RFP 75N95022R00047 Amendment 1.pdf

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

1 4

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.

75N95022R00047

9B. DATED (SEE ITEM 11)

July 14, 2022

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 answer questions and to include the Task Order Detail to the solicitation.

Proposal Due Date: Monday July 25, 2022, 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)

Khurram Shaikh, Contracting Officer, NIDA 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 Amendment 1 RFP No. 75N95022R00047 Page 2 of 4

Request for Proposal (RFP) No. 75N95022R00047 is amended as follows:

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

QUESTIONS/ANSWERS:

1. Can you clarify Attachment 13 Sample Task Order aligning with the Statement of Work, Level of Effort?

• Attachment 13 is an example of the form the Government will use to issue requests for Task Order Proposals under the contract.

2. Can you provide more detailed information from the Statement of Work, Level of Effort to propose on?

• Please see below Sample Task Orders A-G. It is requested that the business proposal incorporate a breakdown of proposed costs by sample task order.

RFP No. 75N95022R00047 Page 3 of 4

Task Order Detail

A. Task Orders for Proposal Evaluation

1. For purposes of proposal preparation, offerors are to provide a technical proposal and cost estimates for each of the types of task orders described below. The types summarized below are general descriptions of task orders that Blueprint MedTech anticipates ordering under the contract. However, throughout the ordering period of this contract, task orders may involve one or more of the Areas (1-8) described above and are not limited by the types described below.

a. Sample Task Order A – Preparation of Pre-submission

This sample task order requires services as described in Task 1 above to support preparation of a medical device pre-submission to US Food and Drug Administration (FDA).

For proposal preparation purposes, offerors may assume that a task order of this nature will require an estimated 100 hours of effort over a period of one year, with an additional four 1-year option periods.

b. Sample Task Order B - Preparation of Investigational Device Exemption (IDE) submission with subsequent regulatory support

This sample task order requires services as described in Tasks 2-3 above to support preparation of an IDE submission with accompanying regulatory support to answer questions and prepare IDE supplements, annual reports, etc.

For proposal preparation purposes, offerors may assume that a task order of this nature will require an estimated 200 hours of effort over a period of one year, with an additional four 1-year option periods.

c. Sample Task Order C – Preparation of a PMA submission

This sample task order requires services as described in Task 4 above. The contractor shall provide support for preparing all necessary parts of a PMA submission to the US FDA. This includes collection and preparation of all data necessary for a complete PMA submission including all verification and validation testing from bench, pre-clinical, and clinical protocols to support safety and effectiveness of the device.

Additionally, this will require assistance with responses to deficiency letters, and support for meetings, including a panel meeting, if applicable.

For proposal preparation purposes only, offerors may assume that a task order of this nature will require an estimated 3,000 hours of effort in the base period of one to two years, with an additional four 1-year option periods.

d. Sample Task Order D – Support for activities related to the Quality System

This sample task order requires services as described in Task 5 above. The contractor shall provide support for a company to develop a new Quality System for the medical device. For the purposes of this sample task order, the offeror should assume the medical device company has no established quality system in place, and will provide all necessary assistance to establish a new quality system as listed in the

SOW.

For proposal preparation purposes only, offerors may assume that a task order of this nature will require an estimated 400 hours of effort in the base period of one year, with an additional four 1-year option periods.

e. Sample Task Order E – Support for activities related to Regulatory Compliance

This sample task order requires services as described in Task 6 above. The contractor shall provide support for a company to develop a new Regulatory Compliance Program for the medical device. For the purposes of this sample task order, the offeror should assume the medical device company has no regulatory compliance program in place, and will provide all necessary assistance as listed in the SOW.

For proposal preparation purposes only, offerors may assume that a task order of this nature will require an estimated 400 hours of effort in the base period of one year, with an additional four 1-year option periods.

RFP No. 75N95022R00047 Page 4 of 4

f. Sample Task Order F – Support for activities related to market/user research and commercialization strategy

This sample task order requires services as described in Task 7 above. The contractor shall provide support for a medical device company to assess the existing and potential market as it relates to their novel device. Additionally, the contractor should work with the company to develop a commercialization strategy for the medical device.

For proposal preparation purposes only, offerors may assume that a task order of this nature will require an estimated 200 hours of effort in the base period of one year, with an additional four 1-year option periods.

g. Sample Task Order G – Support for activities related to evaluating and obtaining payor coverage

This sample task order requires services as described in Task 8 above. The contractor shall provide support for a medical device company to evaluate the landscape with respect to obtaining payor coverage and reimbursement. For the purposes of this sample task order, the offeror should assume that the medical device company will pursue coverage and reimbursement from CMS and private payors.

For proposal preparation purposes only, offerors may assume that a task order of this nature will require an estimated 400 hours of effort in the base period of one year, with an additional four 1-year option periods.

NIDA intends to award multiple Task Orders of Types A-G during the course of the contract