RFP No. 75N95020R00036 - Amendment 1.pdf

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

1 2

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

01 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, 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 update Section J to add Attachment 20, Sample Task Order 1. All other terms and conditions of the RFP remain unchanged.

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 Red

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.

Request for Proposal 75N95020R00036

Amendment No. 1

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

SECTION J - LIST OF ATTACHMENTS is updated to add:

Attachment 20: Sample Task Order 1

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

FORCE AND EFFECT.

Attachment 20 RFP No. 75N95020R00036

NIDA CONTRACT TASK ORDER (T.O.)

Contractor: TBD T.O. Title: Development and Manufacture of

Drug Products

Contract No.: TBD T.O. No.: 1 (Cost Plus Fixed Fee, Term/Level of

Effort)

NIDA Ref No.: TBD T.O. Originator: NIDA COR

PART I: T.O. REQUEST FOR PROPOSAL

A. Period of Performance: 12 months from the date of award.

Task Description:

The Contractor shall complete all subtasks described in the subject contract’s statement of work for Tasks A, B, C, D, E and F. The number of drug substances and drug products to be studied, etc. is given under each task as described below:

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

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

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.

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.

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.

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.

C. Task Leader: the NIDA COR as specified in Section G of the Contract.

D. Deliverables: As stated in Section C.2., Reporting Requirements and Section F.2., Deliveries.

E. Task Order Response Due Date: With contract proposal.

F. Level of Effort:

During the period of performance of this Task Order, the Contractor shall provide direct labor hours. The number of labor hours exclude vacation, holiday, and sick leave. These labor hours exclude subcontractor and consultant labor hours.

Task Order Labor Hours Task Order 1: Development and Manufacture of Drug Products

3,200

The Contractor shall have satisfied the requirement herein if not less than 90% or more than 110% of the total direct labor hours specified herein are furnished.

Contract No.: TBD T.O. No.: 1 (Cost Plus Fixed Fee, Term/Level of

PART II. CONTRACTOR'S RESPONSE TO T.O. REQUEST

(Contractor may attach additional sheets to this form to present requested data)

A. Estimated Cost and Effort:

1. List T.O. leader, specific individuals to be assigned, labor category, and estimated hours and hourly rates for each

2. Employee fringe benefits

3. Other direct costs

4. Travel

5. Subcontracts

6. Consultants

7. Indirect costs

8. Total estimated costs for this T.O.

9. Fee

10. Total estimated costs and fee for this T.O.

B. Detailed description of the approach to be used and of the deliverable(s). (Be specific.)

APPROVAL TO PROCEED: The Contractor shall not exceed the estimated T.O. amount, or change the T.O. leader without the prior written approval of the Contracting Officer.

l. For the Contractor: Date:

(Signature)

Typed name:

2. For the Government: Date:

(Contracting Officer’s Representative)

Date:

(Contracting Officer)

Contract No.: TBD T.O. No.: 1 (Cost Plus Fixed Fee, Term/Level of

PART III. CONTRACTOR'S REPORT OF T.O. PERFORMANCE

(Contractor may attach additional sheets to this form to present the requested data.)

A. Actual Cost and Effort

1. Labor hours - list specific assigned individuals, labor category, and actual hours worked.

2. Labor costs - list labor category, individual, and total amount.

3. Employee fringe benefits

4. Direct Materials

5. Travel

6. Subcontracts

7. Other direct costs

8. Indirect costs

9. Total actual costs for this T.O.

10. Fee

11. Total actual costs plus fee for this T.O.

B. Report of Deliverables

REVIEW AND APPROVAL OF SATISFACTORY PERFORMANCE

The signatures below indicate that the services/products required under Task Order No. 1 have been delivered, received and satisfactorily meet the requirements of this Task Order.

l. For the Contractor: Date:

(Signature)

Typed name:

2. For the Government: Date:

(Contracting Officer’s Representative)

Date:

(Contracting Officer)