FBODaily.com | FedBizOpps: MOD | D | Citeline Pharmaprojects Drug Pipeline License. Proposal due date changed from 05/24/2017 @ 3:00PM, Eastern Time to 06/03/2017 @ 3:00PM, Eastern Time. Any questions must be addressed to Jacquelyne.Ngegba@fda.hhs.gov by 12 pm, Eastern Time on 05/23/2017.

FBO DAILY - FEDBIZOPPS ISSUE OF MAY 21, 2017 FBO #5658
MODIFICATION

D -- Citeline Pharmaprojects Drug Pipeline License. Proposal due date changed from 05/24/2017 @ 3:00PM, Eastern Time to 06/03/2017 @ 3:00PM, Eastern Time. Any questions must be addressed to Jacquelyne.Ngegba@fda.hhs.gov by 12 pm, Eastern Time on 05/23/2017.

Notice Date: 5/19/2017
Notice Type: Modification/Amendment
NAICS: 511120 — Periodical Publishers
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: FDA-SS-17-1179172
Archive Date: 6/18/2017
Point of Contact: Jacquelyne A. Ngegba, Phone: 301-796-6761
E-Mail Address: Jacquelyne.Ngegba@fda.hhs.gov
(Jacquelyne.Ngegba@fda.hhs.gov)
Small Business Set-Aside: N/A
Description: Statement of Work (SOW) The United States Food and Drug Administration (FDA) Citeline Pharmaprojects Drug Pipeline License 1. OBJECTIVE The purpose of this procurement is to establish a contract for 24/7 web access license to the Citeline Pharmaprojects Drug Pipeline database for one (1), 12-month period. The license shall support the FDA library and researchers assigned to all sites within the FDA. This requirement will allow for unlimited IP access for the online application. The FDA requests a proposal response from a qualified source capable of providing 24 hours a day, 7 days a week web access to the Citeline Pharmaprojects Drug Pipeline database. 2. SCOPE / REQUIREMENTS The proposed product shall meet the following salient, functional characteristics in order to be considered for award: 1. Resource shall include reports on the progress of new pharmaceutical products, both new chemical entities and biotechnological entities at all stages of development from early pharmaceutical studies to final launch in all major international markets and cover discontinuation. 2. Product shall be completely web based and be updated in real time as well as provide a development timeline on each drug and data including diseases, therapy, mechanism, delivery routes, biological targets, molecular structure, chemical data, licensing information, and company data. 3. Product shall have one search platform providing over 60,000 online drug profiles and have the capability to be searched by a minimum of 75 different criteria such as: target family, new chemical entity, company pipeline, trends, therapy pipeline, therapeutic class, drug registration by country, first launch date, delivery mode, and chemical substructure within a therapy, pharmacology or indication. 4. Resource shall provide key data on drug profiles: therapies and indications by phase, originator and licenses, pharmacokinetic data, clinical trials data, and country information. 5. Products search capabilities shall include: Trend Analysis, Company, Therapy Profile, chemical structure search. 6. Resource shall allow for the reviewing of incidences, prevalence, and market data for at least 218 drug therapeutic areas as well as provide customizable reports and graphs that can be exported in a variety of formats. 7. Resource shall provide linking to SCRIP articles and PubMed citation and have the capability for users to create watch lists on drugs and drug development milestones. 8. The Vendor shall provide users with the ability to submit an unlimited number of research requests to expert analysts and receive responses within 48 hours. 9. The Vendor shall provide an unlimited number of training sessions on the use of the database as well as provide online tutorials or web-based training. 10. The Vendor shall provide technical assistance related to website/software issues via phone or email. This support shall be available during normal operational hours (8:30 AM - 5:00 PM Eastern Time (ET), Monday - Friday, excluding Government holidays). Support will not be necessary during any other hours. 11. The Vendor shall provide usage statistics on a monthly basis. The format of the usage statistics shall be provided via email by the vendor. Reports shall include session count. 12. This requirement is subject to Section 508 compliance. The Vendor proposal shall address how the proposed solution will comply with Section 508. Specifically, the following 508 Standards are applicable: • §1194.21 - Systems • §1194.22 - Web-based intranet and internet information and applications • §1194.31 - Functional requirements • §1194.41 - Information, documentation, and support 3. DELIVERY Access to the database shall be made available to the FDA beginning September 30, 2017. The Vendor shall coordinate delivery with the Contracting Officer's Representative (COR) identified in Government Points of Contact section of this SOW. 4. INSPECTION AND ACCEPTANCE The FDA shall have ten (10) business days from delivery to formally accept the product. The Vendor will have ten (10) subsequent business days to remedy any deficiencies identified. 5. SECTION 508 STANDARD COMPLIANCE Deliverables will conform to 36 CFR Part 1194.41, "Information, Documentation and Support," and 36 CFR Part 1194.24 "Video and Multimedia Products" which are of particular importance with regard to all written, graphical or broadcast, video materials or products produced for HHS (to include training). 36 CFR Part 1194.41 outlines the requirements supporting services for products accommodating the communication needs of end-users with disabilities. The deliverables will be provided in Microsoft Word and Adobe PDF formats and compatible with versions currently used at FDA. C.A. Section 508 This language is applicable to Statements of Work (SOW) or Performance Work Statements (PWS) generated by the Department of Health and Human Services (HHS) that require a contractor or consultant to (1) produce content in any format that could be placed on a Department-owned or Department-funded Web site; or (2) write, create or produce any communications materials intended for public or internal use; to include reports, documents, charts, posters, presentations (such as Microsoft PowerPoint) or video material that could be placed on a Department-owned or Department-funded Web site. Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase electronic and information technologies (EIT) that meet specific accessibility standards. This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services. There are three regulations addressing the requirements detailed in Section 508. The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board's Web site at http://www.access-board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of Electronic and Information Technology (EIT) comply with the Access Board's standards. The entire FAR is found at Chapter 1 of the Code of Federal Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing Section 508 can be found at http://www.section508.gov. The third applicable regulation is the HHS Acquisition Regulation (HHSAR). Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites - including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors) or consultants responsible for preparing or posting content intended for use on an HHS-funded or HHS-managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW or PWS, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material. The following Section 508 provisions apply to the content or communications material identified in this SOW or PWS: • §1194.21 - Systems • §1194.22 - Web-based intranet and internet information and applications • §1194.31 - Functional requirements • §1194.41 - Information, documentation, and support 6. PERIOD OF PERFORMANCE The period of performance is 9/30/2017-9/29/2018. 7. CONTRACT TYPE The contract type will be a firm-fixed-price order for this requirement. 8. GOVERNMENT POINTS OF CONTACT Contracting Officer: Brendan McCarthy (240) 402-7540 Brendan.McCarthy@fda.hhs.gov Contract Specialist: Jacquelyne Ngegba 301-796-6761 Jacquelyne.Ngegba@fda.hhs.gov Contracting Officer's Representative (COR): To Be Determined 9. ORDER OF PRECEDENCE The Vendor shall follow the terms and conditions of this order. Should the Vendor include any additional terms and conditions resulting in conflicts between this document and the Vendor's document, the Order of Precedence shall be as specified in FAR Clause 52.212-4 - Contract Terms and Conditions - Commercial Items (May 2015). Any indemnification and governing law language in the vendor's terms and conditions shall be invalid and shall be stricken and removed from the contract. Any additional terms and conditions shall not be prohibited by applicable laws and regulations. Any additional terms and conditions identified with a web link and/or incorporated by reference shall be stricken and removed from the contract. The Vendor shall provide all terms and conditions, in full text, with their quotations as attachments, appendixes, etc. 10. CONTRACTING OFFICER AUTHORITY The Contracting Officer (CO) is the sole person authorized to make or approve any changes in any of the requirements of this purchase order and notwithstanding any provisions contained elsewhere in thE purchase order, the said authority remains solely with the CO. In the event the Vendor makes any changes at the direction of any person other than the CO, the change shall be considered to have been made without authority and no adjustment will be made in the purchase order terms and conditions, including price. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the purchase order and modify any term or condition of the purchase order. The CO is the only individual who can legally obligate Government funds. The Contracting Officer's Representative (COR) or Project Officer is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the order price, terms or conditions. The COR/Project Officer is responsible for the technical aspects of the project and serves as technical liaison with the Vendor and is responsible for the final inspection and acceptance, and such other responsibilities as may be specified in the purchase order. 11. CONFORMANCE WITH APPLICABLE LAWS, REGULATIONS, POLICIES, AND STANDARDS 11.1 FAR / HHSAR Provisions 11.1.1 FAR 52.252-1: Solicitation Provisions Incorporated by Reference (Feb 1998) This solicitation incorporates one or more solicitation 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this address: http://www.acquisition.gov/far/current/html/FARTOCP52.html#wp372482 (End of Provision) 11.1.2 FAR 52.212-1: Instructions to Offerors - Commercial Items (Oct 2015) 11.1.3 FAR 52.212-3: Offeror Representations and Certifications - Commercial Items (July 2016) 11.1.4 FAR 52.222-22: Previous Contracts and Compliance Reports (Feb 1999) 11.1.5 This solicitation incorporates one or more Health and Human Resource Acquisition Regulations (HHSAR) provisions by reference, with the same force and effect as if they were given in full text. The full text of these HHSAR provisions can be viewed at: http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html. 11.1.6 HHSR 352.239-73: Electronic and Information Technology Accessibility Notice (Dec 2015) 11.2 FAR / HHSAR Clauses 11.2.1 FAR 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 this address: http://www.acquisition.gov/far/current/html/FARTOCP52.html#wp372482 (End of Clause) 11.2.2 FAR 52.217-8: Option to Extend Service (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 six months. The Contracting Officer may exercise the option by written notice to the Contractor within the period of performance of this contract. 11.2.3 FAR 52.212-4: Contract Terms and Conditions - Commercial Items (May 2015) 11.2.4 FAR 52.212-5: Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (June 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, 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: ___ (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 (Jun 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 (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). _X_ (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. ___ (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 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. _X_ (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-Subcontracting 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. 657f). _X_ (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). _X_ (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). ___ (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). ___ (31) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212). ___ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). _X_ (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). (E. O. 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) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O.13693). ___ (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693). ___ (38) (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. ___ (39) (i) 52.223-14, Acquisition of EPEAT® -Registered Television (Jun 2014) (E.O.s 13423 and 13514). ___ (ii) Alternate I (Jun 2014) of 52.223-14. ___ (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b). ___ (41) (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. _X_ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513). ___ (43) 52.223-20, Aerosols (Jun 2016) (E.O. 13693). ___ (44) 52.223-21, Foams (Jun 2016) (E.O. 13696). ___ (45) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83). ___ (46) (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. ___ (47) 52.225-5, Trade Agreements (Feb 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). _X_ (48) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). ___ (49) 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). ___ (50) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). ___ (51) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150). ___ (52) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)). ___ (53) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). _X_ (54) 52.232-33, Payment by Electronic Funds Transfer- System for Award Management (Jul 2013) (31 U.S.C. 3332). ___ (55) 52.232-34, Payment by Electronic Funds Transfer-Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332). ___ (56) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332). _X_ (57) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a). ___ (58) (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) 52.222-17, 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) (E.O. 13658). ___ (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 (Sep 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 (1) 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) _X_ (A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627). S d3f___ (B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 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) 11.2.5 FAR 52.232-39: Unenforceability of Unauthorized Obligations (June 2013) 11.2.6 This contract incorporates one or more Health and Human Resource Acquisition Regulations (HHSAR) clauses by reference, with the same force and effect as if they were given in full text. The full text of these HHSAR clauses can be viewed at: http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html. 11.2.7 HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) 11.2.8 HHSR 352.239-74 Electronic and Information Technology Accessibility (Dec 2015) The Section 508 accessibility standards applicable to this contract are: • §1194.21 - Systems • §1194.22 - Web-based intranet and internet information and applications. • §1194.31 - Functional performance criteria. • §1194.41 - Information, documentation, and support. 12. SPECIAL NOTICE AND AGREEMENT REGARDING SOFTWARE EULA/TOS Computer software and services are often subject to license agreements, referred to as End User License Agreements (EULA), Terms of Service (TOS), or other similar legal instruments or agreements. Many of these agreements contain indemnification clauses that are inconsistent with Federal law and unenforceable, but which could create a violation of the Anti-Deficiency Act (31 U.S.C. 1341) if agreed to by the Government. Therefore, by submitting a quotation the offeror shall agree that the inclusion of any Limitation of Liability, Indemnification, and any other clauses that conflict with Federal law or regulation in any EULA or TOS are NULL AND VOID. The offeror agrees that any EULA/TOS clauses conflicting with Federal law or regulation and are not agreed to by the Government if included with the submission of a quotation. Additionally, by submission of the quotation the offeror must agree to the inclusion of FAR 52.232-39 Unenforceability of Unauthorized Obligations in any resulting contract or order, if awarded. 13. EVALUATION FACTORS FOR AWARD The Government shall award a contract resulting from this solicitation to the responsible Vendor whose offer is technically acceptable and which shall represent best value to the Government. The award will be made on the basis of the meeting or exceeding the technical conformance to the requirements of the solicitation. The Government intends to evaluate the offer and award a contract without discussions. The Vendor's initial offer should contain the Vendor's best terms from a price standpoint. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government may reject the offer if such action is in the best interest of the Government. The following factors shall be used to evaluate the quote: 1. Technical Features Meeting/Exceeding Salient Requirements 2. Total Price DA Three-Way Invoicing The contractor shall submit one (1) original copy of each invoice to the address specified below: FDA/OC/OA/OFO/OFS 10903 New Hampshire Ave WO32 - Second Floor, MAIL HUB 2145 Silver Spring, MD 20993-0002 Attn: Vendor Payments Phone 301-827-ERIC (3742) fdavendorpaymentsteam@fda.gov The Contractor shall submit one (1) original copy of each invoice to the contracting officer representative (COR) clearly marked "courtesy copy". Acceptable methods of delivery include: e-mail (preferred) or standard mail Invoices submitted under this contract must comply with the requirements set forth in FAR clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment By Electronic Funds Transfer - System for Award Management) and/or 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 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 shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading; (vi) terms of any discount for prompt payment offered; (vii) name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment) (viii) name, title, and phone number of person to notify in event of defective invoice; (ix) taxpayer identification number (tin); (x) electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment; (xi) name and telephone number of the FDA Contracting Officer's Representative (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. An electronic invoice is acceptable if submitted in Adobe Acrobat (pdf) format. All items in (i) through (xii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing. Questions regarding invoice payments should be directed to the FDA Payment Office at a telephone number provided above. 14. INSTRUCTIONS TO THE VENDOR The Vendor is required to submit their quote in two separate volumes as follows: • Volume I - Technical • Volume II - Pricing Proposal The completion and submission of the above items will constitute an offer (quote) and will indicate the Vendor's unconditional assent to the terms and conditions of this RFQ 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. Offerors are advised that additional terms and conditions submitted with their quotation that is in conflict of the terms and conditions of this solicitation may be deemed as technically unacceptable and may not be considered for award. Volume I - Technical: This portion of the proposal to include all data and information required for technical evaluation and exclude any reference to the pricing information. The Vendor shall demonstrate in sufficient detail that the proposed solution will successfully meet the requirements of the salient characteristics. For purposes of clarification, the Vendor is 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. The Vendor shall propose pricing for a 12-month period: 9/30/2017 to 09/29/2018. The Vendor shall clearly state the overall cost to the Government. Additional Administrative Instructions: System for Award Management (SAM). In accordance with FAR 52.212-4, Offerors shall be registered in the CCR database to be considered for award. Registration is free and can be completed on-line at http://www.ccr.gov; provide DUNS number; Cage Code and TIN. Proposals shall be submitted by email only as a MS Word attachment to Jacquelyne Ngegba at Jacquelyne.Ngegba@fda.hhs.gov. Proposals are due by 3:00 pm, Eastern Time on Wednesday, May 24th, 2017. Any questions must be addressed to Jacquelyne.Ngegba@fda.hhs.gov by 12 pm on Friday, on May 12th, 2017. 15.0 Award Determination All quotations will be evaluated on a Lowest Priced Technically Acceptable (LPTA) basis. The award will be made to the lowest price bidder that demonstrates they can meet all the requirements of this solicitation. Failure to demonstrate meeting any of the requirements will result in a rating of technically unacceptable and will not be considered for award. As part of the technical acceptability determination the Government will review all information related to 508 submitted by the vendor. Section 508 conformance of the proposed solution is based upon all information provided by the vendor relevant to accessibility. The Government will evaluate: • Submission of an HHS PAT for the solution. • Quality of the accessibility documentation provided. This includes the submission of an HHS PAT to the instructions, inclusion of all applicable standards, and clarity of the information (including additional or supplementary information beyond the HHS PAT) provided. • Qualitative evaluation of the accessibility of the proposed solution. This includes an evaluation of the proposed solution's technical conformance to standards for accessibility, in relation to the needs of the agency. The Vendor shall certify that its quote is valid for 120 days. Justification and Approval: Justification and Approval for Soliciting to a Single Source: FAR 13.106-1(b) Citeline/Pharmaprojects The purpose of this justification and approval memo is to document the rationale and acquisition information for this procurement's single source determination, pursuant to FAR 13.106-1(b)(1)(i). Agency and Contracting Activity Identification: U.S. Food and Drug Administration (FDA), Department of Health and Human Services (HHS) Program Office / Center: OO/OIMT/OIM 3 White Flint North (3WFN) 11601 Landsdown Street North Bethesda, MD 20852 Contracting Activity: The FDA's Office of Acquisitions and Grants Services (OAGS) Nature of Action Being Proposed for Approval: Award of a sole source purchase order to Informa Business Intelligence, Inc. (Informa) for a site license for Citeline Pharmaprojects Drug Pipeline software pursuant to FAR 13.106-1(b) and 41 U.S.C. 1901. Description of Supplies or Services and Estimated Value: Project Title: Citeline Pharmaprojects Drug Pipeline License Description of Supplies or Services: Site license with unlimited search access to Pharmaprojects drug pipeline database. This database provides access to over 60,000 highly detailed and fully searchable drug profiles, 13,000 of which are in active development, early stage, and through market release. They are updated on a real-time basis with granular information on development history timelines, licensing information, and molecular structure. Purchase Requisition No.: 1179172 Estimated Dollar Value (IGCE): $111,892.80 Identification of the Exception to Other than Full and Open Competition: FAR 13.106-1(b)(1)(i) states: "For purchases not exceeding the simplified acquisition threshold... contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available." A Demonstration of the Proposed Contractor's Unique Qualifications or Nature of Acquisition: The FDA has an ongoing business need for access to drug pipeline information. Such information is used heavily by Advisory Committee Staff, International Programs, and Economists. The Office of the Commissioner also relies heavily on such information for its regular required review of new active substances launched on the world market. Due to these mission-critical, drug-related research needs, the FDA requires a research and knowledge management tool that provides in-depth and up-to-date drug information, quick search tools, and research support and expertise to meet these research needs and fulfill the Agency's public health mission. Though drug pipeline information is widely available, Informa's Pharmaprojects tool is the only resource currently in the market that pools this information into one database and provides all of the following requirements: • In-depth, up-to-date drug pipeline information on over 50,000 drug profiles in one interface capable of generating various reports and exporting data to Excel for analysis. • A search platform with the capability of drilling down and refining searches across multiple, highly-detailed fields, including drug name, status, disease, disease status, company, country, therapeutic class, mechanism of action, biological target, delivery route, origin, chemistry, and event type (which includes information on licensing, first launches and discontinued products). • Quick, user-friendly search functions, such as "Watch this Search," that can immediately alert the user of any changes that match a certain search criteria. • Unlimited access to Informa's Pharamprojects expert research analysts that conduct primary and secondary research in for customers. The Government notes that there are no other resellers of the Pharmaprojects tool and that Informa is the sole manufacturer/provider of the tool. In addition, previously competed requirements for this product only resulted in one offeror: Citeline, Inc., which was acquired by Informa in January 2016. Description of Efforts to Ensure Offers Are Solicited from as Many Potential Sources as Practicable: The Notice of Intent was posted on Federal Business Opportunities on March 27th, 2017 and closed on April 10th, 2017. No other vendors expressed interests in the requirement. A Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: An Independent Government Cost Estimate (IGCE) has been provided by the program office to help determine price reasonableness. In addition, the Government has acquired this product in the past when competed and will compare Informa's quote to those of prior acquisitions' whose prices were determined to be fair and reasonable.
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D -- Citeline Pharmaprojects Drug Pipeline License. Proposal due date changed from 05/24/2017 @ 3:00PM, Eastern Time to 06/03/2017 @ 3:00PM, Eastern Time. Any questions must be addressed to Jacquelyne.Ngegba@fda.hhs.gov by 12 pm, Eastern Time on 05/23/2017.