December 11, 2015

Frequently Asked Questions for Other Transaction Awards

Application Related

1) Can the NIH please provide more clarity on the funding instrument that is noted in the OT award solicitations?

Other Transaction Authority is limited to those government agencies and operational divisions with appropriated authority, and is a funding mechanism which targets non-traditional sources and allows a high degree of flexibility in how the agreement is awarded.  Typical government procurement and grant laws, regulations and policies do not apply to OT awards.

2) Can I apply to both the OT award and grant solicitations?

You may apply to both OT award (OT-PM-16-001; OT-PM-16-002) and grant solicitations (RFA-PM-16-001; RFA-PM-16-002; RFA-PM-16-003; RFA-PM-16-004).

3) Are application due dates firm or is there a possibility that these dates may be extended?

The application due dates are non-negotiable.  Late applications will not be considered.

4) Can we include appendices to supplement the 25-page proposal?

The total application is not to exceed 25 pages. 

5) Can the NIH provide guidance on application submission requirements?

The submission requirements are outlined within the particular funding opportunity, each of which can be found here and reference the application process.

6) Does the NIH have an individual/group identified for the OT awards?

No. Applicants are encouraged to review the eligibility criteria outlined in the OT opportunities.  All eligible entities are welcome to apply.

7) Can an entity with a tax exempt status other than 501(c)(3) apply?

Yes, nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education), are eligible to apply.  Please see the Eligibility Information row in the table at the front of OT-PM-16-001.

8) Is partnering permitted among eligible applicants?

Yes, partnering is allowed among eligible applicants.  See the “Eligible Applicants” section of the funding opportunity.

9) Does the NIH have a forum for large and small organizations to discover one another?

The NIH does not connect organizations to respond to the PMI Cohort Program funding opportunities.  We suggest that organizations work with their professional networks to identify potential partners.

10) How many firms do you anticipate are replying to these opportunities?

It is not known how many applications will be received.

11) What is the initial period of performance?

An award will be made upon selection and award negotiation.  The earliest anticipated start date is January 2016 and the award will run through December 30, 2016.

12) Are there qualification requirements that key personnel must meet?

Generally speaking, NIH defines key personnel as individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation.  Key personnel are always named in the Notice of Award (NoA).

13) Will there be any expectation to integrate with non-US systems?

There is no expectation to integrate with non-US systems.

14) Is any documentation required for subawards?

Applicants are not required to list subawards or provide budget breakdowns in their applications, however, subawardee information may be helpful to reviewers and may be required by the final awardee.

15) What is a reasonable start date for the OT awards?

Awards will be made upon selection and award negotiation.  The earliest anticipated start date is January 2016.

16) Are traditional Government contractors allowed to respond to these funding opportunities?

Yes, provided they meet the eligibility criteria.

17) What are the steps in the award process? Does the award process consist of a) Notice of Award and then b) Final negotiation of terms?

The award process will include final negotiation of terms followed by the Notice of Award.  In the table of OT-PM-16-001, the Award Timeline states, “Award will be made upon selection and award negotiation.”  For more information, please see Part II, Section 2 in the Other Transaction Award Policy Guide for the NIH Precision Medicine Initiative® Research Programs.

18) Does HHS require the use of at least one nontraditional government contractor when utilizing Other Transaction Authority (OTAs)?

There is no such requirement for the PMI Cohort Program OT funding opportunities.  Please refer to Other Transaction Award Policy Guide for the NIH Precision Medicine Initiative® Research Program for more details.

19) Are the eligible applicants listed in order of preference or is preference given to one eligible applicant over another?

These are not listed in order of preference.  All listed entities are equally eligible.

20) What is the NIH’s policy related to intellectual property?

Please refer to the Other Transaction Award Policy Guide for the NIH Precision Medicine Initiative® Research Programs,  section 6 (page 12) “Availability of Research Results:  Publications, Invention Rights, and Sharing Research Resources”.  Section 6.1 covers Rights in Data and has two components, “Ownership of Participant Data and Biospecimens” and “Ownership and Rights to Materials and Resources’.

As stated in the OT-PM-16-001, “In summer 2016, the NIH anticipates awarding cooperative agreements for the full implementation phase. One award will establish a Coordinating Center (alone or with subcontractors; see RFA-PM-16­ -001) that will assume final responsibility for implementation of the Direct Volunteer component of the program. The awardee for this Pilot Phase solicitation will be expected to collaborate closely with the CC awardee to complete pilot phase testing and ensure smooth transition of data structures and data acquired in the pilot phase.”

Applicants should discuss how they will handle patented technology with regard to transitioning of the data and data structures to the full implementation phase with the CC awardee.

21) Can the NIH provide a template of the Notice of Award, which includes NIH’s standard terms and conditions for this type of funding action?

Other Transaction Authority allows NIH the flexibility to negotiate the terms and conditions of awards and we expect that each award will differ.  For this reason we do not have a template for the Notice of Award which we can provide.  Applicants should consult the Other Transaction Award Policy Guide for the NIH Precision Medicine Initiative® Research Programs.

22) Is the application required to be sent by an Institutions Office of Sponsored Programs?

As long as the institutional business office has an actual or digital signature, the application can be sent from either office.

23) Can the NIH provide more information about the OT application requirements?  For example, is there a preferred format or template available for an “Other Transaction Award”?

In the “Overview Information” table, the application instructions state: “Applications should include the following with the total application package not exceeding 25 pages:

  • Technical Approach: Not to exceed 15 pages
  • Past Performance (Corporate/Organizational experience as relate to the solicitation): Not to exceed 5 pages
  • Key Personnel (Applicants should provide brief bios of key personnel): Not to exceed 3 pages. Each application must identify a Program Director/Principal Investigator
  • Cost Proposal: Applicants should build a milestone driven, cost allocated plan for proposal.  Cost models can be cost-sharing, fixed price, adjustable (cost reimbursable) or a hybrid approach: Not to exceed 2 pages.”

Please note that:

  • A cover letter does not count against the 25 page limit for the proposal.
  • References count against the 25 page limit for the proposal.
  • Letters of support are allowed, but will need to be included within the 25 page limit.
  • All applications will be provided to reviewers on standard 8.5 x 11 paper.  The font should be of a size that is legible and convenient for reviewers to read.

Applicants should consult the Other Transaction Award Policy Guide for the NIH Precision Medicine Initiative® Research Programs.

24) How do you apply for these funding announcements? 

Other Transactions do not have a required form.  As stated in the table under “Application Instructions,” “Applications should be submitted in an email attachment in PDF (Adobe) format to Ms. Irene Haas, PMI Cohort Program Agreements Officer, at PMICPFOAInquiries@mail.nih.gov.  Applications must be submitted by an authorized organization representative. Paper applications will not be accepted.”

25) Is the 15-page technical approach is in addition to the past performance, key personnel, and cost proposal?

The technical approach listed in the evaluation process section should have a bullet next to it, and should read:

  • Technical Approach (15 Pages)
  • Past Performance (5 pages)
  • Key Personnel (3 pages)
  • Cost Proposal (2 pages)

Therefore the 15 page technical approach is in addition to the past performance, key personnel, and cost proposal.

26) Will the NIH review applications on a rolling basis?

These funding opportunities are not reviewed on a rolling basis.  All applications are due on December 22, 2015. 

27) Will the NIH pre-review a draft proposal to determine fit?

The NIH will not pre-review drafts of applications.  As stated in Communication Support for the Precision Medicine Initiative® Research Programs at NIH (OTA), “Applications will be evaluated for scientific, programmatic, and technical merit based on the following criteria: technical approach; past performance; key personnel; cost proposal.”

28) Will there be a DSMB/OSMB?

The PMI Cohort Program is currently evaluating the needs and responsibilities of an Observational Study Monitoring Board (OSMB).  Applications will be evaluated for involvement of human subjects and the proposed protections from research risk relating to their participation, as detailed in the Guidelines for the Review of Human Subjects.  As there is no intention of a multi-site clinical trials being developed, there is no requirement for a DSMB.

Administrative and Budget Related

1) Can the NIH provide guidance on the level of effort and funding available for the projects?

The level of effort and the budget proposed will should reflect the needs of the proposed project.  Applicants are encouraged to develop proposals that are realistic and meet the requirements as stated in the funding opportunity. Actual amounts will be determined by NIH and the funds available.

2) Is profit allowed in the budget?

Under the Other Transactional Award solicitations, profit is an allowable cost subject to NIH review and negotiation.

3) Does the NIH have a preference for the cost proposal as the different cost mechanisms connote different levels of financial risk for both the government and offeror?

All cost proposals will be considered and evaluated. Reviewers will evaluate applications based on the following criteria: technical approach, past performance, key personnel, and cost proposal.

4) Are there additional reporting requirements (i.e. status of funds reporting) during execution of the award?

Yes, awardees will be responsible for financial and progress reports. Details of all reporting requirements will be included in the Notice of Award (NoA).  Applicants are referred to Section 8 of Other Transaction Award Policy Guide for the NIH Precision Medicine Initiative® Research Programs for reporting requirements: http://www.nih.gov/sites/default/files/research-training/initiatives/pmi/20151118-ot-award-policy-guide.pdf.

5) Are there any cost categories that should not be included in the budget?

PMI other transaction (OT) awards will use the cost principles found at Title 45 Code of Federal Regulations (CFR) Part 75, Subpart E.  Applicants should also reference the Other Transaction Award Policy Guide for the NIH Precision Medicine Initiative® Research Programs, section 4, for additional information on Cost Principals.

6) What is the range that the NIH expects for direct costs of “Precision Medicine Initiative Cohort Program Direct Volunteers Pilot Studies”?

NIH has not set a predetermined funding amount for the Precision Medicine Initiative® Cohort Program Direct Volunteers Pilot Studies. Applicants are asked to propose budgets that reflect the requirements as outlined in the funding opportunity.  Actual amounts awarded will be determined by NIH and are dependent upon funds available.

7) Can NIH provide clarification on how this pilot project relates to the separate, four Funding Opportunity Announcements associated with Precision Medicine Initiative?

The efforts will be expected to collaborate and potentially use the same IT infrastructure, as described in Task 7 of RFA-PM-16-001, which states “create a secure data management environment to implement tasks listed above, to acquire, analyze and safeguard all user-submitted data, make it available for analysis, and ensure smooth transition of data and IT infrastructure to awardees funded for the full implementation phase.”

8) For the Direct Volunteer Pilot Studies program, is the NIH expecting a cost for each milestone or a list of planned milestones and cost breakdown for the whole year?

Applicants should provide a list of planned milestones with individual cost allocation per milestone as well as a summary budget for the year.

9) Can institutions use their own standard indirect costs F&A rate?

Applicants should propose their current negotiated F&A rate, as applicable.  If no negotiated rate is in place, the applicant should propose an F&A rate which may be subject to further negotiation.

Specific to OT-PM-16-001: Cohort Program Direct Volunteer Pilot Studies

1) Would a project focused on a specific disease population be seen as competitive?

An application that focuses on a specific disease/population will not be responsive to the funding opportunities.  However, applicants may build upon and expand an infrastructure developed for a specific disease/population as long as it is clear in the application that this will not inhibit its generalizability and applicability to the NIH PMI Cohort Program.

2) Is the awardee of the PMI Cohort Program Direct Volunteers Pilot Studies opportunity precluded from applying for the PMI Coordinating Center FOA?

No.  The awardee for the OT-PM-16-001 is also eligible to apply for RFA-PM-16-001.

3) Does the work to be conducted in one year, outlined in Tasks 1-7 of the PMI Cohort Pilot solicitation include IRB reviews and approvals?

Yes.  For further information on the NIH’s approach the IRB, please review Section 1 of the Funding Opportunity Description of RFA-PM-16-001, which states “the PMI Cohort Program will have a single Institutional Review Board (IRB), to the extent permitted by law, constituted to ensure prompt and thoughtful consideration of the evolving protocols in the PMI Cohort Program and the central importance of participants as research partners. The PMI Cohort Program IRB will include significant representation by members of the public and representatives of the participant community.”  This IRB will be established at the NIH and is expected to be able to carry out thorough and timely reviews.

4) Is there the potential for the Coordinating Center and PMI Pilot Study to have overlapping enrollment periods for volunteers?

The Coordinating Center, the Participant Technologies Center, and the PMI Pilot Study will likely have overlapping periods of support.

5) If there may be overlapping enrollment, would the two efforts (Coordinating Center and PMI Pilot Study) leverage the same IT infrastructure simultaneously?

The efforts will be expected to collaborate and potentially use the same IT infrastructure, as described in Task 7 of RFA-PM-16-001, which states “create a secure data management environment to implement tasks listed above, to acquire, analyze and safeguard all user-submitted data, make it available for analysis, and ensure smooth transition of data and IT infrastructure to awardees funded for the full implementation phase.”

6) Is OMB clearance required for the PMI Cohort Program Direct Volunteers Pilot Studies?

No.

7) Is the NIH concerned that volunteers enrolled during the pilot study phase could in fact also be part of a participating, but yet to be awarded, HPO?

The PMI Cohort Program recognizes that some direct volunteers may be a part of a healthcare provider organization (HPO) that may be awarded through the PMI Cohort Program.  It is also possible that over the life of the Cohort Program some HPO enrollees may cease participation in their HPO and convert to direct volunteers.  Applicants may address these scenarios but are not required to do so.

8) What is the source the messages that will motivate the individual to visit the PMI cohort Program Pilot phase website and what is the tentative timeline for launching these communications?

Applicants are encouraged to refer to OT-PM-16-002, which will support communications planning, messaging and visual identity development.

9) Can the NIH provide applicants with a minimum amount of time that NIH will need to accomplish reviews of the database design, data dictionary and overall data security plans?

We anticipate the program review of database design, data dictionary and data security plans to take no more than 5 business days.

10) What considerations must be made with regards to the Genetic Information Non-Discrimination Act as it relates to the genetic information sharing policy?

The Genetic Information Nondiscrimination Act of 2008 (GINA) is a federal law that protects individuals from genetic discrimination in health insurance and employment. Genetic discrimination is the misuse of genetic information. The PMI Cohort Program will not provide genetic information to health insurance companies or employers. 

Applicants are referred to the funding opportunity, which states that “applicants should familiarize themselves with the PMI Working Group report. All partners in the President's PMI are expected to adhere to the PMI privacy and trust principles developed by the White House, which may be accessed at https://www.whitehouse.gov/sites/default/files/microsites/Final%20PMI%20Privacy%20and%20Trust%20Principles.pdf.””

11) What is the anticipated implementation timeline for the pilot study?

An award will be made upon selection and award negotiation.  The earliest anticipated start date is January 2016 and the award will run through December 30, 2016.    In summer 2016, the NIH anticipates awarding cooperative agreements for the full implementation phase. One award will establish a Coordinating Center (CC) (alone or with subcontractors; see RFA-PM-16­ 001) that will assume final responsibility for implementation of the Direct Volunteer component of the program. The awardee for this Pilot Phase solicitation will be expected to collaborate closely with the Coordinating Center awardee to complete pilot phase testing and ensure smooth transition of data structures and data acquired in the pilot phase.

12) Will the pilot study involve actual participants or is this phase only to demonstrate technical abilities?

Yes, in the pilot phase the awardee will collect valuable information from our volunteers.  In the solicitation, please reference on page 8, “Task 3: Participant Provided Information”.  This section focuses on the data to be collected during the pilot phase.  

13) Do the technologies in this announcement include –omics measurements (genomics, metabolomics, etc.)?

At this time, there are no established -omics measurements being conducted within the OT-PM-16-001 that would be ready for data integration. Rather, the Pilot Phase is to provide a ready informatics framework for –omics types of data to be integrated within the Data Core of the Coordinating Center when those assays are conducted.

Please refer to OT-PM-16-001 Task Set 7, which states:

      “The tasks related to creating a secure data management environment include:

  • Define hardware and software environments;
  • Create and implement a systems security plan. Optimized data security is a high priority;
  • Create data models and common data elements for the initial PMI scientific data to be acquired during pilot testing;
  • Design and implement secure web services for tasks listed above;
  • Develop and implement query and analysis tools; and
  • Archive data for carrying forward to PMI Cohort Program full implementation phase.”

14) How many direct volunteers does the NIH expect to be enrolled in the Pilot Studies?

Applicants may propose an appropriately sized pilot cohort to answer the questions put forth in the funding opportunity.  OT-PM-16-001 states, “The pilot phase envisions an iterative process to meet the following four goals:

1. An informational website and potentially other materials which, through extensive experimentation and testing, will be used to help identify what communications and approaches will motivate and interest volunteers to become participants

2. A participant interface which has, through extensive user testing, been optimized to keep participants engaged, maximize their interests and ongoing engagement, and returns to the participants information of value

3. Data structures to implement 1 and 2, and ensure the secure collection and maintenance of data from the first set of volunteers

4. An engagement strategy and process, which motivates volunteers to provide biosamples needed for different types of PMI cohort program research Phased implementation is envisaged, beginning with design, development and implementation of the Pilot Phase Direct Volunteers informational website.

The website will educate users about the program, and offer potential volunteers the opportunity to provide contact information and indicate ‘expression of interest’ and willingness to be re-contacted. Those in the ‘interested’ group will serve as a pool of potential volunteers for continued refinement of the informational website and subsequent pilot testing of the prototypes described below in the Task list.

In summer 2016, the NIH anticipates awarding cooperative agreements for the full implementation phase. One award will establish a Coordinating Center (alone or with subcontractors; see RFA-PM-16­ 001) that will assume final responsibility for implementation of the Direct Volunteer component of the program. The awardee for this Pilot Phase solicitation will be expected to collaborate closely with the CC awardee to complete pilot phase testing and ensure smooth transition of data structures and data acquired in the pilot phase. Another award will establish a Biobank (RFA-PM-16-004). The awardee for the Pilot Phase solicitation will be expected to work closely with Biobank awardee in implementation of Task 6 listed below.”

15) Has IRB approval for the Pilot Studies already been obtained or will the contractor be responsible for writing a protocol and obtaining IRB approval?

The awardee, in cooperation with the PMI Cohort Program Governance Structure, will be responsible for the development of the protocol.  The NIH is establishing a PMI Cohort Program IRB, which is described in Section 1, Funding Opportunity Description of RFA-PM-16-001: “the PMI Cohort Program will have a single Institutional Review Board (IRB), to the extent permitted by law, constituted to ensure prompt and thoughtful consideration of the evolving protocols in the PMI Cohort Program and the central importance of participants as research partners. The PMI Cohort Program IRB will include significant representation by members of the public and representatives of the participant community.”  This IRB is expected to be able to carry out thorough and timely reviews of protocols submitted by PMI Cohort Program PIs.

16) Is the contractor responsible for hosting the website and data on their own servers or will these items be hosted on government property?

We recommend that applicants review the tasks outlined in the Pilot phase goals of OT-PM-16-001 and propose a hosting solution that will best meet the goals and allow a smooth transition to the full implementation phase of the PMI Cohort Program. The efforts will be expected to collaborate and potentially use the same IT infrastructure, as described in Task 7 of RFA-PM-16-001, which states “create a secure data management environment to implement tasks listed above, to acquire, analyze and safeguard all user-submitted data, make it available for analysis, and ensure smooth transition of data and IT infrastructure to awardees funded for the full implementation phase.”

17) Would a research approach, which includes offering a pre-existing software platform as a service to execute the pilot study, be appropriate for this funding opportunity OT-PM-16-001)?

Although open source tools and platforms are preferred, we anticipate that rapid development of a PMI website and mobile capabilities may require the use of proprietary tools and platforms.  It is correct that the NIH expects all data collected from participants, content, and any new software developed under this pilot OT to be transferred to the entities that will continue the PMI cohort project long-term. The OT awardee can offer the capabilities of the proprietary platforms and tools as a web service to the NIH, but the NIH has the option of pursuing other avenues for providing the functions and features of the website and mobile software for continued direct participant use.

18) What type of PII or PHI will NIH be collecting in the PMI prototypes, and will NIH require HIPPA compliant prototypes for the collection of this this information?

PII and PHI are expected data to be held by the PMI Cohort Program.  NIH requires appropriate collection and storage of these data.  Applicants should refer to “Section 7d. Data Security Requirements" within OT-PM-16-001.

19) Are there limitations as to what web analytics data can be collected from users?

There are no limitations on what web analytics can be collected.  These analytics will be reviewed and vetted through the PMI Cohort Program Governance Structure.

20) What is the NIH defining as diversity for this pilot study?

Applicants should reference the PMI Working Group Report, The Precision Medicine Initiative Cohort Program – Building a Research Foundation for 21st Century Medicine , page 26, “Vision for the PMI cohort sample” for information on diversity for the Cohort Program.

21) Will the data returned in Task 3 be individual level patient data or aggregated cohort data?

For the pilot phase, providing access to individual and aggregate data are envisioned.  However, final decisions on type and content of data that participants may access and how it will be accessed will be established in the PMI Cohort Program governance structure.

22) Will patients be consented online for all results self-reported and extracted from EMRs in a comprehensive consent agreement?

It is expected that the initial consent for enrollment will be broad and allow for re-contact over the life of the PMI Cohort Program.  It is expected that consents will be requested at each time additional information is requested from participants.

23) For Task 4, please describe the envisioned division of effort between audience typology research and experiments to test the viability of the items developed in the prior tasks.

Applicants are expected to propose the best strategy to answer the questions for Task 4.  As stated in OT-PM-16-001, “the applicant is invited to propose a prioritized set of questions for achieving the goals indicated above, and a quantitative approach to develop and conduct user-centered experiments to answer them.”

24) Can typology research performed in Task 4 precede the other three tasks?

If the applicant proposes the typology research needed to conduct the tasks outlined in the funding opportunity, the applicant may propose the sequence with which those tasks are conducted.  The tasks are not listed in a chronological order, but are tasks that are requirements for the funding opportunity.

25) Could you please clarify if biospecimens other than saliva are intended to be collected from participants under this task?

Yes, blood and/or saliva may be collected in the pilot phase where the awardee will collect valuable information from our volunteers.  In the solicitation, please reference on page 10, “Task 6: In collaboration with the Biobank awardee, test the impact of specimen collection (blood or saliva) on participant engagement, and the optimum methods to obtain specimens by mail.  Pilot studies to aid in establishing the most effective strategies for mail-in biospecimen collection are an important aspect of the pilot phase. We anticipate these studies will be performed after the award in summer of 2016 of the cooperative agreement for the Biobank (RFA-PM-16-004), and will require close partnership between the Biobank awardee and the awardee for this solicitation.”  This section focuses on the understanding the optimal methods for collecting biospecimens, and will require close interactions with the PMI Biobank awardee.

26) Can non-sensitive tasks required within the OT-PM-16-001 effort may be supported by a non – US citizen and/ or an individual who has permanent residency status?

Please reference the eligibility information on pages 2 and 3 of the solicitation Precision Medicine Initiative® Cohort Program Direct Volunteers Pilot Studies  which states, “Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.  Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.”  There are no other limitations on eligibility.

Specific to OT-PM-16-002: Communication Support for the Precision Medicine Initiative Research Programs at NIH

1) Are creative development resources available or does the scope of the OT-PM-16-002include their development?

There are no separate resources for creative development.  Development of resources and plans would be within the scope of OT-PM-16-002.

2) Should paid advertising costs be included in the overall budget?

Paid advertising should be a cost included within the overall budget plan.

3) Is there a specific metrics platform applicants should be familiar with?

Metrics are not pre-determined, but some are suggested in “Task 3. Collection and analysis of evaluation metrics” within the solicitation OT-PM-16-002

4) What does success look like?

The OT-PM-16-002 requests applications that will address the goals outlined in the FOA: “The NIH envisions an iterative process to meet the following three goals:

  • “Increase engagement around the research components of the PMI,
  • Convey the value of precision medicine and participating in such research,
  • Develop consistent messaging that is effective at engaging the target audiences and can then be used by others to communicate about PMI.” 

It is incumbent upon the applicant to describe how they will succeed in addressing these goals and the tasks outlined in the solicitation.

5) What is the expected period of performance of the Communication Support for the Precision Medicine Initiative Research Programs at NIH (OTA)?

The total project period will be two (2) years for OT-PM-16-002.

6) Within task #2 of the Communication Support FOA, is there a minimum number of events which the contractor should anticipate supporting?

The applicant should propose and account for events they expect would be needed for the task.

7) Can the NIH clarify what specific components of the PMI should be considered when developing the communications plan?

As stated in the funding opportunities, “applicants should familiarize themselves with the report of the PMI Working Group to the Advisory Committee to the Director entitled The Precision Medicine Initiative Cohort Program – Building a Research Foundation for 21st Century Medicine.”  Applicants are also encouraged to review the “Related Notices” listed in the table of the funding opportunity.

Applicants should propose a plan that they feel best meets the requirements outlined in the OT funding opportunities.

8) Can the NIH advise on the planned recruitment timeframe to meet the one million person goal?

The goal of the PMI Cohort Program is to conduct a pilot phase to build the necessary communications support (OT-PM-16-002) and direct volunteer infrastructure (OT-PM-16-001) to be able to enroll one million or more individuals over the course of the full implementation phase.  The purpose of OT-PM-16-002 is to “provide comprehensive Purpose communications support for the development and initiation of the Precision Medicine Initiative® research programs at the NIH, particularly the PMI Cohort Program. The goal of the PMI is to pioneer new models of participant engaged research that promise to accelerate biomedical discoveries and provide clinicians, individuals, families, and communities with new tools, knowledge, and therapies to select which preventions and treatments will work best for which people. The award made through this announcement will support communication efforts for the PMI research programs at NIH, with particular emphasis on the PMI Cohort Program, including communications planning, message and visual identity development, and collection and analysis of evaluation metrics. It also involves outreach through a variety of strategies and platforms for the PMI Cohort Program to put the full body of NIH PMI research program efforts into context.”

The total project period will be two (2) years.

9) Can the NIH provide more detail on the list of key influencers?

The OT-PM-16-002 provides some examples of key influencers and target audiences, who may include “community leaders, researchers, the scientific community, patient advocates, and various media segments.”  Applicants may have additional ideas on other key influencers, and are encouraged to propose how they will engage them.

10) Are there other direct recruitment efforts that will occur outside of the PMI Communications activities to recruit PMI Cohort Program volunteers?

Yes, these activities will occur through other funding opportunities within the PMI Cohort Program (see also “Related Notices” within the “Overview Information” table in the OT-PM-16-002).  The goal of the PMI Cohort Program is to conduct a pilot phase to build the necessary communications support (OT-PM-16-002) and direct volunteer infrastructure (OT-PM-16-001) to be able to enroll one million or more individuals over the course of the full implementation phase.  The purpose of OT-PM-16-002 is to “provide comprehensive Purpose communications support for the development and initiation of the Precision Medicine Initiative® research programs at the NIH, particularly the PMI Cohort Program. The goal of the PMI is to pioneer new models of participant engaged research that promise to accelerate biomedical discoveries and provide clinicians, individuals, families, and communities with new tools, knowledge, and therapies to select which preventions and treatments will work best for which people. The award made through this announcement will support communication efforts for the PMI research programs at NIH, with particular emphasis on the PMI Cohort Program, including communications planning, message and visual identity development, and collection and analysis of evaluation metrics. It also involves outreach through a variety of strategies and platforms for the PMI Cohort Program to put the full body of NIH PMI research program efforts into context.

11) For planning efforts, has the NIH prioritized relevant audiences for the Precision Medicine Initiative?

The NIH expects applicants to prioritize the planning efforts.

12) What are the main communications lessons that have been learned from previous cohort programs?

The applicant may provide this analysis to justify their approach.

13) What is the typical attrition/dropout rate in this type of program?

This program is unprecedented, and applicants may want to consider a reasonable attrition rate for planning purposes.

14) What percentage of the cohort is currently expected to be sourced from existing HPO communities?

In the long-term, more than half of the cohort is expected to come from HPOs.

15) Would there be an opportunity for integrated communications with HPO?

Absolutely.  The NIH expects a highly organized and collaborative Governance Structure to nurture these opportunities.

16) What “other federal entities” might be involved in communications support for the program?

The President’s Precision Medicine Initiative® is coordinated through the White House and includes collaborations with a variety of federal agencies, including FDA and CMS.  Details of this will not be realized until the awards are made.  Applicants may propose a vision for future collaborations.

17) Should we interpret “engagement” under the first goal as “participation”? Or is this a broader goal?

The purpose of the OT-PM-16-002 is: “to provide comprehensive Purpose communications support for the development and initiation of the Precision Medicine Initiative® research programs at the NIH, particularly the PMI Cohort Program. The goal of the PMI is to pioneer new models of participant engaged research that promise to accelerate biomedical discoveries and provide clinicians, individuals, families, and communities with new tools, knowledge, and therapies to select which preventions and treatments will work best for which people. The award made through this announcement will support communication efforts for the PMI research programs at NIH, with particular emphasis on the PMI Cohort Program, including communications planning, message and visual identity development, and collection and analysis of evaluation metrics. It also involves outreach through a variety of strategies and platforms for the PMI Cohort Program to put the full body of NIH PMI research program efforts into context.”

18) Is there more detailed audience segmentation available, or would that work be conducted by the awardee?

The applicant is expected to propose the audience segmentation and prioritize key influencers as they see fit for the success of this program.

19) Can the NIH specify what site the awardee will promote?

The website(s) to be promoted will be developed within the OT-PM-16-001.  Please see the “Pilot phase goals” described in OT-PM-16-001.

20) Has the NIH previously conducted social media outreach around the Precision Medicine Initiative?

Social media is among the many tools for outreach that may be proposed.  The PMI Cohort Program is new, and no data are available.

21) What advertising platforms (digital, print, out-of-home) would NIH expect the awardee to utilize, and what is its preferred advertising budget for these platforms?

The NIH expects applicants to propose the best advertising platforms, as well as the applicant’s cost proposal that will reasonably accomplish the goals.

22) What paid media mix has been used for previous programs?

The NIH expects that applicants to conduct their own research on previous work to justify and put forth their best proposal.

23) To what extent, if any, does the government expect that the paid advertising or other communications efforts under this contract will specifically aim to recruit study participants?

Please refer to the goals outlined in the solicitation:

     "The NIH envisions an iterative process to meet the following three goals:

  • Increase engagement around the research components of the PMI
  • Convey the value of precision medicine and participating in such research
  • Develop consistent messaging that is effective at engaging the target audiences and can then be used by others to communicate about PMI”

The DV Pilot will test methods and platforms for recruitment, in collaboration with the Communications effort. It is envisioned that any paid advertising would be intended to recruit participants and would take place following the full implementation phase.

24) Will the contractor be responsible for handling production of print materials developed under this award?

The awardee will be responsible for handling all aspects of the communications.

25) Is website development, design, and maintenance are included in the scope of work?

Website development, design, and maintenance are not within the OT-PM-16-002 scope of work.  The Website(s) to be promoted by the OT-PM-16-002 awardee will be developed within the OT-PM-16-001.  The data from usability testing will come from the OT-PM-16-001 to help evaluate the metrics for Task 3.  Please see also the “Pilot phase goals” described in OT-PM-16-001.

This page last reviewed on March 24, 2016