Presolicitation Notice: Request for Proposals (RFP) N01CN77019-18 "PREVENT Cancer Preclinical Drug Development Program: Preclinical Services for Biopharmaceutical Product Development and Manufacturing, Toxicology and Pharmacology Testing"

Notice Number: NOT-CA-18-070

Key Dates
Release Date: April 23, 2018
RFP Release Date: May 7, 2018
Proposal submission date: June 21, 2018
Estimated award date: On or before September 30, 2018

Related Announcements
NOT-CA-18-073

Issued by
National Cancer Institute (NCI)

Purpose

Contracting Office Address:
Department of Health and Human Services, National Institutes of Health (NIH), National Cancer Institute (NCI), Office of Acquisitions(OA), Riverside Five, 8490 Progress Drive, Suite 400, Frederick, MD 21701.

Note: This notice follows Small Business Sources Sought (SBSS) notices that were released in FedBizOpps on July 31, 2017 under HHS-NIH-NCI-SBSS-TSB-77019-18, HHS-NIH-NCI-SBSS-TSB-77006-79 and HHS-NIH-NCI-SBSS-TSB-77005-16.

Description:

NCI intends to issue a Request for Proposals (RFP) to support the PREVENT Cancer Preclinical Drug Development Program.

The NCI PREVENT Cancer Preclinical Drug Development Program (PREVENT; http://prevention.cancer.gov/major-programs/prevent-cancer-preclinical) is a peer-reviewed research program managed by the Division of Cancer Prevention (DCP) with its primary mission to advance the preclinical development of cancer-preventive interventions and intermediate biomarkers toward clinical trials. The overall objective of the current acquisition is to provide a structured approach to drug and vaccine development, from discovery to the clinic.

To achieve these goals, this acquisition is broken out into three (3) separate Indefinite Delivery-Indefinite Quantity (IDIQ) Pools as described below, and as outlined in greater detail in the Draft Background Statement and in the three (3) Draft IDIQ Statements of Work (SOWs) available through the pre-solicitation notice posted on FedBizOpps (https://www.fbo.gov/spg/HHS/NIH/FCRF2/N01CN77019-18/listing.html):

Preclinical Efficacy and Intermediate Endpoint Biomarkers (Efficacy Pool)

The Preclinical Efficacy and Intermediate Endpoint Biomarkers IDIQ contracts will encompass the continued evaluation of the efficacy of potential chemopreventive and immunopreventive regimens, and the identification of pharmacodynamic and or efficacy biomarkers which will enhance the development of these regimens for clinical trials. Resources from these contracts will be used to support development of several candidate cancer preventive agents. Up to nine (9) IDIQ awards are anticipated for the Efficacy Pool.

The qualification criterion establishes conditions that must be met at the time of receipt of Technical Proposals by the Contracting Officer, in order for a proposal to be considered any further for award. The following Mandatory Qualification Criteria apply to the Efficacy Pool:

1. Demonstration of an Approved Animal Welfare Assurance from the Office of Extramural Research (OER), Office of Laboratory Animal Welfare (OLAW), Office of the Director, NIH;
2. Current Accreditation by the Association for Assessment and Accreditation of
Laboratory Animal Care (AAALAC) (or equivalent); and
3. Documented participation of an American College of Laboratory Animal Medicine
(ACLAM) certified veterinarian.

This is a recompetition of seven (7) IDIQ contracts, contract number HHSN261201500018I awarded to University of Texas MD Anderson Cancer Center; contract number HHSN261201500032I awarded to The Institute for Research at Fox Chase Cancer Center; HHSN261201500036I awarded to University of Alabama at Birmingham; HHSN261201500037I awarded to Medical College of Wisconsin; contract number HHSN261201500038I awarded to University of Oklahoma Health Sciences Center; contract number HHSN261201500039I awarded to Weill Medical College of Cornell University; contract number HHSN261201500041I awarded to SRI International; and contract number HHSN261201500042I awarded to IIT Research Institute (IITRI), each for a three-year period of performance.

Preclinical Services for Biopharmaceutical Product Development and Manufacturing (CGMP Pool)

The PREVENT Preclinical Services for Biopharmaceutical Product Development and Manufacturing (CGMP Pool), encompasses four main technical task areas: (1) product development planning and evaluation; (2) analytical assay development and product characterization; (3) process development and related activities; and (4) CGMP manufacture, related activities and documentation, as described in detail in the Statement of Work. The key objective of the PREVENT CGMP Pool is to provide preclinical product development and CGMP manufacturing support for candidate cancer preventive vaccines for preclinical and clinical testing. Up to six (6) IDIQ contract awards are anticipated for the CGMP Pool.

There are no mandatory qualification criteria for the CGMP Pool and there are no incumbent contractors for the CGMP Pool.

Toxicology and Pharmacology Testing (Toxicology Pool)

The Toxicology and Pharmacology Testing IDIQ contracts will continue evaluation of the pharmacological and toxicological effects of potential cancer preventative agents. Resources from these contracts will be used to support development of several candidate cancer preventive agents. Up to five (5) IDIQ contract awards are anticipated for the Toxicology/Pharmacology Pool.

The qualification criterion establishes conditions that must be met at the time of receipt of Technical Proposals by the Contracting Officer, in order for a proposal to be considered any further for award. The following Mandatory Qualification Criteria apply to the Toxicology Pool:

1. Demonstration of compliance to perform studies in accordance with Food and Drug Administration (FDA) Good Laboratory Practice (GLP) Regulations as published in CFR Title 21, Part 58, and as updated. Compliance shall be documented with the two most recent FDA inspection reports;
2. Current AAALAC (or equivalent) accreditation;
3. Nuclear Regulatory Commission licensure for use of radioactive materials and presence of organizational unit monitoring safe use and disposal; and
4. Documented participation of an ACLAM certified veterinarian on their staff. Alternatively, the ACLAM veterinarian may have an established relationship as a contracted on-call consultant veterinarian.

This is a recompetition of five (5) IDIQ contracts, contract number HHSN261201500021I awarded to SRI International; contract number HHSN261201500022I awarded to Southern Research Institute; contract number HHSN261201500023I awarded to Lovelace Biomedical & Environmental Research Institute; contract number HHSN261201500024I awarded to IIT Research Institute (IITRI); and contract number HHSN261201500026I awarded to University of Illinois at Chicago (UIC), each for a three-year period of performance.

The solicitation is anticipated to result in up to twenty (20) Indefinite Delivery-Indefinite Quantity (IDIQ) contracts across the three pools described above. Each base IDIQ contract will be for five years with awards anticipated on or before September 30, 2018 to Offerors capable of performing the work described in the Draft SOWs available through FedBizOpps (internet address below). Task orders placed within the ordering period of these base IDIQ contracts' period of performance/ordering period. NCI anticipates task orders issued against the IDIQ contracts will be cost reimbursement and/or firm fixed price. While the base IDIQ contracts will not have options, options may be included at the individual task order level. 

This advertisement does not commit the United States Federal Government to award any contract. The 2017 NAICS code for this acquisition is 541714 (formerly 541711) with a size standard of 1,000 employees. THIS ACQUISTION IS UNRESTRICTED (NOT A SET-ASIDE FOR SMALL BUSINESSES).

Place of Performance:
The place of performance will be the Contractor’s work site.

Set Aside Status:
None.

The Request for Proposal N01CN77019-18 is scheduled for electronic release on or about 5/7/18 and receipt of proposals will be due at 3:00 pm ET on or about 6/21/2018. 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 Proposal (RFP) package. No collect calls will be accepted. No facsimile transmissions will be accepted. It is the offerors responsibility to monitor the sites mentioned above 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 DOWLOADING THEIR OWN COPY OF THE SOLICITATION AND ANY AMENDMENTS THAT MAY BE ISSUED. FAILURE TO DO SO WILL BE AT THE ORGANIZATION'S OWN RISK. ALL INQUIRIES SHALL BE SUBMITTED ELECTRONICALLY TO THE CONTRACTING OFFICER LISTED AS THE POINT OF CONTACT BELOW.

This advertisement does not commit the Government to award a contract.

Inquiries

Please direct all inquiries to:

Nicole Belanger
National Cancer Institute (NCI)
Telephone: 301-624-8754
Email: belangern@mail.nih.gov