SOLICITATION NOTICE
A -- Regulatory Management Center
- Notice Date
- 11/20/2003
- Notice Type
- Solicitation 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
- NIH-NIAID-DAIT-04-44
- Response Due
- 2/17/2004
- Archive Date
- 3/3/2004
- Point of Contact
- Dominic Reeves, Contract Specialist, Phone 301-496-0612, Fax 301-402-0972, - Barbara Shadrick, Senior Contracting Officer, Phone 301-496-7288, Fax 301-480-5253,
- E-Mail Address
-
DReeves@niaid.nih.gov, bs92y@nih.gov
- Small Business Set-Aside
- Total Small Business
- 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. This solicitation is being issued as a 100% Small Business Set-Aside, NAICS Code 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 who 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 provided under a subcontract to The EMMES Corporation (N01-AI-95382). Work to be performed includes: 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; establish and maintain an electronic tracking system for the reporting and disposition of adverse events for all ITN clinical trials; develop and maintain an electronic clinical site registration system for ITN clinical trials; provide administrative support for regulatory affairs and Good Clinical Practice (GCP) compliance activities for all DAIT sponsored clinical trials; provide logistical services for DAIT sponsored clinical trials; and facilitate an orderly transition to a subsequent contractor. All proposals will be evaluated, at a minimum, 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 beginning on or about September 30, 2004, and require an estimated 4 to 5 FTEs with expertise consistent with the operations of a project of this size and complexity. RFP-NIH-NIAID-DAIT-04-44 will be available electronically on or about December 3, 2003, may be accessed through the NIAID Contract Management Program (CMP) Home Page at http://www.niaid.nih.gov/contract and will be posted on FedBizOpps. Any responsible offeror may submit a proposal that will be considered by the Government. See Government-Wide Numbered Notes 1 and 26. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.
- Place of Performance
- Address: Continental United States
- Record
- SN00473424-W 20031122/031120211952 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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