RFP 75N95022R00047 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.

75N95022R00047

9B. DATED (SEE ITEM 11)

July 15, 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 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 2 RFP No. 75N95022R00047 Page 2 of 6

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. Regarding Attachment 1 on page 2 of 2, could you please clarify the Technical Proposal page limit, including any pertinent sections or attachments/appendices that are exempt from the page limit?

• There is a 200 page limits which is inclusive of all attachments, but which does not include title pages and tables of contents.

2. Regarding Attachment 1 on page 2 of 2 could you please confirm the page limit for each CV/resume?

• There is no page limit, but those pages are included in the technical proposal page limits.

3. In accordance with Attachment 13, is NIDA looking for one (1), 5-year CPFF Excel workbook that covers all 8 Tasks, OR is NIDA looking for eight (8) separate CPFF Task budgets?

• Please provide a business proposal for each Sample Task Order A-G and a separate Excel Spreadsheet.

4. Please confirm that the total contract value for each Task Order will be no more than $24MM.

• The maximum total value combined for all Task Order will not exceed $24 million.

5. The Government states that offerors may complete Reps and Certs via sam.gov, which will then be incorporated by reference into the contract. However, the government also instructs offerors to include Section K/Reps and Certs into its Business Proposal. Since offerors will be completing electronically and it will be incorporated by reference, please confirm electronic Reps and Certs submission is sufficient.

• Electronic Reps and Certs submission will be accepted.

6. Please confirm the Government intends to award to a single offeror.

• The government intends to award to a single offeror.

7. This offeror assumes that the Government's requirement for 'General Experience, Organizational Experience Related to this

RFP, Performance History, and Pertinent Contracts' is similar to a Corporate Experience Requirement. This requirement is redundant to the Past Performance Information requested as a part of the Business Proposal instructions. Please either combine these requirements with instruction to respond with this information in a Past Performance Volume or give clearer instruction as to why Past Performance and General/Organizational Experience are separated within the Business Volume.

• The requirement for “General Experience, Organizational Experience Related to this RFP, Performance History, and Pertinent Contracts” is a request for the Offeror to discuss how its experience informs its ability to perform the requirements of this RFP. The requirement for submission of Past Performance information in the Business Proposal is a request to provide information regarding any Government contracts the Offeror has performed or is performing that are similar in scope to this award. Please address both of these requirements in your submission.

8. The Government has included Past Performance as an evaluation factor yet has Past Performance and

'General/Organizational Experience' in the Business Proposal. Please consider breaking out Past Performance and Corporate Experience into its own Volume.

• Past performance information should be provided as part of the business proposal, however, NIDA clarifies that this is an organizational requirement. Past performance evaluations and cost/price evaluations will be conducted separately.

RFP No. 75N95022R00047 Page 3 of 6

9. Please provide an extension of 10 weeks for offerors to properly prepare.

• NIDA regrets to inform you that an extension is not possible.

10. Please confirm offeror's EVMS compliance plan is to be submitted post award.

• EVMS is applicable to this contract, and any Task Orders requiring IBR submission shall have that submission conducted on a post-award basis.

11. There appears to be a missing number within the body of this paragraph. The Government has asked for "ALL _ CONTRACTS" currently being performed that are similar in nature to the solicitation workscope. Since a maximum number was not included, offerors' responses could be tens of pages long. To fulfill this requirement, please confirm offerors may submit no more than 3 (three) Past Performance references currently being performed or completed within the last 5 (five) years.

• NIDA requests that you provide a list of all contracts currently being performed for the Government similar in scope to this requirement. This information should be included in the business proposal, which does not have a limit on pages.

12. Please confirm that cover page, table of contents, and appendices are not included in the technical proposal page count limitation.

• The cover page, table of contents, are not included in the technical proposal page count limitation, however, appendices are included in the page count.

13. Please confirm CV/resumes are not included in the technical proposal page count limitation.

• CV/resumes are included in the technical proposal page count limitation.

14. Please confirm the business proposal does not have a page count limitation.

• There is not a page count limit for the business proposal.

15. Please confirm no more than 3 pages for CV/resumes.

• There are no page limits for CV/resumes, but they are included in the page count of the technical proposal.

16. On page 43 of 123, in Part III - List of Documents, Exhibits, and Other Attachments, the Government lists Business Proposal Attachments. Attachment 10 has two links. The first link directs to NIH OAM website that has a link ""Electronic Contract Business Proposal. However, on page 78 of 123, Attachment 1 - Packaging and Delivery of Proposals for Use with the NIH Electronic Contract Proposal Submission (eCPS) Website, Section B, there are two links listed (That both direct to the same worksheet). The government indicates the two links in this section is the ""Breakdown of Proposed Estimated Costs (plus Fee) w/Excel Spreadsheet. Please confirm the correct excel spreadsheet that should be used by offerors to submit its Breakdown of Proposed Estimated Costs (plus Fee).

• Please use the Breakdown of Proposed Estimated Costs (plus Fee) w/Excel Spreadsheet.

17. As a follow up question to above; the periods of performance are incorrect in the links the Government provided. Please confirm the periods of performance offerors should price and update the Excel Spreadsheet to reflect the correct periods of performance.

• Please update the Excel Spreadsheet to reflect the correct periods of performance.

RFP No. 75N95022R00047 Page 4 of 6

18. Please confirm that all subcontractor costs should be completed in the tab labeled "Subcontracts" within the Breakdown of

Proposed Estimate Costs (plus Fee) w/Excel Spreadsheet. Please remove the requirement in the Business Proposal Instructions 13. Subcontractors, bullet "f" that states subcontractors must submit "A complete cost proposal in the same format as the offeror's cost proposal.

• All subcontractor costs should be completed in the tab labeled "Subcontracts" within the Breakdown of Proposed

Estimate Costs (plus Fee) w/Excel Spreadsheet, however, subcontractor costs must include a similar cost breakdown as demonstrated by the spreadsheet, and you may submit them in a sperate spreadsheet if necessary to accomplish this.

19. Please confirm the level of effort included in this section is a baseline only, and offerors are to build off of this to our proposed level of effort across each performance area.

• The level of effort in this section is provided for estimation purposes.

20. It is this offeror's understanding that the BluePrint RFP is a new requirement. As there are no incumbent employees to hire, please confirm a Total Compensation Plan is unnecessary.

• This a new requirement and there are no incumbent employees.

21. For part of the Blueprint Medtech Initiative, the products in scope could potentially be therapeutic medical devices

(Combination Products) and diagnostic devices (Invitro Diagnostics Devices - IVDs) related to Neurotechnologies. Would there be any additional categories of products such as Software as Medical Devices (SAMDs), Software in Medical Devices (SIMD), AI-based Devices etc. that must consider while responding to the RFP? If yes, please specify the details.

• BPMT applicants can include any innovative neurotechnology including therapeutic and diagnostic devices ranging from Software as a Medical Device to fully implantable devices. The program will not support devices that are not regulated or that fall under enforcement discretion, such as general wellness devices. Combination products can apply, but it is expected that any applicants accepted to BPMT will be presumed a device-based primary mode of action (PMOA). Drug or biologic PMOA would go to one of the sister programs in the Blueprint portfolio, BPN or BPN-Biologics https://neuroscienceblueprint.nih.gov/ and are not expected to be part of BPMT.

22. For products categories such as SAMD (if they would be in scope), there are additional specific regulatory requirements such as Validation, HIPAA compliance, Cybersecurity compliance etc. as part of Submissions. Would NIDA/NIH prefer to consider these additional requirements in scope under Performance Area 4- "Regulatory Support for Medical Device Marketing Submissions", as well, while responding to the RFP?

• All medical products are expected to meet the regulatory requirements for their device class. Yes, SaMD would have to comply with appropriate validation and HIPAA and cybersecurity guidelines as part of any future FDA submission and subsequent requirements from payors. We do not expect that the Regulatory CRO would provide the specific support for these tasks (validation, HIPAA, cybersecurity) as they will be provided by other vendors with specific software development knowledge.

23. In regard to Performance Area 3- "Regulatory Study for Clinical Studies", does the current scope also include identifying the relevant Testing Laboratories and support with communication/liaison with them?

• BPMT has not yet identified specific testing laboratories, and it is possible that grantees may already have established relationships with their own preferred test laboratory vendors. It is expected that the regulatory CRO will work with the grantee to obtain all information necessary to assemble regulatory submissions, including possibly liaising with test laboratories.

https://neuroscienceblueprint.nih.gov/

RFP No. 75N95022R00047 Page 5 of 6

24. From our past experiences of working on marketing submissions of Novel Technologies/Devices with FDA, we foresee a requirement of multiple and different types of Q-Submissions and requests for additional information during the pre-approval stages of the device life cycle. Would NIDA/NIH prefer to consider mitigation scenarios in such cases for cost estimations under Performance Areas 1, 2 and 4?

• We understand that multiple pre-submissions and Requests for Information may occur during the development of a medical device. The specific needs for each grantee and associated regulatory support will be clarified with each task order.

25. In regard to Performance Area 4- "Regulatory Support for Medical Device Marketing Submissions" NIDA/NIH expects the

Contractor to support with submissions; however as part of compiling the Submission Packages, there will be some Core Technical Documentation required such as human factor, biocompatibility studies, stability studies specific to the product category and its associated risk classification. Would these Core Technical Documentation and technical data be provided to in their final form i.e Submission-ready? Or would need to prepare these Core Technical Documentation based on the available data provided to us?

• It is expected that information from core technical testing, such as biocompatibility studies, animal studies, human factors analysis, and sterilization testing would be provided in final report form. However, the specific needs of each grantee will be clarified with each task order. It is expected that the CRO with interact with the grantee and test laboratories to obtain all necessary test reports and supporting documentation.

26. In regard to Performance Area 5- " Regulatory Support for Establishing a Quality System", understands that the Contractor must help with establishing a Quality Management System (QMS) and given that US is the target market, 21 CFR Part 820 is the usual standard followed for QMS. Would NIDA/NIH prefer the QMS to be specific to 21 CFR Part 820 or would NIDA/NIH prefer a holistic approach for the QMS, including compliance with both ISO 13485 and 21 CFR Part 820?

• The QMS system should align with the regulatory requirements as stated in federal regulations, including 21 CFR

Part 820. There may be additional compliance needs with ISO 13485, but needs of each grantee will vary and will be specified in the individual task order.

27. In regard to Performance Area 5, along with establishing the QMS, should Implementation and maintenance of the QMS also be considered in the current scope of activities?

• It is expected that the Regulatory CRO will provide services to establish the QMS and train the company in use of the system, but once established, maintenance of the QMS will be transferred to the company.

28. FDA offers various pilot programs such as Safer Technologies Program (STeP) and Breakthrough Devices Program to enable quicker market access for innovative technologies. Would NIDA/NIH prefer to consider support with these programs as part of scope under Performance Area 4, while responding to the RFP?

• Yes, it is possible that BPMT grantees would require assistance with the STeP and Breakthrough Devices Programs, and those activities would be described in the specific task order.

29. "Early-stage development to first-in-human clinical studies" implies that BluePrint does not support BP MedTech through marketing applications. What is the number of expected marketing submissions per year?

• As noted, BPMT will support early stage and first-in-human clinical studies. However, it is feasible that grantees in the program may acquire enough data during the course of the grant to make significant progress toward a marketing application. There total number of marketing applications per year is unknown and will depend on the progress of each individual project.

RFP No. 75N95022R00047 Page 6 of 6

30. Please provide a list of all the HHS/NIDA physical locations via city and state that offerors may have to support in anticipated performance of this contract. Offerors will also require this information to accurately estimate travel costs.

• The Blueprint MedTech regulatory contract supports grantees and program participants needing regulatory advice.

We expect that these grantees may be from any state or territory. While a large portion of work could be conducted virtually, there may be need to travel to a grantee site or to the Washington, DC area for a meeting with FDA. As far as practical, meetings should be conducted virtually, and all travel to be authorized by the COR.

31. Please confirm that the services in all Performance Areas will be provided to BluePrint Medtech grantees only.

• The services will be provided to Blueprint MedTech grantees and program participants. All Performance Areas may be called upon, on an individual Task Order basis.

32. Please confirm incubator BP MedTech grantees will develop products remotely at their respective corporate offices.

• It is expected that BPMT grantees will develop their products at the respective research lab and/or corporate office.

33. Since this requirement involves inspection preparation, we suspect BP MedTech grantees will require assistance with GCP and GLP inspections. Please confirm that the quality systems should be designed to comply with quality system regulations (QSR) for medical devices, specifically 21 CFR Part 820.

• Yes, the quality system should comply with 21 CFR Part 820. The proposal should demonstrate the offeror’s capability to assist a small business or other developer of a novel medical device in establishing a new quality system. It is important to understand that not all participants in the BPMT program will require this assistance, and the specific level of involvement will vary per task order.