SF30 - Amendment P00001.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)

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

Erin Felent, Contracting Officer

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

The purpose of this amendment is to provide responses to the questions received for this solicitation. Please make sure you acknowledge this amendment as stated in Item 11 above, either within your proposal submission or by a separate letter sent via email.

National Cancer Institute Office of Acquisitions NCI Shady Grove 9606 Medical Center Drive, MSC 9705 Rockville, MD 20850-9705

To All Potential Offerors 75N91023R00042

1 5

05/15/2024

05/01/2024

75N91023R00042 Amendment 01 Page 2 of 5

Childhood Cancer Data Ini0a0ve (CCDI) Molecular Research Characteriza0on 75N91023R00042 Amendment 01

Number Ques,on Government Response

1. How many awardees will be chosen for each service area?

As stated in SecEon L.1.c. of the RFP (page 67), it is anEcipated that one award will be made for a single firm fixed-price type contract. The awardee, along with any proposed subcontractors, will be responsible for fulfilling the requirements for every service area (the enEre SOW).

2. Can unused funds be rolled over? Can unused funds be used for other services within the same period of performance?

Services in each one-year period, for a total of five years (base plus four opEons), will be priced using a fixed unit price per sample up to a total ceiling cost for each year. A schedule of services and prices will be provided in the contract. As long as funds remain in the ceiling for each year, they may be used for any of the services listed in the schedule during that year. However, unused funds cannot be rolled over from prior base or opEon period years.

3. When evaluating vendor proposals, will each service area be evaluated separately?

All service areas and relevant capability elements described in the SOW will be evaluated as a whole per the stated SecEon M EvaluaEon Factors For Award.

4. Our understanding is that technical evaluation factors rank significantly higher than cost/price factors for decision criteria. Can you confirm?

Technical evaluaEon factors are of paramount consideraEon in the award decision, however, the Government will make an award based on the best overall value, considering all evaluaEon factors, as defined in FAR 2.101 “Best value”.

5. Does the proposal request pricing based on 100 units of single cell/single nuclei DNA, RNA, and methyl sequencing each (e.g. 100 of DNA, 100 of RNA, 100 of methyl) or is the request for 100 units total of DNA, RNA OR methyl?

100 units is in reference to 100 units of DNA, 100 units of RNA and 100 units of methyl if all types of analytes per sample are available on the same paEent. However, this may vary depending on the sample availability as pediatric cancers are rare diseases and samples are scarce. O(erors should provide fixed unit pricing and throughput for sc/sn- DNA sequencing, sc/sn-RNA-sequencing, and sc/sn-methyl sequencing per pediatric sample so that to ensure a fair evaluaEon.

6. Is there an incumbent for this work? If yes, who and can you provide the contract link or information?

No, this is a new requirement.

75N91023R00042 Amendment 01 Page 3 of 5

7. As work will be performed over multiple years, would updated versions of panels, reagents, products, or instrumentation be accepted (if available) or would everything need to be consistent year-to-year, project-to-project? What about in the case of anything originally proposed being discontinued by 3rd party manufacturers?

From SOW section 3.0, Requirements: The NCI-required research characterization specifications may change based on changing scientific needs, incremental increase needs in sample throughput in the out years, available characterization options, and novel validated assays coming online. As a result, characterization laboratories shall implement changes expeditiously when NCI specifications change. A robust platform is considered analytically validated if it has successfully been tested in at least one other laboratory, is capable of generating reproducible results within and across laboratories using standards and metrics in previous research studies and has been previously published in a peer-reviewed journal or other reliable source of validation information. NCI is well aware that technology, platform, and workflow would evolve over time. As long as offerors can demonstrate equivalent or more superior analytical capabilities using new platforms including new reagents, instruments, and assay workflows in each Service Area and specific assays (see definition of analytically validated platform above), it will be considered acceptable.

8. How long is analysis data required to be stored at the service provider?

Regarding the molecular characterizaEon data (primary and derived analysis results of genomics, transcriptomics, proteomics, etc.), the awardee must store and maintain the data on their local servers for an addiEonal 30 – 45 days aeer the data have been successfully transferred to the CCDI data ecosystem, which should be confirmed by NCI via formal wrifen communicaEons.

9. Please confirm that contractors will not be receiving any Patient Identifying Information

Correct. Samples provided to the awardee for molecular characterizaEon by NCI or other groups will be de-idenEfied first to protect paEent privacy and confidenEality.

10. For the single-cell/single-nuclei workflows, how many cells or what cell number range should be considered?

NCI is asking offerors to describe the opEmum range of sample input amounts (in this case, the number of cells or a range of cells) to reach the analyEcal outputs desired by CCDI.

75N91023R00042 Amendment 01 Page 4 of 5

11. Please clarify the sample type(s) that could be submitted for single-cell/single-nuclei DNA/RNA/methyl sequencing (e.g.

cryopreserved cells, FFPE tissue, fixed cells, single-cell suspensions in plates, etc.).

Currently, there could be a wide range of sample types and sample formats that could be provided to the awardee for molecular characterization in three Service Areas, including but not limited to FFPE and/or fresh frozen tissues for solid tumors or extracted DNA/RNA from tumor tissues, or blood/bone marrow for liquid cancers. The exact number of samples with definitive sample formats are still to be determined at the current time.

Therefore, CCDI is asking offerors to describe their analytically validated pipelines and capabilities for each potential sample type and format in order to reach the desired coverage or depth with optimum sample input amounts to demonstrate their extensive experience in molecular characterization areas of genomics, proteomics, and metabolomics.

12. On page 112 it specifies >1,000 metabolites identified as a requirement for the project. Does this include unknowns, or only metabolites that are confidently named? Also, is this >1000 metabolites identified in at least one sample across the cohort, or in every sample across the cohort?

1000 metabolites refer to known metabolites and metabolite features consistently detected in the majority of the samples across a cohort.

Bear in mind that pediatric cancers are rare diseases, so in some cases, a cohort will only comprise of a few samples.

13. It mentions the expectations of global proteomics to be >8,000 unique proteins from “biological samples”. Does this include blood/serum/plasma? And then again, is this in just one sample, or in every sample across a cohort?

It is 8,000 unique proteins from every sample across a cohort at a minimum except for blood/plasma/serum proteomic profiling. In other words, proteomic profiling directly from blood/serum/plasma +/- immunodepleEon of highly and moderately abundant proteins will not be allowed under this RFP due to the limitaEons of a wide dynamic range of protein concentraEons in blood/serum/plasma. That said, purificaEon of cells from liquid cancers that will undergo proteomic profiling will be within scope.

14. Do you expect to prioritize the most affordable option that meets these coverage requirements, or might you consider premium offerings that are more expensive but offer coverage and performance that blows past the floor expectations? We have multiple metabolomics/proteomics workflows, this answer will help determine which we

The evaluaEon criteria are listed in SecEon M of the RFP. EvaluaEon factors will be a combinaEon of analyEcal/technology capability, past performance and experience to produce results of similar-scale projects, and cost and other factors. The RFP is not R&D in nature and has clearly defined producEon-driven milestones and Emelines.

75N91023R00042 Amendment 01 Page 5 of 5 propose to bring to bear in this application.

15. Please confirm: As stated in FAR 52.219- 9, our deliverables are commercial services and as such it is permissible for us to submit a commercial plan for the small business subcontracting plan requirement.

*Reference:

https://www.acquisition.gov/far/52.219- 9#FAR_52_219_9__d3281e624

Yes, a commercial subcontracEng plan is allowed.

16. As we are providing commercial services (as defined in FAR 2.101), we would submit a commercial plan for the small business subcontract plan that outlines company-wide goals for small business spend (rather than small business spend directly related this contract)?

A commercial plan as defined in FAR 52.219-9 and FAR 19.701 is acceptable, however, please review SecEon L.2.c.4 of the RFP on page 81- 83, “Small Business Subcontract Plan”, which provides the HHS minimum small business subcontracEng goals (page 83, paragraph xi.)

for all acquisiEons.

17. Will proposals containing small business subcontracts have higher value than proposals without small business subcontracts?

SecEon M of the RFP provides Small Business ParEcipaEon as an evaluaEon factor for award for all Offerors that are other than small businesses. Also, the AddiEonal Business Proposal InstrucEons state “If subcontractors are proposed, preference for award decision will be given to offerors subcontracEng with small businesses.”

Therefore, those Offerors who propose subcontractors under this requirement will be rated higher if they propose small business subcontractors.