SOURCES_SOUGHT_NOTICE.pdf

RFP Clinical Central Lab services

Sources Sought 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

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:________________

Recompetition (if applicable) NOT APPLICABLE

Contracting Office Address

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

Sources Sought Notice Information

Introduction

This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) small businesses, HUBZone small businesses, service-disabled veteran-owned small businesses, 8(a) small businesses, veteran-owned small businesses, woman-owned small businesses, or small disadvantaged businesses classifications; and (3) size classification relative to the North

American Industry Classification System (NAICS) code for the proposed acquisition.

Information submitted in response to this notice will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.

An organization that is not considered a small business under the applicable NAICS code

541712 should not submit a response to this notice.

A determination by the Government not to compete this requirement as a set-aside based upon responses to this notice is solely within the discretion of the Government.

Responses submitted must indicate if you have a GSA schedule contract, a contract on GSA

8(a) STARS, or a contract on GSA VETS GWAC.

Background

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 DMID supports extramural research to study, control, and prevent diseases caused by all infectious agents. 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 (3) 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.

Purpose and Objectives

Contracts to be awarded under a Request for Proposal (RFP) for the requirements stated herein will provide central lab services to support clinical research studies conducted at the

VTEUs. The NIAID anticipates awarding multiple Indefinite Delivery Indefinite Quantity

(IDIQ) contracts to fulfill the technical requirements of DMID. However, the NIAID reserves the right to award a single award IDIQ.

Task orders for specific tasks will be competed for issuance among the IDIQ pool after the award of IDIQ contracts.

All projects carried out under resultant contracts 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.

The anticipated start date is on/or about August 13, 2013 with an ordering period of seven

(7) years.

Capability Statement/Information Sought

Sources must have the expertise, personnel, and facilities to meet the requirements of the project stated herein. Tailored capability statements submitted as a result of this notice must demonstrate the organization’s qualifications and experience, specifically providing evidence as to the organization’s capability to perform the requirements stated herein, with particular attention to the following areas:

1. Perform clinical laboratory testing to support multi-center clinical trials, including but not limited to the following:

Maintaining current Clinical Laboratory Improvement Amendments (CLIA) certification (http://www.cms.gov/clia) and other certifications as appropriate;

Providing clinical supply kits, investigator manuals, lab requisition forms and shipping supplies;

Providing courier services and tracking for all clinical supply and clinical specimen shipments;

Providing investigator training and ongoing support;

Providing test results to clinical sites (per patient visit) within 24 hours of receipt of specimen;

Performing cumulative data transmissions sent to the Statistical Data and

Coordinating Center (SDCC) daily, weekly or monthly, depending on the needs of the study; and

Performing data management support to include maintenance of the results database, prompt issue resolution and documentation of data revisions.

2. The availability, adequacy and suitability of clinical laboratory facilities, equipment and other resources of the organization 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.

3. The ability to provide adequate scientific and technical personnel who have expertise with Good Laboratory Practices, Good Clinical Practices, and federal regulations governing the conduct of research involving human subjects.

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

http://www.cms.gov/clia

How to Submit a Response

1. Page Limitations:

Interested qualified small business organizations should submit a tailored capability statement for this requirement not to exceed five (5) pages, excluding resumes, describing the organization’s experience and ability to perform the efforts stated herein, which includes the following: (1) a summary list of similar work previously performed or being performed; (2) demonstrated scientific and technical ability to carry out the work; (3) the professional qualifications and specific experience of staff who may be assigned to the requirement; (4) the capability to provide the required level-of-effort on a continuing and emerging needs basis; (4) resumes for proposed key personnel, which reflect education, and previous work relevant to the proposed requirement; and (5) a general description of the facilities and other resources needed to perform the work. Tailored capability statements must also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern’s name and address).

Responses will be reviewed only by NIH personnel and will be held in a confidential manner.

All information received within fifteen (15) days after the date of publication of this synopsis will be considered by the Government.

2. Required Business Information:

DUNS

Company Name

Company Address

Company Point of Contact, Phone and Email address

Current GSA Schedules, GSA 8(a) STARS, and/or GSA VETS GWAC appropriate to this Sources Sought

Do you have a Government approved accounting system? If so, please identify the agency that approved the system.

Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the Central Contractor Registration (CCR). All organizations must register on the CCR located at http://www.ccr.gov/index.asp

3. Number of Copies:

Please submit one (1) electronic copy of your capability statement in response to this

SMALL BUSINESS SOURCES SOUGHT notice, to Mr. Chase Lucas, Contract Specialist, at lucasca@niaid.nih.gov in MS Word, WordPerfect or Adobe Portable Document Format

(PDF). The e-mail subject line must specify RFP-NIAID-DMID-AI2013171. Facsimile and mail delivery responses will not be accepted.

4. Common Cut-off Date:

Electronically submitted tailored capability statements are due no later than 2:00PM

(Eastern Prevailing Time) on February 25, 2013. CAPABILITY STATEMENTS

RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED.

http://www.ccr.gov/index.asp mailto:lucasca@niaid.nih.gov

Disclaimer and Important Notes.

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response to the notice. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work stated herein. Respondents are advised that the

Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in

Federal Business Opportunities. Responses to this notice will not be considered responses to a solicitation.

Confidentiality.

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).”

Points of Contact:

Inquiries concerning this notice may be directed to:

Mr. Chase Lucas, Contract Specialist

Ph: 301-402-0641

Email: lucasca@niaid.nih.gov

Aileene Mitchell Ford, Contracting Officer

Ph: 301-496-7288

Email: aileene.mitchellford@nih.gov mailto:lucasca@niaid.nih.gov mailto:aileene.mitchellford@nih.gov