Vendor_questions_(10_May_19).pdf

Amendment 0001 Solicitation No. W81XWH19R0011

Vendor questions / Government responses

General Question 1: Who is the incumbent?

RESPONSE: ICON Government and Public Solutions 1265 Ridge Road, Suite A Hinckley, OH 44233-9801

Formally:

Clinical Research Management, Inc.

1265 Ridge Road, Suite A Hinckley, OH 44233-9801

Question 2: Given that this procurement is a small business set aside and requires a 75 page technical response, we respectfully request an extension to provide more time in order to be able to submit a response.

RESPONSE: Per SF 33 Section “L” the page limit for Volume II (minus Cover page) is 75 pages. If the Offeror is able to complete Volume II in less than 75 pages, that is permitted. The due date and time shall remain unchanged at 10:00am eastern Thursday, 23 May 2019. NOTE:

Section “L” paragraph 2.4 changes the following sentence FROM: Pages shall be double-sided and single spaced” TO: Pages shall be single-sided and single-spaced.

Question 3: We are located in Seattle. Would it be possible to serve this project primarily from Seattle with occasional visits to Silver Springs?

RESPONSE: Per the Attachment 1 – PWS, the prime location for services will take place at WRAIR located in Silver Spring, MD. If the Offeror feels they are capable of meeting the requirements contained within the PWS, they are encouraged to submit their proposal package within the timeframe allotted.

Question 4: Will the Government please confirm that the submittal email address julia.l.burns3.civ@mail.mil is correct?

RESPONSE: Yes, this is correct.

Question 5: May subcontractor costs be delivered to the Government in sealed envelopes?

RESPONSE: No. Subcontractor proposed costs may be emailed directly by subcontractor to:

julia.l.burns3.civ@mail.mil by the due date and time of proposal submission contained in the SF 33 Section “L.” The subcontractor shall ensure the Prime Offeror is identified in both the subline line of the email AND within the proposal cost submission.

Question 6: Please confirm that the Government will be the official Sponsor of the clinical trials conducted under this contract? If not please clarify?

RESPONSE: The Government and/or other non-government organizations (NGOs) may be official Sponsors.

Question 7: Does the Government foresee any vendor requirements that will involve requesting waivers of current Information Assurance (IA) policies (i.e., software solutions to data or other information management)?

RESPONSE: No.

Question 8: FAR Clause 52.237-7 “Indemnification and Medical Liability Insurance” is listed within the PWS Section 19.3, but is not listed in Section I FAR Clauses nor is it listed as full text. Will the Government please add FAR Clause 52.237-7 “Indemnification and Medical Liability Insurance” to Section I FAR Clauses.

RESPONSE: FAR 52.237-7 is now included as full text under Section “I” of the SF 33.

SF 33 / Solicitation (Section “B” Supplies or Services and Prices) Question 9: Can the Government please clarify whether the ceilings described in this section are temporary rate ceilings used for billing purposes until the rate is officially modified, or does the Government intend a permanent indirect rate ceiling, where the contractor will not be reimbursed above the capped indirect rates when the approved or final rate exceeds it? Please note that indirect rate ceilings are not common in cost type contracts and the increased financial risk associated with indirect rate ceilings are usually reflected in a higher fee.

RESPONSE: Indirect rates are temporary rate ceilings used for billing purposes until the rate is officially modified and approved by DCAA.

Question 10:

a. Can the Government provide clarification regarding the situations when it ordinarily expects to use FFP v. CPFF task orders?

RESPONSE: Please refer to Section B, of the SF 33, “Task Order Types,” for determination of task order type.

b. The RFP indicates that each clinical trial will have its own task order – Do you anticipate that most clinical trial task orders will be FFP or CPFF?

RESPONSE: That is unknown at this time. Please refer to Section B, of the SF 33, “Task Order Types,” for determination of task order type.

c. The RFP indicates the first task order will be for Administrative/Business Infrastructure Support Services, do you anticipate that it will be FFP or CPFF?

RESPONSE: We anticipate this being a CPFF type task order.

d. Will the Administrative/Business Infrastructure task order be issued on a 12-month basis with options periods or do you anticipate issuing it for longer (or shorter) periods (such as the full 5-year duration of the Base Period)?

RESPONSE: The Government anticipates that the Administrative/Business Infrastructure task order will be issued on a 12 month bases, with no options year included within the task order.

That is, a new Administrative/Business Infrastructure task order will be issued every 12 months.

e. Will the Administrative/Business Infrastructure task order include the labor costs for the incumbent staff on the expiring contract?

RESPONSE: Labor costs within the Administrative/Business Infrastructure task order will be those proposed by the successful Offeror and incorporated in the base SA-ID/IQ contract. Labor categories within the Administrative/Business Infrastructure task order will be those associated with Administrative/Business Infrastructure tasks. They may or may not include incumbent staff/positions.

SF 33 / Solicitation (Section “L” Instructions to Offeror) Question 11: Will the Government please confirm that only an electronic submittal is required?

RESPONSE: Yes, only electronic proposal submission is allowed. No hard copies shall be submitted. The SF 33, Section “L” paragraph 2.5 “These limitations shall apply to both hard and electronic proposals” have been removed.

Question 12: Will the Government please consider allowing the use of font size 10 for tables and graphics?

RESPONSE: Yes, font size 10 for tables and graphics is acceptable. SF 33, Section “L” paragraph 2.5 has been updated to reflect this.

Question 13: Will the Government allow 10 pt font in graphics, tables, and charts?

RESPONSE: Yes, font size 10 for tables and graphics is acceptable. SF 33, Section “L” paragraph 2.5 has been updated to reflect this.

Question 14: "These page format restrictions shall apply to both hard and electronic proposals" and another part says "Both sides of a sheet display printed material shall be considered one (1) page. Page size shall be 8.5 x 11 inches, not including foldouts (See Table, Charts, Graphs, and Figures below). Pages shall be double-sided and single spaced." However, the only guidelines for submission refer to electronic submission. Are proposals due in both hard copy and electronic form or only in electronic form? If a hard copy is to be submitted, where should it be mailed?

RESPONSE: Proposal submission must be ONLY electronic. The SF 33, Section “L”, paragraph 2.4 has been corrected to read, “A single side of a sheet display printed material shall be considered one (1) page.”

Question 15: Due to the complexity of the technical response, would the Government allow a separate page limit for the following deliverables/requirements:

Volume II, Section II - Technical Volume/Technical Approach Volume II, Section III - Technical Volume/Experience Volume II, Section IV -Technical Volume/Quality Management Approach Deliverable 5-Quality Control Plan

Volume II, Section V- Technical Volume/Past Performance Deliverable 12 – Transition In Plan RESPONSE: No. Volume II (minus Cover page) shall be a total combined limit of 75 single-sided pages. SF 33, Section “L” paragraph 2.4 has been updated to reflect this.

Question 16: As this is an IDIQ, where defined level of effort (LOEs) will be forthcoming through release of Task Order RFPs, will the Government please confirm that the Key Personnel resume and letter of commitment (LOC) requirement for this IDIQ proposal, per RFP Section L, Paragraph 4.2 requires Offers to present only one (1) candidate per Key Personnel Labor Category (LCAT)? If this is not the intent, can the Government please clarify the specific number of Key Personnel resumes and LOCs required for each Key Personnel Labor Category

(LCAT)?

RESPONSE: The Government requires a resume and signed letter of commitment for only 1 candidate per Key Personnel.

NOTE: Registered Nurse is no longer considered “Key Personnel.” Attachment 1 – PWS, Attachment 5 – labor categories (rev), Attachment 13 –WRAIR Organizational Chart (rev) have all been updated to reflect this.

Key Personnel Biostatistician Staff Supervisor Clinical Research Coordinator II Clinical Research Coordinator III (Regulatory) Clinical Study and Volunteer Assistance Medical Officer Program Manager/Clinical Portfolio Manager Quality Assurance Officer

Question 17:

a. Section “L” paragraph 5.1 discusses the use of “Additional labor categories” not already defined in RFP Attachment 5. The instructions indicate that offerors wanting to add additional categories should add them by creating “Position Number 50 and adding as many rows as necessary ….” Is the reference to Position Number 50 a typo? (The labor categories listed in Attachment 5 – Labor Categories and on the Attachment 6 – Pricing Sheet, are not numbered, but there are significantly fewer than 50 categories currently.)

RESPONSE: SF 33/Solicitation, Section “L” paragraph 5.1, has been corrected/revised to read…”Additional Labor Categories - If the Offeror intends to propose additional labor categories which are not included in Attachment 5 - Labor Categories, it shall do so by adding the position and a description of skills/tasks/experiences expected in that specific position to Attachment 5 - Labor Categories. Additionally, the Offeror shall include corresponding rates for the base period and all option periods to Attachment 6 – Pricing Sheet, by creating Position Number 33 and adding as many rows as necessary with subsequent positions until all additional labor categories have been proposed for the base and all option periods. Any rows added to Attachment 5, Labor Categories and Attachment 6 – Pricing Sheet, for the purposes of proposing additional labor categories, must be in Font type: Times New Roman, size 12.”

b. Section “L” paragraph 5.1 there are similar instructions related to adding subcontractor labor categories by creating a “Position Number 60 .…” Is this a Typo? If it’s not a typo and the prime contractor adds more than 10 labor categories starting at 50 (from the question a. above), then starting at Position Number 60 for subcontractor categories is confusing. Will the Government please provide clarify the instructions?

RESPONSE: SF 33/Solicitation, Section “L” paragraph 5.1, has been corrected/revised to read…”Subcontractors - If the Offeror intends to propose subcontractor labor categories, it shall do so by adding the position and description of skills/tasks/experiences expected in that specific position to Attachment 5 - Labor Categories. Additionally, the Offeror shall include corresponding rates for the base period and all option periods to Attachment 6 – Pricing Sheet, by creating Position “34” and adding as many rows as necessary with subsequent position numbers until all additional subcontractor labor categories have been proposed for the base and all options periods. Any rows added to Attachment 5 -Labor Categories and Attachment 6 – Pricing Sheet for the purposes of proposing additional labor categories must be Font type: Times New Roman, size 12.

c. If subcontractor labor rates are required, please clarify how they should be listed, for example, for the fully loaded rates does the Government want the fully loaded rate of the Subcontractor or the Prime Contractor’s fully loaded rate that contains the subcontractor’s rate plus any mark-up by the prime contractor? If the Government wants the Subcontractor’s rate, how should prime contractor’s account for their mark-up?

RESPONSE: How the subcontractor cost is reflected on Attachment 6 – Pricing Sheet, will depend on the agreement/contract negotiated between the prime and subcontractor. The Government prefers Time & Material (T&M). The prime has the responsibility to evidence to the Government how their subcontractor rates are fair and reasonable. Per SF 33, Section “L” paragraph 5.1… “The Offeror shall not propose labor rates that are derived from blending two or more separate Contractors or Subcontractors.” SF 33, Section “L” paragraph 5.1 has been updated to reflect the preference of T&M type contracts between the prime & subcontractor.

Attachment 6 – Pricing Sheet has been updated to reflect a T&M column.

Question 18: Are the cost breakdown requirements listed in Section “L” paragraph 5.2 applicable to both the IDIQ and individual task orders?

RESPONSE: Yes, cost breakdown are applicable to both base IDIQ and task order.

Question 19: Section “L” “Instructions to Offerors,” Table 1, states that Past Performance Questionnaires do not count against the page count, but also says they must be sent directly from the Offeror’s client. Are Past Performance Questionnaires supposed to be included in the proposal or are they supposed to be sent directly to the government from the offeror's client?

RESPONSE: Past Performance Questionnaires must be submitted to the Government from the Offeror’s client/customer only. Past Performance Questionnaires MUST not be submitted by the Offeror. Past Performance Questionnaires must be received by Thursday, 23 May 2019, or they will NOT be considered. Attachment 7 – Past Performance Questionnaire (rev) has been corrected to reflect this due date.

Question 20: Section “L” “Instructions to Offerors,” paragraph 4.4, states that Past Performance Questionnaires are due “by proposal due date”, which is May 23rd; however, RFP Attachment 7 - Past Performance Questionnaires states on the first page that the they are due “15 April 2019” and on the 3rd page states that they are due by “Wednesday, 15 May 2019”. Please confirm that Past Performance Questionnaires are due to the Government by May 23rd (proposal due date).

RESPONSE: Past Performance Questionnaires are due Thursday, 23 May 2019 (proposal due date). Attachment 7 - Past Performance Questionnaire has been corrected to reflect this date.

SF 33 / Solicitation (Section “M” Evaluation factors for award) Question 21: The RFP only requests pricing by labor category, as opposed to Level of Effort at the IDIQ level. Will the Government please clarify how it plans to evaluate Level of Effort for price?

RESPONSE: Level of effort will be determined at the task order level. The SF 33 “Section “M” Factor 5 have been revised to remove level of effort. SF 33, Section “L” paragraph 4.3 “Quality Management Approach” and paragraph 5.2 entitled, “Subject Matter Expert (SMEs)/Consultants” as well as have been updated Section “M” Factor 1 – Technical Approach and Factor 3 – Quality Management Approach.

Question 22:

a. On page 116 under the paragraph labeled “Subject Matter Experts (SMEs)/ Consultants”, please clarify whether the Government will allow SMEs/Consultants to be added at the task order level instead?

RESPONSE: SMEs/Consultants will be determined at the task order level. SF 33, Section “L” paragraph 4.3 “Quality Management Approach” and paragraph 5.2 entitled, “Subject Matter Expert (SMEs)/Consultants” as well as have been updated Section “M” Factor 1 – Technical Approach and Factor 3 – Quality Management Approach.

b. Given that individual clinical trials have not been identified and there is no way to know specifically what SMEs/consultants might be needed in the future, we want to confirm that the Government does not intend that offerors submit an exhaustive list of SMEs/Consultants at this time?

RESPONSE: SMEs/Consultants will be determined at the task order level. SF 33, Section “L” paragraph 4.3 “Quality Management Approach” and paragraph 5.2 entitled, “Subject Matter Expert (SMEs)/Consultants” as well as have been updated Section “M” Factor 1 – Technical Approach and Factor 3 – Quality Management Approach.

c. If the Government does require SMEs/Consultants to be listed at this point, please clarify where they should be added on Attachment 6 and what pricing information is needed? (e.g., most consultants do not have indirect rates, they simply charge a fixed hourly rate or fee per service, so it seems like SMEs/Consultants would more appropriately be handled as specifically approved ODCs if the need arises during performance of a clinical trial).

RESPONSE: Government does NOT require SMEs/Consultants to be listed at the time of proposal submission, nor are hourly rates. The need and type specific type of SME/Consultant will be determined at the Task Order level. SME/Consultant shall be billed under “other direct costs.”

Attachment 1 – Performance Work Statement (PWS) Question 23: Is there any statistical work in this RFP?

RESPONSE: Yes. See PWS, Task 10.

Question 24: Would you kindly provide even a very rough description of the statistical work needed?

RESPONSE: The contractor shall provide statistical support for the design, implementation, analysis, and reporting of research protocols that will include, at a minimum: 1) assisting in developing and reviewing study related documents (e.g. protocols, statistical analysis plans, tables, listings and figures (TLFs) shells, manuscripts, study reports, data specifications) for protocols involving clinical trials of investigational products, 2) generating and validating TLFs to support interim and final study analyses, 3) generating and validating analysis datasets to include Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) compliant datasets, and 4) assisting in the preparation and review of standard operating procedures and validation documentation.

Question 25: PWS, Task 2. Will the Government please clarify if this area includes development of all study documentation including informed consent forms, IRB materials, etc.?

RESPONSE: Yes, Task 2 includes development of all study documentation (e.g., informed consent forms, institutional review board (IRB) materials, etc.).

Question 26: PWS, Task 3. Will the Government please provide additional information on the required Medical Liability Insurance – including the required minimum coverage?

RESPONSE: The Government response to this question will be provided under another solicitation amendment (i.e. amendment 0002) prior to the proposal due date.

Question 27: PWS, Task 8. Are the College of American Pathologists (CAP)/Clinical Laboratory Improvement Amendments (CLIA) certified laboratory support/testing labs in-house? Or do you want to send the samples out to a CAP/CLIA certified lab?

RESPONSE: Samples are sent to a CAP/CLIA-certified lab, no in-house testing.

Question 28: PWS, Task 11. Will the Government please clarify if there is a current Trial Master File (TMF) in place under the existing Clinical Trials Center (CTC) support services contract? Is it paper or electronic based?

RESPONSE: Yes, the WRAIR’s CTC has an electronic (i.e. e-TMF) Government-owned in place.

Question 29: PWS, Task 16. Will the Government please provide estimates for the number of protocols/clinical trial design that require this service per contract year? Will the service be required at all Military Treatment Facilities (MTF) listed in the PWS?

RESPONSE: The Government is unable to provide estimates at this time, as the use of these mobile therapeutic apheresis services is determined at the time of protocol/clinical trial design.

At present, 2 clinical trials have required these services. There are NO Memorandum of Understanding (MOUs) in place and therefore services have not been used at any of the MTF facilities.

Question 30: PWS, Task 16. Do these mobile therapeutic apheresis services need to be performed CONUS and OCONUS?

RESPONSE: These services will be needed for CONUS locations. It is estimated these services will be also be needed at the MTF located in Hawaii/OCONUS (Tripler Army Medical Center (TAMC) only. With this being said, the need of these services will determined at the time when the protocol/clinical trial is being developed by Sponsor and will be identified at the task order level.

Question 31: PWS, Task 16. “Mobile Apheresis services shall include Plasmapheresis, Cytapheresis, Photopheresis, low density lipoproteins (LDL) Apheresis, and Hematopoietic Progenitor Cell (HPC) harvest.” Does the Government anticipate having all of these services in a single mobile unit or will the need for a specific services be based on the individual task order?

RESPONSE: Individual task order(s) will identify the need for specific services, which could include some or all in a single mobile unit.

Question 32: PWS, Task 16. Will the Apheresis Services be limited to CONUS work or will they also be used for OCONUS work?

RESPONSE: These services will be needed for CONUS locations. It is estimated these services will be also be needed at the MTF located in Hawaii/OCONUS (Tripler Army Medical Center (TAMC) only. With this being said, the need of these services will determined at the time when the protocol/clinical trial is being developed by Sponsor and will be identified at the task order level.

Question 33: PWS, Task 16. Will Mobile Apheresis Units be expected to store cells and plasma?

If so, is there an expected storage duration?

RESPONSE: Storage requirements will determined during the protocol/clinical trial development phase and will be identified at the task order level.

Question 34: PWS, Task 16. Other than standard precautions, should the Mobile Apheresis Units be equipped to handle contagious pathogens in outbreak regions?

RESPONSE: No.

Question 35: PWS, Task 19. "Data from any previously existing system shall be extracted/obtained and merged with any new/replacement systems in a timely, complete, and confidential manner." Will the Government please provide information on the amount of data to be extracted/obtained and merged from the existing system? What is the expected format of this data?

RESPONSE: Merge Clinical Trial Management System ((CTMS) is a Government-owned system where there is NO extracting or merging with any new/replacement data. Attachment 1 – PWS (rev), Task 19 has been updated with revised language.

Question 36: PWS, Task 19. Does WRAIR currently use an in-house system? If so, what is it?

RESPONSE: Yes, MERGE clinical trial management system. Attachment 1 – PWS(rev), Task 19 has been updated with revised language.

Question 37: PWS, Task 19. Is the expectation to bring in data management software / propose data management software, or will it already be provided by the government?

RESPONSE: Data management software will already be provided by the Government, which is called MERGE clinical trial management system. Attachment 1 – PWS (rev), Task 19 has been updated with revised language.

Question 38: PWS, Task 19. Can the Government provide the name of the current healthcare information system the CTC uses? Is the government expecting the awardee to procure a new COTS CTMS or use the existing one?

RESPONSE: The Clinical Trials Center (CTC) currently uses the Merge clinical trial management system (CTMS). The Offeror will NOT be procuring Merge CTMS, rather only using this system for execution of clinical trial task completion and management. Attachment 1

– PWS (rev), Task 19 has been updated with revised language.

Question 39: PWS, Task 19. Is the expectation the awardee will need to provide IT support to transition files from an existing CTMS to a new one that will be purchased/developed?

RESPONSE: No contractor-provided IT support is needed. Attachment 1 – PWS (rev), Task 19 has been updated with revised language.

Question 40: PWS, Task 19. Does the Clinical Trial Center (CTC) use a Clinical Trial Management System (CTMS)? If so, is there a fully licensed system or software, such as “Software as a Service (SAAS)” model? If a fully licensed system, does the WRAIR maintain the hardware/software requirements separate from this solicitation?

RESPONSE: Yes, the WRAIR uses a fully-licensed clinical trial management system (Merge) and WRAIR currently maintains the hardware/software requirements. Contractor is NOT responsible for hardware/software requirements associated with Merge. Attachment 1- PWS(rev), Task 19 has been updated with revised language.

Question 41: PWS, Section 11.0. Are key personnel only being staffed to Walter Reed or will they also be staffed to other sites? If they are to be staffed to other sites, which sites will they be?

RESPONSE: Key Personnel will need to be staffed to WRAIR CTC and possibly other MTF locations in the future. Currently there are no Memorandum of Understanding (MOUs) in place for clinical trials to be performed anywhere outside of WRAIR. That is, the Government will need to execute an MOU between WRAIR and the MTF before any clinical trials can be performed at these location.

Question 42: The RFP does not state qualifications for the key personnel in the solicitation. Can

WRAIR provide more specific position descriptions for the key personnel?

RESPONSE: Key personnel labor category descriptions are located under Attachment 5 – Labor Categories (rev).

Question 43:

a. PWS, Section 19.4. Contractor Personnel Performance/Replacement – The language related to NON-Key personnel says no substitution or replacement shall be allowed for a period of 6 months after contract award. As proposing specific/named NON-Key Personnel does not appear to be a part of the requirements of this solicitation, we respectfully request that the Government remove this language as it is not consistent with the spirit of a non-personal services contract.

RESPONSE: This language has been removed from Section 19.4 of the Performance Work Statement (PWS).

b. The PWS, Section 11.2 states that “The Contractor shall ensure the labor categories, as defined in the Labor Categories and Descriptions labor rates, and labor-hours utilized in the performance of each task order issued hereunder shall be the minimum necessary to accomplish the task.” This alludes to definition of Key Personnel qualifications and Labor Category Descriptions at the task order level.

The language in the Key Personnel, Section 19.4 requires that if a Key person leaves they must be replaced by someone of “equal or greater qualifications.” Will the Government please revise the language of PWS, Section 19.4 to indicate that the Government means Key Personnel must be replaced by a fully qualified person that is able to meet the requirements outlined in the Task Order RFPs?

As a non-personal services contract, offerors are required to provide Key Personnel to perform to the defined standards of the RFP. The language, as written, creates an upward spiral of unstated requirements (qualifications). For example, a Principal Investigator with 30 years’ experience retires, the Contractor is then required to find a PI with 30 or more years of experience to perform in the role when a candidate with 10-20 years of experience is similarly or even more qualified as a replacement. The critical factor should be whether the replacement candidate is fully qualified to perform the job.

RESPONSE: This language has been removed from Section 19.4 of the PWS and replaced with… “Any substitutions or replacement of Key Personnel shall be a fully qualified individual (reference Attachment 5 - Labor Categories) who is able to meet the requirements and successfully complete tasks.

Question 44: Are the transition in and out periods to be priced separately?

RESPONSE: There will NOT be separate contract line items (CLINs) associated with “Transition In” or “Transition Out.” These services shall be priced at the task order level. See response below for additional information.

Question 45: What is the number of existing/ongoing trials that would be part of the transition period?

RESPONSE: There is a potential for administrative tasks associated with 5-6 clinical trials. The

PWS(rev), Section 1.10 has been updated to reflect this.

Question 46: Will the Government clarify which positions are full-time OCONUS positions?

RESPONSE: The only OCONUS MTF is located in Hawaii (Tripler Army Medical Center).

There is a potential to have fulltime position(s) at this location. The specific labor categories are unknown at this time.

Question 47: Can the Government clarify whether it expects that contractor personnel will primarily work on-site at the Government location? If not, can the Government provide a rough estimate of what percent of personnel performing the RFP-listed labor categories the Government expects will work from the Contractor’s site (i.e., Off-site)?

RESPONSE: The primary work site location will be at the WRAIR. There may be administrative tasks/duties that can be completed off-site. Per the PWS, the Government anticipates there will be future clinical trial locations outside of WRAIR, occurring at various Military Treatment Facilities (MTFs), although not currently planned. There may be a need for additional administrative tasks associated with this added MTFs, but more than likely these admin tasks can be executed at the contractor facility.

Question 48: Regarding Attachment 1 – PWS, Section 12.2 Travel Claim Procedures, the PWS indicates that “Contractor travel costs associated with travel (i.e., as receipts, proof of expenses, and/or invoices) are due to the COR ten (10) calendar days after the completion of the trip.” The PWS then goes on to state that “All travel costs shall be billed within thirty (30) calendar days after completion of travel, unless approved by the COR for later billing.” These appear inconsistent.

Will the Government provide clarification and confirmation that it means to require the contractor to provide all travel costs, including invoices, to the COR within 10 days of the travel when the PWS allows contractors 30 days to bill for the travel? We believe the best practice is to allow the Contractor to review and audit the travel claims of its employees and submit the appropriate documentation at the time of regular monthly invoicing, rather than having the information submitted twice.

Will the Government please consider removing the requirement to provide travel cost information to the COR prior to the normal invoicing process?

RESPONSE: The PWS, Section 12.2 is correct as stated. The purpose of submission of travel receipts ten (10) calendar days after completion of the trip, is for the preparation and submission of the Travel Claims/Trip Reports (Deliverable 14).

Question 49: Desktop computers, phones, shredders, copy machines, Government web servers, desks, etc. that are standard Government property used at the Government facility are not typically listed as GFP. Regarding Attachment 1 – PWS, Section 13.0 Government/Contractor Furnished Property, please confirm that the property described in Section 13.1.1 regarding routine office equipment that contractor personnel use when working at the Government site is not considered GFP?

RESPONSE: Actual “assigned” GFP is located in Attachment 3 – Government-Furnished Property. Only items listed in Attachment 3 are considered GFP, which the contractor will have to sign for and track. Fax machines, printers, telephones, etc. will be available at Government facility for contractor use, these items are NOT considered GFP.

Question 50: Regarding Attachment 1 – PWS, Section 16.7 Dissemination of Information/Publishing, please confirm whether the Government intends this section to also control the publication of scientific papers or articles, including those being made in collaboration with Army scientific personnel?

Does the Government intend that the Contracting Officer (KO) and/or Contracting Officer Representative (COR) will review and approve all scientific papers prior to publication? We note that under PWS section 16.21 it says that manuscripts intended for publication in any media shall be submitted to the KO and COR simultaneously with submission for publication, so this seems to contradict the requirement for advance approval in 16.7.

RESPONSE: Yes, the intent is to have the KO and COR review scientific papers prior to publication. PWS, Section 16.21 has been corrected to the following: “Manuscripts intended for publication in any media shall be submitted to the USAMRAA Contracting Officer and COR prior to submission for publication.”

Question 51: Regarding Attachment - 1 PWS, Section 19.1 Seminars and Training, there is a subsequent section 19.1 related to Option (Surge), will the Government please confirm that the Seminars and Training PWS section numbering is supposed to be 18.1?

RESPONSE: Correct. PWS, Section 19.1 “Seminars and Training” and has been corrected to “18.1 Seminars and Training.”

Question 52: Does the Government have a preferred asset management program?

RESPONSE: If “assessment management program” is referring to a system or software that manages and track Government-Furnished Property, the Government’s response is “no.” The Contractor shall have internal process/procedures for managing and tracking of all GFP. A list of “assigned GFP” will be incorporated into the contract at the task order level.

Attachment 3 – GFP Question 53: Will the Government please provide a list of the current GFE systems currently being used on this contract?

RESPONSE: See response above.

Attachment 5 – Labor Categories Question 54: Is the role of Registered Nurse considered key? In Attachment 5, the role does not have an asterisk, which is the symbol to note which roles are key, but the last column of the table does say the role is key.

RESPONSE: No. “Registered Nurse” is NOT a Key Personnel position. Attachment 1 – PWS (rev), Attachment 5 – Labor Categories (rev) , and Attachment 13 – WRAIR organizational chart (rev) have all been corrected.

Question 55: If the Quality Assurance Officer comprises both the Quality Assurance Officer and

Quality Assurance Coordinator roles, is there a difference in expertise and/or years of experience between the two roles? Attachment 5 – Labor Categories puts the two key personnel in the same labor category but Attachment 13 – WRAIR Organizational Chart shows one of the roles as a subordinate that reports to the other, who would then be in a supervisor role/level.

RESPONSE: Quality Assurance Officer is a separate and distinct position from Quality Assurance Coordinator. Attachment 5 – Labor Categories (rev) have been corrected to include the “Quality Assurance Coordinator.”

Question 56: The description for the Quality Assurance Officer states a need for two individuals.

However, on Attachment 13 – WRAIR Organizational Chart, distinguishes those roles as the Quality Assurance Officer and Quality Assurance Coordinator. Is the requirement for two (2) QA Officers or is it for one (1) QA Officer and one (1) QA Coordinator?

RESPONSE: 1 QA Officer and 1 QA Coordinator. Attachment 5 – Labor Categories (rev) has been corrected to include the “Quality Assurance Coordinator.”

Question 57: The roles of Clinical Research Coordinator III (Regulatory) and Registered Nurse requires that the individuals have Case Manager Certification (CCNC) certification. Can the individuals be “eligible” for CCNC instead and be required to obtain the CCNC certification with three months of contract award, or do they need to have it upon submission?

RESPONSE: Individuals who fulfill Clinical Research Coordinator III (Regulatory) and Registered Nurse positions must have proof of certification prior to beginning any work.

Attachment 6 – Pricing Sheet Question 58: Will the Government allow a single labor rate for both on-site and off-site work?

RESPONSE: Yes

Question 59: If the offeror does not maintain separate cost pools for calculating on-site and off-site rates as part of its accounting system, please confirm the Government will accept the same rate for both locations so the offeror can maintain consistency with its accounting system?

RESPONSE: The Government will allow a single labor rate for both on-site and off-site work.

Question 60: For the indirect rates on the “Indirect and ODC’s” tab of Attachment 6 – Pricing Sheet, does the Government require percentages or dollar amounts?

RESPONSE: Both are requested/required. Attachment 6 - Pricing Sheet (rev), have been revised to reflect this.

Question: Is Medical Malpractice a separate line on the cost proposal?

RESPONSE: Yes. Attachment 6 - Pricing Sheet (rev), have been revised to reflect this. NOTE:

Medical Malpractice insurance will be billed under ODCs of the Administrative/Business Infrastructure task order.

Question 61: Will the Government please confirm that it is acceptable for a prime contractor to submit a single set of fully loaded rates and cost-type ceiling rates (as required on RFP Attachment 6 – Pricing Sheer), and that the prime contractor can manage its subcontractor costs under these fully loaded rates/capped cost-type rates? i.e. Please confirm that the prime contractor is not required to submit separate rates for its subcontractors and that a separate detailed Subcontractor Cost Proposal is not required for the IDIQ proposal if prime proposes that subcontractor will work under prime contractor price ceilings.

RESPONSE: How the subcontractor cost is reflected on Attachment 6 – Pricing Sheet, will depend on the agreement/contract negotiated between the prime and subcontractor. The Government prefers Time & Material (T&M). The prime has the responsibility to evidence to the Government how their subcontractor rates are fair and reasonable. Per SF 33, Section “L” paragraph 5.1… “The Offeror shall not propose labor rates that are derived from blending two or more separate Contractors or Subcontractors.” SF 33, Section “L” paragraph 5.1 has been updated to reflect the preference of T&M type contracts between the prime & subcontractor.

Attachment 6 – Pricing Sheet has been updated to reflect a T&M column.

Attachment 7 – Past Performance Questionnaire Question 62: We have found in the past that KOs have been reluctant to complete a questionnaire if a CPARS is on file. Would the Government waive the need for submission of a Past Performance Questionnaire for contracts where a CPARS evaluation is available?

RESPONSE: Per the Solicitation, the Government may use various methods for assessing past performance, CPARS is one them. Though Past Performance Questionnaires are requested, the Offeror has no control of whether or not their client/customers fills out and responds/submits the questionnaire to the Government. The Government is aware of this. If no Past Performance Questionnaires are received from the Offeror’s client, this will NOT count for or against the Contractor.

Question 63: Will the Government allow Cooperative Agreements and/or Grants to be submitted as Past Performance references?

RESPONSE: Yes, this is acceptable.

Attachment 13 – WRAIR’s Organizational Chart Question 64: Attachment 13 – WRAIR Organization Chart, indicates two (2) labor categories (LCATs) that are not covered within Attachment 5 – Labor Categories, and therefore there are no listed for either (i.e. CRC/Volunteer Recruiter and Quality Assurance Coordinator). Will the Government please amend Attachment 5 – Labor Categories, to include example task descriptions for the following 2 LCATs?

CRC/Volunteer Recruiter

Quality Assurance Coordinator

RESPONSE: Attachment 5 – Labor Categories has been updated to reflect “Quality Assurance Coordinator” task description and only 1 Quality Assurance Officer. Additionally, Attachment 13 – WRAIR’s Organizational Chart has been updated to reflect “Volunteer Recruiter.”