SPECIAL NOTICE
A -- Clinical Products Distribution Center - DAIT
- Notice Date
- 8/12/2003
- Notice Type
- Special Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Contract Management Branch 6700 B Rockledge Room 2230 MSC7612, Bethesda, MD, 20892-7605
- ZIP Code
- 20892-7605
- Solicitation Number
- Reference-Number-SS-NIH-NIAID-DAIT-04-45
- Response Due
- 8/26/2003
- Archive Date
- 8/27/2003
- Point of Contact
- Barbara Shadrick, Senior Contracting Officer, Phone 301-496-7288, Fax 301-480-5253,
- E-Mail Address
-
bs92y@nih.gov
- Description
- The Division of Allergy, Immunology and Transplantation (DAIT), of the National Institute of Allergy and Infectious Diseases (NIAID), of the National Institutes of Health (NIH), plans, sponsors and directs national and international extramural research programs in basic immunology, asthma and allergic and immunologic diseases. Through these programs, DAIT-supported investigators conduct basic, pre-clinical and clinical investigations into the causes, diagnosis, prevention and treatment of a broad range of immune-mediated disorders. DAIT is seeking capability statements from organizations capable of providing clinical product distribution services to DAIT?s clinical research programs. 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 CAPABILITIES RECEIVED FROM THIS SOURCES SOUGHT THIS ACQUISITION MAY BE SOLICITED AS AN 8(a) SET-ASIDE; 100% SMALL BUSINESS SET-ASIDE OR AS FULL AND OPEN. ALL SIZE ORGANIZATIONS ARE ENCOURAGED TO RESPOND. THE NAICS CODE IS 541710 WITH A SIZE STANDARD OF 500 EMPLOYEES. The support to be provided under this contract will provide the services required to obtain, store and deliver investigational agents used in clinical trials performed by the Immune Tolerance Network (ITN) and provide a central location to receive, store, repackage, label and distribute study products in accordance with Federal regulations governing investigational agents. The work to be performed under this contract is currently being carried out by the Eminent Services Corporation, under a subcontract to The EMMES Corporation under contract N01-AI-95382. We are seeking to absolve the subcontracting arrangement by soliciting this activity to be awarded as a new contract. Work to be performed includes: 1) purchase study products; 2) receive and store study products; 3) label and package study products; 4) ship and distribute study products; 5) provide inventory control and quality assurance; 6) provide pharmaceutical services; 7) develop and implement security and safety measures for the storage of study products; 8) process and dispose of returned drugs; 9) maintain a dedicated computerized tracking system for the range of product inventory services; and 10) facilitate an orderly transition to a subsequent contractor. For purposes of determining your related capabilities, you may assume: 1) the ITN may have as many as 20 active studies at any given time and that the number of clinical sites will range from 1 to10 per study, with as many as 5 to 8 of these sites located in Canada and Europe; 2) an estimate that as many as 5 different study products per year will require repackaging or labeling; 3) an estimate that as many as many as 5 different study products per year will require auxiliary labeling. All capability statements will be evaluated against related ability and experience for providing support for receipt, storage and inventory maintenance of domestic and international shipping of clinical trial study products; available qualified personnel; organizational background and experience and documented availability of facility, equipment and other required resources to be dedicated to this project. It is anticipated that this contract will be for a 7-year period of performance and require an estimated 2 to 3 FTEs with expertise consistent with the operations of a project of this size and complexity. All interested organizations should submit two (2) copies of their capability statement addressing each of the areas cited above. Please respond as directed by Government-Wide Numbered Note 25 which states: ?Information submitted should be pertinent and specific in the technical area under consideration, on each of the following qualifications: (1) Experience: An outline of previous projects, specific work previously performed or being performed and any in-house research and development effort; (2) Personnel: Name, professional qualifications and specific experience of scientist, engineers and technical personnel who may be assigned as a principal investigator and/or project officer; (3) Facilities: Availability and description of special facilities required to perform in the technical areas under consideration. A statement regarding industry security clearance. Any other specific and pertinent information as pertains to this particular area of procurement that would enhance our consideration and evaluation of the information submitted.? In addition, in accordance with Government-Wide Numbered Note 26, ?Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons may identify to the contracting officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice.? No collect calls will be accepted. No facsimile transmissions will be accepted.
- Record
- SN00398388-W 20030814/030812213324 (fbodaily.com)
- Source
-
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