JOFOC-Draft 8-5-25 Final_signed 8725.pdf

TMPLT 2016.06-011

Justification for Other than Full and Open Competition

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

Food and Drug Administration/Center for Tobacco Products

b. Sponsoring organization.

Office of Science/Division of Nonclinical Science

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

COR:

i. Name: Nabanita Nag

ii. Mailing address: 10903 New Hampshire Ave.; Silver Spring, MD 20903

iii. E-mail address: Nabanita.Nag@fda.hhs.gov

iv. Telephone number: 240-402-9768

POC:

i. Name: Prabha Kc

ii. Mailing address: 10903 New Hampshire Ave.; Silver Spring, MD 20903

iii. E-mail address: Prabha.kc@fda.hhs.gov

iv. Telephone number: 301-796-6456

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

This JOFOC is for a follow-on contract to complete the work started under contract no.

75F40119C10161. The Period of Performance was: 09/30/2019 to 02/28/2025

a. Acquisition purpose and objectives.

To regulate the manufacture, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

Premarket tobacco product applications (PMTAs) are submitted for any new tobacco product seeking an FDA marketing order under the FD&C Act. A PMTA is required to provide sufficient scientific evidence demonstrating that marketing of the new product is appropriate for the protection of public health (APPH). Scientific data must address, among other things, any health

Template mailto:Nabanita.Nag@fda.hhs.gov mailto:Prabha.kc@fda.hhs.gov risks and benefits of the new product to the US population as a whole. This requirement includes a thorough toxicological assessment that directly addresses the health risks associated with a product. The final PMTA rule emphasizes detailed assessment of the toxicological profile from the use of or exposure to a new tobacco product. Electronic cigarettes are very recent additions to the United States tobacco market compared to conventional cigarettes. Sufficient time has not yet passed to directly assess the effects of electronic cigarettes in humans and yet there are many constituents in electronic cigarette vapor, such as aldehydes like formaldehyde and metals like nickel, that raise concerns about the long-term effects of e-cigarette use. Moreover, unlike conventional cigarettes, e-cigarettes are wholly manufactured consumer products that have different electrochemical components. In order to fully evaluate e-cigarettes that come in for pre-market review, FDA needs to have some understanding of the toxicological effects of different kinds of e-cigarettes. In lieu of long-term data epidemiological data, FDA awarded contract 75F40119C10161 to understand the effects of longer-term exposures to e-cigarettes in rodents. While the data that comes in with applications can be useful, currently available in vivo data for electronic cigarettes is limited and the in-depth toxicological study necessary to understand these necessary details of e-cigarette toxicity relevant to long-term e-cigarette exposure in humans is not available.

The objective of this study is to investigate repeated dose (28-day, 90-day, and 180-day) inhalation of Electronic Nicotine Delivery System (ENDS) aerosols in male and female Sprague Dawley rats. Results will be used to evaluate potential adverse effects of ENDS inhalation.

The purpose of this requirement is to allow the Lovelace Biomedical Research Institute to complete all existing deliverables associated with contract 75F40119C10161.

b. Project background.

In Fiscal Year 2019 (FY19), FDA awarded contract 75F40119C10161 to Lovelace Biomedical Research Institute. Under this contract, a comprehensive, large multi-faceted, and repeated chronic exposures of ENDS aerosols with pharmacokinetic study, including dose-range finding, 28-day, 90-day and 180-day with 45-day recovery of Products A and B; and pharmacokinetic study, including dose-range finding, 28-day and 90-day with 45 day recovery of Product C in vivo toxicological studies, were performed to address unique toxicological issues that cannot be addressed by alternative computational or in vitro culture approaches. The period of performance start date was September 30, 2019 and end date was February 28, 2025. The total budget obligated for the completion of the study was up to $36,286,201.

The outcome of this project will be CTP mission-relevant in better understanding and addressing potential in vivo toxicological risks including pathology, biomarkers of harm associated with repeated use of electronic cigarettes that can be used to inform tobacco product regulations, regulatory application reviews, and to continue CTP’s mission of protecting public health. The contractor has completed all in-life experiments associated with the contract, but there was not sufficient time to complete the data analysis, generating interim reports, and final reports. FDA is seeking to award a sole source contract to Lovelace Biomedical Research Institute to complete the data analysis, interim reports, and final reports for the work started under contract 75F40119C10161.

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

In Fiscal Year 2019, FDA awarded contract 75F40119C10161 to Lovelace Biomedical Research Institute. Under this contract, a comprehensive, large multi-faceted, and repeated chronic exposures of ENDS aerosols with pharmacokinetic study, including dose-range finding, 28-day, 90-day and 180-day with 45-day recovery of Products A and B; and pharmacokinetic study, including dose-range finding, 28-day and 90-day with 45 day recovery of Product C in vivo toxicological studies, were performed to address unique toxicological issues that cannot be addressed by alternative computational or in vitro culture approaches.

The contractor is to provide all interim final reports and final reports for the 28-day, 90-day, 180-day including recovery phase study of the Products A and B; All interim final reports for the 28-day and 90-day including recovery phase of the Product C; and a final report of the 28-day study except a final report for the 90-day study of Product C as stated in on the SOW/Contract 75F40119C10161.

Additionally, the contractor is to provide specific protocols, methods, materials, and equipment used for each experiment, including test material, doses, number of animals, Sprague- Dawley rats’ strain supplier information (including city, state, and country for all animals, test material, equipment, and materials), and software information shall be provided to FDA.

Data analyses shall include appropriate statistical analyses. The details of analytical methods used according to the study design, such as urine nicotine, blood COHb level, and other parameter calculations should be adequately described and referenced. All SOPs referenced in the study shall be provided to FDA. Interpretation and summary of results. A brief paragraph summarizing the pertinent conclusions of the study shall be provided. All individual data needed for conclusions shall be presented in coherent tables (as recommended above).

A copy of the raw data shall be provided separately in an appendix.

Documentation shall be provided to demonstrate the sensitivity, linearity, specificity, and reproducibility of the analytical method, including sample chromatographs, recovery studies, etc. as stated in the SOW/Contract 75F40119C10161.

The contractor is to report if any changes to the approved protocol, the reason for the change in the form of a protocol revision and will be signed by the Sponsor, Study Director and Contractor Management. Any deviation from Good Laboratory Practices, the Study Protocol, and Standard Operating Procedures, the effect on the study, and corrective action taken, if any, will be promptly reported by the Contractor Study Director to the FDA.

a. Project title.

Electronic Nicotine Delivery System Toxicological Studies

b. Project Description.

This sole source requirement will complete the deliverables for the study that was started under contract 75F40119C10161. Please see 3. above for project description.

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:

☐ Completion Form

☐ Term Form

Acquisition identification number.

Electronic Nicotine Delivery System Toxicological Studies

c. Total estimated dollar value and performance/delivery period.

$7,080,013.25. The period of performance will be two years from the date of award. The estimated period of performance dates will be September 30, 2025-September 29, 2027.

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).

Lovelace Biomedical Research Institute 2425 Ridgecrest Dr. SE Albuquerque, NM 87108

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

Biomedical Research Institute has been the contractor conducting this study under contract 75F40119C10161 since the fiscal year 2019. CTP has already invested over $25 million in this research study. This is a follow-on contract for the work started under contract 75F40119C10161 to complete the data analysis, generating interim reports and final reports. The in-life experiments have been completed, the data analysis and interim reports were being generated. Currently, one of the reports is at the stage of final signature; the remainder are in various stages of completion.

However, the contract 75F40119C10161 has expired. It would be impractical for a new contractor to complete the data analysis of these studies without having conducted them. This study will provide valuable information regarding the toxicity of e-cigarette aerosols, but the results of the scientific study need to stand up to the scrutiny of scientific peer review. Having a contractor perform the data analysis who did not conduct the experiment would not stand up to peer review scrutiny in the scientific community and would adversely affect any use of these results in creating tobacco product regulations. Moreover, in order for a new contractor to successfully provide FDA with usable data in promulgating tobacco regulations, they would have to repeat the experiments that have already been completed. This would essentially double the investment FDA has made in time and money to get usable results from this study. Additionally, there would be great risks in transporting the samples, including freeze-thaw of the biological samples, from one contractor to another for data analysis to occur. If one of the samples were to be damaged, the study would have to be repeated again. Furthermore, as the contractor is in various stages of completion of data analysis and generating the interim reports, Lovelace Biomedical Research Institute would be able to finalize the deliverables at a faster pace. Therefore, a sole source contract award to Lovelace Biomedical Research Institute to complete the study work they have started will allow FDA to get the results of this study in a more timely and cost-effective manner.

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.

A summary of FDA’s intent to a sole source (FAR 6.302-1) was posted on SAM.gov on July 18, 2025 for 15 days.

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

A formal proposal has not been received. Upon receipt, the Government will determine price reasonableness in accordance with FAR 15.404-1(b) using price analysis techniques. Certified cost or pricing data will not be required, and no audit is anticipated.

The evaluation will include comparison to the IGCE, historical pricing for similar services and market research. This determination will be documented in the contract file prior to award.

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

Additional market research was not conducted since this contract is completing the work already started under contract 75F40119C10161. Use of another contract would cause FDA to have to repeat the work already completed since fiscal year 2019 at the cost of approximately over $25 million. It is not practical from a cost and time standpoint to seek out a new contractor to complete the data analysis and generate final reports of this study.

A pre-solicitation notice of intent to sole source this procurement was posted publicly on SAM.gov on July 18, 2025. Capable parties who wished to challenge the sole source award were asked to contact the Contracting Officer and Contract Specialist by 8/1/2025 4PM est. No responses were received.

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

Last Modified: April 5, 2017 Page 7 of 9

The U.S. Food and Drug Administration (FDA) intends to solicit a 2-year base, sole source, firm-fixed-price type contract from Lovelace Biomedical Research Institute; 2425 Ridgecrest Dr. SE; Albuquerque, NM 87108, in accordance with the authority under Federal Acquisition Regulation (FAR) 6.302-1 – Only one responsible source and no other supplies or services will satisfy agency requirements, and 15.101 Contracting by Negotiation. The North American Industry Classification System (NAICS) code is 541380

– Testing Laboratories. The anticipated period of performance consists of a 2-year base contract. .

If another contractor were to be used for this work, FDA would have to repeat the experiments that have already been completed under contract 75F40119C10161. This work has been ongoing since fiscal year 2019 and has already cost the agency approximately over $25 million. Investing time and money into another vendor to conduct the same work is impractical and not a prudent use of Tobacco User Fees.

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

No other sources have expressed interest in writing for this requirement.

9. 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.

This is a stand-alone study. Once the work under this bridge contract is completed, FDA will have no need to contract further for this work.

10. 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:

Nabanita Nag

COR/Requiring Activity POC Digitally signed by Prabha Kc -S Date: 2025.08.05 15:13:18 -04'00'

Prabha Kc

COR/Requiring Activity POC

HANS M. 2025.08.05

Signature: ROSENFELDT -S 16:21:52 -04'00'

Hans Rosenfeldt

COR/POC Immediate Supervisor

Prabha Kc -S

Last Modified: April 5, 2017 Page 8 of 9

Digitally signed by BRIDGET K. AMBROSE -S Date: 2025.08.06 14:29:03 -04'00'

Head of the Sponsoring Program Office

Last Modified: April 5, 2017 Page 9 of 9

11. 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.

Ian Weiss

Contracting Officer

12. Division Director.

Vidya Vish

Division Director

13. Competition Advocate signature.

Bryan Jones

Competition Advocate

Digitally signed by IAN S.

WEISS -S

-04'00'