QMS_Pre-Sol_Notice_FedBizOpps_N02CO67004-02.pdf

Pre-Solicitation Notice, N02CO67004-02

Presolicitation Notice: RFP No. N02CO67004-02

Contracting Office Address:

Department of Health and Human Services, National Institutes of Health (NIH), National Cancer Institute (NCI), Office of Acquisitions, Riverside Five, Suite 400, 8490 Progress Drive, Room 4045, Frederick, MD 21701-4998.

Note: This synopsis follows a Sources Sought notice that was released on 12/4/15 under HHS-

NIH-NCI-SBSS-TSB-67004-02.

Description:

The National Institutes of Health (NIH), Office of the Director (OD) of the Center for Strategic Scientific Initiatives (CSSI) of the Office of Cancer Clinical Proteomics Research (OCCPR) of the National Cancer Institute (NCI) is seeking a Quality Management System (QMS) in support of the Clinical Proteomic Tumor Analysis Consortium (CPTAC) Program.

The National Cancer Institute is expanding its basic and translational research programs that rely heavily on sufficient availability of high quality well annotated biospecimens suitable for concurrent use in proteomic and genomic studies. The NCI’s overarching goal with such programs is to improve the ability to diagnose, treat, and prevent cancer.

The Clinical Proteomic Tumor Analysis Consortium (CPTAC), one such program, is a comprehensive and coordinated effort to accelerate our understanding of the molecular basis of cancer through the application of proteomic and genomic technologies. The National Cancer Institute (NCI) launched CPTAC as a technology assessment program in 2006. In its second phase, CPTAC provided proteomic analysis to selected biospecimens from The Cancer Genome Atlas (TCGA). Now in its third phase, CPTAC will expand the depth of analysis and breadth of tumor types to systematically explore the entire spectrum of proteomic and genomic changes involved in human cancer. Specifically, the project is designed to comprehensively analyze protein, RNA, and DNA sequences, DNA copy number changes, protein and transcription profiles, sequence variation, and sequence in both tumor tissue and case-matched germline DNA.

The suite of analysis platforms will be applied to a common set of molecular analytes obtained from clinically annotated, high-quality, tumor biospecimens and case-matched nonmalignant tissue. More detailed information can be found at the project’s website:

http://proteomics.cancer.gov. To successfully generate comprehensive data, CPTAC will need in excess of 4,000 biospecimens over the course of the project.

During its second phase CPTAC generated 20 terabytes (TB) of data, spanning biospecimen information, patient information, and proteome, genome, exome and epigenetic data for both tumor and normal specimens per patient. The ability to ensure data completeness associated with each specimen required a coordinated effort across numerous institutions and information systems. This coordination will become increasingly difficult and important as the program triples the number of tumor types in the coming five years. The value of the data generated in CPTAC will lie in its quality, as all subsequent analyses and research outcomes will be dependent on the quality of the information generated. The Quality Management System (QMS) will serve as the basis by which the quality and value of the CPTAC data may be measured.

Key to the program will be the establishment of a process and system to ensure data completeness and quality. To facilitate expansion of the program, CPTAC will focus on quality as a best management practice, and is seeking support to define and implement a Quality Management System (QMS). The rest of this statement of work document outlines the purpose, requirements and scope of the CPTAC QMS.

Request for Proposal (RFP) N02CO67004-02 will be available on or about March 11, 2016 and receipt of proposals will be due at 2:00 p.m., Eastern Prevailing Time on or about April 11, 2016. The RFP will only be available electronically and must be accessed through the FedBizOpps website (www.fbo.gov) and the National Cancer Institute homepage at http://rcb.cancer.gov/rcb-internet/index.jsp. All information required for submission of a proposal will be contained in the electronic RFP package. It is the offeror’s responsibility to monitor the above Websites for the release of this RFP and amendments, if any. All responsible sources may submit a proposal, which shall be considered by the agency. This notice does not commit the Government to award a contract. Collect calls will not be accepted. Facsimile transmissions will not be accepted.

This solicitation is anticipated to result in one (1) award to an offeror capable of performing all aspects of the work described in the Statement of Work (SOW). It is anticipated that a single award, cost-plus-fixed-fee contract will be awarded on or before August 1, 2016, for a base period of one-year, plus four (4) successive one-year option periods. This advertisement does not commit the Government to award any contract. The North American Industry Classification System (NAICS) code is 541990, with a size standard of $15.0 million.

This is a new requirement through the Clinical Proteomic Tumor Analysis Consortium (CPTAC) Program.

POTENTIAL OFFERORS WILL BE RESPONSBILE FOR DOWNLOADING THEIR OWN

COPY OF THE RFP AND ANY POSSIBLE AMENDMENTS, FAILURE TO DO SO WILL

BE AT YOUR FIRM’S OWN RISK. ALL INQUIRIES SHALL BE SUBMITTED

ELECTRONICALLY TO THE CONTRACTING OFFICER LISTED AS THE POINT OF

CONTACT HEREIN.

Point of Contact:

Mandie S. White, Contracting Officer; Phone: 301-624-8756; Email: whitems@mail.nih.gov .