Solicitation_FDA-2014-SOL_1134643.doc

COMBINED SYNOPSIS/SOLICITATION: FDA-2014-SOL-1134643

Company Name/ADDRESS:

DUNS Number:

Subject - Hip Simulator Study of Mal-Positioned Hard-On-Hard Hip Replacements to Aid Regulatory Science and Standards Development.

The U. S Food & Drug Administration, Office of Acquisitions and Grants Services is requesting quotes to conduct a “Hip Simulator Study of Mal-Positioned Hard-On-Hard Hip Replacements To Aid Regulatory Science And Standards Development”.

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in 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. This solicitation is issued as a Request For Quotations (RFQ), using the Simplified Acquisitions Procedures of FAR 13. The solicitation document/incorporated provisions and clauses are those in effect through the current Federal Acquisition Circular: FAC 2005 - 74.

The associated North American Industry Classification System (NAICS) Code is-541711 Research and Development in Biotechnology.

Part 1 – Background/Description

The primary objective of this project is to procure the services of a contractor who has expertise in designing, piloting, and executing hip simulator tests on hard-on-hard bearings in accordance with the attached Statement of Work (Attachment 1). The contractor must complete the pricing sheet attached to this RFQ (Attachment 2 - Request For Pricing).

Part 2 - STATEMENT OF WORK (SOW)/SPECIFICATIONS

2.1 The contractor must meet the qualifications provided in the statement of work, in order to participate in this project. See Attachment 1.

2.2 TASKS

The FDA intends to accomplish the following tasks within one year of the initiation of this project:

Task 1(a): Protocol Design Contractor shall collaborate with CDRH to identify the combination of input parameters to yield a wear test that will meet the CDRH stated goals. Both teams will then collaborate to finalize a testing protocol.

Task 1(b): Fixture Design and Manufacture

Contractor shall collaborate with CDRH to design and manufacture test fixtures to hold all MoM total hip bearings during hip simulator testing. These fixtures will include specially designed femoral taper components that mimic currently marketed devices.

Task 1(c): Pre-Test Analysis

Contractor shall ensure that all test specimens have been subjected to pre-test measurements, such as coordinate measuring machine (CMM) analysis and surface roughness analysis. This analysis will include detailed measurements of taper angles of both femoral head components and taper fixtures.

Task 1(d): Adverse Hip Simulator Wear Study

Contractor shall perform hip joint simulation (totaling 3 to 5 million cycles) on a number of MoM bearings (minimum n=6) using wear model(s) determined in 1a, likely incorporating steeply inclined cups and third-body particles. This study will help determine how effective such a test will be in re-creating high clinical wear rates.

Task 1(e): Peer Reviewed Journal Submission

Contractor shall collaborate with CDRH to combine all test results into a journal article submission(s) for peer review.

2.4 Reports:

2.4.1 The contractor shall submit Quarterly Reports provided to the COR (on dates TBD prior to award).

2.4.2 The contractor shall also submit a final report (on date TBD prior to award). The final report shall summarize accomplishments and knowledge gained and project future next steps in the continuation of the work.

Part 3 – Packing, Marking and Shipping:

3. At a minimum, all deliverables shall be marked with the solicitation number and contractor’s name.

3.1. The contractor shall deliver all items related to this requirement at the following address:

Food and Drug Administration Division of Physics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, 10903 New Hampshire Avenue, Building 62, Silver Spring

MD 20993.

Part 4 – Inspection and Acceptance:

4. The Contracting Officer’s Representative (COR– TBD upon contract award) will perform inspection and acceptance of materials and services to be provided. Invoices shall be submitted on a monthly basis for review and approval by the COR (See Part 6 for invoicing instructions).

4.1. For the purpose of this PART, (COR) is the authorized representative of the Contracting Officer.

4.2. Inspection and acceptance will be performed at: the locations identified in 3.1. Acceptance is communicated in writing unless otherwise indicated in writing by the Contracting Officer or COR within 30 days of receipt.

4.3. 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 5 – Contract Administration Data

5. Contracting Officer’S Representative (COR)

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

5.1.1. 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.

5.1.2. 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.

5.1.3. The contact information for the Contracting Specialist is:

Emmanuel T. Mbah 5630 Fishers Lane

Room 2142 Rockville, MD 20857

Emmanuel.mbah@fda.hhs.gov Part 6 - Instructions to the Offerors.

6.1 Response Dates.

RFQ Due Date: All quotes and revisions shall be submitted via email (Emmanuel.mbah@fda.hhs.gov) before 12:00 PM Eastern Time on July 30, 2014. Offerors shall ensure that the RFQ number is visible in the header of the email. Fax quotes shall not be accepted. All questions relating to this solicitation shall be submitted in writing via email only. no phone calls shall be permitted.

6.2 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/CCR Registered under NAICS Code 541711; delivery date (delivery date is of the utmost importance); business size; and payment terms.

6.3 Contract Type.

Commercial Type - Firm Fixed Price

Part 7 – Contract clauses.

This solicitation incorporates the following provisions and clauses.

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:

52.204-7, Central Contractor Registration (Jul 2013).

52.212-1, Instructions to Offerors - Commercial Items (Apr 2014).

52.212-2, Evaluation-Commercial Items (Jan 1999) is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (1) of that provision are as follows (See Part 8):

52.212-3, Offeror Representations and Certifications - Commercial Items (Nov 2013).

52.212-4, Contract Terms and Conditions-Commercial Items (May 2014).

52.212-5, Contract Terms and Conditions Required to implement Statutes or Executive Orders-Commercial Items. (May 2014). As prescribed in 12.301(b)(4), insert the following clause:

(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).

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 (Jun 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 (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note).

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

X (6) 52.209-6, Protecting the Government Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Aug 2013) (31 U.S.C. 6101 note).

___ (7) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).

X (8) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (section 740 of Division C of Public Law 111-117, section 743 of Division D of Public Law 111-8, and section 745 of Division D of Public Law 110-161). (May 2012) ___ (9) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a). ___ (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 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).

___ (i) Alternate I (Oct 1995) of 52.219-7.

___ (ii) Alternate II (Mar 2004) of 52.219-7.

___ (14) 52.219-8, Utilization of Small Business Concerns (Jul 2013) (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 2010) of 52.219-9.

___ (iv) Alternate III (July 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, Subcontracting 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).

___ (i) Alternate I (June 2003) of 52.219-23.

___ (20) 52.219-25, Small Disadvantaged Business Participation Program, Disadvantaged Status and Reporting (Jul 2013) (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. 657f).

___ (23) 52.219-28, Post Award Small Business Program Re-representation (Jul 2013) (15 U.S.C. 632(a)(2)).

___ (24) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business Concerns (Jul 2013).

___ (25) 52.219-30, Notice of Set-Aside for Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Jul 2013).

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

X (27) 52.222-19, Child Labor, Cooperation with Authorities and Remedies (Jan 2014) (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).

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

X (34) 52.222-54, Employment Eligibility Verification (Aug 2013). (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.)

___ (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).

X (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 (Nov 2012) (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 (Mar 2012) of 52.225-3.

___ (iii) Alternate II (Nov 2012) of 52.225-3.

___ (41) 52.225-5, Trade Agreements (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

X (42) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 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 (Jul 2013) (31 U.S.C. 3332).

___ (48) 52.232-34, Payment by Electronic Funds Transfer, Other Than Central Contractor Registration (Jul 2013) (31 U.S.C. 3332).

___ (49) 52.232-36, Payment by Third Party (Jul 2013) (31 U.S.C. 3332).

X (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 (Feb 2006) 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 U.S.C. 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.).

The following additional FAR clauses cited in this clause are applicable: 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.222-51, 52.225-1, 52.225-13, and 52.232-33.

The following additional provisions and/or clauses apply:

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.

52.232-40 – Providing Accelerated Payments to Small Business Subcontractors (Dec 2013).

(a) Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

(b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

CONTRACTOR ADVERTISING OF CONTRACT AWARD (Sep 2012)

The Contractor shall not refer to the product or service awarded under this contract in commercial advertising, as defined in FAR 31.205-1, in any manner which states or implies the Food and Drug Administration's approval or endorsement of the product or service being provided; or, states or implies that the product or service being provided is considered to be superior to other industry products or services. The Contractor may request the Contracting Officer to make a determination as to the propriety of promotional material.

The Agency Clause Library is a reference for non-regulatory solicitation provisions and contract clauses. It is to be used in conjunction with the FAR and the Health and Human Services Acquisition Regulation (HHSAR). The individual clauses are not part of the FAR System or HHSAR and are non-regulatory in nature. While the Library is designed to provide standardization to agency contracts, the language can be tailored by contracting officials as necessary to reflect the specific contract requirement. The OAGS Policy Team has developed this Library and will maintain it for all acquisition staff. Any suggested additions or revisions should be addressed to the Team Leader, Acquisition Policy Team.

DISCLOSURE OF INFORMATION

Contractors are reminded that information furnished under this solicitation and resulting contracts and task orders may be subject to disclosure under the Freedom of Information Act (FOIA). Therefore, all items that are confidential to business, or contain trade secrets, proprietary, or personnel information must be clearly marked. Marking of items will not necessarily preclude disclosure when the U.S. Office of Personnel Management (OPM or The Government) determines disclosure is warranted by FOIA. However, if such items are not marked, all information contained within the submitted documents will be deemed to be releasable.

Any information made available to the Contractor by the Government must be used only for the purpose of carrying out the provisions of this contract and must not be divulged or made known in any manner to any person except as may be necessary in the performance of the contract.

In performance of this contract, the Contractor assumes responsibility for protection of the confidentiality of Government records and must ensure that all work performed by its subcontractors shall be under the supervision of the Contractor or the Contractor's responsible employees.

Each officer or employee of the Contractor or any of its subcontractors to whom any Government record may be made available or disclosed must be notified in writing by the Contractor that information disclosed to such officer or employee can be used only for a purpose and to the extent authorized herein, and that further disclosure of any such information, by any means, for a purpose or to an extent unauthorized herein, may subject the offender to criminal sanctions imposed by 19 U.S.C. § 641. That section provides, in pertinent part, that whoever knowingly converts to their use or the use of another, or without authority, sells, conveys, or disposes of any record of the United States or whoever receives the same with intent to convert it to their use or gain, knowing it to have been converted, shall be guilty of a crime punishable by a fine of up to $10,000, or imprisoned up to ten years, or both.

REPORTING EXECUTIVE COMPENSATION and FIRST - TIER SUBCONTRACT AWARDS (SEP 2012) Awards (For all awards over $25,000.)

This clause implements FAR Acquisition Circular (FAC) 2005-60 final rule, published on July 26, 2012 (FAR Case 2008-039) which amends the Federal Acquisition Regulations (FAR) to implement a section of the Federal Funding Accountability and Transparency Act of 2006, as amended by a section of the Government Funding Transparency Act of 2008. In compliance with FAC 2005-60,

(a) Federal contractors shall report all executive compensation and first-tier subcontractor awards on contracts of $25,000 or more.

(b) Include the substance of this clause, including this paragraph (a) in all subcontracts with contractors doing business with the federal government.

Part 8 - INVOICE SUBMISSION

RECEIPT AND ACCEPTANCE OF SUPPLIES/SERVICES:

The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the contracting officer's representative (COR) specified below. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer.

THE COR FOR THIS ORDER IS: (TBD)

POINTS OF CONTACT:

QUESTIONS CONCERNING THE PRICING OR TERMS OF THIS ORDER SHOULD BE DIRECTED TO: EMMANUEL MBAH.

TEL: (240 402 7598)

Email: Emmanuel.mbah@fda.hhs.gov The contractor shall submit one (1) original copy of each invoice to the address specified below:

FDA Payment Services ATN: Vendor Payments, OFS FDA 10903 New Hampshire Avenue Building 32, Room 2162 Mail Hub 2145 Silver Spring, MD 20993-0002, U.S.A.

Tel: 301-827-3742 or 866-807-3742 FDA Invoice Requirements:

Invoices submitted under this contract must comply with the requirements set forth in far clauses 52.232-25 (prompt payment) and 52.232-33 (payment by electronic funds transfer - central contractor registration) and/or other applicable far clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Purchase order/award number;

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including: (a) period of performance for which costs are claimed; (b) itemized travel costs, including origin and destination; and (c) any other supporting information necessary to clarify questionable expenditures;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment)

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer identification number (TIN);

(x) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited;

(xi) Name and telephone number of the FDA contracting officer’s representative (COR) or other program center/office point of contact, as referenced on the purchase order; and

(xii) Any other information or documentation required by the purchase order/award.

An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in (i) through (xii) 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 regarding invoice payments should be directed to the FDA Payment Office at a telephone number provided above.

Questions relating to when payment will be received should be directed to the FDA Payment Office at 301 827 3742.

Part 9 - EVALUATION FACTORS FOR AWARD

Offerors shall submit a Quote/Plan that addresses how the requirements of the SOW will be met. The quote will be evaluated based on the degree to which the requirements are met. The quotation must contain sufficient information to allow the Government to perform a basic analysis of the proposed price of the work.

ATTACHMENTS:

Attachment 1 (Statement of Work)

Attachment 2 (Request For Pricing)