Analysis of Anti-Cancer Chemicals & Pharmaceutical Formulations

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 4030, Frederick, MD 21701-4998. Note: This synopsis follows a SBSS notice that was released on 12/07/2016 under N02CM77004-16. Description The Pharmaceutical Resources Branch (PRB), Developmental Therapeutics Program (DTP), Division Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is seeking services for the analysis of bulk drug substances and formulated drug products. Reports of these analyses will be used as a basis for assessing the suitability of these materials for use in biological activity screening, pharmacological studies, toxicological studies, formulation studies and clinical trials. Data provided in these analytical reports will be supplied to the Food and Drug Administration (FDA) as part of the Investigational New Drug (IND) filings for new anti-tumor agents. Historical summaries of the data are used in preparing specifications of the various bulk drug substances. These specifications are used in procurement actions as well as for the routine quality control of these materials. Awardees selected should be experienced in the analytical assessment of bulk drug substances and clinical drug products, according to FDA regulations and guidelines, and will be expected to have operational equipment and capabilities. Contractors shall complete and deliver approximately 5-7 Task Orders (TO) each year. The actual number of Task Orders is expected to be variable, dependent upon the existing approved compounds and approval rate of new developmental compounds. These assignments will involve the following project activities: 1. Complete all work required by typical "TO-Release Analysis" on bulk drug substances. Approximately 3-4 bulk drug lots per year are anticipated. 2. Complete all work required by typical "TO-Release Analysis" on formulated drug products. Approximately 1-2 lots of formulated drug products per year are anticipated. 3. Develop complete physicochemical characterization and validated chromatographic methods for bulk drug substances and formulated drug products. Analytical development will be required for approximately 2-3 new drug substances per year. 4. Complete assigned work on approximately 2-3 long-term projects (6-12 months in duration) each year, usually involving stability studies on bulk drug substance, in accordance with FDA guidance. Contractors shall perform analysis of bulk drug substances and their pharmaceutical formulations. All materials to be analyzed will be assigned and usually supplied by the NCI Contracting Officer's Representative (COR). The COR will transmit each sample through a Task Order Request for Proposals (TORFP). The TORFP will list the TO Number, date, The solicitation is anticipated to result in up to five Indefinite Delivery/Indefinite Quantity (IDIQ) contracts with a five-year ordering period, awarded on or before August 1, 2017, to Offerors capable of performing all aspects of the work described in the Statement of Work (SOW). We anticipate task orders issued against the IDIQ contracts will be cost reimbursement and/or firm fixed price. The following mandatory qualification criteria will apply: The proposed facilities shall meet FDA standards for Laboratory Quality Control Unit in accordance with the current Good Manufacturing Practices (cGMP) regulations. The contractor shall also conform to the applicable regulations of the U.S. Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), U.S. Department of Transportation (DOT) and those of state and local regulatory agencies. This is a recompetition of three IDIQ contracts, contract number HHSN261201200026C awarded to MRIGlobal., HHSN261201200027C awarded to Research Triangle Institute, and HHSN261201200028C awarded to SRI International., each for a five-year period of performance. Freedom of Information Act request should be sent to Suzy Milliard at suzanne.milliard@nih.gov. This advertisement does not commit the United States Federal Government to award any contract. The NAICS code for this acquisition is 325412 with a size standard of 1,250 employees. THIS ACQUISTION IS BEING ADVERTISED AS A PARTIAL (40%) SET-ASIDE FOR SMALL BUSINESSES. TWO OF THE FIVE IDIQ AWARDS ARE SET-ASIDE FOR SMALL BUSINESSES. The Request for Proposals (RFP) N02CM77004-16 solicitation is scheduled for electronic release on or about 3/02/2017 and receipt of proposals will be due at 6:00 pm EST on or about 3/30/2017. The RFP will only be available electronically and must be accessed through the Office of Acquisitions, NCI homepage by using the following address: http://rcb.cancer.gov/rcb-internet/ or through FedBizOpps.gov https://www.fbo.gov/. All information required for submission of a proposal will be contained in the electronic Request for Proposals (RFP) package. No collect calls will be accepted. No facsimile transmissions will be accepted. It is the offerors responsibility to monitor the above mentioned sites for release of the solicitation and any amendments. All responsible sources may submit a proposal, which shall be considered by the agency. POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITIATION AND ANY AMENDMENTS THAT MAY BE ISSUED. Failure to do so will be at your firm's own risk. Points of contact: Nicole Belanger, Contracting Officer at email belangern@mail.nih.gov