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This document is an amendment to a solicitation for clinical trials sponsor and regulatory management support services. The National Cancer Institute, Center for Cancer Research is seeking proposals to provide compliance with U.S. and international regulations, regulatory support to ensure FDA adherence, safety monitoring and reporting, clinical site assessment and monitoring, trial master file support, sponsor quality management support, medical writing, administrative support, and computerized activity tracking and reporting systems. Services are also required to support management of multi-center trials where NCI is the sponsor, and non-NCI site recruitment and management. Offerors should direct any questions in writing to the point of contact by October 30, 2020 for potential responses in amendments to the solicitation.

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75N91020R00027_amendment 2.pdf PDF
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AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

N/A

PAGE

OF PAGES

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

October 5, 2020

4. REQUISITION/PURCHASE

REQ. NO.

5. PROJECT NO. (if applicable)

6. ISSUED BY CODE

7. ADMINISTERED BY (If other than Item 5) CODE

National Cancer Institute Office of Acquisitions 9609 Medical Center Drive Room 1E620, MSC 9705 Bethesda, MD 20892-9705

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

TO ALL POTENTIAL OFFERORS

9A. AMENDMENT OF SOLICITATION NO.

75N91020R00027

9B. DATED (SEE ITEM 11)

September 25, 2020

10A. MODIFICATION OF

CONTRACT/ORDER NO.

CODE

FACILITY CODE

10B. DATED (SEE ITEM 13)

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 Offersis 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 Items 8 and 15 and returning ___ copies of the amendment; (b) By 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 THE 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 hour 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 FAR 52.243-2. 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 date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b) and Contract ARTICLE B.4.

C.THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D.OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor _ _ is not X is required to sign this document and return 1 _ copies to the issuing office.

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

Article A.11. of the Solicitation is amended to add the following:

Submit all questions in writing to: paula.wilkison@nih.gov Responses to questions will be provided in Amendments to the Solicitation.

Questions received after 4:00 P.M. Eastern Time on October 30, 2020 may not be addressed.

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

Paula A. Wilkison

15B. CONTRACTOR/OFFEROR

BY ______________________________________________

(Signature of person authorized to sign)

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

BY _____________________________________

(Signature of Contracting Officer)

16C.DATE SIGNED

NSN 7540-01-152-8070 30-105 STANDARD FORM 30 (REV 10-83.)

PREVIOUS EDITION UNUSABLE Prescribed by GSA

FAR (48 CFR) 53.243

mailto:paula.wilkison@nih.gov

2020-10-05T10:50:54-0400
Paula A. Wilkison -S

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