QA Tracker_ROA OTA-22-006 - QAs Amendment 9 01-17-25.pdf

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

Q&A Tracker 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

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.

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).

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.

Offeror Question All of Us Response

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.

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.

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.

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.

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.

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

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.

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

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.

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.

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.

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.

Offeror Question All of Us Response

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.

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

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

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

Offeror Question All of Us Response

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.

If we choose to write a White Paper in response to Area of Interest 1, must all related tasks be included, or can we choose to focus on one or two?"

For Area of Interest 1, Offerors have the option to address one or more task areas (unless the offeror is responding to Task 2, which then the offeror must include Task 1) in their Technical Approach. For example, the offeror can choose to only focus on Task 1. However, if they are focusing on Task 2, then their technical approach must include Task 1 and Task 2 when responding to the white paper.

Are there any font requirements for the graphics and tables that will be placed in the white paper?

For graphics and tables, there is no font specification, therefore offerors are free to use any font style and size they like.

Task 5: Engage and collaborate with health care providers serving communities that are historically underrepresented in biomedical research (UBR) to facilitate enrollment and retention.) Within this area of interest and tasks, is part of the deliverables to connect recruited individuals to enrollment centers?

1) Can an awardee’s solution include having enrollment sites as subcontractors? 2) Is All of Us most interested in adding enrollment sites, adding community partners that work with existing enrollment sites, or both? 3) Is there a separate process outside this white paper/RFP process for an institution that would like to become an All of Us Research Program enrollment site? 4) What are the program’s minimum qualifications for an entity to become an All of Us Research Program enrollment site?

1. Yes, awardee’s solutions can include having community and enrollment sites as subcontractors. 2.The offeror should submit a proposal that includes components that align with their strengths. We are interested in collaborations with across community and enrollment partners that ultimately support the "Enrollment activities…focused on communities that are historically underrepresented in biomedical research to ensure reflection of the broad diversity of people living in the United States" if the collaborations align with the offeror’s proposed activities and ultimate goal. 3. No, all potential partners must submit through the whitepaper/RFP process. 4. Aligning with program priorities, filling gaps that exist within the program, and continued operations for the program.

On page 14 of 42, in Area of Interest 1, Task 2, sub-item 5, could we partially enroll participants by collecting and shipping the biospecimen?

If an Offeror submits a white paper for Area of Interest 1, Tasks #2 (must also include Task #1 in their response) will need to address all associated workflow requirements. Thus a white paper that does not contain collaborations necessary to meet all criteria (e.g., IT, biospecimen collection, EHR, engagement) would not be responsive to this specific task area.

1. Is it possible to amend a White Paper sent at the end of August to include additional institutions; how flexible is the ROA-recommended cap budget?

2. If it is not possible or desirable to amend an existing White Paper and submit a single proposal at budgets higher than stated in the ROA, is it possible to link two or more proposals? This can leverage central resources for the proposals, reducing cost and using the dollars to recruit and retain more participants.

3. Are Health Information Exchanges (HIEs) allowed to be part of an RMC proposal, or will there be a separate RFA for them?

1. Previously submitted White Papers cannot be amended. Offerors may email AOU-ROA@nih.gov and ask that their submission not be considered for evaluation and they can resubmit for a later deadline submission if changes to their White Paper are needed. The ROA states anticipated funding by Area of Interest (AOI), per award, per year. Per the ROA, lower or higher cost efforts may be considered. The white paper should reflect the true estimated costs of the proposed approach.

2. The offeror should submit one white paper per Area of Interest (AOI) and include all tasks. The white paper should reflect the true estimated costs of the proposed approach. Per the ROA, lower or higher cost efforts may be considered. 3. White paper would need to describe how the HIE's would address the respective Areas of Interest and Tasks to be relevant to their proposal

Given that we already submitted a white paper to be an independent site, can we be included in more than one white paper/application?

Yes, Offerors can submit multiple whitepaper where one white paper proposes one solution, where as another white paper include a different solution including a partnership model.

Offeror Question All of Us Response

1. We have obtained commitments from several rural partners. Should we be attaching any Letters of Support?

2. Our strength as a team is the extensive rural network of community organizations, health care systems and rural practices that we can leverage to recruit participants. The challenge however is to find a place that is convenient to refer the participants to for enrollment. In order to achieve the goal of “recruit to retain” we need to address the enrollment piece and would like your feedback on options given the constraints mentioned in #3.

3. One of the limitations in rural communities is the access to an All of Us enrollment site for the data collection. Participants would have to travel long distances - over an hour to get to the closest site and this poses a significant barrier. We have questions about the possible options

a. Can rural participants provide saliva samples and how would that work? My understanding is that they can provide the sample by mail.

b. What will it take for a Critical Access Hospital / or a rural health system to be a clinical collection site.

i. What is the criteria for the facility?

ii. What is the process to be designated as a site?

iii. How long does this process take?

Thank you for your interest in the All of Us Research Program. Letters of support are not required for the white paper submission, and can be included with a full proposal if you are invited to submit one.

With regards to questions 2 and 3, participants who are long distances from an All of Us physical enrollment site receive an immediate invitation within the participant portal to request a saliva kit mailed to their home address. The saliva kit is mailed to the participant, and they mail it back using USPS. The program also partners with Quest Diagnostics to offer mailed blood collection kits that participants may take to a local Quest site for biospecimen donation, and offers home visits in partnership with ExamOne in select areas. These capabilities can be leveraged for participants who are far from a physical enrollment site location.

For a Critical Access Hospital or rural health system to become a clinical collection site, appropriate paperwork must be filed with All of Us Program officials and the All of Us Institutional Review Board, defining why, who, what, where, and how a site may operate. Guidance and specifics will be provided to those sites that are successfully selected for programmatic funding.

In the ROA No. OTA-22-006 for the White Paper, the request for a budget is required. The information regarding the budget indicates the need for direct and indirect costs and the calculation for said costs, what level is detail is needed? Do you expect to see ERE rates and personnel costs or pools of costs with the corresponding indirect costs rates?

My other question is, is the expectation for the emailed White Paper be that it comes from an AOR at the institution, or can any Offerer submit

-Per the ROA, for the white paper submission, we are asking that you provide total estimated costs for years 1-5.

-The White Paper can be sent by someone other than the AOR. After review of the white paper, if the Government is interested in receiving a full proposal, you will need to follow the instructions in the ROA, Section 8.3 Full Proposal Submission Instructions page 32.

Is there was a limit to the # of white papers submitted for AOI during each cycle? For example can more than 1 white paper for Area of Interest 1 be submitted by 1 institution per application cycle?

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.

We have several inquiries regarding the above full proposal request:

-What is the direct costs budget limit for the ROA-OTA AOI 4?

-What is considered Key Personnel vs Personnel? On page 34 of the OTA it refers to the Personnel section which includes Key personnel and other personnel. There is not a page limit for this section but there is a page limit for the key personnel ( See inquiry below).

-Does the 3 pages max for key personnel ( page 33 of the OTA) refer only to the biosketch length for each key personnel biosketch or total biosketch pages for all key personnel ?

-Is there any opportunity to get specific feedback on our white paper submission?

-We are looking for specific instructions on what the reviewers are expecting for the 12 page technical approach section. Is it to expand on what was in the 5 page white paper or to submit new content?

1. The approximate funding estimates are for total costs, direct and indirect. There is not an estimated direct cost budget limit. 2.Key Personnel are individuals who contribute to the scientific development or execution of a project in a substantive measurable way. The program director/principal investigator (PI) are always considered key personnel. Resume and bibliographies on Key Personnel are not included in the 5 page limit for the White Paper. Resume and bibliographies are not needed on individuals who are not considered Key Personnel. 3. The Full Proposal has a 3 page max limit for the Key Personnel section of the proposal, which includes the biosketches of all key personnel. 4.- Per the ROA, the Government does not intend to provide technical feedback on white paper submissions. 5. The 12 page Technical Approach section of the Full Proposal should expand upon the approach submitted in the white paper. The Technical Approach section should a clear description of the technical approach being proposed in response to the specific Area of Interest (1-4). This section should provide the technical foundation and justification for pursuing this particular approach/direction and why one would expect it to enable the Area of Interest proposal to be met.

For charts, tables, and figures, including the chart of the Summary of Planned Milestones---should this also be in size 12, or is this ROA connected to general NIH guidance on figures which can be smaller but must be readable at 100% printed? https://grants.nih.

gov/grants/how-to-apply-application-guide/format-and-write/format-attachments.htm#font

For charts, tables, and figures, there is no font specification, therefore offerors are free to use any font style and size they like as long as figures are readable.

Our team is planning to submit a white paper for this application. We missed the June 27 webinar. Is there a link to the webinar recording and briefing slides?

A recording of the June 27, 2022 webinar can be found under the Links section of the ROA OTA-22-006 sam.gov posting (https://sam.gov/opp/0dae1301126e4f3ebac1ccb2a2e84d6d/view)

Offeror Question All of Us Response

My organization is submitting a white paper in response to the Research Opportunity Announcement: NIH All of Us Engagement, Communications, and Enrollment Partnerships.

One of our community partners recently brought this to our attention and we missed the pre-submission webinar conducted earlier on June 27, 2022. Is there a recording of the webinar and/or a link to the presentation. If there was an opportunity to ask questions, are they published anywhere? Alternately, is it still possible to schedule a quick consultation call?

A recording of the June 27, 2022 webinar can be found under the Links section of the ROA OTA-22-006 sam.gov posting.

Previously submitted Questions and Answers are posted under the ROA OTA-22-006 Amendment 3 attachment located on the sam.gov posting.

The sam.gov posting can be found at https://sam.gov/opp/0dae1301126e4f3ebac1ccb2a2e84d6d/view

The Government is not conducting consultation calls at this time so please submit any additional questions to aou-roa@nih.

gov.

1. Can you define long distance as stated in the Answer for #69? 2. Are we allowed to budget for personnel at organizations who will assist in recruitment? Or other forms of compensation. 3. Finally can we provide incentives for participants – such as travel vouchers, mileage, gas etc?

1. Long distance is a subjective assessment based on the culture of the region and is dependent on how far individuals in that region are used to traveling. For example, a long distance in NYC could be quite different from a long distance in North Dakota. Saliva samples for participants not near an enrollment center is an option of participation. 2. The budget should include estimated allowable costs to complete the project that align with generally accepted and established federal costs principles. 3. Per the ROA, Monetary incentives are not allowed to support outreach and engagements. Awarded funds may not be used for entertainment costs, alcoholic beverages, alteration and renovation costs, bad debts, bonding costs, building acquisition costs, dues or membership fees, promotional items, for the purchase of laptops or other equipment including costs of computing devices, fines, penalties, damages, or other settlements, tuition costs, legal services, maintenance and repair costs, meals, subscription costs, professional activity costs, proposal costs, publication costs, service charges, stipends, trainee costs, and any out-year direct cost escalations without the express written approval of the NIH.

Is the $2M for the total budget or is the $2M the direct budget not including indirect costs? The $2M is total budget (Direct and Indirect).

Is the Approximate Funding Amount per Award, per Year inclusive of direct AND indirect costs? Or just Direct Costs?

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

Are we permitted to include additional program schedule and cost estimate details as an annex and keep only the high-level/topline items in the body of the white paper? The program schedule and cost estimate details should be within 5 page limit for the whitepaper.

For the ROA OTA-22-006 White Paper, on page 31 (Section 8.2.4) do you want the total direct and indirect costs for the total consortium (consisting of 4 different HPO sites), or would you like us to provide the direct and indirect costs by individual enrollment HPO site?

The White Paper cost estimate should reflect the total estimated cost for each year

Does the NIH have a central IRB supporting the program? Or do we need to set up a local IRB for the enrollment of these patients?

All of Us Research Program has a single IRB. Offerors will not be required to set up a local IRB. Additional information about the All of Us IRB can be found here: https://allofus.nih.gov/about/who-we-are/institutional-review-board-irb-of-all-of-us-research-program

Is an appendix allowed as part of the white paper submission? For example, are appendix items presenting demographics of HPO catchment areas or a map of proposed sites allowed? Or a list of potential engagement partners?

An appendix is allowed but will count as part of White paper page limit.

1. Regarding the full proposal, Is there an opportunity to exceed the 5-page limit? To highlight the unique qualities that each partner brings to All of Us.

2. Can we exceed the $6M budget if we are able to justify. 3. Is a separate budget for each partner or a combined budget?

1. All offerors are required not to exceed the 5-page limit.

2. Proposed budget may exceed the $6M if justified.

3. White paper should include the combined total budget. Within that budget, it should show spending per partner.

Our intent is to submit a whitepaper for Area 1 Tasks 1,3,4 &5

Task 2 includes biospecimen collection along with other inclusion requirements.

1. Am I correct in assuming - If not applying for Task 2, no specimen collection plan is required?

2. If we were not applying for Task 2 but still wanted to try to have one site do specimen collection, is that permitted?

1. Yes, this is correct. Only task 2, which is scoped to encompass all programmatic activities related to participant engagement, enrollment and retention would require a biospecimen collection plan.

2. No, this activity would not be permitted if the applicant did not submit under task 2, since task 2 is the only task that is scoped for biospecimen collection.

Offeror Question All of Us Response

As we are planning our Feb 28 submission, one of our white paper partners has been approached by another institution and asked partner with them for their white paper. They were told that NIH permits an institution to be part of two separate white paper submissions for Feb 28. As far as I know, dual submission for the same deadline has not been the usual NIH policy for RFAs. I would not want dual submissions from the same institution result in rejection of our applications.

A prime organization is limited to a single submission, per AOI, per submission cycle, but may be included as a collaborating partner on more than one submission. Additionally, collaborating partners may be included on more than one prime organization's submission. It is the prime organization's responsibility to obtain commitments from collaborating partners and ensure they have adequate capacity/level of effort available to perform the work proposed should the NIH decide to move forward with award."

Can partners be included in more than one white paper? Yes. Collaborating partners may be included on more than one prime organization's submission. It is the prime organization's responsibility to obtain commitments from collaborating partners and ensure they have adequate capacity/level of effort available to perform the work proposed should the NIH decide to move forward with award.

Do references count toward the page limitations? Yes

1. Do awardees need some kind of affiliation/relationship with a health care provider organization (HPO) that recruits/enrolls All of Us participants? If they do not have HPO affiliation, could awardees focus specifically on direct volunteers?

Yes, however, program priorities will be considered with overall review.

2. In addressing the five tasks outlined for Area of Interest 4, if the outputs of activities that center participants and their advocates as partners to the research include recommendations – for example, study communication practices, implementation processes, and/or compensation for participants – what governance will be in place to ensure recommendations are fully considered and addressed or implemented? Who are the expected final decision-makers in this process? Is there an expectation that there is a real opportunity to impact/guide the participant engagement process and policies?

The awardee can propose recommendations for how to successfully meet the outputs of activities. Additional details can be discussed if the awardee moves forward in the process.

3. Is this particular opportunity focused primarily on developing communications and social marketing to achieve recruitment and retention outcomes of the trial? Or, does this ROA also include developing mechanisms for ongoing communication and feedback on issues that might be limiting recruitment and retentions, for example to not join the study or withdraw all personal data?

This area of interest opportunity is not primarily focused on developing communications and social marketing.

4. Does All of Us have any processes or language around models of risk that extend beyond the individual to include family or community risk? Can you share the ethical guidance you have used for recruitment for this study, in particular those that address underrepresented populations in biomedical research?

Additional details can be discussed if the awardee moves forward in the process. Public resources for review: https://allofus.

nih.gov/news-events/announcements/statement-data-security-all-us-research-program, https://allofus.nih.gov/protecting-data-and-privacy, https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0234962

5. We were not able to find the appendices on the website, are these available? Can you please share Appendix F, the Informed Consent Forms?

The publicly available Appendix F can be found here: https://allofus.nih.gov/sites/default/files/Consent_to_Join_AoU_English.

pdf

6. Are any alternative models for distributing benefits gleaned from research conducted using the All of Us data being considered (i.e., profit sharing, etc.)? Is there transparency in All of Us communications that clearly outlines who will financially benefit from the use of participant data from this government-funded research?

Different options are being investigated to understand how for-profit organizations would use and contribute to our resources.

The program is planning to host roundtables for further discussion.

The aspect of commercialization is in our materials, and in the consent.

For example: All of Us Research Program data may be used to discover or create new products, or tests, and some of these may have commercial value. Participants acknowledge through the program’s informed consent process that they will not get any profits from these discoveries. Any inventions will be the property of the researchers who develop them.

7. If important issues arise around data security concerns by participants involved in study oversight and design, what are the strategies that NIH will use (existing or planned) to ensure that data security concerns and learnings from the proposed research are heard and addressed?

Please refer to the following resource for additional information: https://allofus.nih.gov/news-events/announcements/statement-data-security-all-us-research-program and https://allofus.nih.gov/protecting-data-and-privacy

8. Can you share with us the current enrollment status, how many have registered, actively enrolled and shared their electronic health data, and how many have withdrawn?

You can find the real time public data on what we have available in the Data Snapshots: https://www.researchallofus.

org/data-tools/data-snapshots/

9. In Area 4, under Task 3, the ROA states that the awardee “…will be responsible for providing resources, expectations, and appropriate compensation to participant partners.”

Will the purchase of food for participant and community engagement meetings be an allowable expense?

10. Do co-PIs need a terminal degree, or will a master’s degree combined with years of experience be an acceptable alternative?

It is not required for PIs to have a terminal degree

Offeror Question All of Us Response

Given the page limits: How we can comply with the above with a 5 page limit—e.g. the bio sketches alone wouldn’t fit that. Can you clarify?

Thank you question, we would like to clarify the requirements.

In terms of the page limit of the Key Personnel section, please do your best to comply with the 5-page limit in accordance with the ROA. To further clarify, bio-sketches should include a short description of the key personnel within the 5-page limit.

1) Are Letters of Support counted towards the total number of allowed pages?

2) Is the list of references/sources/bibliography counted towards the total number of allowed pages?

1. Letters of Support are counted towards the total number of allowed pages.

2. The list of references/sources/bibliography count towards the total number of allowed pages.

1. From page 34-35 of the ROA (snapshot below, attached doc), we have staffing personnel requirements. Are these staff members required to submit a biosketch (they are not faculty), or is a resume okay for the proposal submission? [For our current OT award, when we’ve had changes in these required positions we’ve informed NIH through our institution officials and provided the resume of the incoming staff member.]

2. Do you require R&R forms for each sub and task or is the Cost proposal the only portion of the budget needed?

1. For staff members that are not faculty- A resume will be acceptable for this type of personnel

2. While this form isn’t a requirement; we do prefer that they use this form to show the breakdown of salaries for personnel and the consortium costs. The consolidated budget should include the budget breakdown for each sub award on the project.

It also allow for us to capture cost properly.

On the grant submission: the instructions say the Key Personnel section has a max of 5 pages but later says this section should include:

1. Key Personnel (provide key personnel and sub-recipient):

2. Biosketches of key personnel

3. One or multiple Program Directors/Principal Investigators (with a level of effort of at least 10% each).

4. An overall leadership structure and management plan. For proposals with multiple PDs/PIs, a leadership plan that incorporates a conflict resolution plan is required (no page limit).

5. Proposed sub-recipient(s) I don’t see how we can comply with the above with a 5 page limit—e.g. the bio sketches alone wouldn’t fit that. Can you clarify?

In terms of the page limit of the Key Personnel section, please do your best to comply with the 5-page limit in accordance with the ROA. To further clarify, bio-sketches should include a short description of the key personnel within the 5-page limit.

1. Will a Consortium/Contractual Arrangements Form be required for subaward recipients? I did not see any mention of it in the ROA.

2. Should we upload all costing information as an individual pdf within the Core Tab in ASSIST as an attachment (rather than within a budget form as is typically included with NIH grant submissions)?

1. A Consortium/Contractual Form isn’t required.

2. Please include all costs within the budget form.

Are we permitted to have an upload with the Bibliography/Literature Cited? The list of references/sources/bibliography count towards the total number of allowed pages.

Do you have a specific format/template for the Cost Proposal since we are limited to 5 pages maximum? Or do you suggest we use an excel sheet converted to PDF?

They are permitted to use an excel spreadsheet converted to PDF. However, we prefer that they submit their budget using the SF424 form. If they choose to provide their budget using the excel spreadsheet, they must include all related costs, including salary of all personnel and level of effort in CMs for all 5 year budget periods.

Is it allowed to have 0.5 inch margins for the pages that include budget tables as part of the cost proposal? Since it’s a large 5-year budget, numbers and letters become really small on the 1 inch margins page.

They are required to use 1-inch margins. It might be helpful to them if they use SF424 to include their budget.

Question 1: What, if any, patient incentives for engagement and/or enrollment, are allowed under this opportunity?

Question 2: Regarding area of interest 1, does any task other than task 2 include enrollment of patients in the study? In other words, do tasks 1,3,4,5 include enrolling patients? Or is it only task 2?

Q1. Yes, under this opportunity, Incentives are given for enrollment, gift cards.

Q2. Only Task 2 under Area of Interest 1 includes enrollment of participants.

I wondered if there was a preference for communication that focuses on study participants who are of course the most important. Have you funded projects that focus on communication or collaboration with the All of Us data researchers exclusively?

Yes, in the Research Opportunity Announcement (ROA), one of the areas you can respond to is Area of Interest 2: Engage researchers from diverse backgrounds, including those from underrepresented groups, to utilize the All of Us data resources to advance precision medicine, which focuses on engaging researchers.