ROA OTA-22-006_AMENDMENT 2_ATTACHMENT 2_QandAs.pdf

Amendment2_OTA22006_Attach2_QAs 05.26.2022-07.06.2022

ROA # OTA-22-006: All of Us Engagement, Communications, and Enrollment Partnerships

Q&As 5/26/2022 - 7/6/2022 # Offeror Question All of Us Response

a. I would like to confirm if the effort included in this ROA is considered as new requirement or are there incumbent contract(s)?

b. If there is an incumbent vendor(s), would you be able to provide the contract details (such as: Vendor Name, Contract Number, Award and end dates, total contract value) please?

a. This ROA is an expansion of existing All of Us requirements.

b. For a list of existing partners, you may visit this link: https://allofus.nih.gov/funding-and-program-partners

2 Is an estimated value available for this procurement? Please refer to section 3.2.1--Anticipated Funding in the ROA document.

3 Are current All of Us awardees eligible to apply for this new funding opportunity?

Current All of Us awardees are eligible to submit white papers, as long as the proposed effort is not duplicative of the work being performed under their current award. However, if an existing awardee is performing a scope of work covered under one or more of the ROA's areas of interest, and the award is in its final year of performance, it is acceptable for that existing awardee to submit a white paper with the intent of performing under a potential new award.

4 Is the approximate funding amount per award, per year Total Costs or is that direct costs only?

The approximate funding estimates are for total costs, direct and indirect.

The White paper process for AOI 4, per ROA OTA-22-006 section 8.3 Full proposal submission instructions: The white paper submission and evaluation (within 120 days) proceeds the full technical proposal with associated documents. Conceivably, white papers submitted on August 31, 2022 will be notified by email by December 29, 2022 if they are advanced to full proposal.

Yes, that is correct.

Per ROA OTA-22-006 section 8.2.5 Oral presentation: Will this occur within the 120 day period noted above and how much advance notice will PIs get to present their white paper?

The date and time of the oral presentation will be determined between the government and the offeror.

Is a National Community Engagement Partner currently funded under an OTA for Task Area 1 (Recruit and retain one million or more participants who reflect the rich diversity of the United States) eligible to apply to OTA-22-006 for Area of Interest 1, Tasks 3, 4, and 5, if not currently doing work in those task areas?

Yes, the current funded National Community Engagement Partner is eligible to apply for the ROA opportunity as long as there is no duplication in scope of work.

Can you clarify the importance of collecting lifestyle and motivation data as part of the All of Us database?

Most lifestyle and motivation data are collected through the Lifestyle, Social Determinants of Health Survey and the COVID-19 Participant Experience (COPE) survey. By readily connecting biological and social determinants of health data (i.e., neighborhood safety, social support, discrimination, food security, etc.) on a large, inclusive scale and following participants as they move, age, and grow, the All of Us dataset is driving new insights into health and disease. The integration of lifestyle and motivation data allows registered researchers to explore potential associations across a variety of lifestyle factors and how these factors impact the physical and mental health of the participants (link to additional resource).

We are a small business with HUBZone certification along with WBENC and NMSDC certifications, can you clarify is this classification fits what you are looking for? We ask because we are not an academic or university, etc?

Small businesses are eligible to apply per the eligibility criteria in section 6.3--For-Profits.

ROA # OTA-22-006: All of Us Engagement, Communications, and Enrollment Partnerships

Q&As 5/26/2022 - 7/6/2022 # Offeror Question All of Us Response

a. We have original IP, a gamified card sort digital experience, it is designed to collect hard to get personal information about one’s passions, talents, values and impact plus personal goals. We can offer and engage with trusted organizations as stated in 5.1 AOI, is that useful to this initiative?

b. For AOI 5.2 and 5.3 we can offer the same support for Researchers and Tribal Nation outreach, is this applicable?

c. Or, are we better to focus on 5.4 engagement and retention of participants, we can use our card sort IP/technology and data science teams to collaborate in this area of focus, please advise?

a. It is at the discretion of the offeror to propose a solution and partner with different organizations to deliver on the solution for the AOI. All white papers and proposals will be evaluated based on the evaluation criteria outlined in the ROA.

b. It is at the discretion of the offeror to propose the same solution for multiple AOI. All white papers and proposals will be evaluated based on the evaluation criteria outlined in the ROA.

c. Please see response to the above answer a.

11 Will NIH be developing the informed consent process and materials for pediatric participants to provide to awardees for use during engagement and enrollment?

Yes, NIH in coordination with the All of Us Consortium members will be developing the consent, collaterals and materials for use during engagement and enrollment.

Regarding 5.1.3 Technical Approach If an offeror is responding to multiple tasks for Area of Interest (AOI) 1, including Task 2, should only one white paper be submitted? Or should one white paper be submitted for AOI 1, tasks 1 and 2, and a second white paper for AOI 1, tasks 3, 4, and 5?

If the response is part of a combined approach, the offeror should submit one white paper and include all tasks, otherwise multiple white papers would be acceptable.

Regarding 5.1.3 Technical Approach, Task 2 Does NIH expect each offeror to “engage, enroll, and retain one million or more participants” or does NIH expect each offeror to engage, enroll, and retain participants that contribute to the overall goal of one million program participants?

The expectation is that each offeror engage, enroll, and retain participants that contribute to the overall goal of enrolling one million or more participants.

Regarding 5.1.3 Technical Approach Task 2 Does a proposal for AOI 1 need to include a plan to capture all the diversity metrics outlined in Section 10.1.2.1 on page 41?

The proposal should include a plan to capture one or more diversity metrics outlined in Section 10.1.2.1.

15 Regarding 5.1.3 Technical Approach Task 3 What age range does NIH consider “pediatric” for the All of Us program?

Pediatric is defined as individuals under the age of 18.

Regarding 5.1.3 Technical Approach Task 3 Does NIH anticipate that contractors will enroll pediatric patients for the All of Us program under this ROA? If not, what does NIH consider “facilitate” pediatric participation in the program?

At the present time, we do not expect awardees to enroll in the pediatric population. Facilitating enrollment involves activities intended to drive enrollment, including but not limited to mitigating the digital divide by providing sites with computers or tablets with secure internet access, connecting prospects with local enrollment sites, and hosting community-based enrollment events.

Would the award be required to go through our existing HPO consortium or could it go directly to the new HPO site?

HPO sites can apply independently as long as the work is new and is not already funded by an existing award.

We are also partnering with this institution as part of a Nutrition for Precision Health Clinical Center, so could the award go through the lead site of the NPH Clinical Center?

An organization that has received direct funding from NIH, is working as a sub-recipient to an NIH recipient, or is working as a partner of an NIH recipient, is not precluded from applying to this ROA. Any concerns of COI or the like should be discussed with your partner organization (s).

If we want to target two different populations/locations for AOI 1:

1. Rural adult communities in two California counties

2. Pediatric enrollment in another California county

Can this be two different white papers, or do we have to combine this into one white paper?

If the work will be part of a related/widespread effort, one white paper should be submitted. If the offeror considers these to be two separate efforts, multiple white papers may be submitted.

ROA # OTA-22-006: All of Us Engagement, Communications, and Enrollment Partnerships

Q&As 5/26/2022 - 7/6/2022 # Offeror Question All of Us Response

AOI 4, bullet 5 (retention program) Will we have access to participant information in order to develop a retention program?

And what is considered to be a retention activity?

A retention activity is any activity beyond the baseline visit. The program is looking to awardees to identify the best practices and strategies to keep UBR participants actively engaged with the program over numerous years. Awardees should also identify additional ways that participants can engage as partners in the program.

21 Please provide an example of successful retention activities. The examples are variable and there is not a one-size-fits-all approach to retention activities.

22 Does the page count remain intact if answering multiple areas of interest? Please submit one white paper per area of interest proposed.

23 Can offerors submit multiple white papers for a given AOI? i.e., if the white papers did not overlap with each other, could the offeror submit multiple white papers for one AOI?

If the effort(s) proposed in the white papers do not overlap, it is acceptable to submit more than one white paper under the same AOI.

24 Please confirm that applications will only be accepted via ASSIST (as opposed to grants.

gov)

Per section 8.3 of the ROA, full proposals shall be submitted via the NIH eRA ASSIST System.

Per section 8.2.2 of the ROA, white papers shall be submitted via email to AOU-ROA@nih.gov

25 For AOI 1 does a new site need to apply through an existing HPO consortium or can the site apply independently?

The site can apply independently as long as the work is new and is not already funded by an existing award.

26 Can an organization be a part of multiple white papers and proposals? Organizations may submit multiple white papers that address different areas of interest.

27 Would local public health departments be considered non-traditional partners for AOI 1? Please refer to section 6.2 for complete eligibility criteria.

What is the expected timeframe receiving final approval (the award) to receiving the funding?

It depends on the timeline for the full proposal submission. This timeframe will be at least 45 days, potentially longer. The review and negotiation timeline could be anywhere from three to six months, depending on the complexity of the proposal.

Will children be approved for the program by the time the first round of ROA is approved?

It is unlikely that children will be approved to enroll for the program by the first round of award approvals under this ROA, as the timeline for pediatric enrollment has not been confirmed within the program.

30 Will a language be approved and accessible outside of Spanish by the time the first round of ROA is approved, with regard to operations and enrollment?

All of Us welcomes ideas from offerors on how to expand the available languages in the program.

AOI 4, Task 4 - Can you please expand on this: "The awardee must be able to assess participant engagement within the consortium and the program overall." What is meant by participant engagement overall - is this in reference to all participants in the All of Us program?

Participant engagement means engaging participants who have already enrolled in and started their journey in All of Us.

32 Would it be possible to address AOI 1 task 1 in year 1 and expand to also include task 2 and task 3 in year 2? In other words, scale up over time.

Yes, this is acceptable; the proposed effort must address how the scale-up would be achieved during the proposed period of performance.

33 Through this ROA, is All of Us enrollment supported or is this specifically about building partnerships?

Enrollment is included; please refer to the Area of Interest descriptions in the ROA.

34 For institutions who already have engaged participants in precision medicine research, how can you envision their involvement in All of Us?

Please see response to question 39.

35 For researcher area of interest (AOI 2), do researchers have to be affiliated to an organization with an existing Division of Extramural Research Activities (DERA)?

Researchers are not required to be affiliated with an organization with an existing DERA.

36 For engagement, can budget be used for out of pocket expenses like food or technology purchase?

These expenses may be considered as valid expenses for engagement; proposals will be evaluated and offerors will be informed if a proposed cost is considered unallowable.

37 For engagement, is enrollment only done through existing HPOs and DV app? Can other methods be proposed?

The program welcomes diverse methods of enrollment and engagement; out-of-the box ideas other than activities that have been proven to be successful.

38 Was the June 27 webinar recorded or are there meeting notes? That would be extremely helpful.

The June 27, 2022 webinar slides have been posted with this amendment. The webinar recording will be posted in the near future.

ROA # OTA-22-006: All of Us Engagement, Communications, and Enrollment Partnerships

Q&As 5/26/2022 - 7/6/2022 # Offeror Question All of Us Response

For institutions that have ongoing All of Us work – like population-based studies, how might you envision their involvement with All of Us? Might there be a “federated” or “affiliate” model that would be beneficial to both?

Participants in other studies can also participate in the All of Us Research Program if they choose to. Currently, the All of Us Research Program does not have a federated or an affiliate model. The focus of this ROA is not on ancillary studies. Please see the section that describes the purpose of the ROA.

40 Is my LLC eligible to apply for this funding? Please refer to Section 6--Eligibility Information of the ROA.

41 Are HPO’s with existing awards eligible to submit requests? Please see response to queston 3.

42 What is the anticipated format for the single page principal investigator summary resume? Narrative, date format or both?

The offeror's preferred format will be accepted as long as it meets the criteria listed in the ROA.