16T0375_Combined_Syn_Solic_Rev.pdf

COMBINED SYNOPSIS/SOLICITATION

1. Issue Date: 12/06/2016 Close Date: 01/05/2017 10:00 AM EDT

2. Requiring Activity: US Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD for the US Army Medical Research Institute of Infectious Diseases (USAMRIID), Fort Detrick, MD

3. Description of Requirement:

USAMRIID has a requirement for services to evaluate potential therapeutic and vaccines against encephalitic alphaviruses eastern equine encephalitis virus (EEEV), western equine encephalitis virus (WEEV), and Venezuelan equine encephalitis viruses (VEEV).

This is a combined synopsis/solicitation for commercial item services 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; quotation being requested and a written solicitation will not be issued.

4. Solicitation Number: W81XWH-16-T-0375

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 2005-89, August 15, 2016.

This is an unrestricted procurement. The relevant PSC Code is B507 and NAICS code is 541690 with a small business size standard of $15.0M.

Contract shall be firm-fixed-price.

5. Schedule:

CLIN DESCRIPTION QTY U/I UNIT PRICE NET PRICE:

0001 Data Analysis Services 1 Job ___________ ___________ (Phase One – IAW the PWS)

Payment Method: ____________

0002 Data Analysis Services 1 Job ___________ ___________ Optional Quantity (Phase Two – IAW the PWS) Payment Method: ____________

0003 Data Analysis Services 1 Job ___________ ___________ Optional Quantity (Phase Three – IAW the PWS)

Payment Method: ____________

0004 Disposal or Shipping of Material 1 Job ___________ ____________

(IAW the PWS)

0005 Contractor Manpower Reporting (CMR) 1 Job ___________

6. PERFORMANCE WORK STATEMENT (PWS)

1. INTRODUCTION

Since 1969, the U.S. Army Medical Research Institute of Infectious Disease (USAMRIID) has served as the Department of Defense's (DoD) lead laboratory for medical biological defense research. While its core mission is to protect the warfighter from biological threats, USAMRIID also investigates disease outbreaks and threats to public health. Research conducted at

USAMRIID leads to medical solutions—therapeutics, vaccines, diagnostics, and information— that benefit both military personnel and civilians. USAMRIID is a subordinate laboratory of the

U.S. Army Medical Research and Materiel Command at Fort Detrick, located in Frederick, MD.

2. BACKGROUND.

The Virology division is developing the non-human primate (NHP) model to evaluate potential therapeutic and vaccines against encephalitic alphaviruses eastern equine encephalitis virus

(EEEV), western equine encephalitis virus (WEEV), and Venezuelan equine encephalitis viruses

(VEEV). In humans, the initial encephalitic alphavirus infection diagnosis can be aided by the utilization of brain imaging via MRI and CT scans and monitoring of brain electrical activity via

EEG. Additionally, the combination of MRI, CT, and EEG has been utilized to follow brain pathology and abnormal activity associated with alphavirus induced encephalitis (4-16). However, the published data is limited, and the available imaging data is exclusively from EEEV infections

(4-12). MRI and CT imaging of EEEV infection have shown the presence of cerebral edema, intracranial hypertension, as well as lesions in the thalamus, basal ganglia, and brain stem. In contrast to MRI and CT scans, an EEG enables continuous monitoring of the brain’s electrical activity and has been used to monitor EEEV, WEEV, and VEEV infections (8-15). The EEG data show a general decreased and/or altered electrical activity, particularly the alpha and delta wave patterns, indicative of seizures and encephalopathy (8-15). These findings have not been investigated in the NHP models. In addition, the telemetry technology has advanced to the point that additional physiological parameters, such as an EEG, can be investigated using new implants and analysis tools. By incorporating implants that can measure an EEG, respiratory rate, activity, along with body temperature and heart rate into the cynomolgus macaque model, a more comprehensive picture of the disease process can be discerned and compared to human cases.

3. PURPOSE AND OBJECTIVE OF THE PROCUREMENT

The objective of these studies is to further define animal models of encephalitic alphavirus disease by investigating alterations of brain electrical activity via electroencephalography (EEG) in non-human primates (NHPs) following infection. This will be the first investigation into the alteration of electrical activity in the brain of NHPs infected with encephalitic alphaviruses. The purpose of this procurement is to obtain expert EEG analysis following the conclusion of the studies. These data will provide critical insights into kinetics and dynamics of alphavirus-induced encephalitis in NHP modeling. These studies are the initial steps necessary for preclinical evaluation that will lead to advanced development efforts.

To accomplish this work within scope of this requirement, the contractor shall have access to USAMRIID telemetry data files from NHPs studies including but not limited to raw physiological data and associated videos . Because of the sensitive nature of this data, all copies of this data must be safely stored in a secured (locked) container when not in used and subject to inventory procedures. Video analysis will need to be done at USAMRIID. The contractor shall not copy the data nor disclose any information from this library to outside parties. The contractor shall not use this information for any purpose other than the performance of this contract. USAMRIID will retain all proprietary rights and privileges to all Government-furnished information. Once the final report is completed on a set of data, all copies will be returned to USAMRIID.

4. CONTRACTOR REQUIREMENTS

Phase 1: Data Analysis of Electroencephalography

Objective: The contractor shall analyze the electroencephalogram (EEG) signals for one (1) group of four (4) animals with approximately 15 days (5 days pre-infection through 10 days post infection) of EEG and video data recording.

Task 1: Analysis will include quantitative EEG analysis with 3D graphical representation, and characterization of EEG morphologies, circadian cycles, paroxysmal and ictal activity.

Task 2: Interpret EEG signals using the NeuroScore software, or equivalent.

Task 3: Video will be used as a complement for interpretation of EEG and this analysis will need to be done at USAMRIID.

Task 4: Evaluation of EEG by a Board Certified Veterinary Neurologist (American College of Veterinary Internal Medicine Neurology) or equivalent is important. An established, documented track record of video-EEG analysis, especially with seizure detection and characterization is a plus.

Quantity: One (1) group (of 4 animals)

Compliance: non-GLP

Timeframe: 4 months

Deliverable: Presentation of preliminary interpretation within 4 weeks. Draft Phase Report within

12 weeks after reception of the video-EEG data. Final Phase Report within 4 weeks after reception of the comments from USAMRIID on the Draft Phase Report.

Phase 2 (optional): Data Analysis of Electroencephalography

Objective: The contractor shall analyze the electroencephalogram (EEG) signals for two (2) additional groups of four (4) animals with approximately 15 days (5 days pre-infection through 10 days post infection) of EEG and video data recording.

Task 1: Analysis will include quantitative EEG analysis with 3D graphical representation, and characterization of EEG morphologies, circadian cycles, paroxysmal and ictal activity.

Task 2: Interpret EEG signals using the NeuroScore software, or equivalent.

Task 3: Video will be used as a complement for interpretation of EEG and this analysis will need to be done at USAMRIID.

Task 4: Evaluation of EEG by a Board Certified Veterinary Neurologist (American College of Veterinary Internal Medicine Neurology) or equivalent is important. An established, Quantity: Up to two (2) groups (of 4 animals)

Timeframe: 4 months per group

Compliance: non-GLP

Deliverable: Presentation of preliminary interpretation within 4 weeks. Draft Phase Report within

12 weeks after reception of the video-EEG data (Neuroscore compatible). Final Phase Report within

4 weeks after reception of the comments from USAMRIID on the Draft Phase Report.

Phase 3 (optional): Data Analysis of Electroencephalography

Objective: In the event that animals survive challenge past 10 days, the contractor shall analyze the electroencephalogram (EEG) signals for the additional days (up to 50 days) of EEG and video data recording.

Task 1: Analysis will include quantitative EEG analysis with 3D graphical representation, and characterization of EEG morphologies, circadian cycles, paroxysmal and ictal activity.

Task 2: Interpret EEG signals using the NeuroScore software, or equivalent.

Task 3: Video will be used as a complement for interpretation of EEG and this analysis will need to be done at USAMRIID.

Task 4: Evaluation of EEG by a Board Certified Veterinary Neurologist (American College of Veterinary Internal Medicine Neurology) or equivalent is important. An established, Quantity: Up to fifty (50) additional days

Deliverable: Add preliminary/final interpretations with Draft and Final Phase Reports.

5. DELIVERABLES

1. The Contractor shall submit monthly technical progress reports in accordance with

REPORTING REQUIREMENTS (OCT 2009) (USAMRAA).

2. The Contractor shall provide all electronic and hard copy data and material(s) to the COR on an annual basis no later than fifteen (15) calendar days from the end date of the period of performance

3. The COR is required to submit to the Contract Specialist and Contracting Officer a monthly report concerning performance of services rendered under this contract. See Paragraph 8:

Quality Assurance Surveillance Plan for details

4. The Contractor shall report contract‐related information in accordance with the Contractor

Manpower Reporting (CMR) clause by 31 October of each year to the CMR website at:

https://cmra.army.mil

6. GOVERNMENT-FURNISHED PROPERTY

The Government shall ship, at no cost to the Contractor, all required data (with the exception of video data) for analysis in order to facilitate the performance of this contract. The Government shall provide the Contractor with access to the video data on site at USAMRIID.

7. SECURITY AND SAFEGUARD METHODS

1. The contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all Government data. The contractor shall ensure the confidentiality, integrity, and availability of Government data is in compliance with all applicable laws and regulations, including data breach reporting and response requirements, in accordance with DFARS

Subpart 224.1 (Protection of Individual Privacy), which incorporates by reference DoD

5400.11, “DoD Privacy Program,” May 8, 2007, and DoD 5400.11-R, “DoD Privacy

Program,” May 14, 2007. The contractor shall also comply with federal laws relating to freedom of information and records management.

2. The Contractor must provide analyzed data within the established timeframe.

8. QUALITY ASSURANCE SURVEILLANCE PLAN

The QASP is a tool used by the Government (i.e. COR) as a way to assess contractor performance.

The following performance based service acquisition items will be monitored under this QASP and shall be uploaded to the Virtual Contractor Enterprise (VCE) at https://cor.army.mil on a monthly basis by the COR:

See attachment 2 – Quality Assurance Surveillance Plan

9. TRAVEL

None

10. PERIOD OF PERFORMANCE

The anticipated period of performance (PoP) is:

Phase One: 16 Jan 2017 -15 Jan 2018

Phase Two (Option Qty): 16 Jan 2018 – 15 Jan 2018

Phase Three (Option Qty): 16 Jan 2018 - 15 Jan 2019

Disposal or Shipping: 16 Jan 2017 – 15 Jan 2019

Because the Contractor’s Period of Performance is dependent on receiving EEG and video data from USAMRIID, this timeframe may slip due to circumstances out of the Contractor’s control.

11. ANTITERRORISM/ OPERATIONS SECURITY REQUIREMENT – None required based on the approved Contact Requirements Package Antiterrorism/ Operations Security Review Sheet.

12. POINTS OF CONTACT

To be completed upon award.

13. INSPECTION AND ACCEPTANCE: The Government will inspect and accept upon performance of all services.

14. MISCELLANEOUS INFORMATION:

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

Please include your DUNS Number, CAGE Code, and Taxpayer Identification Number (TIN) with your quote.

It is preferred that quotations be sent electronically to sharon.r.smith.civ@mail.mil. Quotations may be sent to USAMRAA, 820 Chandler Street, Fort Detrick 21702-5014, Attention: Sharon Smith. 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.

10. CLAUSES AND PROVISIONS

CLAUSES INCORPORATED BY REFERENCE

52.203-3 Gratuities APR 1984 52.204-16 Commercial and Government Entity Code

Reporting

JUL 2016

52.204-18 Commercial and Government Entity Code Maintenance

JUL 2016

52.209-7 Information Regarding Responsibility Matters JUL 2013 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

252.203-7996 (Dev)

Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements - Representation (Deviation 2016- O0003)

OCT 2015

252.203-7997 (Dev)

Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements (Deviation 2016-O0003)

OCT 2015

252.204-7008 Compliance With Safeguarding Covered Defense Information Controls

DEC 2015

252.204-7011 Alternative Line Item Structure SEP 2011 252.204-7012 Safeguarding Covered Defense Information and

Cyber Incident Reporting.

DEC 2015

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

MAY 2016

252.205-7000 Provision Of Information To Cooperative Agreement Holders

DEC 1991

252.215-7008 Only One Offer OCT 2013 252.222-7007 Representation Regarding Combating Trafficking in Persons

JAN 2015

252.225-7012 Preference For Certain Domestic Commodities AUG 2016 252.225-7031 Secondary Arab Boycott Of Israel JUN 2005 252.225-7050 Disclosure of Ownership or Control by the

Government of a Country that is a State Sponsor of Terrorism

OCT 2015

252.226-7001 Utilization of Indian Organizations and Indian- Owned Economic Enterprises, and Native Hawaiian Small Business Concerns

SEP 2004

252.232-7003 Electronic Submission of Payment Requests and Receiving Reports

NOV 2015

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

Contractor Personnel

JUN 2013

252.243-7002 Requests for Equitable Adjustment DEC 2012 252.244-7000 Subcontracts for Commercial Items JUN 2013 252.246-7008 Sources of Electronic Parts AUG 2016 252.247-7022 Representation Of Extent Of Transportation Of

Supplies By Sea

AUG 1992

252.247-7023 Transportation of Supplies by Sea APR 2014

CLAUSES INCORPORATED BY FULL TEXT

52.212-2 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:

1. BASIS FOR AWARD

(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:

1.1. Award of a single contract shall be made on a competitive basis, using the best value tradeoff process among price and non-price factors described at FAR 15.101-1. The resulting contract is expected to be firm-fixed-price.

1.2. 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.

1.3. Award of this contract will be made on a competitive best value basis, using tradeoff among price and non-price factors. Thus, the Government may elect to award to other than the lowest priced offeror, or other than the highest technically rated offeror. Past Performance will be evaluated independently from the other non-price evaluation factors using different standards.

The evaluation factors are listed below in descending order of importance.

Factor 1 – Technical Capability Factor 2 – Experience Factor 3 – Past Performance Factor 4 – Price

1.4. Government evaluators will not assume that the offeror possesses any capability or knowledge unless it is specified in the proposal.

1.5. After Factors 1 and 2 are rated individually, an overall rating will be assigned to these factors collectively. If Factor 1 or 2 receives an individual rating of “Unacceptable,” the overall rating will also be “Unacceptable.” Proposals that receive an overall rating of “Marginal” for Factors 1 and 2 will not be considered in the tradeoff process. Only proposals receiving an overall rating of “Acceptable” or higher will be considered for award.

2 EVALUATION CRITERIA

2.1. Factor 1 – Technical Capability: The technical capability will be evaluated for the degree to which the Offeror’s technical capability demonstrates a clear understanding of the PWS and all the tasks to be performed; the methodology and flexibility that will be utilized; and how the approach will accomplish all tasks, subtasks, and administrative tasks as are necessary to ensure program success within the proposal’s required time frame.

This capability will be evaluated for the degree to which the technical capability demonstrates a clear working knowledge of data analysis of Electroencephalography in non-human primates.

2.2. Factor 2 – Experience: The Offeror’s proposal will be evaluated to the degree to which the Offeror’s proposal reflects experience identical to, similar to, or related to performing services contained within the PWS. The experience will be evaluated to the degree to which the Offeror demonstrates relevant experience in providing data analysis of EEG in non-human primate animals with Alphavirus infection as specified in the the PWS.

Offeror proposals will be evaluated to the degree proposals cite specific examples of relevant experience in the areas of data analysis as it relates to the specif tasks listed in the PWS relating to data analysis of Electroencephalography.

2.3. Factor 3 - Past Performance: Past performance shall be evaluated on the basis of the offeror’s demonstrated recent and relevant record of performance in services that meet the contract’s requirements. The Government will conduct a past performance risk evaluation and confidence assessment of the offeror that will be based on the relevance, recency, and quality of the offeror’s past performance on projects of similar size, scope, and complexity within similar periods of performance.

a. Offerors shall submit a list of no more than two (2) references familiar with the offeror’s performance on relevant contracts within the past three (3) years. It is the offeror’s responsibility to provide valid, current, and verifiable references. References must include the following information:

i. Name of the organization that will be providing the reference

ii. Name of the point of contact (POC) familiar with contract performance

iii. POC telephone number

iv. POC email address

v. Contract number

vi. Period of performance

vii. Summary of the scope of work performed

b. The Government will review the relevant and recent past performance information to determine the risks associated with an offeror’s probability of successfully performing the required efforts.

c. The Government may elect to consider data obtained from other sources. Other sources available to the Government include, but are not limited to, the Federal Awardee Performance and Integrity Information System (FAPIIS) and Past Performance Information Retrieval System (PPIRS).

d. In the case of an Offeror who has no recent/relevant performance record available or the

Offeror’s performance record is so sparse that no meaningful confidence assessment 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 will be determined to have “Unknown Confidence” for its past performance evaluation factor.

2.4. Factor 4 – Price: Price will be evaluated separately from non-price and past performance factors. A price analysis will be performed in order to evaluate the fairness and reasonableness of the proposed price.

(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). The option in accordance with FAR 52.217-8 will be evaluated using the same prices proposed for the last option period under FAR 52.217-9.

(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.

3. EVALUATION RATING STANDARDS

3.1. RATING STANDARDS FOR THE NON-PRICE PROPOSAL (EXCLUDING PAST

PERFORMANCE)

Combined Technical/Risk Ratings Table Rating Description

Outstanding Proposal meets requirements and indicates an exceptional approach and understanding of the requirements. Strengths far outweigh any weaknesses.

Risk of unsuccessful performance is very low.

Good Proposal meets requirements and indicates a thorough approach and understanding of the requirements. Proposal contains strengths which outweigh any weaknesses. Risk of unsuccessful performance is low.

Acceptable

Proposal meets requirements and indicates an adequate approach and understanding of the requirements. Strengths and weaknesses are offsetting or will have little or no impact on contract performance. Risk of unsuccessful performance is no worse than moderate.

Marginal

Proposal does not clearly meet requirements and has not demonstrated an adequate approach and understanding of the requirements. The proposal has one or more weaknesses which are not offset by strengths. Risk of unsuccessful performance is high.

Unacceptable Proposal does not meet requirements and contains one or more deficiencies.

Proposal is unawardable.

3.2 Best Value Tradeoff Evaluation Standard Definitions

Clarifications Limited exchanges between the Government and Offerors that may occur when award without discussions is contemplated.

Communications Exchanges, between the Government and Offerors, after receipt of proposals, leading to establishment of the competitive range.

Deficiency

A material failure of a proposal to meet a Government requirement or a combination of significant weakness in a proposal that increases the risk of unsuccessful contract performance to an unacceptable level. See FAR 15.001

Discussions Negotiations conducted in a competitive acquisition. Discussions take place after establishment of the competitive range.

Performance Confidence Assessment

An evaluation of the likelihood (or Government’s confidence that the Offeror will successfully perform the solicitation’s requirements; the evaluation is based upon past performance information.

Recency

As it pertains to past performance information, is a measure of the time that has elapsed since the past performance reference occurred. Recency is generally expressed as a time period during which past performance references are considered relevant.

Relevancy

As it pertains to past performance information, is a measure of the extent of similarity between the service/support effort, complexity, dollar value, contract type, and subcontract/teaming or other comparable attributes of past performance examples and the source solicitation requirements; and a measure of the likelihood that the past performance is an indicator of future performance.

Risk

The potential for unsuccessful contractor performance. The consideration of risk assesses the degree to which an Offeror’s proposed approach to achieving the technical factor or subfactor may involve risk of disruption of schedule, increased cost (not applicable to firm-fixed price contracts) for degradation of performance, the need for increased Government oversight, and the likelihood of unsuccessful contract performance.

Significant Strength A significant strength appreciably enhances the merit of a proposal or appreciably increases the probability of successful contract performance.

Significant Weakness

A flaw that appreciably increases the risk of unsuccessful contract performance. See FAR 15.001.

Strength An aspect of an Offeror’s proposal that has merit or exceeds specified performance or capability requirements in a way that will be advantageous to the Government during contract performance.

Weakness A flaw the proposal that increases the risk of unsuccessful contract performance. See FAR 15.001.

3.3. RATING STANDARDS FOR PAST PERFORMANCE

Past Performance Relevancy Ratings Standards for the Non Cost/Price Proposal

Rating Definition

Very Relevant Present/past performance effort involved essentially the same scope and magnitude of effort and complexities this solicitation requires.

Relevant Present/past performance effort involved similar scope and magnitude of effort and complexities this solicitation requires.

Somewhat Relevant

Present/past performance effort involved some of the scope and magnitude of effort and complexities this solicitation requires.

Not Relevant Present/past performance effort involved little or none of the scope and magnitude of effort and complexities this solicitation requires.

3.4 Past Performance Confidence Assessments Standards for the Non Cost/Price Proposal

Rating Description

Substantial Confidence

Based on the Offeror’s recent/relevant performance record, the Government has a high expectation that the Offeror shall successfully perform the required effort.

Satisfactory Confidence

Based on the Offeror’s recent/relevant performance record, the Government has a reasonable expectation that the Offeror shall successfully perform the required effort.

Limited Confidence

Based on the Offeror’s recent/relevant performance record, the Government has a low expectation that the Offer shall successfully perform the required effort.

No Confidence Based on the Offeror’s recent/relevant performance record, the Government has no expectation that the Offeror shall successfully perform the required effort.

Unknown Confidence (Neutral)

No recent/relevant performance record is available or the Offeror’s performance record is so sparse that no meaningful confidence assessment rating can be reasonably assigned.

(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). The option in accordance with FAR 52.217-8 will be evaluated using the same prices proposed for the last option period under FAR 52.217-9.

(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 (JUL 2016) ALTERNATE I (OCT 2014)

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

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

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

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

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

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

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

(6) Have been voluntarily suspended.

Sensitive technology—

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

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

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

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

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

(1) Means a small business concern—

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

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

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

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

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

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

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

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

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

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

(1) Directly by a parent corporation; or

(2) Through another subsidiary of a parent corporation.

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

(1) Not less than 51 percent of which is owned by one or more veterans(as defined at 38 U.S.C.

101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and

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

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

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

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

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

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

(b)

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

(2) The offeror has completed the annual representations and certifications electronically via the SAM website accessed through https://www.acquisition.gov. After reviewing the SAM database information, the offeror verifies by submission of this offer that the representation and certifications currently posted electronically at FAR 52.212-3, Offeror Representations and Certifications— Commercial Items, have been entered or updated in the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201), except for paragraphs ___ . [Offeror to identify the applicable paragraphs at (c) through (q) of this provision that the offeror has completed for the purposes of this solicitation only, if any. These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer. Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted electronically on SAM.]

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

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

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

(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:

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:

LINE ITEM NO. COUNTRY OF ORIGIN

[List as necessary]

(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:

LINE ITEM NO. COUNTRY OF ORIGIN

[List as necessary]

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

(2) Buy American—Free Trade…