Amendment_1_10.06.2022-S.pdf

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 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.

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

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

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

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NUMBER

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

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.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

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 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, 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)

15C. DATE SIGNED

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

16C. DATE SIGNED

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

Previous edition unusable

SCR

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

Nancy Lamon-Kritikos

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 of its Business or Technical Proposal receipt of this RFP and its amendment.

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.

NIDA Section, Contracts Management Office of Acquisition, NIDA c/o 3WFN MSC 6012 301 N Stonestreet Ave Bethesda, MD 20892

75N95022R00058

1 6

See Block 16C

9B. DATED (SEE ITEM 11)

10/06/2022

X

X

Request for Proposal Amendment No. 01 RFP No. 75N95022R00058 Page 2 of 6

AMENDMENT 01

RESPONSES TO QUESTIONS

1. Would it be possible to get a 2 week extension on the due date to November 11, 2022?

Response: There will be no extension at this time.

2. Would it be acceptable to have a pending application for a DEA registration for manufacture and distribution of Schedule 1 controlled substances?

Response: Per the RFP, Section M.3, offerors must possess, at the time of proposal submission, the Drug Enforcement Agency (DEA) Registrations for manufacture and distribution of Schedule I controlled substances including cannabis and its active and nonactive constituents.

3. Confirming this is to be proposed as Cost-Plus-Fixed-Fee for the Prime Contractor, although subcontractors could be Firm Fixed Price?

Response: Correct.

4. Contract mentions "quantities of cannabis in targeted THC and CBD potencies as identified by the

COR."

a. Is there potential for requiring low potency strains?

Response: Yes, there is potential for requiring low potency strains.

5. Statement of Work Section C. Schedule of Work states that at least Task 1 for 500 KG of cannabis shall be produced in Year 1, and the maximum amount to be provided are four batches of the same, or differing, strengths (GMP or non-GMP) per year. Because cannabis “production” includes cultivation, processing, irradiation, packaging, and testing prior to delivery to the NIDA Drug Supply Program, it is not clear what constitutes a “batch” or the government’s expectations on deliveries.

a. Must the entire 500 KG quantity be delivered in Year 1?

Response: Yes.

b. Can the 500 KG quantity be produced over the 5-year period with the various batches delivered as required by the COR?

Response: No.

c. Will the 500 KG amount be of one variety or of different varieties.

Response: Different varieties.

d. Are all cannabis bulk plant materials produced in Tasks 1 through 5 to be GMP grade?

Response: Yes.

e. Why is non-GMP cannabis included in the above statement regarding a Task 1 order?

Response: It may be that we don’t need GMP for some task orders, as directed by the

COR.

f. Please clarify the statement regarding the total number of batches of drug substances for Years 2-5 not exceeding sixteen.

Response: There may be as many as 16 but there may be less, subject to the needs and funding availability of NIDA. Fair opportunity for task orders will be given to contract-holder(s).

RFP No. 75N95022R00058 Page 3 of 6

6. Will a 5-year base budget be allowed for costs not associated with a specific task but including activities necessary for performance of the contract.

Response: No. Per RFP Sections B.2 and G.3 individual Task Orders will be issued based on the needs and funding availability of NIDA. Costs must be allocated based on the specified requirements of each individual Task Order.

7. Will each task order be a 1-year contract or may the task be performed over multiple years.

Response: Task Orders performance periods will generally be for one year based on a one grow cycle. However, some task orders may have longer performance periods with option periods.

8. Article B.2.b Prices/Costs states that the fixed fee for individual task orders will be negotiated by task order.

a. Are cost budgets and pricing for each task order required in this original proposal, and if so, how will this original proposed price be considered in those negotiations?

Response: Yes. Cost budgets and pricing are required, per RFP Section M.2, for the sample task order provided as Attachment 20.

b. Will the price be negotiated if the full quantity required in a task is ordered?

Response: Per RFP Section G.3, proposed prices will be reviewed and approved by NIDA and mutually agreed upon prior to execution of the Task Order.

9. Article F.2. Deliveries includes deliveries throughout the 5-year contract period but not specific to a Task Order. Should these deliveries be included in the anticipated Year 1 Task 1 order?

Please elaborate on the funding process for deliveries and expenses occurring over the 5-year contract period but not associated with a specific task.

Response: Deliveries shall be included in the cost of each Task Order issued through the ordering period of the contract. Funding will only be provided through the issuance of the individual Task Orders.

10. Instructions to Offers 2.6 allows alternate proposals. Please elaborate on how to submit an alternate proposal.

a. May the alternate proposal be submitted as an attachment to the primary proposal?

Response: Yes. Alternate proposals may be provided in compliance with RFP Section L.2.5.

b. Does an alternate proposal count against the 200-page limit of the technical proposal?

Response: No.

11. Article B.1-5&6 requires the contractor to maintain CMC information for cannabis to provide IND information and LOAs to investigators (or through a DMF submission).

a. Will the current NIDA DMF #1631 no longer be referenced by investigators?

Response: Referencing depends on what supply the investigators will be using.

b. Is the contractor required to submit DMFs to FDA and not provide information to NIDA’s

DMF?

Response: The contractor is required to maintain CMC information to support regulatory submissions for clinical study. NOTE: The contractor may be required to provide information to submit to NIDA’s DMF. Depending on the award, NIDA may expect the contractor to maintain their own DMFs. Alternately if awardee does not

RFP No. 75N95022R00058 Page 4 of 6 want to maintain a DMF then they can provide all the info to the investigators to be included in the investigator IND, depending on the situation.

c. Will CMC information (or DMF) also be required for GMP extract and GMP cannabinoids?

Response: Yes.

12. Do investigators’ CVs and resumes count against the 200-page limit of the technical proposal?

Response: Yes.

13. Should the cost that we include in the proposal for marihuana and CBD raw plant material include the total cost to cultivate, cure and transport the plant material in addition to the post-cultivation labor costs?

Response: All costs associated with an individual Task Order should be included in proposed pricing for the Sample Task Order (RFP Attachment 20) and all Task Orders issued over the Ordering Period.

14. Does the cost to cultivate raw plant material need to be broken down by labor type and hours per kilogram/gram?

Response: No. Costs should be proposed by labor type and hour to accomplish the requirements of the Sample Task Order (Attachment 20) overall (i.e. “1,000 Kilograms quantities of cannabis in targeted THC and CBD potencies as identified by the COR.”)

15. Does the cost for extract products need to be broken down by labor type and hours per kilogram/gram?

Response: Refer to answer and methodology for question 24 and RFP Attachment 9:

Breakdown of Proposed Estimated Costs (plus fee) w/Excel Spreadsheet.

16. For products acquired from subcontractors, do we need to provide the subcontractor’s costs by labor type and hours per kilogram/gram to provide the product?

Response: Refer to answer and methodology for question 24 and RFP Attachment 9:

Breakdown of Proposed Estimated Costs (plus fee) w/Excel Spreadsheet.

17. If subcontracted sources of raw material and/or extract product will result in the final cost of the product being less expensive for NIDA, will NIDA prefer the subcontracted/less expensive source of materials?

Response: Proposals, including proposed prices, will be evaluated as described in Section M of the RFP. The grower would need, at the time of proposal submission, to have Drug Enforcement Agency (DEA) Registrations for manufacture and distribution of Schedule I controlled substances including cannabis and its active and non-active constituents.

18. Does this contract allow for subcontract sources of raw materials and/or extracts outside the US?

Response: It will depend on the proposal specifics. Proposals will be evaluated against criteria described in Section M. Refer to response for question 18 regarding the Mandatory DEA requirements and Section I – Contract Clauses for Buy American and foreign requirements and restrictions.

19. Does NIDA have a preference for US based sources raw plant materials / extracts? Ie. Plant material grown in the US vs outside the US or extracts processed within the US vs outside the US.

Response: Refer to response for questions 17 and 18.

RFP No. 75N95022R00058 Page 5 of 6

20. Can the analysis of materials for product grown or manufactured by the contractor be conducted internally? Or is a 3rd party analysis required?

Response: It can be performed internally.

21. Does NIDA have a preference of outdoor vs indoor cultivated marijuana / cannabis?

Response: No preference, as long as the products meet the requirements stated in the

RFP.

22. p9. Article C.1 TEXT "the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work" Does this exclude the use of subcontractors? If subcontractors are allowed, what obligations does the contractor have to document any subcontractors' compliance with other articles of this RFP?

Response: Supporting subcontractors may be utilized to accomplish the requirements of the RFP. Details regarding the information required in the proposal submissions can be found in L.12. Specific requirements regarding subcontractor compliance for individual clauses are captured within the clauses in the RFP document.

23. p21. Article G.6. Indirect Cost Rates: What is the range of allowable indirect cost rates?

Response: Section M.2 COST/PRICE EVALUATION outlines how cost proposals will be evaluated.

24. p28. Article H.16 RESPONSIBILITIES OF INSTITUTIONS REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST It appears that the contractor has an obligation to ensure no financial conflicts of interest exist for the end user (investigators) of materials provide under task orders. Is that correct?

Response: No. The terms and conditions of H.16, ensures that the Offeror does not have a financial conflict of interest for the requirements of the RFP and subsequent work executed during the term of the Ordering Period.

25. p63. Technical Proposal Instructions As part of the application instructions it requires descriptions of how each aspect of the scope of work is to be accomplished. But, no scope of work exists until task orders are issued. How does one comply with this part of the application?

Response: In accordance with Section M.4, Offerors should base responses on the provided Scope of Work (Attachment 3) and Sample Task Order (Attachment 20) to provide descriptions of how the requirements will be accomplished and their associated costs.

26. p92. TEXT " Irradiate all cannabis prior to shipment to the NDSP. This may be accomplished using a commercial firm or an in-house irradiator, (ex. RS 420-XL model available from Rad Source Technologies, Inc.)" Is NIDA aware of any commercial irradiation services in the US that hold a schedule 1 DEA registration and handle cannabis?"

Response: Offerors are to propose the optimal solution to meet the requirements specified in the RFP.

27. I am writing to inquire if you will accept submission of the "Proposal Intent Response Sheet" after the Wednesday, September 28th deadline. If you are willing to accept this document after the posted deadline, please confirm the latest you would allow for receipt.

Response: Offerors may submit a proposal without having submitted the Proposal Intent Response Sheet.

RFP No. 75N95022R00058 Page 6 of 6

28. The PSC code and the organizational code for Sam.gov’s “Procurement of market research” tool related to this rfp.

Response: The PSC code and all other relevant information regarding this opportunity can be found at SAM.gov at the following link:

https://sam.gov/opp/42462662aee24fb9b988b8bff64a6d64/view

29. Additionally, if you have any additional information on previous RFP's of similar nature that would be helpful. EG: how much of the contract was truly fulfilled and needed.

Response: All relevant information pertaining to this contract can be found within the RFP document and provided Attachments.

https://sam.gov/opp/42462662aee24fb9b988b8bff64a6d64/view