Amendment_1_N02CP71005-72_MEAS.pdf

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OMB No 0990-0115

1. CONTRACT ID CODE PAGE OF PAGES

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT N/A 1 8

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

1 November 15, 2016 N/A

6. ISSUED BY CODE 7. ADMINISTERED BY (If other than Item 6)

CODE N/A

National Cancer Institute Office of Acquisitions NCI Shady Grove, Room 1E610 9609 Medical Center Drive, MSC 9705 Rockville, MD 20850

8. NAME AND ADDRESS OF CONTRACTOR (No. Street, County, State and ZIP: Code) (X) 9A. AMENDMENT OF SOLICITATION NO.

TO ALL POTENTIAL OFFERORS

N02CP71005-72

X 9B. DATED (SEE ITEM 11)

October 19, 2016

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing Items 8 and 15, and returning one (1) copy of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATA SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and data specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

(x) A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO

THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return 1 copy to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

PURPOSE: 1) To provide clarification to questions received by the deadline for questions of October 26, 2016; 2) Revise “Small Business Subcontracting Plan” and “Data Other than Certified Cost or Pricing Data”; and 3) Update Section K – Representations, Certifications and Other Statements of Offerors and the Small Business Subcontracting Plan.

Deadline for Questions: October 26, 2016; 10:00 AM (EST) (Unchanged)

Proposal Due Date: November 18, 2016; 12:00 PM (EST) (Unchanged)

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

Jill Johnson, Contracting Officer

15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

(Signature of person authorized to sign)

BY _______________/ S /_____________________________

(Signature of Contracting Officer)

November 15, NSN 7540-01-152-8070 30-105 STANDARD FORM 30 (REV. 10-83)

PREVIOUS EDITION UNUSABLE Computer Generated Prescribed by GSA FAR (48 CFR) 53.243

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RFP N0CP71005-72

Amendment #1 – Questions/Responses

Base IDIQ

1. Reference Attach 8, p5 of 5, Transition Plan: Will the Contractor assume use of the current instance of BSI, or will a data migration be necessary? Will the Contractor be responsible for database maintenance as indicated in (1b)?

Answer: A data migration will not be necessary. The contractor will be named as a repository using the current version of the NCI database. Any migration of data will be handled by the contractor that maintains the BSI system.

2. Reference Attach 3 SOW Task Area I #9: Will the Government provide a plug number for required supplies and third party carrier costs? If not, will the Government provide a list of required supplies and international and domestic field sites?

Answer: Yes, the Government will provide a list of supplies with suggested manufacturers and item numbers for supplies. It is up to the Contractor’s discretion to propose substitutions of items and NCI will then consider the suitability of the proposed substitution. This list would only apply to future task orders which would require supplies. The list of supplies to include the manufacturers and item numbers will be submitted when the request for support is initiated.

3. Reference SOW Task Area II: What type and what number of samples will need to be transferred? Are there any collection supplies (or other) to be transferred? Is the requested transfer period 30 days or from 2/7/17-3/23/17 (45 days)? Can an estimate be given on how long the Government will take to approve the final transition plan after contract award?

Answer: It is unlikely that any specimens will be transferred in, unless there is an activity that needs to be carried over from an existing request. The Government will make every attempt to complete activities with the incumbent during the transition phase, if not before. It is possible that some supplies will be transferred in, if they are present at the incumbent’s location at the close of the contract. The transition is expected to move at a rapid pace and transition plans are expected to be approved within one week.

4. Reference Attach 3 SOW #2, Task Area 001 and 002: Please clarify if environmental samples (soil and water) will potentially be collected, submitted and/or processed under this contract. Will the Government provide an estimated number of each sample type expected?

Answer: Environmental specimens will not be collected, but may be processed under this contract. Should this be the case, a separate task order for this work will be created.

5. Reference Attach 3 SOW Task Area III: Should Phase-Out be priced as FFP or T&M?

Answer: Offerors are only required to price out the sample task orders, not the Base IDIQ.

6. Should a separate Technical Proposal Cost Info Sheet be provided for the three sample Task Orders as well as the

IDIQ?

Answer: Yes, please submit a separate Technical Proposal Cost Info Sheet for the three sample Task Orders. There is no need to submit one for the IDIQ SOW.

7. Please confirm that the Proposal Summary and Data Record Form NIH-2043 is to be submitted with the Technical Proposal, as instructed per Attachment 8, Section 1.D, instead of Attachment 5-Technical Proposal Cost Summary.

RFP N02CP71005-72 Molecular Epidemiology Assay Support (MEAS) 3 of 8

Answer: The 2043 should be submitted with the business proposal while the Technical Proposal Cost Summary should be submitted with the technical proposal.

8. Reference Attach 8 p1 of 5: Please clarify the discrepancy between paragraph 4 and paragraph 5 regarding whether the PI’s CV should or should not count towards the 200-page limit.

Answer: Any CVs submitted will count towards the 200-page limit.

9. If this is a single award contract, please confirm that the Contractor does not have to propose on all TORFP’s per Article G.3.c.

Answer: This is a single award contract. Per Article G.3.c., Contractors are not required to propose on all TORFPs.

However, proposals for all Sample Task Orders contained in this RFP are necessary for evaluation purposes.

10. Will the Contractor’s fixed hourly rates be negotiated at the IDIQ contract level, or separately with each individual task order?

Answer: For the most part, the Contractor’s fixed hourly rates will be negotiated at the IDIQ contract level. However if the need arises for additional labor categories during the period of performance, those may be negotiated at the task order level.

11. Will a list of current SOPs be acceptable for inclusion in the Technical Proposal?

Answer: A list is acceptable, however, Offerors are requested to provide an example of one complete SOP with their proposal. After award, all SOPs pertinent to this contract should be made fully available for viewing within DCEG and for sharing with collaborators, as requested.

12. Should the proposal response submission be printed single sided (Attach 8 p1 of 5) or double sided (Section L p49)?

Answer: Double-sided as indicated on Section L page 49.

13. Are resumes from all staff including contracts/finance to be included? Or should they be limited to key personnel and full time technical staff?

Answer: Resumes for any staff proposed that will be direct charged to the contract should be included.

14. Please confirm the GFE listed in Attach 17 are located in Wayne, PA.

Answer: The GFE is now located in Highland Heights, KY.

Task Order 0001

15. Is it necessary to provide the Information Security and Physical Access Reporting for BSI? (Reference Attach 3 Sample Task Order 001 Reporting Requirement #7)

Answer: Yes. This is required when Contractor personnel may require access to HHS-controlled facilities and/or information systems, including sensitive data/information, in order to perform the contract.

RFP N02CP71005-72 Molecular Epidemiology Assay Support (MEAS) 4 of 8

16. Reference Attach 3 Sample Task Order 001 Technical Requirements # 6: Shipping of supplies is to be a direct pass through. What about other shipping charges - of specimens to/from the Contractor and to/from external labs? Please confirm whether collection supplies pricing should not be discussed in the response, or provide a sample list of items to be priced.

Answer: Other shipping charges will also be covered as a direct pass through. Offerors should provide estimates from up to three vendors for certain purchases. The Contractor will be provided with a list of proposed manufacturers and item numbers if a future task order requires supplies/shipping, but comparable items may be approved by the COR and Principal Investigator(s) if proposed as alluded to above in question 3. The list of supplies to include the manufacturers and item numbers will be submitted when the request for support is initiated.

17. Please define innovative molecular testing. What testing is required and on how many samples?

Answer: The Division of Cancer Epidemiology and Genetics (DCEG) conducts leading-edge cancer research on population-based studies. DCEG desires to work with a Contractor that is familiar with the latest research techniques in the fields of genomics, metabolomics, microbiomics, etc. The Contractor should either have the breadth within their organization to assist DCEG in evaluating new testing modalities or be able to identify consultants/subcontractors who can meet this need, if requested.

18. At what frequency will the 20,000 2mL cryovials be received?

Answer: The specimens temporarily stored at the Contractor’s facility will be ones that have either come in for alliquoting, or have come in to be sent to be prepared for shipment to a testing laboratory. Once testing is completed, it is possible that residual material might be returned prior to being transferred to long term storage in Frederick, Maryland (NCI Central Repository which is operated under a separate contract mechanism). The actual numbers of specimens stored is not expected to be more than 5,000 at any one time, with the number 20,000 provided as an upper limit. Please note that this is a volumemetric estimate for storage space and actual containers stored may vary in size.

19. Will the 20,000 2mL cryovials be required to be aliquoted?

Answer: Not under this task order. Any aliquotting work would be covered under a separate task order.

20. Is the contractor responsible for the inbound shipment of the aliquots from site/field locations to the contractor? If so, will all shipments be made at frozen temperatures?

Answer: The contractor may be asked to arrange for shipping from the field sites to the contractor, or to the long-term storage facility (NCI Central Repository). The temperature of the shipment will depend on the material type of the specimens being transported. Most specimens are expected to be shipped on dry ice, but it may be possible that the specimens are shipped at ambient temperatures (e.g., formalin-fixed, paraffin-embedded specimens or Oragene saliva kits) or possibly in liquid nitrogen vapor dry shippers (e.g., PBMCs or other cell lines). For estimating purposes, the offeror should provide the cost of managing the shipment, with the actual cost of the shipment being billed as a direct cost on invoices. The contractor may be requested to provide estimates from several vendors for the Government to evaluate prior to the selection of the shipper used. Please see the list below as an example of the types of supplies that could be ordered.

Supply Item Description/Size Vendor Catalog # per Unit

Unit Cost/ Unit

Hong Kong

Lyon Total to purchase

Total Cost

Label sample box; (Avery 5162) Anth-Lee 1 ea ea $0.22 354 98 452 $99.44

Label set charge vial Anth-Lee 1 ea ea $20.00 6 2 8 $160.00

Label set charge Forms Anth-Lee 1 ea ea $20.00 6 2 8 $160.00

RFP N02CP71005-72 Molecular Epidemiology Assay Support (MEAS) 5 of 8

Label set charge sample box Anth-Lee 1 ea ea $20.00 1 1 2 $40.00

Label shipping Anth-Lee 1 ea ea $25.00 1 $25.00

Box, 2" hold 1.5 and 1.8 ml vials (CIC) Cryostuff.com

BX2 1 ea ea $1.50 0 34 34 $51.00

Box, 3" hold buffy/RBC vials (CIC) Cryostuff.com

BX3 1 ea ea $1.80 0 11 11 $19.80

Box, divider divider, 81 places (CIC) Cryostuff.com

D81 1 ea ea $1.35 0 45 45 $60.75

Bag 6"x9"; 4 mil Uline S-498 1000 cs cs $126.00 1 1 2 $252.00

Bag 9"x12"; 2 mil Uline S-1299 1000 cs cs $50.00 1 1 2 $100.00

Bag 12"x12"; 2 mil Uline S-1703 1000 cs cs $97.00 1 1 2 $194.00

Bag, 1 kit 15"x17"x3", w/snap seal handle; 1.75 mil

Uline S-5478 250 cs cs $114.00 3 1 4 $456.00

Bag, 3 kit 20"x16"x6", non closeable blue w/long handles

Uline S-14330BLU 100 cs cs $145.00 3 1 4 $580.00

Absorbent Paper 18"x20", collection area VWR 89126-794 350 cs cs $94.81 1 1 2 $189.62

Bandaids 1 x 3, flexible VWR 15431-467 100 pk pk $7.64 7 2 9 $68.76

Cup 15 ml; graduated in ml (was Daigger EF1846A)

VWR 414004-143 100 pk pk $32.67 7 2 9 $294.03

Cup, collection 118ml, individual wrap VWR 15704-085 100 cs cs $0.00 7 2 14 $0.00

Cup, collection 118ml, individual wrap VWR 25384-146 100 cs cs $39.07 7 2 9 $351.63

Gauze pad 2"x2" VWR 89133-086 100 pk pk $13.63 7 2 9 $122.67

Gloves, nitrile size large VWR 32934-082 100 bx bx $10.49 10 1 11 $115.39

Gloves, nitrile size small VWR 32934-078 100 bx bx $10.49 10 1 11 $115.39

Gloves, nitrile size medium VWR 32934-080 100 bx bx $10.49 10 1 11 $115.39

Pipet, Transfer Individual wrap;

hold 4.6 ml

VWR 73990-098 3200 cs cs $681.24 0 0.33 0 $224.81

Slides VistaVision Histobond, white

VWR 16004-406 1440 cs cs $721.49 12 4 16 $11,543.84

Tube, centrifuge 15 ml, sterile, polyprop VWR 89039-670 500 cs cs $142.15 0 1 1 $142.15

Vial, sample 1.8 ml, Nunc, 4 pk of 450 VWR 66021-986 1800 cs cs $846.72 0 1 1 $846.72

Vial, sample 3.6 ml, Nunc, 4 pk of 400 VWR 66021-989 1600 cs cs $967.21 0 0.75 1 $725.41

Vial, sample Eppendorf, 1.5 ml (Pathology tissue sections)

VWR 21008-959 500 cs cs $37.99 0 1 1 $37.99

Supplies $17,091.79

21. At what frequency will samples be forwarded to other lab locations?

Answer: This will depend on the needs of the Division, but for cost estimation purposes, assume once per month.

22. Regarding supplies:

o What type of supplies?

RFP N02CP71005-72 Molecular Epidemiology Assay Support (MEAS) 6 of 8

Answer: The supplies are ones that are commonly used for collecting human biospecimens, such as sharps, vacutainers urine cups, saliva collection containers.

o What quantity of each supply?

Answer: As a part of a request for shipping supplies, the Offeror will provide a list and quantity of items to be ordered to NCI. The list should include vendor names and order numbers. The Offeror may be able to substitute comparable items with prior approval from the COR and the requesting DCEG Principal Investigator.

o What locations will the supplies be sent to? How many sites/locations?

Answer: The number of locations depends on the given requests for the period of performance. Examples of possible locations are Lyon, France and Hong Kong, China.

o How often will supplies be sent?

Answer: Generally, twice per year.

23. Please define the 40-hour turnaround time required per shipment of supplies.

Answer: The Government may need to rapidly respond to requests to deliver supplies to collection sites so the contractor should be able, if needed, to have orders with supply vendors placed within a week. It is understood that delivery times for the supplies to the contractor’s location may need additional time, depending on the items requested.

Task Order 0002

24. Per the task order, each of the 900 specimens will be made into 6 aliquots, one of which will be forwarded for testing.

o At what frequency will the aliquot for testing be forwarded?

Answer: Parent samples are expected to be received at one time.

o Will the remaining 5 aliquots be kept in storage by the contractor until the end of the period of the task order? Where will they be forwarded to after the storage period?

Answer: Residual aliquots will be sent to the long-term storage repository (the NCI Central Repository) located in Frederick, Maryland (operated under a separate contract) soon after they are created.

25. At what frequency will the 25 batches of 40 samples be forwarded to the testing laboratory?

Answer: The batches will be sent to the testing laboratory at one time.

26. The task order states that the child vials that are not forwarded to the testing laboratory will be returned to the NCI Central Repository. When the aliquots are being performed should there be a target number of extra aliquots that will not go to the testing laboratory? If so, how many?

Answer: The number of child vials returned to the NCI Central Repository can be estimated based on the 1.8 ml starting volume.

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27. Is NCI open to an alternative label for the aliquot tubes as long as it meets the requirements required?

Answer: Yes, provided it meets all requirements.

28. Attachment #3, page 1, bullet 2a: Is there an acceptable thaw time for specimens with volumes >1.8mls?

Answer: Thaw times should be minimized so that the least amount of time at 0-4oC is used prior to initiating the aliquotting. Actual thaw times will depend on the starting volume. Samples should be aliquoted once the thawing process is complete.

29. Attachment #3, page 3, bullet 10: Will sub-contracted laboratories be providing data to the Offerors for analysis of accuracy? Clarify expectations of monitoring “accuracy of data”. Is the Contractor then providing final data to investigator from the sub-contracted laboratory?

Answer: Usually, data will be provided directly to the Principal Investigator. It may be possible that the Contractor is asked to evaluate the results from quality control specimens to determine the cv for given assay to assess testing variability, as appropriate.

30. Attachment #3, page 4: is a draft transition “phase-in” plan required if we are the incumbent contractor?

Answer: No.

31. Attachment #3 Sample Task Order 1, bullet 6: Please clarify…is time estimated (40 hours) per shipment, total expected turnaround time, in business hours, or total estimated time needed to complete the tasks?

Answer: The Government may need to rapidly respond to requests to deliver supplies to collection sites so the contractor should be able, if needed, to have orders with supply vendors placed within a week. It is understood that delivery times for the supplies at the contractor’s location may need additional time, depending on the items requested.

32. Attachment #3 Sample Task Order 2: are the specified samples labels required (Manufacturer – Brady; item number Y537142; description, THT-875-427-5-Perforated, IP; measurements 1.0” x 1.0” with 2.75” clear tail)? Or may the contractor use their own labels as long as their performance has been validated to meet temperature requirements?

Answer: The contractor may propose an alternative if a comparable/improved product is proposed.

33. What is the thaw protocol for samples with volumes >1.8mL (e.g. the seven 15mL serum samples referenced for task order 2)?

Answer: The contractor will need to determine the minimum time needed to thaw specimens greater than 1.8 ml.

34. Reference Attach 3 Sample Task Order 2: Will the Government provide a plug number for dry ice and shipping costs to the test lab and Central Repository? If not, will the Government specify a test laboratory location?

Answer: No, the Government will not provide a plug number. The NCI Central Repository is located in Frederick, Maryland. Offerors may use Raleigh, North Carolina as the recipient location for testing for estimating purposes.

35. Reference Attach 3 Sample Task Order 0002: Please clarify “The contractor will receive seven (2) 15 mL samples…”.

Answer: Seven is the correct number.

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RFP N0CP71005-72

Amendment #1 – Revisions to RFP

6. Small Business Subcontracting Plan: introductory paragraph and paragraph d.9. is modified as follows:

If the proposed contract exceeds a total estimated cost of $650,000 for the entire period of performance, the offeror shall be required to submit an acceptable subcontracting plan in accordance with the terms of the clause entitled "Small Business Subcontracting Plan," FAR Clause No. 52.219-9, incorporated herein by reference in the Solicitation, See SECTION J - LIST OF ATTACHMENTS, BUSINESS PROPOSAL ATTACHMENTS of this RFP for an example of such a plan.

9. Assurances that the offeror will include in all subcontracts the contract clause "Utilization of Small Business Concerns." Assure that all subcontractors, other than small businesses, in excess of $650,000 adopt a plan similar to the plan agreed upon by the offeror.

3. Data Other than Certified Cost or Pricing Data: paragraph c. is modified as follows:

c. Subcontracted Items

Include parts, components, assemblies, and services that are to be produced or performed by others in accordance with offeror's design, specifications, or direction and that are applicable only to the prime contract. For each subcontract over $750,000, the support should provide a listing by source, item, quantity, price, type of subcontract, degree of competition, and basis for establishing source and reasonableness of price, as well as the results of review and evaluation of subcontract proposals when required by FAR 15.404-3.

SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER

STATEMENTS OF OFFERORS

Updated through FAC 2005-89

Last updated: 07/2016

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— 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.

(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://sam.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://sam.gov/

2. COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING, (JUL 2016) 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 or FAR Provision 52.204-7.

3. PREDECESSOR OF OFFEROR, (JUL 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) Commercial 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 Commercial 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—

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:

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.

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 term “commercially available off-the-shelf (COTS) item,” is defined in the clause of this solicitation entitled “Combating Trafficking in Persons” (FAR clause 52.222-50).

(b) The apparent successful offeror shall submit, prior to award, a certification, as specified in paragraph (c) of this provision, for the portion (If any) of the contract that—

(1) Is for supplies, other than commercially available off-the-shelf, to be acquired outside of the

United States, or services to be performed outside the United States; and

(2) Has an estimated value that exceeds $500,000.

(c) The certification shall state that—

7. It has implemented a compliance plan to prevent any prohibited activities identified in paragraph (b) of the clause at 52.222-50, Combating Trafficking in Persons, and to monitor, detect, and terminate the contract with a subcontractor engaging in prohibited activities identified at paragraph (b) of the clause at 52.222-50, Combating Trafficking in Persons; and

8. After having conducted due diligence, either—

(a) To best of the offeror’s knowledge and belief, neither it nor any of its proposed agents, subcontractors, or their agents is engaged in any such activities; or

(b) If abuses relating to any of the prohibited activities identified in 52.222-50(b) have been found, the offeror or proposed subcontractor has taken the appropriate remedial and referral actions.

6. CERTIFICATION REGARDING ENVIRONMENTAL TOBACCO SMOKE (December 1994)

Public Law 103-227, also known as the Pro-Children Act of 1994 (Act), requires that smoking not be permitted in any portion of any indoor facility owned or leased or contracted for by an entity and used routinely or regularly for the provision of health, day care, early childhood development services, education or library services to children under the age of 18, if the services are funded by Federal programs either directly or through State or local governments, by Federal grant, contract, loan, or loan guarantee. The law also applies to children's services that are provided in indoor facilities that are constructed, operated, or maintained with such federal funds. The law does not apply to children's services provided in private residences; portions of facilities used for inpatient drug or alcohol treatment; service providers whose sole source of applicable federal funds is Medicare or Medicaid; or facilities where WIC coupons are redeemed.

Failure to comply with the provisions of the law may result in the imposition of a civil monetary penalty of up to $1,000 for each violation and/or the imposition of an administrative compliance order on the responsible entity.

By submission of its signed offer, the offeror/contractor (for acquisitions) or applicant/grantee (for grants) certifies that the submitting organization will comply with the requirements of the Act and will not allow smoking within any portion of any indoor facility used for the provision of services for children as defined by the Act.

The submitting organization agrees that it will require that the language of this certification be included in any subawards which contain provisions for children's services and that all subrecipients shall certify accordingly.

7. CERTIFICATION OF INSTITUTIONAL POLICY ON FINANCIAL CONFLICTS OF INTEREST

Note: This certification is applicable to all Research and Development (R&D) Contracts except Phase I SBIR/STTR and Contracts with Federal Agencies.

By Submission of its signed offer, the offeror certifies that:

(1) there is in effect at the Institution (the term…

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