19-223-SOL-00023_-_Amendment_2.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

04/15/20190002

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 after the solicitation question period closed. While the solicitation question period had closed, the FDA thought it would be prudent to provide this clarifying information for potential offerors. 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 2

The following questions were received after the close of the question period under solicitation number 19-SOL-223-00023, however given the nature of the questions the FDA has provided the following answers (in red):

1. We have noted the different personnel listed under section C.7 (Staffing/Key Personnel Minimum Requirements) and details on the key personnel that have been provided. Can some details also be provided on the role of the program manager and research specialist so as can identify and assign the appropriate resources for these functions.

Per Sections L and M of the solicitation, resumes are only required for Key Personnel and minimum qualifications will only be evaluated for Key personnel. The other staff are expected to have necessary/relevant experience to perform the work of the contract as defined in the IDIQ SOW and Task Order IDIQ.

2. Can you clarify if the key personnel can play more than one role – for e.g. Can the veterinarian for the dermal studies also function in the capacity of the PI?

Yes, they can serve in more than one role, however for the purposes of comparing like proposals, please ensure the rates are applied to the estimated hours for both labor categories.

3. We have noted under section C.4.3 that IVRT and/or IVPT have to be performed GLP and per C.4.4 bioanalytical work has to be GLP ( using validated methods).

Can you clarify the in vivo PK studies ( dermal and /or ophthalmic) have to be GLP?

We assume the PD studies will be non-GLP.

All non-clinical animal studies should follow developed protocols that meet and are approved by an Institutional Animal Care and Use Committee (IACUC) and the COR prior to being conducted but need not necessarily be conducted per Good Laboratory Practice.

4. Can you confirm the studies to be performed under Task Order 1 (Attachment #4) will be non-GLP ?

See response to Question 3 – Task Order 1 is an in vivo animal model so should follow developed protocols that meet and are approved by an Institutional Animal Care and Use Committee (IACUC) and the COR prior to being conducted but need not necessarily be conducted per Good Laboratory Practice.

19-SOL-223-00023- In Vitro and Non-Clinical Evaluation of Locally-Acting Topical Dermal and Ophthalmic Formulation Properties Amendment 2

5. Per the amendment which included FDA responses to questions previously received for this solicitation it is indicated - 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). Can you clarify:

That we have to submit the technical approach (scopes of work) for IVRT, IVPT, In Vivo Ocular and Dermal PK and PD as contained under the Section C? We can certainly provide this for IVRT, IVPT and standards designs for PK but for the PD are we submitting some representative models (e.g. IOP reduction, dry eye model) for the PD studies?

Per Section M of the solicitation, the Offeror needs to “demonstrate its understanding and its overall technical approach to satisfying the requirements for each assignment [emphasis added] in the Base IDIQ Statement of Work (SOW) as well as the Task Order SOW (Attachment 4).”

In response to the IDIQ Statement of Work technical approach, the offeror may prepare and/or describe their potential capabilities and/or high level approach to address monitoring key PD parameters associated with common ophthalmic products such as dry eye, inflammation, and glaucoma animal models and corresponding equipment and expertise to measure tear film break up time, anterior chamber cell count, and intraocular pressure. The offeror does not need to address all potential PD models and measurements, however providing detail of the scope of their capabilities is preferred.

As for responding to the Task Order SOW, it is expected the offerors would include information on their proposed animal dry eye model and technical approach to measure tear film break up time, as this is specific to Task Order 1.

[END of AMENDMENT 2]