Responses to Questions.docx

REQUEST FOR PROPOSAL

(RFP) NUMBER: NIAID-NIH-AI-75N93020R00023

AMENDMENT NUMBER: 1

TECHNICAL VOLUME QUESTIONS

Solicitation Reference (page and section)

General

The offerors do not need to have an IND in place, mainly because NIAID plans to hold the IND. If, on the rare occasion the offeror does plan to hold their IND, that plan will go through DMID or OCRR for appropriate review before acceptance.

Offerors need to apply to Task Area A, plus any one or more of the other Task Areas (B through E).

General

General

General

General

General

Please confirm the Page limit for the Technical Proposal is 150 pages for each individual Task Area.

The page limit for Task Area A is 75 pages and the page limit for Task Areas B-E is 150 pages.

Attachment 1.II.B.1

Attachment 10, pg. 3 The total page count of the Technical proposal shall not exceed __150__ pages.

Offerors responding to multiple Task Areas must provide separate Technical and Business Proposals for each Task Area.

Create one PDF file of your Technical Proposal, including all attachments.

The proposal should address general technical requirements in the SOW for Task Areas B, C, D or E, and a separate technical response that demonstrates the capabilities, plans and procedures for carrying out the specific tasks and functions for any specific Sample Task Order requirements.

“Offerors shall submit proposals in response to Task Area A, as well as one or more additional Task Area(s) that they are capable of performing. Offerors are not expected to respond to all Task Areas i.e. B, C, D, and E. Offerors responding to multiple Task Areas must provide separate Technical and Business Proposals for each Task Area.”

Based on that requirement, if an offeror plans to submit a proposal for multiple task areas, which require separate Technical and Business Proposals for each Task Area, we have the following questions around the requirements for response to Task Area A (Administrative and Overall Clinical Operations Support and Concept Development):

a. In the scenario presented above, does the Government intend to award one Task Area A to support all administrative project management, technical preparedness, and concept development for all successful task areas, OR does the Government plan to award a separate Task Area A to support each successful task area?

b. If the Government intends to award one Task Area A to support all administrative project management, technical preparedness, and concept development for all task areas awarded, should offerors simply duplicate their Task Area A responses across each separate task area Technical Proposal? Further, should the Task Area A costs be included in each separate task area Business Proposal?

a. One task order for Task Area A will be awarded to each successful offeror. This will be the “project management task order” for the entire contract. Task orders awarded for other Task Areas will be for the specific clinical trial, with project management included specific to the clinical trial.

b. Task area A is for the overall contract; provide one task area A response that will serve to cover work under all other task areas being responded to. Project management will be for the specific clinical trial for that specific Task Area.

Section 3: Technical Plan/Approach for Each Task Area, page 4 (188/221)

1. Can the government confirm that Offerors are to include in Section 3 of their Technical Proposal (based on the Attachment 10 instructions related to Section 3 on page 188 of the RFP document) the technical plan/approach for the SOW activities for Task Areas A-E, while separately addressing the detailed technical plan/approach for each Sample Task Order SOW for Sample Task Orders B-E in the separate “Section 7 Task Order/Sample Task Order Options” section of the Technical Proposal?

For example, if an Offeror is responding to Task Order A and Sample Task Order B, Section 3 of the Offeror’s Technical Proposal would respond to requirements for Task Areas A and B in Attachment 3 SOW. Section 7 of the Offeror’s Technical Proposal would respond to the proposed approach for accomplishing the specific activities in Task Order A and Sample Task Order B (i.e. site(s), laboratory, etc.)?

Section 3 pertains to the overall SOW and is nonspecific to task orders.

Section 7 is applicable to performance on each task order.

Attachment 10 Additional Technical Proposal Instructions, page 3 (187/221)

Technical Proposal – Table of Contents

The Technical Proposal Instructions state, “Offerors shall submit proposals in response to Task Area A, as well as one or more additional Task Area(s) that they are capable of performing. Offerors are not expected to respond to all Task Areas i.e., B, C, D, and E. Offerors responding to multiple Task Areas must provide separate Technical and Business Proposals for each Task Area.”

1. If an Offeror is proposing on Task Order A and all Task Areas (i.e., B, C, D, and E), can the government confirm that:

0. Offerors will submit 1 comprehensive Technical Proposal with a 150-page limit that addresses both Task Area A/Task Order A and Task Areas B, C, D, E/Sample Task Orders B, C, D, E and a Business Proposal that includes a response for Task Order A + Sample Task Orders B-E

OR

0. Four (4) separate Technical and Business Proposals – each with a Technical Proposal 150-page limit that cover the following?

1. Task Area A/Task Order A + Task Area B/Sample Task Order B

1. Task Area A/Task Order A + Task Area C/Sample Task Order C

1. Task Area A/Task Order A + Task Area D/Sample Task Order D

1. Task Area A/Task Order A + Task Area E/Sample Task Order E

0. If Offerors are to complete separate Technical and Business Proposals for Task Areas B-E and assuming all Technical Proposals will have 150-page limits, how are Offerors to submit via the eCPS portal as options include an upload for a single Technical Document, a single PHS Human Subjects and Clinical Trials Document, a single Business Document? Also, the eCPS portal has a Max File Upload Size: 387.19 MB.

Offerors will submit 1 comprehensive Technical Proposal with a 75-page limit that addresses Task Area A/Task Order A and a 150-page limit for each Task Area B, C, D, and E/Sample Task Orders B, C, D, E, and a Business Proposal that includes a response for Task Order A + Sample Task Orders B-E.

If offerors encounter difficulties with entering their proposal into the system due to the size, please label your proposal Part 1, Part 2, etc.

4. Human Subjects IMPORTANT NOTE TO OFFERORS: The following subparagraphs shall be addressed, as applicable, in a SEPARATE FILE of the Technical Proposal entitled, "HUMAN SUBJECTS."

TASK AREAS B TO E QUESTIONS

Solicitation Reference (page and section)

Attachment 5 – Task Area B

Please assume standard screening and safety labs and procedures

SoE table on pp.7-8 is duplicated on pp.9-10.

Please assume standard screening and safety labs and procedures

Duplication is an error

Attachment 8 – Task Area E, vs Attachment 11

Attachment 8 Study design, Page 3 (Page 174/221) and Page 5 (Page 175/221) vs Attachment 11, 2.e.2 – Page 6 (Page 201/221)

will include five visits in total – a Screening Visit, an Enrollment Visit, and 33 Follow- up visits.

This is a randomized, double-blind, placebo-controlled Phase II study. It is anticipated that 245 women will be screened in order to enroll 98 participants to achieve 82 evaluable participants. Participants will be randomized to ABC-401 2 x 250 mg PO bid or placebo, for 7 days. Participation will include five visits in total – a Screening Visit, an Enrollment Visit, and 3 Follow- up visits. Total participation for each woman will be approximately 30 days.

Yes, that is a typo: 3 visits, and a window of 30 days are the correct numbers.

Also, please confirm the total duration of study participation is 30 days; in the study design section it states, “approximately 3030 days” (suspect typo).

Both are typos: 3 follow up visits, and 30 days.

Please address all objectives.

Attachment 8 P5 Attachment 11 P6

In Attachment 8 Sample Task Order E states that the contractor need to enroll 98 participants but In Attachment 11 Additional Business Proposal Instructions states the contractor shall be responsible for enrolling 150 volunteers. Please clarify how many participants shall be enrolled in sample task order E.

Please follow sample task order.

Page 201 includes the following language:

For Sample Task Order E assume:

6) The clinical trial will recruit in two (2) international sites.

1. Can the Government please confirm if US or international sites should be assumed for Sample Task Order E?

1. If international sites are assumed, can the Government provide guidance on the location of the international sites so that competing proposals are based similar assumptions? Or should the Offeror make an assumption based on experience?

a. Please see response above.

b. Please see response above.

Task Area B Sample Task Order

Task Area B Sample Task Order

SOW

P13

No, there is no clinical trial network for the EPCTU contracts.

SOW

p17

SOW

p14

Offeror will collaborate with NIAID safety support contractors.

SOW

p17

Specific training requirements will be protocol driven.

The “at least 200 volunteers” applies across the board in total for all task orders B through E

For Sample Task Orders under Task Area B, C, D, or E assume:

d) One (1) study-specific Site Initiation Visit (SIV) per protocol.

e) One (1) clinical site assessment visit per site per protocol.

f) One (1) close-out visit.

6) 100% monitoring of ICFs and 100% monitoring of 25% of CRFs.

Please provide your assumptions for the liability insurance.

Section 2.a. Clinical Quality Management Plan Section 2.a. Clinical Quality Management Plan states:

Clinical Quality Management Plan (CQMP): develop, maintain, update, and submit the CQMP to the COR for approval in accordance with the NIAID DMID CQMP Policy. Update the CQMP annually, or as specified by the COR. CQMP shall be contractor specific as well as site-specific.

NIAID DMID Data Monitoring Contractor: Statistical Data and Coordinating Center (SDCC): The SDCC (a NIAID Contractor) is responsible for the operation of a central data management system for the receipt, storage, tracking and retrieval of all clinical and laboratory data, and for implementing quality assurance/quality control procedures to ensure the accuracy, completeness and timeliness of data for clinical trials.

#23 – SAE Notification and available information #24 - SAE Follow up information #26 - Clinical Quality Management Report Summaries of QC/QA activities/findings and CAPA and/ or any remedial actions #27 - Data Management Plan (for collection, verification for completeness; and accuracy/entry of all data to the data analysis contractor) #28 - Clinical and laboratory study data #35 - Trial Master File contents #40 - Copies of all study data and files pertaining to this Task Order Deliveries Table in the RFP states:

#23 “Within 24 hours of learning of event” #24 “As requested by the COR” #26 “As requested by COR” #27 “As requested by the COR” #28 “Within 72 hours of study activity” #35 “As requested by the COR” #40 “Due at the request of the COR”

The Offeror will be responsible for entering data into the CROMS or SDCC systems/databases for each clinical trial and have no ability to transfer data to DMID based on deliverable timelines. Please clarify if it is DMID’s expectation that Offerors will be expected to provide QM oversight of DMID contractors (e.g., CROMS, SDCC)? If so, will we be provided access and/or reports to monitor contractor data?

Offerors will need to report requested information into appropriate data system within specified time.

However, the transfer from data system is not the offeror’s responsibility.

e. Assume one (1) GCP audit per year for three (3) days.

f. Assume one (1) site assessment visit.

1. Is the expectation for Offerors to facilitate/host DMID or their contracted auditor or for Offerors to perform these audits?

1. What is the scope of the GCP audit, for example is it a GCP audit of the Offeror for all services they will be performing within the scope of Task Area A/Task Order A?

1. What is the scope, duration, and confirm that this will occur one time over the contract?

2. Both are possible, depending on the nature of the audit.

2. Scope will depend on what needs to be audited and will be provided to contractor before the audit.

2. Cannot confirm only one-time audit.

1. Will the meeting occur at NIAID facility, Offeror facility or an off-site location?

1. Typically, one day

1. Depends on circumstances: may be face-to-face at contractor’s site, or NIAID; or may be held remotely if on-site is not possible.

· d) Transfer complete and accurate Serious Adverse Event (SAE) information to the central Safety Reporting Database System operated by the NIAID or any applicable sponsor’s clinical monitoring contractor within twenty-four (24) hours of learning of the SAE. Provide follow-up information, as required, to meet FDA IND reporting requirements and to support SMC/DSMB meetings.

· 3. Data Management and Quality Control Make staff available for training in the use of the data management system.

· 2) Clinical Specimens. The Contractor shall provide for:

a) Timely collection, processing, labeling, temporary storage under appropriate conditions, and management of all collected clinical specimens, including use of the DMID centralized clinical specimen barcoding and tracking system;

Please provide the systems that will be utilized by the DMID third-party contractors (i.e., CROMS, SDCC, centralized clinical specimen barcoding and tracking system, etc.).

EPCTU awarded contractors will need to interact with all database, safety, monitoring, and other systems such as NIAID SDCC, centralized clinical specimen barcoding and tracking systems, etc., and safety reporting system.

Will provide details and specifics upon award of the task order.

Please confirm for each of the Task Areas that study drug is being supplied by the sponsor.

Yes, that is correct.

No non-standard safety labs needed. Please assume standard screening and safety labs and procedures.

BUSINESS VOLUME QUESTIONS

Solicitation Reference (page and section)

Access to several documents listed below through provided web links could not be completed. Please provide current web link or document

http://www.hhs.gov/web/508/contracting/technology/vendors.html

https://oamp.od.nih.gov/content/breakdown-proposed-estimated-cost-plus-fee-and-labor-hours https://oamp.od.nih.gov/sites/default/files/DFASDocs/buscntrctprpslsprdsht08-2014_508.xlsx

https://grants.nih.gov/policy/inclusion/lifespan.htm - Please confirm or provide document- Yes, this is correct.

https://oamp.od.nih.gov/DGS/reference-material-prospective-offerors-and-contractors/contracting-forms

https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html Yes, that is correct.

https://obamawhitehouse.archives.gov/sites/default/files/omb/memoranda/2011/m11-35.pdf http://www.whitehouse.gov/the-press-office/2011/06/13/executive-order-delivering-efficient-effective-and-accountable-governmen http://www.whitehouse.gov/the-press-office/2011/11/09/executive-order-promoting-efficient-spending http://www.hhs.gov/grants/contracts/contract-policies-regulations/efficient-spending/ http://oamp.od.nih.gov/

http://www.hhs.gov/web/508/contracting/technology/vendors.html

FORMAT OF PROPOSAL SUBMISSION

There is a discrepancy as noted below. We assume it is electronic. Please confirm

Proposals will be typewritten, paginated, 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), and will be legible in all required copies.

Please confirm this is not required as submissions will be electronic.

Yes, that is correct.

website at https://ecps.nih.gov . Confirm that paper proposals are not expected.

Yes, that is correct. Paper proposals will not be accepted.

Part II, Article I.1 (2 articles with same number), Page 37

Section L, 1.c, Page 52

Section L, 2.a.1, Page 56 Section L, 2.c.10.d

Attach. 11, Section 3, Page 3 (Page 198/221)

Invoice Submission/Contract Financing Request and Contract Financial Reporting, NIH(RC)-4 for NIH Cost- Reimbursement Type Contracts are attached and made part of this contract. (Section G, Article G.4, a, Page 17)

COST-REIMBURSEMENT and FIXED-PRICE (Part II, Article I.1, 2 articles with same number, Page 37

… this solicitation will be multiple-year Cost-Reimbursement type Completion contract (Section L, 1.c, Page 52)

… [cost-reimbursement [(completion/level of effort)/fixed price] … (Section L, 2.a.1, Page 56) … the resultant contract will not be Firm-Fixed Price. (Section L, 2.c.10.d)

Task Orders issued against the IDIQ contracts will be cost reimbursement and/or firm fixed price. (Attachment 11, Section 3, Page 3 (Page 198/221) Task Orders awarded under these IDIQ contracts may be cost reimbursement or fixed price.

General

Section 4 – Level of Effort;

Section 5 – Uniform Cost Instructions Section 6 – Table of Contents for Documentation Required under Section L of the Solicitation The instructions in Attachment 11 appears to indicate the Government wants Business Proposals to follow the outline of Sections provided. We want to confirm the Government is not indicating that all these sections need to be placed into our business proposal as listed in Attachment 11 per the questions below:

1. The third item is “Section 3 – General Instructions” and it contains basic information about the structure of the IDIQ contract and the Task Orders. Please confirm the Government does not require offerors to have a section of their business proposal labeled “General Instructions”? If this is required, please clarify what items the Government wants addressed in this section?

1. The fourth item is “Section 4 – Level of Effort” which provides information regarding the expected level of effort for Task Area A, Task Order A. Please confirm the Government does not require offerors to have a section of their business proposal labeled “Section 4 – Level of Effort” and that we can address this item within our response to Task Order A? If this is required as section of the business proposal, please confirm if you also want it addressed in the Task Order A response?

1. The fifth item is “Section 5 – Uniform Cost Assumptions” and it provides a variety of assumptions regarding Task Order A and the 4 sample task orders. Please confirm the Government does not require us to have a section of the business proposal labeled “Section 5 – Uniform Cost Assumptions” and that we can address the cost aspects of these assumption in the relevant Task Order and sample Task Order responses? If it is required, please clarify how the Government would like us to address these assumptions in the proposal separate from the individual task order responses?

1. The sixth item is “Section 6 – Table of Contents for Documentation Required under Section L of the Solicitation” and contains instructions that the Small Business Subcontracting Plan, Extent of SDB Participation, and Past Performance Data should be submitted with all related documentation and included in a clearly marked section applicable to each. 1). Please confirm the Government does not require offerors to have a section of the business proposal labeled “Section 6 – Table of Contents for Documentation Required under Section L of the Solicitation” and that we do not need to include a separate table of contents for these 3 items described in Section 6 of Attachment 11? 2) We assume it is okay for us to list these 3 items in the main table of contents of the business I believe proposal and provide a separate location for each within the business proposal either as separate section or an attachment? Please clarify is our assumption is not correct?

3. No, a separate section for general instructions is not required.

3. Please address within response to Task Area A

3. The cost assumptions should be addressed in your response to each task area.

3.

0. Please provide as a separate attachment reflected in the table of contents.

0. Yes, that is correct.

P85 and Attachment 10 P11

Attachment 11 P7 Section L c.6 , Attachment 10 Additional Technical Proposal Instructions. Attachment 11 Additional business Proposal Instructions

Per the business proposal instructions and additional business proposal instruction, small business subcontracting plan was required if total estimated cost exceeds $700,000. ATTACHMENT 10, additional technical proposal instructions, format for technical proposal, and table of contents also requested small business subcontracting plan. Please clarify the small business subcontracting plan should be included in business proposal or technical proposal, or both technical and business proposal. Should it be included in the page count?

Please include as part of the business proposal only.

1. Small Business Subcontracting Plan

1. Extent of Small Disadvantaged Business Participation

1. Past Performance Data, Including References

If you are unable to access this SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS electronically, you may request a copy from the Contracting Officer identified on the cover page of this solicitation.