Presolicitation_Notice.pdf

RFP CLINICAL RESEARCH CENTRAL LABORATORY SERVICES TO

SUPPORT VACCINE TREATMENT AND EVALUATION UNITS (VTEU)

PreSolicitation Notice- RFP-NIAID-DMID-AI2013171 Page 1 of 3

PRESOLICITATION NOTICE

CLINICAL RESEARCH CENTRAL LABORATORY SERVICES TO SUPPORT VACCINE

TREATMENT AND EVALUATION UNITS (VTEU)

RFP-NIAID-DMID-AI2013171

Type of Requirement

New Requirement

Re-competition (see contract list below)

Expansion of (Contract/RFP No.:______________)

Place of Performance

Place of performance is unknown at this time

Place of performance is known. Address or general location:__________________

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: __7 ordering period____ Years

If Options will be included, describe Options _______________________________

Anticipated award date: ___November 1, 2013____________

The National Institute of Allergy and Infectious Diseases (NIAID) intends to solicit proposals on a full and open competitive basis for Clinical Research Laboratory Services to Support

Vaccine Treatment and Evaluation Units (VTEU)

This is a synopsis and IS NOT a solicitation.

Introduction

The National Institute of Allergy and Infectious Diseases, 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 Microbiology and

Infectious Diseases (DMID) has a need for central laboratory services to support multi-center clinical trials.

Description

Research supported by the NIAID, NIH, DHHS, strives to understand, treat, and ultimately prevent the myriad of infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to study, control, and prevent diseases caused by all infectious agents.

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This includes basic, clinical, and applied research to develop and evaluate therapeutics, vaccines and diagnostics that are funded through a variety of research grants and contracts.

The evaluation of new and improved vaccine, diagnostics and therapeutic candidates in clinical trials and clinical studies is an essential element of the efforts of the NIAID. The

Vaccine and Treatment Evaluation Units (VTEU), supported by the NIAID since the 1960’s, have designed and conducted a broad range of clinical studies and clinical trials of bacterial, viral and parasitic vaccines, therapeutics, and other biologics and drugs as preventive and therapeutic measures against infectious diseases in people of all ages and risk categories.

These have included Investigational Device Exemption (IDE), Investigational New Drug

(IND) and non-IND trials, many Phase I first in-man clinical trials, and Phase II proof-of-concept trials. The VTEUs have also undertaken a variety of other studies, including:

targeted surveillance for pathogens of interest in study populations; evaluations of novel investigational product delivery systems; and reevaluation of current vaccine formulations, schedules and modes of delivery.

The VTEUs also have an important role in responding to emerging public health needs at the direction of NIAID. Approximately 40 clinical trials and clinical studies have been conducted during the past three years in the VTEUs. Several of these clinical trials/studies were performed in a compressed time frame to address emergent public health research needs, for example the 2009 H1N1 influenza pandemic.

The VTEUs conduct clinical studies and Phase 0 through Phase IV clinical trials related to infectious diseases in a variety of domestic and international populations. These populations include healthy volunteers from birth to mature adults, pregnant women and subjects with endemic diseases for the specific international location. Many clinical trials conducted in the

VTEUs are multi-center trials. When data is collected from multiple local laboratories that use different testing methodologies, reference ranges, and standard operating procedures, difficulties in data interpretation and delays in study timelines may result. A need for a clinical research central laboratory, a laboratory that will process all screening and safety labs collected at all sites participating in one trial, has been identified.

The contracts to be awarded under the impending Request for Proposal (RFP) will provide central laboratory services to support clinical research studies conducted at DMID.

Offerors are expected to have the expertise, personnel, and facilities to meet requirements stated in the RFP, and be able to demonstrate their capability to perform the requirements, to include but not limited to, the following:

1. to perform clinical laboratory screening and safety testing, such as hematology, chemistry, HIV, HBC, HCV and urinalysis, to support multi-center clinical trials, including maintaining current Clinical Laboratory Improvement Amendment certification (http://www.cms.gov/clia) and other certifications as appropriate.

2. availability, adequacy and suitability of clinical laboratory facilities, equipment and other resources of the Offeror and all proposed subcontractors to perform clinical laboratory testing in accordance with federal regulatory requirements and guidelines, including Good Laboratory Practices, Good Clinical Practices, NIH, NIAID and DMID policies and procedures and the scope and requirements of the RFP.

3. provision of adequate scientific and technical personnel who have expertise with

Good Laboratory Practices, Good Clinical Practices, and federal regulations governing the requirements associated with the conduct of research involving human subjects.

http://www.cms.gov/clia

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4. provision of technical and administrative management infrastructure to ensure the efficient planning, implementation, oversight, and completion of all required activities.

The NIAID anticipates awarding multiple Indefinite Delivery/Indefinite Quantity (ID/IQ) contracts to fulfill the technical requirements of this solicitation. However, the NIAID reserves the right to award a single award IDIQ. All projects carried out under a contract must be conducted in a manner consistent with all applicable Federal regulations and the

DMID, NIAID, NIH and DHHS policies and guidelines for the conduct and oversight of research involving human subjects.

This RFP will be available electronically on/about March 25, 2013, and may be accessed through FedBizOpps http://www.fedbizopps.gov/. This notice does not commit the

Government to actually issuing an RFP or to awarding a contract.

Any responsible offeror may submit a proposal which will be considered by the Agency.

No collect calls or facsimile transmissions will be accepted.

http://www.fedbizopps.gov/