FDA-SOL-1071399 v3.doc

Solicitation: FDA-SOL-1071399

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 full and open competition solicitation; proposals are being requested and a written solicitation will not be issued. Simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-43.

Solicitation number FDA-SOL- 1071399 is issued as a Request for Quotation (RFQ).

This synopsis, NAICS code 541380, size standard $12.0, is to notify contractors that the government intends to issue a Single Award Indefinite Delivery Indefinite Quantity (IDIQ) Contract in accordance with FAR Part 15 for the following statement of work. Any firm that believes it is capable of providing the required service as stated herein may submit a proposal. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary.

PART 2

SERVICES AND PRICES/COSTS

2.1

DESCRIPTION OF SERVICES

The Department of Health and Human Services, Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN), requires chemical analysis services.

2.2

CONTRACT CEILING

The contract minimum ceiling amount will be the value of the first order over five years (5). The contract maximum ceiling amount will be $9,000,000.00 over five (5) years.

2.3

PLACEMENT OF TASK ORDERS

When contractual services are required under this contract to perform chemical analysis, the Government will issue a task order. The Contracting Officer (CO) will provide a written request for task order proposal (RTOP) document to the Contractor describing the task project. Task orders against this contract will be placed in writing, by means of a written task order. The Contracting Officer or his/her designee is/are the only person(s) authorized to place these orders. The Contractor shall provide the required services in accordance with Part Three, Statement of Work and the individual Task Orders.

2.4

PRICING

The price chart below outlines all of the chemicals that shall be analyzed throughout the life of the contract. The analytical methods provided are required by the FDA for the corresponding chemical tests described. The analytical methods left blank shall be provided by the contractor. Price per test shall be based on the chemical test described and the analytical method.

Analytical Method

*Footnotes in

Part 3.5.E Price per Test

Base YR

PART 3

STATEMENT OF WORK –

Chemical Analysis Services

3.1

INTRODUCTION

To better protect the U.S. food supply, the Center for Food Safety and Applied Nutrition (CFSAN) and its various offices nationwide, including the Office of Regulatory Science (ORS), the Office of Food Safety (OFS), the Office of Food Additive Safety (OFAS), the Office of Compliance (OC) has the need to obtain information about the levels of chemicals in a wide variety of foods, dietary supplements and cosmetics, through the collection of food, dietary supplement and cosmetic samples, and their subsequent analysis by chemical analytical methods to be specified by CFSAN.

In addition, CFSAN and its offices have the need to obtain third party validation of methods developed at CFSAN for the analysis of chemicals in foods, dietary supplements and cosmetics.

Finally, CFSAN has the need for services by which chemical standards, not available through current commercial vendors, can be synthesized to meet the needs of analytical methods that require internal standards by the FDA.

3.3

BACKGROUND

In order to support the FDA’s overall mission, CFSAN is required to produce information about the nature of chemical contaminants in food. Over the past several years, the agency has faced a wide range of issues related to direct and indirect contamination of food that have required information the levels of specific chemicals. In many cases, the type of information required is a survey of the levels of contaminants in order to provide CFSAN with information necessary to formulate policy and to assess potential risks. In the past, this information has been provided by scientists within CFSAN: 1) through small scale in-house surveys; 2) through contracts with outside laboratories and 3) through surveys conducted by the FDA’s Office of Regulatory Affairs. The information from these surveys is not used for direct regulatory action, but is instead used to make decisions about scientific issues associated with food safety problems and to guide policy. This information was used to inform the agency about the nature of acrylamide levels in food, and was followed up in 2003 by a larger study, done by a contract laboratory which established the levels of acrylamide in a larger set of representative types of foods. This information was used to develop guidance about ways to reduce the occurrence of melamine in foods. Future studies will examine how guidance and policy have affected the levels of this chemical in foods.

3.4 Scope

The first principal objective of this contract will be to develop a capability to support CFSAN research by rapidly assessing the quantities of specified chemicals in foods, dietary supplements, and cosmetics through surveys of these commodities. The purpose of these surveys will be to develop a better understanding of the quantities of chemicals and their distribution. The types of samples to be collected for these studies will include food products from across the United States, including to fresh fruits and produce, packaged and processed foods of all types, dietary supplements and cosmetics. The analytical targets of these studies will include chemical contaminants in foods (e.g. pesticides, industrial chemicals), direct food additives, indirect food additives (those produced by processing or transfer from packaging), deliberate adulterants, nutrients, naturally occurring chemical components (such as metals), as well as the chemical constituents of dietary supplements, botanical extracts and cosmetics. The analytical methodology for any specified study will be established and provided by CFSAN, and will include methods based upon state-of-the-art analytical techniques, including many based on instrumental analysis with various types of separation techniques and spectrometers.

3.5

TECHNICAL REQUIREMENTS

Chemical Analysis: CFSAN will specify the types of samples, quantities (between 50 and 1000), analytical methodology and data reporting requirements with each specified task.

The contract is required to:

A. Collect raw, minimally processed (e.g. bagged), and processed/package foods, dietary supplements and cosmetics from local supermarkets and stores in major metropolitan areas in some parts of the United States. Cities chosen may include the metropolitan areas of Atlanta, Chicago, Dallas, Denver, Los Angeles, New York, San Francisco, Seattle and Washington, DC. CFSAN will specify the type of commodity, the brand distribution, lot number and manufacturing date distribution, quantity and geographic location of the samples. While the geographic distribution is not expected to be extensive, the ability to obtain samples from major metropolitan areas is required.

B. Perform analysis for specified chemicals in the samples collected for CFSAN, using methods specified by CFSAN at the time of order. In some cases, the samples will be provided directly by CFSAN. CFSAN may provide proficiency samples for analysis with the specified sample sets. CFSAN will provide complete details of the specified methods, which may include some of the following:

1. Sample preparation methodologies

a. sample grinding with genogrinders and related food sample preparation technology

b. cryogrinding

c. liquid-liquid extraction, solid phase extraction,

d. dispersed solid-phase extraction

e. solid phase microextraction

f. immunoaffinity extraction,

g. other related techniques.

2. Analytical methods to be employed in these studies may include:

a. Gas chromatography (GC) with flame ionization or electron capture detection

b. Gas chromatography/mass spectrometry (GC/MS)

c. GC/tandem mass spectrometry (MS/MS and multiple reaction monitoring-MRM)

e. Liquid chromatography (LC)/UV-Visible spectrophotometry

f. LC/Fluorescence

g. LC/light scattering

h. LC/mass spectrometry

i. LC/tandem mass spectrometry (MS/MS and Multiple reaction monitoring)

k. inductively coupled plasma mass spectrometry (ICP-MS)

l. Enzyme-linked immunoassay (ELISA) ands related methods

3. The following analytical instrumentation shall be employed in one or all of the task orders:

a. gas chromatographs (GC)

b. mass spectrometers (MS)

c. tandem mass spectrometers (MS/MS)

d. liquid chromatographs (LC)

e. fluorescence detectors (FL)

f. light scattering detectors (ELS)

g. inductively couple plasma atomic emission (ICP/AE)

h. inductively coupled plasma mass spectrometers (ICP/MS)

i. infrared spectrometers (IR)

j. UV-visible spectrometers (UV-vis) C. Data reporting

1. Reports with appropriate statistical analysis, as specified in the assigned analytical method provided in Part 2.4 “pricing”, will be provided to CFSAN after completion of the assigned task. Description of report format and content shall be specified at the time of order.

D. Accreditation

Vendor shall possess an ISO 17025 Accreditation or the equivalent.

E. The following footnotes provided are for informational purposes regarding the analytical methods required.

1. FDA method specified in “Rugged LC-MS/MS Survey Analysis for Acrylamide in Foods”, J. A. G. Roach,* D. Andrzejewski, M. L. Gay, D. Nortrup, S. M. Musser, J. Agric. Food Chem. 2003, 51, 7547-7554.

2. Microwave digestion combined with inductively coupled plasma mass spectrometry (ICP-MS).

3. Headspace or solid-phase microextraction gas chromatography-mass spectrometry with stable isotope labeled standards.

4. Method specified in “Determination of Bisphenol A in U.S. Infant Formulas: Updated Methods and Concentrations”Luke K. Ackerman, Gregory O. Noonan, Wendy M. Heiserman, John A. Roach, William Limm and Timothy H. Begley J. Agric. Food Chem., 2010, 58 (4), pp 2307–2313.

5. FDA Interim Method for Determination of Melamine and Cyanuric Acid Residues in Foods Using LC-MS/MS: LIB No. 4422 or equivalent.

3.6

PLACE OF PERFORMANCE

The services shall be performed at the contractor(s) facility.

3.7

PERIOD OF PERFORMANCE

The period of performance is one base year and 4 option years.

PART 4

PACKAGING AND MARKING

RESERVED

PART 5

INSPECTION AND ACCEPTANCE

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

Description

Date 52.246-4

Inspection of Services—Fixed-Price

(AUG 1996)

PART 6

DELIVERIES OR PERFORMANCE

Deliverables shall be established through the individual task orders.

PART 7

CONTRACT ADMINISTRATION DATA

7.1 CONTRACTING OFFICER’S TECHNICAL REPRESENTATICE (COTR)

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.

7.2 CONTRACT ADMINISTRATION

7.2.1 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.

Doreen Williams

Contracting Officer

Doreen.Williams@fda.hhs.gov 301-827-3366

Ariana Nijaradze

Contract Specialist

Ariana.Nijaradze@fda.hhs.gov 301-827-7161

7.3

CONTRACTOR REPRESENTATIVE

The Contractor's representative shall be responsible for all contract administration issues and shall act as the central point of contact with the FDA. The representative shall have full authority to act for the Contractor in all contractual matters.

Name:

Email:

Telephone:

PART 8

SPECIAL CONTRACT REQUIREMENTS

8.1 HHSAR CLAUSES

This contract incorporates one or more clauses by reference, noted in Title 48, Federal Acquisition Regulations System, 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: http://www.gpoaccess.gov/cfr/index.html.

HHSAR Clause

352.202-1

Definitions

(Jan 2006)

352.215-70

Late proposals and revisions

352.223-70

Safety and health

352.224-70

Confidentiality of information

(Jan 2006)

352.228-7

Insurance--Liability to third persons

(Dec 1991)

352.232-9

Withholding of contract payments

(Jan 2006)

352.233-70

Litigation and claims

352.242-71

Final decisions on audit findings

(Apr 1984)

352.249-14

Excusable delays

352.270-1 Accessibility of meetings, conferences, and seminars to persons with disabilities

(Jan 2001)

352.270-10

Anti-lobbying

352.270-11

Privacy Act

352.270-13

Tobacco-free facilities

8.2 INVOICING

The Contractor shall submit invoices to the Contract Specialist and the FDA COTR concurrently via email. To constitute a proper invoice, the invoice must be submitted on company letterhead and include:

1. Name and address of the Contractor

2. Invoice date and invoice number

3. Purchase order number

4. Description, Quantity, Unit of Measure, Unit Price, and Extended Price of supplies delivered

5. Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading

6. Terms of any discount for prompt payment offered

7. Name and address of official to whom payment is to be sent (Must be the same as that in the purchase order or in a proper notice of assignment)

8. Name, title, and phone number of person to notify in event of defective invoice

9. Taxpayer identification number

10. Electronic Funds Transfer (EFT) banking information

11. Name and telephone number of the FDA COR referenced on the purchase order

12. Any other information or documentation required by the purchase order

An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in 1-12 of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

Questions relating to when payment will be received should be directed to the FDA payment office at 301.413.0450.

PART 9

CONTRACT CLAUSES

9.1 52.216-22 Indefinite Quantity (OCT 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the “maximum.” The Government shall order at least the quantity of supplies or services designated in the Schedule as the “minimum.”

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor’s and Government’s rights and obligations with respect to that order to the same extent as if the order were completed during the contract’s effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after contract expiration.

9.2 52.217-8 Option to Extend Services (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor any time prior to the contract expiration date.

9.3 52.217-9 Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within anytime prior to contract expiration.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 years.

9.4 52.252-2 Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at: www.acquisition.gov/far/index.html tc “52.203-3 Gratuities. APR 1984 “ \l 2

52.212-4 Contract Terms and Conditions - Commercial Items

(MAR 2009)

9.5 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (JUL 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:

x_ (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).

_x (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)).

_x (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]

__ (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.

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

__ (13) 52.219-16, Liquidated Damages—Subcontracting 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).

__ (18) 52.219-28, Post Award Small Business Program Rerepresentation (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).

__ (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).

__ (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)).

_x (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:

__ (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.).

__ (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)).

___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.

PART 10

LIST OF ATTACHMENTS

RESERVED

PART 11

REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS OR RESPONDENTS

11.1 52.204-8 Annual Representations and Certifications (FEB 2009)

(a)(1) The North American Industry Classification System (NAICS) code for this acquisition is 541380.

(2) The small business size standard is $12 Million.

(3) The small business size standard for a concern which submits an offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it did not itself manufacture, is 500 employees.

(b)(1) If the clause at 52.204-7, Central Contractor Registration, is included in this solicitation, paragraph (d) of this provision applies.

(2) If the clause at 52.204-7 is not included in this solicitation, and the offeror is currently registered in CCR, and has completed the ORCA electronically, the offeror may choose to use paragraph (d) of this provision instead of completing the corresponding individual representations and certifications in the solicitation. The offeror shall indicate which option applies by checking one of the following boxes:

[x ] (i) Paragraph (d) applies.

[ ] (ii) Paragraph (d) does not apply and the offeror has completed the individual representations and certifications in the solicitation.

(c)(1) The following representations or certifications in ORCA are applicable to this solicitation as indicated:

(i) 52.203-2, Certificate of Independent Price Determination. This provision applies to solicitations when a firm-fixed-price contract or fixed-price contract with economic price adjustment is contemplated, unless—

(A) The acquisition is to be made under the simplified acquisition procedures in Part 13;

(B) The solicitation is a request for technical proposals under two-step sealed bidding procedures; or

(C) The solicitation is for utility services for which rates are set by law or regulation.

(ii) 52.203-11, Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions. This provision applies to solicitations expected to exceed $100,000.

(iii) 52.204-3, Taxpayer Identification. This provision applies to solicitations that do not include the clause at 52.204-7, Central Contractor Registration.

(iv) 52.204-5, Women-Owned Business (Other Than Small Business). This provision applies to solicitations that—

(A) Are not set aside for small business concerns;

(B) Exceed the simplified acquisition threshold; and

(C) Are for contracts that will be performed in the United States or its outlying areas.

(v) 52.209-5, Certification Regarding Responsibility Matters. This provision applies to solicitations where the contract value is expected to exceed the simplified acquisition threshold.

(vi) 52.214-14, Place of Performance—Sealed Bidding. This provision applies to invitations for bids except those in which the place of performance is specified by the Government.

(vii) 52.215-6, Place of Performance. This provision applies to solicitations unless the place of performance is specified by the Government.

(viii) 52.219-1, Small Business Program Representations (Basic & Alternate I). This provision applies to solicitations when the contract will be performed in the United States or its outlying areas.

(A) The basic provision applies when the solicitations are issued by other than DoD, NASA, and the Coast Guard.

(B) The provision with its Alternate I applies to solicitations issued by DoD, NASA, or the Coast Guard.

(ix) 52.219-2, Equal Low Bids. This provision applies to solicitations when contracting by sealed bidding and the contract will be performed in the United States or its outlying areas.

(x) 52.222-22, Previous Contracts and Compliance Reports. This provision applies to solicitations that include the clause at 52.222-26, Equal Opportunity.

(xi) 52.222-25, Affirmative Action Compliance. This provision applies to solicitations, other than those for construction, when the solicitation includes the clause at 52.222-26, Equal Opportunity.

(xii) 52.222-38, Compliance with Veterans’ Employment Reporting Requirements. This provision applies to solicitations when it is anticipated the contract award will exceed the simplified acquisition threshold and the contract is not for acquisition of commercial items.

(xiii) 52.223-1, Biobased Product Certification. This provision applies to solicitations that require the delivery or specify the use of USDA–designated items; or include the clause at 52.223-2, Affirmative Procurement of Biobased Products Under Service and Construction Contracts.

(xiv) 52.223-4, Recovered Material Certification. This provision applies to solicitations that are for, or specify the use of, EPA–designated items.

(xv) 52.225-2, Buy American Act Certificate. This provision applies to solicitations containing the clause at 52.225-1.

(xvi) 52.225-4, Buy American Act—Free Trade Agreements—Israeli Trade Act Certificate. (Basic, Alternate I, and Alternate II) This provision applies to solicitations containing the clause at 52.225-3.

(A) If the acquisition value is less than $25,000, the basic provision applies.

(B) If the acquisition value is $25,000 or more but is less than $50,000, the provision with its Alternate I applies.

(C) If the acquisition value is $50,000 or more but is less than $67,826, the provision with its Alternate II applies.

(xvii) 52.225-6, Trade Agreements Certificate. This provision applies to solicitations containing the clause at 52.225-5.

(xviii) 52.225-20, Prohibition on Conducting Restricted Business Operations in Sudan—Certification.

(xix) 52.226-2, Historically Black College or University and Minority Institution Representation. This provision applies to—

(A) Solicitations for research, studies, supplies, or services of the type normally acquired from higher educational institutions; and

(B) For DoD, NASA, and Coast Guard acquisitions, solicitations that contain the clause at 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns.

(2) The following certifications are applicable as indicated by the Contracting Officer:

__ (i) 52.219-19, Small Business Concern Representation for the Small Business Competitiveness Demonstration Program.

__ (ii) 52.219-21, Small Business Size Representation for Targeted Industry Categories Under the Small Business Competitiveness Demonstration Program.

__ (iii) 52.219-22, Small Disadvantaged Business Status.

__ (A) Basic.

__ (B) Alternate I.

__ (iv) 52.222-18, Certification Regarding Knowledge of Child Labor for Listed End Products.

__ (v) 52.222-48, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment Certification.

__ (vi) 52.222-52, Exemption from Application of the Service Contract Act to Contracts for Certain Services–Certification.

__ (vii) 52.223-9, with its Alternate I, Estimate of Percentage of Recovered Material Content for EPA–Designated Products (Alternate I only).

__ (viii) 52.223-13, Certification of Toxic Chemical Release Reporting.

__ (ix) 52.227-6, Royalty Information.

__ (A) Basic.

__(B) Alternate I.

__ (x) 52.227-15, Representation of Limited Rights Data and Restricted Computer Software.

(d) The offeror has completed the annual representations and certifications electronically via the Online Representations and Certifications Application (ORCA) website at http://orca.bpn.gov. After reviewing the ORCA database information, the offeror verifies by submission of the offer that the representations and certifications currently posted electronically that apply to this solicitation as indicated in paragraph (c) of this provision have been entered or updated within the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201); except for the changes identified below [offeror to insert changes, identifying change by clause number, title, date]. 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.

FAR Clause # Title Date Change

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 on ORCA.

PART 12

INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS OR RESPONDENTS

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

52.204-6

Data Universal Numbering System (DUNS) Number

(APR 2008)

52.215-1

Instructions to Offerors— Competitive Acquisition

(JAN 2004)

12.2 52.216-1 Type of Contract (APR 1984)

The Government contemplates award of Single Award Indefinitely Delivery Indefinite Quantity (IDIQ) contract with fixed price task orders.

12.3 Response Instructions All questions shall be submitted to Ariana Nijaradze via email at Ariana.Nijaradze@fda.hhs.gov.

Questions are due no later than 5 August 2010, 4:30PM Eastern Time.

All quotes and revisions shall be submitted to Ariana Nijaradze via email at

Ariana.Nijaradze@fda.hhs.gov.

Quotes and all revisions are due no later than 12 August 2010, 4:30PM Eastern Time.

Offerors shall ensure the RFQ number is visible in the header of the email.

Faxed quotes shall not be accepted.

12.4 Quote Format

The cover letter shall include; FOB point; a POC (name and telephone number); a statement from the offeror verifying that they are CCR Registered under NAICS code 541380; delivery date (delivery date is of the utmost importance); business size; and payment terms.

12.5 Factor 1: Technical Capability. Subfactors 1 and 2 are of equal importance and more important than the remaining subfactors. Subfactors 3 and 4 are of equal importance.

The offeror shall demonstrate they can meet or exceed all of the capabilities listed in the Technical Requirements, Part 3, 3.5.

12.5.1 The offeror shall demonstrate their capability to perform the specific standard analyses outlined in the pricing table (or a close equivalent, which shall be noted in the response to the solicitation). If no method is specified, then the vendor may specify their own method).

12.5.2 The offeror shall demonstrate their capability to analyze a wide array of additional chemical contaminants in food, cosmetics and dietary supplements. Capability shall be demonstrated by generating an alphabetized list of chemical contaminants and corresponding analysis methodology, detection limits and typical costs per sample.

12.5.3 The offeror shall demonstrate their capability to collect specified food, cosmetic, or dietary supplement samples from major cities in the United States, including metropolitan areas on the western U.S. (for example, Los Angeles, San Francisco or Seattle), the mid-west (for example, Chicago, St. Louis, Dallas or Denver), and the east coast (for example, Washington, DC, New York, Boston, Or Atlanta). Demonstrated capability to receive food samples shipped from the FDA.

12.5.4 The offeror shall demonstrate their capability to employ a wide array of sample preparation methods and analytical instrumentation in food, cosmetics and dietary supplements analysis. Capability shall be demonstrated by supplying a list of sample processing methodologies and analytical instrumentation available for use in food, cosmetics and dietary supplements analysis, with particular attention to those outlined in the technical requirements section, but also including any additional capabilities deemed relevant for foods, cosmetics and dietary supplements analysis.

12.6 Factor 2: Past Performance:

The offeror shall submit three references for work performed during the last three years that demonstrate satisfactory performance.

12.7 Factor 3: Relevant Experience:

The contractor shall demonstrate that they have provided the same or similar experience by providing three references for commensurate projects in accordance with the statement of work that are in progress or were completed within the past three (3) years, in up to three occasions to a Federal, State, or local government agency or private industry.

12.8 Price Proposal:

The Offeror shall submit a complete firm-fixed price per test and sample collection pricing matrix as indicated in PART 2, 2.4 “Pricing”.

PART 13

EVALUATION FACTORS FOR AWARD

13.1 Award will be made to the party whose quote offers the best value to the Government. The Government may award this contract to other than the lowest price technically acceptable quote.

Technical Capability and Past Performance combined are significantly more important than price. When all other factors are equal, price becomes the determining factor. The FDA intends to make an award soon after the response date of this notice.

The offeror’s ability to demonstrate the following factors as noted in PART 12.

13.2.

FAR Provisions Incorporated by Reference

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

52.217-5

Evaluation of Options

(JUL 1990)

13.3 Factor 1: Technical Capability. Subfactors 1 and 2 are of equal importance and more important than the remaining subfactors. Subfactors 3 and 4 are of equal importance.

The offeror shall demonstrate they can meet all of the capabilities listed in the Technical Requirements, Part 3, 3.5.

13.3.1 The offeror meets or exceeds the capability to perform the specific standard analyses outlined in the pricing table according to the methods noted in the table (or a close equivalent, which must be noted in the response to the solicitation). If no method is specified, then the vendor may specify their own method).

13.3.2 The offeror meets or exceeds the capability to analyze a wide array of additional chemical contaminants in food, cosmetics and dietary supplements. Capability shall be demonstrated by generating an alphabetized list of chemical contaminants and corresponding analysis methodology, detection limits and typical costs per sample (with volume discounts indicated if applicable).

13.3.3 The offeror meets or exceeds the capability to collect specified food, cosmetic, or dietary supplement samples from major cities in the United States, including metropolitan areas on the western U.S. (Los Angeles, San Francisco or Seattle), the mid-west (Chicago, St. Louis, Dallas or Denver), and the east coast (Washington , DC, New York, Boston, Or Atlanta). Other cities may be included, but must be major metropolitan areas. Demonstrated capability to receive food samples shipped from the FDA.

13.3.4 The offeror meets or exceeds the capability to employ a wide array of sample preparation methods and analytical instrumentation in food, cosmetics and dietary supplements analysis.

13.4 Factor 2: Past performance:

The contractor shall demonstrate that they can meet past performance requirement.

13.5 Factor 3: Relevant Experience:

The contractor shall demonstrate that they can meet or exceed the relevant experience requirement.

13.6 Price Proposal:

The price proposal shall represent the Offeror’s response to the requirements of the solicitation. The Government will evaluate the total price of all base and option years contract line items. In addition, this evaluation will include an assessment of the Offeror’s proposal for completeness, realism, reasonableness and risk.

� For the purposes of this solicitation, “survey” is defined as the collections of a general or specific sub group of products and analyze them for specific chemical analyses. For example, determine the concentration of bisphenol A in canned infant formulas produced in the US. Surveys are undertaken in order to acquire information about contaminants in food outside of direct regulatory action.

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