SF_30-Amendment_1_lvb_signed.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

9B. DATED (SEE ITEM 11)

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)

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.

15C. DATE SIGNED

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

16C. DATE SIGNED

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

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

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

IO-NIDA

Lisa V. Bielen, Contracting Officer NIDA Section, CMB Blue

Purpose: To respond to formal questions submitted in response to the solicitation.

Proposal Due Date: 3:00 p.m. (Eastern) on April 26, 2019 (UNCHANGED)

NIDA Section Contracts Management Branch Blue Office of Acquisition, NIDA 6001 Executive Blvd, Room 4211 - MSC 9559 Bethesda, MD 20892-9559

National Institutes of Health National Institute on Drug Abuse 6001 Executive Boulevard, Suite 4211 MSC 9559 Bethesda, MD 20892-7511

75N9502019R00003

1 5

04/04/2019

03/12/2019

Lisa V. Bielen -S Digitally signed by Lisa V. Bielen -S Date: 2019.04.04 14:53:11 -04'00'

4/4/2019

Title: Analytical Chemistry and Stability Testing of Treatment Drugs for Substance Use Disorders RFP No. 75N9502019R00003

SOLICITATION: 75N9502019R00003

AMENDMENT: One (1)

TITLE: Analytical Chemistry and Stability Testing of Treatment Drugs for Substance Use Disorders.

DATE OF ISSUANCE: April 4, 2019

ISSUED BY:

Contracts Management Branch Blue Office of Acquisition, NIDA National Institute on Drug Abuse, NIH 6001 Executive Boulevard Room 4211, MSC 9559 Bethesda, MD 20892-9559

The above numbered solicitation is amended as set forth below. The hour and the date specified for receipt of proposals remains unchanged. All other terms and conditions of the solicitation remain unchanged. Offerors must acknowledge receipt of the amendment prior to the hour and the date specified in the solicitation or as amended, by one of the following methods:

I. By acknowledging receipt of this amendment on each copy of the proposal submitted.

Please note that this is the preferred method.

II. By separate letter or email which includes a reference to the solicitation and amendment number.

FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE

DESIGNATED FOR THE RECEIPT OF PROPOSALS PRIOR TO THE HOUR AND DATE

SPECIFIED MAY RESULT IN REJECTION OF YOUR PROPOSAL. If by virtue of this amendment you desire to change a proposal already submitted, such change may be made by letter, provided each letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

PURPOSE: The purpose of this amendment is to: (1) include questions from offerors and responses in reference to the solicitation.

QUESTIONS/ANSWERS

Question: Section L.2.b.4 sates “Specifically, the offeror shall describe in its technical proposal the information described below:” then does not provide additional information within the section. Can the Government provide the information we must address, or state that there is no need to respond to this section in the proposal?

Reference: Section L.2.b.4 Enhancing Reproducibility through Rigor and Transparency Response: Description of technical proposal shall comply with the NIH policy described in NOT-OD-15-103.

Is there a list of methods/techniques that the contractor will be required to use? i.e GC, LC, NMR etc. for the validations?

Response: There is no requirement of use a specific method, but it is more likely to be HPLC methods even though it depends on nature of molecules assigned.

Will the finished format of the drug substances be powders or liquids?

Response: Drug substances to be assigned will be powder form but it could be plant extracts in some case.

Can we get the list of compounds to be synthesized? Or at least the compound class?

Response: No synthetic works will be performed under this contract, but purification of compounds assigned will be performed to prepare reference standard of the compounds. As long as there is a compound which the NIDA is interested in drug development, the compound will be assigned regardless of a compound class.

Are these required to be made as a Certified Reference Materials?

Response: When an analytical method is developed, a reference standard is needed.

Therefore, preparation of the reference standard is necessary unless it is commercially available.

Examples of materials have been provided, is there a list of actual products that will need testing?

Response: The examples provided in this RFP were compounds assigned for the previous projects or current projects.

Will the products for each year be delivered at the same time or will a calendar be provided?

Response: Deliverables and delivery time will be determined when an assignment is made after discussion the

When/if the contract is renewed will the contractor be informed at that time of the materials that will be analyzed to verify the current contractor has capabilities and the correct outsourcing in place?

Response: NIDA expects for to have capabilities to develop analytical method and validation of the method at the time of

The request on page 58 #2 and 3 state detailed approaches and methods need to be described – again without knowing the materials this would have to be generic, will the material list be provided so this might be complied with?

Response: It is possible to describe general approach and method, but it is preferable to describe approach and method for specific compounds of choice based on institutional experiences.

Page 2 of the SOW states the government is only suppling bulk drug and we would need to purchase final forms, at a later point it states they would be coming from the third parties – clarification is needed to know who is supplying and who is responsible for the cost of materials Response: Regarding the dosage forms, it is generally acquired, manufactured, and supplied by other NIDA contractor for dosage form manufacturer.

f the finished dosage form is purchased by this contractor

Task 4 talks about the need for up to 100 overnight shipments – are there requirements for weekends?

Response: Work on the weekend not required.

If we are provided with 3 drug substances, 2 drug products and 3 reference standard requirements for the first year – will these materials come in a staggered fashion, possible to come together or overlap or 1 at a time?

Response: The contractor will work depending on current workload.

Priority could be discussed when multiple compounds are assigned at the similar time.

Through one of our partners we can complete DMF’s, IND’s and NDA’s, is this a part of the program or will the NIH be handling that part directly?

Response: The contractor will provide CMC data in the preferably FDA acceptable format to the NIDA. The NIDA regulatory division prepares a final package and submit it to the FDA.

14. On page 4 of Attachment 03 of the RFP, Statement of Work II.B.1 Task 4–Storage and Shipment of Drug Substances and Dosage Forms, bullet 3) a. states, “A procedure for selecting and checking analytical samples, on a random basis, from materials prepared for shipment to qualified researchers”. Given the specific requirements listed for bullet

3) b. and c. that detail additional procedures to ensure accurate preparation and shipment of drug materials including a sample preparation facility, computer recorded weighing, and a barcode labeling and tracking system, please confirm that random sampling of materials prepared for shipment is necessary.

Response

15. On page 2 of the RFP, the instructions note to include the “Technical Cover Sheet,” and to “list all professional personnel and organizations named in the proposal who have any role in the proposed work including staff, subcontractors, collaborating organizations, and consultants.” These instructions are different than the instructions for first page of the technical, included on pg. 44. Can you please clarify what is required for the cover and if there is a required template for this cover sheet?

Response: