National Institutes of Health, National Institute of Allergy and Infectious Diseases, Contract Management Branch, Solar Bldg., Room 3C07, 6003 Executive Blvd. MSC 7610, Bethesda, MD 20892-7610

A -- NIAID CLINICAL RESEARCH PRODUCTS MANAGEMENT CENTER POC Mr. Bruce E. Anderson, Contracting Officer, 301-496-8371, Email Address ba9i@nih.gov, Fax # 301-402-0972 The National Institute of Allergy and Infectious Diseases is seeking SMALL BUSINESS firms (under Standard Industrial Code 8731) with the capability to operate and maintain the NIAID Clinical Research Products Management Center (the CENTER) for investigational agents used in clinical trials sponsored by the Division of AIDS. In 1992, re-competition of the current five year contract was not considered for the small business/8A set-aside program because capability statements from small businesses were solicited (under SIC Code 8731) but none were received. Award was made under full and open competition to a large business concern. Organizations must demonstrate that they meet all applicable Food and Drug Administration Current Good Manufacturing Practice regulations, (Title 21, Code of Federal Regulations, Parts 210 and 211) and hold current distributor's, manufacturing and infectious waste licenses for the locality and/or state and a Drug Enforcement Agency (DEA) license. The CENTER receives shipments ofinvestigational products from domestic, commercial or foreign sources, reconciles shipments with shipping lists, monitors conditions, identifies discrepancies and stores the study products under appropriate storage conditions (controlled room temperature, 2 to 8 degrees Celsius, -20 to -10 degrees Celsius and -80 degrees Celsius). The facility must have a 24 hour monitored security system, fire protection and an emergency generator. The CENTER submits samples of product containers and/or labeling for approval by the DAIDS Quality Assurance Committee; confirms that product requests are from authorized investigators, and then processes orders and appropriately packages items to ensure safe, intact delivery; ships to domestic and foreign sites, keeping records of all transactions; maintains the inventory and monitors the usage rate of investigational study products; packages and labels for patient specific dispensing; maintains distribution records; follows quality assurance measures; in certain cases, purchases the study agent as required; receives and processes recalled, expired or unused products from clinical sites; documents and disposes of returns according to applicable regulations; and maintains a computerized data processing system for inventory and distribution records. It is estimated that, at a minimum, approximately 1,000 orders per month will be processed. Successful operation, management and coordination of the activities of the CENTER require the following demonstrated capabilities: (1) knowledge, recent experience and demonstrated competence in storing, packaging, labeling and distributing pharmaceuticals, biologics and vaccines according to regulations governing investigational agents; (2) available staff who can effectively and efficiently coordinate the operation of the CENTER by interacting with the Division of AIDS, pharmaceutical and biotechnology companies, and with clinical site pharmacists and investigators (it is estimated that the level of effort required will be 7-9 full-time equivalents per year); (3) personnel with recent documented experience in operating a similar facility of comparable size and complexity; the proposed Principal Investigator must be a Registered Pharmacist with clinical trial and hospital pharmacy management experience, licensed in the local jurisdiction; (4) documented experience in maintaining and updating a database system to track all information related to the activities of the CENTER, including receipt, shipping, distribution, inventory, packaging, labeling, purchasing, processing returns, disposal of study products; (5) ability to efficiently and safely move the operation of the present CENTER to a the Contractor's location in one month, and to transfer the CENTER to a new location at the conclusion of this contract; (6) experience in providing pharmaceutical and drug information services; (7) availability of adequate facilities, equipment and resources necessary to operate and maintain the CENTER; facilities to receive and dispose of biohazardous and infectious agents; compliance with all safety standards, guidelines and regulations, including training and monitoring of personnel for exposure to biohazardous and infectious agents; (8) ability to maintain close and effective communications and interactions with the DAIDS/NIH as well as various pharmaceutical and biotechnology companies and clinical trial pharmacists and investigators; this contract will require frequent close communication and interaction between the Contractor and the DAIDS; the Government believes that the ability to meet face-to-face on a weekly and impromptu basis with the DAIDS (at the NIH) is necessary in order to effectively manage this contract; therefore, either the Contractor and the CENTER should be located in the Washington D.C. area, or the company should submit plans demonstrating how the contract can be managed successfully at a distance; the current location of the DAIDS, NIH is at the Solar Building on Executive Boulevard in Rockville, MD; the company should address their location in relation to the DAIDS, NIH, in the capability statement, explaining how their location will enhance performance of this contract. The DAIDS may periodically site visit the CENTER to determine the adequacy of the facilities, resources and condition of research products. The offeror must have a minimum of 12,000 square feet of storage at controlled room temperature, 4,500 cubic feet at 2 to 8 degrees Celsius, 2,000 cubic feet at -20 degrees Celsius and 20 cubic feet at -80 degrees Celsius. The contract period is estimated to be seven (7) years, beginning on or about August 15, 1998, and a cost reimbursement contract is expected to be awarded. The Government must have direct oversight of this contract in order to ensure the appropriate distribution of study products. The Prime contractor is responsible for all work performed under this contract. While subcontracting is permitted, the storage and distribution of products, and the management of the NIAID Clinical Research Products Management Center as described herein must be performed by the Prime contractor; product purchasing, specialized packaging and quality control of study agents, as well as other activities, may be subcontracted. Sources who believe they have the capability necessary to undertake this project should submit complete documentation demonstrating all required capabilities, licenses, facilities, systems and personnel detailed above. At this time, responses are sought from SMALL BUSINESS (under 500 employees -- SIC Code 8731). Five (5) copies of this documentation must be submitted to Mr. Bruce Anderson, Contracting Officer, no later than fourteen (14) calendar days after publication of this document in the Commerce Business Daily. The documentation submitted must be complete to allow evaluation without further discussions. We are not requesting proposals at this time, and responses should not include budgetary information. No collect calls with be accepted. (0171)

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