RFP Announcement:   NIAID Division of Allergy, Immunology And Transplantation: Clinical Products Center (CPC) - NIH-NIAID-DAIT-NIHAI2010094


Notice Number:  NOT-AI-11-008

Key Dates

Release Date:   November 19, 2010  

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

THE FOLLOWING IS A TOTAL SMALL BUSINESS SET-ASIDE:

It is anticipated that up to one cost reimbursement level of effort contract will be awarded for a period of one base year and six option years, beginning approximately November, 2011.  RFP-NIH-NIAID-DAIT-NIHAI2010094 will be available electronically on or about November 18, 2010 and may be accessed at http://www.fbo.gov/.  Only electronic copies of the RFP will be available.  All information required for the submission of an offer will be contained in the RFP.  Responses to this RFP will be due approximately February 22, 2011. 

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.  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 that 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

Please direct all inquiries to:

CONTRACTING OFFICE ADDRESS

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

POINT OF CONTACT

Deborah Blyveis
Contract Specialist
Office of Acquisitions, Division of Extramural Activities, NIAID, NIH, DHHS
6700-B Rockledge Drive, Room 3214, MSC 7612
Bethesda, MD  20892-7612 (Express mail:  Use Zip Code 20817-7612)
Phone 301-594-7211
Fax 301-402-0972
Email: 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
Bethesda, MD  20892-7612 (Express mail:  Use Zip Code 20817-7612)
Phone 301-451-2617
Fax 301-402-0972
Email: dLisle@NIAID.NIH.GOV


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