Amendment 0001 of RFP 15DDHQ24R00000021_04.19.2024.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE PAGE OF PAGES

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

4/19/2024

4. REQUISITION/PURCHASE REQ. NO 5. PROJECT NO. (If applicable)

6. ISSUED BY CODE 7. ADMINISTERED BY (IF OTHER THAN ITEM 6) CODE

Drug Enforcement Administration

8701 Morrissette Drive

Springfield, VA 22152-1080

Drug Enforcement Administration

Diversion Control Division

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State, and Zip Code) 9A. AMENDMENT OF SOLICITATION NO.

15DDHQ24R00000021

9B. DATED (SEE ITEM 11) 4/10/2024

10A. MODIFICATION OF CONTRACT/ORDER NO.

CODE: FACILITY CODE: 10B. DATED (SEE ITEM 11)

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.

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) Not applicable.

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

IT MODIFIES THE CONTRACT/ORDER NO., AS DESCRIBED IN ITEM 14

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.

RFP Amendment No. 0001 is issued for the following reason(s):

1) To provide the Government's Q&A response.

2) To reference the SOW change on Page 15, Section 5 - Deliverables Table, No. 7 (Changes are in red).

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

16A. NAME AND TITLE OF CONTRACTING OFFICER

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 STANDARD FORM 30 (REV. 10-83)

Previous Edition Unusable Prescribed by GSA FAR (48 CFR) 53.243

04/19/2024

Denise Scott

RFP 15DDHQ24R00000021 - Q&A RESPONSE - Evaluation of Abuse Potential of Hallucinogenic Substances Using In Vivo Pharmacological Studies

Page, Section and Paragraph # and/or

Attachment

Ordering Period tables on pages 2-5.

The ordering period tables contain 16 units of “Drug Discrimination of Test Drug.” Does each unit of “Drug Discrimination of Test Drug” cover the costs of testing one drug for substitution for both LSD and PCP, or testing one drug for substitution for a single training drug?

The 16 units of "Drug Discrimination of Test Drug" represents the total test drugs assessed in drug per year of contract. These 16 units would be divided up between the up to two groups of rats trained during the base year or each option year of the BPA, based on need and trends. The training drug may change each year and may not necessarily LSD and PCP. If say, LSD and PCP were decided on for the year, it could be 9 tests drugs tested in LSD-trained rats and 7 tested in PCP-trained rats. A drug could be tested in both drug-trained groups, but would count for 2 units.

Section 2.1, page 6.

Will some of the “Drug Discrimination of Test Drug” units be used for the dose-response studies of training drugs and reference drugs? If not, how should the offeror supply the costs for determining dose-response curves for the training and reference drugs?

The dose-response curve and reference drug(s) will be included as part of the total "Drug Discrimination of Test Drug" units.

Task 3, page 9.

How many rats and how many experimental doses should be used for each test drug for drug discrimination?

At least eight rats should be used per drug. The number of doses needed would vary based on the effects of the drug, but would be vehicle and training drug controls and at least three doses of the test drug.

Task 3, page 9.

Will all novel test drugs be tested for substitution for both training drugs in drug discrimination?

The novel drug might be tested in both training drugs in drug discrimination. It would depend on the training drugs, effects, or other factors. If this were the case testing the drug in both training drugs would count for two units.

Task 5, page 11.

For pharmacokinetic studies, will identification and disclosure of metabolites used for LC-MS based calculation of pharmacokinetic parameters suffice?

Yes. Specific information can be decided and agreed upon after the contract is awarded and the drugs for pharmacokinetic studies are decided.

Task 5, page 11. Does DEA prefer use of mice or rats for the pharmacokinetic studies?

There is no preference by DEA. The vendor should be able to justify their choice.

Deliverables table in Section 5, page 15.

The table mentions potential travel to DEA headquarters for meetings. How should we supply the costs for this? How many trips will there be in each ordering period and how many days will the trips need to be?

Travel is not a requirement. See change in the SOW, Deliverables table in Section 5, page 15.

Page 21, Section 5, Proposal Format and Content.

The table said to include a Pricing Spreadsheet (Attachment 1) and a Sample BPA Call Order (Attachment 2). Will DEA be providing blank template attachments?

Attachment 1 & Attachment 2 was provided in the solicitation. Contractor are required to price the quantities provided.

Page 21, Section 5, Proposal Format and Content.

Would DEA allow the key person letter of commitment be included as an appendix outside of the technical page limits? Yes.

Page 21, Section 5, Proposal Format and Content.

Would DEA allow references to be included as an appendix outside of the technical page limits? Yes.

Questions Comments Government Technical ResponseItem

DEA/DC/DOE 15

7 Meetings between DEA and contractor and supporting materials (as needed, may be waived)

To or With DEA:

i. Monthly conference calls:

once a month after submission of monthly report

ii. In-person meetings (as needed)

iii. Pre-Meeting Materials:

three weeks before each meeting for approval; two weeks before each meeting for dissemination

iv. Post-Meeting Materials:

within three weeks after each meeting

v. Meeting Location(s): to be determined as specified by DEA (may include video conferencing, scientific meetings. DEA headquarters, etc.)

6.0 Use of Data

All documents, data, materials, records, and information sources provided to the contractor, developed or maintained by the contractor in the performance of this contract under this Statement of Work are deemed to be the property of DEA. All data collected, generated, manipulated or otherwise processed under this agreement are confidential information unless or until DEA authorizes its release. None of these data may be used at any time for any purpose except to generate reports or other requirements specified in the Statement of Work, without prior written approval of DEA. The contractor and DEA will mutually agree to discuss matters of Freedom of Information Act (FOIA) policy before each agency independently discloses requested information.

On or before the agreement year expiration, the contractor shall deliver (or otherwise dispose per DEA) all data, including raw databases (electronic or hard copies), tapes, software programs used to interpret or analyze data, weight calculation files, data collection forms, file definitions, and various edited databases generated under this contract to DEA (except for data necessary only to comply with other Federal data retention requirements, such as requirements pertaining to clinical trials or the Food and Drug Administration's rules pertaining to drug applications).

During or after the agreement, no data may be released, presented or published except upon prior approval of DEA. All requests which the contractor will receive from third parties for access to the data must be referred to DEA.