75N94024R00001_Amendment_No__002_FINAL_0002.pdf

(x)

75N94024R00001 x x copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT 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.

x

NICHD

Bethesda, MD 20892-7511 National Institute of Child Health National Institutes of Health

75N94024R0000103/04/20240002

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

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

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

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

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

02/26/2024

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

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

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

ORDER NO. IN ITEM 10A.

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

TY B. MAIN

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

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

This amendment provides responses to the questions received regarding this RFP. Please note that individual questions may have been combined or re-worded. The responses become a part of this RFP.

In addition, please note that the proposal due date remains April 12, 2024 at 4:00PM (EDT).

Estimated Period of Performance: 08/09/2024 to 08/08/2034

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

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RFP: 75N94024R00001

AMENDMENT NO.: 0002 CONTINUATION PAGE Page 2 of 8

This amendment provides responses to the questions received regarding this RFP. Please note that individual questions may have been combined or re-worded. The responses become a part of this RFP.

1. Question: Can the offeror propose grant or assistance agreement past performance for the 3 contracts to be listed?

• Answer: Yes

2. Question: “The work being conducted under this contract may involve the possession, use, or transfer of a select agent or toxin.” can you verify that the ability to work with select agents is a requirement for performance of tasks under this contract.

• Answer: There is no requirement for working with select agents. At times some of the samples might have select agents in them, but this is rare. We would not expect these samples to be opened or aliquoted.

3. Question: Is it possible to provide clarification on the extent of leased equipment the contractor is expected to provide? Similarly, are the 115 units expected to be transferred under this contract considered leased?

• Answer: The Government owns 115 units. In addition, the Government is currently leasing (59) -80ºC and (3) Liquid Nitrogen units.

4. Question: Are Individual SOPs and QAPs required for each task order?

• Answer: No

5. Question: Can you please indicate what inventory database management and tracking system the current contract is using?

• Answer: This varies. Some of the studies use LIMS. Others use proprietary systems that have been modified over time to accommodate searching the large number of specimens via a web-based portal.

6. Question: Can you provide estimates on the number of incoming, outgoing, aliquot and relabel tasks expected under the DASH Task Oder?

• Answer: Unfortunately, this is unknown at this time, as the DASH BioBank will be formally established with this contract. The number of specimens available to be shared via DASH just recently changed from 178,957 to 968,259. With the 178,957 samples formerly available there have been 6 requests over 5 years. Currently DASH procedures are that no aliquoting will take place, but with the establishment of the BioBank that could change.

7. Question: For DASH and other Task Orders, would it be possible to provide the number of authorized users that are anticipated, or are currently, making direct requests for specimen with the repository? Additionally, would this be a defined/controlled list?

AMENDMENT NO.: 0002

CONTINUATION PAGE

• Answer: This varies for each Task Order. For all work besides that of the DASH BioBank all work must be routed through and approved by an NICHD COR. All queries for the BioBank will come directly from DASH. Authorization for access to inventories includes more individuals, who are established on a Task Order basis or through requests from the COR.

8. Question: Can you please clarify what the “integration of residual samples” entails?

• Answer: At times samples are sent to analysis or testing labs, after which some sample remains. Where appropriate the remaining, or residual, samples are returned to the repository to be added back to the collection.

9. Question: Is the government requesting estimated costing on bulk relocation? If so, can specific parameters be provided to allow for accurate pricing?

• Answer: We expect to transition in full as each Task Order is awarded.

10. Question: Are any government owned backup freezers being included with the initial transfer?

• Answer: All government owned freezers are expected to be transferred.

11. Question: Are the different task orders included in a single monthly report or is NICHD requesting a monthly report for each Task Order separately?

• Answer: The monthly report should include information for all extant Task Orders in one document

12. Question: SOW : IDIQ section H. Storage facilities and equipment bullet point 4, Please confirm the second temperature range listed is -10 to -20, I normally expect -20 + / - 5°C .

• Answer: The temperature range should be -10 to -20.

13. Question: SOW : IDIQ section H. Storage facilities and equipment bullet point 5, Is there a preference for any specific makes or models for leased freezers?

• Answer: No

14. Question: SOW: IDIQ section H. Storage facilities and equipment bullet point 9, please confirm NICHD wants a notification any time the alarm is triggered, or if only OOS for the agreed limits for 30 minutes? Do you require a Quality Event opening each time?

• Answer: NICHD expects that temperature excursions lasting less than 30 minutes be listed in the monthly reports, while excursions lasting over 30 minutes must trigger a notification.

15. Question: Attachment 4 – Government Furnished Property: Will the government or incumbent be providing service records, temp data records and breakdown records with trend analysis data for the government owned property?

• Answer: Yes

AMENDMENT NO.: 0002

CONTINUATION PAGE

16. Question: Attachment 4 – Government Furnished Property: Can we perform an onsite audit of equipment if we were successful prior to move to establish any potential equipment points of failure.

• Answer: No; given the reports available this is unnecessary.

17. Question: Please provide more information on the inbound shipments from the Subject’s homes.

What is the format of the specimens? What type of packaging is used, and how is the cold chain maintained (if applicable)? How are these samples de-identified, as the RFP states there is no

PII?

• Answer: Samples from participant's homes will be barcoded with unique codes that contain no PII. The type of packaging depends on the sample collected. Most are frozen in the homes, packaged into Styrofoam boxes with cold packs, and delivered overnight.

We understand that these might not remain frozen during shipment and ask that the status (frozen v thawed) be recorded at the time of arrival.

18. Question: Historically, can you provide information on how many weeks are required for the surge capacity of 80,000 vials/week? For surges of 80,000 vials/week, how much advance notice can be expected?

• Answer: We have never compiled these data, but a guess is that this probably happens for incoming samples once a year. For outgoing samples this occurs more frequently; maybe every 4 months. When a large shipping request occurs, we expect to have repository personnel meet with the requestors to establish a schedule that accommodates both parties.

19. Question: What is the minimum font size for figures and tables?

• Answer: Please reference https://www.access-board.gov/ict/.

20. Question: If the offeror can supply new freezers that reduce sample risk, can the offeror limit the

GFE to be transferred to those freezers newer than 2019?

• Answer: Yes

21. Question: Does the base SOW have a section I? The SOW skips from section H, storage facilities, to section J, the final transition.

• Answer: This is a formatting error. “J” should be considered as “I”.

22. Question: Please confirm that the unit pricing list is the service costs that would be recovered from outside investigators.

• Answer: This should be the cost for outside investigators as well as the firm fixed pricing for the government

23. Question: Do any specimens require storage conditions above BSL-2?

• Answer: No https://www.access-board.gov/ict/

AMENDMENT NO.: 0002 CONTINUATION PAGE Page 5 of 8

24. Question: "The RFP states that a growth rate of 20% should be assumed. Please clarify if the offeror should assume 1,200,000 new specimens per year. The RFP also states that the offeror should assume 50,000 new specimens per month, which contradicts a 20% growth yearly.

Please also confirm if 20% per year is a compounded growth rate or 1,200,000 should be assumed yearly. Is 20% a year-over-year projection (ending at 37M samples) or 1.2M additional annually?"

• Answer: Offeror should estimate 1-2 new studies per year, each with about 500,000 samples. For proposal purposes, assume these additional studies will collect 100,000 per year for 5 years, after which there will be associated storage costs for the remaining years of the contract.

25. Question: For costing purposes, how many specimens per shipment should be assumed for the base SOW and the DASH SOW? What would be the frequency of shipments?

• Answer: There are no standards in this regard.

26. Question: For costing purposes, should the offeror assume temperature monitors will be used in all shipments outbound?

• Answer: We do not currently use these unless specifically asked by the requestors due to the cost.

27. Question: Historically, how many relabeling events is the contractor expected to generate?

• Answer: Relabeling is on a per-request basis. No schedule exists.

28. Question: "Please elaborate on aliquoting requirements for the base SOW, DASH SOW, and

MPIDB SOW.

For example, what is the timeline for aliquoting from request to shipment? How many parent vials are expected to be aliquoted? How many children vials per parent will be requested? Is there a standard aliquoting schema, or will it be ad-hoc, depending on the individual vial?

Historically, is there a subset of samples expected to be aliquoted or could it be any vial in inventory?

• Answer: There are no standards.

29. Question: Due to the number of unknowns affecting costing, would the government consider extending the deadline until May 1?

• Answer: No

30. Question: "In the technical proposal instructions the government states “Documents such as the Draft Information Security Plan, …..and NIST SP 800 53 Self-Assessment, would not be considered as part of the 25-page limitations of the Technical Proposal.”

AMENDMENT NO.: 0002 CONTINUATION PAGE Page 6 of 8

However, the Draft information security plan and NIST SP 800 53 Self Assessment are not described in the solicitation itself. Please clarify if these two documents are required for the offeror’s proposal response, and if so, elaborate on what information is required in the documents."

• Answer: For any (government or contractor) system that includes FISMA as part of their contract requirements, a system security plan (1 of several documents) and a FISMA security control assessment would be necessary to operate in or on behalf of the government. There are specific core documents required for an Authority to Operate (ATO) that (at minimum) the System Owner and Authorizing Official would have to sign off and accept whatever risks were found in the system as part of the security assessment.

Per NIST: A system security plan (SSP): A formal document that provides an overview of the security requirements for an information system and describes the security controls in place or planned for meeting those requirements.

i. That document will contain possibly anywhere from 200 to 400 NIST SP 800-53 security controls that a system needs to provide information if how, what is used to, who is responsible for and they (or do not) implement the requirements for a system to operate. The plan includes (but not limited to) system and component descriptions, network and data flow diagrams, lists of roles and responsibilities, cryptographic modules, what technologies are used and how they configured.

ii. Several core documents should be created/maintained as a part of any FISMA security assessment in addition to other artifacts of evidence that show proof that the “system” implements what they say it does.

Below is core documenta�on for a FISMA security control assessment that an organiza�on would be responsible to provide if required (outside of any other contract obliga�ons):

• SSP (and all associated policies and procedures related to the applicable security controls)

• Privacy Impact Assessment

• FIPS 199 Security Categoriza�on

• Boundary Scope

• Configura�on Management Plan

• Con�ngency Plan/Con�ngency Plan Test

• Incident Response Plan/Incident Response Plan Test

• Digital Iden�ty Acceptance (take place of E-auth)

• Plan of Ac�on and Milestones

• (if applicable) Memorandum of Understanding / Interconnec�on Security

Agreement (ISA)

AMENDMENT NO.: 0002 CONTINUATION PAGE Page 7 of 8

A “self-assessment” is one that an organiza�on will conduct a NIST security assessment against its own system, to determine if it will “pass” those FISMA requirements in order to operate in their (or other) environment(s). They in turn would provide the assessment results and associated documenta�on to who would want to use their services for a review.

31. Question: SAM.gov includes an attachment (Additional Technical and Business Proposal Information and Instructions) that is not included in Section J Attachments. Is this attachment required and if so, are the assumptions and the sample fixed price schedule required for each task order proposal?

• Answer: The document “Additional Technical and Business Proposal Information and Instructions” serves as additional guidance for offerors in separate document for convenience. This contract will feature both cost-reimbursement and fixed-price elements. As such, we’ve requested that offerors provide fixed price information including, but not limited to, the items identified within the sample schedule provided as part of this document.

32. Question: What contract type does the government intend to award for each task order?

• Answer: Contract type varies based on Task Order, and the Government anticipates cost-reimbursement plus firm-fixed-price. Some task orders will be a hybrid of both cost-reimbursement and fixed-price elements.

33. Question: Given that business titles and responsibilities for those titles vary within organizations, would the Government please provide the descriptions of what it envisions the roles and responsibilities would be for the various titles under the Key Personnel section (Principal Investigator, Project Director/Manager (or equivalent), Assistant Director/Manager (or equivalent)) in support of the Program?

• Answer: The Principal Investigator/Project Director ensures that administrative and technical resources are available as required; manages and reviews the budget, provides the CO and COR with all deliverables on a timely basis (including periodic performance reports); continues to monitor the overall performance and activities of the Repository;

and interacts/facilitates discussions with other departments (including Quality, IT, Contracts, Finance, Facilities, and Metrology) to ensure that that performance is maintained at the highest level. This person serves as the primary point of contact for the COR and COR-approved designees, and ensures clear, effective, and timely dialogue between the contractor and the NICHD regarding shipments, receipts, study set-ups, schedules, budgetary issues and any other administrative topics. In addition, the PI/PD (along with any other necessary Repository staff) participates in any teleconferences requested by the COR regarding logistics, set-up of new studies within the Repository contract, Task Order requirements/specifications/clarification, etc. The Assistant Project Director should act as deputy to the PI/PD and serve as the primary coordinator for the overall operations of the Repository. The Assistant responds to inquiries from the NICHD, study sites, and Data Coordinating Centers regarding receipts and shipments;

AMENDMENT NO.: 0002 CONTINUATION PAGE Page 8 of 8 works with senior Repository staff to schedule shipments of requested samples; works with the Senior Operations Supervisor to assign tasks to staff; and interacts with Facilities, Environmental Health and Safety, and other support staff to ensure optimal performance.

34. Question: The instruction states, "The following Section 508 accessibility standards apply to the content or communications material identified in this Statement of Work Performance Work Statement: Chapter 1: Application and Administration Chapter 2: Scoping Requirements Chapter 6: Supporting Documentation & Services Chapter 7: Referenced Standards" The latest Voluntary Product Accessibility Template (VPAT), VPATR Version 2.5 (November 2023) does not have a Chapter 1 or 2. Can the government please clarify this requirement, or is the government referring to a different document?

• Answer: Please see the following web-address: https://www.access-board.gov/ict/. Let us know if you are still unable to locate said chapters.

35. Question: Is it the Government's interpretation of dedicated personnel that this individual would be providing support equivalent to an FTE on a singular TO or could dedicated personnel be interpreted as personnel dedicated (FTE) to the overall operations and flex between programs and TOs as needed to provide support?

• Answer: Personnel dedicated (FTE) to the overall operations should be able to flex between programs and TOs as needed to provide support.

36. Question: Does NICHD DASH have an existing solution to use the API's output? If so, please describe the solution.

• Answer: No

37. Question: Is the data exchange going to be bi-directional?

• Answer: It was envisioned that DASH would query the repository inventory but all changes to the internal repository inventory to accommodate a DASH request would be captured in the repository inventory as the request was fulfilled, so bi-directionality of an API exchange was not anticipated. Though as this is theoretical at this point, efficiencies in the operationality of such a system would be encouraged. Establishment of such communication has not been finalized and development of such is expected to be a team effort between the repository contractor and DASH.

https://www.access-board.gov/ict/