A15 - Question Responses.pdf

Number Document/ Attachment Page Number/ Location Question Response

1 S4 RFP 75N98020R00010 N/A

Is a small business allowed to submit a response and perform as a prime contractor for Task Area 5 and also team with another large business Offeror to perform as a subcontractor for the other Task Areas?

Yes, a small business may submit a response and perform as a prime contractor for Task Area 5 and also perform as a subcontractor for the other Task Areas

A12 - SB Setaside Labor Rate Chart - Task Area 5

Labor Rate Chart Can the Government indicate which Labor Categories it would like see designated as Key Personnel for the performance of Task Area 5?

The Government expects an offeror to identify which proposed personnel (and assigned labor categories) will serve as "Key Personnel" [See RFP, Item No. 1 on page 69]

A5 -S4 Set-aside - Labor Hours Table (03-16-2020)

Page 73 of the RFP titled "S4 RFP 75N98020R00010" states "The Offeror shall also include the estimated dollar amounts of the “Other Direct Costs” as specified in the attached Statement of Work Attachment – Labor Hours Table." However, there are no ODCs indicated for the Small Business set-aside in "A5 -S4 Set-aside - Labor Hours Table (03-16-2020)".

Does the Government intend for Task 5 to have ODCs?

See the revised table.

A12 - SB Setaside Labor Rate Chart - Task Area 5

Labor Rate Chart

Understanding that the Government is requesting the fully loaded rates for each of the requested Labor Categories, is there a template the Government would like the Offeror to use that multiplies the identified Labor Hours to arrive at a total cost or would the Government like the Offeror to develop such a table and include it in the Business proposal?

The Government has provided a template for the fully loaded labor rates. Formating for other price tables is at the offerors discretion.

5 S4 RFP 75N98020R00010 69

The Government indicates it is requesting at least 2 past performances in the following statement "The Offeror shall identify at least two similar contracts/orders with the Federal Government and/or commercial customers within the past three years. The proposal shall include the following information on each." If the Offeror has additional relevant and exemplary past performance beyond 2 instances, can the Offeror submit the past performance for consideration as long as it is falls within the requisite Technical Volume page limits?

Yes, subject to the page limitations, offerors should identify at least two, but no more than five.

6 S4 RFP 75N98020R00010 71

The Government indicates that Letters of Commitment are required for "each person proposed as “Key Personnel” if the proposed individual(s) is not currently employed by the Offeror." This section also indicates that "For each person proposed, the Offeror shall provide a point of contact (name and telephone number) to support past experience." Is this request for a point of contact to validate past experience for Key Personnel only for proposed Key Personnel who are not currently employed by the Offeror? If the request for a point of contact to validate past experience extends to all proposed Key Personnel (currently employed by the Offeror or not) will the Government accept a point of contact from the Offeror's company, such as the Offeror's Human Resources representative or C-Level executive to validate the Key Personnel's past experience or is the Government looking for something else?

The requirement to provide a point of contact applies to each person proposed who is not currently employed by the offeror. This applies to individuals proposed as "Key Personnel", as well as individuals who are proposed in non-Key positions.

7 A2 - S4 SoW 2020-02-13 10

Task 5 scope states: "Provide business process management, reengineering and data modeling." Could the Government provide more detail on the type of data modeling and level of effort that is required by

IRP?

Data modeling that involves novel quantitative and computational methods that solve challenging problems across the entire spectrum of biology and medicine, from genomic research to new applications of basic biology. Level of effort required via contract is not yet speficied;

depending upon investigator need, staffing and funding.

8 A2 - S4 SoW 2020-02-13 11

Task 5 scope states: "Prepare and document all functional, technical, and security requirements in enough detail to develop and test recommendations for change." Is this referring to business requirements for IT development? Could the Government please provide additional definition and detail.

Requirements such as capabilities, performance measurements and processes needed to address program and business areas; developed and validated to meet desired goals and outcomes to achieve success.

MIght also include business requirements for IT development

9 A2 - S4 SoW 2020-02-13 15

Under 7.0 Deliverables/Delivery Schedule on page 15 of the SOW it states: "Electronic documents delivered must be made available in alternate formats when requested by the designated COR, including formats compatible with assistive technology at no additional charge."

Can the Government provide a list of alternate formats or examples of such formats that are included in this requirement? Does this differ for Task 5?

A list of possible alternate electronic formats is not known at this time.

This requirement does not differ for Task 5.

10 SOW Page 15/Section 7.0

Within this section, there is a reference to Information and Communication Technology (ICT). Is there a specific method that ICT is expected to be acquired, implemented and used under the contract? It is unclear what this requirement is.

Acquisition and implementation of any ICT will be coordinated with the Contracting Officer's Representative and in accordance with the Revised Section 508 Standards specified in Article H.6 of the RFP and the Accessibility Requirments Tool (ART).

11 SOW

Page 10/Section 5.4 Task Area 4

SOW Section 5.4 states that the contractor shall “Provide systems(s) support for the collection, storage, import, investigation, management, tracking, updating, and exchange of a variety of data types, sources, and formats from all research activities conducted within the NIH IRP.” Please provide some information on the general types of systems supported, IT environments, languages, storage systems, and cloud or local nature of the systems and networks that the contractor is expected to support and if the system is expected to be government or contractor-provided.

The types of systems, IT environments, languages, storage systems are those that are typically used in biomedical and clinical research enterprises. A variety of networks, local and cloud, are included.

Systems might be government and/or contractor provided.

12 RFP Page 5/Section B.3

Is the amount of $105,000,000 (maximum) for delivery of the services specified in the Statement of Work the yearly value of the contract or inclusive of all option years of the contract? The annual contract value is important for us to develop our subcontracting plan.

The amount of $105,000,000 is inclusive of the entire 4-year period of performance for the "Unrestricted" work (i.e., Tasks 1, 2, 3, 4, 6, 7, and 8).

13 General General Is there any incumbent workforce that will transition from an existing NIH contract to this one?

The Government has not instructed any incumbent workforce to be transitioned from an existing NIH contract.

14 RFP Page 73 /Section L.2.d

Section L, Business Proposal Instructions state: Proposed hourly rates shall be "fully loaded" rates inclusive of all related costs, including direct labor, fringe benefits, training, overhead, profit, vacation and holiday pay, future pay/benefit increases, overtime and shift differential, materials, and subcontracts.

a) Does the NIH anticipate utilizing overtime under the terms of the contract?

b)Several of the labor categories identified in the RFP may qualify for overtime. It would be an unnecessary cost to the government to include overtime in those bill rates without necessity. Is it possible that overtime be addressed at the task order level to avoid this inflation of certain bill rates?

The Government expects the contractor to make the determination whenever overtime may be required from time to time during the period of performance to successfully accomplish the work requirements. The offeror shall take into account any anticipated overtime requirements when it prepares its fully loaded hourly rates.

The submission of two loaded hourly rates per labor category - one for normal working hours and one for overtime - will not be accepted.

Again, the Goverment expects the offeror to take into account any overtime expectations when preparing its loaded hourly rates.

15 RFP Page 73 /Section L.2.d Does the government anticipate the use of multiple shifts in the performance of the contract? If yes, can it be addressed at the task order level?

Not expected. However, the Government expects the contractor to make any determination about any multiple shifts that may be required to successfully accomplish the work requirements.

16 RFP Pages 39-45 /PartII, Section I A review of Section I did not reveal a reference to Contractor insurance requirements. Were the FAR clauses found in 52.228 and 52.237 intentionally omitted from the RFP?

See the revised proposal.

17 SOW Page 9/Section 5.3 Task Area

SOW Section 5.3 Task Area 3 states that the contractor shall “Provide direct and indirect patient care activities. Contractor must have appropriate medical liability coverage”. Please specify what level of liability coverage and for which practitioners.

The Government expects the offeror to know what appropriate levels of medical liability coverage is required and factors such costs into its loaded hourly rates. Offerors shall identify levels of coverage in its Business Proposal.

18 SOW Page 9/Section 5.3, Task Are

SOW Section 5.3 Task Area 3 states that the contractor shall “Provide support, accommodate and quickly onboard subject matter experts (SMEs) with competence in special areas beyond, or in addition to, the existing NIH IRB members, i.e., unaffiliated NIH IRB members; provide liability coverage at $2M per event/occurrence and $2M in aggregate for the unaffiliated IRB members.” Please specify what specific events or occurrences are envisioned for this coverage.

Events and occurrences typical in the clinicial reserach arena pertaining to institutional review board duties and activities. Unaffiliated NIH IRB members are not government employees and therefore require personal liability coverage from negligence.

19 SOW Page 9/Section 5.3, Task Are In reference to Task Area 3 - Clinical Research Studies and Trials Support Services, please confirm that clinical trial design and management will be controlled by the government.

Confirmed.

20 Attachment A3 Labor CategoAttachment A3 Labor Catego

Does the Service Contract Act apply to any of the following labor categories:

• Laboratory Technician

• Sr. Laboratory Technician

• Clinical Trials Nurse (Registered Nurse / RN)

• Graphic Designer

• Scientific Writer (Technical Writer)

No. This acquisition is not subject to the Service Contract Labor Standards.

21 SOW Pages 5-7/Section 5.1, Task A

a. Can the contractor staff supporting the services of Task Area 1 be directly billed against the contract?

b. If yes, will the Contractor be required to use the fully loaded hourly bill rates included with the proposal?

a) It is antcipated that Task Orders issued under Task Area 1 will be Firm- Fixed-Price. B) In the prepartion of any Firm-Fixed-Price proposal for work under Task Area 1, the contractor shall use the applicable loaded hourly rates negotiated at time of contract award.

22 RFP Page 9/Article F.2 Place of Pe

10. Article F.2 Place of Performance states: Contract and Task Order Management, including administrative support of all work performed under this contract, shall be performed at the Contractor’s facility.

a. Must the Contractor have a facility in the vicinity of Bethesda, MD? If so, what radius?

b. Will the government provide space to perform the services associated with Task Area 1?

a) No. There is no geographical restriction on the location of a contractor's facility. B) No.

23 RFP Page 69/Section 2.c.1.a)1

“Sufficiently describe which key personnel will be used on the project.

Documentation shall be provided on the decision-making authority of the Project Manager as related to other elements of the organization.” Please confirm the Project Manager is the only “key personnel” required for proposal submission.

See response to Question No. 2 above.

24 RFP Page 9/Section F.2 Place of P Is it the government's preference that the Contractor's Project Manager be located on-site?

No.

25 RFP Page 69/Section 2.c.1.a)1

“The extent to which outside consultants and specialists will be used shall be documented and evidence of their availability shall be provided.” Is the government requesting documentation and evidence of availability for consultants and/or specialists the Offeror will employ to perform work on the resulting contract?

The offeror may provide documentation and evidence of its own, from a consultant and/or specialist, or both.

26 RFP Page 75/Section L.2.d Busine Is it acceptable for a Contractor to submit its Annual Report to support its financial capability to perform the contract? If yes, will the Annual Report be excluded from the page limit of the Business Proposal?

Financial capability of the apparently successful offeror will be assessed as a responsibility critierion subsequent to source selection and prior to award. An annual report may be submitted and will be excluded from the page limit of the business proposal; otherwise, the Government will request an annual financial report from the apparently successful offeror prior to award.

27 General General Will the government please provide either historical insight on task area spend, and/or anticipated task area spend, for each of the task areas?

Historical insight into the amount spent for each task area is not available as this is a new contract.

28 Attachment A4

"All Other Direct Costs, if applicable, shall be paid at actual cost." Given the government-provided plug numbers for ODCs is ~$14M/year, which is roughly 14% of the annualized value of the contract, please describe the ODCs to be acquired by the Offeror under the resulting contract.

ODCs are expected to consist of direct materials, travel, subcontracts, and other direct costs utilized under the contract that have received prior written approvel from the Contracting Officer's Representative. It is expected that approximately 25% of the ODCs for the "Unrestricted" work will be subcontracts.

29 RFP Page 72/Section 2.d

"All Other Direct Costs, if applicable, shall be paid at actual cost." Given the government-provided plug numers for ODCs is ~$14M/year, which is roughly 14% of the annualized value of the contract, requiring the Offeror to only invoice actual costs of ODCs appears to be a burdensome requirement. Would the government consider allowing Offerors to apply G&A and a defined fee to ODCs?

No. Any anticipated G&A costs associated with ODCs shall be included as part of the offeror's loaded hourly rates.

30 RFP Page 68/Section 2.b.5

“Do you have a Government approved accounting system? If so, please identify the agency that approved the system.” Given task orders under the anticipated IDIQ contract award are to be FFP or T&M, would the government consider removing this requirement or provide an explanation for the need of an approved accounting system?

The RFP does not require an offeror to have a Government-approved accounting system. The instruction requests that an offeror identify the Government-approved accounting system, if it has one. However, please note the requirement for the accounting system certification required as part of the business proposal.

31 SOW Page 4/Section 5.0 Task Area

SOW Section 5.0 Task Areas states that, "the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, transportation, tools, supervision, facilities, and other items; and non-personal services, not otherwise provided by the Government, necessary to perform Task Orders issued under this SOW at the direction of the Contracting Officer’s Representative (COR).” What types of non-government material, equipment, transportation, and tools might be expected to be provided by the contractor?

This refers to ODCs that may be required. See related responses to Questions 28 and 29 above.

32 RFP Page 73/Section L.2.d Busine

Business Proposal Instructions, Financial Management of Subcontracts states: "It is estimated that approximately 25% of the total contract dollar value will be subcontracts (to commercial small and non-small companies, non-profits, and educational institutions)." Please clarify the subcontracting goal required under this contract. Please also provide insight or historical data associated with the number and nature of these subcontracts.

The Government expects an offeror to determine appropriate subcontracting goals. Insight or historical data is not readily available as this is a new contract.

33 Page 70/Section 2.c.1.b)

“Experience and past performance shall include a subcontract portfolio consisting of a wide variety of subcontract types (firm-fixed-price;

indefinite-delivery, indefinite-quantity; time-and-materials; and cost-reimbursement)…” Given the resulting IDIQ contract will contain FFP and/or T&M task orders, would the government consider removing corporate experience and past performance pertaining to “cost-reimbursement” contracts?

No. Experience is focused on awarding and managing cost-reimbursement subcontracts. An offeror need not have experience under a cost-reimbursement type prime contract.

34 RFP Pages 72-75 /Business Propo

Does the government expect offerors to include pricing from each subcontractor in the offerors' Business Proposal response?

a. If so, what elements of the business proposal would be required from each subcontractor?

b. If elements of the business proposal are required, is there a secure method in which the subcontractor can submit directly to the government to safeguard the proprietary nature of the data?

a) No. b) not applicable.

35 SOW Page 20/Section 13, List of SO The Assignment of Contractor Employee Work Products attachment was not located within the RFP documents A1 through A13. Please provide the attachment.

See attachment 14

36 RFP Page 71, Second paragraph, It is stated that "The Government will conduct reference checks to determine past experience of proposed personnel", does the Government intend to limit reference checks to key personnel only?

Not necessarily.

37 RFP Page 25, Article H.9.A.12.

Will the Privacy Impact Analysis be required in the Technical Proposal or will this be required following award?

Following award.

38 SOW Page 15, 7.0 Please confirm that a Supplemental Accessibility Conformance Report (SAR) is not required within the proposal response but only in response to future issued TO's as necessary based on new ICT requirements.

Confirmed.

39 SOW Page 12, 5.7 Is the intent of the third requirement "Providing FDA approved and commercially manufactured drug products" a request for the contractor to procure goods in association with the contract?

Yes.

40 General General Will there be a phase-in timeline identified for the successful contractor?

Yes. The Government expects an offeror to proposed a phase-in time line which will be made part of the Contract Management Plan following award.

41 RFP Page 70/Section 2.c.1.b)

"In addition, a representative sample of resumes of the management, technical, and support staff…." In addition to Key Personnel, the government requests representative resumes for each labor category.

Given the anticipated IDIQ contract award is performance-based and non-key personnel resume requirements are merely representation of the types of staff an Offeror can provide, would the government consider removing the requirement to provide reference contact information for each person proposed? Requiring such information appears to be contradictory to performance-based contracting.

No. Note that reference contact information is only requred for the "Key Personnel" and representative resumes of those individuals who are not currently employed by the offeror.

42 RFP Pages 70-71/Section L.2.c.1.

The resume requirements listed on page 71 state that resumes shall include: "approximate number of total class hours." Please provide additional clarification on this requirement, including whether offerors are required to list class hours for all candidates and all types of education.

The requirement to Include the approximate number of total class hours applies only to the resumes for "Key Personnel" and representative resumes of those individuals who are not currently employed by the offeror.

43 RFP Pages 70-71/Section L.2.c.1.

The resume requirements listed on page 71 state that resumes shall include: "Certification that the information contained in the resume is correct and accurate." Please provide more information on what type of certification is requested. Is there a preferred format or method of certification?

A single, signed and dated statement on the resume certifying that the information is correct and accurate is sufficient. There is no preferred format.

44 RFP Page 62/L.2.a.3 Page and For If offerors include a cross-reference matrix in the technical and business proposals, can these be excluded from the page limit?

No.

45 RFP Page 62/Section 2.a.3 “Tables and graphics may be landscape; all other text must be portrait.”

Would the government consider allowing the use of 9pt font for tables, graphics, and charts?

No. Tables, graphics, and charts shall comply with the formatting instructions in the RFP.

46 RFP Page 63/Section 2.a.3 “The Technical Proposal page limitation excludes the following….” Please confirm Table of Contents, List of Tables, Executive Summary, List of Figures, and List of Acronyms are excluded from page count.

The excluded elements are specifically identified in the solicitation.

47 General General In light of the current circumstances that the country is dealing with, will you consider an extension of the proposal due date to May 1, 2020?

No.

48 General General Will the government publish the names of the companies who intend to submit a proposal for the above referenced IDIQ contract?

Except as required by Federal Regulation, the Government will not publish the names of companies who intend to submit a proposal for the IDIQ contract.

49 General General Has a decision been made to only award a single IDIQ contract for Task Areas 1,2,3,4,6,7,8?

Yes

50 S4 RFP 75N98020R00010 Section L.2.a.2, pg 63

The HHS Subcontracting Plan and SF-LLL are listed under “Technical Proposal” page limitations; however, these are both listed as “Business Proposal Attachments” under Section J. Please confirm that these completed forms should be included as part of the Business Volume and that both should remain excluded from the Business Proposal page limit.

Both forms shall be submitted with the offeror's Business Proposal.

Each is excluded from the page limitation.

51 S4 RFP 75N98020R00010 Section L.2.a.2, pg 63

Throughout the Solicitation the Agency has indicated that Attachment 11 should be completed in Excel and provided as a separate file/attachment to the Business Proposal; however, the cited Section L.2.a.2 makes no reference to whether Attachment 11 is included in the page limit for this Volume. Please confirm that the completed Excel version of Attachment 11: Price Proposal should be excluded from the Business Proposal page limit.

The Excel submission is not included in the page count for the Business Proposal; however, the Government will only consider the information in the format provided. Any additional price information must be included in the business proposal .pdf

52 RFP 54

Per the Notice of Partial Small Business Set-Aside, only small businesses can respond to Task 5. Given this, can the government clarify whether a proposal will be considered compliant if a small business responds ONLY to Task 5 and does not respond to all other tasks?

Yes, the proposal will be considered compliant if a small business responds only to task 5.

53 RFP pg. 36

"The Contractor shall be ineligible to participate in any capacity in contracts, subcontracts, or proposals therefore (solicited and unsolicited) which stem directly from the Contractor's performance of work under this contract for a period of one (1) year after the completion of this contract, except as provided hereinafter." Question: Does this restriction apply to extramural as well as intramural opportunities under NIH?

The restiction applies to both extramural and intramural opportunities which stem directly from the contractor's performance of work under the contract.

54 RFP pg. 12 No Key Personnel are listed. Is it up to the offeror to determine who is key personnel?

Yes. See response above to Question 2.

55 RFP pg. 70

For the representative sample of resumes to be provided are these just considered examples to illustrate we have a qualified, candidate pool or will the resumes put forward be considered the personnel who will be working on this program?

The representative sample of resumes shall be for personnel proposed to work under the contract.

56 RFP/Instructions to Offerors Page 62/Page and Formattin Will there be a separate page/formatting limitations for the Small Business set-aside performance of the work?

No.

57 Attachment 2/SOW Page 13/Task Area 8 – Trans Will the Small Business Offeror need to address Task Area 8 - Transition Plan (Optional) in addition to the Task Area 5 of the SOW in the technical approach?

No.

58 Attachment 5/SOW Labor Categories Are resumes and letters of commitment required for all seven positions specified within Task Area 5?

No. Resumes and letters of commitment are required for each person proposed as "Key Personnel" and for each person proposed in the offeror's representative sample. The representative sample of resumes cannot simply be examples to illustrate an offeror's qualified candidate pool. The representative sample shall be personnel proposed to work under the contract.

59 RFP/Instructions to Offerors Solicitatation

Given the current situation with COVID-19 and the coronavirus, there is an exceptional resource burden for small businesses. Could the Government grant an extension on the due date for the small business set-aside portion?

No.

60 RFP/Instructions to Offerors General Would a small business that is awarded Task Order 5 be precluded from entering a subcontractor agreement with the large business awardee on the other Task areas?

No.

61 RFP/Instructions to Offerors General Could a small business submitting a proposal for Task Order 5, also partner with and submit a proposal as a sub-contractor with a large business?

If you are asking whether a large business may subcontract on the set-aside portion, the set-aside portion is subject to SBA's limitation on subcontracting requirements. If this is a restatement of question 60, see above.

62 RFP Overall Is small business expected to respond to the full soliciation No. A small business may respond to the Restricted portion, the Unrestricted portion, or both.

63 RFP 72

Does the requirement for a VPAT test include small businesses applying for task 5 only

Yes.

64 A5 - S4 Are resumes required for all positions? No. See response to Question 58 above.

65 General Is there an incumbent for this requirement? No.

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