JOFOC_Atomic_Bomb_Survivors.pdf

Radiation Effects Research Foundation (RERF)

"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)/Radiation Epidemiology Branch

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

The objective of this acquisition is to continue to obtain data from epidemiological and multi-disciplinary studies of cancer in a defined population of atomic bomb survivors and their children. This study, known as the Life Span Study, consists of individuals born before the August, 1945 bombings of Hiroshima and Nagasaki that resided in these areas as of October 1, 1950.

The Radiation Effects Research Foundation (RERF) currently has analyses in progress of incidence data on solid cancers, cancers of all major organs/tissues, leukemia and other hematopietic cancers, and also is conducting frozen-sera based case control studies of breast and ovary cancers to investigate the joint effects of hormonal factors and radiation exposure, incidence studies of cancers of the female breast, uterine corpus and cervix, and sarcomas of connective and bone tissues, and an archived-tissue based case-control study of XP heterozygosity and skin cancer risk. The plan is to continue with these analyses and studies so that they can be completed within the next two years.

NCI aims to develop and conduct new genetic/genomic studies on radiation-related cancer risks.

There are plans for RERF to conduct pilot studies for a thyroid tumor genomic characterization study and a central nervous system tumor molecular genetic study related to radiation exposure

Justification for Other than Full and Open Competition in the LSS cohort. If found feasible based on the pilot study results, full studies will be conducted.

The data obtained by this acquisition will clarify a number of outstanding scientific questions.

These include the long-term temporal pattern of radiation-related cancer risks, organ-specific cancer risks, and modifying effects of age, gender and other factors.

b. Project Background

The mission of the Radiation Epidemiology Branch (REB), Epidemiology and Biostatistics Program (EBP), Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute (NCI) is to plan and conduct studies on cancer risk associated with exposure to radiation. The work under this project is relevant to understanding the role of radiation exposure as a cancer cause and, more generally, to understanding principles and mechanisms of carcinogenesis through epidemiological and multi-disciplinary investigations of the action of a particular carcinogen and its modification by other factors. Ionizing radiation is the best understood, and best quantified, of common human carcinogens, and this knowledge base is an enormous advantage for investigating why certain individuals, under certain circumstances or with certain characteristics, have a higher risk of developing radiation-related cancers than others.

In support of this mission, Radiation Effects Research Foundation (RERF) has collected data on cancer risk in the long-term follow up of cohorts of Japanese atomic-bomb survivors and their children (mainly in Hiroshima and Nagasaki but also in other places in Japan to which they may have migrated). Cancer cases have been identified by RERF primarily through its mortality surveillance program that covers all of Japan and its tumor registry that covers the general populations in Hiroshima and Nagasaki prefectures.

Ancillary information on tumor characteristics and/or access to tissue specimens have been obtained from tissue registries in Hiroshima and Nagasaki and other sources including RERF data files and records, its autopsy series and hospital and clinic records at other institutions in Hiroshima and Nagasaki. Well-characterized individual radiation dose estimates from the dosimetry system have been made available for RERF cohort subjects by RERF, together with information on lifestyle and other cancer risk factors obtained from a series of previously conducted mail and interview surveys in the cohort population. Information for epidemiological studies has been obtained by conducting specially designed case-control studies, and through pathology reviews and biomedical and molecular assays of stored or fresh biological specimens.

The proposed project is a follow-on to two previous projects; one of which was with the National Academy of Sciences, and the other of which was with Radiation Effects Research Foundation (RERF).

On November 19, 1979, the first of five non-competitive contracts were awarded to the National Academy of Sciences (NAS), who in turn, established subcontracts with RERF. The basis for these non-competitive awards was in accordance with a presidential directive from Harry S.

Truman to the NAS to conduct investigations of the late effects of radiation among the atomic-bomb survivors in Hiroshima and Nagasaki requiring that research for health studies on A-bomb survivors in Japan be conducted in partnership with RERF and NAS. Under these contracts, NAS primarily provided administrative support for supplies, travel, and subsistence for non-Japanese consultants and collaborators, while RERF as the subcontractor, conducted health studies on A-bomb survivors within Japan. The NAS awarded contracts were as follows:

N01-CP-01012 – 11/19/79-9/29/87

N01-CP-71128 – 9/30/87-9/29/92

N01-CP-21028 – 9/30/92-9/29/97

N01-CP-71015 – 9/30/97-3/31/03

N01-CP-31012 – 4/1/03-11/30/08

Over the years however, the administrative support and non-Japanese acquisitions provided by NAS decreased significantly, and these tasks became manageable directly by RERF with increasing efficiency, therefore eliminating the need for NAS’s involvement. On December 1, 2008, a non-competitive contract (HHSN261200900005C) was awarded to RERF under the basis of FAR 6.302-1 “Only One Responsible Source“. The purpose of this contract is for RERF to conduct studies through the collection of data in the long-term follow up cohorts of Japanese atomic-bomb survivors and their children. The period of performance of this contract is December 1, 2008 to July 31, 2014.

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

a. Project title.

“Support for Epidemiological Studies of Cancer Among Atomic Bomb Survivors”

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): _________

• 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): Cost-reimbursement No Fee Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): _____ Other (specify): ___ Completion Form Term form

•Acquisition identification number. RFP N01CP41003-72

b. Total estimated dollar value and performance period if JOFOC is approved:

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.

Radiation Effects Research Foundation (RERF) 5-2 Koen, Hijiyama, Minami-Ku Hiroshima, Japan, 732-0815

b. Nature of the acquisition and proposed unique qualifications of the Contractor.

The proposed Contractor, RERF, is uniquely qualified as follows:

1. As emphasized in the Contractor’s Act of Endowment; a binational treaty between the U.S.

and Japan, dated December 27, 1974, the RERF was established and organized under the laws of Japan to conduct research and studies, for peaceful purposes, on the medical effects of radiation on man and on diseases which may be affected by radiation, with a view to contributing to the maintenance of the health and welfare of atomic bomb survivors and to the enhancement of the health of all mankind. The Contractor has sole access to a cohort of a unique population entity consisting of survivors of the atomic bombings of Hiroshima and Nagasaki. Large cohorts of survivors, and their children, with documented exposure to radiation from the 1945 atomic bombings with individual estimates of radiation dose ranging from minimal to near-lethal levels, have been followed for health status since 1947 by National Academy of Sciences (NAS) and its present-day successor, the Radiation Effects Research Foundation (RERF). The Contractor thus owns and controls the most extensive and complete set of information on atomic bomb survivors available. No other Contractor has knowledge of the identity of the cohort participants, whose personal identity is protected. As a result, no other Contractor is capable of collecting the required information and relating it to previous data.

2. The Contractor has developed working relationships with important entities, such as the Ministry of Health, various regulatory boards, registries and various hospitals in order to collect data in Hiroshima, Nagasaki, and other regions of Japan. The Contractor has built long-lasting relationships with members of the community and are recognized and trusted within the community.

3. The Contractor has established the necessary infrastructure to ascertain cancer cases among members of the cohort. The Contractor’s mission is to continue health follow-up studies in the cohorts of the atomic bomb survivors and their children, the only organization of its kind in Japan. The existing infrastructure includes two RERF laboratories in Hiroshima and Nagasaki, with the combined staff of over 250 scientists and support personnel, who have completed training tailored to provide support to REB studies in the areas of data collection and entry, administration of questionnaires, and collection and processing of biological specimens specific to this study. The staff has extensive expertise in multidisciplinary study epidemiology, statistics, clinical medicine, genetics and cellular and molecular biology as it relates to the cohorts.

4. The Contractor is the sole source of the data collected on the cohorts of Japanese atomic-bomb survivors and their children. The Contractor has successfully assembled and established the unique cohort populations for follow-up, and conducts nation-wide mortality follow-up through the Japanese family registry system, cancer incidence follow-up by linkage to the Hiroshima and Nagasaki tumor registries (which are also operated by RERF) and clinical follow-up by biennial health examinations. The Contractor provides individual radiation dose estimates for cohort members, and has databases containing data from previously conducted mail surveys in the LSS cohort, providing information on lifestyle and other risk factors. The Contractor has a large depository of archived pathology specimens from the previously active autopsy and other pathology programs as well as biological specimens obtained at the time of health examination.

The Contractor maintains computer systems and software, managing relational databases containing all cohort information, accessible to investigators.

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 through the release of a sources sought notice published in FedBizOpps on December 18, 2013. No responses were received.

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

Certified cost and pricing data will be obtained from the offeror since this is a non-competitive 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.

RERF is the only organization uniquely capable of performing this study because they hold sole and secure access to the cohort and data on Japanese atomic-bomb survivors and their children.

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

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

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

No expressions of interest have been received to date.

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.

The RERF study cohorts are unique, as are the accumulated data on dosimetry, mortality, and morbidity.

There is no reasonable alternative to contracting directly with RERF, and thus no realistic opportunity to remove barriers to competition.