PEP_RFP_66811.pdf

11. DELIVERY FOR FOB

DESTINATION UNLESS

BLOCK IS MARKED

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

1. REQUISITION NUMBER

PAGE 1 OF

2. CONTRACT NO.

3. AWARD/EFFECTIVE

DATE

4. ORDER NUMBER

5. SOLICITATION NUMBER

2017-N-66811

6. SOLICITATION

ISSUE DATE

07/06/2017

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME Florence P. Black

b. TELEPHONE NUMBER (No collect calls)

(412) 386-6455

8. OFFER DUE DATE/

LOCAL TIME

07/25/2017

9. ISSUED BY CODE 10. THIS ACQUISITION IS 12. DISCOUNT TERMS

Centers for Disease Control and Prevention Office of Acquisition Services 626 Cochrans Mill Rd, Building 140 Pittsburgh, PA 15236-0070

X UNRESTRICTED

SET ASIDE: % FOR

SMALL BUSINESS

SMALL DISADV. BUSINESS

8(A)

SIC: 541380

SIZE STANDARD: $15,000,000

X SEE SCHEDULE

13a. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

X RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE 436

SAME AS BLOCK 9

CODE 18a. PAYMENT WILL BE MADE BY CODE 434

Centers for Disease Control and Prevention (FMO) PO Box 15580 Atlanta, GA 30333-0080

TELEPHONE NO.

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

SEE ADDENDUM

19.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

“See Continuation Pages”

(Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

X 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA X ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

28.

CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN COPIES

TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER ALL ITEMS SET

FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL SHEETS SUBJECT

TO THE TERMS AND CONDITIONS SPECIFIED HEREIN.

29.

AWARD OF CONTRACT: REFERENCE OFFER

DATED . YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

HEREIN, IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (Signature of Contracting Officer)

30b. NAME AND TITLE OF SIGNER (Type or print)

30c. DATE SIGNED

31b. NAME OF CONTRACTING OFFICER (Type or print)

Stephanie D Cruz 31c. DATE SIGNED

32a. QUANTITY IN COLUMN 21 HAS BEEN 33. SHIP NUMBER 34. VOUCHER NUMBER

RECEIVED INSPECTED

PARTIAL FINAL

36. PAYMENT 37. CHECK NUMBER

32b. SIGNATURE OF AUTHORIZED GOV’T REPRESENTATIVE 32c. DATE COMPLETE PARTIAL FINAL

41a. I CERTIFY THIS AMOUNT IS CORRECT AND PROPER FOR PAYMENT 41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

38. S/R ACCOUNT NUMBER 39. S/R VOUCHER NUMBER

42a. RECEIVED BY (Print)

42b. RECEIVED AT (Location)

42c. DATE REC’D 42d. TOTAL CONTAINERS

40. PAID BY

AUTHORIZED FOR LOCAL REPRODUCTION SEE REVERSE FOR OMB CONTROL NUMBER AND PAPERWORK BURDEN STATEMENT STANDARD FORM 1449 (10-95)

ACCEPTED, AND CONFORMS TO THE

CONTRACT, EXCEPT AS NOTED

35. AMOUNT VERIFIED

CORRECT FOR

17a. CONTRACTOR/

OFFEROR

FACILITY

CODE

IS CHECKED

SECTION B - CONTINUATION CONTINUATION OF SF1449

ITEM SUPPLIES / SERVICES QTY UNIT TOTAL PRICE

0001 IDENTIFICATION OF NANOPARTICLES:

Identify printer-emitted engineered nanoparticles (PEPs)- induced gene signatures in accordance with the Statement of Work.

The period of performance will be 26 months from the effective date of award.

JOB

SECTION C - CONTRACT CLAUSES

Contract Terms and Conditions

FAR/HHSAR TITLE AND DATE

52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements

(Jan 2017) 52.204-13 System for Award Management Maintenance (Oct 2016) 52.204-18 Commercial and Government Entity Code Maintenance (July 2016) 52.204-19 Incorporation by Reference of Representations and Certifications (Dec 2014) 52.212-4 Contract Terms and Conditions – Commercial Items (Jan 2017) 52.232-39 Unenforceability of Unauthorized Obligations (June 2013) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) 352.222-70 Contractor Cooperation in EEO Investigations (Dec 2015) 352.224-71 Confidentiality of Information (Dec 2015) 352.239-74 Electronic Information and Technology Accessibility (Dec 2015)

C.1 52.252-2 --CLAUSES INCORPORATED BY REFERENCE (Feb 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses:

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/far1toc.htm http://www.hhs.gov/policies/hhsar/subpart301-1.html

C.2 52.204-21 Basic Safeguarding of Covered Contractor Information Systems (Jun 2016)

(a) Definitions. As used in this clause– “Covered contractor information system” means an information system that is owned or operated by a contractor that processes, stores, or transmits Federal contract information.

“Federal contract information” means information, not intended for public release, that is provided by or generated for the Government under a contract to develop or deliver a product or service to the Government, but not including information provided by the Government to the public (such as on public websites) or simple transactional information, such as necessary to process payments.

“Information” means any communication or representation of knowledge such as facts, data, or opinions, in any medium or form, including textual, numerical, graphic, cartographic, narrative, or audiovisual (Committee on National Security Systems Instruction (CNSSI) 4009).

“Information system” means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information (44 U.S.C. 3502).

“Safeguarding” means measures or controls that are prescribed to protect information systems.

(b) Safeguarding requirements and procedures.

(1) The Contractor shall apply the following basic safeguarding requirements and procedures to protect covered contractor information systems. Requirements and procedures for basic safeguarding of covered contractor information systems shall include, at a minimum, the following security controls:

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/far1toc.htm http://www.hhs.gov/policies/hhsar/subpart301-1.html http://uscode.house.gov/

(i) Limit information system access to authorized users, processes acting on behalf of authorized users, or devices (including other information systems).

(ii) Limit information system access to the types of transactions and functions that authorized users are permitted to execute.

(iii) Verify and control/limit connections to and use of external information systems.

(iv) Control information posted or processed on publicly accessible information systems.

(v) Identify information system users, processes acting on behalf of users, or devices.

(vi) Authenticate (or verify) the identities of those users, processes, or devices, as a prerequisite to allowing access to organizational information systems.

(vii) Sanitize or destroy information system media containing Federal Contract Information before disposal or release for reuse.

(viii) Limit physical access to organizational information systems, equipment, and the respective operating environments to authorized individuals.

(ix) Escort visitors and monitor visitor activity; maintain audit logs of physical access; and control and manage physical access devices.

(x) Monitor, control, and protect organizational communications (i.e., information transmitted or received by organizational information systems) at the external boundaries and key internal boundaries of the information systems.

(xi) Implement subnetworks for publicly accessible system components that are physically or logically separated from internal networks.

(xii) Identify, report, and correct information and information system flaws in a timely manner.

(xiii) Provide protection from malicious code at appropriate locations within organizational information systems.

(xiv) Update malicious code protection mechanisms when new releases are available.

(xv) Perform periodic scans of the information system and real-time scans of files from external sources as files are downloaded, opened, or executed.

(2) Other requirements. This clause does not relieve the Contractor of any other specific safeguarding requirements specified by Federal agencies and departments relating to covered contractor information systems generally or other Federal safeguarding requirements for controlled unclassified information (CUI) as established by Executive Order 13556.

(c) Subcontracts. The Contractor shall include the substance of this clause, including this paragraph (c), in subcontracts under this contract (including subcontracts for the acquisition of commercial items, other than commercially available off-the-shelf items), in which the subcontractor may have Federal contract information residing in or transiting through its information system.

C.3 FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (JAN 2017)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015)

(3) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(4) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77, 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the contracting officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

___ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

___ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).

___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub L. 111-5) (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009).

_X__ (4) 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Oct 2016) (Pub. L. 109-282) (31 U.S.C. 6101 note).

___ (5) [Reserved] ___ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__X_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Oct 2015) (31 U.S.C. 6101 note).

___ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).

___ (10) [Reserved] ___ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

___ (ii) Alternate I (Nov 2011) of 52.219-3.

___ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a).

___ (ii) Alternate I (Jan 2011) of 52.219-4.

___ (13) [Reserved] ___ (14) (i) 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644).

___ (ii) Alternate I (Nov 2011).

___ (iii) Alternate II (Nov 2011).

___ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

___ (ii) Alternate I (Oct 1995) of 52.219-7.

___ (iii) Alternate II (Mar 2004) of 52.219-7.

___ (16) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (15 U.S.C. 637(d)(2) and (3)).

___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Jan 2017) (15 U.S.C. 637 (d)(4)).

___ (ii) Alternate I (Nov 2016) of 52.219-9.

___ (iii) Alternate II (Nov 2016) of 52.219-9.

___ (iv) Alternate III (Nov 2016) of 52.219-9.

___ (v) Alternate IV (Nov 2016) of 52.219-9.

___ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

__ (19) 52.219-14, Limitations on Subcontracting (Jan 2017) (15 U.S.C. 637(a)(14)).

___ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

___ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f).

_X_ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C.

632(a)(2)).

___ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)).

___ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Dec 2015) (15 U.S.C. 637(m)).

_X_ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

___ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Oct 2016) (E.O. 13126).

_X__ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X__ (28) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).

___ (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

_X_ (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

___ (31) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).

___ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

_X__ (33) (i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).

___ (ii) Alternate I (Mar 2015) of 52.222-50, (22 U.S.C. chapter 78 and E.O. 13627).

___ (34) 52.222-54, Employment Eligibility Verification (Oct 2015). (E. O. 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

___ (35) 52.222-59, Compliance with Labor Laws (Executive Order 13673) (Oct 2016). (Applies at $50 million for solicitations and resultant contracts issued from October 25, 2016 through April 24, 2017;

applies at $500,000 for solicitations and resultant contracts issued after April 24, 2017).

Note to paragraph (b)(35): By a court order issued on October 24, 2016, 52.222-59 is enjoined indefinitely as of the date of the order. The enjoined paragraph will become effective immediately if the court terminates the injunction. At that time, DoD, GSA, and NASA will publish a document in the Federal Register advising the public of the termination of the injunction.

___ (36) 52.222-60, Paycheck Transparency (Executive Order 13673) (Oct 2016).

___ (37) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

___ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

___ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O.13693).

___ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

___ (40) (i) 52.223-13, Acquisition of EPEAT® -Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514 ___ (ii) Alternate I (Oct 2015) of 52.223-13.

___ (41) (i) 52.223-14, Acquisition of EPEAT® -Registered Television (Jun 2014) (E.O.s 13423 and 13514).

___ (ii) Alternate I (Jun 2014) of 52.223-14.

___ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

___ (43) (i) 52.223-16, Acquisition of EPEAT® -Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514).

___ (ii) Alternate I (Jun 2014) of 52.223-16.

__X_ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513).

___ (45) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

___ (46) 52.223-21, Foams (Jun 2016) (E.O. 13696).

___ (47) (i) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

___ (ii) Alternate I (Jan 2017) of 52.224-3.

___ (48) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83).

___ (49) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (May 2014) (41 U.S.C.

chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L.

103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112- 43).

___ (ii) Alternate I (May 2014) of 52.225-3.

___ (iii) Alternate II (May 2014) of 52.225-3.

___ (iv) Alternate III (May 2014) of 52.225-3.

___ (50) 52.225-5, Trade Agreements (Oct 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X_ (51) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

___ (52) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

___ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

___ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

___ (55) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)).

___ (56) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C. 4505, 10 U.S.C.

2307(f)).

_X_ (57) 52.232-33, Payment by Electronic Funds Transfer— System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (58) 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (59) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

___ (60) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

___ (61) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(12)).

___ (62) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631).

___ (ii) Alternate I (Apr 2003) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or executive orders applicable to acquisitions of commercial items:

___ (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495) __ (2) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67.).

__ (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

___ (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C.206 and 41 U.S.C. chapter 67).

___ (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

___ (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67).

___ (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67).

__ (8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015) (E.O. 13658).

__ (9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

___ (10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C.

1792).

___ (11) 52.237-11, Accepting and Dispensing of $1 Coin (Sep 2008) (31 U.S.C. 5112(p)(1)).

(d) Comptroller General Examination of Record The Contractor shall comply with the provisions of this paragraph

(d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records -- Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)

(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c) and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).

(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iii) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iv) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17.

(v) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

(vi) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).

(vii) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

(viii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

(ix) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).

(x) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222- 40.

(xi) 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67).

(xii) (A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O.

13627).

(B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 E.O. 13627).

(xiii) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67.)

(xiv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67)

(xv) 52.222-54, Employment Eligibility Verification (Oct 2015) (E. O. 12989).

(xvi) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

(xvii) 52.222-59, Compliance with Labor Laws (Executive Order 13673) (Oct 2016) (Applies at $50 million for solicitations and resultant contracts issued from October 25, 2016 through April 24, 2017; applies at $500,000 for solicitations and resultant contracts issued after April 24, 2017).

Note to paragraph (e)(1)(xvii): By a court order issued on October 24, 2016, 52.222-59 is enjoined indefinitely as of the date of the order. The enjoined paragraph will become effective immediately if the court terminates the injunction. At that time, DoD, GSA, and NASA will publish a document in the Federal Register advising the public of the termination of the injunction.

(xviii) 52.222-60, Paycheck Transparency (Executive Order 13673) (Oct 2016).

(xix) 52.222-62, Paid sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

(xx) (A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

(B) Alternate I (Jan 2017) of 52.224-3.

(xxi) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008;

10 U.S.C. 2302 Note).

(xxii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxiii) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of Clause)

C.4 CDC37.0001 Non-Personal Services (April 2013)

(a) Personal services shall not be performed under this contract. Although the Government may provide sporadic or occasional instructions within the scope of the contract, the Contractor is responsible for control and supervision of its employees. If the Contractor (including its employees) believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

(b) The contractor shall comply with, and ensure their employees and subcontractors comply with, CDC Policy titled “Identification of Contractors' Employees and Safeguarding Government Information.” No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. . The contractor is limited to performing the services identified in the contract statement of work and shall not interpret any communication with anyone as a permissible change in contract scope or as authorization to perform work not described in the contract.

All contract changes will be incorporated by a modification signed by the Contracting Officer.

(c) The Contractor shall ensure that all of its employees and subcontractor employees working on this contract are informed of the substance of this clause. The Contractor agrees that this is a non-personal services contract; and that for all the purposes of the contract, the Contractor is not, nor shall it hold itself out to be an agent or partner of, or joint venture with, the Government. The Contractor shall notify its employees that they shall neither supervise nor accept supervision from Government employees. The substance of this clause shall be included in all subcontracts at any tier.

(d) Nothing in this clause shall limit the Government's rights in any way under any other provision of the contract, including those related to the Government's right to inspect and accept or reject the services performed under this contract.

C. 5 Payment by Electronic Funds Transfer

(a) The Government shall use electronic funds transfer to the maximum extent possible when making payments under this contract. FAR 52.232-33, Payment by Electronic Funds Transfer – System For Award Management requires the contractor to designate in writing a financial institution for receipt of electronic funds transfer payments.

(b) In addition to System for Award Management Registration, the contractor shall make the designation by submitting the form titled “ACH Vendor/Miscellaneous Payment Enrollment Form” to the address indicated below.

Note: The form may be obtained by contacting the Contracting Officer or the CDC Financial Management Office at (678-475-4510).

(c) In cases where the contractor has previously provided such designation, i.e., pursuant to a prior contract/order, and been enrolled in the program, the form is not required unless the designated financial institution has changed.

(d) The completed form shall be mailed after award, but no later than 14 calendar days before an invoice is submitted, to the following address:

The Centers for Disease Control and Prevention Financial Management Office (FMO) P.O. Box 15580 Atlanta, GA 30333 Or – Fax copy to: 404-638-5342

(End of Clause)

C.6 Invoice Submission

(a) The Contractor may submit a paper copy of the contract invoice/voucher to the address shown below The Centers for Disease Control and Prevention Financial Management Office (FMO) P.O. Box 15580 Atlanta, GA 3033

Or – The Contractor may submit the original invoice/voucher via facsimile or email:

Fax: 404-638-5342

Email: FMOAPINV@CDC.GOV

NOTE: Submit to only one (1) of the above locations.

(b ) In accordance with 5 CFR part 1315 (Prompt Payment), CDC's Financial Management Office is the designated billing office for the purpose of determining the payment due date under FAR 32.904.

(c) The Contractor shall include (as a minimum) the following information on each invoice:

(1) Contractor’s Name & Address mailto:FMOAPINV@CDC.GOV

(2) Contractor’s Tax Identification Number (TIN)

(3) Purchase Order/Contract Number and Contract Number, if Appropriate

(4) Invoice Number

(5) Invoice Date

(6) Contract Line Item Number and Description of Item

(7) Quantity

(8) Unit Price & Extended Amount for each line item

(9) Shipping and Payment Terms

(10) Total Amount of Invoice

(11) Name, title and telephone number of person to be notified in the event of a defective invoice

(12) Payment Address, if different from the information in (c) (1).

(13) DUNS + 4 Numbers

(End of Clause)

C.7 352.270-5b Care of Live Vertebrate Animals (December 18, 2015)

(a) Before undertaking performance of any contract involving animal-related activities where the species is regulated by the United Sates Department of Agriculture (USDA), the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR sections 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer.

(b) The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR sections 2.1-2.11, or from a source that is exempt from licensing under those sections.

(c) The Contractor agrees that the care, use, and intended use of any live vertebrate animals in the performance of this contract shall conform with the Public Health Service (PHS) Policy on Humane Care of Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall govern.

(d) If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer’s written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor’s name may be removed from the list of those contractors with Animal Welfare Assurances.

Note: The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737 (E-mail: ace@aphis.usda.gov; website:

http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalwelfare).

(End of clause) mailto:ace@aphis.usda.gov http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalwelfare

SECTION D - CONTRACT DOCUMENTS, EXHIBITS OR ATTACHMENTS

Statement of Work – RFQ 2017-N-66811

STUDY OF PRINTER-EMITTED ENGINEERED NANOPARTICLES (PEPS) –INDUCED GENOMIC CHANGES

The services contemplated under this contract are considered to be an “Other Functions” as defined by the Office of Federal Procurement Policy in OFPP letter 11-01 and by HHS in Acquisition Policy Memorandum 2012-01.

BACKGROUND AND NEED – Previous PEPs studies consisted of the following research: particle generation, characterization and fractionation, in vitro dosimetric determination, in vitro toxicity investigation in multiple cell lines, pilot study in in vivo evaluation of PEP-induced cardiovascular effects via inhalation. In the proposed study, emphasis will be given on biokinetics of inhaled PEPs, other PEP-targeted organ toxicity, prolong PEP exposure-induced cardiopulmonary responses studies, and genomic studies.

The unique physicochemical properties of engineered nanomaterials (ENMs) are being exploited for use in a growing variety of commercial nano-enabled products (NEPs), including electronics, cosmetics, and structural materials, as well as a wide variety of products for medical applications. Numerous in vitro and in vivo studies have investigated the possible adverse effects of inhalation exposure to pristine ENMs during synthesis and handling by workers and consumers. However, human exposure is not limited to pristine ENMs, but also includes a wide variety of particles released from NEPs across their life cycle, including consumer use and disposal. Therefore, these results cannot be correlated to exposures at consumer level since the test particles used are not representative of the “real world” exposure of consumers to PEPs. Indeed, the potential for exposure from such life cycle particulate matter (“LCPM”) may exceed that of pristine engineered nanoparticles (“ENPs”). Moreover, the physico-chemical properties and toxicological profiles of LCPM may differ greatly from those of pristine ENPs. Despite the potential for LCPM exposure, most nanotoxicological studies have focused on pristine ENPs, and toxicological evaluation of LCPM has been limited. NIOSH and the EPA have therefore recommended life cycle analyses in their nanotechnology research programs. Most importantly, researchers need to develop a methodology that can link real world LCPM exposures to toxicology and cardiopulmonary risk.

This study will specifically address this important research gap.

This current study will use state-of-the-art PEP exposure generation systems and in vivo bioassays combined with traditional pathological analysis and advanced computational genomic modeling to assess mechanisms of potential PEP-induced cardiopulmonary and other organ diseases and predict potential disease implications in humans. The integrated approach will identify mechanistic pathways predictive of LCPM-induced cardiopulmonary diseases in animal models, and by extrapolation, in humans.

Moreover, this current study will identify PEP-induced gene signatures from the cultured cells, lung and blood samples from in vivo models and determine whether these signatures predictively match those for known pathways of cardiopulmonary and other organ diseases in humans. This multi-disciplinary screening approach, linking in vitro and in vivo PEP exposures to in vitro and in vivo toxicological evaluation, as well as computational modeling results will provide a robust and useful framework for risk assessment of engineered nanomaterials released across the life cycle of NEP. This contract will address genomic profiling and computational toxicology.

Project Objective – This study will apply advanced computational genomic modeling to assess mechanisms of potential PEP-induced cardiopulmonary and other organ diseases and predict potential disease implications in humans, and provide a robust and useful framework for risk assessment of engineered nanomaterials released across the life cycle of NEP. The development of genomic-based non-invasive diagnostic blood tests of cardiopulmonary and other targeted organ diseases will provide valuable predictive biomarkers for surveillance and early risk assessment of engineered nanomaterial exposures.

Scope of Work – This study will identify and compare pathway-based gene signatures from in vitro and in vivo PEP-induced genome-wide mRNA expression profiles and evaluate the identified PEP-induced gene signatures as predictive indicators of pulmonary and cardiovascular damage for risk surveillance.

Moreover, this study will predict possible LCPM-induced disease implications in other tissue organs based on the analysis of genome-wide expression profiles in blood samples from rats exposed to PEPs by whole-body inhalation. Bioinformatics analysis will be performed in the genome-wide profiles of the rat blood samples to identify significantly over-represented biological pathways, processes, molecular networks, diseases, and physiological functions.

TECHNICAL REQUIREMENTS –The contractor shall complete the following tasks:

1. Microarray profiling data preprocessing and filtering.

2. Identification of PEP-induced gene signatures.

3. Evaluate the identified gene signatures in predicting human cardiopulmonary disease using patient data for risk assessment.

4. Rat blood miRNA data analysis and biomarker identification.

5. Integrated mRNA and miRNA analyses. The pathway relevance and functional annotation of the identified miRNA markers will be evaluated with Ingenuity Pathway Analysis. Results from the integrated analysis of PEP-induced mRNA and miRNA expression changes from the rat model will be compared with those from human patients.

6. Comparative analysis of human and rodent genome. Rat and human genomes will be matched by gene name, using the data mining tool Biomart based on Ensemble Genes .

7. Predict possible disease implications in other PEP-targeted organs.

8. Provide deliverables as shown in the Deliverables section.

SPECIAL REQUIREMENTS

1. Any presentations in scientific conferences and any publications of the work under this contract should be published in peer-reviewed scientific journals within three years of the end of the period of performance of this contract.

2. This contract shall be conducted in compliance with the Public Health Service (PHS) Policy on the Humane Care and Use of Laboratory Animals, the Animal Welfare Act and Regulations, the current edition of the “Guide for the Care and Use of Laboratory Animals (the Guide), and all local, state, or federal regulations.

3. Data Management Plan For all New Contracts Awarded After January 1, 2017: HHS/CDC policy requires that contract award recipients make research resources including data readily available after publication to qualified individuals within the scientific community for research purposes. CDC requires that all new collections of public health data include a Data Management Plan (DMP). For purposes of this statement of work, “public health data” means digitally recorded factual material commonly accepted in the scientific community as necessary to validate research findings including datasets used to support scholarly publications. The CDC AR-25 outlines the components of a Data Management Plan (DMP) and provides additional information for investigators regarding the requirements for data accessibility, storage, and preservation. This new requirement ensures that CDC is in compliance with the following; Office of Management and Budget (OMB) memorandum titled “Open Data Policy–Managing Information as an Asset” (OMB M-13-13); Executive Order 13642 titled “Making Open and Machine Readable the New Default for Government Information”; and the Office of Science and Technology Policy (OSTP) memorandum titled “Increasing Access to the Results of Federally Funded Scientific Research” (OSTP Memo).

Investigators, upon award of a NIOSH contract that will generate “public health data” must provide a data management plan for how they will collect, analyze, store, use and make available the data collected for the proposed project or activity. If data sharing is not possible, applicants need to provide a justification explaining the reasons for not sharing their data. The costs of sharing or archiving data may be included as part of the total budget requested for first-time or continuation awards. Awardees for CDC funds should incorporate data release into their study designs and should do the following: (a) set up procedures for protecting personal or proprietary information, (b) ensure data quality, and (c) include appropriate documentation (e.g., data dictionary, codes, etc.) for reuse of data. The CDC AR-25 outlines the components of a DMP and provides additional information for investigators regarding the requirements for data accessibility, storage, and preservation.

The contractor should address the following questions in their DMP:

What types of data do you plan to generate include the size, file formats, number of files?

Who will find your data useful?

Are there limitations on the secondary research use of data, if the study involved human data?

What transformations will be necessary to prepare data for preservation and sharing?

What metadata documentation will be submitted with the data?

Will a data sharing agreement be required?

Describe whether data will be provided directly to the researchers, or if access will be provided to a restricted online database or at a CDC-controlled site (e.g., the National Center for Health Statistic’s Research Data Center)?

Which archive/repository/central database have you identified as a place to deposit?

What is the expected timeline from data collection to release or anticipated date of release?

http://www.cdc.gov/grants/additionalrequirements/ar-25.html https://www.whitehouse.gov/sites/default/files/omb/memoranda/2013/m-13-13.pdf https://www.whitehouse.gov/sites/default/files/microsites/ostp/ostp_public_access_memo_2013.pdf http://www.cdc.gov/grants/additionalrequirements/ar-25.html

Data Management Plan Progress Reporting

Routine reviews and reports specified within the contract terms and conditions will be used to monitor contractor progress. Contractors must justify changes from the original DMP, and these changes should be concurred by the NIOSH COR.

At the end of the contract funding period, the contractor will submit a final DMP. The final DMP will include the location of each dataset, any restriction to access, and changes to the plans for long term preservation of the data. The final DMP should also indicate that all laws, regulations, and rights regarding the data have been complied with.

Awardees who fail to release public health data in a timely fashion will be subject to procedures normally used to address lack of compliance consistent with 45 CFR 74.62 or other authorities as appropriate. Such procedures include, but are not limited to, reduction in funding, restriction of funds, or contract termination. The DMP is not intended to replace other contract reporting requirements.

Reporting Schedule/Deliverables –

Items

Description Quantity or No.

Delivery Date

Deliver To

Initial Report Initial report detailing the research design and data management plan (DMP)

No later than four (4) weeks after the start of the project

NIOSH COR

Interim Report 1 Interim report detailing the project progress and any updates to DMP.

January 26, 2018

Interim Report 2 Interim report detailing the project progress and any updates to DMP.

August 1, 2018

Draft Final Report Draft Final report for review and approval, including update to DMP.

February 1, 2019

Final Report Final report including COR-idenitified revisons and a final DMP.

July 20, 2019

The draft final report will include a statement of the problem, a list of project aims, description of methods used, summary of results, and conclusions. The NIOSH COR will have 45 calendar days to provide comments and suggested revisions. The contractor can request one set of clarifications concerning the COR response, and the final report will include all revisions. A separate document labeled Final Data Management Plan must be submitted concurrently with the final report.

In addition, the contractor will provide informal reports as to progress or unanticipated technical issues at least monthly via phone or email communication with NIOSH scientists.

PERIOD OF PERFORMANCE

The period of performance is expected to be 24 months, from approximately August 1, 2017 to July 31, 2019.

SECTION E - SOLICITATION PROVISIONS

FAR/HHSAR TITLE/DATE

52.204-7 System for Award Management (Oct 2016)

52.204-16 Commercial and Government Entity Code Reporting (July 2016) 52.204-19 Incorporation by Reference of Representations and Certifications

(Dec 2014) 352.239-73 Electronic Information and Technology Accessibility Notice (Dec

2015)

E.1 52.209-11 – Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law (Feb 2016)

(a) As required by sections 744 and 745 of Division E of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L 113-235), and similar provisions, if contained in subsequent appropriations acts, the Government will not enter into a contract with any corporation that--

(1) Has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, where the awarding agency is aware of the unpaid tax liability, unless an agency has considered suspension or debarment of the corporation and made a determination that suspension or debarment is not necessary to protect the interests of the Government; or

(2) Was convicted of a felony criminal violation under any Federal law within the preceding 24 months, where the awarding agency is aware of the conviction, unless an agency has considered suspension or debarment of the corporation and made a determination that this action is not necessary to protect the interests of the Government.

(b) The Offeror represents that—

(1) It is [ ] is not [ ] a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability; and

(2) It is [ ] is not [ ] a corporation that was convicted of a felony criminal violation under a Federal law within the preceding 24 months.

(End of Provision)

E.2 52.212 -1 Instructions to Offerors -- Commercial Items (Jan 2017)

(a) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code and small business size standard for this acquisition appear in Block 10 of the solicitation cover sheet (SF 1449). However, the small business size standard for a concern which submits an offer in its own name, but which proposes to furnish an item which it did not itself manufacture, is 500 employees.

(b) Submission of offers. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation.