MOD | B | Clinical Study | 28-Jul-11

FBO DAILY ISSUE OF JULY 28, 2011 FBO #3533
MODIFICATION

B -- Clinical Study

Notice Date: 7/26/2011
Notice Type: Modification/Amendment
NAICS: 541712 — Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
Contracting Office: Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
ZIP Code: 20857-0001
Solicitation Number: FDA-SOL-1090427
Point of Contact: William T. Lee, Phone: 3014435863
E-Mail Address: william.lee@fda.hhs.gov
(william.lee@fda.hhs.gov)
Small Business Set-Aside: Total Small Business
Description: PART 1 - DESCRIPTION THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERICAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT I FART 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. The solicitation number for this requirement is FDA-SOL#1090427 is being issued as a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-52. The associated North American Industrial Classification System (NAICS) code for this procurement is 541712. Its associated Small Business size standard is $500 Million. The requirement is for 100% Total Small Business Set-aside. The FDA requires a prospective assessment of clinical and patient-reported outcomes for female patients undergoing percutaneous coronary intervention (PCI) procedures via femoral and radial access as a result of this combined synopsis/solicitation that will include the terms and conditions that are set in PART 3. This requirement is subject to the AVAILABILITY OF FUNDS - FAR CLAUSE 52.232-18 until further notice. PART 2 - SUPPLIES OR SERVICES AND PRICES/COSTS 2. Description of Services The FDA/ CDRH/ODE has a requirement for prospective assessment of clinical and patient-reported outcomes for female patients undergoing percutaneous coronary intervention (PCI) procedures via femoral and radial access for the assessment of outcome measures that evaluate how women feel, function, or survive during and after PCI procedures via femoral or radial access. 2.1. Contract type 2.1.1. Firm-Fixed Price Purchase Order CLIN Product Description Quantity Price 0001 Prospective assessment of clinical and patient-reported outcomes for female patients undergoing percutaneous coronary intervention (PCI) procedures via femoral and radial access. 1 Lot $ Contract Total $ PART 3: DISCRIPTION 1. Purpose To develop a deeper understanding of the relevant health status outcomes that are important to females undergoing PCI procedures, to assist in the evaluation of the safety and effectiveness of medical products utilized in these procedures. 2. Background Cardiovascular mortality is the leading cause of death in the United States, accounting for more deaths per year than all cancers combined. While significant advances have been made in medical care and distribution of treatment, there are still substantial gaps in our understanding of how females respond to the same treatments and procedures given to males. Measures that assess not only clinical outcomes but also how well females feel and function after PCI, are important in assessing response to therapeutic intervention and in determining the safety and effectiveness profiles of PCI-related medical products in this sub-population. Still needed are data that allow patients and clinicians to determine if sex-based differences exist which influence decisions and outcomes for PCI procedures. These data will inform the assessment of effectiveness of medical products associated with PCI procedures. In the past, PCI procedures have been assessed using only clinical outcome measures or using standard health status outcome measures which were developed and refined based upon studies comprised of mostly males (e.g., SF-36 quality of life questionnaire). 3. Scope An essential piece of this overall comparative effectiveness research will involve the assessment of outcome measures that evaluate how women feel, function, or survive during and after PCI procedures via femoral or radial access. 4. Work Requirements A) Technical Requirement: 1. Evaluate standard clinical outcomes of PCI in females undergoing PCI via femoral vs. radial access (e.g., procedural success, ischemic complications, bleeding, target vessel revascularization, etc.) 2. Develop a set of performance metrics for evaluation of PCI health status outcomes of interest to female patients and their physicians (e.g., vascular complications, total radiation dose, quality of life metric components, etc) 3. Submit a report summarizing: Outcomes of femoral or radial PCI in females; and a set of metrics, preliminary data, and recommendations for further development/utilization of health status outcome assessment tools specific to female patients B) Deliverables: The contractor shall provide:  Brief quarterly reports on the progress.  A final report summarizing the work completed and results thereof. 4. Supporting Information A) Period of Performance The contract performance period shall be 12 months from the date of contract execution. B) Payment Schedule Quarterly invoices shall be submitted for completed work detailing work hours spent and services completed during the past month. Upon approval of each quarterly invoice, payment shall be provided for services completed from 30 days of approved submission. PART 4 - PACKING, MARKING AND SHIPPING 4. All deliverables required under this contract shall be in accordance with FAR Part 52.212-4 (see Part 9). PART 5 - INSPECTION AND ACCEPTANCE 5. The Contracting Officer's Technical Representative (COTR) will, in accordance with FAR 52.212-4, perform inspection and acceptance of instrument and services to be provided. 5.1. For the purpose of this PART, (COTR - to be determined upon contract award) is the authorized representative of the Contracting Officer. 5.2. Inspection and acceptance will be performed at: the location identified in Part 6.1.3. Acceptance is communicated in writing unless otherwise indicated in writing by the Contracting Officer or the COTR within 30 days of receipt. PART 6 - DELIVERIES LOCATION 6. DELIVERIES 6.1.1. Satisfactory performance of this contract shall be deemed to occur upon performance of the work described in PART 3 of this solicitation and upon delivery and acceptance by the Contracting Officer, or the COTR, of the services and final report required within PARTS 3 of this contract... 6.1.2. Deliveries required by the contractor shall be made F.O.B. destination to the Address/addresses listed below: 6.1.3. DELIVERY POINT: The U.S. Food and Drug Administration White Oak Campus; Building#32, Rm 2312 10903 New Hampshire Avenue Silver Spring, Maryland 20993 6.1.4. Unless otherwise specified, deliveries shall be made to the Delivery Point specified above, Monday through Friday (excluding Federal Holidays, see Part 8) between the hours of 8:30 a.m. and 5:30 p.m. EASTERN TIME only. PART 7: CONTRACT ADMINISTRATION CONTRACTING OFFICERS TECHNICAL REPRESENTATIVE (COTR) 7.1. The following COTR will represent the Government for the purpose of this contract: (To be determined upon contract award) 7.1.1. The COTR is responsible for: (1) monitoring the Offeror's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. 7.1.2. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the RFQ; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Offeror any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. 7.1.3. The contact information for the Contracting Officer: William Lee William.lee@fda.hhs.gov 301-443-5863 7.2. INVOICE SUBMISSION 7.2.1. In accordance with clause 52.232-22 all payments made under this contract shall be made using electronic funds transfer through the Automated Clearing House (ACH). The Contractor shall provide the following information to the Food and Drug Administration no later than 14 days prior to submission of the first invoice: A. The contractor shall submit all invoices to all addresses in the manner specified below: (I) One original to the Contracting Officer: U.S. Food and Drug Administration Office of Acquisition and Grants Services ATTN: William Lee, Contracting Specialist 5630 Fishers Lane Room 2086, HFA-500 Rockville, MD 20852 Email: William.lee@fda.hhs.gov ****Acceptable methods of delivery include: mail, hand delivery and email***** (II) One copy to the contracting officer technical representative (COTR), clearly marked "Courtesy Copy Only": U.S. Food and Drug Administration ATTN: (To be determined upon contract award) White Oak Campus; Building#66 10903 New Hampshire Avenue Silver Spring, Maryland 20993 Email: XXXXX@fda.hhs.gov *****Acceptable methods of delivery include: mail, hand delivery and email***** B. 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 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 shipping, 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 Technical Representative (COTR) 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. C. 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. D. Questions regarding invoice payments should be directed to the FDA Payment Office at: FDA/OD/OA/OFO/OFS ATTN: Division of Payment Services 12345 Parklawn Drive, HFA-720 Rockville, MD 20857 301-827-3742 OR 866.807-3742 fdavendorpaymentsteam@fda.gov 7.2.1. Final payments will occur upon verification by FDA COTR and the FDA Technical Advisor, noting successful integration and proper functionality of the laboratory equipment. 7.2.2. Payment will be made after acceptance and receipt of a proper invoice, and in accordance with the pricing matrix described in the Pricing Terms. 7.2.2.1. Payment will be made on a firm fixed price basis in accordance with the pricing matrix. PART 8 - CONTRACT CLAUSES FAR CLAUSES INCORPORATED BY REFERENCE 52.252-2 Clauses Incorporated by Reference (FEB 1998) 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 www.acquistion.gov/far/index.html 52.212-4 Contract Terms and Conditions - Commercial Items (June 2010) 52.212-3, Offeror Representations and Certifications - Commercial (Jan 2011) 52.203-5 Covenant Against Contingent Fees (Apr 1984) 52-233-2 Service of Protest (Sep 2006) 52.247-35 F.O.B. Destination within Consignee Premises (Apr 1984) 52.212-1 Instruction to Offerors - Commercial Items (Jun 2008) FAR CLAUSES BY FULL TEXT 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items. CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS-COMMERCIAL ITEMS (APR 2011) (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 (Jul 2010) (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). (Applies to contracts over $30,000). (Not applicable to subcontracts for the acquisition of commercially available off-the-shelf items). __ (7) 52.219-3, Notice of Total HUBZone Set-Aside or Sole-Source Award (Jan 2011) (15 U.S.C. 657a). __ (8) 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). __ (9) [Reserved] X (10)(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. __ (11)(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. __ (12) 52.219-8, Utilization of Small Business Concerns (Jan 2011) (15 U.S.C. 637(d)(2) and (3)). __ (13)(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. X (14) 52.219-14, Limitations on Subcontracting (Dec 1996) (15 U.S.C. 637(a)(14)). __ (15) 52.219-16, Liquidated Damages-Subcon-tracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)). __ (16)(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. __ (17) 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). __ (18) 52.219-26, Small Disadvantaged Business Participation Program- Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). __ (19) 52.219-27, Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside (May 2004) (15 U.S.C. 657 f). __ (20) 52.219-28, Post Award Small Business Program Rerepresentation (Apr 2009) (15 U.S.C. 632(a)(2)). __ (21) 52.219-29 Notice of Total Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Apr 2011). __ (22) 52.219-30 Notice of Total Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Apr 2011). X (23) 52.222-3, Convict Labor (June 2003) (E.O. 11755). __ (24) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jul 2010) (E.O. 13126). X (25) 52.222-21, Prohibition of Segregated Facilities (Feb 1999). X (26) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). X (27) 52.222-35, Equal Opportunity for Veterans (Sep 2010)(38 U.S.C. 4212). X (28) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793). X (29) 52.222-37, Employment Reports on Veterans (SEP 2010) (38 U.S.C. 4212). __(30) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). __ (31) 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.) __ (32)(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.) __ (33) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C. 8259b). __ (34)(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. __ (35) 52.223-18, Contractor Policy to Ban Text Messaging While Driving (SEP 2010) (E.O. 13513). X (36) 52.225-1, Buy American Act-Supplies (Feb 2009) (41 U.S.C. 10a-10d). __ (37)(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. __ (38) 52.225-5, Trade Agreements (AUG 2009) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). __ (39) 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). __ (40) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). __ (41) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150). __ (42) 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)). __ (43) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)). X (44) 52.232-33, Payment by Electronic Funds Transfer-Central Contractor Registration (Oct 2003) (31 U.S.C. 3332). __ (45) 52.232-34, Payment by Electronic Funds Transfer-Other than Central Contractor Registration (May 1999) (31 U.S.C. 3332). __ (46) 52.232-36, Payment by Third Party (Feb 2010) (31 U.S.C. 3332). __ (47) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a). __ (48)(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 (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. HSAR CLAUSES INCORPORATED BY REFERENCE HHSAR Clause Description Date 352.202-1 Definitions (Jan 2006) 352.203-10 Anti-lobbying (Jan 2006) 352.215-70 Late proposals and revisions (Jan 2006) 352.223-70 Safety and health (Jan 2006) 352.224-70 Privacy Act (Jan 2006) 352.228-7 Insurance--Liability to third persons (Dec 1991) 352.233-71 Litigation and claims (Jan 2006) 352.242-73 Withholding of contract payments (Jan 2006) 352.242-71 Tobacco-free Facilities (Jan 2006) 352.242-74 Final decisions on audit findings (Apr 1984) 352.270-1 Accessibility of meetings, conferences, (Jan 2001) and seminars to persons with disabilities 352.270-5 Key Personnel (Jan 2006) PART 9 - INSTRUCTIONS TO THE OFFERORS RESPONSE DATES QUESTIONS DEADLINE: All questions shall be submitted via email to William.lee@fda.hhs.gov before 4:30 p.m., Eastern Standard Time on July 29, 2011. RFQ Due Date: All quotes shall be submitted via email before 4:30 p.m. August 9, 2011. Offerors shall ensure the RFQ number is visible in the subject line of the email. FAX QUOTES SHALL NOT BE ACCEPTED. 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 ORA website, the offeror shall complete only paragraphs (c) through (m) of this provision. FAR PROVISIONS INCORPORATED by REFERENCE This contract incorporates one of 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.acquistion.gov/far/index.html 52.212-3, Offeror Representations and Certifications - Commercial (April 2011) 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 541712; delivery date (delivery date is of the utmost importance); business size; and payment terms. Page Limitations The technical information for quotes shall not exceed 10 pages. The text shall be printed in not smaller than 12 pitch type (Times New Roman) not inclusive of the cover, past performance information, or offeror resumes. Pages in excess of the page limitation for technical information will be physically removed from the quote before the technical evaluation commences. Technical Instructions The Offeror shall address the following factors listed in descending order of importance. Sub-criteria under any particular evaluation criterion shall be weighted as specified below. The evaluation factors are as follows: a. Technical Approach b. Understanding the Requirement c. Key Personnel d. Relevant Experience e. Price 9.1. Technical Approach - Subfactors are of equal weight The Offeror shall demonstrate by explanation a general, but thorough, understanding of the tasks within the SOW for development of a health status outcome measure specific to women undergoing PCI procedures. 1.1.1. The Offeror shall demonstrate that they have the resources necessary to manage the development of a health status outcome measure. 1.1.2. The Offeror shall have personnel with the technical and clinical expertise to guide the development, data collection, and analysis of the outcome measure 1.1.3. The Offeror shall have personnel in place to perform the needed tasks. 1.1.4. The Offeror shall have a mechanism for making periodic progress evaluations of the project. 9.2. Understanding the Requirement 9.2.1. The Offeror's quote shall demonstrate by explanation a through understanding of the requirement, in terms of: 9.2.1.1. Technical, Analytical, Clinical Services 9.2.1.2. Documentation Services 9.2.1.3. Communication Services 9.2.1.4. Program management services 9.2.1.5. Staffing Plan 9.3. Key Personnel- subfactors are of equal weight 9.3.1. The Offeror shall include a Staffing Plan for the performance of work, including roles and responsibilities of Key personnel in the overall management of the contract. 9.3.2. The Offeror shall submit resumes for personnel who may be utilized during this contract period. Resumes shall be limited to two pages. If subcontractors are proposed, resumes shall be provided for any Key Personnel positions. 9.3.3. The Offeror shall identify the name(s) of major subcontractor(s), the type of contract anticipated, an explanation of the subcontract effort, the degree of competition obtained, basis for the selection of each subcontractor, and the rationale for determining that the proposed prices are reasonable and realistic for the anticipated subcontract effort if subcontracting possibilities exist. 9.3.4. The Contractor shall provide Key Personnel with documented experience in their resumes for the responsibilities as described in the matrix below. 9.4. Relevant Experience 9.4.1. The Offeror shall demonstrate by documenting experience in the field of PCI and clinical outcome assessment research. 9.4.2. The Offeror shall demonstrate, by explanation that the key personnel are experienced and knowledgeable of and has documented experience leading and managing a project to develop clinical out come measures. 9.4.3. The Offeror shall identify up to three (3) of the most relevant scientific research projects or contracts (why would they "identify" contracts?) related to clinical outcome measure research currently being performed. For each relevant contract, the Offeror shall list the following: contract name, description of relevant experience, period of performance, place of performance, project contact name and telephone number. 9.4.4. The Offeror shall demonstrate by explanation the ability to organize and manage resources and personnel effectively. 9.4.5. By relevant experience, the government means the Offeror's experience that is directly related to the requirements as outlined in this statement of work. 9.5. Price 9.5.1. The Offeror shall submit a complete pricing matrix for a firm fixed-price as indicated in PART 2, 2.3. PART 10 - EVALUATION FACTOR FOR AWARD 10.1 EVALUATION FACTORS The offeror's ability to demonstrate/describe the following factors as noted in PART 11 are listed in descending order of importance. a. Technical Approach b. Understanding the Requirement c. Key Personnel d. Relevant Experience e. Price 10.2 Technical Capability - Sub-factors are of equal weight 10.2.1. The Offeror has demonstrated that their personnel posses expertise in Decision Analysis, Multi-Criteria (multi-attribute) decision making, Assessment of probabilities (also based on subject matter experts), Assessment of utilities and risk analysis (also based on subject matter experts), Development of processes for decision making, Organization of Decision Conferences, Decision facilitation, Value of Information analysis, Bayesian methods, Cognitive Sciences Training and Workshops. 10.3 Key Personnel 10.3.1. Offerors has identified key personnel who will perform or personally direct the work and submitted the percentage of their time they will commit to the project. 10.4. Past Performance 10.4.1 The Government will evaluate the extent to which the Offeror's past performance demonstrates overall client satisfaction on current and previous contracts. Ratings for this section is Pass, Fail or Neutral (no past performance history). 10.5. Price 10.5.1. The price proposal shall represent the Offeror's response to the requirements of the solicitation. The Government will evaluate the total price of all contract line items. Evaluation of Award: Award will be made to the party whose quote offers the best value to the Government, price and other factors considered. The Government may award this contract to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability, 2) Key Personnel, 3) Past Performance and 4) Price. Technical Capability, Key Personnel and Past Performance when combined are significantly more important than Price. When all technical factors are equal, price becomes the determining factor.
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