75N91021R00003- Presolicitation Notice.pdf

Pre-Solicitation Notice: RFP No. 75N91021R00003 Preclinical Toxicology of Small Molecule Drugs Developed for Cancer and Other

Indications

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 21701-4998.

Note: This synopsis follows the Small Business Sources Sought (SBSS) notice released on April 6, 2020 under HHS-NIH-NCI-SBSS-TSB-00305-55.

Description

The Toxicology and Pharmacology Branch (TPB) of the Developmental Therapeutics Program (DTP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is the focus for obtaining and evaluating preclinical toxicology and pharmacology data on anti-cancer drugs and biologicals that have been approved for NCI discovery and development. The ultimate goal is to identify and characterize the toxicologic profile and pharmacokinetic properties of potential drug candidates and to support an Investigational New Agent Application (IND) or a Drug Master File (DMF) with the U.S.

Food and Drug Administration. The objective of the “Preclinical Toxicology of Small Molecule Drugs Developed for Cancer and Other Indications” contract will be to conduct toxicology studies that will be used in the preclinical development of drugs for patients with cancer and other diseases. One award is anticipated to result from any solicitation posted for this requirement, for services outlined in greater detail in the Draft Statement of Work (SOW) attached to this notice.

The qualification criteria establish conditions that must be met at the time of receipt of the Final Proposal Revision by the Contracting Officer in order for a proposal to be considered any further for award. The following Mandatory Qualification Criteria for this RFP is as follows:

GLP Compliance: The laboratory facility must be in compliance with the Food and Drug Administration's (FDA) Good Laboratory Practice Regulations (GLP) as published in CFR Title 21, Part 58, and as updated. Some, but not all, toxicology studies submitted in support of an Investigational New Drug application to the FDA must be GLP-compliant. As such, the contractor must be able to conduct GLP-compliant studies since DTP/NCI anticipates needing several of these studies each year. Documentation shall be in the form the most recent FDA Establishment Inspection Report demonstrating that the facility is currently in compliance with FDA GLP regulations, i.e. not currently disqualified.

Animal Care and Use: The Offeror shall establish and provide resources for an animal care and use program that is managed in compliance with applicable federal, state, and local laws and regulations, such as:

• Animal Welfare Regulations (9 CFR, 1985/1989) https://www.nal.usda.gov/awic/final-rules-animal-welfare-9-cfr-parts-1-2-and-3

• Guide for the Care and Use of Laboratory Animals 8th ed., National Research Council, http://www.ncbi.nlm.nih.gov/books/NBK54050/

• Public Health Service Policy on Humane Care and Use of Laboratory Animals, revised 2015.

https://grants.nih.gov/grants/olaw/references/phspol.htm.

To demonstrate compliance with the above policies and guidance, Offerors shall submit with their Technical Proposal: 1) a copy of your organization’s most recent letter from NIH’s Office of Laboratory Animal Welfare (OLAW) documenting approval of a valid Animal Welfare Assurance, and 2) a copy of your organization’s most recent USDA Animal Welfare Act registration certificate.

This is a recompetition of five (5) IDIQ contracts supporting small and large molecule projects, under contract number HHSN261201600015I awarded to IIT Research Institute; contract number HHSN261201600016I awarded to Battelle; HHSN261201600017I awarded to SRI International; HHSN261201600018I awarded to Southern Research Institute; and contract number HHSN261201600019I awarded to University of Illinois at Chicago, each for a five-year period of performance.

The solicitation is anticipated to result in one Cost-Plus-Fixed-Fee contract. The duration of the contract will be a one-year base period, with six subsequent one-year option periods, for a total period of performance of seven years. The anticipated start date is on or about July 1, 2021.

This advertisement does not commit the United States Federal Government to award any contract. The 2017 NAICS code for this acquisition is 541715 with a size standard of 1,000 employees. THIS ACQUISTION IS ANTICIPATED TO BE UNRESTRICTED (NOT A SET-

ASIDE FOR SMALL BUSINESSES); HOWEVER, THE GOVERNMENT RESERVES THE

RIGHT TO CHANGE THIS DESIGNATION IN THE RFP 75N91021R0003 BASED ON ANY

NEW INFORMAITON RECEIVED IN RESPONSE TO THE CORRECTION TO THE

SOURCES SOUGHT NOTICE BELOW (NAICS CODE CHANGE).

The Request for Proposal (RFP) 75N91021R00003 is scheduled for electronic release on or about 11/16/2020 and receipt of proposals will be due at 3:00 pm ET on or about 12/16/2020.

The RFP will only be available electronically and must be accessed through https://www.beta.sam.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 offeror’s 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

https://www.nal.usda.gov/awic/final-rules-animal-welfare-9-cfr-parts-1-2-and-3 http://www.ncbi.nlm.nih.gov/books/NBK54050/ https://grants.nih.gov/grants/olaw/references/phspol.htm https://www.beta.sam.gov/

SO WILL BE AT THE FIRM’S OWN RISK. ALL INQUIRIES SHALL BE SUBMITTED

ELECTRONICALLY TO THE CONTRACTING OFFICER LISTED AS THE POINT OF

CONTACT HEREIN.

Point of contact: Randall Tiqui, Contracting Officer via email at randall.tiqui@nih.gov.

Secondary Point of contact: Carrie Mills, Contracting Officer via email at carrie.mills@nih.gov.

CORRECTION TO SOURCES SOUGHT NOTICE: HHS-NIH-NCI-SBSS-TSB-00305-55

The purpose of this Small Business Sources Sought Notice CORRECTION is to update the NAICS code included in the original Sources Sought Notice. The purpose of a Sources Sought Notice is to identify qualified small business concerns including HUBZone small businesses;

service disabled, veteran-owned small businesses; 8(a) small businesses; women-owned small businesses; or small disadvantaged businesses that are interested in and capable of performing the work described herein. The NCI does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information received in relation to this correction.

As a result of this SBSS notice correction, the NCI may issue a Request for Proposal (RFP).

THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claim against the NCI shall arise as a result of a response to this Small Business Sources Sought Notice correction or the NCI’s use of such information as either part of our evaluation process or in developing specification for any subsequent requirement. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. A determination by the Government not to compete this requirement as a set-aside is based upon responses to this notice is solely within the discretion of the Government.

An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.

CORRECTION- NAICS Code and Size Standard:

The NAICS code for this acquisition is revised from Sources Sought Notice: HHS-NIH-NCI- SBSS-TSB-00305-55 from 541714- Research & Development (R&D) in Biotechnology (except Nanobiotechnology), which has a size standard of 1,000 employees, to 541715- Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology), which also has a size standard of 1,000 employees.

Capability Statement/Information Sought:

Sources are expected to furnish the necessary services, qualified personnel, materials, facilities, equipment and experience to meet the requirements in the attached, draft SOW. Respondents mailto:randall.tiqui@nih.gov mailto:carrie.mills@nih.gov must prepare a tailored capability statement that demonstrates a clear understanding of all Task Areas outlined in the attached, draft Statement of Work.

To determine qualifications, the Capability Statement will be evaluated based on the information provided in relation to the project requirements and the respondents current capability and capacity to:

1) Perform the work outlined in the Task Area(s) in the attached, draft Statement of Work (e.g., Technical Approach and Awareness);

2) Provide appropriate Personnel for the project;

3) Access appropriate resources (e.g., Facilities & Equipment); and

4) Organizational Experience

Information Submission Instructions:

1. Page Limitations: Interested, qualified small business organizations should submit a tailored capability statement for this requirement not to exceed twenty (20) single-sided pages excluding all attachments, resumes, charts, and other relevant supporting documentation (single spaced, 12 point font minimum) that clearly details the firm’s ability to perform the aspects of the notice described above and in the draft SOW.

Tailored capability statements should also include an indication of current certified small business status. This indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern’s name and address) as well as the eligible small business concern’s name, point of contact, address and DUNS number. All pages must be numbered including attachments, resumes, charts, etc.

2. Delivery Point:

All capability statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via email) to Randall Tiqui, Contracting Officer at randall.tiqui@nih.gov in Microsoft Word or Adobe Portable Document Format (PDF). The subject line must specify HHS-NIH-NCI-SBSS-TSB-00305-55.

Facsimile responses will not be accepted.

3. Common Cut-Off Date:

Electronically submitted tailored capability statements are due no later than 2:00 PM (Eastern Prevailing Time) on Saturday, November 14, 2020. CAPABILITY

STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE

CONSIDERED.

mailto:randall.tiqui@nih.gov

DISCLAIMER AND IMPORTANT NOTES: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. Responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).