RFP_NIHES2016089_Attachments.pdf

Attachment 1

PACKAGING AND DELIVERY OF PROPOSALS

Your proposal shall be organized as specified in SECTION L.2. General Instructions. Shipment and marking shall be as indicated below.

EXTERNAL PACKAGE MARKING

In addition to the address cited below, mark each package as follows:

“RFP NO. NIHES2016089

TO BE OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY”

PLEASE READ THE FOLLOWING INFORMATION CAREFULLY:

NUMBER OF COPIES

TECHNICAL PROPOSAL: 1 ORIGINAL* AND 4 COPIES (HARDCOPY) AND 2 USB FLASHDRIVES

BUSINESS PROPOSAL: 1 ORIGINAL* AND 1 COPY (HARDCOPY) AND 2 USB FLASHDRIVES

If hand delivered or delivery service:

Kristina Filardo, Contract Specialist Office of Acquisitions

NIEHS

530 Davis Drive Morrisville, NC 27560

If using U.S. Postal Service:

Kristina Filardo, Contract Specialist Office of Acquisitions

NIEHS

P.O. Box 12874 Research Triangle Park, NC 27709

*THE ORIGINALS MUST BE READILY ACCESSIBLE FOR DATE STAMPING PURPOSES.

NOTE: Please be aware that the U.S. Postal Service’s “Express Mail” DOES NOT deliver to the hand-delivered address. If a proposal is not received at the place, date, and time specified herein, it will be considered a “late proposal.”

PROPOSAL INTENT RESPONSE FORM

RFP No:

RFP Title:

Please review the Request for Proposal (RFP). Furnish the information requested below and return this page to the Contracting Officer/Contract Specialist identified on Section A-Solicitation/Contract Form by

Your expression of intent is not binding but will greatly assist us in planning for proposal evaluation.

Choose one of the following Options:

Do intend to submit a proposal Do Not intend to submit a proposal

If you are not responding to this RFP, please provide your reason(s):

Please provide the following contact information:

Name (First, Middle Initial, Last):

Title:

Organization:

E-mail:

smithj3 Typewritten Text Attachment 2 smithj3

Attachment 3

STATEMENT OF WORK

FOR THE CONDUCT OF STUDIES TO EVALUATE

THE TOXICOLOGIC POTENTIAL

OF SELECTED TEST AGENTS

FOR THE NATIONAL TOXICOLOGY PROGRAM (NTP)

December 28, 2015

The National Toxicology Program (NTP) is responsible for evaluating the toxic and carcinogenic potential of test materials of health concern to the citizens of United States and therefore to the US

Government. The purpose of this contract is to conduct studies which will assist the NTP in the toxicologic characterization of chemicals/test agents.

A. General Objectives and Requirements

The projects conducted under this contract are designed to study diverse agents that may include, but will not be limited to, industrial solvents, plasticizers, food additives, preservatives, flavorings and colorants, drugs, pesticides, dietary supplements, heavy metals, ingredients found in a wide variety of consumer products, flame retardants, nanomaterials, or other materials not specified at this time.

Independently, and not as an agent of the Government, the contractor shall furnish all the necessary services, qualified personnel, procedures, materials, equipment and facilities not otherwise provided by the Government as needed to perform the work set forth below. In general, studies shall be conducted according to the requirements described in the Study Assignment and in the “Specifications for the

Conduct of Studies to Evaluate the Toxic and Carcinogenic Potential of Chemical, Biological and

Physical Agents in Laboratory Animals for the National Toxicology Program” -January 2011 and subsequent revisions: https://ntp.niehs.nih.gov/ntp/Test_Info/FinalNTP_ToxCarSpecsJan2011.pdf

Specific study designs (or portions of) may require the use of the “Specifications for the Conduct of

Studies to Evaluate the Reproductive and Developmental Toxicity of Chemical, Biological and Physical

Agents in Laboratory Animals for the National Toxicology Program” -May 2011 and subsequent revisions:

https://ntp.niehs.nih.gov/ntp/test_info/finalntp_reprospecsmay2011_508.pdf

Specific study designs (or portions of) may require the use of the “National Toxicology Program

Neurobehavioral Testing Specifications” dated June 2015:

http://ntp.niehs.nih.gov/testing/types/neuro/index.html

Contractors will be directed as to studies or portions of studies that require these specifications. For general study designs, assume that the Tox/Car Specs will be used unless there is a perinatal component to the study.

https://ntp.niehs.nih.gov/ntp/Test_Info/FinalNTP_ToxCarSpecsJan2011.pdf https://ntp.niehs.nih.gov/ntp/test_info/finalntp_reprospecsmay2011_508.pdf http://ntp.niehs.nih.gov/testing/types/neuro/index.html

The Contractor shall have a working facility and have on staff experienced personnel to conduct the work described herein. A working facility means that the facility has in place essential features and staff with appropriate expertise to fulfill the requirements outlined in this SOW. Principal Investigator and discipline leaders for Toxicology, Developmental and Reproductive Toxicology, Neurotoxicology, Chemistry, Laboratory Animal Management, Pathology, Health and Safety and Quality Assurance, shall be employees (e.g. not consultants or subcontractors). The Neurotoxicologists, Molecular/cell biologists and Study Directors shall also be employees. The daily interaction and constant coordination of efforts needed among these disciplines requires that they are physically and organizationally together.

The contractor shall have the facilities and capability to develop specialized methodology for other than routine biochemical, histologic and chemical analyses.

Work shall be performed in accordance with the Good Laboratory Practice Regulations established by the

FDA for Non-clinical Laboratory Studies

(http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr58_01.html) or as most recently updated. The contractor shall have in place a quality management plan. Information on quality management plans can be found at http://www.epa.gov/quality/qmps.html

The contract shall be conducted in compliance with the Public Health Service (PHS) Policy on Humane

Care and Use of Laboratory Animals, the Animal Welfare Act Regulations, the current edition of the

Guide for the Care and Use of Laboratory Animals (the Guide), and all local, state or federal regulations.

The contractor shall have an approved Animal Welfare Assurance on file with the Office of Laboratory

Animal Welfare (OLAW), at the time of contract award. The contractor shall be accredited by the

Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC).

The contractor shall be registered with the Secretary of Agriculture of the United States in accordance with 7 U.S.C 2136 and 9 CFR sections 2.25 through 2.28. Animal experimental protocols, approved by the contractor’s institutional animal care and use committee (IACUC), shall be deliverables to the NIEHS

COR prior to the commencement of work. These contractor-approved protocols shall also be available to the NIEHS ACUC. The Contractor shall have an animal disease-screening program that complies with the NTP Specifications. The NTP will provide the address for shipment of samples for disease screening.

Test agents will typically be provided by the Government to the contractor. Test agents will have been evaluated for identity and purity prior to shipment to the contractor, and bulk chemical reanalysis methods

(identity and purity) and dose formulation and analysis methods will typically be provided to the contractor. The contractor will be required to demonstrate method performance prior to starting the studies.

Contractors shall have the capability to perform diverse arrays of in-vitro assays in-house or by subcontract. If performing in-vitro assays using a subcontracting mechanism, the contractor shall describe how it will be accomplished.

Contractors shall have the capability to perform alternative animal models (e.g. C. elegans, Zebrafish) in-house or by subcontract. If performing these studies using a subcontracting mechanism, the contractor shall describe how it will be accomplished.

The contractor shall enter study data directly into a COR-specified laboratory information management system (LIMS). The contractor shall not record data on paper (or other means) for which a COR-specified

LIMS is available, unless the LIMS is temporarily unavailable and/or the COR has granted special http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr58_01.html http://www.epa.gov/quality/qmps.html permission. If data cannot be captured by the LIMS, the contractor shall provide the data to the COR in an electronic file using a COR-specified format.

The current LIMS is Provantis, a hosted application that is accessed via the Internet. The NTP will provide the contractor with access, system support and training on Provantis. The contractor shall provide the computer, networking hardware and software necessary to connect to Provantis (for example

Citrix client solution). The contractor shall install the Citrix client locally on workstations that require access to Provantis. The contractor shall demonstrate the ability to use the system to collect data under

GLP regulations for electronic records. Note that with the use of Provantis, the contractor is not expected to require access to government computer systems. If the Government decides to use another or an additional LIMS, the contractor shall conform to using those newly NTP-specified LIMS.

B. Project Management

Although the contract, as a whole, shall be for the ongoing support of the NTP toxicology research and testing activities, the COR shall manage the daily administration of the contract on a “Study Assignment” basis, with Assignments initiated and administered by the COR. Study Assignments will be prepared and issued for each study, test article or group of test articles to be studied under the contract.

Each Study Assignment prepared by the COR will include a description of work to be performed. In response, the Contractor shall submit technical and cost information to include a description of how the work shall be conducted, a study-specific protocol, schedule of events, list of key personnel, references to chemical specific health and safety and quality assessment matters and an estimate of the anticipated cost and effort. This proposal should only include those details specific for the proposed Study Assignment.

An “Administrative Assignment” will be issued for the Contractor to use for preparation of Technical and cost/effort information for each study assignment, periodic reports, monthly reports, water analysis reports, Health and Safety reports, etc., or other COR-approved work not directly attributable to a specific

Assignment.

Additional details regarding management of the contract through Study Assignments shall be provided in

Section G of the contract award.

C. General Study Designs

The actual mix of studies may vary each year according to the test agents selected. Study designs shall be somewhat flexible, depending on the needs of the NTP. The NTP anticipates that the following study design elements will be frequently encountered:

1. In vitro studies using tissues, cells or cell components will be conducted on a group of chemicals

(e.g. 20-25 chemicals). The results of these studies may be used to select a smaller group (e.g.

five) for five-day toxicology and toxicogenomic studies. The results of the five-day studies may then be used to select a smaller number of chemicals (e.g. one or two) for 28- or 90-day studies.

2. Study designs may include alternative animal models such as C. elegans, zebrafish etc.

3. Study designs will frequently include biochemical/molecular assays, toxicogenomic and functional toxicity assays, including cardiac, pulmonary function and neurotoxicity.

Ongoing and recurring evaluations shall be conducted to evaluate the toxicity of test agents by various routes of exposure. The design of studies assigned to the contract will vary depending on the test agents, route(s) of exposure, and endpoints to be evaluated. In vivo studies will typically utilize Harlan Sprague

Dawley rats and B6C3F1/N mice; however, other stocks/strains or other species (e.g. hamsters, dogs, rabbits and guinea pigs) may be utilized. Study duration may be from one to a few days up to lifetime;

exposure may begin in utero or in young animals; the route of administration may be oral (dosed feed, dosed water, gavage), dermal, inhalation, or parenteral (intraperitoneal, subcutaneous, intravenous, intratracheal). Occasionally, dosing may be also administered by cannulating the mandibular or parotid gland. Details for typical study designs and for individual routes of administration are found in the NTP

Specifications cited above.

Ongoing activities and evaluations may include, but are not limited to, the following:

- chemistry activities typically to be conducted prior to the start of the studies include the characterization of the bulk material (identity and purity); evaluation of method performance for dose formulation and analysis methods; homogeneity and stability; preparation of a prestart chemistry report or prestart data summary that will ultimately be included in a study report

- disease screening

- exposure to test agents by various routes

- for perinatal studies, evaluation of dams for signs of parturition and numbers of implantations/resorptions, determinations of litter parameters such as survival, size, weight, abnormalities, gavage dosing of pups

- in-life chemistry activities during these studies include periodic bulk chemical reanalysis, dose formulation preparation and analysis

- other in-life activities may include clinical observations; body weights; food or water consumption; clinical pathology (hematology, clinical chemistries, urinalysis, hormones, methemoglobin, clotting time, etc.); collection and storage of blood and tissues; collection of excreta using metabolism cages; bronchioalveolar lavage and evaluation of cytokines, enzyme assays, albumin concentration, cell counts and differentials;

- neurotoxicity endpoints such as detailed clinical observations (DCO), functional observation battery (FOB), motor activity, Morris water maze, prepulse startle inhibition, etc. Newer technologies for gait analysis such as used by DigiGait, Motorater, or Catwalk may also be utilized.

- at sacrifice, necropsies, gross evaluations, organ weights; collection and storage of blood and tissues

- histopathology; cell proliferation

- characterization/fate/reactivity of material in the biological system (for example concentration of test agent or metabolite in blood/tissue/excreta biochemical and molecular assays including, but not limited to measurement of cytochrome P450s, glutathione, alpha-2-globulin, marker enzymes for peroxisomes, or protein kinase activities; assessment of enzyme activities in urine and other urine analyses

- immunotoxicity measurements (typically to involve only collection and shipment of samples to an NIEHS contractor for evaluation)

- reproductive and developmental endpoints (such as developmental landmarks, sexual maturation, fertility/fecundity, teratology, etc.); sperm and vaginal cytology sample collection and evaluations

- other functional toxicologic assessments (for example, cardiac function using radio telemetry to assess QT prolongation, pulmonary function using Flexivent or plethysmography, etc.)

- in vitro assays, such as cellular stress pathways, cell death, receptor signaling pathways, cellular communication, active transport, metabolism and disposition, cell differentiation; cell and tissue culture models, transcriptomics, epigenetics; etc.

- “Omics” including toxicogenomics, metabolomics, proteomics

- gene expression studies such as miRNA microarrays to capture small RNA species for microarray or qPCR applications http://www.qiagen.com/products/catalog/sample-technologies/rna-sample-technologies/mirna/mirneasy-mini-kit), qRT-PCR http://www.lifetechnologies.com/search/global/searchAction.action?query=taqman&resultPage=1

&resultsPerPage=15&autocomplete=), Nanostring

TM

technologies which would allow Nexgen

Sequencing Gene expression profiling by RNAseq (e.g. mRNA or miRNA) or genomic sequencing (e.g. whole genome, exome sequencing) by DNAseq multiplexing of many transcripts and several samples at once http://www.nanostring.com/.

- submission of study reports, electronic data, pathology specimens and study files according to milestone and deliverable schedules

D. Base and Options

The Period of Performance for the contract is for one (1) base year with nine (9) option years for a total period of performance not to exceed 10 years.

During the period of performance of the contract, the Government may, depending on the program needs and availability of funds, exercise an option to increase the level of effort performed under the contract.

This option may be exercised multiple times a year up to a level of effort and cost that does not exceed

100% of the base amount for the year. The contractor shall have the capability and capacity to perform this additional level of effort if necessary.

E. Travel Requirements

Under this contract, travel is authorized for activities pursuant to contract requirements, in accordance with Efficient Spending Policies and the Office of Management and Budget (OMB) Memo, M-12-

12. Travel to professional meetings is authorized, with prior approval of the COR, only for the purpose of presenting work conducted under this contract or for meetings with NTP COR and other Project Staff.

F. Reporting and Submissions

General Reporting Requirements

Narrative reports shall include charts, graphs, tabulations and pictures as necessary for explanation or support of the narrative. All final reports shall be dated and signed by the individual(s) responsible and the QAU auditor. Reporting requirements are listed in the table at the end of this section. Also listed in the tables are the due dates and number of copies required. All reports shall be sent directly to the appropriate recipient as indicated in the table. The NTP will supply names of individual recipients as indicated.

Monthly and Annual Reports

A Monthly Progress Report shall be submitted electronically by the 10 th day of the following month. Each

Monthly Progress Report shall be submitted in the format specified in the NTP Specifications.

An Annual Report shall be submitted at the end of each year. Each Report shall include the information listed in the monthly report format in the NTP Specifications III. C.1. In addition, the report shall provide the status of each study assignment and overall financial status of the contract.

http://www.qiagen.com/products/catalog/sample-technologies/rna-sample-technologies/mirna/mirneasy-mini-kit http://www.qiagen.com/products/catalog/sample-technologies/rna-sample-technologies/mirna/mirneasy-mini-kit http://www.lifetechnologies.com/search/global/searchAction.action?query=taqman&resultPage=1&resultsPerPage=15&autocomplete http://www.lifetechnologies.com/search/global/searchAction.action?query=taqman&resultPage=1&resultsPerPage=15&autocomplete http://www.nanostring.com/

Sanitation Methods Report

A Sanitization Methods Report shall be due 90 days after contract award and shall describe in detail the following:

1) The methods being used (and/or proposed for future use) for sanitization of equipment used in the studies to include at least cages, racks, feeders, watering devices, magnetic field generating system, rooms, walls, halls and buildings. Describe methods in detail, including commercial products used, their EPA registration number and their chemical constituents, if possible.

Include any change made in procedure or products used in the appropriate Monthly Progress

Report.

2) The methods in use to keep animal quarters free of insects and other vermin. Again, specify commercial products used, EPA registration number and their chemical constituents, if possible.

Report any changes in procedures or products used in the appropriate Monthly Progress Report.

Water Analysis Report

Water samples shall be collected for analysis and a report of the results submitted to the COR at least once per year. An analysis is required during the in-life portion of the prechronic study. For laboratories that are not currently conducting studies for NTP, a report shall also be submitted within 30 days of contract award.

Health and Safety Plan

A Health and Safety plan shall be submitted prior to any work commencing under the contract. An updated

Health and Safety plan shall be submitted to the COR for review and approval every 2 years and anytime it is modified. Action to correct deficiencies shall be taken within 30 days of notification that such action is required.

Study Reports

Study reports shall be submitted in accordance with the format instructions in Specifications, Section

III.C.2. and the table in Section G. below. Information on specific reporting requirements is presented below. Electronic report deliverables shall be Section 508 compliant according to checklists at http://www.hhs.gov/web/508/index.html under "Helpful Resources”. In some cases, there may be accommodations for which the PO/COR will provide information annually.

Other Reports

Other reports/submissions of data are listed in Milestones and Deliverables (Section G. below).

Any incident or unforeseeable occurrences not listed in this document, or any physical modifications to the laboratory facilities, as well as any changes in personnel which might have an impact on the conduct and results of the studies shall be reported immediately to the COR.

Submission of Archival Materials

Archival Materials (Study Data) - See NTP Specifications - Section III.B. for details.

http://www.hhs.gov/web/508/index.html

Histopathology Materials - See NTP Specifications - Section II.H.9. for details.

Tracking Schedules

NTP tracks all studies using a NTP tracking database; the contractor shall provide updated information on studies assigned to them on a regular basis. The NTP shall provide the contractor with an update sheet for each study being tested at the contractor’s facility. The update sheet contains general study data and selected milestones. The contractor shall review, provide updates on the update sheet, and return to the

COR. NTP expects that the method of collecting updates will change over the period of performance.

Progress with reference to this shall be reported to the COR and adjustments made as required by the

COR on a monthly basis. The contractor shall direct any questions to the COR.

G. Milestones and Deliverables

Abbreviations and General Delivery Addresses follow the list of milestones and deliverables.

Exact Names and Addresses to be supplied by the COR.

Note that the information contained in this table may be modified for actual Study Assignments.

PERIODIC

SUBMISSIONS

PER FACILITY

FREQUENCY DUE DATES DISTRIBUTION (Number of copies)

Monthly Report One per month Electronic submission by 10 th day of following month

CC (1)

Annual Progress Report Annually Hard copy- Mail by 15 th of the following month

Sanitation Methods 1 only 90 Days after

Contract Award

Water Analysis At a minimum, 1/yr;

1/prechronic study; For new labs, an analysis is req’d 30 days after receipt of a new award

Safety Plan Initially before award/every 2 years/as modified

As modified or at least every

2 years

PRESTART

ACTIVITIES

FREQUENCY DUE DATES DISTRIBUTION (Number of copies)

Submission of 1 Before study start CC (2)

Prestart Chemistry Report

NTP Review and Approval to Proceed

NA Within 30 days of receipt of report

Study Protocol

(with contractor's

IACUC approval)

1/species Prior to study start CC (2)

ACUTE, 5-DAY, 14-

DAY, 28-DAY, Dose

Range Finding

Studies

FREQUENCY DUE DATES DISTRIBUTION (Number of copies)

Start of Study NA Within 1-4 weeks from approval to proceed

Study Reports 1/Species 2-6 weeks from necropsy CC (1), PC (1)

Approval to Proceed to next study, if applicable

NA TBD SA - Send Samples for Evaluation

90-DAY and Modified

One Generation (MOG)

STUDIES

FREQUENCY DUE DATES DISTRIBUTION (Number of copies)

Start of 90-Day Study NA Within 4 weeks from approval to proceed

Clinical Lab Study Data Per design

See Specs

7 days for early timepoints;

21 days for terminal pt.

CC (1), PC (1)

Serum Samples for

Disease Screening

1/Species As collected SA - Send Samples for Evaluation

Blood for micronuclei determination

Per protocol Ship on day of collection MN – Blood, transmittal letter and decoding information

CC - transmittal letter and decoding information

SCVCE Per protocol With Study Report CC (1)

90-Day Study Report 1/Species 16 weeks from last day of necropsy

CC (2) and DVD, CO –cover page only

MOG Study Report Per protocol Per protocol CC (2) and DVD, CO – cover page only

Slides and Inventory 1/Species 30 days after submission of

90-Day Study Reports

REP

CC, PC - Copy of Transmittal Letter

Histology

Processing Records, Pathology Disks, and

Notification of Storage on Provantis

1/Species Same as above REP

CC, PC - Copy of Transmittal Letter to include notification of pathology storage on TDMS

Wet Tissues and Blocks 1/Species Same as above REP

CC, PC - Copy of Transmittal Letter

Study Raw Data Archival

Records for 90-Day Study and microfiche

1/Species Same as above REP

CC - Copy of Transmittal Letter and

Inventory

Notification of intention to dispose of residual chemical

1/chemical 30 days prior to terminal sacrifice COR

Shipment of 100 g aliquot of chemical to Chemistry

Contractor

1/chemical At time of final bulk analysis CH

CC - Copy of Transmittal Letter

Study assignment Closeout NA 60 days from submission of

Study Data/ Materials to

Archives

Abbreviations and General Addresses for Deliverables. Exact names and addresses will be supplied by the COR.

CC Contracts Coordinator NIEHS, Research Triangle Park, NC 27709

CH Chemistry Contractor NIEHS designated analytical contractor (Specified by work assignment)

CO Contracting Office

NIEHS,

Research Triangle Park, NC 27709

COR Contracting Officer’s Representative NIEHS, Research Triangle Park, NC 27709

HS NTP Health and Safety

NIEHS

Research Triangle Park, NC 27709

MI Micronuclei Evaluation NIEHS designated lab (to be specified at time of award) Research Triangle Park, NC 27709

PC Pathology Coordinator

NIEHS, ETP

Research Triangle Park, NC 27709

QA Quality Assurance

NIEHS/NTP, ETP

Research Triangle Park, NC 27709

REP Archives (Repositories):

Archival Material - Raw Data:

Research Triangle Park, NC 27709

Wet Tissues and Blocks:

Research Triangle Park, NC 27709

Frozen samples:

Research Triangle Park, NC 27709

SA Sentinel Animal Serum Samples

SCVCE Sperm Count and Vaginal Cytology Evaluation

SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER

STATEMENTS OF OFFERORS

Updated through FAC 2005-88 Last updated: 04/2016

This SECTION is made up of six parts as follows:

1. Annual Representations and Certifications, FAR 52.204-8

2. Commercial and Government Entity Code Reporting, FAR 52.204-16

3. Predecessor of Offeror, FAR 52.204-20

4. Information Regarding Responsibility Matters, FAR 52.209-7

5. Cost Accounting Standards

6. Certification Regarding Trafficking in Persons Compliance Plan

7. Certification Regarding Environmental Tobacco Smoke

8. Certification of Institutional on Financial Conflicts of Interest

9. Disaster or Emergency Area Representation

To Be Completed by the Offeror: This document must be completed and included as part of your Business Proposal. By submission of its signed offer, the offeror makes the following Representations and Certifications:

1. ANNUAL REPRESENTATIONS AND CERTIFICATIONS (APRIL 2016), FAR Provision 52.204-8

(a) (1) The North American Industry Classification System (NAICS) code for this acquisition is [insert NAICS code].

i. The Small Business Size Standard is [insert size standard].

ii. The small business size standard for a concern which submits an offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it did not itself manufacture, is 500 employees.

(b) (1) If the provision at 52.204-7, System for Award Management, is included in this solicitation, paragraph (d) of this provision applies.

i. If the provision at 52.204-7 is not included in this solicitation, and the offeror is currently registered in System for Award Management (SAM), and Representations and Certifications section of SAM has completed the Representations and Certifications section of SAM electronically, the offeror may choose to use paragraph (d) of this provision instead of completing the corresponding individual representations and certifications in the solicitation. The offeror shall indicate which option applies by checking one of the following boxes:

(i) Paragraph (d) applies.

(ii) Paragraph (d) does not apply and the offeror has completed the individual representations and certifications in the solicitation. [See Individual Representations and Certifications]

(c) (1) The following representations or certifications in SAM are applicable to this solicitation as indicated:

(i) 52.203-2, Certificate of Independent Price Determination. This provision applies to solicitations when a firm-fixed-price contract or fixed-price contract with economic price adjustment is contemplated, unless—

Attachment 4 http://oamp.od.nih.gov/DGS/rc.html http://oamp.od.nih.gov/DGS/rc.html http://oamp.od.nih.gov/DGS/rc.html

(A) The acquisition is to be made under the simplified acquisition procedures in Part 13;

(B) The solicitation is a request for technical proposals under two-step sealed bidding procedures; or

(C) The solicitation is for utility services for which rates are set by law or regulation.

(ii) 52.203-11, Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions. This provision applies to solicitations expected to exceed $150,000.

(iii) 52.204-3, Taxpayer Identification. This provision applies to solicitations that do not include the provision at 52.204-7, System for Award Management.

(iv) 52.204-5, Women-Owned Business (Other Than Small Business). This provision applies to solicitations that—

(A) Are not set aside for small business concerns;

(B) Exceed the simplified acquisition threshold; and

(C) Are for contracts that will be performed in the United States or its outlying areas.

(v) 52.209-2, Prohibition on Contracting with Inverted Domestic Corporations— Representation.

(vi) 52.209-5, Certification Regarding Responsibility Matters. This provision applies to solicitations where the contract value is expected to exceed the simplified acquisition threshold.

(vii) 52.209-11, Representation by Corporations Regarding Delinquent Tax Liability or Felony Conviction under any Federal Law.

(viii) 52.214-14, Place of Performance--Sealed Bidding. This provision applies to invitations for bids except those in which the place of performance is specified by the Government.

(ix) 52.215-6, Place of Performance. This provision applies to solicitations unless the place of performance is specified by the Government.

(x) 52.219-1, Small Business Program Representations (Basic & Alternate I). This provision applies to solicitations when the contract will be performed in the United States or its outlying areas.

(A) The basic provision applies when the solicitations are issued by other than DoD, NASA, and the Coast Guard.

(B) The provision with its Alternate I applies to solicitations issued by DoD, NASA, or the Coast Guard.

(xi) 52.219-2, Equal Low Bids. This provision applies to solicitations when contracting by sealed bidding and the contract will be performed in the United States or its outlying areas.

(xii) 52.222-22, Previous Contracts and Compliance Reports. This provision applies to solicitations that include the clause at 52.222-26, Equal Opportunity.

Attachment 4

(xii)52.222-25, Affirmative Action Compliance. This provision applies to solicitations, other than those for construction, when the solicitation includes the clause at 52.222-26, Equal Opportunity.

(xiii) 52.222-38, Compliance with Veterans' Employment Reporting Requirements. This provision applies to solicitations when it is anticipated the contract award will exceed the simplified acquisition threshold and the contract is not for acquisition of commercial items.

(xiv)52.223-1, Biobased Product Certification. This provision applies to solicitations that require the delivery or specify the use of USDA-designated items; or include the clause at 52.223-2, Affirmative Procurement of Biobased Products Under Service and Construction Contracts.

(xv) 52.223-4, Recovered Material Certification. This provision applies to solicitations that are for, or specify the use of, EPA-designated items.

(xvi) 52.225-2, Buy American Certificate. This provision applies to solicitations containing the clause at 52.225-1.

(xvii) 52.225-4, Buy American--Free Trade Agreements—Israeli Trade Act Certificate. (Basic, Alternates I, II, and III.) This provision applies to solicitations containing the clause at 52.225- 3.

(A) If the acquisition value is less than $25,000, the basic provision applies.

(B) If the acquisition value is $25,000 or more but is less than $50,000, the provision with its

Alternate I applies.

(C) If the acquisition value is $50,000 or more but is less than $79,507, the provision with its

Alternate II applies.

(D) If the acquisition value is $79,507 or more but is less than $100,000, the provision with its

Alternate III applies.

(xviii)52.225-6, Trade Agreements Certificate. This provision applies to solicitations containing the clause at 52.225-5.

(xix) 52.225-20, Prohibition on Conducting Restricted Business Operations in Sudan-- Certification. This provision applies to all solicitations.

(xx) 52.225-25, Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran—Representation and Certification. This provision applies to all solicitations.

(xxi) 52.226-2, Historically Black College or University and Minority Institution Representation. This provision applies to solicitations for research, studies, supplies, or services of the type normally acquired from higher educational institutions.

(2) The following certifications are applicable as indicated by the Contracting Officer: [Contracting Officer check as appropriate.]

(i) 52.204-17, Ownership or Control of Offeror

(ii) 52.204-20, Predecessor of Offeror

(iii) 52.222-18, Certification Regarding Knowledge of Child Labor for Listed End Products.

(iv) 52.222-48, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment Certification.

(v) 52.222-52 Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Certification.

(vi) 52.223-9, with its Alternate I, Estimate of Percentage of Recovered Material Content for EPA-Designated Products (Alternate I only).

(vii)52.227-6, Royalty Information.

(A) Basic.

(B) Alternate I.

(viii) 52.227-15, Representation of Limited Rights Data and Restricted Computer Software.

(d) The offeror has completed the annual representations and certifications electronically via the SAM website accessed through https://www.acquisition.gov. After reviewing the SAM database information, the offeror verifies by submission of the offer that the representations and certifications currently posted electronically that apply to this solicitation as indicated in paragraph (c) of this provision have been entered or updated within the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201); except for the changes identified below [offeror to insert changes, identifying change by clause number, title, date]. These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

FAR Clause No. Title Date Change

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted on SAM.

(End of Provision) https://www.acquisition.gov/

2. COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING, (JUL 2015) FAR Provision 52.204-16

Note to Offeror: This provision is incorporated by reference and is applicable when the resultant contract will contain FAR Provision 52.204-6 and/or FAR Provision 52.204-7.

3. PREDECESSOR OF OFFEROR, (APRIL 2016) FAR Provision 52.204-20

(a) Definitions. As used in this provision— Commercial and Government Entity (CAGE) code means—

(1) An identifier assigned to entities located in the United States and its outlying areas by the Defense Logistics Agency (DLA) Contractor and Government Entity (CAGE) Branch to identify a commercial or government entity, or

(2) An identifier assigned by a member of the North Atlantic Treaty Organization (NATO) or by NATO's Support Agency (NSPA) to entities located outside the United States and its outlying areas that DLA Contractor and Government Entity (CAGE) Branch records and maintains in the CAGE master file. This type of code is known as an NCAGE code.

Predecessor means an entity that is replaced by a successor and includes any predecessors of the predecessor.

Successor means an entity that has replaced a predecessor by acquiring the assets and carrying out the affairs of the predecessor under a new name (often through acquisition or merger). The term “successor” does not include new offices/divisions of the same company or a company that only changes its name. The extent of the responsibility of the successor for the liabilities of the predecessor may vary, depending on State law and specific circumstances.

(b) The Offeror represents that it is or is not a successor to a predecessor that held a Federal contract or grant within the last three years.

(c) If the Offeror has indicated “is” in paragraph (b) of this provision, enter the following information for all predecessors that held a Federal contract or grant within the last three years (if more than one predecessor, list in reverse chronological order):

Predecessor CAGE code: ____ (or mark “Unknown”).

Predecessor legal name: ____.

(Do not use a “doing business as” name).

(End of provision)

4. INFORMATION REGARDING RESPONSIBILITY MATTERS, (JUL 2013) FAR Provision 52.209-7

Note to Offeror: This provision is applicable when the resultant contract is expected to exceed $500,000.

(a) Definitions. As used in this provision— Attachment 4

Administrative proceeding means a non-judicial process that is adjudicatory in nature in order to make a determination of fault or liability (e.g., Securities and Exchange Commission Administrative proceedings, Civilian Board of Contract Appeals Proceedings, and Armed Services Board of Contract Appeals Proceedings). This includes administrative proceedings at the Federal and State level but only in connection with performance of a Federal contract or grant. It does not include agency actions such as contract audits, site visits, corrective plans, or inspection of deliverables.

Federal contracts and grants with total value greater than $10,000,000 means--

(1) The total value of all current, active contracts and grants, including all priced options; and

(2) The total value of all current, active orders including all priced options under indefinite-delivery, indefinite-quantity, 8(a), or requirements contracts (including task and delivery and multiple-award Schedules).

Principal means an officer, director, owner, partner, or a person having primary management or supervisory responsibilities within a business entity (e.g., general manager; plant manager; head of a division or business segment; and similar positions).

(b) The offeror has does not have current active Federal contracts and grants with total value greater than $10,000,000.

(c) If the offeror checked “has” in paragraph (b) of this provision, the offeror represents, by submission of this offer, that the information it has entered in the Federal Awardee Performance and Integrity Information System (FAPIIS) is current, accurate, and complete as of the date of submission of this offer with regard to the following information:

(1) Whether the offeror, and/or any of its principals, has or has not, within the last five years, in connection with the award to or performance by the offeror of a Federal contract or grant, been the subject of a proceeding, at the Federal or State level that resulted in any of the following dispositions:

(i) In a criminal proceeding, a conviction.

(ii) In a civil proceeding, a finding of fault and liability that results in the payment of a monetary fine, penalty, reimbursement, restitution, or damages of $5,000 or more.

(iii) In an administrative proceeding, a finding of fault and liability that results in—

(A) The payment of a monetary fine or penalty of $5,000 or more; or

(B) The payment of a reimbursement, restitution, or damages in excess of $100,000.

(iv) In a criminal, civil, or administrative proceeding, a disposition of the matter by consent or compromise with an acknowledgment of fault by the Contractor if the proceeding could have led to any of the outcomes specified in paragraphs (c)(1)(i), (c)(1)(ii), or (c)(1)(iii) of this provision.

(2) If the offeror has been involved in the last five years in any of the occurrences listed in (c)(1) of this provision, whether the offeror has provided the requested information with regard to each occurrence.

(d) The offeror shall post the information in paragraphs (c)(1)(i) through (c)(1)(iv) of this provision in FAPIIS as required through maintaining an active registration in the System for Award Management database at www.acquisition.gov (see 52.204-7).

5. COST ACCOUNTING STANDARDS

(1) Cost Accounting Standards Notices and Certification (October 2015), FAR Provision 52.230-1

Note: This notice does not apply to small businesses or foreign governments. This notice is in three parts, identified by Roman numerals I through III.

Offerors shall examine each part and provide the requested information in order to determine Cost Accounting Standards (CAS) requirements applicable to any resultant contract.

If the offeror is an educational institution, Part II does not apply unless the contemplated contract will be subject to full or modified CAS-coverage pursuant to 48 CFR 9903.201- 2(C)(5) or 9903.201-2(c)(6), respectively.

I. Disclosure Statement -- Cost Accounting Practices and Certification

(a) Any contract in excess of $750,000 resulting from this solicitation will be subject to the requirements of the Cost Accounting Standards Board (48 CFR Chapter 99), except for those contracts which are exempt as specified in 9903.201-1.

(b) Any offeror submitting a proposal which, if accepted, will result in a contract subject to the requirements of 48 CFR Chapter 99 must, as a condition of contracting, submit a Disclosure Statement as required by 9903.202. When required, the Disclosure Statement must be submitted as a part of the offeror's proposal under this solicitation unless the offeror has already submitted a Disclosure Statement disclosing the practices used in connection with the pricing of this proposal. If an applicable Disclosure Statement has already been submitted, the offeror may satisfy the requirement for submission by providing the information requested in paragraph (c) of Part I of this provision.

CAUTION: In the absence of specific regulations or agreement, a practice disclosed in a Disclosure Statement shall not, by virtue of such disclosure, be deemed to be a proper, approved, or agreed-to practice for pricing proposals or accumulating and reporting contract performance cost data.

http://www.acquisition.gov/

(c) Check the appropriate box below:

(1) Certificate of Concurrent Submission of Disclosure Statement.

The offeror hereby certifies that, as part of the offer, copies of the Disclosure Statement have been submitted as follows:

(i) original and one copy to the cognizant Administrative Contracting Officer (ACO), or cognizant Federal agency official authorized to act in that capacity (Federal official), as applicable, and;

(ii) one copy to the cognizant Federal auditor.

(Disclosure must be on Form No. CASB DS-1 or CASB DS-2, as applicable.. Forms may be obtained from the cognizant ACO or Federal official and/or from the looseleaf version of the Federal Acquisition Regulation).

Date of Disclosure Statement:

Name and Address of Cognizant ACO or Federal Official Where Filed:

The offeror further certifies that the practices used in estimating costs in pricing this proposal are consistent with the cost accounting practices disclosed in the Disclosure Statement.

(2) Certificate of Previously Submitted Disclosure Statement.

The offeror hereby certifies that the required Disclosure Statement was filed as follows:

Date of Disclosure Statement:

Name and Address of Cognizant ACO or Federal Official Where Filed:

The offeror further certifies that the practices used in estimating costs in pricing this proposal are consistent with the cost accounting practices disclosed in the applicable Disclosure Statement.

(3) Certificate of Monetary Exemption.

The offeror hereby certifies that the offeror together with all divisions, subsidiaries, and affiliates under common control, did not receive net awards of negotiated prime contracts and subcontracts subject to CAS totaling more than $50 million or more in the cost accounting period immediately preceding the period in which this proposal was submitted. The offeror further certifies that if such status changes before an award resulting from this proposal, the offeror will advise the Contracting Officer immediately.

(4) Certificate of Interim Exemption.

The offeror hereby certifies that:

(i) the offeror first exceeded the monetary exemption for disclosure, as defined in

(3) of this subsection, in the cost accounting period immediately preceding the period in which this offer was submitted, and

(ii) in accordance with 48 CFR 9903.202-1, the offeror is not yet required to submit a Disclosure Statement. The offeror further certifies that if an award resulting from this proposal has not been made within 90 days after the end of that period, the offeror will immediately submit a revised certificate to the Contracting Officer, in the form specified under subparagraph (c)(1) or (c)(2) of Part I of this provision, as appropriate, to verify submission of a completed Disclosure Statement.

CAUTION: Offerors currently required to disclose because they were awarded a CAS- covered prime contract or subcontract of $50 million or more in the current cost accounting period may not claim this exemption (4). Further, the exemption applies only in connection with proposals submitted before expiration of the 90-day period following the cost accounting period in which the monetary exemption was exceeded.

(5) Certificate of Disclosure Statement Due Date by Educational Institution.

(ALTERNATE I - April 1996)

If the offeror is an educational institution that, under the transition provisions of 48 CFR 9903- 202-1(f), is or will be required to submit a Disclosure Statement after receipt of this award, the offeror hereby certifies that (check one and complete):

(i) A Disclosure Statement filing Due Date of _ has been established with the cognizant Federal agency.

(ii) The Disclosure Statement will be submitted within the 6-month period ending _ months after receipt of this award.

Name and Address of Cognizant ACO or Federal Official Where Filed:

Page 10 of

II. Cost Accounting Standards—Eligibility for Modified Contract Coverage

If the offeror is eligible to use the modified provisions of 48 CFR 9903.201-2(b) and elects to do so, the offeror shall indicate by checking the box below. Checking the box below shall mean that the resultant contract is subject to the Disclosure and Consistency of Cost Accounting Practices clause in lieu of the Cost Accounting Standards clause.

The offeror hereby claims an exemption from the Cost Accounting Standards clause under the provisions of 48 CFR 9903.201-2(b) and certifies that the offeror is eligible for use of the Disclosure and Consistency of Cost Accounting Practices clause because during the cost accounting period immediately preceding the period in which this proposal was submitted, the offeror received less than $50 million in awards of CAS-covered prime contracts and subcontracts. The offeror further certifies that if such status changes before an award resulting from this proposal, the offeror will advise the Contracting Officer immediately.

CAUTION: An offeror may not claim the above eligibility for modified contract coverage if this proposal is expected to result in the award of a CAS-covered contract of $50 million or more or if, during its current cost accounting period, the offeror has been awarded a single CAS-covered prime contract or subcontract of $50 million or more.

III. Additional Cost Accounting Standards Applicable to Existing Contracts

The offeror shall indicate below whether award of the contemplated contract would, in accordance with subparagraph (a)(3) of the Cost Accounting Standards Clause, require a change in established cost accounting practices affecting existing contracts and subcontracts.

YES NO

(2) Proposal Disclosure-Cost Accounting Practice Changes, (March 2005)(FAR Provision 52.230-7)

The offeror shall check “yes” below if the contract award will result in a required or unilateral change in cost accounting practice, including unilateral changes requested to be desirable changes.

YES NO

If the offeror checked “Yes” above, the offeror shall–

(1) Prepare the price proposal in response to the solicitation using the changed practice for the period of performance for which the practice will be used; and

(2) Submit a description of the changed cost accounting practice to the Contracting Officer and the Cognizant Federal Agency Official as pricing support for the proposal.

Page 11 of

6. CERTIFCATION REGARDING TRAFFICKING IN PERSONS COMPLIANCE PLAN (March 2015), FAR Provision 52-222-56

Note to offeror: This provision is applicable when services will be performed outside of the United States;

and the estimated value exceeds $500,000.

(a) The…