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FBO DAILY ISSUE OF AUGUST 27, 2010 FBO #3198
SOLICITATION NOTICE

R -- Creating Analysis Dataset for HIV Clinical Trials - Package #1

Notice Date

8/25/2010
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

541511 — Custom Computer Programming 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

FDA-SOL-1078128
 

Archive Date

9/23/2010
 

Point of Contact

Linda Troutman, Phone: 3018277168, Doreen Williams, Phone: 3018273366
 

E-Mail Address

linda.troutman@fda.hhs.gov, doreen.williams@fda.hhs.gov
(linda.troutman@fda.hhs.gov, doreen.williams@fda.hhs.gov)
 

Small Business Set-Aside

Total Small Business
 

Description

Security Chart Efficacy Data Submission Document Commitment to Protect Non-Public Information Employment Agreement Form Subject: Creating Analysis Dataset for HIV Clinical Trials PART 1: Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only full and open competition solicitation; proposals are being requested and a written solicitation will not be issued. Simplified acquisition procedures FAR PART 13 and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-43 This announcement constitutes the only 100% small business set aside solicitation and a written solicitation will not be issued. This synopsis, NAICS code 541511, is to notify contractors that the government intends to issue a Firm Fixed Price Purchase Order in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procedures. Any firm that believes it is capable of providing the required service as stated herein may submit a capability statement to document its ability to provide the required services. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. PART 2: Supplies or Services and Price/Costs The government anticipates a firm fixed price contract for Statistical Programmers for Creating Analysis Dataset for HIV Clinical Trials 2.1 Pricing: CLIN Item Description Quantity Hours Price 0001 Statistical Programming Services $ Contract Total $ PART 3: REQUIREMENTS 3.1 Introduction Creating Analysis Dataset for HIV Clinical Trials 3.2 Background Over the years has accumulated legacy clinical trials data on over 20,000 HIV patients from NDA submissions. In a separate project, these data have been converted and harmonized to conform to the Clinical Data Study Interchange Standards Consortium's (CDISC) Study Data Tabulation Model (SDTM) standard. However, the converted data alone do not always directly provide variables of interest to reviewers for further analysis. There are many important clinical questions that the accumulated data can be used to help address. Such questions include identifying the role of various covariates in predicting the trial outcome, comparative safety and effective research, surrogate endpoint or correlates identifications, etc. Currently there are several ongoing research projects using HIV clinical trials data-the analysis variables created in this dataset shall help carry out those analyses. 3.3 Objective The principle objective of this project is to acquire statistical programming support to provide the analysis dataset specified in Attachment 1. 3.3 Scope Independently and not as an agent of the Government, the contractor shall provide qualified clinicians, statisticians and programmers highly experienced in HIV trials, HIV dataset and SDTM to create an analysis datasets using SAS xpt 5.0 according to the specification provided in Attachment 1. This work shall include programming and analysis support to: 3.3.1 Derive the requested variables. 3.3.2 Help define additional variables where requested by FDA during the course of the completion of this task 3.3.3 Provide technical assistance in properly handling the variables specified when there are inconsistencies across studies in data collection and storage. 3.3.4 Validate the derived variables by providing summary statistics and comparing the results to FDA reviews and sponsor's study reports.. 4.0 Task Deliverables and Milestones Item # Deliverable Date Due 1 Initial meeting with COTR and designated FDA staff to discuss work plan Within 2 weeks of contract award 2 In consultation with FDA staff, provide analysis dataset for all of the studies in the first two HIV drugs: maraviroc and raltegravir Within 4 weeks of contract award 3 Provide SDTM study results as described in Attachment 1 January 31, 2010 4 Provide an analysis dataset for SDTM datasets comprising all of the studies for all of the HIV drugs and studies that have been converted to SDTM (total of 20 drugs comprising 51 studies-total includes maraviroc and raltegravir) January 31, 2010 5.0 Qualifications of Staff/Key Personnel Statistical Programmer(s) • Demonstrated experience in SAS programming in a health care environment, preferably in the creation of study analysis datasets • Hands-on programming with SAS v9, SAS xpt5 • Experience in working with SDTM, ADaM for production clinical study datasets • Experience in working with HIV clinical trials data 6.0 Period of Performance September 15, 2010 - January 31, 2011 7.0 Place of Performance: The Food and Drug Administration 10903 New Hampshire Avenue Building 21 Silver Spring, MD 20993 8.0 Criteria for Acceptance FDA shall review contractor deliverables in accordance with specifications and standards stated in the criteria established and any directives issued during the term of this contract. FDA has the authority to accept or reject deliverables. The acceptance of deliverable and satisfactory work performance required herein shall be based upon the timeliness, accuracy and suitability of the deliverables. The specific deliverables and schedule for delivery shall be as agreed upon and documented. All documents, plans, diagrams, presentations, etc., are to be submitted on a flash drive, in hardcopies, or burned onto a CD. Deliverables shall be submitted to the COTR who initiated the request. a. Contractor shall provide monthly status report describing the current status and anticipated completion date for any deliverable. The contractor shall also include information about any unanticipated problems with completion of any deliverable. b. Contractor's meetings with FDA to review and discuss project outcomes shall involve all relevant FDA organization components 9.0 Government-Furnished Equipment/Information • Laptop and network account to access HIV datasets that shall be located on FDA servers. • Access to HIV datasets needed to prepare the analysis datasets • Use of Government equipment shall follow section 9.0, Security and Privacy. • 10.0 Status Reporting The contractor shall provide quarterly reports on the status/progress of deliverables and any current or anticipated problems with required activities. All reports shall be submitted in a Microsoft word format 11.0 Security and Privacy Performance of work may require the contractor personnel to have access to and use of data and information which may be considered proprietary to regulated industry, a government agency or Government contractor, or which may otherwise be of such nature that its dissemination or use, other than in performance of a subsequent work statement, would be adverse to the interest of FDA or others. (a) The Contractor agrees, in the performance of this contract, to keep the information furnished by the Government and designated by the Contracting Officer or Contracting Officer's Technical Representative in the strictest confidence. The Contractor also agrees not to publish or otherwise divulge such information in whole or in part, in any manner or form, nor to authorize or permit others to do so, taking such reasonable measures as are necessary to restrict access to such information while in the Contractor's possession, to those employees needing such information to perform the work provided herein, i.e., on a "need to know" basis. The Contractor agrees to immediately notify the Contracting Officer in writing in the event that the Contractor determines or has reason to suspect a breach of this requirement. (b) The Contractor agrees that it shall not disclose any information described in Subsection (a) to any persons or individual unless prior written approval is obtained from the Contracting Officer. The Contractor agrees to insert the substance of this clause in any consultant agreement or subcontract hereunder. 12.0 Contractor Conformance with Applicable Laws, Regulations, Policies and Standards The Contractor shall be responsible for knowledge of and compliance with all applicable Federal information technology and information management laws, regulations, policies and standards at the government-wide, HHS and FDA levels. At the government-wide level, these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST) and General Accounting Office (GAO). 13.0 CONTRACT ADMINISTRATION CONTRACTING OFFICERS TECHNICAL REPRESENTATIVE (COTR) 13.1. The following COTR will represent the Government for the purpose of this contract: (To be determined upon contract award) 13.1.1. 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. 13.1.2. 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. 13.1.3. The contact information for the Contracting Officer: Doreen Williams Doreen.Williams@fda.hhs.gov 301-827-3366 13.1.4 The contact information for the Contract Specialist: Linda Troutman Linda.T.Robinson@fda.hhs.gov 301-827-7168 14.0 INVOICING INSTRUCTIONS 14.1 INVOICING INSTRUCTIONS The Offeror shall submit invoices to the Contract Specialist and the Project Officer concurrently, via email. To constitute a proper invoice, the invoice must be submitted on company letterhead and include: 1. Name and address of the Offeror 2. Invoice date and invoice number 3. Purchase order number 4. Description, Quantity, Unit of Measure, Unit Price, and Extended Price of supplies delivered 5. Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading 6. Terms of any discount for prompt payment offered 7. Name and address of official to whom payment is to be sent (Must be the same as that in the purchase order or in a proper notice of assignment) 8. Name, title, and phone number of person to notify in event of defective invoice 9. Taxpayer identification number 10. Electronic Funds Transfer (EFT) banking information 11. Name and telephone number of the FDA COR referenced on the purchase order 12. Any other information or documentation required by the purchase order An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in 1-12 of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing. 15.0 FAR and HHSAR CLAUSES 52.252-2 Clauses Incorporated by Reference This contract incorporates one of more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at http://www.arnet.gov 52.227-14 Rights in Data - General (DEC 2007) 52.227-17 Rights in Data - Special Works (DEC 2007) 52.227-18 Rights in Data - Existing Works (DEC 2007) 52.212-4 Contract Terms and Conditions - Commercial Items (JUN 2010) 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (JUL 2010) a) The Offeror 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 Offeror shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: x_ (1) 52.203-6, Restrictions on Subofferor 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, Offeror Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)). _x (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (MAR 2009) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.) __ (4) 52.204-11, American Recovery and Reinvestment Act-Reporting Requirements (Mar 2009) (Pub. L. 111-5). __ (5) 52.219-3, Notice of Total HUBZone Set-Aside (Jan 1999) (15 U.S.C. 657a). __ (6) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (JULY 2005) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a). __ (7) [Reserved] _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. __ (12) 52.219-14, Limitations on Subcontracting (Dec 1996) (15 U.S.C. 637(a)(14)). __ (13) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)). __ (14)(i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (OCT 2008) (10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer). __ (ii) Alternate I (June 2003) of 52.219-23. __ (15) 52.219-25, Small Disadvantaged Business Participation Program-Disadvantaged Status and Reporting (Apr 2008) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). __ (16) 52.219-26, Small Disadvantaged Business Participation Program- Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). __ (17) 52.219-27, Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside (May 2004) (15 U.S.C. 657 f). __ (18) 52.219-28, Post Award Small Business Program Rerepresentation (Apr 2009) (15 U.S.C. 632(a)(2)). _x (19) 52.222-3, Convict Labor (June 2003) (E.O. 11755). _x (20) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Aug 2009) (E.O. 13126). _x (21) 52.222-21, Prohibition of Segregated Facilities (Feb 1999). _x (22) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). _x (23) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212). __ (24) 52.222-36, Affirmative Action for Workers with Disabilities (Jun 1998) (29 U.S.C. 793). _x (25) 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212). _x (26) 52.222-54, Employment Eligibility Verification (JAN 2009). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.) __ (27)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.) __ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.) __ (28) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C. 8259b). __ (29)(i) 52.223-16, IEEE 1680 Standard for the Environmental Assessment of Personal Computer Products (DEC 2007) (E.O. 13423). __ (ii) Alternate I (DEC 2007) of 52.223-16. _x (30) 52.225-1, Buy American Act-Supplies (Feb 2009) (41 U.S.C. 10a-10d). __ (31)(i) 52.225-3, Buy American Act-Free Trade Agreements-Israeli Trade Act (June 2009) (41 U.S.C. 10a-10d, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, Pub. L. 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, and 110-138). __ (ii) Alternate I (Jan 2004) of 52.225-3. __ (iii) Alternate II (Jan 2004) of 52.225-3. __ (32) 52.225-5, Trade Agreements (AUG 2009) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). __ (33) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). __ (34) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). __ (35) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150). __ (36) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)). __ (37) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)). _x (38) 52.232-33, Payment by Electronic Funds Transfer-Central Offeror Registration (Oct 2003) (31 U.S.C. 3332). __ (39) 52.232-34, Payment by Electronic Funds Transfer-Other than Central Offeror 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 Offeror 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 Offeror 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 Offeror's directly pertinent records involving transactions related to this contract. (2) The Offeror 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, Offeror 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 Offeror to create or maintain any record that the Offeror 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 Offeror 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, Offeror 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 subofferor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities. (iii) [Reserved] (iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). (v) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006) (38 U.S.C. 4212). (vi) 52.222-36, Affirmative Action for Workers with Disabilities (June 1998) (29 U.S.C. 793). (vii) [Reserved] (viii) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.). (ix) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)). ___Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)). (x) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (Nov 2007) (41 U.S.C. 351, et seq.). (xi) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements (Feb 2009) (41 U.S.C. 351, et seq.). (xii) 52.222-54, Employment Eligibility Verification (JAN 2009). (xiii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub. L. 110-247). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6. (xiv) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64. (2) While not required, the offeror may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations. 16.0 ATTACHMENTS • Form FDA 3398 - Commitment to Protect Non-Public Information Employee Agreement • Security Chart • Efficacy Data Submission 17.0: INSTRUCTIONS TO OFFERORS 17.1 FAR provisions Incorporated by Reference This contract incorporates one or more provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at: www.acquisition.gov/far/index.html: 17.2 FAR Provisions Incorporated by Reference 17.2.1. This contract incorporates one or more provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at: www.acquisition.gov/far/index.html: 52.212-1, Instructions to Offerors - Commercial Items (June 2008) An offeror shall complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. If an offeror has not completed the annual representations and certifications electronically at the ORCA website, the offeror shall complete only paragraphs (c) through (m) of this provision. 52.212-3, Offeror Representations and Certifications - Commercial Items (Aug 2009) All questions shall be submitted to Linda Troutman via email at Linda.T.Robinson@fda.hhs.gov. Questions are due no later than August 30, 2010, 3:00 PM Eastern Time. All quotes shall be submitted to Linda Troutman via email at Linda.T.Robinson@fda.hhs.gov. Quotes are due no later than September 8, 2010, 4:30 PM Eastern Time. Offerors shall ensure the RFQ number is visible in the header of the email. Faxed quotes shall not be accepted. 17.3 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 541511; delivery date (delivery date is of the utmost importance); business size; and payment terms. 18.0 Evaluation Criteria Factor A - Qualifications of Staff/Key Personnel: Criteria Used for Evaluation: Offeror shall submit resumes of all proposed personnel and a description of the experience and qualifications of the personnel who shall be assigned to work on this project. Each personnel shall indicate their recent experience relative to the tasks required in the statement of work. Information on staff qualifications shall clearly demonstrate the relevant skills, expertise, and knowledge and any proposed subcontractor to successfully perform the work described in the Statement of Work and the Sample Task. The contractor shall identify key personnel in the technical proposal. Factor B - Corporate Experience: The Contractor shall describe their past experience in providing similar efforts in data management and statistical programming support during the last 3 years. Offerors shall provide references of similar efforts performed during the last 3 years, including a project title, description of the work performed, contract number, contract amount, client identification including agency or company name, contracting and technical reviewing official, address, and telephone number. Factor C - Management Approach/Staffing Plan The offeror's proposal shall demonstrate a though understanding of the requirement of the Statement of Work and describe an approach which demonstrates the achievement of timely and acceptable performance. The proposal shall provide a management approach and staffing plan that describe how the activities described in the sample task in the Statement of Work (SOW) shall be accomplished. The management approach shall demonstrate a clear understanding of the nature of the work being performed and include information on how the project shall be organized, staffed, and managed. The offeror also shall provide information on how they shall ensure quality products are delivered, how they shall mitigate risk, and how they shall communicate with the Government. Factor D - Past Performance Offeror shall provide three references of similar efforts performed during the last 3 years. Include a description of the project, project title, contract number, contract amount, client identification including agency or company name, contracting and technical reviewing official, address and telephone number. In addition, provide one example (with reference contact information) of corporate experience that demonstrates how the corporation responded when a project went off track, either over budget, behind schedule, below quality standards or some other difficulty. The Government shall evaluate the offeror's past performance based on information obtained from references provided by the offeror, other relevant past performance Information obtained from other sources known to the Government, and any information supplied by the offeror concerning problems encountered on the identified contracts and corrective action taken. The Government shall contact each reference by phone to verify information past performance references. The Government may use the NIH Contractor Past Performance System, technical personnel, or contact other government agencies. Criteria Used for Evaluation: Ratings of exceed the requirement, fully successful and fail to meet the requirement shall be given. A rating of good past performance shall take precedence over neutral or poor past performance. Neutral past performance takes precedence over poor past performance. The Governmentshall assess the relative risks associated with each offeror. Performance risks are those associated with an offeror's likelihood of success in performing the acquisition requirements as indicated by that offeror's record of past performance. The performance record may result in a neutral performance risk assessment, which shall neither be used to the advantage nor disadvantage of the offeror. However, a positive past performance would be evaluate higher than a natural rating
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-1078128/listing.html)
 

Place of Performance

Address: The Food and Drug Administration, 10903 New Hampshire, Building 21, Silver Spring, Maryland, 20993, United States

Zip Code: 20993
 

Record

SN02255006-W 20100827/100825235856-471bae39bdbaa238a8e4a5b8d61974d9 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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