18-233-SOL-00115_EPA_Microelectronic_Monitoring_of_Cellular_Status.pdf

SECTION A - Solicitation/Contract Form

A.1 PROPOSAL REQUEST

From:

Department of Health and Human Services

Program Support Center

Acquisition Management Services

Subject: Request for Offer 18-233-SOL-00115: EPA Microelectronic Monitoring of Cellular Status

The Department of Health and Human Services (HHS), Program Support Center (PSC) is issuing this solicitation for the purpose of entering into an Indefinite Delivery, Indefinite Quantity Contract. PSC will conduct this acquisition using Subpart 16 under the Federal Acquisition Regulation. PSC will conduct this acquisition using Federal Acquisition Regulations Subpart 12 and

13.5. This requirement will be a Total Small Business Set-aside This requirement is for the Environmental Protection Agency

(EPA).

Offeror is required to submit a written technical proposal and a price proposal to Government officials for the purposes of assuring that the prospective Contractor is fully cognizant of the scope of this contract and has the capability to complete all Statement of

Work (PWS) requirements. The Government anticipates making a single award as a result of this notice. Awards will be made to the responsible offeror(s) whose offer(s) conform to the solicitation and are the most advantageous to the Government, price and other factors considered.

This solicitation does not commit the Government to pay any costs for the preparation and submission of your proposal. It is also brought to your attention that the Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with the proposed requirement.

SOLICITATION TECHNICAL INQUIRIES AND QUESTIONS

All questions regarding the solicitation, of a contractual nature or technical nature, must be submitted in writing no later than

3:00pm Eastern Time, February 12, 2018. Submission shall be via email to Jimmy.Nguyen@psc.hhs.gov. See Section L of the solicitation for inquiry and submission instructions.

PROPOSAL SUBMISSION

Proposal must be submitted in writing no later than 3:00pm Eastern Time, March 22, 2018. Submission shall be submitted electronically via email to Jimmy.Nguyen@psc.hhs.gov.

All questions pertaining to the contents of this solicitation must be submitted in writing. See Section L of the solicitation for inquiry and submission instructions.

This solicitation does not commit the Government to pay any costs for the preparation and submission of your proposal. It is also brought to your attention that the Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with the proposed requirement.

mailto:Jimmy.Nguyen@psc.hhs.gov

Document Title: EPA Microelectronic Monitoring of Cellular Status Document Number:

18-233-SOL-00115

Page:

Contents

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 TITLE

B.2 BRIEF DESCRIPTION OF SERVICES/SUPPLIES

B.3 INDEFINITE DELIVERY, INDEFINITE QUANTITY CONTRACT

B.4 ORDER TYPES

B.5 MINIMUM AND MAXIMUM QUANTITIES (IDIQ)

B.6 CONTRACT LINE ITEM PRICING

SECTION C - DESCRIPTION/SPECIFICATIONS/PERFORMANCE WORK STATEMENT

C.1. SUMMARY

C.2. BACKGROUND

C.3. SCOPE

C.4. TASKS

SECTION D - PACKAGING AND MARKING

D.1 PACKAGING AND MARKING

D.2 PAYMENT OF POSTAGE AND FEES

SECTION E - INSPECTION AND ACCEPTANCE

E.1 INSPECTION AND ACCEPTANCE

E.2 PLACE OF INSPECTION AND ACCEPTANCE

E.3 INSPECTION AND ACCEPTANCE BY THE GOVERNMENT

E.4 SCOPE OF INSPECTION

E.5 BASIS OF ACCEPTANCE

E.6 NON-CONFORMING PRODUCTS OR SERVICES

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SECTION F - DELIVERIES OR PERFORMANCE

F.1 ORDERING PERIOD

F.2 PERIOD OF PERFORMANCE………………………………………………………………..…………………14

F.3 PLACE OF PERFORMANCE

F.4 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

F.5 OBSERVANCE OF LEGAL HOLIDAYS AND DAYS OF GOVERNMENT CLOSURE – ONSITE

CONTRACTOR EMPLOYEES

SECTION G - CONTRACT ADMINISTRATION DATA

G.1 AUTHORITIES OF GOVERNMENT PERSONNEL

G.2 CONTRACTING OFFICER'S REPRESENTATIVE (COR) AUTHORITY

G.3 INVOICE SUBMISSION

G.4 ELECTRONIC SUBCONTRACTING REPORTING SYSTEM (eSRS) REPORTING .. Error! Bookmark not defined.

SECTION H - SPECIAL CONTRACT REQUIREMENTS

H.1 INDIVIDUALS AUTHORIZED TO PURCHASE UNDER THE IDIQ

H.2 FREQUENCY OF ORDER

H.3 IDIQ TASK ORDER PROCEDURES

H.4 PRICE REDUCTIONS

H.5 PROHIBITION AGAINST PERSONAL SERVICES

H.6 CONTRACTOR PERFORMANCE EVALUATION(S)

H.7 RESTRICTIONS ON CONTRACTOR ACCESS TO GOVERNMENT OR THIRD PARTY

INFORMATION

H.8 MANAGEMENT OF SENSITIVE INFORMATION

H.9 POST AWARD ORGANIZATIONAL CONFLICT OF INTEREST

H.10 TASK ORDER/DELIVERY ORDER OMBUDSMAN

H.11 KEY PERSONNEL

H.12 HIGHER-LEVEL CONTRACT QUALITY REQUIREMENT (FAR 52.246-11) (DEC 2014)…………

SECTION I - CONTRACT CLAUSES .............................................................................. ERROR! BOOKMARK NOT DEFINED.

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I.1 FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

I.2 52.212-4 CONTRACT TERMS AND CONDITIONS – COMMERCIAL ITEMS (Jan 2017) (DEVIATION)

I.3 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR

EXECUTIVE ORDERS – COMMERCIAL ITEMS (Nov 2017)

I.4 52.216-18 ORDERING

I.5 52.216-19 ORDER LIMITATIONS (DEVIATION)

I.6 52.216-22 INDEFINITE QUANTITY

I.7 FAR 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

I.8 FAR 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) Error! Bookmark not defined.

I.9 52.232-40 PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS .. 33

I.10 HHSAR 352.203-70 ANTI-LOBBYING (MAR 2012)

I.11 HHSAR 352.237-73 NON-DISCRIMINATION IN SERVICE DELIVERY (MAR 2012)

I.12 52.203-99 PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN

INTERNAL CONFIDENTIALITY AGREEMENTS (FEB 2015) (DEVIATION 2015-02)

I.13 52.252-6 AUTHORIZED DEVIATIONS IN CLAUSES (Apr 1984)

SECTION J – LIST OF ATTACHMENTS

SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS OR

RESPONDENTS

K.1 FAR 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

K.2 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS

K.3 52.209-11 REPRESENTATION BY CORPORATIONS REGARDING DELINQUENT TAX LIABILITY

OR A FELONY CONVICTION UNDER ANY FEDERAL LAW

K.4 FAR 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS-COMMERCIAL ITEMS (Jan

2017)

K.5 52.223-22 PUBLIC DISCLOSURE OF GREENHOUSE GAS EMISSIONS AND REDUCTION GOALS -

REPRESENTATION

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS OR RESPONDENTS

L.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE. (FEB 1998)

L.2 52.216-1 TYPE OF CONTRACT

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L.3 52.233-2 SERVICE OF PROTEST

L.4 52.252-5 AUTHORIZED DEVIATIONS IN PROVISIONS. (APR 1984)

L.5 NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM CODE

L.6 INQUIRIES/SUBMISSION

L.7 GENERAL INSTRUCTIONS

L.8 ADMINISTRATIVE VOLUME INSTRUCTIONS (VOLUME 1)

L.9 TECHNICAL VOLUME INSTRUCTIONS (VOLUME 2)

L.10 PAST PERFORMANCE (VOLUME 3)

L.11 BUSINESS VOLUME INSTRUCTIONS (VOLUME 4)

SECTION M - EVALUATION FACTORS FOR AWARD

M.1 GENERAL

M.2 AWARD WITHOUT DISCUSSIONS AND COMPETITIVE RANGE DETERMINATIONS

M.3 BASIS FOR AWARD

M.3 TECHNICAL EVALUATION CRITERIA

M.4 RATING FOR TECHNICAL EVALUATION

M.7 PAST PERFORMANCE EVALUATION

M.8 PRICE EVALUATION

M.9 RESPONSIBILITY

M.10 ORGANIZATIONAL CONFLICT OF INTEREST

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SECTION B - Supplies or Services and Prices/Costs

B.1 TITLE

EPA ToxCast Prioritization of Environmentally Relevant Chemicals: Microelectronic Monitoring of Cellular Status

B.2 BRIEF DESCRIPTION OF SERVICES/SUPPLIES

The Environmental Protection Agency requires a contractor to perform microelectronic monitoring of cells in culture to measure altered cellular physiology/pathology in response to exposure to potential environmental toxicants. Use of this approach provides a sensitive measure of changes in cellular physiology that may correlate with toxic activities of test compounds. These results will be used in the ToxCast Project for prioritizing compounds for more in-depth toxicological evaluation. Use of physiologically relevant cells (lines) is required, including cells with phase I and phase II metabolic capabilities as well as primary cells. Co-cultures of multiple cell types that provide relevant physiological conditions are also of interest. The Contractor shall use a microelectronic cell monitoring system to measure the response of one or more rodent or human cells types to compounds from the ToxCast library. The compounds from the ToxCast library will be supplied to the contractor by the EPA or by an EPA contractor.

B.3 INDEFINITE DELIVERY, INDEFINITE QUANTITY CONTRACT

This award is for a single award Indefinite Delivery, Indefinite Quantity Contract (IDIQ). The government estimates, but does not guarantee, that the volume of purchases using this IDIQ will be $6,000,000.00. The IDIQ does not obligate funds. The government is obligated only to the extent authorized in IDIQ task orders (also referred to as “task orders”) placed against this

IDIQ.

B.4 ORDER TYPES

Task orders issued under this IDIQ shall be: Firm-Fixed-Priced (FFP) orders.

B.5 MINIMUM AND MAXIMUM QUANTITIES (IDIQ)

During the contract period, the Government shall place orders totaling a minimum of 10 samples and a maximum of 10,000 samples. This reflects the contract minimum for the entire period of performance. The contract maximum for the entire period of performance shall be for the placement of orders totaling a maximum of 10,000 samples.

B.6 CONTRACT LINE ITEM PRICING

The price for each task order will be based on the negotiated unit prices listed below and estimated level of effort, or firm fixed price amount, to be determined at the time of task order award.

The Contractor will be reimbursed in accordance with pricing section of each task order for satisfactory performance of the work.

The following price chart per CLIN shall apply for payment purposes for the duration of the IDIQ.

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TASK DESCRIPTION

MAX

QTY

UNIT

UNIT

PRICE

EXTENDED

PRICE

001: General Toxicity

Testing

Expose A549 cells to compounds supplied by EPA and micro-electronically monitor response 24-48 hrs. Sample in 8-point concentration response dilution series, in duplicate.

Other cell types may be used instead of

A549 per EPA request.

Sample

002: Estrogen Receptor

Agonist Identification

Expose T-47D cells to compounds supplied by EPA and mirco-electronically monitor response for 72hrs or longer. Sample in 8-point concentration response dilution series, in duplicate. Other cell types such as

LNCaP and MCF-7 may also be used per

EPA request. Prices are for single cell line testing.

003: Estrogen Receptor

Antagonist (include agonist) Identification

Expose T47D cells to a) EPA compounds alone, and b) EPA compounds followed with 17-betaestradiol; and micro-electronically monitor responses for 72 hrs longer. Sample in 8 point concentration response dilution series, in duplicate. Other cell types such as

LNCaP and MCF-7 may also be used per

EPA request. Prices are for a single cell line testing.

004: Cardio Toxicity

Testing

Expose iCELLS to compounds supplied by EPA and micro-electronically monitor response general toxicity and beating patter for 24 hrs. Sample in 8-point concentration response dilution series in duplicate.

005: Hepatotoxicity

Hepatotoxicity testing to evaluate cytotoxicity with relevance to metabolism and species differences.

Expose co-cultures to compounds supplied by EPA and micro-electronically monitor response for 2 weeks, with treatment repeated 7 times, once every two days. Each co-culture system is tested a) in the absence; and b) in the presence of P450 inhibitor. Each sample is tested for 6 concentrations with half log dilution series, in triplicates.

006: Hepatotoxicity

Hepatotoxicity testing to evaluate cytotoxicity with relevance to metabolism and species differences.

Expose co-cultures to compounds supplied by EPA and micro-electronically monitor response for 7 days, with treatment repeated 4 times, once every two days. Each co-culture system is tested a) in the absence; and b)

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in the presence of P450 inhibitor. Each sample is tested for 6 concentrations with half log dilution series, in triplicates.

007: Media Collection and Storage

Media collection and storage at one time point for hepatotoxicity evaluation under two testing conditions. Collect the replaced media at one selected time point from all co-cultures treated with EPA compounds and microelctronically monitored as described in CLIN#5 or 6.

008: Media Collection and Storage

Media collection and storage at 7 time points for 2 weeks hepatotoxicity evaluation under two testing conditions.

For 14 days exposure experiment, collect the replaced media once every two days from all co-cultures treated with EPA monitored as described in CLIN#5.

009: Media Collection and Storage

Media collection and storage at 4 time points for 1 week's hepatotoxicity evaluation under two testing conditions.

For 8 days exposure experiment, collect the replaced media once every two days from all co-cultures treated with EPA monitored as described in CLIN#6.

010: CellTiter Blue assay

CellTiter Blue assay at the end of RTCA experiment under two testing conditions.

At the end of the RTCA assay as described in CLIN#5 or CLIN#6, perform Cell Titer Blur assay in all tested cell plates.

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SECTION C - Description/Specifications/Performance Work Statement

C.1. SUMMARY

C.1.1. TITLE

ToxCast Prioritization of Environmentally Relevant Chemicals: Microelectronic Monitoring of Cellular Status

C.1.2. This section describes, in general terms, the work to be performed by the Contractor throughout the performance period of the Indefinite Delivery, Indefinite Quantity Contract (IDIQ). The contractor shall not rely solely on the description provided in this section to identify all project components. Any provision or clause not already defined in this IDIQ will be provided with each individual order.

C.1.3. This is a non-personal service requirement for microelectronic monitoring of cellular status support services. This

Performance Work Statement (or PWS) summarizes the work to be performed to include but not limited to, scope;

applicable documents; performance requirements/tasks; and, contractor quality assurance.

C.2. BACKGROUND

C.2.1. The Environmental Protection Agency requires a contractor to perform microelectronic monitoring of cells in culture to measure altered cellular physiology/pathology in response to exposure to potential environmental toxicants. Use of this approach provides a sensitive measure of changes in cellular physiology that may correlate with toxic activities of test compounds. These results will be used in the ToxCast Project for prioritizing compounds for more in-depth toxicological evaluation. Use of physiologically relevant cells (lines) is required, including cells with phase I and phase II metabolic capabilities as well as primary cells. Co-cultures of multiple cell types that provide relevant physiological conditions are also of interest. The Contractor shall use a microelectronic cell monitoring system to measure the response of one or more rodent or human cells types to compounds from the

ToxCast library. The compounds from the ToxCast library will be supplied to the contractor by the EPA or by an

EPA contractor.

C.3. SCOPE

The Contractor shall furnish all resources including the necessary personnel, material, equipment, services, and facilities to perform the tasks outlined in the Performance Work Statement (PWS). This includes general contract management and oversight functions such as meetings and teleconferences with EPA to review issues, problems, and performance.

Work shall be issued through task orders and the requirements for deliverables, delivery schedule, and acceptance criteria shall be specified in the task orders. Each task order shall be processed and data submitted to EPA within

120 days of receipt of samples. The EPA or one of its contractors will provide compounds at a minimum of 10 samples and a maximum of 1,000 samples per task order.

Note: The one term or unit of measure that captures what is being tested under each Contract Line item (CLIN) is

“Sample”. A sample is defined as an individual chemical compound sample, which may include multiple dilutions or technical replicates.

C.4. TASKS

C.4.1. The contractor shall provide Microelectronic Monitoring of Cellular Status of the ToxCast Compound Library using biologically and statistically validated bioassays. The Contractor shall receive compounds in 96 or 384-well plates in neat Dimethyl Sulfoxide (DMSO) and test these in assays monitoring cell impedance, growth and cytotoxicity.

The EPA will specify which assays offered by the Contractor should be used for each batch of compounds provided.

The contractor shall test these at either a single concentration, in duplicate or higher replicates, or in a concentration-response format of 5 or more concentrations. In general, all compounds will be tested at the same set of concentrations. Because chemicals can cause cytotoxicity or other types of assay interference at high concentration, the Contractor shall define a method to quantitatively (i.e. as a function of concentration) detect cytotoxicity and other known modes of assay interference.

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The Contractor shall describe how they will determine appropriate testing concentrations for the types of compounds being submitted for testing by the EPA. The EPA will make the final decision about the final screening concentration of the compounds. Cell impedance and growth shall be continuously monitored for a period of at least 24-hr following treatment with compound. The exact duration for the monitoring should be chosen by the

EPA following discussions with the Contractor.

Processing of each sample may include multiple Contract Line Items (CLINs) offered by the contractor. The

CLINs that will be ordered will be chosen by the EPA. Thus, any combination of CLINs may be ordered and applied to each sample batch. Processing of each sample batch shall be in accordance with the contractor’s approved task order work plan.

In most instances, compounds will be provided by the EPA or its contractor in 96 or 384-well plates in 100% DMSO at a single concentration, e.g. 20 mM. The Contractor shall indicate how compounds will be handled and the amount of compound required to ensure the running of the complete proposed panel of bioassays. The Contractor shall also indicate what format (e.g. 96- or 384-well), diluents and concentration(s) are compatible with their assays and capabilities.

The Contractor shall indicate how the testing process will ensure the minimal number of false negatives in the bioassays being conducted. Examples of such procedures include:

Use of statistically validated bioassays

Testing of replicate wells

Data showing the effect of DMSO on assay performance

Positive and negative controls used on all plates tested

Compounds not stored as aqueous dilutions

Performance shall be closely coordinated with EPA staff throughout the process. This coordination shall be facilitated through periodic meetings or teleconferences between contractor staff, EPA Contracting Officer

Representative(s) (COR) and other EPA staff as appropriate. At these meetings, the following issues will be discussed:

-- compound batches to be shipped for testing

-- specific assays to be conducted on each compounds batch

-- testing concentration of each compound batch

-- quality control/quality assurance issues for the assays being conducted

-- overall project planning and scheduling.

The Contractor shall certify that all animal research, procedures and facilities utilized within the scope of this requirement are consistent with the recommendations of the 1996 NRC "Guide for the Care and Use of Laboratory

Animals," the Animal Welfare Act and Public Health Service Policy on the Humane Care and Use of Laboratory

Animals.

C.4.2. QUALITY ASSURANCE

C.4.2.1. The Contractor shall carry out a comprehensive Quality Assurance (QA) program for this contract.

C.4.2.2. All Standard Operating Procedures (SOPs) used under this contract shall include adequate Quality Control (QC) to ensure the data are within acceptable error limits and are of known, acceptable, and verifiable quality. At a minimum, the Contractor shall include quantitative criteria for the decision to pass or fail test data for each assay on a per plate basis. The pass/fail criteria will typically be based on positive and negative controls run on the same plate as samples and on results that indicate patterns significantly different from normal. The Contractor shall repeat the assay(s) for those that do not meet the appropriate QC standard at no cost to the Government.

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C.4.2.3. EPA may conduct external systems audits of contract activities including sample preparation, analytical, and data management procedures. EPA may also conduct performance audits by using independent QC and performance evaluation (PE) samples, (i.e. standards, blind samples, split samples, etc.) to verify the contractor's analytical performance. EPA may conduct an onsite quality systems and technical systems audit of the facility where the contract work is conducted within one year of the award of the contract. The onsite audit will include a walk-through of the lab spaces where the work for the contract is conducted and will usually be half-day in duration.

C.4.2.4. The contractor shall notify the Contracting Officer Representative of any personnel changes to the Quality

Assurance Manager. Proposed substitutes shall have comparable qualifications to those of the persons being replaced.

C.5. OPEN ACCESS STATEMENT

C.5.1. As part of EPA’s commitment to gather and share its chemical data openly and clearly, all ToxCast chemical data is publicly available for anyone to access and use through user-friendly Web applications called interactive

Chemical Safety for Sustainability (iCSS) Dashboards. Currently, iCSS dashboards provide an accessible portal for users to search and query the ToxCast chemical screening data.

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SECTION D - Packaging and Marking

D.1 PACKAGING AND MARKING

All deliverables shall be delivered to the Contracting Officer’s Representative (COR) identified in Section G and shall be marked as follows, unless changed at the order level:

1. Name and address of the Contractor;

2. Contract Number;

3. Description of item contained therein; and

4. Consignee's name and address.

D.2 PAYMENT OF POSTAGE AND FEES

All postage and fees related to submitting information including forms, reports, etc. to the Contracting Officer or COR shall be paid by the Contractor.

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SECTION E - Inspection and Acceptance

E.1 INSPECTION AND ACCEPTANCE

Pursuant to 52.212-4, all work described in the PWS to be delivered under this IDIQ is subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the Government's COR, who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor.

E.2 PLACE OF INSPECTION AND ACCEPTANCE

Inspection and acceptance of all work performed, reports, and other deliverables required under this contract shall be performed by the COR at the addresses specified in the individual order / call.

E.3 INSPECTION AND ACCEPTANCE BY THE GOVERNMENT

The Contracting Officer Representative (COR), as a duly authorized representative of the Contracting Officer, shall assume the responsibilities for monitoring the Contractors’ performance, evaluating the quality of services provided by the Contractor, and performing final inspection and acceptance of all deliverables for payment. Inspection of services performed under this contract shall be performed in accordance with FAR 52.212-4 Contract Terms and Conditions – Commercial Items (May 2015).

All deliverables shall be considered accepted within three weeks of submission to the COR unless the COR, or other designee, has provided written comments to the contractor requesting revisions to the deliverables.

E.4 SCOPE OF INSPECTION

All deliverables will be inspected for content, completeness, accuracy, and conformance with contract requirements by the COR.

The scope and nature of this inspection will be sufficiently comprehensive to ensure the completeness, quality, and adequacy of all deliverables.

E.5 BASIS OF ACCEPTANCE

The basis for acceptance shall be compliance with the requirements and relevant terms and conditions of set forth in the contract.

Deliverable items rejected shall be corrected in accordance with the applicable clauses.

If the Government finds that a draft or final deliverable contains spelling errors, grammatical errors, or improper format, or otherwise does not conform to the requirements stated within this contract, the document may be immediately rejected without further review and returned to the contractor for correction and resubmission. If the contractor requires additional Government guidance to produce an acceptable draft, the contractor shall arrange a meeting with the COR.

All of the Government’s comments on deliverables must either be incorporated in the succeeding version of the deliverable, or the contractor must demonstrate to the Government's satisfaction why such comments should not be incorporated.

Deliverables will be accepted when all discrepancies, errors, or other deficiencies identified in writing by the Government have been corrected.

E.6 NON-CONFORMING PRODUCTS OR SERVICES

Non-conforming products or services will be rejected. Deficiencies will be corrected by the contractor, within ten workdays of the rejection notice. If the deficiencies cannot be corrected within ten workdays, the contractor will immediately notify the COR of the reason for the delay and provide a proposed corrective action plan within ten workdays.

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SECTION F - Deliveries or Performance

F.1 ORDERING PERIOD

The ordering period shall be for a base period of 60 months from date of award.

The period of performance for individual orders can extend beyond the expiration date of the IDIQ. The Contractor shall not be required to make any deliveries under this IDIQ after the completion of the order which should not extend 60 months following the expiration of the IDIQ ordering period.

F.2 PERIOD OF PERFORMANCE

The period of performance for individual task orders can extend beyond the expiration date of the IDIQ. The Contractor shall not be required to make any deliveries under this contract after the completion of the order, which should not extend recommend

60 months following the expiration of the IDIQ ordering period.

F.3 PLACE OF PERFORMANCE

Unless specifically stated otherwise in the individual task order/call, the place of performance shall be at the contractor’s facilities. However, as appropriate to the specific tasks, the contractor will have access to Government facilities in order to facilitate meetings and other discussions.

F.4 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

The contractor shall submit all required deliverables in accordance with the schedule established in the statement of work and each individual task order. Deliverables submitted under each individual task order shall reference and cite the IDIQ Number and the specific task order number, if applicable.

F.4.1 For each task order the contractor shall submit reports to the Task Order Contracting Officer Representative (TOCOR) or designated alternate. The reports shall be in the following format which is consistent with the ToxCast Data Analysis

Pipeline, where applicable:

Compound key

Assay name

Assay method

Assay target

Assay target species

Substrate/radioligand

Positive control

Positive control bioactivity results

Negative control

Negative control bioactivity results

Compound screening concentration

Compound bioactivity results, well level, raw data

Compound bioactivity results, well level, expressed as percent of positive control or fold change relative to negative control

Short assay protocol

QA/QC test results

F.4.2 Electronic files shall be delivered via the following methods based on the size of the files.

Electronic files less than 2 gigabytes in size will be uploaded to a contractor provided Dropbox, FTP or

SharePoint. The contractor will provide access to the Contracting Officer Representative (COR) via their

EPA email.

Electronic files equal to and greater than 2 gigabytes will be delivered via USB drive. EPA will provide the drive via FedEx delivery with a return envelope.

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Additional requirements for deliverables may be specified in the task orders.

F.5 OBSERVANCE OF LEGAL HOLIDAYS AND DAYS OF GOVERNMENT CLOSURE – ONSITE

CONTRACTOR EMPLOYEES

(a)(1) Performance requires contractor employees of the prime contractor or any subcontractor, affiliate, partner, joint venture, or team member with which the contractor is associated, including consultants engaged by any of these entities, to have access to, physical entry into, and to the extent authorized, mobility within, a Federal facility.

(2) HHS may close and or deny contractor access to a Federal facility for a portion of a business day or longer due to any one of the following events:

(i) Federal public holidays for federal employees in accordance with 5 U.S.C. 6103.

(ii) Fires, floods, earthquakes, unusually severe weather to include snow storms, tornadoes and hurricanes.

(iii) Occupational safety or health hazards.

(iv) Any other reason.

(3) In such events, the contractor employees may be denied access to a Federal facility, in part or in whole, to perform work required by the contract. Contractor personnel already present at a Federal facility during such events may be required to leave the facility.

(b) In all instances where contractor employees are denied access or required to vacate a Federal facility, in part or in whole, the contractor shall be responsible to ensure contractor personnel working under the contract comply. If the circumstances permit, the contracting officer will provide direction to the contractor, which could include continuing on-site performance during the

Federal facility closure period. In the absence of such direction, the contractor shall exercise sound judgment to minimize unnecessary contract costs and performance impacts by, for example, performing required work off-site if possible or reassigning personnel to other activities if appropriate.

(c) The contractor shall be responsible for monitoring when the Federal facility becomes accessible and shall resume contract performance as required by the contract.

(d) For the period that Federal facilities were not accessible to contractor employees, the contracting officer may—

(1) Adjust the contract performance or delivery schedule for a period equivalent to the period the Federal facility was not accessible;

(2) Forego the work;

(3) Reschedule the work by mutual agreement of the parties; or

(4) Consider properly documented requests for equitable adjustment, claim, or any other remedy pursuant to the terms and conditions of the contract.

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SECTION G - Contract Administration Data

G.1 AUTHORITIES OF GOVERNMENT PERSONNEL

Notwithstanding the Contractor's responsibility for total management during the performance of this contract, the administration of this contract will require maximum coordination between the Government and the Contractor. The following individuals will be the Government's points of contact during the performance of this contract:

Administrative Contracting Officer

Samuel Layton

(801)-524-3440

Samuel.Layton@psc.hhs.gov

All communications pertaining to contractual and/or administrative matters under this IDIQ and the TOs shall be sent to:

Contract Specialist

Jimmy Nguyen, Contract Specialist

DHHS/PSC/AMS

7700 Wisconsin Avenue

Bethesda, Maryland 20857

Office: (703) 259-9375

Jimmy.Nguyen@hhs.psc.gov

Contracting Officer's Representative

TBD

Note: The Government Contracting Officer is the only individual authorized to modify this requirement.

G.2 CONTRACTING OFFICER'S REPRESENTATIVE (COR) AUTHORITY

(a) Performance of work under this contract must be subject to the technical direction of the Contracting Officer's Representative identified above, or a representative designated in writing. The term "technical direction" includes, without limitation, direction to the contractor that directs or redirects the labor effort, shifts the work between work areas or locations, fills in details and otherwise serves to ensure that tasks outlined in the work statement are accomplished satisfactorily.

(b) Technical direction must be within the scope of the specification(s)/work statement. The Contracting Officer's Representative does not have authority to issue technical direction that:

(1) Constitutes a change of assignment or additional work outside the specification(s)/statement of work;

(2) Constitutes a change as defined in the clause entitled "Changes";

(3) In any manner causes an increase or decrease in the contract price, or the time required for contract performance;

(4) Changes any of the terms, conditions, or specification(s)/work statement of the contract;

(5) Interferes with the contractor's right to perform under the terms and conditions of the contract; or

(6) Directs, supervises or otherwise controls the actions of the contractor's employees.

(c) Technical direction may be oral or in writing. The Contracting Officer's Representative shall confirm oral direction in writing within five work days, with a copy to the Contracting Officer.

(d) The contractor shall proceed promptly with performance resulting from the technical direction issued by the Contracting

Officers, Representative. If, in the opinion of the contractor, any direction of the Contracting Officers, Representative, or his/her designee, falls within the limitations in (b), above, the contractor shall immediately notify the Contracting Officer no later than the beginning of the next Government work day.

(e) Failure of the contractor and the Contracting Officer to agree that technical direction is within the scope of the contract shall be subject to the terms of the clause entitled "Disputes."

G.3 INVOICE SUBMISSION

mailto:Samuel.Layton@psc.hhs.gov mailto:Jimmy.Nguyen@hhs.psc.gov

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(1) Invoice Submission

The Contractor shall submit invoices once per month.

A proper invoice, not including non-invoice related documents (i.e. deliverables, reports, balance statements) shall be sent electronically, via email, to:

1. Contract Specialist via mailbox: pscsas.invoices@psc.hhs.gov

2. Financial Management Service (FMS) via mailbox: psc_invoices@psc.hhs.gov

3. Contracting Officer’s Representative (COR): TBD

4. Contract Specialist: Jimmy.Nguyen@psc.hhs.gov

The subject line of your email invoice submission shall contain the contract number, order number (if applicable), and the number of invoices. The Contractor shall send one email per contract per month. The email may have multiple invoices for the contract.

Invoices must be in the following formats: PDF, TIFF, or Word. No Excel formats will be accepted. The electronic file cannot contain multiple invoices; example, 10 invoices requires 10 separate files (PDF or TIFF or Word).

Invoices shall be submitted in accordance with the contract terms, i.e. payment schedule, progress payments, partial payments, deliverables, etc.

All calls concerning contract payment shall be directed to the COR.

Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget

(OMB) prompt payment regulations at 5 CFR Part 1315.

(2) Invoice Elements

In accordance with FAR 52.212-4, Contract Terms and Conditions-Commercial Items, the Contractor shall submit an electronic invoice to the email addresses designated in the contract to receive invoices. A proper invoice must include the following items:

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, contract line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on

Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice.

(B) In accordance with the requirements of the Debt Collection Improvement Act of 1996, all payments under this order will be made by electronic funds transfer (EFT). The Contractor shall provide financial institution information to the Finance Office designated above in accordance with FAR 52.232-33 Payment by Electronic Funds Transfer - System for Award Management.

Additionally, the Program Support Center (PSC) requires:

(i) the invoice to break-out price/cost by contract line item number (CLIN) as specified in the pricing section of the contract

(ii) the invoice to include the Dun & Bradstreet Number (DUNS) of the Contractor mailto:pscsas.invoices@psc.hhs.gov mailto:psc_invoices@psc.hhs.gov mailto:gary.wright4.civ@mail.mil

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SECTION H - Special Contract Requirements

H.1 INDIVIDUALS AUTHORIZED TO PURCHASE UNDER THE IDIQ

The ordering activity is defined as Contracting Officers working for the Acquisition Management Services of the Program

Support Center for the U.S. Department of Health and Human Services.

H.2 FREQUENCY OF ORDER

The amount of total IDIQ task orders and service tickets issued under this IDIQ is unknown.

H.3 IDIQ TASK ORDER PROCEDURES

The Contractor will be provided with a description of the work to be performed (Statement of Work, Performance Work

Statement, or Statement of Objectives), schedule of deliverables and other additional instructions as needed for each individual task order to be issued under this IDIQ. These documents collectively referred to as a Request for Quotation (RFQ), will be issued by email.

Special conditions such as Section 508 Compliance, HSPD-12, Human Subjects, etc. will be addressed at the task order level when the requirement is defined.

The RFQ package will include special instructions that are particular to the requirement. Provisions specific to the work to be performed under an order will be included in the RFQs per applicable regulations and policies.

The Government is not obligated to issue an order against any RFQ. The Government may modify, delay action on, or cancel any RFQ when deemed to be in the Government’s best interest. The Government will not reimburse the Contractor for any expenses related to offer preparation and submission.

H.4 PRICE REDUCTIONS

Ordering activities may request a price reduction at any time before placing an order or in conjunction with the annual IDIQ review. However, the ordering activity shall seek a price reduction when an individual order exceeds the simplified acquisition threshold.

H.5 PROHIBITION AGAINST PERSONAL SERVICES

The Contractor shall not perform personal services under this contract. Contractor personnel are employees of the Contractor or its subcontractors and are under the administrative control and supervision of the Contractor. A Contractor supervisor must give all individual Contractor employee assignments and daily work direction. The Government will not supervise or direct Contractor employees in the performance of their assignments. If at any time the Contractor believes that any Government action or communication has been given that would create a personal service relationship between the Government and any Contractor employee, the contractor shall promptly notify the Contracting Officer of this communication or action. The Contractor shall not perform any inherently-governmental functions under this contract. No Contractor employee shall represent or give the appearance that he/she is a Government employee, agent or representative. The Contractor is responsible for ensuring that all employees assigned to this contract understand and are committed to following these requirements.

H.7 CONTRACTOR PERFORMANCE EVALUATION(S)

During the life of this contract, Contractor performance may be evaluated on a per individual call, interim, and/or final basis pursuant to FAR Supart 42.15. The Contractor Performance Assessment Reporting System (CPARS) may be utilized for these reviews. Information on CPARS can be located at http://www.cpars.gov.

H.8 RESTRICTIONS ON CONTRACTOR ACCESS TO GOVERNMENT OR THIRD PARTY INFORMATION

The purpose of this clause is to set forth the restrictions that will govern Contractor employees access to Government or third party information in order to protect the information from unauthorized use or disclosure.

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A. Under this contract, the Contractor will have access to Contractor proprietary information and other nonpublic information.

B. Restrictions on use and disclosure of information.

(1) With regard to any information to which the Contractor is given access in performance of this contract, whether the information comes from the Government or from third parties, the Contractor shall:

(i) Utilize the information only for the purposes of performing the services specified in this contract, and not for any other purposes;

(ii) Safeguard information from unauthorized use and disclosure;

(iii) Allow access to the information only to those employees who need it to perform services under this contract;

(iv) Preclude access and disclosure of information to persons and entities outside of the

Contractor's organization that do not have authority to access the information;

(v) Inform employees, who may require access to information, about their obligations to utilize it only to perform the services specified in this contract and to safeguard that information from unauthorized use and disclosure; and

(vi) Ensure each employee complies with the restrictions set forth in (i), (ii), (iii), and (iv) above.

(2) Unless specifically permitted in writing by the Contracting Officer, the Contractor shall not use information acquired in performance of the contract, or generated by or for the Government to:

(i) Compete for work for the Government; or

(ii) Submit an unsolicited proposal to the Government.

(3) If the Contractor is exposed to information that is marked in a way that indicates the Contractor should not receive this information, the Contractor shall:

(i) Notify the Contracting Officer and COR; and

(ii) Use the information only in accordance with the instructions of the

Contracting Officer.

C. Breach of any of the conditions of this modification may provide grounds for the Government to:

(i) Require the contractor to remove the contract employee or employees from the performance of the contract;

(ii) Require the contractor to terminate the subcontractor;

(iii) Suspend contractor payments;

(iv) Terminate this contract for default or cause;

(v) Suspend or debar the Contractor for serious misconduct affecting present responsibility; and;

(vi) Pursue such other remedies as may be permitted by law, regulation, or this contract.

D. Unauthorized disclosure or other misuse of information protected by the Privacy Act of 1974 may result in a fine up to $5000 and /or other penalties. In addition, unauthorized disclosure or other misuse of information covered under the Federal Trade

Secrets Act (18 USC 1905) may result in a fine, or imprisonment up to 1 year, or both.

E. The Contractor shall flow down this clause to subcontractors at all tiers.

H.9 MANAGEMENT OF SENSITIVE INFORMATION

In addition to electronic data security requirements, the contractor must have a plan for the protection of any paper records, field notes, or other documents that contain sensitive or personally identifiable information. In addition, the contractor must notify – within one hour – the COR of any suspected or confirmed instance of compromised data security.

In addition to the requirements specified elsewhere in this contract, the Contractor must have a plan for the protection of any

18-233-SOL-00115

paper records, field notes, or other documents that contain sensitive or personally identifiable information. The Contractor shall ensure that all of its employees, subcontractors (at all tiers), and employees of each subcontractor, who perform work under this contract/subcontract, are trained on data privacy issues and comply with the above requirements.

The Contractor shall submit a written plan and assurance for complying with the above requirements at least annually. See

Personally Identifiable Information (PII) Breach Response Team (BRT) Policy:

http://www.hhs.gov/ocio/policy/20080001.003.html.

H.10 POST AWARD ORGANIZATIONAL CONFLICT OF INTEREST

a. General: The Contractor shall have programs in place to identify, report, and mitigate actual and potential conflicts of interest for itself, its employees, subcontractors and consultants. The existence of such programs and the disclosure of known actual or potential conflicts are material performance requirements of this contract.

b. Disclosure: The Contractor shall report all actual and potential conflicts of interest pertaining to this contract to the

Contracting Officer, including those that would be caused by a contemplated modification to this contact or another contract.

Such reports shall be in writing (including by email). Upon request, the Contractor shall respond to a Contracting Officer's request for an OCI mitigation plan.

c. Resolution: In the event the Contracting Officer determines that a conflict of interest exists, based on disclosure from the Contractor or from other sources, the Contracting Officer shall take action which may include, but is not limited to, requesting a mitigation plan from the Contractor, terminating part or all of the contract, modifying the contract or obtaining a waiver in accordance with applicable law, including FAR 9.503 and EPAAR prrt 1509 as applicable.

H.11 TASK ORDER/DELIVERY ORDER OMBUDSMAN

In accordance with FAR 16.504, the following individual has been designated as the Program Support Center (PSC) task order and delivery order Ombudsman:

Mr. Darryl Grant

PSC Ombudsman

U.S. Department of Health and Human Services

7700 Wisconsin Avenue, Mail Stop 10230B

Bethesda, MD 20857

Phone: 301-492-4724

Email: Darryl.Grant@psc.hhs.gov

H.12 KEY PERSONNEL

The key personnel subject to HHSAR Clause 352.237-75 are as follows:

(a) The Contractor shall assign to each task order the following key personnel:

Program Manager

Senior Scientist

(b) During the first ninety (90) days of performance, the Contractor shall make no substitutions of key personnel unless the substitution is necessitated by illness, death, or termination of employment. The Contractor shall notify the Contracting Officer within 15 calendar days after the occurrence of any of these events and provide the information required by paragraph (c) of this clause. After the initial 90-day period, the Contractor shall submit the information required by paragraph (c) to the

Contracting Officer at least 15 days prior to making any permanent substitutions.

(c) The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the Contracting Officer. Proposed substitutes should have comparable qualifications to those of the persons being replaced. The Contracting Officer will notify the

Contractor within 15 calendar days after receipt of all required information of the decision on substitutions. This clause will be modified to reflect any approved changes of key personnel.

http://www.hhs.gov/ocio/policy/20080001.003.html mailto:Darryl.Grant@psc.hhs.gov

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H.13 HIGHER-LEVEL CONTRACT QUALITY REQUIREMENT (FAR 52.246-11) (DEC 2014)

(a) The Contractor shall comply with the higher-level quality standard(s) listed below.

Specifications and Systems for Environmental Data Collection and Environmental Technology Programs, ANSI/ASQC

E4, 1994.

(b) The Contractor shall include applicable requirements of the higher-level quality standard(s) listed in paragraph

(a) of this clause and the requirement to flow down such standards, as applicable, to lower-tier subcontracts, in—

(1) Any subcontract for critical and complex items (see 46.203(b) and (c)); or

(2) When the technical requirements of a subcontract require—

(i) Control of such things as design, work operations, in-process control, testing, and inspection; or

(ii) Attention to such factors as organization, planning, work instructions, documentation control, and advanced metrology.

As authorized by FAR 52.246-11, the higher-level quality standard ANSI/ASQC E4 is tailored as follows:

The solicitation and contract require the offeror/contractor to demonstrate conformance to ANSI/ASQC E4 by submitting the quality documentation described below.

In addition, after award of the contract, the contractor shall revise, when applicable, quality documentation submitted before award to address specific comments provided by EPA and submit the revised documentation to the

Contracting Officer’s Representative.

After award of the contract, the contractor shall also implement all quality documentation approved by the

Government.

A. Pre-award Documentation:

The offeror must submit the following quality system documentation as a separate and identifiable part of its technical proposal:

Documentation Specifications Due

X Quality Management Plan - NOTE**

Only a list of Standard Operating

Procedures (SOPs) is required with the offer.

EPA Requirements for Quality Management

Plans (QA/R-2) [dated 03/20/01]

With offer

Joint Quality Management Plan / Quality

Assurance Project Plan for the Contract

EPA Requirements for Quality Management

Plans (QA/R2) [dated 03/20/01] and

EPA Requirements for Quality Assurance

Project Plans (QA/R-5) [dated 03/20/01]

With offer

Programmatic Quality Assurance Project

Plan for the Entire Program (Contract)

EPA Requirements for Quality Assurance

Project Plans (QA/R-5) [dated 03/20/01]

With offer

Othe…