19-223-SOL-00023_-_A0001.pdf

(x)

19-223-SOL-00023

x x 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 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 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.

x

DAP

Beltsville MD 20705 4041 Powder Mill Road ATTN: Richard Robinson

DHHS/FDA/OAGS/DAP

DAP

Beltsville MD 20705 4041 Powder Mill Road ATTN: RIchard Robinson

DHHS/FDA/OAGS/DAP

04/15/20190001

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

04/15/2019

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 date, 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.)

The purpose of this amendment is to provide the FDA responses to questions submitted during the solicitation question period. See attached pages for a list of questions asked and the

FDA responses.

No other changes are made to the solicitation information and the proposal due date remains unchanged (May 16, 2019, 2:00 pm EST).

Period of Performance: 07/28/2019 to 07/27/2024

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)

RICHARD W. ROBINSON

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA

FAR (48 CFR) 53.243

NSN 7540-01-152-8070

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 .

19-SOL-223-00023- In Vitro and Non-Clinical Evaluation of Locally-Acting Topical Dermal and Ophthalmic Formulation Properties Amendment 1

The following questions were received prior to the close of the question period under solicitation number 19-SOL-223-00023 (FDA Answers in red):

1. Which attachment to consider for “statement of work”? Attachment 4 or 19-223-SOL- 00023-Final.

In accordance with the paragraphs on “Technical Understanding and Approach” of Sections L and M of the solicitation, Offerors are required to submit a technical approach responsive to both the IDIQ Statement of Work (Section C of the 19-223-SOL- 00023-Final document) and the statement of work for Task Order 1 (Attachment 4).

Please also note that in the Section L and M paragraphs on Price, Offerors are required to submit Pricing information responsive to the IDIQ (attachment 1) and Task Order 1 (Attachment 3). See Section L and M of the solicitation in its entirety for more specific details on this.

2. Would you be able to tell me if there is an incumbent contractor for this requirement?

If so, could you please provide the contractor name and the contract number that was awarded?

This is a new requirement with no previous contracts awarded for this work.

3. Could you please tell me if the Combined Synopsis/Solicitation posted as solicitation number 19223SOL00023 on FBO contains requirements similar to any work performed currently or in the past, or will this be a new requirement? If possible, can you please provide the most recent contract or task order number?

See answer to question 2.

[END of AMENDMENT 1]