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 regulatory support 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 the resultant contract will enable DAIT to fulfill its responsibilities as a sponsor of a large portfolio of clinical trials, some of which are conducted under DAIT-held investigational new drug applications (INDs) with some of the trials conducted at sites in Canada and Europe. This contract will support all regulatory activities of the DAIT clinical research programs, provide day-to-day management of the regulatory activities of the Immune Tolerance Network (ITN) and assist with the regulatory responsibilities 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 of 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 McKesson BioServices 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) Prepare, distribute, track, and archive Investigational New Drug Applications (INDs) and all amendments for INDs sponsored by NIAID, ITN clinical investigators, and, when appropriate, pharmaceutical companies; 2) Establish and maintain an electronic tracking system for the reporting and disposition of adverse events for all ITN clinical trials; 3) Develop and maintain an electronic clinical site registration system for ITN clinical trials; 4) Provide administrative support for regulatory affairs and Good Clinical Practice (GCP) compliance activities for all DAIT sponsored clinical trials; 5) Provide logistical services for DAIT sponsored clinical trials; and 6) 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 to 10 per study, with as many as 5 to 8 of these sites located in Canada and Europe; 2) other DAIT clinical programs may have as many as 4 to 5 active studies per program at any given time and the number of clinical sites will range from 3 to 20 and are U.S. based; 3) the ITN will initiate 5 to 6 new studies per year, including 2 to 3 original submissions (new INDs) and 2 to 3 studies to be conducted under existing INDs; and 4) there may be 7 to 12 Autoimmunity Centers of Excellence (ACE) clinical sites; 5 to 10 Stem Cell Transplantation Consortium (SCTC) sites; 20 to 30 Cooperative Clinical Trials in Pediatric and Adult Kidney Transplantation (CCTPT and CCTAT) sites; and 10 Inner-City Asthma Consortium (ICAC) sites. All capability statements will be evaluated against related ability and experience for providing support for regulatory affairs, the administrative/management framework, available qualified personnel 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.
