LIMS Questions and Answers.pdf

Q1. We note that the software license is not included in years 4 and 5. Normally, there would be a perpetual license for software. Sometimes such a license might be the equivalent of 3 years. Is this why the license is not included in years 4 and 5? In other words, is this your short-hand way of saying to give a quote for a perpetual license? Is there another reason for expressing the license as you did?

A1. Software license is included in years 4 and 5 - as annual maintenance and support, license costs. We are not necessarily requesting a perpetual license.

Q2. Can you provide documentation on the WAAM System and Interface Specification?

A2. WAAM System is best described in the following attachments and sections.

“Attachment #10. Filename: MARCS Framework 1_0 System Design”. Section 4.2.1.5.

pp 4-40 - 4-46; Section C5. pp C-4 1- C-51.

“Attachment #11. Filename: MARCS Framework 2.1”. Section 3.3.1 pp 22 - 29.

SEE ALSO “Attachment #14: MARCS Addendum to MARCS Framework 2.1”

Q3. Please provide the following for each lab

a. Size (square ft)

b. Location

c. Number of lab personnel

d. Methods performed

e. Samples analyzed for each method per year

A3. Lab size is not currently available. For Lab Location and Methods performed, please see Attachment #38 File name: ORA Lab Locations and Capabilities .pdf. For Number of Lab Personnel, please see Attachment #37 File name: Laboratory Staff Size.pdf. Please see below for Samples analyzed (approximate) for each method per year:

Samples analyzed/year

Domestic Imports Total Regional Laboratories

Pacific Regional Lab -(PRL-NW) 843 3,079 3,922 Pacific Regional Lab - (PRL-SW) 1,300 5,614 6,914 Arkansas Regional Lab (ARL) 1,286 3,947 5,233 National Regional Lab (NRL) 1,450 8,206 9,656 Southeast Regional Lab (SRL) 2,947 6,601 9,548

District Laboratories

San Francisco District Lab 482 1,853 2,335 Denver District Lab 1,315 2,613 3,928 Kansas City District Lab 5,114 1,262 6,376 Detroit District Lab 428 236 664

Specialty Laboratories

Forensic Chemistry Center

(FCC) 1,106 34 1,140

Winchester Engineering & Analytical Center (WEAC) 435 1,339 1,774 Philadelphia Pharmaceutical Lab 715 269 984 San Juan District Lab 360 2 362

Q4. Please describe the MARCS, RBIS, ALM and QMIS systems including

a. Functionality

b. Data Inputs

c. Data Outputs

d. Technical Architecture A4.

MARCS

The MARCS program is the primary IT mechanism for realizing ORA program goals. It also directly supports the programs of CBER, CDER, CDRH, CFSAN, and CVM. MARCS manages the integration, reengineering and enhancement of seven legacy systems into work flows and services to better support these programs. It aligns directly with Objective 2.2 of the HHS strategic plan: Protect the Public Against injuries and Environmental Threats and enables FDA Centers to meet FDA Strategic Goal 4: Improve the Quality and Safety of Manufactured Products and the Supply Chain. FDA uses MARCS’ applications to: plan FDA field activities and assign staff to inspections, investigations, recalls and other compliance activities; track and control samples and the results of laboratory analysis; collect and maintain information from field activities; collect performance data, particularly that related to FDAAA; send Prior Notice for food imports to Customs and accept import product information from Customs for screening; screen some 20 million import lines a year based on calculated risk; collect information about the facilities FDA regulates and those in the import supply chain for risk-based targeting; provide FDA Centers with information on inspections, compliance actions, recalls, laboratory analysis and facilities. MARCS fills the current performance gap by providing for 1 the convergence of Center and ORA workflows, in particular for compliance, recalls, and complaints 2 the convergence of Imports and Domestics workflows by reengineering and integrating components 3 better cooperation through electronic communication with industry, academia, and state and local organizations through such components as eSAF, ITACS, and CLEARS 4 a national workforce where resources can be assigned using WAAM and ARRMS to any area of the USA rather than being confined to only one geographical area. 5 reusable services for MARCS and other FDA investments to reduce duplication of effort This is being accomplished by improving upon and replacing legacy functionality according to useful segments. Services such as ARRMS, NS and DGS and work flows such as ITACS, Inspections and Field Exams are expected to be fully implemented by the budget year. Additional integration with other FDA investments such as ALM, RBIS, HI, and cEDR will enhance functionality. MARCS will also support functionality for tobacco regulation.

MARCS is described in the following Attachments and Sections:

“Attachment #10 Filename: MARCS Framework 1_0 System Design”. Section 1 “Attachment #11 Filename: MARCS Framework 2.1”. Section 2, Section 3 “Functional

Architecture”; Section 5 “Interfaces and Integration Patterns;

SEE ALSO “Attachment #14 File name: MARCS Addendum to MARCS Framework 2.1” “Attachment #26 File name: Current MARCS Web Services”

RBIS

Regulatory Business Information Services (RBIS) manages ORA’s reporting and information management projects. It aligns directly with Objective 2.2 of the HHS strategic plan: Protect the Public Against Injuries and Environmental Threats and enables FDA Centers to meet FDA Strategic Goal 4: Improve the Quality and Safety of Manufactured Products and the Supply Chain. RBIS includes 1 a centralized data warehouse, the Online Reporting, Analysis, and Decision Support System (ORADSS), implemented to provide integrated information for regulatory compliance and risk-based analysis 2 the Firms Master List Services (FMLS), to manage, improve the quality of, and standardize data on firms. ORA and Center staff access these integrated systems for analysis and decision-making used to protect public health and safety and communicate to the public. Over 5,000 users throughout FDA use ORADSS in regulatory compliance and risk-based analysis. In addition, the MARCS and ALM investments at FDA depend on RBIS for reports and firm information. RBIS fills the current performance gap by providing for 1 standardized access to decision support information for a large number of non technical users, including ORA program management users. ORADSS uses a COTS solution that allows access to canned reports and simplifies the creation of ad-hoc reports without specialized knowledge of the underlying data. 2 standardized firm information that allows for reliable firm identification. Without FMLS, the Agency would be limited in protecting the public by evaluating risks using data on firms in the supply chain. Specific accomplishments expected by the budget year include improved data mart capabilities for the ORA laboratories allowing for access to near real time decision support information to give ORA the information to respond more quickly to public health emergencies and improvements in the firm survivorship rules to reduce the number of duplicate firms, especially amongst foreign firms, to improve risk-based targeting and allocation of resources. RBIS makes decision support information available to a wide variety of users and other IT systems. It directly supports management decisions and risk-based activities.

RBIS is described in the following Attachments:

“Attachment #24 File name: RBIS Current and Future Architecture”

ALM is the name of the overarching program - it is not a system.

QMIS is the quality management system that the ORA labs use. The system uses the COTS application MasterControl. The interface requirements for the LIMS/QMIS interface can be found in the non-functional section of the SRS (Attachment #20 File name: ALM – LIMS SRS Version

1.0.3 – 01.18.2011.pdf) and requirements repository (Attachment #12 File name: ALM – LIMS Requirements Repository Version 1.0.3 – 01.18.2011.xls)).

Q5. Please describe the Laboratory Exchange Network (eLEXNET) A5. The Electronic Laboratory Exchange Network (eLEXNET) is a secure web-based application that shares real-time food safety information and facilitates proactive collaboration among Federal, state, and local government laboratories including a major stakeholder, the Food Emergency Response Network (FERN). Providing a centralized repository for sharing food sample and test result information, eLEXNET allows effective risk assessment and decision-support capabilities and improves early detection and surveillance of problem products in America’s food supply. Currently, eLEXNET has more than 250 registered labs, over 1,800 users and the database contains over 500,000 sample data submissions from all participating laboratories.

Q6. Section 2.1.5.6 of Task Order 1 references other applications that require a DAR. Please describe these applications.

A6. They are small applications developed by laboratory staff. Most of these applications are developed in Microsoft Access to track various information for sample analysis. One application uses FileTrail.

Q7. Section 2.2. Number 8 of Task Order 1 specifies interoperability with several systems. Please provide information about the systems including:

a. Functionality

b. Data Inputs

c. Data Outputs

d. Technical Architecture

A7. The systems targeted for interoperability are described in the following attachments:

“Attachment #10 File name: MARCS Framework 1_0 System Design”.

“Attachment #11 File name: MARCS Framework 2.1”.

SEE ALSO “Attachment #14 File name: MARCS Addendum to MARCS Framework 2.1” “Attachment #13 File name: MARCS Interface Control Document for SERS” “Attachment #26 File name: Current MARCS Web Services”

Q8. Is there a reason for not having a pre-proposal conference?

A8. The Government determined that a pre-proposal conference was not needed for this procurement.

Q9. Section 3.1 of Task Order 1 – Are the due dates estimates or hard delivery dates?

A9. They are hard delivery dates.

Q10. Section 3.1 of Task Order 1 – Several deliverables (i.e. Updated RTM and SRS) are required 30 days after task award. It is possible that an FDA SME may be needed to answer questions but a lead time of 30 days is required to obtain an FDA SME. Is it possible to secure an FDA SME in less than 30 days?

A10. It is possible to secure an FDA SME in less than 30 days in certain cases but should not be assumed in all cases. It is possible to secure an FDA SME for a web-conference in a short notice.

Q11. Are barcode scanner/printer peripherals already in place for Pilots labs or does contractor need to perform analysis to select these solutions?

A11. We have the following barcode printers and scanners at these two labs:

Zebra 3844-Z Printers - 2 at each lab Symbol Barcode Scanners – 53 at Northeast Regional Lab (NRL) and 30 at Denver District Office (DENDO) Lab

Q12. By limiting Pilots to microbiology disciplines, does this limit pilot to Micro lab sections within the pilot sites?

A12. Yes. LIMS Pilot work shall only comprise of Micro Lab functions/sections of the lab.

Q13. In Section 2.2.2.2 of SOW Task Order #2, could you please confirm that you are only expecting us to train the users of the pilot in the use of the system and not in the configuration and modification of software. If not, could you explain your thought process in training users how to configure or modify the system?

A13. Contractors shall train power users and DHRD Training staff in some configurations and modifications of the software application in addition to the regular usability of the system for the Lab Pilot.

Q14. RFP Section 16 – Personnel Security Clearance Requirements, are non-US Citizens permitted to work on this project?

A14. Yes.

Q15. Within Attachment 41- LIMS Mandatory Requirements Checklist.xlsx. Ability to manage user accounts by utilizing ARRMS, if available, SSO capability. Please provide more information on ARRMS and SSO?

A15. The Authorization Roles and Responsibilities Management Service (ARRMS) is a support component of MARCS that will satisfy the need for role-based access to the other MARCS components. The ARRMS component of MARCS will provide functionality to:

• Control access by users, applications, and services to MARCS components

• Manage user’s associations, roles, and responsibilities

• Provide ORA’s managers the ability to design and modify the structure of their organizational units based on their business needs without IT support

• Provide the capabilities for managers and supervisors to assign employees or certified auditors work outside of their home/assigned district

• Provide the capability to associate workers with assignments and permit the manager or supervisor the authority to provide the worker with temporary access as necessary

• Integrate the service with any MARCS applications or services that requires the service

• Provide a robust, easily maintained role-based service to control access for users and applications, and

• Provide a robust and easily maintained means to define, control, and modify organizational structures which are utilized by MARCS.

ARRMS will be built using the concepts of distributed computing and hardware scalability. Using load balancer appliances and virtual IP (Internet Protocol) addresses, the services will be able to scale to any number of users just by adding hardware to the pool of servers. End users will leverage their laptops to access the ARRMS services, and applications will make web service calls to the operations that are exposed as web services by ARRMS.

ARRMS adheres to the MARCS layered service-oriented architecture that supports flexibility for future change and scalability for future growth. Each layer provides a specified set of services. In general, a layer accepts requests from the layer(s) “above” it and, in turn, requests services of any layer “below” it, using well-defined interfaces, as described and depicted.

Each layer hides the implementation of its services from other layers and makes no assumptions about the implementation details of layers of which it makes requests. In this way, the implementation of the services provided in one layer can change with minimal impact to other system components, as long as its request/response interface does not change. The middle layer, the Business Layer, provides the software elements that implement the key functionality of ARRMS, i.e., Provisioning and Management of Roles.

Single Sign-On (SSO) is intended to be a session-based user authentication process that permits a user to authenticate with single set of credentials in order to access multiple applications in

MARCS.

The SSO credentials is used to verify that the Actor is an authenticated User prior to granting authorized access to MARCS (within ARRMS). The Actor will be identified via SSO. The Actor will be presented with a screen that allows them to state their reason for requesting access. The access request will be sent for approval via the Notification Services (NS), another MARCS services, to the Actor’s ORA Manager in MARCS having Administrative privileges for granting user access.

Q16. Within Attachment 41- LIMS Mandatory Requirements Checklist.xlsx Ability to generate secure worksheets via Microsoft Word. Can you elaborate on what is meant by secure?

A16. The Government removes this requirement for generation of secure worksheets via Microsoft Word from Attachment 41 and the solicitation.

Q17. The FDA requires compatibility with the Oracle 11g suite. Does the FDA currently possess full-use Oracle database licenses or should the vendor include database licenses in its cost proposal?

A17. FDA has Oracle database licenses. The vendor should NOT include database licenses in its cost proposal.

Q18. Is there a requirement to migrate the data from the legacy system (FACTS)? If so, what type of data (i.e. client contacts, sample results, locations etc.) needs to be migrated.

A18. No. Historical data will continue to reside in the legacy database. Legacy access should be via the MARCS service bus.

Q19. In the “LIMS IDIQ – SOW” document, paragraph 2.4 refers to the “FDA SDE” attachment.

Which attachment contains the FDA SDE?

A19. Attachment #33 File name: FDA SDE.pdf

Q20. What do the Year 1, Year 2 and Year 3 quantities represent on the “LIMS Software” tab in “Attachment 2 RFP Pricing Spreadsheet”? How do the quantities relate to Task Order 1 (NRL = 128, DEN = 73 staff according to the RFP) and Task Order 2? Is it the government’s intent to purchase the entire license quantity (1476) in a single purchase order, or to place two separate orders with the license quantities divided between Task Order 1 and (following success of Task Order 1) and Task Order 2? If the latter, how are the quantities to be divided?

A20. Year 1, 2, and 3 quantities represent the original purchases of the LIMS Software. The quantity in year 1 is for the 128 and 73 that you have pointed out (for Task Order 1) and 52 users in the first Center lab (for the IDIQ – not TO2). The Government intends to make the purchases in as many orders as necessary. The Government will not buy the 1,476 all at once. Licenses will be purchased in the years that they are intended to begin being used. The government’s estimate breaks them down by contract year. The first year estimate is for 253, the second year is for 800 more, and the third year is for 423 more. The quantities will be divided as needed for subsequent Task Orders under the IDIQ.

Q21. According to the “LIMS Request for Proposal” document, Paragraph (C)(2)(b) on p. 46, the hours indicated in the “Attachment 2 RFP Pricing Spreadsheet” represent the government’s estimate of labor hours required to complete performance of all task orders under this contract.

This seems to conflict with the instructions provided to bidders relating to the Level of Effort (LOE), on p. 47. In the spreadsheet, there are 215,250 hours estimated over 5 years at the Contractor Site, and 160,250 hours over 5 years at the Government site. At 2000 hours/year, this translates to roughly 188 man-years of labor, or about 38 FTEs dedicated to the project each year. Is this truly an accurate reflection of the government’s estimates? Are all of these labor hours to be provided by the contractor, or through a combination of the contractor’s and government’s resources? Why is there roughly 10X the amount of labor in Year 2 than in Year 1?

If the bidder believes these numbers are not accurate, can the bidder alter the estimates on the pricing worksheets to reflect the bidder’s estimated LOE?

A21. The offeror is to propose their estimated LOE for the Task Orders and use the Government’s labor hour estimates for the IDIQ. The offeror shall not alter the labor hour estimates for the IDIQ portion Yes, this is the Government’s estimate for all work under the IDIQ with the exception of the work under Task Orders 1 and 2. Task Orders 1 and 2 effort is not included in these labor hour estimates. The offeror’s own estimates should be entered into Task Order 1 and 2 worksheets.

For Task Order 1 and 2, the bidder has been provided enough detailed information for the bidder to propose an accurate estimate No Government personnel labor hours have been included in these estimates.

Some of the main reasons for the significant increase in the estimates from Year 1 to Year 2 are - Task Order 1 and 2 estimates will make up most of the Year 1 estimates and in the second year the scope increases significantly as a result of the number of labs being brought online simultaneously.

Q22. Is it the government’s expectation that the selected COTS software will conform to the “LIMS Solution Conceptual Architecture, Products, SOA v0.4.pdf” specifications, or that the COTS software will be modified to conform to these specifications? Or is the intent of the document to describe what the government believes to be a representative or ideal solution, in relation to the government’s architecture standards or roadmap?

A22. The second question describes the Government’s intent of the document. The document was included to provide a better understanding of the Government’s current vision. The document was not intended to be prescriptive of a solution.

Q23. Task Order 1, Page 5, #4 under Section 2.1.Integration Assessment: Provide an assessment of integration with MARCS, RBIS, QMIS, eLEXNET, and additional interfaces. Can you please clarify which additional interfaces other than the one enumerated need to be integrated with?

A23: Please refer to the system requirements for the answer to this question. The interface and reference site requirements can be found in the non-functional section of the SRS (Attachment 20 File name: ALM-LIMS SRS Version 1.0.3 – 01.18.2011.pdf) and requirements repository (Attachment 12File name: ALM-LIMS Requirements Repository Version 1.0.3 – 01.18.2011.xls).

Q24. Task Order 1, Page 5–6, #5 under Section 2.1. …based Inductively Coupled Argon Plasma (ICP) Database Program (IDP), Agilent OpenLab, and other legacy custom applications. Can you please clarify which other legacy custom applications need to be evaluated?

A24. Please see the answer to Question 6.

Q25. Task Order 1, Page 9, Section 2.1.5.6. Can you please clarify what other legacy systems need to be evaluated?

A25. Please see the answer to Question 6.

Q26. Task Order 1, Page 12, Section 2.2.6. This section mentions that a GFE for the pilot is hardware. Is there any software in this hosting environment that can also be leveraged like Oracle SOA Suite?

A26. The bidder should assume we have no other software that can be leveraged for the pilot.

Q27. Task Order 1, Page 13, Section 2.3.4, The scope of the Pilot is to be implemented for one laboratory … and Page 15, Section 2.3.4, The Contractor shall interface the LIMS with the instrumentation detailed for each laboratory in the attached spreadsheets (titled Lab Instruments).

Is the document still referring to the one laboratory (NRL lab) for the pilot—the NRL lab— mentioned on page 15, section 2.3.4 ?

A27. Question referred to an incorrect document section number on Page 13. Therefore, further clarification is needed to best answer the question. However, for Lab Pilot Task Order One (Base Task) NRL Micro Lab instruments shall be considered (Attachment# 35 File Name: NRL Instrument Survey). For Lab Pilot Task Order Two (Option Task) Denver Micro Lab instruments (Attachment# 34 File Name: Den Instruments) shall be considered. For Lab Assessment Task Order One (Base Task) all instruments from the Global Instruments Lists shall be considered (Attachment #36 File Name: Labs- Global Instrument List v1.0 Redacted.pdf) for Instrument integration.

Q28. Task Order 1, Page 14, Section 2.3 and Page 24, Section 4.1. Can you please clarify whether or not Pilot 2 is marked as an optional task that shall be performed at DEN? In one instance it is marked optional and in another it is marked as a determining factor for deciding whether or not to continue with the LIMS implementation.

A28. Pilot 2 is an optional task that shall be performed at DEN.

Q29. Attachment 41 – LIMS Mandatory Requirements Checklist, Page 2, #8: Ability to interface effectively with MARCS WAAM functionality. A number of the requirements involve interfacing with the MARCS system. Can you please provide additional information on exactly what functionality MARCS provides and what the interface is planned to do?

A29. Please see the answers to Question 4 and Question 2.

Q30. Attachment 5 – Offerors Questionnaire, There is no mention of a number of configuration items. Will the vendor or FDA handle configuration items? If the vendor, what is the scope in regards to:

• Test Workflows

• Reports

• External interfaces besides MARCS

A30. The vendor will handle the configuration items. The scope is all necessary artifacts will be maintained by the vendor.

Q31. Attachment 1 – LIMS IDIQ SOW, Page 4, letter i: Asset management – where the LIMS solution would assist ORA Laboratories to manage their assets such as temperature monitoring systems, laboratory specific databases, online reference material, software/hardware licenses, and software/hardware upgrade schedule. For the asset management what types of assets do you wish to track in addition to instruments?

A31. The assets that the Government wants to track in addition to instruments is human resources, supply inventories, chemical Inventory system such as (CisPro), lab specific databases: media prep database, purchasing database, employee training database,QMIS, culture control database, online reference material such as BAM, AOAC OMA, USP, FDA LIBs, etc, software/hardware licenses, software/hardware upgrade schedules, temperature monitoring systems such as checkpoint, equipment inventory system such as IMSPro, Q32. Attachment 5 – Offerors Questionnaire, Question #4.3. Describe legacy data migration and conversion to LIMS. In regards to data migration, are you looking for static data only or transaction data as well?

A32: The specific data to be migrated to the LIMS has not yet been identified.

Q33. Is there a Q&A Period and if so until when?

A33. The question and answer period ended on April 19, 2011 @ 12 PM ET.

Q34. Are we required to provide a budget at the sample task order level for the two tasks?

A34. Offerors shall submit proposals for both task order 1 and task order 2. These proposals are to include all pricing and proposed labor hours for each labor category. See answer to question 21 for further details.

Q35. Are the two tasks simply evaluatory? OR would the government be awarding these tasks?

A35. The Government intends to award both task order 1 and task order 2.

Q36. Is there an established budget at the IDIQ level or at the task order levels? If so, please advise.

A36. There is no established budget for the IDIQ contract or the task orders.

Q37. Can you please confirm if there will be more than one vendor selected?

A37. The Government intends to issue a single-award contract.

Q38. Is this going to be a GSA schedule procurement?

A38. This procurement is being conducted by the FDA and the potential award will be an FDA contract, not a GSA order.

Q39. Can a Sub-Contractor to the MARCS IDIQ Prime Contractor participate as a Prime or Sub- Contractor on the LIMS Automation?

A39. See Section 19 “Organizational Conflict of Interest (OCI)” of the Request for Proposal.

Q40. If the Participating Team of the MARCS IDIQ Sub-Contractor is not a resource on the MARCS IDIQ, i.e., Not Currently FDA badged or cleared, Can this team of the MARCS IDIQ Sub-contractor Prime or Participate on the LIMS Automation?

A40. See Section 19 “Organizational Conflict of Interest (OCI)” of the Request for Proposal.

Q41. There are references to many documents that are provided on the CD. Once these files are received will there be an opportunity to submit questions about those documents?

A41. The Government does not intend to extend the deadline for questions.

Q42. Given the complexity of the Task Orders and the size and scope of the attachments, would the government consider an extension to allow offerors the time to adequately prepare a response that meets the needs of the FDA?

A42. The Government does not intend to extend the proposal deadline at this time.

Q43. Given the volume of technical documentation offered by the FDA, would it be possible to submit technical questions on the attachments beyond April 19, 2011?

A43. The Government does not intend to extend the deadline for questions.

Q44. Will this be a single or multi-award IDIQ?

A44. See response to question 37.

Q45. Is there a projected/estimated ceiling amount for this contract?

A45. The price ceiling shall be the awarded offeror’s total proposed price for the entire contract.

Q46. The language in the RFP states “For proposal preparation purposes, the following designations apply”: [x] Level 5: Public Trust - Moderate Risk (Requires Suitability Determination with NACIC). Contractor employees assigned to a Level 5 position with no previous investigation and approval shall undergo a National Agency Check and Inquiry Investigation plus a Credit Check (NACIC). Can you please explain what is required for proposal preparation purposes?

A46. For the proposal no documentation regarding this requirement is required. However, offerors should be cognizant of the security requirements for proposed personnel.

Q47. Can the FDA define the small business size standards incorporated in this clause? Is it below annual revenues of $25MM? Are organizations that do not meet this definition precluded from bidding on this RFP?

A47. The size standard for this procurement for NAICS code 541519 “Other Computer Related Services” is an annual revenue not exceeding $25 million. Those prime offerors who do not qualify under this size standard shall not be considered for award.

Q48. Which LIMS products has the FDA evaluated in the past 12 months, either informally or as part of the LIMS RFI dated November 4, 2010?

A48. No LIMS products have been evaluated by the Government.

Q49. 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS – COMMERCIAL

ITEMS. (AUG 2009). “Emerging small business” means a small business concern whose size is no greater than 50 percent of the numerical size standard for the NAICS code designated.

What is the designated NAICS code for this RFP? What is the numerical size standard for that NAICS code?

A49. See answer to question 47.

Q50. The solicitation online lists “All Files” and the “LIMS RFP Package,” containing 12 documents and attachments, while the description refers to a “majority of documents” and “background documents” that have been placed on a CD. Given that there are 42 documents associated with the solicitation, some of which are included in the LIMS RFP Package and some of which are only available on a CD for pickup at the FDA, would the government consider extending the due date for questions to allow prospective bidders a reasonable opportunity to obtain and review the seek clarification on the entire set of documents?

A50. The Government does not intend to extend the deadline for questions.

Q51. Can bidders arrange for the CD to be over‐nighted to them at the bidder’s expense?

A51. The Government has allowed for the files on the CD to be sent via email. CDs will not be sent via mail.

Q52. Did the FDA utilize a consultant/contractor to assist in developing this RFP and/or in evaluation of LIMS vendors/products, and if so, which consultant/contractor and over what time period?

A52. This information is not available.

Q53. Can you please clarify whether or not Pilot 2 is marked as an optional task that shall be performed at DEN? In one instance it is marked optional and in another it is marked as a determining factor for deciding whether or not to continue with the LIMS implementation.

A53. Pilot #2 (to be performed at the DEN lab) is an optional task under task order 1. The Government intends to award the Lab Assessment and Pilot #1 at the time task order 1 is awarded. Performance of work for Pilot #2 shall not commence until the option is exercised by the Government.

Q54. The RFP states: "It is understood that the past performance questionnaires are to be sent separately from the bound volumes, directly from the references." Further on in the same Section, Page 40 of the RFP states that "Past Performance Questionnaires are to be included in Volume II: Business, Section C of the proposal.” Should copies of the completed Past Performance Questionnaires be included in the proposals? Please clarify.

A54. Past Performance questionnaires are to be sent to the reviewers. The questionnaires shall then be sent directly from the reviewer to the email address listed in the RFP. Therefore the questionnaires are not included with the initial proposal volume II.

Q55. The RFP states that "the font used shall be no smaller than size 12 font Times New Roman." May the font size be smaller in graphics and tables?

A55: Yes per the following instructions:

• Use single spacing and 9pt Arial narrow font for text in graphics

• Use single spacing and 9pt Arial font for text in tables

• Use any size text in headers and footers