75N95022R00013_Amn 1_S.pdf

Nancy L. Lamon-kritikos -S

Digitally signed by Nancy L.

Lamon-kritikos -S Date: 2022.02.25 20:35:09 -05'00'

Questions and Answers

Request for Proposals (RFP) Number: 75N95022R00013

Project Title: Manufacturing and Nonclinical Studies Support for Development of Therapeutic Biotechnology Products (Biologics) for Neurological-related Disorders

Question Number Question and Answer

1.

On the 2nd page of the announcement the following statement is made "It is important that Offerors list all professional personnel and organizations named in the proposal that have any role in the proposed work. This includes staff, subcontractors, collaborating organizations, and consultants. Show organization affiliation(s) for every person named".

Question: The phrase any role or roster could refer to any staff member that could possibly work on this program. That could be a large number of people, does the NINDS agree that we should limit the staff who are listed to those in decision making roles?

Answer: This information is being requested for the purpose of identifying any potential conflicts of interest. While it is critical that any individuals with decision making authority be named (study directors, program manager, etc.), offerors should also list key professional personnel who do not have this authority.

2.

Page 120, Section 2. 5 Resumes states that “resumes of all key personnel are required”

Question (i): Are key personnel resumes to be provided as an Attachment to Technical Proposal?

Question (ii): Could the government clarify the definition of key personnel

Answer:

(i) All personnel qualifications (including key personnel’s) should be included directly in the offeror’s Technical Proposal.

(ii) “Key personnel” refers to individuals who are considered specifically and uniquely important due to the nature of their role and who are considered essential to the performance of the contract. At a minimum, this should include the “Head Program Manager.” Per HHSAR Clause 352.237-75 Key Personnel (pg 28 of the RFP), any such individuals will be specified in any resultant contract(s). The Contractor must notify the Contracting Officer in writing if any key personnel need to be replaced and identify a suitable replacement.

3.

Page 105, 16. Past Performance Information states that:

a. Offerors shall submit the following information as part of their Business proposal.

A list of the last 5 contracts completed during the past Three years and ALL CONTRACTS currently being performed that are similar in nature to the solicitation workscope…

Question: Would the government agree examples of past performance (including the completed contracts) should be limited to contracts that are similar in nature, and similar in nature is defined as manufacturing or preclinical efforts for pharmaceutical products?

Answer: This appears to be consistent with the instructions for past performance information included in page 105 of the RFP.

4.

Section L, Page 101, Item 4 States “The technical proposal must include direct cost and resources information, such as labor-hours and categories and applicable rates, materials, subcontracts, travel, etc., …However, the technical proposal should not include pricing data relating to individual salary information, indirect cost rates or amounts, fee amounts (if any), and total costs.

Question: Please clarify that applicable rates by labor category are not required to be included based on the Government’s statement of “However, the technical proposal should not include pricing data relating to individual salary information, indirect cost rates or amounts, fee amounts (if any), and total costs.”

Answer: Correct, while labor rate data is required for offerors’ business proposals, this information should not be included in the technical proposal.

Page 135, Section L item 11, Bullet d – Pertinent Contracts.

States: “Pertinent contracts is defined as a listing of each related contract completed within the last three years or currently in process.

5.

The listing should include: 1) the contract number; 2) contracting agency; 3) contract dollar value; 4) dates contract began and ended (or ends); 5) description of contract work; 6) explanation of relevance of work to this RFP; 7) actual delivery and cost performance versus delivery and cost agreed to in the contract(s). For award fee contracts, separately state in dollars the base fee and award fee available and the award fee actually received. The same type of organizational experience and past performance data should be submitted.”

Question. Is this list different from the list required as part of the Business Volume Past Performance Section (Page 105, 16. Past Performance Information) where contractors are to list “ALL CONTRACTS currently being performed that are similar in nature to the solicitation workscope”?

Answer: Information relevant to Past Performance should be included in the Business Volume. Information relevant to Organizational Experience should be included in the Technical Volume.

6.

On page 36 the RFP states It is hereby understood and agreed that research involving human subjects shall not be conducted under this contract, On page 41 the RFP states

Based on information provided by the ISSO, Privacy Office, system/data owner, or other security or privacy representative, it has been determined that this solicitation/contract involves:

[ ] No PII [X] Yes PII

Question: Would the government agree that if this contract is not going involve the human subjects research, it is unlikely any Personally Identifiable Information (PII) is likely to be generated or transferred as part of this contract? If this is not accurate, would it be possible to provide an example of the PII anticipated.

Answer: While this contract will not involve human subjects, it is possible that PII will be generated or transferred as part of this contract. An example is if there is a need to conduct bioassays on human specimens.

7.

The RFP requires responses to four Sample Task Orders

Question: Does the government plan to award some or all of these Sample Task Orders?

Answer: The only sample task order which the Government intends to award is Sample Task Order 1. This Task Order will be issued to each successful offeror concurrent with award. The remaining sample task orders were provided to represent some but not all of the types of manufacturing and nonclinical studies that may be required. Their purpose is to assist offerors with preparation of their technical and business proposals, however, the specific details of individual Task Order Requests for Proposals submitted after award may differ significantly.

8.

On the 2nd page of the announcement, under “Offeror Questions”, it is stated that “NOTE: Site visits may be requested”

Questions: Can the government clarify if this refers to bidder’s site or NIH site and what is the intended purpose of such potential site visits?

Answer: This statement refers to offeror sites. For example, as part of evaluation the NIH may visit sites where the work would be performed; the NIH may have a kick-off meeting on site at the Primary contractor’s location; NIH may review or conduct an audit at primary or subcontractor sites.

9.

In Part II - Contract Clauses, Section l – Contract Clauses the link referenced takes the reader to NIH Document Generation System and allows review of the General Clause Listing (by reference). FAR Clause 52.216-11 COST CONTRACT - NO FEE (APR 1984) (a), which states that “the Government shall not pay the Contractor a fee for performing this contract” is included. However, Attachment 12 for Sample Task Order 2 “SUMMARY OF PROPOSED COSTS”, shows lines for “Proposed Fee/Profit”. The RFP also references that the Task Orders will be CPFF and FFP.

Question: Can the government confirm that fee is allowed on this contract?” If so, can the Government remove the FAR Clause since after award an auditor would only see the clauses and not the RFP.

Answer: The allowability of fee is determined by the offeror’s organizational structure, and FAR Clause 52.216-8 (Jun 2011) Fixed- Fee may be included in contract(s) awarded from this RFP. The Organizational structure of the successful offeror(s) will determine the specific general clause listing to be contained in the contract(s) awarded from this RFP.

The solicitation includes three listings of Article I.1: “General Clause listings for cost-reimbursement contracts with educational institutions,” “General Clause listings for cost-reimbursement contracts with non-profit organizations other than educational institutions”, and “General Clause listings for cost-reimbursement research and development contract.”

10.

In Section L.2.c.6, Item 11 provides subcontracting goals for all procurements.

Question: Would the government please confirm if the percentages listed represent a percentage of contract value or subcontract value?

Answer: The Government’s stated goals represent the percentage of total subcontracted dollars that will be awarded to small businesses and small business socioeconomic programs.

11.

Sample Task order 4, page 6, Study 4 Question: Can the government confirm the animal numbers for this study are correct? For a mouse study with the number of samples to be collected, the total number of mice listed (48) would have insufficient volumes for sample collections/analysis.

Answer: For the purposes of Sample Task Order 4, please assume that sufficient sample volume can be safely collected from mice.

Attachment 10 HHS Subcontracting Plan Template Note to Government: Attachment 10 states goals for Fiscal Year 2017, includes fill-in for base period and 4 Option periods.

Question: Can offeror provide a DCMA approved SB Master Plan and contract specific addendum be submitted in lieu of the provided

12.

Attachment 10 document in the RFP?

If not, will the government be providing an updated Attachment 10 for Offerors to complete?

Answer: All offerors are required to address the NIH small business subcontracting goals and the HHS Subcontracting Plan Template.

Offerors must address the NIH goals. You may propose your subcontracting plan in the format you believe most appropriate for consideration by the NIH.

13.

Question: Page 2 of the RFP cover letter for “Offer Questions” includes a note that site visits may be requested. Please clarify if Offerors or the Government would be initiating the site visit request.

How is this different from the site visit references in Article B.4.

Advance Understandings (p. 6) and Section L.2.a.11, para. A Selection of Offerors (p. 107)?

Answer: Page 2 of the RFP cover letter and page 103 of the RFP both refer to site visits (likely virtual) that may be requested for any offeror included in the competitive range. Page 6 of the RFP refers to site visits that may be requested after award for any offeror that is issued a contract resulting from this RFP. Any site visit requests, either before or after award, would be initiated by the Government.

14. Question: Upon review of the four areas of additional clauses, will the government incorporate FAR 52.244-2 and 52.244-2 Alt 1 if a Fixed- Price R&D Contract is awarded?

Answer: Clauses in the parent IDIQ contract will apply to task orders.

Both cost and fixed-price task orders are anticipated.

15. Question: Under the RFP Cover Letter, General paragraph it states that offeror’s should not fill in the blanks or otherwise complete portions of Parts I, II, and III which appear to require additional information. Should the offeror complete Part II – Contract Clauses, ARTICLE I.5. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED

IN FULL TEXT?

Answer: An offeror must provide a completed representation and certification for FAR Provision 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (NOV 2021) only if it has NOT represented that it "does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services" in paragraph (c)(2) of the provision at 52.204-

26. If an offeror HAS represented the above through its annual SAM.gov representations and certifications, it does not need to fill in this, or any other provision located under ARTICLE I.5.

16. Question: Paragraph 1 stipulates “… reproduced on letter size paper, printed/copied double-sided, on at least 30 percent post consumer fiber paper, as required by FAR 4.302(b)…” The referenced Section J Attachment 1 Packaging and Delivery of Proposals Section 1.A.1 stipulates proposals must be submitted via eCPS. Please confirm proposal submission is via eCPS as stipulated in Attachment 1 and hard copies are not required for this proposal submission.

Answer: Yes, that is correct. All proposal submissions must be made via eCPS. Hard copy submissions will not be accepted.

17. Question: To ensure Offeror’s proposal is considered for award, please provide the evaluation criteria for “Other Considerations” items a-e on p. 120 and whether they are included in the mandatory qualifications criteria, scored technical evaluation factors, or non-scored technical evaluation factors.

Answer: The items listed in the referenced section are not tied to any specific evaluation criteria as they are entirely dependent on the individual offeror and any unique aspects of their proposal, which they feel merit further consideration. Depending on the nature of any such information that is submitted, it may be evaluated under one, some, or all of the mandatory qualification criteria, scored technical evaluation factors, or non-scored technical evaluation factors.

18. Question: Section L has conflicting language as to whether it is

"certified cost or pricing data" OR "other than certified cost or pricing data". Please confirm this RFP requires "other than certified pricing data".

Answer: At this point, the Government is not requesting certified cost or pricing data (CCPD). The Government will only request CCPD if, after reviewing the initial proposals, it determines that none of the exceptions listed at 15.403-1 “Prohibition on obtaining certified cost or pricing data” apply.

19. Question: Please confirm Offerors are required to submit its technical responses for Sample Tasks 2 and 3 in Task Area 1 – Manufacturing of the Technical Proposal to ensure Offerors are evaluated the same in accordance with evaluation factor for Task Area 1?

Answer: All offerors’ technical responses to Sample Task Orders 2 and 3 must be included within their Technical Proposals and will be evaluated against the “Task Area 1 – Manufacturing” evaluation criteria. Offerors are free to determine which section of their Technical Proposal to include these responses in so long as they are clearly identified and logically consistent with the rest of their proposal.

20. Question: Please confirm Offerors are required to submit its technical responses for Sample Task 4 in Task Area 2 – Nonclinical Studies of the Technical Proposal to ensure Offerors are evaluated the same in accordance with evaluation factor for Task Area 2?

Answer: All offerors’ technical responses to Sample Task Order 4 must be included within their Technical Proposals and will be evaluated against the “Task Area 2 - Nonclinical Studies” evaluation criteria. Offerors are free to determine which section of their Technical Proposal to include these responses in so long as they are clearly identified and logically consistent with the rest of their proposal.

21. Question: To ensure all Offerors are evaluated on an even playing field, please advise if the Government will limit page count to a not to exceed (NTE) page limit of 150 pages with text font size of 11-point Times New Roman with 1” margins and smaller font and sizes for tables and figures for the scored technical evaluation factors in its Technical Proposal.

Answer: The Government is allowing offerors to determine the number of pages necessary for its proposal.

22. Question: The Government stipulates its assessment of past performance will be based on the Offeror’s likelihood of successful performance and is based on “subjective judgment by the after it considers relevant information.” To ensure equitable evaluation and judgment of performance risks across Offerors past performance submissions, please provide an adjectival rating scale to determine level the Government’s assessment of an Offeror’s likelihood for successful contract performance.

Answer: Past performance is a non-scored evaluation factor. All past performance information, both that which is provided by the offeror and that which is researched independently by the Government, will be reviewed for relevancy and performance risk (low, medium, high).

Any concerns regarding an offeror’s assessed risk level resulting from this review will be addressed during negotiations, as appropriate.

23. Question: RFP Attachment 1 stipulates “The Technical Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned, but must be merged into the Technical Proposal PDF file.” Please confirm original documents with specific security restrictions (e.g., audit report) are excluded from the requirement for searchable text.

Answer: Yes, this is acceptable. Original documents with specific security restrictions (e.g., audit report) may be excluded from the requirement for searchable text.

24. Question: RFP Attachment 1 stipulates “The Technical Proposal should be created in a PDF format that enables word searches to the maximum extent practicable.” To ensure all Offerors are evaluated equally, does the Government require graphics to be word searchable?

Answer: No, the Government does not require graphics to be word searchable.

25. Question: This sentence reads, “The Contractor shall provide project management support for the overall administration of the contract; and development, tracking and management of all TOs issued under this contract.” Does the Government intend to award an IDIQ-level Task Order for the administration of the IDIQ contract?

Answer: No, all project management/contract administration responsibilities will be performed at the task order level for specific manufacturing or nonclinical study requirements.

26. Question: The bullet reads, “At the direction of the COR, the

Contractor shall perform other TOs directly relating to Manufacturing and Nonclinical Studies that are within the scope of Task Areas 1 and 2.” What is the context of this condition?

Answer: The intent of this language is that the specific requirements listed under the two task areas are not necessarily exhaustive as it would be difficult to anticipate every biologic modality or type of study required. Tasks/subtasks that are not specifically listed here would still be within the scope of the contract, however, so long as they are consistent with biologic manufacturing activities and nonclinical studies as defined in the SOW.

27. Question: Does the Government intend to award the Sample Task

Order #1 as Task Order #001 at contract award?

Answer: Yes, that is correct.

28. Question: Does the Government require evidence to support the DEA

Research Registration for Schedules II to V and Schedule I at the time of proposal submission? If so, what evidence is required?

Answer: Yes, offerors may provide the name and DEA registration number as evidence.

29. Question: Does the Government require evidence to support the

Animal Welfare Assurance approval at the time of proposal submission? If so, what evidence is required?

Answer: Yes, offerors should provide a copy of any official documentation stating that the institution’s (and/or, if applicable, their proposed subcontractors’ institutions) Animal Welfare Assurance was reviewed and approved. This documentation should include the Assurance identification number, as well as the effective and expiration dates.

30. Question: With the questions due February 14, 2022, when does the

Government intend to release answers to questions?

Answer: The Government intends to release additional answers to questions on Monday, February 28, 2022 by 5 pm ET.

31. Question: To allow Offerors the ability to provide adequate time to fairly compete sample task orders among its small business subcontractors after the receipt of questions and answers, we respectfully request the proposal submission deadline be extended two weeks to March 21, 2022.

Answer: The Government is extending the proposal submission deadline to March 14, 2022 at 5 pm ET. It does not intend to grant any further extensions.

32. Question: Section L of the RFP stipulates a requirement for either single Principal Investigator/Project Director or Multiple Principal Investigators. Section M stipulates evaluation criteria for Head Program Manager and Other Scientific and Technical Personnel.

Does the Government consider the Head Program Manager as the same as a Principal Investigator/Project Director or as two separate roles and requirements? If separate, does the evaluation criteria for “Other Scientific and Technical Personnel” apply to the Principal Investigator/Project Director or Multiple Principal Investigators?

Answer: The Head Program Manager will have responsibility for managing the overall contract and will be the key point of contact for the NIH. This position will have the responsibility of ensuring that single or multiple task orders/projects executed internally or at subcontractor sites are scheduled appropriately and are successfully completed on time. The evaluation criteria for “Head Program Manager” applies to this individual.

As such, this may be a distinct role compared to that of the team of Principal Investigators or Project Directors, who may be more directly involved in overseeing specific types of projects. The evaluation criteria for “Other Scientific and Technical Personnel” applies to the team of Multiple Principal Investigators as well as the support personnel that are required to execute each project.

33. Question: There appears to be a conflict between A27 STO #1 SOW

Period of Performance (three months) and A11 STO #1 Business Proposal Budget Template (12 months – “7/1/2022 Through 6/30/2023”). Please confirm the Government’s period of performance for STO #1 is three months as represented in A27, and the period is specifically 7/1/2022 Through 9/30/2022. If the period of performance for STO #1 is three months, will the Government accept Offerors editing its completed A11 – Business Proposal Budget for STO #1 to reflect a three month of 7/1/2022 Through 9/30/2022?

Answer: It is correct that the duration of STO #1 is three months and that the Government’s estimated PoP for this task order is 7/1/2022 Through 9/30/2022. To clarify, the dates in A11 STO #1 “Business Proposal Budget Template” are meant to show that the task order would be taking place during Year One of the contract, not the start and end date of the task order itself.

If it assists offerors with their preparation, however, they may insert the estimated STO #1 PoP of 7/1/2022 Through 9/30/2022 into the budget template.

34. Question: Nowhere in the RFP or attachments is there any mention of page limitations on the content of the technical or business volumes.

Please advise if the government wishes to impose page limits on any portion of the offeror’s response.

Answer: The Government is allowing offerors to determine the number of pages necessary for its proposal.

35. Question: Can details regarding the stability study for the Drug

Substance (DS) Drug Product (DP) be provided? For example, total duration of the study, timepoints, etc.

Answer: Stability testing should be industry standard stability testing for this type of Drug Product and following relevant guidance from the FDA.

36. Question: Is the expectation that analytical methods are fit for purpose/qualified to support Phase I/II study? The RPF mentions validation. Is this a requirement?

Answer: Analytical methods development should be fit for purpose/qualified to support Phase I clinical studies, as required by the FDA for this stage of development. Methods that are typically required to be validated by the FDA should be validated (see FDA guidance).

37. Question: Is a cGMP production of an MCB, DS, and DP expected under the BASE option?

Answer: cGMP manufacturing is not included in the base. (This is stated in the Objectives section of the Task Order)

38. Question: Can the government confirm that one cGMP production of an MCB, one lot of DS, and the corresponding DP fill-finish is expected for the Optional Task?

Answer: Yes, assume one MCB lot, one lot of DS, and the corresponding DP fill-finish.

39. Question: Could details on the desired fill configuration be provided, e.g., vial size, fill volume, etc.?

Answer: Offerors should provide a best guess estimate for these items. Fill volumes should be for approximately one human dose per vial.

40. Question: Under Optional Task 5 – Study 6: Assay Development, and/or Qualification, and/or Validation, and/or Plasma and Tissue Sample Analysis. The SOW states, “For the purposes of proposal development, assume that bioanalytical methods including: 1) AAV9 qPCR and 2) AAV9 ELISA development, assay qualification, and assay validation will be required.”

Given that the sample task orders require conducting PK and toxicology studies in mice, rat, dog and NHP, species-specific anti- AAV9 antibodies ELISA will be needed. Therefore, for costing purposes, should efforts under Study 6 include development, qualification and validation for all species-specific ELISA or a single ELISA format?

Answer: For the purposes of proposal development assume a single species-specific ELISA will be required.

41. Question: Appreciating that the government wants a response that can provide flexibility, product related details are missing from the Sample Task Order 3, making it very difficult to price. Can the government provide some details related to the following:

1. Target indication

2. Delivery method and anticipate dose

3. Length and type (MOE, LNA, RNA, etc.) of ASO and anticipated mode of action

4. Scale of preclinical and clinical lots required.

5. Desired concentration and formulation, if known

6. Desired drug product configuration (syringe, vial, etc.)

Answer: Offerors should make their own assumptions for what may be required for this type of manufacturing run and communicate the assumptions in its proposal.

42. Question: Section M on page 138 makes reference to the requirement of a DEA RESEARCH REGISTRATION. While many of our small molecule sites have DEA registrations, this is not standard for biologics labs as biologics by their very nature are not typically controlled substances. Was this included in error or, if not, can the requirement be qualified further to only apply to a specific scope or task (I am assuming some sort of bioanalytical assay)? If not, I suspect your pool is going to get a lot smaller.

Answer: Experimental positive controls may be required in certain in vivo or in vitro studies, and these may include substances that require DEA registration. This will not apply to all studies executed under this contract, but rather to specific task orders. The Offeror (prime and/or subcontractor) must possess a DEA registration for Schedules II to V substances and possess or demonstrate the ability to obtain a DEA registration for Schedule I substances. Not all organizations within an offeror’s team are required to have DEA registrations.