RFP_75N95022R00009_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 7

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.

75N95022R00009

9B. DATED (SEE ITEM 11)

January 21, 2022

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 ACKNOWLEDGMENT 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. All other terms and conditions of the RFP remain unchanged.

PROPOSAL DUE DATE: February 7th, 2022, 3:00 P.M. (Eastern Time) (UNCHANGED)

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)

Joshua Lazarus, Contracting Officer, NIDA Section

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)

Request for Proposal Amendment No. 01 75N95022R00009 Page 2 of 7

RESPONSE TO QUESTIONS

QUESTION 1: As it pertains to Attachment 3, Sections II.D.1, 2, and 3 – Cost Assumptions for each Task Order Type; for Task Order Type A in D.1 it states: “For Task Order Type A, offerors may assume, for proposal preparation purposes that each task order will require 15,245 hours of effort over a period of one year.” II.D.2 and II.D.3 have identical language indicating the offeror “may assume”. Did the Government intend this to mean that each offeror should use the hours listed in their cost estimate?

RESPONSE 1: Correct.

QUESTION 2: As it pertains to Attachment 3, Section II.D.2 – Cost Assumptions for Task Order Type B, it states, “For Task Orders of Type B, offerors may assume, for proposal preparation purposes that each task order will require 9,000 hours of effort over a period of four years …”.

Please confirm this means that the sample task order for Type B will have a duration of 4 years and that the 9,000 hours of effort should be estimated as a total amount spread across all 4 years? If not, please clarify.

RESPONSE 2: Correct.

QUESTION 3: In Attachment 3, Section II.D.2 – Cost Assumptions for Task Order Type B, under Task Order Sample of Type B – Research Protocol Development and Support; can the Government provide example number of units for the following: datasets; unique tables; repeat tables; figures; listings?

RESPONSE 3: As stated in Attachment 3, Section II.D.2 – Cost Assumptions for Task Order Type B, under Task Order Sample of Type B – Research Protocol Development and Support offeror should assume fifty (50) CRFs per protocol averaging 3 pages of data for each form.

QUESTION 4: In Attachment 3, Section II.D.3 – Cost Assumptions for Task Order Type C, it states that offerors should include, “500 consultant hours at a rate not to exceed $150 and a sub-contract with a total value of $100,000.” We understand from the information in Task 7 of the SOW (Attachment 3 page 7 of 10) that the government anticipates the need for consultants as requested by the COR. Given this understanding we have the following questions:

a) With regard to pricing these consultant costs, we assume NIDA does not require offerors to name any specific consultants in the RFP that will be tied to the rate of $150/hour, and that this is just a placeholder for a future consultant? Please confirm.

b) Does the Government intend the language in II.D.3 regarding “a sub-contract with a total value of $100,000” to mean a sub-contract with a separate entity other than the consultant priced at $150/hour (e.g., should offerors price both a To-Be-Determined consultant and a To-Be-Determined subcontractor?)

c) Assuming NIDA intends offerors to name a To-Be-Determined subcontractor, please confirm offerors are not expected to specifically name or propose such a subcontractor for purposes of the sample task order for Type C, and that this is just a placeholder for future anticipated activity.

d) The overall effort requested is 700. In addition to the 500 consultant hours, does the government anticipate that the additional 200 hours will come from the effort performed under the $100,000 sub-contract, or should offerors assume that the offeror’s personnel will also perform 200 hours under Task 7 of the SOW in the period?

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RESPONSE 4: Please see individual responses below:

a) Correct.

b) Correct.

c) Correct.

d) Offerors should assume that the 700 hours of effort under Task Order Type C, are reserved for the Contractor to manage, collaborate, and coordinate the sub-contractor supported project (i.e., not consultant hours).

QUESTION 5: Within Section L.2.c.4 Business Proposal Instructions on page 91 for the Requirement for Certified Cost or Pricing Data and Data Other than Certified Cost or Pricing Data under FAR Clause 52.215-20, please confirm that the Government expects adequate independent competition such that offerors are not required to submit certified cost or pricing data per FAR 15.403-1(b).

RESPONSE 5: Correct, the Government expects adequate independent competition such that offerors are not required to submit certified cost or pricing data per FAR 15.403-1(b).

QUESTION 6: In Attachment 3, Section II.C. Task 5.a, under Adverse Events and Serious Adverse Events for DSMB, can the Government provide information on which contractor is holding the safety database?

RESPONSE 6: Please refer to the scope of Task 1 in Attachment 3, Section II.C. As such, the offeror will be responsible to program and maintain the safety database.

QUESTION 7: In Attachment 3, Section I. B. it states, “The CTN anticipates requiring support for initiation of six to eight large multi-site research studies (engaging several large health care systems and as many as 20-30 sites per study) during the first year of this contract and approximately four to eight research studies annually thereafter.” Does the Government expect to transfer ongoing studies at the start of this contract to the Offeror? If so, how many?

RESPONSE 7: The Government shall not transfer any ongoing studies at the start of the new contract. A majority of the ongoing studies are non-severable in nature and cannot be transferred.

QUESTION 8: In Attachment 3, Section II.C. Task 1.a. it states, “Establish and maintain state-of-the-art, efficient, reliable, responsive, and secured electronic, web-based systems for the collection, storage, management, quality assurance and reporting of all study data, including data extracted from CRFs in a foreign language (e.g. Spanish) with foreign language data dictionaries.” A data dictionary contains the metadata for the database (variable names, labels, attributes, etc.). Offeror’s Database Developers and Statisticians require English while using the metadata. Will the Government please clarify what is needed with regards to a foreign language data dictionary?

RESPONSE 8: An English language data dictionary describing the metadata for the database will be required to assist investigators in their use and application of study data. NIDA anticipates that most data collected will be in English, however data may be submitted in other languages. NIDA cannot determine what applicable languages may be relevant prior to the implementation of the actual studies.

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QUESTION 9: In Attachment 3, Section II. C. Task 1.k it states, “Upon completion of each study, prepare a complete, final, cleaned, edited, and documented data set containing all study data”. Please confirm if this data should be CDISC compliant or if NIH has a preferred standard for the Statistical Analysis Plan, mock shells, and the datasets.

RESPONSE 9: Study data are typically provided in SAS format and, Statistical Analysis Plans are developed in collaboration with supported study Investigators per the requirements of their studies.

QUESTION 10: In Attachment 3, Section II. C. Task 1.m it states, “De-identify each trial’s final database for public use (e.g. according to HIPAA), and handle database requests from the public (see the NIH’s public data sharing policy website at http://grants.nih.gov/grants/policy/data_sharing/). Transfer the databases, along with corresponding documentation (data dictionary, protocol, Case Report Forms) to NIDA’s Data Share point of contact for posting. Create and maintain a public website to house the completed databases if needed.” Please respond to the following questions:

a) Please confirm if the de-identified data is to be based on the raw data from the clinical database or analysis datasets.

b) If CDISC will be adopted please clarify if the de-identified data will be based on SDTM or ADaM structures.

c) Please clarify if the de-identification task includes the reproduction of a selection of the primary and secondary analyses on the de-identified data.

d) Please confirm the timeframe post DBL expected to produce the de-identified data

RESPONSE 10:

a) Correct, de-identified data should be based on the raw data from the clinical database.

b) CDISC is not required.

c) The de-identification task does not include the reproduction of a selection of the primary and secondary analyses on the de-identified data.

d) Deidentified data should be available for posting 18 months after completion of the study or upon publication of the study’s primary outcome manuscript; whichever occurs first

QUESTION 11: In Attachment 3, Section II.B. it states: “The CTN anticipates requiring support for initiation of six to eight large multi-site research studies (engaging several large health care systems and as many as 20-30 sites per study) during the first year of this contract and approximately four to eight research studies annually thereafter.” What is the proportion of studies that are expected to support regulatory submissions?

RESPONSE 11: The proportion of studies that are expected to support regulatory submissions are completely dependent on which studies are funded in the future and cannot be determined at this time.

QUESTION 12: In Part II, Section I, Article I.3. Additional Contract Clauses on page 49, number 13 is FAR Clause 52.227-14, Rights in Data - General (May 2014). Given the requirement for commercial off-the-shelf (COTS) technical solution, would the Government consider the modification of ARTICLE 1.3 ADDITIONAL CONTRACT CLAUSES to include FAR 52.227-14, Rights in Data – General (May 2014) Alternate I, II, and III.

75N95022R00009 Page 5 of 7

RESPONSE 12: Generally, a contract should contain only one data rights clause.

However, where more than one is needed, offerors should identify and distinguish the portion of contract performance to which each separate alternate clause pertains. If applicable these clauses can be reviewed and finalized during negotiations.

QUESTION 13: As it pertains to Attachment 20, Part I.B Task Description under Task Order Type B Task Description, can the Government provide the typical screen fail rate seen in Task Orders of Type B for estimating purposes?

RESPONSE 13: The Government did not identify a target sample size for Task Order Type B, and therefore is not able to provide a typical screen fail rate for participants.

QUESTION 14: In Part I, Section B. Article B.1, it mentions that sites may be located across the nation and in other countries. Can the Government specify the proportion of domestic US versus ex-US sites anticipated so the Offeror is able to provide the appropriate technical approach?

RESPONSE 14: For proposal purposes please assume that the study sites will be within the USA.

QUESTION 15: In Attachment 3, Section II.C. Task 1.a, it addresses Web-based systems for the collection, storage, management, quality assurance and reporting of all study data. What is the clinical electronic, web-based systems for the collection, storage, management, quality assurance and reporting of all study data currently being used to support the current active studies? Is it Commercial off-the-shelf or commercially available off-the-shelf (COTS) technology?

RESPONSE 15: The Government does not intend to provide an Electric Data Capture system or database. As part of its proposal the offeror should propose and describe a system that will provide for the collection, storage, management, quality assurance and reporting of all study data.

QUESTION 16: In Attachment 3, Section II.C. Task 1.c, it requires that offerors establish and administer a web-based document management system for secure electronic communications.

What is the web-based document management system for secure electronic communications?

Is it COTS technology?

RESPONSE 16: The Government does not intend to provide a web-based document management system. As part of its proposal the offeror should propose and describe a system that will allow for secure electronic sharing of study documents.

QUESTION 17: As it pertains to Attachment 3, Section II.C. Task 2.e under standard protocol templates, is the protocol template provided by the Government or should Offeror use our own standard template?

RESPONSE 17: For each Task Order the Government uses a standard protocol template.

QUESTION 18: With regard to Section L.2.a.17.B, Security Assessment And Authorization (SA&A), is an ATO required for the EDC and document management systems under the DSC6 contract?

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RESPONSE 18: As stated in Article H.15.3. Government Information Processed on GOCO or COCO Systems, subpart A.1. A valid authority to operate (ATO) certifies that the Contractor's information system meets the contract's requirements to protect the agency data. If the system under this contract does not have a valid ATO, the Contractor (and/or any subcontractor) shall work with the agency and supply the deliverables required to complete the ATO within the specified timeline(s) within 90 calendar days after contract award.

QUESTION 19: With regard to Section L.2.a.17.B, Security Assessment And Authorization (SA&A), is the information covered under this contract considered controlled unclassified information (CUI)?

RESPONSE 19: Correct, NIDA defines Controlled Unclassified Information (CUI) as information that requires safeguarding or dissemination controls pursuant to and consistent with applicable law, regulations, and government-wide policies but is not classified under Executive Order 13526.

QUESTION 20: With regard to Section L.2.a.17.B, Security Assessment And Authorization (SA&A), as clinical study designs continue to evolve, does the government anticipate that there will be a need to support design and analysis of trials with adaptive designs, master protocols, etc.? If so, approximately how many studies may require this support?

RESPONSE 20: This will depend on which studies are funded and cannot be determined at this time.

QUESTION 21: Are there any requirements or guidance for the page count of the technical proposal and business proposal, as well as each of the sample task order proposals?

RESPONSE 21: There are no page limitations established, however proposals should be concise and efficient.

QUESTION 22: Is NIDA looking for the vendor to recommend a clinical trial database for NIDA to purchase with the expectation that the vendor will be managing the database, or is the expectation that the vendor will be the owner of the database and collect NIDA’s clinical data in the vendor’s database?

RESPONSE 22: Please refer to the response to Question 6 above.

QUESTION 23: Does NIDA have an estimation for the extent of travel under the SOW?

RESPONSE 23: Offerors should propose travel as it deems necessary to fulfill the SOW described in Attachment 3 Section II.C. Tasks 5 and 6 as well as Section II.D.

QUESTION 24: Please clarify if the IDIQ will be awarded to one vendor or multiple vendors?

RESPONSE 24: As stated in Section L.1.c.1 of the RFP, it is anticipated that a Single Award IDIQ will be made from this solicitation.

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QUESTION 24: If a small business is bidding as the prime contractor, is a small business plan still required on the proposal?

RESPONSE 24: As stated in Section L.2.c.6.a of the RFP, the Small Business Subcontracting Plan provision does not apply to small business concerns.

QUESTION 25: Is the incumbent staff currently performing some or all of the work covered by the SOW expected to be transitioned upon award to the vendor?

RESPONSE 25: The Government does not have any expectation as it pertains to the incumbent’s current staff.

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