75N94024R00001_Amendment_No__004_04_08_24_FINAL_0004.pdf

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75N94024R00001 x x

0 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.

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NICHD

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

75N94024R0000104/08/20240004

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02/26/2024

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

This amendment provides responses and additional clarification 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.: 0004

CONTINUATION PAGE

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

1. Please provide the number of specimens per storage condition for the current 6,000,000 samples (‑70°C, LN₂, ambient, -20°C).

Temperature -80 -20 Ambient LN2 Number of Specimens

4,371,190 1,252,965 47,266 141,655

2. For costing purposes, please provide assumptions for domestic and international shipments for task orders other than the DASH-Dedicated Biobank.

Answer: Based on historical data, please assume that for every ten shipping requests, one will be international. Please keep in mind that the majority of shipping requests are issued by outside investigators, which are then billed to those outside investigators.

3. Please provide quantities for the most common types of containers that will be stored for this contract.

Answer: The most common vial size is a standard 2 mL cryovial; other commonly used containers are 2.5 mL and 5 mL PAXGene tubes, as well as urine specimen containers. We also store 0.5 mL cryovials, paraffin blocks, and slides. We do ask that, when possible, samples are put in vials that fit into 2” or 3” cardboard storage boxes, and every storage container regardless of size is tagged with a scannable barcode.

4. Are the DASH samples a subset of the 6,000,000 currently stored or in addition? Are DASH samples currently stored in GFE, which is to be transferred?

Answer: Yes; currently the samples we share via DASH are counted in the total. There is no distinction between storage units for DASH samples vs. other samples.

5. Please clarify assumptions for pricing in the administrative task order. Should the offeror price transition and storage of the current 6,000,000 samples in the admin task order?

Answer: No, the costs of transition must be included as part of each collection task order (i.e.

MPIDB and DASH) separately.

6. Please clarify the timing of the freezer transition for costing purposes.

Each Task Order will be transitioned separately, and the timelines vary. We anticipate transition will begin the fall of 2024 and extend until fall 2026. For estimating costs of the Task Orders under evaluation, assume that it might take up to a year to move both the MPIDB and DASH BioBank samples/freezers.

7. It is not clear what the government is asking the offerors to price in the administrative task order.

Is the transfer of 115 GFE freezers and 6,000,000 samples to be priced as part of any of the task orders in the solicitation?

Answer: Yes, the cost of transitioning freezers will be associated with respective Task Orders.

Currently, only two Task Orders will be evaluated for this type of effort (i.e. MPIDB and DASH task orders).

8. The Assumptions attachment states: “The offeror should assume that there will be 1-2 new collections (Task Orders) added per year that have 20,000 – 50,000 specimens with larger collections of approximately 500,000 specimens every three years; each to be stored primarily at - 70o Celsius.”

But answer #24 in amendment 2 states, “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.”

Should the offeror assume up to 200,000 specimens per year or up to 1,000,000 specimens per year?

Answer: Please see further explanation below that provides clarifications to our previous answers:

For The MPIDB task order, historically, we have seen 1-2 additional studies that have 20-30K samples in total. This should not be included in your cost proposal for the MPIDB task order as it is anticipated that these new collections will be added in the future.

In general, for the overall size of the repository, in the past 3 years we have seen approximately 1-2 of the larger collections per year, so this is the number you should use to judge the necessary overall capacity.

9. Should the offeror assume the addition of DASH would be expected as part of the annual growth of the repository or in addition to? For costing purposes, how many new samples should be expected each month for the DASH Task Order?

Answer: Yes, offerors should consider DASH specimens as part of the annual growth. As we are ready to transition, more samples will be added to the BioBank.

Currently, as listed in Table 1 in the DASH Statement of Work, there are approximately 985,783 DASH samples that will require storage at a minimum. Offerors shall include a proposed budget that reflects the storage of the estimated 985,783 samples annually at a minimum. Additionally, offerors must include a budget estimate reflecting the storage of samples of a maximum of 4 million annually should the government exercise FAR 52.217-6, Option to Increase Quantity within any given year. This option will allow for increase in the quantity of samples in the collection by up to 4 million samples during the task order period of performance.

Minimum (Government’s estimate: 985,783 specimens)

Period of Performance Estimated Cost

Fixed Fee

Estimated Cost-Plus

Fixed Fee ($) Base Period: 08/01/2024 – 07/31/2025 Option Period 1: 08/01/2025 – 07/31/2026 Option Period 2: 08/01/2026 – 07/31/2027 Option Period 3: 08/01/2027 – 07/31/2028 Option Period 4: 08/01/2028 – 07/31/2029

TOTALS

Maximum (Government’s estimate: 4,000,000 specimens)

Period of Performance Estimated Cost

Fixed Fee

Estimated Cost-Plus

Fixed Fee ($) Base Period: 08/01/2024 – 07/31/2025 Option Period 1: 08/01/2025 – 07/31/2026 Option Period 2: 08/01/2026 – 07/31/2027 Option Period 3: 08/01/2027 – 07/31/2028 Option Period 4: 08/01/2028 – 07/31/2029

TOTALS

10. On the MPIDB Task Order, please clarify if the 120 incoming shipments comprising 25,400 specimens means that each incoming shipment contains 25,400 specimens or if 25,400 is the total annual number of specimens to be received.

Answer: As stated in the MPIDB statement of work, we looked at historical data to generate the average for incoming samples to be about 120 shipments, totaling 25,400 samples. We estimate future work to be approximately consistent with this. For costing purposes, assume 25,400/year.

11. On the MPIDB Task Order, please clarify if the 30 outgoing shipments include 5,700 specimens or 5,700 is the total for the year.

Answer: For costing purposes, assume 5,700/year. The majority of shipping out of the repository is delivered to outside investigators that are paid by those investigators and are not costs covered by the government under this contract.

12. Clarification regarding submission of Small Business Subcontracting Plans:

Answer: Please submit the Small Business Subcontracting Plan as part of your business proposal.

13. What is the data set/limit expected in each Application Programming Interface (API) output?

Answer: All information regarding the API interface is theoretical at this point. Please estimate costs for sharing inventories via a File Transfer Protocol (FTP) server. We anticipate API will be developed as a team effort between the repository contract and DASH. Please see the DASH statement of work for more information.

14. After the API output is received by NICHD DASH, will there be a process to download data and files?

Answer: We anticipate the information will be accessible and downloadable to both parties.

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.

END OF AMENDMENT