SOURCES SOUGHT
A -- NIAID Division of Allergy, Immunology and Transplantation: Clinical Products Center
- Notice Date
- 5/24/2010
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 6700 B Rockledge Room 3214 MSC7612, Bethesda, Maryland, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- HHS-NIH-NIAID(AI)-SBSS-10-094
- Archive Date
- 6/11/2010
- Point of Contact
- Deborah J Blyveis, Phone: 301-594-7211, David T Lisle, Phone: 301-451-2617
- E-Mail Address
-
blyveisd@niaid.nih.gov, dlisle@niaid.nih.gov
(blyveisd@niaid.nih.gov, dlisle@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Introduction 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 NAICS CODE IS 541711 WITH A SIZE STANDARD OF 500 EMPLOYEES. Description Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to better understand, treat, and ultimately prevent immunologic, infectious, and allergic diseases. The NIAID Division of Allergy, Immunology, and Transplantation (DAIT) supports extramural basic, pre-clinical and clinical research focusing on immune-mediated diseases through a variety of research grants and contracts. This includes support for clinical research programs and individual research projects to evaluate the safety and efficacy of therapeutic and preventive approaches and agents and to elucidate the underlying mechanisms of such approaches and agents. DAIT's largest clinical research program, the Collaborative Network for Clinical Research on Immune Tolerance (hereinafter referred to as the ITN), is carried out under a contract to the University of California, San Francisco. Established in FY 1999, a critical component of the ITN's mission involves the design and conduct of Phase I-IV clinical trials of investigational approaches intended to lead to a functional state of immune tolerance in three clinical areas: autoimmune diseases; asthma and allergic diseases; and immune-mediated rejection of transplanted solid organs, tissues and cells. In FY 2004, a separate, 7-year contract was awarded to Eminent Services Corporation in Frederick, Maryland to establish the "Clinical Products Distribution Center" (Contract No. HHSN266200400090C). This contract provides DAIT with centralized services for the receipt, storage, packaging/repackaging, manufacture of placebo, preparation of serial dilutions, labeling, distribution, inventory and disposal of study products for clinical trials conducted by the ITN. Under this contract, services have been provided for 10 ITN clinical trials per year involving approximately 35 study products per year. The purpose of this contract is to continue these services for the ITN and expand the scope of services provided to include DAIT-supported, investigator-initiated clinical trials conducted under cooperative agreement grants, as well as other DAIT-funded clinical research programs on a limited, as-needed basis. It is anticipated that a level of effort type contract will be awarded. The Government estimates the effort to perform the base requirements of the Statement of Work (Year 1 and Option 1 - additional Years 2 through 7) to be approximately 2.0 full time equivalents (FTEs) per year. Additionally, the anticipated contract award will contain options for increased levels of effort in increments of 10% over the base requirement which can be exercised up to 10 times per contract year. An option for electronic data submission to an internal DAIT-wide system will be included as well. The Government estimates a 10% increase in the total level of effort for this optional activity during the applicable 6-month period. An option for study product validation and identity testing will also be included. The Government estimated a one-time, 12-month 10% increase in the total level of effort for this option. Potential sources must demonstrate and document the following in their capability statements: The Contractor shall establish and manage the Clinical Products Center (CPC) to provide support for clinical research programs and individual research projects, to include the following: 1. establish, operate, manage, and maintain a system for the receipt, storage, inventory, packaging/repackaging, quality assurance, distribution and disposal of study products for clinical trials conducted by the ITN and by other DAIT-support clinical research programs and projects, including: (i) receipt and storage of study products; (ii) inventory control and quality assurance; (iii) manufacture of placebo and preparation of serial dilutions; (iv) shipment and distribution of study products; (v) pharmaceutical services; (vi) the provision of security/safety procedures; (vii) processing and disposal of returned clinical products; (viii) the development and implementation of Standard Operating Procedures; and (ix) compliance with audits by Regulatory Health Authorities and independent audits by DAIT-designated entities. 2. operate, manage, maintain and update a centralized CPC Data Management and Reporting System. 3. coordinate and collaborate with other DAIT clinical research support contractors. develop and implement of a Quality Assurance/Quality Control Plan Capability statements submitted as a result of this announcement should demonstrate the offerors' qualifications and experience, specifically providing evidence as to their capability to perform this requirement, with particular attention to the following: Personnel/Management: adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity. Past Performance: Past performance is considered essential. In addition to demonstrating that they have met the above qualifications, interested parties must identify at least three other projects of similar size and complexity. All capable small business organizations are encouraged to submit capability statements based on this announcement. Interested organizations should submit two copies of their capability statement addressing each of the areas cited above. Written capability statements should be received by the Contracting Officer by June 10, 2010. Please reference the solicitation number on all related correspondence. No collect calls will be accepted. Facsimile and e-mail transmissions will be accepted. 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).
- Web Link
-
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- Record
- SN02158223-W 20100526/100524234558-83067ad88ffcbb090694a841fb84f634 (fbodaily.com)
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