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75N91020C00008 MOD6

75N91020C00008, MOD 6 Page 2 of 8 Justification and Approval 12/2/2022

b. Project background.

The Radiation Epidemiology Branch (REB), Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute (NCI), sponsors joint U.S.-Ukraine studies of the health effects of the Chernobyl accident in the Ukraine. Currently several active components of the U.S.- Ukraine projects are administered by the NCI Contractor. The Contractor has successfully and efficiently managed a number of NCI-supported projects in Ukraine, including the two projects described below, by providing on-site support in project planning and agreement, administrative and financial management oversight of project implementation and funding expenditures through close monitoring and auditing. The Contractor does not perform the field or laboratory work required for the project nor do they have access to the data or biological samples produced by the project. Under a three-way agreement, the Partnership Project Agreement (referred to as “the Agreement”) is signed by the authorized representatives of the Contractor who manage the administrative support of the Ukrainian research institutes (“the NCI collaborating institutions”) who conduct the projects, and NCI who financially supports and direct the projects. It is also required that all the U.S.-Ukrainian projects be approved by the Government of Ukraine. Currently, the NCI-Ukrainian projects are administered by the Contractor in two agreements.

One of the agreements is “Clinical Cohort of Ukrainian Cleanup Workers”, for which NCI is collaborating with the National Research Center for Radiation Medicine (NRCRM), Kiev.

Following the Chernobyl Nuclear Power Plant accident on April 26, 1986, approximately 150,000 Ukrainian cleanup workers (primarily men) participated in various recovery activities.

Although a population of Ukrainian cleanup workers has been established for many years, there is no cohort with reliable dose estimates. To resolve major questions about cancer mediators, precancer risks and other diseases following protractive external exposure to ionizing radiation, NCI is establishing the Clinical Cohort of ~10,000 cleanup workers from which radiation doses may be estimated using a brief survey. Follow-up of this unique cohort occurred through previously established biannual medical examinations at NRCRM and linkage to the Ukrainian cancer registry. Retrospective dose reconstruction was conducted utilizing a limited number of parameters, e.g., category of cleanup worker, date of beginning and duration of cleanup mission. NRCRM provides services needed to create the Clinical Cohort of Cleanup Workers, including radiation dose reconstruction. NRCRM processes and manages data from previous and ongoing projects, organizes analytical data, transfers data, and assists in data analysis and manuscript preparations for NCI.

The other agreement is “Ukrainian Thyroid Cohort/Breast Cancer Project”, for which NCI is collaborating with the Institute of Endocrinology and Metabolism (IEM), Kiev. The aims are: (a) to monitor changes in the thyroid glands in a cohort of about 16,000 persons exposed at young ages or in utero to Chernobyl fallout; and (b) to create the cohort of women who lactating during exposure to 131I after the Chernobyl accident. All subjects are followed for cancer morbidity and mortality through linkage of cohort data with the Ukrainian Cancer Registry.

Exposed children underwent thyroid cancer screening and if indicated, they were referred for a fine-needle aspiration biopsy. Interview information regarding residential, health, diet and lifestyle history was also collected. Radiation doses for the study subjects were reconstructed at IEM based on measured 131I thyroid activity, 131I deposition at places of residence and behavior and dietary data collected for each person throughout the exposure period. IEM also collected and transferred biological samples to NCI for genetic and genomic analysis led by NCI

75N91020C00008, MOD 6 Page 3 of 8 Justification and Approval 12/2/2022 investigators and processes and manages data from previous and ongoing follow-up and screening activities, organizes analytical data, and assists in data analysis and manuscript preparations for NCI.

In either project, requirements relating to biological samples do not include laboratory genomic analysis of samples by the Laboratory of Translational Genomics (DCEG, NCI); laboratory tests at collaborating institutions will be conducted for diagnostic purposes. The NCI collaborators have local Internal Review Boards (IRBs) and have obtained a federal-wide assurance number.

The NCI Collaborators do not provide collected data or samples to the Contractor and therefore, the Contractor does not have access to these project data or samples. The NCI Collaborators share collected data, without personal identifiable information, and samples with the NCI directly.

Contract # Incumbent Contractor

Period of Performance

Total Amt Obligated

Competition/Basis for

JOFOC

HHSN261201300345P STCU 9/20/2013 -

3/27/2014

JOFOC – FAR 6.302-1 Only One Responsible Source

HHSN261201400005P STCU

(Project P004)

3/28/2014 - 4/30/2014

JOFOC – FAR 6.302-1 Only One Responsible Source

HHSN261201400252P STCU

(Project P003)

3/28/2014 - 4/30/2014

JOFOC – FAR 6.302-1 Only One Responsible Source

HHSN261201400291P STCU 5/01/2014 -

4/30/2016

Competitive

HHSN261201600298P STCU 5/01/2016 -

4/30/2018

Competitive

HHSN261201800762P STCU 9/16/2018 -

4/30/2020

Competitive

75N91020C00008 STCU 5/01/2020 -

3/31/2024

Competitive

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

a. Project title.

Administrative Support for Chernobyl Projects in Ukraine

b. Project description.

See attached Statement of Work.

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

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7A Metalistiv Street Kyiv, Ukraine 03057 Phone: + 380 44 490 7150 E-mail: Curtis.bjelajac@stcu.int

DUNS: 683524207

Unique Entity ID: LQXDFF7JAMM9

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

The Science and Technology Center in Ukraine (STCU) is an inter-governmental organization dedicated to the prevention of the proliferation of expertise related to weapons of mass destruction (WMD). The STCU has the status of a diplomatic mission established in 1993 and was created and is governed by the Agreement signed by the United States, Canada, and European Union. To implement the nonproliferation policies, the STCU facilitates research opportunities for former WMD scientists to permanently redirect their talents to peaceful aims, assist with the protection and exploitation of research results attained to benefit the scientists creating them and the economies and societies of the parties governing the STCU, and support the integration of the scientists into credible international, national and regional research efforts in the global scientific and business communities.

The STCU is uniquely qualified for the work that is being added in their knowledge and capability to provide administrative support for NCI Chernobyl projects in Ukraine for the following reasons:

1) Expertise – The STCU has more than 25 years of experience funding and managing multi-national R&D projects and activities. The STCU has successfully and efficiently managed several NCI-supported projects in Ukraine, including the two projects described in the Background, through interagency agreements with the Department of State as well as NCI contracts, by providing on-site support in project planning and agreement, oversight of project implementation and funding expenditures through close monitoring and auditing.

The staff, who are fluent in English, Ukrainian and Russian, have developed a working and trusting relationship with the organizations involved in the projects, IEM and NRCRM. They have the knowledge and familiarity of the projects to provide the administrative support needed for NCI. The facilities are near IEM and NRCRM in order to provide expedited on-site support, if needed.

2) Cost advantage – The STCU has an international agreement that allows cost-effective operation within STCU partner countries as the Center is not required to pay any local duties and taxes. The STCU provides income tax-free (18% from the labor cost) and fringe benefit-free (22% from the labor cost) payments made directly to the project staff doing the work at the NCI collaborating institutions. Procurements for these projects have often required purchases to be made outside or in country and include specific delivery details, and the STCU provides duty-free customs clearance (VAT of 20% plus custom duty from 7% to 20% of the price) assistance for equipment and materials. Use of another vendor unable to provide income tax-free labor and duty-free customs clearance of equipment and materials would increase costs of this acquisition by approximately 35.0%.

3) Existing Ukrainian Authorization - Through the partnership arrangement with STCU, since 1995 NCI has had uninterrupted access to the scientific data that have accumulated over the years on unique Ukrainian populations exposed to Chernobyl fallout. Having a new Contractor to establish similar partnership arrangements with a new approval from the

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Ukrainian government and the collaborating institutions will take from 6 to 12 months considering the situation in Ukraine. Therefore, the absence of STCU services will result in significant disruption that can cause an irreparable break and cost increase in the ongoing research conducted by NCI.

4) Time and harm to scientific progress - If full and open competition were used, there would be unacceptable delays and lapses in work while a new contract was being solicited and awarded. STCU currently provides administrative support to the collaborating institutions to facilitate these studies. It would take from 6 to 12 months for a new vendor to establish successful relationships with the collaborating institutions and become versed in the protocols of the studies. This delay would cause significant harm to the NCI mission that is not recoverable through a full and open competition.

Considering the above and based on our best knowledge, the STCU is the only one who can perform work for this acquisition. There is no reasonable alternative to contracting directly with STCU, and no realistic opportunity to consider full and open competition for these highly complex studies.

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

A presolicitation notice was published on Sam.gov on November 17, 2022. This notice described the work being sought by NCI and requested capability statements from potential sources by December 2, 2022. No capability statements were received in connection with the posting of this notice. A Justification and Approval notice will be posted on SAM within 14 days of a contract action being executed.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable An Independent Government Cost Estimate (IGCE) was developed using historical data on costs incurred on the current, active contract with STCU, as well as the COR’s knowledge of this field. The Contracting Officer (CO) will obtain pricing data as necessary to establish a fair and reasonable price for the services being acquired. After receipt of proposal(s) for this work, the CO will conduct a price analysis as part of the award decision. The NCI Contracting Officer will consider the IGCE in determining price reasonableness. A final determination will be conducted prior to the award of the contract.

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 In doing internet searches and having discussions with colleagues, the NCI COR found that the STCU is the only responsible source that possesses necessary expertise to perform the tasks listed. The STCU’s previous involvement with the NCI epidemiology and dosimetry efforts suggests that it is fully informed of the requirement of this solicitation for services.

In addition, the following Market Research efforts were conducted by the Contracting Officer for modification 4:

a. Published a formal source sought notice in the Government-wide Point of Entry on 2/11/2022 and closed on 2/28/2022. One response to the Sources Sought Notice was received from RV Global Solutions Inc. However, the Offeror was considered unacceptable because the capability

75N91020C00008, MOD 6 Page 7 of 8 Justification and Approval 12/2/2022 statement submitted did not indicate organizational experience with any of the requirements and did not address whether the Offeror has existing knowledge of the Cleanup Worker Project and the Ukrainian Thyroid/Breast Cancer Project. Specifically, the Offeror stated they had experience in the following areas but did not provide information to demonstrate or detail their relevant experience in: maintaining privacy of personally identifiable information (PII) and protected health information (PHI).

b. In addition to the Source Sought notice, a presolication notice was Published on 5/6/2022 with a response date of 5/23/2022. No vendors responded. A presolicitation was posted for this work as stated in response 6.

c. Reviewed responses to original contract solicitation for similar capability. No capable vendor was found.

d. Reviewed Government-wide databases and other commercial databases for information relevant to the acquisition. Based on the search, no capable vendor was found.

Having been conducted between February and June of 2022, this research is less than 1 year old and remains relevant.

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

N/A

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

None

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.

A follow-on contract for the contractual tasks is in progress. Market research will be conducted, and a report will be submitted to the NIH OSDBU office for approval. Despite existing barriers, it is anticipated that the follow-on acquisition will utilize full and open competition to allow for the maximum competition practicable. There are no known measures the agency may take to remove or overcome barriers to competition due to the nature of the requirement and international situation of the location involved.

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.

Official Name & Title Signature Date

Project Officer Vladimir Drozdovitch, Ph.D.

Project Officer’s Immediate Supervisor

Lindsay Morton, Ph.D., Branch Chief, REB

Head of the Sponsoring Program Office

13. Contracting Officer certification.

12/02/2022Vladimir Drozdovitch -S

Digitally signed by Vladimir Drozdovitch -S Date: 2022.12.02 15 48:55 -05'00'

Morton, Lindsay

(NIH/NCI) [E]

Digitally signed by Morton Lindsay (NIH/NCI) [E] Date: 2022 12 02 19:14:00 05'00'

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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.

Official Name & Title Signature Date

Contracting Officer

Kari Peterson

Team Lead

Michael Heaney

Branch Chief

Donna Perry - Lalley

14. Chief of the Contracting Office and Head of the Contracting Activity signature(s).

15. Competition Advocate signature.

N/A

16. HHS Senior Procurement Executive signature.

Michael S. Heaney -S Digitally signed by Michael S. Heaney -S Date: 2022.12.05 08:02:17 -05'00'

Donna M. Perry Lalley -S Digitally signed by Donna M. Perry Lalley -S Date: 2022.12.05 08:12:05 -05'00'

Karina A. Peterson -S Digitally signed by Karina A. Peterson - S Date: 2022.12.05 08:16:18 -05'00'