SOLICITATION NOTICE
A -- Atopic Dermatitis and Vaccinia Immunization Network: Statistical and Data Coordinating Center (SDCC)
- Notice Date
- 4/7/2003
- 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
- 20892-7612
- Solicitation Number
- RFP-NIH-NIAID-DAIT-04-08
- Response Due
- 7/28/2003
- Point of Contact
- Terrie Latimer, Contract Specialist, Phone 301-402-5825, Fax 301-402-0972, - Barbara Shadrick, Senior Contracting Officer, Phone 301-496-7288, Fax 301-480-5253,
- E-Mail Address
-
TLatimer@niaid.nih.gov, bs92y@nih.gov
- Small Business Set-Aside
- Total Small Business
- Description
- The Division of Allergy, Immunology and Transplantation (DAIT), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), has a requirement to establish and implement a Network that will have three components: a Clinical Studies Consortium, an Animal Studies Consortium and a Statistical and Data Coordinating Center (SDCC). Each component will be solicited under separate RFPs (to be posted simultaneously) and established under separate contracts. THIS ACTION IS BEING SOLICITED AS A 100% SMALL BUSINESS SET ASIDE, NAICS CODE 541710; SIZE STANDARD 500 EMPLOYEES. [SEE GOVERNMENT-WIDE NUMBERED NOTE 1] The purpose of this component is the establishment of the “Atopic Dermatitis and Immunization Vaccinia Network: Statistical and Data Coordinating Center (SDCC)” to support clinical and animal studies designed to diminish or eliminate the risk of eczema vaccinatum and other serious adverse reactions to vaccinia virus immunization in atopic dermatitis patients. One award is anticipated. The tasks to be carried out by the SDCC will be coordinated with both the Clinical Studies Consortium and Animal Studies Consortium. To summarize, all offerors must be able to provide the following support: 1) Establish and manage a statistical and data coordinating center (SDCC) (a component of the ADVN). Provide the statistical, clinical, technical, regulatory and administrative expertise necessary to carry out the tasks specified below, and other tasks as may be directed by the Project Officer. 2) Develop and implement a technical and administrative management and coordination plan for the SDCC. Establish the organizational structure of the SDCC, which includes (a) the SDCC Principal Investigator, who will be responsible for the overall leadership, management and coordination of all aspects of the Center’s activities; and (b) the relationship of the SDCC to the Network Executive Committee. 3) Provide statistical, administrative, technical and logistical support for the activities of the Network Executive Committee. Develop and revise, as necessary, Conflict of Interest (COI) and financial disclosure forms for all members of the Network Executive Committee and other ADVN members as appropriate; coordinate the distribution and receipt of completed forms; provide all forms to the Project Officer. 4) Provide statistical and clinical leadership for the design and analysis of human and animal studies conducted by ADVN and clinical site monitoring and training. Provide clinical study expertise for the design, implementation, refinement, modification and monitoring of clinical studies conducted by the ADVN, including the preparation and updating of a Manual of Operations for each clinical protocol. 5) Provide computer-based data collection, management and quality assurance systems for studies conducted by the ADVN. Establish and administer ADVN-wide systems for: a) data collection; b) data management; c) data quality assurance and reporting; d) data and system security and confidentiality; and e) electronic communication linkages among ADVN sites, the NIAID and the Network Executive Committee. 6) Establish and maintain a Registry of patients with Atopic Dermatitis who have documented disseminated infection with vaccinia virus (eczema vaccinatum) and/or herpes simplex virus (eczema herpeticum) and/or persistent and severe infection with molluscum contagiosum; 7) Provide leadership and support for regulatory requirements associated with Investigational New Drug (IND) applications. Tracking of Adverse Events: Develop and maintain a computerized tracking system for the receipt, follow-up, reporting, and disposition of adverse events for all ADVN clinical studies to the Food and Drug Administration (FDA), the NIAID, appropriate ADVN investigators, and the Network Executive Committee, as appropriate. All procedures and systems must meet the guidelines and regulations of the FDA as related to processing of Adverse Event Reporting (AER) and safety information. 8) Provide coordination and support for the activities of the Data and Safety Monitoring Board (DSMB). Coordinate and provide statistical, technical, administrative and logistical support for the activities of the independent DSMB to be appointed by the NIAID to monitor the safety of ADVN clinical studies. The NIAID DSMB shall be composed of scientific and clinical experts, bioethicists, and other representatives as may be necessary: 9) Provide for an orderly transition to a subsequent contractor or the government. The Contractor is required to ensure an orderly transition of contract-related materials to a successor contractor or the Government prior to the completion date of this contract. It is anticipated that the period of performance for the contract will be five (5) years, beginning on/about February 17, 2004. This RFP will be available electronically on/about April 18, 2003, may be accessed through the NIAID Contract Management Branch (CMB) Home Page http://www.niaid.nih.gov/contract, and will also be posted on the FedBizOpps website. All responsible sources may submit a proposal which shall be considered by the agency. This announcement does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. NOTE: THIS NOTICE MAY HAVE POSTED ON WWW.FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (07-APR-2003). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 10-MAY-2004, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/NIH/NIAID/RFP-NIH-NIAID-DAIT-04-08/listing.html)
- Record
- SN00583464-F 20040512/040510213432 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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