SSJ 86386 Redacted.docx

JUSTIFICATION FOR SOLE SOURCE PROCUREMENT (OPEN MARKET OR GSA) UNDER $250,000

Sole source acquisitions may be used on a limited basis and only when the Contracting Officer’s Representative (COR)/Program Official has provided sufficient justification and the Contracting Officer has determined that the circumstances warrant such action. The content for a justification must contain detailed facts and rationale to justify the sole source acquisition. Soliciting from a single source must be done in accordance with FAR 13.106-1(b) or 8.405-6. At a minimum, the following information must be included:

Identification of Program Office, Contracting Activity, and Proposed Requirement, Justification and Program Office Certification:

A. Program Office:

Centers for Disease Control and Prevention National Center for Chronic Disease Prevention and Health Promotion Division of Oral Health 4770 Buford Highway, MS F-80 Atlanta, GA 30341-1737

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch SAP

C. Identification of Requirement:

1. Nature of Action to be Approved by Contracting Officer:

a. Sole source acquisition of: Sole source acquisition of half-time workload for 2 PhD biomedical engineering researchers at Purdue University with subject matter expertise in developing neural networks to detect dental caries and fluorosis from digital photos of students’ teeth taken in schools. CDC’s Division of Oral Health (DOH) is requesting a sole source acquisition to procure 2 subject matter experts to work with Dr. Young Kim from the Biomedical Engineering Department at Purdue University. DOH has an intergovernmental personnel act (IPA) with Dr. Kim. The final deliverable resulting from this collaboration will be dental photo acquisition protocols using smartphones and computer algorithms (deep learning neural networks) in Python and MATLAB that can detect dental conditions by analyzing uploaded digital photos (jpg files, i.e., smartphone photo of 6 upper anterior permanent teeth and intra-oral camera photo of each permanent molar). DOH is the national leader in supporting public oral health surveillance to monitor caries and fluorosis. Currently, DOH funds the National Centers for Health Statistics and 21 states to collect information on population dental health status via clinical examination by a dental professional. It is resource intensive to have dental personnels collect data and many states report difficulty in gaining access to schools since the COVID pandemic. In addition, there have been issues with the quality of the fluorosis data. To address these concerns, the DOH has contracted with Dr.

Young Kim and his research lab to develop protocols to take digital photos of the teeth under field conditions that provide clinically meaningful information for a deep learning neural network to detect caries and fluorosis and test performance against the dental professional’s clinical examination. Dr. Kim and associates have developed unique tools for this effort including novel and innovative protocols and advanced deep learning algorithm frameworks to be employed in primary data collection beginning in May 2024. Dental examiners will screen 1,000 Colorado students for caries and fluorosis and will also take digital photos. The DOH would like to contract for half-time support of 2 biomedical engineering post-doctoral (holding a PhD) subject matter experts to review and process data (photos and screening forms) as they arrive from Colorado via a data collection app with a possible need to revise data collection protocols if quality of photos is low. The researchers would also train and test the deep learning algorithms that will be used in the neural network to detect fluorosis and caries using the photos and screening results from the Colorado students as inputs. Researchers will also assist in writing reports and publications associated with this project.

b. Procurement Request (PR) Number (if available): 000HCLC1-2024-86386

2. Proposed Vendor and Estimated Procurement Amount (if available):

a. Proposed Vendor: Purdue University

b. Estimated Procurement Amount:

3. Is the requirement on GSA Schedule? ☐ Yes ☒ No If yes, provide schedule number: Click here to enter text.

Justification:

1. The justification for this non-competitive action is: (NOTE: Must select only ONE of the listed justifications for other than full and open competition and fully support the justification in the following paragraphs. Please delete this note prior to submitting the justification.)

· In accordance with FAR 13.106-1(b)(1), “only one source [is] reasonably available” which states that, “For purchases not exceeding the simplified acquisition threshold. (i) Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). (ii) Where a single source is identified to provide a portion of a purchase because that portion of the purchase specifies a particular brand-name item, the documentation in paragraph (b)(1)(i) of this section only applies to the portion of the purchase requiring brand-name item. The documentation should state it is covering only the portion of the acquisition which is brand- name.”

· Urgency

· Exclusive licensing agreements/Proprietary data

· Brand name required

· Industrial mobilization

Rev. 5/14/19

· Other (e.g., compatibility, space issues, continuity, compatibility, etc.)

☒ In accordance with FAR 8.405-6 “Limiting Sources” which states that, “the only circumstances that may justify the action are – (A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays; (B) Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; or (C) In the interest of economy and efficiency, the new work is a logical follow-up to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original BPA must not have been previously issued under sole-source or limited-sources procedures.”

· Urgency ☒ Only One Source

· Logical Follow Up

· Brand name required

2. Other facts supporting sole source procurement:

a. What can this product/service do that other products/services cannot do?

Dr. Young Kim and research associates from the Purdue School of Biomedical Engineering are leaders in the field regarding color and spectral analyses in biomedical applications as well as biology-informed machine learning. The team won first prize at the National Institutes of Health Technology Accelerator Challenge in 2020. They are at the forefront of reciprocal Innovation—the bi-directional and iterative exchange of a technology, methodology, or process between lower and higher income countries to address common health challenges and provide mutual benefit to both sides. Reciprocal innovation often entails transferring knowledge/technology used to detect disease in clinical settings to field conditions. For example, Dr. Kim and his team have developed similar applications to assess anemia, inflammation, and blood hemoglobin via digital photos collected in the field as opposed to during a clinical visit. Dr. Kim and his team have already completed several research tasks that underpin the development of the neural network to diagnose dental conditions. They developed the protocols to ensure that data collected under field conditions would be of sufficient quality to provide meaningful information to the deep learning algorithms. Specifically, Dr. Kim and associates have developed the first fluorosis-specific color correction method that standardizes information from photos taken under any lighting condition and devices (this issue is particularly relevant for obtaining high quality phots of dental disease in the field as opposed to a dental/clinical setting). They also used hundreds of photographs of caries and fluorosis obtained from academic researchers in caries and fluorosis to pre-train the neural networks to: 1) correct the color of teeth in photos taken in field conditions (e.g., different lighti conditions) to their true color, 2) segment a photo of the upper front teeth into 6 individual teeth for individual classification, 3) classify the fluorosis severity of each of the 6 upper teeth, and 4) evaluate different camera devices (intra-oral camera and smartphone) based on dental conditions, quality of photos, ease of use in the field setting, and cost. This project has a one- year time horizon, ending May 2025. The researchers in Dr. Kim’s lab have already developed a large amount of knowledge specific to this project and it is doubtful that researchers from other academic institutions could replace researchers from Dr. Kim’s lab without delaying the completion of this project. In other words, the developed protocols specifically incorporate photo acquisition standardizations, including color correction, and will utilize advanced deep learning algorithm frameworks based on unique dental anatomy and clinical information. These elements differentiate their work from other conventional approaches, justifying the solo source procurement.

b. What other products/services were considered and why did they not meet the need? DOH met with leading researchers in caries, fluorosis, and dental public health surveillance and none were aware of any other U.S. researchers doing work in this area (i.e., use advanced color corrections and deep learning neural networks to detect caries and fluorosis from photos of teeth taken in schools). DOH consulted with Dr. Young Kim with whom DOH has an IPA to work on this project and he was unaware of any other researchers in the U.S. with sufficient expertise and experience in this area who could join the project right now and not cause a delay in meeting deadlines. Finally, DOH did a literature search in PubMed to identify other researchers who had published protocols or preliminary findings on using artificial intelligence to detect fluorosis. Only 2 studies were identified. Both studies examined the utility of deep learning algorithm to detect fluorosis with photos taken in clinical as opposed to field settings where lighting conditions would be optimal and specialized equipment would be available in clinical settings. Most importantly, none of the authors on these studies was affiliated with a U.S. university or institution.

3. Program Office efforts to seek potential offerors:

No other potential offerors are considered capable of successfully meeting the timeline for this protocol. Both OMB and IRB approval were required for this research and the date for completion for OMB is 2025 and for IRB, May 2025. DOH is the national leader in monitoring caries and fluorosis. Completion of this project will allow DOH to have more accurate estimates of fluorosis prevalence and to collect national, state, and community data at a lower cost. In 2015 the U.S. Public Health Service (USPHS) released new guidelines for community water fluoridation, one of DOH’s priority areas. The USPHS noted the need to monitor caries and fluorosis prevalence to evaluate the impact of the revised guidelines.

Evaluation of fluorosis data collected in national surveys in 1999– 2004 and 2011– 2016 indicate that the data were likely not accurate. Thus, completing this project in a timely manner is also critical to protecting the nation’s health. This is a novel research project and DOH failed to identify any other U.S. scientists conducting research in this area. This vendor, the only institution doing research in using neural networks to detect caries and fluorosis via digital photos taken in schools, is uniquely situated to complete this project by May 2025.

D. Program Office Certification:

I have reviewed this sole source justification and certify the justification is true and accurate to the best of my knowledge and adequate to support other than full and open competition.

Center/Institute/Office COR/Program Official Name/Title: NCCDPHP, Division of Oral Health, Christopher Callahan, Public Health Analyst, COR

Bridgette Smith Center/Institute/Office COR/Program Official Signature:Bridgette Smith -S Digitally signed by Bridgette Smith -S Date: 2024.05.09 06:41:21 -04'00'

Certification Date: July 30, 2026

E. Contracting Office Certification:

I have fully relied on the information provided herein and hereby certify that this justification is accurate and complete to the best of my knowledge and belief:

Contracting Officer Name: Click here to enter text.

Contracting Officer Signature:

Certification Date: Click here to enter a date.

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