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FBO DAILY - FEDBIZOPPS ISSUE OF JULY 17, 2016 FBO #5350
SOLICITATION NOTICE

A -- Human Tissue-specific Visualization of Cytochrome P450 polymorphisms - FDA SOL 1169500

Notice Date

7/15/2016
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
 

ZIP Code

20857-0001
 

Solicitation Number

SOL1169500
 

Point of Contact

Telisha Wilson, Phone: 2404027572
 

E-Mail Address

telisha.wilson@fda.hhs.gov
(telisha.wilson@fda.hhs.gov)
 

Small Business Set-Aside

N/A
 

Description

Human Tissue-specific Visualization of Cytochrome P450 polymorphisms Human Tissue-specific Visualization of Cytochrome P450 polymorphisms 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. This solicitation is being issued as a Request for Quote (RFQ) for Full and Open Competition. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-88. The associated North American Industrial Classification System (NAICS) code for this procurement is 334516 (Size Standard - 500 employees). The Government intends to award as a firm fixed priced order. DESCRIPTION OF SERVICES AND PRICES The U.S. Food and Drug Administration (FDA)'s Center for Tobacco Products (CTP) has a requirement for a study for a study examining the tissue distribution of major N-nitrosonornicotine (NNN) and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) metabolizing cytochrome P450's (CYP's). This study will examine the distribution of known NNN and NNK metabolizing CYPs (CYP2A6, CYP2A13, CYP3A4, CYP1A2, CYP2E1, CYP2D6, and CYP1B1) in bone marrow, lung, kidney, liver, bladder, oral cavity, and esophageal tissues through the use of antibody-based visualization techniques in commercially-available human tissue sections. This study will answer the question "What is the human tissue-specific expression of cytochrome p450 proteins associated with metabolism of NNN and/or NNK?" PRICING TABLE Contract Line Item Number (CLIN) Service Description Price 0001 Kickoff Meeting 0002 Monthly Report 0003 Conduct Study 0004 Draft Study Report 0005 Final Version of the Study Report TOTAL MAXIMUM POTENTIAL PRICE After the FDA's Contracting Officer's Representative (COR) acceptance of the services delivered and upon the submission of proper invoices, the Government will pay the Contractor no more frequently than monthly for the firm-fixed prices delineated above. BACKGROUND On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) into law (Public Law 111-31). The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and granted the FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. The FDA has authority over cigarettes, smokeless tobacco, and roll-your-own tobacco. The FDA has also expressed intent to deem jurisdiction over other tobacco products. Most tobacco carcinogens are pre-carcinogens that require metabolic activation to exert their effects. Generally, metabolic activation is carried out by cytochrome P450 (CYP) enzymes (Rossini et al, Pharmacogenomics 2008). Activation results in formation of a short-lived electrophile that reacts in situ to produce tumors, for instance through DNA adduct formation. Thus, tumor formation is site-specific and will only occur in those tissues expressing the specific CYPs that metabolize tobacco carcinogens, such as NNN and NNK. Surprisingly, few studies have been carried out to visualize the tissue distribution of CYPs involved in the metabolism of NNN and NNK in human samples, except for Chang, H.C. et al., (Respiration, 2012) who examined distribution of CYP2A6 and CYP2A13 within the respiratory tract. However, the distribution of other CYPs with potential involvement in the metabolism of NNN or NNK has not been established in human tissues. SCOPE OF WORK Contractor shall conduct the following using Good Laboratory Practice (GLP) conditions: 1. The contractor shall examine human CYP2A6, CYP2A13, CYP3A4, CYP1A2, CYP2E1, CYP2D6, and CYP1B1 expression in no less than 10 cases per tissue type from normal human bone marrow, lung, kidney, liver, bladder, oral cavity, and esophageal tissues. 2. The contractor shall include detailed experimental methods utilizing antibody-based characterization and visualization techniques with commercially-available human tissue sections. For instance, the offeror may demonstrate tissue localization of CYP proteins using visible or fluorescence-tagged epitopes and microscopic visualization with quantitation. However other methods may be acceptable, e.g. laser-capture microdissection, FISH, tissue microarray. The specific protocols and method details shall be proposed by the offeror. For instance, the offeror may choose to rely on the manufacturer's published instructions, or to modify such instructions based on their own or others' work. The antibody-based characterization and visualization methods should be appropriate and relevant to characterize the tissue, and ideally, cell type-specific distribution profile of human CYP2A6, CYP2A13, CYP3A4, CYP1A2, CYP2E1, CYP2D6, and CYP1B1 within those human tissues listed above known to be affected by cigarette smoking. Funding for method development of a new assay or for purchase of new equipment required to perform the assays is not within the scope of this work. The chosen methods should already be properly validated and verified for sensitivity, specificity, and reproducibility, and be rapid, efficient, and practical as well as well-accepted and the results comparable within the literature. TASKS AND DELIVERABLES The Contractor shall perform the following tasks and provide the following deliverables. The Contractor shall incorporate the FDA's feedback into its final versions of all deliverables. The Contractor shall deliver all documents to the COR electronically, not in hard copy form, with the document title, and the contract and order numbers identified in the subject line of the email submission. Deliverables shall be in MS Word, MS Excel, Adobe Acrobat, MS Powerpoint, and/or SAS transport (.xpt). All submitted documents shall be verified virus-free. All data shall belong to FDA and there is no permission granted, express or implied, to publish the data. Task 1-Kickoff Meeting The Contractor shall conduct a kickoff meeting with the COR ten calendar days after award. Within two business days after the kickoff meeting, the Contractor shall provide comprehensive meeting minutes, including a summary of issues and discussions, action items, and due dates. Task 2 - Monthly Report The Contractor shall provide a monthly report with comprehensive meeting minutes, including a summary of issues and discussions, action items, and due dates. Task 3-Conduct the Study 1. The contractor shall obtain no less than 10 cases each of human tissue sections including normal bone marrow, lung, kidney, liver, bladder, oral cavity, and esophagus for use in these studies. 2. The contractor shall carry out differential antibody-based staining to identify the expression of human CYP2A6, CYP2A13, CYP3A4, CYP1A2, CYP2E1, CYP2D6, and CYP1B1 proteins within the tissues. 3. The contractor shall provide a quantitative, analysis of the relative distribution of the enzymes within the above-listed tissues relative to one another, i.e. as a percentage of the total sampled. 4. The contractor shall provide the details of the study conducted which shall follow an accepted, validated methodology, and document and justify the source of the protocol and any deviations. 5. The contractor shall follow standard in vitro study QA/QC requirements of GLP for number of replicates, number of assays, positive/negative and vehicle controls, and all controls specific to antibody-based in vitro assays. 6. The contractor shall report all data in raw and adjusted formats where adjusted data are normalized to controls, and test for significance between groups using accepted statistical procedures, such as analysis of variance (ANOVA). Any excluded data shall be justified using an accepted statistical method/criterion and documented. 7. The contractor shall verify that all QA/QC performance metrics were met and flag (*) any unacceptable data points with a notation for the reason for exclusion and the method used to determine acceptability/non-acceptability. 8. The contractor shall provide visual imagery of the experimental results (photomicrographs) in a widely-used electronic format such as TIF, TIFF, GIF or pdf. 9. The contractor shall provide a high-level executive summary of the results with respect to the research question; ‘What is the human tissue-specific expression of cytochrome p450 proteins associated with metabolism of NNN and/or NNK?'. 10. The research must be conducted in a scientifically-justifiable manner and must be traceable (i.e. results obtained should be reproducible under the methods used by the contractor, if duplicated by another researcher). In other words, it must be publishable. Task 4-Draft Study Report The Contractor shall report the results of the experiments to FDA in the form of a Study Report. The Study Report shall include the information as specified in section 3.4 Contract Guidelines. Task 5-Final Study Report The contractor shall submit a final study report to FDA according to the requirements identified in section 3.4.4 Final Report Requirements below and incorporating all of the edits to the draft study report received from the COR. All the data in the final study report shall be properly audited for quality control/quality assurance. GOOD LABORATORY PRACTICES In accordance with the Code of Federal Regulations (CFR) Title 21, Part 58, Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies, the Contractor shall practice Good Laboratory Practices for all applicable work for this contract, including data auditing for quality assurance. EXPERIMENT PARAMETERS The Contractor shall follow all applicable scientific protocols and methodologies obtained from the published literature, the manufacturer, and their own modifications or those from the work of others, including selection of testing system and source, vehicle controls, concentrations of each antibody and vehicle control, negative and positive controls, exposures, endpoints and parameters to be collected and analyzed, the number of replicates and same size per each group, equipment, and materials to be used in each experiment; necessary scientific justifications; and incorporating the detailed procedures specified below. The Contractor shall provide a written draft protocol with their proposal including the rationale, parameters, scientific protocols, and methodologies that will be used for the proposed study. I. In the proposal and protocol, the Contractor shall: 1. Recommend the experimental protocol for collection of each endpoint with rationale and justification. 2. Select the research facility to perform the requirement. 3. Recommend appropriate test vehicle(s) and conditions to generate CYP tissue distribution results, with proper justifications and references. 4. Include the strategy used and a scientific rationale for the methods, protocols, and experimental design. 5. Recommend a timeline for execution, analysis, and reporting of the studies. 6. Deliver the appropriately-QC audited data, results and analysis to FDA and maintain the confidentiality of the data and results. II. The Contractor shall strictly adhere to the following procedures and measures for all experiments, unless indicated by the COR: 1. Appropriate controls, e.g., positive control, negative control IgG control, shall be used for all tissue staining procedures 2. The Contractor shall validate the measurement of endpoints. 3. Each antibody shall be in a proper vehicle that shall allow concentrations that provide the proposed exposure dilution. 4. The contractor shall test for non-specific antibody binding with an appropriate reagent (e.g., IgG from appropriate species). 5. The methods of assays selected should utilize available technology to greatly enhance the throughput efficiency of data gathering, and utilize a comparative approach to generate a relative abundance for each of the test articles within the tissue and compared with other tissues under study. 6. The Contractor shall provide a Data Analysis Plan with their proposal, which shall include details on the collection, organization, analysis, and interpretation of data, such as the personnel who shall conduct the statistical analyses and their credentials (e.g. training and courses completed), the statistical model(s) and software program(s) that shall be used to analyze the data, data normalization, methods and criteria for outlier detection and removal, where applicable, and selection of the significance level and post- hoc analysis, when applicable. 7. The Contractor shall perform the data analysis indicated in the approved Data Analysis Plan. III. The Contractor shall use the following specifications in the proposed studies: 1. Use approved protocols and methods developed by manufacturers, yourself or others that are documented through publication in the peer-reviewed literature. 2. Perform staining on no less than 10 cases per tissue type. 3. Use GLP methods insofar as they apply to in vitro studies. For instance, data QA/QC, statistical methods, rigorous discipline with respect to data integrity, testing of visualization equipment, shelf life, proper storage of reagents, etc. 4. Use appropriate vehicle and positive, negative, and IgG controls. 5. Use technologically modern and well-maintained equipment and supplies. 6. Use approved methods for statistical analysis and exclusion of outliers. 7. Use methods that provide quantitative results and compare relative tissue distribution of human CYP2A6, CYP2A13, CYP3A4, CYP1A2, CYP2E1, CYP2D6, and CYP1B1 in bone marrow, lung, kidney, liver, oral cavity, esophageal, and bladder tissue sections from normal humans. 8. Optimize detection of the above endpoints in an antibody-based visual detection system, the specifics of which are to be proposed by the contractor. Optimization techniques include varying the antibody dilution, exposure duration, diluent, control antibody, etc. to provide maximal results quality. 9. Provide the data results in a widely-used electronic format specified elsewhere herein, in both numerical and visual forms. FINAL REPORT REQUIREMENTS 1. Specific protocols, methods, materials, and equipment used for each experiment, including test material, dilutions, controls, scale bars, and supplier information (including city, state, and country for all test material, equipment, and reagents), and software information shall be provided to FDA. 2. Data analyses should include appropriate statistical analyses. The details of statistical calculations, including models and equations utilized, should be adequately described and referenced. 3. Interpretation and summary of results. An executive summary paragraph summarizing the pertinent conclusions of the study should be provided. 4. All individual data needed for conclusions should be presented in coherent tables. A copy of the raw data should be provided separately in an appendix. 5. Documentation should be provided to demonstrate the sensitivity, linearity, specificity, and reproducibility of the analytical method, including sample chromatographs, recovery studies, etc. as applicable. 6. The final report and contents in the final report cannot be published without receiving approval and clearance from FDA. The Contractor does not have the right to disclose any information related to this study without FDA approval. DELIVERABLE SCHEDULE The Contractor shall complete and provide the deliverables below according to the following schedule: Deliverable Due Date Task 1-Kickoff Meeting Kickoff meeting within 10 calendar days of award; meeting minutes are due within 2 business days of the meeting Task 2-Monthly Report The Contractor shall provide a monthly report with comprehensive meeting minutes, including a summary of issues and discussions, action items, and due dates Task 3 - Conduct Study Study shall be started no later than 20 business days after the kickoff meeting. Task 4-Draft Final Report 30 business days after the last laboratory analysis is completed with pending auditing of quality assurance (QA); QA auditing shall be completed no later than 30 days after draft report is submitted to FDA Task 4-Final Report 20 business days after receipt of the FDA's feedback on the draft report. CONTRACT ADMINISTRATION Contracting Officer's Representative (COR) The following COR will represent the Government for the purpose of this order: [TBD] The COR is responsible for the following as required by this order: (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 evaluations; (4) performing technical inspections and acceptances; and (5) assisting in the resolution of technical problems encountered during performance. The Contracting Officer is the only person with authority to act as an agent of the Government under this order. Only the Contracting Officer has authority to: direct or negotiate any changes in the order, including modifying or extending the period of performance, changing the delivery schedule, authorizing reimbursement to the Contractor for any costs incurred during the performance of this order, or otherwise change any terms and conditions of this order. The contact information for the Contracting Officer is the following:TBD The contact information for the Contractor is the following: [TBD] SPECIAL CONTRACT REQUIREMENTS SAFEGUARDING OF INFORMATION The Contractor and its employees shall exercise the utmost discretion in regard to all matters relating to their duties and functions. They shall not communicate to any person any information known to them by reason of their performance of services under this task order which has not been made public, except in the course of their duties or by written authorization of the Contracting Officer. Furthermore, no article, book, pamphlet, recording, broadcast, speech, television appearance, film, or photographs concerning any aspect of the contract shall be published or disseminated through any media without the prior written authorization of the Contracting Officer. These obligations do not cease upon termination of this contract. The Contractor shall include the substance of this provision in all contracts for employment and in all subcontracts hereunder. CONTRACT CLAUSES FAR CLAUSES INCORPORATED BY REFERENCE 6.1 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 (May 2015) 52.216-24, Limitation of Government Liability (Apr 1984) 52.233-2, Service of Protest (Sep 2006) 52.212-3 Offeror Representations and Certifications-Commercial Items. As prescribed in 12.301(b)(2), insert the following provision: OFFEROR REPRESENTATIONS AND CERTIFICATIONS-COMMERCIAL ITEMS (APR 2016) The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) website accessed through http://www.acquisition.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (r) of this provision. FAR CLAUSES BY FULL TEXT 52.212-3 Offeror Representations and Certifications-Commercial Items. (April 2016) 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 (MAR 2016) (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) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015) (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: [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. 4704 and 10 U.S.C. 2402). __ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509)). __ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.) __ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2015) (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. (Oct 2015) (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) [Reserved]. __ (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a). __ (ii) Alternate I (Nov 2011) of 52.219-3. X__ (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a). __ (ii) Alternate I (JAN 2011) of 52.219-4. __ (13) [Reserved] _X_ (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. __ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)). __ (17)(i) 52.219-9, Small Business Subcontracting Plan (Oct 2015) (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 (Oct 2015) of 52.219-9. __ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)). __ (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) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657 f). __ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)). __ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)). __ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Dec 2015) (15 U.S.C. 637(m)). _X_ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755). __ (26) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Feb 2016) (E.O. 13126). _X_ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015). _X_ (28) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246). X_ (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015)(38 U.S.C. 4212). _X (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). __X (31) 52.222-37, Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212). X__ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). __ (33)(i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627). __ (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627). __ (34) 52.222-54, Employment Eligibility Verification (OCT 2015). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.) __ (35)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.) __ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.) __ (36)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514). __ (ii) Alternate I (Oct 2015) of 52.223-13. __ (37)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514). __ (ii) Alternate I (Jun 2014) of 52.223-14. __ (38) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C. 8259b). __ (39)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s 13423 and 13514). __ (ii) Alternate I (Jun 2014) of 52.223-16. __ (40) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) (E.O. 13513). _X_ (41) 52.225-1, Buy American-Supplies (May 2014) (41 U.S.C. chapter 83). __ (42)(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. __ (43) 52.225-5, Trade Agreements (FEB 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). __ (44) 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). __ (45) 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). __ (46) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). __ (47) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150). __ (48) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). _X_ (49) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). _X_ (50) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Jul 2013) (31 U.S.C. 3332). __ (51) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C. 3332). __ (52) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332). __ (53) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a). __ (54)(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) 52.222-17, Nondisplacement of Qualified Workers (May 2014)(E.O. 13495). __ (2) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67). __ (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). __ (4) 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). __ (5) 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). __ (6) 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). __ (7) 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). __ (8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015). __ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C. 1792). __ (10) 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 (Oct 2015) (41 U.S.C. 3509). (ii) 52.219-8, Utilization of Small Business Concerns (Oct 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 $700,000 ($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) 52.222-21, Prohibition of Segregated Facilities (Apr 2015) (v) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246). (vi) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212). (vii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793). (viii) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212) (ix) 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. (x) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67). (xi) __(A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O 13627). __(B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O 13627). (xii) 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). (xiii) 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). (xiv) 52.222-54, Employment Eligibility Verification (OCT 2015) (E.O. 12989). (xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015). (xvi) 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). (xvii) 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. (xviii) 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) HHSAR CLAUSES INCORPORATED BY REFERENCE 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: http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html. Subpart 352.2-Texts of Provisions and Clauses (December 18, 2015) 352.203-70, Anti-Lobbying (December 18, 2015) 352.215-70 Late Proposals and Revisions (December 18, 2015) 352.223-70 Safety and Health (December 18, 2015) 352.223-71 Instructions to Offerors-Sustainable Acquisition (December 18, 2015) 352.224-70 Privacy Act (December 18, 2015) In accordance with the Code of Federal Regulations (CFR) Title 21, Part 58, Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies, Offerors shall demonstrate: Technical Approach • Capability to select the vehicles and controls used in the studies. • Capability to obtain at minimum 10 cases of normal tissue samples including human bone marrow, lung, kidney, liver, oral cavity, esophageal, and bladder tissues and to prepare these samples for use (e.g., de-paraffinize FFPE tissue sections) • Capability to analytically measure each CYP (2A6, 2A13, 3A4, 1A2, 2E1, 2D6, and 1B1). • Ability to optimize an antibody-based test system to produce clear results useful to FDA, and to produce results that are suitable for publication • Ability to properly conduct the proposed assays, and perform data analyses. • Ability to dose appropriate numbers of test samples/group numbers with proper control groups, for meaningful analysis. • Ability to generate raw/line data, data analysis, and scientific evidence to support a full study report describing the human tissue distribution of each CYP (2A6, 2A13, 3A4, 1A2, 2E1, 2D6, and 1B1). • Ability to conduct the proposed assays using a properly validated method. • Ability to conduct GLP studies and data QA through proper auditing. • Proposed timeline for each deliverable. Protocol • Proposed scientific protocols and methodologies for the procedures specified in section 3.4 Contract Guidelines including: the testing system(s), concentrations of each antibody, vehicle and controls, the endpoints and parameters to be collected and analyzed, the number of replicates and sample size per each group, equipment, and materials to be used in each experiment, and necessary scientific justifications. • Plan and procedure to maintain the security of the data and contract laboratory facilities. Data Analysis Plan • Proposed Data Analysis Plan, which shall include details on the collection, organization, analysis, and interpretation of data, such as the personnel who shall conduct the statistical analyses and their credentials, the statistical model(s) and software program(s) that shall be used to analyze the data, methods and criteria for outlier detection and removal, where applicable, and selection of the significance level and post-hoc analysis, when applicable Proposed Personnel • A description of the proposed personnel's qualifications and experience in the form of tailored resumes shall accompany the narrative discussion, which shall demonstrate the offeror's ability to complete the work described above. • Project management information, preferably in a chart format, to illustrate the work structure and management responsibility that are applied to ensure the quality and schedule of the study. PAYMENT The Government will pay the Contractor only each respective deliverable's firm-fixed-price delineated in the table, upon successful completion, as determined by the COR, and upon submission of a proper invoice. Proper invoice submission includes following the invoice instructions below. INVOICE INSTRUCTIONS The Contractor shall submit all invoices in the manner specified below: The Contractor shall submit one original copy of each invoice to the address specified below: Office of Financial Services Food and Drug Administration 10903 New Hampshire Avenue W032-Second Floor Bldg. 32, Rm. 2162, Mail Hub 2145 Silver Spring MD 20993-0002 Attn: Vendor Payments Phone: (301) 827-3742 or (866) 807-3742 Email: OFS/PaymentServices@fda.hhs.gov Invoices submitted under this order must comply with the requirements set forth in FAR 52.232-33 (Payment by Electronic Funds Transfer - Central Contractor Registration) and the other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following: (I) Name and address of the contractor; (II) Invoice date and Invoice number; (III) Purchase Order/Award Number; (IV) Description, quantity, unit of measure, unit price, and extended price of supplies delivered or services performed, including: (a) period of performance for which costs are claimed; (b) itemized travel costs, including origin and destination; and (c) any other supporting information necessary to clarify questionable expenditures; (V) Shipping number and date of shipping, including the bill of lading number and weight of shipment if shipped on government bill of lading; (VI) Terms of any discount for prompt payment offered; (VII) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment) (VIII) Name, title and phone number of person to notify in event of a defective invoice; (IX) Taxpayer Identification Number (TIN); (X) Electronic Funds Transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited; (XI) Name and telephone number of the COR or other program center/office point of contact, as referenced on the purchase order; and, (XII) Any other information or documentation required by the purchase order/award. Questions regarding invoices shall be directed to the FDA at the telephone numbers provided above. SYSTEM FOR AWARD MANAGEMENT REGISTRATION In accordance with the with the Debt Collection Improvement Act of 1996, in order to be considered for an award of a Federal contract, the contractor must be registered in the System for Award Management (SAM), a free web site that encompasses the capabilities of the - Central Contractor Registry (CCR); Federal Agency Registration (Fedreg); Online Representations and Certifications Application (ORCA); Excluded Parties List System (EPLS); and the Catalog of Federal Domestic Assistance. If a new Contractor, you will need only your personal information to create an account in SAM. If a Contractor with an active record in CCR, you will not need to establish a SAM account. The CCR record transfers to become the active SAM account. (1) Definitions. "Registered in the SAM database" means that- (i) The Contractor has entered all mandatory information, including the DUNS number or the DUNS+4 number, into the SAM database; (ii) The Contractor's CAGE code is in the SAM database; and (iii) The Government has validated all mandatory data fields, to include validation of the Taxpayer Identification Number (TIN) with the Internal Revenue Service (IRS), and has marked the record "Active". The Contractor will be required to provide consent for TIN Attachment, Page 1 of 4 validation to the Government as a part of the SAM registration process. "System for Award Management (SAM)" means the primary Government repository for prospective federal awardee information and the centralized Government system for certain contracting, grants, and other assistance related processes. It includes- (i) Data collected from prospective federal awardees required for the conduct of business with the Government; (ii) Prospective contractor submitted annual representations and certifications in accordance with FAR Subpart 4.12. [If unable to complete updated representations and certifications in SAM, the Contractor must complete a paper copy of their Representations and Certifications and submit it with their proposal]; and (iii) The list of all parties suspended, proposed for debarment, debarred, declared ineligible, or excluded or disqualified under the nonprocurement common rule by agencies, Government corporations, or by the Government Accountability Office. (2) The Contractor shall be registered in the SAM database prior to submitting an invoice and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation. The SAM registration shall be for the same name and address identified on the contract, with its associated CAGE code and DUNS or DUNS+4. If indicated by the Government during performance, registration in an alternate system may be required in lieu of SAM. If the Contractor does not have a DUNS number, it should contact Dun and Bradstreet directly to obtain one. A contractor may obtain a DUNS number- (i) Via the internet at http://fedgov.dnb.com/webform or if the contractor does not have internet access, it may call Dun and Bradstreet at 1-866-705-5711 if located within the United States; or (ii) If located outside the United States, by contacting the local Dun and Bradstreet office. The contractor should indicate that it is a contractor for a U.S. Government contract when contacting the local Dun and Bradstreet office. (3) The Contractor is responsible for the accuracy and completeness of the data within the SAM database, and for any liability resulting from the Government's reliance on inaccurate or incomplete data. To remain registered in the SAM database after the initial registration, the Contractor is required to review and update on an annual basis from the date of initial registration or subsequent updates its information in the SAM database to ensure it is current, accurate and complete. Updating information in the SAM does not alter the terms and conditions of this contract and is not a substitute for a properly executed contractual document. (4) Contractors may obtain information on registration and annual confirmation requirements via the SAM accessed through https://www.acquisition.gov or by calling 866-606-8220, or 334-206- 7828 for international calls. If there is any difficulty in updating this record, contact the Federal Service Help Desk at www.fsd.gov or 866-606-8220 for SAM assistance. https://www.sam.gov/portal/public/SAM/ INSTRUCTIONS COVER PAGE Offerors shall include a cover page which shall include a point of contact (name, telephone number, and email address), proposed firm-fixed-prices (i.e. complete the pricing table estimated delivery date, business size and type (e.g. small, 8(a) small businesses, veteran-owned small businesses, woman-owned small businesses, etc.), Dun and Bradstreet (DUNS) number, country of manufacturing of equipment, and certification that all company information listed in the System for Award Management (SAM) database is complete, accurate, and current. Offerors shall ensure the solicitation number is visible in the header of the email transmission of their quote. Faxed quotes will not be accepted. Offers shall be no more than 20 pages in response, inclusive of cover letter. This documentation should include information on how the offered instrument meets or exceeds each technical detail listed above, and provide customer endorsements, such as references by expert users in the field of study. Offerors Response Date and Time Responses shall be received not later than 3:00 PM EST, July 21, 2016. Quotes will not be accepted after the due date Documentation should be emailed to: Telisha.Wilson@fda.hhs.gov with subject line titled "FDA-SOL-1169500". Payment will only be made on a firm-fixed-price basis. Quotes must be valid through September 30, 2016. Late quotes will not be evaluated. Award will be made to the parties whose quotes offer the Lowest Priced Technically Acceptable overall.
 

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