Amendment 02.pdf

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 or (c) By separate letter or electronic communication 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 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.

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

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

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

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

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 Offers is extended. is not extended.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

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

NUMBER 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, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

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

D. OTHER (Specify type of modification and authority)

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.

15C. DATE SIGNED

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

16C. DATE SIGNED

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

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

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

Previous edition unusable

Jill M. Johnson

The purpose of this amendment is to address questions received on the solicitation and to update Security Plan requirements.

See Q&As following on page 2.

Article B.3. ADVANCE UNDERSTANDINGS Paragraph b. Security is hereby amended to read as follows:

A security plan is required as described in Attachment 15. A security plan template is provided in Attachment 16.

HHS/OS/ASPR/BARDA/CMA

200 C Street SW, Washington, DC 20024

75A50121R00003

1 3

07/15/2021

06/17/2021

RFP No. 75A50121R00003 Amendment 2

Questions and Answers

1. In some cases, information requested for Past Performance conflicts with confidential disclosure agreements with the reference organization. Can we code the organizations and provide names at a later date if needed?

Response: This is fine.

2. Will the reviewers of the Technical Plan Proposal also be able to review or have access to the Mandatory Evaluation Criteria submission? This would help us avoid repetitions in the Technical Proposal that has a page limitation.

Response: Technical reviewers will have access to the Mandatory Evaluation Criteria submission.

3. Page 5 of the RFP, part b states no security plan is required at this point for this effort. It is anticipated that a security waiver will be approved. However, on page 9, 1.1.2 the RFP states that BARDA’s Program Protection Office is authorized to review and approve Security Plans and refers to Attachments 15 and 16, security plan templates. Then again, on page 75, line 7 in the Project management evaluation criteria, adequacy of a security plan is listed in the criteria. Is Offeror correct in interpreting that a security plan waiver will be granted as stated on page 5, and that the proposal submission does not require such a plan?

Response: A security plan is required. The RFP is amended (see SF-30 Form, Block 14 of this amendment) to reflect this correction.

4. Non-Clinical Terms of Award, pg27, #2. A statement is made that the contract does not involve the use of animals. However, pre-clinical tox testing may be required by the FDA for filing an IND and estimating bioequivalence of adult and pediatric doses. Will BARDA accept an Offeror’s proposal to include this testing and cost?

Response: Yes.

5. What tier of EVMS is anticipated for this program?

Response: It is anticipated that the Earned Value Management Tier 2 System will be required.

RFP No. 75A50121R00003 Amendment 2

6. Will Offerors be expected to fully define their EVMS approach in the Business Proposal?

Response: Offerors should use their discretion in regard to addressing EVMS.

7. Is there a required page margin limitation and font type and size for the proposal?

Response: BARDA has not defined a specific page margin limitation nor font type.