118750-Justification and Approval (restricting competition).pdf

Justification for Other than Full and Open Competition

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Office of Commissioner (OC), Office of Operations (OO), Office of Finance, Budget, Acquisition, and Planning (OFBAP), Office of Acquisitions and Grants Services (OAGS)

b. Sponsoring organization.

Center for Food Safety and Applied Nutrition (CFSAN), Office of Analytics and Outreach (OAO), Division of Public Health Informatics and Analytics (DPHIA), Epidemiology Branch

(EB)

c. Contracting Officer’s Representative (COR)/Requiring Activity Point of Contact (POC) information.

i. Name: Beverly J. Wolpert PhD MS (COR); Andrew S. Karasick, MD, MBA, MPH (POC); André O. Markon PhD MPH (POC)

ii. Mailing address: (Please use email addresses)

iii. E-mail address: beverly.wolpert@fda.hhs.gov; andrew.karasick@fda.hhs.gov;

andre.markon@fda.hhs.gov

iv. Telephone number: 828-974-1730 (Wolpert); 610-308-0787 (Karasick); 734-846-3951

(Markon)

2. Nature and/or description of the action being approved.

The purpose of this requirement is to continue access to data and analytic services from IWP Health Inc./Dinesafe.org (IWP/DS) to allow the Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) to evaluate the potential utility of this novel source of information, assess strengths and limitations, and develop recommendations based on the findings for advancing foodborne illness (FBI) signal detection and follow-up activities.

a. Acquisition purpose and objectives.

The objective of this effort is to continue access to FBI data and analytic services from IWP/DS to allow FDA CFSAN to evaluate the potential utility of this novel source of information and associated approaches, assess strengths and limitations, and develop recommendations based on the findings for advancing FBI signal detection and follow-up activities.

mailto:beverly.wolpert@fda.hhs.gov mailto:andrew.karasick@fda.hhs.gov mailto:andre.markon@fda.hhs.gov

The goals and expectations with regard to this objective shall include, but shall not be limited to, addressing the following aims:

• Aim 1. To provide historical and current data and information on recalls, outbreaks, alerts, approaches, and methods to facilitate evaluation of past and current incidents, including by comparisons, examining incidents to identify strengths and limitations of the IWP/DS consumer-reported data in informing detection and response activities, discerning differences in those incidents identified by other sources but not by IWP/DS data and detection approaches, and comparing differences and/or similarities in FDA response activities depending on the signal sources.

• Aim 2. To review and analyze past and current incident data to assess the utility of IWP/DS data in helping to identify and act on food safety signals by evaluating key IWP/DS methods and specific consumer-reported information, reporting timelines, and/or other characteristics, properties, or conditions that constitute a safety signal or that trigger IWP/DS to recognize a safety signal, including for recalls and/or outbreaks where IWP/DS notes “early signals in the data,” such as, but not limited to, serious events (death, hospitalization, other); challenge/re-challenge events; statistical significance of complaint rate increases in current compared to past periods; and/or geotemporal clusters. This aim shall also include identifying, evaluating, and comparing IWP/DS consumer-reported information used to distinguish safety signals from noise.

• Aim 3. To examine past and current incident data to identify and evaluate potential additional IWP/DS consumer-reported data utility for informing further signal detection and response, including, but not limited to, follow-up with consumer-reporters for investigation, product traceback, product sampling, firm inspection planning, and/or other activities.

• Aim 4. To summarize findings and, if FDA determines appropriate, recommendations for uses of IWP/DS incident data and alerts to help identify potential food safety signals, for processes to use in further evaluating and following up on IWP/DS data-based safety signals, for a model workflow for such evaluation and follow-up processes, and for testing that model workflow with new IWP/DS alerts for a period to be designated by the FDA.

This work will help FDA CFSAN understand if crowdsourcing platforms such as IWP/DS may inform FDA action to better understand and respond to food safety issues.

Alignment with organizational goals is as follows: New Era of Smarter Food Safety: FDA’s Blueprint for the Future (https://www.fda.gov/food/new-era-smarter-food-safety;

https://www.fda.gov/media/139868/download), Core Element 2: Smarter Tools and Approaches for Prevention and Outbreak Response, and Core Element 4: Food Safety Culture,

4.3 Develop and Promote a Smarter Food Safety Consumer Education Campaign (pages 15, 16).

b. Project background.

In 2021 and 2022, the FDA CFSAN Office of Analytics and Outreach (OAO) Division of Public Health Informatics and Analytics (DPHIA) Epidemiology Branch (EB) \ acquired access to IWP/DS to help understand FBI reporting dynamics during and coming out of the COVID-19 pandemic, and to help advance signal detection and follow-up. Even in non-pandemic times, underreporting of FBI was widely recognized as a challenge hampering early data capture, detection, and prevention. In the COVID-19 pandemic period, FDA Office of Food Policy and Response and CFSAN leadership from OAO and the Office of Coordinated Outbreak Response and Evaluation (CORE) Network noted declines in FBI reporting. Factors suspected to contribute to the decreases included less fresh food consumption, more washing of fresh fruits and vegetables when https://www.fda.gov/food/new-era-smarter-food-safety https://www.fda.gov/media/139868/download consumed, more handwashing, more home environment sanitizing, less eating out/more cooking and eating at home, more consumption of foods prepped with a kill step, greater consumption of packaged foods, less seeking of medical care because of COVID-19 exposure fears, fewer medical tests administered and processed as visits occurred virtually, and fewer state and local resources to process tests and track FBI because of the pandemic burden. With more evidence, better understanding of already recognized factors, and attention to potential emerging factors, FDA could address gaps and pursue better preparedness for future events and earlier data capture, detection, and prevention of FBI.

To help address those needs, FDA CFSAN OAO DPHIA EB, CORE, and other FDA colleagues accessed the IWP/DS artificial intelligence (AI)-driven, crowdsourced consumer data on FBIs and outbreaks, along with analytic support, including the IWP/DS specialized AI/machine-learning services for capture and analysis of real time raw data on FBI from its consumer reporting platform, iwaspoisoned.com. Functionality includes the ability to generate custom reports and visuals, such as geomaps and heatmaps of current illness activity showing consumers reported sick by product, month, and region; comparisons of FBI by product over time; and alerts to real-time developing clusters, specifically where tied to a single product or location/restaurant/plant.

FDA CFSAN also received multiple alerts from IWP/DS about potential food safety problems based on increases detected in consumer reporting of illnesses associated with intakes of specified foods. In 2022, for example, CFSAN OAO DPHIA and CORE followed up on IWP/DS alerts of spikes in consumer reports of sicknesses after consumption of breakfast cereal, keto shake beverages, and a popular delivery service’s ready-made meal. Based on lessons learned from initiating responses to those incidents, CORE and OAO decided to pursue evaluation of the potential utility of IWP/DS data and approaches for FBI signal detection, surveillance, and follow-up.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

Meeting the agency’s needs will require access to FBI data and analytic services from IWP/DS

a. Project title.

Continuing access to Dinesafe.org data and analytic services

b. Project Description.

The purpose of this requirement is to continue access to data and analytic services from IWP Health Inc./Dinesafe.org (IWP/DS) to allow the Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) to evaluate the potential utility of this novel source of information, assess strengths and limitations, and develop recommendations based on the findings for advancing foodborne illness (FBI) signal detection and follow-up activities.

Requirement type.

☒ Research & Development (R&D)

☐ R&D support services

☐ Support services (non-R&D)

☐ Supplies/equipment

☐ Information Technology (IT)

☐ Construction

☐ Architect-Engineer (A&E) services

☐ Design-build

☐ Other:

Type of action.

☒ New requirement

☒ Follow-on

☐ Other:

Proposed contract/order type.

☒ Firm-fixed-price

☐ Other fixed-price:

☐ Cost-plus-fixed-fee

☐ Other cost reimbursement:

☐ Time and materials

☐ Indefinite delivery:

☐ Other: [Specify]

☐ Completion Form

☐ Term Form

Acquisition identification number.

CIN: CFSN-OAO-23-C-1983, $130K (DP8), FDA CFSAN OAO DPHIA Epidemiology Branch)

Total estimated dollar value and performance/delivery period. $130,000.00, one (1) year from the date of the award (approximately September 30, 2023 to September 29, 2024).

4. Identification of the statutory authority permitting other than full and open competition. Check the applicable block below based on the acquisition circumstance.

Federal Acquisition Regulation (FAR):

☐ 6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(1) or 41 U.S.C. 3304(a)(1).

☐ 6.302-2 Unusual and compelling urgency. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(2) or 41 U.S.C. 3304(a)(2).

☐ 6.302-3 Industrial mobilization; engineering, developmental, or research capability; or expert services. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(3) or 41 U.S.C. 3304(a)(3).

☐ 6.302-4 International agreement. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(4) or 41 U.S.C. 3304(a)(4).

☐ 6.302-5 Authorized or required by statute. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(5) or 41 U.S.C. 3304(a)(5).

☐ 6.302-6 National security. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(6) or 41 U.S.C. 3304(a)(6).

☐ 6.302-7 Public interest. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(7) or 41 U.S.C. 3304(a)(7).

☒ 13.501(a)(1)(ii) Sole source, including brand name, under Simplified Procedures for Certain Commercial Items. This acquisition is using this justification format, modified to reflect that the procedures in FAR subpart 13.5 were used in accordance with 41 U.S.C. 1901 or the authority of 41 U.S.C. 1903.

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Dinesafe.org c/o IWP Health Inc.

2093 Philadelphia Pike #2875 Claymont, DE 19703

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

The Dinesafe.org (IWP/DS) source is the only contractor providing the data aggregation and services that meet agency needs for artificial intelligence (AI)-driven, crowdsourced consumer data on foodborne illness (FBI) and foodborne disease outbreaks, along with analytic services.

IWP/DS supplies specialized AI/machine-learning services for capture and analysis of real time raw data on FBI from its consumer reporting platform iwaspoisoned.com. Functionality includes the ability to generate custom reports and visuals such as geomaps and heatmaps of current illness activity showing consumers reported sick by product, month, and region; comparisons of foodborne illness by product over time; and alerts to real-time developing clusters, specifically where tied to a single product or location/restaurant/plant. Evaluation of the potential utility of https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%2013_5.html https://www.acquisition.gov/far/html/Subpart%2013_5.html http://uscode.house.gov/view.xhtml?req=(title:41%20section:1901%20edition:prelim) http://uscode.house.gov/view.xhtml?req=(title:41%20section:1903%20edition:prelim) this novel source of information, assessment of strengths and limitations, and recommendations based on the findings for advancing FBI signal detection and follow-up activities will help FDA understand if crowdsourcing platforms such as IWP/DS may inform FDA action to better understand and respond to food safety issues.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies.

No other contractors have the food safety-focused, artificial intelligence (AI)-driven, crowdsourced consumer data on foodborne illness and foodborne disease outbreaks, along with the access and specialized analytic support, expertise, and resources to provide as noted in the public health science literature, such as at these links:

(1) https://onlinelibrary.wiley.com/doi/10.1111/risa.13651 (with related news coverage:

https://phys.org/news/2021-01-online-consumers-food-safety.html)

(2) https://publichealth.jmir.org/2017/3/e42/, and

(3) https://meridian.allenpress.com/jfp/article-abstract/doi/10.4315/JFP-20-383/462095/Initial-reports-of-foodborne-illness-drive-more?redirectedFrom=fulltext], as well as in major news media (NPR, Washington Post, New York Times) and recognition from international organizations (World Bank). Therefore, Dinesafe.org (IWP/DS) is the only organization capable to meet the needs of this requirement based upon this market research.

A notice will not be publicized in accordance with the exception at FAR 5.202(a)(13)(i).

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

FDA will evaluate the proposed level of effort and labor mix required for continuing access to the Dinesafe.org (IWP/DS) data and analytic services and will determine the price of the requirement to be fair and reasonable prior to issuance by performing a price analysis of the proposal for the period of performance, which will last one (1) year from the date of the award (approximately September 30, 2023 to September 29, 2024).

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Market research was conducted by reviewing scientific public health and food safety research, which found no other platform that collects these data and provide these services. Dinesafe.org (IWP/DS) is the only organization capable to meet the needs of this requirement based upon this market research.

9. Any other facts supporting the use of other than full and open competition.

As described above, Dinesafe.org (IWP/DS) is uniquely qualified with the food safety-focused, artificial intelligence (AI)-driven, crowdsourced consumer data on foodborne illness and foodborne disease outbreaks, along with the ability to provide the access and specialized analytical support to https://www.acquisition.gov/far/html/Subpart%205_2.html https://www.acquisition.gov/far/html/Subpart%205_2.html https://onlinelibrary.wiley.com/doi/10.1111/risa.13651 https://phys.org/news/2021-01-online-consumers-food-safety.html https://publichealth.jmir.org/2017/3/e42/ https://meridian.allenpress.com/jfp/article-abstract/doi/10.4315/JFP-20-383/462095/Initial-reports-of-foodborne-illness-drive-more?redirectedFrom=fulltext https://meridian.allenpress.com/jfp/article-abstract/doi/10.4315/JFP-20-383/462095/Initial-reports-of-foodborne-illness-drive-more?redirectedFrom=fulltext https://mailtrack.io/trace/link/9d0f592866743d1565650fc1f9e74ce63edb7cd2?url=https%3A%2F%2Fwww.npr.org%2Fsections%2Fthesalt%2F2017%2F11%2F30%2F565769194%2Fi-was-poisoned-can-crowdsourcing-food-illnesses-help-stop-outbreaks&userId=5018876&signature=9e54b9db784c0b88 https://mailtrack.io/trace/link/10ca11086dedc1bf97910d430098390359955a08?url=https%3A%2F%2Fwww.washingtonpost.com%2Fnews%2Fwonk%2Fwp%2F2017%2F07%2F18%2Fa-chipotle-restaurant-is-closed-after-yet-another-foodborne-illness-outbreak&userId=5018876&signature=7139e604de712639 https://mailtrack.io/trace/link/bbe90dcda6e82c49804666a1acc5b19b0418416e?url=https%3A%2F%2Fwww.nytimes.com%2F2018%2F02%2F13%2Fbusiness%2Ftoo-much-power-to-the-people-a-food-safety-site-tests-the-limits.html&userId=5018876&signature=0066209bb7fb27b1 https://mailtrack.io/trace/link/bee065b0953997c4af5b0cf22eeb05b80a3e592f?url=http%3A%2F%2Fblogs.worldbank.org%2Fvoices%2Fhow-crowdsourcing-can-improve-food-safety&userId=5018876&signature=8b0edd454da37313 https://www.acquisition.gov/?q=browse/far/10 accomplish this project, and no other sources can provide the needed data, specialized analytic support, access, expertise, and resources.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No other offers were solicited as explained above in Items 6 and 8.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

There are no known actions within the agency’s power to take to remove or overcome any barriers to competition before any subsequent acquisition of the required data and specialized analytic services.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Signature:____________________________________

André Markon, PhD, MPH Requiring Activity POC

Beverly J. Wolpert, PhD, MS POC Immediate Supervisor

Head of the Sponsoring Program Office

13. Contracting Officer Certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Contracting Officer