Phase II Questions and Government Responses.pdf

Solicitation No. 75N95021R00008 Offeror Phase II Questions and Government Responses

OFFEROR PHASE II QUESTIONS AND GOVERNMENT RESPONSES

Offeror

Question No.

Solicitation No. 75N95021R00008 Section No./Name/Pg. No./Relevant

Text

Offeror Question Government Response

1 Solicitation, page 53. “Technical proposals must not exceed 50 pages. Any pages in excess of 50 pages will not be viewed. The following are NOT included in the page count: cover page, table of contents, resumes, consultant and proposed employee letters of commitment.”

Is the Summary of Related Activities included in the 50-page limit for the Technical Proposal?

No, the Summary of Related Activities is not included in the 50-page limit for the Technical Proposal.

2 Solicitation Attachment 4: TORFP and TOSOW. Attachment 4 states that we are to follow the Technical Proposal Instructions to prepare the task order, but under the Submission Instructions it says that Task Order proposals must be included within in, and submitted with, proposals for Solicitation No.

75N95021R00008.

Does this mean that the response for the Task Order is included in the 50 pages for the Technical Proposal, or is the response for the Task Order a completely separate document listing e.g., Personnel, Past Performance, etc., and submitted at the same time as the Technical Proposal?

If it is not a separate document, do we need to repeat personnel, past performance, etc.?

The response for the task order is part of the Technical Proposal and is not a separate proposal. The response for the task order is included within the 50-page limit for the Technical Proposal.

Past performance information should only be submitted one time. Personnel information should be submitted for the task order and should also be submitted for the IDIQ.

3 Solicitation, page 54. Can we propose a Project Director and a Co- Director?

Offerors may propose a Project Director and a Co-Director.

4 Solicitation Attachment 4: TORFP and

TOSOW.

The sample Task Order RFP is for preparation, submission, and maintenance of an IND. Is it acceptable to propose a pre-IND meeting if we feel it is an important part of the regulatory strategy?

It is not acceptable to propose a pre-IND meeting. A pre-IND meeting has been held with the FDA and another pre-IND meeting is not needed.

5 Solicitation Attachment 4: TORFP and

TOSOW.

For the sample Task Order response, which is to submit an IND for a treatment for JMC, is the intended patient population the pediatric population with JMC, the adult population, or both?

The intended patient population is both adult and pediatric. The adult population will be followed by the pediatric population.

6 Solicitation Attachment 3: IDIQ Statement of WorkSo, Area 3: Regulatory Services for Clinical Studies, anticipated activity 3 states:

Supporting clinical protocol(s) and clinical trial(s) to ensure compliance with Good Clinical Practice (GCP). This may include tasks such as reviewing study regulatory files and subject specific documents such as informed consent, case report forms, medical records, and communication with the regulatory agency and Investigational Review Board (IRB).

Are the subject specific documents (e.g., informed consent, case report forms, etc.) that are mentioned the templates that are developed prior to the trial initiation, or are they actual completed documents for subjects enrolled on the given trial?

The subject specific documents are specific to each task order and are not required for this task order.

7 Solicitation, page 56, Article L.2.d.2.b.

Phase II instructions: Business Proposal.

The Government presents how the data should be submitted in the form of the Excel spreadsheet

(a. Labor Category/ies b. Fully-Burdened Hourly Rate c. Number of Hours d. Other Costs e. Total Price).

Is this format applicable to Task Order A and Task Order B only?

Does the government have a template that can be used?

The Labor Category/ies, Fully-Burdened Hourly Rate, Number of Hours, and Other Costs are only applicable to labor-hour tasks.

Tasks A and B and Firm Fixed Price and Task C is Labor Hour. Business proposals should reflect a Firm Fixed Price approach for Tasks A and B and should reflect a Labor Hour approach for Task C (solicitation p. 55).

An optional template is provided as an attachment to these questions and responses. This template may be used by Offerors but is not required.

8 Solicitation, page 56, Article L.2.d.2.b.

Phase II instructions: Business Proposal.

The Government presents how the data should be submitted in the form of the Excel spreadsheet

(a. Labor Category/ies b. Fully-Burdened Hourly Rate c. Number of Hours d. Other Costs e. Total Price).

However, attachment 9 of the RFP provides instructions on how to submit invoices for fixed price contracts and discusses the unit price for subtasks under a Task Order A or Task Order B.

Can government clarify for Fixed Price Task Orders should contractor present the hours per each labor categories or unit price for a given subtasks/task?

See the above response to Question No.

7.

9 Solicitation, pages 55-56

Does the government have a template for Business Proposal Task C?

See the above response to Question No.

7.

10 Solicitation, page 7- Deliverable No. 8.

Nonclinical and Clinical Study Reports, and Deliverable No. 10. Medical Device Component of a Combination Product Documentation (biocompatibility study reports).

Solicitation Attachment 3: : IDIQ Statement of Work, page 1 “DPI has a need for both preclinical and clinical regulatory support so that projects can meet the regulatory requirements of the FDA and other non- US regulatory bodies.”

Can a list be provided of NCATs qualified vendors that provide nonclinical and IND enabling support services that will be required in fulfillment of the Reporting Requirements?

Will all offerors of regulatory support services be permitted to use NCATS qualified vendors, or can offerors propose nonclinical vendors qualified during the proposal process or during project execution?

The Government is not able to provide a list of vendors at this time. In the future, the Government may be able – but does not guarantee – to provide a list of capable vendors for specific subcontracting needs.

Offerors may propose any qualified subcontractor as needed (and subject to the Limitations on Subcontracting in FAR Clause 52.219-14).

11 Solicitation Attachment 3: IDIQ Statement of Work, page 1-Background and Introduction.

“DPI conducts drug development as collaborations through programs such as the Therapeutics for

In addition to neglected diseases, substance abuse, are there additional therapeutic areas that will require SMEs for protocol development, etc.?

Will NCATS provide a forecast of upcoming tasks to permit identification of additional SMEs?

Areas of expertise include but are not limited to: Pharmacology; Toxicology;

Chemistry, Manufacturing and Controls (CMC); Clinical; Statistical services; and Medical Devices (IDIQ Statement of Work, page 5).

Rare and Neglected Diseases (TRND), Helping to End Addiction Long-term (HEAL) Initiative and the Bridging Interventional Development Gaps (BrIDGs) programs.”

The Government cannot guarantee to provide a forecast of upcoming tasks. The Government will provide advance notice of upcoming tasks when feasible and practicable.

12 Solicitation Attachment 3: IDIQ Statement of Work, page 3.

Government-Furnished Data “The Contractor will have access to any data and materials available at NCATS or the NCATS partner related to each task order that the Government deems necessary to successfully perform under the task order.”

What types of data and in what format would the government provide?

Such data may include but is not limited to: nonclinical and clinical draft and/or final study reports in Microsoft Word or Adobe PDF; raw data; and/or published articles.

13 Solicitation Attachment 4: TORFP and TOSOW. Task A. d.

“d. The contractor will assist in the writing of IND enabling preclinical proof of concept study reports (up to three) that were conducted in an academic laboratory.”

What is the expectation of the government for the contractor to provide non-clinical support services?

These study reports are specific to the in-vivo animal efficacy work that was performed in NCATS collaborators’ academic laboratory. The expectation is to work with the academic lab to compile needed data from published/unpublished lab sources and originate IND enabling study reports from the beginning with the required rigor that are acceptable by the Agency.

14 Solicitation Attachment 4: TORFP and TOSOW. Task Order Report and Delivery Schedule, page 5.

“IND enabling study report for each identified preclinical efficacy study identified by the Government in a formal for IND submission. The Government anticipates up to three study reports will be needed”

What are the anticipated Government- Furnished Data (client deliverables) for the Sample Task Order Statement of Work?

Will the NCATS partner provide all three study reports, or complete study records?

For pivotal safety or toxicology studies will the offeror be required to audit the NCATS partner for compliance with GLP, or alternatively will

See the above response to Question No.

12.

The IND enabling study reports listed in the Task Order Report and Delivery Schedule are to be completed by the contractor.

No, the contractor will not be required to audit any other company for GLP compliance.

the NCATS partner provide and sign the compliance statement?

15 Solicitation, page 6. Technical Reporting Requirements.

“Wherein, NCATS provides Reports, Minutes, Presentations, etc.”

Can NCATs provide an estimate of the current number of existing INDs that require life cycle maintenance, and anticipated number of gap analyses, Pre-IND, IND, Study Protocols, Non-clinical and clinical study reports, designation requests?

The Government is not able to provide an estimate. This information is neither necessary nor relevant to this procurement.

16 Solicitation, pages 14, 43, 44, 54. Multiple sections of Synopsis and Solicitation, including:

Requesting Task Order Proposals, Task Orders Under Multiple Award Indefinite Delivery Contracts Competitive Ordering Process, Additional Personnel and Subcontractors/Consultants.

“All Contractors within a technical area… Issue a notice of intent to award a task order for services to all resultant Contractors within a technical area… All Contractors within a technical area… List names, titles, and proposed duties of additional personnel, if any, who will be required for full-time employment, or on a subcontract or consultant basis. The technical areas, character, and extent of subcontract or consultant activity will be indicated, and the anticipated sources will be specified and qualified.”

Reference is made to contractors within a technical area (Synopsis and Solicitation, p14, 43, 44, 54). However, there is no description of specific non-clinical, IND enabling study SME, regulatory strategy or regulatory operations roles assigned to specific contractors. Will each contractor be able to bid on any/all task orders?

Yes, all contractors can submit a proposal for all/any task orders. It is anticipated that the IDIQ contracts awarded will cover the entire range of activities included in the IDIQ Statement of Work.

17 Solicitation Attachment 4: TORFP and

TOSOW

Please advise the total period of period of performance to use for the pricing of the Sample Task Order RFP .

The base period of performance is 18 months and the total period of performance will not exceed three years (Task Order Request for Proposals, page 1).

18 Solicitation, pages 55-56

Can the Government please provide a pricing template for the Sample Task Order RFP.

See the above response to Question No.

7.

19 Solicitation Attachment 4: TORFP and

TOSOW

Can you please provide the anticipated level of effort for task A & B within the Sample Task Order RFP?

The anticipated level of effort is provided for Task C, which is labor hour. Tasks A and B are firm fixed price and no anticipated level of effort is needed.

20 Solicitation Attachment 4: TORFP and

TOSOW

Can the government please provide a list of staff labor categories and estimated hours for the Sample Task Order RFP?

Vendors should propose the labor categories to be used.

Also see the above response to Question No. 19.

21 Solicitation Attachment 4: TORFP and

TOSOW

With respect to the Task Order Technical Requirements NCATs refers to Task A (Base) and Tasks B and C (Options). Does NCATS anticipate that eCTD publishing (Task B) and IND life cycle management (Task C) sub-tasks will always be exercised as optional tasks?

The Government cannot speculate on future requirements.

22 Solicitation, pages 55-56

Please provide details of ODCs permitted for this effort. Will NCATS provide preferred access to their reference manager software, eCTD compilation software access, approved Style Guide (e.g., AMA), document management systems or will the awardee be permitted to offer a solution wherein costs of ODC will be reimbursed?

NCATS will not provide access to any software. The awardee(s) are expected to provide its own access to all software necessary to perform the work.

The task order Tasks A and B are firm fixed price and the proposed price should include all necessary direct and indirect costs that make up the proposed price.

Task C is labor hour and the fully-burdened rates should include wages, overhead, general and administrative expenses, and profit.

The Government will consider proposals that include ODCs. The Government will review requests for ODCs but does not guarantee approval of any ODCs.

23 Solicitation, page 53

Please advise that the technical 50 page limit includes both the IDIQ and Task Order Statement of Work in the overall page count.

See the above response to Question No.

2.

24 Solicitation Attachment 4: TORFP and

TOSOW

Has NCATS established criteria for determining use of firm-fixed price and/or labor hour task orders?

The Government makes the determination based on the specifications of each requirement. How this determination is made is neither required nor relevant to this procurement.

25 Sample Task Order Will NCATS require/permit the use of sealed bids for subK business proposal?

The use of sealed bidding is likely not appropriate for subcontracts and the Government does not anticipate consenting to subcontracts when sealed bidding was used. However, the Government will review each request to subcontract based on the facts of each situation.

26 Solicitation Attachment 4: TORFP and

TOSOW

Does NCATS anticipate providing a periodic forecast of upcoming programs, initiatives, or task orders on a regular basis?

See the above response to Question No.

11.

27 Synopsis and Solicitation Can the government extend the Phase II submission due date by one week?

The Government will agree to extend the Phase II submission due date until 12:00pm ET on Monday, October 25. An amendment to the solicitation will be issued.

28 Solicitation, page 53

Is the page limit for both the Technical section for the Parent IDIQ and the Technical Section of the TORFP combined? If the page limit only applies to the Parent IDIQ, what is the Page limit for the TORFP?

See the above response to Question No.

2.

29 Solicitation Attachment 7: Proposal Summary and Data Record

Is Attachment 7 for Business Proposal applicable only to the TORFP?

Yes, Attachment 7 is only applicable to the Task Order.

30 Solicitation, pages 55-56. Please confirm there is no separate Business Proposal for the IDIQ

Only one Business Proposal is needed.

The Business Proposal must contain the information outlined in Article L.2.d.

31 Solicitation, pages 55-56. Please confirm the Excel Sheet prices applies only the TORFP.

See the above response to Question No.

7.

Business Proposals must also contain sufficient information to allow the Government to perform a basic analysis of the proposed cost or price of the work for the IDIQ. This information shall include the amounts of the basic elements of the proposed cost or price (solicitation, page 55). Offerors are expected to provide a list of Labor Category/ies with Fully-Burdened Hourly Rates for the IDIQ Statement of Work.

See the attached optional template.

32 Solicitation Attachment 4: TORFP and

TOSOW

Has NCATS/DPI (or its academic collaborator) already appointed a Principal investigator (PI) for the JMC peptide IND application?

Yes, NCATS has appointed a PI for this IND. This clinical trial will be conducted at the NIH Clinical Center.

33 Solicitation Attachment 4: TORFP and

TOSOW

Does NCATS/DPI have a protocol synopsis already drafted for JMC peptide application or is the contractor supposed to perform this task under Task A (Base)?

Yes, a protocol synopsis is drafted. The contractor will review and revise the protocol.

END OF OFFEROR PHASE II QUESTIONS AND GOVERNMENT RESPONSES