SPECIAL NOTICE
A -- Administrative Support Contract for DAIT Clinical Research Programs
- 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-04-43
- 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 technical and administrative support to DAIT?s clinical research programs including the Immune Tolerance Network (ITN), the Autoimmunity Centers of Excellence (ACEs), the Cooperative Clinical Trials in Pediatric and Adult Kidney Transplantation (CCTPT and CCTAT), the Inner-City Asthma Consortium (ICAC), and the Stem Cell Transplantation Consortium (SCTC). 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. This contract will support all regulatory activities of the DAIT clinical research programs, providing day-to-day management of the regulatory activities of the ITN and assisting with the regulatory responsibilities of other DAIT clinical research programs. DAIT and its clinical networks interact in a complex research environment composed of, but not limited to: clinical investigators and their institutions; statistical and data analysis centers; coordinating centers; the U.S. Food and Drug Administration (FDA); DHHS Office for Human Research Protections (OHRP); non-U.S. regulatory agencies; pharmaceutical companies; local and national Institutional Review Boards/Ethics Committees (IRBs/ECs); and NIH scientific and administrative personnel. This contract will be managed by the DAIT Office of Clinical Applications, which is responsible for site monitoring and regulatory activities associated with clinical trials in organ and islet transplantation, autoimmune diseases, and asthma and allergic diseases. The work to be performed under this contract is currently being carried out by Consolidated Safety Services, Inc., 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 providing: 1) pre-meeting planning and services; 2) on-site meeting and conference services; 3) post-meeting/conference services; 4) mailing lists; 5) conference call service; 4) administrative support for the DAIT Data and Safety Monitoring Boards; 5) general and regulatory management and administrative support; and 6) an orderly transition to a new contractor at the completion of this contract. For purposes of determining your related capabilities, you must assure that your facility or satellite office is located near the NIH Community (Bethesda, Rockville, Maryland) and if not in the preferred proximity, submit a plan to demonstrate how the necessary day-to-day interactions and functions will be carried out at a distance. You may assume: 1) approximately 2 scientific/investigator meetings or conferences will be held per year ranging from 10 to 30 participants; 1 to 2 days; require hotel accommodations and on-site meeting/conference support and support travel and per diem of 8 to 10 participants per meeting, all in the Washington, D.C. metropolitan area; 2) you will assist in the preparation of a minimum of 20 protocols (new and ongoing) and 10 protocol amendments per year; and 3) you will support 4 to 6 conference calls per week with each call having 2 to 10 participants and last 1 to 2 hours. All capability statements will be evaluated against related ability and experience for providing administrative support of this type and magnitude, adequacy of administrative framework; available qualified personnel; corporate experience and existing facilities and resources. It is anticipated that this contract will be for a 7-year period of performance and require an estimated 4 to 5 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
- SN00398389-W 20030814/030812213325 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |