COMBINED_SYNOPSIS_RFP19R0087_NMCP_RADIOPHARMACEUTICALS.pdf

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. Vendors must be registered with System for Award Management (SAM) to be considered for award. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2019-06 effective 10 September 2019 and Defense Federal Acquisition Regulation Supplement (DFARS) DPN 20190913 effective 13 September 2019. It is the contractor's responsibility to be familiar with the applicable FAR and DFARS clauses and provisions. The FAR clauses may be accessed in full text at:

http://acquisition.gov/browsefar https://www.acq.osd.mil/dpap/dars/dfarspgi/current/

The NAICS code is 325412. This is Sole Source acquisition, proposals are not being requested.

The Naval Medical Logistics Command (NMLC), on behalf of the Naval Medical Center Portsmouth (NMCP) has a requirement for radiopharmaceutical supplies to be used by the Radiology Department.

The solicitation number is N62645-19-R-0087

Point of Contact The point of contact for administrative concerns at Naval Medical Logistics Command (NMLC), 693 Neiman Street, Fort Detrick, MD 21702 is Karl O Molina, 301-619-7223, karl.o.molina.civ@mail.mil.

FBO INSTRUCTIONS

Do not submit proposals. This is not a request for proposals for a competed requirement. This Solicitation is issued in response to the Notice of Intent(62645TBD) to Sole Source under authority of FAR 13.5 Simplified Acquisition Procedures for Certain Commercial Items.

Notice of Intent posting and closing date: 12 September 2019 – 27 September 2019.

CONTRACTOR SUPPORT

NOTICE: NAVY USE OF SUPPORT CONTRACTOR FOR CONTRACT CLOSEOUT FUNCTIONS

Naval Medical Logistics Command uses two private contractors in support of the contract closeout process. Those companies are Contracting Resources Group (CRG) of Federal Hill, MD, doing business under the authority of the Small Business Administration’s 8(a) program, and the Ability One Program, doing business under the authority of the Javits-Wagner O’Day Act(41 U.S.C. § 47).

The contract closeout process includes activities such as processing deobligation modifications, obtaining contractor and requiring activity concurrence, preparing the DD-Form 1594 (Contract Completion Statement), and preparing closed files for archiving. Support contractors may perform additional administrative duties, including filing and processing simple administrative modifications. Performing these functions require the contractor employees to have access to the contract file. Therefore, information you provide to the Government or information already in the possession of the Government may be viewed by these support contractors in the course of performing contract close-out functions. The information that may be made available to the contractor may include pricing and technical proposals and performance information.

Naval Medical Logistics Command has signed Non-Disclosure Agreements with each support contractor employee and has required both contractors to provide a Conflict of interest Mitigation Plan to ensure these employees are firewalled from all business development activity.

By submission of a proposal to this RFP, the offeror and its subcontractors consent to access of their business sensitive/confidential or proprietary data by the Government’s support contractor personnel in order to perform close out services

LIST OF ITEMS

PRODUCT ID

UNITS

Quantities

DESCRIPTION

102977 Tc-99m Medronate 25 mCi UD (MDP bone) dose 4000

102974 Tc-99m Mebrofenin 6mCi UD (hepatobiliary) dose 1500 102990 Tc-99m Pentetate 15 mCi UD (DTPA renal) dose 50 102999 Tc-99m Succimer 6mCi UD (DMSA renal) dose 50 102980 Tc-99m Mertiatide 15 mCi UD (MAG3 renal) dose 500 102990 (009) Tc-99m Pentetate 40 mCi UD - Aerosol Ventilation (DTPA lung) dose 250 102970, 103728 Tc-99m Macro Aggregated Albumin 5 mCi UD (MAA lung) dose 400 103003 Tc-99m Sulfur Colloid 2 or 4 mCi UD (Imaging to include Sentinal Node) dose 750 103006 Tc-99m Tetrofosmin 30 mCi UD (Myoview cardiac) dose 12500 102984 Tc-99m NaTcO4 up to 30 mCi UD (Imaging) dose 600

102279 Ga-67 Gallium Citrate 6 mCi UD (Inflammatory) dose 25 102338 I-123 NaI 200 uCi Cap - used as 300 uCi/dose - (thyroid) cap 1000 103039 Tl-201 Thallous Chloride 3.5mCi UD (cardiac) dose 100 103012 Tc-99m Exametazime WBC 25 mCi UD (Ceretec WBC) dose 50 102940 Tc-99m Exametazime 25 mCi UD (Ceretec Brain) dose 25 102410 In-111 WBC's Oxine 500 uCi to 1 mCi dose 25 102397 In-111 Pentetate (DTPA) 500 uCi to 1 mCi UD (CSF) dose 25 102569 Macro Aggregated Albumin Vial (MAA cold kit) ea 100 102575 Medronate Vial (MDP cold kit) ea 75 102653 Pentetate Vial ( DTPA cold kit) ea 100 102574 Mebrofenin Vial (IDA cold kit) ea 200 103080 UltraTag RBC Vial (cold kit) ea 300 102684 Pyrophosphate Vial (PYP cold kit) ea 100 102983, 102984 Tc-99m NaTcO4 100 mCi/vial MD (stat) dose 150 102983, 102984 Tc-99m NaTcO4 150 mCi/vial MD (bulk for prep kit) dose 2500 102768 Quadramet (Sm153) dose 10 102781 Sr-89 SrCl UD (Strontium) dose 5 102400 In-111 Pentetreotide UD (Octreotide) dose 75 102994 Tc-99m Sestamibi 25 mCi UD (parathyroid) dose 200 102330 I123 MIBG (Adreview) base mCi UD dose 50 102330 I123 MIBG (Adreview) additional UD - included 1001BG price dose 100 102192, 102234 FDG (PET) UD dose 7000 102204 (151,174) F18 sodium fluoride calibration/Bone Imaging (1-12 mCi UD) dose 625 102372 I-131 NaI TX UD (sodium iodine) - first mCi mCi 500 102372 I-131 NaI TX UD (sodium iodine) - each additional mCi mCi 22500 102943, 103855 Tc-99m Filtered SC UD (sulfur colloid - filtered 0.22 microns) dose 2000 Deliveries Weekdays (first 2 free) - additional ea 100 198002 Delivery Charge After Hours ea 125 Software License Support Fee ea 10

101206 Lymphoseek Procedure (cost per pt per area) ea 500

SPECIAL REQUIREMENTS

1. The contractor shall provide all unit dose Radiopharmaceuticals used by the Radiology Department at NMCP.

2. The contractor shall provide deliver items at NMCP Receiving Dock, Monday through Friday 0700 to 1600 (7:00 a.m. to 4:00 p.m.), excluding federal holidays. Receiving personnel may be reached at 757-953-5770.

3. The contractor will be contacted by the staff of the Radiology Department.

1. All Contractor shall provide delivery and transportation of radioactive materials to the Naval Medical Center Portsmouth (NMCP) compound, conforming to all policies of the NMCP Radiation Safety Committee and all applicable National Regulatory Commission (NRC) and Department of Transportation (DOT) regulations governing transportation and handling of radioactive materials. Point of Contact: Radiation Safety Officer, Naval Medical Center Portsmouth, Phone: 757-953-1192 or pager 757-314-0745. Contractor’s pricing shall include costs of supplies (medical doses per patient), preparation and delivery of radioactive pharmaceuticals directly to the Radiology Department, Nuclear Medicine Division, Building 2, first floor, Room 121102.

2. All aspects of implementing and maintaining this contract relating to the use of radioactive materials will conform to the requirements of the Naval Medical Center Portsmouth Navy Radioactive Materials Permit 4500183-11NP and all applicable federal regulations..

1. Routine Delivery Requirements:

a. Contractor Responsibilities

(1) Delivery of all pharmaceuticals shall occur no later than 7:00 A.M. on the day of use (Monday –

Friday), unless a second day delivery at 10:00 A.M. is required to accommodate the ordered dose calibration time. Except, delivery of NAI-131 orders shall occur no later than 1100 on the day of use (Monday – Friday). DEL MED or FEDEX delivery is acceptable.

(2) Emergent orders (those placed on the same day of need) shall be delivered no later than 2 hours after the order is received by the pharmacy to meet the dose administration for patient care.

(3) Tagged studies (In111 or 99mTc Ceretec) shall be returned to NMCP within 5 hours after radio pharmacy takes custody of the patient sample.

(4) Contractor shall maintain 95% on-time rate for deliveries.

b. Government Responsibilities

(1) Scheduled orders will be made via fax no later than 4:00 P.M. the evening prior to calibration. After

4:00 P.M. orders will be made by phone.

2. Emergent Delivery Requirements:

a. Contractor Responsibilities

(1) Orders made on an emergent basis (outside of normal hours) shall be delivered within 2 hours of being ordered via phone by authorized personnel.

3. Radiopharmaceutical requirements:

a. All radiopharmaceuticals shall be prepared in accordance with manufacturer’s specifications.

b. All applicable manufacturer recommendations pertaining to 99mTc eluate shall be observed including but not limited to 99Mo concentration <0.15 uCi/mCi Tc99m, AI+++ concentration <10ug/ml and expiration shelf life.

c. Radiochemical purity testing shall be performed on all radiopharmaceuticals in accordance with manufacturer recommendations.

d. Product substitutions (or equivalent) shall not be allowed without prior approval of appropriate NMCP Authorized User and Radiation Safety Officer (for radioisotope charges).

e. 99mTc MAA shall not exceed the product insert maximum suggested number of particles per dose, and shall be adjusted at the request of NMCP in cases of patients with right to left shunts and pulmonary hypertension.

f. All diagnostic radiopharmaceutical doses shall be within +/- 10% of the requested activity at calibration time.

g. All therapeutic doses must be within +/-5% of requested activity at calibration time.

N6264519R0087

h. Myoview vial partitioning is acceptable.

i. All “pigs” containing unit doses shall be appropriately labeled in accordance with regulations to include but not be limited to RP name, calibrated activity, Cal time, date, expiration, Pt. Name, Authorized user name.

j. All unit dose syringes/vials shall display RP name, calibrated activity, cal time, date, expiration, Pt. name, authorized user name.

k. All bulk radiopharmaceutical vials shall display RP name, calibrated activity, cal time, date, expiration, and authorized user name.

4. Back-up delivery (Monday – Friday):

Delivery of 1 vial of 99mTc04; 150mCi calibrated @ 2000 .

5. Invoices:

Two (2) copies of the invoice shall be left with the delivery. Under no circumstances shall any price be changed due to problems with the product being delivered to and/or received by the Naval Medical Center Portsmouth. Should the quantities received and our delivery be changed for any reason, a corrected invoiced should be mailed within two

(2) working days with the proper amount of items received.

Base Access (NMCP) Commander, Navy Installations Command (CNIC), has established the Navy Commercial Access Control System (NCACS), a standardized process for granting unescorted access privileges to vendors, contractors, suppliers and service providers not otherwise entitled to the issuance of a Common Access Card (CAC) who seek access to and can provide justification to enter Navy installations and facilities. Vendors visiting Naval Medical Center Portsmouth (NMCP) may obtain daily passes directly from Naval Station Norfolk (NSN) Pass and ID office, located at NSN (Bldg CD-9), 9040 Hampton Blvd, Norfolk, Virginia, 23505, by submitting identification credentials for verification and undergoing a criminal screening/ background check. Alternatively, if the vendor so chooses, it may voluntarily elect to obtain long-term credentials through enrollment, registration, background vetting, screening, issuance of credentials, and electronic validation of credentials at its own cost through one of the designated independent contractor NCACS service providers. Credentials will be issued every five years and access privileges will be reviewed / renewed on an annual basis. The costs incurred to obtain Navy installation access of any kind are not reimbursable, and the price(s) paid for obtaining long-term NCACS credentials will not be approved as a direct cost of this contract. Further information regarding NCACS can be found at http://cnic.navy.mil/CNIC_HQ_Site/index.htm.

NOTICE TO CONTRACTOR

Technical Liasion The Technical Liasion POC will perform inspection and acceptance of services to be provided.

LCDR. James Speitel, 757-953-7612, email: james.d.speitel.mil@mail.mil

Inspection and acceptance will be performed at the assigned location according to the Special Requirements.

START-UP PERIOD

It is intended to make award of the resultant contract in time may allow up to a fifteen (15) day start-up period in advance of the actual commencement of the performance period. The contractor shall make all necessary preparations, during this start-up period, to assume full responsibility for contract performance as of the contract start date. It is noted that invoicing by the contractor will begin as of the commencement of services and no reimbursement will be paid by the Government for efforts expended during the start-up period.

TASK ORDERS

Task orders may be placed by any warranted contracting officer serving at the Naval Medical Logistics Command.

Task orders against this contract may be placed by mail, facsimile, or through electronic commerce including email in accordance with the terms and conditions of the contract.

The period of performance of any task order shall be of one year or less in duration.

ORDERING TERMS

Pursuant to FAR 16.5, the Contractor agrees to the following terms of the proposed Indefinite Delivery Indefinite Quantity (IDIQ) Firm Fixed Price (FFP) contract exclusively with the Naval Medical Logistics Command (NMLC).

Exact item descriptions available through this IDIQ FFP contract are specified in attachment titled, List of Items.

Exact quantities and delivery requirements are not known in advance and may vary considerably per order.

All delivery orders placed against this IDIQ FFP contract are subject to the terms and conditions set forth within or as noted below:

1. In accordance with FAR 16.505(a)(6), orders placed under indefinite delivery contracts must contain the following information:

(i) Date of order

(ii) Contract number and order number

(iii) For supplies and services, contract item number and description, quantity, and unit price or estimated cost or fee

(iv) Delivery or performance schedule

(v) Place of delivery or performance (including consignee)

(vi) Any packaging, packing, and shipping instructions

(vii) Accounting and appropriation data

(viii) Method of payment and payment office, if not specified in the contract (see FAR 32.1110 (e)).

2. Special clauses shall be included, when required, on a delivery order basis and agreed to with contractor.

3. Warranty Terms: All products shall be covered by the standard commercial warranty of the contractor.

4. Delivery and Mark For Terms: Delivery shall be F.O.B. Destination within the continental United States, or as stated in each order. The Mark For Instructions shall be included in each order.

5. This IDIQ FFP contract does not obligate any funds. The Government is obligated only to the extent that an authorized delivery order is issued, while also meeting the minimum quantity as state within this IDIQ FFP.

6. This IDIQ FFP contract expires 30 September 2024, unless terminated in accordance with FAR 52.212-4.

7. The following office is hereby authorized to place delivery orders under this IDIQ FFP contract:

NAVAL MEDICAL LOGISTICS COMMAND Code 05 693 Neiman Street Fort Detrick MD 21702-9203

8. Maximum Order Limitations: a. Maximum Order Limitation : The total ordering limit for all delivery orders under this IDIQ over the period of performance is $5,504,472. This IDIQ has a $1,000.00 guaranteed minimum per FAR 16.504.

9. Delivery orders shall be placed against this IDIQ contract via electronic mail, facsimile, or paper.

10. Invoicing and Shipping Instructions. The following invoicing instructions will appear on each delivery order:

a. The delivery orders written from this IDIQ FFP contract will be paid via Wide Area Work Flow (WAWF). See each delivery order for invoicing.

b. Please ship and bill complete. Partial ship and partial pay may be authorized per delivery order. TAX EXEMPT 30005004.

ITEM NO SUPPLIES/SERVICES MAX

QUANTITY

UNIT UNIT PRICE MAX AMOUNT

0001 1 Lot

RADIOPHARMACEUTICAL SUPPLIES

FFP

See attached list of supplies and associated prices.

Ordering Period: 10/01/2019 - 9/30/2024 FOB: Destination

PSC CD: 6505

MAX

NET AMT

CONTRACT MINIMUM/MAXIMUM QUANTITY AND CONTRACT VALUE

The minimum quantity and contract value for all orders issued against this contract shall not be less than the minimum quantity and contract value stated in the following table. The maximum quantity and contract value for all orders issued against this contract shall not exceed the maximum quantity and contract value stated in the following table.

MINIMUM MINIMUM MAXIMUM MAXIMUM

QUANTITY AMOUNT QUANTITY AMOUNT

1.00 $1,000.00 1.00 $5,508,472.02

DELIVERY/TASK ORDER MINIMUM/MAXIMUM QUANTITY AND ORDER VALUE

The minimum quantity and order value for each Delivery/Task Order issued shall not be less than the minimum quantity and order value stated in the following table. The maximum quantity and order value for each Delivery/Task Order issued shall not exceed the maximum quantity and order value stated in the following table.

MINIMUM MINIMUM MAXIMUM MAXIMUM

QUANTITY AMOUNT QUANTITY AMOUNT

1.00 $1,000.00 1.00 $1,100,000.00

CLIN DELIVERY/TASK ORDER MINIMUM/MAXIMUM QUANTITY AND CLIN ORDER VALUE

The minimum quantity and order value for the given Delivery/Task Order issued for this CLIN shall not be less than the minimum quantity and order value stated in the following table. The maximum quantity and order value for the given Delivery/Task Order issued for this CLIN shall not exceed the maximum quantity and order value stated in the following table.

MINIMUM MINIMUM MAXIMUM

CLIN QUANTITY AMOUNT QUANTITY

MAXIMUM

AMOUNT

0001 $

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination

DELIVERY INFORMATION

Government Destination Government

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 POP 01-OCT-2019 TO 30-

SEP-2024

N/A NAVAL MEDICAL CENTER -

PORTSMOUTH

620 JOHN PAUL JONES CIRCLE

PORTSMOUTH VA 23708-2197

FOB: Destination

N00183

CLAUSES INCORPORATED BY REFERENCE

52.203-3 Gratuities APR 1984 52.204-9 Personal Identity Verification of Contractor Personnel JAN 2011 52.204-13 System for Award Management Maintenance OCT 2018 52.204-18 Commercial and Government Entity Code Maintenance JUL 2016 52.204-19 Incorporation by Reference of Representations and DEC 2014

Certifications.

52.204-21 Basic Safeguarding of Covered Contractor Information JUN 2016

Systems 52.204-25 Prohibition on Contracting for Certain Telecommunications AUG 2019 and Video Surveillance Services or Equipment.

52.212-4 Contract Terms and Conditions--Commercial Items OCT 2018

52.219-9 (Dev) Small Business Subcontracting Plan (Deviation 2018-O0018) AUG 2018 52.219-9 Alt II Small Business Subcontracting Plan (Deviation 2018-O0018) AUG 2018

(Dev) - Alternate II 52.228-5 Insurance - Work On A Government Installation JAN 1997 52.232-40 Providing Accelerated Payments to Small Business DEC 2013

Subcontractors 252.201-7000 Contracting Officer's Representative DEC 1991 252.203-7000 Requirements Relating to Compensation of Former DoD SEP 2011

Officials 252.203-7002 Requirement to Inform Employees of Whistleblower Rights SEP 2013 252.204-7000 Disclosure Of Information OCT 2016 252.204-7003 Control Of Government Personnel Work Product APR 1992

252.204-7009 Limitations on the Use or Disclosure of Third-Party OCT 2016 Contractor Reported Cyber Incident Information

252.204-7012 Safeguarding Covered Defense Information and Cyber OCT 2016 Incident Reporting

252.205-7000 Provision Of Information To Cooperative Agreement Holders DEC 1991 252.209-7004 Subcontracting With Firms That Are Owned or Controlled By MAY 2019

The Government of a Country that is a State Sponsor of Terrorism 252.219-7003 Small Business Subcontracting Plan (DOD Contracts) MAY 2019

252.223-7006 Prohibition On Storage, Treatment, and Disposal of Toxic or SEP 2014 Hazardous Materials

252.225-7012 Preference For Certain Domestic Commodities DEC 2017 252.225-7048 Export-Controlled Items JUN 2013 252.226-7001 Utilization of Indian Organizations and Indian-Owned APR 2019

Economic Enterprises, and Native Hawaiian Small Business Concerns

252.232-7003 Electronic Submission of Payment Requests and Receiving DEC 2018 Reports

252.232-7010 Levies on Contract Payments DEC 2006 252.243-7001 Pricing Of Contract Modifications DEC 1991 252.243-7002 Requests for Equitable Adjustment DEC 2012 252.244-7000 Subcontracts for Commercial Items JUN 2013 252.247-7023 Transportation of Supplies by Sea FEB 2019

CLAUSES INCORPORATED BY FULL TEXT

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL ITEMS (OCT 2018)

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

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

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

"Forced or indentured child labor" means all work or service-

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

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

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

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

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

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

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

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

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

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

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

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

(8) PSC 9610, Ores;

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

(10) PSC 9630, Additive Metal Materials.

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

“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 serviceconnected, 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 stock of which 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 its stock is owned by one or more women; or

(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 in SAM.

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

[Offeror to identify the applicable paragraphs at (c) through (u) of this provision that the offeror has completed for the purposes of this solicitation only, if any.

These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted electronically on SAM.]

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

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

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

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

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

(6) WOSB concern eligible under the WOSB Program. [Complete only if the offeror represented itself as a womenowned 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.

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

(8) Women-owned business concern (other than small business concern). (Complete only if the offeror is a womenowned 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) Certifications and 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 either to the Equal

Opportunity clause of this solicitation, the 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 Subparts 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:

[List as necessary]

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

Line Item No. Country of Origin

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

(2) Buy American Act-Free Trade Agreements-Israeli Trade Act Certificate, Alternate I (Jan 2004). 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.

(3) Buy American-Free Trade Agreements-Israeli Trade Act Certificate, Alternate II (Jan 2004). 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:

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

(g)(1)(ii) The offeror certifies that the following supplies are Free Trade Agreement country end products (other than 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 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 if both of the following criteria apply:

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

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

(ii) Examples.

(A) The taxpayer has received a statutory notice of deficiency, under I.R.C. §6212, which entitles the taxpayer to seek Tax Court review of a proposed tax deficiency. This is not a delinquent tax because it is not a final tax liability.

Should the taxpayer seek Tax Court review, this will not be a final tax liability until the taxpayer has exercised all judicial 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 if the IRS determines to sustain the lien filing. In the course of the hearing, the taxpayer is entitled to contest the underlying tax liability because the taxpayer has had no prior opportunity to contest the liability. This is not a delinquent tax because it is not a final tax liability. Should the taxpayer seek tax court review, this will not be a final tax liability until the taxpayer has exercised all judicial appeal rights.

(C) The taxpayer has entered into an installment agreement 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 11 U.S.C. §362 (the Bankruptcy Code).

(i) Certification Regarding Knowledge of Child Labor for Listed End Products (Executive Order 13126). [The Contracting Officer must list in paragraph (i)(1) 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 22.1503(b).]

(1) Listed end products.

Listed End Product Listed Countriesof Origin

(2) Certification. [If the Contracting Officer has identified end products and countries of origin in paragraph (i)(1) of this provision, then the offeror must certify to either (i)(2)(i) or (i)(2)(ii) by checking the appropriate block.]

[ ___ ] (i) The offeror will not supply any end product listed in paragraph (i)(1) of this provision that was mined, produced, or manufactured in the corresponding country as listed for that product.

[ ___ ] (ii) The offeror may supply an end product listed in paragraph (i)(1) of this provision that was mined, produced, or manufactured in the corresponding country as listed for that product. The offeror certifies that it 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 predominantly—

(1) (…