SOURCES SOUGHT
A -- NIAID PRECLINICAL DEVELOPMENT SUPPORT
- Notice Date
- 7/12/2010
- 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 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-1118
- Archive Date
- 8/10/2010
- Point of Contact
- Kishan Patel, Phone: 3014960612, Michelle L Scala, Phone: 301-496-0612
- E-Mail Address
-
patelki@niaid.nih.gov, mscala@niaid.nih.gov
(patelki@niaid.nih.gov, mscala@niaid.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought Notice Information Type of Requirement 0 New Requirement 1 Re-competition (Contract No.:N01-AI-40045) 0 Expansion of (Contract/RFP No.:______________) Place of Performance 1 Place of performance is unknown at this time 0 Place of performance is known Recompetition (if applicable) Advanced BioScience Laboratories, Inc. 5510 Nicholson Lane Kensington, MD 20895 Contracting Office Address Department of Health and Human Services National Institutes of Health National Institute of Allergy and Infectious Diseases Office of Acquisitions 6700-B Rockledge Drive, Room 3214, MSC 7612 Bethesda, MD, 20892-7612 General Information Document Type: Sources Sought Notice Solicitation/Reference Number: HHS-NIH-NIAID(AI)-SBSS-1118 Posted Date: 07/12/2010 Original Response Date: 07/26/2010 Current Response Date: 07/26/2010 Original Archive Date: Current Archive Date: Classification Code: A -- Research & Development NAICS Code: 541712-Research and Development in the Physical, Engineering and Life Sciences 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; women-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. Background The development of vaccines to prevent the spread of HIV infection is among the National Institute of Allergy and Infectious Diseases (NIAID) highest priorities. In addition, vaccines administered to infected individuals have potential for inducing immune control of the infectious agent. While advances in immunology and molecular biology continue to offer an expanding array of approaches for the development of new vaccines/products, there is limited capacity to move promising concepts through the development process. In order to supplement limited industry involvement in developing vaccines, NIAID requires a nontraditional, proactive and developmentally-oriented program to provide preclinical development support for promising products when such products emerge from investigator-initiated research studies. NIAID will use this contract to more rapidly and efficiently close development and production gaps. We anticipate awarding an Indefinite Delivery Indefinite Quantity (IDIQ) contract to one organization that meets the overall qualifications needed to fulfill the technical requirements of the solicitation, providing a guaranteed minimum award. Task orders for specific tasks requiring specialized expertise will be issued after the award of the base contract. This is a recompetition of an existing contract entitled "Master Contract for Preclinical Development" with Advanced BioScience Laboratory, Inc., under contract number N01-AI-40045. Purpose and Objectives The Contractor shall provide preclinical development support for promising candidates when such candidates emerge from investigator-initiated research studies. These capabilities will allow NIAID to more rapidly and efficiently close development and production gaps. The Contractor shall assist NIAID staff in providing all support needed for small-scale production, preclinical testing and documentation leading to Investigational New Drug (IND) submission for Phase I, II, and III clinical testing. Project Requirements The Contractor will manage a preclinical research program that shall provide NIAID with a broad and flexible range of nontraditional, proactive and developmentally-oriented capabilities to provide preclinical development support for promising products when such products emerge from investigator-initiated research studies. The Contractor will assist in identification, testing, and development of products; participate in and manage preclinical testing including in vitro laboratory testing, immunogenicity testing, efficacy studies, and toxicology testing using laboratory animals; and utilize GMP production protocols to produce products. Furthermore, the Contractor will also maintain inventories of products, provide quality assurance and quality control, provide the appropriate regulatory documentation, and develop and manage a database that tracks the preclinical development of the products. The Contractor will carry out, either directly or through subcontractors and/or consultants, tasks in the following areas: 1. Essential Core Activities: This task area includes essential activities that shall be performed by the Contractor on a regular basis and consists of the following: a. Project Management b. Quality Assurance/Quality Control c. Information Technology and Data Management d. Storage and Shipping e. Reporting Requirements/Deliverables f. Transition 2. Feasibility Assessments: Under this task area, the Contractor shall assess products for feasibility of design, development, manufacture, potency assay development and stability for the development of phase I-III clinical trial materials. 3. Audits: Under this task area the Contractor shall conduct, review and evaluate audits. Types of audits to be conducted include, but are not limited to, technical and/or facilities audits. 4. Regulatory Documentation: Under this task area, for products produced and/or tested for use in NIAID-sponsored research, in collaboration with the product supplier, the Contractor shall develop a Master File, Investigator's Brochure, and compile an IND application, including a clinical trial protocol (provided by NIAID) appropriate for submission to the U.S. Food and Drug Administration (FDA). [Guidance on regulatory requirements can be obtained through the FDA Center for Biologics Evaluation and Research website (www.fda.gov/cber).] 5. Process Development and cGMP Manufacture: Under this task area the Contractor shall produce vaccines and research-grade products as requested by the COTR, including process development and production of cGMP pilot lots suitable for early phase human clinical trials, and perform the necessary characterization tests required for release for clinical use. 6. Safety and Immunogenicity Testing: Under this task area the Contractor shall perform pre-clinical testing of products as required for regulatory compliance prior to initial human clinical trial evaluation. Anticipated Period of Performance The anticipated period of performance is for seven years beginning August 29, 2011 through August 28, 2018. Capability Statement/Information Sought Capability Statements should clearly convey information regarding the respondent's capabilities, including: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. Interested contractors must submit a capability statement (five page limitation, excluding resumes) describing their company's experience and ability to perform this effort that includes the following: (1) a summary list of similar work previously performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) resumes for proposed key personnel, including the Principal Investigator, that reflect education, and previous work relevant to the proposed requirement; (4) a general description of the facilities and other resources needed to perform the work; and (5) demonstrated ability to carry out the work. Each response should include the following Business Information: a. DUNS number b. Company Name c. Company Address d. Company Points of Contact (both technical and administrative), including names, titles, addresses, telephone and fax numbers and Email addresses e. Current GSA Schedule appropriate to this Sources Sought f. Do you have a Government-approved accounting system? If so, please identify the agency that approved the system. g. Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the Central Contractor Registration (CCR). All offerors must be registered in the CCR, located at http://www.ccr.gov/ Teaming Arrangements: All teaming arrangements should also include the above-cited information and certification for each entity on the proposed team. Teaming arrangements are encouraged. NIAID recognizes that no single organization or institution may have the expertise and facilities required to perform all of the tasks mentioned above. Therefore, the Contractor may need to utilize the expertise and resources of subcontractors and specialized consultants to provide the full spectrum of requested activities. The Contractor shall be responsible for ALL work performed under this contract including that performed by any subcontractors and consultants. The Contractor will ensure that any and all processes meet international, federal, local and state regulations to ensure the continuity and validity of the resulting product. Responses must be submitted no later than July 26, 2010. Capability statements will not be returned and will not be accepted after the due date. These statements may be submitted by e-mail or paper copy to Kishan Patel, Contract Specialist. He can be emailed at the address provided below. Electronic submissions should be submitted in PDF format, however, Microsoft Word or Corel WordPerfect will be accepted. In the subject line, please reference: HHS-NIH-NIAID (AI)-SBSS-1118. A paper copy can be sent via regular mail at the address provided below. If sending a paper copy, please send an original and one copy.   Kishan Patel Contract Specialist Office of Acquisitions National Institute of Allergy and Infectious Diseases National Institutes of Health 6700 B Rockledge Drive, Room 3214, MSC 7612 Bethesda, Maryland 20892-7612 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 presolicitation synopsis and solicitation may be published in the Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The Government will not entertain questions regarding this Market Research; however, general questions may be emailed to the following addresses: Contract Specialist: Kishan Patel Email Address: patelki@niaid.nih.gov Contracting Officer: Michelle L. Scala Email Address: mscala@niaid.nih.gov 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.
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