36C25024Q0630 0004.docx

SUBJECT*

Compound Sterile Training VHA VISN 10

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 10 8888 Keystone Crossing Suite 325 Indianapolis IN 46240

POINT OF CONTACT*

Contract Specialist Teri Miller teri.miller@va.gov

All questions shall be emailed to POC above.

PLACE OF PERFORMANCE

VHA VISN 10

Pharmacy

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

THE PURPOSE OF THIS SOLICIATION AMENDMENT IS TO EXTEND THE SUBMISSION DUE DATE, UPDATE THE STATEMENT OF WORK, AND AMEND THE “QUOTE PREPARATION INSTRUCTIONS”, SPECIFICALLY, THE TECHNICAL EVALUATION FACTORS.

All offerors shall submit all items requested in the Quote Preparation Instructions, failure to supply all requested information will result in your quote being immediately excluded for award. All offerors who have previously provided a quote shall have the opportunity to re-send an updated quote that satisfies all of the required items. Vendors shall re-submit the entire quote package including All Administrative, Technical, Pricing, and Past Performance items. Any vendor who does not provide an updated quote package by the solicitation deadline will be evaluated based upon their previous submission. Any vendor who does or does not submit a new quote package shall provide acknowledgement of this and any future amendments before the solicitation deadline in order to be considered eligible for award.

The question and answer period is hereby re-opened and will end at 1:30 PM EST on 6/28/2024. Questions received after this deadline may not be answered.

The submission due date is hereby changed to 1:30 PM EST on July 5, 2024. All responses shall be emailed to teri.miller@va.gov.

Amendment to a Previous Combined Solicitation

Amendment to a Previous Combined Solicitation

Page 1 of

Amendment to a Previous Combined Solicitation

A.1 PRICE/COST SCHEDULE

The guaranteed minimum only applies to the Federal Government Fiscal Year in which the contract is awarded. The guaranteed minimum of this contract is $10,000.00. The guaranteed amount shall be expended in the initial fiscal year in which this contract is awarded. The maximum total value of the contract, inclusive of the base year and all options exercised, shall not exceed $190,000.00. Individual task orders shall be funded annually.

The Contracting Officer is the only authorized individual that can place annual task orders against this contract for the estimated amount of services for the specific timeframe, and the task orders shall be issued to the contractor.

Task order minimums and maximums are addressed in clause FAR 52.216-19.

The items listed below are estimated quantities: CLINS/SLINS 0001, 1001, & 2001.

Vendor shall invoice upon registration and scheduling of the training session(s), for ONLY actual services rendered. DO NOT perform other than those identified, unless the ACO has issued a modification to the contract to add a CLIN for that specific action.

Contractor shall invoice for actual performance and shall indicate CLINs/SLINS Numbers on all Tungsten Network invoices.

ITEM INFORMATION

VISN 10 Pharmacy Compounded Sterile Training Per the PWS, Section II, Contract Requirements Estimated Quantities - Priced per attendee (minimum 11, average 25, maximum 36) for Virtual Training Contract Period: Base POP Begin: 07-29-2024 POP End: 07-28-2025 PRINCIPAL NAICS CODE: 611430 - Professional and Management Development Training PRODUCT/SERVICE CODE: U009 - Education/Training - General

VISN 10 Pharmacy Compounded Sterile Training

Estimated Quantities - Priced per attendee (minimum 11, average 25, maximum 36) for Virtual Training Contract Period: Option 1 POP Begin: 07-29-2025 POP End: 07-28-2026

VISN 10 Pharmacy Compounded Sterile Training

Estimated Quantities - Priced per attendee (minimum 11, average 25, maximum 36) for Virtual Training Contract Period: Option 2 POP Begin: 07-29-2026 POP End: 07-28-2027

STATEMENT OF WORK

VA Healthcare System (VISN 10) Compounded Sterile Preparations Training for Program Managers Statement of Work (SOW)

I. BACKGROUND

The United States Pharmacopeia (USP) general chapters establish procedures, methods, and practices to help ensure the quality of compounded preparations. Several regulatory agencies, such as The Joint Commission, United States Food and Drug Administration (FDA), Office of Inspector General (OIG), and state boards, review practices based on these procedures. VHA Directive 1108.12, Management and Monitoring of Pharmaceutical Compounded Sterile Preparations (dated February 14, 2024) states that it is VHA policy that each VA medical facility that provides compounded sterile preparations (CSP) have a pharmaceutical program in place that conforms to the standards in USP Chapter <797> “Pharmaceutical Compounding Sterile Compounding” and USP <800> “Hazardous Drugs – Handling in Healthcare Settings”. This VHA Directive also states that responsible individuals will receive appropriate education and training necessary to carry out the full range of their responsibilities.

Site visits, gap analyses, and facility self-reporting have revealed that while facilities continue to move forward with compliance, the overall complexity of the requirements support the need for continued training. The 2022/23 version of the USP <795> and <797> standards become effective in November 2023. USP <800> has been applicable to VHA practice since 2019. While the VHA Pharmacy Benefits Management (PBM) have developed tools to assist facilities with implementing the new standards, training is needed for the designated employees responsible for compliance with these requirements and also to prevent adverse patient outcomes due to contaminations.

The VISN 10 Pharmacy program would like to award a 3-year contract that includes 10-15 hours of live training, either virtually or at a site within the VISN catchment area (to be determined), during each year of the contract. The training during the base year should be scheduled prior to the end of the fiscal year (September 2024). The topics, to be selected by the VISN, would be provided to the vendor, along with the two potential dates.

*** NOTE: The Government reserves the right to add, increase, or decrease the number of training sessions and/or quantities to allow for fluctuations of client demand that are otherwise unknown at time of solicitation. The total contract value may increase up to 20% of the base award.

II. CONTRACT REQUIREMENTS: The vendor shall provide a comprehensive training program that include the following aspects.

· Training shall be conducted live virtually. It will be via TEAMS, WebEx, or other mutually agreed upon and VA approved medium.

· Training event will contain no less than 10 hours and no more than 15 hours of training material relative to those in leadership/program management positions.

· Training will be open to VA employees selected by the VISN, a minimum of 11 per year and a maximum of 36 per year.

· Additionally, 2 to 3 attendees may attend for oversight purposes at no cost. These attendees will not receive credits or a completion certificate.

· Training shall be recorded for employees that attend for their future reference and review. Additional employees may review the training material but will not receive a completion certificate or ACPE credit.

· The trainers will possess an extensive background in the course topics and serve as subject matter experts in USP regulations.

· The trainers will be able to confidently answer questions regarding the interpretation of USP, specifically 795, 797 and 800, and the practical application.

· The training is to include pre-work requirements to prepare attendees for the rigorous training agenda.

· ACPE (Accreditation Council for Pharmacy Education or ACPE) credit shall be issued to attendees for both the pre-work and training time as well as a completion certificate.

· Cost shall be all-inclusive of training materials and trainer time.

· All learning objectives outlined shall be addressed.

Course Outline and Learning Objectives:

Overview

· Cover USP Chapters <795>, <797>, and <800>.

· Define the USP requirements for a Designated Person who will be responsible for USP chapter compliance.

· Define a Quality Control Program (like an Environmental Sampling Plan) USP <797>

· Provide a written description of specific training and performance evaluation program for individuals involved in the use of aseptic techniques for the preparation of sterile products shall be developed for each site.

· Compare the key strategies described by OSHA, NIOSH, ASHP and USP for minimizing the risk of occupational exposure to HDs.

· Recognize best practices (as well as worst practices) of aseptic technique in your workplace.

· Summarize the key elements to review during the consideration of a cleanroom renovation or construction project.

· Discuss key issues, challenges and concerns related to selecting a cleanroom certification company as well as how to read a certification report.

· Review current regulations and best practices concerning all aspects of handling hazardous drugs (HDs) as appropriate for pharmacy staff.

Brutal Facts of Compounding

· Correlate the history of compounding mishaps with the evolution of compounding standards of practice and sterile compounding regulations.

· Discuss the current compounding regulations including continuing ambiguities and controversies.

Primary and Secondary Engineering Controls

· Distinguish between primary and secondary engineering controls in the sterile compounding controlled environments.

· Utilize knowledge about the principles of airflow to compound with proper aseptic technique using first air regardless of the type of primary engineering control.

· Describe the function of HEPA filters in cleanroom environments and the application of airflow principles to create a sterile compounding environment.

· Differentiate ISO Class 5, ISO Class 7 and ISO Class 8 work environments as related to cleanliness and particulate counts.

· Outline the different types of laminar airflow work centers (LAFWs) that may be utilized when preparing CSPs.

· Integrate an understanding of the term “state of control” into the certification report for primary and secondary engineering controls.

· Explain the facility and environmental requirements for compounding sterile preparations for each of the categories outlined in USP <797>.

· Differentiate the engineering controls used in the preparation of non-hazardous versus hazardous compounded sterile preparations.

· Summarize how the primary and secondary engineering controls work together to contribute to the overall sterile compounding facility state of control.

Engineering Control Certification Lecture and Demonstration

· Integrate an understanding of the term “state of control” into the certification report for primary and secondary engineering controls.

· Identify and differentiate between the various tests performed during certification of primary and secondary engineering controls (HEPA filter leak test; particle counts, room segregation, airflow velocity and smoke pattern testing).

· Recognize the minimum engineering control requirements for sterile compounding controlled environments and how they contribute to attaining a state of control.

· Address the documentation required to ensure PEC/SEC are performing as expected between certifications (i.e., pressure differentials, temperature, humidity, CAI pressure, etc.).

· Discuss CETA requirements.

Contamination Control: Hand Hygiene and Garbing, Material Handling and Conduct in Cleanrooms

· Discuss contamination control as a critical control point to maintaining a state of control.

· Properly sequence the activities of hand hygiene and garbing for sterile nonhazardous compounding

· Identify cleaning and material handling requirements outlined in USP <797>.

· Integrate best practice material handling work practices into your own facility SOPs.

· Analyze and discuss the rational for best practice conduct within controlled environments and how poor or inconsistent practice can negatively impact the state of microbial control.

Sanitization of Sterile Compounding Controlled Environments

· Discuss principles related to the selection, preparation and use of cleaning agents and supplies.

· Sequence properly critical activities of daily and monthly cleaning.

· List personnel safety, training and competency considerations such as PAPR or elastomeric respirator considerations for use with cleaning agents.

· Describe policy, procedure and documentation requirements.

Environmental and Personnel Sampling

· Explain the importance of Environmental Sampling.

· Discuss basic principles of microbiology as they relate to environmental monitoring.

· Discuss the minimum required elements and best practices related to environmental and personnel sampling.

· Outline a model ongoing environmental monitoring program, including the identification of baseline and action limits of microbial growth detected during environmental monitoring processes.

· Explain the adjustments to the most probable number that may be needed to the actual observed colony counts.

· Develop a robust plan of response to upward trending ES findings as well as an Action Plan in the event of microbial excursions beyond established Action Levels.

Aseptic Media Fill, Process Verification and the Development of an Aseptic Media Fill Procedure

· Summarize the importance of personnel and process media fill testing as verification of the aseptic technique skills of staff and compounding process.

· Define the design requirements of a personnel aseptic media fill as well as media process verification.

· Describe documentation of operator and process media fill tests as well as required actions in the event that growth is detected.

· Compare the various types of media available for media-fill test development.

· Recognize if media-fill tests are designed to reflect compounding under a pharmacy’s most challenging conditions.

Sterile to Sterile Compounding: Assigning BUDs and Quality Release Testing

· List the BUDs for two categories for compounding CSPS from sterile components as well as their storage conditions.

· Discuss two factors that determine the beyond-use date (BUD).

· Differentiate the maximum BUDs for single-dose and multiple-dose containers as well as pharmacy bulk packaging.

· Describe quality release testing for category 1 and category 2 compounding.

· Differentiate BUDs versus expiration dates.

· Describe scenarios in which administration may be impacted by BUD.

Hazardous Drug Overview and Review of USP Chapter <800>

· Cite examples of the effects of exposure to HDs on healthcare staff that handle HDs described in the literature.

· Describe the location of resources with regard to HD practice.

· Define hazardous drugs.

· Recite the major best practice, guidelines, standards and regulatory events related to HD compounding.

· Describe the major elements of USP 800.

· Differentiate the standards that are proposed in USP 800 from those in USP 797 and 795.

· Restate the harmonization that is predicted to occur between relevant USP Chapters.

Use of PPE with Hazardous Drug Handling

· Discuss shortcomings in current practice.

· List the steps to perform donning and doffing of HD PPE correctly.

· Evaluate donning and doffing practice at your facility.

· Modify practices at your facility based on best practice garbing to reduce HD contamination.

Primary, Secondary, and Supplemental Engineering Control Requirements

· Describe the types compliant HD primary and secondary engineering controls for both sterile and non-sterile compounding.

· Discuss considerations relevant to the use of pass-throughs in HD applications.

· Analyze the allowable but suboptimal designs of HD secondary engineering controls.

· List strategies to compensate for suboptimal designs.

· List the required testing performed during certification of primary and secondary engineering controls

Work Practice Strategies for Receiving, Compounding and Transporting HDs

· List the activities necessary when accepting new inventory and transport of that inventory to intermediate storage.

· Describe the known exposure risks with HD inventory.

· Explain proper storage of HD inventory.

· List the practice elements essential to reduction of HD contamination generation from material handling through compounding, labeling, and transport to patients.

· Implement effective decontamination of the final CSPs.

· Evaluate safe transport procedures for HD inventory and final CSPs.

Environmental and Medical Surveillance Considerations

· Describe the recommended environmental and medical surveillance best practices.

· Formulate a plan for initial and ongoing environmental HD surveillance for your organization.

· Evaluate the medical surveillance considerations presented.

· Analyze which elements of medical surveillance can be implemented at your organization.

Decontamination, Cleaning, and Disinfection of HD Compounding Environments

· Define and differentiate the terms deactivation, decontamination, cleaning and disinfection.

· List the classes of agents used for cleaning, decontamination and disinfection.

· Properly sequence and perform decontamination, cleaning and disinfection in HD environments.

· Evaluate your facility’s current practices for decontamination, cleaning and disinfection.

· Modify your facilities procedures with regard to decontamination and cleaning of HD compounding environments.

· Discuss the logistics of spill cleanup as it applies to decontamination, cleaning and disinfection.

Response to HD Exposure and Spills

· List the required elements of an exposure control and response plan and evaluate your organization’s plan for compliance.

· Discuss the requirements for HD Spill clean-up.

· Describe the logistical and practical hurdles that can be encountered in implementing an effective spill management program.

· Contrast the contents of a “generic” spill kit with other equipment and supplies that may be necessary for an ancillary spill kit.

· List potential strategies for effective Spill Management.

Integrating Technology into Sterile Compounding Workflow

· Discus benefits of sterile compounding workflow management systems.

· Identify potential point of contamination or break in aseptic technique when using sterile compounding workflow management system.

Overview of 795

· Learn the history that led to current regulatory framework for nonsterile compounding.

· Describe USP <795> standards that apply to compounding spaces, equipment, and components.

· Review quality assurance and control program requirements that support consistent, high-quality compounding of nonsterile products.

· Identify requirements for personnel qualification, including training, evaluation, and requalification.

· Using USP <795> guidance, apply beyond-use dates to various types of compounded nonsterile products.

Period of Performance:

Base Year: - 7/29/2024 – 7/28/25 Option Period 1 - 7/29/2025 – 7/28/26 Option Period 2 - 7/29/2026 – 7/28/27

The full text of FAR and VAAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

The following solicitation provisions apply to this acquisition:

FAR 52.212-1, “Instructions to Offerors–Commercial Products and Commercial Services”

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021) Provisions that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The version of FAR 52.212-1 in the addendum is tailored for Simplified Acquisition Procedures and supersedes the current version of FAR 52.212-1 contained in the FAR.

The following provision is incorporated into 52.212-1 as an addendum to this solicitation:

FAR 52.252-1, “SOLICITATION PROVISIONS INCORPORATED BY REFERENCE” (FEB 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Provision)

· 52.204-7 “System for Award Management” (OCT 2018)

· 52.204-16 “Commercial and Government Entity Code Reporting” (AUG 2020)

FAR 52.216-1 TYPE OF CONTRACT (APR 1984)

The Government contemplates award of an Indefinite Delivery Indefinite Quantity (IDIQ) contract resulting from this solicitation.

(End of provision)

FAR 52.216-27 SINGLE OR MULTIPLE AWARDS (OCT 1995)

The Government may elect to award a single delivery order contract or task order contract or to award multiple delivery order contracts or task order contracts for the same or similar supplies or services to two or more sources under this solicitation.

(End of provision)

VAAR 852.273-70 LATE OFFERS (NOV 2021)

This provision replaces paragraph (f) of FAR provision 52.212–1, Instructions to Offerors—Commercial Items. Offers or modifications of offers received after the time set forth in a request for quotations or request for proposals may be considered, at the discretion of the Contracting Officer, if determined to be in the best interest of the Government. Late bids submitted in response to an invitation for bid (IFB) will not be considered.

(End of Provision)

(End of Addendum 52.212-1)

Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, “Offerors Representations and Certifications–Commercial Products and Commercial Services.” If paragraph (j) of the provision is applicable, a written submission is required.

FAR 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023) 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 127, and the concern is identified by SBA or an approved third-party certifier in accordance with 13 CFR 127.300. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

Forced or indentured child labor means all work or service—

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

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

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

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

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

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

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

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

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

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

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

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

(8) PSC 9610, Ores;

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

(10) PSC 9630, Additive Metal Materials.

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

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

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—

(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 its field of operation, 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 with 13 CFR 124.1001, 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 the threshold at 13 CFR 124.104(c)(2) 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.

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.

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 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, and the concern is certified by SBA or an approved third-party certifier in accordance with 13 CFR 127.300.

(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 Products and Commercial Services, 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 .

(c) Offerors must complete the following representations when the resulting contract is for supplies to be delivered or services to be performed in the United States or its outlying areas, or when the contracting officer has applied part 19 in accordance with 19.000(b)(1)(ii). Check all that apply.

(1) Small business concern. The offeror represents as part of its offer that—

(i) It [ ] is, [ ] is not a small business concern; or

(ii) It [ ] is, [ ] is not a small business joint venture that complies with the requirements of 13 CFR 121.103(h) and 13 CFR 125.8(a) and (b). [The offeror shall enter the name and unique entity identifier of each party to the joint venture: __________________.]

(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—

(i) It [ ] is, [ ] is not a service-disabled veteran-owned small business concern; or

(ii) It [ ] is, [ ] is not a joint venture that complies with the requirements of 13 CFR 125.18(b)(1) and (2). [The offeror shall enter the name and unique entity identifier of each party to the joint venture: __________________.] Each service-disabled veteran-owned small business concern participating in the joint venture shall provide representation of its service-disabled veteran-owned small business concern status.

(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.

(6) WOSB join venture 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 it [ ] is, [ ] is not a joint venture that complies with the requirements of 13 CFR 127.506(a) through (c). [The offeror shall enter the name and unique entity identifier of each party to the joint venture: __________________.]

(7) Economically disadvantaged women-owned small business (EDWOSB) joint venture. The offeror represents that it [ ] is, [ ] is not a joint venture that complies with the requirements of 13 CFR part 127.506(a) through (c). [The offeror shall enter the name and unique entity identifier of each party to the joint venture: __________________.] Note to Paragraphs (c)(8) and (9): Complete paragraphs (c)(8) and (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, as having been certified by SBA as a HUBZone small business concern in the Dynamic Small Business Search and SAM, and will attempt to maintain an employment rate of HUBZone residents of 35 percent of its employees during performance of a HUBZone contract (see 13 CFR 126.200(e)(1)); and

(ii) It [ ] is, [ ] is not a HUBZone joint venture that complies with the requirements of 13 CFR Part 126.616(a) through (c). [The offeror shall enter the name and unique entity identifier of each party to the joint venture: __________________.] Each HUBZone small business concern participating in the HUBZone joint venture shall provide representation of its HUBZone status.

(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)(i) The Offeror certifies that each end product, except those listed in paragraph (f)(2) of this provision, is a domestic end product and that each domestic end product listed in paragraph (f)(3) of this provision contains a critical component.

(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. For those foreign end products that do not consist wholly or predominantly of iron or steel or a combination of both, the Offeror shall also indicate whether these foreign end products exceed 55 percent domestic content, except for those that are COTS items. If the percentage of the domestic content is unknown, select ‘‘no’’.

(iii) The Offeror shall separately list the line item numbers of domestic end products that contain a critical component (see FAR 25.105).

(iv) The terms ‘‘commercially available off-the-shelf (COTS) item,’’ ‘‘critical component,’’ ‘‘domestic end product,’’ ‘‘end product,’’ ‘‘foreign end product,’’ and ‘‘United States’’ are defined in the clause of this solicitation entitled ‘‘Buy American—Supplies.’’

(2) Foreign End Products:

[List as necessary]

(3) Domestic end products containing a critical component: Line Item No. ___________ [List as necessary]

(4) 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)(A) The Offeror certifies that each end product, except those listed in paragraph (g)(1)(ii) or (iii) of this provision, is a domestic end product and that each domestic end product listed in paragraph (g)(1)(iv) of this provision contains a critical component.

(B) The terms ‘‘Bahraini, Moroccan, Omani, Panamanian, or Peruvian end product,’’ ‘‘commercially available off-the-shelf (COTS) item,’’ ‘‘critical 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 Bahraini, 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 Bahraini, Moroccan, Omani, Panamanian, or Peruvian End Products) or Israeli End Products:

(iii) The Offeror shall list those supplies that are foreign end products (other than those listed in paragraph (g)(1)(ii) 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. For those foreign end products that do not consist wholly or predominantly of iron or steel or a combination of both, the Offeror shall also indicate whether these foreign end products exceed 55 percent domestic content, except for those that are COTS items. If the percentage of the domestic content is unknown, select ‘‘no’’.

Other Foreign End Products:

(iv) The Offeror shall list the line item numbers of domestic end products that contain a critical component (see FAR 25.105). Line Item No. ___________ [List as necessary]

(v) 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 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 Israeli end products as defined in the clause of this solicitation entitled “Buy American—Free Trade Agreements—Israeli Trade Act”:

Israeli End Products:

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

(g)(1)(ii) The offeror certifies that the following supplies are Free Trade Agreement country end products (other than Bahraini, 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 Bahraini, Korean, Moroccan, Omani, Panamanian, or Peruvian End Products) or Israeli End Products:

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

(i) The offeror certifies that each end product, except those listed in paragraph (g)(4)(ii) of this provision, is a U.S.-made or designated country end product, as defined in the clause of this solicitation entitled “Trade Agreements”.

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

Other End Products:

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

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

(1) [ ] Are, [ ] are not presently debarred, suspended, proposed for debarment, or declared ineligible for the award of contracts by any Federal agency;

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

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

(4) [ ] Have, [ ] have not, within a three-year period preceding this offer, been notified of any delinquent Federal taxes in an amount that exceeds the threshold at 9.104–5(a)(2) for which the liability remains unsatisfied.

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

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

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

(ii) Examples.

(A) The taxpayer has received a statutory notice of deficiency, under I.R.C. Sec. 6212, which entitles the taxpayer to seek Tax Court review of a proposed tax deficiency. This is not a delinquent tax because it is not a final tax liability. Should the taxpayer seek Tax Court review, this will not be a final tax liability until the taxpayer has exercised all judicial appeal rights.

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

(C) The taxpayer has entered into an installment agreement…