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NIAID Division of Allergy, Immunology and Transplantation: Regulatory Management Center

Solicitation Number: RFP-NIAID-DAIT-NIHAI2010031
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-NIAID-DAIT-NIHAI2010031
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Award
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November 1, 2011
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HHSN272201200002C
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The total contract value including the base and all options are
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PPD Development, LP
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Added: Oct 28, 2010 10:37 am Modified: Oct 28, 2010 3:43 pmTrack Changes
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 regulatory management center that will provide Regulatory and Good Clinical Practice (GCP) compliance support to DAIT Office of Regulatory Affairs for trials conducted under all Networks funded by DAIT NIAID as well as for trials conducted by individual Principal Investigator's funded by DAIT through a non-Network Mechanism. The scope of this contract will cover all trials whether conducted under Health Authority Application or not.

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.


As the sponsor of Investigational New Drug Application (IND) and Investigational Device Exemption (IDE) applications for a large number of DAIT-supported clinical trials, there is an established requirement for DAIT to provide regulatory support to ensure compliance with applicable regulations, including Title 21 Code of Federal Regulations (CFR) Parts 50, 54, 56 and 312, and Title 45 CFR Part 46. In addition, all DAIT-supported clinical trials, including those conducted under FDA regulation, as well as IND/IDE-exempt studies and trials must be conducted in accordance with the International Conference on Harmonization (ICH) Guidelines: E2A Clinical Safety Data Management and E6 Good Clinical Practices (GCP), as well as country-specific regulatory regulations and requirements.


The purpose of this contract is to establish a Division-wide Regulatory Management Center to: (1) centralize all regulatory support services for DAIT-funded clinical research programs, currently carried out under multiple grants and contracts, into a single contract dedicated to regulatory affairs; (2) provide regulatory support services for individual clinical trial projects conducted under investigator-initiated cooperative agreement grants within a centralized contract; and (3) provide regulatory support services for future DAIT-supported clinical research programs and individual projects.


The Contractor shall serve as the DAIT Regulatory Management Center (RMC) with responsibility for carrying out a broad range of technical and administrative regulatory support functions for the Division's Office of Regulatory Affairs (ORA), and for working with other DAIT scientific/clinical staff responsible for the conduct and oversight of clinical trials, Principal Investigators (PIs) and other senior staff of DAIT-supported clinical research programs and their clinical sites, investigators conducting individual clinical trial projects, and industry collaborators. Support shall be provided for clinical trials conducted under INDs/IDEs and IND/IDE-exempt (non-IND/IDE) clinical trials.


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 10) to be approximately 5.50 full time equivalents (FTEs) per year. Additionally, the anticipated contract award will contain options for increased levels of effort in increments of 25% over the base requirement which can be exercised up to 3 times per contract year. Options for electronic data submission to an internal DAIT-wide system as well electronic submission of IND/IDE documents to the FDA will be included. The Government estimates a 10% increase in the level of effort for each optional activity during the applicable period.


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 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.

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Solicitation 1

Type:
Solicitation
Posted Date:
November 18, 2010
Description: NIAID Division of Allergy, Immunology and Transplantation: Regulatory Management Center

Amendment 1

Type:
Mod/Amendment
Posted Date:
January 11, 2011
Description: Amendment #1

Amendment 2

Type:
Mod/Amendment
Posted Date:
January 24, 2011
Description: Amendment 1, 2nd posting (Questions 10-22)
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:
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:
Liem T. Nguyen,
Contracting Officer
Phone: 301-496-0612
Fax: 301-402-0972