SOURCES SOUGHT
B -- Analysis of Anti-Cancer Chemicals and Pharmaceutical Formulations
- Notice Date
- 10/27/2006
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 427, Room 12, Frederick, MD, 21702, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-SS-NCI-TSB-2007-1
- Response Due
- 11/13/2006
- Archive Date
- 11/28/2006
- Description
- This Source Sought Notice (SS) 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). The purpose of this SS is to identify qualified small businesses including 8(a), HUBZone, or Service-Disabled Veteran-owned business concerns 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 nor otherwise pay for the preparation of any information submitted. As a result of this SS, 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 SS or the NCI?s use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. It is anticipated that three (3) cost-reimbursement, completion type contracts would be awarded for a period of five (5) years with an option for yearly extensions up to two (2) additional years. The National Cancer Institute is seeking qualified small businesses including 8(a), HUBZone, or Service Disabled Veteran-owned business concerns to provide support to NCI's Pharmaceutical Resources Branch (PRB), Development Therapeutics Program (DTP), Division of Cancer Treatment and Diagnosis (DCTD) in providing 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 for screening, pharmacological studies, toxicological studies, formulation studies, or for clinical trails. Data provided in these 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 for the various bulk drug substances. The contractors must be experienced in analytical assessment of bulk drug substances and clinical drug products and will be expected to have operational equipment and capabilities. All materials to be analyzed will be assigned and usually supplied by the NCI Project Officer. The contractors shall complete and deliver approximately 20 to 30 assignments each year. Capability Statements shall demonstrate an understanding of all tasks specified in this draft SOW. Tailored Capability Statements for this requirement shall address the following six (6) areas (mandatory qualifications, information on similar projects, technical approach, personnel, facilities/equipment and corporate experience): 1. Provide evidence that the proposed facility meets FDA standards for Laboratory Quality Unit in accordance with current Good Manufacturing Practice (cGMP) regulation, including compliance with all Occupational Safety and Health Act (OSHA) and United Stated Department of Transportation (DOT) regulations regarding the handling of chemicals. In addition, address compliance with all United Stated Environmental Protection Agency (EPA) regulations regarding discharge of water and air pollutants and assure that disposal of all chemical residues meet current EPA regulations. 2. Document experience with contracts of a similar size and scope to this proposed project. Contract(s)/project(s) listed may include those entered into by the Federal Government, agencies of state or local governments, and commercial concerns. The following information shall be submitted to document this experience: Name of contracting organization; Contract number (for subcontracts, provide the prime contract number and the subcontract number); Contract type; Total contract value; Description of the requirement; Contracting Officer's name and telephone number; Project Manager?s name and telephone number; and Standard Industrial Code or NAICS code. The Project Manager shall be an employee of the Offeror and not a consultant or part of subcontractor staff. 3. A detailed Technical Approach that demonstrates a clear understanding of the draft SOW. Specifically your Capability Statement shall, (a) describe your awareness and understanding of problems associated with the analysis of bulk drug substances and clinical dosage forms; (b) discuss proposed approaches to the resolution of such problems; (c) discuss approaches to analytical method development of drug substance; describing two (2) representative examples for drug substances that are technically challenging; (d) discuss approaches to the definitive structural elucidation of a drug substance; describing two (2) representative examples for drug substances of high structural complexity; and (e) indicate the systems/procedures to be used to ensure that the various activities will be scheduled according to their priority. 4. The proposed Personnel shall demonstrate that your organization has the necessary expertise to perform the requirements of the project. Capability Statements must demonstrate that the personnel experience stated in the Capability Statement occurred in conjunction with projects comparable in size and complexity. The proposed Principal Investigator (PI) must be thoroughly familiar with the analysis of bulk pharmaceutical substances and clinical dosage forms. It is recommended that the PI commit not less than 50% of his/her time to this project. The PI must be trained in Chemistry (Analytical, Pharmaceutical, Organic, etc.), preferably at the Ph.D. level from an accredited school. The PI must have at least three (3) years of recent experience in the analysis of drug substances and drug products. If not trained at the Ph.D. level, the PI must have at least a Master?s Degree with a minimum of five (5) years of recent experience in the analysis of drug substances. He/she should also have three (3) years of recent experience in the analysis of clinical dosage forms. A Principal Assistant (PA) must also be assigned to this project. The PA must be an individual of extensive, relevant analytical experience capable of independently supervising and coordinating the actual laboratory work. Describe background training, recent experience and accomplishments that qualify the individual to lead this project. A clear, specific plan must be presented whereby either the Principal Investigator or the Principal Assistant will be on the job managing the project every day of the contract and available for consultation with the Government Project Officer. Although neither the PI nor the PA are required to be committed full-time to this project, it is essential that one of them be on the job every working day. It is recommended that all other professional staff members commit 100% of their time to this project. Describe the background, training, recent experience and accomplishments that qualify each individual to perform in their area of responsibility. For information purposes, it is estimated that 8,438 direct labor hours of effort will be required on a yearly basis. 5. The Capability Statement shall provide evidence of having all necessary equipment and instrumentation for all aspects of the analytical assessment of bulk drug substances and formulated drug products. The facility shall be equipped with refrigeration and deep freeze storage for the analytical samples and reference materials and shall have a dry box and fume hoods for the proper handling of materials. The Government will not be providing equipment for use on this project; therefore, the contractor shall provide evidence that the equipment and instrumentation identified in this draft SOW shall be accessible and available for immediate use on this project. 6. The Related Experience of the Company must clearly address the capability of the organization to meet the above requirements. Documentation of this experience must include examples of relevant recent experience providing analysis of bulk drug substances and formulated drug products with Government or non-Government agencies. Clearly describe related work within the past two (2) years (of offeror and subcontractors, if any) showing contract number, name of respective contractor's program manager, client name, brief description of work, start and completion dates and approximate funding and contract value, and names and phone numbers of individuals who may be contacted as references for work that is cited. NCI intends to contact these references and to use that information in the evaluation of the Capability Statement. Documented company/organizational experience in the following must also be addressed: (a) experience providing the full range of services outlined in the draft SOW for projects of the same/similar size and magnitude as outline in the draft SOW; (b) providing services related to the analysis of bulk drug substances and clinical dosage forms of the same/similar size and magnitude as outline in the draft SOW; and (c) capability of managing projects efficiently and resolving problems quickly. A copy of the draft Statement of Work (SOW) and Technical Proposal Instructions pertaining to this requirement, which are subject to revisions, may be accessed on the NCI Office of Acquisitions External Website at URL: http://rcb.nci.nih.gov/ Once there, click on Current Requests for Proposals. Under the section entitled Sources Sought, click on number SS-NCI-TSB-2007-1 entitled, "Analysis of Anti-Cancer Chemicals and Pharmaceutical Formulations." Interested parties are expected to review this notice and the draft documents to familiarize yourself with the requirements of this project; failure to do so will be at your firm's own risk. 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 and in the draft SOW. All proprietary information should be marked as such. Responses will be reviewed only by NIH personnel and will be held in a confidential manner. In the event an RFP is issued, North American Industry Classification System (NAICS) code 541710 with a size standard of 500 employees is being contemplated. Capability statements are due no later than 3:00 p.m. eastern prevailing time on November 13, 2006. Please submit one (1) original and three (3) copies of your response to: C. Timothy Crilley, Contracting Officer, Treatment and Support Branch, Office of Acquisitions, National Cancer Institute at Frederick, P.O. Box B, 244 Miller Drive, Room 116A, Fort Detrick, Frederick, Maryland 21702-1201. If courier service is used, the address is the same except delete P.O. Box B, 244 Miller Drive, Room 116A and replace with Building 244, Room 116A. Facsimile responses will not be accepted. Electronic responses, via e-mail, may be sent to tcrilley@mail.nih.gov. Electronic submissions must be in WordPerfect or Microsoft Word. All responses, including electronic responses, must be received at NCI by the specified due date and time in order to be considered. 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. Point of Contacts C. Timothy Crilley, Contracting Officer, Phone (301) 228-4224, Email tcrilley@mail.nih.gov - Robin M. Irving, Contracting Officer, Phone (301) 228-4220, Email irvingr@mail.nih.gov
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