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FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 15, 2014 FBO #4647
SOLICITATION NOTICE

70 -- Pharmacological Mechanism-Based Safety Predicition - Data Mining Software Acquisition and Support

Notice Date

8/13/2014
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

541519 — Other Computer Related 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-14-1130213
 

Archive Date

9/6/2014
 

Point of Contact

Syntoria L Spencer, Phone: 204.402.7555, Linda Giles, Phone: 240.402.7522
 

E-Mail Address

syntoria.spencer@fda.hhs.gov, linda.alexander-giles@fda.hhs.gov
(syntoria.spencer@fda.hhs.gov, linda.alexander-giles@fda.hhs.gov)
 

Small Business Set-Aside

Total Small Business
 

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 solicitation; proposals are being requested and a written solicitation will not be issued. This synopsis is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13 for the following, under simplified acquisition procedures. The Request for Proposal (RFP) number is FDA-14-1130551. Provisions and clauses in effect through Federal Acquisition Circular 05-45 are incorporated into this request. It is the contractor's responsibility to be familiar with the applicable clauses and provisions. The provisions and clauses may be accessed in full text at www.acquisition.gov/far. The NAICS code is 541519. This is small business set-aside for this acquisition. All qualified vendors are encouraged to respond. The purpose of this procurement is to establish a contract for Pharmacological Mechanism-Based Safety Prediction-Data Mining Software Acquisition and Support. Performance for this requirement consists of one 12-month base period and four option years. CLIN 0001 - Base Period: Pharmacological Mechanism-Based Safety Prediction-Data Mining Software Acquisition and Support (Brand Name or Equal), Period of Performance: 12 months CLIN 0002 Option Period One: Pharmacological Mechanism-Based Safety Prediction-Data Mining Software Acquisition and Support (Brand Name or Equal), Period of Performance: 12 months. CLIN 0003 Option Period Two: Pharmacological Mechanism-Based Safety Prediction-Data Mining Software Acquisition and Support (Brand Name or Equal), Period of Performance: 12 months CLIN 0004 Option Period Three: Pharmacological Mechanism-Based Safety Prediction-Data Mining Software Acquisition and Support (Brand Name or Equal), Period of Performance: 12 months CLIN 0005 Option Period Four: Pharmacological Mechanism-Based Safety Prediction-Data Mining Software Acquisition and Support (Brand Name or Equal), Period of Performance: 12 months 1. Background Quoting from the minutes of the February, 2010 meeting of the Science Board to the Food and Drug Administration (FDA), "The Science Board suggested that Center for Drug Evaluation and Research (CDER) widen the prospective approaches to risk detection beyond pharmacoepidemiology, no matter how much that particular approach can be refined. In particular, pharmacoepidemiology can be expected to detect only the tip of the iceberg when seeking an increase in the incidence of common conditions. The need to integrate expertise in human and basic pharmacology is also evident in studies of comparative effectiveness, dominated so far by epidemiology and clinical trials uninformed by this discipline". 1.2 Objective This contract is meant to directly address this matter by supporting the development of a new safety program in the Office of Clinical Pharmacology (OCP)/Office of Translational Sciences (OTS)/CDER called "Pharmacological Mechanism-Based Drug Safety Prediction". 1.2.1 This contract shall provide the support in data-mining and pattern recognition technology to develop predictions for safety signals that have not yet been recognized for drug candidates that have come to the FDA as New Drug Applications (NDA). In addition, the data-mining and analytical technology shall be used to evaluate recognized safety signals for drugs already marketed to determine mechanism and to identify patient subgroups that may be particularly at risk for that safety signal. 1.2.2 An important goal is to allow the development of prospective hypotheses to provide to Office of Surveillance and Epidemiology (OSE) and Office of New Drugs (OND) to inform their evaluation of potential safety signals with the goal of reducing time and effort spent on false positive signals. 1.2.3 Analysis of confidential data submissions shall be done by staff in the OCP Safety Program with appropriate firewalls to the external data-mining technology. 1.3 Project Scope Independently and not as an agent of the Government the contractor/vendor shall furnish the necessary personnel, and services, except as provided in the schedule, and otherwise do all things necessary for the performance of the work as described below: 1.3.1 The contractor/vendor shall work with OCP to develop any necessary elements to permit access to their IT infrastructure currently in place that is required to carry out the safety predictions. Access to the contractor's/vendor's infrastructure will be from FDA systems. 1.3.1.1 Allow infrastructure access from four (4) individual OCP workstations. 1.3.2 Provide technical and analytical support as agreed upon in writing. 1.3.2.1 Provide ongoing technical support to facilitate data analysis and hypothesis generation. 1.3.1.3 Provide technical and analytical support to most effectively evaluate potential safety signals. 1.3.3 Provide one (1), one (1)-hour training session per month, to OCP safety program personnel on data entry and data search within the infrastructure. 1.3.4 As agreed upon in writing, support the execution of at least ten (10), but no more than twelve (12) pilot safety prediction projects, utilizing the infrastructure. This is an ongoing activity and is expected to be renewed, at the option of the Project Officer (PO), for up to four (4) consecutive years to most effectively evolve this new approach to drug safety evaluation. 2.0 Description of Work 2.1 Program Planning The contractor/vendor shall provide appropriately firewalled access to their internal IT infrastructure for FDA by directly working with FDA OCP. The contractor/vendor and OCP shall have an initial meeting to specify standard operating procedures for the work and define detailed time lines. 2.2 Project Management and Control The contractor/vendor shall provide monthly status reports to the PO on the status/progress of deliverables and any current or anticipated problems with required activities. Reports shall be received by the PO no later than the fifteenth (15th) of each month. The contractor/vendor shall provide ongoing infrastructure maintenance with a response time of no more than forty-eight (48) hours from the time of notification. 3.0 Task Deliverables Item # Deliverable 1 Face-to-face pre meeting with designated OCP management to specify standard operating procedures for the work and define detailed time lines FDA shall review and approve in writing all procedures and timelines before work begins. Date Due: No later than two (2) weeks after contract award. 2. Work with OCP to develop any necessary elements to permit access to the IT infrastructure required to carry out the safety prediction. Meetings shall be via conference call or web conference. Date Due: November 1, 2014 3. Allow infrastructure access from four (4) individual OCP workstations. Date Due: December 1, 2014 4. Begin providing ongoing technical support as agreed upon in writing to facilitate data analysis and hypothesis generation. Date Due: December 6, 2014 5. Begin providing technical and analytical support as agreed upon in writing to most effectively evaluate potential safety signals. Date Due: December 6, 2014 6. Provide one (1), one(1)-hour training session per month, to OCP safety program personnel on data entry and data search within the infrastructure. Subsequent training dates to be agreed upon in writing. Date Due: January 6, 2015 7. Support the execution of at least ten (10), but no more than twelve (12) pilot safety prediction projects. Date Due: January 10, 2015 through end of period of performance 4.0 Criteria for Acceptance OCP shall review contractor/vendor deliverables in accordance with specifications and standards stated in the criteria established and any directives issued during the term of this contract. OCP Management 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 deliverable. 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 on a CD. Deliverable shall be submitted to the PO who initiated the request. a. Contractor/vendor shall provide monthly status report that provides information about the current status and anticipated completion date for any deliverable. The contractor/vendor shall also include information about any unanticipated problems with completion of any deliverable. 5.0 Period of Performance September 1, 2014 - August 30, 2015 6.0 Location, Work Schedule and Travel Work to be completed at contractor's location. Unless otherwise specified, meetings between contractor/vendor and FDA shall be in person at FDA/CDER 10903 New Hampshire Avenue, Silver Spring, Maryland, or via conference call and/or web conferencing. Any and all travel required for deliverables shall be at the expense of the contractor/vendor. 7.0 Government-Furnished Information (GFI) and Government-Furnished Equipment (GFE) Issuing and use of Government-furnished equipment shall be based on Security and Privacy requirements described in Section 8. 8.0 Security and Privacy Performance of work shall not require the contractor/vendor 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/vendor, 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. The contractor/vendor agrees that contractor/vendor personnel shall not divulge or release data or information discussed in connection with the performance of the resulting contract, unless made public by FDA, except to authorized FDA personnel or upon written approval of the PO. 9.0 Contractor/vendor Conformance with Applicable Laws, Regulations, Policies and Standards The Contractor/vendor 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, Health and Human Services (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). These can be primarily found at or through the Federal CIO Council website at: http://www.cio.gov. HHS documents are found at: http://www.cdc.gov/irmo. 10. Evaluation Factors for Award The Government will award a task order from this solicitation to the responsible offeror whose offer represents the best value to the Government. The Government is conducting this source selection using a trade-off/best value methodology. Technical merit is significantly more important than price in determining the successful offeror. However, among equally rated technical proposals, price will be the determining factor. The Government reserves the right to award a task order without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the best value and discussions are not necessary. The following factors shall be used to evaluate offers: 1. Technical Acceptability (features Meeting/Exceeding Salient Requirements) 2. Price (all CLINs shall be priced) 11. Proposal Instructions to Offerors Offerors are required to submit their proposals in two separate volumes as follows: Volume I - Technical Proposal Volume II - Business Proposal The completion and submission of the above items will constitute an offer (proposal) and will indicate the offeror's unconditional assent to the terms and conditions of this RFP and any attachments hereto. Alternate proposals are not authorized. Objections to any terms and conditions of the RFP will constitute deficiency, which may render the offer unacceptable. Volume I - Technical: This portion of the proposal to include all data and information required for technical evaluation of brand name or equal product, and exclude any reference to the pricing aspects of each offer. If an equal product is proposed, offeror shall demonstrate how that product is equal to the brand name product. Offerors shall demonstrate in sufficient detail that the proposed solution will successfully meet the requirements of the salient characteristics. For purposes of clarification, offerors are encouraged to provide trial access to their products to demonstrate how the requirements of the salient characteristics will be met. Volume II - Pricing: This volume shall include the complete pricing. Offerors shall propose pricing for one twelve (12)-month base period and four (4) option years. Offerors shall price each CLIN and clearly state an overall cost to the Government (inclusive of options). 12. FAR Provisions and Clauses 52.211-6 Brand Name or Equal (Aug 1999) 52.252 Clause 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 this/these address(es): http://farsite.hill.af.mil/ 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (Jul 2014) (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)"(Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)). (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: _X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402). _X_ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (41 U.S.C. 3509)). X_ (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.) _X_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note). __ (5) [Reserved]. __ (6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111-117, section 743 of Div. C). __ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Jan 2014) (Pub. L. 111-117, section 743 of Div. C). _ _ (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Aug 2013) (31 U.S.C. 6101 note). __ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313). __ (10) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (May 2012) (section 738 of Division C of Pub. L. 112-74, section 740 of Division C of Pub. L. 111-117, section 743 of Division D of Pub. L. 111-8, and section 745 of Division D of Pub. L. 110-161). __ (11) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a). __ (12) 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). __ (13) [Reserved] __ (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C. 644). __ (ii) Alternate I (Nov 2011). __ (iii) Alternate II (Nov 2011). __ (15)(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. X__ (16) 52.219-8, Utilization of Small Business Concerns (May 2014) (15 U.S.C. 637(d)(2) and (3)). __ (17)(i) 52.219-9, Small Business Subcontracting Plan (Jul 2013) (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. __ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011)(15 U.S.C. 644(r)). _X_ (19) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)). __ (20) 52.219-16, Liquidated Damages-Subcon-tracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)). __ (21)(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. __ (22) 52.219-25, Small Disadvantaged Business Participation Program-Disadvantaged Status and Reporting (Jul 2013) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). __ (23) 52.219-26, Small Disadvantaged Business Participation Program- Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323). __ (24) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657 f). __ (25) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)). __ (26) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)). __ (27) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Jul 2013) (15 U.S.C. 637(m)). _X_ (28) 52.222-3, Convict Labor (June 2003) (E.O. 11755). _X_ (29) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2014) (E.O. 13126). _X_ (30) 52.222-21, Prohibition of Segregated Facilities (Feb 1999). _X_ (31) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). _X_ (32) 52.222-35, Equal Opportunity for Veterans (Sep 2010)(38 U.S.C. 4212). X__ (33) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793). _X_ (34) 52.222-37, Employment Reports on Veterans (SEP 2010) (38 U.S.C. 4212). _X_ (35) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). X_ (36) 52.222-54, Employment Eligibility Verification (AUG 2013). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.) __ (37)(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.) __ (38)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O. 13423 and 13514). __ (ii) Alternate I (Jun 2014) of 52.223-13. __ (39)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (E.O. 13423 and 13514). __ (ii) Alternate I (Jun 2014) of 52.223-14. _X_ (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C. 8259b). _X_ (41)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (JUN 2014) (E.O. 13423 and 13514). __ (ii) Alternate I (Jun 2014) of 52.223-16. _X_ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) (E.O. 13513). __ (43) 52.225-1, Buy American-Supplies (May 2014) (41 U.S.C. chapter 83). __ (44)(i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43. __ (ii) Alternate I (May 2014) of 52.225-3. __ (iii) Alternate II (May 2014) of 52.225-3. __ (iv) Alternate III (May 2014) of 52.225-3. __ (45) 52.225-5, Trade Agreements (NOV 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). _X_ (46) 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). __ (47) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note). __ (48) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). __ (49) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150). __ (50) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). __ (51) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). _X_ (52) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Jul 2013) (31 U.S.C. 3332). __ (53) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C. 3332). _X_ (54) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332). _X_ (55) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a). __ (56)(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 Labor Standards (May 2014) (41 U.S.C. chapter 67). __ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). __ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). __ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). __ (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67). __ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67). __ (7) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O.13495). __ (8) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C. 1792). __ (9) 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) (41 U.S.C. 3509). (ii) 52.219-8, Utilization of Small Business Concerns (May 2014) (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) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (l) of FAR clause 52.222-17. (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 Labor Standards (May 2014) (41 U.S.C. chapter 67). (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 Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67). (xi) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67). (xii) 52.222-54, Employment Eligibility Verification (AUG 2013). (xiii) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note). (xiv) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6. (xv) 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. (End of clause) Alternate I (Feb 2000). As prescribed in 12.301(b)(4)(i), delete paragraph (d) from the basic clause, redesignate paragraph (e) as paragraph (d), and revise the reference to "paragraphs (a), (b), (c), or (d) of this clause" in the redesignated paragraph (d) to read "paragraphs (a), (b), and (c) of this clause." Alternate II (May 2014). As prescribed in 12.301(b)(4)(ii), substitute the following paragraphs (d)(1) and (e)(1) for paragraphs (d)(1) and (e)(1) of the basic clause as follows: (d)(1) The Comptroller General of the United States, an appropriate Inspector General appointed under section 3 or 8G of the Inspector General Act of 1978 (5 U.S.C. App.), or an authorized representative of either of the foregoing officials shall have access to and right to- (i) Examine any of the Contractor's or any subcontractors' records that pertain to, and involve transactions relating to, this contract; and (ii) Interview any officer or employee regarding such transactions. (e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), and (c), of this clause, the Contractor is not required to flow down any FAR clause in a subcontract for commercial items, other than- (i) Paragraph (d) of this clause. This paragraph flows down to all subcontracts, except the authority of the Inspector General under paragraph (d)(1)(ii) does not flow down; and (ii) Those clauses listed in this paragraph (e)(1). Unless otherwise indicated below, the extent of the flow down shall be as required by the clause- (A) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (41 U.S.C. 3509). (B) 52.203-15, Whistleblower Protections Under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (C) 52.219-8, Utilization of Small Business Concerns (May 2014) (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. (D) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). (E) 52.222-35, Equal Opportunity for Veterans (Sep 2010) (38 U.S.C. 4212). (F) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793). (G) 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. (H) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67). (I) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)). (J) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67). (K) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67). (L) 52.222-54, Employment Eligibility Verification (Aug 2013). (M) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6. (N) 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 52.217-8 Option To Extend Services (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within the period specified in the Schedule. (End of Clause) 52.217-9 Option To Extend the Term of the Contract (Mar 2000) (a) The Government may extend the term of this contract by written notice to the Contractor any time after contract award and prior to contract expiration. (b) If the Government exercises this option, the extended contract shall be considered to include this option clause. (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 years. (End of Clause) 52.228-5 Insurance - Work on a Government Installation (Jan 1997) (a) The Contractor shall, at its own expense, provide and maintain during the entire performance of this contract, at least the kinds and minimum amounts of insurance required in the Schedule or elsewhere in the contract. (b) Before commencing work under this contract, the Contractor shall notify the Contracting Officer in writing that the required insurance has been obtained. The policies evidencing required insurance shall contain an endorsement to the effect that any cancellation or any material change adversely affecting the Government's interest shall not be effective -- (1) For such period as the laws of the State in which this contract is to be performed prescribe; or (2) Until 30 days after the insurer or the Contractor gives written notice to the Contracting Officer, whichever period is longer. (c) The Contractor shall insert the substance of this clause, including this paragraph (c), in subcontracts under this contract that require work on a Government installation and shall require subcontractors to provide and maintain the insurance required in the Schedule or elsewhere in the contract. The Contractor shall maintain a copy of all subcontractors' proofs of required insurance, and shall make copies available to the Contracting Officer upon request. (End of Clause) FAR 52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS (DEC 2013) (a) Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor. (b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act. (c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items. (End of clause) FAR provisions and clauses incorporated by reference: 52.213-2 Invoices (APR 1984) 52.217-5 Evaluation of Options (July 1990) 52.217-7 Option for Increased Quantity-Separately Priced Line Item (MAR 1989) 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013) 13. HHSAR Provisions and Clauses HHSAR provisions and clauses are incorporated by reference: Full text versions can be viewed at http://www.hhs.gov/policies/hhsar/subpart352.html 352.202-1 Definitions (Jan 2006) 352.203-70 Anti-lobbying (JAN 2006) 352.224-70 Privacy Act (January 2006) 352.270-6 Publications and Publicity (JAN 2006) 352.222-70 Contractor cooperation in equal employment opportunity investigations (Jan 2010) 352.270-19 Electronic and Information Technology Accessibility (Jan 2006) 14. 508 Requirements This requirement is subject to Section 508 compliance. Vendor proposals shall address how the proposed solution will comply with Section 508. Specifically the following 508 Standards are applicable:§ 1194.21 Software applications and operating systems. a) When software is designed to run on a system that has a keyboard, product functions shall be executable from a keyboard where the function itself or the result of performing a function can be discerned textually. (b) Applications shall not disrupt or disable activated features of other products that are identified as accessibility features, where those features are developed and documented according to industry standards. Applications also shall not disrupt or disable activated features of any operating system that are identified as accessibility features where the application programming interface for those accessibility features has been documented by the manufacturer of the operating system and is available to the product developer. (c) A well-defined on-screen indication of the current focus shall be provided that moves among interactive interface elements as the input focus changes. The focus shall be programmatically exposed so that assistive technology can track focus and focus changes. (d) Sufficient information about a user interface element including the identity, operation and state of the element shall be available to assistive technology. When an image represents a program element, the information conveyed by the image must also be available in text. (e) When bitmap images are used to identify controls, status indicators, or other programmatic elements, the meaning assigned to those images shall be consistent throughout an application's performance. (f) Textual information shall be provided through operating system functions for displaying text. The minimum information that shall be made available is text content, text input caret location, and text attributes. (g) Applications shall not override user selected contrast and color selections and other individual display attributes. (h) When animation is displayed, the information shall be displayable in at least one non-animated presentation mode at the option of the user. (i) Color coding shall not be used as the only means of conveying information, indicating an action, prompting a response, or distinguishing a visual element. (j) When a product permits a user to adjust color and contrast settings, a variety of color selections capable of producing a range of contrast levels shall be provided. (k) Software shall not use flashing or blinking text, objects, or other elements having a flash or blink frequency greater than 2 Hz and lower than 55 Hz. (l) When electronic forms are used, the form shall allow people using assistive technology to access the information, field elements, and functionality required for completion and submission of the form, including all directions and cues. § 1194.22 Web-based intranet and internet information and applications. (a) A text equivalent for every non-text element shall be provided (e.g., via "alt", "longdesc", or in element content). (b) Equivalent alternatives for any multimedia presentation shall be synchronized with the presentation. (c) Web pages shall be designed so that all information conveyed with color is also available without color, for example from context or markup. (d) Documents shall be organized so they are readable without requiring an associated style sheet. (e) Redundant text links shall be provided for each active region of a server-side image map. (f) Client-side image maps shall be provided instead of server-side image maps except where the regions cannot be defined with an available geometric shape. (g) Row and column headers shall be identified for data tables. (h) Markup shall be used to associate data cells and header cells for data tables that have two or more logical levels of row or column headers. (i) Frames shall be titled with text that facilitates frame identification and navigation. (j) Pages shall be designed to avoid causing the screen to flicker with a frequency greater than 2 Hz and lower than 55 Hz. (k) A text-only page, with equivalent information or functionality, shall be provided to make a web site comply with the provisions of this part, when compliance cannot be accomplished in any other way. The content of the text-only page shall be updated whenever the primary page changes. (l) When pages utilize scripting languages to display content, or to create interface elements, the information provided by the script shall be identified with functional text that can be read by assistive technology. (m) When a web page requires that an applet, plug-in or other application be present on the client system to interpret page content, the page must provide a link to a plug-in or applet that complies with §1194.21(a) through (l). (n) When electronic forms are designed to be completed on-line, the form shall allow people using assistive technology to access the information, field elements, and functionality required for completion and submission of the form, including all directions and cues. (o) A method shall be provided that permits users to skip repetitive navigation links. (p) When a timed response is required, the user shall be alerted and given sufficient time to indicate more time is required. § 1194.41 Information, documentation, and support. (a) Product support documentation provided to end-users shall be made available in alternate formats upon request, at no additional charge. (b) End-users shall have access to a description of the accessibility and compatibility features of products in alternate formats or alternate methods upon request, at no additional charge. (c) Support services for products shall accommodate the communication needs of end-users with disabilities. 15. Administrative Data System for Award Management (SAM): In accordance with FAR 52.212-4, Offerors shall be registered in the SAM database to be considered for award. 16. Submission of Questions and Proposals QUESTIONS: Offerors shall submit questions to the Contract Specialist, Syntoria L. Spencer via email at syntoria.spencer@fda.hhs.gov. Please reference the specific area and location in the RFP or SOW when asking the question. All questions must be submitted no later than 10:00AM, Eastern Time (ET), Monday, August 18, 2014. FDA will provide responses to questions, if submitted, no later 10:00AM ET, Wednesday, August 20, 2014. RFP DUE DATE: Responses to this RFP shall be submitted to Syntoria L. Spencer, via email at syntoria.spencer@fda.hhs.gov as a MS Word and Adobe PDF attachment no later than 3:00PM ET, Friday, August 22, 2014. The contractor is requested to hold price quotations for a minimum of 45 days.
 

Web Link

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Place of Performance

Address: The U.S. Food and Drug Administration, Silver Spring, Maryland, 201993, United States

Zip Code: 01993
 

Record

SN03463723-W 20140815/140814000032-e237dd7802c45d7326c1fa79f6207628 (fbodaily.com)
 

Source

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