ROA OTA-22-006_AMENDMENT 3_ATTACHMENT 2_QAs_05.26.2022-08.17.2022.pdf

Amendment3_OTA22006_Attacch2_QAs 05.26.2022-08.17.2022

# 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.

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.

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

Q&As 5/26/2022 - 8/17/2022

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

Q&As 5/26/2022 - 8/17/2022

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.

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.

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.

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

Q&As 5/26/2022 - 8/17/2022

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.

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.

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.

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

Q&As 5/26/2022 - 8/17/2022

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.

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.

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.

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.

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.

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

Q&As 5/26/2022 - 8/17/2022

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.

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.

We have a current consortium funded by an All of Us OT award. Does this new ROA submission need to be submitted on behalf of all of the current consortium?

ROA submission's do not need to be on behalf on the current consortium.

44 What happens if some of the institutions want to apply for different areas? Do all institutions need to apply for the same area?

Organizations may submit multiple white papers that address different areas of interest.

45 Is there a total award limit for the consortia? Please refer to section 3.2.1 Anticipated Funding in the ROA document.

46 Will we be provided with a total budget amount for each area divided out by task?

Please refer to section 3.2.1 Anticipated Funding in the ROA document.

We have areas of interest which all institutions would like to apply for and ones that will only be applicable to one or two sites. Should those all be submitted as separate white papers?

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.

If an institution is interested in different areas, should each area be a white paper or should the institution have 1 white paper which describes both areas?

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.

Will there be the possibility of additional enrollment sites opening in our current catchment areas especially with this new ROA announcement? Will they be in competition with us?

Yes this is a possibility, though all partners in the All of Us Research Program work towards the same mission. Rather than in competition with existing partners, it is expected that new partners would collaborate and complement existing partner infrastructure.

52 Is this the mechanism for future “renewals” for our current OT award? The acquisition strategy for current All of Us awardees has not been determined and will be addressed seperately.

53 If so, is the August date for the white paper for HPOs whose awards end sooner?

The acquisition strategy for current All of Us awardees has not been determined and will be addressed seperately.

54 When should we aim to submit given our current award is funded through June 2023? Specifically related to Area of Interest 1 Task 2.

The acquisition strategy for current All of Us awardees has not been determined and will be addressed seperately.

55 Will our current OT award end after Yr5? Will there be a no cost extension? The acquisition strategy for current All of Us awardees has not been determined and will be addressed seperately.

56 If this OT will replace our current OT award after YR5, will it be the same award number?

The acquisition strategy for current All of Us awardees has not been determined and will be addressed seperately.

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

Q&As 5/26/2022 - 8/17/2022

57 Is there a possibility HPOs could be awarded for retention but not recruitment activities?

Yes, this is a possibility.

Question related to Area of Interest 1, Task 3: Should proposals for pediatrics enrollment be delayed for a few more months until there is more program clarity around pediatric enrollment? Or if we know that we need to have this year for laying the groundwork for enrollment, should we move forward with an August submission?

Proposals including pediatric enrollment are welcomed for the current submission, however, it should be noted that enrollment of pediatric participants is unlikely to occur is the first half of 2023. There is a lot of engagement work with families and pediatric populations that would be valuable leading up to actual enrollment-ready dates

Question:The ROA instructions state that fixed price proposals can be submitted. However, the draft terms and conditions are only for cost reimbursable awards. Can you provide clarification on whether fixed price proposals based on commercial pricing are eligible for the program?

Fixed price proposals based on commercial pricing are acceptable under this ROA.

Any resultant fixed price award shall reflect the relevant terms and conditions.

Questions: 1. If selected, how are our efforts recorded/collected/reported? Is there possibility to publish our community engagement key learnings/findings specific to our All of Us work either individually or in partnership with NIH?

2. Will we also gain access to and be able to leverage the All of US database for our own use/community engagement/research purposes?

3. Will we be categorized within a specific Community Partnership level, if funded for this specific ROA? If so, which one? There are several listed on the main All of US Community Partnership page (e.g., Engagement and Retention Innovators, Community Engagement Partners, Champions).

4. Should we focus our efforts in Alabama, the Southern Region or present something more broad? We weren’t sure if you were looking for multiple partners within an area or for us to find partners to work with.

Response 1 - If selected, an awardee’s efforts related to their milestones will be reported via the monthly reports due to NIH. Awardees also can publish community engagement key learnings/findings specific to the All of Us work either individually and may have the opportunity to publish in partnership with NIH. Please reference Appendix A (Terms and Conditions) in regards to publications.

Response 2 - Access to the All of Us Researcher Workbench Controlled and Registered Tier data is available to researchers with an institutional agreement in place – and is available for use outside of the ROA. Any U.S.-based academic, nonprofit, or health care institution can enter into our Data Use and Registration Agreement. If you are interested in applying for Researcher Workbench access, please visit the Register page for information on the steps you will need to complete Response 3 - The partners listed on the All of Us Community Partnership page is categorized based on the funding opportunity that their award was funding under with the exception of Champions. Champions are our unfunded partners.

Response 4 - It is at the discretion of the offeror to identify the geographical and any partners to include in their proposal.

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

Q&As 5/26/2022 - 8/17/2022

Can you confirm if we are expected to recruit community members who are not patients at our health centers? If so, what are the expectations around EHR data sharing for community members who are not patients? Additionally, do you have any suggestions for collecting biospecimen samples in the community (e.g., if community members enroll but do not visit our health centers)?

Yes, a plan for recruiting patients, including EHR sharing and assessing the feasibility of recruiting non-patients during the funding period, is also required. Should the feasibility study show that enrolling non-patients is achievable, this would be added to the milestone negotiations. Part of that feasibility investigation should include buy-in from institutional leadership, an assessment of EHR sharing capabilities (potential use of FHIR methodology as developed by the program) and recruitment strategies of non-patients, including friends/ family of patients, recruitment at community events or pop-up booths for enrollment at community events or outside of their center.

Biosample collection in the community could leverage the program’s saliva kit opportunities and partnership with existing program partners that facilitate additional blood donation locations throughout the county, including blood banks, certain Quest locations, home visits if appropriate, etc.

Question regarding the salary cap, our organization works under FAR-based type contracts. Provided that we are allowed to submit a firm-fixed price proposal under this ROA, we wanted to flag this item for your attention and seek your guidance on addressing the salary rate limitation in a proposal.

Fixed price proposals are acceptable under this ROA. Given that every proposed solution to this ROA will be unique, applicants are encouraged to provide breakdowns showing how they arrived at their projected expenditures - see Section 8.3.2 - 7 of the ROA. When providing breakdowns for proposed costs, applicants should ensure that the Salary Rate Limitations are met.