FDA-RFQ-1239924 Predictive Toxicologist.pdf

FDA-RFQ-1239924

Document Type: Combined Synopsis/Solicitation

Solicitation Number: FDA-RFQ-1239924 Posted Date: May 4, 2021 Title: Predictive Toxicology Technical Expert Services Response Date: May 17, 2021 2:00 PM CT

NAICS Code: 541690 – Other Scientific and Technical Consulting Services Classification Code: B504 – Special Studies/Analysis - Chemical/Biological

Contracting Office Address

FDA/OO/OFBA/OAGS/DAP

National Center for Toxicological Research (NCTR) 3900 NCTR Road Jefferson, AR 72079

1. Notice of Combined Synopsis/Solicitation This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The solicitation is being issued in conjunction with FAR Part 13 - Simplified Acquisition Procedures.

2. Notice of Request for Quote The solicitation number is FDA-RFQ-1239924. This solicitation is issued as a Request for Quote

(RFQ)

3. Notice of FAC The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2021-05 effective March 10, 2021.

FAR provisions and clauses referenced in this solicitation can be found on the following website:

https://www.acquisition.gov/far/index.html.

HHSAR provisions and clauses referenced in this solicitation can be found on the following website: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

4. Notice of NAICS/Set-Aside The associated North American Industry Classification System (NAICS) code for this acquisition is 541690 – Other Scientific and Technical Consulting Services; the applicable Small Business Size Standard is $16.5 million. This requirement is solicited as a full and open; any size businesses may submit a quote.

5. Description of Contract Requirements/Statement of Work (SOW) The Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), Division of Bioinformatics and Biostatistics (DBB) requires a Technical Expert in Predictive Toxicology; an experienced individual with written and oral presentation skills, and a thorough understanding of bioinformatics with specific knowledge in Predictive Toxicology. One of the https://www.acquisition.gov/far/index.html https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html essential roles of the DBB at the NCTR is to deal with the rapid growth of biomedical data present in the public domain and generated within the FDA and develop state-of-art bioinformatics and biostatistics methodologies to translate these burgeoning data to knowledge to be used in the FDA.

One area of this research is Predictive Toxicology. Specifically, the goal is to collect and analyze all clinical and preclinical parameters of each drug that has been reported to cause unwanted side effects, and to generate gene-expression data from in vitro studies and other studies to identify potential biomarkers. This will aid in the efforts to determine drug safety and in the extension of understanding precisely which patients will most likely benefit from a given drug or dose, and which patients would be most likely to suffer unwanted effects from that same drug or dose.

The FDA seeks a contractor with demonstrated expertise in working with Predictive Toxicology.

The contractor will support the FDA/Division of Bioinformatics and Biostatics to develop and coordinate informatics capabilities within NCTR and FDA Centers. The contractor shall have a thorough understanding of bioinformatics with specific knowledge in Predictive Toxicology with bioinformatic tools. The contractor shall work in close coordination with the DBB at NCTR in Jefferson, Arkansas, and shall assist in the formulation of innovative ideas/approaches to address the current needs in Predictive Toxicology development, to advise bioinformatics staff in the appropriate methods of writing papers and protocols, and to provide support in the generation of manuscripts and other documentation. This shall require periodic visits to the NCTR Campus and communication with the DBB staff via other electronic means, including video conferencing.

Specifically, the contractor shall communicate via e-mail, phone calls and video conferences to make recommendations as appropriate, and to schedule visits to the NCTR campus with the Technical Point of Contact (TPOC)/Contracting Officer’s Representative (COR).

For the purposes of this RFQ, the Predictive Toxicologist shall be identified as “key personnel.”

HHSAR Clause 352.237-75 Key Personnel (DEC 2015) applies to this acquisition.

Objective

It is critical for the Division of Bioinformatics and Biostatics to develop and coordinate informatics capabilities within NCTR, across FDA Centers, and in the larger toxicological community. It is important for these capabilities to be communicated in an effective manner with the research community and the FDA. This requires an experienced individual with written and oral presentation skills, a thorough understanding of bioinformatics with respect to drug development and safety evaluation, and extensive experience in the field of Predictive Toxicology.

Tasks

a. The contractor shall conduct Manuscript Review/Protocol Development at the contractor’s facility and shall not exceed 208 hours per year (approximately four hours per week). The contractor shall review draft manuscripts related to Predictive Toxicology;

provide recommendations for revisions to manuscript to prepare for publication following the standard practices in the scientific community for conducting manuscript writing; and assist in the development of research protocols to further the research. The Director of DBB shall have the ultimate decision on all revisions to manuscripts and protocols before final submission to NCTR for approval.

b. The contractor shall visit NCTR one time per year with each visit being for a period of at least 5 business days. The purpose of the visit is to train DBB Junior scientists and to assist the DBB in the writing of manuscripts and research protocols related to Predictive Toxicology. Visits shall include seminars and/or training sessions for groups and individuals within DBB to communicate the latest developments in the field of Predictive Toxicology. The contractor shall perform needed literature assessment, etc., therefore, shall furnish equipment needed to access these resources (i.e. personal laptop). NCTR shall provide access to guest Wi-Fi and projection equipment if needed for presentations.

If unable to visit NCTR due to travel restrictions related to the COVID-19 pandemic contractor shall perform above requirements via virtual platform (video conference).

NOTE: The contractor shall review, one at a minimum but no more than four manuscripts and/or protocols during the contract performance period.

c. Contractor shall participate in one or two video and/or teleconference meetings per month (meetings approximately 1 hour each)

Deliverables The Contractor shall provide all required deliverables in accordance with the following schedule:

Item Deliverable Description Due Date 1 Manuscript

Review/Protocol Development

Review draft manuscripts related to Predictive Toxicology to provide recommendations for revisions to prepare manuscript for publication following the standard practice in the scientific community for conducting manuscript writing and assist in the development of research protocols to further the research. (The Director of DBB shall have the ultimate decision on all revisions to manuscripts and protocols before final submission to NCTR for approval.)

Annually – not to exceed 4 hours per week

2 Visit NCTR one time per year (at least 5 business days)

Visit shall include seminars and/or training sessions for groups and individuals within DBB to communicate the latest developments in the field of Predictive Toxicology. Assist the DBB in the writing of manuscripts and research protocols related to Predictive Toxicology.

Annually

3 Attend meetings Participate in video and/or teleconference meetings

Once or twice per month (approx. one hour each)

4 Quarterly Reports Status reports to include summary of work completed

No less than Quarterly

5 Final Report May be requested by the FDA and shall be a summary of all work completed during each performance period year

At the Government’s request, submitted yearly, not later than 10 days following the end of the period of performance.

All deliverables shall be developed using Microsoft Office products that are compatible with the versions currently utilized by the FDA (i.e., MS 2016) and are 508 compliant. Reports shall be provided by e-mail from the Contractor.

The Contractor shall deliver all products to the TPOC/COR. The COR or other technical staff will notify the Contractor of deliverable acceptance regarding overall compliance with the guideline’s requirements of the task. The Quarterly report shall also be submitted to the Contract

Specialist/Contracting Officer.

The Contractor shall ensure the accuracy and completeness of all deliverables in accordance with referenced policy, regulations, laws, and directives. Reports and presentations shall be concise and clearly written; errors, misleading or unclear statements, incomplete or irrelevant information, and/or excessive rhetoric, repetition, or excessive length if a page limit is imposed, shall be considered deficiencies and will be subject to correction by the contractor at no additional cost to the Government. Unless specified otherwise, the TPOC/COR will review and approve all deliverables.

Unless specified otherwise, the Contractor shall provide a copy of each deliverable listed in DELIVERABLES section to the TPOC/COR for review. The Government will review the deliverable and suggest any changes. If changes are required, unless specified otherwise, the Contractor shall resubmit the revised deliverable to the TPOC/COR five (5) business days after receiving the Government’s input, unless otherwise agreed to in advance.

Deliverable products shall be reviewed, validated, and tested as appropriate to ensure that they meet applicable/specified standards, policy, business requirements, and quality measures. In the event of the rejection of any deliverable, the Contractor shall be notified in writing by the TPOC/Contracting Officer’s Representative (COR), giving the specific reason(s) for rejection. The Contractor shall have ten (10) business days to respond to the rejected deliverable and return it to the COR.

Section 508:

• Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

Minimum Position Requirements and Qualifications

a. Shall have in-depth knowledge of current issues in the field of Predictive Toxicology

b. Shall have presented at one or more international conferences on the subject of Predictive Toxicology

c. Shall have extensive experience in instructing research professionals

d. Shall have extensive experience in technical writing and editing

e. Shall have experience in supervising graduate students and postdoctoral fellows

f. Shall have verifiable records of publications in cited scientific journals and publications

g. Shall have experience within the pharmaceutical industry, specifically related to drug safety and drug development.

h. Shall have Ph.D. and at least 10 years’ experience in the field of Predictive Toxicology http://508.hhs.gov/ https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html

Government-Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or GFI) During site visits the contractor shall perform needed literature assessment, etc., therefore, the contractor shall furnish equipment needed to access these resources (i.e. personal laptop). NCTR will provide access to guest Wi-Fi and projection equipment if needed for presentations.

Security and Privacy The Contractor shall be responsible for determining that the individuals provided to perform under this contract will not have an adverse effect on the efficiency, effectiveness, and integrity of the FDA, and will uphold the scope of work.

Due to the possible sensitive nature of the information discussed, contractor personnel shall be required to sign a Commitment to Protect Non-Public Information form 3398, which will be included as an attachment to any resultant contract.

The Contractor must assure the protection of the information and data it receives in performance of this contract from unauthorized use or disclosure and must avoid actions that would cause a reasonable person to question the impartiality of the Contractor, its employees, or the Government in the performance of this immediate contract and potential participation in future actions. The data provided shall not be used or disclosed outside of this contract without prior approval from the Technical Point of Contact (TPOC).

6. Schedule of Supplies or Services and Prices/Costs, Contract Line Items (CLINs) Line Item 1 – Base Year: Technical Expert, Predictive Toxicology as per the specifications included herein. (Price shall be an all-inclusive price which includes travel and other essentials the contractor will require to perform the work)

QTY: 12 months

Price: $ _____________________

Line Item 2 – Option Year 1: Technical Expert, Predictive Toxicology as per the specifications included above.

QTY: 12 months

Price: $ _____________________

Line Item 3 – Option Year 2: Technical Expert, Predictive Toxicology as per the specifications included above.

QTY: 12 months

Price: $ _____________________

Line Item 4 – Option Year 3: Technical Expert, Predictive Toxicology as per the specifications included above.

QTY: 12 months

Price: $ _____________________

Line Item 5 – Option Year 4: Technical Expert, Predictive Toxicology as per the specifications included above.

QTY: 12 months

Price: $ _____________________

Total Price (Base + 4 Option Years): $ _____________________

GSA Contract Number: __________________ (if applicable)

7. Deliveries, Acceptance, and Performance

Period(s) of Performance. Base plus four (4) Option Years with anticipated period of performance dates estimated as:

Base Year: 08/13/2021 – 08/12/2022 Option Year 1: 08/13/2022 – 08/12/2023 Option Year 2: 08/13/2023 – 08/12/2024 Option Year 3: 08/13/2024 – 08/12/2025 Option Year 4: 08/13/2025 – 08/12/2026

Acceptance

The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the Technical Point of Contact (TPOC) specified at award. If the supplies or services are acceptable, the TPOC shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the TPOC shall document the nonconforming items/services and immediately notify the contracting officer.

Place of Performance

Work shall be performed at the at the contractor’s place of business; however, the contractor shall be required to travel to NCTR to meet with junior staff and the Project Officer/TPOC/COR to review materials and conduct training at:

US FDA National Center for Toxicological Research (NCTR) 3900 NCTR Rd.

Jefferson AR 72079

Payments

Payments will not be made more frequently than monthly in arrears. Advance payments will not be made.

8. Instructions to Offerors

The provision at FAR 52.212-1 Instructions to Offerors - Commercial Items (June 2020) applies to this solicitation. The following addenda apply:

It is the offeror's responsibility to monitor the Government Point of Entry (GPE) (beta.sam) for information relevant to this solicitation, e.g., questions and answers, amendments, etc. An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to complete the required representations and certifications or reject the terms and conditions of the solicitation may be excluded from consideration.

Paragraph (b)(4). Technical Approach/Capability: Offeror must provide sufficient information for the Government to conclusively determine that the offered service meets or exceeds the requirements identified herein. The proposal shall demonstrate that the offeror provides a sound, compliant approach to performing the work described in the Scope of Work, including describing the Offeror’s understanding of the tasks and how the Offeror intends to satisfy the scientific and technical requirements.

Offer shall provide qualifications of proposed Key Personnel and demonstrate that the proposed Key Personnel have the requisite experience and qualifications to meet the requirements outlined herein. Offeror shall provide evidence of related education, knowledge and experience for proposed key personnel in the activities in the statement of work, to include a resumè and/or Curriculum Vitae and letter of commitment from potential candidate.

NOTE: This solicitation is issued under the premise that the offeror’s Key Personnel fulfilling the role of Predictive Toxicologist is exempt from the Service Contract Act as they are considered a Professional employee per (29 CFR 541).

Per FAR 22.1102, a Professional employee, means any person meeting the definition of "employee employed in a bona fide . . . professional capacity" given in (29 CFR 541). The term embraces members of those professions having a recognized status based upon acquiring professional knowledge through prolonged study. Examples of these professions include accountancy, actuarial computation, architecture, dentistry, engineering, law, medicine, nursing, pharmacy, the sciences (such as biology, chemistry, and physics, and teaching). To be a professional employee, a person must not only be a professional but must be involved essentially in discharging professional duties.

The contractor shall check the following certification:

CERTIFICATION

The offeror ☐ does ☐ does not certify that- The employee is considered a “professional employee” as per the definition above and: (1) is compensated on a salary or fee basis at a rate of not less than $455 per week (or $380 per week, if employed in American Samoa by employers other than the Federal Government), exclusive of board, lodging, or other facilities; and (2) Whose primary duty is the performance of work: (i) Requiring knowledge of an advanced type in a field of science or learning customarily acquired by a prolonged course of specialized intellectual instruction; or (ii) Requiring invention, imagination, originality or talent in a recognized field of artistic or creative endeavor. (29 CFR 541)

In the event that a Contractor does not make this certification, the traditional Service Contract Act clause 52.222-41 shall be included in the resulting order award as well as the applicable Wage Determination No. will be inserted (see FAR Clause 52.222-49).

Past Performance: Provide the below information for contracts ongoing or completed during the last three (3) years (“recent”), that are the same or similar in nature to this solicitation (“relevant”).

Contracts may include those entered into with the federal Government, agencies of state and local government, and commercial customers. Include the following information for each reference:

• Description of service

• Period of Performance

• Location

• Total Contract Value

• Prime or Subcontractor (provide name of Prime if subcontractor)

• Names of the personnel who performed the Predictive Toxicology work and identify whether they were an employee, consultant, etc.

• Total amount and percentage of work performed by the contractor (or subcontractor if so indicated above)

• Name of Contracting Agency/Organization

• Contracting Officer/Client’s name and verified telephone number and email address

• Contract number

• Project Officer’s name and verified telephone number and email address

• Identify other Predictive Toxicology work that may have been performed during the same period

Price: Offeror shall complete the pricing table provided in Section 6. Schedule of Supplies or Services/Costs, Contract Line Items (CLINs) above. The Government intends to make an award based on the initial quotations. If further questions are required, the Contracting Officer may contact the offeror. Include the firm’s DUNS number with quote.

The price proposed shall represent the offeror’s response to the schedule of supplies/services above.

The government is not responsible for locating or securing any information which is not identified in the proposal; however, the Government reserves the right to obtain information for use in the evaluation from all sources including sources outside of the Government.

Proprietary and/or confidential information shall be clearly marked.

Microsoft Suite Documents Containing Macros The offeror or applicant shall submit all electronic documents created by Microsoft Office suite products without the use of “macros”. If the offeror or applicant submits documents that contain macros the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offeror’s or applicant’s responsibility to ensure that all electronic documents submitted do not contain or otherwise use macros.

9. Evaluation Criteria The provision at 52.212-2 Evaluation-Commercial Items (OCT 2014) is applicable to this solicitation. The provision is tailored to include evaluation factors.

The Government intends to award a contract with a Base Year and four (4) potential one (1) year Option Periods resulting from this solicitation to the responsible Offeror whose offer is the most advantageous to the Government, price and other factors considered. The Government will make award to the Offeror whose proposal represents the best value to the Government as determined by using tradeoffs among the technical, past performance, and cost or price evaluation factors.

Offerors are placed on notice that any proposals which are not minimally responsive to all the technical factors cited herein will be deemed reflective of an inherent lack of technical competence and may be grounds for the rejection of the proposal(s). Offerors shall ensure that any relevant prior experience to be considered is documented within the proposal. The following factors shall be used to evaluate offers:

• Technical Approach/ Capability

• Recent and Relevant Past Performance

• Price

Technical and recent and relevant past performance are relatively equal, but when combined are significantly more important than price when determining the best overall value to the Government, though price remains an important factor.

Offerors are advised that the Government intends to evaluate proposals and make award without discussions.

Technical Approach/Capability

In evaluating the Offeror’s proposal, the Government shall be able to gain a level of confidence in the Offeror’s understanding of the work requirements as set forth in the SOW and the likelihood that the Offeror’s methods, procedures and approach to performing the work presents a scientifically sound, detailed approach that will lead to successful contract performance. The government will further determine whether the proposed (Key) personnel have the appropriate credentials, licenses/certifications/qualifications, experience, technical skillsets and otherwise have the demonstrated ability to successfully perform the work required under this contract.

Past Performance

The Government will consider the recency and relevancy of the information provided, source of the information, context of the data, and general trends in the offerors performance in order to determine the likelihood of success in performing the requirements of the solicitation. The Government may rely upon data from sources other than the references submitted by the Offeror, such as CPARS.

The lack of a past performance record may result in an unknown performance risk assessment, which will neither be used to the advantage or disadvantage of the Offeror however when conducting a trade-off decision positive past performance is considered higher than unknown/ neutral past performance.

Price

(a) The Price proposed must be detailed and represent the offeror’s response to the schedule of items. Price will be evaluated for fairness and reasonability in terms of reasonable and realistic pricing – that the proposed prices are calculated based on reasonable and realistic assumptions.

Offerors are cautioned that an unrealistically low price or unbalanced pricing of Line Items or Option years, as proposed initially or subsequently, may be grounds for eliminating a proposal from further consideration, either on the basis that the offeror does not understand the requirement or has made an imprudent offer.

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

(c) A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

The Government reserves the right to request additional information at any time. Once the Government determines the quoter that is the best-suited (i.e., the apparent successful quoter), the Government reserves the right to communicate with only that quoter to address any remaining issues, if necessary, and finalize a contract with that quoter. These issues may include technical and price.

10. The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (February 2021)(DEVIATION 2020-05), applies to this acquisition.

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

(a) Definitions. As used in this provision— "Covered telecommunications equipment or services" has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

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.

https://www.sam.gov/ https://www.acquisition.gov/far/part-52#FAR_52_204_25

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

Immediate owner means an entity, other than the offeror, that has direct control of the offeror.

Indicators of control include, but are not limited to, one or more of the following: ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

Inverted domestic corporation, means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

Place of manufacture means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.

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

Reasonable inquiry has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

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"— Sensitive technology— http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title6-section395&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title6-section395&num=0&edition=prelim https://www.acquisition.gov/far/part-52#FAR_52_204_25

(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—

(1) 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.

(2) Affiliates, as used in this definition, means business concerns, one of whom directly or indirectly controls or has the power to control the others, or a third party or parties control or have the power to control the others. In determining whether affiliation exists, consideration is given to all appropriate factors including common ownership, common management, and contractual relationships. SBA determines affiliation based on the factors set forth at 13 CFR 121.103.

Small disadvantaged business concern, consistent with13 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 at13 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 CFR124.104(c)(2); and

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

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

(1) Directly by a parent corporation; or

(2) Through another subsidiary of a parent corporation Successor means an entity that has replaced a predecessor by acquiring the assets and carrying out the affairs of the predecessor under a new name (often through acquisition or merger). The term "successor" does not include new offices/divisions of the same company or a company that only changes its name. The extent of the responsibility of the successor for the liabilities of the predecessor may vary, depending on State law and specific circumstances.

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

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

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

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

http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section101&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section101&num=0&edition=prelim

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.

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 least51 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.

(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 in SAM

(2) The offeror has completed the annual representations and certifications electronically in SAM accessed through http://www.sam.gov. After reviewing SAM information, the Offeror verifies by submission of this offer that the representations and certifications currently posted electronically at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items, have been entered or updated in the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard(s) applicable to the NAICS code(s) referenced for this solicitation), at the time this offer is submitted and are incorporated in this offer by reference (see FAR 4.1201), except for paragraphs ______________.

[Offeror to identify the applicable paragraphs at (c) through (v) 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 will be performed in the United States or its outlying areas. Check all that apply.

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

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

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

(4) Small disadvantaged business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, that it [ ] is, [ ] is not a small disadvantaged business concern as defined in 13 CFR124.1002.

(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.

(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, [ ] s 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 http://www.sam.gov/ https://www.acquisition.gov/far/part-52#FAR_52_212_3 https://www.acquisition.gov/far/part-4#FAR_4_1201 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.

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

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

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

(10) HUBZone small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents, as part of its offer, that–

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

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

(d) Representations required to implement provisions of Executive Order11246-

(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 http://uscode.house.gov/ 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.)

(i) The Offeror certifies that each end product, except those listed in paragraph (f)(2) of this provision, is a domestic end product.

(ii) The Offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products.

(iii) The terms "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."

http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_225_1 https://www.acquisition.gov/far/part-25#FAR_Part_25 https://www.acquisition.gov/far/part-52#FAR_52_225_3

(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) of this provision) as defined in the clause of this solicitation entitled "Buy American-Free Trade Agreements-Israeli Trade Act." The Offeror shall list as other foreign end products those end products manufactured in the United States that do not qualify as domestic end products.

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 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 orIsraeli end products as defined in the clause of this solicitation entitled "Buy American-Free Trade Agreements-Israeli Trade Act":

Canadian or Israeli End Products:

Line Item No. Country of Origin

[List as necessary] (4 [3]) 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 Act":

Free Trade Agreement Country End Products (Other than…