Amendment01_75N95024R00032.pdf

NSN 7540 - 01 - 152 – 8070 STANDARD FORM 30 (REV. 10-83)

PREVIOUS EDITION UNUSABLE Prescribed by GSA

FAR (48CFR) 53.243

OMB No. 0990-0115

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

1 4

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

01 5/3/2024

6. ISSUED BY CODE JTL 7. ADMINISTERED BY (If other than Item 6) CODE National Institutes of Health National Institute on Drug Abuse Office of Acquisitions c/o 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, MD 20892

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

To All Potential Offerors

9A. AMENDMENT OF SOLICITATION NO.

75N95024R00032

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

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 Offer 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 Item 8 and 15, and returning 1 copies of the amendment; (b) 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 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 hours and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

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 data, etc.) SET FORTH IN ITEM 14, 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.)

PURPOSE: To respond to formal questions submitted in response to the solicitation. All other terms and conditions of the RFP remain unchanged.

PROPOSAL DUE DATE: May 17th, 2024, 3:00 P.M. (Eastern Time) (UNCHANGED)

Note: The offeror should acknowledge on the cover page or first page of its business and technical proposals receipt of the RFP and this Amendment.

ALL OTHER TERMS AND CONDITIONS REMAIN UNCHANGED

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)

Joshua Lazarus, Contracting Officer, NIDA Section

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

(Signature of person authorized to sign)

BY

(Signature of Contracting Officer)

RFP 75N95024R00032 Amendment 1

Questions:

1. The SOW states that the contractor shall complete all quantitative analysis of task orders within 4 weeks of receipt of samples. We would like clarification on the number of samples expected to be submitted for a batch. For example, Sample Task 1 mentions up to 1920 samples with ISR with results 4 weeks after shipment. Would the shipments be staggered or will these samples all arrive at once? Sample Task 2 mentions a study that will take up to two years to complete and up to 8,000 samples to analyze on LC-MS/MS.

We understand that these studies are multi-clinic and multi-cohort. Can you please clarify the expected number of samples and frequency of shipment batches? What would be the expected turnaround time per shipment for QCd (or audited?) data? Per the SOW, “[u]nless indicated otherwise by the COR or the individual task order, the Contractor shall complete the quantitative analysis within four weeks.” Depending on the size of the study and the required turnaround, the expected timeline and scheduling of sample delivery would be negotiated as part of the Task Order request. The sample task orders are illustrative and do not reflect a current requirement. For the purposes of a sample budget, they should assume the capability to meet the stated turnaround.

Per the SOW, “[u]nless indicated otherwise by the COR or the individual task order, the Contractor shall complete the quantitative analysis within four weeks.” Depending on the size of the study and the required turnaround, the expected timeline and scheduling of sample delivery would be negotiated as part of the Task Order request. The sample task orders are illustrative and do not reflect a current requirement. For the purposes of a sample budget, they should assume the capability to meet the stated turnaround.

For proposal purposes on Sample Task 1, please assume one shipment of samples.

For proposal purposes on Sample Task 2, please assume shipments every six months of up to 2,000 samples, with an anticipated turnaround of 90 days from receipt of shipment for final audited data.

2. Page four of Attachment #3 – Statement of Work, section IIE states, “offerors are to provide separate technical proposals (including timelines) and cost estimates for each of the 3 sample tasks listed below.” Five sample task orders are then included.

Question: Should the proposal include all five sample task orders, or a selection of 3 of the 5?

Attachment #3 – Statement of Work, Section II, Subpart E, is amended as follow:

E. Task for Proposal Evaluation

For purposes of proposal preparation, offerors are to provide separate technical proposals (including timelines) and cost estimates for each of the 5 sample tasks listed below. Additional information for proposal preparation is provided within the description of each study.

Question: If all five task orders should be proposed, is it anticipated that more than one or up to all five task orders would be awarded at the same time as the contract award?

As stated in the solicitation, “NIDA expects to award at least one task order to a single contractor at the time of contract award. Future funding will be made through issuance of task orders and will be dependent on program needs and funding availability. The contract will contain a guaranteed minimum of an initial kick-off meeting and not-to-exceed maximum of $5,000,000 over the full five-year ordering period.”

3. In Sample Task 3, section c. “Acquisition and Distribution of On-site Testing Devices (Task D).” states “The Contractor shall acquire and distribute 400 on-site multi-panel drug testing devices (5-panel) including THC 50, Cocaine 150, Opioid/Morphine 300, Benzodiazepines 200, Methamphetamine 300 (or lower). The Contractor shall validate the performance of the product by conducting a comparison of the onsite testing device with an automated immunoassay analyzer.”

Question: Since a cut-off of “Methamphetamine 300 (or lower)” would not meet the requirements for CLIA-waived, can the limit be adjusted to “Methamphetamine 500” to meet the CLIA-waived criteria?

For Sample Task proposal purposes, please assume that “Methamphetamine 500” is an acceptable substitute as a CLIA-waived sample product.

Question: Do all immunoassays need to be on automated systems or will traditional ELISAs fulfill the requirement?

For Sample Task proposal purposes, Offerors may propose the use of traditional ELISA instead of the automated analyzer.

4. According to the pre-solicitation notice, a DEA Research Registration for Schedules II to V is a mandatory requirement for handling substances under the Controlled Substances Act of 1970. The RFP has since updated the requirement to include both research and manufacturing registrations for Schedules II to V controlled substances. Given the defined scope of work, it is anticipated that a research license for Schedules II-V is necessary. However, it appears that a manufacturing license may not be required for Schedule II substances, but rather only for Schedules III to V. Could the Government confirm if possession of a research license for Schedules II to V, coupled with a manufacturing license for Schedules III to V, would be adequate to meet the program’s requirements?

SECTION M - EVALUATION FACTORS FOR AWARD, Article 3. MANDATORY QUALIFICATION CRITERIA, Subpart 2. Is amended as follows:

2. Due to the nature of the compounds which will be evaluated under this contract, it is mandatory that offerors possess Drug Enforcement Administration (DEA) Research Registrations for Schedules II to V controlled substances and demonstrate the capability to obtain DEA Research Registrations for Schedule I controlled substances prior to award. Offerors must also posses a DEA Manufacturing license for Schedules III to V prior to award.

5. Will the Government grant a one (1) month extension to the solicitation due date?

As stated in the solicitation, NIDA anticipates an award to be made in September 2024. In order to award the contract by September 2024. NIDA is unable to grant an extension to the solicitation period.

Drug Enforcement Administration (DEA) ResearchRegistrations for Schedules II to V controlled substances and demonstrate the capabilityto obtain DEA Research Registrations for Schedule I controlled substances prior toaward. Offerors must also posses a DEA Manufacturing license for Schedules III to Vprior to award.