Amendment_3_(75A50119R00026)_(10.17.2019).pdf

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Attached to
Clinical Studies Network (CSN) Clinical Trial Planning and Execution (CTPE) Federal contract opportunity
Solicitation number
75A50119R00026
Issued by
Department of Health and Human Services Immediate Office of the Secretary

About this file

This request for proposal solicits clinical trial planning and execution services to support the Biomedical Advanced Research and Development Authority's Clinical Studies Network. BARDA seeks multiple awardees to provide core clinical study services for routine use by BARDA and its product development partners, as well as enhanced capabilities for emergency response to threats such as chemical, biological, radiological, and nuclear incidents, pandemic influenza, and emerging diseases. Services include project management, site management, specimen and product management, central laboratory functions, regulatory support, and quality assurance. Awardees must demonstrate ability to rapidly execute clinical studies under expedited timelines during public health emergencies while maintaining scientific rigor and minimizing disruption to patient care. The projected period of performance is five years including a two-year base period and three one-year options. Task orders will be competed under the Indefinite Delivery, Indefinite Quantity contract mechanism.

Amendment 3 75A50119R00026

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Other files for this federal contract opportunity

Other files attached to Clinical Studies Network (CSN) Clinical Trial Planning and Execution (CTPE), newest first.
File Type Posted
Amendment_2_(75A50119R00026)_10.8.2019.pdf PDF
Amendment_1_(75A50119R00026)_(10.4.2019)_FINAL.pdf PDF
RFP_75A50119R00026_CTPE_(9.6.2019).pdf PDF

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(x)

75A50119R00026 x x

1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT 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 letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

x

ASPR-BARDA

ASPR-BARDA

Tip O'Neill House Office Building Room 24F-15 Washington DC 20201

10/17/2019

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

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

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

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

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

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

09/06/2019

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

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

ORDER NO. IN ITEM 10A.

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

Amendment 3 to RFP 75A50119R00026. The answer for Question #69 has been modified to remove

"response to RTORs" from the answer.

The answer for Question 69 reads as follows: The Offerors are expected to estimate the number of hours a year for administrative functions, labor categories, contract kick off, and general contract deliverables. Since the CTPE establishes a new CSN infrastructure, with the statistical and data coordinating center (SDCC) and biological specimen and investigational product storage facility (BSIP), there will be annual meetings with BARDA for governance planning and coordination of services.

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

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

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

JEFFREY E. BROWN

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

jeffrey.brown Typewritten Text 10/17/2019 jeffrey.brown Typewritten Text

2019-10-17T16:29:34-0400
Jeffrey E. Brown -S

File details come from the government source that posted it. Updated .