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, <20% necrosis), N (no tumor cells); optimal 40mg x 2, minimum 40mg
d. DNA: optimal ≥8ug, minimum ≥4ug; RNA optimal ≥5ug (RIN≥7), minimum ≥2ug (RIN≥6)

Blood (B) 500uL whole blood or buffy coat, or DNA extracted from B:

H&E slides (to be scanned and returned) or H&E images from every tissue block for every tumor

FFPE blocks (at least one from tumor center and one from tumor periphery), or sections from FFPE blocks:
a. Blocks: to be sectioned and remaining material returned
b. Sections: (T) optimal 10 sections x 10um, min 5 sections x 10um; (N) optimal 20 sections x 10um, min 10 sections x 10um

Plasma (P) optimal ≥7 ml, minimum ≥3 ml

Other Materials: IARC shall provide the following additional materials for each case of primary lung cancer in a confirmed never-smoker selected for Sherlock-Lung.

a. De-identified pathology reports or data extracted from pathology reports

DELIVERABLES:

The Contractor shall:
1. Label and ship biospecimens as designated by NCI Technical Point of Contact.
2. 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.
3. 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.
4. Provide de-identified pathology reports for each case or information abstracted from pathology reports.

Biospecimens deliverable:
Shipment of available tumor tissue, normal tissue, and DNA from blood from subjects with primary lung cancer confirmed as never-smokers (for up to 270 cases based on selection criteria) to the NCI.

Shipment of all remaining available biospecimens (fresh frozen tissue, H&E slides or images, FFPE blocks or sections, and plasma) from subjects with primary lung cancer confirmed as never-smokers

Other Materials Deliverables:
Delivery of all de-identified demographic, epidemiologic, and clinical data; and pathology images and reports corresponding to selected subjects with primary lung cancer confirmed as never-smokers (for up to 270 cases based on selection criteria).

Due 30 days after award.

NCI has determined that the International Agency for Research on Cancer (IARC) of the World Health Organization (WHO) are uniquely qualified to perform this work because the of large number of lung cancer cases identified through IARC studies, the Russian Multicancer Study (MLT) and the Early Stage Non-Small Cell Cancer Study (LUN), and the availability of complete sets of existing high quality biospecimens and well characterized data associated with the lung cancer cases that only IARC has access to. Sherlock-Lung seeks to collect biospecimens and data for ~2,000 lung cancer cases from a variety of geographic locations and with a variety of exposures of interest. Since lung cancer in never-smokers is uncommon, the 295 cases to be contributed by IARC are critical to reach the goal of Sherlock-Lung. The availability of fresh frozen tumor and normal tissue, blood, plasma, FFPE, H&E slides, along with high quality clinical and epidemiologic data from 295 lung cancer cases from geographic areas of interest (Eastern and Southern Europe) is both very unique and essential for the success of Sherlock-Lung. The Contractor is the only known source with access for these biospecimens and data at this time. For the aforementioned reasons, the IARC of the WHO the only known source to meet the Government needs for this requirement.

CLAUSES AND PROVISIONS
The following FAR Clauses/Provisions are incorporate as required by the John S. McCain National Defense Authorization Act (NDAA) for FY 2019, Public Law 115-232, Section 889(a)(1)(A).

The following FAR Clauses/Provisions are hereby added in full text.
FAR 52.204-24 - Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment

FAR 52.204-25 - Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

FAR 52.212-5 - Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial.

This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 2:00 PM EST, on August 30, 2019. All responses and questions can be emailed to Ronette Collins, Contract Specialist via electronic mail at [email protected]. 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. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must be registered and have valid certification in the System for Award Management (SAM) through sam.gov. Reference: 75N91019Q00141 on all correspondence.