OD2A in States: Frequently Asked Questions and Answers
Budget Guidance for Surveillance and Prevention Strategies
We received multiple questions related to budget during the Overdose Data to Action in States (OD2A-S) NOFO informational call. The information below clarifies information on the prevention and surveillance budgets, including award amounts anticipated for each surveillance strategy.
The anticipated funding amounts provided below and in the NOFO appendices are a guide for budget preparation. They are not a requirement for spending levels on each strategy (outside of the items listed on page 3), as jurisdictions will have flexibility in allocation of their overall award amount between the prevention and surveillance components, and within the surveillance strategies.
Prevention Funding
Applicants will receive prevention funds based upon their unintentional and undetermined drug overdose death rates for 2021. The 30 states with the highest unintentional and undetermined drug overdose counts will be awarded additional prevention funding. Specific funding levels per state can be found in Appendix 9.
Surveillance Funding
The minimum surveillance funding listed in Appendix 9 includes the following:
- $250,000 for required Strategy 1, “Surveillance Infrastructure” (mentioned on page 17 of the NOFO)
- $150,000 for required Strategy 2, “Morbidity Surveillance,” including funding for annual emergency department discharge data (if unable to meet the monthly syndromic data coverage requirement; mentioned in Appendix 2)
- The dollar amount listed in the last column of Appendix 5, labeled “Anticipated Total SUDORS Funding for Reduced Coverage” for required Strategy 3, “Mortality Surveillance”
The maximum surveillance funding listed in Appendix 9 includes the following:
- $250,000 for required Strategy 1, “Surveillance infrastructure” (mentioned on page 17 of the NOFO)
- $350,000 for required Strategy 2, “Morbidity Surveillance” (mentioned in Appendix 2). This amount includes the following:
- $250,000 for monthly syndromic surveillance data sharing
- $50,000 for optional annual emergency department discharge/billing data sharing (available only for those sharing monthly syndromic data)
- $50,000 for optional annual inpatient hospitalization discharge/billing data sharing (available for those sharing monthly syndromic data or annual emergency discharge/billing data)
- The dollar amount listed in the next to last column of Appendix 5, labeled “Anticipated Total SUDORS Funding” for required Strategy 3, “Mortality Surveillance”
- $350,000 for optional and competitive Strategy 4,“Biosurveillance” (mentioned on page 79 of the NOFO)
- $200,000 for optional and competitive Strategy 5, “Data Linkages” (mentioned on page 79 of the NOFO)
The anticipated funding amounts provided in Appendix 9 are a guide for budget preparation. However, the maximum per strategy may exceed the maximum noted, as jurisdictions will have flexibility in allocation of their overall award amount between the prevention and surveillance components and within the surveillance strategies, with the following exceptions:
- Prevention – Health IT/PDMP
- Up to 20% if PDMP does not meet open standards and open architecture – No minimum
- Up to 30% if PDMP meets open standards and open architecture – No minimum
- Surveillance
- Surveillance Infrastructure – No more than $250,000 for surveillance infrastructure – No minimum level required
- Enhanced Toxicology Testing – Minimum funding level defined in Appendix 5 – No maximum level defined
Example 1: A jurisdiction is funded for the optional and competitive biosurveillance component and needs more than $350,000 to meet the biosurveillance strategy requirements . They do not need the full anticipated CORE funding for SUDORS listed in Appendix 5 to meet the Strategy 3/SUDORS requirements, so some of that funding could be used to meet the biosurveillance requirements.
Example 2: If the core SUDORS funding is insufficient for the jurisdiction’s abstractor staffing needs, funding may be used from surveillance Strategy 1 (Infrastructure) to hire additional SUDORS abstractors.
- Why did CDC reduce the overall funding level for this NOFO?
- In releasing two distinct NOFOs for state and local efforts, CDC allocated funding currently serving city and county health departments to Overdose Data to Action: LOCAL. In addition to funding through the NOFO, CDC is also continuing to offer OD2A staffing support to help implement OD2A activities.
- With the new round of funding, does CDC intend to spend less on Prescription Drug Monitoring Programs (PDMPs) as part of OD2A-S? The NOFO references “the overall prevention budget.” In addition to PDMPs, what does this specifically refer to and how do states account for those expenses?
- This NOFO includes strategies that best position health departments to combat an ever-evolving epidemic now centered around illicitly manufactured fentanyl, while also advancing scalable, equitable PDMP work. Applicants can find estimated prevention budget amounts in Appendix 9. The overall prevention budget includes costs associated with the following strategies: clinician/health system engagement (Strategy 6A); health IT/PDMP enhancement (Strategy 6B, including PDMP costs); public safety partnerships/ interventions (Strategy 7); harm reduction (Strategy 8); and, community-based linkage to care (Strategy 9).
- Could you provide a specific example of how a state would calculate the prevention budget?
- Applicants can use Appendix 9 to determine their anticipated prevention funding amount. Applicants will receive funds based upon their unintentional and undetermined drug overdose death rates for 2021. In addition, the 30 states with the highest unintentional and undetermined drug overdose counts will be awarded additional prevention funding.
- Are the PDMP budget parameters required? What if an applicant’s state PDMP is very advanced and additional funding is not needed?
- States meeting the NOFO requirements can choose to pursue other interventions from strategy 6 or other OD2A-S strategies.
- Can funds for Strategy 1 be used for existing surveillance staff (currently funded under OD2A – RFA-CE-19-1904) or only hiring new positions?
- Funding can be used to support existing staff or new staff. There is no requirement to hire new staff.
- In reviewing Appendix 9, it looks like we will receive a ~25% pay cut in funding from the existing OD2A funding. As a state health department that does not have any local health departments, we will not be able to apply for OD2A: LOCAL. Is there any additional funding that may help us make up the difference?
- At this time, OD2A-S and OD2A: LOCAL are the only direct funding opportunities available from the Division of Overdose Prevention. That said, we do work with national partners in order to further advance and complement strategies within these NOFOs. For example, we are working with colleagues on ways to continue to provide staffing support for recipients.
- Is the SUDORS funding in Appendix 5 in addition to the funding available in the Appendix 9?
- No. The surveillance funding listed in Appendix 9 is inclusive of the SUDORS funding broken out in Appendix 5.
- The minimum funding for surveillance includes funding for required surveillance infrastructure, required annual emergency department discharge data (if unable to meet the monthly syndromic data coverage requirement), and SUDORS funding for reduced coverage.
- The maximum funding for surveillance includes funding for required surveillance infrastructure, optional and competitive Data Linkage and Biosurveillance strategies, monthly syndromic data sharing, optional annual emergency department discharge data (available only for those sharing monthly syndromic data), optional annual hospital billing/discharge data, and total SUDORS funding for full coverage.
- Can you provide any requirements/details on what is needed to allocate funds between Surveillance and Prevention strategies as noted on page 55 of the NOFO?
- Applicants will need to define where funding is being allocated in the budget and budget narrative section of the application. Post-award, further discussions with CDC may occur regarding allocation of budget across prevention and surveillance strategies. Please see the additional budget guidance provided on this page.
- Is CDC creating a template for the budget? Is there a page limit for the budget narrative?
- A budget template will not be provided as part of the application material. There is no page limit for the budget narrative.
- Can a state apply for funding at a specific level and in Years 2-5 readjust their funding for a higher level? Specifically, for Strategy 2: Morbidity Surveillance, could a state apply initially for funding at the Discharge/Billing Data Reporting level but switch to fund at the Syndromic Surveillance level starting in Year 2? This would mean a recipient could potentially receive additional funds in those years in which syndromic surveillance data are shared with CDC.
- Recipients may request additional funds in Years 2-5. However, funding decisions will be based on justified need and availability of funds. For Strategy 2: Morbidity Surveillance, the expectation is that recipients can start reporting monthly syndromic surveillance data in Year 1. However, CDC will work with recipients on a case-by-case basis to address challenges in doing this. For jurisdictions not currently receiving funding through OD2A – RFA-CE-19-1904, required syndromic surveillance data reporting begins 9/2/2024.
- What are the restrictions for the budget amount for toxicology support? Is the amount allocated required to be spent on the actual testing costs? Can it be used to support staffing, purchase of standards, and equipment changes?
- For Strategy 3: Mortality Surveillance, recipients must clearly indicate the amount of funding allocated to support enhanced toxicological testing of opioid and stimulant overdose deaths by their medical examiner and coroner community in the budget. The budget guidance is available in Appendix 5. This funding can be provided directly to forensic toxicology labs supporting medical examiners and coroners or directly to medical examiners and coroners. If the recipient provides evidence of sufficient forensic toxicology testing of opioid and stimulant overdose deaths according to CDC guidance outlined in Appendix 4, jurisdictions can submit requests to fund other activities that support medical examiners/coroners; requests must be approved by CDC. These activities include:
- Improving forensic investigation of drug overdose deaths.
- Reimbursing medical examiners and coroners for SUDORS-related work (i.e., embedded abstractors, forensic epidemiologists, case management systems, modernizing ME/C case management systems).
- Supporting general ME/C staffing needs (i.e., administrative or laboratory staff, medicolegal death investigators, medical examiners, coroners).
Other activities may also be approved by the CDC project and science officers.
- Strategy 4: Biosurveillance funding can be used for anything needed to perform the required activities for biosurveillance, including staffing, purchase of standards, and equipment changes. See the general budget guidance as well for how funding can be used and what items may not be allowable.
- For Strategy 3: Mortality Surveillance, recipients must clearly indicate the amount of funding allocated to support enhanced toxicological testing of opioid and stimulant overdose deaths by their medical examiner and coroner community in the budget. The budget guidance is available in Appendix 5. This funding can be provided directly to forensic toxicology labs supporting medical examiners and coroners or directly to medical examiners and coroners. If the recipient provides evidence of sufficient forensic toxicology testing of opioid and stimulant overdose deaths according to CDC guidance outlined in Appendix 4, jurisdictions can submit requests to fund other activities that support medical examiners/coroners; requests must be approved by CDC. These activities include:
- Where should evaluation activities be included in the budget? Should this come out of the surveillance budget?
- No specific funding is allocated to evaluation activities. Applicants have flexibility in how funds are spent across the program and may use prevention or surveillance funding to support evaluation activities.
- Why did CDC create separate state and local NOFOs?
- CDC’s interest is in tailoring funding opportunities to best serve partners at state, local, and territorial levels. State health departments may be best equipped to serve state-level surveillance efforts, as well as state-wide PDMP practices. Local health departments can leverage proximity to local communities to better engage in harm reduction and linkage to and retention in care efforts.
- What is the anticipated notice of award date for OD2A-S? Will OD2A and OD2A-S funding overlap?
- The anticipated notice of award date is August 1, 2023, and anticipated project start date is September 1, 2023.There will be no overlap in funding.
- Why are there no scores for the base component in the review and selection section of the NOFO?
- You will notice in Section E of the NOFO – The Review and Selection Process – that no scores are listed for the base component of the applicated review. Applications will undergo phase 1 review for eligibility and completeness, then phase 2 non-scored technical review. The two competitive strategies, Biosurveillance and Data Linkage, will be scored in an objective review process. Scoring criteria are listed in the NOFO for those components.
- What materials are required for submission? What is the page limit for the NOFO and workplan?
- OD2A-S is a multi-component NOFO. Submission requirements are listed in the NOFO from pages 74-81.
- Applicants are permitted up to 15 pages to respond to the base requirements of the NOFO and an additional 4 pages each for the project narrative subsections that are specific to required prevention and surveillance components, for a total of 23 pages for the required NOFO strategies. The “base” includes subsections of the Project Description that the components share with each other, which may include target population, inclusion, collaboration, etc.
- Applicants electing to apply to the optional and competitive strategies 4 and 5 may include 4 additional pages for each competitive strategy– for a total of up to 8 additional pages.
- The evaluation and performance measurement plan may be up to 20 pages.
- There is no page limit for the budget narrative.
- Recipients are not required to submit a logic model as part of their evaluation and performance measurement plan.
- Where can applicants find the workplan template and additional information about formatting and other requirements?
- Applicants can use any format they would like for the application workplan if it meets overall application formatting requirements and specific workplan requirements described on page 64 of the NOFO. Recipients will be provided the workplan template to update their application workplan post award for submission to CDC.
- If emergency department and vital records data are available in house to staff and the OD2A Principal Investigator (PI) is the same as the National Violent Death Reporting System (NVDRS) PI, do applicants still need Letters of Support for these items?
- The full list of required collaborations and Letters of Support can be found in the NOFO, starting on page 47 of the NOFO. If your OD2A-SPI is the same as your NVDRS PI, please still provide the LOS indicating agreement to coordinate medical examiner/coroner and vital statistics data collections with this NOFO as requested at the bottom of page 47. If the recipient is the unit responsible for overseeing/maintaining access to emergency department surveillance data, this must be written in the application (page 50 of NOFO).
- How many recipients will be funded for the two optional and competitive strategies?
- Up to 20 recipients will receive funding for each competitive strategy.
- Is a Disparity Impact Statement required upon application submission or post-award?
- A disparity impact statement is required as part of the NOFO application and should address how planned interventions will reach specific populations of focus, including underserved communities and/or disproportionally impacted populations. Applicants may use data tools (such as those at https://www.cdc.gov/about/sdoh/index.html) in developing disparity impact statements.
- Will applicants be notified when local jurisdictions in their state submit a Letter of Intent (LOI) for OD2A: LOCAL?
- We suggest that states reach out to local health departments to determine if they intend to apply for OD2A: LOCAL.
- Where is the OD2A Project Officers List on your website?
- The project officer list is not on our webpage. If you have a specific question, please e-mail od2a-states@cdc.gov.
- Is the workplan a separate document to upload? If so, what is the page length?
- The application work plan must be included in the page limit for the prevention and surveillance project narrative sections. Applicants are permitted up to 15 pages to respond to the base requirements of the NOFO and an additional 4 pages each for the project narrative subsections that are specific to required prevention and surveillance components, for a total of 23 pages for the required NOFO strategies. The work plans for prevention and the non-competitive surveillance strategies must be included in that 23 page total.
- Applicants must submit a work plan that is responsive to the requirements outlined in the NOFO “Work Plan” section (page 64 of the NOFO). Applicants must include a detailed first-year work plan and a high-level plan for subsequent years. The work plan is the applicant’s opportunity to clearly identify what activities they plan to implement and how they plan to do so using the funds provided.
- Applicants applying for the Optional and Competitive Strategies are permitted an additional 4 pages per optional strategy for the project narrative and workplan (i.e., Biosurveillance and/or Data Linkage).
- How should applicants handle letters of support when participating organizations are TBD due to competitive procurement process?
- CDC understands that not all partners will be established prior to the application due date. Please note plans for partnerships that may not be established yet in your application project narrative.
- Can CDC provide more information on what is required for the “Report on Programmatic, Budgetary, and Commitment Overlap” Attachment? (Pages 73-74 of the NOFO)
- If duplication of effort will exist, applicants need to provide the resulting overlap details that would need to be resolved prior to their award being issued. To ensure this requirement is met, applicants are encouraged to submit a statement even if there is no programmatic, budgetary, or commitment overlap. A statement that no duplication of effort will exist is adequate.
- The NOFO mentions a form on page 104 titled “Funding Preference Deliverables,” but this form cannot be located on grants.gov or through online search. Is this a required form for application submission?
- No, the Funding Preference Deliverables Form is for international NOFOs and does not apply to OD2A-S.
- Is the data management plan needed for original (primary) data collection and existing data sources for secondary data analysis, such as what CDC OD2A-S requires for Surveillance Strategies 2, 3, and 5 (syndromic surveillance, death certifications, hospital billing data, and ED billing data)? Can additional guidance be provided on creating and submitting the DMP?
- A data management plan (DMP) is required for all primary data collections and data used for secondary analysis, including for data collected through all the OD2A-S surveillance strategies. The DMP submitted with the application only needs to be a high-level outline of planned data collection activities. If funded, recipients will be required to submit a more detailed DMP within the first 6 months of award. CDC will provide recipients a data management plan template that will highlight the required DMP elements.
- See page 59 of the NOFO for more information regarding the data management plan application requirements.
- Applicants must create their own DMP, and CDC will not create one for applicants/recipients. Example DMP templates are provided in the NOFO.
- The DMP may be its own file.
- For this application, would it be acceptable for a health department to identify anticipated subrecipients after the application is submitted?
- Applicants may propose anticipated or potential sub-recipients as part of their application and finalize sub-recipient plans post-award.
- Does an applicant have to do anything extra for the Pilot Program for Enhancement of Employee Whistleblower protections?
- Recipients funded under OD2A State will be protected under the Pilot Program for Enhancement of Employee Whistle Blowers Protections term. There is nothing needed in the application or to do once funded.
- Specifically, to whom should the Letters of Support be addressed?
- Letters of Support may be addressed to the CDC OD2A in States Program
- I am planning to have my state’s Public Health Lab complete a separate Budget, Narrative, Work Plan, cover letters, etc., and add those as attachments to my OD2A-S grant application with minimal mention of it within my part of the application narrative. I will not add the Lab’s Strategy 4: Biosurveillance $350,000 budget into my part of the budget. Is that what is expected?
- Yes. Applicants applying for the Optional and Competitive Strategies (Biosurveillance and Data Linkage) should submit separate documents (narratives, workplans, and budgets) for each strategy. Documents should be labeled correctly to ensure they are evaluated by reviewers. All documents related to Biosurveillance should be labeled as “S4 Biosurveillance XX,” for example, “S4 Biosurveillance Budget.” Labelling instructions have been included in the relevant sections (Workplan, Project Narrative, Collaborations and Letters of Support, and Budget Narrative) for each strategy. Applicants applying for the optional and competitive strategies are permitted an additional 4 pages per optional strategy.
- The NOFO requests that at least one hospital partner provides a letter of support for Strategy 4: Biosurveillance. Can a fully executed Memorandum of Agreement (MOA) with a hospital count towards this or does it have to be an actual letter from a hospital partner?
- A letter of support from a partner hospital is required for Strategy 4, as described in the NOFO. Fully executed MOAs or Memorandum of Understandings (MOUs can also be included to strengthen the application.
- Regarding Strategy 5: Data Linkage, can Data Use Agreements that specify the specific purpose (e.g., linked opioids data set be submitted in place of letters of support (LOS) for the included agencies/partners?
- Evidence must include letters of support from the agencies that will be sharing data as part of these data linkages. Please see the Collaborations Section (page 47) for file naming and upload instructions. Each agency’s LOS should include the following information: 1) evidence of performing proposed data linkage or details of the proposed data linkage; 2) acknowledgment that necessary data sharing agreements are already in place or being established; 3) evidence that proposed linkages can be performed within the first year of funding; 4) evidence that proposed linkages can be completed within a year of the overdose data. Please label each document (S5 Agency Data Linkage LOS) (number if multiple submissions). Additionally, submission of data sharing agreements established with agencies sharing the data or confirmed access to data warehouse, cubes or similar data infrastructure with the needed databases is preferred and will receive a higher score in the application review process but is not required.
- If a local health department is funded through OD2A: LOCAL, can they continue to receive funding passed through OD2A-S from their state health department?
- Braided funding for activities is encouraged across multiple programs, as long as funding is not duplicating or supplanting funding from one of the programs or resulting in duplication of efforts.
- Are states able to fund local health departments to coordinate linkage of care activities/education if those health departments are not eligible for the current local government NOFO or are an Implementing Overdose Prevention Strategies at the Local Level (IOPSLL) recipient?
- Yes, state health departments may fund local health departments as long as funding is not duplicating or supplanting funding from other programs.
- Can Tribal Health Authorities apply to be subrecipients of OD2A-S? Or can they only apply for the “Strengthening Public Health Systems and Services in Indian Country” grant?
- Tribes are not eligible to apply for OD2A-State or OD2A: LOCAL. Tribes and tribal partners are an important constituent given the overdose burden in Indian Country, and there are other funding opportunities available for them. More information on injury related tribal programs can be found here: Drug Overdose Prevention in Tribal Communities | Budget | Injury | CDC
- What types of organizations can serve as a state’s designated agent?
- Bona fide agents and fiscal intermediaries are organizations designated by the health department as eligible to submit a grant application in lieu of the health department. These organizations may apply for the cooperative agreement and transfer money to the health department or may undertake more of the cooperative agreement activities, depending on the local situation. If applying as a bona fide agent or fiscal intermediary of a state or local government, documentation must be submitted that establishes the validity of the agent.
- Does OD2A-S replace the existing OD2A funding opportunity, or is this additional/separate funding?
- OD2A-S will replace the currently funded OD2A (RFA-CE-19-1904), which ends in August 2023. There are two new OD2A NOFOs – one for state health departments, including the District of Columbia (OD2A-S), and one for localities and territories (OD2A: LOCAL).
- Can multiple key staff positions be filled by the same person? For example, can the PI for the Surveillance Component also be the State Unintentional Drug Overdose Reporting System (SUDORS) lead? Can the same person be the PI for both the Surveillance and Prevention Components?
- Someone can serve as a SUDORS lead and a surveillance PI, but different PIs are needed for prevention and surveillance. Co-PIs for surveillance are acceptable.
- My state has a centralized health department structure and is currently an awardee at the state level. The state health department will be applying for OD2A in States, but the local health departments also apply to grants and would like to apply for OD2A: LOCAL, if allowed. Entities in question share the same DUNS /UEI number. Are both the state and local health departments able to apply for OD2A funding at the various levels (state and local) even though they share the same business identifiers?
- A local entity should have their own UEI number separate and different from the State. Eligible applicants for OD2A: LOCAL are city or county local health departments or bona fide agents. A local health department could apply under their legal entity name and their assigned UEI (Unique Entity ID). Please also see the NOFO’s section on required registrations (page 69). Before applying for funding, all applicant organizations must obtain a UEI, obtain a current SAM registration, and register on grants.gov. To meet the application deadline, it is recommended that all required registrations be completed as soon as possible.
- Can the Surveillance Infrastructure funding be used to enhance statewide capacity through local health department training and technical assistance?
- Yes, this funding can be used as long as it does not duplicate or supplant funding from OD2A: LOCAL.
- For Strategy 2: Morbidity Surveillance, can you clarify the difference between the two data source options? If my state cannot share syndromic data on a monthly basis, I understand that we would be required to share discharge data on an annual basis. Can you explain how this required discharge data submission is different than the optional activity that requests discharge data?” And what does CDC mean by line-level? Is that by patient or by visit or ICD code?
- Recipients must share syndromic surveillance data on drug overdose emergency department visits. However, if syndromic surveillance data cannot be shared, justification must be provided and approved by CDC, and annual line-level hospital discharge/billing data on drug overdose emergency department (ED) visits, as well as aggregate data on total ED visits, must be submitted with a 6-month lag. These discharge/billing data from healthcare facilities (e.g., both discharges from EDs and/or hospital admissions) use the standard UB-04/CMS- 1450 form and ICD-10-CM discharge diagnosis coding. Both required and optional annual ED and inpatient billing/discharge data submissions are expected to be line-level for drug overdose visits (visits with a T36-T50 ICD-10-CM code). The level at which data must be reported is at the visit-level.
- All states may elect to apply for additional funding to submit annual discharge/billing data. If the applicant is sharing monthly syndromic surveillance data, they can receive additional, optional funding to submit ED and/or inpatient hospital admissions data. If the applicant is sharing annual emergency department discharge billing data instead of ED syndromic data, they can receive additional, optional funding to submit data on inpatient hospital admissions.
- Please see NOFO Appendix 2 for more details on discharge data reporting options (required and/or optional) and associated funding amounts. Additional budget guidance is provided on the first page of this Q&A document.
- We understand that Strategy 2: Morbidity Surveillance (DOSE) will now require line-level data sharing. We would like more information about CDC’s data dissemination plans. How will this line-level data be used and publicly disseminated? Also, how will the data be de-identified?
- Line-level data will only be required for discharge/billing data submission. These data will not be publicly released or displayed as visit-level data. All data products will use aggregated data. CDC recognizes the critical importance of maintaining standards of data quality, upholding individual and institutional privacy and confidentiality, and ensuring impartiality in the sharing of public health data. For more information, please see NOFO Appendix 1.
- On page 18 of the NOFO, one of the requirements for Strategy 2: Morbidity Surveillance states that “Both options will require that recipients share historic ED data from January 1, 2018, or the earliest available data for the annual reporting option.” For this ED data from 2018, do we need to include benzodiazepines, methamphetamine, cocaine, and the additional demographic data?
- Recipients submitting syndromic surveillance data must share aggregate historical ED data by month on ED visits suspected to involve the eight required nonfatal drug overdose indicators (all drugs, all opioids, heroin, fentanyl, benzodiazepines, all stimulants, methamphetamine, and cocaine) for January 1, 2018, through August 31, 2023. Aggregate data on ED visits will be reported by (a) patient residence county and (b) a cross-tab of sex and the following age groups (0-10, 11-14, 15-24, 25-34, 35-44, 45-54, 55-64, 65-74, 75-84, and 85 and older), and race and ethnicity at the state or district level. If ED data are not available for historical dates, a written explanation must be included in the first required report to CDC. Applicants selecting the syndromic surveillance reporting option will aggregate ED data into a CDC template using ESSENCE or other local syndromic surveillance system.
- Recipients submitting discharge data must submit annual line-level hospital discharge/billing data on drug overdose ED visits (those with a T36-T50 ICD-10-CM code), as well as aggregate data on total ED visits, from January 1, 2018, or the earliest available data. If ED data are not available for historical dates, a written explanation needs to be provided to CDC as part of the first required report to CDC.
- DOSE will continue to use the Partner’s Portal and SAMS sites for all data submission. More information is in Appendix 2.
- Within the morbidity component, recipients submitting monthly ED syndromic surveillance data are eligible to elect an optional activity to submit line-level data annually on ED and/or inpatient hospital visits for drug overdoses. The file submitted must be a final file and submitted no later than 6 months after the end of the calendar year. Is this due date flexible?
- No, the final data file must be submitted by the due dates found in Appendix 3.
- If a jurisdiction cannot provide line-level discharge/billing data (they don’t have syndromic surveillance), would their entire application be disqualified?
- Jurisdictions must provide either aggregate monthly syndromic surveillance data, with 80% of ED facilities covered, OR they must submit annual line-level hospital discharge/billing data on drug overdose ED visits, as well as aggregate data on total ED visits. One of these is required to apply for OD2A-S. If syndromic surveillance data cannot be shared, a jurisdiction must provide a justification for CDC approval.
- For Strategy 2: Morbidity Surveillance, can we continue to upload DOSE data on the form provided by CDC? Are we required to set up the automated link for CDC to receive ED data through ESSENCE?
- Technical guidance will be provided to recipients that will explain the data submission process for Strategy 2. Templates for data submission will be provided. CDC will not request access to state-level data from NSSP ESSENCE and will not pull data from NSSP for OD2A-S.
- For Strategy 2: Morbidity Surveillance, what data source is used for the calculation of percentage of ED facilities reporting, specifically the denominator?
- There is no required data source. States can use their discretion to determine the best way to calculate the percent of ED facilities covered by their ED data.
- For Strategy 2: Morbidity Surveillance, one of the six requirements is that “Recipients must already be collecting data from a minimum of 80% of ED facilities in their jurisdiction, either through syndromic surveillance or receiving discharge/billing data from healthcare facilities, by the date they receive funding.” Will a minimum of 80% of ED visits meet this requirement as well, or does the data have to be from 80% of ED facilities?
- Submitted data should represent ≥80% of emergency department facilities in the jurisdiction when the recipient begins reporting ED data to CDC. Applicants should include the anticipated number of facilities by the start of funding, including those they are working currently to bring onboard or back online.
- For Strategy 2: Morbidity Surveillance, are the optional annual ED and inpatient billing data required to be line-level data? Also, by line-level data, do you mean what we currently report for the existing OD2A funding, or do you want patient-level information/identifiers?
- Both required and optional annual ED and inpatient billing/discharge data submissions are expected to be line-level for drug overdose visits (visits with a T36-T50 ICD-10-CM code). This is different than what is currently submitted under the current OD2A funding (i.e., RFA-CE-19-1904). The level at which data must be reported is at the visit level. Records that were previously aggregated as monthly overdose counts are now expected to be provided as one record (visit) per line (for drug overdose visits). Patient IDs are not required.
- Additionally, aggregate data on total ED and/or inpatient visits (as applicable) must be submitted.
- If we are currently funded for DOSE using hospital discharge data, and would like to switch to syndromic surveillance reporting in this NOFO, would we have until year 2 to begin reporting syndromic surveillance data?
- The expectation is that recipients can start reporting monthly syndromic surveillance data in Year 1. However, CDC will work with recipients on a case-by-case basis to address challenges in meeting this expectation.
- We have various geographic variables for line-level patient data. For Strategy 2: Morbidity Surveillance, what is the expected level of geographic detail for this data (e.g., county, zip code, or census tract)?
- The level of geographic detail expected for this data submission is county of patient residence.
- If states currently funded under OD2A (RFA-CE-19-1904) are sending data to NSSP ESSENCE, will that data be used for the syndromic data submission in Strategy 2: Morbidity Surveillance once the OD2A-S project year begins? Or will data have to be submitted manually even if a live feed to CDC already exists?
- Aggregate data will have to be submitted by recipients. CDC will not request access to state-level data from NSSP ESSENCE or pull data from NSSP for OD2A-S. Once aggregate data is submitted to CDC, all data are considered final and approved for use by CDC.
- Will a methamphetamine query be created in ESSENCE? It seems that the requirements for syndromic surveillance are the same. We are just adding in additional overdose queries to report on and including race and ethnicity as a field. Is that correct?
- The development of a methamphetamine overdose definition is in progress and will be included in NSSP ESSENCE. Please see specific language in the NOFO, including Appendices 2 and 3 for the changes in morbidity surveillance requirements.
- Will syndromic surveillance queries be created in ESSENCE to track stimulant/opioid use trends?
- At present, CDC has not developed queries to track stimulant/opioid use. The focus of OD2A-S is to better understand trends in overdose-related emergency department and hospitalization visits.
- Regarding one of the Letters of Support (Requirement 8) in the new OD2A-S grant, Strategy 3 (quoted below): “3. State Medical Examiner or state coroner association or if an association does not exist, letters must be obtained from ME/Cs that serve at least 75% of the population in the jurisdiction.” I wanted to clarify, by “population in the jurisdiction,” do you mean the participating C/MEs must serve at least 75% of Missouri’s total population, or they must serve at least 75% of UUDO deaths in the jurisdiction?
- If a state medical examiner or coroner association does not exist, jurisdictions are required to obtain letters of support from medical examiners or coroners (ME/Cs) who serve 75% of a jurisdiction’s total population. Multiple letters of support will likely be required since a single ME/C is unlikely to serve 75% of a state’s population if the system is not centralized.
- For Strategy 3: Mortality Surveillance, what are the specific drugs that need to be tested?
- Appendix 4 provides recommended guidance on comprehensive toxicological testing of drug overdose deaths suspected to involve opioids and/or stimulants for SUDORS.
- Will dissemination of comprehensive toxicology data analysis count as a SUDORS data product required for Strategy 3: Mortality Surveillance?
- As long as the toxicology data are abstracted and entered into the SUDORS system as part of routine data collection for Strategy 3, then dissemination of that data can be counted as a SUDORS data product.
- What if a jurisdiction requires more SUDORS abstracting staff to meet the reporting requirements than can be provided by the base funding level?
- If the core SUDORS funding is insufficient for the jurisdiction’s abstractor staffing needs, funding may be used from surveillance strategy 1 (infrastructure) to hire additional SUDORS abstractors.
- Is there any continued funding for lab testing for fatal overdoses or non-fatal other than those collected from EDs?
- As part of surveillance Strategy 3, jurisdictions must support enhanced testing of suspected opioid and stimulant overdose deaths according to the guidance presented in Appendix 4. Funding may be provided directly medical examiner or coroner offices or to forensic toxicology laboratories supporting them. Recipients of Strategy 4: Biosurveillance funding may elect to perform other lab testing projects if required activities are successfully performed.
- Is funding for any wastewater testing allowed under Strategy 1: Surveillance Infrastructure or Strategy 4: Biosurveillance?
- Wastewater testing cannot be funded through OD2A-S.
- Does toxicology testing funding (Strategy 4: Biosurveillance) include supporting/purchasing fentanyl test strips for the local hospital lab?
- No, purchasing and distributing fentanyl test strips for testing in biological samples for clinical decision-making purposes is not an allowable activity using OD2A-S funding.
- My state performs drug testing on clinical specimens. We have not performed testing for overdose biosurveillance. I am checking with our Bureau of Epidemiology (BOE) to see if they have conducted any overdose biosurveillance projects with another laboratory. If they have not, does that preclude us from applying for this particular strategy?
- There is nothing to preclude potential eligible applicants from applying for Strategy 4 (Biosurveillance). However, a maximum of 20 recipients will be selected and experience in biosurveillance will factor into application scoring.
- Can the funding that is available in Strategy 4 be used to support staff in addition to the funding that is available in Strategy 1 or is it all to be used for supplies?
- Nothing limits funding received for Strategy 4 to supplies. It should be used for any needs, including staffing, related to biosurveillance activities.
- To confirm, for Strategy 5: Data Linkage, we would need to perform at least two data linkages – one linking fatal drug overdose data to nonfatal drug overdose data AND at least one linkage in requirement #2 (on page 29 of the NOFO)?
- Yes, recipients must perform the listed data linkages for both requirements 1 (i.e., link fatal and nonfatal drug overdose data) and 2 (see page 29 for details).
- Related to the second requirement for the optional data linkage strategy on page 29 of the NOFO, does CDC expect states to link using the same data sources over the 5 years?
- While the funding opportunity doesn’t explicitly state that the same data sources should be linked over the course of the funding period, tracking trends in nonfatal and fatal overdose and how they vary across groups at disproportionate risk is central to the funding to inform interventions. Ultimately, any proposed activities should aim to build a better understanding of and response to nonfatal and fatal overdoses over time, as well as key events that occur before, during or after a drug overdose.
- We have a question about the specific requirements for applying for Optional and Competitive Strategy 5 – Data Linkage. The first requirement stipulates linking fatal drug overdose data (i.e., SUDORS, vital records) to at least one data source that captures nonfatal drug overdoses treated by first responders or hospitals (e.g., EMS, or ED/inpatient records). We would like to know if we can propose that during the first year of OD2A 2.0 as we work toward the data linkage goal.
- For Competitive Strategy 5, applications should indicate a commitment of or ability to perform the proposed data linkages by the beginning of year 2 and outline proposed plans to update the linked datasets throughout the calendar year for year 2 and subsequent years, including the production of at least two data products a year to be shared with CDC. Year 1 work plans can include proposed activities that are intended to build data linkage capacity by the end of the first year.
- What would be considered data sources that capture social determinants of health and would meet the requirements of Strategy 5: Data Linkage?
- Examples of data sources that capture social determinants of health include datasets with information on income, employment, or social services data. County Health Rankings data is one specific example. See page 29 of the NOFO for additional information.
- Can the surveillance PI also be the evaluator?
- No, a separate prevention/evaluation PI and surveillance PI are required.
- Are state public health laboratories allowed to perform testing for local health departments under OD2A: LOCAL, or would they only be eligible to work with state health departments under OD2A-S?
- Questions about OD2A: LOCAL funding are answered at OD2A: LOCAL – Frequently Asked Questions and Answers
- Regarding Strategy 1: Surveillance Infrastructure, is it allowable to purchase lab equipment for public health labs, or can these funds also be used to purchase equipment for community lab testing groups?
- Strategy 1: Surveillance Infrastructure funds may be used for enhancing/modernizing public health laboratories, including increased staffing and/or laboratory equipment or supplies for testing related to nonfatal drug overdose. With approval from CDC, funds may be approved for other types of laboratories directly involved with Strategy 4.
- Can the funding for Strategy 1: Surveillance Infrastructure be used for purchases to analyze seized evidence for the presence of controlled or illicit substances?
- No, the funding for Strategy 1: Surveillance Infrastructure cannot be used for purchasing equipment to test seized evidence for the presence of controlled or illicit substances.
- Can CDC please clarify the requirements for Strategy 2: Morbidity Surveillance on page 18? If an applicant submits ED syndromic surveillance data through ESSENCE is there also a requirement to submit hospital discharge data?
- Recipients must meet the Strategy 2 requirements on page 18. States that submit syndromic surveillance data are not required to submit ED/hospitalization discharge data. (Please keep in mind that recipients will have to submit monthly data to CDC on templates that will be provided. CDC will no longer pull this data directly from ESSENCE.)
- States that submit syndromic data may also opt to submit ED and/or inpatient hospitalization discharge data for additional funding. Please see NOFO Appendix 2 for more details on data reporting options (required and/or optional) and associated funding amounts.
- Recipients must commit to sharing ED syndromic surveillance data or ED hospital discharge/billing data with all required data elements and on the routine reporting timeline specified in Appendix 3.
- Regarding Strategy 3: Mortality Surveillance, it states that an applicant must provide the death certificate, and ME/C report, and toxicology results. What happens when no information is available except the death certificate? Is there a specific percentage of cases that must have complete data?
- For Option 1, recipients will:
- Collect data on all Undetermined/Unintentional Drug Overdose (UUDO) deaths that occur in their jurisdiction between January 1, 2023, to December 31, 2027, using all three required data sources: death certificates, Medical Examiner/Coroner (ME/C) reports, and postmortem toxicology results. CDC understands that there may be rare circumstances in which an ME/C or toxicology report is not generated for an overdose death. Those rare circumstances would not typically preclude a recipient from meeting the requirements for Option 1.
- For jurisdictions who are unable to obtain ME/C and toxicology reports for all deaths by the submission deadlines, Option 2 requirements allow recipients to:
- Collect data on all UUDO deaths that occur in their jurisdiction between January 1, 2023, to December 31, 2027, using information from death certificates, and
- Collect information from the remaining two required data sources (ME/C reports and postmortem toxicology results) for all UUDO deaths within a subset of counties whose residents accounted for a minimum of 75% of UUDO deaths in the jurisdiction.
- Obtaining data on the characteristics and circumstances surrounding the overdose allows SUDORS to capture information on risk factors and social determinants of health associated with the overdose death. The Strategy 1: Surveillance Infrastructure funds can be used to increase staffing to aid in meeting SUDORS requirements. Additionally, if the recipient provides evidence of sufficient forensic toxicology testing of opioid and stimulant overdose deaths according to CDC guidance outlined in Appendix 4, with CDC approval, funding may also be used to support SUDORS-related work and staffing within ME/C offices.
- For Option 1, recipients will:
- Is it allowable to use OD2A-S funds to pay for toolkits for the coroners, which may include flashlights, gloves, non-slip shoe covers, ambient air thermometers, clipboards, tape measures, masks, and face shields?
- If the recipient provides evidence of sufficient forensic toxicology testing of opioid and stimulant overdose deaths according to CDC guidance outlined in Appendix 4, jurisdictions can submit requests to fund other projects that support medical examiners/coroners; requests must be approved by CDC.
- Do the two required data dissemination products per year for Strategy 2, Strategy 3, and Strategy 5 need to be two new products per year, or can they be previously developed products that are updated each year (e.g., refreshed data dashboard, annual report, etc.)?
- The two required data dissemination products do not necessarily need to be new each year. If a data dashboard or annual report is refreshed with more recent data or contains additional data elements, the product could count towards the data dissemination requirement.
- For Strategy 4: Biosurveillance, an applicant is asked to provide a “Patient ID.” Can you clarify what counts as a patient ID? Is that the medical record number or a number the state assigns to the specimen when it arrives at the lab (for example)?
- A unique patient ID should be an anonymized identifier that allows for analyses at the patient level, and it will be used to deduplicate and aggregate results if more than one specimen is tested for a patient. Typically, labs use a patient ID assigned in their Laboratory Information Management System (LIMS). CDC will work with recipients to ensure these identifiers are properly sent without compromising patient privacy if this is a concern.
- Under Strategy 4: Biosurveillance, the required activity 5 (page 28) asks applicants to describe how they will work with local jurisdictions on this project. Can CDC please explain what this means? Is it required to partner with law enforcement?
- This is not a specific request to partner with law enforcement. Please describe in your application how you will coordinate activities with local jurisdictions related to biosurveillance to avoid duplication of efforts and ensure coordination. For example, if a city or county health department in your state is engaged in activities related to laboratory testing involving overdose, please describe how you will work with them to ensure that you will not duplicate efforts and will maximize outcomes.
- For Strategy 4: Biosurveillance, on page 28 it states: “Coverage = Testing of a minimum of 20 specimens (preferably from unique overdose events) per week (per initial pilot hospital/hospital system partners; this may expand if the number of submitting hospital facilities expands and laboratory capacity allows.” Can you clarify what is meant by a “unique overdose event” and “specimen”? Does that mean 20 individual patients (specimens) per week per hospital (or system)? Is 20/week an average or absolute requirement? How should applicants handle the two scenarios below?
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- Hospital A and Hospital B are both in the same “System.” Does this mean applicants only need a total of 20 specimen per week since they belong to the same system?
- Hospital A and Hospital B are in two different “Systems.” Would applicants be required to submit a total of 40 specimen (Hospital A = 20 and Hospital B = 20) per week because they are in two systems?
- Ideally, CDC would like specimens from separate overdose events, as patients can have multiple specimens and can present multiple times for the same overdose. This may be difficult to track since this activity does not involve longitudinal patient tracking, but visits could be used as a proxy for overdose events.
- CDC would like recipients to aim for 20 specimens from patients presenting with overdose tested per week as a minimum; however, understanding that ED visits for overdose may fluctuate, an average will also work. Providing a realistic plan to test beyond this minimum will strengthen your application.
- Both scenarios are correct. Applicants should propose plans to distribute this testing across or within systems as it makes the most sense for their jurisdiction.
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- It seems like some of the innovative surveillance projects from the previous OD2A award (RFA-CE-19-1904) no longer fit into the new surveillance strategies and data linkage activities. For OD2A-S, it seems like they are now being funneled into the optional and competitive Strategy 5: Data Linkage. Is this correct?
- Correct, the optional data linkage strategy in OD2A-States will fund data linkage projects. Jurisdictions that were previously funded for data linkage work through the innovative surveillance strategy can apply for this optional strategy if their linkages meet the requirements outlined in the NOFO.
- Other than for the optional, competitive Strategy 5: Data Linkage, do vital records data fit into any other required strategy?
- Vital records data, specifically death certificates, are also a required data source for Strategy 3: Drug Overdose Mortality.
- Is the first required category in Strategy 6: Clinician/Health System Engagement and Health IT/PDMP Enhancement like academic detailing?
- Academic detailing is one intervention that can be implemented within strategy 6. See page 34 of the NOFO for additional interventions under strategy 6.
- Where would we find information on how to become a qualified PDMP? Also, what is a qualified PDMP, and what does an open standards and open architecture mean?
- Additional information on Strategy 6 is located on page 79 of the NOFO. This link may also be helpful: https://www.law.cornell.edu/uscode/text/42/1396w-3a.
- In Strategy 6: Clinician/Health System Engagement and Health IT/PDMP Enhancement, there is a definition for PDMP Hub as the Bureau of Justice Assistance’s (BJA) designated PDMP data sharing system, RxCheck, but it isn’t referenced anywhere in the solicitation except for the definition section. Should applicants expect to see special conditions in the award surrounding this?
- The NOFO does not include an award condition. A recipient may spend up to 20% of its overall prevention budget on Health IT/PDMP Enhancement activities. If a recipient’s PDMP system meets the requirements of a qualified PDMP with open standards and open architecture in alignment with 45 CFR part 170, Subpart B: Standards and Implementation Specifications for Health Information Technology, then a recipient may spend up to 30% of its overall prevention budget on Health IT/PDMP Enhancement activities.
- If the intent is to use data to inform programming, why is CDC pre-defining so many required activities? If a state is experiencing more overdoses because of illicit/black market pills, then tracking prescribing through PDMP across state lines does not seem like a responsible use of funds in order to impact the problem.
- One of the NOFO’s guiding principles is to use data to inform and tailor prevention strategies, with emphasis on reaching groups disproportionately affected by the overdose epidemic. Although some required interventions are included in the prevention component, applicants have the flexibility to propose additional evidence-based or evidence-informed interventions within each strategy that align with the goals of that strategy and with their specific jurisdictional needs. CDC aims to have recipients address overdose prevention across all settings but maintain the flexibility to identify priority needs in their jurisdiction and allocate resources accordingly. In order to maximize the flexibility of the OD2A-S Cooperative Agreement, recipients will be able to move funds between the surveillance and prevention components if they are meeting their programmatic reporting requirements noted under Section 2a(iii) Strategies and Activities on page 13 of the NOFO.
- Are jurisdictions required to directly hire navigators or collaborate with programs that use navigators? Is a linkage to care navigator required for Strategy 7: Public Safety Partnerships/Interventions?
- Recipients will have the option of either directly hiring navigators with OD2A-S funding or using navigators who are employed through partner organizations.
- Linkage to care is not a required intervention within strategy 7. However, if a recipient elects to implement a linkage to care intervention (see strategy 7, categories 4 & 5 on page 41 of the NOFO), navigators must be used to facilitate linkages.
- Can you clarify whether ensuring people who use drugs have access to drug checking equipment is a required intervention within Strategy 8 (Harm Reduction) Category 2, or is this optional?
- Drug checking equipment is not a required intervention. Applicants are required to implement at least the one required intervention in category 2 of the Harm Reduction Strategy. Category 2 is ensuring people who use drugs have access to overdose prevention and reversal tools, treatment options, and drug checking equipment. The only required intervention for that category is “developing and expanding overdose education and naloxone distribution programs that prioritize education and distribution among those who are at the greatest risk of experiencing or witnessing an overdose.”
- What are the restrictions on the purchase of naloxone?
- OD2A-S funds may be used to support naloxone access (distribution, vending machines, etc.) and to purchase syringes for administering injectable naloxone. However, funds may not be used to purchase naloxone at this time.
- Given that there are only 40 OD2A: LOCAL grants to be awarded, how does CDC see local public health authorities fitting into OD2A-S? Related, can funding for Strategy 8: Harm Reduction or Strategy 9: Linkage to Care be contracted to a local public health department?
- CDC encourages OD2A-S recipients to partner with local health departments as appropriate to address overdose prevention among disproportionately affected populations. Braided funding for activities is encouraged across multiple programs. States can fund local health department activities as long as funds do not result in duplication of efforts.
- On page 82 of the NOFO, it clearly states that Neonatal Abstinence Syndrome (NAS) surveillance is an unallowable activity under OD2A-S. However, is NAS-related linkage to care allowable under Strategy 9: Community-Based Linkage to Care? There is no mention of this being an unallowable activity on page 83 of the NOFO.
- CDC defines linkage to and retention in care as 1) linkage to evidence-based treatment for substance use disorders (SUD), to include MOUD and other treatment (e.g., cognitive behavioral therapy CBT, contingency management) and 2) linkage to harm reduction services. Linking pregnant and postpartum people with opioid use disorder to MOUD or other treatments for SUD or to harm reduction services is allowable but linking infants with Neonatal Opioid Withdrawal Syndrome (NOWS) to services is not.
- Can one linkage navigator provide all three required interventions? Or is a separate navigator needed for each required linkage navigator intervention?
- Applicants must include, at a minimum, one linkage to care intervention that utilizes navigators in each of the following strategies: clinician/health system engagement, harm reduction, and community-based linkage to care. The number of navigators needed to implement at least one linkage to care intervention in these three settings will vary depending on the size of the programs and jurisdiction needs. CDC is not requiring a specific number of navigators. Recipients are expected to hire navigators using OD2A-S funding or use navigators who are employed through partner organizations to fully implement these required interventions.
- Can the utilization of navigators employed through partner organizations be clarified? Will we need navigators from partner organizations to report directly to us?
- No, navigators used to implement OD2A-S linkage to care interventions do not necessarily need to report directly to the state health department. OD2A-S recipients can partner with organizations that employ navigators in ways that make the relationship mutually beneficial and that best enable the implementation of these interventions.
- When developing new partnerships or discussing new interventions with partners, it is important to remember that recipients are expected to evaluate all required interventions, including linkage to care efforts utilizing navigators, and use process and outcome evaluation findings to guide ongoing intervention development and refinement. Recipients should therefore plan accordingly when establishing or expanding partnerships with organizations that are needed to support the implementation of linkage to care interventions.
- For Strategy 6: Clinician/Health System Engagement and Health IT/PDMP Enhancement, if an applicant applies for the exemption to spend over the 30% cap, does that mean the state must also meet the “Office of the National Coordinator for Health Information Technology (ONC) certified” criteria as well?
- Yes, to be allowed to spend greater than 20% of your overall budget on health IT, your PDMP must meet the ONC certified criteria.
- Where would applicants find information on how to become a qualified PDMP? Also, what is a qualified PDMP, and what does an open standards and open architecture mean?
- Additional information on Strategy 6 is located on page 79 of the NOFO. This link may also be helpful: Requirements relating to qualified prescription drug monitoring programs and prescribing certain controlled substances.
- For Strategy 7: Public Safety Partnerships/Interventions, do applicants have to collaborate with a state-level partner even though it’s not the primary group that will help us get the work done? Can applicants propose regional partners in our application instead if our state works more closely with them?
- Public Health/Public Safety (PH/PS) partnerships do not have to be established with state-level PS partners. PH/PS interventions should prioritize impacts at the state level or within disproportionately affected populations within the state, but partnerships may be established at any level that is appropriate to achieve these outcomes.
- Are communication activities only allowed under Strategy 8: Harm Reduction?
- Most standalone communication activities, including the development of communication campaigns, should fall under Strategy 8 of this NOFO. However, recipients can integrate communication activities as part of the implementation of interventions within other strategies. For example, ancillary communication activities, such as the promotion of a case management system developed to help individuals navigate access to care as part of Strategy 9, should be integrated into the relevant intervention within each strategy.
- If an applicant would like to expand syringe service programs across the state, which strategy would incorporate these activities?
- The best place to address syringe service programs and partnerships is under Strategy 8: Harm Reduction.
- Are fentanyl test strips an allowable purchase under OD2A-S?
- Yes, the purchase of fentanyl test strips is allowable under OD2A-S for the purposes of drug checking by people who use drugs. Please note that the purchasing and distributing of fentanyl test strips for testing in biological samples for clinical decision-making purposes is not allowable.
- Can existing work be used to demonstrate the required prevention interventions? Many states have already sought alternate funds to implement harm reduction interventions and there are many similarities.
- With the required prevention interventions, recipients have the flexibility to either implement new activities or scale up or enhance existing efforts within their jurisdiction.
- Would naloxone need to be administered by a syringe services program employee or could they be directly distributed to people who use drugs?
- Although naloxone cannot be purchased using OD2A-S funds, there are no restrictions around its distribution. Recipients can choose to work with a syringe services program or other harm reduction organizations for the distribution of naloxone or can choose to distribute directly to people who use drugs or community members.
- Did the rule that prohibits naloxone purchase change because the FDA approved over the counter sales in March 2023?
- The purchase of naloxone is unallowable at this time under OD2A-S, whether purchased via current distribution channels or over the counter.
- On page 46, for Facilitators for Community-Based Linkage to Care Interventions in Strategy 9: Community-Based Linkage to Care, it states “Addressing barriers to care to facilitate engagement in prevention/treatment/long term recovery. For example, transportation barriers may be addressed by using car services, or leasing vehicles for mobile units.” Can you please clarify whether this means applicants can budget and propose a leased mobile unit?
- Yes, leased vehicles or mobile units for the purpose of linkage to care are an allowable expense.
- Like the exclusion for using funds to purchase naloxone, is it permitted to use funds for contingency management (CM), or only for CM referral programs? CM seems to be excluded in Appendix 11.
- OD2A-S funds may only be used for linkage to contingency management. Direct funding support for CM is not allowable.
- For Strategy 6: Clinician/Health System Engagement and Health IT/ Prescription Drug Monitoring Program (PDMP) Enhancement, if an applicant applies for the exemption to spend over 30%, does that mean the state must also meet the “Office of the National Coordinator for Health Information Technology (ONC) certified” criteria as well?
- Yes, to spend greater than 20% of the overall budget on health IT, a recipient PDMP must meet the ONC-certified criteria. Requests to spend over 30% of the overall budget must also meet the ONC-certified criteria and will be handled on a case-by-case basis in discussion with CDC.
- Is there a requirement for Office of the National Coordinator for Health Information Technology (ONC) certification for PDMPs?
- There are no requirements from ONC for PDMPs to be designated or certified as a qualified PDMP. However, to spend greater than 20% of the overall budget on health IT, a recipient PDMP must meet the ONC criteria for certification. Recipients should describe in their application how they are meeting the criteria. (Refer to question 3 for list of criteria.)
- What is a qualified PDMP, and what do open standards and open architecture mean? How will states be expected to demonstrate alignment with 45 CFR Part 170 Subpart B?
- To validate that the state has established a qualified PDMP, states must send in an attestation post-award that their PDMP meets minimum requirements noted below:
- A “qualified PDMP” is one that meets the statutory standards as defined in 45 CFR Part 170 (i.e., open standards, open architecture, and open application programing interfaces), including prescription information for the most recent 12-month period and the name, location, and contact information of each prescriber [Section 5042(a) of the SUPPORT Act].
- States will establish and administer a qualified PDMP that allows access to the following minimum information, in as close to real-time as possible:
- Controlled substance prescription drug history of a covered individual,
- The number and type of controlled substances prescribed to and filled for a covered individual for the most recent 12-month period; and
- The name, location, and contact information of each covered provider who prescribed a controlled substance to a covered individual during the most recent 12-month period.
- To demonstrate alignment with open standards and open architecture, States are encouraged to refer to the information on standards in SMD Letter #18-006 and also to refer to the ONC Interoperability Standards Advisory (ISA). The section called –A Prescriber’s Ability to Obtain a Patient’s Medication History from a Prescription Drug Monitoring Program –describes recommended industry standards for PDMP and electronic health records integration. We also encourage states to take a standards-based approach to the electronic prescribing of controlled substance and electronic case reporting, and to refer to the ISA as appropriate to learn more about those industry standards.
- The Interoperability Standards Advisory (ISA) is ONC’s catalog of curated standards and implementation specifications for health information interoperability that reflects extensive feedback from industry and federal agencies.
- Additional information on Strategy 6 is located on page 79 of the NOFO.
- To validate that the state has established a qualified PDMP, states must send in an attestation post-award that their PDMP meets minimum requirements noted below:
- Related to PDMPs, what is CDC’s definition for of “bi-directional data sharing” and what is required to comply with that requirement? Does bi-directional data sharing allow for using a state’s choice of data-sharing hub? If two states are choosing to share data with each other, does that constitute bi-directional data sharing?
- The recipient must ensure that the recipient’s PDMP system facilitates the bidirectional exchange of PDMP data with other PDMP systems. The system should send a timely and appropriate response to every request received (as applicable under state law).
- If an applicant is already completing the required PDMP activities with other federal funding (data sharing across state lines), can it prioritize optional activities instead? How should the applicant’s plan/address this? Is this supplanting?
- If an applicant is completing the required PDMP activities with other funding, OD2A-S funds may be used for other prevention or surveillance activities. Applicants should explain how the required PDMP activities are being supported and what federal funding is being used. OD2A-S funding must not duplicate or overlap with resources provided under other federal funding sources or CDC mechanisms.
- Applicants are responsible for reporting if this application will result in programmatic, budgetary, or commitment overlap with another application or award (i.e., grant, cooperative agreement, or contract) from another funding source in the same fiscal year.
- Will OD2A-S recipients be required to use RxCheck as their PDMP hub, or can states use their existing PDMP hubs for data sharing?
- Recipients are not required to use Rx Check as their PDMP data hub.
- The Health IT/PDMP Enhancement’s required strategy requires establishing and maintaining a bidirectional connection for the exchange of PDMP data with other PDMP systems (i.e., state, District of Columbia, and commonwealths) and ensuring that every request received by the recipient’s PDMP system sends an appropriate and timely response (in accordance with applicable state law). States can determine its preferred hub for initiating inter- and intrastate data sharing with another state or states (in accordance with state law).
- Is the evaluation plan included in the narrative or submitted separately?
- The evaluation and performance monitoring plan should be submitted separately from the project narrative. The evaluation and performance monitoring plan has a 20-page limit. An evaluation and performance monitoring plan template are available via our ftp site: https://ftp.cdc.gov/pub/OD2A-S
- Is evaluation required for optional prevention activities?
- Evaluation of optional prevention activities is encouraged but not required.
- Are states required to evaluate both surveillance activities and prevention activities or just prevention activities?
- Recipients will only be required to evaluate prevention strategies.
- Can an evaluator be funded out of Surveillance funds or only through Prevention funds?
- Evaluator funding can be supported by funds from either surveillance or prevention funding. The anticipated funding amounts provided in Appendix 9 are meant to serve as a guide for budget preparation. However, there is flexibility in how the jurisdiction allocates their final award amount between the prevention and surveillance components outside of the requirements listed in the budget section of this FAQ.
- On page 63 and 64 of the NOFO, the key staff position of Program Evaluator is listed as 1 FTE. Are states able to split this position across multiple staff, so long as the total FTE is equal to or greater than 1?
- CDC recommends that recipients have an evaluation lead that is responsible for ensuring that all OD2A-S requirements are addressed, and CDC anticipates that completing these evaluation requirements will require a significant amount of time. However, if necessary and as needed, multiple staff members can coordinate to complete evaluation work and address all OD2A-S evaluation requirements.
- Does CDC have any additional specific guidance for the Targeted Evaluation Project or the products that are created from it? (i.e., a report, presentation, materials for the public, etc.)
- Detailed guidance for the Targeted Evaluation Project is presented in Appendix 8. Specific to products developed from the Targeted Evaluation Project, recipients will be asked to disseminate findings among partners and tailor dissemination to appropriate audiences (e.g., internal health department, community-based organizations, and people with lived experience who participate and contribute to the evaluation of overdose prevention efforts). Therefore, the product or products developed from the Target Evaluation Project should be created to address the needs of these intended audiences, and different products might be created to meet the needs of different intended audiences.
- When will more information about the translational product be available? The guidance says more information will be forthcoming about the focus and type of acceptable formats.
- Translational products can include but are not limited to detailed reports, training or technical assistance resources, case studies, or peer-reviewed publications. Further guidance about translational products will be provided to recipients upon award, and recipients will have an opportunity to recommend formats for translational products they will create.
- For the cross-site evaluation requirement, will a specific deliverable be required? In what manner or form are recipients expected to share data with CDC?
- Recipients will not be required to submit a specific deliverable for the cross-site evaluation requirement; however, data provided by recipients to address other requirements of the cooperative agreement (e.g., annual performance reports, performance measures) may be used for cross-site evaluation analyses—by CDC and/or its designee (e.g., contractor). In addition, recipients and their partners may be asked to participate in additional data collection activities (e.g., surveys, focus groups, key informant interviews) to support the cross-site evaluation.
- Is a state-specific logic model a required part of our application for OD2A-S?
- Recipients are not required to submit a logic model as part of their evaluation and performance measurement plan.