N6264518R0058_Combined_Synopsis_Solicitation_17June2018.docx

This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, and FAR 13, Simplified Acquisition Procedures, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation for N6264518R0058 on; proposals are being requested and a written solicitation on an SF1449 will not be issued. The solicitation number is N6264518R0058. The solicitation is issued as a request for proposal (RFP). Provisions and clauses in effect through Federal Acquisition Circular 2005-98 are incorporated. It is the contractor’s responsibility to be familiar with the applicable FAR and DFARS clauses and provisions. The FAR and DFARS clauses may be accessed in full text at this address: http://farsite.hill.af.mil/.

The Naval Medical Logistics Command is requesting responses from qualified sources capable for providing monitoring support, data-management support, and scientific writing for the study titled “Evaluation of a Diagnostic Device, CL Detect™ Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Peru” (LRDD-PERU-02)”. These services will be performed in collaboration with the Naval Medical Research Unit – 6 Peru (NAMRU-6) and the contract for research with Instituto de Medicina Tropical Alexander von Humbolt/Universidad Peruana Cayetano Heredia (UPCH). The successful awardee must be able to provide services upon contract award and be familiar with studies involving the CL Detect™ Rapid Test.

There are no set-aside restrictions for this requirement. The NAICS for this requirement is 541715. This solicitation will result in one firm fixed price contract.

PERFORMANCE WORK STATEMENT

“Evaluation of a Diagnostic Device, CL Detect™ Rapid Test for the Diagnosis of Cutaneous Leishmaniasis in Peru” (LRDD-PERU-02)

1. Introduction:

The Performance Work Statement (PWS) defines the requirements for performing monitoring, data-management and scientific writing for the study entitled “Evaluation of a Diagnostic Device, CL Detect™ Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Peru” (LRDD-PERU-02) NAMRU6-2015.0009. Research activities associated with this requirement will be carried out is Peru.

2. Background:

Cutaneous leishmaniasis (CL) is a complex entity and probably the most neglected of the neglected diseases. CL is a public health and a social problem in many developing countries worldwide. In the New World, cutaneous and mucocutaneous leishmaniasis caused by L. braziliensis, L. panamensis and L. peruviana are considered a major health problem in countries such as Brazil, Bolivia, Peru, Colombia, and Guatemala. The mucocutaneous form typically begins with nasal inflammation and stuffiness followed by ulceration of the nasal mucosa and perforation of the nasal septum. In some cases, the lips, cheeks, soft palate, pharynx, or larynx are also affected. Mucocutaneous leishmaniasis without treatment will not present spontaneous remission, in addition, is very difficult to treat. If mucocutaneous leishmaniasis is not treated early, it can cause disfiguration and death in some cases.

As the clinical presentation of CL lacks specificity and treatment is, costly, cumbersome, or toxic, diagnostic confirmation is required. Definitive diagnosis of CL depends on identification of the Leishmania parasite in slide smears (Leishmania amastigotes visualized) or cultures (Leishmania promastigotes visualized) using tissue obtained from the suspect lesion (Reithinger et al-2007; Reithinger and Dujardin-2007; Sharquie et al-2002). Microscopic examination of Giemsa-stained material is often the only available method at primary, secondary, or tertiary health care level in endemic areas.

CL poses a significant threat to the individual readiness of U.S. forces during all phases of operations in many countries throughout the world. In particular, in the Central Command area of operations and Southern Command area of operations, to include Iraq and Afghanistan, as well as in a number of additional countries in Europe, Asia, Africa and Latin America (Mexico, Honduras, Guatemala, Colombia, Venezuela, Ecuador, Peru and Bolivia). Since 2003, 2,832 service members deployed to Iraq and Afghanistan have been infected with CL, yet only 86 of these cases were successfully diagnosed in the military patients’ theaters of operations. The number of CL cases in SOUTHCOM are not known since most of the cases occurred within the Special Forces community that have their own ways to respond to infectious diseases.

There is an important need to develop a field deployable rapid test assay for the detection of cutaneous leishmaniasis. The CL Detect™ Rapid Test is a U S Food and Drug Administration (FDA) approved qualitative, in vitro immunochromatographic assay for the rapid detection of Leishmania species in skin lesions from individuals suspected of having CL which has proved to have adequate sensitivity in Old World species. The test line of the CL Detect™ Rapid Test strip correlates with the number of parasites present in the lesion sample. Thus is reasonable to believe that the sensitivity of the FDA-cleared CL Detect™ Rapid Test can be lower in New World Leishmania endemic regions (like Peru) where the number of parasites in the tissue is lower compared to Tunisia-L.major infections, known to have a high parasite load.

A recent (2014-2015) study in Peru (titled LRDD-PERU-01) conducted by the Instituto de Medicina Tropical Alexander von Humbolt was conducted testing the sensitivity of the FDA-cleared CL Detect™ Rapid Test. The sensitivity of the FDA-cleared CL Detect™ Rapid Test, was drastically increased from 50% utilizing test procedures describe in the device instructions to over 97% by modifying the test procedures. The modifications consisted of: 1) increase extraction time in lysis buffer from 5 to 10 minutes to 20 to 30 minutes and 2) a 20 µl increase in the volume of the sample to add to the test strip in the area beneath the arrow, from 20 µl to 40 µl.

This project aims to confirm the LRDD-PERU-01 study initial findings by increasing the number of participants/observations from an N of 25 to an N of 100.

3. General Requirements:

This PWS is for a one-year period of performance.

This research associated with this requirement will be conducted in Peru, in two sites:

· Lima:

i. Instituto de Medicina Tropical Alexander von Humbolt (Universidad Peruana Cayetano Heredia, Lima)

ii. NAMRU-6 facilities

· Madre de Dios (Puerto Maldonado): NAMRU-6 Contract/Clinical Research Organization (CRO) shall provide monitoring support to the site teams at Instituto de Medicina Tropical Alexander von Humbolt and NAMRU-6 Puerto Maldonado. Familiarity with the prior PERU-01 study is required. The CRO will coordinate with the Study Coordinator and Investigators for properly keeping the Trial Master File, as well as meeting all the applicable regulatory requirements.

The CRO will also provide data-management support; elaborating/providing input for all study documents (source documents, Standard Operating Procedures - SOPs, etc). They will also perform statistical analysis of the study data.

Finally, the CRO will be responsible for preparing progress reports, the Clinical Study Report at the end of the study, and the scientific manuscript for peer-reviewed publication.

4. Performance Requirements:

The contractor shall provide adequate and qualified staffing to carry out the following requirements:

· Oversees the activities of data managers, statistician, and clinical research assistants.

· Approve study documents such as the Data Management Plan, Statistical Analysis Plan, etc.

· Lead scientific writing of the interim reports, Clinical Study Report (CSR), and scientific publications in coordination with the study investigators.

· Proactively manage project level operational aspects of Clinical Trial.

· Provide efficient updates on trial progress to the Senior Scientist and Study Investigators.

· Lead study startup process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets.

· Ensure potential study risks are escalated to the attention of the Senior Scientist and Study Investigators.

· Review and approve site visit reports.

· Ensure all project-level study documentation is filed in the TMF in accordance with SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance, and archival procedures.

· Effectively provide support to Clinical Site Manager(s) in the conduct of the trial.

· Archive and organize clinical trial master file documents (including clinical study site documents, email correspondence, training materials and other study documents).

· Administer clinical trials according to good clinical practices and standard operating procedures.

· Act as key contacts between the contract laboratory, study team and study site.

· Provide general logistical support for clinical trials, such as creating an agenda and taking minutes at meetings, and assisting with purchasing and/or budget activities.

· Perform sample size/power calculations.

· Author statistical analysis plans.

· Prepare derived datasets for the analyses using SAS (software suite).

· Program and validate statistical analyses in SAS.

· Perform complex statistical analyses.

· Prepare and deliver reports for interim and final analyses.

· Contribute to the interpretation and publication of research results.

· Independently manage all statistical aspects of a project.

MONITORING

· The contractor shall provide monitoring support. The CRO will pay on-site visits before study initiation (as part of study readiness activities) and at the end of the study (for study close).

· Continuing remote monitoring will be conducted during the execution of the study.

· Weekly-monitoring teleconferences will be organized by the CRO. The CRO will elaborate the minutes after each meeting.

· The CRO will provide bi-monthly monitoring reports.

DATA MANAGEMENT

· The CRO will elaborate the following study documents:

· Statistical Analysis Plan (SAP)

· Data-Management Plan

· Monitoring Plan

· Standard Operating Procedures (SOPs)

· Electronic-based Clinical Report Forms (CRFs)

· Laboratory Manual

· Logs (enrollment log, temperature log, device accountability log, temperature logs, etc.).

· The CRO will review the electronic CRFs in real time, and issue queries as needed.

· The CRO will provide monthly Quality Control (QC) reports.

· The CRO will be responsible for the database creation, data cleaning, and database-lock at the end of the study.

· The CRO will perform statistical analysis and provide tables and graphs as stated in the SAP.

SCIENTIFIC WRITING

· The CRO will elaborate the Clinical Study Report (CSR) at the end of the study.

· The CRO in collaboration with the investigators and representatives from the device’s manufacturer will write the scientific manuscript.

TRAVEL

· CRO personnel will travel from the U.S. to Peru two times (before study initiation as part of study readiness activities, and at the end of the study for study close activities). The offeror’s proposal shall be inclusive of all expenses related to travel.

OFFICE SUPPLIES/MATERIALS

· The CRO will cover all office supplies/materials related costs necessary for the execution of their activities.

5. Deliverables: The materials specifically listed and requested must be delivered in a timely manner based on the study requirements.

· Statistical Analysis Plan (SAP)

· Data-Management Plan

· Monitoring Plan

· Standard Operating Procedures (SOPs)

· Electronic-based Clinical Report Forms

· Laboratory Manual

· Logs (enrollment log, temperature log, device accountability log, temperature logs, etc.).

· Clinical Study Report

· Scientific Manuscript

6. Annual Schedule:

Quarter 1:

· Study documents created, approved and distributed to the sites

· Trial Master File creation

· Onsite training for all study team (protocol, procedures, CRF completion, etc.)

· Oversee study initiation

· Conduct onsite monitoring for the first 05 study subjects enrolled

· Conduct remote monitoring for all the study subjects enrolled during the quarter

· Oversee samples shipping and laboratory processing

· Provide bimonthly QC reports of study documentation

· Organize 08 weekly teleconferences with the study team (provide minutes within 48 hours)

Quarter 2:

· Conduct remote monitoring for all the study subjects enrolled during the quarter

· Oversee samples shipping and laboratory processing

· Provide bimonthly QC reports of study documentation

· Organize 12 weekly teleconferences with the study team (provide minutes within 48 hours)

Quarter 3:

· Conduct remote monitoring for all the study subjects enrolled during the quarter

· Oversee samples shipping and laboratory processing

· Provide bimonthly QC reports of study documentation

· Organize 12 weekly teleconferences with the study team (provide minutes within 48 hours)

Quarter 4:

· Conduct remote monitoring for all the study subjects enrolled during the quarter

· Oversee samples shipping and laboratory processing

· Provide bimonthly QC reports of study documentation

· Organize 12 weekly teleconferences with the study team (provide minutes within 48 hours)

· Oversee study closing

· Conduct onsite study close activities

· Database completion / Database lock

· Perform data analysis

· Elaborate the Clinical Study Report (CSR) in collaboration with the investigators

· Write the Scientific Manuscript in collaboration with the investigators

Period of performance:

This is a non-severable services contract. The estimated period of performance for this contract is 12 months upon award/commencement of services.

INSTRUCTIONS TO OFFERORS

ADDENDUM TO 52.212-1 (Dev)

INSTRUCTIONS TO OFFERORS – ADDENDUM TO 52.212-1 (Dev)

In addition to the guidance included in FAR Provision 52.212-1(Dev) titled “Instructions to Offerors – Commercial Items,” the following are applicable for the preparation and submission of proposals.

Proposal Content and Instructions for Preparation of Proposals.

Instructions for preparation of proposals. This section specifies the format and content that offerors shall submit their proposal. The intent is not to restrict the offerors in the manner in which they will perform their work but rather to ensure a certain degree of uniformity in the format of the responses for evaluation purposes. Offerors must submit a proposal that is legible and comprehensive enough to provide the basis for a sound evaluation by the Government. Information provided should be precise, factual, and complete. Legibility, clarity, completeness, and responsiveness are of the utmost importance. Proposals shall be in the form prescribed by, and shall contain a response to, each of the areas identified herein. Any proposal that does not provide, at a minimum, that which is required in this solicitation may be determined to be substantially incomplete and not warrant any further consideration. The Government shall award a contract to the responsible offeror whose offer will be most advantageous to the Government, price and other factors considered.

The proposal shall be submitted in two separate volumes:

Volume I –Non-Price Factors (Technical Approach / Past Performance) Volume II – Price (including required documentation listed below)

A complete Volume I – Non-Price Factors and Volume II – Price shall be submitted by the closing date specified in this solicitation. If any one proposal volume is received past the stated closing date specified in this solicitation, the entire proposal can be considered late.

1. Volume I: Non-Price Factors. Volume I shall not include any pricing information. In accordance with file submission requirements given in this section, the offeror shall submit the following:

1.1. Evaluation Factor I: Technical Approach: The offeror shall provide sufficient technical documentation demonstrating the following:

· The offeror shall demonstrate an understanding of and capability to meet all of the requirements of the PWS. The offeror shall include staffing labor estimates and their associated performance responsibilities.

· The offeror shall provide a statement that they are registered in SAM (System for Award Management, https://www.sam.gov/portal/SAM/#1#1). The statement must also state that the SAM registration is current and that the offeror is listed under NAICS code 541715.

1.2 Evaluation Factor II: Past Performance: The offeror shall describe its past performance on up to two (2) contracts it has held within the last five years that are for the same or similar products to that which is detailed in this solicitation, or affirmatively state the offeror possesses no relevant past performance directly related to or similar past performance. Offerors who present similar contracts shall provide a detailed explanation demonstrating the relevance of the contracts to the requirements of the solicitation. The Government reserves the right to contact any references.

The offeror shall demonstrate relevant past performance or affirmatively state that it possesses no relevant past performance. Relevant past performance is performance under contracts or efforts within the past five years prior to the solicitation closing date that is the same as or similar to, the scope and magnitude of the work described by this solicitation.

The offeror shall complete a “Past Performance Information Form”, Attachment 1(external attachment to this form) for each reference submitted. For additional information regarding a particular reference beyond that which will fit on the form, the offeror may continue onto another sheet of paper. Such continuation sheet(s) for submitted references WILL count toward the Volume I page limit. The offeror shall also provide a copy of the corresponding Performance Work Statement (PWS)/Statement of Work (SOW)/Statement of Objectives (SOO) for each contract referenced in the offeror’s past performance submission. The PWS/SOO will NOT count towards the Volume I page limit.

An offeror’s past performance submission may be determined to be “Not Relevant” if the substantiating information is not provided.

Substantiating Information: In addition to the information requested above, offerors shall contact their past performance references and request that each reference complete the attached “Past Performance Information Form”, Attachment 2 , and email the completed forms directly to cheryl.r.vendemia.civ@mail.mil and roger.k.batchelor2.civ@mail.mil prior to the submission date identified below. The subject line of the email shall read: Solicitation N6264518R0058 Past Performance.

Page limit for Volume I – Non-Cost Factors: not to exceed 10 pages (excluding a Cover Sheet and Table of Contents). Any information submitted that is in excess of the page limit shall not be considered as part of the proposal.

2. Volume II: Price Proposal (Evaluation Factor III - Price). In accordance with file submission requirements given in this section, the offeror shall submit the following:

The offerors title page on the price volume shall contain the following: complete company name and address, company Point of Contact (to include phone and email address), the offeror’s CAGE Code and DUNS number:

The offeror shall include a statement with the offerors Volume II, acknowledging the combined synopsis/solicitation and all amendments issued under this combined synopsis/solicitation.

The offeror shall complete and submit FAR provision 52.212-3 ALT I. Offerors shall only complete paragraph b if they have completed the annual representations and certifications in SAM.

2.1. Pricing shall be submitted in the line items (0001 and 0002 (deliverables are not separately priced). The offeror shall submit firm-fixed pricing for all Contract Line Item Numbers (CLINs). Pricing shall be inclusive of the total cost for completion of the entire requirement to include all required deliverables.

Page limit for Volume II – Price: There is NO page limit for Volume II – Price.

3. Proposal Submission.

The Government intends to award a contract without discussions. Offerors should provide their best, complete proposal upon initial submission. The Government reserves the right to hold discussions if deemed necessary by the Contracting Officer.

Questions shall be submitted (by email) to cheryl.r.vendemia.civ@mail.mil and roger.k.batchelor2.civ@mail.mil prior to 02:00 PM Eastern Time, 25 June 2018. It is requested that only one set of questions be submitted by each offeror, numerous sets of questions from an offeror will not be accepted.

b. The proposal due date is 02:00 PM Eastern Time on 18 July 2018.

The estimated award date is 30 July 2018.

Proposals shall be valid for a period of 90 days.

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

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

The Government intends to award one firm-fixed priced 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:

The proposal shall be submitted in two volumes:

• Volume I – Non Price Factors and Volume II – Price (including completeness as outlined below*)

The proposals will be evaluated under the following factors:

Evaluation Factor I: Technical Proposal Evaluation Factor II: Past Performance Evaluation Factor III: Price

Relative Importance of Factors. The relative importance of each factor is as follows:

Evaluation Factor’s I and II, will be evaluated individually on a pass/fail basis. If an offeror's technical proposal is judged to have failed under Evaluation Factors I or II, the firm's offer will receive no further consideration for award unless there are no other technically compliant proposals.

If an offeror is judged to have passed under Evaluation Factors I and II, then the firm’s offer will be further evaluated on Factor III, Price. In doing so, Factors I, II and III are all equally important. If Factors I and II have all been evaluated and received a ‘pass’ rating, Factor III (price) will be the deciding factor. Factor III is equally important to the combination of evaluation Factors I and II.

Evaluation Factor I: Technical Proposal:

Offeror will be evaluated on its ability to demonstrate understanding of and capability to meet all of the requirements of the solicitation and PWS. The offeror’s performance approach will be evaluated on its feasibility, its comprehensiveness, and the degree to which the offeror demonstrates how the requirements identified in the PWS will be successfully accomplished. Submissions will be rated on a Pass or Fail basis.

Evaluation Factor II: Past Performance:

The Past Performance evaluation will result in an assessment of the offeror’s probability of meeting the solicitation requirements. The Government is likely to randomly select references provided for contact and does not commit to contact every reference.

The Government reserves the right to utilize other information not provided by the vendor and will evaluate information readily available. It is the responsibility of the offeror to ensure names and phone numbers of points of contact are verified and accurate.

The Government will evaluate past performance for:

(a) Relevancy: how pertinent a recent effort accomplished by the offeror is to the effort to be acquired through the source selection.

(b) Responsiveness: vendor's compliance with performance and timely delivery

A relevancy determination will be made solely based on the information provided in the offeror’s proposal and information available to the Government through internal sources. The Government will not call POC’s to determine relevancy.

If a reference contract is determined to be “not relevant” (after review of the offeror’s proposal), then the reference contract will not be evaluated for responsiveness.

Past performance will be evaluated on a pass/fail basis, unless the offeror posses no relevant past performance.

In the case of an offeror without a record of relevant past performance or for whom information on past performance is not available, the offeror will not be evaluated favorably or unfavorably on past performance (FAR 15.305(a)(2)(iv)). The offeror will receive a neutral rating.

Evaluation Factor III – Price.

Price will be evaluated on completeness and reasonableness.

*Completeness – The offeror shall include pricing for all line items as stated in the INSTRUCTIONS TO OFFERORS – ADDENDUM TO 52.212-1(Dev).

*The offeror shall also meet the other requirements as delineated in Volume II, to include:

*The offeror's title page on the price volume shall contain the following: complete company name and address, company Point of Contact (to include phone and email address), the companies CAGE Code and the companies DUNS number:

*Completed line item 0001 to include cost for completion of entire study (0002 should be not applicable as it is not separately priced) (See PRICING)

*The offeror shall include a statement with the offerors Volume II, acknowledging the combined synopsis/solicitation and all amendments issued under this combined synopsis/solicitation.

*The offeror shall complete and submit FAR provision 52.212-3 ALT I

Reasonableness – The degree to which the offeror’s total proposed price represents a fair and reasonable price. The offeror’s total proposed price will be used to evaluate price reasonableness on a competitive basis.

Notice of Award 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.

PRICING

Contract Research Organization

FFP

The total price includes: all services required for monitoring, data management, scientific writing, travel expense, office supplies, etc. through completion of the research and deliverables as outlined in the PWS.

*Duration of Study

NOTE: LINE ITEM 0002 ARE DELIVERABLES AND ARE NOT SEPARATELY PRICED (NSP)

NOT SEPARATELY PRICED

Deliverables

NOT SEPARATELY PRICED

Deliverables are due in accordance with details outlined in the PWS. Final reports are due within 6 months upon completion of the associated research. Reports include, but are not limited to:

Statistical Analysis Plan (SAP),Data-Management Plan, Monitoring Plan, Standard Operating Procedures (SOPs), Electronic-based Clinical Report Forms Laboratory Manual, Logs (enrollment log, temperature log, device accountability log, temperature logs, etc), Clinical Study Report, Scientific Manuscript

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL ITEMS (NOV 2017) ALTERNATE I (OCT 2014)

The offeror shall complete only paragraphs (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) Web site 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-- “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.

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

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

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

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

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

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

(6) Have been voluntarily suspended.

“Sensitive technology”—

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

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

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

(2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3) of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)).

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

(1) Means a small business concern—

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

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

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

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

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

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

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

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

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

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

(1) Directly by a parent corporation; or

(2) Through another subsidiary of a parent corporation.

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

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

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

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

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

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

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

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

(b)

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

(2) The offeror has completed the annual representations and certifications electronically via the SAM website accessed through https://www.acquisition.gov. After reviewing the SAM database information, the offeror verifies by submission of this offer that the representation and certifications currently posted electronically at FAR 52.212-3, Offeror Representations and Certifications—Commercial Items, have been entered or updated in the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201), except for paragraphs ___ . [Offeror to identify the applicable paragraphs at (c) through (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 SAM.]

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

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

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

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

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

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

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

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

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

(ii) It [ ___ ] is, [ ___ ] is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(6)(i) of this provision is accurate for each WOSB concern eligible under the WOSB Program participating in the joint venture. [The offeror shall enter the name or names of the WOSB concern eligible under the WOSB Program and other small businesses that are participating in the joint venture: ___ .] Each WOSB concern eligible under the WOSB Program participating in the joint venture shall submit a separate signed copy of the WOSB representation.

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

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

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

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

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

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

(11) (Complete if the offeror has represented itself as disadvantaged in paragraph (c)(4) of this provision.)

[The offeror shall check the category in which its ownership falls]:

___ Black American.

___ Hispanic American.

___ Native American (American Indians, Eskimos, Aleuts, or Native Hawaiians).

___ Asian-Pacific American (persons with origins from Burma, Thailand, Malaysia, Indonesia, Singapore, Brunei, Japan, China, Taiwan, Laos, Cambodia (Kampuchea), Vietnam, Korea, The Philippines, Republic of Palau, Republic of the Marshall Islands, Federated States of Micronesia, the Commonwealth of the Northern Mariana Islands, Guam, Samoa, Macao, Hong Kong, Fiji, Tonga, Kiribati, Tuvalu, or Nauru).

___ Subcontinent Asian (Asian-Indian) American (persons with origins from India, Pakistan, Bangladesh, Sri Lanka, Bhutan, the Maldives Islands, or Nepal).

___ Individual/concern, other than one of the preceding.

(d) 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 to the Equal Opportunity clause of this solicitation; 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 parts 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:

[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:

(iii) The offeror shall list those supplies that are foreign end products (other than those listed in paragraph (g)(1)(ii) or 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:

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

(2) Buy American—Free Trade Agreements—Israeli Trade Act Certificate, Alternate I. 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.:

[List as necessary]

(3) Buy American—Free Trade Agreements—Israeli Trade Act Certificate, Alternate II. 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:

(4) Buy American—Free Trade Agreements—Israeli Trade Act Certificate, Alternate III. If Alternate III to the clause at 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…