SOURCES SOUGHT
A -- PREVENT Cancer Preclinical Drug Development Program: Preclinical Services for Biopharmaceutical Product Development and Manufacturing - Draft Statement of Work
- Notice Date
- 7/31/2017
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions-Treatment and Support Branch, Bldg 244, Room 112, Frederick, Maryland, 21702
- ZIP Code
- 21702
- Solicitation Number
- HHS-NIH-NCI-SBSS-TSB-77019-18
- Archive Date
- 8/30/2017
- Point of Contact
- Carrie L. Mills, Phone: 3016241274, Mandie S. White, Phone: 3012284217
- E-Mail Address
-
carrie.mills@nih.gov, whitems@mail.nih.gov
(carrie.mills@nih.gov, whitems@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Draft Statement of Work Small Business Sources Sought Notice PREVENT Cancer Preclinical Drug Development Program: Preclinical Services for Biopharmaceutical Product Development and Manufacturing HHS-NIH-NCI-SBSS-TSB-77019-18 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 there are small businesses; HUBZone small businesses; service-disabled sources, veteran-owned small businesses; 8(a) small businesses; veteran owned small businesses; woman-owned small businesses; or small disadvantaged business; 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. 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 (SOW) to familiarize themselves with the requirement of this project; failure to do so will be at your firm's own risk. Background: 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. Following the external advisory committee's recommendations to expand cancer immunoprevention portfolio, the PREVENT has begun implementing an increasing number of highly meritorious cancer preventive vaccine projects in recent years. As the Program matures, multiple cancer vaccine projects are expected to progress to the late stage of preclinical development, requiring the supply of clinical-grade materials for GLP toxicology and other IND-enabling studies. Purpose: The purpose of this Small Business 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. As a result of this SBSS notice, 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 or the NCI's use of such information as either part of our evaluation process or in developing specification for any subsequent requirement. Project Requirements & Objectives: The overall objective of the current acquisition, designated as the PREVENT Preclinical Services for Biopharmaceutical Product Development and Manufacturing (PREVENT GMP Contract), 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 attached draft Statement of Work. The key objective of the PREVENT GMP Contract is to provide preclinical product development and GMP manufacturing support for candidate cancer preventive vaccines for preclinical and clinical testing. Anticipated Period of Performance: It is anticipated that the award from this solicitation will be an Indefinite Delivery/Indefinite Quantity (IDIQ) contract. Task orders issued under this IDIQ contract are anticipated to be cost-plus-fixed-fee (CPFF) and/or Firm Fixed Price (FFP). The duration of the IDIQ contract(s) will be for a five (5) year period. The anticipated start date is on or about September 2018. If a RFP is issued, the NCI anticipates that up to five IDIQ awards may result from the issuance of the RFP. NAICS Code and Size Standard: In event an RFP is issued, the NAICS code for this acquisition is 541711, Research & Development (R&D) in Biotechnology, which has a size standard of 1,000 employees. Capability Statement/Information Sought: Sources are expected to have the personnel, facilities, equipment and experience to meet the requirements in the attached, draft SOW. Respondents must be qualified and prepare a tailored capability statement that demonstrates a clear understanding of all Focus Areas outlined in the attached, draft Statement of Work. The Capability Statement will be evaluated based on the information provided in relation to the project requirements and the current capability and capacity to: 1) Perform the work outlined in the Focus Area(s) in the attached, draft Statement of Work; 2) Provide appropriate Personnel for the project; 3) Access appropriate resources (e.g., Facilities & Equipment); and 4) Implement appropriate Quality Management programs. 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 Carrie Mills, Contract Specialist at Carrie.Mills@nih.gov in Microsoft Word or Adobe Portable Document Format (PDF). The subject line must specify HHS-NIH-NCI-SBSS-TSB-77019-18. 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 Tuesday August 15, 2017. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. 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 notice 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF2/HHS-NIH-NCI-SBSS-TSB-77019-18/listing.html)
- Place of Performance
- Address: TBD (Contractor's Facility), United States
- Record
- SN04604646-W 20170802/170731231605-4e59e3188dfa199547f85d641484e11e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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