RFP_No._N01TR-19-2007_Amendment_No._02.pdf

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 or (c) By separate letter or electronic communication 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 DATE 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 letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

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

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

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

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

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.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

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

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, 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)

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.

15C. DATE SIGNED

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

16C. DATE SIGNED

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

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

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

Previous edition unusable

Jeffrey Schmidt, Contracting Officer

Purpose: Amended to replace SOLICITATION ATTACHMENT 4 and provide questions and answers regarding the Request for Proposal (RFP).

Proposal Due Date: 11:00 A.M., Eastern Standard Time, January 25, 2019. (UNCHANGED)

Note: Offerors should acknowledge receipt of this Amendment via email reply to jeffrey.schmidt@nih.gov and mark.

mcnally@nih.gov or include acknowledgment of receipt in their response to the RFP.

National Institute on Drug Abuse Office of Acquisition, NCATS Section 6001 Executive Blvd., Rm 3150, MSC 9559 Bethesda, MD 20892-9559

TO ALL POTENTIAL OFFERORS

N01TR-19-2007

1 23

See Block 16C.

12/11/2018

1/15/2019

RFP No. N01TR-19-2007 Amendment No. 02

BEGINNING WITH THE EFFECTIVE DATE OF THIS AMENDMENT, THE

SOLICITATION IS AMENDED AS FOLLOWS:

SECTION J - LIST OF ATTACHMENTS, SOLICITATION ATTACHMENT 4, is replaced in its entirety with the attached Section K - Representations, Certifications, and Other Statements of Offerors.

RFP No. N01TR-19-2007 – QUESTIONS AND ANSWERS

1. QUESTION: For b. Task 2: In vitro Testing, how many kinases the compounds should be tested against? The Liu paper mentions mTORC1, mTOR, and PI3K.

ANSWER: The offeror decides the number of kinases and the number of compounds needed to be tested for the selectivity. For front-runners, we prefer tested against >300 kinases.

2. QUESTION: For c. Task 3: Can assays and panels for this specific task be sent to CRO or have to be done in house? We understand that the primary ADME assays will be run at NCATS (SOW page 3, paragraph 2).

ANSWER: We prefer the task to be done in house, but it can be sent to CRO.

3. QUESTION: How many awards will be given?

ANSWER: As referenced under SECTION L, subparagraphs 1.c. and 1.d. (RFP pages 54-55), we anticipate multiple awardees for this indefinite-delivery, indefinite-quantity (IDIQ) contract. One or more task orders may be issued during the performance period of the resultant contract. If a contractor responds to a Task Order Request for Proposal (TORFP) and is the successful offeror, that Contractor will be required to accept and perform the task order issued by the Contracting Officer (CO) within the scope of the resultant contract. The government has no obligation to issue any task orders, beyond the minimum identified in SECTION B of the contract. Contractors will be required to provide services under the resultant contract only in performance of task orders and modifications to task orders signed by the Contracting Officer.

4. QUESTION: Will there be administrative and scientific base support for the contract?

ANSWER: As discussed under the RFP Statement of Work (SOW), subparagraph IV.B.

(page 4 of 5 of RFP Attachment 3), project management will be applicable to every task order issued under this Contract. The Contractor shall provide project management for its own core team to ensure planning, execution, delivery of reports, and accurate and timely communication with the COR, CO, and other stakeholders.

Each TORFP will include, among other things, the reporting requirements and deliverables, technical proposal instructions, and business proposal instructions.

The TORFP business proposal instructions will address how offerors shall identify and list all personnel who will be directly involved in work under this task order and how to provide relevant labor cost/pricing information including indirect costs, if applicable. Offerors’ proposals should include the personnel they determine are necessary to perform the services in the TORFP.

Included with the RFP is Sample Task Order Request for Proposal (TORFP) No. 01.

This is only a sample and not an actual task order. Offerors are to provide responses to the Sample TORFP No. 01, and the Offerors’ responses: (1) are for proposal evaluation purposes; (2) will be relied on in evaluating rates/labor categories for future task order awards; (3) will not result in any task order awards; and (4) are a scored factor included in this RFP's Technical Evaluation Criteria (see RFP Section M

- Evaluation Factors for Award).

5. QUESTION: Will the 6 FTE chemist that are exclusively dedicated to this project be covered by the contract for the entire contract period or will they be paid intermittently by projects?

ANSWER: Each TORFP will include the anticipated Task Order period of performance;

for Sample TORFP No. 01 the period of performance is twelve months. If a contractor responds to a TORFP, that Contractor’s proposal should include the personnel they determine are necessary to perform the services in the TORFP for the duration of the Task Order period of performance. If that Contractor is the successful offeror, they will be required to accept and perform the task order issued by the Contracting Officer in accordance with their successful proposal and within the scope of the resultant contract.

6. QUESTION: Are postdocs classified as trainees?

ANSWER: Yes, postdocs are considered trainees.

7. QUESTION: Please clarify FISMA and IT security requirements.

ANSWER: FISMA and IT security requirements may be required under task orders only and will not be required under the parent IDIQ contract. Please refer to ARTICLE H.13. (RFP pages 19-26) and SECTION L.2., subparagraph 15 (RFP pages 62-70).

8. QUESTION: In Attachment I, Section II “Formatting and Page Limitations” there is a section “A” dedicated to formatting, but there does not appear to be a section “B” dedicated to page limitations for each of the major proposal sections. We offer the following suggested page limitations:

COVER PAGE – no page limit TECHNICAL PROPOSAL – xx pages

Sample Task Order 1 Proposal – xx pages Business Proposal – no page limit Resumes – no page limit

ANSWER: Thank you for this suggestion, but the Government does not anticipate any further changes to RFP Attachment 1.

9. QUESTION: Page 71 of the Instructions to Offerors seems to indicate that the IDIQ Technical Proposal should be written as if to an explicit task order scope; however, at the IDIQ level this does not seem to align with the Section M criteria on pages 86-88. The Section M evaluation criteria seem to be more broadly defined at the IDIQ level (not at the Task Order level). We respectfully suggest that the Section L instructions on page 71 be revised to correlate more closely with the Section M evaluation criteria; i.e.,

1. Technical Plan / Approach

2. Organizational Capabilities

3. Scientific and Technical Personnel

4. Facilities, Equipment and Resources

ANSWER: Thank you for this suggestion, but the language of the Section L instructions is prescribed by the National Institutes of Health (NIH) Office of Acquisition Management and Policy (OAMP). At this time, the Government does not anticipate any further changes to Section L.

10. QUESTION: Regarding the Sample Task Order, Attachment 5, page 3 of 12, paragraph 2.

Can the NIH provide any guidance as to the period of time required by the government to perform these assays, as the time required for the Government to perform this work would affect the period of performance?

ANSWER: The Government can obtain compounds’ anti-malarial activity and cytotoxicity from the in vitro assays, and primary ADME profile data within four weeks. We will test selective compounds (4-6 compounds) in the in vivo efficacy model every three months.

11. QUESTION: Attachment 5, Item 10, d, it says our subcontractor’s commitment letter should include "Information on their cognizant field audit offices". Could you please clarify the intent of this requirement?

ANSWER: Information on the cognizant field audit office(s) is to facilitate compliance with any applicable requirements of FAR 42. On its website, the Defense Contract Audit Agency (DCAA) provides an Audit Office Locator:

https://www.dcaa.mil/FAOLocations/ConusLocator https://www.dcaa.mil/FAOLocations/ConusLocator

One can search by ZIP code, CAGE code or DUNS number. New contractors may search by ZIP.

12. QUESTION: Is there a sample/template of previously awarded proposal available for reference?

ANSWER: No. In accordance with FAR 3.104-2(b)(5) and 3.104-4(f), the Government is unable to release any previous proposal information.

13. QUESTION: As a part of the proposal do you need us to provide an example of one of the programs that we worked on with a major Pharma for their lead optimization program that involved all the metrics?

ANSWER: Providing an example of past projects is good but not necessary.

14. QUESTION: Does the Proposal need to cover all aspects of lead optimization such as analog synthesis, ADME, in vitro/in vivo screening, PK and Tox?

ANSWER: The proposal needs to cover all aspects of lead optimization described in the RFP.

15. QUESTION: What is the page limit for the proposal?

ANSWER: There is no page limit.

16. QUESTION: The Sample Task Order requires Fixed fee total $ amount for Task 2-5 inclusive. Will NCATS define the number of compounds and the tests for these phases for uniform submitter responses or, are you looking for responders to suggest based on experience? Similarly, are you looking for responders to state target criteria for the eventual candidate?

ANSWER: We would like offerors to propose the number of compounds and tests based on their experience, but there is no need to define target criteria for the lead candidates.

17. QUESTION: Task 2 suggests kinase assays. Are any other assays to be considered?

ANSWER: In addition to kinase assays, offerors could propose any other assays.

18. QUESTION: Task 3 (Assay and Panels) indicates it may be necessary to address a specific ADME or toxicological liability. Do you wish to specify #cpds and specific tests for uniformity?

ANSWER: TORFP No. 01 is only a sample and not an actual task order. Offerors are to provide responses to the Sample TORFP No. 01, and the Offerors’ responses: (1) are for proposal evaluation purposes; (2) will be relied on in evaluating rates/labor categories for future task order awards; (3) will not result in any task order awards;

and (4) are a scored factor included in this RFP's Technical Evaluation Criteria (see RFP Section M - Evaluation Factors for Award).

19. QUESTION: Task 4 (PK and Metabolism) – do you wish to define # of compounds for PK and type of metabolism assay?

ANSWER: TORFP No. 01 is only a sample and not an actual task order. Offerors are to provide responses to the Sample TORFP No. 01, and the Offerors’ responses: (1) are for proposal evaluation purposes; (2) will be relied on in evaluating rates/labor categories for future task order awards; (3) will not result in any task order awards;

20. QUESTION: Task 5 (non-GLP tox studies) – do you wish to define # of compounds and duration of studies, how many compounds per species – rat, mouse, dog?

ANSWER: TORFP No. 01 is only a sample and not an actual task order. Offerors are to provide responses to the Sample TORFP No. 01, and the Offerors’ responses: (1) are for proposal evaluation purposes; (2) will be relied on in evaluating rates/labor categories for future task order awards; (3) will not result in any task order awards;

21. QUESTION: The 5 stage process for chemistry implies only 5 stages of chemistry design.

Typically in our experience medicinal chemists design new compounds after each screening round which is every two weeks in this case to ensure that every compound counts and that time is not spent working on unfruitful compounds. Will this be how the program is run in practice?

ANSWER: TORFP No. 01 is only a sample and not an actual task order. New compounds designed for synthesis are indeed based on the data from the previous screening round.

22. QUESTION: Do all Subcontractors used by the Contractor need to be US-based?

ANSWER: No.

23. QUESTION: Can the timeline for proposal submission be extended?

ANSWER: The RFP proposal due date and time will not be extended.

24. QUESTION: Can the government advise on how to fill out the Technical Proposal Cost Summary (Attachment 7) that is to be included in the technical volume given the T&M and FFP requirement of the proposed cost chart in the Business Proposal Instructions of TORFP No. 01 (Attachment 5)?

ANSWER: For RFP Attachment 7 - TECHNICAL PROPOSAL COST INFORMATION/SUMMARY OF LABOR AND DIRECT COSTS, please complete the Year 1 column with the proposal cost information for CLIN 1 (Time & Materials CLIN for TORFP Statement of Work Task No. 1). Please complete the Year 2-5 columns with the proposal cost information for CLINs 2-5 (Firm Fixed Price CLINs for TORFP SOW Task Nos. 2-5). Please either relabel these columns on RFP Attachment 7 from Year 1-5 to CLIN 1-5, or clearly note on RFP Attachment 7 that the proposal cost information in the Year 1-5 columns represents CLINs 1-5 of the Sample TORFP No. 01. The columns for Year 6 and 7 should be omitted. The cost proposal information should only be for the twelve-month period of performance of the Sample TORFP No. 01; therefore, the proposal cost information should be for one year and not the five-year ordering period of the contract.

25. QUESTION: Is the Excel Spreadsheet in Attachment 12 alongside the Breakdown of Proposed Estimated Cost (Plus Fee) And Labor Hours required for the business proposal? If so, can you provide clear instructions on how to fill out the form given the T&M and FFP cost requirement in the business volume?

ANSWER: For the BREAKDOWN OF PROPOSED ESTIMATED COSTS (PLUS FEE) AND LABOR HOURS, please include the information in the format described in RFP Attachment 12 as part of the PDF file of your Business Proposal as instructed under RFP Attachment 1, subparagraph I.B.2. Please complete the Year 1 column with the proposal cost information for CLIN 1 (Time & Materials CLIN for TORFP Statement of Work Task No. 1). Please add and complete Year 2-5 columns with the proposal cost information for CLINs 2-5 (Firm Fixed Price CLINs for TORFP SOW Task Nos. 2-5).

Please either relabel these columns from Year 1-5 to CLIN 1-5, or clearly note that the proposal cost information in the Year 1-5 columns represents CLINs 1-5 of the Sample TORFP No. 01. The columns for Year 6 and 7 should be omitted. The cost proposal information should only be for the twelve-month period of performance of the Sample TORFP No. 01; therefore, the proposal cost information should be for one year and not the five-year ordering period of the contract.

In addition, complete the following Excel spreadsheet:

https://oamp.od.nih.gov/sites/default/files/DFASDocs/buscntrctprpslsprdsht08- 2014_508.xlsx Include this completed Excel spreadsheet in your submission as instructed under RFP Attachment 1, subparagraph I.B.3. Please relabel the PERIOD I-V columns in the Excel spreadsheet as CLINs 1-5 and complete with the corresponding proposed cost information. The PERIOD VI and VII columns of the Excel spreadsheet should be omitted. The cost proposal information should only be for the twelve-month period of performance of the Sample TORFP No. 01; therefore, the proposal cost information should be for one year and not the five-year ordering period of the contract.

26. QUESTION: Is only one budget required to be filled out for CLIN 1, but not CLIN 2 - 5 based on the instructions provided on page 11 – 12 of Attachment 5?

ANSWER: For RFP Attachment 5 pages 11-12, please include the information in the format described in the following link in one table that includes CLINs 1-5:

https://oamp.od.nih.gov/content/breakdown-proposed-estimated-cost-plus-fee-and-laborhours

This should be included as part of the PDF file of your Business Proposal as instructed under RFP Attachment 1, subparagraph I.B.2. For the BREAKDOWN OF PROPOSED ESTIMATED COSTS (PLUS FEE) AND LABOR HOURS, please complete the Year 1 column with the proposal cost information for CLIN 1 (Time & Materials CLIN for TORFP Statement of Work Task No. 1). Please add and complete Year 2-5 columns with the proposal cost information for CLINs 2-5 (Firm Fixed Price CLINs for TORFP SOW Task Nos. 2-5). Please either relabel these columns from Year 1-5 to CLIN 1-5, or clearly note that the proposal cost information in the Year 1-5 columns represents CLINs 1-5 of the Sample TORFP No. 01. The cost proposal information should only be for the twelve-month period of performance of the Sample TORFP No.

01; therefore, the proposal cost information should be for one year and not the five-year ordering period of the contract.

In addition, please also complete one Excel spreadsheet that includes CLINs 1-5:

https://oamp.od.nih.gov/sites/default/files/DFASDocs/buscntrctprpslsprdsht08- 2014_508.xlsx

Include this completed Excel spreadsheet in your submission as instructed under RFP Attachment 1, subparagraph I.B.3. Please relabel the PERIOD I-V columns in the Excel spreadsheet as CLINs 1-5 and complete with the corresponding proposed cost information. The PERIOD VI and VII columns of the Excel spreadsheet should be omitted. The cost proposal information should only be for the twelve-month period of performance of the Sample TORFP No. 01; therefore, the proposal cost information should be for one year and not the five-year ordering period of the contract.

https://oamp.od.nih.gov/sites/default/files/DFASDocs/buscntrctprpslsprdsht08-2014_508.xlsx https://oamp.od.nih.gov/content/breakdown-proposed-estimated-cost-plus-fee-and-laborhours https://oamp.od.nih.gov/content/breakdown-proposed-estimated-cost-plus-fee-and-laborhours

27. QUESTION: The RFP does not include any computational analysis, either for SAR/design purposes or computational ADME. Should these capabilities be included?

ANSWER: These capabilities will be provided by NCATS.

28. QUESTION: In Task 2 of the Sample TO, DPI is asking for the contractor to test in kinase assays, and in the general IDIQ SOW, Task 2 is designed for eliminating liabilities. Does this mean the DPI views the mTOR activity of Torin2 to be a liability that needs to be eliminated, or is the concern other kinase activity, since the request is for kinase assays, not just one?

ANSWER: Human kinase activities of Torin2 are considered off-target activities.

29. QUESTION: For Sample TORFP No. 1, Task 1, part v and Task 4, can the Government clarify whether PK studies will be needed for all or a portion of the 20-40 compounds? Also, will the PK studies be in both rodents and nonrodents?

ANSWER: PK studies will be needed for a portion of the 20-40 compounds. Most of the PK studies will be in rodents.

30. QUESTION: Typically for lead optimization screening projects, only one sex is used for pharmacokinetic studies because of cost and material needs. Does the Government require both male and female animals be included in the pharmacokinetic studies?

ANSWER: Only one sex used for PK studies is fine.

31. QUESTION: Many lead optimization projects only use only 1 species (rodent) for toxicology screening because of cost and material requirements of a nonrodent such as dog. Can the Government clarify if it expects both rodent and nonrodent toxicology studies in Task 5 and for how many compounds?

ANSWER: Most of the early toxicology studies will use mice or rats. NCATS has an active contract to support further toxicology studies.

32. QUESTION: Typically for lead optimization screening projects, only one sex is used for toxicology because of cost and material needs. Does the Government require both male and female animals be included in the toxicology screening studies?

ANSWER: Only one sex used for toxicology studies is fine.

33. QUESTION: With regard to FAR 52.225-1, is any part of this solicitation for COTS items?

ANSWER: No. This Solicitation is for research and development (R&D) services only, and the Government will not be acquiring any supplies for use in the United States under this service contract.

34. QUESTION: Do any of the representations in section 1(c)(2) of Section K apply?

ANSWER: Yes, the following apply:

52.204-17, Ownership or Control of Offeror (Jul 2016).

52.204-20, Predecessor of Offeror (Jul 2016).

See also the replaced SOLICITATION ATTACHMENT 4 - SECTION K -

REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS,

attached herein.

35. QUESTION: Can a copy of the cost accounting disclosure statement that will be required under Section K(5) be provided

ANSWER:

https://www.whitehouse.gov/wp-content/uploads/2017/11/CASB_DS-1.pdf

For Educational Institutions:

https://www.whitehouse.gov/wp-content/uploads/2017/11/CASB_DS-2.pdf https://www.whitehouse.gov/wp-content/uploads/2017/11/CASB_DS-1.pdf https://www.whitehouse.gov/wp-content/uploads/2017/11/CASB_DS-2.pdf

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—

RFP Number N01TR-19-2007 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.

RFP Number N01TR-19-2007 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://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.

RFP Number N01TR-19-2007 Attachment 4 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.

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.

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…