SOURCES SOUGHT
A -- Preclinical Pharmacokinetic and Pharmacologic Studies with Anticancer and Other Therapeutic Agents - Draft Statement of Work
- Notice Date
- 11/17/2009
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd., EPS Suite 600, Rockville, Maryland, 20852
- ZIP Code
- 20852
- Solicitation Number
- HHS-NIH-NCI-RDSS-TSB-07014-39
- Archive Date
- 12/16/2009
- Point of Contact
- Theresa H. Shroff, Phone: (301) 228-4223, MaryAnne - Golling, Phone: (301) 228-4215
- E-Mail Address
-
ts144t@nih.gov, mg345x@nih.gov
(ts144t@nih.gov, mg345x@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Draft Statement of Work SOURCES SOUGHT NOTICE NO. HHS-NIH-NCI-RDSS-TSB-07014-39 " Preclinical Pharmacokinetic and Pharmacological Studies with Anticancer and Other Therapeutic Agents" 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 small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the 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. The NCI does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted. As a result of this Sources Sought, 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 claims against NCI shall arise as a result of a response to this Sources Sought or the NCI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. The National Cancer Institute, Division of Cancer Treatment and Diagnosis, Developmental Therapeutics Program is seeking qualified small businesses including Small Disadvantaged Businesses (SDB), Woman-owned Small Businesses (WOSB), 8(a), Historically Underutilized Business Zone (HUBZone), or Service-Disabled Veteran owned Small Business (SDVOSB) concerns to furnish services, qualified personnel, equipment, and facilities, not otherwise provided by the Government, to conduct a series of preclinical pharmacokinetic and other pharmacology studies in animals on agents having demonstrated antitumor or other therapeutic activity and considered by DCTD to merit further development. The studies to be performed will include: the development of methodology for the quantitative measurement of test agents and/or metabolites in body fluids and tissues; stability studies of test agents in biological fluids; plasma protein binding determinations; characterization of in vivo plasma concentration-time profiles and calculation of relevant pharmacokinetic parameters; determination of test agent levels in samples (including human materials) provided by other DTP designated laboratories; determination of the most effective mode of agent administration to achieve and maintain effective concentrations in body fluids and tissues; bioavailability studies following administration of an agent by various routes; tissue distribution and urinary excretion studies; structural determination of metabolites and/or degradation products of parent agents produced in animals and in model in vitro systems (e.g., animal and/or human liver slices, hepatocytes, S9 fractions, and microsomal preparations). Where appropriate, this information may be correlated with pharmacodynamic or biomarker data obtained in studies with drug-treated animals. The Government will supply assigned test agents, radiolabeled test agents, and when available test animals (rodents only). Contractors will be expected to provide all instrumentation, equipment, solvents, reagents, animals as needed, and animal facilities needed to conduct this type of work. AAALAC accreditation is highly desirable. The following Mandatory Qualification Criteria will apply to any RFP that may be issued and these criteria will need to be met at the time of proposal submission: (1) the Contractor may not be a pharmaceutical or chemical firm since agents of a commercially confidential nature (discreet) may be evaluated; (2) the Contractor must possess a valid NRC license permitting the purchase, storage and use of typical quantities of radioisotopes (e.g., 3H, 14C, 35S) likely to be used in the proposed pharmacological research. A draft Statement of Work (SOW) is attached to this Source Sought. Interested qualified small business organizations should submit a tailored capability statement for this requirement not to exceed twenty (20) single sided pages including all attachments, resumes, charts, etc. (single spaced, 12 point font minimum) that clearly details the ability to perform the aspects of the notice described above. All proprietary information should be marked as such. In the event an RFP is issued, the North American Industry Classification System (NAICS) code 541712 with a size standard of 500 employees is being considered is being considered. Capability Statements shall demonstrate an understanding of preclinical pharmacokinetic and other pharmacology studies in animals. Tailored Capability Statements for this requirement shall address the following four (4) areas: (1) personnel; (2) technical approach and awareness of the problem; (3) facilities and equipment; and (4) organizational support/safety and security. Technical Evaluation Criteria 1. Personnel • Availability and qualifications of a Principal Investigator (PI) with at least 5 years of experience in managing an interdisciplinary team in the conduct of pharmacokinetic and other pharmacological investigations of therapeutic agents. • Adequacy and suitability of the PI's scientific training and experience appropriate for leading this project as evidenced by his/her bibliography and Curriculum Vitae, a list of study reports written, and other unpublished manuscripts. • Training, experience, and qualifications of other personnel to perform the tasks outlined in the Statement of Work (e.g., analytical chemistry, pharmacokinetics, drug metabolism, pharmacodynamic methods, laboratory animal care, etc.). • Extent that the proposed personnel have previously worked together as a research team on projects equivalent to those described in the Statement of Work. 2. Technical Approach and Awareness of the Problem • Demonstration of a sound understanding of analytical methods development and validation procedures relevant to the Statement of Work. • Evidence of a rational approach to the collection, analysis, and modeling of pharmacokinetic data in animals, as evidenced by the examples given in the proposal. • Evidence of a sound approach to the performance of in vitro and in vivo drug metabolism studies. • Understanding of the problems likely to be encountered in the conduct of such studies, and their solution, as demonstrated by first-hand experience with diverse types of agents and preclinical models. 3. Facilities and Equipment Availability and accessibility of suitable laboratory space, equipment, and animal facilities to carry out the Statement of Work, including multiple studies that may need to be run in parallel. • Availability and adequacy of major equipment such as HPLC, GC, NMR, and LC-MS and LC-MS/MS instrumentation. • Adequacy and availability of computing, software, and electronic information and/or library resources. 4. Organizational Experience and Support/Safety & Security • Extent and significance of organizational accomplishments in areas covered by the Statement of Work. • Evidence of the organization's ability to provide appropriate personnel, resources, and capacity to carry out the work and submit deliverables (reports) in an expeditious manner. • Ability of the organization to handle (technically and administratively) varying levels of assigned work, including simultaneous projects or periods with no active scientific projects). • Adequacy of the safety and security procedures to be used in conducting the proposed work. Interested parties are expected to review this notice and the attached draft Statement of Work (SOW) to familiarize yourself with the requirements of this project; failure to do so will be at your firm's own risk. Capability statements are due not later than 3:00 PM eastern prevailing time on Tuesday, December 1, 2009. Please submit one (1) original and three (3) copies of your response to: If hand-delivered or delivery service If using U.S. Postal Service Theresa H. Shroff, Contracting Officer Theresa H. Shroff, Contracting Officer Office of Acquisitions Office of Acquisitions National Cancer Institute National Cancer Institute Building 244, Room 102 P.O. Box B. 244 Miller Drive, Room 102 Fort Detrick Ft. Detrick Frederick, MD 21702-1201 Frederick, MD 21702-1201 NOTE: FORT DETRICK IS A SECURE MILITARY BASE. Couriers delivering proposals must use the Old Farm gate to gain access to Ft. Detrick. It is recommended that you Contact Theresa H. Shroff, Contracting Officer (301-228-4223) to Schedule in advance a specific time in order to deliver your Capability Statement. If Ms. Shroff is not available, please call 301-228-4239. Facsimile responses will not be accepted. Electronic responses, via e-mail, may be sent to shrofft@mail.nih.gov. Electronic submissions must be in Microsoft Word. All responses must be received at NCI by the specified due date and time in order to be considered. ALL QUESTIONS REGARDING THIS SOURCES SOUGHT MUST BE SUBMITTED ELECTRONICALLY. 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. 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) Points of Contact Theresa H. Shroff, Contracting Officer, 301-228-4223 or e-mail shrofft@mail.nih.gov
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