75N95020R00002 - Amendment 1.pdf

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Clinical Coordinating Center for NIDA’s Clinical Trials Network
Solicitation number
75N95020R00002
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This request for proposal solicits clinical research support services for the National Institute on Drug Abuse's Clinical Trials Network. The selected contractor will provide regulatory support, quality assurance, training, pharmaceutical services, drug testing, and protocol development assistance for up to 36 ongoing clinical studies involving around 40 study sites each. Services include advising on submissions, monitoring implementation, assessing compliance, developing training programs, purchasing and distributing study medications and products, coordinating laboratory testing, and contributing to protocol documents. Offerors must have US Drug Enforcement Administration registration to handle controlled substances. The proposal due date is April 16, 2020 with one five-year indefinite delivery/indefinite quantity contract to be awarded to support both ongoing network studies and new initiatives under the HEAL program. Future task orders will specify distinct tasks and funding will depend on programmatic needs and availability of funds.

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OMB No. 0990-0115 AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES

1 2

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

NIDA Section, Contracts Management Branch Blue Office of Acquisitions, NIDA National Institute on Drug Abuse, NIH 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.

75N95020R00002

9B. DATED (SEE ITEM 11)

March 5, 2020

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

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 amend the Request for Proposal (RFP) to incorporate responses to Offerors’ questions. All other terms and conditions of the RFP remain unchanged.

Proposal Due Date: Thursday, April 16, 2:00 PM EST (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.

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 Section, CMB Blue 15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

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

PREVIOUS EDITION UNUSABLE Prescribed by GSA

FAR (48CFR) 53.243

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.

4/9/2020

Title: Clinical Research Coordinating Center for NIDA’s Clinical Trials Network RFP No. 75N95020R00002

Request for Proposal (RFP) No. 75N95020R00002 is amended as follows:

PURPOSE: The purpose of this amendment is to include questions from offerors and responses in reference to the solicitation.

QUESTIONS/ANSWERS

1. Question: For this solicitation, can you please supply further details concerning: Perform quantitative and qualitative confirmatory analyses of study material?

Will (all) the analytic methods be supplied or will they need to be developed?

Response: The offeror should demonstrate their capacity to provide confirmatory analyses of study material. The analytic methods will not be supplied.

RFP Ammendment 1 - SF30
RFP Ammendment 1
2020-04-09T16:22:19-0400
Andrew R. Hotaling -S

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