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A -- Synthesis of Therapeutic Agents for Treatment of Infectious Diseases

Notice Date
Notice Type
Sources Sought
541710 — Research and Development in the Physical, Engineering, and Life Sciences
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, MD, 20892-7612, UNITED STATES
ZIP Code
Solicitation Number
Response Due
Archive Date
This notice is for information and planning purposes only. This is not a request for proposals and does not commit the Government to award a contract now or in the future. No solicitation is available at this time. Based on capability statements received from this sources sought notice, this acquisition may be solicited as a 100% small business set-aside or as full and open. All small business organizations (small business, small disadvantaged business, women-owned small business, HUB Zone small business, veteran-owned small business, small disadvantaged veteran-owned small business) are encouraged to respond to this notice. The NAICS code is 541710 with a size standard of 500 employees. The National Institute of Allergy and Infectious Diseases (NIAID) is seeking qualified small businesses that have the relevant experience and knowledge, and have the available resources to provide organic synthesis of promising microbicides and compounds for the treatment of HIV, opportunistic infections including tuberculosis, and other infectious diseases of relevance to the research agenda of NIAID. It is mandatory that the Contractor be able to synthesize chemicals, in compliance with FDA?s current Good Manufacturing Practice (cGMP) regulations in quantities needed for testing in either in vitro screens, animals, or early Phase I clinical studies. It is anticipated that one (1) completion type contract will be awarded for a period of seven (7) years. It is estimated that six (6) full time equivalents (FTE) will be required on a yearly basis. This contract is intended to provide synthesis of therapeutic reagents on small- and large-scale amounts. Contractor support shall be provided in the following major areas: 1. Synthesis of compounds on a small-scale 2. Synthesis of compounds on a large-scale 3. Scientific and Technical Support 4. Facilities, equipment, and other resources 5. Project Management SERVICES REQUIRED This Sources Sought notice is seeking small businesses that possess relevant experience and knowledge in organic synthesis of therapeutic reagents. The Contractor shall be capable of providing the services described below. SYNTHESIS OF COMPOUNDS ON A SMALL AND LARGE SCALE ? The Contractor shall: 1) Synthesize small-scale (0.01 ? 10g/batch) target compounds. 2) Synthesize 10-1000 g batches of target compounds. 3) Comply with all relevant Federal, State, and local health and safety guidelines and regulations. 4) Provide a summary of the synthetic process including scheme, all materials used and amount, overall yield, solubility, etc.; an analytical data sheet that includes infrared, NMR, and ultraviolet-visible spectra, melting point, elemental analysis, and when requested, MS and/or NMR; and a material safety data sheet as required by the Occupational Safety and Health Administration; and 5) Be registered with the United States FDA as a manufacturer of bulk drugs. SCIENTIFIC AND TECHNICAL SUPPORT - The Contractor shall provide personnel with: 1) Expertise and experience in organic synthesis, purification, and identification of intermediate and target compounds; 2) Capabilities to generate and interpret spectroscopic data; 3) Ability to comply with Federal, state and local regulations and guidelines regarding safety and the handling of chemicals; and 4) Competency in literature searching. FACILITIES, EQUIPMENT, AND OTHER RESOURCES - The Contractor shall have facilities, equipment, and resources to support contract performance. 1) Adequate, suitable, and available laboratory space for the conduct of synthesis activities, in accordance with the current cGMP guidelines; 2) On-site access to the following equipment: infrared spectrometer, UV-VIS spectrometer, low field proton NMR, and analytical HPLC.; 3) Access to library resources including internet search capability; 4) Dedicated space for staff and equipment; and 5) Controlled access areas for safe and secure storage of chemicals, data and confidential data. PROJECT MANAGEMENT - The Contractor shall establish and manage an organizational structure to support contract performance. Specifically, the Contractor shall: 1) Ensure that Contractor staff are available to meet with the Project Officer or his/her designees at the offices of NIAID in Bethesda, Maryland; 2) Ensure senior staff have adequate experience and qualifications to manage multiple projects simultaneously; 3) Willingness to prioritize Government projects within the organization?s overall scheduling framework; 4) Establish electronic communication to support the submission of data files and reports; and 5) Ability to maintain confidentiality of data. CAPABILITY STATEMENT REQUIREMENTS: Interested small businesses must be able to demonstrate in the capability statement the experience and ability to perform work described in this notice. This documentation may include examples of contracts, references, and any other relevant information. In order to be deemed capable, small business organizations should submit capability statements that include: 1) Demonstrated experience with contracts of similar size and scope to this proposed effort. Contract projects listed may include those entered into by the US Federal Government, agencies of state or local governments, for-profit and non-profit entities; 2) Proposed key personnel that demonstrate that your organization has the necessary expertise to perform the requirements of the project; 3) Sufficient corporate qualifications needed to perform the requirements of the project; and 4) A statement identifying the offeror as a small business firm. Any organization responding to this SOURCES SOUGHT notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization?s qualifications to perform this work. Written capability statements must be received no later than March 30, 2007 by 4:00 p.m. (EST time). These submissions must be submitted by E-mail or paper copy to Ms. Anita Hughes, Contract Specialist. She can be emailed at anhughes@niaid.nih.gov. Electronic submissions should be submitted in PDF format, however, Microsoft Word or Corel WordPerfect will be accepted. In the Subject line Reference: NIH-NIAID-DAIDS-08-19. A paper copy can be sent via regular mail at the address provided below. All inquiries concerning this announcement shall be directed to Ms. Anita Hughes or Ms. Eileen Webster-Cissel (telephone number 301-496-0612). Mailing address: National Institutes of Health, National Institutes of Allergies and Infectious Diseases, ATTN: Anita Hughes, Office of Acquisitions, Room 3214, MSC 7612 6700-B Rockledge Drive Bethesda, Maryland 20892
SN01251723-W 20070317/070315220552 (fbodaily.com)
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