16-223-SOL-1169013..pdf

RFQ#16-223-SOL-1169013

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 SEPARATE WRITTEN

SOLICITATION DOCUMENT WILL NOT BE ISSUED. THE SOLICITATION IS BEING ISSUED USING

SIMPLIFIED ACQUISITION PROCEDURES.

This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-88.

This is a BRAND NAME OR EQUAL acquisition; in accordance with FAR 52.211-6 to be considered for award, offers of equal products must meet the salient physical, functional, or performance characteristics provided in the Statement of Work.

Offerors must submit all questions concerning this solicitation in writing, via email to the Contract Specialist, Laurel Woest at laurel.woest@fda.hhs.gov Questions should be received no later than 12:00PM Eastern Time, Friday, September 10th. All responses to questions will be made in writing, without identification of the questioner, and will be included in an amendment to the solicitation.

The associated North American Industrial Classification System (NAICS) code for this procurement is 541519 other computer related services. The size standard associated with NAICS 541519 is $25.0 Million.

Statement of Work: ExLibris Alma or Equal

1. Background

The U.S. Food and Drug Administration (FDA), is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics and products that emit radiation. The FDA Library (FDAL) is a critical component in the FDA meeting that responsibility and the overall mission of the agency.

In Sept 2007, the FDAL purchased an Integrated Library System (ILS) that provided catalog (Aleph) and open URL (SFX) functionality. Following an independent review of the FDAL and an internal expert review of the existing infrastructure and best practices it was determined that the Aleph/SFX system should be updated to a comprehensive, unified library services platform and discovery system Alma or equal solution. A Library services platform and discovery system represents the state of the art in next generation e-library systems and offers the FDAL many additional capabilities that were identified as being needed such as electronic resource management, access to a comprehensive resource knowledgebase, digital repository, and a discovery system with faceted results able to search across a diverse set of resources from one search interface.

The upgrade and implementation of the unified library services platform and discovery system shall deploy so as to avoid any downtime. Any disruption in continuity of service, even for a brief period of time, would negatively impact the delivery of services to customers and our ability to meet performance metrics, collect required data, and provide access to resources to support Agency critical work.

FDA researchers require access to the ILS as it is the interface to the resources available Agency wide for staff to complete their mission critical work. The current ILS is limited to bibliographic information about the print and electronic resources like title, authors, and subject. FDA researchers typically search other electronic systems outside of the FDA network to find which resources they require and then come to the ILS to determine if we have access to those resources. A library services platform and discovery system allows FDA researchers to search most of those external systems through a unified interface. The search results are highly faceted and are based on cutting edge semantic pre and post processing. The FDA researcher is provided with detailed information directly in a single user mailto:laurel.woest@fda.hhs.gov interface and linked to the full text based on complex rules and a comprehensive knowledgebase that represents the tens of thousands of journals, e-books, and databases that the FDAL provides access to.

SFX is the current open URL link resolver providing “find it fast” linking to the journals FDAL owns. It is the number one reason why FDA staff have quick access to the library subscribed titles in databases and Google Scholar.

The unified library services, Alma platform and discovery system replaces Aleph and SFX with similar but enhanced functionality that is integrated directly with a vendor maintained knowledgebase and electronic resource manager.

The system’s open URL technology keeps track of all user activities. With the integrated statistics tools, FDAL can obtain a detailed picture of e-resource usage, down to the title and platform, allowing FDAL to make critical purchasing decisions.

2. Scope

The contractor shall provide an upgrade and migration from the existing ExLibris Aleph and SFX hosted ILS to a SaaS based multi-tenant, unified library services, Alma or equal platform with digital repository, and discovery system.

A. High Level Requirements:

1. The system shall provide unified management of all of the print, electronic, and digital resources that the FDAL owns, licenses, stewards, and makes available to end users for discovery and delivery. This includes acquisition support for both physical and electronic resources, metadata management across all resource types and fulfillment across all resource types.

2. The system shall be a Web-based SaaS multi-tenant solution that requires only a Web browser, not the installation of staff clients.

3. The system shall feature at least quarterly updates to all customers, released by the vendor and requiring no library IT intervention.

4. The system shall be designed to leverage true cloud technologies

5. The system shall support single sign-on.

6. The system shall include in the base package, at the point of purchase, the following live components:

• Discovery

• Print management

• Electronic management

• Acquisitions

• Request fulfillment & circulation

• Metadata management

• Administration

• Link resolution

• Knowledgebase

• Analytics

• Digital repository

7. The discovery system shall ensure that the library can, upon migration, decommission the following local systems:

• The hosted Aleph Integrated Library System [ILS]

• The hosted SFX Open URL link resolution software and any linked knowledgebase

8. The system shall accommodate multi-site institutions by allowing for member libraries within such an organization to maintain separate policies for:

• User management

• Vendors

• Funds management

• Licenses

• Metadata management

• Configurations

• Analytics and statistics

B. Acquisitions Requirements:

9. The system shall support acquisition related workflows.

10. The system shall be able to automatically create purchase orders based on vendor-supplied machine readable cataloging (MARC) records electronic order confirmation record (EOCR) for resources ordered in the external system.

11. The system shall provide links from a purchase order to other related information.

12. The system shall support a full electronic data interchange (EDI) interface with major library vendors for ordering and invoicing.

13. The system shall support setting up trials for both electronic collection packages and databases to evaluate e-resources before purchasing.

14. The system shall support the ability to evaluate existing e-resource subscriptions and make a decision to renew or cancel based on parameters such as usage and cost.

15. The system shall allow for the activation of approved purchases for electronic packages and titles.

16. When an electronic package or title is activated, descriptive records to describe the title(s) shall be added to the catalog automatically.

17. The system shall support the ability to perform an overlap analysis report for electronic resources, including the ability to upload a list of titles (using an Excel file) that the library is considering acquiring in order to determine whether the titles are part of the library collection.

C. Receiving Requirements:

18. The system shall allow print items to be received either as part of the invoicing process, or as a separate process.

19. The system shall be able to automatically create new item records when an item is received, or if items are created at the time of acquisitions, the system shall allow for updating item information.

20. The system shall notify staff when a volume or issue of a series has not arrived after a predefined interval, and allow for claiming of missed items.

21. The system shall identify where to route received items based on the completeness of their metadata and item information.

D. Subscription Vendor Requirements:

22. The system shall provide the ability to maintain multiple accounts for a single vendor.

23. The system shall provide the ability to maintain multiple physical and email addresses for a single vendor, with the potential to tie these addresses to individual accounts.

24. The system shall offer the ability to maintain discount and delivery and claim information in the vendor record.

25. Invoices linked to a vendor shall be linked to the vendor record.

26. It shall include vendor-specific EDI information.

27. Vendor records shall have links to all vendor related invoices

28. The vendor record shall include links to all purchase orders made against the vendor.

E. Invoices and Payments Requirements:

29. The system shall support the ability to automatically create an invoice from the purchase order.

30. It shall manually create an invoice, or to load invoices from an Excel file.

31. An invoice/license audit history shall be available in the system.

F. Claims Requirements:

32. The system shall provide automatic claiming for items not received within an expected number of days after placing the order; such intervals shall be based on library-defined date and time parameters

33. It shall manually generate claims (on demand).

34. The system shall support EDI claiming.

G. Fulfillment (Circulation) Requirements:

35. The system shall have the capacity to manage all types of library material, e.g. books, serials, electronic resources, digital materials, etc.

36. The system shall support ANSI/NISO z39.83 (NISO Circulation Interchange Protocol) in the base package to facilitate lending and borrowing actions between systems.

37. The system shall provide integration with ILLiad using standard protocols, including ISO 10160/10161 and ANSI/NISO z39.83 (NCIP).

38. The system shall include an offline circulation component.

39. The system shall support self-service machines

H. Fulfillment Policy Requirements:

40. Libraries shall define the policies by which their physical inventory is circulated to library customers.

41. The system shall provide extensive ability to set parameters including for loans, limits and calendar, globally or at the branch level.

Customer Management Requirements:

42. The system shall provide the ability to create different customer types and set circulation parameters for each type of customer.

43. It shall define more than one customer identifier linked to a customer record.

44. The system shall allow authorized staff to create, modify, and delete customer records.

45. Customer information shall be updateable through an application programming interface (API) via FDA systems that serve as the initial source of that customer information.

46. The system shall integrate with external identity management systems (e.g. LDAP/Shibboleth) for authentication.

47. It shall update defined areas of each customer record. Customers shall be able to have multiple addresses.

I. Request Fulfillment Management Requirements:

48. The system shall support business rules that automatically manage customers’ requests, requiring staff user mediation only when necessary.

49. When placing a request it should be possible to define if the request is for digitization or for a physical item

50. A customer-initiated digitization request shall trigger an alert and a pick slip at a specific digitization location.

51. The system shall automatically generate a notice to customers when requested items are available.

52. The system shall support the administration of access rights for digital materials, based on customer group and collection.

53. The system shall support the administration of access rights for electronic materials, including the ability to restrict access by IP address.

54. The system shall support hold queue priority.

55. The product shall support digitization on demand workflows.

J. Interlibrary Loan (ILL) Requirements:

56. The system shall support ILL functionality – both for borrowing and lending.

57. There shall be support for at least one of the following ILL software solutions: Illiad, OCLC Navigator, Relais D2D.

58. The system should support the ISO 1060/10611 ILL protocols.

59. The system shall allocate a unique request number as each request is created on the system.

60. The ILL component shall link to and be fully integrated with other components within the discovery system.

61. The system shall contain ‘status history’ function to record all changes and updates within the ILL request record.

K. Metadata Management (Cataloging) Requirements:

62. The system shall support multiple metadata formats and be extensible to additional formats. At a minimum, MARC21 and Dublin Core shall be available out-of-the-box for the library, with future support for other formats.

63. The system shall allow staff to create, edit, and delete records in any of the system supported formats.

64. The system shall support import and export (with no loss of data) in all system supported formats.

65. The system shall have embedded support for RDA including the indexing of RDA specific elements.

66. The system shall support validation of appropriate use of elements, fields, subfields, and values, including validation of controlled vocabularies for fields.

L. Editing Requirements:

67. The system shall support the ability to edit all records through an online editor, including any element, field, subfield, or fixed field value as appropriate for the format.

68. The system shall support the creation and storing of record templates for use in creating and editing records, including specifying default elements, fields, subfields, and values stored in these templates.

69. The system shall support record versioning, including the ability to view and roll back to past versions of that record.

70. The system shall support hotkeys for navigation and actions that allow editing entirely with the keyboard.

71. The system shall support the ability to perform changes in bulk against a set of records, including the ability to alter any element, field, subfield, or fixed field value.

72. The system shall support the option of library defined merge routines that can be applied to records imported in bulk or one by one in the catalog editor.

73. It shall link an electronic, digital or physical item to one metadata record.

74. The system shall provide the ability to derive a new bibliographic record from an existing record.

75. The system shall allow global changes of item and order records within the system.

76. The system shall support a tool for printing labels.

M. Authority Control Requirements:

77. The system shall provide access to global, shared authority files without the need for individual libraries to synchronize with the authorizing agency. The files should include Library of Congress Subject Headings and Names, and MeSH.

78. The system shall allow FDAL to create or load local authority files and records for subjects (including genre terms) and names.

N. Holdings Management Requirements:

79. The system shall support the MARC21 format for holding records.

80. The system shall allow for the creation of holdings and item records for physical resources.

81. The system shall support the recording of missing/lost items.

82. The system shall support the suppression of records from the discovery layer.

O. Importing Records Requirements:

83. The system shall allow for the loading records singly or in bulk.

84. The system shall allow for searching external databases through the online interface via z39.50 or search and retrieval via url (SRU/W) protocols and importing resulting records to the catalog. Copy cataloging can be done within the system, without requiring separate login.

85. The system shall allow for the enhancement of incoming records according to library-defined bulk record change rules.

86. The system shall prevent the overlay of a non-brief record by a brief record on import.

P. Exporting Records Requirements:

87. The system shall allow for the export of individual, groups of records, or an entire catalog to a predefined target with no additional fees. The records to be exported may be based on a selected set, or records that have changed since the last export to that target.

88. The system shall allow for the enhancement of exported records according to library-defined bulk record change rules, including the ability to enhance bibliographic records with holdings information.

Q. Shared Bibliographic Records Requirements:

89. The system shall provide access to a catalog of bibliographic records shared by all libraries of that system.

Libraries shall be able to attach holdings directly to the shared records, edit the records, or copy them from the shared catalog to the libraries’ local catalog.

90. Members of the consortium shall be able to update or edit records in the shared catalog, according to set standards.

91. The system shall support a local catalog in addition to the shared catalog for storing records that have local descriptive needs or terms of use that prevent their being shared with other libraries. Libraries shall be able to use the shared catalog, the local catalog, or both simultaneously.

92. The system shall support the addition of local fields to the shared records that are viewable only to the local library.

93. For consortia, the solution shall allow for sharing bibliographic metadata across the consortium, while at the same time allowing individual libraries to record and maintain information of local importance.

R. Digital Resource Management Requirements:

94. The digital objects that are currently managed by the institution’s current digital asset management system should both be migrated and stored within the unified resource management repository, or can continue to reside in their current storage environment but be managed by the unified resource management system.

95. The system shall support bulk upload of files.

96. The system shall include built-in views to access digital objects including text, video and audio.

97. Digital collections managed by the library services platform shall be made discoverable in the discovery layer.

S. Central Knowledge Base Requirements:

98. The Knowledge Base should be maintained and updated to track changes made by providers and additions of resources to collections, as well as other changes.

99. The Knowledge Base should be updated at least once a month.

100. The organization of the Knowledge Base should accommodate the different levels of electronic resources information.

101. The Knowledge Base should support accurate data that facilitates resource discovery.

102. The system shall allow for the addition of titles not currently in the Knowledge Base.

T. Link Resolution Requirements:

103. The system shall be able to accept OpenURL and context sensitive services as well as resolving the services.

104. The system shall augment the OpenURL metadata.

105. The system shall provide users with the ability to link directly to full text content.

106. The system’s electronic journals shall be searchable via an A-Z list in the discovery layer.

107. The system shall display license terms as part of the services offered in the end user interface.

108. The system shall be able to assign accurate access rights to the correct populations of users.

U. Licenses Management and Amendments Requirements:

109. The system shall be able to manage licenses and amendments, including attaching digital versions.

110. License management shall be included in the system and not require additional setup or fees.

111. The system shall support the Electronic Resources Management Initiative (ERMI) schema for licenses, including the ability to display only those fields that the library uses, excluding the remainder if the library so chooses.

112. The system shall enable license terms to be displayed to the end user. The terms that are displayed as well as the labels should be configurable.

V. Reporting and Analytics Requirements:

113. The system shall include a comprehensive analytics component that covers all of the ILS data and is an integral part of the system.

114. The analytics component shall form part of the standard package at no additional cost.

115. It shall be possible to utilize canned reports provided by the vendor.

116. The reporting tool shall support a variety of output options including, but not limited to viewable online, send to printer, email and export to a spreadsheet.

117. The reporting system shall support the customization of reports by librarians; this includes, but is not limited to:

changing of reports parameters, views, time range, etc.

118. The reporting system shall support the ability to collaborate and share reports made by other parties.

119. The reporting solution shall be able to provide usage statistics reports and comply with industry usage reporting standards such as SUSHI, COUNTER.

120. The solution shall support role-based report generation and viewing such that a user will only be able to view reports and data according to his role.

121. The solution shall include a dashboard in which it is possible to monitor performance, view user-specific tasks, and detect trends. Information in the dashboard shall be based on staff user roles, allow for customization, and support the embedding of widgets.

122. The tool shall be able to analyze history data and provide trends analysis.

123. The reporting application shall allow for the automatic scheduling of reports at defined intervals.

124. The reporting application shall provide cost-per-use reports.

125. The tool shall allow for report creation and filtering based on advanced user information or statistical categories.

126. The system shall store records, data, and reports from library processes indefinitely at no additional charge.

127. For consortia, the solution shall support the ability to run reports across institutions, for the purposes of cross-institutional reporting and comparisons.

W. System Administration and Management Requirements:

128. The system shall come with a set of “Out of the Box” definitions and configurations so that the library need only make minimal changes to the standard settings.

129. The system shall allow authorized staff to configure various aspects of the system without vendor intervention.

130. The system shall allow for customizing the acquisition workflows in order to accommodate specific library needs as well as control over when orders and invoices need mediated handling.

131. The system shall allow the library to configure when fulfillment processes such as hold request/call slips can be automated or need to be mediated.

132. The system shall come with the ability to add notes and file attachments to various resources managed in the system.

133. The system shall display ‘created by’, ‘last updated by’, and (where applicable) ‘modified by’ information for various types of records.

X. FDAL Staff Search Requirements:

134. The system shall offer intuitive and easy to use search methods; both basic and advanced searching shall be supported.

135. Advanced search shall allow for the option of searching multiple fields simultaneously for words or phrases.

FDAL staff shall be able to define their own search conditions – based on standard indexed options.

136. The system shall be delivered with out of the box set of indexed fields, including, but not limited to:

• author

• title

• subject

• call number

• ISBN/ISSN

• publisher

137. It shall search across all types – bibliographic physical, digital, electronic in one search query.

138. Based on FDAL staff queries it shall be possible to save and manage sets.

139. It shall search for electronic resources by, but not limited to: title (e.g. journal title), package, and by provider.

140. Dependent on the search type, it should be possible – from the results list - to edit a record, create an order, view holdings, items, and other connected information.

141. It shall sort result sets by various parameters – e.g. ranked, title, author. There should be more than one level of sorting.

142. When logging in to the solution, the staff user should be navigated to a personalized dashboard.

143. It shall be possible to post widgets of report outputs on the dashboard.

144. It shall be able to add/remove/reorder the widgets on the dashboard.

145. It shall be possible to view the library’s calendar (open hours and days) from the dashboard.

Y. User Management Requirements:

146. The system shall support a web based interface for assigning roles and permissions to staff functions.

147. The system shall provide granular access control rights for staff accounts and be able to facilitate multiple profiles accessing different combinations of functional areas.

148. The system shall support the option of defining role templates which can then be easily assigned to new users.

Z. Discovery Layer Interoperability Requirements:

149. The system shall support a complete and transparent integration with a next-generation library services platform.

150. The system shall support seamless customer-driven workflows initiated from discovery and served by the system such as, but not limited to: digitization on demand, customer driven acquisition, ILL requests, and course reserve requests.

151. The discovery system shall support discovery and delivery of all resource types: physical, electronic and digital, as well as discovery by collections.

152. The discovery layer shall allow for local library resources to be searched either on its own or combined with other resources.

153. The system shall have the ability to publish records to discovery with enriched headings information from the shared catalog.

154. The system shall publish authentication and public notes for display to the customer.

155. Customers shall be able to see all of their account information (loans, requests, fines, saved searches, etc.) in the library’s discovery solution.

156. The system shall present to customers options to fulfill customer requests across all relevant resource types. The system should include a citation linker to request services for a specific article, book, or journal either through the library or as a resource sharing request.

157. The system shall provide published APIs or Web Services to facilitate interoperability with external services.

158. The discovery solution shall de-duplicate search results.

159. The discovery solution shall allow the library to tweak the algorithm used for relevancy ranking.

160. The solution shall include personalized ranking to tailor search results based upon end-user research preferences.

161. The solution shall include an article recommender service that suggests articles based on actual researcher activity.

162. The solution shall be delivered with a mobile phone interface.

163. Discovery shall work with and across consortium content. Consortium members should be able to provide a customized view to their users.

164. The solution shall support the ability to display an online resource’s license information to end users in the discovery interface.

165. The system shall interoperate with an integrated reading list for the creation, maintenance, and use of course reading lists.

AA. Migration and Implementation Requirements:

166. Vendor shall provide a detailed migration plan that shall be approved by FDAL.

167. Vendor shall develop an implementation schedule in accordance with FDAL hours of operation so as to ensure FDAL staff availability.

168. Vendor shall accommodate existing Aleph and SFX systems until full production deployment of new discovery system is completed and signed off for decommissioning.

AB. Security Requirements:

Please see Attachment 1 marked Security Requirements and Constraints

3. Deliverables

Item Deliverable Description Due Date 1 Cloud based discovery system FedRAMP authorized SaaS multi-tenant discovery system on cloud architecture with following integrated components:

Print management Electronic management Acquisitions Request fulfillment & circulation Metadata management Administration Link resolution Knowledgebase Analytics Digital repository

Implementation Phase

2 Project plan Overarching project management plan with milestones and timelines.

Planning Phase

3 Migration and testing plan Aleph and SFX data migration and testing plan. Planning Phase

4 System Security Plan Develop and update the System Security Plan using the provided FDA template. Acceptance provided by the Information Systems Security Officer (ISSO).

Planning Phase

5 Privacy Impact Assessment (PIA) Form

Develop and update the Privacy Impact Assessment form using the provided FDA template. Acceptance provided by the Privacy Office.

Planning Phase

6 Security Categorization Form Develop and update the Security Categorization Form using the provided FDA template. Acceptance provided by the Information Systems Security Officer (ISSO).

Requirements Analysis Phase

7 E‐Authentication Form Develop and update the E‐Authentication Form using the provided FDA template. Acceptance provided by the Information Systems Security Officer (ISSO).

Requirements Analysis Phase

8 Information System Contingency Plan (ISCP)

Develop and update the Information System Contingency Plan using the provided FDA template. Acceptance provided by the Information Systems Security Officer (ISSO).

Testing and Training Phase

9 FDAL Staff Training On-site and/or web based training of FDAL staff in all modules and components of discovery system

Testing and Training Phase

4. Period of Performance

The implementation and migration process is expected to take six (6) months to complete from award of contract to production release and decommissioning of existing services; this period includes a two-month pre-implementation phase, followed by the four (4) month project. After the estimated 6 months for implementation and switchover to production, a separate contract for hosting and maintenance will be set in place. All data shall remain the property of the government.

Pre-implementation:

Requirements Analysis Phase – 2-3 weeks Planning Phase – 1 month

Following Pre-implementation:

Implementation Phase – 3 months Testing and Training Phase – 1 month Decommissioning of existing services and cutover to new system – 1 week

5. Points of Contact:

Contract Specialist:

Name: Laurel Woest 5630 Fishers Lane, Office 2093 Rockville, MD. 20857 240-402-7671 laurel.woest@fda.hhs.gov

Contract Officer (CO):

Brendan McCarthy brendan.mccarthy@fda.hhs.gov

Contracting Officers Representative (COR)

Name: TBD Location: FDA Library, WO2, Room 3320I, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:

6. Contracting Officers Authority

The Contracting Officer (CO) identified above has responsibility for ensuring the performance of all necessary actions for effective contracting; ensuring compliance with the terms of the contract and safeguarding the interests of the United States in its contractual relationships. The CO is the only individual who has the authority to enter into, administer, or terminate this contract and is the only person authorized to approve changes to any of the requirements under this contract, and not withstanding any provision contained elsewhere in this contract, this authority remains solely with the CO.

No statement, whether oral or written, by anyone other than the Contracting Officer, shall be interpreted as modifying the terms and conditions of this task order. It is the Contractor’s responsibility to contact the CO immediately if there is even the appearance of any technical direction that is or may be outside the scope of the contract. The Government will not reimburse the Contractor for any work not authorized by the CO.

7. Certificate of Maintainability

At such time as the services of the Contractor are terminated, expire contractually or are otherwise not extended, or upon request by the Contracting Officer at any time, the Contractor shall issue, within five (5) working days, a "Certificate of Maintainability" for any or all equipment acquired and/or maintained under this contract.

The certificate shall state that preventive maintenance in accordance with the specifications of the Original Equipment Manufacturer (OEM) has been performed and that the equipment is performing in accordance with the OEM's specifications such that the OEM (or the OEM's successor in interest) would commit that it would assume maintenance of the equipment without billing any one-time charges (including but not limited to repair or inspection charges) if such maintenance were assumed effective the day after the Contractor's performance ceases. The Contractor is responsible for bearing all costs associated with obtaining such certification at no separate charge to the Government.

Should the Contractor fail to issue the required Certificate of Maintainability in accordance with this clause, or should any equipment fail to perform in accordance with the certification, the Contractor shall be liable to the Government for any reasonable costs incurred by the Government for the purpose of bringing the equipment up to the required OEM maintenance level.

If equipment is acquired under this contract, without maintenance of such equipment being concurrently acquired under the contract, the Contractor shall issue a Certificate of Maintainability for such equipment at the time of delivery for each piece of equipment. The certificate shall state that the equipment is in such condition that the OEM (or the OEM's successor in interest) would commit that it would assume maintenance of the equipment without billing any charges to the Government. All charges required to obtain the requisite performance of the equipment, up to the later of the time the equipment is accepted by the Government or the warranty expires, shall be borne by the Contractor. The time the equipment is accepted by the Government is the date that the Government determines that the equipment has passed acceptance testing, not the effective date of acceptance.

The fact that the equipment may have been acquired with a warranty does not relieve the Contractor of its obligations under this clause.

8. 508 Standard Requirements:

All Electronic and Information Technology (EIT) must meet the applicable accessibility standards at 36 CFR 1194, unless an agency exception to this requirement exists. 36 CFR 1194 implements Section 508 of the Rehabilitation Act of 1973, as amended, and is viewable at http://www.access-board.gov/sec508/standards.htm.

The Contractor shall abide by the requirements described in HHSAR Clause 352.270-19. Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) as amended by Public Law 105–220 under Title IV (Rehabilitation Act Amendments of 1998), all EIT developed, procured, maintained, and/or used under this contract shall be in compliance with the ‘‘Electronic and Information Technology Accessibility Standards’’ set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the ‘‘Access Board’’) in 36 CFR part 1194. The complete text of Section 508 Final Standards can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards/section-508-standards. Any amendment or modification to the Section 508 standards shall be applicable.

Section 508 requires that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

The Contractor shall comply with Section 508 requirements as described at http://www.section508.gov/ in order to ensure that deliverables generated as part of the tasks are fully Section 508-accessible using the available COTS tools.

508 Standard Requirements include:

1194.21 Software applications and operating systems

1194.22 Web-based intranet and internet information and applications

1194.31 Functional performance criteria

1194.41 Information, documentation, and support

All EIT must meet the applicable accessibility standards at 36 CFR 1194, unless an agency exception to this requirement exists. 36 CFR 1194 implements Section 508 of the Rehabilitation Act of 1973, as amended, and is viewable at: http://www.section508.gov/summary-section508-standards.

All deliverables must meet HHS 508 compliance formatting based on the criteria available on HHS’s Making Files Accessible web page: http://www.hhs.gov/web/508/accessiblefiles/index.html

9. Invoicing Instructions

THE CONTRACTOR SHALL SUBMIT ONE (1) ORIGINAL COPY OF EACH INVOICE TO THE ADDRESS

SPECIFIED BELOW:

Office of Financial Services Food and Drug Administration

10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002

Attn: Vendor Payments 301-827-3742 or 866-807-3742 fdavendorpaymentsteam@fda.gov

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 – CENTRAL CONTRACTOR REGISTRATION) 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 AND THE NUMBER OF THE

ACCOUNT INTO WHICH FUNDS ARE TO BE DEPOSITED;

(XI) NAME AND TELEPHONE NUMBER OF THE FDA CONTRACTING OFFICER 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 LISTED IN (I) THROUGH (XII) OF THIS CLAUSE MUST BE INCLUDED IN THE ELECTRONIC

INVOICE. ELECTRONIC INVOICES MUST BE ON COMPANY LETTERHEAD AND MUST CONTAIN NO

INK CHANGES AND BE LEGIBLE FOR PRINTING.

QUESTIONS REGARDING INVOICE PAYMENTS SHOULD BE DIRECTED TO THE FDA PAYMENT

OFFICE AT A TELEPHONE NUMBER PROVIDED ABOVE.

10. Special Contract Requirements

Government Holidays:

Workplace is not available on the Government Holidays stated below, or as prescribed by an Executive Order (EO) or OPM.gov due to inclement weather.

January (New Year’s Day) September (Labor Day) January (Martin Luther King Day) October (Columbus Day) February (President’s Day) November (Veterans Day) May (Memorial Day) November (Thanksgiving) July (Independence Day) December (Christmas Day)

11. Provisions and Clauses

52.211-6 Brand Name or Equal (Aug 1999)

(a) If an item in this solicitation is identified as “brand name or equal,” the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that “equal” products must meet are specified in the solicitation.

(b) To be considered for award, offers of “equal” products, including “equal” products of the brand name manufacturer, must—

(1) Meet the salient physical, functional, or performance characteristic specified in this solicitation;

(2) Clearly identify the item by—

(i) Brand name, if any; and

(ii) Make or model number;

(3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and

(4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications.

(c) The Contracting Officer will evaluate “equal” products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer.

(d) Unless the offeror clearly indicates in its offer that the product being offered is an “equal” product, the offeror shall provide the brand name product referenced in the solicitation.

(End of provision)

52.212-1, Instructions to Offerors – Commercial Items (Oct 2015) 52.212-3, Offeror Representations and Certifications – Commercial Items (Apr 2016)

The Offeror shall complete only paragraphs (b) of this provision if the Offeror has completed the annual representations and certifications 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 and provide a written submission.

Contractor Tax Liability or Felony Conviction The Consolidated and Further Continuing Appropriations Act, 2015 Pub. L 113-235, Division E, Sections 744 and 745 prohibits covered agencies from using funds to enter into contracts with corporations that have unpaid federal tax delinquencies or certain felony convictions unless certain conditions are met.

The Offeror represents that – It is [ ] is not [ ] a corporation that was convicted of a felony criminal violation under a Federal or State law within the preceding 24 months.

It is [ ] is not [ ] a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability.

52.203-98, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements—Representation (DEVIATION 2015-02)

(a) In accordance with section 743 of Division E, Title VII, of the Consolidated and Further Continuing Resolution Appropriations Act, 2015 (Pub. L. 113-235), Government agencies are not permitted to use funds appropriated (or otherwise made available) under that or any other Act for contracts with an entity that requires employees or subcontractors of such entity seeking to report fraud, waste, or abuse to sign internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information.

(b) The prohibition in paragraph (a) of this provision does not contravene requirements applicable to Standard Form 312, Form 4414, or any other form issued by a Federal department or agency governing the nondisclosure of classified information.

(c) Representation. By submission of its offer, the Offeror represents that it does not require employees or subcontractors of such entity seeking to report fraud, waste, or abuse to sign internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information.

Clauses:

52.203-99 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements (Feb 2015) 52.212-4, Contract Terms and Conditions – Commercial Items (May 2015) 52.212-5, Contract Terms and Conditions Required to Implement Statues of 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, 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:

52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2015) 52.209-6, Protecting the Government’s Interests when Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Oct 2015) 52.222-3, Convict Labor (Jun 2013) 52.222-19, Child Labor – Cooperation with Authorities and Remedies (Feb 2016) 52.222-21, Prohibition of Segregated Facilities (Apr 2015) 52.222-26, Equal Opportunity (Apr 2015) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) 52.222-50, Combating Trafficking in Persons (Mar 2015) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) 52.232-33, Payment by Electronic Funds Transfer – System for Award Management (Jul 2013)

(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:

52.222-41, Service Contract Labor Standards (May 2014) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014)

(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…