SOLICITATION NOTICE
A -- Statistical and Clinical Coordinating Center: Immunologic Approaches to Reduce Asthma Severity
- Notice Date
- 5/24/2001
- 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 Drive, MSC 7612, Bethesda, MD, 20892-7612
- ZIP Code
- 20892-7605
- Solicitation Number
- RFP-NIH-NIAID-DAIT-02-12
- Response Due
- 10/5/2001
- Point of Contact
- Ross Kelley, Contract Specialist, Phone (301) 402-2234, Fax (301) 480-5253, - Barbara Shadrick, Senior Contracting Officer, Phone 301-496-7288, Fax 301-402-0972,
- E-Mail Address
-
rk17a@nih.gov, bs92y@nih.gov
- Small Business Set-Aside
- N/A
- Description
- The Division of Allergy, Immunology and Transplantation of the National Institute of Allergy and Infectious Diseases (NIAID), NIH, has a requirement for a Contractor having the capabilities and facilities to establish and manage a Statistical and Clinical Coordinating Center (SACCC) to support the ?NIAID Inner-City Asthma Consortium: Immunologic Approaches to Reduce Asthma,? to be established in FY 2002. The goals of this Consortium are to develop and carry out a long-range scientific plan to reduce asthma severity and prevent asthma among inner-city children. The Consortium includes the following components: ?Clinical trials to evaluate the safety and efficacy of promising immune-based therapies in reducing asthma severity and preventing disease onset in minority children residing in inner cities in the United States; ?Adjunct studies to delineate the underlying mechanisms of such therapies as an integral part of the clinical trials undertaken by the Consortium; ?Clinical studies on the immunopathogenesis of asthma onset, progression and severity; and ?Adjunct studies to develop and validate surrogate/biomarkers to measure disease stage, progression and therapeutic effect. Specifically, the SACCC will provide the statistical, clinical, regulatory, technical and administrative expertise necessary to support clinical trials and mechanistic and biomarker studies of therapies to reduce asthma severity and prevent asthma in minority children residing n inner cities of the United States, including: (1) statistical leadership and clinical trial design expertise for the development, implementation and analysis of clinical trials and studies of underlying mechanisms and of biomarkers/surrogate markers; (2) establishment and administration of systems for the collection, storage, management, quality assurance and reporting of study data, including systems of patient registration and randomization for clinical trials; (3) clinical site monitoring and training; (4) regulatory and technical functions and requirements associated with Investigational New Drug (IND) Applications; (5) preparation and final analyses of study data; (6) coordination and support, of technical and administrative activities of the Consortium Executive Committee and subcommittees and an independent Data and Safety Monitoring Board; and (7) providing for the receipt, storage and distribution of study products. RFP NIH-NIAID-DAIT-02-12 will be available electronically on or about May 30, 2001, and may be accessed through the NIAID Contract Management Branch (CMB) Homepage by using the following electronic address and instructions: NIAID-CMB Homepage (via the World Wide Web): Use http://www.niaid.nih.gov/contract to access the NIAID/CMB Home Page. Once at the NIAID/CMB Home Page, click on the ?RFPs? link and then click on ?RFP NIH-NIAID-DAIT-02-12.? Proposals in response to this RFP will be due on or about October 5, 2001. Any responsible Offeror may submit a proposal, which will be considered by the Government. This advertisement does not commit the Government to award a contract. It is anticipated that one cost-reimbursement type contract with options will be awarded for a period of seven (7) years, beginning approximately May 1, 2002. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (24-MAY-2001). IT ACTUALLY FIRST APPEARED ON THE FEDBIZOPPS SYSTEM ON 20-SEP-2002. 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-02-12/listing.html)
- Record
- SN00172894-F 20020922/020920221736 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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