SOLICITATION NOTICE
B -- MDEpiNET
- Notice Date
- 8/17/2010
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- 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
- 1075976-1
- Archive Date
- 9/11/2010
- Point of Contact
- George Gonzalez, Phone: (301)-827-9361
- E-Mail Address
-
George.Gonzalez@fda.hhs.gov
(George.Gonzalez@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Subject: MDEpiNet Solicitation Number: FDA1075976-1 PART 1 - Description THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6-STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS-AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION; QUOTATIONS ARE BEING REQUESTED, AND A WRITTEN SOLICITATION DOCUMENT WILL NOT BE ISSUED. THIS SOLICITATION IS BEING ISSUED USING SIMPLIFIED ACQUISITION PROCEDURES 13.5. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-40. The associated North American Industrial Classification System (NAICS) code for this procurement is 541690. This RFQ solicits quotations for Development of Infrastructure to support Medical Devices Epidemiology for the FDA Center for Devices and Radiologic Health (CDRH). PART 2 - SUPPLIES OR SERVICES AND PRICES/COSTS DESCRIPTION OF SUPPLIES & SERVICES TASKS Develop a strategic plan for establishment of an administrative and scientific infrastructure to support a series of scientific projects under the MDEpiNet PPP. It is expected that coordination activities will require part-time effort from an Executive Director, Project Manager, and Administrative Coordinator over the contract period. Develop a strategy to identify and establish relationships with key experts in the field, including stakeholders from academia, professional organizations, other government agencies, medical products industry, and health care providers, both domestic and international, for leveraging and collaborative efforts under the MDEpiNet PPP Develop an Executive Committee to lead activities under the auspices of the MDEpiNet PPP. The Executive Committee must include broad representation from the sectors listed in item #2 above. Identify additional resource needs to support activities under the MDEpiNet PPP Work to establish the necessary steering committees and working groups to ensure appropriate project implementation, management, oversight for all projects under MDEpiNet Coordinate document and communicate feedback from partners participating in existing demonstration projects that would inform the development of follow-on studies Develop forums for stakeholder engagement to discuss the implementation of the MDEpiNet PPP PART 3 - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT BACKGROUND AND OBJECTIVES GENERAL The MDEpiNet PPP is intended to be created through a strategic collaboration with academia and involving a broad spectrum of stakeholders, including, but not limited to, academia, professional organizations, other government agencies, medical products industry, and health care providers both domestic and international. The Agency is seeking an outside entity to work collaboratively with on the initial phases of developing a strategic plan for establishment of an administrative and scientific infrastructure to support a series of scientific projects under the MDEpiNet PPP. BACKGROUND Objective: The MDEpiNet PPP is intended to be created through a strategic collaboration with academia and involving a broad spectrum of stakeholders, including, but not limited to, academia, professional organizations, other government agencies, medical products industry, and health care providers both domestic and international. The Agency is seeking an outside entity to work collaboratively with on the initial phases of developing a strategic plan for establishment of an administrative and scientific infrastructure to support a series of scientific projects under the MDEpiNet PPP. Background: The Center for Devices and Radiologic Health (CDRH) Epidemiologic Research Program is a combined intramural/extramural program within the CDRH's Office of Surveillance and Biometrics/Division of Epidemiology that provides independent epidemiologic research contributions to medical device regulatory decision-making through well designed original studies of safety and/or effectiveness and public health impact of marketed medical devices. The MDEpiNet PPP is envisioned as a consortium of experts in medical device epidemiology and it is designed to advance the methodologies of studying medical devices through a collaborative network with academic institutions. MDEpiNet structure emphasizes the intersection between meeting FDA regulatory responsibilities and addressing the public health needs surrounding medical devices. The ultimate goal is to substantially contribute to the understanding of medical device performance and CDRH decision making. The initial MDEpiNet Public Meeting was held at the FDA White Oak Conference Center on April 30, 2009. This meeting was widely attended and generated significant interest from representative members of the aforementioned stakeholder community. The next step in the development of the MDEpiNet is the development of the infrastructure to support MDEpiNet effort. Planning and conducting studies to advance the mission of the MDEpiNET PPP will involve enormous challenges in terms of product design, access to data from multiple public and privately-held sources, leveraging of resources and expertise from stakeholders across multidisciplinary fields, and development of novel techniques for epidemiology research. Further, it is unlikely that any one entity will possess the necessary expertise and resources to accomplish all the work needed to address the issues in an expeditious manner. Thus, to achieve the goals of MDEpiNET, CDRH seeks, under FDA's public health mission, to establish an administrative and scientific infrastructure to support the MDEpiNet PPP, consisting of partners representing academia, professional organizations, other government agencies, medical products industry, and health care providers both domestic and international, among others. It is anticipated that the MDEpiNet PPP will be a multi-phased, multi-year effort that will include research projects as well as overarching coordination and program management activities. PART 4 - PACKING, MARKING AND SHIPPING All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition. PART 5 - INSPECTION AND ACCEPTANCE The Contracting Officer's Technical Representative (COTR) will perform inspection and acceptance of materials and services to be provided. For the purpose of this PART, (COTR - to be determined upon contract award) is the authorized representative of the Contracting Officer. Inspection and acceptance will be performed at: the locations identified in 6.1.3. Acceptance is communicated in writing unless otherwise indicated in writing by the Contracting Officer or COTR within 30 days of receipt. This contract incorporates the following clause, 52.246-2 Inspection of Supplies-Fixed Price (Aug 1996) by reference, with the same force and effect as if it was given in full text. Upon request, the Contracting Officer will make its full text available. PART 6 - DELIVERIES OR PERFORMANCE DELIVERABLES The contractor shall prepare and deliver the following items specified to the COTR. Brief monthly reports on the progress of the infrastructure development, formation of the executive and steering committees. The monthly reports shall also provide an update on the contacts made with stakeholders, feedback from internal and external partners, and resource needs identified for implementing and sustaining MDEpiNet. Final report that includes the Implementation Plan for administrative and scientific infrastructure of MDEpiNet. This should include a description the organizational structure and roles and responsibilities for the Executive and Steering Committees. Develop forums for stakeholder engagement to discuss the implementation of the MDEpiNet PPP Unless otherwise specified, deliveries shall be made to the Delivery Point specified above, Monday through Friday (excluding Federal Holidays, see PART 8) between the hours of 8:30 a.m. and 5:30 p.m. EASTERN TIME only. Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day. PART 7 - CONTRACT ADMINISTRATION DATA TYPE OF CONTRACT: FIRM FIXED PRICE PERIOD OF PERFORMANCE: The period of performance for this requirement is one year from date of award. CONTRACTING OFFICERS TECHNICAL REPRESENTATIVE (COTR) The following COTR will represent the Government for the purpose of this contract: (To Be Determined upon Contract Award) 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. 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. The contact information for the Contracting Officer is: George Gonzalez 5630 Fishers Lane Rockville, MD 20857 INVOICE SUBMISSION Pursuant to the provisions of the following FAR Clauses: 52.232-25 Prompt Payment; 52.232-33, Payment by Electronic Funds Transfer - Central Contractor Registration; the Contractor shall submit invoices for costs incurred and claimed for reimbursement in accordance with the following instructions. The contractor shall submit invoices to the address designated in the purchase order (see block 21) to receive invoices. To constitute a proper invoice, the invoice must be submitted on company letterhead and include- (I) Name and Address of the Contractor. (II) Invoice date and invoice number. (III) Purchase order number. (IV) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed. (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 or in a proper notice of an 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. (XI) Name and telephone number of the FDA project officer reference on the purchase order, and (XII) 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 (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 relating to when payment will be received should be directed to the FDA Payment Office at (301) 827-3742 or FDAVENDORPAYMENTSTEAM@FDA.GOV Invoice Payment: In consideration of satisfactory performance of the work as described throughout this order, the Government will pay the Contractor in accordance with the price sheet. This amount will be payable upon presentation of a proper invoice and upon receipt and acceptance by the Government of the services specified in the Schedule. It is the requirement of the Government to obtain complete and satisfactory performance in accordance with the terms of the specifications and quality standards of this contract. An original shall be submitted via email to the attention of the designated Contract Specialist at the following address: HHS/FDA/OAGS/DAO 5630 Fishers Lane Rockville, MD 20857 Attention: Contract Specialist, Contracting Officer Final payments will occur upon verification by the FDA Project Officer and the FDA Technical Advisor, noting successful integration and proper functionality of the laboratory equipment. Payment will be made after acceptance and receipt of a proper invoice, and in accordance with the pricing matrix described in Pricing Terms. Payment will be made on a firm fixed price basis in accordance with the pricing matrix. GOVERNMENT FURNISHED PROPERTY No Government Furnished Property shall be provided to the Contractor for this requirement. PART 8 - SPECIAL CONTRACT REQUIREMENTS Government Holidays Workplace is not available on the Government Holidays stated below, or as prescribed by an Executive Order (EO) or OPM.gov due to inclement weather. January (New Year's Day) January (Martin Luther King Day) February (President's Day) May (Memorial Day) July (Independence Day) September (Labor Day) October (Columbus Day) November (Veterans Day) November (Thanksgiving) December (Christmas Day) PART 9 - CONTRACT CLAUSES FAR CLAUSES INCORPORATED BY REFERENCE 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at: www.acquisition.gov/far/index.html 52.212-4 Contract Terms and Conditions-Commercial Items (Mar 2009) 52.203-7, Anti-Kickback Procedures (Jul 1995). 52.217-4, Evaluation of Options Exercised at Time of Contract Award (June 1988) 52.219-17, Section 8(a) Award (Dec 1996). 52.222-50, Combating Trafficking in Persons (Feb 2009) 52.233-2, Service of Protest (Sep 2006) 52.233-3, Protest after Award (Aug 1996) 52.243-1, Changes-Fixed Price (Aug 1987) 9.1. FAR CLAUSES BY FULL TEXT 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items. As prescribed in 12.301(b)(4), insert the following clause: Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Apr 2010) (a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items: (1) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)). ___Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)). (2) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553). (3) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Pub. L. 108-77, 108-78). (b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: [Contracting Officer check as appropriate.] __ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 253g and 10 U.S.C. 2402). __ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)). __ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (MAR 2009) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.) __ (4) 52.204-11, American Recovery and Reinvestment Act-Reporting Requirements (Mar 2009) (Pub. L. 111-5). __ (5) 52.219-3, Notice of Total HUBZone Set-Aside (Jan 1999) (15 U.S.C. 657a). __ (6) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (July 2005) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a). __ (7) [Reserved] _X (8)(i) 52.219-6, Notice of Total Small Business Set-Aside (June 2003) (15 U.S.C. 644). __ (ii) Alternate I (Oct 1995) of 52.219-6. __ (iii) Alternate II (Mar 2004) of 52.219-6. __ (9)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644). __ (ii) Alternate I (Oct 1995) of 52.219-7. __ (iii) Alternate II (Mar 2004) of 52.219-7. __ (10) 52.219-8, Utilization of Small Business Concerns (May 2004) (15 U.S.C. 637(d)(2) and (3)). __ (11)(i) 52.219-9, Small Business Subcontracting Plan (Apr 2008) (15 U.S.C. 637(d)(4)). __ (ii) Alternate I (Oct 2001) of 52.219-9. __ (iii) Alternate II (Oct 2001) of 52.219-9. _X (12) 52.219-14, Limitations on Subcontracting (Dec 1996) (15 U.S.C. 637(a)(14)). __ (13) 52.219-16, Liquidated Damages-Subcon-tracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)). __ (14)(i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (Oct 2008) (10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer). __ (ii) Alternate I (June 2003) of 52.219-23. __ (15) 52.219-25, Small Disadvantaged Business Participation Program-Disadvantaged Status and Reporting (Apr 2008) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). __ (16) 52.219-26, Small Disadvantaged Business Participation Program- Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). __ (17) 52.219-27, Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside (May 2004) (15 U.S.C. 657 f). _X (18) 52.219-28, Post Award Small Business Program Representation (Apr 2009) (15 U.S.C. 632(a)(2)). _X (19) 52.222-3, Convict Labor (June 2003) (E.O. 11755). _X (20) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Aug 2009) (E.O. 13126). _X (21) 52.222-21, Prohibition of Segregated Facilities (Feb 1999). _X (22) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). _X (23) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212). _X (24) 52.222-36, Affirmative Action for Workers with Disabilities (Jun 1998) (29 U.S.C. 793). _X (25) 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212). _X (26) 52.222-54, Employment Eligibility Verification (Jan 2009). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.) __ (27)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.) __ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.) __ (28) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b). __ (29)(i) 52.223-16, IEEE 1680 Standard for the Environmental Assessment of Personal Computer Products (Dec 2007) (E.O. 13423). __ (ii) Alternate I (Dec 2007) of 52.223-16. _X (30) 52.225-1, Buy American Act-Supplies (Feb 2009) (41 U.S.C. 10a-10d). __ (31)(i) 52.225-3, Buy American Act-Free Trade Agreements-Israeli Trade Act (June 2009) (41 U.S.C. 10a-10d, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, Pub. L. 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, and 110-138). __ (ii) Alternate I (Jan 2004) of 52.225-3. __ (iii) Alternate II (Jan 2004) of 52.225-3. __ (32) 52.225-5, Trade Agreements (Aug 2009) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). _X (33) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). __ (34) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). __ (35) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150). __ (36) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)). __ (37) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)). __ (38) 52.232-33, Payment by Electronic Funds Transfer-Central Contractor Registration (Oct 2003) (31 U.S.C. 3332). __ (39) 52.232-34, Payment by Electronic Funds Transfer-Other than Central Contractor Registration (May 1999) (31 U.S.C. 3332). __ (40) 52.232-36, Payment by Third Party (Feb 2010) (31 U.S.C. 3332). __ (41) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a). __ (42)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). __ (ii) Alternate I (Apr 2003) of 52.247-64. (c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: [Contracting Officer check as appropriate.] __ (1) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.). __ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 1989) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.). __ (3) 52.222-43, Fair Labor Standards Act and Service Contract Act-Price Adjustment (Multiple Year and Option Contracts) (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.). __ (4) 52.222-44, Fair Labor Standards Act and Service Contract Act-Price Adjustment (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.). _X (5) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (Nov 2007) (41 351, et seq.). __ (6) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements (Feb 2009) (41 U.S.C. 351, et seq.). __ (7) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub. L. 110-247). __ (8) 52.237-11, Accepting and Dispensing of $1 Coin (Sept 2008) (31 U.S.C. 5112(p)(1)). (d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records-Negotiation. (1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract. (2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved. (3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law. (e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause- (i) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)). (ii) 52.219-8, Utilization of Small Business Concerns (May 2004) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $550,000 ($1,000,000 for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities. (iii) [Reserved] (iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). (v) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212). (vi) 52.222-36, Affirmative Action for Workers with Disabilities (June 1998) (29 U.S.C. 793). (vii) [Reserved] (viii) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.). (ix) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)). _X Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)). (x) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (Nov 2007) (41 U.S.C. 351, et seq.). (xi) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements (Feb 2009) (41 U.S.C. 351, et seq.). (xii) 52.222-54, Employment Eligibility Verification (Jan 2009). (xiii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub. L. 110-247). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6. (xiv) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64. (2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations. 9.2. HHSAR CLAUSES 352.202-1 Definitions (January 2006) (a) In accordance with 52.202-1(a)(1), substitute the following as paragraph (a): ‘‘(a) The term ‘‘Secretary'' or ‘‘Head of the Agency'' (also called ‘‘Agency Head'') means the Secretary, Deputy Secretary, or any Assistant Secretary, Administrator or Commissioner of the Department of Health and Human Services; and the term ‘‘his/her duly authorized representative'' means any person, persons, or board authorized to act for the Secretary.'' (b) In accordance with 52.202-1(a)(1), add the following paragraph (h): ‘‘(h) The term ‘‘Project Officer'' means the person who monitors the technical aspects of contract performance. The Project Officer is not authorized to issue any instructions or directions which cause any increase or decrease in the scope of work which would result in the increase or decrease in the price of this contract, or changes in the delivery schedule or period of performance of this contract. If applicable, the Project Officer is not authorized to receive or act upon any notification or revised cost estimate provided by the Contractor in accordance with the Limitation of Cost or Limitation of Funds clauses of this contract.'' HHSAR 352.224-70 Confidentiality of Information (January 2006) (a) Confidential information, as used in this clause, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization. (b) The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate which is confidential. Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract. Failure to agree will be settled pursuant to the ‘‘Disputes'' clause. (c) If it is established elsewhere in this contract that information to be utilized under this contract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a (New Window), and implementing regulations and policies, with respect to systems of records determined to be subject to the Privacy Act. (d) Confidential information, as defined in paragraph (a) of this clause, shall not be disclosed without the prior written consent of the individual, institution, or organization. (e) Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if the material in question is subject to the Privacy Act or is confidential information subject to the provisions of this clause, the Contractor should obtain a written determination from the Contracting Officer prior to any release, disclosure, dissemination, or publication. (f) Contracting Officer Determinations will reflect the result of internal coordination with appropriate program and legal officials. (g) The provisions of paragraph (d) of this clause shall not apply to conflicting or overlapping provisions in other Federal, State, or local laws. 352.232-9 Withholding of contract payments (January 2006) Notwithstanding any other payment provisions of this contract, failure of the Contractor to submit required reports when due or failure to perform or deliver required work, supplies, or services, may result in the withholding of payments under this contract unless such failure arises out of causes beyond the control, and without the fault or negligence of the Contractor as defined by the clause entitled ‘‘Excusable Delays'' or ‘‘Default'', as applicable. The Government shall immediately notify the Contractor of its intention to withhold payment of any invoice or voucher submitted. 352.233-70 Litigation and claims (January 2006) The Contractor shall provide written notification immediately to the Contracting Officer of any action, including any proceeding before an administrative agency, filed against the Contractor arising out of the performance of this contract, including, but not limited to the performance of any subcontract hereunder; and any claim against the Contractor the cost and expense of which is allowable under the clause entitled ‘‘Allowable Cost and Payment.'' Except as otherwise directed by the Contracting Officer, the Contractor shall furnish immediately to the Contracting Officer copies of all pertinent papers received by the Contractor with respect to such action or claim. To the extent not in conflict with any applicable policy of insurance, the Contractor may, with the Contracting Officer's approval, settle any such action or claim. If required by the Contracting Officer, the Contractor shall effect an assignment and subrogation in favor of the Government of all the Contractor's rights and claims (except those against the Government) arising out of any such action or claim against the Contractor; and authorize representatives of the Government to settle or defend any such action or claim and to represent the Contractor in, or to take charge of, any action. If the settlement or defense of an action or claim is undertaken by the Government, the Contractor shall furnish all reasonable assistance in effecting a settlement or asserting a defense. Where an action against the Contractor is not covered by a policy of insurance, the Contractor shall, with the approval of the Contracting Officer, proceed with the defense of the action in good faith. The Government shall not be liable for the expense of defending any action or for any costs resulting from the loss thereof to the extent that the Contractor would have been compensated by insurance which was required by law or regulation or by written direction of the Contracting Officer, but which the Contractor failed to secure through its own fault or negligence. In any event, unless otherwise expressly provided in this contract, the Contractor shall not be reimbursed or indemnified by the Government for any liability loss, cost or expense, which the Contractor may incur or be subject to by reason of any loss, injury or damage, to the person or to real or personal property of any third parties as may accrue during, or arise from, the performance of this contract. 352.242-71 Final decisions on audit findings (Apr. 1984) For the purpose of issuing final decisions under the Disputes clause of this contract concerning monetary audit findings, the Contracting Officer shall be that person with ultimate responsibility for making that decision in accordance with Chapter 1-105, Resolution of Audit Findings, of the Department's Grants Administration Manual. 352.249-14 Excusable delays (January 2006) (a) Except with respect to failures of subcontractors, the Contractor shall not be considered to have failed in performance of this contract if such failure arises out of causes beyond the control and without the fault or negligence of the Contractor. (b) Such causes may include, but are not restricted to, acts of God or of the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, freight embargoes, and unusually severe weather, but in every case the failure to perform must be beyond the control and without the fault or negligence of the Contractor. If the failure to perform is caused by the failure of a subcontractor to perform, and if such failure arises out of causes beyond the control of both the Contractor and subcontractor, and without the fault or negligence of either of them, the Contractor shall not be deemed to have failed in performance of the contract, unless: (1) The supplies or services to be furnished by the subcontractor were obtainable from other sources, (2) The Contracting Officer ordered the Contractor in writing to procure such supplies or services from such other sources, and (3) The Contractor failed to comply with such order. Upon request of the Contractor, the Contracting Officer shall ascertain the facts and extent of such failure and if the Contracting Officer determines that any failure to perform was caused by circumstances beyond the control and without the fault or negligence of the Contractor, the delivery schedule shall be revised accordingly, subject to the rights of the Government under the termination clause contained in this contract. (As used in this clause, the terms ‘‘subcontractor'' and ‘‘subcontractors'' mean subcontractor(s) at any tier.) 352.270-10 Anti-lobbying (January 2006) Pursuant to the current HHS annual appropriations act, except for normal and recognized executive-legislative relationships, the Contractor shall not use any HHS contract funds for (i) publicity or propaganda purposes; (ii) the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television or video presentation designed to support or defeat legislation pending before the Congress or any State legislature, except in presentation to the Congress or any State legislature itself; or (iii) payment of salary or expenses of the Contractor, or any agent acting for the Contractor, related to any activity designed to influence legislation or appropriations pending before the Congress or any State legislature. 352.270-13 Tobacco-free facilities (January 2006) In accordance with Department of Health and Human Services (HHS) policy, the Contractor and its staff are prohibited from using tobacco products of any kind (e.g., cigarettes, cigars, pipes, and smokeless tobacco) while on any HHS property, including use in personal or company vehicles operated by Contractor employees while on an HHS property. This policy also applies to all subcontracts awarded under the contract or order. The term ‘‘HHS properties'' includes all properties owned, controlled and/or leased by HHS when totally occupied by HHS, including all indoor and outdoor areas of such properties. Where HHS only partially occupies such properties, it includes all HHS-occupied interior space. Where HHS leases space in a multi-occupant building or complex, the tobacco-free HHS policy will apply to the maximum area permitted by law and compliance with the provisions of any current lease agreements. The Contractor shall ensure that each of its employees, and any subcontractor staff, is made aware of, understand, and comply with this policy. 352.270-5 Key Personnel (APR 1984): The personnel specified in this contract are considered to be essential to the work being performed hereunder. Prior to diverting any of the specified individuals to other programs, the Contractor shall notify the Contracting Officer reasonably in advance and shall submit justification (including proposed substitutions) in sufficient detail to permit evaluation of the impact on the program. No diversion shall be made by the Contractor without written consent of the Contracting Officer; provided, that the Contracting Officer may ratify in writing such diversion and such ratification shall constitute the consent of the Contracting Officer. The contract may be modified from time to time during the course of the contract to either add or delete personnel, as appropriate. PART 10 - LIST OF ATTACHMENTS • Reserved PART 11 - INSTRUCTIONS TO THE OFFERORS OFFEROR INSTRUCTIONS QUESTIONS DEADLINE: All questions shall be received by email (george.gonzalez@fda.hhs.gov) before 1:00 pm (1300) EASTERN TIME on 23 August 2010. RFQ Due Date: All quotes and revisions shall be submitted via email and be received by 1:00 PM (1300) Eastern Time on 27 August 2010. Quote Format The cover letter shall include price (s); FOB point; a poc (name and telephone number); a statement from the offeror verifying that they are CCR Registered under NAICS code 541690; delivery date (delivery date is of the utmost importance); business size; and payment terms. Technical Proposal The Offeror shall address these factors as follows: 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 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 the development of an administrative infrastructure to support the operations of the MDEpiNet PPP. The Offeror shall demonstrate that they have the resources necessary to manage the development of a multi-stakeholder public-private partnership. The Offeror shall have personnel with the technical and clinical expertise to guide the development of the scientific oversight body of MDEpiNet The Offeror shall have personnel in place to perform the needed tasks. The Offeror shall have a mechanism for making periodic progress evaluations of the project. Understanding the Requirement The Offeror's quote shall demonstrate by explanation a through understanding of the requirement, in terms of: Technical, Analytical, Clinical Services Documentation Services Communication Services Program management services Staffing Plan Key Personnel- subfactors are of equal weight 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. 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. 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. The Contractor shall provide Key Personnel with documented experience in their resumes for the responsibilities as described in the matrix below. It is important that the Offeror, in performing the tasks under this award, including, but not limited to administrative and financial oversight of activities therein, not have any fiducial responsibility in an organization or entity regulated under the Food, Drug, and Cosmetics act and its amendments. This requirement is to ensure the impartiality of the contractor in implementing and managing projects through MDEpiNet that may be funded from multiple sources, including private firms. The Offeror must have capabilities for developing and managing broad scientific programs among multiple stakeholders and either possess or are capable of assembling and managing the necessary governance and steering committees having specific expertise in the field of epidemiology research. Relevant Experience The Offeror shall demonstrate by explanation that the key personnel are experienced and knowledgeable of and has documented experience leading and managing a scientific partnership among multiple stakeholders. Relevant experience may include management of multi-center clinical trials, medical practice guideline writing committees, focus groups, multi-stakeholder workshops and proceedings papers, among other experiences The Offeror shall identify up to three (3) of the most relevant scientific research projects or contracts related to epidemiology 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. The Offeror shall demonstrate by documenting experience in the field of epidemiology research. The Offeror shall demonstrate by explanation the ability to organize and manage resources and personnel effectively. By relevant experience, the government means the Offeror's experience that is directly related to the requirements as outlined in this statement of work. Price Proposal The Offeror shall prepare a Price Proposal that contains all information necessary to allow for a comprehensive evaluation of the prices proposed by the Offeror. Price proposals will be evaluated to determine fairness and reasonableness. The Government will use commercial or market price lists, Independent Government Cost Estimate (IGCE), or other information available to the HHS in assessing the reasonableness of prices proposed. Past Performance Past Performance will be evaluated as a pass or fail but will not be part of the evaluation factors. PART 12 - EVALUATION FACTORS FOR AWARD EVALUATION FACTORS Factor 1: The offeror's ability to demonstrate/describe the following factors as noted in PART 11. Factor 2: Price The price proposal shall represent the Offeror's response to the requirements of the solicitation. In addition, this evaluation will include an assessment of the Offeror's proposal for completeness, realism, reasonableness and risk. EVALUATION AWARD CRITERIA: The Government will evaluate the quote to ensure that it is technical acceptable in accordance with the requirements in PART 3 and that the price is fair and reasonable from the Offeror. FDA intends to make an award soon after the response date of this notice and all quotes and revisions shall be submitted via email and be received by 1:00 PM (1300) Eastern Time on 27 August 2010 to the attention of Contract Specialist, george.gonzalez@fda.hhs.gov. Offerors shall ensure the RFQ number is visible in the header of the email. FAX QUOTES SHALL NOT BE ACCEPTED.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1075976-1/listing.html)
- Record
- SN02244234-W 20100819/100818000241-9d9210b75450a267bd202dacf0b3c5b1 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |