1074542.doc

Subject: Laboratory Equipment

Solicitation Number: FDA1074542 Part 1 – Description

THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6-STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS-AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION; QUOTATIONS ARE BEING REQUESTED, AND A WRITTEN SOLICITATION DOCUMENT WILL NOT BE ISSUED. THIS SOLICITATION IS BEING ISSUED USING SIMPLIFIED ACQUISITION PROCEDURES FAR PART 13.

The associated North American Industrial Classification System (NAICS) code for this procurement is 112519 and is a small business set aside with a size standard of .75 million.

This is a RFQ Primates- Rhesus Monkeys. The FDA intends to issue a firm fixed-price purchase order for Primates- Rhesus Monkeys that meets or exceeds the following specifications described in Part 2.

Part 2 – Supplies or services and Prices/Costs

2. Description of Supplies & Services

2.1. The FDA has a requirement for Primates- Rhesus Monkeys.

2.2. Contract Type

2.2.1. Firm-Fixed Price Contract.

2.1.3 CLIN0001 FY 10, Rhesus Monkeys EA:____________

2.1.4 CLIN0002 FY 11, Rhesus Monkeys EA:____________

2.1.5 CLIN0003 Shipping round trip, Rhesus Monkeys EA___________

Total order not to exceed 50 time dated pregnant females (29 male fetuses and 21 female fetuses)

Part 3 – Description/Specifications/Work Statement

3. Background and Objectives

3.1 Objective:

It is believed that the non-human primate is closest to humans in predicting behavior and response to drugs. Rhesus monkeys will be exposed, beginning at birth, to Bisphenol-A (BPA) via infant formula and reared in a nursery environment with around-the-clock care. At 7 months of age, BPA exposure will continue via drinking water for the duration of the study and animals will begin cognitive assessments using the National Center for Toxicological Research (NCTR) Operant Test Battery (OTB). Tasks in the OTB have been designed to model specific aspects of cognitive function and include: color and position discrimination; learning; short-term memory; timing ability and motivation. These assessments will continue daily (M-F) for the duration of the study (to six years of age). These studies in rhesus monkeys will clarify the relationship of the rodent findings to humans and allow for the use of a lower uncertainty factor in the analysis of the risk. If negative findings are noted in rodent studies, this study could also be used to clarify whether there is the potential for a species-specific response in humans.

3.2 Project requirements:

3.2.1 This requirement will facilitate the efficient procurement and testing of nonhuman primates as detailed in the statement of work (SOW) which should meet the specifications as described herein. The contractor shall provide and deliver the primates as requested in as many shipments as required, with the shipping expense defined ‘per animal’ and not as ‘a lot’, with orders meeting the specifications described in the purchase order. The origin of the rhesus monkeys can be either Indian or Chinese, but once the first order is shipped all subsequent shipments must include animals of the same origin.

3.3 Specifications:

3.3.1 All shipments shall contain timed mated - sexed pregnancies at 90 -110 days of pregnancy.

Monkeys shall be received at the Government site some time between the 90th and 110th day of gestation and shall remain at the Government facility for a period no longer than 30 after birthing, at which time the animals will be shipped back to the contractor. Contractor must notify the Government of the sex of the offspring in utero prior to shipping. The contractor will coordinate the return of mothers shipping back to contractor within 30 days of birthing. If termination of pregnancy is premature and the offspring is not of a serviceable condition for this protocol, then the contractor assumes all responsibility for the welfare (disposal/return) of this undesirable outcome.

3.3.2 All monkeys shall be examined by a licensed, accredited veterinarian and documented on health certificate APHIS form 7020. Veterinarian must determine all monkeys to be in good health prior to shipping. Prior to shipping back to contractor a Government veterinarian will examine and determine monkeys to be in good health. Health records and documentation shall accompany each monkey.

3.3.3 All monkeys shall test negative with documentation for the following pathogens before shipping:

a. Tuberculosis (a negative TB shall be confirmed just prior to shipping)

b. Cercopithecine herpes virus 1 (B virus)

c. SRV/D (Simian Retrovirus type D)

d. SIV (Simian Immunodeficiency Virus)

e. STLV-1 (Simian T-Lymphotropic Virus-1)

3.3.4 Monkeys must be tested for Shigella, Salmonella, Campylobacter, Yersinia, and helminth & pathogenic protozoal parasites. Treatment regimens for any monkeys testing positive for these organisms must be discussed with the Government before initiation of treatment. If treatment has begun before contract award this must be reported to the Government prior to shipping. Animals that begin testing for these parasites will not automatically be disqualified for shipping.

Part 4 – Packing, Marking and Shipping

4.1 All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor Name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

4.2 Shippers must comply with Animal Welfare Act Regulations regarding the transportation standards for nonhuman primates Title 9, subchapter A Part 3 “Transportation Standards.

The contractor shall be responsible for meeting all requirements associated with shipment and delivery of animals. The contractor shall maintain liaison with carrier personnel in order to assure the animals receive proper care in accordance with USAD standards and AAALAC guidelines during transit. The contractor shall submit to the Project Officer by phone the proposed shipment schedule and method of transport no less than 72 hours prior to shipment.

Animals shall be delivered in properly ventilated escape-proof crates furnished by the contractor(s). Each animal shall be situated in a separate compartment for delivery purposes. Only clean uncontaminated crates shall be used in transporting the animals. Each crate shall be marked with the delivery address, purchase request number, contract number and animal identification.

Part 5 – Inspection and Acceptance

5. The Contracting Officer’s Technical Representative (COTR) will perform inspection and acceptance of materials and services to be provided.

5.1. For the purpose of this PART, (COTR – to be determined upon contract award) is the authorized representative of the Contracting Officer.

5.2. Inspection and acceptance will be performed at: the locations identified in 6.1.3. Acceptance is communicated in writing unless otherwise indicated in writing by the Contracting Officer or COTR within 30 days of receipt..

5.3. This contract incorporates the following clause, 52.246-2 Inspection of Supplies-Fixed Price (Aug 1996) by reference, with the same force and effect as if it was given in full text. Upon request, the Contracting Officer will make its full text available.

Part 6 – Deliveries or Performance

6. Deliveries

6.1.1. Satisfactory performance of this contract shall be deemed to occur upon performance of the work described in the Statement of Work in PART 3 of this contract and upon delivery and acceptance by the Contracting Officer, or the COTR, of the services, plans and reports required at the dates specified within PART 3 of this contract.

6.1.2. Deliveries required by the contractor shall be made F.O.B. destination to the address/addressee listed below:

6.1.3. Delivery Point:

FDA

3900 NCTR Road Jefferson, AR 72079

6.1.4. Unless otherwise specified, deliveries shall be made to the Delivery Point specified above, Monday through Friday (excluding Federal Holidays, see PART 8) between the hours of 8:30 a.m. and 5:30 p.m. EASTERN TIME only. Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day.

6.1.5 We can accept ‘up to’ 20 animals per shipment (if the vendor can only provide 7 animals in the first shipment and then 4 animals in a shipment two months later, this is acceptable as long as we have no more than 20 animals on premises at one time). The return shipments will emulate the incoming shipments as to the animals return to the vendor. Program Office with coordinate shipping dates with contractor.

Part 7 – Contract Administration Data

7. Contracting Officers Technical Representative (COTR)

7.1. The following COTR will represent the Government for the purpose of this contract: (To Be Determined Upon Contract Award)

7.1.1. The COTR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

7.1.2. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the RFQ; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

7.1.3. The contact information for the Contract Specialist is:

George Gonzalez

5630 Fishers Lane, RM 2067

Rockville, MD 20857

George.gonzalez@fda.hhs.gov

7.2. INVOICE SUBMISSION

7.2.1. Pursuant to the provisions of the following FAR Clauses: 52.232-25 Prompt Payment; 52.232-33, Payment by Electronic Funds Transfer – Central Contractor Registration; the Contractor shall submit invoices for costs incurred and claimed for reimbursement in accordance with the following instructions.

7.2.1.1. In accordance with clause 52.232-33 all payments made under this contract shall be made using electronic funds transfer through the Automated Clearing House (ACH). The Contractor shall provide the following information to the Food and Drug Administration, Office of Financial Management, Systems Accounting Branch, HFA-120, 5600 Fishers Lane, Rockville, MD 20857 no later than 14 days prior to submission of the first invoice:

· FDA contract number Name and address of contractor

· Invoice date and invoice number

· Contract number including task order number and contract line item number

· Description, quantity, unit of measure, unit price, and extended price of supplies delivered or services performed

· Shipping and payment terms

· Name and address of contractor official to whom payment is to be sent

· Taxpayer Identification Number

· Electronic Funds Transfer (EFT) banking information (if required in the contract) Routing transit number of the financial institution receiving payment.

· Contractor’s DUNS number

7.2.1.2. An original shall be submitted via email to the attention of the designated Contract Specialist at the following address:

HHS/FDA/OAGS/DAO

5630 Fishers Lane

Rockville, MD 20857

Attention: George Gonzalez, Contract Specialist

7.2.2. Final payments will occur upon verification by the FDA Project Officer and the FDA Technical Advisor, noting successful integration and proper functionality of the laboratory equipment.

7.2.3. Payment will be made after acceptance and receipt of a proper invoice, and in accordance with the pricing matrix described in Pricing Terms.

7.2.3.1. Payment will be made on a firm fixed price basis in accordance with the pricing matrix.

7.3. Government Furnished Property

7.3.1.1. No Government Furnished Property shall be provided to the Contractor for this requirement.

Part 8 – Special Contract Requirements

8. Government Holidays

8.1.1. Workplace is not available on the Government Holidays stated below, or as prescribed by an Executive Order (EO) or OPM.gov due to inclement weather.

January

(New Year’s Day)

January

(Martin Luther King Day)

February (President’s Day)

May

(Memorial Day)

July

(Independence Day)

September (Labor Day)

October (Columbus Day)

November (Veterans Day)

November (Thanksgiving)

December (Christmas Day)

8.1.2 Liability coverage – All non-human primates transported in conjunction with this contract must be adequately insured for the complete replacement cost of the animal and have liability coverage (this will be the responsibility of the contractor). All animal transports in conjunction with this contract shall be insured for the full replacement cost of each animal. Project Officer shall be provided with certificates of insurance prior to shipping.

8.1.3 `Animal guarantee – All animal that are provided to the FDA through this contract shall guarantee in accordance with the requirements for thirty days (30) from date of delivery. The vendor shall at no extra cost to the government replace any animal that does not perform in accordance with this contract.

8.1.4 Replacement of an undesirable product shall be within 6 months of original shipment.

8.1.5 Each return shipment will be of the same number of animals that were originally shipped to the government, i.e. 3 were in original shipment, 3 will be returned within 30 days after delivery, given that the animals are in good health and able to travel. The veterinarian on site has stated that the animals can be ready for shipment 5 days after delivery, so if we were sent 3 animals with the following criteria:

Animal #1 at 90 day gestation

Animal #2 at 100 day gestation

Animal #3 at 110 day gestation

All animals can be returned in one shipment 5 days after Animal #3 gives birth. Hence all three animals would be shipped back within 30 days of delivering a desirable offspring. If however, the offspring is not of the stated sex or is stillborn, etc. then the vendor will be liable for replacement of the undesirable product. In addition, the contract needs to state the cost of shipping a single animal and not as a bulk shipment, as each shipment may have a different number of animals.

Part 9 – Contract clauses

9. FAR Clauses Incorporated by Reference

9.1. 52.252-2 Clauses Incorporated by Reference (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at: www.acquisition.gov/far/index.html

52.212-4 Contract Terms and Conditions-Commercial Items (Mar 2009)

52.203-5, Covenant Against Contingent Fees (Apr 1984).

52.203-7, Anti-Kickback Procedures (Jul 1995).

52.216-24, Limitation of Government Liability (Apr 1984).

52.219-6, Notice of Total Small Business Set-Aside (June 2003) (15 U.S.C. 644)

52.222-50, Combating Trafficking in Persons (Feb 2009)

52.233-2, Service of Protest (Sep 2006)

52.233-3, Protest after Award (Aug 1996)

52.243-1, Changes—Fixed Price (Aug 1987)

52.247-35, F.O.B. Destination Within Consignees Premises (April 1984)

9.2. FAR Clauses by Full Text

52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items.

As prescribed in 12.301(b)(4), insert the following clause:

Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (Apr 2010)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)).

___Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)).

(2) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(3) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Pub. L. 108-77, 108-78).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.]

__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 253g and 10 U.S.C. 2402).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (MAR 2009) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

__ (4) 52.204-11, American Recovery and Reinvestment Act—Reporting Requirements (Mar 2009) (Pub. L. 111-5).

__ (5) 52.219-3, Notice of Total HUBZone Set-Aside (Jan 1999) (15 U.S.C. 657a).

__ (6) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (July 2005) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (7) [Reserved]

_X (8)(i) 52.219-6, Notice of Total Small Business Set-Aside (June 2003) (15 U.S.C. 644).

__ (ii) Alternate I (Oct 1995) of 52.219-6.

__ (iii) Alternate II (Mar 2004) of 52.219-6.

__ (9)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

__ (ii) Alternate I (Oct 1995) of 52.219-7.

__ (iii) Alternate II (Mar 2004) of 52.219-7.

__ (10) 52.219-8, Utilization of Small Business Concerns (May 2004) (15 U.S.C. 637(d)(2) and (3)).

__ (11)(i) 52.219-9, Small Business Subcontracting Plan (Apr 2008) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (Oct 2001) of 52.219-9.

__ (iii) Alternate II (Oct 2001) of 52.219-9.

_X (12) 52.219-14, Limitations on Subcontracting (Dec 1996) (15 U.S.C. 637(a)(14)).

__ (13) 52.219-16, Liquidated Damages—Subcon-tracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

__ (14)(i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (Oct 2008) (10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer).

__ (ii) Alternate I (June 2003) of 52.219-23.

__ (15) 52.219-25, Small Disadvantaged Business Participation Program—Disadvantaged Status and Reporting (Apr 2008) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

__ (16) 52.219-26, Small Disadvantaged Business Participation Program— Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

__ (17) 52.219-27, Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside (May 2004) (15 U.S.C. 657 f).

_X (18) 52.219-28, Post Award Small Business Program Representation (Apr 2009) (15 U.S.C. 632(a)(2)).

_X (19) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

_X (20) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Aug 2009) (E.O. 13126).

_X (21) 52.222-21, Prohibition of Segregated Facilities (Feb 1999).

_X (22) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

_X (23) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212).

_X (24) 52.222-36, Affirmative Action for Workers with Disabilities (Jun 1998) (29 U.S.C. 793).

_X (25) 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212).

_X (26) 52.222-54, Employment Eligibility Verification (Jan 2009). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

__ (27)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (28) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

__ (29)(i) 52.223-16, IEEE 1680 Standard for the Environmental Assessment of Personal Computer Products (Dec 2007) (E.O. 13423).

__ (ii) Alternate I (Dec 2007) of 52.223-16.

_X (30) 52.225-1, Buy American Act—Supplies (Feb 2009) (41 U.S.C. 10a-10d).

__ (31)(i) 52.225-3, Buy American Act—Free Trade Agreements—Israeli Trade Act (June 2009) (41 U.S.C. 10a-10d, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, Pub. L. 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, and 110-138).

__ (ii) Alternate I (Jan 2004) of 52.225-3.

__ (iii) Alternate II (Jan 2004) of 52.225-3.

__ (32) 52.225-5, Trade Agreements (Aug 2009) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X (33) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (34) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

__ (35) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

__ (36) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

__ (37) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

__ (38) 52.232-33, Payment by Electronic Funds Transfer—Central Contractor Registration (Oct 2003) (31 U.S.C. 3332).

__ (39) 52.232-34, Payment by Electronic Funds Transfer—Other than Central Contractor Registration (May 1999) (31 U.S.C. 3332).

__ (40) 52.232-36, Payment by Third Party (Feb 2010) (31 U.S.C. 3332).

__ (41) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

__ (42)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).

__ (ii) Alternate I (Apr 2003) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.]

__ (1) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.).

__ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 1989) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

__ (3) 52.222-43, Fair Labor Standards Act and Service Contract Act—Price Adjustment (Multiple Year and Option Contracts) (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

__ (4) 52.222-44, Fair Labor Standards Act and Service Contract Act—Price Adjustment (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

_X (5) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (Nov 2007) (41 351, et seq.).

__ (6) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services—Requirements (Feb 2009) (41 U.S.C. 351, et seq.).

__ (7) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub. L. 110-247).

__ (8) 52.237-11, Accepting and Dispensing of $1 Coin (Sept 2008) (31 U.S.C. 5112(p)(1)).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records—Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).

(ii) 52.219-8, Utilization of Small Business Concerns (May 2004) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $550,000 ($1,000,000 for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iii) [Reserved]

(iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

(v) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212).

(vi) 52.222-36, Affirmative Action for Workers with Disabilities (June 1998) (29 U.S.C. 793).

(vii) [Reserved]

(viii) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.).

(ix) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)).

_X Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)).

(x) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (Nov 2007) (41 U.S.C. 351, et seq.).

(xi) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements (Feb 2009) (41 U.S.C. 351, et seq.).

(xii) 52.222-54, Employment Eligibility Verification (Jan 2009).

(xiii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub. L. 110-247). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xiv) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

9.3. HHSAR Clauses

352.202-1 Definitions (January 2006)

(a) In accordance with 52.202–1(a)(1), substitute the following as paragraph (a):

‘‘(a) The term ‘‘Secretary’’ or ‘‘Head of the Agency’’ (also called ‘‘Agency Head’’) means the Secretary, Deputy Secretary, or any Assistant Secretary, Administrator or Commissioner of the Department of Health and Human Services; and the term ‘‘his/her duly authorized representative’’ means any person, persons, or board authorized to act for the Secretary.’’

(b) In accordance with 52.202–1(a)(1), add the following paragraph (h):

‘‘(h) The term ‘‘Project Officer’’ means the person who monitors the technical aspects of contract performance. The Project Officer is not authorized to issue any instructions or directions which cause any increase or decrease in the scope of work which would result in the increase or decrease in the price of this contract, or changes in the delivery schedule or period of performance of this contract. If applicable, the Project Officer is not authorized to receive or act upon any notification or revised cost estimate provided by the Contractor in accordance with the Limitation of Cost or Limitation of Funds clauses of this contract.’’

352.232-9 Withholding of contract payments (January 2006)

Notwithstanding any other payment provisions of this contract, failure of the Contractor to submit required reports when due or failure to perform or deliver required work, supplies, or services, may result in the withholding of payments under this contract unless such failure arises out of causes beyond the control, and without the fault or negligence of the Contractor as defined by the clause entitled ‘‘Excusable Delays’’ or ‘‘Default’’, as applicable. The Government shall immediately notify the Contractor of its intention to withhold payment of any invoice or voucher submitted.

352.233-70 Litigation and claims (January 2006)

The Contractor shall provide written notification immediately to the Contracting Officer of any action, including any proceeding before an administrative agency, filed against the Contractor arising out of the performance of this contract, including, but not limited to the performance of any subcontract hereunder; and any claim against the Contractor the cost and expense of which is allowable under the clause entitled ‘‘Allowable Cost and Payment.’’ Except as otherwise directed by the Contracting Officer, the Contractor shall furnish immediately to the Contracting Officer copies of all pertinent papers received by the Contractor with respect to such action or claim. To the extent not in conflict with any applicable policy of insurance, the Contractor may, with the Contracting Officer’s approval, settle any such action or claim. If required by the Contracting Officer, the Contractor shall effect an assignment and subrogation in favor of the Government of all the Contractor’s rights and claims (except those against the Government) arising out of any such action or claim against the Contractor; and authorize representatives of the Government to settle or defend any such action or claim and to represent the Contractor in, or to take charge of, any action. If the settlement or defense of an action or claim is undertaken by the Government, the Contractor shall furnish all reasonable assistance in effecting a settlement or asserting a defense. Where an action against the Contractor is not covered by a policy of insurance, the Contractor shall, with the approval of the Contracting Officer, proceed with the defense of the action in good faith. The Government shall not be liable for the expense of defending any action or for any costs resulting from the loss thereof to the extent that the Contractor would have been compensated by insurance which was required by law or regulation or by written direction of the Contracting Officer, but which the Contractor failed to secure through its own fault or negligence. In any event, unless otherwise expressly provided in this contract, the Contractor shall not be reimbursed or indemnified by the Government for any liability loss, cost or expense, which the Contractor may incur or be subject to by reason of any loss, injury or damage, to the person or to real or personal property of any third parties as may accrue during, or arise from, the performance of this contract.

352.242-71 Final decisions on audit findings (Apr. 1984)

For the purpose of issuing final decisions under the Disputes clause of this contract concerning monetary audit findings, the Contracting Officer shall be that person with ultimate responsibility for making that decision in accordance with Chapter 1-105, Resolution of Audit Findings, of the Department's Grants Administration Manual.

352.249-14 Excusable delays (January 2006)

(a) Except with respect to failures of subcontractors, the Contractor shall not be considered to have failed in performance of this contract if such failure arises out of causes beyond the control and without the fault or negligence of the Contractor.

(b) Such causes may include, but are not restricted to, acts of God or of the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, freight embargoes, and unusually severe weather, but in every case the failure to perform must be beyond the control and without the fault or negligence of the Contractor. If the failure to perform is caused by the failure of a subcontractor to perform, and if such failure arises out of causes beyond the control of both the Contractor and subcontractor, and without the fault or negligence of either of them, the Contractor shall not be deemed to have failed in performance of the contract, unless:

(1) The supplies or services to be furnished by the subcontractor were obtainable from other sources,

(2) The Contracting Officer ordered the Contractor in writing to procure such supplies or services from such other sources, and

(3) The Contractor failed to comply with such order. Upon request of the Contractor, the Contracting Officer shall ascertain the facts and extent of such failure and if the Contracting Officer determines that any failure to perform was caused by circumstances beyond the control and without the fault or negligence of the Contractor, the delivery schedule shall be revised accordingly, subject to the rights of the Government under the termination clause contained in this contract. (As used in this clause, the terms ‘‘subcontractor’’ and ‘‘subcontractors’’ mean subcontractor(s) at any tier.)

352.270–10 Anti-lobbying (January 2006)

Pursuant to the current HHS annual appropriations act, except for normal and recognized executive-legislative relationships, the Contractor shall not use any HHS contract funds for (i) publicity or propaganda purposes; (ii) the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television or video presentation designed to support or defeat legislation pending before the Congress or any State legislature, except in presentation to the Congress or any State legislature itself; or (iii) payment of salary or expenses of the Contractor, or any agent acting for the Contractor, related to any activity designed to influence legislation or appropriations pending before the Congress or any State legislature.

Part 10 – List of Attachments

· Reserved Part 11 – Instructions to the Offerors

11. Offeror Instructions Questions Deadline: All questions shall be received by email (george.gonzalez@fda.hhs.gov) before 4:30 pm (1630) EASTERN TIME on 23 July 2010.

RFQ Due Date: All quotes and revisions shall be submitted via email and be received by 4:30 PM (1630) Eastern Time on 30 July 2010.

11.1. Quote Format

The cover letter shall include price (s); FOB point; a poc (name and telephone number); a statement from the offeror verifying that they are CCR Registered under NAICS code 112519; delivery date (delivery date is of the utmost importance); business size; and payment terms.

11.2. Technical Proposal

The Offeror shall address these factors as follows:

11.2.1. Factor 1: Technical Capability – Sub-factors are of equal weight

11.2.2. The Offeror shall provide documentation that they are an authorized distributor/reseller.

11.3. Price Proposal

11.3.1. Factor 2: Price

11.3.2. The Offeror shall submit a complete pricing matrix for a firm fixed price as indicated in PART 2,.

11.3.3. The Government expects quantity discounts when proposing. Offerors are encouraged to propose a discount off their current pricing for the additional quantities identified in

CLINS. The discount proposed by the selected vendor for a CLIN will be applicable to and applied to any orders placed during the 1 year period of performance.

PART 12 – Evaluation Factors for Award

12. Evaluation Factors The offeror’s ability to demonstrate/describe the following factors as noted in PART 11.

12.1. Factor 1: Price

12.1.1. The price proposal shall represent the Offeror’s response to the requirements of the solicitation. The Offeror ability to submit a complete pricing matrix for a firm fixed-price as indicated in PART 2, 2.3.

12.1.2. 3. Past Performance will be used on a pass fail basis.

Evaluation Award Criteria:

The Government will evaluate the quote to ensure that it is technical acceptable in accordance with the requirements in PART 3 and that the price is fair and reasonable from the Offeror. FDA intends to make an award soon after the response date of this notice and all quotes and revisions shall be submitted via email and be received by 4:30 PM (1630) Eastern Time on 30 July 2010 to the attention of George Gonzalez, george.gonzalez@fda.hhs.gov. Offerors shall ensure the RFQ number is visible in the header of the email.

Fax quotes shall not be accepted.

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