16-223-SOL-00101_Q A_2.pdf

Document Name Section # Page # Question Answer

1 Solitication General N/A

The initial release of the solicitation was missing Appendix documents that were not provided until 10/5. Will the FDA provide the courtesy of extending the solicitation due date by at least one week? see answer 28 on the initial questions pdf 16-22-sol-00101_QA (1).pdf

2 Solitication 9.2.3. 9

The document states "Sub-Factor D: The proposed facility square footage must be contiguous and capable of supporting the functions outlined in ID/IQ SOW Task areas.

Current footage for task order one footprint is 2600 contiguous usable square feet."

Please confirm if this space includes the 2 private offices for FDA use and other rooms (file room, LAN room). Please confirm the number of workstations in this space and equipment (scanners, printers, etc.)

confirmed Note we do not have a separate file room as we scan and after 90 days shred.

We are not providing the number of workstations (ie number of workers you need)

3 Solitication 8.1.c 5 The document states "The facility is owned or leased by the Offeror". Please confirm that a contingent lease is acceptable. confimed

4 Solitication 8.1.c 5

The document states "The proposed facility square footage is contiguous and capable of supporting the functions outlined in Task Order SOW Task areas. Current footage for the initial task order is 2,600 contiguous usable square feet". Please identify the estimated or currently required contiguous square feet required to support the functions outlined in the Task Order SOW areas.

only task order one is specified bidders should show a plan for future growth; perhaps ability to lease more space in the same building as needs grow

5 Solitication 8.1.c 5 Please confirm whether contiguous square feet refers to building or floor contiguous

sq. ft. (e.g. sq ft within one building or sq ft on one floor).

the 2600 sq feet is for the first task order only ; having this on one floor would be preferable but not required

6 Attachment C 4.4 12

The solicitation states in Section 9 page 22 of Attachment C that FDA will provide any required hardware and software for performance under the task order. Will the government provide new equipment or reuse existing equipment currently in place at the incumbent facility? If equipment will be moved rather than replaced, will the movement occur during transition period? If so, are there any SLAs that need to be maintained? If equipment will be moved rather than replaced, will the government be responsible for moving government equipment from one facility to the next or will contractor? If contractor, please provide an inventory of the equipment that needs to be moved.

As far as computers some may be up to three years old and we will be doing an inventory after award. As far as network equipment FDA generally builds new at each site but remember when it starts it will be VPN not a full network node with a router. If we can get VPN for large number of data entry at one site that is great . If this does not work we will need to build a new node and this will take a min of six months. The contractor will be responsible to move equipment. This will include a laptop for each employee and one desktop scanner and some other small items. There will be no moving of network equipment by the contractor. During the transition the contractor will be expected to gradually take on processing of reports and this must be done on FDA equipment. The SLA of the help desk for computer equipment will be unchanged throughout transition

7 Solicitation olume 2 Evaluation 5

The document states "The offsite facility is compliant with all FISMA building and physical regulations." Will Appendix A - Facility be used as the basis to establish compliance? If not, please identify the FISMA controls from NIST-800-53r4 that are required and the priority and baseline allocation (Low, Moderate, or High) for each that will be used as the basis for establishing facility compliance. (E.g. PE-11 Low)

There will be a FISMA inspection and all controls will be required. This will include but not limited to not having any false ceilings that can allow people to climb over from one work area to the FDA area; having badges that open the door so only FDA personnel can gain access and that access of personnel is logged. Log books that show visitors are badged and escorted; clearning crews that only come in during work hours etc.

Contractors are responsible to comply with all FISMA controls at their expense

8 Attachment C 4.1 4

The document states “Figure 1 depicts and describes the processes and flow of information including input of adverse event reports to FDA.”, however there is no Figure 1 in the document. Please provide Figure 1. This should say Appendix F

9 General N/A N/A What are the average number of contractor FTE over the past year that support task orders on the current IDIQ?

These are not comparable the current IDIQ was limited to adverse event reporting and the new one is broader, dealing with general data management services

10 Attachment A 5.3 5

Task Area 3 states “The contractor shall furnish the necessary personnel, materials, services, and facility to do all things necessary….for off-site scanning.” However, in Task Order 1, Attachment C Section 9 page 22 states that "FDA will provide any required hardware and software for performance under this task order." Should the respondent provide pricing for equipment and software necessary to complete scanning activities at the IDIQ Level? If so, what is volume of scanning in terms of documents per day that is required across all task orders on average? FDA will provide all equipment. Only task order one work load will be specified

11 Attachment A 5.5 6

The document states "Provide temporary storage periods which range significantly…" Does the contractor need to have a dedicted file room(s)? If so, please specify the minimum sizing for the file room in terms of cubic feet or linear feet of cabinet space required.

Please see SOP we keep for 90 days; confirm it is in system then shred we can keep all boxes in one office

12 Attachment A 6 10

The document states "All infrastructure must obtain an Authority to Operate (ATO)."

Please clarify what system this statement applies since it appears that the government will furnish "any required hardware and software", and that no information systems will be hosted in contractor facilities.

FDA supplies all software and all computers. Technical support of the FAERS software system used in data entry is handled under a separate contract, that contractor will be tasked with making sure the software for the data entry system has an authority to operate certificate from the agency

13 Attachment C 4.1 6

The document states that the table summarizes the number of reports from October 1st 2015 through December 31st 2015. Please confirm that the numbers provided are for the 3 month period specified and not the Calendar Year. The numbers are for the three month period as stated in Attachment _c

14 Attachment C 4.1 6 Can FDA provide the number of cases received within the last year by case type (Paper, eSub, eSub Fallout)? Historical values are provided on pg 6

Appendix D - Final DSI May 2015 6 Month Review N/A 34

On Slide 34, it indicates that 10% or 130,295 paper cases were received in 2014.

However, on slide 32, percentages are given "After June 10, 2015" of 4% Paper and 96% electronic. What is the current percentage of cases received by case type (Paper, eSub, eSub Fallout)?

Note the slides say 2014 and in 2015 FDA mandated that all industry reports needed to be submitted electronically. So as of 2015 the 4% figure is correct

16 Attachment C 4.6.8 19

The document states “The contractor shall provide a detailed pictorial representation of all network equipment in the building”. Please clarify if the government meant to say “building” or just the space controlled by the contractor and used to perform work on this contract. Contractor may not have visibility or control other tenants’ equipment.see question 50 in the intial questions

17 Attachment C 4.6.8 19

The document states the contractor shall work closely...”to ensure that the information systems can be accommodated in the Facility Space Plan”. Will any information systems (other than workstations) be hosted at the contractor facility? If so, what equipment will be located at the facility? If not, please clarify what “information systems” refers to. see question 50 in the intial questions

18 Attachment C 4.6.8 19

The document states “sufficient space exists for the workstations, workflow equipment (scanners, printers, and other equipment)”. Please identify the types of equipment and the number of units of each item.

Each worker will need a workdesk that can support two monitors; one large high speed scanner is used for imaging; an FDA suppied large networked copier will be supplied

19 Attachment C 4.6.8 19

The document states “The contractor will supply all hardware needed to connect to FDA computer equipment to one ISP by traditional wires. In addition the second ISP will use wireless connections for quick switch over in case of primary ISP failure.” 1) Please confirm the contractor will be responsible for purchasing and maintaining a) Internet service purchased from the ISP, b) the network within the office space including switches, firewalls, etc. 2) Please clarify that “traditional wires” means any high speed internet service such as Comcast cable or Verizon FIOS and not a dedicated leased line to FDA. 3) Wireless network speeds may not be sufficient for an office of a certain size. Will the government allow the contractor to use a second ISP with physical connection for backup rather than wireless? 4) If the FDA is providing equipment (laptops, phones, printers), but the contractor is providing the network, will FDA equipment be allowed to connect to the contractor's network?

1 a) contractor must pay for ISP and we hope to have two providers; b) switches and routers will provided by FDA if it ends up being a new network node, at first everything will be VPN and go through contractor equipment; 2) traditional wires does mean high speed internet service; 3) wireless network speeds are sufficient if wireless routers are industrial size and properly provisioned; The government now uses a wired connection and when that goes down workers switch to wireless without having to change any connections on their equipment if the contractor can have a backup ISP that can be switched over in a few seconds without any changes to individual workstations that is acceptable 4) At the begining we will be using VPN where fda computer will be hooked up to the contractors equipment, if this cannot be scaled an FDA network node will be installed over the course of a few months, this means FDA switches and routers and an FDA caged and locked lan closet and FDA lines inside seperate pipes down to the building MUX which will be shared with other tenants

20 Attachment C 9 22

The document states “FDA will provide any required hardware and software for performance under this task order.” In section 4.6.9 on Page 19, the document refers to a Facility Space Plan that must be completed and submitted with this proposal (Item 9, page 20). Please provide an inventory of equipment that needs to be documented and accounted for in the requested Facility Space Plan.

This plan should show the architecture and robustness of the current buidling including routers muxes and other network equipment. This will be used initially for VPN connections to FDA systems just as our remote home users now use. If this scales well enough we can stay VPN. If putting all these VPN connections in one place causes poor performance an FDA network will need to be constructed by the FDA. The bidder must show that there is room for an FDA lan closet, network cage, seperate fda datalines that are enclosed in pipe etc. This should be part of the proposal not after award.

21 Attachment C 4.6.9 19

The document states “After the contract is awarded the contractor shall work closely with FDA…..to ensure that information systems can be accommodated in the Facility Space Plan.” However, on page 20 of Attachment C, Item 9 of the deliverables table indicates that the Facility Space Plan is due upon submission of the proposal.

Additionally, on Page 22 Section 9 of Attachment C the document states “FDA will provide any required hardware and software for performance under this task order.”

Please clarify if the government would like the Facility Space Plan to be submitted as part of this proposal response or if this will be due after award. If the Facility Space Plan is due as part of the response, please provide an inventory of government furnished equipment that must be accounted for in the document.

The government wants Facility Space Plan as part of the proposal. Please see question 20 in this spreadsheet for more information.

22 Attachment C 4.1.3 9

The document states "Manage storage, report retrieval and destruction (shredding).

The shredding task includes shredding the MedWatch reports or managing the shredding schedule, if another vendor provides that service.". Must shredding be done on site?

At one time shredding was done on site but now a contractor uses a private service which FDA also uses and they pick up the paper to be shreded. This can be billed like a courier service on the FDA invoice

23 Solicitation me 3 Past Perform 6 Will the FDA accept Past Performance submissions from proposal subcontractor team members? see question 27 in the initial questions

24 Solicitation e 2 Relevant Expe 6 Will the FDA accept Relevant Experience provided by proposal subcontractor team members? Yes, though the prime must past the first technical evaluation criteria (go-no go criteria).

25 Solicitation me 3 Past Perform 6

The document states that past performance must include "the references Company Name, DUNS…", but does not request a corresponding contract number, Contracting Officer, Program Officer, or Agency. How will the FDA verify past performance without this information?

The items presented are the required items. If the offeror determines more information is required for the FDA to evaluate its past performance, then it is the offeror's responsibility to provide this information.

26 Attachment C General N/A What are the platforms for each of the applications that are used for Task Order 1?

A separate technical support contract supports this effort. Most data entry is done through a browser based COTS products called ORACLE AERS which the FDA has modified and is named FAERS in FDA

27 Attachment A Task Area 6 6

The first paragraph of Task Area 6 appears to describe activities that would typically be found in the management approach. activities, however the subsequent representative activities? We consider "meetings" and "staff training" to be part of the management approach

Appendix_E1_- _FAERSWeeklySt ats2015_11_17.xls General N/A

The spreadsheet provided is dated November 2015. Can the FDA please provide a more recent version of this type of report for 2016? See answer 42 in the initial questions

Appendix D - Final DSI May 2015 6 Month Review General N/A

What are the current number of FTEs supporting the DMP FAERS project (Task Order 1)? see answer 42 in the intial questions

30 Solicitation 14.7 23

The document states "It is the Government’s intention to perform closeout procedures on an individual task order basis as well as for the IDIQ Contract.". Task Order 1 includes a transition in task for the task order but there is not a transition task for the overall IDIQ Contract. Are there any overall IDIQ level activities that the new contractor will be required to perform during the performance of Task Order 1? If so, how will the overall IDIQ Contract be transitioned in to the new contractor? The current contract has a transition order for task order one.

31 Attachment C General N/A Can the FDA please provide platform (Database, App, Web tiers) of each of the major systems that supports Task Area 1? see question 26 in this spreadsheet

32 General What organization within FDA is the Program Office? CDER Office of Surveillance and Epidemiology

33 Attachment C Attachment C has 6 embedded files that cannot be opened. Please provide these appendices. These have been provided

34 General Given that the ordering period for HHSF223201000031I expired in 2015, how is the incumbent contractually able to perform the work currently? HHSF223201000031I expired 3/12/2016, though it has active Task Order(s)

35 General What centers is the incubment currently supporting? The solicitation clearly states what Centers this contract will support 36 General In what city/cities is the incumbent currently performing the work? Rockville MD / Gaithersburg MD

37 Solicitation 9.2.3 9

Factor 4 – Offsite Facilities states "Current footage for task order one footprint is 2600 contiguous usable square feet". What centers are support under this referenced "task order one"? CDER adverse event data entry

38 General Please provide the volume of adverse event reports by center for 2015 Bidders are only being given information on task order one, reference TASK ORDER:

Attachment C, Page 6.

39 General

Which contracts currently support the data management needs for Center for Biologics Evaluation and Research (CBER) and Center for Tobacco Products (CTP)?

Please provide contract numbers. HHSF223201510011I, HHSF223201510012I, HHSF223201610014I

40 Solicitation 9.2.3 9

Factor 4 – Offsite Facilities states "…the Governmnent will evaluate….ability to acquire additional facilities for multiple, concurrent off-site task orders that adheres to FDA IT Facilities Requirements." but also states "Sub‐Factor B: The Offeror must propose ONLY one (1) facility to perform all services during the ID/IQ Period of Performance inclusive of Task Order 1 and future awarded task orders". Please confirm that this means space expansion within the same facility is allowed, and space expansion at multiple facilities is not allowed.

All offsite work should be done in one building; The government may request work be done onsite in other task orders.

41 Solicitation 9.1 8 Factor 1 references Attachment B, however there is no attachment B. Please clarify. This has been restated

42 Solicitation 9.1 8

Factor 1 evaluation states "The Offeror’s response to ramping up and staffing the three sample task orders, is logical, reasonable, and likely to be effective". Please clarify what "three sample task orders" refers to". This has been restated there is only one sample task order

43 Solicitation 14.3 22

Place of performance states "The places of performance will be defined in the requirements of each task order. Location information will be specified in each task order." Please confirm whether or not performance may be on FDA site.

For task order one which bidders will price all the work will be done offsite except for the relativley small amount of DQRS work. Other task order may have all or part of the work done offsite

44 Solicitation 14.3 22

Place of performance states "The places of performance will be defined in the requirements of each task order. Location information will be specified in each task order." Please confirm whether different Task Orders may require performance at different sites. In other words, would different Centers require distinct locations and separate processes?

There should be one building for all offsite work and it should be able to expand for multiple task orders as needed. Some task orders may require onsite work

45 Solicitation 5

Evaluation Factor 3 states "The Offeror shall provide a signed letter of commitment and resume for the proposed IDIQ Program Manager…". Please confirm whether or not resumes and letters of commitment are needed for the task order 1 key personnel. Yes, resumes and letters of commitment are required for key personnel under task order 1.

46 Solicitation 5

Evaluation Factor 3 states "The proposed facility square footage is contiguous and capable of supporting the functions outlined in Task Order SOW Task areas." Please clarify what contiguous means; whether separate floors in the same building qualifies, and whether kitchen space or individual offices within an open space qualify.

this IDIQ may require more than one floor of space; the 2600 ft figure that was given included offices and a common eating area

47 Solicitation 5

Evaluation Factor 3 states "The proposed facility square footage is contiguous and capable of supporting the functions outlined in Task Order SOW Task areas." Will each center require its own processes and space requirements, or is a common process at one location acceptable? Centers will require their own area for each task order

48 Solicitation 5 Evaluation Factor 3 states "The Contractor shall provide documentation demonstrating they possess the fully improved facility". Please clarify what "fully improved" means.

If awarded the FDA must be able to move in within 10 days and have all necessary equipment available

49 Solicitation 6 Please confirm that past performance questionnaires are not necessary if there are CPARS available for those contracts.

If the contractor has the appropriate past performance evaluations in PPIRS, these may be used/referenced in the past performance submission, so long as there is enought information provided which the government may be able to know which evaluations are most appropriate for the offeror's proposal.

50 Solicitation 4

Instructions for Factor 1 states "….and through the narrative response required by the second part of this factor." However, there is not a second part to the instructions.

Please clarify. This has been restated

51 Solicitation 4 Please confirm whether experience offeror's teammates can be used to satisfy Factor 1.

Only if the temmates are in a Joint Venture type relationship. Under a prime/sub relationship, only the primes experience will be admissable to the evaluation factor.

52 Solicitation 4 Please confirm whether past performance of offeror's teammates can be submitted for Volume 4. See answer to question 27 on first set of questions.

53 Solicitation 4 Please confirm whether relevant experience of offeror's teammates can be provided for Factor 5. Confirmed

54 Solicitation 9.2 8

Weighted Technical Factors states "Factors 2, 3, 4 and 5 are listed below and will be evaluated in descending order of importance". Please clarify how Past Performance is weighted against Factors 2-5. Past performance is not a weighted technical factor, it is a risk factor.

55 Attachment C 1

Attachment C is labeled "FAERS DMP Task Order" however, Task 1 is labed as "Program Management" in Attachment E Price Summary tab. Please confirm whether these are one and the same. Confirmed

56 Solicitation 7

Pricing instructions requires "labor categories will include on site and offsite rates as applicable within the worksheet." Please confirm whether Task Orders may require work to be performed on Government site. In task order one only a small amount of DQRS work is done at a government site

57 Attachment C 1 Please confirm that the Government is not providing labor categories and it's up to the Offeror to propose rate categories. confirmed

58 Attachment C 9 22

Section 9 states "FDA will provide any required hardware and software for performance under this task order". Please confirm whether this includes scanning machines. confirmed

59 Attachment C 9 22

Section 9 states "FDA will provide any required hardware and software for performance under this task order". Please provide a listing of current hardware and software provided to the incumbent. This will be provided at award.

60 Attachment C Please provide the volume of documents by center and by type for Task Order 1 Volume of data entry for task order one was included in attachment c. This sample task order is what bidders will bid on

61 Attachment C 20

Deliverable #9 indicates that Facility Space Plan is due with the Offeror's "Task Order Proposal". Please confirm whether Facility Space Plan is due as part of this proposal response. Confirmed

62 Solicitation 5

Evaluation Factor 4 requests documentation that the "facility is owned or leased by the Offeror". Please confirm that contingent leases are acceptable for the proposal response. confirmed

63 Solicitation 5 Please confirm whether or not facilities owned or leased by the offeror's subcontractors will be accepted. confirmed

64 Solicitation 2

The RFP states “The resultant contract will have an ordering period of five years from the date of award. Each task/delivery order issued under this contract will specify”. Is this a base period of 5 years/60 months? it is a base period of one year followed by four option years

65 Solicitation 3

Please confirm that If the potential Offeror that forms a CTA wants all members of the CTA to be considered for evaluation, the CTA must be a CTA as defined under FAR 9.601(1) or be a Mentor-Protégé Arrangement that has been approved by the Small Business Administration. This is correct.

66 Solicitation 3

Please confirm that for an Offeror that submits a proposal as a CTA to be considered an 8(a) for thepurposes of award, the prime contractor/team lead must be 8(a), and all members of the CTA must be considered small businesses under the NAICS code.

All members are not required to be a small business, but the work performed under the contract by the CTA must adhere to FAR 52.219-14 Limitations of subcontracting and must be performed by the 8(a) prime contractor or similarly situated team members.

67 Solicitation 7

"Each labor category identified as an Service Contract Act (SCA) category as provided in Attachment 8, shall be annotated in this spreadsheet and the rate shall broken down in the Labor Breakdown Tab of this worksheet." Please confirm this is a correct requirement as there is no Labor Breakdown Tab. confirmed

68 General What is the anticipated date of award? see question 5 in the original questions

69 General What are the shift shedules of the incumbent staff?

The bidders will define if they want to use more than one shift. Presently only one shift is used

70 General Are office supplies, such as paper, reimbursed by the Government as ODCs? No 71 General Is shredding required to be conducted on the contractor's site? See question 22 in this spreadsheet 72 General What is the FTE count for the incumbent staff? See question 42 in the original questions 73 General What is the current FTE count for Task Order 1? See question 42 in the original questions

74 General What are the current service level agreements for productivity on Task Order 1?

required service level are spread throughout attachment C. Example are in section 4.1.5, section 4.1.2, section 4.14 etc

75 Appendix C Please provide the approximate physical dimensions of "cases" as referenced in the courier route (Appendix C)

Consumers often send reports to the wrong centers and the courier must also pick up physical mail. This can still fit in one or two standard 1 ft x 1ft x 1.5 ft crates

76 Appendix C

Appendix C cites 20 Direct cases per day under "MEDWATCH MAILROOM" and about 217 Expedited paper cases per day under "CDER-CDR*". Please clarify what "case" refers to. An adverse event report sent in by either a consumer or by industry Ex include adverse event forms 3500, 3500B, 3500A

77 General Please provide average volume, in terms of physical dimensions, daily courier needs. see question 75

78 General For each center supported by this contract, please provide any center-specific tools and applications used.

The scope of this IDIQ only covers data entry with hardware and software provided by the FDA. If software needs support it will be under a different vehicle.

79 General Is the Government responsible for the serving and maintenance of scanners?

In some cases the contractor will be asked to pay and manage the service contracts but the cost can be billed on the invoice to the government

80 General What systesm are used for Task 2?

Task 2 is DQRS data entry. This is an older FDA designed and built software system. It is just referred to as the DQRS system internally

81 General Are paper, ink cartriges, and other consummables reimbursed by the Government? See question 70 in this document

82 General Will the incumbent staff that's hired by the awardee retain their FDA system credentials? FDA badges? Access to FDA laptops?

They will need to have their credientials updated with the date of the new contract and the new contractor name. They should be able to keep their badges and not have to have their current software accounts changed

83 General Is the Government responsible for GFE equipment moving cost during the transition? The contractor is responsible for this cost

84 General Will the Government provide new GFE equipment for Task Order 1, or will the Government re-locate equptment that's currently being used by the incumbent?

laptops and scanner be re-used. If the government builds a new network it will be built new

85 General During transition, will the Government be responsible for providing and tracking to a manifest of phyiscal files and documents being moved?

The contractor will be responsible for moving about 50 crates. Note with our scan and shred policy we do not keep large amounts of documents

86 General Will the Government provide VOIP phones?

The contractor must provide phones ; the government may decide to put in a few voip phones for it own employee but this will only happen if FDA decides to build a network node and any network node will take at least six months to build

87 Task Order 1 4.4 12 Will the new awardee be allowed on the incumbent's site for trainsition training? Yes 88 General Is the time employees spend on training billable to the Government? Yes if training has been approved in advance by the FDA

89 Base IDIQ 5.5 6

Task 5 states that contractor will "provide temporary storage periods which range significantly and will be contingent on the types of document and records". Can the Government provide an estimate storage need for Task Order 1? see question 85 in this spreadsheet

90 Base IDIQ 5.3 5 Is Task 3 required to be performed within 20 miles of FDA's White Oak campus? yes 91 Base IDIQ 5.3 5 Can Task 3 be performed off contractor's site? Task 3 is training; normally this is done at the worksite

92 Attachment C Can the Government please provide volume by type for the last available 12-month period? See question 42 in the original questions

93 a What the are labor categories and labor category descriptions for the current contract? See question 44 in the original questions

94 Attachment A

Task Area 7 Process and Procedure Improvement includes transition activities.

Should transition activities be part of Task Area 6 Program and Task Order Management Support? It was decided to give this a seperate section

95 Attachment A Attachment A lists the FDA Centers who my participate in this contract. Can the Government provide a listing of Centers that are currently supported by this contract? CDER

96 General What the are labor categories and labor category descriptions for the current contract? see question 44 in the original questions 97 Attachment C What are the technical platforms for each application used on Task Order 1? see question 26 in this spreadsheet

98 Attachment A

Training is found under both Task 6 (Program and Task Order Management Support) as well as Task 4 (Data Management Migration and Process Changes). Can the Government clarify the difference in required training under these tasks?

Task area 6 talks about training a new employee on current system Task area 4 covers when new software is introduced and the entire staff needs to be trained on the new software

99 Attachment A

Task Area 3 Document Scanning states that "Requirements for off-site scanning, photocopying, and conversion services will vary from Center to Center and will be outline in the ITOs". Is it required that "off-site" location be within a 20-mile radius from FDA White Oak Campus? yes

100 Solicitation 5

The requirement for facilities states "The Facility has the ability to be expanded beyond the needs of the first task order to other future task orders as needed". Where and how large is the incumbent's facility?

The current IDIQ has almost 30 task orders and has multiple off site locations. It was decided to only relase the sq footage for task order one as this sample task order is the noe being bidded on

101 Solicitation 5 Please confirm whether the required Detailed Architectural Blueprint is part of page count for Volume II confirmed

102 Solicitation 6 Will the agency accept past performance references for all teammates of the offeror, or will only the primary offeror's contract references be considered? See question 27 in the original questions

103 Solicitation 5 Will the agency accept relevant experience for all team members for the offeror? see answer to question 25 above

104 General Giving the proposal requirements and the timing of the release of appendicies, will the Government extend the due date by 3 weeks? See question 28 in the orginal questions

105 General What is the period of performance end date for the current Task Order 1? see question 5 in the original question set

106 Attachment A 4 2 Medical coding of reports using various taxonomies (Eg., MedFRA, VeDDRA) - Will VeDDRA coding require the same qualifications as MedDRA? VeDDRA coders will need to be Veterinarians

107 Attachment C Can the Government please provide system architecture details for Task order 1?

This will need to be provided by the offeror as part of the proposal . The offeror will need to show their proposed sight has a robust internet architecture and has the capability to host an FDA node if VPN cannot scale. Note all software will be provided by the FDA

108 General Does FDA provide access to MedDRA – training or subscription?

The FDA does have a current MedDRA subscription however training of MedDRA coding personnel should initially be for competency and ongoing to keep up with the latest coding idea and this training must be supplied by the bidder. This training should be approved by the FDA head of MedDRA and is part of normal billable hours.

109 Solicitation 8.1(c) 4

If there are multiple concurrent Task Orders (three or more concurrent task orders) in the same GSA schedule contract number will it pass ‘Factor 1’ and be considered as ‘Multiple Concurrent Task Order Management and will pass the factor Go’?"

No, the IDIQ must be an independent IDIQ, similar to the described work under the solicitation SOW.