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NIAID Division of Allergy, Immunology and Transplantation: Clinical Products Center (CPC)

Solicitation Number: RFP-NIAID-DAIT-NIHAI2010094
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute of Allergy and Infectious Diseases
  • Print
December 13, 2011
Base $532,826, Option 1 $3,329,444, Option 2 $3,233,860, Option
EMINENT Services Corporation
7495 New Technology Way

Frederick, Maryland 21703
United States
Added: Oct 28, 2010 2:22 pm

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 a clinical products center that will obtain, store, and deliver investigational agents to the appropriate clinical trials sites and personnel for DAIT-supported clinical trials, primarily those conducted by the Immune Tolerance Network (ITN). The center will be a central location for the receipt, storage, repackaging, labeling, and distribution of study products in accordance with federal regulations governing investigational agents.
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 programs and individual research projects to evaluate the safety and efficacy of therapeutic and preventive approaches and agents and to elucidate the underlying mechanisms of such approaches and agents.
DAIT's largest clinical research program, the Collaborative Network for Clinical Research on Immune Tolerance (hereinafter referred to as the ITN), is carried out under a contract to the University of California, San Francisco. Established in FY 1999, a critical component of the ITN's mission involves the design and conduct Phase I-IV clinical trials of investigational approaches intended to lead to a functional state of immune tolerance in three clinical areas: autoimmune diseases; asthma and allergic diseases; and immune-mediated rejection of transplanted solid organs, tissues and cells.
The current contract provides DAIT with centralized services for the receipt, storage, packaging/repackaging, manufacture of placebo, preparation of serial dilutions, labeling, distribution, inventory and disposal of study products for clinical trials conducted by the ITN.
The purpose of this contract is to continue these services for the ITN and expand the scope of services provided to include DAIT-supported, investigator-initiated clinical trials conducted under cooperative agreement grants, as well as other DAIT-funded clinical research programs on a limited, as-needed basis.
The following three Mandatory Qualification Criteria (MQC) must be met at the time of receipt of the Original Proposal.
Offerors must have a permit to purchase and distribute drug products; 2.) staff must include a licensed pharmacist able to purchase and distribute drug products and; 3.) offerors must currently have or have had within the past 12 months the appropriate permits and/or licenses to import and export drug products.

It is anticipated that a level of effort type contract will be awarded. The Government estimates the effort to perform the base requirements of the Statement of Work (Year 1 and Option 1 - additional Years 2 through 7) to be approximately 2.0 full time equivalents (FTEs) per year. Additionally, the anticipated contract award will contain options for increased levels of effort in increments of 10% over the base requirement which can be exercised up to 10 times per contract year. An option for electronic data submission to an internal DAIT-wide system will be included as well. The Government estimates a 10% increase in the total level of effort for this optional activity during the applicable 6-month period. An option for study product validation and identity testing will also be included. The Government estimated a one-time, 12-month 10% increase in the total level of effort for this option.

Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about November 18, 2010 and may be accessed through FedBizOpps This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.




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Solicitation 1

Posted Date:
November 18, 2010
Description: NIAID Division of Allergy, Immunology and Transplantation: Clinical Products Center
Office of Acquisitions
6700 B Rockledge Room 3214 MSC7612
Bethesda, Maryland 20892-7612

Office of Acquisitions
6700B Rockledge Drive, Room 3214, MSC 7612
Bethesda, MD 20892-7612

United States
Deborah J Blyveis,
Contract Specialist
Phone: 301-594-7211
Fax: 301-480-4675
David T. Lisle,
Contracting Officer
Phone: 301-451-2617
Fax: 301-402-0972