Preclinical Toxicology of Drugs Developed for Cancer Patients

Background: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small business; veteran-owned small business; woman-owned small businesses, or small disadvantaged businesses; and (3) their size classification relative to North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This National Cancer Institute (NCI), National Institutes of Health (NIH) project is a recompetition of the following: Battelle Memorial Institute contract HHSN261201100019C; IIT Research Institute contract HHSN261201100027C; Southern Research Institute contract HHSN261201100021C; SRI International contract HHSN261201100028C; and University of Illinois at Chicago contract HHSN261201100029C. This Small Business Sources Sought notice is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Cancer Institute (NCI). A determination by the Government not to compete this requirement as a set-aside based upon responses to this Notice is solely within the discretion of the Government. Interested parties are expected to review this Notice and the draft Statement of Work to familiarize themselves with the requirements of this project; failure to do so will be at your firm's own risk. Purposes and Objectives: Toxicology studies conducted under the contracts are designed to meet Program objectives by providing: characterization of dose limiting toxicities (DLT); determination of schedule-dependent toxicity; determination of the reversibility of adverse effects; determination of a safe clinical starting dose via a margin of safety determination. Project Requirements: A. Analytical Phase: Drug identity analysis (e.g., IR, NMR, MP, MS, or other emergent assay methodology designated by the Contracting Officer's Representative (COR).) B. Pharmacokinetic Phase: Plasma elimination kinetics shall be determined in one or more of the following species: dogs, rodents and non-human primates after single intravenous doses of drugs. C. Screening and Preliminary Phase: For each drug, establish a maximum tolerated dose (MTD) and dose limiting toxicities (DLT). D. IND-Directed Toxicology Assessment Phase: For each drug, establish toxicity and safety in relation to drug plasma concentrations or area-under-the-curve. Anticipated Period of Performance: The period of performance for this requirement would be five years. The anticipated start date is June 1, 2014. Multiple IDIQ awards are anticipated with Task Orders issued. Other Important Considerations: Draft Statement of Work: A copy of the draft Statement of Work (SOW), which is subject to revisions, may be accessed at the end of this document. NAICS Code and Size Standard: In the event an RFP is issued, North American Industry Classification System (NAICS) code 541690 with a size standard of $14,000,000 is being considered. Accreditation by the American Association for Accreditation of Laboratory Animal Care (AAALAC) is desirable. Documentation of a lack of findings from one or more ALLAC inspections may also be provided. Under governing policy, federal funds administered by the Public Health Service (PHS) shall not be expended for research involving live vertebrate animals without prior approval by the Office of Laboratory Animal Welfare (OLAW). An assurance to comply with the PHS policy on humane care and use of laboratory animals and/or a valid Institutional Animal Care and Use Committee (IACUC) approval shall be submitted at the time of proposal submission, if a RFP is issued. This restriction applies to all performance sites (e.g. collaborating institutions, subcontractors, subgrantees) without OLAW-Approved Assurances, whether domestic or foreign. Capability Statement/Information Sought: Tailored Capability Statement shall demonstrate a clear understanding of all tasks specified in the draft Statement of Work (SOW). Tailored Capability Statements for this requirement shall address the following areas: A. PERSONNEL: - Availability and qualifications of a Program Director (Principal Investigator [PI]) with at least 5 years of relevant experience in managing an interdisciplinary team in the conduct of toxicology and pharmacology investigations of therapeutic agents. Suitability and adequacy of the PI's recent scientific accomplishments to this project as evidenced by bibliography and Curriculum Vitae (including study reports, published and accepted manuscripts). - Availability of Task Order Project Leaders (Study Directors) with leadership experience in performing team oriented studies of a similar nature to that to be performed under this contract. Suitability and adequacy of recent scientific accomplishments to this project as evidenced by bibliography and Curriculum Vitae (including study reports, published and accepted manuscripts). - Suitability and adequacy of the training, experience and qualifications of other personnel in pathology, laboratory animal care, clinical pathology, analytical chemistry, pharmacokinetics, and quality assurance. In addition, describe the availability and suitability of special personnel for performing in vitro assays, cardiotoxicity, immunotoxicity and neurotoxicity studies. - Extent of experience of the proposed staff functioning as a study team. B. TECHNICAL APPROACH AND AWARENESS: - Documentation of a realistic technical approach to the program as a whole and to each protocol, drawing upon recent experience in the conduct of toxicology and pharmacology studies including discussions on analytical chemistry, animal care, clinical pathology, histopathology, toxicity evaluations (drug versus nondrug related) and quality assurance. Understanding of the problems likely to be encountered in the studies as demonstrated by firsthand experience with diverse types of drugs. - Adequacy of technical approach with regard to specialty studies such as in vitro assays, cardiotoxicity, immunotoxicity and neurotoxicity studies. - Ability to provide high quality data and service. - Appropriateness of an offeror's means to provide interim data sets, raw data and derived parameters to the COR when needed in a consumable and integrative format. C. FACILITIES AND EQUIPMENT: - Availability and accessibility of suitable animal and laboratory space for the projected studies. Adequate capacity for multiple studies to be conducted simultaneously. Accessibility and adequacy of major equipment and software needed for the proposed work including analytical and computer equipment. Adequacy of systems and processes for collection and handling of data and capability for electronic transfer of information to the NCI. Adequacy of library resources. D. ORGANIZATIONAL EXPERIENCE: - Evidence of organizational support for proposed work. Extent of organizational ability to provide appropriate manpower and resources for each Task Order and meet turnaround times for reporting and data acquisition. Documented evidence of Q.C. procedures for study reports and data. Documented ability to handle increases and decreased in workload over the contract period. Adequacy of the safety and security procedures for the proposed work. Information Submission Instructions: 1. Page Limitations: Interested qualified small business organizations should submit a tailored capability statement for this requirement not to exceed fifteen (15) single sided pages including all attachments, resumes, charts, etc. (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. 2. Number of Copies: One (1) electronic copy of the capability statement submitted electronically (via e-mail) to MaryAnne Golling, Contracting Officer, and Brian Madgey, Contract Specialist. In addition, one (1) hard copy of the capability statement mailed on or before the due date to Brian Madgey, Contract Specialist. 3. Delivery Point: Electronic copy of the capability statements sent in response to this SMALL BUSINESS SOURCES SOUGHT notice must be submitted electronically (via e-mail) to MaryAnne Golling, Contracting Officer, at gollingm@mail.nih.gov and Contract Specialist, Brian Madgey, at madgeyba@mail.nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify HHS-NIH-NCI-SBSS-TSB-47001-42. Facsimile responses will not be accepted. One (1) hard copy of the capability statement must be mailed to Brian Madgey, Contract Specialist, at the following address. Brian Madgey Contract Specialist Riverside Five 8490 Progress Drive, Suite 400 Frederick, MD 21701 4. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 12:00PM (EST) on August 15, 2013. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. The hard copy of the capability statement must be postmarked on or before the due date. DISCLAIMER AND IMPORANT 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. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, 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).