RFQ_N6264517Q0015_Scanning_System_NMC_Portsmouth.pdf

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 1 Each

SCANNING SYSTEM, ULTRASONIC

FFP

Ultrasonic Scanning System Naval Medical Center (NMC) Portsmouth

Medical Device Risk Assessment Questionnaire GOLD SECTION - Must be completed and submitted to Naval Medical Logistics Command (NMLC) within 10 business days after award via email, to usn.detrick.navmedlogcomftdmd.list.mdra@mail.mil

FOB: Destination

MILSTRIP: N6264517RCES070

PURCHASE REQUEST NUMBER: N6264517RCES070

ADDITIONAL MARKINGS: ATTN: JESUS SAENZ; TP3; N00183-7131-E070;

N00183-16M031

NET AMT

ESSENTIAL CHARACTERISTICS

The Naval Medical Logistics Command has a requirement for one (1) scanning system, ultrasonic, general-purpose, for Naval Medical Center Portsmouth. The ultrasonic scanning system shall be compatible for use with the Intuitive Surgical da Vinci Si Surgical System (IS3000). The ultrasonic scanning system shall include the following transducers:

One (1) hockey stick transducer One (1) T-shaped transducer One (1) endocavity transducer, to be used for transvaginal and transrectal applications One (1) abdominal transducer One (1) robotic drop-in transducer, for use with the da Vinci Surgical System One (1) curved array transducer One (1) burr hole transducer One (1) laparoscopic transducer

The ultrasonic scanning system shall include a starter set of all consumables necessary for the above transducers.

The ultrasonic scanning system shall include all hardware and software necessary for full system functionality. The ultrasonic scanning system shall include a printer. The system shall be DICOM compatible. The system shall include at least two (2) sterilization trays. The system shall include operator training for at least one (1) person. The system shall include two (2) service and operator manuals, each.

Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system, such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

The system, including claims made for the product, shall be compliant with FDA regulations, in respect to marketing and delivering medical products for use in the United States of America. These requirements shall apply even if delivery is requested outside of the United States of America.

ECMRA

ENTERPRISE-WIDE CONTRACTOR MANPOWER REPORTING APPLICATION (ECMRA)

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the Navy via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address https://doncmra.nmci.navy.mil.

Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year. Contractors may direct questions to the help desk, linked at https://doncmra.nmci.navy.mil.

CONTRACTOR SUPPORT

NOTICE: NAVY USE OF SUPPORT CONTRACTOR FOR CONTRACT CLOSEOUT FUNCTIONS

Naval Medical Logistics Command 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).

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.

Naval Medical Logistics Command 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 quote in response to the RFQ (N6264517Q0015), 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.

INSTRUCTIONS TO OFFERORS

Addendum to 52.212-1 Instructions to Quoters

This section specifies the format and content that vendors shall use in response to the Request for Quote (RFQ).

Vendors shall submit a response that is legible and comprehensive enough to provide the basis for a sound evaluation by the Government. The intent is to ensure a certain degree of uniformity in the format of the responses for evaluation purposes. Information provided shall be precise, factual, and complete. Legibility, clarity, completeness and responsiveness are important. Quotes shall be in the form prescribed by, and shall contain a response to, each of the areas identified. Any quote which does not provide, as a minimum that which is required or meet the requirements of the solicitation, may be determined to be substantially incomplete and may result in rejection of the vendor's entire quote and therefore not warrant any further consideration.

Vendors shall provide sufficient technical documentation (including but not limited to: part numbers, product literature, specifications) to allow for a thorough evaluation of the quote. Additionally, the vendor shall fully explain their ability to meet requirements.

https://doncmra.nmci.navy.mil/ https://doncmra.nmci.navy.mil/

The quote shall be submitted in two separate volumes:

Volume I: Technical and Past Performance Volume II: Price

A complete Volume I (Technical and Past Performance); and Volume II Price, shall be submitted no later than (NLT) the closing date and time specified under “File Submission” below. If any of the volumes are received past the stated closing date, the entire quote will be considered late. No further consideration will be given to any vendor who submits any of the volumes late.

Volume I: Technical. The vendor shall include the following:

Conformance to Essential Characteristics – Vendors shall submit a quote including all necessary documentation demonstrating that its solution/product meets all of the requirements within the Essential Characteristics. If marketing brochure(s) is submitted, please ensure that it denotes exactly how all Essential Characteristics are met;

otherwise, provide the supplemental information within the technical approach of the quote. Quoters shall submit sufficient documentation to allow for an evaluation of its abilities to meet the Essential Characteristics.

Conformance to Navy Cybersecurity Requirements – Vendors shall submit a completed Medical Device Risk Assessment (MDRA) Questionnaire (blue section only) form. The MDRA questionnaire can be found on the Naval Medical Logistics Command (NMLC) webpage (http://www.med.navy.mil/sites/nmlc/Pages/default.aspx) by clicking “Request For Proposals (RFP)” on the left hand side of the webpage. At the bottom of the page click on “MDRA 3.0-20160815RX”. Please refer to “Cybersecurity Requirements” for additional information.

Design Quality and Capability – Vendors shall submit sufficient documentation to allow for an evaluation of the design quality and capabilities of the proposed equipment/system to perform ultrasonic scanning procedures.

Page limitation for Technical: The total number of pages submitted for Volume I (Technical) shall not exceed 20 pages, excluding the MDRA questionnaire, cover letter, title page and table of contents. If Volume I contains more than 20 pages, only the first 20 pages will be evaluated.

Volume I: Past Performance. The vendor may include the following:

Vendors may provide past performance data for all similar contracts for the last 3 years, up to 3 data points, or 3 data points for delivery starting with the most recent contracts for which delivery occurred at least 3 months prior to the closing of this solicitation. If past performance information is provided for more than three (3) contracts, only the first three (3) will be considered. Each reference shall include:

Organization/Location;

Point of Contact (POC) to include Title/Phone Number/ Email Address;

Contract Reference Number;

Contract Start Date;

Contract Delivery Date;

Value of the Contract (rounding to the nearest $5K is acceptable);

Whether or not the POC has agreed to be contacted as a reference.

Volume II: Price. The vendor shall include the following:

Complete Provision 52.209-11 – Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law. (See solicitation for full text).

Acknowledgement of solicitation number N6264517Q0015 as well as all amendments (if applicable).

Price – Adequate price competition is expected for this acquisition. Vendor shall submit pricing, reflective of all equipment, components, training, etc., specified in the essential characteristics. Vendor shall include timeframe, after receipt of order (ARO) for delivery.

http://www.med.navy.mil/sites/nmlc/Pages/default.aspx

Vendor shall be registered in the System for Award Management (SAM) database in accordance with FAR 52.212-

3. The vendor shall verify its online representation and certifications are current, accurate, complete and applicable to this solicitation as of the date of its quote and are incorporated in its quote for reference. The vendor shall also be registered in SAM under the applicable NAICS code for this solicitation, 339112. Registration is free and can be completed on-line at https://www.sam.gov/portal/public/SAM/. No documentation is required to be submitted in response to this paragraph.

Any questions must be addressed to:

Christina Boyd-Brown at Christina.BoydBrown.civ@mail.mil and Joyce Richardson at Joyce.R.Richardson4.civ@mail.mil by email only, no later than (NLT) 1300 (1:00pm) local time, Tuesday, 01 August 2017.

No phone calls will be accepted.

FILE SUBMISSION

Only electronic files will be accepted. Email shall be no larger than 10MB. All responses should be submitted to Christina Boyd-Brown at Christina.BoydBrown.civ@mail.mil and Joyce Richardson at Joyce.R.Richardson4.civ@mail.mil by email only, no later than 1300 (1:00pm) local time, Monday, 21 August 2017.

Subject Line should read: Solicitation N6264517Q0015

The Technical, Past Performance and Price volumes shall be submitted via e-mail only. Files shall be in Microsoft Word, Microsoft Excel or Adobe PDF only.

Shipping shall be FOB destination. Vendor shall provide the number of delivery days required after receipt of order

(ARO).

Upon delivery, the vendor shall be responsible for uncrating the equipment/system, transporting it through the facility to the location of intended use for installation, and removing all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage.

DELIVERY

Naval Medical Center Portsmouth 620 John Paul Jones Circle, Bldg. 250 Portsmouth, VA 23708-5000

The Contracting Officer reserves the right to adjust the start date of the contract based on the actual award date.

Period for Acceptance of Offers

The period for acceptance of offers is 60 days after the closing date of the solicitation.

Pre-Contract Costs

The Contractor will not be reimbursed for any costs incurred prior to the effective date of the contract.

CYBERSECURITY REQUIREMENTS

Risk Management Framework (RMF) https://www.sam.gov/portal/public/SAM/ mailto:Christina.BoydBrown.civ@mail.mil mailto:Joyce.R.Richardson4.civ@mail.mil mailto:Christina.BoydBrown.civ@mail.mil mailto:Joyce.R.Richardson4.civ@mail.mil

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.

EVALUATION FACTORS FOR AWARD

Addendum to 52.212-2 Evaluation The government intends to award one (1) firm-fixed price contract resultant from the issuance of this solicitation to the responsible quoter whose offer conforming to the solicitation is determined most advantageous to the Government, price and other factors considered. Awards under this procurement will be made to the quoter determined to be the best value to the Government. The evaluation of quotes will be based on the following factors:

Volume I: Technical and Past Performance Volume II: Price

Since awards will be made on a best value basis, the Contracting Officer reserves the right to award to other then the lowest priced quoter providing the prices are determined fair and reasonable.

The evaluation factors for Technical, Past Performance and Price are listed below; quotes shall include sufficiently detailed information to enable evaluation based on the following factors:

Volume I – Technical.

Conformance to the Essential Characteristics - The government will evaluate each offer to determine the ability to meet the essential characteristics as outlined for this requirement. The Government will not assume that the quoter possesses any capability or knowledge unless it is specified in the Technical volume.

Conformance to Navy Cybersecurity Requirements – The Government will evaluate the capability of the proposed equipment/system to meet Navy Cybersecurity requirements. This evaluation will be based on the information provided in the completed “Blue Section” of the Medical Device Risk Assessment (MDRA) form. The MDRA will be rated as Pass or Fail.

Design Quality and Capability – The government will evaluate the design quality and capability of the proposed equipment/system to perform ultrasonic scanning procedures. Volume I – Past Performance.

Past Performance – The Government will evaluate the quoter’s recent relevant past performance record as to (1) the functional performance of the proposed or similar general purpose ultrasonic scanning systems that the quoter has delivered to previous customers and (2) the quality and timeliness of the technical assistance, hardware and software updates/upgrades that the quoter has supplied to its customers following the initial fielding of those systems.

The Government reserves the right to consider other past performance information at its disposal, in addition to any information obtained from the references provided. It is the responsibility of the quoter to ensure names and phone numbers of points of contacts are verified and accurate. In the case a quoter does not possess relevant past performance or for whom information on past performance is not available, the quoter will not be evaluated favorably or unfavorably on past performance; the quoter will receive a neutral rating.

The Government will then review past performance information and determine the quality and relevancy as it applies to the performance confidence assessment.

Volume II – Price

Price - Adequate price competition is expected for this acquisition. The Price volume will be evaluated with consideration to the following factors:

COMPLETENESS. The quoter’s Price volume will be examined to ensure all items required in the Instructions to Quoter’s have been submitted and are complete.

REASONABLENESS. The quoter’s proposed price will be evaluated to determine the degree to which the total proposed price compares to the price a reasonable prudent person would expect to incur for the same or similar equipment. The quoter’s total proposed price will be used to evaluate price reasonableness. Since awards will be made on a best value basis, the Contracting Officer reserves the right to award at a premium, provided that the proposed price is determined to be reasonable.

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

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 30-SEP-2017 1 NAVAL MEDICAL CENTER -

PORTSMOUTH

JESUS SAENZ

620 JOHN PAUL JONES CIRCLE

BUILDING 250

PORTSMOUTH VA 23708-5000

757-953-5769 FOB: Destination

N00183

CLAUSES INCORPORATED BY REFERENCE

52.203-18 Prohibition on Contracting With Entities That Require Certain Internal Confidentiality Agreements or Statements-- Representation

JAN 2017

52.204-7 System for Award Management OCT 2016 52.204-13 System for Award Management Maintenance OCT 2016 52.204-16 Commercial and Government Entity Code Reporting JUL 2016 52.204-18 Commercial and Government Entity Code Maintenance JUL 2016 52.204-19 Incorporation by Reference of Representations and

Certifications.

DEC 2014

52.212-1 Instructions to Offerors--Commercial Items JAN 2017 52.212-2 Evaluation - Commercial Items OCT 2014 52.212-4 Contract Terms and Conditions--Commercial Items JAN 2017 52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

DEC 2013

52.242-15 Stop-Work Order AUG 1989 52.247-34 F.O.B. Destination NOV 1991 252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.204-7008 Compliance With Safeguarding Covered Defense Information Controls

OCT 2016

252.204-7009 Limitations on the Use or Disclosure of Third-Party Contractor Reported Cyber Incident Information

OCT 2016

252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting

OCT 2016

252.204-7015 Notice of Authorized Disclosure of Information for Litigation Support

MAY 2016

252.213-7000 Notice to Prospective Suppliers on Use of Past Performance Information Retrieval System--Statistical Reporting in Past Performance Evaluations

JUN 2015

252.222-7007 Representation Regarding Combating Trafficking in Persons JAN 2015 252.223-7008 Prohibition of Hexavalent Chromium JUN 2013 252.225-7001 Buy American And Balance Of Payments Program-- Basic

(Dec 2016)

DEC 2016

252.225-7012 Preference For Certain Domestic Commodities DEC 2016 252.225-7050 Disclosure of Ownership or Control by the Government of a

Country that is a State Sponsor of Terrorism

OCT 2015

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 252.247-7022 Representation Of Extent Of Transportation Of Supplies By

Sea

AUG 1992

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)

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL ITEMS (JAN 2017)

The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) Web site located at https://www.sam.gov/portal. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (u) of this provision.

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

“Administrative merits determination” means certain notices or findings of labor law violations issued by an enforcement agency following an investigation. An administrative merits determination may be final or be subject to appeal or further review. To determine whether a particular notice or finding is covered by this definition, it is necessary to consult section II.B. in the DOL Guidance.

“Arbitral award or decision” means an arbitrator or arbitral panel determination that a labor law violation occurred, or that enjoined or restrained a violation of labor law. It includes an award or decision that is not final or is subject to being confirmed, modified, or vacated by a court, and includes an award or decision resulting from private or confidential proceedings. To determine whether a particular award or decision is covered by this definition, it is necessary to consult section II.B. in the DOL Guidance.

“Civil judgment” means—

(1) In paragraph (h) of this provision: A judgment or finding of a civil offense by any court of competent jurisdiction.

(2) In paragraph (s) of this provision: Any judgment or order entered by any Federal or State court in which the court determined that a labor law violation occurred, or enjoined or restrained a violation of labor law. It includes a judgment or order that is not final or is subject to appeal. To determine whether a particular judgment or order is covered by this definition, it is necessary to consult section II.B. in the DOL Guidance.

https://www.sam.gov/portal

“DOL Guidance” means the Department of Labor (DOL) Guidance entitled: ``Guidance for Executive Order 13673, `Fair Pay and Safe Workplaces' ''. The DOL Guidance, dated August 25, 2016, can be obtained from www.dol.gov/fairpayandsafeworkplaces.

“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.

“Enforcement agency” means any agency granted authority to enforce the Federal labor laws. It includes the enforcement components of DOL (Wage and Hour Division, Office of Federal Contract Compliance Programs, and Occupational Safety and Health Administration), the Equal Employment Opportunity Commission, the Occupational Safety and Health Review Commission, and the National Labor Relations Board. It also means a State agency designated to administer an OSHA-approved State Plan, but only to the extent that the State agency is acting in its capacity as administrator of such plan. It does not include other Federal agencies which, in their capacity as contracting agencies, conduct investigations of potential labor law violations. The enforcement agencies associated with each labor law under E.O. 13673 are--

(1) Department of Labor Wage and Hour Division (WHD) for--

(i) The Fair Labor Standards Act;

(ii) The Migrant and Seasonal Agricultural Worker Protection Act;

(iii) 40 U.S.C. chapter 31, subchapter IV, formerly known as the Davis-Bacon Act;

(iv) 41 U.S.C. chapter 67, formerly known as the Service Contract Act;

(v) The Family and Medical Leave Act; and

(vi) E.O. 13658 of February 12, 2014 (Establishing a Minimum Wage for Contractors);

(2) Department of Labor Occupational Safety and Health Administration (OSHA) for--

(i) The Occupational Safety and Health Act of 1970; and

(ii) OSHA-approved State Plans;

(3) Department of Labor Office of Federal Contract Compliance Programs (OFCCP) for--

(i) Section 503 of the Rehabilitation Act of 1973;

(ii) The Vietnam Era Veterans' Readjustment Assistance Act of 1972 and the Vietnam Era Veterans' Readjustment Assistance Act of 1974; and

(iii) E.O. 11246 of September 24, 1965 (Equal Employment Opportunity);

(4) National Labor Relations Board (NLRB) for the National Labor Relations Act; and

(5) Equal Employment Opportunity Commission (EEOC) for--

(i) Title VII of the Civil Rights Act of 1964;

(ii) The Americans with Disabilities Act of 1990;

http://www.dol.gov/fairpayandsafeworkplaces

(iii) The Age Discrimination in Employment Act of 1967; and

(iv) Section 6(d) of the Fair Labor Standards Act (Equal Pay Act).

"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.

“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).

“Labor compliance agreement” means an agreement entered into between a contractor or subcontractor and an enforcement agency to address appropriate remedial measures, compliance assistance, steps to resolve issues to increase compliance with the labor laws, or other related matters.

“Labor laws” means the following labor laws and E.O.s:

(1) The Fair Labor Standards Act.

(2) The Occupational Safety and Health Act (OSHA) of 1970.

(3) The Migrant and Seasonal Agricultural Worker Protection Act.

(4) The National Labor Relations Act.

(5) 40 U.S.C. chapter 31, subchapter IV, formerly known as the Davis-Bacon Act.

(6) 41 U.S.C. chapter 67, formerly known as the Service Contract Act.

(7) E.O. 11246 of September 24, 1965 (Equal Employment Opportunity).

(8) Section 503 of the Rehabilitation Act of 1973.

(9) The Vietnam Era Veterans' Readjustment Assistance Act of 1972 and the Vietnam Era Veterans' Readjustment Assistance Act of 1974.

(10) The Family and Medical Leave Act.

(11) Title VII of the Civil Rights Act of 1964.

(12) The Americans with Disabilities Act of 1990.

(13) The Age Discrimination in Employment Act of 1967.

(14) E.O. 13658 of February 12, 2014 (Establishing a Minimum Wage for Contractors).

(15) Equivalent State laws as defined in the DOL Guidance. (The only equivalent State laws implemented in the FAR are OSHA-approved State Plans, which can be found at www.osha.gov/dcsp/osp/approved_state_plans.html).

“Labor law decision” means an administrative merits determination, arbitral award or decision, or civil judgment, which resulted from a violation of one or more of the laws listed in the definition of ``labor laws''.

“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.

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

“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 http://www.osha.gov/dcsp/osp/approved_state_plans.html

(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.

“Successor” means an entity that has replaced a predecessor by acquiring the assets and carrying out the affairs of the predecessor under a new name (often through acquisition or merger). The term

“successor” does not include new offices/divisions of the same company or a company that only changes its name.

The extent of the responsibility of the successor for the liabilities of the predecessor may vary, depending on State law and specific circumstances.

“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 stock of which 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 its stock is owned by one or more women; or

(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.

Note to paragraph (a): By a court order issued on October 24, 2016, the following definitions in this paragraph (a) are enjoined indefinitely as of the date of the order: ``Administrative merits determination'', ``Arbitral award or decision'', paragraph (2) of ``Civil judgment'', ``DOL Guidance'', ``Enforcement agency'', ``Labor compliance agreement'', ``Labor laws'', and ``Labor law decision''. The enjoined definitions 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.

(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 electronically on the SAM website.

(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 representations 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 (u) 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 ORCA.]

(c) Offerors must complete the following representations when the resulting contract will be performed in the United States or its outlying areas. Check all that apply.

https://www.acquisition.gov/

(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.

(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 to paragraphs (c)(8) and (9): 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 in paragraph (c)(1) of this provision.) The offeror represents, as part of its offer, that--

(i) It [ ___ ] is, [ ___ ] is not a HUBZone small business concern listed, on the date of this representation, on the List of Qualified HUBZone Small Business Concerns maintained by the Small Business Administration, and no material changes in ownership and control, principal office, or HUBZone employee percentage have occurred since it was certified in accordance with 13 CFR Part 126; and

(ii) It […