Solicitation_W81XWHT0195.docx

W81XWH-16-T-0195

Section SF 1449 - CONTINUATION SHEET

DEVELOP A PRE-CLINICAL PORCINE MODEL

FFP-LOE

DEVELOP A PRE-CLINICAL PORCINE MODEL

FOB: Destination

PURCHASE REQUEST NUMBER: 0010820002

NET AMT

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT (PWS)

PORCINE PRE-CLINICAL MAXILLO-FACIAL BURN MODEL

Vision Statement (United States Army Institute of Surgical Research) (USAISR) The USAISR Dental and Trauma Research Detachment's mission is to provide militarily relevant research and solutions for the prevention and rehabilitation of craniofacial trauma and infections dental diseases.

1.0. Introduction

The U.S. Army Institute of Surgical Research (USAISR) Dental and Trauma Research Detachment (DTRD) has a plan to develop a pre-clinical porcine model mimicking maxillofacial burn trauma seen clinically.

1.2. Background

The Problem: Burn injuries (Bl) are common to all military conflicts and historically constitute approximately 5 to 10% of all military casualties. The most severe maxillofacial BI characterized by contaminated lacerations and open fractures are occasionally further complicated by composite tissue avulsions and burns (77% of evacuated burn casualties involve the face). The mission of the Institute of Surgical Research (ISR) and Dental and Trauma Research Directorate (DTRD) is to optimize combat casualty care. Currently, there are very few therapeutic options for scar management as the result of burn injury. As such, we are interested in obtaining the preclinical data through the use of a clinically relevant animal model for studying the disease process and scar formation of facial burns. Knowledge gained will be used for clinical translation to improve quality of healed wounds for the wounded warrior.

The Solution: The US Army ISR and DTRD has a requirement to develop a pre-clinical porcine model for maxillofacial burn trauma that can be studied non-invasively using different imaging modalities that monitor blood flow (laser speckle flowmetry), wound depth, elastic properties and scar formation (ultrasound based). Such a pre-clinical model shall be suitable for testing various treatment strategies aimed at improving the wound outcomes.

2.0. Performance Requirements. DEVELOPMENT OF A PRE-CLINICAL PORCINE MODEL FOR MAXILLO-FACIAL BURN TRAUMA

2.2 Provide project management support activities to include the following:

2.2.1 Develop Preliminary and Final Project Plan. This includes the establishment of Gantt Chart(s), or similar, listing all tasks and milestones detailing study dates and timelines assigned to each task. Provide the estimate dates of the initiation and completion for each task. As applicable, define what is needed to complete the study and identify tasks that could be dependent on the other tasks to complete the study.

2.2.2 Provide personall to coordinate contact specific research and provide finanical management and reporting on all research conducted by the Contractor.

2. 3 Conduct and monitor the development of the porcine model for maxillofacial burn trauma. The deliverables shall include the following in the quarterly and final reports to USAISR Dental and Trauma Research Detachment:

Deliverables:

Number

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the US Army Institute of Surgical Research via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.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, beginning with 2016. Contractors may direct questions to the help desk at help desk at: http://www.ecmra.mil1.

QASP

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

FOR

PORCINE PRE-CLINICAL MAXILLOFACIAL BURN MODEL

1. PURPOSE:

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated non-personal services contract. This QASP explains the following:

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government's responsibility to be objective, fair, and consistent in evaluating performance. Inaddition, the QASP should recognize that unforeseen and uncontrollable situations may occur.

This QASP is a "living document" and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Updates shall ensure that the QASP remains a valid, useful, and enforceable document. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

a. QASP RELATION TO THE SOLICITATION:

QASPs shall be developed and appear in every solicitation, as well as the resultant service contract. The Government will retain the right to change the surveillance methods and Quality Assurance (QA) procedures, or to increase or decrease the degree of surveillance efforts at any time necessary to assure contract compliance

b. REVISIONS TO THE QASP:

The QASP is a tool for use in Government administration of the Performance Work Statement/Statement of Work (PWS/SOW) and remains subject to revision at any time by the Government throughout the contract performance period. Revisions to this surveillance plan are the responsibility of the Contracting Officer's-Representative-(COR). Changes to the QASP shall be made bilaterally.

The contractor will assume responsibility for all tasks and deliverables in the PWS under this award. As the performance period progresses, the levels of surveillance may be altered for service areas in cases where performance is either consistently excellent or consistently imsatisfactory. Ifobservations reveal consistently good performance, then the amount of surveillance may be reduced. Ifobservations reveal consistent deficiencies, increased surveillance may be implemented.

2. GOVERNMENT ROLES AND RESPONSIBILITIES:

The following personnel shall oversee and coordinate surveillance activities.

a. Contracting Officer (KO) - The KO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The KO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The KO is ultimately responsible for the fmal determination of the adequacy of the contractor's performance.

Assigned KO: TBD Organization or Agency: U.S. Army Medical Research Acquisition Activity Telephone:

Email:

b. Contracting Officer's Representative (COR) -The COR will be located at US Army Institute of Surgical Research, Fort Sam Houston, TX. The COR will be responsible for technical administration of the contract, and shall assure proper Government survei11ance ofllie contractor's performance. The COR shall keep a quality assurance file. At the conclusion of the contract or when requested by the KO, the COR shall provide documentation to the KO. A COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government's behalf. The contractor shall refer any changes they deem may affect contract price, terms, or conditions to the KO for action.

Assigned COR: TBD

3. CONTRACTOR ROLES AND RESPONSIBILITIES:

The contractor is responsible for delivering services in accordance with the Contract. The contractor shall appoint a single off-site point-of-contact to act as a central recipient of communication from the Government.

5. "Critical nonconformance" means a nonconformance that is likely to result in hazardous or unsafe conditions for individuals using, maintaining, or depending upon the supplies or services; or is likely to prevent performance of a vital agency mission.

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

Regardless of the surveillance method, the COR shall always contact the contractor's point of contact inform the manager of the specifics of the problem. The COR shall be responsible for monitoring the contractor's performance in meeting the contract's quality requirements.

Surveillance results may be used as the basis for actions (to include payment deductions) against the contractor. In such cases, the Inspection of Services clause in the Contract becomes the basis for the KO's actions.

6. FREOUENCY OF MEASUREMENT: During contract performance, the COR shall periodically analyze whether the frequency of measurement is appropriate for the work being performed.

FAR 52.212-1 ADDENDUM

1. PROPOSAL SUBMISSION INSTRUCTIONS.

a. POINT OF CONTACT (POC): Katrina L. White @ katrina.l.white17.civ@mail.mil. Due to the difficulties in receipt of mail through normal postal services, questions and proposals shall be sent via E-mail to the POC for RFQ. The Offeror is responsible for ensuring receipt by the POC.

b. PROPOSAL QUESTIONS: Questions may be submitted to the POC via email No Later 15 June 2016, 11:00 A.M. Eastern Time. Follow-up/additional questions will not be accepted after this date.

c. PROPOSAL DUE DATE: No Later Than July 1, 2016, 12:00 P.M. Eastern Time.

d. ELECTRONIC SUBMISSION: Proposals shall be electronically submitted to the POC above. Your submission should include two separate parts: a Price proposal and a Non-Price proposal. The Non-Price proposal shall be submitted in MS Word or searchable PDF format. The price proposal shall be submitted in MS Word or MS Excel 2000 or higher, but not greater than MS Word or MS Excel 2007 format. The firewall utilized by the Government contracting office does not authorize or accept zip files.

2. PROPOSAL CONTENT AND FORMAT INSTRUCTIONS.

The Offeror’s submission shall include two separate parts: a Price proposal and a Non-Price proposal.

a. ADMINISTRATIVE FORMAT INSTRUCTIONS:

b. NON- PRICE PROPOSAL CONTENT INSTRUCTIONS: The Offeror’s non- price proposal shall not mention cost/price. Proposal shall clearly reflect the Offeror’s approach to execute and comply with the performance requirements identified in the PWS, regardless of the Government’s estimated effort. Your non-price proposal, including any supporting documentation, should be clear and concise. The level of effort proposed must be consistent with the proposed solution outlined in your non-price proposal. The proposal must fully document and substantiate a cross mapping of your cost/price approach as it equates to the non- price proposal. If you intend to use any labor categories that you feel are consistent in duties with the level of effort labor categories but are titled differently, in accordance with your cost accounting procedures, you must cross map those labor categories to the Government’s PWS to ensure your proposal receives a proper evaluation.

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

DELIVERY INFORMATION

31-JUL-2017

3400 RAWLEY E. CHAMBERS AVENUE

FORT SAM HOUSTON TX 78234-7767

FOB: Destination

W45MW3

CLAUSES INCORPORATED BY REFERENCE

CLAUSES INCORPORATED BY FULL TEXT

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

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

(b) Submission of offers. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. Offers may be submitted on the SF 1449, letterhead stationery, or as otherwise specified in the solicitation. As a minimum, offers must show--

(1) The solicitation number;

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

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

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

(5) Terms of any express warranty;

(6) Price and any discount terms;

(7) "Remit to" address, if different than mailing address; katrina.l.white17.civ@mail.mil

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

(9) Acknowledgment of Solicitation Amendments;

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

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

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

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

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

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

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

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

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

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

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

(ii) However, a late modification of an otherwise successful offer, that makes its terms more favorable to the Government, will be considered at any time it is received and may be accepted.

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

(4) If an emergency or unanticipated event interrupts normal Government processes so that offers cannot be received at the Government office designated for receipt of offers by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation or other notice of an extension of the closing date, the time specified for receipt of offers will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.

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

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

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

(i) Availability of requirements documents cited in the solicitation. (1)(i) The GSA Index of Federal Specifications, Standards and Commercial Item Descriptions, FPMR Part 101-29, and copies of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained for a fee by submitting a request to--GSA Federal Supply Service Specifications Section, Suite 8100, 470 East L'Enfant Plaza, SW, Washington, DC 20407, Telephone (202) 619-8925, Facsimile (202) 619-8978.

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

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

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

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

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

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

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

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

(iii) Ordering from DoDSSP, Building 4, Section D, 700 Robbins Avenue, Philadelphia, PA 19111-5094, Telephone (215) 697-2667/2179, Facsimile (215) 697-1462.

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

(j) Data Universal Numbering System (DUNS) Number. (Applies to all offers exceeding $3,500, and offers of $3,500 or less if the solicitation requires the Contractor to be registered in the System for Award Management (SAM) database. The offeror shall enter, in the block with its name and address on the cover page of its offer, the annotation “DUNS” or “DUNS +4” followed by the DUNS or DUNS +4 number that identifies the offeror's name and address. The DUNS +4 is the DUNS number plus a 4-character suffix that may be assigned at the discretion of the offeror to establish additional SAM records for identifying alternative Electronic Funds Transfer (EFT) accounts (see FAR Subpart 32.11) for the same concern. If the offeror does not have a DUNS number, it should contact Dun and Bradstreet directly to obtain one. An offeror within the United States may contact Dun and Bradstreet by calling 1-866-705-5711 or via the internet at http://fedgov.dnb.com/webform. An offeror located outside the United States must contact the local Dun and Bradstreet office for a DUNS number. The offeror should indicate that it is an offeror for a Government contract when contacting the local Dun and Bradstreet office.

(k) System for Award Management. Unless exempted by an addendum to this solicitation, by submission of an offer, the offeror acknowledges the requirement that a prospective awardee shall be registered in the SAM database prior to award, during performance and through final payment of any contract resulting from this solicitation. If the Offeror does not become registered in the SAM database in the time prescribed by the Contracting Officer, the Contracting Officer will proceed to award to the next otherwise successful registered Offeror. Offerors may obtain information on registration and annual confirmation requirements via the SAM database accessed through https://www.acquisition.gov.

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

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

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

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

(4) A summary of the rationale for award;

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

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

(End of provision)

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 CRITERIA - EVALUATION FACTORS FOR AWARD

a. Basis for Award: The Offeror’s proposal will be evaluated to ensure the Government receives a technically acceptable award at a fair and reasonable price. The selection for award will be based on the following equally important non-cost/price factors:

(1) Technical Approach

(2) Past Performance

Price will be evaluated separately from the above technical factors, for fairness and reasonability.

b. Evaluation for Technical Acceptability: An evaluation for technical acceptability will be made to ensure satisfactory responsiveness to the requirements as set forth in this solicitation. Each non-cost/price factor will be rated “Acceptable” or “Unacceptable” using the following rating standards:

For Factor 1 – Technical Approach rating standards will be:

Acceptable: Proposal clearly meets the minimum requirements of the solicitation.

Unacceptable: Proposal does not clearly meet the minimum requirements of the solicitation. If any of the following non-cost/price evaluation factors receives an individual rating of “Unacceptable,” the entire proposal will be deemed “Unacceptable”.

For Factor 2 – Past Performance rating standards will be:

Acceptable: Base on the Offeror’s performance record, the Government has a reasonable expectation that the Offeror will successfully perform the required effort, or the Offeror’s performance record is unknown. (See note below)

Unacceptable: Based on the Offeror’s performance record, the Government has no reasonable expectation, that the Offeror will be able to successfully perform the required effort.

*Note: In the case of an Offeror without a record of relevant past performance or for whom information on past performance is not available or so sparse that no meaningful past performance rating can be reasonably assigned, the Offeror may not be evaluated favorably or unfavorably on past performance (see FAR 15.305 (a)(2)(iv)). Therefore, the Offeror shall be determined to have unknown past performance. In the context of acceptability/unacceptability, “unknown” shall be considered “acceptable.”

(1) Technical Approach: All surgical techniques must be successfully tested. All animal experiments must be approved by local Institute Animal case Use Committee. The technical approach for establishing the porcine maxillofacial burn model must include proven, non-invasive imaging techniques to measure skin/tissue response to thermal injury and during healing of burn wounds. The ability to determine and quantitate skin fibrosis noninvasively as a result of thermal injury is a plus. The technical approach shall include histological (e.g., hematoxylin and eosin staining and Masson Trichrome staining) and immunohistochemical (e.g., α-smooth muscle actin) characterization of thermal facial injury and wound healing response.

Minimum technical requirements for this procurement include:

• A clear understanding of all the tasks and how the approach is likely to yield the required results within the required timeframe.

• The methodology and flexibility that will be used in accomplishing any resultant award.

• Describe qualifications/capabilities specifically related to performance of PWS requirements.

• Describe ability to recruit and maintain a stable workforce.

• Describe knowledge and understanding of the requirement(s) as outlined in the PWS.

• Provide resumes of proposed personnel’s ability to perform the requirements outlined in the PWS.

(2) Past Performance: The offeror must demonstrate the ability and experience working with and developing porcine burn models for studying wound healing. This includes evidence in the form of publications showing the use of successful completion of porcine model development for studying burn injuries.

Minimum past performance requirements for this procurement include:

Past Performance will be evaluated for the Offeror’s probability of meeting the solicitation requirements. The Past Performance evaluation will consider the Offeror’s demonstrated relevant and recent record of performance in supplying products and services that meet the requirements. A performance confidence assessment rating will be assigned for each Offeror focusing on relevant and recent Past Performance. The Government will review the Past Performance information to determine the quality and usefulness as it applies to performance confidence assessment. The Past Performance risk evaluation will assess the risks associated with an Offeror’s likelihood of success in performing the PWS requirements indicated by the Offeror’s record of past performance on relevant efforts, either included in the proposal or identified by the evaluators in any other manner. In this context, “Offeror” refers to the proposed Prime Contractor and all proposed Subcontractors. The Prime Contractor and proposed Subcontractors will first be assessed individually and the results will then be assessed in their totality to derive the Offeror’s Past Performance rating. The Government will conduct a past performance risk evaluation that will be based on the quality, relevance, and currency of the Offeror's past performance, as well as that of its Subcontractors. This evaluation will consider how each Offeror’s past performance relates to the probability of successful accomplishment of the required effort.

Price Evaluation:

Price will be evaluated separately from past performance and other non-cost/price factors, and will be evaluated for fairness and reasonableness. The total evaluated cost/price will be evaluated for reasonableness in terms of:

• Provide a spreadsheet which lists each labor category, the hourly rate, and extended labor costs for the base period, as well was each outlying option period as specified in the PWS.

• The total evaluated price will consist of the total proposed costs for the base period, as well as the outlying option periods.

• Consistency with the technical approach, in that the prices are consistent with and reflect the proposed staffing requirement for all years. Evaluation of options shall not obligate the Government to exercise the option(s).

(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.

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

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 (r) of this provision.

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

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

"Forced or indentured child labor" means all work or service-

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

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

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

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

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.

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

(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…