Amendment_2_10.14.2022.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1

1. CONTRACT ID CODE

I

PA

E OF PAGES

I 5

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER

5. PROJECT NUMBER (If applicable)

02 See Block 16C

6. ISSUED BY CODE SCR 7. ADMINISTERED BY (If other than Item 6) CODE I NIDA Section, Contracts Management Office of Acquisition, NIDA c/o 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, MD 20892

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X) 9A. AMENDMENT OF SOLICITATION NUMBER

[x] 75N95022R00058

9B. DATED (SEE ITEM 11)

10/14/2022

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

CODE I FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

[8}rhe above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers D is extended [Kl 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 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or electronic communication 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 letter or electronic communication, provided each letter or electronic communication 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)

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

IT MODIFIES THE CONTRACT/ORDER NUMBER 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

NUMBER IN ITEM 1 OA.

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, 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 D is not Dis 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 condition of the Request for Proposal (RFP) remain unchanged.

Proposal Due Date: 3:00 p.m. (Eastern) on October 28, 2022 (UNCHANGED) Note: The Offeror should acknowledge on the cover page or first pages on its Business or Technical Quotes receipt of this RFP and its amendment.

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 1 OA, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED

(Signature of person authorized to sign)

Previous edition unusable

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

Nancy Lamon-Kritikos

16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

Nancy L. Lamon- Digitally signed by Nancy L.

Lamon-kritikos -S kritikos-S Date: 2022.10.14 07:45:34 -04'00' 10/14/2022

(Signature of Contracting Officer)

STANDARD FORM 30 (REV.11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Request for Proposal Amendment No. 02 RFP No. 75N95022R00058 Page 2 of 5

RESPONSE TO QUESTIONS

1. Can you provide more details on the storage requirements? Amount of material anticipated?

Duration of storage? Storage conditions required?

Response: Storage requirements will be based on the stability data generated by the contractor. Most of NIDA’s current materials are stored frozen. Amounts of materials will depend on the specifics of the individual task order. Some materials that are grown will be shipped to another contractor site for distribution.

2. Would the State of California cannabis testing requirements be sufficient to qualify bulk cannabis and finished goods for release, in addition to any Federal testing requirements that are not covered?

Response: Per the RFP, Section M.3, the Contractor must have Drug Enforcement Agency (DEA) Registrations for manufacture and distribution of Schedule I controlled substances including cannabis and its active and nonactive constituents. The testing requirements are in Attachment 3 of the RFP and the material has to be GMP certified.

3. If a company is not a grower of Marijuana crop, but they are an FDA/DEA inspected operation capable of preparing Marijuana extracts and preparations/dosage forms. If the company’s primary operation is for the preparation of finished drug products under DEA Schedules I-V, are they still eligible under this multiple contract IDIQ?

Response: Please refer to response to Question 2. Contractor has to be able to grow/produce cannabis as specified in Attachment 3 of the RFP.

4. What is the timeframe for providing up to 1000 kg?

a. Is it annual?

Response: Timeframe for provision of grown materials will be dictated by the individual task order. It is expected that 1000 kg would be able to be provided within one grow cycle.

b. What increments/frequency will you need this shipped in.

Response: Increments/frequency of need will be determined by the Government and will be dictated by the release of individual task orders.

c. We are not able to ship across state lines, what would be the preferred mode of transportation?

Response: Cannabis grown by federally approved growers (per mandatory criteria in RFP Section M.3) will be able to be shipped across state lines. Shipping will involve the use of DEA Forms 222.

d. Will this be picked up or will we need to arrange transportation?

Response: The contractor will be expected to ship the materials to the location directed by the task order or Contracting Officer’s Representative (COR).

e. If we are providing transportation what provisions made to carrier to be exempt from prosecution?

Response: There are carriers that will transport controlled substances (FedEx, etc.) with the required DEA forms and registrations in place.

5. For the flower that needs to be sent, does it need to be in a state as if it was going to a consumer?

a. e.g. trimmed, untrimmed, rough trimmed?

RFP No. 75N95022R00058 Page 3 of 5

Response: Most grown materials will be desired in roughly ground homogenous batches. If another form is desired it will be dictated by the task order and/or the COR.

b. Preferred packaging, bulk packed with nitrogen flush, bagged etc.

Response: Cannabis batches should be bagged. Specific instructions will be provided in the task orders and/or by the COR.

6. Can all tests for this program be done in-house as opposed to having 3rd party compliance testing labs do the testing?

Response: Yes, testing of the grown materials can be performed “in-house”. Testing should include all the tests specified in the RFP and be reported on batch certificate of authenticity.

a. If there are additional requirements for testing than what is required by the state, the 3rd party compliance testing companies may not have the capability to perform all tests.

Meaning we would have to purchase equipment and train employees to perform the tests in-house. Is this an issue?

Response: Yes, it can all be done in house as long as it meets the requirements specified in the RFP.

7. Although the production of cigarettes is not included in the Statement of Work or in any task description, the manufacture and maintenance of cigarettes is mentioned in several sections. In Section D. Packaging, Marking and Shipping the requirements for packaging cigarettes is stated.

Attachment 3-II. Services to be Performed (page 2) requires the contractor to produce and maintain cigarettes. Please confirm that the production of cigarettes is not required under this contract.

Response: Task orders for specific tasks will generally be competed and awarded on the basis of fair opportunity. It is anticipated but not guaranteed that one or more task orders will require the contractor to manufacture and maintain a stock of marijuana cigarettes of varying potencies of various different cannabinoids as part of this contract as directed by task orders and/or the COR. The contractor shall also analyze the marijuana cigarettes for cannabinoid content under direction of the COR.

8. Task 6–Provision of cGMP Cannabinoid Extract requires extraction for production of 1 KG THC (>99%) and 1 KG CBD (>99%) and the depleted plant material used for extraction is to be provided as placebo marijuana. Tasks 7&8–Provision of (purified) Cannabinoids requires production of synthetic or extracted cannabinoids having purities ³ 98%. Please clarify these task requirements and address the following questions:

a. Cannabinoid extract rich in THC or CBD and containing other naturally occurring cannabinoids is currently provided to investigators. Does Task 6 require provision of extract for this purpose, and what amount of extract is required?

Response: Yes, it is expected that the NIDA Drug Supply Program will continue to send cannabinoid rich extracts to researchers. The range of amounts is specified in Attachments 3 and 20 of the RFP.

b. Must the extract or purified cannabinoids produced under a single task order be delivered within one year or may they be produced and delivered over the 5-year period as required by the COR?

Response: It is expected that extract will be provided as requested by the task order within a one year or a shorter time period as directed by the task order and/or the COR.

c. While only THC and CBD are mentioned in the task requirements the production of

RFP No. 75N95022R00058 Page 4 of 5 other minor cannabinoids may require different costs and pricing. Will other minor cannabinoids be required? Please specify those other cannabinoids.

Response: Some tasks may be generated requesting minor cannabinoids as specified in the RFP. Example minor cannabinoids are CBN, CBC, CBG, CBA-A, THCV, etc.

d. Please clarify the purity limits for all cannabinoids as the production of neat >99% THC and CBD is not a feasible process.

Response: The target purity for requested cannabinoids is >98% or as agreed to by the Government.

9. Tasks 4&5–Provision of Placebo Cannabis requires the contractor to “grow, harvest and analyze placebo cannabis.” However, cannabis plant material suitable as placebo must contain only negligible amounts of all cannabinoids, not just THC. Hemp varieties of cannabis without undergoing extraction are not suitable as placebo materials for clinical studies. Are these tasks intended to provide starting materials for Task 6?

Response: The contractor will be required to provide placebo that is low in cannabinoid levels. The THC level must me below 0.3% and others should be minimal. Refer to RFP Attachment 3 for additional details.

10. Article B.1.7 requires the contractor to supply three categories of items: cannabis, cannabis extract, and other cannabis products. We assume that cannabis is bulk plant materials and cannabis extract is extract containing the natural constituents of cannabis. Pure cannabinoids are not specifically stated. Please define these three categories. Are any other “products” required?

Response: Other products do include purified cannabinoids as described in the RFP.

Specifics will be dictated in task orders and/or by the COR.

11. Does the contract allow for costs to acquire specialized equipment to meet general and specific manufactured product as requested through the contract? (examples: specific extractions, gel cap machines, packaging machines, irradiator, etc.)

Response: It is expected that the contractor will have access to much of the equipment needed prior to contract award. The purchase of specific equipment can be proposed and are subject to the needs and funding availability of the Government.

12. p14. Section E Inspection and Acceptance TEXT " Inspection and acceptance will be performed at:

National Institute on Drug Abuse National Institutes of Health 3WFN MCS 6016 301 North Stonestreet Ave Bethesda, MD 20892" Does this imply that all materials are shipped to NIDA? Will NIDA be providing DEA Form 222 for all controlled substance transfers? Will NIDA then be responsible for appropriate storage and shipment of materials to the end user?

Response: Unless otherwise directed, materials will be shipped to a NIDA contractor where it will be stored and shipped to researchers. DEA Forms 222 will be provided as required.

13. p91. TEXT "The Contractor shall grow cannabis, produce research and cGMP-grade bulk cannabis and cannabis cigarettes, and maintain a stock of cannabis preparations such as bulk and cigarettes of varying potencies of various cannabinoids, ...The Contractor shall serve as NIDA's cannabis drug repository and keep these products in proper storage conditions

a. Is the contractor required to produce finished goods formulation and packaging to satisfy this RFP? It appears the contractor is expected to maintain an inventory. At what scale?

RFP No. 75N95022R00058 Page 5 of 5

Response: Contractors will be required to store materials based on individual task order requirements (e.g. amounts needed to conduct stability testing).

14. P93. TEXT "Grow and harvest up to 500 Kilogram quantities of cannabis in targeted THC and CBD potencies as identified by the COR." Will NIDA need original quotes for all material bought to produce finished product? Can NIDA please provide specifications and exact amounts of THC/CBD potencies and cGMP finished products? In order to be GMP certified, Contractor will need to build clean rooms. Can these clean rooms be used outside of the contract?

Response: The contractor’s accounting system must be adequate for determining, tracking and invoicing costs applicable to the contract or order. Amounts and specifications will be identified in the individual task orders. Clean rooms can be used outside of the contract.

15. In regards to DEA forms in class 225a along with the DEA memorandum; we’re trying to make sure there are no conflicts of interest related to us continuing to operate under both a private industry purview towards prospects as well as those governmental in this case?

Response: Contractors are required to comply with the requirements of the DEA to maintain DEA registration as well as the terms and conditions of this RFP and subsequent contract. Refer also to ARTICLE H.16. RESPONSIBILITIES OF INSTITUTIONS

REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST.

16. Can you provide more detail on the cGMP requirements relative to FDA and what certifications must be in the proposal?

Response: Please refer to FDA guidelines on cGMP requirements:

(https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps). Offerors should demonstrate proof of the inspection and acceptance of the designated facility by the FDA in accordance with the FDAs GMP guidelines in order to address their ability to manufacture cannabis cigarettes, cannabis extract and other cannabis products at the levels of Good Manufacturing Practices (GMP) purity and potency requested and in quantities needed.