RFP NIH-NICHD-NIDDK-2020-01 Amendment Questions.pdf

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

E. IMPORTANT: Contractor is not is required to sign this document and return copies to the issuing office.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

7. ADMINISTERED BY (If other than Item 6) CODE

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended. is not extended.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15C. DATE SIGNED

15A. NAME AND TITLE OF SIGNER (Type or print)

16C. DATE SIGNED

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

Previous edition unusable

00001

Kyle Wisor

The purpose of this soliciation amendment is to include the questions and answers as an attachment to the solicitation.

Confirmation of this amendment is requested no later than COB 5/27/2020.

National Institutes of Health Eunuice Kennedy Shriver National Institute of Child Health and Human Development

NIH-NICHD-NIDDK-2020-01

1 29

5/21/2020

5/21/2020

Overall # RFP Reference Question Rationale Response

1 1 Could the government please provide a technical architecture diagram of the current data repository system?

The government does not have a technical architecture diagram of the current data repository system to be shared with potential offerors.

Database instances include:

Website: development, beta, mirror, and production BSI: development, training, mirror, production

Non-proprietary software includes – CentOS, Python, uWSGI, Apache, PostgreSQL, Bootstrap, CKEditor, Django, Publication Manager Proprietary/Commercial software includes – SAS, BSI, communications

2 2 Should a separate technical volume be submitted for each task area?

Yes, per the technical evaluation factors, each task area will be evaluated independently.

3 3 The “Multiple PI” structure indicates this work is grant-funded. Why are there references to “Principal Investigators” (page 96) when this is not a grant?

“Investigators (defined as the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded under NIH contracts…” (pg. 47).

The RFP states “Single Principal Investigator/Project Director”.

Government is asking for either a PI or a PD and the Multi-PI is optional.

4 4 Can a description of the Principal Investigator role please be provided by the government?

Please refer to description under Technical Proposal Instructions

(pg. 95-96), ”Principal Investigator/Project Director responsible for overall implementation of the contract and key contact for technical aspects of the project…”

5 5 What are anticipated key and non-key personnel?

Government intentionally did not specify labor categories or which, if any, are key. Key and non-key personnel should be proposed per the description of work to be performed under the task areas.

6 6 Could the government please disclose the historical labor categories, FTE count, and current level of effort for this project?

Historical information will not be provided as it is not directly relatable to the SOWs in the RFP. Refer to Additional Proposal Information and Instructions for anticipated level of effort/FTE assumptions. “To assist Offerors in the preparation of their proposals, the Government estimates the effort required for successful completion of the following Task Area A / Task Order 1

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Data Repository RFP # NIH-NICHD-NIDDK-2020-01 Questions and Answers

(Administrative, Programming, Statistical, Scientific, and IT Support) will be 6.0% Full-Time Equivalent each year.”

7 7 Per the cross-cutting themes section in the RFP (page 164), what type of access or security levels are the government looking for in terms of data sharing? Should it be openly accessible, or user permissions-based?

Government intentionally did not specify type of access to repository held resources, specifically data sharing. The Repository currently adheres to a controlled release model.

Refer to the HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS section for information related to security levels.

8 1 L.2.A.11, p. 80-

81; L.2.A.14, p.

81-82; L.2.C.9,

p. 111-112;

M.1, p. 113;

M.8, p. 116

Do the terms "Organizational Experience Related to the RFP", "Pertinent Contracts" and "Pertinent Grants" refer to the requirements for "Past Performance" as defined at Sections L.2.A.11, L.2.A.14, M.1, and M.8? Please confirm the specific section in the Business Volume where offerors should address Past Performance.

These three subsections mention "past performance" but it is unclear if they are synonymous. None of these terms are mentioned in Sections L.2.A.14 or M.8.

"The same type of organizational experience and past performance data should be submitted" is similarly unclear.

Past Performance is not a separate section in the Business Volume instructions (L.2.C).

The terms Organizational Experience, Pertinent Contracts, Pertinent Grants, and Past Performance are independent and they have their own separate instructions listed in the RFP. There is no specific location where past performance should be included in the business proposal.

9 2 L.2.A.14, p. 82;

L.2.C.9,d, p. 111

If "Pertinent Contracts" is synonymous with "Past Performance", would the Government please clarify the requirements for past performance references?

"Pertinent contracts is defined as a listing of each related contract completed within the last three years or currently in process." This is different from the past performance requirement for "A list of the last 3 contracts completed during the past 5 years and all contracts currently being performed that are similar in nature to the solicitation work scope."

To clarify it is not synonymous they each have their own separate instructions.

10 3 L.2.A.14, p. 82;

L.2.C.9.b, p. 111

If "Organizational Experience Related to the RFP" is synonymous with "Past Performance", would the Government please clarify the relevance of individual experience?

"This [Organizational Experience Related to the RFP] includes overall offeror or corporate experience, but not the experience and/or past performance of individuals who are proposed as personnel involved with the Statement of

To clarify it is not synonymous with past performance.

Work in this RFP." This is different from the past performance statement, "Offerors may also submit past performance information regarding predecessor companies, key personnel who have relevant experience or subcontractors that will perform major or critical aspects of the requirement when such information is relevant to the instant acquisition."

11 4 Atch 1, p. 118

What proposal topics are exempt from the technical volume page limits as "other support"?

This term does not appear elsewhere in the RFP (e.g., Sections L or M).

Although no proposal topics are exempt from the technical volume page limits offerors are encouraged to limit its content to only this necessary information to provide adequate detail for their technical proposal.

12 5 Atch 1, p. 118

Is a Data Information Security Plan required to be submitted with proposals? If so, where is this to be included?

This term does not appear elsewhere in the RFP (e.g., Sections L or M).

Please refer to page 7 of the RPP. The Data Information Security Plan is due within 30 days after contract award and thus is not required to be submitted with proposals.

13 6 Atch 1, p. 118

What information is to be included in the Appendices, which are limited to 10 pages?

The Technical Volume Instructions (L.2.B) and Business Volume Instructions (L.2.C) do not mention appendices or direct any items there. Items could include resumes, letters of commitment, and/or institutional certification for data sharing.

There is no specific information requirement.

14 7 B.1, p. 4; IDIQ SOW 3.B and 3.C, p. 124-125;

Task Area A SOW 3.A, p.

129; Atch 6, p.

Is Task Area C a requirement for proposals addressing only Task Area B / Sample Task Order?

B.1 states, "Task Area C will be made part of all resultant contracts." The IDIQ SOW, Task Area A SOW, and Additional Technical Proposal Instructions for Task Area A (Atch 6, #12) include this requirement, but the Task Area B SOW and corresponding additional instructions for Task Area B do not

Offerors are not required to address Task Area C on their Task Area B Proposal.

include this requirement. IDIQ SOW 3.B states, "Task Area B is an Optional task to be ordered when required" so a formal transition might not be necessary.

15 8 L.2.B.4, p. 98- 99; Atch 1, p.

Is the requirement to address Obtaining and Disseminating Biomedical Research Resources exempt from the page limits for the technical volumes?

This requirement appears between Other Considerations and Section 508 Accessibility, both of which are exempt from technical volume page limits. This requirement also has separate pass/fail evaluation criteria similar to Section 508 Accessibility. Exempting this requirement simplifies compliance with the page limit while keeping the presentation order of technical topics aligned with the RFP. This topic could be considered "other support" as defined at RFP Atch 1.

This topic is exempt from the page limitations requirement for the technical volume.

16 9 L.2.a.4, p. 78;

M.5, p. 114- 115; M.6, p.

115-116

How does the Government intend to evaluate the direct cost and resources information to be included in the technical volumes?

The evaluation criteria at M.5 do not mention "cost" or "resources". The rating definitions at M.6 do not mention "cost" and mention the more-widely-used (e.g., in Other Considerations) term "resources" only in marginal and unacceptable ratings.

Every technical proposal is evaluated on its own merits and in accordance with the technical evaluation criteria stated within the RFP.

17 10 L.2.B.2, p. 98

Do "hazards" refer to physical, biomedical, and/or information security risks?

All other RFP references to "hazards" refer to information security risks.

Hazards related to data are in reference to the confidentiality, integrity, and availability of federal data or to the protection of information systems.

18 11 L.2.B.5, p. 99- 100; M-7, p.

116; SOW

Section 3 p. 123

Is the requirement for offerors to submit a completed HHS Section 508 Product Assessment Template relevant for offerors who are bidding only Task Area B?

IDIQ SOW 3.B states, "Task Area B is an Optional task to be ordered when required". Some fill-in fields in the HHS Section 508 Product Assessment Template anticipate delivery of a proposed system/capability, to include

It is applicable to future task orders issued from IDIQ B. It is not applicable to the Sample Task Order B.

design and architecture documents. The requirement for this completed template does not appear to be applicable to IDIQ proposals for only Task Area B. This requirement for a filled-in template could be implemented for subsequent task order proposals where applicable.

19 12 M.3, p. 113;

IDIQ SOW 3.B,

p. 124

Does the evaluation of options apply to Task Area A, Task Area B, and/or task orders?

The first paragraph/sentence at M.3 mentions task orders. The second paragraph does not mention the IDIQ, either task area, or task orders; so it is unclear where it applies. Also, IDIQ SOW 3.B states, "Task Area B is an Optional task to be ordered when required".

The evaluation of options applies Task Area A. It is possible this will apply to some task orders awarded under Task Area B. Task orders will specify if options are to be evaluated.

20 13 L.2.B.4.b, p. 99;

IDIQ SOW 3.B,

p. 124

What are the institutional certification requirements for an offeror for Task Area B only? What are the minimum requirements for its Institutional Signing Official, and is a Provisional Institutional Certification sufficient for Task Area B?

The NIH website referenced at L.2.B.4.b states, "An Institutional Signing Official is generally a senior official at an institution who is credentialed through the NIH eRA Commons System …" and mentions a Provisional Institutional Certification "to be used in a situation such as for a prospective study ..." IDIQ SOW 3.B states, "Task Area B is an Optional task to be ordered when required".

The definition on the NIH website is correct and is relevant to individuals depositing or requesting research resources.

21 14 L.c.1, p. 74

How many awards does the Government anticipate making in each Task Area?

It is anticipated the government will make multiple award IDIQ contracts to establish two (2) pools one for Task Area A, and one for Task Area B. Task Area A / Task Order 1 will be awarded simultaneously.

with the IDIQ contract for Task Area A. The NICHD reserves the right to make a single award, multiple awards, or no award at all to the SOLICITATION.

22 15 Atch 1, Section II.A.4, p. 118

Would the Government allow fonts for graphics and/or tables of at least 8 points?

The RFP states, "Font size must be 10 to 12 points." This constraint can be cumbersome for graphics and tables, so

Font size must be 10 to 12 points.

RFPs often specify a smaller font for them.

23 16 L.2.B.1.b.3-4, p.

97-98; IDIQ

SOW 3.B, p. 124

Are the requirements for "Other Investigators" and "Additional Personnel" relevant for offerors who are bidding only Task Area B?

IDIQ SOW 3.B states, "Task Area B is an Optional task to be ordered when required". Since award of an IDIQ contract for Task Area B only does not involve initial task order work, these RFP requirements might not be necessary for offerors who are bidding only Task Area B.

Yes.

24 17 Atch 1, p. 117

Since offerors cannot currently see this solicitation in eCPS, when will the Government make this solicitation visible to offerors on eCPS?

Offerors are not currently able to see this solicitation in eCPS.

Solicitation was made available through beta.SAM.gov.

Offerors must register with eCPS system to submit their proposal.

Please see Attachment 1 for eCPS registration information.

25 18 L.2.C.2.2.B, p.

Are offerors required to propose direct labor hours for the IDIQ, for Task Area A Task Order 1, and/or for Task Area B Sample Task Order?

RFP instructions related to Direct Labor do not distinguish between Task Area A or B nor between the IDIQ and task order.

Offerors are required to propose direct labor hours for Task Area A Task Order 1, and/or for Task Area B Sample Task Order.

26 19 Atch 6, p. 141

Please provide size estimates of the current technical environment, such as size of the databases along with descriptions/inventory of the current technical environment (platforms, versions).

Additional details about the current technical environment will improve the accuracy of offerors' estimates of the direct labor hours required.

Please refer to responses for Overall #1, Overall #36, and Overall #63

27 1 RFP NIH-

NICHD-NIDDK-

2020-01;

Attachment 1 - Packaging and Delivery of Proposals

The RFP States, “This page limitation does not include the cover sheet, table of contents, personnel, facilities, equipment and resources, other considerations, schedule, other support, cost information, data Information Security Plan, HHS "Section 508 Product Assessment Template.

Appendices shall not exceed a total of 10 pages.” Please confirm responses to Task Area B / Sample Task Order Evaluation Criterion 1:

Capability and Experience of the Organization and Criterion 2: Personnel and Qualifications are what is being referenced as “personnel, facilities, equipment and resources” in the above, and therefore exempt from the 20 page limit of the Technical Proposal Task Area B/Sample Task Order.

This is to clarify technical volume for Task Area A Task Order 1 and Task Area B Sample Task Order should focus only on the technical solution and the following items are outside the page limitation: Personnel, facilities, equipment and resources, other considerations, schedule, other support, cost information, data Information Security Plan, HHS "Section 508 Product Assessment Template.

28 2

RFP NIH-

NICHD-NIDDK-

2020-01;

Attachment 1

- Packaging and Delivery of Proposals the cover sheet, table of contents, personnel, facilities, equipment and resources, other considerations, schedule, Please refer to response to question #27.

other support, cost information, data Information Security Plan, HHS "Section 508 Product Assessment Template.

Appendices shall not exceed a total of 10 pages.” Given that the Section 508 Product Assessment Template alone is 13 pages, please confirm that personnel, facilities, equipment and resources, other considerations, schedule, other support, cost information, data Information Security Plan, and the HHS "Section 508 Product Assessment Template are not subject to the 10 page limit for appendices.

29 3

NICHD-NIDDK-

2020-01;

Attachment 1 - Packaging and the cover sheet, table of contents, personnel, facilities, equipment and resources, other considerations, schedule, other support, cost information, data Information Security Plan, HHS "Section 508 Product Assessment Template.

Appendices shall not exceed a total of 10 to the 10 page limit for pages.” please

Personnel, facilities, equipment and resources, other considerations, schedule, other support, cost information, data Information Security Plan, and the HHS "Section 508 Product Assessment Template are subject to the 10 page limit for confirm that personnel, facilities, equipment and resources, other considerations, schedule, other support, cost information, data Information Security Plan, and the HHS "Section 508 Product Assessment Template are not subject

30 4

NICHD-NIDDK-

2020-01;

Attachment 1 - Packaging and

Please confirm that Graphics may use 8-point font.

Please refer to response to question #22.

31 5

RFP NIH-

NICHD-NIDDK-

2020-01;

SECTION M -

EVALUATION

FACTORS FOR

AWARD; 5.

TECHNICAL

EVALUATION

FACTORS

Please confirm the number of awardees expected for the Task Area A pool and the number expected for the Task Area B pool.

Please refer to response to question #21.

32 6

RFP NIH-

NICHD-NIDDK-

2020-01;

Additional Proposal Information

Please confirm the contract type, period of performance and level of effort for Task Area B / Sample Task Order.

Assume the contract type is cost reimbursement cost plus fixed fee. Period of performance is one year.

and Instructions

33 1 Page 118 of

235.

Can NNIDK confirm that the following are excluded from the page limit:

• Resumes Data Sharing Plan resume This is to confirm Resumes and the Data Sharing Plan are exempt from page limit.

34 2 Page 10 of 235;

Page 27 of 235;

Page 29 of 235;

Page 66 of 235;

Page 10, Item 6, Contractor Non- Disclosure Agreement (NDA);

Page 27, Item 6, Confidentiality and Nondisclosure of Information;

Page 29, Item 11, Contractor Non- Disclosure Agreement (NDA);

Page 66, Part III, Section J, Solicitation Documents, Attachment 8;

Page 92, Item 16, Confidentiality and Nondisclosure of Information;

Please verify the document referenced as Attachment 8 (page 66 of 235) is for informational purposes only and that awardees of applicable Task Orders will be required to gather signed forms from project personnel prior to performing any work under this acquisition and submit 30 calendar days following the start date of the Task Order (page 10, 27, 29 and 92 of 235).

If this interpretation is incorrect, please provide a corrected link to the document that is required for offerors’ to submit with their proposals.

This interpretation is correct.

35 1 Page 124 of

235. Section B Can the Government share technical architecture documents that list the current solution components including database, ETL, analytics applications and how they are interrelated to meet the NIDDK’s Data Repository functions?

Please refer to overall answer #1.

36 2 Page 124 of

235. Section B

Can the Government share interface documents that list all systems and methods of data input to the NIDDK data repository? Can the Government also specify any other systems that may be sourcing data out of the Data Repository to meet other data integration needs across the NIH/HHS or other agency systems?

Currently the clinical research data are submitted to the NIDDK Central Repository by the project Data Coordinating Center via secure file transfer protocols. Biospecimens received at the NIDDK biorepository are accompanied by electronic manifests that are imported into BSI during the accessioning process.

There are no systems sourcing data out of the NIDDK data repository to meet data integration needs.

37 3 Page 124 of

235. Section B

Can the Government specify the current Governance model and how system enhancements are currently being performed in the existing Data Repository environment?

System enhancements have been limited to improving routine repository operations per the needs of the research projects and the community interested in accessing repository held resources.

The Government anticipates a greater level of system enhancements than in the past with the award of this contract.

38 4 Section L (page 94-98), Attachment 6 and Section M (page 114-115)

The instructions to offerors are not clear as to whether offerors need to respond to the IDIQ SOW. There are additional proposal instructions for both Task Areas A and B (attachment

6) but none for the IDIQ SOW. The technical evaluation factors only include criterion for Task Area A and Task Area B Task Order responses.

Can the government clarify if we need to respond to the IDIQ SOW? If yes, can you also provide the criteria for how the IDIQ response will be evaluated.

IQIQ SOW Attachment 3 represents the overall IDIQ ONLY.

Offeror are not required to respond to the IDIQ SOW.

39 5 Section L: Past

Performance (page 82) and Qualifications of Offerors (page 111-112)

There is a discrepancy in the instructions provided in these two sections for past performance qualifications. Page 82 states a list of the last 3 contracts completed during the past 5 years and all contracts being performed that are similar in nature to the solicitation work scope. Page 111 states listing of each related contract completed within the last 3 years or currently in process. Can the government clarify the number of references to include and the timeframe? Also the requested information for each contract is different on these two pages, can the government clarify which is the correct contract information that offerors should include?

Page 82 refers to Past Performance. Page 111 refers to Pertinent Contracts. They are separate requirements. The Government confirms the number of references are correct per each requirement.

40 6 Business Proposal Instructions Paragraph 2 – page 100;

Paragraph 2 - Certified Cost or Pricing Data

Requirements for Certified Cost or Pricing Data and Data Other than Certified Cost or Pricing Data, FAR Clause

Please confirm that the Government has determined adequate price competition is anticipated, and therefore the submission of a Certificate of Current Cost or Pricing Data is not anticipated, as provided for in the exceptions noted in Paragraph 3 Requirements for Certified Cost or Pricing Data and Data Other than Certified Cost or Pricing Data, FAR Clause 52.215-20 (page 103).

The Government has not determined that adequate price competition is anticipated, and therefore the submission of a Certificate of Current Cost or Pricing Data is required.

52.215-20 (October 2010)

41 7 Technical Evaluation Factors (JM.5)

The direct labor cost data submitted by individual offerors in isolation from the indirect cost burdens will yield costs that aren’t comparable across offerors as they account for time differently. Differences in the annual hours divisor among offerors (e.g. 1820 hrs vs 2080 hrs annually) for example will result in substantially different direct labor cost estimates even assuming the same salary. The higher annual hours divisor (2080 hrs) in this example results in a lower direct labor cost rate because the remaining hours (benefit time for example) are effectively accounted for in the offeror’s indirect cost rates. The result is that, even though the total labor cost including burdens might be equal, the different composition of the direct and indirect components of this fully burdened labor cost will result in very different, and therefore not comparable, direct labor cost rates.

How will the technical evaluators normalize these direct labor cost rates so that they may be meaningfully evaluated?

Evaluators do not compare offerors. Every technical proposal is evaluated on its own merits and in accordance with the technical evaluation criteria stated within the RFP.

42 8 Technical Evaluation Factors (JM.5)

How will the technical evaluators determine what direct labor cost values are appropriate for the requirements specified in an objective manner? While the

Evaluators do not compare offerors. Every technical proposal is evaluated on its own merits and in accordance with the technical evaluation criteria stated within the RFP.

evaluators can discern the direct labor costs proposed in relation to other offeror proposals, the single point of direct costs by task submitted by offerors alone will not provide the information necessary to evaluate realism against the requirements. For example, labor cost efficiencies that might arise from proposed technical accelerators may not be apparent from this single cost data point by task.

43 9 Task Area B / Sample Task Order SOW (Solicitation Part 1 page 4, Section L page 74, and IDIQ and Task Area B Sample Task Order SOWs)

There are several references in the RFP (page 4 and 74) that indicate that the government intends to establish two pools of contractors:

one for Task Area A and one for Task Area B as a result of the solicitation.

On page 74 it also states that Task Area A will be awarded simultaneously with the IDIQ contract for Task Area A. Both the IDIQ SOW and the Task Area B SOWs indicate that Task Area B is optional and to be ordered when required.

Does the government intend to Award Task Area B? If yes, what in the anticipated award date?

The IDIQ for Task Area B will be awarded at the same time as IDIQ Task Area A. At the time of the IDIQ award the task order for Task Area B will not be awarded. It is unknown when future task orders will be awarded for Task Area B.

44 1 Pg 141

Attachment 6 - Deliverables and Technical Reporting Requirements for Task Area B

Does the government intend for the 6.0% to be 6.0 FTE each year?

RFP Text, “To assist Offerors in the preparation of their proposals, the Government estimates the effort required for successful completion of the following Task Area A / Task Order 1 (Administrative, Programming, Statistical, Scientific, and IT Support) will be 6.0%

This is to confirm the estimated effort required is 6 FTEs as opposed to 6.0%.

/ Sample Task Order

Additional Business Proposal Instructions:

Task Area A / Task Order 1

Full- Time Equivalent each year.

45 2 Pg 143 Attachment 6 - Deliverables and Technical Reporting Requirements for Task Area B / Sample Task Order

Additional Business Proposal Instructions:

Task Area A / Task Order 1

How would the government like to see evidence of institutional commitment?

RFP Text, “7. Provide evidence of institutional commitment for this program.

Demonstrate the organization’s ability to provide resources and expertise to provide stable operation of the repository over the life of the contract.

46 3 Attachment 1 - Packaging and Delivery of Proposals

The guidance provides for the contents of a response to Task Areas A and B. Are bidders required to respond in a separate volume with a technical response to the IDIQ and it's three Task Areas?

RFP text - All Please refer to overall answer #2.

4 Pg 74 Section L.

1.b.1

The incumbent contract to this work HHSN276201300007C FPDS record indicates it is classified under NAICS 541690 Other Scientific and

RFP Text, “

1. The North American Industry Classification System (NAICS) code for this acquisition is 541714.

Activities to enhance and expand the Repository operations, to benefit from advances in technology and align with the NIH and

Technical Consulting Services. This work indicated classification under NAICS 541714 - Research and Technology in Biotechnology. Will the government consider revising the RFP to change the NAICS code back to 541690 given the non-research related work, especially in task Are B?

NLM strategic plans for data science, are considered research and development.

48 5 Pg 74 Section L.

1.b.1

Could the government provide a rational for changing the NAICS code from 541690 (the incumbent work) to 541714?

RFP Text, “

1. The North American Industry Classification System (NAICS) code for this acquisition is 541714.

Please refer to response to #47.

49 6 Attachment -spshexcel_dec2

Web address gives a 404 error.

Please provide the correct address.

RFP Text, “ Summary Tab Note 2 - "If you have questions regarding indirect (F&A) rates see website:

http://oamp.od.nih.gov/dfas/IdCSubmiss ion.asp"

Please see the revised link below for Attachment 17 Breakdown of Proposed Estimated Costs(plus fee) w/Excel Spreadsheet https://oamp.od.nih.gov/content/breakdown-proposed-estimated-cost-plus-fee-and-labor-hours

Please link below for the referenced Summary Tab Note 2 -regarding indirect (F&A) rates:

https://oamp.od.nih.gov/dfas/indirect-cost-branch/indirect-cost-submission

50 7 Pg 74 Section L.

c .1

What is the maximum and minimum number of awards the government will make in each pool for Task Area and Task Area B.

RFP Text, “ Type of Contract and Number of Awards

Please see response to question #21

51 8 Pg 100 Attachment 6 - Additional Proposal

This task is not listed in Attachment 5 Task Area B / Sample Task Order. It is listed in a task in Attachment 4 - Task Area A/Task Order 1 SOW (page

RFP Text, “

1. Describe the plans and experience for reimbursing expert panel meeting participants

Include in response to Task Area B if relevant to proposal.

https://oamp.od.nih.gov/content/breakdown-proposed-estimated-cost-plus-fee-and-labor-hours https://oamp.od.nih.gov/content/breakdown-proposed-estimated-cost-plus-fee-and-labor-hours https://oamp.od.nih.gov/dfas/indirect-cost-branch/indirect-cost-submission https://oamp.od.nih.gov/dfas/indirect-cost-branch/indirect-cost-submission

Information and Instructions For Task Area B

6-7). Could the government clarify if the requirement to address this task area should be in the technical response to Task Area B?

and arranging meeting rooms travel, hotel, per diem expenses, and honorarium.

52 9 Pg 74 Section L.

c. 1.

Can the same vendor win both task areas?

RFP Text, “Type of Contract and Number of Awards”

Yes.

53 10 Pg 74 Section L.

c. 1.

If a contractor bids both, can the contractor be awarded one?

RFP Text, “Type of Contract and Number of Awards”

Yes. If the offeror is a successful awardee. For example, if an offeror wins task Area A and is unsuccessful for Task Area B they will be awarded an IDIQ for Task Area A but not for Task Area B.

54 11 Pg 97 Section L.

b.

Can you provide a list of desired Key Personnel requirements or position descriptions?

Personnel

Please see answer to overall question #5.

55 12 Section L Is this a Cost Plus Contract or a FFP Contract? For instance, would the pilot in Task B, as an optional task be priced as a FFP task? How will the government evaluated pricing without first determining a baseline of tasks and work

Business Volume

Please refer to Attachment 6. Additional Proposal Information page 141. Assume the contract type is cost reimbursement cost plus fixed fee. The Sample Task Order B pricing will be evaluated for cost reasonableness.

56 13 Attachment 4 - Task Area A/Task Order 1

SOW

Have all current systems been through ATO?

No.

57 14 Attachment 4 - Task Area A/Task Order 1

SOW

Please provide a list of all hardware and software currently in use.

#63.

58 15 Attachment 4 -

A/Task Order 1

SOW

Please provide an as it and to be infrastructure for the repository.

#63.

59 16 Attachment 4 -

Please provide current FTEs count per Task Area

Please refer to overall answer #6.

A/Task Order 1

SOW

60 17 Attachment 4 - Task Area A/Task Order 1

SOW

Please provide a list including number of conferences, webinars, training sessions per year.

Please refer to RFP, Attachment 6 for annual activities.

61 18 Attachment 4 - Task Area A/Task Order 1

SOW

What are the current LCATs and staffing levels that manage and support the current infrastructure?

Please see overall answer #6.

62 19 Attachment 4 - Task Area A/Task Order 1

SOW

What are the current LCATs and staffing levels that provide current development?

Please see overall answer #6.

63 20 Attachment 4 - Task Area A/Task Order 1

SOW

What is the current list of property under management by the incumbent?

Please refer to Attachment 3 IDIQ Statement of Work, pg. 116, for the data and/or samples made available via the NIDDK Central Repository. More information on study-specific holdings can be found on the repository website.

The data repository contractor holds process data related to routine operations. For example, in 2019, the repository received 131 data requests and fulfilled 134 sample requests.

Refer to Attachment 6, pg. 116, for assumptions about annual activities to be used for proposal purposes.

64 21 Attachment 4 - Task Area A/Task Order 1

SOW

What is the current list of systems and tools that comprise the NIDDK central repository?

Government cannot provide this information to potential offerors.

65 22 Attachment 4 - Task Area A/Task Order 1

SOW

Does NIDDK envision the current systems to remain in place? Or is the agency open to a new cloud-based solution?

NIDDK is open to new solutions.

66 23 Attachment 4 - Task Area A/Task Order 1

SOW

Do the current systems utilize GFE and run within the NIH internet hosting?

Current systems do not use GFE and are not hosted by NIH.

67 24 Attachment 4 -

Task Area A/Task Order 1

SOW

Does NIDDK envision a different hosting strategy than is currently in place?

NIDDK is open to different hosting strategies.

68 25 Attachment 4 - Task Area A/Task Order 1

SOW

What is the level of experience and education requirements of the Principal Investigator/Project Director (PI/PD)?

See overall answer #4

69 26 Attachment 4 - Task Area A/Task Order 1

SOW

Would the PI/PD lead or initiate scientific efforts?

Per Task Area Task Order 1 SOW, the NIDDK Repository does not conduct research.

70 27 Attachment 4 - Task Area A/Task Order 1

SOW

Can NIDDK provide examples of typical informatics and statistical analytics requests?

Under Task Area A Task Order 1 SOW, analytics requests are typically related to the data curation process, assisting requestors with cross-study data/biospecimen requests or identifying relevant biospecimen subsets, and developing resource utilization and performance metrics

71 28 Attachment 4 - Task Area A/Task Order 1

SOW

Can NIDDK provide examples of a typical “custom search” that may be requested?

An example may be to identify a set of samples across five study collections where there is overlap in disease area, per specific inclusion/exclusions criteria specified by a requestor.

72 29 Attachment 4 - Task Area A/Task Order 1

SOW

To better be able to respond to the task orders, will the government provide the following before the submission deadline?

Architecture Diagrams / Documents

System Documentation, Diagrams

Interface Diagrams

User Documentation

Quality Standards and Tests currently in place.

Architecture Diagrams see overall answer #1

Performance metrics current in place.

Current NIDDK SOPs.

73 1 Attachment 1, I.B.4, pg 118 Can the Government confirm that the contractor is not required to submit a business volume or a technical volume for the overall

IDIQ?

Yes.

74 2 Solicitation IV.M.5 pg 114

Can the Government provide evaluation criteria for the Task A IDIQ pool and the Task B IDIQ pool?

The Solicitation document describes evaluation criteria for the Task Orders ("Task Area A / Task Order 1" and "Task Area B / Sample Task Order"), but not does not specify how the two IDIQ pools will be evaluated.

Future task orders from IDIQ pools A and B will be evaluated per the evaluation criteria stated in task order RFP.

75 3 Solicitation C.2, pg 6

Can the Government clarify if the reporting requirements listed in Section C.2 are required for the

IDIQ?

In addition to the IDIQ Task Area A and Task Area B reporting requirements offerors are required to submit to solicitation reporting requirements listed in Section C.2.

76 4 Solicitation, IV.M.5 pg 114

Can the Government confirm that multiple awardees can be awarded to multiple task Areas, and only one awardee will be awarded the Task Orders?

It is anticipated the government will make multiple award IDIQ contracts to establish two (2) pools one for Task Area A, and one for Task Area B. Task Area A / Task Order 1 will be awarded simultaneously with the IDIQ contract for Task Area A. The NICHD reserves the right to make a single award, multiple awards, or no award at all to the SOLICITATION.

77 5 Attachment 1 I.B.4, pg 118

Can the Government confirm that separate business and technical volumes should be submitted for 1) Task Area A / Task Order 1; and 2) Task Area B/Sample Task Order?

Yes.

78 6 Attachment 1, II. FORMATTING

AND PAGE

LIMITATIONS,

pg 118

Could the Government clarify the following statement: "This page limitation does not include the cover sheet, table of contents, personnel, facilities, equipment and resources, other considerations, schedule, other support, cost information, data Information Security Plan, HHS "Section 508 Product Assessment Template. Appendices shall not exceed a total of 10 pages." Can the Government clarify that the technical volume should focus only on the technical solution and the following items are outside the page limitation: Personnel, facilities, equipment and resources, other considerations, schedule, other support, cost information, data Information Security Plan, HHS "Section 508 Product Assessment Template.

This is to clarify the technical volume for Task Area A Task Order 1 and Task Area B Sample Task Order should focus only on the technical solution and the following items are outside the page limitation: Personnel, facilities, equipment and resources, other considerations, schedule, other support, cost information, data Information Security Plan, HHS "Section 508 Product Assessment Template.

79 7 Attachment 1, II. FORMATTING

AND PAGE

LIMITATIONS,

pg 118

Can the Government clarify the content to be included in 1) personnel, 2) facilities, equipment and resources, and 3) schedule, as described in the following statement: "This page limitation does not include the cover sheet, table of contents, personnel, facilities, equipment and resources, other considerations, schedule, other support, cost information, data Information Security Plan, HHS

The content to be included in 1) personnel, 2) facilities, equipment and resources, and 3) schedule, as described in the following statement: "This page limitation does not include the cover sheet, table of contents, personnel, facilities, equipment and resources, other considerations, schedule, other support, cost information, data Information Security Plan, HHS "Section 508 Product Assessment Template. Appendices shall not exceed a total of 10 pages.", pertains to information that the offeror deems necessary in support for their proposal submission.

"Section 508 Product Assessment Template. Appendices shall not exceed a total of 10 pages."

80 8 Attachment 6, Additional Technical Proposal Instructions / Task Area A, paragraph 4

Can the Government confirm that the administrative structure is that of the offerrors as stated in Attachment 6: "Describe the administrative structure of NIDDK Central Repository group and provide an organizational chart"

The government confirms that the administrative structure and organizational chart is that of the offerors.

81 9 Attachment 3, IDIQ Technical Requirements, pg 124

Can the Government provide a list of the types of government owned resources, including size and quantity as applicable? As described in Attachment 2: "If the successor Contractor is not the incumbent, the successor contractor shall work with the incumbent to transfer the government owned resources, including those necessary to maintain the website which supports NIDDK Central Repository activities within six (6) weeks of contract award."

Same as Overall #63 with this additional statement.

Project specific clinical research data and biospecimen metadata along with repository operation process data would be transferred to the successor contractor. Process data would be provided to import into successor’s systems.

82 10 Attachment 3, IDIQ Technical Requirements, pg 122

Could the government please define what is meant by "a secure environment"? Is this referring to physical security, cloud security, etc?

Primarily physical and information security.

83 11 Solicitation, IV.L.1.b.4.a, pg

Is the data sharing plan considered outside of the page count and the appendices count?

The Data Sharing Plan is excluded from the appendices count.

84 12 Attachment 3, IDIQ Technical Requirements, pg 124

Can the government provide the following information about the current repository: 1) Total number of releases per year, 2) Number of operations and maintenance releases, 3) Number of

There is not a set number of releases per year.

There may be monthly releases that include operations and maintenance or enhancements.

Releases related to internal operations may be incremental and reflect iterative development.

enhancements released, 4) Number of help desk tickets submitted

85 13 Attachment 3, IDIQ Technical Requirements, pg 124

Can the government provide the technical sizes of the current repository that would have to be transitioned within six weeks, including amount of data and total number of systems?

Please refer to responses for Overall #1, Overall #36, and Overall #63.

86 14 Attachment 3, IDIQ Technical Requirements, pg 122

Could the government describe the data standards established by NIDDK? As described in this sentence: "The contractor shall ensure that the computer programs, databases and other resources developed through this contract are compliant with terminology and data standards established by NIDDK."

Data standards and terminology beyond those specified in the IDIQ SOW, Task Area A Task Order 1, and Task Area B Sample Task Order will be specified in any task orders placed.

87 15 Attachment 6, Additional Business Proposal Instructions, pg

Will the government confirm that the estimated effort required for successful completion of Task A/Task Order 1 is 6 FTEs as opposed to 6.0% of an FTE?

This is to confirm the estimated effort required is 6 FTEs as opposed to 6.0%.

88 16 Attachment 6, Additional Business Proposal Instructions, pg 141-143

Will the Government please confirm that a price submission volume is required for both Task Area A and Task Area B/Sample Task Orders, and if so, please confirm the contract type for each and confirm what is the period of performance for Task B?

Assume the contract type is cost reimbursement cost plus fixed fee. Period of performance is for one year.

89 17 Solicitation, Section M Evaluation Factors for Award, pg 113

Can the government please clarify the price evaluation used for Task Area B/Sample Task Order given the possibility offerors may propose different solutions for the pilot project and/or strategic plan?

The Government recognizes there will be different approaches and solutions for the Sample Task Order. Sample to pricing will be evaluated on a cost reasonableness basis.

90 18 Solicitation, Certified Cost or Pricing Data and Data Other than Certified Cost or Pricing Data, pg 103-

Can the government confirm procurement determination will be based on adequate price competition and that offerors may submit data other than certified cost or pricing data?

Please see response to question #40.

91 19 Attachment 5, Task Area B/Sample Task Order SOW, pg

Will the government please confirm that Task Area B / Sample Task Order will be awardable during the next fiscal year?

Area B will not be awarded. It is unknown when future task orders will be awarded for Task Area B.

While the Government cannot guarantee a task order for Task Area B will be awarded during the next fiscal year, the government is interested in moving toward FAIR principles for existing data and establishing improved standards for active projects.

92 20 Solicitation, Section L.2.c.10, pg 112

If subcontractors are to submit a complete cost proposal, will the government please allow for subcontractors to submit a sealed bid to the government with their cost proposal information? If a sealed bid is allowed, please provide instructions on how the subcontractors should submit this to the government?

Sealed bidding procedures are not allowed.

93 21 Attachment 6, Additional Business Proposal Instructions, pg 141 - 143

Will the Government please confirm that a price submission volume is required for Task B/Sample Task Order and if so what is the contract type?

Yes a price submission volume is required. Assume the contract type is cost reimbursement cost plus fixed fee.

94 1 Can the Government elaborate and provide the below information about the Central Repository:

a. What is the data architecture?

b. How large is the dataset?

c. What is the refresh rate?

d. How many systems does the Central Repository interfaces with?

e. Do you have a sample set of data that you are planning to use? Can you share that dataset?

f. What kind of front end are you looking for? Is it collaborative? Is it database records? Or is it documents/files?

#63. The government is not looking for any specific type of front end.

95 2 Section J of the

RFP

The link for Attachment 22 gives an error page

Please see revised link below for Attachment 22:

https://oma.od.nih.gov/forms/Privacy%20Documents/Document s/Privacy%20Act%20Systems%20of%20Records%20Notices%20(S ORNs)%205-1-15.pdf

96 3 Section J of the

RFP

The link for Attachment 24 does not link to anything.

Please see revised link below for Attachment 24:

https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition /Documents/Nondisclosure.pdf https://oma.od.nih.gov/forms/Privacy%20Documents/Documents/Privacy%20Act%20Systems%20of%20Records%20Notices%20(SORNs)%205-1-15.pdf https://oma.od.nih.gov/forms/Privacy%20Documents/Documents/Privacy%20Act%20Systems%20of%20Records%20Notices%20(SORNs)%205-1-15.pdf https://oma.od.nih.gov/forms/Privacy%20Documents/Documents/Privacy%20Act%20Systems%20of%20Records%20Notices%20(SORNs)%205-1-15.pdf https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf

97 4 Section J of the

RFP

The link for Attachment 26 does not link to anything.

Please see revised link below for Attachment 26:

https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition /Documents/Emp-sep-checklist.pdf

98 5 page 118 for the RFP

Page limitations are given for the technical proposal. Is there a page limitation for the business proposal?

No.

99 6 page 113 of the

RFP

There is reference to a Data Sharing Plan. If the offeror is only bidding Task Area B, does the offeror need to provide a Data Sharing Plan?

Please see page 99 of RFP. The offeror must submit a plan in its technical proposal for data sharing or state why data sharing is not possible. If data sharing is limited, the offeror should explain such limitations in its data sharing plan. NIH's data sharing policy may be found at the following Web site:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03- 032.html

100 7 How many awards will be made for each Task Area A and Task Area B?

Please refer to overall response to question #21.

101 8 If the offeror submits a response for both Task Areas, but only Task Area B is a successful bid, would such offeror be awarded only Task Area B.

In other words, if the offeror responds to both, must the offeror be successful…