RFP No. 75N95020R00036 - Amendment 2.pdf

OMB No. 0990-0115 AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES

1 6

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

02 See Block 16C

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

NIDA Section, Contracts Management Branch Blue Office of Acquisitions, NIDA National Institute on Drug Abuse, NIH 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.

75N95020R00036

9B. DATED (SEE ITEM 11)

March 2, 2021

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

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 ACKNOWLEDG- MENT 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, x 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 amend the Request for Proposal (RFP) to incorporate questions from offerors and responses in reference to the solicitation.

Proposal Due Date: Friday, April 16, 2:00 PM EST (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.

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)

Tracy L. Cain, Contracting Officer, NID Section, CMB Blue

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 (48CFR) 53.243

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.

RFP No. 75N95020R00036 2

Request for Proposal (RFP) No. 75N95020R00036 is amended as follows:

PURPOSE: The purpose of this amendment is to include questions from offerors and responses in reference to the solicitation.

QUESTIONS/ANSWERS:

1. Question:

Reference: RFP Attachment 1, II.B Numbers 1 and 3.

Question: The instructions contained in Attachment 1 state:

1. The total page count of the Technical proposal shall not exceed ____ pages.

[Contract specialist must specify a page limit].

And

3. Each Curriculum Vitae (CV) shall not exceed ____ pages. [Contract specialist may specify a page limit].

Does the government intend to have page limits for the technical proposal or CV’s?

Response:

There is no page limit for either the technical proposal or the CVs.

2. Question:

Reference: RFP page 10, Section C.1.II.C Question: The Statement of Work on Page 10, part C for sample task orders states “An example of Sample Task Order 1 is included in the Attachments”. A sample task order is not included and is not listed in section J. Did the government intend to provide an example Sample task Order 1?

Please see Amendment 1 to this RFP, incorporating Sample Task Order 1 as Attachment 20.

3. Question:

Sample Task Order 1 attachment could not located within the published RFP package. Should we assume the following activities listed on Page 12 (Table 1) for costing purposes within 3,200 hours?

a. Task A (Pre-formulation Study): Three drug substances, new chemical entities or previously approved drug substances, to be studied.

b. Task B (Formulation Study): Formulation studies for two drug substances.

c. Task C (Development and Validation of Stability Indicating Methods for Drug Products):

Develop and validate methods for the formulations (active and matching placebo) developed under Task B for two drug substances.

d. Task D (Manufacture of Drug Products for Phases I and II Clinical Trials, such as tablets, sublingual tablets, hard gelatin capsules, soft gelatin capsules, etc.): Manufacture up to 30,000 dosing units of active and 30,000 dosing units of matching placebo for two strengths or batches for each of two drug substances.

RFP No. 75N95020R00036 3

e. Task E (Stability Study I): Perform stability studies for two batches of active drug products and up to two strengths or batches of matching placebos manufactured under Task D.

f. Task F (Stability Study II): Perform continuing stability studies for 7 batches of active drug products and 7 batches of matching placebos that have been under study about a year or longer.

Please see Amendment 1 to this RFP, incorporating Sample Task Order 1 as Attachment 20.

4. Question:

Just to confirm, there are no specified page limitations as described in Attachment 1 of the RFP. Is this the correct assumption?

There is no page limit for either the technical proposal or the CVs.

5. Question:

Will NIDA accept a proposal in response to this RFP that proposes bulk production of mitragynine, and is it at least technically possible that that proposal could be funded?

Response:

As stated in the RFP, this requirement is contemplated as an IDIQ contract because NIDA is not able at this time to specify the exact compounds and quantities thereof which will be required to be produced. Task Orders shall be issued under this proposed contract using the methodology outlined in Section G of the RFP, and shall be based on NIDA’s programmatic requirements. NIDA is unable to state conclusively whether any specific compound shall or shall not be required.

6. Question:

Do assigned project directors or investigators need to be Full Time Employees? Could they be contractors/consultants?

Response:

Vendors should propose personnel based on their own business judgement, and are asked to include letters of commitment for any consultants or subcontracting personnel essential to their proposal.

7. Question:

Do the project directors/investigators need to be a Manager per the formation documents of the entity submitting or is having signing authority as a representative of the entity sufficient?

This is important because in certain circumstances a CFO can be an authorized signatory but may not be listed as a Manager of an entity.

All documents requiring signature must be signed by an entity authorized to bind the company.

8. Question:

RFP No. 75N95020R00036 4

Is DEA registration mandatory in advance of the award or should the contractor only attest that they can get a DEA registration if needed? Note that mitragynine, the chemical entity relevant to our proposal, is not a scheduled substance.

Response:

As described in the mandatory criteria requirements in Section M of the RFP, Offerors must possess the described registrations at the time of receipt of technical proposals.

9. Question:

The Statement of Work on the RFP states that NIDA is soliciting a Contractor to provide services for developing and manufacturing dosage forms to be used in support of NIDA’s medication development programs. Specifically, Task A requires preformulation studies performed on the drug substance, and Task I requires that drug substances or drug products be purchased on the open market.

a. Question: Will NIDA be providing any drug substances? Or must all be acquired on the open market?

Response:

NIDA may either provide drug substances or require the vendor to secure them, depending on the substance in question.

b. Question: Can the Contractor use our own supply chain to supply a drug substance, assuming it is in the interest of the Government?

Response:

NIDA may either provide drug substances or require the vendor to secure them, depending on the substance in question.

10. Question:

Task D, E, and F all appear related. This question is regarding all 3 tasks. In Sample Task Order 1, Task D, it is asked that the Contractor manufactures a batch of each drug product and matching placebo “for two strengths or batches for each of two drug substances”. We understand this to mean: [1 DP batch + 1 Placebo batch] x 2 strength or batches x 2 DPs = 8 manufactured batches in Task D. Task E asks to execute the described stability for the products manufactured in Task D Task F: Asks to “continue” the study from task E, but for 7 batches of each product that have been under study for about a year or longer

a. Question: Is “strength” and “batch” used interchangeably, or is each drug product meant to be formulated in a high and low dose?

Response:

Specific doses of drug products required under the contract will be specified at the Task Order level, and based on the needs of NIDA.

b. Question: Is Task D described correctly above? (8 manufactured batches total)

RFP No. 75N95020R00036 5

Task D is requesting, for proposal purposes, 2 batches (1 DP, 1 placebo) for 2 different drugs. Total batches would be 4 (1 DP and 1 placebo for each drug).

c. Question: Could you clarify the difference between Task E and Task F?

Task E is stability study to be conducted on products being produced at that time.

Task F refers to long term stability study that is continued on batches of products that had been produced previously. (Other products.)

d. Question: Does Task F require additional manufacturing, separate of Task D? Or should Task D include all the requested manufactured lots [1 DP + 1 Placebo] x 7 batches x 2 DPs = 28 manufactured batches

Response:

It is not expected that NIDA will need any further production of product past Task D. Tasks E and F are for stability assays.

11. Question:

What is the OEL range for the compound? Low to intermediate toxicity, or high potent compound?

Response:

There is no predetermined set of task orders to be issued during the life of this contract. With that in mind there is no way to accurately determine what the OEL range will be of the products that will be needed. Having said that, there is very little probably a product with an OEL of <1 µg/m3.

12. Question:

Is the Finished Product expected to contain single drug substance or multiple drug substance in a fixed dose combination product?

Response:

It is vastly more likely that requested products will contain 1 API. If a task does involve products from multiple APIs, it is almost certain that each product will only contain 1 API. Depending on the need of the Government though, it is possible that a product with more than 1 API would be requested.

13. Question:

Does NIDA have a list of products (API’s) they are looking to develop for this program.

Response:

There is no set list of products that are expected to be produced. Task orders will depend on the need of NIDA at the time they are issued.

14. Question:

RFP No. 75N95020R00036 6

Are these expected to be selected under the other contract opportunity, In Vitro Metabolism and Non-Clinical ADME Studies?

Response:

While is it possible that there would be a link between the compounds we have assayed in vitro metabolism and non-clinical ADME studies, there is no reason to suspect a relationship to exist.

ALL OTHER TERMS AND CONDITIONS OF THE RFP REMAIN UNCHANGED AND IN FULL

FORCE AND EFFECT