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A -- STATISTICAL AND DATA COORDINATING CENTER (SDCC): NIAID IMMUNE TOLERANCE NETWORK AND ASTHMA AND ALLERGIC DISEASES COOPERATIVE RESEARCH CENTERS

Solicitation Number: RFP-NIH-NIAID-DAIT-08-10
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute of Allergy and Infectious Diseases
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RFP-NIH-NIAID-DAIT-08-10
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Solicitation
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Added: April 25, 2007 Modified: June 25, 2007Track Changes
Type of Requirement:Re-competition (Contract No.: HHSN266200400075C)



Place of Performance

Place of performance is unknown at this time



Recompetition (if applicable)



PPD Development, Inc.

929 N. Front Street

Wilmington, NC 28401.



Contracting Office Address

Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Office of Acquisitions, 6700-B Rockledge Drive, Room 3214, MSC 7612, Bethesda, MD, 20892-7612



Duration of contract: Six (6) Years

If Options will be included, describe Options _ The contract will be funded for a base period of six (6) years to provide SDCC support for the research activities of the ITN and the AADCRCs. In addition, the Government reserves the right to exercise three (3) options: Option 1 provides for an extension of the contract for one (1) additional year to continue the SDCC support services specified in the base period for both research programs; Option 2 provides for additional SDCC support for data collection, storage, management, quality control and reporting for the AADCRCs; and Option 3 provides SDCC support for other DAIT-sponsored research programs and projects involving clinical research on immune-mediated diseases, including asthma and allergic diseases, solid organ, tissue and cell transplantation, and autoimmune disorders. These other programs and projects that may be supported under Option 3 include new individual clinical trial grants and existing and future clinical research programs/networks and projects awarded by DAIT.



Anticipated award date: July 31, 2008











Presolicitation Notice Information



Introduction

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 Data Coordinating Center (SDCC) to support NIAID sponsored clinical research programs in allergy/asthma, autoimmune, and transplant-related diseases.

Description

The Division of Allergy, Immunology, and Transplantation (DAIT) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), intends to recompete a requirement for capabilities and facilities to establish and manage a Statistical and Data Coordinating Center (SDCC) to support NIAID sponsored clinical research programs in allergy/asthma, autoimmune, and transplant-related diseases.



Under the current contract to the PPD Corporation (HHSN266200400075C), the SDCC has served to provide a broad range of clinical research support services to the Immune Tolerance Network (ITN). Under this contract, the Statistical and Data Coordinating Center (SDCC) will support each of the following two research programs:



The Immune Tolerance Network (ITN) was established in 1999 and is currently under a contract to the University of California, San Francisco. The overall goal of the ITN is to accelerate the evaluation of promising approaches for the induction and maintenance of immune tolerance in four clinical areas: solid organ transplantation, islet cell transplantation, autoimmune diseases, and asthma and allergic diseases.



The Asthma and Allergic Diseases Cooperative Research Centers (AADCRCs) were established in 1971 to promote integrated, multidisciplinary basic and clinical research on the immunologic mechanisms underlying the onset and progression of asthma and allergic diseases. The overall goal of this program is to improve the diagnosis and treatment of asthma and allergic diseases, and to provide a rational foundation for the development of effective therapeutic and prevention strategies.





The Contractor shall serve as the SDCC for clinical and non-clinical research activities carried out by the ITN with the responsibility for a broad range of support functions, including: statistical design and analysis; clinical data collection, storage, management, quality control, reporting and associated training for clinical site personnel; safety oversight; preparation of study-related materials; and clinical study website development and maintenance.



In addition, the Contractor shall also support the AADCRCs by providing assistance in the statistical design, analysis and final reporting for some clinical trials and mechanistic studies upon request of the Project Officer. This will typically involve a multi-center effort and a collaborative relationship with clinical investigators, other supporting contractors, and DAIT/NIAID staff.



(Note: Although the ITN generates both clinical and mechanistic data from each trial, the scope of SDCC statistical functions is limited only to clinical data as specified in each protocol. Statistical design and analysis of mechanistic data and combined data from both clinical trials and mechanistic studies will be performed collaboratively by the ITN Clinical Trials Group and the ITN Bioinformatics Group).



The contract will be funded for a base period of six (6) years to provide SDCC support for the research activities of the ITN and the AADCRCs. In addition, the Government reserves the right to exercise three (3) options: Option 1 provides for an extension of the contract for one (1) additional year to continue the SDCC support services specified in the base period for both research programs; Option 2 provides for additional SDCC support for data collection, storage, management, quality control and reporting for some AADCRC studies at the request of the Project Officer; and Option 3 provides SDCC support for other DAIT-sponsored research programs and projects involving clinical research on immune-mediated diseases, including asthma and allergic diseases, solid organ, tissue and cell transplantation, and autoimmune disorders. These other programs and projects that may be supported under Option 3 include new individual clinical trial grants and existing and future clinical research programs/networks and projects awarded by DAIT. It is anticipated that up to one cost reimbursement completion type contract will be awarded for a period of six years, beginning approximately September 29, 2008, with an anticipated total effort of approximately 25.5 FTEs for the Base period, zero additional FTEs for Option #1, 6 additional FTEs for Option #2, and 3 additional FTEs for Option 3. The anticipated total effort for the Base period and Options 1, 2, and 3 is approximately 34.5 FTEs.



TECHNICAL EVALUATION CRITERIA:

CRITERIA WEIGHT



1: TECHNICAL PLAN/APPROACH 100

2: SCIENTIFIC AND TECHNICAL PERSONNEL 25

3: FACILITIES, EQUIPMENT AND OTHER RESOURCES 20

4: PROJECT MANAGEMENT 15

TOTAL POSSIBLE WEIGHT: 160



X EVALUATION OF OPTIONS 20

Other Factors:

X PAST PERFORMANCE FACTOR



TOTAL POSSIBLE WEIGHT (with Options): 180



It is anticipated that one cost reimbursement, completion type contracts will be awarded for a 6-year period of performance beginning on or about July 31, 2008. In addition, the Government reserves the right to exercise three (3) options: Option 1 provides for an extension of the contract for one (1) additional year to continue the SDCC support services specified in the base period for both research programs; Option 2 provides for additional SDCC support for data collection, storage, management, quality control and reporting for the AADCRCs; and Option 3 provides SDCC support for other DAIT-sponsored research programs and projects involving clinical research on immune-mediated diseases, including asthma and allergic diseases, solid organ, tissue and cell transplantation, and autoimmune disorders. These other programs and projects that may be supported under Option 3 include new individual clinical trial grants and existing and future clinical research programs/networks and projects awarded by DAIT. It is estimated that the provision of 25.5 FTEs for the Base period, zero additional FTEs for Option #1, 6 additional FTEs for Option #2, and 3 additional FTEs for Option 3 will be needed. The anticipated total effort for the Base period and Options 1, 2, and 3 is approximately 34.5. All potential offerors are required to propose to the base period and all three (3) options in order for their proposal to be responsive to the solicitation.



Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about July 18, 2007, and may be accessed through FedBizOpps http://www.fedbizopps.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. See Government-Wide Numbered Note 26.

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Solicitation 1

Type:
Solicitation
Posted Date:
July 20, 2007
20070720114405.zip (699.94 Kb)
Description: All Files

Amendment 1

Type:
Mod/Amendment
Posted Date:
August 8, 2007
Description: All Files

Amendment 2

Type:
Mod/Amendment
Posted Date:
October 2, 2007
20071002163151.zip (315.20 Kb)
Description: All Files

Amendment 3

Type:
Mod/Amendment
Posted Date:
October 25, 2007
20071025154136.zip (155.67 Kb)
Description: All Files
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Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions 6700 B Rockledge Room 3214 MSC7612, Bethesda, MD, 20892-7612, UNITED STATES
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6700-B Rockledge Drive, Room 3214,Bethesda, MD, 20892-7612, MSC 7612
20892-7612
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Deborah Blyveis, Contract Specialist, Phone 301-594-7211, Fax 301-480-4675, Email blyveisd@niaid.nih.gov - Donald Collie, Contracting Officer, Phone 301-496-0992, Fax 301-480-4675, Email dc128b@nih.gov