Amendment_1_NIH-P16-0018F_Attachments.pdf

Amended List of attachments in Section J of the Combined Synopsis/Solicitation NIH-P16-0018F

Attachment Packaging and Delivery of Proposals (1 page) (DELETED)

Attachment 2: Proposal Intent Response Sheet (1 page) (UNCHANGED)

Attachment 3: Statement of Work (5 pages) (CHANGED)

Attachment 4: FAR ~ Offeror Representations and Certifications ~ Commercial Items (Apr

2016) (19 pages) (CHANGED)

Attachment 5: Pricing Table (1 page) (UNCHANGED)

Attachment 6: Past Performance Questionnaire (2 pages) (UNCHANGED)

Attachment 7: Summary of Related Activities (1 page) (DELETED)

Attachment 8: Proposal Summary and Data Record, NIH-2043 (2 pages) (DELETED)

Attachment 9: Offeror's Points of Contact (1 page) (DELETED)

Attachment Disclosure of Lobbying Activities, OMB form SF-LLL (2 pages) (UNCHANGED)

Attachment Invoice Instructions for Fixed Price Contracts (RC)-2 (3 pages)

(UNCHANGED)

Combined Synopsis/Solicitation

Attachment 1: Packaging and Delivery of Proposals

(DELETED)

Attachment 2: Proposal Intent Response Sheet

PROPOSAL INTENT RESPONSE FORM

RFP No:

RFP Title: FDG Unit Doses in Shielded Delivery and Administration Containers

Please review the Request for Proposal (RFP). Furnish the information requested below and return this page to the Contracting Officer/Contract Specialist identified on Section A-Solicitation/Contract Form by the earliest practical date

Your expression of intent is not binding but will greatly assist us in planning for proposal evaluation.

Choose one of the following Options:

© Do intend to submit a proposal Do Not intend to submit a proposal

If you are not responding to this RFP, please provide your reason(s):

Please provide the following contact information:

Name (First, Middle Initial, Last):

Title:

Organization:

E-mail:

Combined Synopsis/Solicitation NIH-Pl

Attachment 3: Statement of Work (CHANGED)

STATEMENT OF WORK

Procurement of in Shielded Delivery and Administration System Nuclear Pharmacy, Nuclear Medicine

Department of Radiology and Imaging Sciences Clinical Center

National Institutes of Health Bethesda, MD 20892

A. BACKGROUND

The NIH Clinical Center Nuclear Pharmacy regularly purchases and compounds radiopharmaceuticals (radioactive drugs) for life-saving clinical nuclear medicine procedures which are essential for the NIH Clinical Center to achieve optimal patient care. These radiopharmaceuticals are United States Food and Drug Administration (FDA) approved drugs for use in patients. They are also radioactive materials that are regulated by the United States Nuclear Regulatory Commission (USNRC) through the NIH radioactive material license (RAM) administered by the NIH Radiation Safety Office (RSO). Accordingly, procurement and use of these radiopharmaceutical drugs must meet federal regulations to ensure safety and minimize health risks to both the staff and patients. Hence, only qualified vendors that meet the FDA and USNRC regulations can provide these radiopharmaceuticals for compounding and dispensing at the NIH Nuclear Pharmacy to NIH Clinical Center patients.

As part of NIH obtaining these materials, only RSO certified Nuclear Medicine personnel can order the radiopharmaceuticals directly for patient use. The NIH Nuclear Medicine clinic performs imaging and therapy procedures for admitted to the NIH Clinical Center. These procedures are essential and necessary for the NIH clinical staff to save patients' lives and minimize suffering. The contractor supplying the radiopharmaceuticals shall be supporting this function.

of further background information, F-18 or fludeoxyglucose F 18 and USP), also commonly called fluorodeoxyglucose and abbreviated or FDG, is a radiopharmaceutical (radioactive drug) approved by the FDA for use in the medical imaging modality positron emission tomography (PET). Chemically, it is a glucose analog, with the positron-emitting radioactive isotope substituted for the normal group at the 2' position in the glucose molecule. The uptake of by tissues is a marker for the tissue uptake of glucose, which in turn is closely correlated with certain types of tissue metabolism. After is injected into a patient, a PET scanner can form two-dimensional or three-dimensional images of the distribution of within the body. Since its development in had a profound influence on research in the neurosciences. The subsequent discovery in that

FDG accumulates in tumors underpins the evolution of PET as a major clinical tool in cancer diagnosis. is now the standard radiotracer used for PET and cancer patient management. The images can be assessed by a nuclear medicine physician or radiologist to provide diagnoses of various medical conditions.

Since emits high energy ionizing (500 keV), the drug must be properly shielded to minimize unnecessary radiation exposure to both NIH staff and patients (FO Roberts, DH Gounawardana, et a. Radiation Dose to PET Technologists and Strategies to Lower Occupational Exposure. J Med 2005; 33:44-47).

Although public health data do not absolutely establish the occurrence of cancer following exposure to low doses and dose rates, the radiation protection community conservatively assumes that any amount of radiation may pose some risk for causing cancer and hereditary effect, and that the risk is higher for higher radiation exposures

A linear no-threshold (LNT) dose-response relationship is used to describe the relationship between radiation dose and the occurrence of cancer. The dose-response model suggests that any increase in dose, no matter how small, results in an incremental increase in risk. The USNRC accepts the LNT hypothesis as a conservative model for estimating radiation risk. In addition, the USNRC has mandated the "ALARA" concept in the Code of Federation Regulations C.F.R. § 20.1003).

ALARA is an acronym for "as low as is reasonably achievable," which means making every reasonable effort to maintain exposures to ionizing radiation as far below the dose limits as is practical, consistent with the purpose for which the licensed activity is undertaken Hence, 10 C.F.R. § provides that "[t]he licensee shall use, to the extent practical, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA)." 10 C.F.R. §

In complying with the ALARA regulations as well as USNRC recommendations for achieving and maintaining a safety conscious work environment (NRC Regulatory Issue Summary Guidance For Establishing And Maintaining A Safety Conscious Work Environment, ML052220239), the NIH Nuclear Pharmacy requires the qualified vendor to deliver each unit dose of in shielded dose administration container (referred to as a "pig"), which sits inside a further shielded shipping container.

This configuration provides the lowest reasonably achievable radiation exposure to the staff and patients in the NIH Nuclear Medicine Clinic (USNRC Regulatory Guide 8.18, Information Relevant to Ensuring that Radiation Exposures at Medical Institutes will be As Low As Is Reasonably Achievable, April Revision 2).

Finally, each radiopharmaceutical must be properly compounded, dispensed, calibrated and delivered for a specific patient at a specific time on a specific date. The useful dose activity (radioactivity) of FDG decays away very fast minutes).

Hence, the dose must be delivered at a specific, required time and contain a specific, required dose activity in order for the imaging/therapy study to be properly performed.

B. PURPOSE

The purpose of the SOW is to procure unit doses of each contained in a shielded single-dose administration container (referred to as a "pig"), and at least two pigs further contained in a shielded shipping container. The complete system must meet DOT regulations, USNRC ALARA, and Government weight guidelines. The deliveries must come from a source appropriately licensed by the FDA and USNRC as described below. In turn, the deliveries shall allow the NIH Nuclear Medicine Department of Radiology and Imaging Sciences to perform clinical imaging studies as required by necessary patient care protocols at the NIH Clinical Center.

C. P L A C E OF PERFORMANCE/DELIVERY

The radioactive drugs must be delivered to the National Institutes of Health in Bethesda, MD. A radiopharmaceutical shall not be considered delivered unless: (1) it is delivered in a proper dose administration and shipping system; (2) the radiopharmaceutical arrives at the specified point of destination; (3) the contractor/contractor's agent has placed the radiopharmaceutical in the custody of an NIH RSO certified Nuclear Medicine person; and (4) the radiopharmaceutical is delivered on time.

D. REQUIREMENTS OF THE DELIVERY SYSTEM

The Government has no specific requirement as to the composition of the shielded single-dose administration container/pig, the shielded shipping container that two or more pigs will sit in. For example, the Government has seen systems comprised of lead or tungsten shielding. Rather, the Government requires a system that meets the following standards.

(1) The shielded shipping container, when loaded with two doses contained in individual pigs, cannot weigh more than 51.0 pounds. A shipping container which can only carry one dose will not be acceptable.

This requirement derives from the US Occupational Safety & Health Administration (OSHA) and the National Institute of Occupational Safety and Health (NIOSH). OSHA has found that lifting heavy items is one of the leading causes of injury in the workplace Accordingly, previous NIOSH guidelines state that maximum weight to be lifted with two hands, under ideal conditions, is 51 pounds." Guidelines for Manual Material Handling, DHHS (NIOSH) Publication No. at (Apr. 2007). However, OSHA currently recommends that "lifts be limited to 35 pounds or less." OSHA, Safe Patient Handling, OSHA Pamphlet 3708 (Feb. 2014). Hence, in order to minimize weight lifting injuries to the staff, the NIH Nuclear Pharmacy seeks the FDG doses to be shipped in acceptably shielded containers which weigh as little as is possible. Unfortunately, the NIH Nuclear Pharmacy is currently not confident that it will obtain an adequate system if it limits the weight of the loaded shipping container to 35 pounds. Thus, the NIH Nuclear Pharmacy seeks a dose administration and transportation system, when loaded with two doses, which does not weigh more than 51 pounds.

Doses are typically delivered to secure storage, which is not a large area, and must accommodate other materials, in addition to the doses. Consequently, in order to ensure that the deliveries meet space constraints, each shipping container must contain at least two doses.

(2) In order to facilitate handling of each single-dose pig, the pig must have a durable handle. A strap or similarly tractable handle shall not suffice this requirement.

This requirement helps ensure safe handling of each pig. Specifically, a nuclear medicine technologist typically must walk each pig down a relatively long hallway.

Hence, having a durable handle to grasp on to, and use to control the pig, allows a technologist to safely and securely control the pig. Additionally, if there is an issue with the FDG dose which requires staff to calibrate the dose, staff must be able to manipulate the pig and the dose contained therein within the confines of a biological safety cabinet. A durable handle also helps facilitate this activity.

(3) Each shielded pig, when loaded with one 4-5 dose of 7.5 F-FDG, must not emit radiation greater than 37 milliRoentgen per hour (hr), as measured on the exterior surface at the center of the pig. The measurement is made by the FH 40G Multi-Purpose Digital Survey Meter (Thermo Scientific Eberline ESM model FH40G-L).

In accordance with 10 C.F.R. § 20.1101(b), the NIH Nuclear Pharmacy is required to limit radiation dosage to employees and members of the public to the extent as low as is reasonably achievable. The Pharmacy knows that there are pigs currently available that limit exposure to as low as 37 milliRoentgen per hour (hr). Hence, 37 milliRoentgen per hour (hr) is the currently demonstrated standard for as low as is reasonably achievable.

(4) The shielded pig must allow a nuclear medicine technologist to administer a dose of to a patient without completely the dose from the containment of the pig.

In order to further the goal of limiting radiation exposure to employees to as low as is reasonably achievable, the pig shielding must allow a technologist to administer the directly to the patient without completely un-shielding the dose from the containment of the pig. For example, the pig could be constructed to allow a staff member to insert a 4-5 syringe containing the into an IV line, and allow a staff member to push the plunger on the syringe, all without the staff member having to remove the syringe from the shielding of the pig. The Government is open to various ways a proposed pig may facilitate safe dose administration, but any pig which requires a technologist to remove the syringe from the pig in order to administer the dose is not acceptable.

E. OTHER REQUIREMENTS

(1) The production facility of the must be approved by the FDA (or the approval request pending and on file with the FDA), with registration in good standing, to produce for human use.

(2) The offeror must be licensed, with the license in good standing, by either the USNRC, or the relevant State Radioactive Materials Licensing Agency (provided that the State has an agreement with the USNRC which makes its approval a sufficient alternative to USNRC approval), the production and/or distribution of

This requirement may also be applied to any subcontractor, sub-subcontractor, manufacturer, carrier, or other entity which the offeror is relying upon to create or handle the depending on the offeror's performance approach.

(3) The calibrated dose activities shall be between and within of calibrated activity ordered by the NIH

(4) The required calibration times the doses shall be between 6 a.m. to 6 p.m. Eastern Time (ET).

(5) The contractor shall provide Monday-to-Friday dose deliveries to the NIH campus in Bethesda, MD. Each dose shall be delivered no later than 30 minutes prior to the appointed calibration time for that dose. Delivery times and locations shall be specified by the NIH Radiopharmacy when an order is placed. The typical order will be placed on the business day prior to the requested delivery, or earlier, as circumstances allow. Typically, but not guaranteed, the contractor will be able to deliver multiple doses in one delivery.

Administrative note, when the contractor makes a delivery, it should also retrieve empty pigs and shipping containers.

(6) When requested, the contractor shall provide a STAT or (Immediate) delivery. A STAT order is a request for delivery of a dose as soon as is possible.

When NIH makes a STAT order, the contractor shall deliver the unit dose no later than 3 hours after the order is placed. not guaranteed, NIH typically places 1-2 STAT orders per week. Additionally, unlike normal orders, a STAT order may require a weekend delivery. Recognizing that a STAT order may increase a contractor's costs (e.g., employees, lost efficiencies, overtime, etc.), NIH requests a different unit price for STAT orders than it does for normal orders.

(7) The packaging and transport of all deliveries shall meet relevant U.S.

Department of Transportation transportation requirements for radioactive materials.

Combined NIH-P

Attachment 4: 52.212-3 - Offeror Representations and Certifications - Commercial Items (Apr 2016)

Attachment 4: NIH-P16-0018F

52.212-3 ~ Offeror Representations and Certifications ~ Commercial Items (Apr 2016)

The offeror shall complete only paragraphs (b) of this provision i f the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) Web site accessed through . I f 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 disadvantaged women-owned small business concern" means a small business concern that is at least 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 CFR part It automatically qualifies as a women-owned small business eligible under the WOSB Program.

"Forced or indentured child labor" means all work or

(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 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.

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

(1) PSC Lumber and Related Basic Wood Materials;

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

(3) PSG 88, Live Animals;

NIH-P16-0018F

(4) PSG 89, Subsistence;

(5) PSC 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. I f 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. 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

(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

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

(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.

"Service-disabled veteran-owned small business concern"—

(1) Means a small business

(i) Not less than percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 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 CFR means a small business concern under the size standard applicable to the acquisition, that—

(1) Is at least percent unconditionally and directly owned (as defined at 13 CFR

(i) One or more socially disadvantaged (as defined at 13 CFR and economically disadvantaged (as defined at CFR 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

CFR and

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

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

(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

(1) Not less than 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 percent owned by one or more women; or in the case of any publicly owned business, at least 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 percent owned by one or more women or, in the case of any publicly owned business, at least 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 CFR part 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 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 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 code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 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 and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer. Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted electronically on SAM.]

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

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

(2) Veteran-owned small business concern. [Complete only i f 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 [ J is, is not a veteran-owned small business concern.

(3) Service-disabled veteran-owned small business concern. [Complete only i f the offeror represented itself as a veteran-owned small business concern in paragraph 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 i f 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 CFR 124.1002.

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

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

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

(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 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 concern.

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

(i) It [ J is, [_] is not an WOSB 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 CFR part and the representation in paragraph (c)(7)(i) of this provision is accurate for each WOSB concern participating in the joint venture. [The offeror shall enter the name or names of the WOSB concern and other small businesses that are participating in the joint venture: .] Each

WOSB concern participating in the joint venture shall submit a separate signed copy of the WOSB representation.

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

(9) Tie bid priority for labor surplus area concerns. I f 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:

HUBZone small business concern. [Complete only i f the offeror represented itself as a small business concern in paragraph of this provision.] The offeror represents, as part of its offer, that—

(i) It is, [ J 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 CFR part 126; and

(ii) It is, [ J not a HUBZone joint venture that complies with the requirements of 13 CFR part and the representation in paragraph 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 —

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

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

(ii) It has not previously had contracts 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 i f the contract is expected to exceed By submission of its offer, the

Attachment 4:

offeror certifies to the best of its knowledge and belief that no Federal appropriated funds have been paid or w i l l 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. I f any registrants under the Lobbying Disclosure Act of 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 i f 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" defined in the clause of solicitation entitled "Buy

(2) Foreign End Products:

LINE NO. OF ORIGIN

[List as necessary]

(3) The Government will evaluate offers in accordance with the policies and procedures

(g)

(1) Buy American — Free Trade Agreements — Israeli Trade Act Certificate. (Applies only i f 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)(h) or (g)(l)(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 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 Trade Trade Act":

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

LINE ITEM NO. (COUNTRY OF ORIGIN

[List as necessary]

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

Other Foreign End Products:

LINE NO. COUNTRY OF ORIGIN

[List as necessary]

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

(2) Buy Trade Trade Act Certificate, Alternate I . I f Alternate I to the clause at FAR 52.225-3 is included in this solicitation, substitute the following paragraph (g)(1)(h) for paragraph (g)(1)(h) of the basic provision:

(g)(1)(h) The offeror certifies that the following supplies are Canadian end products as defined in the clause of this solicitation entitled "Buy

Trade Trade Act":

Canadian End Products:

Line Item No.:

[List as necessary]

(3) Buy Trade Trade Act Certificate, Alternate II.

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

(g)(1)(h) 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 Trade Trade Act":

Canadian or Israeli End Products:

[Line Item No.: of Origin:

[List as necessary]

(4) Buy Trade Trade Act Certificate, Alternate III.

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

(g)(1)(h) 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

Trade Trade Act":

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

Country of Origin:

r [List as necessary]

(5) Trade Agreements Certificate. (Applies only i f 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

[Line No.: Country of Origin:

[List as necessary]

(iii) The Government wil l 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 wi l l 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 i f 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

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

Line Item No.:

Page of 19

(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; and

(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 $3,500 for which the liability remains unsatisfied.

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

(A) The tax liability is finally determined. The liability is finally determined i f it has been assessed. A liability is not finally determined i f 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 i f 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 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 wil l not be a final tax liability until the taxpayer has exercised all judicial appear 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. §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 i f 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 pursuant to I.R.C. §6159. The taxpayer is making timely payments and is in full compliance with the agreement terms. The taxpayer is not delinquent because the taxpayer is not currently required to make full payment,

(D) The taxpayer has filed for bankruptcy protection. The taxpayer is not delinquent because enforced collection action is stayed under U.S.C.

(the Bankruptcy Code).

(i) Certification Regarding Knowledge of Child Labor for Listed End Products (Executive Order [The Contracting Officer must list in paragraph (i)(l) any end products being acquired under this solicitation that are included in the List of Products Requiring Contractor Certification as to Forced or Indentured Child Labor, unless excluded at

(1) Listed End Product

Listed Countries of Origin:

(2) Certification. [If the Contracting Officer has identified end products and countries of origin in paragraph (i)(l) of this provision, then the offeror must certify to either (i)(2)(i) or (i)(2)(ii) by checking the appropriate block.]

[ J (i) The offeror will not supply any end product listed in paragraph (i)(l) of this provision that was mined, produced, or manufactured in the corresponding country as listed for that product.

[ J (ii) The offeror may supply an end product listed in paragraph (i)(l) of this provision that was mined, produced, or manufactured in the corresponding country as listed for that product. The offeror certifies that is has made a good faith effort to determine whether forced or indentured child labor was used to mine, produce, or manufacture any such end product furnished under this contract. On the basis of those efforts, the offeror certifies that it is not aware of any such use of child labor.

(j) Place of manufacture. (Does not apply unless the solicitation is predominantly for the acquisition of manufactured end products.) For statistical purposes only, the offeror shall indicate whether the place of manufacture of the end products it expects to provide in response to this solicitation is

Listed End Product:

(1) In the United States (Check this box i f the total anticipated price of offered end products manufactured in the United States exceeds the total anticipated price of offered end products manufactured outside the United States); or

(2) Outside the United States.

(k) Certificates regarding exemptions from the application of the Service Contract Labor Standards. (Certification by the offeror as to its compliance with respect to the contract also constitutes its certification as to compliance by its subcontractor i f it subcontracts out the exempt services.) [The contracting officer is to check a box to indicate i f paragraph (k)(l) or (k)(2) applies.]

(1) Maintenance, calibration, or repair of certain equipment as described in FAR 22.1003-4(c)(l). The offeror [ J does [ J does not certify that—

(i) The items of equipment to be serviced under this contract are used regularly for other than Governmental purposes and are sold or traded by the offeror (or subcontractor in the case of an exempt subcontract) in substantial quantities to the general public in the course of normal business operations;

(ii) The services will be furnished at prices which are, or are based on, established catalog or market prices (see FAR for the maintenance, calibration, or repair of such equipment; and

(iii) The compensation (wage and fringe benefits) plan for all service employees performing work under the contract will be the same as that used for these employees and equivalent employees servicing the same equipment of commercial customers.

(2) [_] Certain services as described in FAR 22.1003-4(d)(l). The offeror [_] does [_] does not certify

(i) The services under the contract are offered and sold regularly to non- Governmental customers, and are provided by the offeror (or subcontractor in the case of an exempt subcontract) to the general public in substantial quantities in the course of normal business operations;

(ii) The contract services will be furnished at prices that are, or are based on, established catalog or market prices (see FAR

(iii) Each service employee who wil l perform the services under the contract will spend only a small portion of his or her time (a monthly average of less than 20 percent of the available hours on an annualized basis, or less than 20 percent of available hours during the contract period i f the contract period is less than a month) servicing the Government contract; and

(iv) The compensation (wage and fringe benefits) plan for all service employees performing work under the contract is the same as that used for these employees and equivalent employees servicing commercial customers.

(3) I f paragraph (k)(l) or (k)(2) of this clause

(i) I f the offeror does not certify to the conditions in paragraph (k)(l) or (k)(2) and the Contracting Officer did not attach a Service Contract Labor Standards wage determination to the solicitation, the offeror shall notify the Contracting Officer as soon as possible; and

(ii) The Contracting Officer may not make an award to the offeror i f the offeror fails to execute the certification in paragraph (k)(l) or (k)(2) of this clause or to contact the Contracting Officer as required in paragraph (k)(3)(i) of this clause.

(1) Taxpayer identification number (TIN) (26 U.S.C. 6109, 31 U.S.C. 7701). (Not applicable i f the offeror is required to provide this information to the SAM database to be eligible for award.)

(1) A l l offerors must submit the information required in paragraphs (1)(3) through (1)(5) of this provision to comply with debt collection requirements of 31 U.S.C. 7701(c) and 3325(d), reporting requirements of 26 U.S.C. 6041, 6041A, and 6050M, and implementing regulations issued by the Internal Revenue Service (IRS).

(2) The TIN may be used by the government to collect and report on any delinquent amounts arising out of the offeror's relationship with the Government U.S.C.

I f the resulting contract is subject to the payment reporting requirements described in FAR 4.904, the TIN provided hereunder may be matched with IRS records to verify the accuracy of the offeror's TIN.

(3) Taxpayer Identification Number (TIN).

[_] TIN has been applied for.

[ TIN is not required because:

f Offeror is a nonresident alien, foreign corporation, or foreign partnership that does not have income effectively connected with the conduct of a trade or business in the United States and does not have an office or place of business or a fiscal paying agent in the United States;

[_] Offeror is an agency or instrumentality of a foreign government;

Offeror is an agency or instrumentality of the Federal Government;

(4) Type of organization.

Sole proprietorship;

[ 1 Partnership;

[_] Corporate entity (not tax-exempt);

Corporate entity (tax-exempt);

[ J Government entity (Federal, State, or local);

1 Foreign government;

International organization per 26 CFR 1.6049-4;

[ J Other .

(5) Common parent.

Offeror is not owned or controlled by a common parent:

[ 1 Name and TIN of common parent:

Name

TIN,

(m) Restricted business operations in Sudan. By submission of its offer, the offeror certifies that the offeror does not conduct any restricted business operations in Sudan.

(n) Prohibition on Contracting with Inverted Domestic

(1) Government agencies are not permitted to use appropriated (or otherwise made available) funds for contracts with either an inverted domestic corporation, or a subsidiary of an inverted domestic corporation, unless the exception at applies or the requirement is waived in accordance with the procedures at

(2) Representation. The offeror represents

(i) It [ ] is, [ ] is not an inverted domestic corporation; and

(ii) It [ ] is, [ ] is not a subsidiary of an inverted domestic corporation.

(o) Prohibition on contracting with entities engaging in certain activities or transactions relating to Iran.

(1) The offeror shall email questions concerning sensitive technology to the Department of State at

(2) Representation and Certification. Unless a waiver is granted or an exception applies as provided in paragraph (o)(3) of this provision, by submission of its offer, the

(i) Represents, to the best of its knowledge and belief, that the offeror does not export any sensitive technology to the government of Iran or any entities or individuals owned or controlled by, or acting on behalf or at the direction of, the…