RFP 75N95020R00018 Amendment 01.pdf

NSN 7540 - 01 - 152 – 8070 STANDARD FORM 30 (REV. 10-83)

PREVIOUS EDITION UNUSABLE Prescribed by GSA

FAR (48CFR) 53.243

OMB No. 0990-0115

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

1 6

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

01 See Block 16C

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

National Institutes of Health National Institute on Drug Abuse Office of Acquisitions c/o 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, MD 20892

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

To All Potential Offerors

9A. AMENDMENT OF SOLICITATION NO.

75N95020R00018

9B. DATED (SEE ITEM 11)

February 25, 2020

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

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 Offer is extended is not extended.

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 Item 8 and 15, and returning 1 copies of the amendment; (b) acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDG- MENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR 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 telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hours and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

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

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT/ORDER NO. 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, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

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

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

PURPOSE: To respond to formal questions submitted in response to the solicitation and extend the solicitation due date to May 8, 2020.

PROPOSAL DUE DATE: 3:00 p.m. (Eastern) on May 8, 2020 (CHANGED)

Note: The offeror should acknowledge on the cover page or first page of its business and technical proposals receipt of the RFP and this Amendment.

ALL OTHER TERMS AND CONDITIONS REMAIN UNCHANGED

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.

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

Andrew R. Hotaling, Contracting Officer, NIDA

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

(Signature of person authorized to sign)

BY

(Signature of Contracting Officer) 3/27/2020

Request for Proposal Amendment No. 01 75N95020R00018 Page 2 of 6

RESPONSE TO QUESTIONS

QUESTION 1: Please clarify if the intent is to award an IDIQ for fixed price (FFP) task orders or Cost Plus Fixed Fee (CPFF)?

RESPONSE 1: As stated in Section B, Article B.2 PRICES/COSTS, subparagraph 1.

and 3., “This is an Indefinite Delivery Indefinite Quantity contract as contemplated by FAR 16.504. The Contractor shall be reimbursed by the Government in an amount not less than a total of $300,000 (minimum) nor more than a total of $47,000,000 (maximum) for successful performance of this contract. The minimum amount is inclusive of all task orders issued under this contract. Total compensation will be based on the combined negotiated task orders (fixed price).” And “The Government will compete and award fixed price Task Orders based on the work described in SECTION C of this contract.”

QUESTION 2: Can you clarify if this will encompass the data generation as referenced as 'performing cutting-edge, high-throughput genotyping, sequencing, and gene-expression analyses; and developing an Application Programming Interface (API) for the transmission of data to the Data Centers''. Or will this be a separate Request for Applications (RFAs) ?

RESPONSE 2: Please refer to Attachment 3 - Statement of Work (SOW). As stated on page 2 of 14, a key objective of this contract is to “provide or develop an Application Programming Interface (API) for the transmission of data to the ABCD and HBCD Data Centers and a cyberinfrastructure that enables interoperability and full access to distributed data, software and other information science resources”. Furthermore, Task 2 describes the contract requirements to create and maintain a database and data sharing infrastructure. These services are specific requirements of the Request for Proposal (RFP) and will not be requested through a separate RFP or RFA.

QUESTION 3: Regarding Task 2 – Section C – iv in the SOW; is the provider of the biorepository expected to store phenotypic data, and if so what entity or entities will provide these data and quality control these data?

RESPONSE 3: As stated in the RFP Section M – Evaluation Factors For Award, subpart 6.3.c. under Informatics Component, “NIDA will evaluate the Contractor's plan and ability to (1) create large databases of clinical, diagnostic, and other phenotypic information along with genotypic databases; (2) develop a cyberinfrastructure that enables interoperability with the Data Centers, including full access to distributed data, software and other information science resources. This will include transmitting data to the Data Centers via a secure API and providing the Data Centers with all necessary data in a timely manner to ensure a punctual annual data release and quality control review.”

Furthermore, in the SOW on page 9 of 14 under Task 2, Section C, subpart iv, the Contractor shall, “Use the unique Cell Repository ID and subject/site IDs to retrieve all data for a subject across databases of clinical, diagnostic, pedigree structure, and other phenotypic information along with genotype data, and shall be used by qualified investigators to request biological materials”. The biorepository will only need to store basic phenotypic data (e.g., age, sex) that will be provided by site. The SOW goes on to state under Task 3 subpart d. that the Contractor shall create “A timeline for microarray genotyping as well as for submitting genotype and phenotypic data to the Data Centers after having received all phenotypic data and samples.” As such phenotypic data shall be provided by qualified investigators and sites that have been approved by NIDA.

75N95020R00018 Page 3 of 6

QUESTION 4: Regarding Task 2 – Section B – 4 in the SOW; aside from the ABCD and HBCD Data Centers, what other centers will the contractor/performer be distributing data to?

RESPONSE 4: Please refer to Attachment 3 – SOW, Task 1, Distribution of Biospecimens, subpart d, on page 6 of 14. It states, “The Contractor shall operate in accordance with Department of Health and Human Services regulations specified in 45 CFR Part 46 regarding protection of human subjects as these are applied to the distribution of data and biological materials to qualified investigators for purposes set forth in this contract. In addition, although all samples are de-identified, the Contractor should obtain a certificate of confidentiality as an added assurance. Investigators and collaborators who desire access to biospecimens in the NIDA Developmental Studies Repository for scientific study shall apply for access via the Biospecimens Access Program grant mechanism. The Contractor shall determine whether sufficient samples exist to allow for the amount requested in the application, and provide successful applicants with the specified DNA, serum or other biospecimen samples in the amounts/volumes approved in the application, no later than 1 week after samples have been recovered”.

QUESTION 5: Regarding Task 2 – Section B – 4 in the SOW; will the NIDA Developmental Studies Biorepository and Analysis Center be expected to distribute data? If so, are there any data requirements or distribution restrictions that need to be considered?

RESPONSE 5: As stated in Attachment 3 – SOW, Task 1, Distribution of Biospecimens subpart d.v.5., on page 7 of 14, the Contractor shall, “Develop and maintain a secure password-protected site on the Internet, to permit the rapid and efficient distribution of electronic data files to qualified investigators granted access by the Biospecimens Access Program to data relevant to the approved specimens.” The specific data requirements are described in Task 2 of the SOW beginning on page 7 of 14.

Additionally, please refer to Section H – Special Contract Requirements beginning on page 30 of the RFP. Specifically, Articles H.8, H.9, H.18, H.27, address special considerations related to the data and information security requirements.

QUESTION 6: Regarding Task 2 – Section B – 3 in the SOW; will all the ABCD and HBCD data centers use the same API/upload mechanism?

RESPONSE 6: As stated in the RFP Section M – Evaluation Factors For Award, subpart 6.3.c. under Informatics Component, “NIDA will evaluate the Contractor's plan and ability to (1) create large databases of clinical, diagnostic, and other phenotypic information along with genotypic databases; (2) develop a cyberinfrastructure that enables interoperability with the Data Centers, including full access to distributed data, software and other information science resources. This will include transmitting data to the Data Centers via a secure API and providing the Data Centers with all necessary data in a timely manner to ensure a punctual annual data release and quality control review.”

Since the API/upload mechanism for this requirement has not yet been determined, a capable offeror should address this aspect and procedure in its technical proposal.

QUESTION 7: Regarding Task 2 – Section D – iv; does NIDA prefer a specific and direct communication approach that will enable investigators from ABCD/HBCD to interact with the

75N95020R00018 Page 4 of 6

Biorepository and Analysis Center and other investigators interested in the ABCD/HBCD mission (e.g., social media)?

RESPONSE 7: Within its technical proposal, a capable offeror should describe how it shall accomplish the “Creation and maintenance of an e-mail list of all qualified investigators to enable rapid and efficient electronic communication among the investigators, the Contractor, and the COR.” As well as how it shall establish, “…lines of communication between the ABCD and HBCD Coordinating Centers, Data Centers, Site coordinators, Research Assistants, and site PIs, the Contracting Officer's Representative (COR) and the Contracting Officer, as well as lines of communication and authority with subcontractors”.

QUESTION 8: Regarding Attachment 3, Task 1, pp 2-7, Can services be added to the services listing to comply with descriptions in the SOW and the services listing?

RESPONSE 8: Please refer to Attachment 3 -SOW, Part II, all services to be performed and technical requirements are described in scope are identified in this section.

QUESTION 9: With regard to the unprecedented impacts of COVID-19 on normal workplace practices, will NIDA be offering an extension to the RFP due date?

RESPONSE 9: In response to the impact that COVID-19 has had on normal workplace practices, NIDA shall extend the solicitation period for this RFP 75N95020R00018 by 30 calendar days. Please Note: as a result of this extension, proposal shall now be due on May 8, 2020 at 3:00 P.M. (Eastern Time).

QUESTION 10: Regarding the Business Volume Instructions, pp.105 It is unclear in the solicitation if Certified Cost or Pricing Data is required or if Data Other than Certified Cost or Pricing Data is acceptable. Will the Government please clarify?

RESPONSE 10: As stated in Section L, Article L.2.c.4.(a) on page 105 of the Solicitation this solicitation is excepted from certified cost or pricing data. Subpart (1) on page 106, goes on to state, “In lieu of submitting certified cost or pricing data, offerors may submit a written request for exception by submitting the information described in the following subparagraphs. The Contracting Officer may require additional supporting information, but only to the extent necessary to determine whether an exception should be granted, and whether the price is fair and reasonable.”

QUESTION 11: Will this testing be used for active clinical trial studies? Will any of the testing be used for inclusion/exclusion criteria for clinical trials?

RESPONSE 11: No, all samples will be coming from non-clinical trial studies.

QUESTION 12: How long does the program require the data to be stored? Will the data be stored by participant or by test for the study duration?

RESPONSE 12: The successful Contractor shall store the data for the duration of the contract. The Contractor shall store the data by participant and by test.

QUESTION 13: Can you offer more specifics about the kitting? What type of collection devices are needed? How many kits would you need to be provided? Do the kits need to be

75N95020R00018 Page 5 of 6 customized? Will all specimens be collected at one time – or will there be longitudinal sample collection from the same participant? Can you provide any additional specifics as that will impact cost and number of kits?

RESPONSE 13: NIDA anticipates that for the ABCD study, samples will be collected biannually from the same participants. All kits will be the same. Initially kits will include supplies for whole blood and serum collection. However, this may change as the study evolves. Collection for the HBCD study has not yet begun, so for proposal purposes please assume the samples that will be collected for HBCD and their frequency have not yet been determined.

QUESTION 14: Can you speak more to the logistics of how samples will be routed throughout the process? Is testing expected immediately after receipt at the biorepository or when instructions are provided?

RESPONSE 14: For proposal purposes offerors should assume that all samples shall be sent directly from collection sites to the Biorepository and Analysis Center. Testing on those samples should be done immediately upon receipt.

QUESTION 15: Regarding the testing requirement of “metabolic assays such as CBC with differential, HbA1c, ferritin, cholesterol, and total cholesterol”. Are these the only metabolic assays? If there are more, can you please specify these?

RESPONSE 15: For proposal purposes please assume that metabolic assays include CBC with differential, HbA1c, ferritin, cholesterol, and total cholesterol. If additional clarification is required on specific metabolic assays to be completed during the performance of the contract, NIDA will work with the Contractor to provide additional clarification.

QUESTION 16: Regarding the testing requirement of “DNA/RNA genotyping, high-throughput sequencing, epigenetic, gene expression, RNA transcriptome analyses, microarray analyses, or other genetic analyses.” Can you be more specific about this? Will this type of testing be needed on all samples? Will NIDA specify the genes needed in each of these assays? If we do not offer the exact test, is the expectation that we will validate an assay for use for this program? If we do not have a particular sample type validated for a particular test, can positive samples be provided for the validation?

RESPONSE 16: An interested offeror should clearly identify and describe its specific capabilities in DNA/RNA genotyping, high-throughput sequencing, epigenetic, gene expression, RNA transcriptome analyses, microarray analyses, or other genetic analyses. For proposal purposes please assume that all testing will be done using validated assays.

QUESTION 17: Regarding the analysis of neuroactive chemicals, illicit substances, small molecules, and heavy metals, what is the time period between each collection? Are the counts in the RFP number of participants or total tests? For example, 1 person has 10 tests, does that count as 1 or 10? Will this be on all samples or select samples?

RESPONSE 17: For proposal purposes please assume that the minimum time period between collections is one year. Additionally, offerors should assume that the counts in the RFP represent the numbers of samples not participants or tests. For example, one

75N95020R00018 Page 6 of 6 person may provide multiple samples (e.g., repeated saliva, blood collections) that are each used for multiple tests (e.g., genotyping, metabolic assays).

QUESTION 18: Do you know the estimated percentage of samples that will need each type of testing?

RESPONSE 18: For proposal purposes please assume that all samples will undergo the same type of testing.

QUESTION 19: Will results be distributed to participant or does this stay within the program only? Can the results be distributed individually or do they need to be batched? Do you have a specific format for results distribution? Is a .csv format the requirement?

RESPONSE 19: For proposal purposes, please assume that most results will stay within the program, with the exception of total cholesterol, HDL cholesterol, and hemoglobin A1C. These results will be provided to participants by the ABCD Data Center, not the Biorepository and Analysis Center. The results will need to be batched and sent to the respective ABCD or HBCD Data Centers. In the technical proposal, offerors should clearly describe the data formats used by the proposed API to share data.

QUESTION 20: Is contractor expected to create algorithms for data interpretation?

RESPONSE 20: As stated on page 10 of Attachment 3 – SOW, as part of the Work Plan, the Contractor shall create a, “data management protocol to ensure the creation of processing algorithms and software needed for the creation of: i) Phenotypic and genotypic databases; ii) A cloud-based cyberinfrastructure that enables interoperability with the Data Centers, including full access to distributed data, software and other information science resources. iii) Create a system that allows for positive, auditable sample tracking in the event of modifications to any of the sample data, either intentional or accidental.

[End of Page Intentionally Left Blank]