N62645-16-R-0014_AttachmentVI_CombinedSynopsisSolicitation_Final.pdf

N62645-16-R-0014

This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR 12.6, Streamlined

Procedures for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; Proposals are being requested and a written solicitation will not be issued. The solicitation is issued as a request for Proposals (RFP). Provisions and clauses in effect through Federal

Acquisition Circular 2005-87 are incorporated. It is the contractor’s responsibility to be familiar with the applicable clauses and provisions. The clauses may be accessed in full text at these addresses https://acquisition.gov/far/index.html and http://farsite.hill.af.mil/. The NAICS code is 325413, with a small business size of 500 employees.

The Naval Medical Logistics Command (NMLC), on behalf of the Naval Medical Center San Diego (NMCSD) has a Brand Name Only requirement for Bio-Rad Bioplex 2200 system on a Cost Per Reportable Result (CPRR) basis.

All qualified vendors are encouraged to submit a proposal.

The solicitation number is N62645-16-R-0014.

ITEM NO SUPPLIES/SERVICES MAX

QUANTITY

UNIT UNIT PRICE MAX AMOUNT

0001 1 Lot Cost Per Reportable Result (CPRR)

FFP

Refer to Statement of Requirements for detailed information.

See Attachment 1: Preliminary Proposal for Reportable Tests and provide the pricing information for all reportable tests.

FOB: Destination

MAX

NET AMT

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0002 1 Each Medical Device Risk Assessment (MDRA)

FFP

Refer to Conformance to Information Assurance under Instructions to Offerors.

Completed Gold Section returned to Naval Medical Logistics Command (NMLC) within seven (7) days after award.

https://acquisition.gov/far/index.html http://farsite.hill.af.mil/

UNIT UNIT PRICE MAX AMOUNT

1001 1 Lot OPTION Cost Per Reportable Result (CPRR)

FFP

Refer to Statement of Requirements for detailed information.

UNIT UNIT PRICE MAX AMOUNT

2001 1 Lot OPTION Cost Per Reportable Result (CPRR)

FFP

Refer to Statement of Requirements for detailed information.

UNIT UNIT PRICE MAX AMOUNT

3001 1 Lot OPTION Cost Per Reportable Result (CPRR)

FFP

Refer to Statement of Requirements for detailed information.

UNIT UNIT PRICE MAX AMOUNT

4001 1 Lot OPTION Cost Per Reportable Result (CPRR)

FFP

Refer to Statement of Requirements for detailed information.

STATEMENT OF REQUIREMENTS

The Naval Medical Center San Diego (NMCSD) has a requirement for a Cost Per Reportable Result (CPRR) contract for a multi-technology laboratory analyzer, reagents, calibrators and control items. Specifically, the requirement is for a BioRad Bioplex 2200 laboratory analyzer to include reagents, calibrators, and control items on a

CPRR basis and a service maintenance plan. This requirement includes recurring shipments of materials and reagents needed to perform serological testing for infectious disease and autoimmune markers as listed below.

Supplies shall be FDA approved and comply with FDA standards.

The contractor is hereby advised that the United States Government and agencies are exempted from state and local government tax by virtue of article 6 of the United States Constitution. No exemption certificate is required.

The Contractor shall meet the following requirements:

a. A fully automated system capable of detecting serological immune markers directly from human plasma. The system shall use flow cytometry based technology and fluorescent microbeads to detect multiple targets simultaneously from patient serum or plasma. The system shall be random-access allowing patient specimens to be added continuously and to allow different tests to be performed on samples without requiring users to organize, group, or batch specimens to perform testing. The system shall be capable of multiplex analysis through the performance of different tests simultaneously on each individual specimen, allowing for high throughput and not requiring additional runs for each specimen. Automated steps in the processing specimens shall include: specimen processing (pipetting, aliquoting, and reagent distribution), incubation, wash steps, analysis, and data processing.

b. The system shall be capable of high throughput by processing no less than fifty (50) patient specimens per hour, with multiple tests capable of being performed simultaneously on each specimen.

c. Sample analysis shall include detection of a sufficient sample size of markers (> 50 beads/assay) to ensure the precision and accuracy of results. Software shall be capable of independent data analysis that does not require the user to manipulate flow cytometry gates, adjustment of fluorescent laser intensity (gain), and other sample analysis parameters. Data reporting shall be qualitative (positive or negative) calculated based on the threshold number of positive fluorescent microbeads required for a positive results (> 50 beads/assay). Despite independent system data analysis, users shall be able to access raw data to aid in troubleshooting and/or further analysis of results.

d. The system shall include an internal control(s) that is analyzed alongside all tests performed on each patient specimen.

e. The system shall be capable of testing for: Measles IgG, Mumps IgG, Rubella IgG, Varicella IgG, Toxoplasma

IgM/IgG, Cytomegalovirus IgM/IgG, Herpes Simplex Virus 1 and 2 IgG, Epstein-Barr Virus IgM/IgG markers

(EAD, EBNA, VCA), Treponema pallidum (syphilis) IgG, celiac disease IgG and IgA panels, and Antiphospholipid

Syndrome IgG, IgM and IgA panels (anti-cardiolipin and anti-beta-2 glycoprotein I). The system shall also be able to screen for autoimmune anti-nuclear antibodies (ANA) as a panel and also be capable of differentiating between the following markers without requiring additional testing: dsDNA, chromatin DNP, ribosomal P, ss-A, ss-B, Sm, Sm/RNP, Scl-70, Jo-1, and centromere B. Furthermore, assays for Measles IgM, Mumps IgM, Rubella IgM, Varicella IgM, Toxoplasma IgM and Treponema pallidum (Syphilis) IgM are highly desirable and should be in progress towards FDA-clearance.

f. The system shall include software to guide users through daily preventative maintenance procedures, analysis of control and calibration tests, and alert users when problems that may affect instrument performance arise.

g. The system shall be capable of reading Type 39 bar codes in real time to be used to determine the tests ordered for each patient specimen and to report results.

h. The system shall be capable of bi-directional communication (downloading test orders and reporting patients’ results) through an interface with the Composite Health Care System (CHCS) laboratory information system (LIS).

i. The system shall be capable of storing reagents for multiple tests onboard the instrument to allow random access and rapid testing of patient specimens. The shelf-life of unused reagents shall be no less than 6 months and no less than 30 days for opened reagents when stored either on the instrument or an external refrigerator.

j. An unlimited service maintenance plan (at least 5 days/week) shall be included in the arrangement between diagnostics companies and laboratories in which an analyzer will be placed in a laboratory in exchange for the purchase of cost per reportable test. This shall include at a minimum all of the following: Telephone technical support and on-site service Monday through Friday, 8:00 a.m. to 4:00 p.m. (local time), excluding national holidays, hardware and software upgrades when available, and semiannual preventative maintenance.

k. The contractor shall provide cost per reportable result pricing to include costs for all reagents, controls, calibration reagents, maintenance reagents, all consumables required to perform testing.

l. Delivery times at NMCSD will be Monday through Friday between the hours of 8:00 AM and 3:30 PM local time.

m. Deliver to:

Naval Medical Center San Diego (NMCSD)

Receiving Officer

Loading Dock #1

34800 Bob Wilson Drive

San Diego, CA 92134-5000

OTHER CONTRACTING REQUIREMENTS

Risk Management Framework (RMF)

The contractor shall comply with RMF requirements, as specified by the Defense Health Agency (DHA) that meet appropriate DoD, DHA and Navy Cybersecurity requirements. The contractor shall initiate the process by providing the required documentation necessary to submit their system to the Authorizing Official (AO) for assessment and authorization (A&A) for all orders delivered against this contract. The requirements shall be met before the contractor's system is authorized to access DoD data or to interconnect with any DoD network or system that receives, processes, stores, displays or transmits DoD data. The contractor shall ensure the proper contractor support staff is available to participate in all phases of the RMF process. This includes, but is not limited to;

Attending and supporting RMF and A&A meetings with Navy and DHA cybersecurity representatives as required.

Support/conduct vulnerability mitigation to comply with cybersecurity controls listed in National Institute of

Standards and Technology (NIST) Special Publication (SP) 800-53; Security and Privacy Controls for Federal

Information Systems and Organizations and DHA Administrative Instruction 77. In order for a system to be authorized, there shall be zero Category 1 findings.

Support the A&A Team during system security testing.

Once the system has been authorized, the contractor shall maintain an acceptable security baseline consistent with the authorization granted by the AO throughout the life of the system. This includes ensuring that all vulnerabilities affecting the operating system, primary application, database and all third party software have validated and applied within 30 days.

Cybersecurity

The vendor shall establish appropriate administrative and technical safeguards to protect any and all data, to ensure the confidentiality, integrity, and availability of Government data under their control. At a minimum, this shall include provisions for vendor personnel security and electronic security.

The proposed system shall be capable of supporting the use of Defense Information Systems Agency (DISA) approved antimalware applications. The Navy uses McAfee Host Based Security System (HBSS) as their solution.

The vendor shall provide technical specifications that clearly demonstrate whether the proposed solution can integrate and support, either fully or partially the operation without performance degradation of the medical system/device. In cases where the operation of HBSS is not technically achievable, the vendor shall provide detailed justification and a Plan of Actions and Milestones (POA&M) describing steps towards compliance with this requirement.

The vendor must provide their Antivirus (AV) policy and a list of AV Exceptions (if applicable) to the NMLC prior to AV installation on the system/device. AV must be installed on all devices before they are placed on the Navy network.

Systems shall be configured in such a way to allow for the updating of malware definition signatures on a scheduled basis. Scanning shall encompass the entire system (file system, operating system, real-time processes), by default. In cases where scanning of the entire system may negatively affect its operation, the vendor shall provide a detailed list of exclusions with justifications.

Vulnerability Management

Vulnerability mitigation strategies include security updates, service packs, and changes to operating procedures as physical and cyber vulnerabilities are detected. Operating systems, servers, development platforms and the application being delivered to the Navy shall be in compliance with all known applicable guidelines. The vendor shall agree to be proactive in working with the Navy to mitigate new threats as they emerge.

All vendor validated and approved patches, up to and including the date of install, must be loaded on the system prior to system go-live. Security scans will be run during government acceptance testing. All Category I (CAT I) findings must be remediated prior to government acceptance of the system. A CAT I vulnerability is any vulnerability, the exploitation of which will, directly and immediately result in loss of Confidentiality, Availability, or Integrity. There shall be no more than 10 Category II (CAT II) findings at the time of government acceptance.

CAT II vulnerabilities are any vulnerability, the exploitation of which has a potential to result in loss of

Confidentiality, Availability, or Integrity.

Domain Name System Realm/Directory Services

Contractor will be required to provide technical evidence, if applicable, whether client/server topology based medical systems can integrate with Directory Services and support LDAP authentication.

Local Privileged and Administrative User/Local System Accounts

Contractor shall create a single local user account with administrative/root level privileges for purposes of conducting system repairs and maintenance only. This account shall be separate and distinct from the built-in local administrative/root account provided by the Operating System and shall comply with DoD policy. All factors required to complete successful identification, authentication and authorization against the built-in local

Administrative/Root level account shall be provided to the MTF Biomedical Engineering Department.

Complete administrative system rights shall be provided to the government System Administrator for the purpose of conducting device vulnerability scans as needed.

DHA Business to Business (B2B) Gateway. All contractor systems that will communicate with

DON systems will interconnect through the established DHA Business to Business (B2B) gateway.

Contractors will connect to the B2B gateway via a contractor procured Internet Service Provider (ISP) connection and assume all responsibilities for establishing and maintaining their connectivity to the B2B gateway. This will include acquiring and maintaining the circuit to the B2B gateway and acquiring a Virtual Private Network (VPN) device compatible with the DHA VPN device. Maintenance and repair of contractor procured VPN equipment shall be the responsibility of the contractor.

Contractors shall configure their network to support access to government systems (e.g., configure ports and protocols for access).

Contractors shall provide full time connections to a TIER1 or TIER2 ISP. Dial-up ISP connections are not acceptable.

Contractors will comply with DoD guidance regarding allowable ports, protocols and risk mitigation strategies prior to accessing DoD/DHA networks. All contractors will be required to complete a DISA Form 2875, System

Authorization Access Request form (SAAR) and submit it to the Navy PACS Office for processing. Contractor personnel will be required to complete applicable DoD cybersecurity training.

IPv6

The proposed system shall be Internet Protocol version 6 (IPv6) capable or the vendor shall provide a detailed project, migration or planning documentation to show when the proposed system shall be IPv6 capable.

Minimum IPv6 capabilities include:

Conformant with the IPv6 standards profile contained in the DoD IT Standards Registry (DISR);

Maintaining interoperability in heterogeneous environments with IPv4;

Commitment to upgrade as the IPv6 standard evolves;

Availability of vendor IPv6 technical support.

The contractor shall be able to demonstrate or provide documentation to prove that their product is IPv6 capable

Health Insurance Portability and Accountability Act (HIPAA)

The contractor shall comply with the HIPAA Act of 1996 (Public Law 104-191) requirements, specifically the administrative simplification provision s of the law and the associated rules and regulations published by the

Secretary, Health and Human Services (HHS). This includes the Standards for Electronic Transactions, the

Standards for Privacy of Individually Identifiable Health Information and the Security Standards.

Applicable References:

DoD Instruction 8510.01, Risk Management Framework (RMF) for DoD Information Technology (IT)

NIST SP 800-37 Guide for Applying the Risk Management Framework to Federal Information Systems of February

2010, as amended

NIST SP 800-53 Security and Privacy Controls for Federal Information Systems and Organizations, of 30 April

2013, as amended

DoD Instruction 500.01 of 14 March 2014, DoD Cybersecurity

DHA Administrative Instruction 77 of 28 May 2015

DoD Instruction 6025.18-R, DoD Health Information Privacy Regulation

DoD Instruction 8580.02, Security of Individually Identifiable Health Information in DoD Health Care Programs

ATTACHMENTS

Attachment 1: Preliminary Proposal for Reportable Tests

ADMINISTRATIVE INFORMATION

The point of contact for administrative concerns at NMLC, 693 Neiman Street, Fort Detrick, MD 21702 is Yun

Hong, yun.p.hong.civ@mail.mil.

Designation of Ordering Activity

The following requiring activity and their ordering office are hereby named to place a delivery order.

Warranted Contracting Officer

NMLC

693 Neiman Street

Fort Detrick, Maryland 21702-9203

CONTRACTOR SUPPORT

Notice: Navy Use of Support Contractor for Contract Closeout Functions

Naval Medical Logistics Command (NMLC) uses two private contractors in support of the contract closeout process. Those companies are Contracting Resources Group (CRG) of Federal Hill, MD, doing business under the authority of the Small Business Administration’s 8(a) program and the Ability One Program, doing business under the authority of the Javits-Wagner O’Day Act (41 U.S.C. § 47).

mailto:yun.p.hong.civ@mail.mil

The contract closeout process includes activities such as processing deobligation modifications, obtaining contractor and requiring activity concurrence, preparing the DD-Form 1594 (Contract Completion Statement), and preparing closed files for archiving. Support contractors may perform additional administrative duties, including filing and processing simple administrative modifications. Performing these functions require the contractor employees to have access to the contract file. Therefore, information you provide to the Government or information already in the possession of the Government may be viewed by these support contractors in the course of performing contract close-out functions. The information that may be made available to the contractor may include pricing and technical proposals and performance information.

NMLC has signed Non-Disclosure Agreements with each support contractor employee and has required both contractors to provide a Conflict of interest Mitigation Plan to ensure these employees are firewalled from all business development activity.

By submission of a proposal, the offeror and its subcontractors consent to access of their business sensitive/confidential or proprietary data by the Government’s support contractor personnel in order to perform close out services.

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government

0002 Destination Government Destination Government

1001 Destination Government Destination Government

2001 Destination Government Destination Government

3001 Destination Government Destination Government

4001 Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC

0001 POP 01-JUL-2016 TO

30-JUN-2017

N/A NAVAL MEDICAL CENTER SAN DIEGO

RECEIVING LOADING DOCK 1

34800 BOB WILSON DRIVE

SAN DIEGO CA 92134-5000

619-532-6078

N00259

0002 7 dys. ADC 1 NAVAL MEDICAL LOGISTICS COMMAND

CODE 03 - PACS

693 NEIMAN STREET

FORT DETRICK MD 21702-9239

301-619-9349

N62645

1001 POP 01-JUL-2017 TO

30-JUN-2018

N/A NAVAL MEDICAL CENTER SAN DIEGO

RECEIVING LOADING DOCK 1

34800 BOB WILSON DRIVE

SAN DIEGO CA 92134-5000

619-532-6078

2001 POP 01-JUL-2018 TO

30-JUN-2019

N/A (SAME AS PREVIOUS LOCATION)

3001 POP 01-JUL-2019 TO

30-JUN-2020

N/A (SAME AS PREVIOUS LOCATION)

4001 POP 01-JUL-2020 TO

30-JUN-2021

N/A (SAME AS PREVIOUS LOCATION)

CLAUSES INCORPORATED BY REFERENCE

52.203-3 Gratuities APR 1984

52.204-7 System for Award Management JUL 2013

52.204-13 System for Award Management Maintenance JUL 2013

52.204-16 Commercial and Government Entity Code Reporting JUL 2015

52.204-18 Commercial and Government Entity Code Maintenance JUL 2015

52.209-7 Information Regarding Responsibility Matters JUL 2013

52.212-4 Contract Terms and Conditions--Commercial Items MAY 2015

52.219-9 (Dev) Small Business Subcontracting Plan (Deviation 2013-O0014) OCT 2015

52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

DEC 2013

52.242-15 Stop-Work Order AUG 1989

52.242-17 Government Delay Of Work APR 1984

52.246-2 Inspection Of Supplies--Fixed Price AUG 1996

52.247-34 F.O.B. Destination NOV 1991

252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7005 Representation Relating to Compensation of Former DoD

Officials

NOV 2011

252.204-7008 Compliance With Safeguarding Covered Defense Information

Controls

DEC 2015

252.204-7012 Safeguarding Covered Defense Information and Cyber

Incident Reporting.

DEC 2015

252.204-7015 Disclosure of Information to Litigation Support Contractors FEB 2014

252.205-7000 Provision Of Information To Cooperative Agreement Holders DEC 1991

252.213-7000 Notice to Prospective Suppliers on Use of Past Performance

Information Retrieval System--Statistical Reporting in Past

Performance Evaluations

JUN 2015

252.215-7008 Only One Offer OCT 2013

252.219-7003 (Dev) Small Business Subcontracting Plan (DOD Contracts)

(Deviation 2013-O0014)

OCT 2014

252.222-7007 Representation Regarding Combating Trafficking in Persons JAN 2015

252.223-7008 Prohibition of Hexavalent Chromium JUN 2013

252.225-7012 Preference For Certain Domestic Commodities FEB 2013

252.225-7021 Trade Agreements--Basic (OCT 2015) OCT 2015

252.225-7050 Disclosure of Ownership or Control by the Government of a

Country that is a State Sponsor of Terrorism

OCT 2015

252.226-7001 Utilization of Indian Organizations and Indian-Owned

Economic Enterprises, and Native Hawaiian Small Business

Concerns

SEP 2004

252.232-7003 Electronic Submission of Payment Requests and Receiving

Reports

JUN 2012

252.232-7010 Levies on Contract Payments DEC 2006

252.243-7002 Requests for Equitable Adjustment DEC 2012

252.244-7000 Subcontracts for Commercial Items JUN 2013

252.247-7023 Transportation of Supplies by Sea APR 2014

CLAUSES INCORPORATED BY FULL TEXT

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)

52.212-1 INSTRUCTIONS TO OFFERORS--COMMERCIAL ITEMS (OCT 2015)

(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. Offers may be submitted on the SF 1449, letterhead stationery, or as otherwise specified in the solicitation. As a minimum, offers must show--

(1) The solicitation number;

(2) The time specified in the solicitation for receipt of offers;

(3) The name, address, and telephone number of the offeror;

(4) A technical description of the items being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary;

(5) Terms of any express warranty;

(6) Price and any discount terms;

(7) "Remit to" address, if different than mailing address;

(8) A completed copy of the representations and certifications at FAR 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the offeror shall complete electronically);

(9) Acknowledgment of Solicitation Amendments;

(10) Past performance information, when included as an evaluation factor, to include recent and relevant contracts for the same or similar items and other references (including contract numbers, points of contact with telephone numbers and other relevant information); and

(11) If the offer is not submitted on the SF 1449, include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Offers that fail to furnish required representations or information, or reject the terms and conditions of the solicitation may be excluded from consideration.

(c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 30 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation.

(d) Product samples. When required by the solicitation, product samples shall be submitted at or prior to the time specified for receipt of offers. Unless otherwise specified in this solicitation, these samples shall be submitted at no expense to the Government, and returned at the sender's request and expense, unless they are destroyed during preaward testing.

(e) Multiple offers. Offerors are encouraged to submit multiple offers presenting alternative terms and conditions or commercial items for satisfying the requirements of this solicitation. Each offer submitted will be evaluated separately.

(f) Late submissions, modifications, revisions, and withdrawals of offers:

(1) Offerors are responsible for submitting offers, and any modifications, revisions, or withdrawals, so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that offers or revisions are due.

(2)(i) Any offer, modification, revision, or withdrawal of an offer received at the Government office designated in the solicitation after the exact time specified for receipt of offers is “late” and will not be considered unless it is received before award is made, the Contracting Officer determines that accepting the late offer would not unduly delay the acquisition; and--

(A) If it was transmitted through an electronic commerce method authorized by the solicitation, it was received at the initial point of entry to the Government infrastructure not later than 5:00 p.m. one working day prior to the date specified for receipt of offers; or

(B) There is acceptable evidence to establish that it was received at the Government installation designated for receipt of offers and was under the Government's control prior to the time set for receipt of offers; or

(C) If this solicitation is a request for proposals, it was the only proposal received.

(ii) However, a late modification of an otherwise successful offer, that makes its terms more favorable to the

Government, will be considered at any time it is received and may be accepted.

(3) Acceptable evidence to establish the time of receipt at the Government installation includes the time/date stamp of that installation on the offer wrapper, other documentary evidence of receipt maintained by the installation, or oral testimony or statements of Government personnel.

(4) If an emergency or unanticipated event interrupts normal Government processes so that offers cannot be received at the Government office designated for receipt of offers by the exact time specified in the solicitation, and urgent

Government requirements preclude amendment of the solicitation or other notice of an extension of the closing date, the time specified for receipt of offers will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.

(5) Offers may be withdrawn by written notice received at any time before the exact time set for receipt of offers.

Oral offers in response to oral solicitations may be withdrawn orally. If the solicitation authorizes facsimile offers, offers may be withdrawn via facsimile received at any time before the exact time set for receipt of offers, subject to the conditions specified in the solicitation concerning facsimile offers. An offer may be withdrawn in person by an offeror or its authorized representative if, before the exact time set for receipt of offers, the identity of the person requesting withdrawal is established and the person signs a receipt for the offer.

(g) Contract award (not applicable to Invitation for Bids). The Government intends to evaluate offers and award a contract without discussions with offerors. Therefore, the offeror's initial offer should contain the offeror's best terms from a price and technical standpoint. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government may reject any or all offers if such action is in the public interest; accept other than the lowest offer; and waive informalities and minor irregularities in offers received.

(h) Multiple awards. The Government may accept any item or group of items of an offer, unless the offeror qualifies the offer by specific limitations. Unless otherwise provided in the Schedule, offers may not be submitted for quantities less than those specified. The Government reserves the right to make an award on any item for a quantity less than the quantity offered, at the unit prices offered, unless the offeror specifies otherwise in the offer.

(i) Availability of requirements documents cited in the solicitation. (1)(i) The GSA Index of Federal Specifications, Standards and Commercial Item Descriptions, FPMR Part 101-29, and copies of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained for a fee by submitting a request to--GSA

Federal Supply Service Specifications Section, Suite 8100, 470 East L'Enfant Plaza, SW, Washington, DC

20407, Telephone (202) 619-8925, Facsimile (202) 619-8978.

(ii) If the General Services Administration, Department of Agriculture, or Department of Veterans Affairs issued this solicitation, a single copy of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained free of charge by submitting a request to the addressee in paragraph (i)(1)(i) of this provision.

Additional copies will be issued for a fee.

(2) Most unclassified Defense specifications and standards may be downloaded from the following ASSIST websites:

(i) ASSIST (https://assist.dla.mil/online/start/).

(ii) Quick Search (http://quicksearch.dla.mil/).

(iii) ASSISTdocs.com (http://assistdocs.com).

(3) Documents not available from ASSIST may be ordered from the Department of Defense Single Stock Point

(DoDSSP) by--

(i) Using the ASSIST Shopping Wizard (https://assist.dla.mil/wizard/index.cfm);

(ii) Phoning the DoDSSP Customer Service Desk (215) 697-2179, Mon-Fri, 0730 to 1600 EST; or

(iii) Ordering from DoDSSP, Building 4, Section D, 700 Robbins Avenue, Philadelphia, PA 19111-5094, Telephone

(215) 697-2667/2179, Facsimile (215) 697-1462.

(4) Nongovernment (voluntary) standards must be obtained from the organization responsible for their preparation, publication, or maintenance.

(j) Data Universal Numbering System (DUNS) Number. (Applies to all offers exceeding $3,500, and offers of

$3,500 or less if the solicitation requires the Contractor to be registered in the System for Award Management

(SAM) database. The offeror shall enter, in the block with its name and address on the cover page of its offer, the annotation “DUNS” or “DUNS +4” followed by the DUNS or DUNS +4 number that identifies the offeror's name and address. The DUNS +4 is the DUNS number plus a 4-character suffix that may be assigned at the discretion of the offeror to establish additional SAM records for identifying alternative Electronic Funds Transfer (EFT) accounts

(see FAR Subpart 32.11) for the same concern. If the offeror does not have a DUNS number, it should contact Dun and Bradstreet directly to obtain one. An offeror within the United States may contact Dun and Bradstreet by calling

1-866-705-5711 or via the internet at http://fedgov.dnb.com/webform. An offeror located outside the United States must contact the local Dun and Bradstreet office for a DUNS number. The offeror should indicate that it is an offeror for a Government contract when contacting the local Dun and Bradstreet office.

(k) System for Award Management. Unless exempted by an addendum to this solicitation, by submission of an offer, the offeror acknowledges the requirement that a prospective awardee shall be registered in the SAM database prior to award, during performance and through final payment of any contract resulting from this solicitation. If the Offeror does not become registered in the SAM database in the time prescribed by the Contracting

Officer, the Contracting Officer will proceed to award to the next otherwise successful registered Offeror. Offerors may obtain information on registration and annual confirmation requirements via the SAM database accessed through https://www.acquisition.gov.

(l) Debriefing. If a post-award debriefing is given to requesting offerors, the Government shall disclose the following information, if applicable:

https://assist.dla.mil/online/start/ http://quicksearch.dla.mil/ http://assistdocs.com/ https://assist.dla.mil/wizard/index.cfm https://www.acquisition.gov/

(1) The agency's evaluation of the significant weak or deficient factors in the debriefed offeror's offer.

(2) The overall evaluated cost or price and technical rating of the successful and the debriefed offeror and past performance information on the debriefed offeror.

(3) The overall ranking of all offerors, when any ranking was developed by the agency during source selection.

(4) A summary of the rationale for award;

(5) For acquisitions of commercial items, the make and model of the item to be delivered by the successful offeror.

(6) Reasonable responses to relevant questions posed by the debriefed offeror as to whether source-selection procedures set forth in the solicitation, applicable regulations, and other applicable authorities were followed by the agency.

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL ITEMS (MAR 2016)

ALTERNATE I (OCT 2014)

The offeror shall complete only paragraphs (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) Web site accessed through http://www.acquisition.gov . If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (q) of this provision.

(a) Definitions. As used in this provision--

“Economically disadvantaged women-owned small business (EDWOSB) concern” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

“Forced or indentured child labor” means all work or service—

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

“Highest-level owner” means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

“Immediate owner” means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following: Ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

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“Inverted domestic corporation,” means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

“Manufactured end product” means any end product in product and service codes (PSCs) 1000-9999, except—

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

“Place of manufacture” means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

“Restricted business operations” means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate—

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote health or education; or

(6) Have been voluntarily suspended.

Sensitive technology—

(1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically—

(i) To restrict the free flow of unbiased information in Iran; or

(ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and

(2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3) of the International Emergency Economic Powers Act

(50 U.S.C. 1702(b)(3)).

“Service-disabled veteran-owned small business concern”—

(1) Means a small business concern—

(i) Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.

(2) Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

“Small business concern” means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR Part 121 and size standards in this solicitation.

“Small disadvantaged business concern, consistent with 13 CFR 124.1002,” means a small business concern under the size standard applicable to the acquisition, that--

(1) Is at least 51 percent unconditionally and directly owned (as defined at 13 CFR 124.105) by--

(i) One or more socially disadvantaged (as defined at 13 CFR 124.103) and economically disadvantaged (as defined at 13 CFR 124.104) individuals who are citizens of the United States; and

(ii) Each individual claiming economic disadvantage has a net worth not exceeding $750,000 after taking into account the applicable exclusions set forth at 13 CFR 124.104(c)(2); and

(2) The management and daily business operations of which are controlled (as defined at 13.CFR 124.106) by individuals, who meet the criteria in paragraphs (1)(i) and (ii) of this definition.

“Subsidiary” means an entity in which more than 50 percent of the entity is owned—

(1) Directly by a parent corporation; or

(2) Through another subsidiary of a parent corporation.

“Veteran-owned small business concern” means a small business concern—

(1) Not less than 51 percent of which is owned by one or more veterans(as defined at 38 U.S.C. 101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and

(2) The management and daily business operations of which are controlled by one or more veterans.

“Women-owned business concern” means a concern which is at least 51 percent owned by one or more women; or in the case of any publicly owned business, at least 51 percent of the its stock is owned by one or more women; and whose management and daily business operations are controlled by one or more women.

“Women-owned small business concern” means a small business concern --

(1) That is at least 51 percent owned by one or more women or, in the case of any publicly owned business, at least

51 percent of the stock of which is owned by one or more women; and

(2) Whose management and daily business operations are controlled by one or more women.

“Women-owned small business (WOSB) concern eligible under the WOSB Program (in accordance with 13 CFR part 127),” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the

United States.

(b)

(1) Annual Representations and Certifications. Any changes provided by the offeror in paragraph (b)(2) of this provision do not automatically change the representations and certifications posted on the SAMwebsite.

(2) The offeror has completed the annual representations and certifications electronically via the SAM website accessed through https://www.acquisition.gov. After reviewing the SAM database information, the offeror verifies by submission of this offer that the representation and certifications currently posted electronically at FAR 52.212-3, Offeror Representations and Certifications—Commercial Items, have been entered or updated in 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 paragraphs ___ . [Offeror to identify the applicable paragraphs at (c) through (q) of this provision that the offeror has completed for the purposes of this solicitation only, if any. 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. 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 electronically on SAM.]

(c) Offerors must complete the following representations when the resulting contract is to be performed in the

United States or its outlying areas. Check all that apply.

(1) Small business concern. The offeror represents as part of its offer that it [ ___ ] is, [ ___ ] is not a small business concern.

(2) Veteran-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents as part of its offer that it [ ___ ] is, [ ___ ] is not a veteran-owned small business concern.

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(3) Service-disabled veteran-owned small business concern. [Complete only if the offeror represented itself as a veteran-owned small business concern in paragraph (c)(2) of this provision.] The offeror represents as part of its offer that it [ ___ ] is, [ ___ ] is not a service-disabled veteran-owned small business concern.

(4) Small disadvantaged business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.]The offeror represents that it [ ___ ] is, [ ___ ] is not, a small disadvantaged business concern as defined in 13 CFR 124.1002.

(5) Women-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.]The offeror represents that it [ ___ ] is, [ ___ ] is not a women-owned small business concern.

Note: Complete paragraphs (c)(8) and (c)(9) only if this solicitation is expected to exceed the simplified acquisition threshold.

(6) WOSB concern eligible under the WOSB Program. [Complete only if the offeror represented itself as a women-owned small business concern in paragraph (c)(5) of this provision.] The offeror represents that—

(i) It [ ___ ] is, [ ___ ] is not a WOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and

(ii) It [ ___ ] is, [ ___ ] is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(6)(i) of this provision is accurate for each WOSB concern eligible under the WOSB

Program participating in the joint venture. [The offeror shall enter the name or names of the WOSB concern eligible under the WOSB Program and other small businesses that are participating in the joint venture: ___ .] Each

WOSB concern eligible under the WOSB Program participating in the joint venture shall submit a separate signed copy of the WOSB representation.

(7) Economically disadvantaged women-owned small business (EDWOSB) concern. [Complete only if the offeror represented itself as a WOSB concern eligible under the WOSB Program in (c)(6) of this provision.] The offeror represents that—

(i) It [ ___ ] is, [ ___ ] is not an EDWOSB concern, has provided all the required documents to the WOSB

Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and

(ii) It [ ___ ] is, [ ___ ] is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(7)(i) of this provision is accurate for each EDWOSB concern participating in the joint venture. [The offeror shall enter the name or names of the EDWOSB concern and other small businesses that are participating in the joint venture: ___ .] Each EDWOSB concern participating in the joint venture shall submit a separate signed copy of the EDWOSB representation.

(8) Women-owned business concern (other than small business concern). [Complete only if the offeror is a women-owned business concern and did not represent itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it [ ___ ] is, a women-owned business concern.

(9) Tie bid priority for labor surplus area concerns. If this is an invitation for bid, small business offerors may identify the labor surplus areas in which costs to be incurred on account of manufacturing or production (by offeror or first-tier subcontractors) amount to more than 50 percent of the contract price:

(10) HUBZone small business concern. [Complete only if the offeror represented itself as a small business concern…