A29 - Amendment 2 SF30_D-20-DC-0018_Amendment P00002.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES 1 3

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable) P00002 04-28-2020

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

DRUG ENFORCEMENT ADMINISTRATION

OFFICE OF ACQUISITION AND RELOCATION MGMT

8701 MORRISSETTE DRIVE

SPRINGFIELD, VA 22152

DRUG ENFORCEMENT ADMINISTRATION

OFFICE OF ACQUISITION AND RELOCATION MGMT

8701 MORRISSETTE DRIVE

SPRINGFIELD, VA 22152

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, state and ZIP Code) (X) 9A. AMENDMENT OF SOLICITATION NO.

To all interested offerors D-20-DC-0018

9B. DATED (SEE ITEM 11)

04-01-2020

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 11)

CODE FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDENTS 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.

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) N/A

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

IT MODIFIES THE CONTRACT/ORDER NO. 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

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).

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

D. OTHER (Specify type of modification and authority)

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

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

The purpose of this amendment to Request for Information (RFI) number D-20-DC-0018 is to provide answers to the questions received on 4/22/2020. Questions and answers are attached.

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 (Type or print)

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

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

NSN 7540-01-152-8070

Previous edition unusable

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA FAR (48 CFR) 53.243

REQUEST FOR INFORMATION – D-20-DC-0018

QUESTIONS AND ANSWERS

1. QUESTION: This is a 12 month contract listing for June 2020 to June 2021. Is the agency allowing for the training phase required to allow for the duration of time needed to train a stock colony of rats in a standard 2-choice operant drug discrimination task once the training dose, pretreatment intervals, full study design is approved by the agency. No training could be initiated until the specific training dose, route-of-administration, pretreatment intervals, and session durations are approved by the contractor.

As you know, the initial training period for a similar behavioral assay has been reported in peer-reviewed scientific journals to be approximately 45 to 60 days in duration from animal receipt to first day of testing. Once trained the dose-effect functions for morphine and fentanyl would take another 14 days to generate. This suggests that the first compound may not be “testable” for 3 months following contractual approval. The SOW does not allow for this timing interval and thus it requires 10 compounds to be tested and reported in 7 months-time.

ANSWER: Under a purchase order agreement, the maximum number of months is 12. We strongly encourage the vendor to complete all studies within the contract timeline. However, in the event the testing is not complete, DEA can issue a no cost extension to extend the time to complete the studies. To clarify the SOW details, the testing is for 10 compounds in both analgesia and drug discrimination for a total of 20 tests (20 study reports).

2. QUESTION: We conduct both of these assays under FDA’s Good Laboratory Practices guidelines.

While not stated in the SOW, is it the intent of the agency (contractor) to require full formulation characterization for each compound being tested per GLPs?

Formulation concentration, homogeneity, and bench-top stability are required under the GLPs, but no mention of this requirement is found in the SOW.

ANSWER: The test substances will be provided by DEA and therefore will not need additional formulation characterization. It is the vendor’s responsibility for obtaining the training drug (morphine), reference substances (fentanyl), and antagonists (naltrexone) or any other substances needed to complete the studies. All substances shall be maintained as per the Good Laboratory Practices (GLP) or GLP-like conditions. Please refer to Task 1. Drug source, storage and recordkeeping of the SOW for more details.

3. QUESTION: The SOW has listed 5 year data archiving. Can this be at an official “off site” archiving storage facility or must the records remain on site of the CS registrant? The implication here is that any contractor-based visit or audit would require a short notice of intent to be able to transport data records from an off-site facility to the test facility for a scheduled meeting or audit.

ANSWER: DEA has no preferred location for the storage of the data by the vendor. However, as stated in the SOW, if so instructed by DEA, the vendor shall ship these items to the DEA representative in Arlington, VA.

4. QUESTION: The RFQ requests only a quote to complete the requested study. Is only a quote needed at this time? Or should research protocols be submitted with the quote as well?

ANSWER: The RFQ is the final stage before selection of a vendor. Therefore, the RFQ requests a quote as well as research protocols per the SOW. DEA needs to be able to evaluate the potential vendor to ensure that all requirements in the SOW are met. Please review the SOW in detail.