NIDA_RFP_No._N01DA-15-7793 _Amendment_No._01.pdf

“PRODUCTION, ANALYSIS, AND DISTRIBUTION OF

CANNABIS AND RELATED MATERIALS”

AMENDMENT OF SOLICITATION NO.: RFP No. N01DA-15-7793

AMENDMENT NO.: 01

EFFECTIVE DATE: October 23, 2014

DUE DATE FOR PROPOSALS: November 10, 2014, 3:00 P.M. Local Time (Unchanged)

ISSUED BY:

National Institute on Drug Abuse, NIH NIDA R&D Contracts Management Branch Office of Acquisitions, NIDA 6001 Executive Boulevard Room 4211, MSC 9559 Bethesda, Maryland 20892-9559

* For FedEx/UPS/Courier/Hand-Delivery, use Rockville, MD 20852

Primary Point of Contact: Secondary Point of Contact:

Andrew Hotaling, Contract Specialist Kenneth E. Goodling, Contracting Officer Phone: (301) 443-6677 Phone: (301) 443-6677 E-Mail: hotalingar@mail.nih.gov E-Mail: kgoodlin@mail.nih.gov

NAME AND ADDRESS OF CONTRACTOR: To All Offerors

The above numbered solicitation is amended as set forth below. All other terms and conditions of the RFP remain unchanged.

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

PURPOSE: To respond to formal questions submitted in response to the solicitation and to amend the

RFP.

Note 1: Each offeror should acknowledge on the cover page or the first page of its Business and Technical Proposals receipt of the RFP and Amendment No. 01.

(over)

RESPONSES TO QUESTIONS

QUESTION 1:

Section M, Article M.3.D. of the RFP (p. 97) indicates that “the successful offeror and/or the successful offeror’s subcontractor responsible for the production/manufacture of cannabis extract drug dosage form, and marijuana cigarettes must be registered with the Food and Drug Administration (FDA) as a pharmaceutical manufacturer for both sterile products and for drug dosage form.” Since the dosage forms specified are cannabis extracts and marijuana cigarettes and not injectables, please clarify the requirement for FDA registration for sterile products.

ANSWER 1:

The successful offeror and/or the successful offeror’s subcontractor do not need to register with the FDA as a pharmaceutical manufacturer for sterile products. For clarity, Section M.3.D. of the RFP is amended to read as follows:

D. The successful offeror and/or the successful offeror's subcontractor responsible for the production/manufacture of cannabis extract drug dosage form and marijuana cigarettes must be registered with the FDA as a pharmaceutical manufacturer for drug dosage forms.

QUESTION 2:

Please clarify the requirement in Section M, Article M.3.B. of the RFP (p. 97) for back-up systems for outdoor and indoor growing facilities by providing examples.

ANSWER 2:

Section M, Article M.3.B. requires that “[t]he successful offeror shall have provisions for back-up systems for the outdoor and indoor facilities in case of emergency.” (p. 97) Specifically, the successful offeror shall have backup systems for water, electricity, and lighting in the outdoor and indoor facilities in the case of inclement weather or other destructive events.

QUESTION 3:

If NIDA exercises Option Quantity 4c. in Section C, Article C.1.II.D. of the RFP (p. 14), will the Contractor need to manufacture 5,000 standardized marijuana cigarettes in total “containing a high concentration of delta-9-tetrahydrocannabinol (THC), or cannabidiol (CBD) or both (greater than 5.0%) or as required by the COR” or will the Contractor need to manufacture 5,000 cigarettes of each concentration specified above (15,000 cigarettes in total)?

ANSWER 3:

The Contractor needs to manufacture 5,000 cigarettes in total “containing a high concentration of THC, or CBD or both (greater than 5.0%) or as required by the COR” (p. 14).

QUESTION 4:

Since NIDA intends to request production of cannabis with specific chemical profile that would be produced through vegetative propagation, notification of intent to exercise Option Quantity 1 in Section C, Article C.1.II.D. of the RFP (p. 12) should be made early enough to allow the Contractor to acquire the Drug Enforcement Administration (DEA) quota and produce enough cuttings for the requested cultivation size. Will NIDA consider changing the notification date towards the end of the calendar year (e.g., October) prior to the growing year?

ANSWER 4:

NIDA will consider the recommendation for future contract implementation. However, we are not amending Option Quantity 1 at this time.

QUESTION 5:

Please clarify whether the cannabis extract described in Section C, Articles C.1.II.B.2. (p. 10) and C.1.II.D., Option Quantity 2 (pp. 12 – 13) of the RFP is to be decarboxylated or not.

ANSWER 5:

The Contractor should prepare decarboxylated cannabis extract as described in Section C, Articles C.1.II.B.2. (p. 10) and C.1.II.D., Option Quantity 2 (pp. 12 – 13) (if exercised).

QUESTION 6:

Since the dosage form required is of cannabis extract, which cannot be an injectable and most likely oral, please clarify the need for an ampoule manufacturing requirement in Section C, Articles C.1.II.D., Option Quantity 3 of the RFP (p. 13).

ANSWER 6:

If NIDA exercises Option Quantity 3, the Contractor should develop a suitable dosage form of cannabis after consultation with team of research investigators who plan to use the dosage form in their experiments/clinical study.

QUESTION 7:

For Section C, Article C.1.II.D., Option Quantity 3 of the RFP (p. 13), which dosage form should we consider for proposal purposes? Different dosage forms will require different resources.

ANSWER 7:

Oral dosage forms are preferred; however, offerors are free to propose and justify other dosage forms.

QUESTION 8:

Section C, Article C.1.II.B.4.iv. of the RFP (p. 11) specifies that the Contractor shall “[s]hip marijuana cigarettes to research investigators as required by NIDA.” Since cigarettes are dosage forms shouldn’t cigarettes be distributed through the NIDA Drug Supply Program (DSP)? Also, should the bulk cannabis, cannabis extracts, cannabinoids, and extract formulation dosage forms described be shipped to the DSP for distribution to investigators?

ANSWER 8:

Per Section C, Article C.1.I.B., the Contractor and its subcontractor(s) (if applicable) “supply cannabis, cannabis extract, other cannabinoids, and marijuana cigarettes to research investigators and/or to the NIDA Drug Supply program upon NIDA authorization.” (p. 9).

For clarity, Section C.1.II.B.2. of the RFP (p. 10) is amended to read as follows (changes italicized):

2. Extract cannabis to produce approximately 1 Kg of cGMP-grade marijuana extract of known CBD and THC contents as required by the COR.

If additional cannabis and cannabis extract are required beyond 10 Kg and 1 Kg limits respectively, the Contractor shall grow additional cannabis and produce additional cannabis extract (10 Kg, 50 Kg, and/or 100 Kg) upon the exercise of respective Option Quantities 1 and 2. Disposal of all waste materials is inclusive to this task.

The Contractor shall quantitatively analyze samples of cannabis extract for determining the THC, CBD and other cannabinoids contents, and upon NIDA authorization supply cannabis extract of known potency and specifications to research investigators and/or to the NIDA Drug Supply inventory.

Section C.1.II.B.3. of the RFP (pp. 10-11) is also amended to read as follows (changes italicized):

3. Extract cannabis to isolate cGMP-grade/research grade (>95%) delta-9-THC and other cannabinoids, such as CBD, CBN, CBG, CBC, tetrahydrocannabivarin (THCV), and additional cannabinoids as required by the COR.

The Contractor shall manufacture, and provide the following cannabinoids to research investigators and/or the NIDA drug supply inventory upon COR authorization, and dispose of the resulting waste materials per year:

a. delta-9-THC - 200.00 grams (g)

b. CBD - 4.00 g

c. CBN - 2.00 g

d. CBG, CBC, and THCV - 0.200 g, each

Section C.1.II.B.4.iv. of the RFP (p. 11) is also amended to read as follows (changes italicized):

iv. Ship cannabis, cannabis extract, other cannabinoids, and marijuana cigarettes to research investigators and/or to the NIDA Drug Supply program upon NIDA authorization. The Contractor shall enclose analytical data sheets with each shipment or as specified by the

COR.

QUESTION 9:

Section C, Article C.1.II.D., Option Quantity 6 of the RFP (p. 14) requires the analysis of up to 150 samples per month (or 1,800 samples per year). If NIDA exercises this option five (5) times per year, does that mean exercising the monthly amount of 150 samples per month for a maximum of five (5) times per year (i.e., a maximum of 750 samples per year) or five (5) times the yearly amount of 1,800 samples five (5) times per year (i.e., 9,000 samples per year)? Please clarify.

ANSWER 9:

Under this Option Quantity, the number of samples for analysis is up to 150 per month (for a total of 1,800 per year). NIDA may exercise this Option Quantity as and when warranted during the period of performance of the contract up to a maximum of five (5) times per Contract Year.

QUESTION 10:

Outdoor grow facilities suffer from limited growing seasons and a lack of control over environmental conditions that may affect product yields and quality. Can appropriately-sized indoor facilities replace the outdoor facilities so long as the quantitative yields of cannabis and cannabinoids can be achieved on an annual basis?

ANSWER 10:

No. Per Section M.3.B. of the RFP (p. 96-97), “the successful offeror must possess, and maintain (1) a secure and video monitored outdoor facility of approximately 12 acres for growing and processing cannabis, and (2) an indoor growing facility for the purpose of growing, propagating, and sustaining cannabis plants under controlled conditions. The indoor facility must be at least 1000 square feet, having controls for light intensity, photo cycles, temperature, humidity, and carbon dioxide concentration. The successful offeror shall have provisions for back-up systems for the outdoor and indoor facilities in case of emergency.”

QUESTION 11:

Will NIDA be providing the seed materials for the cannabis varieties indicated in Section C, Article C.1.II.B.1.a. of the RFP (p. 9) throughout the duration of the contract? If no, please explain how the sponsor envisions seed sourcing and management to occur by the contractor.

ANSWER 11:

Yes. NIDA will provide available seeds from its current inventory.

QUESTION 12:

Section C, Article C.1.II.B.1.b. (p. 10) requires the Contractor to determine cannabinoid content of harvested and inventoried cannabis. Will the sponsor be providing the contractor with Standard Operating Procedures (SOPs) for these methods to complete this? If no, please explain how the sponsor envisions the development of these SOPs and please also comment on the Contractor’s ability to use of state of the art techniques to improve these assays and set acceptance criteria.

ANSWER 12:

NIDA will provide the Contractor with known and published methods; however, the Contractor should develop its own SOPs.

QUESTION 13:

For Section C, Article C.1.II.B.3. (pp. 10-11) and Section C, Article C.1.II.D., Option Quantity 3 (p. 13) of the RFP, will NIDA be providing the Contractor with Master Production Records and/or SOP’s to complete the production process? If no, please explain how NIDA envisions the development of the Master Production Records and/or SOPs and please also comment on the Contractor’s ability to use of state of the art techniques to improve the production process.

ANSWER 13:

No. The Contractor has to develop its own GMP methods, and SOPs to accomplish the required tasks and use its experience for state of the art techniques.

QUESTION 14:

For Section C, Article C.1.II.B.3. (pp. 10-11) and Section C, Article C.1.II.D., Option Quantity 3 (p. 13) of the RFP, will NIDA be providing the Contractor with product specific SOPs for the analytical assays required for in-process and release assays used in current Good Manufacturing Practices (cGMP) production of cannabinoids? If no, please explain how NIDA envisions the development of these SOPs and please also comment on the Contractor’s ability to use of state of the art techniques to improve these assays and set acceptance criteria.

ANSWER 14:

No. It is the responsibility of the Contractor to use established or published assays or develop its own assays.

QUESTION 15:

For Section C, Article C.1.II.B.3. (pp. 10-11) and Section C, Article C.1.II.D., Option Quantity 3 (p. 13) of the RFP, does the Contractor have to show comparability to cGMP-manufactured cannabinoids produced under the predecessor contract? Please comment on your concerns related to the contractor supplying cGMP materials to currently open Investigational New Drugs (INDs); specifically, are there any comparability concerns related to the change in cGMP production site and/or process?

ANSWER 15:

The product should be cGMP grade and approved by FDA for human research. No comparability issues exist.

QUESTION 16:

For Section C, Article C.1.II.B.3. (pp. 10-11) and Section C, Article C.1.II.D., Option Quantity 3 (p. 13) of the RFP, does NIDA expect for the Contractor to perform traditional cGMP technology transfer activities and create a Master Validation Plan for the cGMP production process and analytical methods used in production?

ANSWER 16:

Yes.

QUESTION 17:

For Section C, Article C.1.II.B.4.b. of the RFP (p. 11), is a small scale mechanical rolling devices acceptable for preparing a small batch of marijuana cigarettes containing varying concentrations of THC or CBD or both as required by NIDA?

ANSWER 17:

It is the responsibility of the Contractor to use any suitable technique or device to make small batches of cigarettes.

QUESTION 18:

For Section C, Article C.1.II.B.4.b. of the RFP (p. 11), offerors are told to assume production of 5,000 standardized marijuana cigarettes containing a high concentration of delta-9-THC, or CBD or both (greater than 5.0%) or as required by the COR upon exercise of Option Quantity 4. Is this expected to all come from a single batch of cannabis (i.e., are all of the cigarettes prepared as one group or are they prepared as smaller batches throughout the year)?

ANSWER 18:

No. It may come from single or more batches of cannabis provided the THC, CBD or other cannabinoids content remains as required.

QUESTION 19:

For the mandatory qualification criteria in Section M, Article M.3. of the RFP (pp. 96-97), does “met” mean that at time of the final proposal revision (FPR), the successful offeror should be in their possession of a Schedules II to V DEA license, have a working secure video monitored indoor/outdoor facility, have the vault on their organizational property records, and be registered with the FDA or must the proposal basically show that the proposer will develop the capabilities of meeting these requirements for successful completion of the project near the beginning of the project?

ANSWER 19:

At time of FPR, the successful offeror (for Section M, Article M.3.B., the successful offeror and/or the successful offeror’s subcontractor) must comply with all of the mandatory criteria as written in Section M.3.

Regarding the possession of outdoor and indoor facilities in Section M, Article M.3.D., the successful offeror must demonstrate possession of the facilities in question at time of FPR. Regarding the vault facility in Section M, Article M.3.C., the successful offeror must have the vault on its property records.

QUESTION 20:

For the mandatory qualification criteria in Section M, Article M.3.A. of the RFP (p. 96), if each contributing institution has multiple contributing departments does each department of each institution need to have a current DEA registration or does one registration for the institution cover any department within that Institution? By department, this could mean a separate storage site, cultivation site, manufacturing site, and testing facility.

ANSWER 20:

Each separate facility must have its own DEA registration. This requirement should further be verified with the DEA. Please contact the DEA Office of Diversion Control at (800) 882-9539 or DEA.Registration.Help@usdoj.gov.

QUESTION 21:

When we used DEA Form - 225 Application for Registration and tried to fill out Section 2, it states that only one business activity box may be checked of the 10 that are listed. When one of our researchers checked two boxes (Researcher and Manufacturer), the DEA Form was sent back without action because two boxes had been checked. Does NIDA expect that each subcontractor as well as the lead contractor have one or more employees with registrations in all three categories?

ANSWER 21:

Per Section M, Article M.3.A. of the RFP (p. 96), the successful offeror (and/or the successful offeror’s subcontractor, as applicable), must possess, by time of receipt of FPR, “a current Drug Enforcement Administration (DEA) registration for Schedules II to V substances and demonstrate the capability to obtain DEA registration for Schedule I controlled substances including marijuana and its active and non-active constituents. In addition, any offeror must also possess DEA registration for research, manufacture, and distribution of Schedule I through V controlled substances before the award of this contract.”

Please contact the DEA Office of Diversion Control at (800) 882-9539 or DEA.Registration.Help@usdoj.gov if you have specific questions about the registration process.

QUESTION 22:

Does the facility that is growing the cannabis have to be located in the same state as the pharmaceutical grade facility that will be responsible for the testing results? If there is a collaboration of the two best facilities to accomplish this goal - what would be the requirements for the facility responsible for transportation?

ANSWER 22:

Both farming and testing facilities should be in the same state as well as in close vicinity. This should further be verified with the DEA. Please contact the DEA Office of Diversion Control at (800) 882-9539 or DEA.Registration.Help@usdoj.gov for more information.

QUESTION 23:

Do the DEA registration required in Section M, Article M.3.A. of the RFP (p. 96) have to be obtained at the offeror's personal expense?

ANSWER 23:

Yes.

QUESTION 24:

Is it possible to apply only for doing the indoor growing aspect of this contract?

ANSWER 24:

No. Per Section C, Article C.1.II.A. of the RFP (p. 9), “independently, and not as an agent of the Government, the Contractor shall be required to furnish all necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government, as needed to perform the requirements specified [in the entire Statement of Work].” The Statement of Work includes additional tasks beyond the cannabis production and maintenance work described in Task 1 (p. 10) which must be performed by the prime contractor and any subcontractor(s), if applicable.

QUESTION 25:

If awarded the contract, can we subcontract the marijuana cigarettes work described in Section C, Article C.1.II.B.4. of the RFP (p. 11)?

ANSWER 25:

Yes, provided the subcontractor, as applicable, complies the mandatory criteria necessary to perform the marijuana cigarettes work described in Section C, Article C.1.II.B.4 at time of FPR.

QUESTION 26:

Would an expired DEA registration for Schedules II to V controlled substances be acceptable for a proposal to be considered prior to commencement of the contract?

ANSWER 26:

No. Per Section M, Article M.3.A. of the RFP (p. 96), the successful offeror (and/or the successful offeror’s subcontractor, as applicable), must possess, by time of receipt of FPR, “a current [DEA] registration for Schedules II to V substances and demonstrate the capability to obtain DEA registration for Schedule I controlled substances including marijuana and its active and non-active constituents. In addition, any offeror must also possess DEA registration for research, manufacture, and distribution of Schedule I through V controlled substances before the award of this contract.”

QUESTION 27:

We do not have the outdoor facility of approximately 12 acres for growing and processing cannabis as a prime contractor. Can this task be subcontracted or is this is an absolute requirement for the prime contractor?

ANSWER 27:

Per Section M, Article M.3.B. of the RFP (pp. 96-97), the successful offeror (and/or the successful offeror’s subcontractor, as applicable), must possess and maintain, by time of FPR, “(1) a secure and video monitored outdoor facility of approximately 12 acres for growing and processing cannabis, and

(2) an indoor growing facility for the purpose of growing, propagating, and sustaining cannabis plants under controlled conditions. The indoor facility must be at least 1000 square feet, having controls for light intensity, photo cycles, temperature, humidity, and carbon dioxide concentration. The successful offeror shall have provisions for back-up systems for the outdoor and indoor facilities in case of emergency.” This is the requirement of the contract. It is the proposer’s business decision to determine how to fulfill the requirement, i.e., through subcontract(s), etc.

QUESTION 28:

Section F, Article F.3. of the RFP (pp. 22-28) calls for 14,093 labor hours and the diagrams all call for labor hours. However, FAR Subpart 31.3 calls for Institutions of Higher Education to use Office of Management and Budget (OMB) Circular A-21 which calls for full time equivalents (FTEs) not labor hours. Will offerors be able to propose FTE’s in lieu of labor hours for Institutions of Higher Education as either the prime or subawardees? Will the award instrument include cost accounting requirements appropriate for the applying institution? For example, will institutions of higher education receive FAR

31.3 including effort certification in lieu of labor hour reporting and accounting?

ANSWER 28:

Yes. If the offeror is an educational institution, it may propose FTEs in lieu of labor hours per FAR Subpart 31.3 and OMB Circular A-21 when proposing as the prime contractor or as a subcontractor. The eventual contract award will also include cost accounting requirements and other clauses appropriate for the successful offeror (see clauses listed in Section I, Articles I.3.a.8-11 of the RFP (p. 49)).

QUESTION 29:

Section B, Article B.3. of the RFP (p. 8) indicates “items that may be included in the resultant contract” and further refers to real property, alteration of facilities, office equipment, etc. Does NIDA make public note of any specific items within the allowable categories listed in Article B.3 that should not be included in an applicant’s proposal?

ANSWER 29:

No. However, please note that the items listed in Section B, Article B.3. may be included in the resultant contract as items for which the use of contract funds will be prohibited or restricted.

QUESTION 30:

Who will be the owner of any intellectual property created during the term of the contract?

ANSWER 30:

For data rights, please see FAR Clause 52.227-14, Rights in Data—General in Section I, Article I.1. of the RFP (p. 48) (Note: the organizational structure of the successful offeror will determine the specific general clause listing to be contained in the contract awarded from this RFP) and FAR Clause 52.227- 16, Additional Data Requirements (June 1987) in Section I, Article I.3.a.7. of the RFP (p. 49)).

For patent rights, please FAR Clause 52.227-11, Patent Rights—Ownership by the Contractor in Section I, Article I.1. of the RFP (p. 48) (Note: the organizational structure of the successful offeror will determine the specific general clause listing to be contained in the contract awarded from this RFP).

QUESTION 31:

Will any of the cannabis product produced be permitted to be sold to NIDA-approved buyers? If yes, how much and at what price?

ANSWER 31:

No.

QUESTION 32:

Does NIDA intend to exercise any Option Periods or Option Quantities during performance of the contract?

ANSWER 32:

The exercise of any negotiated contract option is a unilateral right of the Government and will be determined on an as needed basis. However, NIDA will provide notification to the Contractor per Section H, Article H.11 of the RFP (p. 34) should we decide to exercise Option Periods or Option Quantities during the period of performance, and will effect the option(s) in question via modification to the contract.

QUESTION 33:

Would NIDA consider extending the proposal submission deadline by a period of 60 days making the proposal new deadline, no later than 3:00 PM local time on January 9, 2015?

ANSWER 33:

No. The due date for proposals is November 10, 2014 at 3:00 P.M. local time (unchanged).