Amendment_1_-_Questions_and_Responses_.pdf

RFP_NIAID_DMID_NIHAI2015036

Amendment 1

Amendment 1: RFP_NIAID_DMID_NIHAI2015036

GENERAL COMMENTS

***The page numbers provided below refer to the page number of the PDF of the Solicitation.***

1. The NIAID is providing a second opportunity to ask questions regarding RFP_NIAID_DMID_NIHAI2015036. Please submit any remaining questions by Monday, July 13, 2015.

2. There is a revision to Section L, 2. a. 15. a. Past Performance Information on page 56.

Paragraph a. currently reads, “Offerors shall submit the following information as part of their Business Proposal. A list of the last 5 contracts completed during the past Five years and all contracts currently being performed that are similar in nature to the solicitation workscope…” (underline added for clarification)

Paragraph a. is hereby revised to read, “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…” (underline added for clarification)

3. Some potential offerors have received an error message when clicking the website links to Solicitation Attachments provided in Section J on page 41. A working list of the links is provided in a Word document as Attachment 1 of this Amendment 1. In addition, an Excel spreadsheet for Attachment 15: Breakdown of Proposed Estimated Costs (plus fee) is included as Attachment 2.

4. Please see the Table on pages 10 & 11 of this amendment for other revisions to

RFP_NIAID_DMID_NIHAI2015036.

QUESTIONS AND RESPONSES

1. Question: Reading the recent RFP "PRECLINICAL SERVICES FOR BIOPHARMACEUTICAL PRODUCT DEVELOPMENT," it sounds like it is exclusively for infectious agents. However, the first sentence says, "New therapeutic products against potential agents of bioterrorism …," which is pretty general, so I am writing you to confirm that this announcement does not extend to chemical agents.

Response: Chemical agents are not covered. The solicitation title states biopharmaceutical product development and biopharmaceuticals are defined in the Statement of Work Section 3, which also provides further information for the disease causes that are covered.

2. Question: In Attachment 8 to the RFP under (Additional Proposal Technical Instructions) under the header “Technical Proposal – Table of Contents”, is the requirement that Offerors propose to Task Area F and at least one Task Area from task areas B‐D? Task Areas B‐D include scope typically associated with Contract Manufacturing Organizations (CMOs) that do not always have product development planning and regulatory expertise as part of their service offerings.

There is not a clear rationale for this requirement in the RFP and it limits competition of sources highly qualified in Task Areas A (Product Development Planning and Evaluation) and E (Regulatory Activities and Documentation), many of which are small businesses. Would you consider removing this requirement from the RFP and allow Offerors to bid Task Areas A and/or E in combination with Task area F?

Response: Offerors should follow the instructions as stated in the RFP document. No change is needed for this requirement.

3. Question: Is this RFP open to non‐mammalian cell using facilities?

a. Task Area B, Technical Requirement 6 indicates the need to do safety assessment studies on mammalian cells. If we use only non‐mammalian cell facilities, do we meet the requirement for this task area?

b. Task Area C, Technical Requirement 3, we routinely produce recombinant proteins and peptides but have little to no expertise with nucleic acid vectors, monoclonal antibodies, natural products, etc. Do we meet this technical requirement?

c. Task Area D, Technical Requirement 4, once again, we fulfill the requirement for recombinant proteins and peptides. Do we need to fulfill the requirement for all products listed to meet this requirement?

d. For the sample Task Orders, for example for Task Area C, my understanding of the intent is that we would write a Statement of Work of how we would address this specific request. However, since we do not utilize mammalian cell culture for production, we would not address section 4.2.

Response: The Government anticipates requiring services with Technical Requirements in all Task Areas for all types of Biopharmaceutical Products as described in Section 3 of the SOW. An offeror’s proposal should describe how services would be provided for all product types described in Section 3.

4. Question: Can you provide more information on how task orders will be bid out? For example will there be bids encompassing the full development spectrum (PDP development through cGMP manufacturing, i.e. Task area A through E) with vendors then bidding on the entire or sub components? Or will all task order bids only focus on a single Task Area?

Response: NIAID intends to use the contracts awarded to provide gap‐filling biopharmaceutical product and diagnostic reagent product development services to investigators who qualify for such support. While Task Orders are anticipated in all Task Areas, a majority of Task Orders will likely be limited to one or two Task Areas. The NIAID reserves the right to award single Task Orders, which would cover all Task Areas.

5. Question: The RFP is consistent with manufacturing services up to supporting Phase 1. The example task order for task area E requires 10,000L scale culture that would typically only be required for Phase 3/commercial production. How should groups that can support nearly all of the listed biotech products at typical Phase 1/2 scale respond to task area E if they don't have commercial scale (10,000L) bioreactors?

Response: As noted in the Parent Contract Statement of Work General Task Order Requirements (Section 3): "The NIAID recognizes that a single organization may not have the full spectrum of expertise or facilities to perform all activities set forth in the Statement of Work.

Contractors may need to be supported to a certain extent by the expertise and resources of other organizations or persons through consortia agreements, partnerships, subcontracts, and/or consultants."

6. Question: Is RFP_NIAID_DMID_NIHAI2015036 open to proposals from non‐US based entities?

Response: There is no restriction on foreign institutions responding to

RFP_NIAID_DMID_NIHAI2015036.

7. Question: Per page 43 of RFP_NIAID_DMID_NIHAI2015036, I have not been able to locate the REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS from the SAM website. Per the instructions on page 43, I am requesting a copy be furnished to me.

Response: The PDF of SECTION K ‐ REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS is Attachment 3 of this Amendment 1.

8. Question: For Sample Task Order BPPD‐004, please confirm that Streptomyces sp. K01‐0607 is considered a spore‐forming organism such that 21CFR600.11(e)(3) is applicable for cGMP operations.

Response: Sample Task Order BPPD‐004: it is confirmed that Streptomyces sp.K01‐0607 is considered a spore‐forming organism and 21CFR600.11(e)(3) is applicable for CGMP operations.

9. Question: Please provide clarification between Task Order and Scope for Task Order 4.E: Is the preparation of the CMC for inclusion in a Pre‐IND package or an IND submission?

Response: Sample Task Order BPPD‐005 scope covers CMC preparation for inclusion in an IND submission. The title will be revised to read, “Preparation of anti‐mAb product XYZ CMC section for inclusion in an IND submission.” Please see General Comments, Note 3. of this Amendment.

10. Question: Does our company need to be GMP to pursue each of these Task Areas?

Response: Regulatory compliance requirements are specified in the Task Area scope in Section 4 of the parent SOW.

11. Question: Is it assumed that everyone will bid Task Area A? In other words, is it a requirement?

Response: Offerors are not required to propose to Task Area A. Proposal requirements are specified in Attachment 8: Additional Technical Proposal Instructions on page 142.

12. Question: Will Task Order Requests for Proposals (TORFPs) only be issued to awardees in the Task Areas that were included in their original proposal, or will TORFPs be issued to all IDIQ contract awardees? For example, if an offeror elects not to include Task Area C in their proposal due to limited current capabilities, but in the future acquires those capabilities, does that offeror have the opportunity to bid on TORFPs in Task Area C or is it limited to Task Areas included in their original proposal?

Response: This is addressed in Attachment 3: SOW Background and Introduction (page 94, paragraph 2. Organizations will be considered for Task Order Awards only in the Task Area(s) included in their proposal.

13. Question: The sample Task Order for Task Area D (BPPD‐004) requests manufacturing of DS at a commercial‐like scale (i.e., 10,000L); however, we would anticipate that product needed to enter a Phase I clinical trial could be produced at a smaller scale especially if some process improvement can be made to improve overall yields. For Task Area D, could NIAID provide additional information on the anticipated manufacturing scale of future Task Orders?

Response: The manufacturing scale requirements for future Task Orders are currently unknown and will be specified when they are issued. However, Task Orders awarded/anticipated under the current biopharmaceutical product development contract required 10,000L bacterial fermentation and 1,000L mammalian cell culture.

14. Question: What cell culture capacity would be required to provide the amount of product you will most likely need?

Response: Please refer to the Response to Question #13.

15. Question: Section L.2.a.17 (Information and Physical Access Security, page 57) of the solicitation and Section L.2.b.6 (Electronic and Information Technology Accessibility, Section 508 Compliance, page 72) state that separate sections for each should be included in the Technical Proposal. Section L.2.b.6.c also requires that the offeror prepare an HHS Section 508 Product Assessment Template. Attachment 8, does not include these sections in the Table of Contents. Are these sections required to be included in the offeror’s proposal? If so, can NIAID please provide guidance on where these sections should reside in the proposal? Given that these sections and the form will be lengthy and complex, can the offeror assume that these sections will not count toward the Technical Proposal page limitations identified in Attachment 1?

Response: Responses to Information and Physical Access Security, and Electronic and Information Technology Accessibility will not be evaluated as part of your technical proposal.

With respect to “Information and Physical Access Security,” Item #17 on page 57 states information relating to “Information and Physical Access Security” “shall be addressed in a separate section of the Technical Proposal entitled, “Information Security.”

With respect to “Electronic and Information Technology Accessibility,” Item #6 on page 72 states information relating to “Electronic and Information Technology Accessibility” “shall be addressed in a separate section of the Technical Proposal entitled, “Section 508 Compliance.”

Note: The information contained in the “Information Security” and “Section 508 Compliance” sections will not count against the Technical Proposal page limits.

16. Question: NIAID has estimated that the start date for any resultant contracts under this solicitation is July 29, 2016. For pricing estimation purposes, should offerors also assume a July 29, 2016 start date for the sample task orders?

Response: Offerors should use current year costing for pricing estimation purposes.

17. Question: Throughout the RFP, NIAID has requested that offerors estimate the level of effort for personnel that may participate in the program. Since the body of work for this program is not defined, this is difficult to do. Can NIAID provide guidance on the factors on which to base these level of effort estimates?

Response: Costing should be provided for the Sample Task Orders matching the Task Area the offeror includes in their proposal and Task Order BPPD‐F001 FY’16. Uniform cost assumptions are provided in Attachment 9: Additional Business Proposal Instructions and Uniform Cost Assumptions (pages 149‐152).

18. Question: Due to the complexity of the RFP, would NIAID consider extending the due date of proposals under this solicitation to August 31, 2015?

Response: The NIAID considered this request; however, no extension to the proposal due date will be granted at this time.

19. Question: RFP L.2.c.6 Do we complete the Small Business Subcontracting Plan based on the values of the model Task Orders or the entire 10‐year period of performance?

Response: Offerors should complete the Small Business Subcontracting Plan based on the entire seven year ordering period using the information supplied in the model task orders as a reference.

20. Question: RFP L.1.a.f.6 How many prime awards are anticipated?

Response: The NIAID anticipates making multiple awards from this solicitation (page 48, paragraph c.); however, the government reserves the right to make a single award or no award at all to the solicitation (page 55, paragraph f.).

21. Question: RFP L.2.c.11.d (Pertinent Contracts) requires past performance over the past three years. Page 56 of the RFP (Past Performance Information) requires past performance for five completed contracts and any ongoing contracts. Please clarify whether there are two separate requirements for past performance.

Response: See General Comments, Note 2.

22. Question: RFP L.2 a.15 specifies submission of Past Performance information for the offeror. Is Past Performance information on proposed subcontractors required to be submitted in addition to Past Performance information from the offeror?

Response: Yes, on page 56 under “Past Performance Information,” the RFP states offerors may also past performance information regarding “subcontractors that will perform major or critical aspects of the requirement…” The solicitation defines a major subcontract “as any proposed subcontract effort at or greater than $650,000” (page 56). Major subcontractors’ past performance information will be considered.

23. Question: RFP Attachment 5, F.4 indicates the Task Order BPPD‐F001 FY’16 period of performance is 12 months in duration. Are 80 hours to be applied to each 12 month period over the contract duration?

Response: The NIAID intends to issue Task Order BPPD‐F001 FY’16 on the effective date of the contract award (page 133, Note) and award any awardee one, twelve month award for Task Order BPPD‐F001 FY’16 (page 151, Section 4).

24. Question: Section J‐List of Attachments. Attachment 12‐ Summary of Related Activities is listed in J but not mentioned in RFP; link specified in J goes to "page not found". Please clarify.

Response: Please see General Comments, Note 3.

25. Question: Sample Task Order D requires scaling to 10,000L. Is it acceptable to propose multiple runs at a smaller scale to meet the 10,000L requirement?

Response: As specified in Attachment 8: Additional Technical Proposal Instructions, Section 3, Item 4) Task Area D on page 146, offerors proposing to this Task Area “should describe their proposed plans, processes and procedures for the implementation and performance of the scope of activities described in Sample Task Order BPPD‐004”. The proposed project schedule and budget should be consistent with the strategy.

26. Question: For Sample Task Order BPPD‐04, section 3.12, is stability expected for Drug Substance only or for Drug Substance and Drug Product?

Response: Offerors should describe a stability program that meets the requirements of 3.11 for the materials being manufactured.

27. Question: Would NIAID consider adding pages to Sample Task Area A given the amount of detailed information requested in the Product Development Plan?

Response: Additional pages will not be added for Task Area A since offerors responding to this Task Area and Sample Task Order BPPD‐001 are not being asked to provide a Product Development Plan in their proposal. Offerors responding to this Task Area are asked to describe their approach as specified in Attachment 8: Additional Technical Proposal Instructions Section 3

1) Task Area A (page 144).

28. Question: Attachment 7: Additional Technical Proposal Instructions, page 46, requires offerors to "address all elements of the proposed Task Areas and detailed plans in response to the Sample Task Orders matching the proposed task areas, and all General TO Requirements in the SOW”. However, instructions for preparing Section 6, Project Management, on page 55 do not require offerors to provide a Sample Task Order Plan as do the other Task Areas (A through E). Is the offeror required to provide a detailed task plan in response to Task Order BPPD‐F001 FY'16 (corresponding to Task Area F) in its proposal? If so, should this Task Order response be included in the Technical or Business Proposal volume?

Response: As specified in Section III of Task Order BPPD‐F001 FY’16 (page 134) there is no Project Management requirement for this Task Order.

29. Question: RFP L.2.b. Technical Proposal Instructions, item 2. Other Investigators (page 68), requires offerors to "list all other investigators/professional personnel who will be participating in the project. Discuss the qualifications, experience, and accomplishments. State the estimated time each will spend on the project, proposed duties on the project, and the areas or phases for which each will be responsible." Given that all work has not been defined at proposal and an offeror's team including subcontractors could consist of hundreds of available qualified personnel, is it acceptable to provide qualifications/experience/ accomplishments for the personnel ‐‐ offeror and subcontractors ‐‐ who would be supporting the Sample Task Orders as a representative set of non‐key personnel to meet this requirement?

Response: The government finds this approach acceptable.

30. Question: RFP L.2.b. Technical Proposal Instructions, Personnel, requires that offerors assure that the PI and all other personnel proposed shall not be committed on Federal grants and contracts for more than a total of 100% of their time. Please confirm that a formal statement of assurance in the proposal that personnel will not be committed on Federal grants and contracts for more than 100% of their time will be sufficient to meet this requirement, or otherwise indicate what form this assurance must take.

Response: The government finds this approach acceptable.

31. Question: Is it acceptable to have some of the work performed in other countries? Are any countries restricted?

Response: Refer to Question #6 above and the Response.

32. Question: Attachment 4.B §III. Regarding the α‐BoNT/A activity assay development, what information is available on the toxin epitopes to which the α ‐BoNT binds? Are they linear epitopes?

Response: Offerors should develop their response to Sample Task Order BPPD‐002 using the assumptions provided. An offeror’s proposed plan should include any assumptions made to develop the proposed approach.

33. Question: Attachment 4.B §III. For the α‐BoNT/A activity assay, are there any specific requirements for sensitivity, specificity, accuracy or precision?

Response: There are no specific requirements for sensitivity, specificity, accuracy or precision.

Offerors should develop their response to meet the objectives of the Sample Task Order for a Phase I/II clinical candidate described in the scope.

34. Question: Attachment 4.B §III. Do any of the tasks/milestones for Sample Task Order BPPD‐ 002 need to be performed under Good Laboratory Practices (GLP) (21 CFR Part 58)?

Response: Quality standards applicable to product characterization for a Phase I/II clinical candidate should be followed.

35. Question: Attachment 4.B §III.2.2. Please clarify any specific requirements for assay qualification. Does this include reagents?

Response: There are no specific requirements for assay qualification. Offerors should develop their response to meet the objectives of the Sample Task Order for a Phase I/II clinical candidate described in the scope. An offeror’s proposal should describe their plans to implement and perform the scope of activities described.

36. Question: Attachment 4.B §III. Please confirm that the α‐BoNT/A assay and reagents are not required to be fully validated.

Response: Full validation is not required.

37. Question: Attachment 4.B §III. Is there a specific throughput or format requirement (e.g. use of 12‐well plates) for the cell‐based α‐BoNT/A assay?

Response: There are no specific requirements for assay format. Offerors should develop their response to meet the objectives of the Sample Task Order for a Phase I/II clinical candidate described in the scope. An offeror’s proposal should describe their plans to implement and perform the scope of activities described.

38. Question: Attachment 4.B §III.1.2. Do the α‐BoNT/A assay reference and control reagents need to be produced under current Good Manufacturing Practices (cGMP)?

Response: Production of assay reference and control reagents under CGMP is not required.

39. Question: With respect to Attachment 5: Task Order for Parent Contract Management Support Activities Associated with Task Area F, and Attachment 8: Additional Technical Proposal

Instructions, is the Project Management information required in Attachment 8 sufficient, or is a separate Task Order Plan also required for this task area?

Response: As specified in Section III of Task Order BPPD‐F001 FY’16 (page 134), there is no Project Management requirement for this Task Order.

40. Question: RFP Attachment 8: Additional Technical Proposal Instructions contains instructions for Task Area F: Project Management. Page 51 states, "Task Area F will only be evaluated in the Business Proposal;" however, page 55 requires offerors to include Section 6:

Project Management in their Technical Proposals, not their Business Proposals. Should offerors include Project Management in the Technical Volume or in the Business Volume, or in both?

Further, RFP Attachment 7: Evaluation Criteria indicates that adequacy of the Quality System will be evaluated as part of Project Management, so should Quality System be included in the same volume as Project Management?

Response: No Technical Proposal is required for Task Area F. The Technical Proposal should contain all information specified in Attachment 8 for the Task Areas proposed by the offeror: all Technical Proposals should contain Sections 1, 2, 4, 5, 6, 7, 8 and 3 only for the Task Areas proposed by the offeror. Information provided by offerors in Sections 1, 2, 4, 5, 6, 7, and 8 will be evaluated to determine an offeror’s ability to meet General Task Orders Requirements specified in the Parent SOW Section 3.

41. Question: RFP L.2.b. Technical Proposal Instructions, Personnel, items 1. Single PI/Project Director and 2. Other Investigators, require offerors to state the estimated time each person will spend on the project. Since this RFP is not ordering specific work, other than the Project Management task that will be issued on award, and since the estimated time personnel will spend on the contract will be based on the nature/extent of work ordered after award which is not known at this point, please confirm that it is sufficient to estimate time each person would spend based on the Sample Task Orders as proposed. Alternatively, please confirm that estimating time that Key Personnel (excluding nonkey personnel) will spend on the contract is sufficient to meet this requirement.

Response: The government finds that estimating time based on the Sample Task Orders to which the offeror responds, and based on Task Order BPPD‐F001 FY’16 is acceptable.

42. Question: Attachment 4.A §IV. Section IV of Attachment 4.A states that Sample Task Order BPPD‐001 does not require updates; however, periodic updates are included in Attachment 4.A., Section 2 of “Other Reports and Deliverables”. Please confirm that periodic updates are not required for this task order.

Response: Project Management requirements for all Task Orders are described in parent contract SOW General Task Order Requirements Section 3. A. (page 95). Section IV of Attachment 4.A covers Project Management requirements for Sample Task Order BPPD‐001 and changes to the parent contract PM requirements are described. It is stated that no Project Management Plan or updates is required. The updates referred to in this sentence clearly are attached to Project Management Plan requirements. Periodic task updates are required as specified in the Reporting and Deliverables section of Sample Task Order BPPD‐001.

43. Question: Attachment 5 §F.4. According to the RFP, each sample task order indicated project management should not be included in the sample task and is covered under the parent contract. However, Task Order BPPD‐F0001 only allows for 80 hours to cover 6 one‐hour ad hoc meetings and one kick‐off/annual meeting every year (Uniform Cost Assumptions). Please advise on whether task‐specific project management should be included in each sample task order or whether the base program in Task Area F will be increased.

Response: As specified in the parent contract SOW General Task Order Requirements, (page 95) there are “requirements [that] shall apply to each Task Order” including Project Management.

Project Management for specific Task Orders is not included in Task Area F. Changes to the parent contract requirements will be specified in specific Task Orders as described in the Sample Task Orders included in the RFP. Offerors should refer to the Project Management section of the Sample Task Order(s) associated with the Task Area(s) included in their proposal for any revision to PM requirements specified in the parent contract SOW General Task Order Requirements that are applicable to specific Sample Task Order(s).

TABLE: REVISIONS TO RFP‐NIAID‐DMID‐NIHAI2015036

Solicitation location (Page/Section/Paragraph)

Current language Amended language

Pg101/Sec 4.3/P1 Scope “…manufacture of biopharmaceutical products or diagnostic reagents defined in the parent contract scope, Section 2…”

“…manufacture of biopharmaceutical products or diagnostic reagents defined in the parent contract scope, Section 3…”

Pg103/Sec 4.4/P1 Scope “…production of CGMP biopharmaceutical products defined in the parent contract scope, Section 2…”

“…production of CGMP biopharmaceutical products defined in the parent contract scope, Section 3…”

Pg115/Sample Task Order BPPD‐003/P1 Note

“Task Orders may be awarded for any product class described in the parent contract scope, Section 2.”

“Task Orders may be awarded for any product class described in the parent contract scope, Section 3.”

Pg122/Sample Task Order BPPD‐004/P1 Note

“Task Orders may be awarded for any product class described in the parent contract scope, Section 2.”

“Task Orders may be awarded for any product class described in the parent contract scope, Section 3.”

Pg129/Sample Task Order BPPD‐005/Heading

“Preparation of anti‐ Ebola mAb product XYZ CMC section for inclusion in a Pre‐IND meeting briefing package.”

“Preparation of anti‐mAb product XYZ CMC section for inclusion in an IND submission.”

Solicitation location (Page/Section/Paragraph)

Current language Amended language

Pg145/Additional Technical Proposal Instructions Sec 3, Item 3)/P1

“…described in Task Area C for the product classes described in the parent contract scope, Section 2, as follows…”

“…described in Task Area C for the product classes described in the parent contract scope, Section 3, as follows…”

Pg145/Additional Technical Proposal Instructions Sec 3, Item 4)/P1

“…described in Task Area D for the product classes described in the parent contract scope, Section 2, as follows…”

“…described in Task Area D for the product classes described in the parent contract scope, Section 3, as follows…”