Attach_8_Pre-Sol_Notice_N02CM57004_05.pdf

Pre-Solicitation Notice

N02-CM-57004-05

CHEMICAL BIOLOGY CONSORTIUM SCREENING LIBRARIES CENTER

Background

The Chemical Biology Consortium (CBC) was established in 2009 through the NCI Division of Cancer Treatment and Diagnosis (DCTD) in conjunction with the Center for Cancer Research (CCR) and the Office of the Director (OD). The CBC is a multidisciplinary network comprised of academic, government and private entities that interacts collaboratively to support execution of drug discovery and development projects within the NCI Experimental Therapeutics Program (NExT). The CBC along with DCTD’s existing resources establishes a complete drug discovery and development platform for oncology therapeutics. One critical infrastructure resource within the CBC is small molecule screening library services in support of high-throughput screening (HTS) projects. The CBC Screening Libraries Center (CBCSLC) will provide this resource capability. The resource was originally established in 2010 under the name Chemical Biology Consortium Small Molecule Repository (CBCSMR) and will continue under the name CBCSLC.

The CBCSLC will be responsible for the storage, distribution, replenishment and expansion of our current 130,000 compound small molecule screening library and providing associated infrastructure, technical and informatics services.

In the 5-year initial phase of the CBC Screening Libraries Center (CBCSLC) a ~130,000 small molecule chemical screening library was established. The library has been one resource used to support 1) NExT project HTS campaigns and 2) extramural and NIH intramural investigator HTS projects. The on-going Project will be specifically responsible for continuation of this resource and include the storage, production, QC analysis and distribution of the current library 130,000 compound collection as diversity, focused and cherry-picked sets. The collection includes solid stores, working solution stores and plated sets. The CBCSLC will also be responsible for maintaining a secure, electronic database of all associated chemical, inventory, and distribution related information and interfacing, as necessary, with other DCTD infrastructure components. The CBCSLC should have the capability to support expansion of the library, employing state-of-the art expertise in library design and analysis. It should also have capability and extensive experience in procurement of selected solid chemical samples, including a thorough knowledge of the commercial vendor universe.

Project Requirements:

A Statement of Work (SOW) is attached to this notice

SERVICES TO BE PERFORMED:

A. Organizational Structure

All work under this contract shall be monitored by the Contracting Officer’s Representative (COR), the COR shall be the Contractor’s primary point of contact for technical matters under this contract.

B. Specific Technical Requirements

Independently, and not as an agent of the Federal government, the Contractor shall furnish all necessary labor, services, equipment, materials, supplies, and facilities, except as otherwise specified herein, as needed to perform the work set forth below. The contract may be used to purchase new compounds, as directed by the COR, but compounds acquired from other sources may also be managed under this contract. The Contractor shall have a suitable facility, equipment and staff available at the time of proposal submission.

Task 1. Library Storage, Operational Maintenance, Security and Safety

The listed tasks will be performed on an on-going basis throughout the contract life.

a. Storage- Storage of the 130,000 compound CBCSLC library in a suitable facility under conditions that ensure optimal stability and purity, along with background tasks related to the maintenance of associated infrastructure. The library collection is maintained as a mix of: 1) 4 dram vialed neat solid/films, 2) working solution stores in Matrix tubes and 3) 384-well microtiter plates. The Contractor shall have the capability to store all samples long-term at -78, -20, and 0°C under inert atmosphere as appropriate for maintaining quality in a cost effective manner. The standard storage conditions are -20°C under an inert atmosphere employing DMSO as a solution solvent.

There shall be sufficient storage space and flexibility to accommodate changes in the mix of storage types. The Contractor shall provide all the necessary expertise, equipment, and facilities to store, maintain, and track the inventory. Storage and handling shall comply with all applicable local, state and Federal regulations. – ANY AND ALL COMPOUNDS SUPPLIED OR

PURCHASED UNDER THIS CONTRACT, STORED AS SOLIDS, SOLUTIONS OR

PLATED, SHALL REMAIN THE PROPERTY OF THE GOVERNMENT THROUGHOUT

THE LIFE OF THE CONTRACT. THE CONTRACTOR SHALL TRANSFER THESE

COMPOUNDS TO THE FOLLOW-ON CONTRACT SHOULD ONE BE ISSUED OR

TRANSFER THE COMPOUNDS TO THE APPROPRIATE FACILITY AS DIRECTED BY

THE CONTRACTING OFFICER OR HIS REPRESENTATIVE. See section K of this SOW -

b. Quality Control – The Contractor shall perform rapid, low throughput analyses of chemical purity

(e.g., LC/MS, HPLC, and/or NMR) as requested by the COR. It is anticipated that this will involve 50-250 samples annually. The Contractor shall be required to have an on-going Quality Assurance plan for instruments and other equipment. The QC requirement (purity and identity) shall include but is not limited to ability to carry out high throughput analysis by GC-MS or LC- MS and interpret results as passing or failing to meet QC criteria by showing specified purity (as specified by the COR). The primary method of analysis shall be LC-MS and/or GC-MS. When these methods are not suitable the Contractor shall have the capability to routinely perform purity analysis by 1H-NMR. It is anticipated that <1% of samples will require 1H-NMR analysis.

Structure not confirmed by lack of observed molecular ion by MS or NMR spectra inconsistent with structure is deemed as failing.

c. Distribution – The Contractor shall have the capability to ship plated sets (e.g. diversity library, focused libraries and single-use sets) to the CBC screening centers and external investigators, as requested by the COR. The Contractor shall have capability to ship on a weekly basis using “next business day” for domestic shipments. The Contractor shall also have the capability to ship internationally including regions in India and China. It is estimated that international shipments will be minimal. It is anticipated that 10-15 institutes will comprise the CBC including 5-8 screening centers. Compound shipments shall be made in such a way as to ensure the integrity of the contents (e.g. packed in dry ice) and shall comply with all applicable federal, state, and local regulations and international shipping and custom regulations. It is anticipated that 15-20 individual shipments will be made annually that include existing libraries and cherry-picked sets.

The direct shipping costs will be charged to the recipient through their Fedex number while the cost associated with packaging will be the responsibility of the Contractor.

d. Inventory Monitoring and Repurchase- The Contractor shall monitor and maintain adequate compound inventory, both solution and dry store, to ensure that sufficient threshold quantities, as specified by the COR, of all compounds are available to support screening needs. As compounds fall below threshold inventory (e.g. 5 mg), either by depletion or degradation, the Contractor shall undertake all activities necessary to purchase sufficient quantities of the compound to replenish the inventory upon approval by the COR. It is anticipated that no more than 0.5% of the sample collection will need to be replenished annually. It is estimated that this would be ~300 compounds over the life of the contract.

e. CBC Synthetic Compounds – The Contractor shall also have the capability to manage CBC member generated dry powder synthetic samples. It is anticipated that the number of compounds will be minimal over the life of the contract (i.e. <50). Management of samples will involve receipt, registration, inventory, storage, analysis and distribution activities.

f. Disposal – The Contractor shall comply with all local, state and Federal regulations in the disposal of chemical samples, personal protective equipment, solvents and chemically contaminated vials, tubes and plates.

g. Informatics and Documentation - The Contractor shall maintain and update the CBCSLC electronic database containing individual chemical structures, descriptors, associated physiochemical data along with distribution and inventory information. The Contractor’s database shall be functionally compatible with the internal Oracle-based NCI/CBC database. The Contractor shall be responsible for regularly synchronizing the CBC-related information between the databases. In addition, the Contactor shall produce archival documents that describe the design history, physiochemical characteristics and content of new libraries added to the collection over the life of the contract.

h. Reporting Requirements - The Contractor shall provide quarterly reports, annual reports and a final report describing contract-related activities spanning the time period, including issues encountered and solutions implemented. The subject emphasis within the reports should be based on magnitude of resource allotted. The reports should contain a 1-paragraph executive summary of important activities and issues. The reports should include any significant personnel changes that may impact the execution of work. The annual and final reports should be a summary of work completed over the time period. Additionally, the contractor will be required to submit annually a Section 508 compliance report. Reporting requirements can be found in section C of this contract.

Task 2. Production of Arrayed Sets and Distribution

a. Compound Arrays and Replicates – The Contractor shall have the capability for automated arraying of compounds in DMSO or other suitable solvent in a format suitable for rapid re-formatting (e.g. deep-well mother plates) and long-term storage. In addition, the Contractor should have the capability for production of daughter plates for distribution to high-throughput screening (HTS) centers. It is anticipated that most libraries will be plated and distributed in 384-well format although the Contractor should also have the capability to work in a 96-well and 1536-well environment. Depending on demand, up to 4 replicates of the collection may be produced annually (~500,000 wells). All arrayed sets will become property of the Federal government.

b. Distribution – The Contractor shall distribute compound arrays to the CBC screening centers, as requested by the COR. The Contractor shall have capability to ship on a weekly basis using “next business day” for domestic shipments. The Contractor shall also have the capability to ship internationally including regions in India and China. It is estimated that international shipments will be minimal. It is anticipated that 10-15 institutes will comprise the CBC including 5-8 screening centers. Compound shipments shall be made in such a way as to ensure the integrity of the arrays and shall comply with all applicable federal, state, and local regulations and international shipping and custom regulations. It is anticipated that 15-20 individual shipments will be made annually that include existing libraries and cherry-picked sets. The direct shipping costs will be charged to the recipient through their Fedex number while the cost associated with packaging will be the responsibility of the Contractor.

Task 3. Production of Single-Use Sets

a. Single-Use Sets – The Contractor shall have the capability for automated arraying of the Diversity Collection (83K) and selected focused libraries in DMSO or other suitable solvent in 384-well, single-use and assay-ready formats (e.g. 384-well Greiner 781280, 1uL vol) for long-term storage and for distribution to external investigators. All stored arrayed sets will become property of the Federal government.

Task 4. Production of Cherry-Pick Sets and Distribution

a. Cherry-pick Production – The Contractor shall have the capability for automated cherry-picking of the screening collection to produce plated sets based on screening hits or other selected criteria as directed by the COR. The general format will be 384-well but other formats may be selected.

Cherry-picks to support up to 4 HTS screens annually may be requested (5,000 wells).

b. Distribution – The Contractor shall distribute cherry-picked sets as requested by the COR. The Contractor shall have capability to ship on a weekly basis using “next business day” for domestic shipments. Shipments shall be made in such a way as to ensure the integrity of the arrays and shall comply with all applicable Federal, state, and local regulations. It is anticipated that 5-10 individual shipments will be made annually. The direct shipping costs will be charged to the recipient through their Fedex number, while the cost associated with packaging will be the responsibility of the Contractor.

Task 5. Expansion of Screening Collection

a. Design and Identification - The Contractor shall, in coordination with specifications provided by the COR, employ state-of-the-art computational methods to identify candidate compounds from government and commercial sources for inclusion in new focused libraries. The libraries may, for example, be based on structure subtypes, molecular targets or biological activity.

b. Acquisition – The Contractor shall undertake all activities necessary to acquire sufficient quantities (typically 5-30 mg) of compounds selected for expansion of the current CBCSLC screening collection. It is anticipated that the collection will not expand beyond an additional

5,000-10,000 compounds although this will be based on future needs and available funding resources. Compounds will be obtained primarily through direct purchase from commercial vendors but may also be obtained from CBC synthetic efforts and other NIH programs (e.g.

CMLD; Chemical Methodologies and Library Development). All compounds, either in solution or dry solid, will become property of the Federal government.

C. Project Management

The Contractor may designate a Project Manager (PM) in addition to a Project Director (PD). The PD and PM shall act as points of contact with the COR, the PM will act as the day-to-day point of contact. Based on workload the PD and PM may be the same person.

D. Confidentiality

The Contractor shall protect the confidentiality of any proprietary compound synthesized or received under the contract. The Contractor shall not release information regarding a proprietary compound or associated proprietary data to parties exclusive of the CBC program without the express written consent of the NCI. The Contractor shall agree to sign CBC Participant agreements, Material Transfer Agreements, and Confidentiality and Nondisclosure Agreements (e.g. see http://ott.od.nih.gov).

E. Licenses and Permits

The Contractor will be required to maintain all necessary licenses and permits throughout the life of the contract. The Contractor shall have in place at the time of proposal submission all local, state and federal licenses and permits necessary for the execution of the proposed work. This shall include, but may not be limited to, permits to occupy a suitable repository facility and permits to store, distribute and dispose of hazardous materials (e.g. EPA hazardous waste generator identification number).

F. Safety

The Contractor shall operate in compliance with OSHA Safety regulations, State and local regulations. They shall provide a satisfactory Chemical Hygiene plan. The Contractor shall update the plan as required by regulation.

G. Security

The Contractor shall take adequate measures to insure the security of all Government property, including compounds, arrayed sets and associated data. All IT systems and procedures shall conform to NIH IT Security policies and procedures. The Contractor shall update their procedures and systems as necessary. In addition to the standard background investigations, non-disclosure agreements, and IT security awareness training, a system security plan conforming to NIST 800-18, Guide for Developing Security Plans for Federal Information Systems (http://csrc.nist.gov/publications/nistpubs/800-18-Rev1/sp800-18-Rev1-final.pdf) covering security controls recommended in NIST 800-53, Recommended Security Controls for Federal Information Systems and Organizations (http://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf) shall be implemented, if required. Additionally, the IT systems containing sensitive information shall be covered under a certification and accreditation that includes an independent agent System Test and Evaluation as well as written and annually tested contingency plans as outlined in NIST Guide for the Security and Certification and Accreditation of Federal Information Systems (https://www.fismacenter.com/SP800-37-final.pdf) and NIST Contingency Planning Guidelines (http://csrc.nist.gov/publications/nistpubs/800-34-rev1/sp800-34-rev1_errata-Nov11-2010.pdf.

H. Section 508 Compliance

All products and deliverables associated with the tasks described within this Statement of Work that are intended for distribution via the Internet or have the potential for access through the Internet must be compliant with requirements specified in Section 508 of the Federal Rehabilitation Act, as amended in 1998. This Act addresses any/all electronic and information technology (EIT). As such, those procured through this effort must meet the applicability accessibility standards at 36 CFR 1194.36. CFR1194 implements Section 508 of the Rehabilitation Act of 1973, as amended, and is viewable at http://www.section508.gov. The contractor is responsible for reviewing this regulation, which can also be reviewed on http://www.access-board.gov/index.php.

The following Section 508 standard applies to this project:

1194.22 – Web-based Intranet and Internet Information and Application

I. Transition to the Subsequent Contractor

1. At least twelve (12) months prior to the completion date of this contract, the Contractor shall submit a written plan/system to the COR for the potential transfer of all compounds, arrayed sets and Government property to an offsite storage facility (potentially a successor Contractor or the NCI). A general inventory of compounds, arrayed sets and other Government property shall be included.

2. Upon request by the COR, at least three (3) months prior to the completion of the contract, a full and complete inventory of compounds and arrayed sets in the repository and all Government-owned property including scientific equipment, software programs and databases, data files, etc., shall be provided. At this time, the Contractor shall also describe their specific plans for packaging and shipping all such compounds, arrayed sets, data and Government property to a successor Contractor or the NCI, and a cost estimate for this transition.

3. The Contractor shall fully cooperate with any successor Contractor and the NCI to ensure the smooth, efficient and timely transfer of all such data and Government property, including providing access to any essential uniquely trained staff to complete the transfer of informatics and any other critical components of the operation.

Solicitation Date:

The solicitation is scheduled for electronic release on or about April 10, 2015. The RFP may be accessed through the NCI Office of Acquisitions, NCI homepage by using the following address:

http://rcb.cancer.gov/rcb-internet/index.jsp; or through FedBizOpps.gov https://www.fbo.gov/.

It is the offeror’s responsibility to monitor the above internet sites for the release of this solicitation and amendments if any. ALL OFFERORS WILL BE RESONSIBLE FOR

DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. IN

ADDITION, ALL QUESTIONS MUST BE SUBMITTED ELECTRONICALLY. NO FAX

SUBMISSIONS WILL BE ACCEPTED. NO COLLECT CALLS WILL BE ACCEPTED.

Other Important Considerations:

The contract type is single award, five (5) year, Indefinite Delivery Indefinite Quantity (IDIQ) (FAR 16.5) type contract. Task Orders will be either cost reimbursement completion, fixed price completion, or a combination of both. Offerors shall submit two sample task orders with their proposal. The sample tasks will be detailed in the solicitation. This acquisition will be full and open due to the responses that were received from a small business sources sought notice that was posted on January 5, 2015.

NAICS Code and Size Standard: The North American Industry Classification System (NAICS) code that will be used is 541990 and a size standard of $15.0 Million.

DISCLAIMER AND IMPORANT NOTES: This notice does not obligate the Government to award a contract. Interested parties are advised that the Government is under no obligation to acknowledge receipt of any information received or provide feedback to interested parties with respect to any information submitted.

Point of Contact: Heidi A Crawley, Contracting Officer crawleyha@mail.nih.gov Riverside Five, Suite 400 8490 Progress Drive Frederick, MD 21701 Phone: 301-624-8764