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In Vitro Testing Resource for HIV Therapeutics and Topical Microbicides

Solicitation Number: RFP-NIAID-DAIDS-NIHAI2013172
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-DAIDS-NIHAI2013172
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Solicitation
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Added: Aug 01, 2013 9:20 am
Introduction
Research supported by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (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 Acquired Immunodeficiency Syndrome (DAIDS) supports extramural research to study, control and prevent diseases caused by the human immunodeficiency virus (HIV). Support for basic and applied research to develop and evaluate therapeutics, vaccines, non-vaccine prevention modalities, and diagnostics is provided through a variety of research grants and contracts. DAIDS also supports an array of research resources to assist investigators, including programs that provide or produce organisms, state-of-the-art reagents, and preclinical and clinical translational research services (http://www.niaid.nih.gov/LabsAndResources/resources/ATRG/Pages/default.aspx).

The development and introduction of new therapeutics and topical microbicides against HIV remains a high public health priority. To assist in filling these public health gaps, the NIAID supports preclinical development of promising therapeutic and topical microbicide candidates that emerge from academia, the private sector, or other sources.


The purpose of the proposed contract is to provide product development services utilizing biochemical and cell-based assays in both standard and high throughput screening (HTS) formats. Both contracts are currently awarded to Southern Research Institute. These services have assisted a wide variety of investigators in obtaining critical data needed to acquire additional funding, gain prospective partnerships (either for further development or to support Phase I trials), and fulfill regulatory agency requirements.


The Government anticipates awarding one (1) Indefinite Delivery/Indefinite Quantity (ID/IQ) type contract to an organization able to provide the technical requirements of the solicitation and with documented access to BSL-2+ facilities (for the purposes of this solicitation, BSL-2+ is defined as BSL-2 facilities with BSL-3 practices).


Technical Requirements
The Contractor shall provide support to carry out activities in the following five task areas:


1. Administration and Data Coordination: This task area includes essential activities that shall be performed by the Contractor on a regular basis and consists of the following:


a. Overall Project Management
b. Subcontract Managing and Reporting
c. Quality assurance and quality control
d. Intellectual Property Management
e. Initial and Final Transition
f. Meetings and Teleconferences
g. Reporting Requirements/Deliverables
h. Receipt, shipping and storage of compounds and reagents
g. Management/Reporting of Data/Results
h. Provide updates to a Public Database


2. In Vitro Confirmatory Testing and Screening of Interventional Agents in Standard Formats: Under this task area, the Contractor shall conduct confirmatory in vitro testing of anti-HIV therapeutics and topical microbicides.


3. In Vitro Screening of Interventional Agents in High Throughput Screening (HTS) Formats: Under this task area, the Contractor shall acquire and store chemical compound libraries and conduct screening to identify anti-HIV therapeutics and topical microbicides using a HTS format. Note: Under the current contract, the Contractor has been required to select, purchase, and plate a 100,000 compound chemical library and conduct HTS on 700,000 compounds per year. Offerors responding to the solicitation will be asked to describe their rationale in the selection of a 100,000 compound chemical library for purchase and their capability to conduct HTS on at least 700,000 compounds per year in cell based or biochemical assays.


4. Develop New In Vitro Assays: Under this task area, the Contractor shall develop new assays to evaluate the efficacy of interventional agents against HIV.


5. Conduct Hit-To-Lead Progression Studies on Interventional Agents: Under this task area, the Contractor shall perform activities required for the optimization, development, and synthesis of lead candidates and analogs, which may include resynthesis, acquisition, or purchase of new compounds.


Anticipated Period of Performance
It is anticipated that one (1) Indefinite Delivery/Indefinite Quantity (ID/IQ) type contract will be awarded on or about September 14, 2014 for a period of 7 years through September 13, 2021. Task Orders to be issued against the base contract will primarily be cost-reimbursement type, both term and completion form. The Government reserves the right, however, to issue fixed price type Task Orders, when appropriate.


Upon award of the base contract, the Government anticipates awarding Task Orders as follows:


1) Task Order #001, Administration and Data Coordination. The period of performance will be for one (1) year (Base Period), plus six one-year options (terms) that may be exercised by the Government unilaterally, for a total possible performance period of seven (7) years, beginning on or about September 14, 2014. The requirement will be for the delivery of 0.50 full time equivalent (FTE) per year for the base period (Year 1) and 0.50 FTE per year for Options 1-6 (Years 2-7).

2) Task Order #002, In Vitro Confirmatory Testing and Screening of Interventional Agents in Standard Formats. This Task Order will be a cost reimbursement type, completion form contract for the delivery of a Task Order Final Report. The period of performance will be for one year, beginning on or about September 14, 2014. For proposal purposes only, it is estimated that the level of effort needed to carry out this Task Order will be 1.00 FTE.

3) Task Order #003, In Vitro Screening of Interventional Agents in High Throughput (HTS) Formats. This Task Order will be a cost reimbursement, completion type contract for the delivery of a Task Order Final Report. The period of performance will be for one year, beginning on or about September 14, 2014. For proposal purposes only, it is estimated that the level of effort needed to carry out this Task Order will be 1.00 FTE.

4) Task Order #004, Develop New In Vitro Assays. This Task Order will be a cost reimbursement, completion type contract for the delivery of a Task Order Final Report. The period of performance will be for one year, beginning on or about September 14, 2014. For proposal purposes only, it is estimated that the level of effort needed to carry out this Task Order will be 0.50 FTE.

5) Task Order #005, Conduct Hit-to-Lead Progression Studies on Intervention Agents. This Task Order will be a cost reimbursement, completion type contract for the delivery of a Task Order Final Report. The period of performance will be for one year, beginning on or about September 14, 2014. For proposal purposes only, it is estimated that the level of effort needed to carry out this Task Order will be 1.00 FTE.


Any responsible Offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about August 15, 2013, 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.

Added: Sep 23, 2013 3:39 pm
Solicitation posting modified to update proposal response date to read 3:00 p.m. local time on November 14, 2013.
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Solicitation 1

Type:
Solicitation
Posted Date:
September 20, 2013
Description: In Vitro Testing Resource for HIV Therapeutics and Topical Microbicides

Amendment 1

Type:
Mod/Amendment
Posted Date:
October 24, 2013
Description: Amendment 1

Amendment 2

Type:
Mod/Amendment
Posted Date:
October 25, 2013
Description: Amendment 2
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