JOFOC_FBO.pdf

Justification for Other than Full and Open Competition

"Source Selection Information - see FAR 2.101 and 3.104"

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity.

Department of Health and Human Services (DHHS)/ National Institutes of Health (NIH)

b. Sponsoring organization.

DHHS/NIH/NCI/Division of Cancer Epidemiology and Genetics (DCEG)/Chernobyl Research Unit

c. Project Officer Information.

• Project Officer Name.

• Mailing address.

• E-mail address.

• Telephone number.

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

a. Acquisition purpose and objectives.

This contract supports the “Study of Thyroid Cancer and Other Thyroid Diseases in Belarus”, a large-scale epidemiological study detecting thyroid and other pathology in persons who have been exposed to radiation as released by the accident at the Chernobyl Nuclear Power Station in April 26, 1986. The study deals with two cohorts: (1) the main cohort that has been established and consists of about 12,000 subjects who were age 18 or under at the time of the accident, had their dose to the thyroid gland measured, and lived in the Chernobyl affected areas in Belarus;

and (2) the in-utero cohort (to be constructed) of estimated 3,000 persons who were exposed to Chernobyl fallout radiation in-utero and early post-natal life.

The objectives of the contract are to: (1) maintain the main and in-utero cohorts by updating contact and medical diagnostic information, including occurrences of thyroid cancer, other cancer and thyroid non-cancer disease, though linkage with the Chernobyl State Registry and the National Belarusian Cancer Registry; (2) recruit in-utero cohort subjects by identifying and contacting eligible subjects followed by conducting personal interviews of mothers of cohort subjects; and (3) reconstruct the individual doses to the subjects of in-utero cohort using information obtained from personal interviews of mothers of cohort subjects, supplemented by existing thyroid activity measurement data.

b. Project Background.

The Chernobyl Research Unit (CRU), Radiation Epidemiology Branch (REB), National Cancer Institute (NCI) is responsible for a research program in radiation effects on cancer and other diseases. CRU develops, administers, and evaluates a contract-supported applied research program.

The accident at the Chernobyl nuclear power plant in 1986 resulted in massive releases of radioactive materials into the atmosphere and contamination of large areas with significant levels of radioiodines (up to two months after the accident), radiocesiums and other radionuclides. Among the population groups affected by the accident, a large number of individuals who were exposed to radioiodines as fetuses, children or adolescents present a special concern, as their young thyroids are known to be especially susceptible to the carcinogenic effect of radiation exposure.

The Belarus-American Study of Thyroid Cancer and Other Thyroid Diseases following the Chernobyl Accident (BelAm) is a part of NCI's Chernobyl research program. Belarus was chosen as a study site because it was considered to be one of the most contaminated areas by radioiodine fallout from the Chernobyl accident. The original BelAm cohort population consisted of persons who were children or adolescents at the time of the accident, who had thyroid activity measurements made within a short time following the accident on April 26, 1986, and who lived in specified affected areas.

There is special concern for cancer and other health risks associated with exposure to radiation during prenatal periods (in-utero), as fetuses are considered especially vulnerable to radiation damage. Initial data from a parallel study suggested a high risk of thyroid cancer associated with prenatal (in-utero) exposure to radioactive iodine from the Chernobyl fallout. In 2011, NCI began collaboration with Belarusian investigators to evaluate the feasibility of a new cohort study in Belarus of persons who were in-utero at the time of the accident to be added to the BelAm research program. Initial efforts are currently underway to construct this cohort and radiation doses.

The following chart lists information on previous contract awards to the Republican Research Center of Radiation Medicine and Human Ecology:

Contract # Name of Incumbent Contractor(s):

Period of Performance:

Competition/Basis for

JOFOC:

HHSN261200455006C Republican Research Center of Radiation Medicine and Human Ecology (RRCRM&HE)

September 30, 2004 to September 29, JOFOC – FAR 6.302-1

Only One Responsible Source

HHSN261201000021C GU RNPTS RMIECH,

Republican Research Center of Radiation Medicine and Human Ecology (RRCRM&HE)

September 15, 2010 to November 14, JOFOC – FAR 6.302-1

Only One Responsible Source

HHSN261201100539P GU RNPTS RMIECH,

Republican Research Center of Radiation Medicine and Human

September 21, 2011 to July 20, 2012

JOFOC – FAR 6.302-1

Only One Responsible Source

Ecology (RRCRM&HE)

HHSN261201300002C GU RNPTS RMIECH,

Republican Research Center of Radiation Medicine and Human Ecology (RRCRM&HE)

February 15, 2013 to February 14, JOFOC – FAR 6.302-1

Only One Responsible Source

HHSN261201400464P GU RNPTS RMIECH,

Republican Research Center of Radiation Medicine and Human Ecology (RRCRM&HE)

August 15, 2014 to December 14, 2014

JOFOC – FAR 6.302-1

Only One Responsible Source

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

a. Project title.

“Support for the Study of Thyroid Cancer & Other Thyroid Diseases in Belarus”

b. Project description.

See Statement of Work - Tab 2

• 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 (specify): ________

• Type of action.

New requirement Follow-on Other (specify): Modification to existing contract to extend the period of performance and increase the contract value.

• Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed price incentive-fee): ___ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): _____ Time and materials

Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): _____

Other (specify): ___ Completion Form Term form

•Acquisition identification number: HHSN261201300002C

4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1(a)(2)(ii).

This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of

1996.

This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

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

a. Name and address of the proposed contractor.

GU RNPTS RMIECH, Republican Research Center of Radiation Medicine and Human Ecology Ilicha Street 290 Gomel, Belarus 246040

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

The proposed contractor is uniquely qualified as follows:

1. The Republican Research Center of Radiation Medicine and Human Ecology (RRCRM&HE) has already established the needed infrastructure and built up extensive expertise for this project based on their 8 years of successful performance. The contractor has successfully established and maintained databases on the main cohort of approximately 12,000 subjects and has recently assembled the in-utero cohort of approximately 3,000 subjects.

2. The contractor has invested substantial time and resources in obtaining the necessary IRB approvals for this study from the Belarusian government and for data linkage with the National Cancer Registry and State Chernobyl Registry in Belarus. Due to the effort put forth by the contractor, the Belarusian government has designated the contractor to be the official institution devoted to studies of the aftereffects of the Chernobyl accident and mandated that all research related to the Chernobyl accident go through the contractor. As such, the contractor is the only institution who has access to the study population.

3. The contractor is the sole source of the data collected on the two important cohorts exposed early in life (such as fetuses, children or adolescents) who experienced fallout from Chernobyl. The contractor has accumulated a substantial amount of data by following the malignant and benign thyroid disease experience in this cohort since 2004. Only through an active collaboration with the contractor can NCI gain access to this valuable data and make productive use of it. No other such cohort of substantially exposed children exists in Belarus and there is no other reasonable alternative to contracting directly with this contractor.

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

Market Research was conducted for the award of the contract through the release of a sources sought notice published in FedBizOpps. This modification is subject to the exception for not submitting the pre-solicitation notice required by FAR 5.201. The Belarusian Government has designated the Awardee to be the official institution devoted to studies of the aftereffects of the Chernobyl accident and has mandated that all research related to the Chernobyl accident go through the Awardee. Because this mandate is an international agreement or treaty between the United States and a foreign government, or international organizations and has the effect of requiring that the acquisition shall be from specified sources – this Awardee, the modification is subject to the exception listed under FAR 5.202-3.

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

A cost analysis of the proposal will be conducted by the Contracting Officer using FAR Subpart

15.404 and the principles established in OMB Circular A-122 “Cost Principles for Non-Profit Organizations”.

The Project Officer and Contracting Officer will evaluate all proposed costs, then complete and sign the Project Officer Technical Questionnaire form;

Certified cost and pricing data will be obtained from the offeror since this is a noncompetitive acquisition.

An evaluation of the separate cost elements of the proposal will be compared against the Independent Government Cost Estimate.

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.

The COR held discussions with other knowledgeable investigators in the Government, Academia and Industry regarding the unique capabilities required to perform the work under this contract award. It was concluded that only the Republican Research Center of Radiation Medicine & Human Ecology could perform this work as they hold sole and secure access to the cohort and data on the approximately 12,000 subjects exposed to fallout from the Chernobyl nuclear accident.

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

All facts and rationale to justify the cited authority have been provided above.

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

Medical Service Corporation International submitted a response to the sources sought for the original contract by the deadline of February 8, 2012. No other sources expressed an interest, in writing, to the proposed acquisition. The Contracting Officer Representative found that Medical Service Corporation International was not capable of performing the services based on the capability statement submitted in response to the sources sought notice. Their response was found to be unacceptable overall. No other sources have expressed interest since award of the contract on February 15, 2013.

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.

It is unknown at this time whether follow-up is planned after the completion of this study. There are no known measures the agency may take to remove or overcome barriers to competition before any subsequent acquisition due to the international restrictions on this work.