RFP ANNOUNCEMENT: Statistical and Clinical Coordinating Center for Autoimmune Disease Clinical Trials (SACCC-ADCT)

Notice Number: NOT-AI-08-064

Key Dates
Release Date:  September 16, 2008
Receipt Date: January 9, 2009

Issued by
National Institutes of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)

Description

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases.  The NIAID, Division of Allergy, Immunology, and Transplantation (DAIT) has a requirement for capabilities and facilities to establish and manage a Statistical and Coordinating Center to provide support for autoimmune disease clinical trials. 
Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to better understand, treat, and ultimately prevent immunologic, infectious, and allergic diseases.  The NIAID Division of Allergy, Immunology, and Transplantation (DAIT) supports extramural basic, pre-clinical and clinical research focusing on immune-mediated diseases through a variety of research grants and contracts.  This includes support for clinical research to evaluate the safety and efficacy of therapeutic and preventive approaches and agents and to elucidate the underlying mechanisms of such approaches and agents.

The Statistical and Clinical Coordinating Center for Autoimmune Disease Clinical Trials (SACCC-ADCT) provides critical services for the design, implementation, oversight (including regulatory support and compliance, safety and clinical site monitoring and reporting, training, and distribution and quality control of study products), and analysis of DAIT-supported autoimmune disease clinical trials (ADCT) and associated mechanistic studies being conducted by two cooperative groups:
The Autoimmunity Centers of Excellence (ACE) program is designed to accelerate the discovery, development, and testing of new immunological therapies for autoimmune diseases.  This program fosters collaborations between basic and clinical scientists and supports cooperative single- and multiple-site Phase 1 and 2 clinical trials, as well as associated mechanistic studies.  It was established in 1999 and expanded in 2004 to the current 9 sites with a total annual budget of $11.6 million.  Since 2004, 13 protocols have been developed or are in development; of these 6 protocols have initiated enrollment and 3 are in follow-up or have been completed.  The program will be renewed in FY 2009 (RFA-AI-08-010; http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-08-010.html) under the co-sponsorship of NIAID, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS), the National Institute of Neurological Disorders and Stroke (NINDS), and the NIH Office of Research on Women’s Health. The renewed program is expected to be comparable in size to the current program.
The Stem Cell Therapy Consortium (hereinafter referred to as “Consortium”) was created in 1999 through the award of several contracts to study hematopoietic stem cell transplantation (HSCT) for the treatment of autoimmune diseases (http://www.niaid.nih.gov/contract/archive/9931rfp.htm).  The contracts resulted in the opening and active enrollment of clinical protocols using high dose immunosuppressive therapy (HDIT), followed by HSCT for the treatment of Severe Systemic Sclerosis (SSC) and Multiple Sclerosis (MS).  In addition to clinical outcomes, mechanisms of disease, remission and relapse are evaluated as part of these studies. The SSC trial is a Phase II/III pivotal trial evaluating safety and clinical efficacy in subjects with severe, rapidly progressive systemic sclerosis. (See http://clinicaltrials.gov/ct2/show/NCT00114530.) The Phase II single arm MS trial focuses on safety and the assessment of biological activity using MRI measures and clinical outcomes. (See http://clinicaltrials.gov/ct2/show/NCT00288626.)

The initial SACCC-ADCT contract was awarded to Rho Federal Systems, Inc. in 2002 (Contract Number N01-AI-25481) and has served to provide a broad range of clinical research support services to the ACE and the Consortium networks.  Under this contract, those services will be continued and will also be expanded to provide support for DAIT-funded investigators conducting autoimmune disease clinical trials (ADCT) outside the ACE and Consortium networks through a variety of mechanisms, for example, the NIAID R34/U01 mechanism (http://www.niaid.nih.gov/ncn/clinical/R34.htm).
The contract will be funded for a period of seven (7) years to provide Statistical and Clinical Coordinating Center support for autoimmune disease clinical trials including the activities of the ACE and Consortium. 
TECHNICAL EVALUATION CRITERIA: CRITERIA, WEIGHT: 1. TECHNICAL PLAN/APPROACH, 120; 2. SCIENTIFIC AND TECHNICAL PERSONNEL, 50; 3. FACILITIES, EQUIPMENT AND OTHER RESOURCES, 15; 4. PROJECT MANAGEMENT, 15.  TOTAL POSSIBLE WEIGHT: 200.  Other Factors: EVALUATION OF DATA SHARING PLAN; PAST PERFORMANCE FACTOR

It is anticipated that up to one cost reimbursement completion type contract will be awarded for a period of seven years, beginning approximately August 2009, with an anticipated annual total effort of approximately 16.0 FTEs per annum for the seven year period.  RFP NIH-NIAID-DAIT-NIHAI2008049 will be available electronically on/about September 19, 2008, and may be accessed through FedBizOpps http://www.fedbizopps.gov/.  Only electronic copies of the RFP will be available.  All information required for submission of an offer will be contained in the RFP.  Responses to this RFP will be due on January 9, 2009.

Any responsible offeror may submit a proposal which will be considered by the Government, however, this notice does not commit the Government to the award of a contract.  No collect calls will be accepted.  No facsimile submissions will be accepted.

Inquiries

For questions or further information, contact:

Deborah B. Blyveis,
Contract Specialist
Office of Acquisitions, Division of Extramural Activities, NIAID, NIH, DHHS
6700-B Rockledge Drive Room 3214, MSC 7612 (Express mail:  Use Zip Code 20817-7612)
Phone: 301-594-7211
Fax: 301-402-0972
blyveisd@niaid.nih.gov

David T. Lisle,
Contracting Officer
Office of Acquisitions, Division of Extramural Activities, NIAID, NIH, DHHS
6700-B Rockledge Drive Room 3214, MSC 7612 (Express mail:  Use Zip Code 20817-7612)
Phone: 301-451-2617
Fax: 301-402-0972
dlisle@niaid.nih.gov


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