No_setaside_RFQ_AG-6395-S-16-0137.pdf

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APHIS-MRPBS-ASD-6395

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USDA APHIS MRPBS

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RFQ

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07/22/2016 1700 CT

06/22/2016

612-336-3205ROBERT ZEGLIN

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FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBER a. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

AG-6395-S-16-0137

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1 34 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

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Minneapolis MN 55403 100 North Sixth Street Butler Square West 5th Floor APHIS MRPBS HRD HR Operations MN

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ITEM NO.

Tax ID Number: Not Available DUNS Number: Not Available Aerobic soil metabolism study in accordance with attached statement of work and bid schedule. This requirement is subject to the service contract act. The applicable wage determination for your businesses principal place of performance is applicable.

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evaluation criteria and synopsis.

Period of Performance: 06/22/2016 to 06/21/2017

001 See bid schedule.

Product/Service Code: Q301

Product/Service Description: MEDICAL- LABORATORY

TESTING

Delivery: 07/22/2017

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34 2 of

Statement of Work

3-chloro-p-toluidine hydrochloride Aerobic Soil Metabolism Study

Prepared by USDA APHIS WS National Wildlife Research Center (NWRC) June 21, 2016

1.0 Introduction

The USDA APHIS maintains six EPA pesticide registrations for the manufacture and use of 3-chloro-p-toluidine hydrochloride (CPTH). The EPA reviews existing pesticide registrations on a schedule of approximately 15 years. CPTH is currently under EPA Registration Review. The review consists of reevaluating existing data and other information to determine if the pesticide is eligible for continued registration. If EPA determines there is not sufficient data to conduct their risk assessment, they may require that the registrant provides additional data to maintain that registration. In the current registration review, EPA has required USDA APHIS to provide the EPA guideline study Aerobic Soil Metabolism:

OPPTS 835.4100 (1). These data are necessary to maintain the EPA’s registration of APHIS’s six CPTH products.

1.1 Definitions:

1.1.1 3-chloro-p-toluidine hydrochloride (CPTH, DRC-1339, Starlicide) – This study will support the EPA registration of the following APHIS pesticide products:

1.1.1.1 EPA Registration Number 56228-10: Compound DRC-1339 Concentrate

Feedlots

1.1.1.2 EPA Registration Number 56228-17: Compound DRC-1339 Concentrate –

Gulls

1.1.1.3 EPA Registration Number 56228-28: Compound DRC-1339 Concentrate –

Pigeons

1.1.1.4 EPA Registration Number 56228-29: Compound DRC-1339 Concentrate –

Livestock, Nest & Fodder Depredations

1.1.1.4 EPA Registration Number 56228-30: Compound DRC-1339 Concentrate –

Staging Areas

1.1.1.5 EPA Registration Number 56228-59: DRC-1339 Technical

1.1.2 U.S. Environmental Protection Agency (EPA) – Federal regulatory agency responsible for the regulation of pesticides including pesticide product registration.

1.1.3 Federal Food, Drug, and Cosmetic Act (FFDCA) – Federal pesticides and food safety regulation legislation (21 U.S.C. 301, et seq.)

1.1.4 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) – Federal pesticide regulation legislation (7 U.S.C.136, et seq.)

1.1.5 Good Laboratory Practices (GLP) – is a set of organizational processes and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support research or marketing permits for products regulated by government agencies including the EPA (40 C.F.R. part 160) (2). The Organisation for Economic Co-operation and Development (OECD) Principles of Good Laboratory Practice are accepted by member countries including the United States. Reference to EPA GLP standards in this document is intended to include OECD standards as appropriate GLP requirements for this proposed study.

1.2 Purpose

The USDA APHIS is seeking to contract the EPA guideline study Aerobic Soil Metabolism: OPPTS

835.4100 (1) to be conducted on the test substance CPTH with an independent contract laboratory. The EPA has required USDA APHIS to submit this study for all six USDA APHIS pesticide products containing the active ingredient CPTH. Failure to provide these data impacts EPA’s risk assessment assumptions, and EPA would assume a worst-case scenario in their risk assessment to ensure human and/or environmental safety. The result could be that EPA requires additional label use restrictions to mitigate the assumed risk, or could pursue regulatory action as severe as the cancelation of USDA APHIS’s products. See Primus et al. 1997 (5) for information on degradation products.

2.0 Scope of Work

The Aerobic Soil Metabolism: OPPTS 835.4100 (1) is required for pesticides applied directly to soil, or that are likely to reach soil via some other route. The study will be conducted by the contract laboratory in compliance with EPA FIFRA GLP requirements (2). EPA will use the data to assess the environmental fate of CPTH in aerobic soil conditions. At a minimum, the scope of work includes the baseline study.

Additional contingencies are discussed in the attached Bid Schedule and will be priced as options.

2.1 Requirements

The requirement is to conduct the aerobic soil metabolism study on the test substance CPTH according to EPA guidance (1). The requirement includes:

2.1.1 Compliance with EPA FIFRA GLP requirements (2) for all aspects of the study

2.1.2 Synthesis and 14C-labeling of the CPTH test substance under contract or subcontract with

GLP certificate of analysis. The chemical purity will be ≥ 98%. The radiopurity will be ≥ 98%.

2.1.3 Acquisition of four test soils by collection.

2.1.4 Soil characterization per OPPTS 835.4100 (1).

2.1.5 Conduct the laboratory phase of the aerobic soil metabolism study on CPTH to determine test substance transformation pathways and disappearance rates.

2.1.6 Identify and characterize the transformation products.

2.1.7 Upon study sponsor approval by the USDA APHIS WS NWRC Registration Unit (RU), conduct study contingencies such as additional sampling time points, and evaluate and implement additional residue extraction methods for unextractable residues, as required (4).

2.1.8 Prepare the EPA FIFRA GLP-compliant final study report.

2.2 Period of Performance

Depending upon study contingencies, it is expected that meeting the requirements of the contract will take 10 - 16 months. This timeframe is intended to accommodate seasonal conditions impacting the collection of soils.

2.3 Laboratory Deliverables

2.3.1 Development and delivery of the draft study protocol.

2.3.2 The CPTH analytical reference standards of two commercially available transformation products will be provided by the study sponsor if required.

2.3.3 Collect the four test soils in accordance with EPA Guidance OPPTS 835.4100 (1). One of these four soils will be from a region representative of the pesticide product use sites in the U.S.

2.3.4 Characterize the four soils in accordance with EPA Guidance OPPTS 835.4100 (1). The guidance document specifies a range of soil types, organic matter content, pH, and microbial biomass. All soils should be characterized, at a minimum, for texture according to FAO and USDA classification, pH, cation Exchange capacity, organic carbon, bulk density, water retention characteristic, and microbial biomass.

2.3.5 Conduct the standard laboratory phase of the aerobic soil metabolism study. The study experiment will determine the rate of transformation of the CPTH (the test substance) in soil and the nature and rates of formation and decline of transformation products. The following items should be included, but are not limited to:

2.3.5.1 Method development

2.3.5.2 Study set-up and conduct

2.3.5.3 Determination of soil biomass at study beginning and end of study at a minimum

2.3.5.4 Minimum of six sampling intervals (0-Day sample plus five additional time points

2.3.5.5 Determination of rate of transformation

2.3.5.6 Isolation and identification of known transformation products.

2.3.5.7 Quality Control, and Quality Assurance in compliance with EPA FIFRA GLP

2.3.5.8 Review of data, and report preparation in compliance EPA PR Notice 2011-3 (3)

2.3.6 A brief written status report following completion of the study set-up (time zero of the incubation period), and also at day 30, 60, and 120 as appropriate for the length of the soil incubation phase.

2.3.7 EPA FIFRA GLP-compliant final study report

2.3.8 Provide sample disposal

2.3.9 Additional time point contingency -

EPA Guidance OPPTS 835.4100 (1) specifies that in addition to the soil sample taken directly after application (0-day sample), at least five additional sampling points or intervals (six total) should be included. Time intervals should be chosen in such a way that the pattern of decline of the test substance and patterns of formation and decline of major transformation products can be established (e.g., 0, 1, 3, 7 days; 2, 3 weeks; 1, 2, 3 months, etc.)

2.3.10 Additional residue extractions contingency -

CPTH is expected to have non-extractable residues, and additional extractions are anticipated

2.3.11 Transformation product(s) contingency -

Isolation and identification of major unknown transformation products

2.4 USDA APHIS Deliverables

APHIS will provide the contract lab with non-radioactive analytical reference standards of CPTH and two commercially available transformation products if required. Relevant publications, reports and methods are also available upon request.

2.5 Deliverables Schedule

The study will be scheduled to facilitate the collection of soils containing sufficient viable microorganisms. The draft final report is due within two months of study completion, and the completed final report is due within one month of authorization by APHIS.

2.6 Applicable Standards

2.6.1 All aspects of the study and study records will be completed in compliance with EPA FIFRA GLP standards (40 CFR part 160, 2016) (2). The contract laboratory will be responsible for compliance with all EPA FIFRA GLP regulations.

2.6.2 The protocol and final report will be formatted to conform to EPA PRN 2011-3: Standard Format for Data Submitted under FIFRA and Certain Provisions of FFDCA (3).

2.7 Acceptance Criteria

The USDA APHIS WS NWRC RU will represent USDA APHIS, as the study sponsor, in matters related to this study. The contract laboratory will provide a draft study protocol to the RU prior to the start of the study, and also provide a draft final study report at the conclusion of the study. The RU will review both documents and provide comments if necessary. The contract laboratory will work with the RU to finalize both documents. The RU will approve both documents.

2.7.1 The study will begin after the protocol is approved by the RU. The protocol will be in compliance with EPA FIFRA GLP standards (2). Any protocol deviations or amendments must be approved by the RU, and the contract laboratory will document such changes in compliance with EPA FIFRA GLP standards (2).

2.7.2 The study final report will be in compliance with EPA FIFRA GLP standards.

2.8 Special Requirements

The contract laboratory shall have demonstrated successful experience in conducting the Aerobic Soil Metabolism: OPPTS 835.4100 study in compliance with EPA guidance (1), and have appropriate skill in conducting studies in compliance with EPA FIFRA GLP standards.

3.0 Payment Schedule

Progress payments will be authorized monthly, all payments will be made only for work already completed.

4.0 Miscellaneous

The transformation of a chemical in soil is due, in part, to degradation by soil microorganisms.This study has several sequential steps. The synthesis of 14C-CPTH can take several weeks to months and must be completed prior to collection of soils. The soils must be fresh when the laboratory phase of the study is initiated. Therefore, soil must be collected outside of winter conditions, and no later than September or October 2016 in most of the United States, depending upon latitude. Depending upon when this contract is awarded, it is understood that seasonal conditions may delay the soil collection until sufficient microbial biomass is assured. See section 2.2 Period of Performance.

5.0 Evaluation

All offers will be evaluated based on Lowest Price Technically Acceptable (LPTA). The quantities outlined in the bid schedule are hypothetical quantities. These hypothetical quantities and the pricing submitted for these hypotheticals will be used to evaluate offers on the basis of price.

Technical Acceptability will be assessed on a pass/fail basis of the following factors:

5.0.1 The laboratory must have had at least one inspection or data audit by the U.S. EPA for compliance with EPA FIFRA GLP standards within the last 10 years. If one or more audits were conducted in the past 10 years, the three most recent closed audits within the timeframe must not have resulted in EPA’s rejection of a study either partially or fully due to failure to comply with all EPA GLP standards. Provide documentation of the one, or if available in the previous 10 years, up to three most recent audit findings. Foreign companies may provide the results of the most recent inspection by their authority responsible for GLP compliance.

5.0.2 The laboratory must have a record of conducting the Aerobic Soil Metabolism study per OPPTS 835.4100 guidelines. Provide documentation from the facility’s ‘Master Schedule’ of at least three aerobic soil metabolism studies per EPA guidelines within the past five years.

5.0.3 The intended Study Director and at least 20% of other laboratory scientists contributing to this study must demonstrate prior experience participating in at least two other aerobic soil metabolism studies per OPPTS 835.4100 guidelines. Provide documentation of personnel experience. A statement summarizing key personnel experience in at least two studies of this type shall meet the requirement.

6.0 References

1. Fate, Transport and Transformation Test Guidelines: OPPTS 835.4100 Aerobic Soil Metabolism and OPPTS 835.4200 Anaerobic Soil Metabolism, October 2008, p. 1-17, https://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0152-0038

2. Good Laboratory Practices Standards, 40 CFR, Part 160, 2016 ed., http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=efa9dd97aedac90d1fe9419044fe13dc&ty=HTML&h=L&mc=true&r= PART&n=pt40.24.160

3. 2011-3: Standard Format for Data Submitted Under FIFRA and Certain Provisions of FFDCA, November 30, 2011, p. 1-23, https://www.epa.gov/pesticide-registration/prn-2011-3-standard-format-data-submitted-under-fifra-and-certain-provisions

4. “Guidance for Addressing Unextracted Residues in Laboratory Studies”, September12, 2014 memorandum from Donald J. Brady, PhD, Director Environmental fate and Effects Division (7507P), Office of Pesticide Programs. Guidance for Addressing Unextracted Pesticide Residues in Laboratory Studies | Pesticide Science and Assessing Pesticide Risks | US EPA

5. Primus, Thomas M., et al. "Identification of degradation products of the avicide 3-chloro-p-toluidine hydrochloride in Louisiana rice fields." Environmental science & technology 31.2 (1997): 346-350.

http://pubs.acs.org/doi/abs/10.1021/es9600789

7.0 Bid Schedule:

https://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0152-0038 http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=efa9dd97aedac90d1fe9419044fe13dc&ty=HTML&h=L&mc=true&r=PART&n=pt40.24.160 http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=efa9dd97aedac90d1fe9419044fe13dc&ty=HTML&h=L&mc=true&r=PART&n=pt40.24.160 http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=efa9dd97aedac90d1fe9419044fe13dc&ty=HTML&h=L&mc=true&r=PART&n=pt40.24.160 https://www.epa.gov/pesticide-registration/prn-2011-3-standard-format-data-submitted-under-fifra-and-certain-provisions https://www.epa.gov/pesticide-registration/prn-2011-3-standard-format-data-submitted-under-fifra-and-certain-provisions https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/guidance-addressing-unextracted-pesticide-residues http://pubs.acs.org/doi/abs/10.1021/es9600789

3-chloro-p-toluidine hydrochloride Aerobic Soil Metabolism Study

NOTE: The unit price listed will be the price paid per occurrence. No price ranges will be accepted. The quantity shown here is hypothetical and will be used to evaluate your offer against other offers. Actual contingencies are unknown but will be priced per occurrence as outlined in this bid schedule. Contingency options will be exercised by a subsequent modification, if required, and funded.

A. Base Award Qty. Unit Price Total Price

0001 – Develop Study Protocol 1

0002 – 14C-radiolabeling of CPTH 1

0003 – Collect four Test Soils 1

0004 – Characterize four Test Soils 1

0005 – Standard Laboratory Phase of Study N/A (Includes six time points)

0005AA - Method Development 1

0005AB - Study Set-Up and Conduct (4 soils) 1

0005AC - Determination of Soil Biomass 1

0005AD - Determination of Rate of Transformation 1

0005AE - Confirmation of Known Degradation Products 1

0006 - Sample and Test Substance Disposal 1

0007 - EPA GLP-Compliant Final Study Report 1

B. Options (These will be exercised by a subsequent modification, if required, and funded)

0008 - Contingency – Additional Time Points (Per four Soils) 3

0009 - Contingency – Isolation and ID of Unknown

Transformation Products N/A

0009AA - Isolation and ID of One Unknown Transformation Product 1

0009AB - Isolation and ID of Each Additional

Unknown Transformation Product 3

0010 - Contingency – Additional Residue Extractions (Per Soil) 4

8.0 Clauses and Provisions

Provisions Incorporated by Reference

52.204-16 -- Commercial and Government Entity Code Reporting (Jul 2015)

52.212-1 --Instructions to Offerors -- Commercial Items (Oct 2015)

Full Text Provisions

52.212-3 -- Offeror Representations and Certifications -- Commercial Items.

As prescribed in 12.301(b)(2), insert the following provision:

Offeror Representations and Certifications -- Commercial Items (Apr 2016)

The offeror shall complete only paragraphs (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) Web site accessed through http://www.acquisition.gov . If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (r) of this provision.

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

“Economically disadvantaged women-owned small business (EDWOSB) concern” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/12.htm#P120_20013 http://www.acquisition.gov/ management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

“Forced or indentured child labor” means all work or service—

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

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

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

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

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

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

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

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

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

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

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

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

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

(8) PSC 9610, Ores;

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

(10) PSC 9630, Additive Metal Materials.

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

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

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

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

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

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

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

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

(6) Have been voluntarily suspended.

Sensitive technology—

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

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

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

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

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

(1) Means a small business concern—

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

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

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

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

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

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

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

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

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

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

(1) Directly by a parent corporation; or

(2) Through another subsidiary of a parent corporation.

“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 the its stock is owned by one or more women; and whose management and daily business operations are controlled by one or more women.

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

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

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

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

(b)

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

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

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

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

https://www.acquisition.gov/

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

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

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

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

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

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

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

and

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

(7) Economically disadvantaged women-owned small business (EDWOSB) concern.

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

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

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

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

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

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

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

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

__________.] Each HUBZone small business concern participating in the HUBZone joint venture shall submit a separate signed copy of the HUBZone representation.

(d) Representations required to implement provisions of Executive Order 11246 --

(1) Previous contracts and compliance. The offeror represents that --

(i) It [_] has, [_] has not, participated in a previous contract or subcontract subject to the Equal Opportunity clause of this solicitation; and

(ii) It [_] has, [_] has not, filed all required compliance reports.

(2) Affirmative Action Compliance. The offeror represents that --

(i) It [_] has developed and has on file, [_] has not developed and does not have on file, at each establishment, affirmative action programs required by rules and regulations of the Secretary of Labor (41 CFR parts 60-1 and 60-2), or

(ii) It [_] has not previously had contracts subject to the written affirmative action programs requirement of the rules and regulations of the Secretary of Labor.

(e) Certification Regarding Payments to Influence Federal Transactions (31 U.S.C. 1352).

(Applies only if the contract is expected to exceed $150,000.) By submission of its offer, the offeror certifies to the best of its knowledge and belief that no Federal appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress or an employee of a Member of Congress on his or her behalf in connection with the award of any resultant contract. If any registrants under the Lobbying Disclosure Act of 1995 have made a lobbying contact on behalf of the offeror with respect to this contract, the offeror shall complete and submit, with its offer, OMB Standard Form LLL, Disclosure of Lobbying Activities, to provide the name of the registrants. The offeror need not report regularly employed officers or employees of the offeror to whom payments of reasonable compensation were made.

(f) Buy American Certificate. (Applies only if the clause at Federal Acquisition Regulation (FAR) 52.225-1, Buy American – Supplies, is included in this solicitation.)

(1) The offeror certifies that each end product, except those listed in paragraph (f)(2) of this provision, is a domestic end product and that for other than COTS items, the offeror has considered components of unknown origin to have been mined, produced, or manufactured outside the United States. The offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products, i.e., an end product that is not a COTS item and does not meet the component test in paragraph (2) of the definition of “domestic end product.” The terms “commercially available off-the-shelf (COTS) item,” “component,” “domestic end product,” “end product,” “foreign end product,” and “United States” are defined in the clause of this solicitation entitled “Buy American—Supplies.”

(2) Foreign End Products:

LINE ITEM NO. COUNTRY OF ORIGIN

[List as necessary]

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

(g)

(1) Buy American -- Free Trade Agreements -- Israeli Trade Act Certificate. (Applies only if the clause at FAR 52.225-3, Buy American -- Free Trade Agreements -- Israeli Trade Act, is included in this solicitation.)

(i) The offeror certifies that each end product, except those listed in paragraph (g)(1)(ii) or (g)(1)(iii) of this provision, is a domestic end product and that for other than COTS items, the offeror has considered components of unknown origin to have been mined, produced, or manufactured outside the United States. The terms “Bahrainian, Moroccan, Omani, Panamanian, or Peruvian end product,” “commercially available off-the-shelf (COTS) item,” “component,” “domestic end product,” “end product,” “foreign end product,” “Free Trade Agreement country,” “Free Trade Agreement country end product,” “Israeli end product,” and “United States” are defined in the clause of this solicitation entitled “Buy American--Free Trade Agreements--Israeli Trade Act.”

(ii) The offeror certifies that the following supplies are Free Trade Agreement country end products (other than Bahrainian, Moroccan, Omani, Panamanian, or Peruvian end products) or Israeli end products as defined in the clause of this solicitation entitled “Buy American—Free Trade Agreements—Israeli Trade Act”:

Free Trade Agreement Country End Products (Other than Bahrainian, Moroccan, Omani, Panamanian, or Peruvian End Products) or Israeli End Products:

(iii) The offeror shall list those supplies that are foreign end products (other than those listed in paragraph (g)(1)(ii) or this provision) as defined in the clause of this solicitation entitled “Buy American—Free Trade Agreements—Israeli Trade Act.” The offeror shall list as other foreign end products those end products manufactured in the United States that do not qualify as domestic end products, i.e., an end product that is not a COTS item and does not meet the component test in paragraph (2) of the definition of “domestic end product.”

Other Foreign End Products:

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

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

(g)(1)(ii) The offeror certifies that the following supplies are Canadian end products as defined in the clause of this solicitation entitled “Buy American—Free Trade Agreements—Israeli Trade Act”:

Canadian End Products:

Line Item No.:

[List as necessary]

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

If Alternate II to the clause at FAR 52.225-3 is included in this solicitation, substitute the following paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision:

(g)(1)(ii) The offeror certifies that the following supplies are Canadian end products or Israeli end products as defined in the clause of this solicitation entitled “Buy American--Free Trade Agreements--Israeli Trade Act'':

Canadian or Israeli End Products:

Line Item No.: Country of Origin:

(4) Buy American—Free Trade Agreements—Israeli Trade Act Certificate, Alternate III.

If Alternate III to the clause at 52.225-3 is included in this solicitation, substitute the following paragraph (g)(1)(ii) for paragraph (g)(1)(ii) of the basic provision:

(g)(1)(ii) The offeror certifies that the following supplies are Free Trade Agreement country end products (other than Bahrainian, Korean, Moroccan, Omani, Panamanian, or Peruvian end products) or Israeli end products as defined in the clause of this solicitation entitled “Buy American—Free Trade Agreements—Israeli Trade Act”:

Free Trade Agreement Country End Products (Other than Bahrainian, Korean, Moroccan, Omani, Panamanian, or Peruvian End Products) or Israeli End Products:

(5) 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)(5)(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…