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. This work 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 cancer 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 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, "DS02", have been made available for RERF cohort subjects, 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 Division of Cancer Epidemiology and Genetics (DCEG) at the National Cancer Institute (NCI), through the Office of Acquisitions, intends to negotiate with RERF, located at 5-2 Koen, Hijiyama, Minami-Ku, Hiroshima, Japan 732-0815 on a sole source basis. The anticipated award will be a purchase order with a one-year base period and one one-year option period, to construct updated data sets that will enable the REB investigators to conduct statistical and epidemiological analyses, specifically focusing on four major cancer sites/purposes, i.e., prostate cancer/Prostate Specific Antigen (PSA) measurement, lymphoid malignancies/myeloid leukemia, skin cancer, and second primary cancers.

In accordance with statutory authority 41 U.S.C. 253(c)(1), as set forth in FAR 6.302-1(a)(2), RERF is the only responsible source and no other supplies or services will satisfy agency requirements. The studies to be conducted by REB require the following data that is only available to RERF. The cohort populations, radiation dosimetry, cancer follow-up data, risk factor information and other cohort data to which NCI seeks access are not accessible outside RERF. The proposed Contractor, RERF, is uniquely qualified for the following reasons:

1. RERF 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 with documented exposure to radiation from the 1945 atomic bombs and their children, and with individual estimates of radiation dose ranging from minimal to near-lethal levels, have been followed for health status since 1947 by the Atomic Bomb Casualty Commission (ABCC) and its present-day successor, 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 and updating the required information and relating it to previous data.

2. RERF 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 nationwide mortality follow-up through the Japanese family registry system, cancer incidence follow-up by linkage to the Hiroshima and Nagasaki tumor registries (to which RERF provides technical support) 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.

3. RERF has obtained the necessary internal organization Institutional Review Board (IRB) approvals for the cohort studies. Given the breadth of the studies, obtaining these approvals has required dedicated staff and the development of an ongoing relationship with various IRBs. RERF is the only entity that has IRB approval to follow the participants.

4. RERF 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. In combination, these factors make RERF uniquely qualified to update data from the cohort for NCI studies.

5. RERF has the infrastructure to provide support services for NCI to carry out the work described in the SOW. The infrastructure includes 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 proposed contract action is for services for which the Government intends to continue with one source under the authority of FAR 6.302. However, interested sources may identify their interest and capability by submitting a capability statement, not to exceed 20 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space using a 12-point font size minimum, within 15 days of publication of this synopsis.

A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. The capability statement will be considered solely for the purpose of determining whether to conduct a competitive procurement.

All capability statements sent in response to this notice must be submitted electronically (via email) to Gary Debes, Contract Specialist, at [email protected] in MS Word or Adobe Portable Document Format (PDF) by April 19, 2019, 3:00 PM EST. All responses must be received by the specified due date and time in order to be considered. No collect calls or facsimile transmissions will be accepted.