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September 25, 2019

Request for proposals for funding opportunity

The Public Health Informatics Institute (PHII) is pleased to announce a request for proposals (RFP) in collaboration with the Centers for Disease Control and Prevention (CDC) for the MATernaL and Infant NetworK to Understand Outcomes Associated with Treatment for Opioid Use Disorder during Pregnancy (MAT-LINK).

The goal of MAT-LINK is to establish a surveillance network to collect data on maternal, infant and child health outcomes associated with treatments for opioid use disorder during pregnancy. The purpose of the RFP is to award clinical sites that have the ability to integrate or link maternal and newborn data and the authority to access and share these data with the Centers for Disease Control and Prevention. 

Applicants may send in questions about the RFP at any time before the submission deadline; all answers will be posted to this page in the expandable "frequently asked questions" boxes below.

Key dates

October 4, 2019: Applicants may send in questions to [email protected] before this date to be addressed in the pre-proposal webinar. (Questions submitted after this date and before the proposal deadline will still be answered under FAQs on this page.)

October 10, 2019: A pre-proposal webinar will be held for interested applicants at 1 p.m. EDT. The link for this future webinar is available here.

November 15, 2019: All proposals are due by 5 p.m. EDT.

Frequently asked questions (FAQs)

Click to expand question categories.

1. Regarding the format of the application, template, required attachments, page limits, font type and size, and margins: are there examples of prior applications that can be shared to better understand the format?

The format for responding can be found beginning on page 8 of the RFP. You will see four sections with a series of bullets under each heading that will require a response. The sections are: 

  1. Summary of Applicant Background 
  2. Financial Information 
  3. Equipment, Service or Technology 
  4. Cost Proposal Summary and Breakdown 

When assembling your proposal, the order should be: 

  1. Proposal Submission Section 
  2. Questionnaire 
  3. Budget and Budget Justification 
  4. Attachments  

The required attachments include: 

  • CVs of Key Personnel 
  • Organizational Chart of your institution 
  • Federally Negotiated Indirect Cost Rate Documentation

The proposal submission section should not be more than 25 pages, which includes the proposal submission section, the completed questionnaire and budget documents. Required attachments include CVs of key personnel and evidence of Federally Negotiated Indirect Cost Rate. Please use Helvetica 12 point typeface, single-spaced. There are no required margins.

Unfortunately, we do not have any examples that we can share.

2. Regarding the 25-page proposal limit: are references/citations counted in the 25-page limit? What about letters of support? Are they welcome as attachments? 

Yes, any references/citations should be included in the 25-page limit.  You are welcome to provide letters of support as attachments, but they are not required.

3. My team and I will be the key individuals working with PHII to achieve the RFP outcomes. I do have an extensive list of collaborators (some in-kind, some paid) whom I will be listing in the budget and narrative. These individuals are resources for existing data collection tools and content expertise. Would you want to see CVs from all of them, or is a paragraph description of their role and experience sufficient?

The only required CVs are for key personnel with a major role on the project. CVs for subcontractors, consultants and other subject matter experts are not required. A description of their role and background will be accepted.
 

1. Is there more guidance regarding budget templates and guidelines?

Applicants may use a budget template of their choosing but should provide two separate budgets—one for each of the two budget periods indicated in the RFP (budget period 1: March 1, 2020 – August 31, 2020; budget period 2: September 1, 2020 – August 31, 2021).

2. Is there an indirect cost rate, and if so, is there a maximum? Are there other rules surrounding indirect costs, or costs that cannot be included? Does the total budget include both direct and indirect costs?

The total budget should include both direct and indirect costs, and there is no maximum to the indirect cost rate; however, it cannot exceed the federally negotiated rate for your institution. The indirect cost rate will vary and depends on the applicant/agency. These costs are usually overhead costs and also depend on the applicant/agency but could include general and administrative expenses (G&A) and fringe benefits. If you have a federally negotiated indirect cost rate, we ask that you submit documentation of that as an attachment.

3. Can the budget include aspects other than staffing, such as transportation needs of clients?

The budget can include aspects other than staffing, but because this is a public health surveillance project, it does not allow for or provide reimbursement for treatment of patients, including transportation needs of clients. This is not a direct services or client support services project, only public health surveillance.

4. What costs are not allowable?

Unallowable costs include: (1) food (no food can be charged for staff, patients, or other) and (2) direct services to patients.

5. Do we need to use a salary cap? If so, which one?

Yes, please use the NIH salary cap, which is $192,300.

6. Will the funds awarded be considered federal or non-federal funds?

The funds are considered federal funds.

7. Does the $300,000 - $500,000 MAT-LINK budget include only the direct portion of our budget, or does the indirect + direct cost need to stay under $500,000?

The budget range of $300,000 - $500,000 does include both indirect and direct costs.

8. Do you anticipate any domestic travel for participants in the MAT-LINK project such a meeting of all site PIs? Is that a budgetary expense that we should include?

PHII will travel up to three (3) staff from each of the selected sites to attend a two-day consensus building and training workshop at PHII offices in Decatur, GA. This travel will be paid directly by PHII and does not need to be included in your budget.

9. Can you please tell me how the funding would flow if this project were awarded? I am asking so that I can create the proposal in our internal system correctly. Would the funding be issued by Emory, CDC Task Force or PHII?
 
The Task Force for Global Health (TFGH) will issue the contract for this project directly to the selected sites.
 

1. I took the call to mean linkage from clinical sites where mothers would deliver their babies, and to collect clinical data on MAT and newborn NAS and other clinical outcomes. For us, that would mean capturing maternal report from a convenience sample of women who contacted us, and then requesting medical records for mother and infant. Is that acceptable?

2. Though we do not provide direct services ourselves, we have access to data relevant to the analysis. We meet all the eligibility criteria for the data listed in the RFP but we are not a health care facility. Are we still able to submit an application?

We are seeking applications from sites that have access and authority to share linked maternal, infant, and child health data. Additionally, we are asking that sites demonstrate existing or previously successful linkage or integration of maternal, prenatal, delivery and newborn hospitalization records. If you can meet these criteria in addition to the other criteria outlined in the RFP, then we encourage you to complete a full application.

3. With systems where the inpatient electronic medical system is different from the outpatient systems, will you entertain contracting separately with respective legal/administrative teams, for instance in order to get data transferred from the hospital/inpatient record separately from the data from the outpatient record?

4. One of the requirements for applicants is to demonstrate licensure/certification as a treatment center.  I practice in a university setting where we have a program to care for women who are pregnant with substance use disorders. As we are a prenatal clinic and our patients receive their MAT at outside treatment centers in the community, we are not a treatment center per se, so we have no license or certification as such. However, we do have relationships with the outside treatment centers and we communicate regarding patients. Is that setup acceptable to be considered as an applicant?

If you can partner with the other entities to submit a single application and meet the criteria outlined in the RFP, then we encourage you to complete a full application.

5. Some patients may end up receiving treatment from detox centers, methadone clinics etc. We are assuming that information, thus data, about such occurrences may come only from referral data within the in and/or outpatient record. (For instance, when referrals are seen as a “order” in a chart). Does this seem responsive to the RFP?

As outlined in the inclusion criteria in the RFP, clinical sites must demonstrate access to clinical data from pregnant women treated for OUD (medication-assisted treatment (MAT) or detoxification) and demonstrate the ability to capture data on duration, frequency, and intensity of maternal OUD treatment. This can be done through partnerships to obtain the necessary data to meet the requirements of the RFP.

6. We would also like to inquire about the need for the identifiable metric of newborn date of birth. Specifically, it is highly unlikely we would be able to provide any identifiable data under Pennsylvania state law (71 PS 1690), which is more strict on data sharing related to substance use than 42 CFR and HIPAA. Is the sharing of identifiable newborn date of birth required to submit an application? We would likely be able to share de-identified newborn date of birth with the appropriate assurances in place.

No, sharing the newborn date of birth is not a requirement to submit an application. However, in your application, we would request that you propose an alternative method for preserving temporal relationships between events. For example, “date shifting” could be used, which involves all the dates collected from the medical record being shifted by the same number of days, but without the number of days being disclosed to CDC. These shifted dates could be used to accurately calculate intervals such as the newborn length of stay. Please provide evidence of legal authority to share, provide authorization to access, and collaborate on public health surveillance activities.
 

1. The application requests 75 OUD patients. Is that a prospective data collection from 2020-2022? Is that retrospective only? Can it be a combination (e.g., include patients with complete data for the past 1-2 years with a prospective component if will reach the end point of interest by 2022)?

2. Are the 75 dyads prior to being selected, at the time of funding, or for the duration of the study time?

3. Prospective or retrospective data collection only? 

4. After birth, how long will data be collected for mothers and babies?

We are asking for data on births in the year 2014 or later, and so it may be a combination of retrospective and prospective data. The babies can then be followed through 2022 or age 2, whichever comes first.  Please note that maternal information from 2013 may be required for babies born in 2014. 

We are asking for data on a minimum of 75 mother and baby dyads total from 2014 through 2022.

5. What data is wanted on the 75 dyads?
We have a list in the RFP that are related to the variables that we are interested in. Number 20 in the RFP Questionnaire is broken out as maternal health, obstetrical, newborn, early childhood. In addition to the listed variables we will work closely with the sites to identify any additional variables that are important to collect across all sites. 

6. Re: Summary of Applicant’s background, RFP p. 8, the 4th bullet from the bottom reads, “Provide data on a minimum of 75 mother-infant dyads,” I assume in the application you are just looking for an affirmation that we are able to provide that data on 75 or more dyads and not that any actual data will be included in the application itself, correct?
Yes, that is correct.
 

1. How will investigators and research team members involved in data provisioning to the PHII/CDC team members be able to understand the data quality and engage in coming up with the research questions that the registry data may be able to shed light on?

2. Are there any planned analyses out of Mat-Link? Will the researchers at each site be able to propose analyses out of Mat-Link? 

3. Will investigators at clinical sites be invited to co-author publications, scientific presentations, or other dissemination activities?

4. Will there be any restrictions on ongoing studies with those mother-infant dyads during the study time? Will the home institution be able to continue or initiate new studies on the moms, babies, or dyads during the funded time?

5. Will site PIs get to be part of the process of approving analyses in the future of de-identified data sets?

During the project period, clinical sites will work collaboratively with CDC on the priority analyses and will have opportunities to work with the other sites to answer additional questions of interest. With input from all collaborating sites and CDC investigators, analyses will be prioritized based on the anticipated public health impact of findings. CDC will establish a data use working group composed of representatives from all sites and CDC, and all analyses will go through a formal proposal process for prioritizing analyses. All co-investigators with approved proposals through this data use working group will be able to obtain access to de-identified data. 

Each clinical site may analyze its own data at any time; being a part of the MAT-LINK collaborative does not in any way preclude sites from engaging in analyses of their own data. However, we hope sites will join CDC in prioritizing analyses of the pooled data from all sites when possible. 

Following completion of the project period, access to data will be limited to investigators who make a request through a formal proposal process; all proposals will need approval by the CDC Steering Committee. 

Primary analyses planned include:

  • Compare maternal, infant and child outcomes of OUD across treatment regimens.
  • Assess the impact of timing of opioid or polysubstance exposure, OUD treatment initiation, and other maternal factors (e.g., diabetes, hypertension, weight gain during pregnancy, social and mental health conditions, and nutritional status) on maternal, infant and child health outcomes.
  • Assess the impact of mediating and moderating factors, including prior substance exposure, social support and availability of comprehensive services, that contribute to treatment compliance and success.
  • Compare infant and child health outcomes across clinical interventions to treat neonatal abstinence syndrome (NAS), a drug withdrawal syndrome that most commonly occurs among infants after in utero exposure to opioids, overall, and across OUD treatment regimens.

1. Is there any specific information you would like to see in the letter of intent?

In addition to notifying us of your intent to apply for this opportunity, it would be helpful if you could include an estimate of the number of mother/infant dyads your site could contribute to this surveillance system.

2. Do you have a fillable version of the MAT-LINK Questionnaire at the end of the RFP? 

Unfortunately, there is not a PDF fillable version of the MAT-LINK Questionnaire. 

3. Must the sites/applicants be based in the U.S., or can they be international?

The clinical sites must be in the United States.

4. Is the RFP for the MAT-LINK Surveillance Project grant-funded? The RFP refers to contracts and bidders.

The clinical sites will be sub-contractors to a grant-funded project awarded to the Public Health Informatics Institute (PHII).

5. Will you all entertain a dual-PI structure? One PI would certainly be the key point of contact, but I am interested in submitting this with a co-PI/multi-PI structure (with complementary expertise).

Yes, we will accept a dual-PI structure as long as they are both included under a single project application.

6. Our IT Security and Compliance areas have asked whether the data will be aggregated and not identifiable?

Data from sites will de-identified, with the exception of infant’s date of birth, before being sent to CDC. All results in scientific presentations and manuscripts describing the data will be aggregated. After data collection is completed, external researchers will be able to submit a formal proposal requesting access to the de-identified data with the infant’s date of birth recalculated so it won’t be identifiable. Additionally, CDC has submitted a request for an Assurance of Confidentiality to protect potentially identifiable data shared by clinical sites. 

7. What is the fidelity of data required?

Data quality will be assessed throughout the project period and any issues or concerns around data fidelity or quality will be addressed.

8. Will data be aggregated and not identifiable to individuals? Is this HIPAA compliant?

The data will be aggregated and as was stated previously, there will not be identifiable information shared except the infant's birth date because of the importance of that will analyses. This all falls under public health authority, and therefore the data can be shared.

9. Can you please expand on data governance and data sharing requirements?

PHII and CDC will have a data use agreement with individual sites that outlines the flow of the data and the protection of the data and the rites of the data. In addition to that, we have submitted an Assurance of Confidentiality to protect the data from any other entities being able to access it.

10. We are presently collecting data for another project. Is it permitted to utilize that data for this project as well?

As long as there is demonstrated ability to access the data and authority to share, provide authorization to access and collaborate on public health surveillance activities of those data, then please feel free to submit an application.

11. Do we need to get public health authorization from the health department for this project for the submission?

Our current understanding is no. This is covered under the public health authority that CDC has under our public health law.

12. Could you provide further explanation and/or examples of what is requested in the question, “Do you have any data quality and data control procedures in place? Please explain.”?

We are looking for descriptions on each clinical site’s current data quality and data control procedures that are in place. These procedures may include standard operating procedures related to data validation, data linkages of mother-infant dyads, data transfer, data security, quality assurance, etc.

13. How are you defining  rural and urban?

We do not have a specific definition for urban vs. rural. When providing this information, please notate the definition you are using when describing your data.  

14. Certification/licensure for program - what qualifies as licensure or certification for programs? Does licensure of providers suffice? Our providers are licensed and we are a fully licensed health and hospital system but not sure what you are looking for in terms of "program" licensure/certification.

You do not have to provide individual providers’ licenses. We are looking for evidence of legal authority to conduct business in healthcare, which may be the health center’s license number, from sites that have access and authority to share linked maternal, infant and child health data.  
 
15. I have one question not included in the RFP. My team and I will be the key individuals working with PHII to achieve the RFP outcomes. I do have an extensive list of collaborators (some in-kind, some paid) whom I will be listing in the budget and narrative. These individuals are resources for existing data collection tools and content expertise. Would you want to see CVs from all of them, or is a paragraph description of their role and experience sufficient?

The only required CVs are for key personnel with a major role on the project. CVs for subcontractors, consultants and other subject matter experts are not required. A description of their role and background will be accepted.