RFQ Posting 1105005.doc

RFQ- FDA-1105005

REQUEST FOR QUOTATION

Part 1: Description

THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERICAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT I PART SUBPART 12.6 – STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERICAL ITEMS - AS SUPPLEMENTED WITH ADDITIONAL INFORMATON INCLUDED IN THIS NOTICE. THIS ANNOUNCMENT CONSTITUTES THE ONLY SOLICITATION: QUOTATION ARE BEING REQUESTED, AND A WRITTEN SOLICITATION DOCUMENT WILL NOT BE ISSUED. THIS SOLICITATION IS BEING ISSUED USING SIMPLIFIED ACQUISITION PROCEDURES 13.5.

This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-60.

This is an RFQ to purchase 708-DS (Dissolution System) for Apparatus 5 6 with Autosampler.

This requirement is for Full and Open Competition. The associated North American Industrial Classification System (NAICS) code for this procurement is 333298.

PART 2: Supplies and Price/Costs The government anticipates a firm fixed price order.

2.1 Pricing:

Total

PART 3: Technical Requirements

3.1 Background

The FDA, Division of Product Quality Research conducts research on assessing the quality and safety of drug products. One of the on-going research activities is to assess the quality of transdermal drug delivery systems. The research involves preparation of transdermal patches on a laboratory scale to study the influence of product and process variables on quality and safety. One of the requirements is to test the dissolution characteristics of transdermal patches, which in turn plays an important role in transdermal drug permeation. The testing procedure needs to be carried out for at least 24 hours with multiple sampling times. Manual sampling is both tedious as well as leads to large error. Furthermore, the working times within FDA do not favor to withdraw samples throughout the day for 24 hours. Thus, the 708-DS (Dissolution System) for Apparatus 5/6 requires an autosampler with all essential accessories to run dissolution testing with automatic sample withdrawal for longer periods of time.

3.2 Functional Specifications

0001: Dissolution apparatus 708-DS with 8-position dosage delivery module, 8 1-TruAlign vessels and 8 receptor shafts

In addition to dissolution apparatus 708-DS with 8-position dosage delivery module, this component has 8 TruAlign vessels and 8 receptor shafts. This has three components including drying chamber, electric box and coating device). There shall be a sampling manifold with temperature control.

0002: Spin On/Off Paddle E-Polished

There shall be 8 number of spin on/off paddles with e-polished, and shall be compatible to work with item 1.

0003: VK8000 autosampler including Syringe Pump and related accessories for use with 708-DS Dissolution System

This autosampler shall be able to work with 708-DS dissolution system and its dosage delivery modules (item 1). It shall be also provided with a syringe pump to withdraw precise and accurate samples from the dissolution vessels.

0004: AccKit 8000,6/8 Valve,16x100mm Tray

This is a sample tray that shall fit with autosampler (Item 3) to hold the dissolution samples with drawn from dissolution apparatus (item 1).

0005: Dissolution 708DS Apparatus Enhanced features

The enhanced features of 708-DS (Dissolution System) for Apparatus 5/6 shall have Classic Qualification OQ, Classic Qualification IQ and Performance Qualification to obtain valid data.

Part 4 – Packing, Marking and Shipping

4. 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.

4.1. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

Part 5 – Inspection and Acceptance

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

5.1. For the purpose of this PART, (COR – 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 COR within 30 days of receipt.

5.2.1. System installation by authorized service engineer at FDA site. The installer of the laboratory instrument shall test the equipment to ensure that it is fully functional before FDA accepts the delivery.

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: Delivery Schedule 6.1 Delivery Location

FDA, White Oak Campus 10903 New Hampshire Avenue WO Building 62 Loading Dock

Silver Spring, Maryland 20993

6.2 The contractor shall deliver the instrument within 90 days after receipt of award (ARO).

PART 7: CONTRACT ADMINISTRATION

Contracting OFFICERS REPRESENTATIVE (COR)

7.1.

The following COR will represent the Government for the purpose of this contract: (To be determined upon contract award)

7.1.1.

The COR 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 COR contact information shall be provided at the time of award.

7.1.3.

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.

7.1.4.

The contact information for the Contracting Officer:

Doreen Williams

Doreen.Williams@fda.hhs.gov

301-827-3366

7.1.5 The contact information for the Contract Specialist:

Lacetta T. Bowman

Lacetta.Bowman@fda.hhs.gov

301-827-6790

PART 8: INVOICING INSTRUCTIONS

8.1 INVOICING INSTRUCTIONS

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

1. Name and address of the Offeror

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.

PART 9: FAR CLAUSES BY FULL TEXT

52.212-3 Offeror Representations and Certifications—Commercial Items.

Offeror Representations and Certifications—Commercial Items (Nov 2011)

An offeror shall only complete paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. If an offeror has not completed the annual representations and certifications electronically at the ORCA website, the offeror shall complete only paragraphs (c) through (m) of this provision 52.252-2 Clauses Incorporated by Reference This contract incorporates one of 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 http://www.arnet.gov

(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:

__ (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 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

__ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Feb 2012) (Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (5) 52.204-11, American Recovery and Reinvestment Act—Reporting Requirements (Jul 2010) (Pub. L. 111-5).

__ (6) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Dec 2010) (31 U.S.C. 6101 note).

__ (7) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jan 2012) (41 U.S.C. 2313).

__ (8) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (section 740 of Division C of Pub. L. 111-117, section 743 of Division D of Pub. L. 111-8, and section 745 of Division D of Pub. L. 110-161).

__ (9) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

_X_ (10) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Jan 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (11) [Reserved]

__ (12)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C. 644).

__ (ii) Alternate I (Nov 2011).

__ (iii) Alternate II (Nov 2011).

__ (13)(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.

__ (14) 52.219-8, Utilization of Small Business Concerns (Jan 2011) (15 U.S.C. 637(d)(2) and (3)).

__ (15)(i) 52.219-9, Small Business Subcontracting Plan (Jan 2011) (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.

__ (iv) Alternate III (Jul 2010) of 52.219-9.

__ (16) 52.219-13, Notice of Set-Aside of Orders (Nov 2011)(15 U.S.C. 644(r)).

__ (17) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)).

__ (18) 52.219-16, Liquidated Damages—Subcon-tracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

__ (19)(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.

__ (20) 52.219-25, Small Disadvantaged Business Participation Program—Disadvantaged Status and Reporting (Dec 2010) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

__ (21) 52.219-26, Small Disadvantaged Business Participation Program— Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

__ (22) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657 f).

__ (23) 52.219-28, Post Award Small Business Program Rerepresentation (Apr 2009) (15 U.S.C. 632(a)(2)).

__ (24) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Apr 2012) (15 U.S.C. 637(m)).

__ (25) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Apr 2012) (15 U.S.C. 637(m)).

_X_ (26) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

_X_ (27) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Mar 2012) (E.O. 13126).

X__ (28) 52.222-21, Prohibition of Segregated Facilities (Feb 1999).

_X_ (29) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

X__ (30) 52.222-35, Equal Opportunity for Veterans (Sep 2010)(38 U.S.C. 4212).

_X_ (31) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793).

_X_ (32) 52.222-37, Employment Reports on Veterans (Sep 2010) (38 U.S.C. 4212).

__ (33) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

__ (34) 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.)

__ (35)(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.)

_X_ (36) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

__ (37)(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.

__ (38) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513).

__ (39) 52.225-1, Buy American Act—Supplies (Feb 2009) (41 U.S.C. 10a-10d).

__ (40)(i) 52.225-3, Buy American Act—Free Trade Agreements—Israeli Trade Act (Mar 2012) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, Pub. L. 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, and Pub. L. 112-41).

__ (ii) Alternate I (Mar 2012) of 52.225-3.

__ (iii) Alternate II (Mar 2012) of 52.225-3.

__ (iv) Alternate III (Mar 2012) of 52.225-3.

__ (41) 52.225-5, Trade Agreements (Mar 2012) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

__ (42) 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).

__ (43) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

__ (44) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

__ (45) 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)).

__ (46) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

__X (47) 52.232-33, Payment by Electronic Funds Transfer—Central Contractor Registration (Oct 2003) (31 U.S.C. 3332).

__ (48) 52.232-34, Payment by Electronic Funds Transfer—Other than Central Contractor Registration (May 1999) (31 U.S.C. 3332).

__ (49) 52.232-36, Payment by Third Party (Feb 2010) (31 U.S.C. 3332).

__ (50) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

__ (51)(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.).

__ (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 (Dec 2010) (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 $650,000 ($1.5 million 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 Veterans (Sep 2010) (38 U.S.C. 4212).

(vi) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793).

(vii) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(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.

HHSAR Clauses Incorporated by Reference 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: http://www.gpoaccess.gov/cfr/index.html.

352.202-1, Definitions (Jan 2006) 352.203-70, Anti-Lobbying (January 2006) 352.215-70, Late proposals and revisions (Jan 2006)

352.223-70, Safety and health (Jan 2006)

352.224-70, Privacy Act (January 2006) 352.228-7, Insurance--Liability to third persons (Dec 1991)

352.242-71, Tobacco-free Facilities (January 2006) 352.242-73, Withholding of Contract Payments (January 2006)

352.270-10 Anti-lobbying (Jan 2006)

PART 10: INSTRUCTIONS TO OFFERORS

10.1 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:

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:

52.212-1, Instructions to Offerors - Commercial Items (June 2008)

An offeror shall complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. If an offeror has not completed the annual representations and certifications electronically at the ORCA website, the offeror shall complete only paragraphs (c) through (m) of this provision.

52.212-3, Offeror Representations and Certifications - Commercial Items (Aug 2009)

All questions shall be submitted to Lacetta Bowman via email at Lacetta.Bowman@fda.hhs.gov. Questions are due no later than Thursday, August 16, 2012, 1:00PM Eastern Time.

All quotes shall be submitted to Lacetta Bowman via email at

Lacetta.Bowman@fda.hhs.gov. Quotes are due no later than Monday, Aug 20, 2012, 3:00 PM Eastern Time. Offerors shall ensure the RFQ number is visible in the header of the email.

Faxed quotes shall not be accepted.

10.2 Quote Format

The cover letter shall include; FOB point; a POC (name and telephone number); a statement from the offeror verifying that they are SAM Registered under NAICS code 334516; business size; and payment terms.

10.3 Technical Capability:

8.3.1 The contractor shall demonstrate that they can provide all of the items listed under the technical requirements in Part 3.

8.3.2 The offeror shall demonstrate that they can deliver all the items according to Part 4 Delivery Schedule.

10.4

Past Performance:

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

10.5 Price Proposal

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

PART 11: EVALUATION FACTORS

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.

11.1 Technical Capability:

9.1.1 The contractor has demonstrated they can provide all of the items listed under the technical requirements in Part 3.

9.1.2 The offeror meets the requirement to deliver all of the items according to Part 4 Delivery Schedule.

11.2 Past Performance: The offeror meets and has demonstrated the past performance requirement.

11.3 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 the contract. In addition, this evaluation will include an assessment of the Offeror’s proposal for completeness, realism, reasonableness and risk.

PAGE