strategies (A, B, and/or C) and corresponding activities for each component. The work plan should address the following:

Activities and timeline to support achievement of NOFO outcomes Specific public health needs the state biomonitoring program will address Personnel and equipment to support implementation of the award Validation and continuous quality assessment of laboratory methods Internal and external training for staff Activities to establish and maintain an advisory panel or seek citizen/stakeholder input Communication plans for reporting laboratory findings to biomonitoring participants and/or publishing findings in peer reviewed literature Protocol for follow-up and treatment referral in response to exposures above a known toxicity threshold Collaboration with other biomonitoring stakeholders Evaluation and assessment processes to ensure successful implementation and quality assurance

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

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

Tracking recipient progress in achieving the desired outcomes.

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

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

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

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

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

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

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

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

CDC will also monitor recipients' activities to demonstrate biomonitoring capability through documented method validation, demonstration of competency, and independent CLIA certification by:

Review of CLIA certifications annually for all biomonitoring methods Review of laboratory biomonitoring methods and publications

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

COOPERATIVE AGREEMENTS)

In a cooperative agreement, CDC and recipients share responsibility for successfully implementing the award and meeting identified outcomes. The following are potential areas of substantial involvement, others may also be included:

Analytical method training at CDC for selected chemicals or groups of chemicals Analytical method transfer to state public health laboratories Quality assessment testing services to laboratories for selected, existing CDC methods Technical review and consultation on biomarker and matrix selection, sample collection, and other aspects of laboratory method and biomonitoring investigation design Assistance in developing and evaluating laboratory methods, especially with respect to

Quality Assurance/ Quality Control (QA/QC) Technical review of final laboratory method Technical review of scientific manuscripts and/or other documents disseminating biomonitoring findings before submission for publication Facilitation of communication among recipients and other active biomonitoring programs Facilitation of use of select reference materials to promote comparability of biomonitoring findings Assistance in developing training materials for laboratory methods, evaluations, risk communication, and other topics for state biomonitoring programs Convene recipients to facilitate information exchange and collaboration

B. Award Information

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

2. Award Mechanism: U88 U88, Services Demonstration - Cooperative Agreements

3. Fiscal Year: 2019 Estimated Total Funding: $25,000,000

4. Approximate Total Fiscal Year Funding: $5,000,000

This amount is subject to the availability of funds.

5. Approximate Period of Performance Funding: $25,000,000 Throughout the period of performance, CDC will continue the award based on the availability of funds, the evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the federal government. The total number of years for which federal support has been approved (period of performance) will be shown in the Notice of Award. This information does not constitute a commitment by the federal government to fund the entire period. The total period of performance comprises the initial competitive segment and any subsequent non-competitive continuation award(s).

6. Total Period of Performance Length: 5

7. Expected Number of Awards: 6

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

Component A and/or B: $350,000 - $1,000,000 Component C: not to exceed $400,000

This amount is subject to the availability of funds.

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

10. Award Floor: $350,000 Per Budget Period

11. Estimated Award Date: 09/01/2019

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

12. Budget Period Length: 12 month(s)

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

C. Eligibility Information

1. Eligible Applicants Eligibility Category: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

Additional Eligibility Category:

Government Organizations:

State (includes the District of Columbia) Local governments or their bona fide agents Territorial governments or their bona fide agents in the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.

State controlled institutions of higher education

American Indian or Alaska Native tribal governments (federally recognized or state-recognized)

Non-government Organizations:

American Indian or Alaska native tribally designated organizations

Other:

Private colleges and universities Community-based organizations Faith-based organizations

2. Additional Information on Eligibility N/A

3. Justification for Less than Maximum Competition N/A

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

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

D. Required Registrations

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

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

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

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

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

b. System for Award Management (SAM): The SAM is the primary registrant database for the federal government and the repository into which an entity must submit information required to conduct business as a recipient. All applicant organizations must register with SAM, and will be assigned a SAM number. All information relevant to the SAM number must be http://www.cdc.gov/od/pgo/funding/docs/FinancialReferenceGuide.pdf http://www.cdc.gov/od/pgo/funding/docs/FinancialReferenceGuide.pdf https://www.grants.gov/ http://fedgov.dnb.com/webform/displayHomePage.do current at all times during which the applicant has an application under consideration for funding by CDC. If an award is made, the SAM information must be maintained until a final financial report is submitted or the final payment is received, whichever is later. The SAM registration process can require 10 or more business days, and registration must be renewed annually. Additional information about registration procedures may be found at www.SAM.gov.

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

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

Step System Requirements Duration Follow Up 1 Data

Universal Number System

(DUNS)

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

2. Select Begin DUNS search/request process

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

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

1-2 Business Days To confirm that you have been issues a new DUNS number check online at (http:// fedgov.dnb.

com/ webform) or call 1-866-705-

2 System for Award Management

(SAM)

formerly Central Contractor Registration

(CCR)

1. Retrieve organizations DUNS number

2. Go to www.sam.gov and designate an E-Biz POC (note CCR username will not work in SAM and you will need to have an active SAM account before you can register on grants.gov)

3-5 Business Days but up to 2 weeks and must be renewed once a year

For SAM Customer Service Contact https://fsd.gov/fsd-gov/home.do Calls: 866-606-

3 Grants.gov 1. Set up an individual account in Grants.gov using organization new DUNS number to become an authorized organization representative (AOR)

2. Once the Account is set up the E_BIZ POC will be

Same day but can take 8 weeks to be fully registered and approved in the system (note, applicants MUST obtain a DUNS number and SAM account before applying to grants.gov)

Register early! Log into Grants.gov and check AOR status until it shows you have been approved https://www.sam.gov/portal/public/SAM/ https://grants.gov/ https://www.grants.gov/ http://www.grants.gov https://www.grants.gov/ http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://www.sam.gov https://fsd.gov/fsd%20-gov/home.do https://fsd.gov/fsd%20-gov/home.do notified via email

3. Log into grants.gov using the password the E- BIZ POC received and create new password

4. This authorizes the AOR to submit the applications on behalf of the organization

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

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

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

OGS.

a. Letter of Intent Deadline (must be emailed or postmarked by) Due Date for Letter of Intent: 03/15/2019

b. Application Deadline Due Date for Applications: 04/26/2019 , 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov. If Grants.gov is inoperable and cannot receive applications, and circumstances preclude advance notification of an extension, then applications must be submitted by the first business day on which grants.gov operations resume.

Date for Informational Conference Call: 02/19/2019 Informational conference calls covering identical content will be held on Tuesday, February 19, 2019, 10:00-11:00 a.m. EST and Thursday, February 21, 2019, 4:30-5:30 p.m. EST. Join by phone 770-488-3600 or (855) 644-0229; conference ID: 5661594 Join Skype Meeting

5. CDC Assurances and Certifications https://www.grants.gov https://www.grants.gov mailto:ogstims@cdc.gov https://webconf.cdc.gov/iop2/YC0LZ74J

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

Applicants may follow either of the following processes:

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

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

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

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

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

When uploading supporting documentation for the Risk Questionnaire into this application package, clearly label the documents for easy identification of the type of documentation. For example, a copy of Procurement policy submitted in response to the questionnaire may be labeled using the following format: Risk Questionnaire Supporting Documents _ Procurement Policy.

Duplication of Efforts Applicants are responsible for reporting if this application will result in programmatic, http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx https://www.grants.gov http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf budgetary, or commitment overlap with another application or award (i.e.