Etiology of Lung Cancer in Never Smokers and Special Exposure Cohorts

The purpose of this modification is to attach the John S. McCain National Defense Authorizatin Act (NDAA) for FY 2019, Public Law 115-232, Section 889(a)(1)(A). in full text.
Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E132, Bethesda, MD 20892, UNITED STATES

Description
The U.S. Department of Health and Human Services, National Institutes of Health (NIH), National Cancer Institute (NCI), Intramural Research Program at the Division of Cancer Epidemiology and Genetics (DCEG), Office of Acquisitions (OA) plans to procure on a sole source basis with the International Agency for Research on Cancer (IARC); World Health Organization, 150 Cours albert Thomas, 69372 Lyon Cedex 08, France for retrieval, label and shipment of fresh frozen tissue samples, whole blood or buffy coat or DNA extracted from blood, H & E slides and FFPE blocks to NCI.

This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.106-1 (b) (1) using simplified acquisition procedures for commercial acquisitions. The North American Industry Classification System Code is 541380 and the business size standard is $15 million.

Only one award will be made as a result of this solicitation. This will be awarded as a
non-severable firm fixed price type contract.

The base period of performance shall be for twelve (12) months from date of award

It has been determined there are no opportunities to acquire green products or services for this procurement.

Sherlock Lung is a research project funded by the National Cancer Institute (NCI) Intramural Research Program at the Division of Cancer Epidemiology and Genetics (DCEG) aiming to investigate the etiology and progression of lung cancer in never-smokers from the general population, as well as from populations with substantial levels of special exposures through: (1) an integrative genomic analysis, and (2) pathology, clinical, radiological and epidemiologic assessment. Given the rarity of lung cancer in non-smokers and the paucity of pathology material and other related data, NCI will collaborate with a number of domestic and international sites to obtain de-identified biospecimens and data. The International Agency for Research on Cancer (IARC) is one such site. Services are required from this site for the retrieval of biospecimens and associated data, processing of specimens, and shipment of data and materials.

The overall goals of the Integrative Tumor Epidemiology Branch (ITEB) Sherlock-Lung study are to collaborate with several domestic and international sites to obtain de-identified biospecimens and data. The specific aim for this procurement is to retrieve, label and ship fresh frozen tissue samples, whole blood or buffy coat or DNA extracted from blood, H & E slides and FFPE blocks to the NCI.

CONTRACT REQUIREMENTS:

The contractor shall perform the following tasks:
a. Label and ship biospecimens as designated by NCI Contracting Officer's Representative (COR).
b. Provide de-identified epidemiologic data associated with each case. Variables may include, but are not limited to, demographics, BMI, smoking, passive smoking, history of lung disease or infections, personal/family history of cancer, medical history, chronic medications/NSAID, occupational or environmental exposures, and detailed residential history.
c. Provide de-identified clinical data associated with each case. Variables may include, but are not limited to, clinical stage, histology, grade, survival, recurrence, metastasis and treatment categories.
d. Provide de-identified pathology reports for each case or information abstracted from pathology reports.

Biospecimens: IARC shall ship the following biospecimens for each case of primary lung cancer in a confirmed never-smoker selected for Sherlock-Lung.

Fresh frozen tissue samples:
a. Tumor tissue (T) plus source of germline (G) DNA, or DNA and RNA extracted from T and G
b. Paired fresh frozen normal tissue (N) is highly desirable (multiple samples preferred), or DNA and RNA extracted from N
c. Tissue characteristics: T (>50% tumor cells,.