Solicitation for NCI Genomic Characterization Centers

Amendment No.: 2 to RFP N02CO87001-94

Date of Issuance: 2/15/2019

The above numbered Request For Proposal (RFP) is amended as set forth below. The hour and date specified for receipt of offers remains unchanged: 3/18/2019 at 4:00 PM Wash. DC local prevailing time.

Offerors MUST acknowledge receipt of the amendment prior to the hour and the date specified in the solicitation or as amended, by separate letter, telegram, or email which includes a reference to the RFP and Amendment number. For your convenience, the Proposal Intent Response Form is provided in SECTION J - List of Attachments of this RFP, for this purpose.

This Amendment provides responses to questions received under RFP N02CO87001-94:
*Note: Please carefully review the RFP Section L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS, specifically (II. TECHNICAL PROPOSAL) I., II. and III. on page 45 of the RFP with regards to responding to the IDIQ Base Contract SOW and the Task Order SOWs. Attachment 3 is for the Base IDIQ SOW and Attachments 5 - 7 are the DNA, RNA and Protein Task Order SOWs. Please carefully review ALL attachments to the RFP.

Question 1: Is there a posting of the projects the CCG is working on that might give some idea of the type of work to expect?
Answer 1: The CCG website: https://www.cancer.gov/about-nci/organization/ccg/research

Question 2: Is it possible that some projects envisioned by the CCG might want CLIA lab capability?
Answer 2: It is not required for offerors to have capability of CLIA certified service in this RFP.

Question 3: I unfortunately missed the kick off Webinar. Was that recorded and still available?
Answer 3: There was no kick-off webinar for RFP No. N02CO87001-94. Please carefully read the Request for Proposals (RFP) and all attachments, as well as Amendment 1 for complete information.

Question 4: If a small business wishes to submit a proposal, what % of the contract dollars are they allowed to subcontract with another firm - large or small? Since this solicitation is not a set-aside for small business, would subcontracting with large firms be allowed as a small business and if "yes" what are the restrictions? Also, what are the restrictions for small to small business subcontracting?
Answer 4: Please reference FAR Part 52.219-14 Limitations on Subcontracting.

Question 5: How can a small business become part of the subcontracting plan for a large firm that is competing for this solicitation? In other words, if a small business wishes to be included for a larger firm's proposal, is there a way to be considered as a subcontractor to meet their SB and/or WOSB requirements before the contract is awarded?
Answer 5: Please reference FAR Subpart 44.2 - Consent to Subcontracts - a large business would have to competitively select the small business.

Question 6: Are prime contractors required to identify subcontractors (WOSB, HUBzone, 8a etc) and submit the subcontracting agreements along with the proposal or only state the dollar and percentage amounts they plan to subcontract in attachment #16 of this solicitation?
Answer 6: Prime contractors that are not small businesses must submit a Small Business Subcontracting Plan. Please reference the RFP under BUSINESS PROPOSAL INSTRUCTIONS section, subpart "Subcontractors" for specific details when proposing subcontractors and complete Attachment 16.

Question 7: Can foreign entities be subcontractors for either parts or all tasks listed in the SOW for DNA, RNA, and Protein. Do they have to be listed and active in SAM.gov?
Answer 7: Yes, foreign entities can be subcontractor as long as they can perform the work within the SOW (DNA, RNA and or Protein). Yes, all prime contractors and subcontractors performing work for the Government have to be registered and active in SAM (https://www.sam.gov/SAM/).
Question 8: Can a small business submit a proposal for subcontracting with a potential prime contractor (unknown) that is yet to be awarded for this RFP due on March 18, 2019?
Answer 8: See response to question 5 above.

Question 9: I was writing to get some clarification on what content should appear in the Base IDIQ Technical Proposal vs. the Task Order Technical Proposals. Would you be able to provide some guidance on how the Technical sections should differ for each? Also, should we repeat whole sections (e.g. - Organizational Experience, Personnel, Facilities) in both the Base IDIQ Proposal and Task Order Proposals?
Answer 9: Offerors should address individual Statements of Work (SOWs) separately. Please be sure to review each SOW. Generally speaking, your proposal responding to the Base IDIQ SOW should explain and demonstrate your firm's ability to perform all the requirements of that SOW. Likewise, your proposal(s) addressing a Task Order should address very specifically the requirements of that SOW. To the extend necessary to do this, yes, your proposals may repeat certain information. In addition, overall sequencing capabilities and qualifications should go into the Base response and individual Task Order response(s) should address approaches to specific characterization requirements.

Question 10: In fulfilling the task orders in the RFP can a US company use a global supply chain, for example can DNA be extracted in the US and samples sequenced in a different country?
Answer 10: Foreign subcontractors must be registered and active in SAM and go through a review/approval process to be a subcontractor under a Government contract. In terms of the example provided, it is not correct since Molecular analyte will be provided by a different NCI contract. Therefore, DNA extraction is out of the scope of this RFP.

Question 11: Is there an obligation to be FedRAMP and FISMA compliant? If yes, at time of contract do we need to be FedRAMP and FISMA compliant.
Answer 11: Neither FISMA nor FedRAMP are applicable to this RFP. However, the SOW does require offeror to treat all produced molecular characterization results as protected information and abide by NIH patient and data protection policies.
https://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm
https://www.cancer.gov/grants-training/policies-process/nci-policies/genomic-data/about-policy

Question 12: In considering data delivery and cost implications it would be helpful to understand if transferring data from an AWS S3 bucket is a viable option to the NCI Data Sharing Portal?
Answer 12: The data transfer option/s are implemented and controlled by NCI Genomics Data Commons (GDC) in a separate contract. This GCC RFP is not able to make assumptions on GDC's data submission options. GCC centers are required to comply with data submission standards published by GDC. Those standards might vary in the future due to systematic enhancements, and the GCCs need to modify their submission pipeline accordingly.

Question 13: In the Additional Instructions Technical Proposal Instructions, it states we need to obtain a document for IRB approval or waivers to perform relevant work. We are a CLIA/CAP certified lab, can you supply us with a template and or requirements to secure the waiver? Our understanding is the BPCs will be providing de-identified data and we will put an MTA in place.

Transition Plan
The Offeror shall include a Draft Transition-In Plan comprised of the following:
Additional Technical Proposal Instructions Page 4 of 5
The Offeror shall include a start-up plan of how the Contractor shall commence operations, including specifically the scale up of staffing (including key personnel) and operational resources as well as obtaining required certifications and the incorporation of data, SOPs, and materials and other transition information. The offeror shall include in the plan a timeline to obtain document for IRB approval or waivers to perform relevant work.
Biospecimen Processing Center (BPC): The BPC serves as the tissue processing center and provides the biomolecules for GCCs. Standard operating procedures will be used for clinical data collection, sample collection, pathological examination, biomolecule (e.g., DNA and RNA) extractions, quality control, laboratory data collection, and biomolecule distribution to the GCCs. The samples are required to have patient informed consent for the public release of data or an IRB waiver. (https://cancergenome.nih.gov/abouttcga/policies). All GCC awardees will be required to work with the BPC to establish legal framework document entitled Material Transfer Agreement (MTA) for the transfer of analytes.
NIH recognizes that data sharing may be complicated or limited, in some cases, by institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule (see HHS-published documentation on the Privacy Rule at http://www.hhs.gov/ocr/). The rights and privacy of people who participate in NIH-funded research must be protected at all times; thus, data intended for broader use should be free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects.
Answer 13: The program does not have requirement for documentation of local IRB approvals or waiver. We just need to know that offerors have a viable plan to comply with all local regulations to start the work of contract. The second italic sentence in BPC paragraph above is a description for BCP contract which is different than GCC contract. In addition, this GCC RFP has no requirement for CLIA certification since data are generated for general research purposes.

Question 14: This is a follow-up to my initial call and message left on your voicemail. We are in the process of securing our SAM registration and hope to have that soon. To that end, and given that this is an IDIQ opportunity, will we also need to be established via GSA as a primary contractor in the appropriate Schedule? I did see that because of the amount, up to $49,832,452, there will need to be a subcontracting plan in place by the primary contractor, so we could also consider that course as well. Would we still need a SAM number for that, or would it be required of the primary contractor only?
Answer 14: All prime and subcontractors must be registered and active in SAM to perform work under any contract with the government. For this project it is not required that the prime or any subcontractors be registered/established under the GSA.

Question 15: Would you be sending us gDNA (extracted from FFPE samples and fresh frozen samples) as the starting material for DNA sequencing protocols?
Answer 15: Yes.
Question 16: There are several data QC metric items from each sequencing protocols. Do we need to meet ALL the QC metrics requirements? If not, what is/are the most important item(s) to meet? I'm asking this question because some data QC items are contradicted each other and some items we cannot guarantee.
Answer 16: Yes. All QC metrics are required. If some metrics are overlapping, then the intersection of higher standards should apply.

Question 17: For the Whole Genome Sequencing, I believe low depth coverage is for 15X coverage; high depth coverage is for 30X (non-tumor samples) and 80X (tumor samples). Would you please provide data QC metrics for WGS 60X, which are not included in the DNA Pool SOW?
Answer 17: The QC metrics for 60X WGS is extrapolated below using 30X and 80X. WGS 60X is not part of the specific Task Order so it is not in the DNA Pool SOW. It may be used in future task orders.
1) Average coverage of bases will be 60X or greater for tumor.
2) >85% of bases in genome will have >30x for tumor.

Question 18: Would you please specify library kits that you prefer to use for all protocols under DNA and RNA sequencing? (WGS, WES, WGMetSeq, total RNAseq, Transcriptome sequencing, micro RNA sequencing)?
Answer 18: The RFP does not have recommendations on specific library kits. The offerors are expected to propose their complete pipelines to meet requirements in the SOWs.

Question 19: For the deep sequence targeted validation, we will need custom library kit to sequence. Will you be sharing the kit design number, or will you be providing the custom kit for deep targeted sequencing?
Answer 19: The deep sequencing library design will be project specific. The information is not available at this time.

Question 20: Would you be sending us total RNA (extracted from FFPE samples and fresh frozen samples) as the starting material for RNA sequencing protocols?
Answer 20: Yes.

Question 21: For RNA sequencing, 'number of mapped reads' is per sample total reads? 150 Million reads under the QC metrics will be 75M from read1 and read2 from the paired-end read setting. Can you confirm this is what you are looking for?
Answer 21: Yes, 'number of mapped reads' refers to total reads per sample. If 100% of mapped reads are properly paired reads, then the calculation of read 1 and read 2 is 75M.

Question 22: For RNA sequencing, 'maximum number of genes not detected' and 'percentage of miRNA detected' are not being guaranteed as these are very different from the type of sample source. Are these the requirements that we need to meet?Answer 22: Yes, these metrics are expected. Our current studies showed that large percent of genes and miRNA are expressed in interested tumor samples. In case of sample sources with limited gene and miRNA expressions in future task orders, the metrics will be adjusted.

Question 23: What is the preferred data deliver method among external hard drive, server upload, or cloud (client account) upload?
Answer 23: This RFP does not specify a preferred data deliver method. Offerors should comply with the data submission instructions provide by NCI-GDC (https://gdc.cancer.gov/submit-data). The delivery method might change with time and the offerors need to be able to adapt to those changes.

Question 24: In the DNA SOW on page 4 of Attach5DNApoolSOW.pdf the WGS Low coverage quality control metrics (d) are
#1 Average coverage of bases 15X or greater, and #3. At least 30 Gb or greater.
The genome is 3 Gb, so if we are allowed to provide 30 Gb or greater, this would deliver Average coverage of 10X. To deliver Average coverage 15x, you would need at least 45 Gb. Similarly, on page 5, the WGS High coverage quality control metrics (d) are #1 Average coverage of base 30X/80X for normal/tumor, but #3 says at least 220 Gb sequence per sample [this must mean patient consisting of tumor and normal?]. 30X requires ~90Gb, and 80X requires ~240Gb. If there was a T/N pair, it would require 330Gb, or if tumor only at least 240 Gb. The WGS parameters are somewhat at odds. Should we take #1 (target coverage) or #3 (target base count) as the relevant minimum standard. There is a significant difference with regard to pricing. Or should we price it both ways?
Answer 24: For DNA WGS quality control metrics, offeror should take #1 (depth-of-coverage) and #2 (breadth-of-coverage) as absolute minimum requirements and price tasks accordingly. #3 only suggests an " at least" measure of sequence quantity and is not a QC standard on its own. As offeror pointed out, sequence quantity numbers are usually larger when requirements #1 and #2 are achieved. Under WGS high coverage quality control metrics, "at least 220 Gb sequence per sample" is for tumor/normal pair.

Question 25: The document Attach3BaseIDIQ(allpools)SOW describes 3 Task Areas. In Task Areas 1 & 2, Single cell DNA and RNA sequencing is mentioned; however, in the corresponding Attach5DNApoolSOW and Attach6RNApoolSOW, there is no mention of the criteria for single cell sequencing. We can provide those data types. Should we include those in our proposal?
Answer 25: The document Attach3BaseIDIQ(allpools)SOW is the statement of work for the Base IDIQ contract. It has a broad scope of work anticipated to cover all potential future task orders related to this project. The documents, Attach5DNApoolSOW, Attach6RNApoolSOW and Attach7ProteinpoolSOW are the first set of Task Orders to be awarded under the Base IDIQ contract. Not all items in Base IDIQ are subscribed in these task orders. While single cell DNA and RNA sequencing are not part of the current task orders, it is possible that these platforms will be called in task orders for future projects. Offerors should include responses to single cell DNA and RNA sequencing in the proposal to the Base IDIQ SOW if offerors want to propose the capability. Offerors should address task order requirements in the proposals to individual task orders should they choose to respond.

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Amendment No.: 1 to RFP N02CO87001-94

Date of Issuance: 12/20/2018

The above numbered Request For Proposal (RFP) is amended as set forth below. The hour and date specified for receipt of offers remains unchanged: 3/18/2019 at 4:00 PM Wash. DC local prevailing time.

Offerors MUST acknowledge receipt of the amendment prior to the hour and the date specified in the solicitation or as amended, by separate letter, telegram, or email which includes a reference to the RFP and Amendment number. For your convenience, the Proposal Intent Response Form is provided in SECTION J - List of Attachments of this RFP, for this purpose.
FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERORS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.

This Amendment provides responses to questions received under RFP N02CO87001-94:

Note of clarification:
Indefinite Delivery, Indefinite Quantity (IDIQ) contracts are used when the Government cannot determine the precise quantities of products or services that will be required during the contract period of performance. Under this particular requirement the base awards will be for a five-year period of performance. Once the quantity of supplies/services are determined, a Task Order (TO) for services will be competed in their respective (DNA, RNA or Protein) pools and a TO award will be made after an evaluation of the proposals received. For this RFP N02CO87001-94 please provide separate responses to the Base SOW AND all of the TO SOWs (DNA, RNA or Protein) pools for which your firm would like to be considered for an award.

Question 1:
Article B.2. Prices/Costs says maximum of $49,832,452 for successful performance of the contract. Is that the maximum budget amount that can be requested; and, is it for one task order or all three; and, is that including indirect costs?
Answer:
Under Article B.2. Prices/Costs the $49,832,452 is the maximum dollar/ceiling amount (inclusive of indirect costs) for all potential task order awards made under all contract awards resulting from this solicitation for Indefinite Delivery Indefinite Quantity (IDIQ) type contracts. As noted in the Additional Business Proposal Instructions, proposed fixed per-unit prices shall include all direct and indirect costs.

Question 2:
On page 57 item #4 Small Business Subcontracting Plan states "if the proposed contract exceeds a total estimated cost of $700K for the entire period of performance, the offeror shall be required to submit an acceptable subcontracting plan..." - Is that $700K for one task order or total for all 3, including indirect costs?
Answer:
Any contracts awarded under this RFP will have a ceiling amount of $49,832,452, which exceeds the $700K subcontracting plan threshold. Therefore, offerors (except for small businesses) must submit a subcontracting plan with their proposal submission that uses the ceiling amount as the total estimated cost of the contract.

Question 3:
Can a non-US organization apply for this RFP?
Answer: Yes, a non-US organization may submit a proposal under this Request for Proposal (RFP) if they can perform all tasks within the statement(s) of work.

Question 4:
The question came up about whether there is any notion of what kind of output would be needed. I know there is a reference in the RFP to having a capacity for 100 genomes per month, but the actual contracts could be for far less, correct?
Answer: Correct. No minimum volume is guaranteed by the base contract or any individual task order. Actual amount of work load may be more or less than the minimum capacity for 100 genomes per month.

Question 5:
What is the source for tumors?
Answer: All tumor or normal samples are of human origin.

Question 6:
The RFA lists Baylor as a current contract through 8/19 - what is this for?
Answer: The Request for Proposal (RFP) N02CO87001-94 lists Baylor as the incumbent currently performing work under a subcontract from Leidos Biomedical Research which is the current prime contract holder for this requirement. This arrangement is not being replicated; contracts awarded as a result of this RFP will not be subcontracts under the Leidos contract. (It also should be noted that this requirement is a RFP which would result in a contract award; RFA is a Request for Application and is used only for grant awards.)

Question 7:
The scope looks like DNA, RNA and protein are covered in the RFA, perhaps a call might be helpful.
Answer: This is a Request for Proposal (RFP) and phone calls to discuss the tasks under the Statements of work (SOW) are not authorized. Any discussions and or questions related to the NCI's Genomic Characterization Center's project must go through the Office of Acquisitions office and must be in writing. All questions need to be directed to Contracting Officer via email provided under the RFP post.

Question 8:
The RFP list Baylor University - is this Baylor College of Medicine?
Answer: Yes.

Question 9:
The overall document alludes to the fact that the cancer genomics program at NCI is planning to continue with a number of components, as it has in the past such as the Genome Data Analysis Centers (GDAC). We're wondering whether there is an RFA that is currently posted for the GDAC, or whether this is something that we should expect in the future? We're also hoping to know whether we missed the announcement about GDAC.
Answer: This Request for Proposal (RFP) No. N02CO87001-94 is for the NCI's Genomic Characterization Centers (GCCs) project, as specified in the RFP and explains the work to be done under each Statement of Work (SOW). This RFP is for production of genomic data under a contract mechanism. It is not for data analysis such as the Genome Data Analysis Centers (GDAC), which is performed under a separate cooperative agreement grant mechanism.

Question 10:
For all task order statements of work, the Characterization Platform requirements refer to DNA/RNA/protein "extracted from...samples". Will the GCCs be receiving from the BPC DNA/RNA/protein, or will GCCs receive samples in form of FFPE/Fresh-Frozen/samples of limited size and be required to extract DNA/RNA/protein?
Answer: For DNA and RNA sequencing, GCCs will be receiving DNA or RNA molecular analytes from the BPC. For protein characterization, GCC will receive samples relevant to their analysis platforms.

Question 11:
For the task order statement of work for DNA samples, the Characterization Platform requirements do not list whole genome bisulphite sequencing as one of the platforms. The "Additional Business Proposal Instructions" do list this protocol. Can you provide the performance criteria for whole genome bisulphite sequencing?
Answer: The DNA pool SOW has platform "Whole Genome Methylation Sequencing". Offerors should propose relevant methods and parameters to be used.

Question 12:
For the task order statement of work for RNA samples, the Characterization Platform requirements list FFPE samples, fresh frozen samples, and minimal quantity samples for all three platforms. The "Additional Business Proposal Instructions," only include FFPE and fresh frozen in the pricing table. Can you confirm which sample types will be required for the RNA platforms?
Answer:
Both FFPE and fresh frozen samples should be considered for pricing. Minimal quantity cases can be from either FFPE or fresh frozen samples. The contract does not ask a pricing on minimal quantity samples, but rather the ability to develop a protocol to deal with those situations.

Question 13:
The Pricing Table instructions indicate that for protocols where the Number of Cases is 0, it is because the protocol is not required in the "Task Area Statement of Work." Should this read "Task Order Statement of Work?" Assuming yes, the task order DOES list those protocols - please confirm that offerors should provide pricing for all protocols for which they wish to be considered for service, even where the number of cases currently shows 0.
Answer:
The offeror should provide pricing for all protocols for which they consider providing service, even where the number of cases currently shows 0.

Question 14:
Can offerors for service for DNA or RNA samples offer only some of the characterization protocols, or must offerors be willing and able to provide service in all platforms and protocols in the statement of work?
Answer:
Offerors are not required to address all the platforms in the characterization pool Task Order SOW. However, ability to perform multiple platforms listed in a characterization pool Task Order SOW will be considered favorably.

Question 15:
The task order statement of work lists Whole Genome Sequencing low coverage depth at 15X, but the pricing table includes 15X, 30X, 60X and 80X for both tumor and normal samples. Can you confirm that all coverage options are required for all sample types (FFPE, Fresh-frozen, limited input) for both tumor and normal?
Answer: The task order statement of work lists WGS low coverage depth and WGS high coverage depth. Offerors should provide pricing on all services to be provided in the pricing table.

Question 16:
In the price list table for DNA, the number of cases for the selected platforms is 1,200. Can you confirm whether this is 600 cases, each with a tumor and a normal for a total of 1,200 samples? Or is it 1,200 cases each with a tumor-normal pair, for a total of 2,400 samples?
Answer: It is 1,200 cases each with a tumor-normal pair, for a total of 2,400 samples for DNA. Please note that the numbers in pricing table are just estimate for cost calculation. Proposals should not take the numbers as a firm commitment from NCI. Cases may also come with different configuration in specific projects. For example, some may be collections of primary tumors, recurrences, metastasis, while others may be single tumors only.

Question 17:
For RNA work, please confirm whether the work would be on tumor samples only, or on a tumor-normal pair.
Answer: Both situations are possible. In the pricing table, only tumor samples are listed.

Question 18:
For DNA work, please confirm whether sample type "limited input" is a requirement for deep sequence targeted validation.
Answer: "Limited input" is unlikely to be used for deep sequence targeted validation but is possible.

Question 19:
The characterization pipelines listed in the Attach3BaseIDIQ(allpools) SOW document do not correspond to the numbered lists of characterization platforms listed in the documents Attach5DNApoolSOW and Attach6RNApoolSOW. Section B.2 in Base IDIQ(allpools) for instance, references single cell DNA and single cell RNA sequencing (among other things), neither of which are listed as characterization platforms in the DNA or RNA SOW's. Are we correct in assuming that for either document our application only needs to encompass a subset of the characterization pipelines/platforms within each Task Area of interest? That is, for DNA can we, for instance, apply to perform only WGS, WES and WGMetSeq?
Answer: Yes. Offerors do not have to propose on all platforms. We ask for information on new technologies, like single cell sequencing, so that offerors can discuss their capabilities, but we do not ask for a firm fixed unit price for these new technologies.

Question 20:
I know that NCI intends to award up to 10 contracts, but do you know how many it expects to award for each pool (DNA, RNA, and protein)?
Answer: The number of awards made in each pool will depend upon the number and type of qualified proposals received across all pools.

Question 21:
Is there somewhere online I might find a list of the organizations who have been funded from this program in the past?
Answer: This is an existing requirement currently supported through subcontracts that were awarded under the Federally Funded Research and Development Center (FFRDC) contract number HHSN261200800001E, the Frederick National Laboratory for Cancer Research, operated by Leidos Biomedical Research, with a period of performance of 09/26/2008 - 08/30/2019. The contract is entitled "Operations and Technical Support Services at NCI-Frederick" at the FFRDC.

Leidos subcontract numbers and periods of performance are listed below:
• The Broad Institute of MIT and Harvard = 15X054, 6/24/2015 - 8/30/2019
• MD Anderson Cancer Center = 15X140, 6/19/2015 - 8/30/2019
• University of North Carolina = 16X250, 11/17/2016 - 8/30/2019
• Stanford University = 17X029, 1/1/2017 - 8/30/2019
• Baylor University = 17X184, 10/25/2017 - 8/30/2019

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Please see the attached documents related to the Presolicitation Notice for solicitation RFP #N02CO87001-94, "NCI Genomic Characterization Centers."
Please carefully review the RFP solicitation document and ALL ATTACHMENTS for properly submitting a proposal via NIH's electronic Contract Proposal System (eCPS) by the due date and time specified below.

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Pre-Solicitation Notice: RFP No. N02CO87001-94
Title: NCI Genomic Characterization Centers
Contracting Office Address

Department of Health and Human Services, National Institutes of Health (NIH), National Cancer Institute (NCI), Office of Acquisitions, Riverside Five, 8490 Progress Drive, Suite 400, Frederick, MD 21701-4998.

Note: This synopsis follows Small Business Sources Sought (SBSS) notice that was released on January 16, 2018 under HHS-NIH-NCI-SBSS-TSB-87001-94.

Description

The Center for Cancer Genomics (CCG) provides genomic characterization services through several Genomic Characterization Centers (GCC) to NCI programs and deposits the resulting data in the Genomic Data Commons, a large-scale database of cancer genomic data for public use.

This is a non-Research and Development, Indefinite Delivery/Indefinite Quantity (IDIQ) requirement, which will provide for firm fixed unit price type task orders to be placed. This solicitation will include three separate IDIQ pools (DNA characterization pool, RNA characterization pool, and Protein characterization pool).

The objective of this project is to acquire high-resolution, systematic, comprehensive (genome-wide) characterization services of cancer-related genomic alterations. The contractor(s) shall function as a fundamental resource and play a key role in the CCG research programs. Key goals shall include ensuring that standards are developed, implemented, continually improved, and maintained to support the entire genomic characterization pipeline. Study variables shall be minimized with rigorous Quality Assurance/Quality Control of all parts of the operation.

The contractor(s) shall offer the types of characterizations using validated methods in a high-throughput fashion at the start of the project. The biomaterial for these studies (DNA, RNA, or Protein) will be provided by the Biospecimen Processing Centers (BPC) of CCG. The aim is to have all molecular characterizations conducted on biomolecules from the same biospecimens for optimal analytical integration for data comparability.

The contractor(s) shall support all genomics projects with following services in scope:

1. Receive biomaterial from BPC
2. Operate molecular characterization pipelines
3. Improve and optimize performance of characterization pipelines
4. Implement quality control procedures
5. Support informatics and data delivery
6. Perform transition activities

Multiple awards are anticipated for each pool, although not every offeror who submits a technically acceptable proposal will necessarily be chosen for award. It is estimated that approximately ten IDIQ base contracts will be awarded, among the three IDIQ pools.

This is an existing requirement currently supported through subcontracts that were awarded under the Federally Funded Research and Development Center (FFRDC) contract number HHSN261200800001E, the Frederick National Laboratory for Cancer Research, operated by Leidos Biomedical Research, with a period of performance of 09/26/2008 - 08/30/2019. The contract is entitled "Operations and Technical Support Services at NCI-Frederick" at the FFRDC.

Leidos subcontract numbers and periods of performance are listed below:

• The Broad Institute of MIT and Harvard = 15X054, 6/24/2015 - 8/30/2019
• MD Anderson Cancer Center = 15X140, 6/19/2015 - 8/30/2019
• University of North Carolina = 16X250, 11/17/2016 - 8/30/2019
• Stanford University = 17X029, 1/1/2017 - 8/30/2019
• Baylor University = 17X184, 10/25/2017 - 8/30/2019

The solicitation is anticipated to result in up to ten IDIQ contracts being awarded across the three pools (DNA, RNA and Protein). Each base IDIQ contract will be for five years with awards anticipated on or before July 31, 2019 to offerors capable of performing the work. This advertisement does not commit the United States Federal Government to award any contract. The 2017 NAICS code for this acquisition is 541990 with a size standard of $15.0 million. THIS ACQUISTION IS UNRESTRICTED (NOT A SET-ASIDE FOR SMALL BUSINESSES).

The Request for Proposal (RFP) N02CO87001-94 is scheduled for electronic release on or about 11/20/2018 and receipt of proposals will be due at 3:00 pm ET on or about 2/18/2019. The RFP will only be available electronically and must be accessed through the Office of Acquisitions, NCI homepage by using the following address: http://rcb.cancer.gov/rcb-internet/ OR through FedBizOpps.gov https://www.fbo.gov/. All information required for submission of a proposal will be contained in the electronic RFP package. No collect calls will be accepted. No facsimile transmissions will be accepted. It is the offeror's responsibility to monitor the above-mentioned sites for release of the solicitation and any amendments. All responsible sources may submit a proposal, which shall be considered by the agency. POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITIATION AND ANY AMENDMENTS THAT MAY BE ISSUED. FAILURE TO DO SO WILL BE AT THE FIRM'S OWN RISK. ALL INQUIRIES SHALL BE SUBMITTED ELECTRONICALLY TO THE CONTRACTING OFFICER LISTED AS THE POINT OF CONTACT HEREIN.

Point of Contact: Alexis Hudak, Contract Specialist at email alexis.hudak@nih.gov

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