A -- STATISTICAL AND CLINICAL COORDINATING CENTER: = IMMUNOLOGIC APPROACHES TO REDUCE ASTHMA SEVERITY

Notice Date

May 24, 2001

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

20892-7612

Solicitation Number

RFP-NIH-NIAID-DAIT-02-12

Response Due

October 5, 2001

Point of Contact

Ross Kelley, Contract Specialist, Phone (301) 402-2234, Fax = (301) 480-5253, Email rk17a@nih.gov -- Barbara Shadrick, Senior = Contracting Officer, Phone 301-496-7288, Fax 301-402-0972, Email = bs92y@nih.gov

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;=20 ?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. =20 =20

Web Link

Visit this URL for the latest information about this (http://www.eps.gov/spg/HHS/NIH/NIAID/RFP-NIH-NIAID-DAIT-02-12/listi= ng.html)

Record

Loren Data Corp. 20010529/ASOL002.HTM (D-144 SN50N0V3)