Combined_Synopsis_Solicitation_16-T-0062.pdf

COMBINED SYNOPSIS/SOLICITATION

1. Issue Date: 01/20/2016 Close Date: 02/01/2016 02:00 PM

2. Requiring Activity: US Army Medical Research Acquisition Activity (USAMRAA) for the US Army Aeromedical Research Laboratory (USAARL), Fort Rucker, AL 36362.

3. Description of Requirement:

USAARL has a requirement for the acquisition, screening, transportation, and disposal of PMHS specimens for injury biomechanics research.

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested and a written solicitation will not be issued.

4. Solicitation Number: W81XWH-16-T-0062

This combined synopsis/solicitation is issued as a request for quotations (RFQ) This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-85, January 4, 2016.

This is an unrestricted procurement. The relevant NAICS code is 621991 with a small business size standard of $32.5M.

Contract shall be Firm Fixed-Price.

5. Schedule:

CLIN DESCRIPTION QTY U/I UNIT PRICE NET AMT

0001 Whole Body Cadaver 5 Ea ___________ ___________

0002 Whole Head to C7 Cadaver 20 Ea ___________ ___________

0003 Contractor Manpower Reporting 1 Ea ___________ ___________

6. Statement of Work:

Performance Work Statement to provide acquisition, screening, transportation, and disposal of PMHS specimens for injury biomechanics research

1. General information.

1.1. Period of performance. The period of performance for this contract shall be one 12-month period from the date of contract award.

1.2. Description of services and introduction. The contractor shall provide all personnel, equipment, tools, materials, supervision, other items, and non-personnel services necessary to acquire, screen, ship, and, at the discretion of the Government, store, receive, and/or dispose of post mortem human subject (PMHS) specimens for musculoskeletal injury biomechanics research as defined in this performance work statement (PWS). The PMHS specimens must meet Army-specific regulatory and study-specific inclusion-exclusion criteria. The Government will not furnish equipment, tools, materials, or other items needed to accomplish the objectives of the PWS. The contractor shall perform to the standards in this contract.

1.3. Objectives. The objective of this contract is to provide the services necessary to ensure a supply of PMHS specimens meeting Army-specific requirements are available for injury biomechanics research at the U.S. Army Aeromedical Research Laboratory, Fort Rucker, AL. This ultimate goal of this research is to provide injury-based performance metrics relevant to military environments and personnel.

1.4. Scope of work. The contractor shall provide the services necessary to assure at least one (1) 5 whole body PMHS specimens, but up to five (5), are available for military research into human tolerance to vertical accelerations. The contractor shall also provide the same services to assure at least five (5) PMHS whole heads with full cervical spines, but up to twenty (20), are available for military research. Services include initial tissue harvesting, screening, shipping, and, at the discretion of the Government, storage, receipt, and/or disposal of post mortem human subject (PMHS) specimens. All PMHS specimens will be from fresh frozen, un-embalmed donors. PMHS specimens shall meet Army-specific regulatory requirements described in the “Army Policy for Use of Human Cadavers for Research, Development, Test and Evaluation, Education, or Training,” dated 20APR2012, as well as study-specific inclusion-exclusion criteria. The contractor shall be familiar with and comply with all federal and state laws applicable to the services listed above.

1.5. Delivery schedule. The Government anticipates initiating acquisition of the services described in this PWS no earlier than one week after contract award. Additionally, the Government anticipates acquiring services sufficient to provide a maximum of five (5) whole PMHS bodies (including all bones, tissues, and organs) ordered and delivered one at a time, equaling up to five (5) deliveries per year for injury biomechanics research. A maximum of twenty (20) PMHS whole heads with entire cervical spines shall be ordered and delivered five at a time, equaling up to four deliveries per year. Due to the irregular nature of research, orders for services may not be placed during consecutive weeks. Periodically individuals authorized to purchase using this contract will contact the contractor with requested dates. Orders will be requested at least two weeks prior to need.

1.6. Quality assurance. The Government shall evaluate the contractor’s performance under this PWS in accordance with the quality assurance surveillance plan (QASP).

1.7. Government remedies: The contract officer (KO) shall follow Federal Acquisition Requirement (FAR) 52.212-4, “Contract Terms and Conditions-Commercial Items” or 52.246-4, “Inspection of Services-Fixed Price” for a contractor’s failure to perform satisfactory services or failure to correct non-conforming services.

2. Definitions and acronyms.

Code of Federal Regulations (CFR).

Contracting officer’s representative (COR): a representative from the requiring activity appointed in writing by the KO to perform surveillance and to act as liaison to the contractor.

Defective service: A service output that does not meet the standard of performance associated with it in the PWS.

Defense Travel Regulation (DTR).

Personally identifiable information (PII): information that can be used on its own or with other information to identify, contact, or locate a single person, or to identify an individual in context.

Post-mortem human subject (PMHS): a deceased person or portion thereof, which may include organs, tissue, eyes, bones, arteries, and other specimens obtained from an individual upon or after death. The terms post-mortem human subject and PMHS are synonymous with the terms cadaver and human cadaver.

Quality assurance surveillance plan (QASP): a written document specifying the surveillance method used for surveillance of contractor performance.

Quality assurance: actions taken by the Government to assure contracted services meet PWS requirements.

3. Government-furnished items and services. The Government will not provide personnel, equipment, tools, materials, supervision, or other items needed to perform the tasks defined in this PWS.

4. Contractor-furnished items and services. The contractor shall furnish personnel, equipment, tools, materials, supervision, other items, and non-personnel services necessary to accomplish the task contained within this PWS.

5. Specific tasks

5.1. The contractor will screen potential PMHS specimens to ensure specimens meet inclusion criteria specific to the research study. The inclusion criteria will be as follows:

• Specimens shall be between 17 and 80 years of age.

• Specimen shall be male or female (determined by study needs).

• Specimens shall be free of traumatic damage (ante-mortem and post-mortem), radiographic anomalies (including fractures), signs of osteoporosis, osteopenia, or osteo-arthritis, or cancer that has metastasized in the bone in the anatomical region of interest.

• Specimens shall be without existing, unhealed soft tissue injury in the region of interest.

• Specimens shall be free of prior surgical intervention in the region of interest.

• Specimens shall not have evidence of any wasting disease.

• Specimen serology exams shall ensure no history of HIV; Hepatitis B, or C; and syphilis.

• Specimens shall be from fresh, frozen cadavers and shall not have undergone any embalming process.

5.2 The contractor shall notify the COR when a potential PMHS specimen becomes available to allow the Government the opportunity to accept or decline use of the potential PMHS specimen. At the time of notification, the contractor shall provide, at a minimum, the following information:

• Gender

• Age

• Serology screening results

• Redacted copy of the donor consent form. Redacted copies will not contain any PII.

• Point of origin documentation

• Documentation necessary to verify potential specimens meet inclusion criteria (Para 5.1)

If available, the contractor shall also provide as much of the following information as possible:

• Cause of death

• Weight

• Height

• Ethnicity

Government pre-acceptance for shipment will be determined by the COR or their representative based on the criteria above, donor consent form, specimen point of origin, and study needs. PMHS specimens will not be accepted if specimen point of origin cannot be determined and documented or if PMHS specimens originated from suppliers currently under investigation for misconduct involving PMHS tissue.

5.3 The contractor shall provide redacted copies of the donor consent forms for each PMHS specimen accepted by the Government. The redacted copies shall not include any PII. The redacted copies shall include the PMHS specimen’s unique identification number generated by the contractor.

5.4 The contract shall ship PMHS specimens within a Government-specified time period after Government acceptance of the potential specimen and indication that the requesting agency is ready to receive the specimen. The contractor shall coordinate shipments with the COR or their designee to ensure personnel will be available to take receipt of the shipment. The contractor shall ensure each specimen is clearly identified with the specimen unique identification number generated by the contractor. PMHS specimens shall be packaged to prevent damage during transit. PMHS specimens shall not arrive at the requesting agency’s location in a completely thawed state and shall be packaged to prevent leakage from thawing that may occur during transit. The contractor shall ship PMHS specimens in accordance with all applicable federal and state regulations as described in Title 49 of the Code of Federal Regulations (49 CFR) and the Defense Transportation Regulation (DTR) 4500.9-R.

Upon arrival of the PMHS specimen and associated documentation at the requesting agency’s location, the COR or their representative will exercise the QASP. If inspection shows a deviation from the standards set forth in the QASP, the specimen will not be accepted and will be returned to the contractor.

5.5 The contractor shall provide disposal services for the PMHS specimens, including return shipment services. The contractor shall dispose of the PMHS tissue in accordance with the donor or next-of-kin’s wishes, if known. If the donor or next-of-kin provide no guidance as to disposition of the PMHS tissue, the contractor shall dispose of the PMHS tissue in accordance with the contractor’s standard procedures. The contractor’s standard procedures for disposition of PMHS tissue shall be conducted in accordance with applicable local, state, and federal regulations.

5.6 At the request of the Government, the contractor shall temporarily store Government-accepted PMHS specimens for up to 3 months. Execution of this task will be exercised in the event the requesting agency does not have sufficient storage capacity to take immediate delivery of the specimens. The contractor shall have the capability of temporarily storing Government-accepted PMHS specimens at temperatures of -20° Celsius (-4° Fahrenheit) or below.

5.7 OPTIONAL TASK. At the request of the Government, the contractor shall provide medical imaging services for Government-accepted PMHS specimens. Medical imaging modalities that may be requested include radiographic imaging (x-ray), computed tomography, medical resonance imaging, and dual-energy x-ray absorptiometry (DEXA) scanning. Meta-data associated with medical imaging files shall not include any PII; the meta-data shall include the PMHS specimen’s unique supplier-generated identification number. Medical imaging shall be provided to the Government in Digital Imaging and Communications in Medicine (DICOM) format on compact disc or digital versatile disc.

6. Applicable publications

“Army Policy for Use of Human Cadavers for Research, Development, Test and Evaluation, Education, or Training,” dated 20APR2012. A digital copy of the policy can be downloaded from the USAMRMC website at http://mrmc.amedd.army.mil/assets/docs/orp/army-policy-for-use-of-human-cadavers_042012.pdf.

Defense Transportation Regulation. DTR 4500.0-R. A digital copy of this regulation can be found at http://www.transcom.mil/dtr/dtrHome/.

Title 49 Code of Federal Regulations. 49 CFR. A digital copy of this regulation can be found at http://www.ecfr.gov/cgi-bin/text-idx?tpl=/ecfrbrowse/Title49/49tab_02.tpl.

H. PERIOD OF PERFORMANCE

The period of performance for this contract shall be twelve (12) months from the date of award.

http://mrmc.amedd.army.mil/assets/docs/orp/army-policy-for-use-of-human-cadavers_042012.pdf http://www.transcom.mil/dtr/dtrHome/

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

Performance requirement Standard Performance threshold Method of surveillance

Contractor shall screen PMHS specimens against study-specific inclusion criteria. (PWS para. 5.1)

PMHS specimens will meet study-specific inclusion criteria.

Zero deviations from standard

100 percent inspection of contractor-supplied demographic information, serology results, consent form, and documentation verifying specimens meet inclusion criteria by COR or their designee

Contractor shall provide documentation regarding PMHS specimen point of origin. (PWS para. 5.2)

PMHS specimens will not originate from suppliers currently under investigation for misconduct involving PMHS tissue

Zero deviations from standard

100 percent inspection of contractor-supplied point of origin information by COR or their designee.

Contractor shall notify the COR of a potential PMHS specimen by telephone or electronic mail and confirm Government pre-acceptance for shipment. (PWS para.

5.2)

No PMHS specimens will be shipped to the requesting agency without prior acceptance.

Zero deviations from standard

100 percent inspection by COR or their designee

Contractor shall ship specimens such that they arrive at the requesting agency location within an acceptable time period.

(PWS para. 5.4)

Specimens arrive within one week of Government indication of readiness for receipt.

Zero deviations from standard

100 percent inspection by COR or their designee

Contractor shall ship specimens such that they are partially frozen upon arrival at the requesting agency’s location. (PWS para. 5.4)

PMHS specimens will not be completely thawed upon arrival at the requesting agency’s location. Specimen external temperature shall be lower than ambient.

Zero deviations from standard

100 percent inspection of PMHS specimen upon arrival at requesting agency’s location by COR or their designee.

Contractor shall ship specimens to prevent leaks resulting from thawing during transit. (PWS para.

5.4)

Exterior of shipping containers will exhibit no evidence of fluid absorption or contamination.

Zero deviations from standard

100 percent inspection of PMHS specimen shipping container upon arrival at requesting agency’s location by COR or their designee.

Contractor shall ship only fresh frozen PMHS specimens. (PWS para. 1.4)

PMHS specimens will show no signs of dehydration or tissue degradation due to long-term storage.

Zero deviations from standard

100 percent inspection of PMHS specimen upon arrival at requesting agency’s location by COR or designee.

7. Miscellaneous Information:

Billing Information: Invoicing will be completed using the Wide Area Work Flow (WAWF) system.

Please include your DUNS Number and Cage Code with your offer.

Questions should be addressed to Samantha L. Connors at samantha.l.connors.civ@mail.mil and are due no later than 2:00 p.m. EDT on Monday January 25, 2016. Answers will be posted via amendment.

Questions will not be accepted by telephone.

It is preferred that quotations be sent electronically to samantha.l.connors.civ@mail.mil. Quotations may be sent to USAMRAA, 820 Chandler Street, Fort Detrick 21702-5014, Attention: Samantha Connors. Regardless of how they are submitted they must be received no later than the closing date and time given on the first page of this solicitation.

8. Inspection and Acceptance: The Government will inspect and accept upon performance of all services.

9. Delivery Information:

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC

0001 1 yr. ADC 5 SR W03Y USA AEROMED RSCH LAB

W03Y USA AEROMED RSCH LAB

BLDG 6901

FERRELL RD

FT RUCKER AL 36362-0577

210-295-2896 FOB: Destination

W31NWX

0002 1 yr. ADC 20 (SAME AS PREVIOUS LOCATION)

0003 1 yr. ADC 1 (SAME AS PREVIOUS LOCATION)

10. CLAUSES AND PROVISIONS

CLAUSES INCORPORATED BY REFERENCE

52.204-16 Commercial and Government Entity Code Reporting JUL 2015 52.204-18 Commercial and Government Entity Code Maintenance JUL 2015 52.212-1 Instructions to Offerors--Commercial Items OCT 2015 52.212-4 Contract Terms and Conditions--Commercial Items MAY 2015 52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

DEC 2013

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

252.203-7998 (Dev) Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements - Representation. (DEVIATION 2015-O0010)

FEB 2015

252.203-7999 (Dev) Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements. (DEVIATION 2015-O0010)

FEB 2015

252.204-7008 (Dev) Compliance with Safeguarding Covered Defense Information Controls

OCT 2015

252.204-7011 Alternative Line Item Structure SEP 2011 252.204-7012 (Dev) Safeguarding Covered Defense Information and Cyber

Incident Reporting

OCT 2015

252.204-7015 Disclosure of Information to Litigation Support Contractors FEB 2014 252.225-7031 Secondary Arab Boycott Of Israel JUN 2005 252.232-7003 Electronic Submission of Payment Requests and Receiving

Reports

JUN 2012

252.232-7010 Levies on Contract Payments DEC 2006 252.237-7010 Prohibition on Interrogation of Detainees by Contractor

Personnel

JUN 2013

252.244-7000 Subcontracts for Commercial Items JUN 2013 252.247-7023 Transportation of Supplies by Sea APR 2014

CLAUSES INCORPORATED BY FULL TEXT

52.212-2 EVALUATION--COMMERCIAL ITEMS (OCT 2014)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

Evaluation Factors To provide acquisition, screening, transportation, and disposal of

PMHS specimens for injury biomechanics research

The Government will evaluate the Offeror’s technical capability and approach to meet the agency’s requirements against the following evaluation factors. Oral presentations are not required. This contract will be awarded on a best value, meaning that all factors and their relative importance will affect the contract award decision (please see factors and importance below).

Evaluation Factors in Order of Importance

Factor 1: Technical Approach Factor 2: Past Performance Factor 3: Price

Technical Approach is more important than Past Performance. Past performance is more important than Price. Price is an important part of the selection decision; however, the non-cost/price factors are more important than Price.

Factor 1: Technical Approach

The offeror shall describe the techniques, methods and processes to be used to accomplish the tasks specified in the Performance Work Statement. The offeror’s proposal shall demonstrate that their consent forms and consenting process meet the requirements of the “Army Policy for Use of Human Cadavers for Research, Development, Test and Evaluation, Education, or Training,” dated 20APR2012. Additionally, offerors shall demonstrate their process for acquiring, harvesting, screening, and storing potential PMHS tissue, to include serology and medical imagery screening processes. The offeror shall demonstrate their capacity to meet the anticipated demand for PMHS tissue described in the PWS within a timely manner. Offerors will also be evaluated on their ability to facilitate PMHS tissue disposal.

Factor 2: Past Performance

The past performance evaluation will examine how the offeror’s past and present performance validates expected performance and customer satisfaction for the agency.

The offeror’s proposal shall demonstrate performance of services of same or similar nature to that described in the solicitation over the past three (3) years. A contract of a similar nature is a contract of comparable risk – the functions, responsibilities, and control exercised by the offeror are essentially the same as required under the solicitation. The offeror shall have completed the services in a timely, professional manner, and in accordance with all contract requirements. The past performance shall specifically identify what that offeror did wrong in previous contracts and what the offeror did to resolve the problems.

Factor 3: Price

Each offeror’s cost/price proposal will be evaluated on the proposed price/cost; reasonableness (using a representative sample of the proposed prices/costs to industry averages and/or rates from other contracts for similar work); and realism (technical review and evaluation of the skill mix and specific hours proposed for the work to be performed).

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party.

Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of provision)

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL ITEMS (NOV 2015)

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 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 (p) 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.

http://www.acquisition.gov/

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).

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 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.

(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 (p) 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.

(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--https://www.acquisition.gov/

(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 [ ___ ] is, [ ___ ] is not a HUBZone joint venture that complies with the requirements of 13 CFR Part 126, and the representation in paragraph (c)(10)(i) of this provision is accurate for each HUBZone small business concern participating in the HUBZone joint venture. [The offeror shall enter the names of each of the HUBZone small business concerns participating in the HUBZone joint venture: ___ .] Each HUBZone small business concern participating in the HUBZone joint venture shall submit a separate signed copy of the HUBZone representation.

(d) Certifications and representations required to implement provisions of Executive Order 11246--

(1) Previous Contracts and Compliance. The offeror represents that--

(i) It ( ___ ) has, ( ___ ) has not, participated in a previous contract or subcontract subject either to the Equal Opportunity clause of this solicitation, the and

(ii) It ( ___ ) has, ( ___ ) has not, filed all required compliance reports.

(2) Affirmative Action Compliance. The offeror represents that--

(i) It ( ___ ) has developed and has on file, ( ___ ) has not developed and does not have on file, at each establishment, affirmative action programs required by rules and regulations of the Secretary of Labor (41 CFR Subparts 60-1 and 60-2), or

(ii) It ( ___ ) has not previously had contracts subject to the written affirmative action programs requirement of the rules and regulations of the Secretary of Labor.

(e) Certification Regarding Payments to Influence Federal Transactions (31 U.S.C. 1352). (Applies only if the contract is expected to exceed $150,000.) By submission of its offer, the offeror certifies to the best of its knowledge and belief that no Federal appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress or an employee of a Member of Congress on his or her behalf in connection with the award of any resultant contract. If any registrants under the Lobbying Disclosure Act of 1995 have made a lobbying contact on behalf of the offeror with respect to this contract, the offeror shall complete and submit, with its offer, OMB Standard Form LLL, Disclosure of Lobbying Activities, to provide the name of the registrants. The offeror need not report regularly employed officers or employees of the offeror to whom payments of reasonable compensation were made.

(f) Buy American Certificate. (Applies only if the clause at Federal Acquisition Regulation (FAR) 52.225-1, Buy American --Supplies, is included in this solicitation.)

(1) The offeror certifies that each end product, except those listed in paragraph (f)(2) of this provision, is a domestic end product and that for other than COTS items, the offeror has considered components of unknown origin to have been mined, produced, or manufactured outside the United States. The offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products, i.e., an end product that is not a COTS item and does not meet the component test in paragraph (2) of the definition of “domestic end product.” The terms “commercially available off-the-shelf (COTS) item,” “component,” “domestic end product,” “end product,” “foreign end product,” and “United States” are defined in the clause of this solicitation entitled “Buy American--Supplies.”

(2) Foreign End Products:

Line Item No. Country of Origin

(List as necessary)

(3) The Government will evaluate offers in accordance with the policies and procedures of FAR Part 25.

(g)(1) Buy American--Free Trade Agreements--Israeli Trade Act Certificate. (Applies only if the clause at FAR 52.225- 3, Buy American--Free Trade Agreements--Israeli Trade Act, is included in this solicitation.)

(i) The offeror certifies that each end product, except those listed in paragraph (g)(1)(ii) or (g)(1)(iii) of this provision, is a domestic end product and that for other than COTS items, the offeror has considered components of unknown origin to have been mined, produced, or manufactured outside the United States. The terms ``Bahrainian, Moroccan, Omani, Panamanian, or Peruvian end product,'' ``commercially available off-the-shelf (COTS) item,'' ``component,'' ``domestic end product,'' ``end product,'' ``foreign end product,'' ``Free Trade Agreement country,'' ``Free Trade Agreement country end product,'' ``Israeli end product,'' and ``United States'' are defined in the clause of this solicitation entitled ``Buy American--Free Trade Agreements--Israeli Trade Act.''

(ii) The offeror certifies that the following supplies are Free Trade Agreement country end products (other than Bahrainian, Moroccan, Omani, Panamanian, or Peruvian end products) or Israeli end products as defined in the clause of this solicitation entitled ``Buy American--Free Trade Agreements--Israeli Trade Act'':

Free Trade Agreement Country End Products (Other than Bahrainian, Moroccan, Omani, Panamanian, or Peruvian End Products) or Israeli End Products:

[List as necessary]

(iii) The offeror shall list those supplies that are foreign end products (other than those listed in paragraph (g)(1)(ii) of this provision) as defined in the clause of this solicitation entitled "Buy American-Free Trade Agreements-Israeli Trade Act." The offeror shall list as other foreign end products those end products manufactured in the United States that do not qualify as domestic end products, i.e., an end product that is not a COTS item and does not meet the component test in paragraph (2) of the definition of “domestic end product.”

Other Foreign End Products:

Line Item No. Country of Origin

(iv) The Government will evaluate offers in accordance with the policies and procedures of FAR Part 25.

(2) Buy American Act-Free Trade Agreements-Israeli Trade Act Certificate, Alternate I (Jan 2004). If Alternate I to the clause at FAR 52.225-3 is included in this solicitation, substitute the following paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision:

(g)(1)(ii) The offeror certifies that the following supplies are Canadian end products as defined in the clause of this solicitation entitled "Buy American -Free Trade Agreements-Israeli Trade Act":

Canadian End Products:

Line Item No.

(3) Buy American-Free Trade Agreements-Israeli Trade Act Certificate, Alternate II (Jan 2004). If Alternate II to the clause at FAR 52.225-3 is included in this solicitation, substitute the following paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision:

(g)(1)(ii) The offeror certifies that the following supplies are Canadian end products or Israeli end products as defined in the clause of this solicitation entitled "Buy American-Free Trade Agreements-Israeli Trade Act":

Canadian or Israeli End Products:

Line Item No. Country of Origin

(4) Buy American--Free Trade Agreements--Israeli Trade Act Certificate, Alternate III. If Alternate III to the clause at FAR 52.225-3 is included in this solicitation, substitute the following paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision:

(g)(1)(ii) The offeror certifies that the following supplies are Free Trade Agreement country end products (other than Bahrainian, Korean, Moroccan, Omani, Panamanian, or Peruvian end products) or Israeli end products as defined in the clause of this solicitation entitled ``Buy American --Free Trade Agreements--Israeli Trade Act'':

Free Trade Agreement Country End Products (Other than Bahrainian, Korean, Moroccan, Omani, Panamanian, or Peruvian End Products) or Israeli End Products:

(5) Trade Agreements Certificate. (Applies only if the clause at FAR 52.225-5, Trade Agreements, is included in this solicitation.)

(i) The offeror certifies that each end product, except those listed in paragraph (g)(5)(ii) of this provision, is a U.S.-made or designated country end product, as defined in the clause of this solicitation entitled ``Trade Agreements''.

(ii) The offeror shall list as other end products those end products that are not U.S.-made or designated country end products.

Other End Products:

(iii) The Government will evaluate offers in accordance with the policies and procedures of FAR Part 25. For line items covered by the WTO GPA, the Government will evaluate offers of U.S.-made or designated country end products without regard to the restrictions of the Buy American statute. The Government will consider for award only offers of U.S.-made or designated country end products unless the Contracting Officer determines that there are no offers for such products or that the offers for such products are insufficient to fulfill the requirements of the solicitation.

(h) Certification Regarding Responsibility Matters (Executive Order 12689). (Applies only if the contract value is expected to exceed the simplified acquisition threshold.) The offeror certifies, to the best of its knowledge and belief, that --

(1) The offeror and/or any of its principals ( ___ ) are, ( ___ ) are not presently debarred, suspended, proposed for debarment, or declared ineligible for the award of contracts by any Federal agency,

(2) ( ___ ) Have, ( ___ ) have not, within a three-year period preceding this offer, been convicted of or had a civil judgment rendered against them for: commission of fraud or a criminal offense in connection with obtaining, attempting to obtain, or performing a Federal, state or local government contract or subcontract; violation of Federal or state antitrust statutes relating to the submission of offers; or commission of embezzlement, theft, forgery, bribery, falsification or destruction of records, making false statements, tax evasion, violating Federal criminal tax laws, or receiving stolen property; and

(3) ( ___ ) Are, ( ___ ) are not presently indicted for, or otherwise criminally or civilly charged by a Government entity with, commission of any of these offenses enumerated in paragraph (h)(2) of this clause; and

(4) ( ___ ) Have, ( ___ ) have not, within a three-year period preceding this offer, been notified of any delinquent Federal taxes in an amount that exceeds $3,500 for which the liability remains unsatisfied.

(i) Taxes are considered delinquent if both of the following criteria apply:

(A) The tax liability is finally determined. The liability is finally determined if it has been assessed. A liability is not finally determined if there is a pending administrative or judicial challenge. In the case of a judicial challenge to the liability, the liability is not finally determined until all judicial appeal rights have been exhausted.

(B) The taxpayer is delinquent in making payment. A taxpayer is delinquent if the taxpayer has failed to pay the tax liability when full payment was due and required. A taxpayer is not delinquent in cases where enforced collection action is precluded.

(ii) Examples.

(A) The taxpayer has received a statutory notice of deficiency, under I.R.C. Sec. 6212, which entitles the taxpayer to seek Tax Court review of a proposed tax deficiency. This is not a delinquent tax because it is not a final tax liability.

Should the taxpayer seek Tax Court review, this will not be a final tax liability until the taxpayer has exercised all judicial appeal rights.

(B) The IRS has filed a notice of Federal tax lien with respect to an assessed tax liability, and the taxpayer has been issued a notice under I.R.C. Sec. 6320 entitling the taxpayer to request a hearing with the IRS Office of Appeals contesting the lien filing, and to further appeal to the Tax Court if the IRS determines to sustain the lien filing. In the course of the hearing, the taxpayer is entitled to contest the underlying tax liability because the taxpayer has had no prior opportunity to contest the liability. This is not a delinquent tax because it is not a final tax liability. Should the taxpayer seek tax court review, this will not be a final tax liability until the taxpayer has exercised all judicial appeal rights.

(C) The taxpayer has entered into an installment agreement pursuant to I.R.C. Sec. 6159. The taxpayer is making timely payments and is in full compliance with the agreement terms. The taxpayer is not delinquent because the taxpayer is not currently required to make full payment.

(D) The taxpayer has filed for bankruptcy protection. The taxpayer is not delinquent because enforced collection action is stayed under 11 U.S.C. 362 (the Bankruptcy Code).

(i) Certification Regarding Knowledge of Child Labor for Listed End Products (Executive Order 13126). [The Contracting Officer must list in paragraph (i)(1) any end products being acquired under this solicitation that are included in the List of Products Requiring Contractor Certification as to Forced or Indentured Child Labor, unless excluded at 22.1503(b).]

(1) Listed end products.

Listed End Product Listed Countriesof Origin

(2) Certification. [If the Contracting Officer has identified end products and countries of origin in paragraph (i)(1) of this provision, then the offeror must certify to either (i)(2)(i) or (i)(2)(ii) by checking…