RFP_75N95022R00009_Amendment 02.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 3

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

02 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 27, 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 provide additional clarification to formal questions submitted in response to the solicitation. This amendment shall also extend the solicitation due date to February 15, 2022 at 03:00 pm EST.

PROPOSAL DUE DATE: February 15, 2022 at 03:00 pm EST (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)

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. 02 75N95022R00009 Page 2 of 3

RESPONSE TO QUESTIONS

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: Per Task 1 of the Statement of Work, offerors are expected to establish and maintain a 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. NIDA does not prescribe a unique approach for this. Offerors should include in their technical approach a discussion of their proposed EDC system and the necessary datasets/tables based on an assumption that fifty (50) CRFs will be required, each averaging 3 pages (or approximately 25 questions per CRF) of data. .

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: Serious Adverse Events and Adverse Events are expected to be collected via electronic CRFs (included in the assumed 50 CRFs) and stored in the overall study database developed under Task 1.a. The DSC will be expected to make stored data available to Clinical Coordinating Center staff (Task 1.e) and Data and Safety Monitoring Boards (Task 5.a).

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: Screen failure rates vary significantly based on the inclusion/exclusion requirements of each supported study, but it is anticipated offerors will only need to provide the support necessary for programming of the screening CRFs and study databases only. The actual screening of study participants will be conducted by CTN Node staff (i.e., grantees).

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?

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. If it’s determined that all of the systems components reside within the same boundary (NIST definition: “All components of an information system to be authorized for operation by an authorizing official. This excludes separately authorized systems to which the information system is connected.”) then just one ATO is required.

Request for Proposal Amendment No. 02 75N95022R00009 Page 3 of 3

If not, then more than one is required. This determination should be made by the system owner(s), the vendor/hosting team, and the “independent assessor” that the vendor uses for the assessment.

QUESTION 26: Can the Government please provide additional clarification on questions 3, 6, 13, and 18?

RESPONSE 26: Please refer additional information provided in the responses above in questions 3, 6, 13, and 18.

QUESTION 27: Given the number of questions and additional clarification required, would the Government please consider extending the solicitation due date?

RESPONSE 27: Yes the Government shall extend the solicitation due date to February 15, 2022 03:00 pm EST.

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