AoU_CLAD_ROA_OTA-23-003 Informational Webinar 3 March 2023.pdf

All of Us Research Program Research Opportunity Announcement - Informational Webinar ROA No. OTA-23-003

Center for Linkage and Acquisition of Data (CLAD) Date: March 3, 2023; 1:00-2:30 P.M. ET All of Us Research Program

Today’s Presenters

Chris Lunt Chief Technology Officer

Lew Berman, Ph.D.

Chief, Digital Health Technologies and Data Branch

Jessica Ely Team Lead, Awards Management Branch

Webinar Agenda: All of Us Center for Linkage and Acquisition of Data ROA

● Provide an overview of the All of Us Research Program

● Outline the Center for Linkage and Acquisition of Data (CLAD) Research Opportunity

Announcement

● Review the submission requirements and timelines

● Address questions and answers

Webinar Opening

Opening

The purpose of this announcement is to solicit and review proposals, evaluate potential partners, and ultimately fund the future

All of Us Center for Linkage and Acquisition of Data (CLAD).

All of Us Research Program Overview

All of Us Research Program Mission

All of Us Consortium Members (as of August 2022)

The Participant Center

RMCs

All of Us California

Illinois Precision Medicine Consortium

All of Us New England

Trans America Consortium

New York City Consortium

Participant Technology Systems Center (PTSC)

All of Us Pennsylvania

All of Us Southern Network

All of Us Southeast Enrollment Center

All of Us Wisconsin FQHCs (Federally Qualified Health Centers) VA Medical Centers

Communications & Engagement

Biobank Genomics Partners

Data & Research Center (DRC)

University of Arizona and Banner Health

HPO Network (Health Care Provider

Organizations)

HPO Lite

All of Us Community and Provider Partner Network (as of August 2022)

Black Greek Letter Consortium

BGLC

All of Us Aims to Enroll 1M+ Participants Who Complete Initial Program Opportunities

(Updated 1/25/23) Enrollment Numbers The following numbers are approximated to protect participants’ privacy.

Numbers are updated as of January 25, 2023.

All of Us Supports Regional Enrollment Centers & Nationwide Virtual Participation

All of Us supports nationwide enrollment in all 50 states through a combination of virtual recruitment, regional enrollment centers, and interactive mobile exhibits. Participants can currently enroll and participate in English or Spanish.

All of Us Strives to Enroll a Cohort that Reflects the Diversity of the U.S.

Race & Ethnicity of Participants

51.0%

18.4%

16.2%

3.1%

6.8% 2.8%

0.6%

White

Black, African American, or African

Hispanic, Latino, or Spanish

Asian

More than one race/ethnicity

Other communities

Prefer not to say

About 80% of All of Us participants identify with a group that is underrepresented in biomedical research (UBR)

0.02%

49.6%

UBR Category

Numbers current as of January 31, 2023

All of Us Most Talked About Publications of 2022 Metrics as of December 22, 2022

Not for distribution. Intended for internal discussion only.

Association of step counts over time with the risk of chronic disease in the All of Us Research Program.

Master, H., Annis, J., Huang, S. et al. (2022) Nature Medicine

Association of longitudinal activity measures and diabetes risk: an analysis from the NIH All of Us Research Program.

Perry, A (2022) The Journal of Clinical Endocrinology & Metabolism

Revisiting the Latino Epidemiologic Paradox: an analysis of data from the All of Us Research Program.

Montanez-Valverde R, et al. (2022) Journal of General Internal Medicine

Association of everyday discrimination with depressive symptoms and suicidal ideation during the COVID-19 pandemic in the All of Us Research Program.

Lee Younga H, et al. (2022) JAMA Psychiatry

Wearable fitness tracker use in federally qualified health center patients: strategies to improve the health of all of us using digital health devices.

Holko Michelle, et al. (2022) NPJ Digital Medicine (1) 53

AltMetric is an indicator of the volume and type of attention a research publication has received. The donut score reports identify how much and what type of attention a publication received.

Between December 2021 and December 2022, 100+ articles using All of Us data were published in peer-reviewed publications.

Using the holistic reference tool, AltMetric, we see the five studies to the right rose as the most talked about All of Us publications of 2022. This serves as a complementary metric to citations, as it shows a fuller view of an article’s influence across research, policy, and general public audience.

All five of these articles score in the top 5% of all research publications scored by Altmetric. Each of these articles were also amplified through NIH All of Us communications tactics and materials to help build additional momentum.

Media Outreach

Social Media

Researcher Spotlight

Research Highlights

Research Roundup Newsletter https://pubmed.ncbi.nlm.nih.gov/36216933 https://pubmed.ncbi.nlm.nih.gov/36216933 https://pubmed.ncbi.nlm.nih.gov/36458881 https://pubmed.ncbi.nlm.nih.gov/36458881 https://pubmed.ncbi.nlm.nih.gov/35505219 https://pubmed.ncbi.nlm.nih.gov/35505219 https://pubmed.ncbi.nlm.nih.gov/35895053 https://pubmed.ncbi.nlm.nih.gov/35895053 https://pubmed.ncbi.nlm.nih.gov/35469045 https://pubmed.ncbi.nlm.nih.gov/35469045

Data on the Researcher Workbench is Diverse and Longitudinal

324,000+ EHRs

311,000+ Physical Measurements

12,880+ Fitbit Records

372,000+ Surveys

374,000+ Participants 374k participants in dataset

68 million conditions

30 million procedures

67 million drug exposures

33 billion Fitbit data points

278 million labs and measurements

68 million survey answers

Center for Linkage and Acquisition of Data

(CLAD)

Vision Current State including Experimental Work Data Flow Key functions and Operational Goals Cores and Staffing Milestones Factors Affecting Data Linkages Optional Periods

A key goal of All of Us is to build a broad dataset including behavioral, biospecimen, environmental, health, and other data over an individual’s life-course. This data accounts for modifiers of health such as individual mobility, where people live and work, where they seek care, and environmental exposures. An important aspect of this vision is a recognition that new data acquisition methods are needed that reduce participant burden.

Consequently, the vision for CLAD is to expand our understanding of health, increase research utility, align with the expectations of consented participants, and increase retention metrics all through data linkage.

The Overarching Vision for CLAD

Preschool

Child Adoles -cence

Young adult Middle aged Aged 80 and over Life-course

Birth/Infant

Charles Driesell

Norfolk, VA

Durham, NC

Davidson, NC

College Park, MD

Harrisonburg, VA

Streams of Data Currently Collected on All of Us Participants

● Wearable device data

● Fitbit data

Physical Activity Data

Surveys

● The Basics

● Overall Health

● Lifestyle

● Health Care

Access & Utilization

● Personal & Family Health History

● SDOH

● COVID

Bioassays

● Assay data from blood, saliva, and urine

● Whole Genome Sequencing and Arrays

Physical Measurements

● Blood pressure

● Heart rate

● Height and weight

● BMI

● Hip and waist circumference

Demographics

● Participant demographics

● Consent

● HIPAA

authorization

EHR

● Healthcare Provider acquired data

● Participant health data from portals

● Apple Health

● Two experiments have been completed and one is planned. The focus has been on cohort discovery, EHR completeness, and EHR acquisition. We are considering a fourth experiment with an imaging repository.

● Some key factors to consider when choosing PPRL technologies and methods

○ Verification of matching accuracy needs to be undertaken / understood

○ Robust tokenization is needed as patient interactions with the health system can result in different demographics

● Some key results

○ Cohort discovery: found ~19.5 All of Us participants in N3C and a health information network

○ EHR completeness: A significant amount of patient activity across diagnoses, procedures and drugs is not in All of Us EHR data

Experimental Work with Privacy Preserving Record Linkages (PPRL)

People Have Different Disease RisksData Linkages During the Base Period

● Initial linkages selected to better understand a participant’s health, increase research utility of the data, align with the expectations of consented participants, quality, and to increase retention metrics

● Clinical Data

○ Mortality Data

○ Health Care Claims Data

○ HIN / HIE Pilot for EHR data

● Geospatial Data

○ Residential history - addresses for where study participants have lived

○ Geocodes - home latitude & longitude, Census block / block group, etc.

● Environmental Data

○ Centers for Disease Control and Prevention’s Environmental Index

CLAD Data Flow and Researcher Access within the All of Us Data Ecosystem

Healthcare Provider Organization EHRs Physical Measures

Physical Activity

Bio Assay

CLAD

Merged

OMOP

Datasets

Merged Raw Data

Curated Data

SurveyDemo-graphics

Data and Research Center

Investigators

Registered

Public

Controlled

Mortality

Claims

Residential History

Geocodes

Environmental

HIN/HIE

CLAD Operational Goals

● The focus is on developing a Center (not just a platform) that drives value for researchers using advanced methods and technology

● Provide program management, scientific, and technological personnel & services for data acquisition, governance & quality, de-identification, and linkage

● Acquire data from new data streams and from existing data streams, such as electronic health records (EHRs), through new methods

● Matching of linked data to participants with an acceptable level of sensitivity, specificity, positive predictive value, and negative predictive value

● Build and/or customize and deploy a secure cloud-based data linkage platform

● Produce data, documentation, and tools for dissemination on the Researcher Workbench

Core Functions and Key Personnel

Program Compliance Core

Core Lead Lead Platform Engineer

Principal Investigator Program Manager

Research Management Core

Data Platform Core

Data Linkage Core

Core Lead De-identification / Disclosure Expert

Info. Sys. Security Official

Core Lead Lead Data Architect Data Quality Expert

○ Leadership, management, administration, coordination, and staffing

○ Oversight of platform development, linkage efforts, and compliance

○ Implement and manage the Data Linkage Platform

○ Provide Identity Management, Integration and Monitoring Functionality

○ Data Governance and Quality

○ Acquire and Manage Linked Data

○ Develop documentation & tools for researchers; support dissemination

○ Ensure compliance with laws, regulations, and policies

○ Enable disclosure review and IRB approval

○ Safeguard participant privacy and security

Core Lead Lead Platform Engineer

Principal Investigator Program Manager

CLAD Milestones and Relationships

Milestone 12

Strategic & Innovation Planning

Planning Next Optional Period Months 13 - 18

Milestone 3

DLP Security and ATO

Milestone 4

DLP

Development

& Maintenance

Data Linkage Platform Efforts 3: Months 2 - 12

Data Linkages 5: Months 4 - 18

6 - 11: Months 3 - 18

Milestone 5

Data Quality, Governance,& Sustainability

Milestone 6

Mortality Data

Milestone 7

Residential History

Milestone 8

Geocoding

Milestone 9

Environmental Data

Milestone 10

Health Care Claims Data

Milestone 11

HIN/HIE Pilot

Milestone 1

Award Onboarding and Access

Milestone 2

Regulatory and Policy

Preparatory Efforts

1: Month 1 2: Months 1 - 4

Repeatable Pipeline within Data Linkage Milestones

Identify Linkage

Assess Blockers

Scientific

Merit

End

Repeatable Data Linkage Pipeline

Objective 1

Gather Requirements

Objective 2

Procure Data

Objective 3

Configure & Test Data Linkage

Platform

Objective 4

Ingest Data & Assure Quality

Objective 5

Develop Analytic Tools

Objectives 6 & 7

Transfer Data, Docs, & Tools;

Provide Support

● All of Us IRB submission and approval should be accounted for with each linkage

● ATO must precede acquisition of PII from the DRC and linkage data (unless it is public domain); offerors should be creative however in using approaches (e.g., synthetic data) to advance linkage work before ATO

● CLAD data deliveries need to align with the All of Us Data Roadmap which provides for

○ A manifest of which participants are included in a specific delivery of data to the Researcher Workbench

○ Anticipated dates of each (~yearly) curated data release to the Researcher Workbench

● The impact of participants that withdraw from the program in terms of

○ Delivery of data to the DRC

○ Destruction of data within the CLAD data linkage platform

Some Factors Affecting Data Linkages

People Have Different Disease RisksDependencies within the Baseline Data Linkages

Milestone 9 Environmental Data

Milestone 11

HIN / HIE

Pilot

Milestone 7 Residential History

Milestone 8 Geocoding

Milestone 10 Health Care Claims

Data

Milestone 6 Mortality Data

CLAD

Data Linkage

Platform

(May not require address information)

N/A N/A

1:M Relationships Exist Between Residential Address and Data Linkages

Althea Dumas

Norfolk, VA

Davidson, NC

College Park, MD

Harrisonburg, VA

Birth Death

Environmental X X each available address results in a separate set of geocodes and related dataset linkages

N/A - no data available

HIN/HIE Pilot (possibly) X X XN/A

Geocodes X X XN/A

Residential History X X XN/A

Alignment of Source Data Provider Updates, Data Acquisition, and Data Production

Less Frequently

More Frequently

Residential History, Geocodes, EJI

Health Care Claims, EHR from HIN/HIEMortality possibly > 1 data pull from source provider during the base period possibly 1 data pull from source provider during the base period

Data production schedule for delivery of data to the Researcher

Workbench

Optional Periods

● Examples of future linkages during the optional periods

○ Disease specific areas

○ Environmental data (e.g., air quality, water quality)

○ Occupational history

○ Radiologic & other clinical images (e.g., optical coherence tomography)

○ Registry data (e.g., cancer, immunization)

○ Social Determinants of Health

○ Waveform (e.g., EKG)

● What will drive decisions on the milestones for the optional periods?

○ Research utility, research utility, research utility

○ Funding

○ CLAD Milestone 12 - Strategic & Innovation Planning

○ Partners, Scientific Roadmap, Steering Committee, Science Committee, trans-NIH activities, …

○ All of Us Ancillary Studies

○ Participant expectations

Lastly, thank you

Submission Requirements & Timeline

People Have Different Disease RisksAward Information

● Award Type: Other Transactions (OT)

● OT Authority: Public Health Service Act (PHSA) sec. 402(n), 42 U.S.C. sec. 282(n)

● Budget: $30 million total costs (Base Period)

● Period of Performance

○ 18-month base period

○ Up to four 12-month optional periods

People Have Different Disease RisksCompetition Process

● This Other Transactions Award competition process will include three phases:

○ Phase I - Submission and Evaluation of Full Technical and Cost Proposal

○ Phase II - Data Linkage Platform (DLP) Capabilities Demonstration and Evaluation (Invitation Only)

○ Phase III - Negotiation and OT Award (Invitation Only)

● The NIH intends to down-select at each phase resulting in making one OT award in Phase III

● Depending on program requirements, the NIH reserves the right to omit Phase II, or to combine the Phase submissions as needed

● For selected proposals invited to Phase II and III further instructions will be provided

● Participation in Phase I is required to be eligible for invitation to Phase II and III

People Have Different Disease RisksLetter of Intent

● Requesting that offerors who intend to submit a proposal in response to the CALD ROA complete the

Intent to Submit Proposal Form (ROA Appendix E) and return to

AllofUsDTPDAwardRequirements@nih.gov by March 15, 2023 at 3pm ET

● Letter of Intent is not binding and does not enter into the review of a subsequent proposal

● Letter of Intent is not required but allows the All of Us Research Program to estimate the potential review workload and plan the review mailto:AllofUsDTPDAwardRequirements@nih.gov

Phase I - Proposal Submission Instructions

● Full technical and cost proposal must be submitted via the NIH eRA ASSIST System

● To submit a proposal via ASSIST, the applicant organization must be registered in eRA Commons.

○ Please plan accordingly, as registration approval does not occur immediately upon request.

○ Organizations already registered in eRA Commons do not need to reregister.

○ The individual(s) with the role of Signing Official (SO) and Program Director/Principal Investigator

(PD/PI) must be affiliated with the organization and have eRA Commons credentials to complete the submission process

● Use the ROA number, OTA-23-003, in the field requesting “Funding Opportunity Announcement #”

● Instructions for submitting a proposal in eRA ASSIST can be found at https://www.era.nih.gov/help-tutorials/assist/era-training-assist.htm

● eRA Technical help is available at https://www.era.nih.gov/need-help https://www.era.nih.gov/help-tutorials/assist/era-training-assist.htm https://www.era.nih.gov/need-help

Phase I - Proposal Submission Instructions

● Full technical and cost proposal due April 17, 2023 at 3 p.m. Eastern Time

● Proposal Submission Requirements

○ Paper Size: 8.5 x 11 inch paper

○ Margins: 1 inch on all sides

○ Spacing: single-spaced

○ Font: Times New Roman, 12 point

○ Adobe PDF files are required for eRA ASSIST submission

○ No hard copies, facsimiles, zip files, or password protected files

● One proposal submission per offeror

Phase I - Proposal Content Requirements

● Proposal Content

○ Cover page: does not count against page limit

○ Table of Contents: does not count against page limit

○ Abstract: not to exceed 1 page total

○ Specific Aims: not to exceed 1 page total

○ Team Structure and Partnerships: not to exceed 2 pages total

○ Leadership and Management Plan: not to exceed 2 pages total

○ Technical Approach: not to exceed 17 pages total

○ Milestone Plan: not to exceed 3 pages total

○ Relevant Past Experience: not to exceed 3 pages total

○ Key Personnel Overview: not to exceed 3 pages total

○ Appendix A: Key Personnel NIH Biosketches and Resumes

■ Principal Investigator, Program Manager, and the De-identification /Disclosure Expert: for each, a maximum four-page NIH biosketch

■ Other key personnel: for each, either a maximum four-page NIH biosketch or a two-page resume.

■ The biosketches and resumes in Appendix A do not count against the page limit.

○ Cost proposal: does not count against the page limit

Phase I - Proposal Content Requirements

● Cost Proposal must include a cost narrative and cost breakdown to complete each milestone in the milestone plan submitted

● A cost breakdown sample is provided in Appendix F of the ROA

● The breakdown of each milestone cost must include:

○ Personnel Cost

○ Cost for each sub-award

○ Consultant Cost

○ Travel Cost

○ Material/Equipment Cost

○ Other Direct Cost

○ Indirect Cost

○ Fee/Profit, if For-profit institution

● Cost breakdown must show costs allocated to each of the four cores in Section 5.2 of the ROA

People Have Different Disease RisksPhase I Proposal Evaluation Criteria

● Proposals will be scored on the following evaluation criteria:

● Cost proposals will be assessed to determine if the cost proposed:

○ Is within the available funding limits

○ The ability and/or likelihood of the offeror to successfully execute the proposed approach within the financial resources proposed

Each Core Each core will be assessed along four dimensions including:

- Team

- Understanding

- Science and Technology

- Past Experience

Each Data Linkage Each Linkage will be assessed along three dimensions including:

- Data Acquisition Preparation

- Platform Preparation and Ingestion

- Effective Documentation, Tools, and Assistance

Schedule The milestone plan will be assessed for the ability to satisfactorily meet the schedule of milestones.

People Have Different Disease RisksPhase I Proposal Selection

● A numerical scoring system will be used in the technical evaluation of each proposal.

○ Evaluators score each proposal on three elements (cores, linkages, and milestone plan) to produce a composite score for a proposal.

● The overall cost proposed will be given a rating of Insufficient, Sufficient, or Excessive.

● Offerors whose full proposals are deemed to have significant merit may be selected and invited to provide a demonstration in Phase II.

● The NIH does not intend to provide feedback/debriefings on proposal submissions.

● Offerors will receive notification should the All of Us Research Program decide not to provide an invitation for the next Phase.

Note: To be eligible for invitation to subsequent Phases and award, offerors must submit a Proposal in Phase I.

People Have Different Disease RisksPhase II and Phase III

● Phase II - Data Linkage Platform (DLP) Capabilities Demonstration and Evaluation

○ This phase is by invitation only

○ The primary purposes for the Phase II Capabilities Demonstration and Evaluation is to better understand the composition and abilities of the offeror’s team, to assess security readiness, and to demonstrate the offeror’s DLP.

○ Details for requirements of technical demonstration will be provided to the offeror(s) in the invitation for Phase II.

● Phase III - OT Award

○ This phase is by invitation only

○ Upon favorable evaluation and available funds, the NIH will proceed to negotiation and award with one offeror to make an OT Award.

Questions & Answers

Questions & Answers - Security and Clearances

● (Chris) Because we need an Authorization to Operate (ATO), does NIH help sponsor this?

○ An ATO is not FedRAMP certification, and does not require “sponsorship.” The offeror may incorporate into their cost breakdown the fees associated with receiving Authorization to Operate (ATO), which includes a third-party controls assessment.

● (Chris) Is it sufficient for a collaborating entity to have ATO?

○ The ATO process is specific to the All of Us Research Program. So, the CLAD awardee will need to receive ATO from All of Us, regardless of ATO status by the offeror or collaborating entity on other projects.

● (Chris) Is Public Trust or any higher level security clearance required for the offeror’s team members working in CLAD?

○ No. The CLAD award will be implemented through an Other Transaction (OT) award as an extramural research project through the All of Us Research Program consortium. No federal clearances will be required for staff.

● (Lew) Will the CLAD offeror be required to have their own Institutional Review Board (IRB) as part of the team?

○ The CLAD offeror will rely on the All of Us single IRB (sIRB). The offeror will need to hold a Federalwide

Assurance (FWA) for the protection of human subjects and have the relevant policies described in the assurance. The awardee is also expected to prepare materials related to each data linkage that is necessary for submission to the IRB. The awardee should be prepared to answer questions that the IRB may have regarding these linkages.

● (Lew) Will all CLAD team members of the offeror be required to have active Human Subjects Research Protections training/Certification?

○ The CLAD Principal Investigator, Program Manager, and De-identification / Disclosure Expert and all other personnel who work with identifiable private information on CLAD must have Human Subjects Research Protections (HSRP) training / certification. Training should be updated regularly, according to organization policy but should not exceed five years for recertification. The specific content requirements of the HSRP training are flexible, but must at a minimum involve HSRP topics relevant to CLAD and the All of Us Research Program.

Questions & Answers - Human Subjects Research Protections

Questions & Answers - Data Linkage Platform

● (Lew) The requirement states that data will be exchanged with the Data and Research Center (DRC) implying a bi-directional flow. What data will be coming from the Data Research Center to the CLAD Data Linkage Platform?

○ The Data Linkage Platform will receive participant personally identifiable information and perhaps other types of data from the DRC that will be needed to link participants to the acquired data. For each data linkage the CLAD awardee will be required to transmit the linked data, documentation, and tools to the DRC so that this data may be moved to the Researcher Workbench after any additional curation by the DRC.

● (Lew) Does the government have a preferred provider for the data linkage platform and for privacy preserving record linkage tokenization?

○ No. The government is neutral to the data linkage platform and tokenization. We are open to platforms that are either to be built, ready to go, or need some modification. The platform must satisfy the functions described in the ROA. Moreover, we are not looking for a single tokenization solution. There may be situations where different types of tokens are required. Offerors should consider how best to do this to satisfy the base period linkages and for future growth and opportunities.

Questions & Answers - Data Linkages

● (Lew) Is the primary cause of death expected on every death record linked? Can NIH provide examples of "other relevant data" that is expected for Mortality Data?

○ The program is seeking the underlying cause(s) of death for every linked individual. Additional data elements might include the age at death, marital status, and the location of the death. However, the final elements will be uncovered during Milestone 6 Objective 6.1.1 where requirements for the mortality linkage will be gathered.

● (Lew) Would NIH or the CLAD awardee establish the relationship with the Environmental Justice Index coordinator to link to other All of Us Data?

○ The awardee will establish a relationship with the CDC EJI coordinator. All of Us will certainly be involved with the awardee in developing this relationship.

Questions & Answers

● (Jessica) Regarding the recipient's pre-existing software platform or other trade secrets and materials (part of the recipient's Background Data as defined in the Appendix A Terms and Conditions), the Terms and Conditions contain contradictory terms on whether the NIH is expecting to have use of that software platform, trade secrets and materials only during the term of the agreement, or perpetually. What is NIH's expectation?

○ Per the ROA, The Terms and Conditions attached in Appendix A serve as a baseline for Other Transactions agreements awarded by the All of Us Research Program in Phase III. The NIH may modify these terms and conditions throughout the selection process. Requests by offeror(s) to modify the terms and conditions language will be considered by the NIH on a case-by-case basis and negotiated as deemed appropriate.

Discussion/negotiation of agreement terms and conditions will take place with the invitees of Phase II and Phase

III.

● (Jessica) Can the bidders add rows and columns to Appendix F as needed to reflect their accounting system setup and the specific costs elements they're proposing as well as profit/fee?

○ Yes, the vendor can add as many row and columns needed to reflect their accounting system setup and the specific costs elements they're proposing as well as profit/fee.

Questions & Answers - Cost and Pricing Information

● (Jessica) Can you also provide clarification on whether fixed price models based on commercial pricing are eligible for the program?

○ Due to uncertainties and flexibility needed in the project,a fixed price agreement would not be appropriate, therefore a cost-reimbursable or cost plus fixed fee payment agreement would be needed. The offeror can have sub awards with fixed priced labor rate arrangements for commercial services and fixed priced commercial products. Any fixed price cost shall still breakdown labor categories, hours, and itemized list of materials/equipment and travel in proposal.

● (Jessica) Can the NIH please clarify if all personnel in the Cost Proposal must be named individuals? Can unnamed TBD individuals be included in the cost proposal?

○ Only Key Personnel must be named. So, unnamed TBD individuals may be included in the cost proposal for non-Key Personnel.

Questions & Answers - Cost and Pricing Information

● (Jessica) Under ROA Section 8. Milestone Plan it asks for a table with a column for Estimated Total Cost in Dollars. Is the NIH permitting offerors to include costs within their Technical Proposals?

○ The costs in the milestone table are high level cost estimates for each milestone and should match directly with the formal and full cost proposal.

● (Jessica) Can NIH please confirm whether ROA Section 11, Cost Proposal,should be submitted separately as a PDF along with ROA Appendix F in Excel or included with the Technical Proposal as one submission document?

○ The cost proposal along with Appendix F should be submitted as a PDF and included with technical proposal submission into the NIH eRA ASSIST System.

● (Jessica) ROA Appendix F only gives a breakdown through Milestone 12 and the first 18 months. Where should the bidders provide optional cost breakdowns?

○ Cost estimates for optional periods are NOT being requested in Phase I proposals but may be requested in

Phase III for planning and budgeting purposes.

Questions & Answers - Eligibility and Partnering

● (Jessica) Are for-profit entities and small businesses eligible for the CLAD award?

○ CLAD is open to all entities listed in the ROA Section 6: Eligibility Information, including for-profit organizations and small businesses. There is no specific set-aside for small businesses in this award.

● (Jessica) Will the program provide potential collaborating partners for applicants?

○ No, offerors are encouraged to seek out partners for strong solutions, cooperative working relations, and collaboration with the All of Us Research Program and program partners.

● (Jessica) Are applicants expected or required to apply for all cores of the CLAD ROA?

○ There will only be one award for CLAD so offerors are required to support all four cores. Offerors may apply for the award on their own or as a team. Offerors are limited to one submission, but may be included as a partner on more than one submission. Staffing is to be decided by the offeror and partners. This should be done in a way that is logical and supportive of the key functions.

Closing

1. ROA Informational Webinar slides and Questions and Answers will be posted as an amendment on Sam.gov

2. Follow this opportunity on Sam.gov to get notifications to amendments

3. Email any inquires to AllofUsDTPDAwardRequirements@nih.gov

4. Questions must be submitted at least 14 calendar days prior to the proposal due date (April 17) to ensure a response https://sam.gov/opp/69da7ceff0e4456b9fad4b15f074d4de/view mailto:AllofUsDTPDAwardRequirements@nih.gov

AllofUs.nih.govhttps://www.joinallofus.org/

@AllofUsResearch #JoinAllofUs

Thank You!

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