18-233-SOL-00577_EPA_NCCT_Transcription.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-00577: EPA NCCT Transcription

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, July 30, 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, August 17, 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 Multiplexed Transcription Factor Profiling of the ToxCast

Compound Library Document Number:

18-233-SOL-00577

Page:

Contents

A.1 PROPOSAL REQUEST

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

Document Number:

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E.6 NON-CONFORMING PRODUCTS OR SERVICES

SECTION F - DELIVERIES OR PERFORMANCE

F.1 ORDERING PERIOD

F.2 PERIOD OF PERFORMANCE

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

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.7 CONTRACTOR PERFORMANCE EVALUATION(S)

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

INFORMATION

H.9 MANAGEMENT OF SENSITIVE INFORMATION

H.10 POST AWARD ORGANIZATIONAL CONFLICT OF INTEREST

H.11 TASK ORDER/DELIVERY ORDER OMBUDSMAN

H.12 KEY PERSONNEL

A. Pre-award Documentation:

B. Post-award Documentation:

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18-233-SOL-00577

SECTION I - SPECIAL CLAUSES

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

I.9 HHSAR 352.203-70 ANTI-LOBBYING (MAR 2012)

I.10 HHSAR 352.237-73 NON-DISCRIMINATION IN SERVICE DELIVERY (MAR 2012)

I.11 52.203-99 PROHIBITION ON REQUIRING CERTAIN INTERNAL CONFIDENTIALITY

AGREEMENTS OR STATEMENTS (JAN 2017)

I.12 52.252-6 AUTHORIZED DEVIATIONS IN CLAUSES (APR 1984)

I.13 1552.237-70 CONTRACT PUBLICATION REVIEW PROCEDURES

SECTION J – LIST OF ATTACHMENTS

ATTACHMENT A – PAST PERFORMANCE QUESTIONNAIRE

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 FAR 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (JUL 2013)

K.3 FAR 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 FAR 52.223-22 PUBLIC DISCLOSURE OF GREENHOUSE GAS EMISSIONS AND REDUCTION

GOALS – REPRESENTATION (DEC 2016)

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

Document Number:

18-233-SOL-00577

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

L.2 FAR 52.216-1 TYPE OF CONTRACT(JUN 2013)

L.3 FAR 52.233-2 SERVICE OF PROTEST (SEP 2006)

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.4 TECHNICAL EVALUATION CRITERIA

M.5 RATING FOR TECHNICAL EVALUATION

M.6 PAST PERFORMANCE EVALUATION

M.7 PRICE EVALUATION

M.8 RESPONSIBILITY

M.9 ORGANIZATIONAL CONFLICT OF INTEREST

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SECTION B - Supplies or Services and Prices/Costs

B.1 TITLE

EPA Multiplexed Transcription Factor Profiling of the ToxCast Compound Library

B.2 BRIEF DESCRIPTION OF SERVICES/SUPPLIES

Use of cellular assays to define activity of compounds against a broad spectrum of transcription factor targets is being used for screening the environmentally relevant chemical universe with program such as Tox21. The ability to multiplex many transcription factors into a single assay has proven to not only be cost effective, but also provides integrated information from a single well. The EPA is continuing to evaluate this approach to build methods prioritizing compounds for additional screening and testing based on predicted hazard and potential toxicity. This project is entitled the ToxCast Program.

The EPA has a need for contractor-supplied laboratory testing and analysis services in support of this program. The contractors shall use technologies aimed at profiling, in a multiplexed fashion, transcription factor activity in cell lines and cell culture conditions appropriate for toxicity testing when performing these services. Assays may be either mono- or co-culture system, but each assay shall address multiple transcriptional factor targets within a single well.

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 $5,000,000.00. 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 16,000 samples per task order. 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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BIOASSAY

MAX

QTY

PER

YEAR

UNIT

YEAR 1

PRICE

YEAR 2

YEAR 3

YEAR 4

YEAR 5

TOTAL

PRICES

PER YEAR

001: Multiplexed Transcription

Factor Profiling, Mono-culture

System, Derived Cell Line

(Endogenous Targets)

Sample

002: Multiplexed Transcription

Factor Profiling, Mono-culture

(Exogenous Targets)

003: Multiplexed Transcription

Factor Profiling, Co-culture

004: Multiplexed Transcription

(Exogenous Targets)

005: Multiplexed Transcription

System, Primary Cells

(Endogenous Targets

006: Multiplexed Transcription

System, Primary Cells (Exogenous

Targets)

007: Multiplexed Transcription

System, Primary Cells

008: Multiplexed Transcription

System, Primary Cells (Exogenous

Targets)

009: Multiplexed Transcription

Factor Profiling, In Vivo System

010: Exposure of cell lines to cmpd and collection, freezing and shipment of cells and cell culture medium

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SECTION C - Description/Specifications/Performance Work Statement

C.1. SUMMARY

C.1.1. TITLE

EPA Multiplexed Transcription Factor Profiling of the ToxCast Compound Library

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

Use of cellular assays to define activity of compounds against a broad spectrum of transcription factor targets is being used for screening the environmentally relevant chemical universe with program such as Tox21. The ability to multiplex many transcription factors into a single assay has proven to not only be cost effective, but also provides integrated information from a single well. The EPA is continuing to evaluate this approach to build methods prioritizing compounds for additional screening and testing based on predicted hazard and potential toxicity. This project is entitled the ToxCast

Program.

The EPA has a need for contractor-supplied laboratory testing and analysis services in support of this program. The contractors shall use technologies aimed at profiling, in a multiplexed fashion, transcription factor activity in cell lines and cell culture conditions appropriate for toxicity testing when performing these services. Assays may be either mono-or co-culture system, but each assay shall address multiple transcriptional factor targets within a single well.

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 16,000 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

The contractor shall provide Multiplexed Transcription Factor Profiling of the Toxcast Compound Library as defined in the individual task orders issued by the Contracting Officer. The contractor shall receive compounds in 96- or 384-well plates in DMSO and test these in multiplexed cellular assays.

The contractor shall provide a complete listing of the transcription factor targets for each of the assay groups listed in the

CLINs in the contract. The contractor’s work plan for each task/delivery orders issued under the contract will include information as to the makeup of each assay including cell line lineage, culture conditions, number and name of readouts, number of replicates tested per compound, number of concentrations and time-points, and level of validation. Additional

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assays, perhaps even in vivo studies, may be useful for targeted or follow-up testing on a limited number of compounds.

EPA will specify which characteristics offered by the contractor shall be used for each batch of compounds provided.

NOTE: The panels of assays selected by the contractor for the task/delivery order shall encompass mono- and co-culture systems, derived and primary cell lines, and a broad range of transcription factor families including, but not limited to, transcription factors regulating steroidal and non-steroidal nuclear receptors, oxidative stress, cell-to-cell signaling, genetic damage, and tumor promotion for maximum coverage of biological space. Across the various systems and cell lines, similar panels of multiplexed transcription factor readouts should be provided. Examples of the types of cell-based systems of interest to the EPA include:

Derived versus Primary cell lines

Mono-culture versus Co-Culture

Multiplexed

Targeting Endogenous versus Exogenous Transcriptional Units

C.4.1. Sample/Compound Ordering & Delivery

To ensure sensitivity for detecting weak activity against targets, compounds shall be screened at a maximally tolerated concentration. This concentration shall be defined as the highest concentration at which the compound can be tested without non-specific interference with the assay. (NOTE: The contractor work plan shall elaborate on how they will determine the concentration for the types of compounds being submitted for testing by the EPA. The EPA will make the final decision about the final screening concentration(s) of the compounds.)

In most instances, EPA or its samples inventory contractor may provide compounds in 96- or 384-well plates in 100%

DMSO at a single concentration, e.g. 20 mM. Alternative solvents may also be used. The contractor’s work plan 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’s work plan shall also indicate what format (e.g. 96- or 384-well), diluent(s) and concentration(s) are compatible with their assays and capabilities.

The contractor’s work plan 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

Determination of the effect of DMSO, or other solvents, on assay performance

Positive and negative controls used on all plates tested

Testing format that includes an optimal number of replicates, number of concentrations

Avoiding use of compounds stored as aqueous dilutions

C.4.2. Communication & Oversight

The contractor shall provide panels of bioactivity profiling assays or services as described in the attached schedule of items and delineated in the offeror’s proposal. 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, beginning upon award of the contract. At these meetings, the following issues will be discussed:

-- compound batches to be shipped for testing

-- specific panels of assays to be conducted on each compound batch

-- testing concentration of each compound batch

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

-- overall project planning and scheduling.

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The contractor shall provide for efficient and accurate data capture, management, and transmittal to EPA staff in a manner that facilitates data analysis within the ToxCast program.

The contractor shall certify that all primary human cells utilized in this work have been obtained via commercially available sources.

The contractor shall certify that all animal research, procedures and facilities utilized within the scope of this proposal or contract 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.5. QUALITY ASSURANCE

C.5.1. 1. The contractor shall carry out a comprehensive Quality Assurance (QA) program for this contract.

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.

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.

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.

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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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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:

Sample ID (including neutral, negative and positive controls)

Assay Name

Assay Component Name (specific readout name)

Assay Plate ID

Row Index

Column Index

Well Type (test material or control)

Well Quality (pass or fail indication)

Raw Response Value

Concentration (in micromolar, where applicable)

Additional information may be included:

Method name

Method type

Short method protocol

QA/QC test results (Plate variance, z-prime, etc.)

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.

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

SECTION F - Deliveries or Performance

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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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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."

SECTION G - Contract Administration Data mailto:Samuel.Layton@psc.hhs.gov mailto:Jimmy.Nguyen@hhs.psc.gov

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G.3 INVOICE SUBMISSION

(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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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.

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

SECTION H - Special Contract Requirements

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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 paper records, field notes, or other documents that contain sensitive or personally identifiable information. The Contractor shall ensure that

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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

Other Equivalent: With Offer

This documentation will be prepared in accordance with the specifications identified above, or equivalent specifications defined by EPA. Work involving environmental data generation or use shall not commence until the Government has approved this documentation and incorporated it into the contract.

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B. Post-award Documentation:

The contractor shall submit the following quality system documentation to the Contracting Officer’s Representative at the time frames identified below:

Documentation Specifications Due

X Quality Management Plan -

Actual complete SOPs shall be required 28 calendar days after award.

SOPs shall follow the guidance contained in EPA’s “Guidance for Preparing

Standard Operating Procedures

(QA/G6)”. Resources for preparing

SOPs, including the QA/G6 guidance document, may be found at https://www.epa.gov/quality/agency-wide- quality-system-documents. SOPs shall cover all contract activities and ensure that appropriate methods for sampling, analysis, data handling, and quality control (QC) are employed and are properly documented.

28 calendar days after award.

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]

Programmatic Quality

Assurance Project Plan for the Entire Program (Contract)

EPA Requirements for Quality Assurance

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

X Quality Assurance Project

Plan for Each…