SOURCES SOUGHT
B -- Centralized Chemopreventive Agent Repository and Chemistry Support
- Notice Date
- 11/23/2010
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 1050, Frederick, Maryland, 21702, United States
- ZIP Code
- 21702
- Solicitation Number
- SS-PCPSB-5003-44
- Point of Contact
- Rukshani Fernnado, Phone: 3014353783, Virginia DeSeau, Phone: 301-435-3978
- E-Mail Address
-
rf212s@nih.gov, vd9t@nih.gov
(rf212s@nih.gov, vd9t@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This Notice is a revision of the Sources Sought Notice previously posted on August 28, 2009 (SS-PCPSB-95003-47) and is intended to provide updated information regarding the requirement. Sources Sought Notice No: SS-PCPSB-5003-44 Title: "Centralized Chemopreventive Agent Repository and Chemistry Support" The Division of Cancer Prevention (DCP) of the National Cancer Institute (NCI) is planning to award a contract for a centralized chemopreventive agent repository with multiple functions and duties. This Small Business Sources Sought notice (SBSS) is for informational 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 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. This requirement is assigned a code of 541690 in the North American Industry Classification System (NAICS), and the size standard for such requirements is $7 million average annual receipts. The purpose of the acquisition is to continue a well-established Repository program. The contract awardee is to maintain a centralized source of agents and development services necessary to support chemoprevention studies. The repository provides important logistic organization for the acquisition, tracking, storage, maintenance, testing, quality control, and distribution of investigational agents to be used in animal and human studies of chemoprevention. Project Requirements: 1) The Core Competencies required include agent receiving, specification setting, cost estimation, analytical testing, material acceptance and release, packaging and labeling, stability testing, proper environmental storage, shipping domestically and abroad, inventory tracking of clinical trial materials, agent returns and destruction or disposal of investigational agents and clinical study supplies. All information to support regulatory filings to health authorities, scientific reports for research documentation and manuscript publication will be maintained by the contractor and provided to DCP, when requested. If the contract requires specialty [subcontracted] services for the timely development of agents identified through DCP programs (e.g., the DCP RAPID program), a well-organized and effective subcontracting administrative unit will be needed. 2) An offeror's facility must have sufficient space for: storage of pre-clinical agents (estimated at 5,000 sq. ft. of useable space); storage of clinical study supplies (estimated at an additional 5,000 sq. ft. of useable space); a staging/quarantine area; separate shipping and receiving rooms; and, space devoted to an analytical chemistry unit (estimated at an additional 5,000 sq. ft.) with a detached weighing area. The space must include areas for refrigerated and other environmentally-controlled storage conditions (e.g., light protection, humidity controlled cabinets - estimated at approximately 500 sq. ft.). A estimate total of 15,500 sq ft useable space will be needed. 3) A comprehensive and continuously updated computerized logistics management system containing inventory movements, quantities on hand, expiration or re-test information, Certificates of Analysis and analytical testing results on all materials must be made available electronically to the Project Officer/Contracting Officer's Technical Representative on demand through a secure, password-protected, DCP-dedicated server. 4) The Contractor will be required to demonstrate experience and competency in domestic and international shipping of pharmaceuticals, especially through U.S. and foreign Customs, the FDA, and other health authorities in accordance with applicable regulations. The Contractor must have experience in obtaining a Quality Persons Determination for agents shipped into the European Union. Capability Statement/ Information Sought: Small businesses that believe that they have the ability to satisfy all of the above stated Project Requirements, and who meet the stated size standards, are encouraged to submit a capability statement. On the first page of the capability statement, clearly state the small business concern's size status and type(s), name, address, point of contact, and DUNS number. To be deemed capable, the offeror must submit a written capability statement based on the Project Requirements and the current in-house capacity to perform the work and must demonstrate that similar work has been performed in the past, including the dollar value of that work. Organizations that submit capability statements in response to this notice will be evaluated against the following technical areas of experience and expertise: 1. Technical Approach a. Demonstration of an understanding of the needs of the project and an understanding of Repository operations b. Demonstration of an understanding of preclinical and clinical study support needs c. Experience in delivery of biological materials and laboratory services d. Experience in inventory management and quality control procedures e. Demonstration of experience in or an understanding of compound acquisition f. Standard Operating Procedures for task areas in place 2. Personnel The Offeror shall document staff experience to conduct this work. It should be clear to the reviewers how the respective education, training and expertise of the offeror's proposed staff relate to the needs of the project. 3. Facilities The Offeror shall document the availability of adequate facilities with proper equipment to include: a. Compliance with all fire and safety requirements required by the state, county, and municipality in which the site is located b. Inert gas fire suppression system c. Alarmed and secure storage areas d. Separate office, pre-clinical, clinical, laboratory, quarantine, storage and shipping/receiving areas e. Adequate analytical instrumentation installed and operational 4. Organizational Experience The Offeror shall document the organizational experience needed to accomplish the Project Requirements. Anticipated Period of Performance: The anticipated period of performance is for five years starting about July 2011. Information Submission Instructions: Capability statements should not exceed twenty (20), single-sided pages (including all attachments, e.g., resumes, charts, etc.), presented in single-spaced, 12-point font size minimum. All capability statements sent in response to this SMALL BUSINESS SOURCES SOUGHT notice must be submitted electronically (via e-mail) to Rukshani Fernando, Contracting Officer Representative at rf212s@nih.gov in either MS Word, WordPerfect, or Adobe Portable Document Format (PDF), by December 13, 2010 at 3:00 PM (EST). All responses must be received by the specified due date and time in order to be considered. ANY RESPONSES RECEIVED AFTER THAT 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 determination will be made as to whether the project will or will not be set-aside for small businesses. At a later date, a pre-solicitation synopsis and solicitation [Request for Proposal (RFP)] may be published in Federal Business Opportunities (http://fbo.gov). 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. Primary Point of Contact: Rukshani Fernando Contracting Officer Representative National Cancer Institute, NIH E-mail: rf212s@nih.gov Phone: (301) 435-3783 Fax: (301) 402-8579
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF/SS-PCPSB-5003-44/listing.html)
- Record
- SN02332884-W 20101125/101123234456-5aa977a3f33c4877d0d2b72370d99b6a (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |