Amendment_3_NIAID-DAIDS-NIHAI2015029.pdf

AMENDMENT #3 RFP NIAID-DAIDS-NIHAI2015029 1

Amendment No. 3

NIAID-DAIDS-NIHAI2015029

“Comprehensive Resources for HIV Microbicides and Biomedical Prevention”

Solicitation Number: NIAID-DAIDS-NIHAI2015029

Amendment Number: Three (3)

Amendment Issue Date: September 30, 2015

Proposal Due Date/Time: Monday, November 16, 2015 at 3:00 PM, Local Time

(CHANGED)

Issued By: John R. Manouelian

Contracting Officer

OA/DEA/NIAID/NIH/DHHS

5601 Fishers Lane, Room 3D10, MSC 9821 Bethesda, Maryland 20892-9821

Points of Contact: PRIMARY cornorj@mail.nih.gov Robert Corno, Contract Specialist Phone: 240.669.5151

SECONDARY

manouelj@mail.nih.gov John R. Manouelian, Contracting Officer Phone: 240.669.5152

Offerors must acknowledge receipt of this Amendment by identifying the amendment number and the date of the amendment on each copy of the submitted proposal. Failure to receive your acknowledgement may result in the rejection of your proposal. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

The purpose of Amendment 3 is to: (1) extend the proposal due date, from September 24, 2015 to November 16, 2015; (2) remove the restrictive language that prohibits an offeror from receiving a base award under Task Area E if the offeror is also awarded a base contract under Task Area A, B, C, and/or D; and (3) require an offeror who submits a proposal under Task Area E in addition to submitting a proposal under Task Areas A, B, C, and/or D to submit a conflict of interest mitigation plan.

mailto:cornorj@mail.nih.gov mailto:manouelj@mail.nih.gov

AMENDMENT #3 RFP NIAID-DAIDS-NIHAI2015029 2

As a result of the above revisions, the following areas of the solicitation are revised to read as follows:

Section L – Proposal Instructions, Conditions, and Notices to Offerors, paragraph 2.

Instructions to Offerors, subparagraph a. General Instructions, subparagraph 1. Contract Type and General Clauses, is hereby amended to read as follows (specifically, see bold and italicized text):

It is contemplated that Indefinite Delivery/Indefinite Quantity (IDIQ) type contracts will be awarded (see General Information). Offerors are not required to propose on all Task Areas and may propose on any or all of the Task Areas. However, in order to ensure the independence and objectivity required for the functions carried out under Task Area E, if an offeror submits a proposal under Task Area E in addition to submitting a proposal under any of Task Areas A, B, C, and/or D, then the offeror shall provide a Conflict of Interest Mitigation Plan (please refer to Attachment 10, Additional Business Proposal Instructions and Uniform Cost Assumptions, Section 5: Conflict of Interest Mitigation). This includes both Prime Contractor as well as any potential Subcontractor(s). Any resultant contract shall include the clauses applicable to the selected offeror’s organization and type of contract awarded as required by Public Law, Executive Order, or acquisition regulations in effect at the time of execution of the proposed contract.

Attachment 3: Statement of Work for Base Contract, the 6th paragraph under item 1) Background and Introduction, is hereby amended to read as follows (specifically, see bold and italicized text):

It is anticipated that NIAID will award base contract awards to multiple contractors for Task Areas A, B, C, and D; however, NIAID anticipates awarding a base contract to a single contractor for Task Area E. In order to ensure the independence and objectivity required for the functions carried out under Task Area E, if an offeror submits a proposal under Task Area E in addition to submitting a proposal under any of Task Areas A, B, C, and/or D, then the offeror shall provide a Conflict of Interest Mitigation Plan (please refer to Attachment 10, Additional Business Proposal Instructions and Uniform Cost Assumptions, Section 5: Conflict of Interest Mitigation). This includes both Prime Contractor as well as any potential Subcontractor(s).

Attachment 8: Statement of Work and Reporting Requirements for Task Order E-001, is hereby amended to revise: (1) paragraph A. Deliverables and Reports, item 3. Monthly Progress Reports, to include the requirement for the reporting of Conflict of Interests; and

(2) paragraph B, Technical Requirements, to incorporate paragraph 6, Conflict of Interest Mitigation Plan.

As a result of the foregoing, paragraph A. Deliverables and Reports, item 3. Monthly Progress Reports, is revised to read as follows (specifically, see bold and italicized text):

A. Deliverables and Reports

AMENDMENT #3 RFP NIAID-DAIDS-NIHAI2015029 3

3. Monthly Progress Reports

Unless otherwise directed by the COR, a Monthly Progress Report is due within 3 calendar days of the end of each month and shall describe all contract-related work accomplished during the preceding month. Reports shall summarize progress made on active Task Orders, describe activities planned for the ensuing reporting period, identify deviations from prior plans, provide updated timelines, and describe technical or administrative problems encountered and their resolution or proposed corrective action.

Monthly Progress Report shall include details regarding any breaches of the Conflict of Interest Mitigation plan, how they were resolved, recommended modifications to the extant Conflict of Interest Mitigation Plan and any additional efforts the Contractor shall undertake to prevent any future occurrences. The reports shall also include individual project budget(s), the funds that have been spent to date, and the remaining available funds.

As a result of the foregoing, paragraph paragraph B, Technical Requirements, is revised to incorporate paragraph 6, Conflict of Interest Mitigation Plan, which shall read as follows:

B. Technical Requirements

6. Conflict of Interest Mitigation Plan (if applicable)

a. Implement and monitor, on an ongoing basis, the Conflict of Interest Mitigation Plan as negotiated prior to contract award and incorporated by reference in the contract.

b. Conduct an annual review and include in the Monthly Progress Report details regarding any breaches of the plan, how they were resolved, recommended modifications to the extant Conflict of Interest Mitigation Plan and any additional efforts the Contractor shall undertake to prevent any future occurrences.

Attachment 9: Additional Technical Proposal Instructions, Format for Technical Proposal, and Table of Contents, the 1st paragraph under Technical Proposal – Additional Instructions, is hereby amended to read as follows (specifically, see bold and italicized text):

It is anticipated that NIAID will award base contract awards to multiple contractors for Task Areas A, B, C, and D; however, NIAID anticipates awarding a base contract to a single contractor for Task Area E. In order to ensure the independence and objectivity required for the functions carried out under Task Area E, if an offeror submits a proposal under Task Area E in addition to submitting a proposal under any of Task Areas A, B, C, and/or D, then the offeror shall provide a Conflict of Interest Mitigation Plan (please refer to Attachment 10, Additional Business Proposal Instructions and Uniform Cost Assumptions, Section 5: Conflict of Interest Mitigation). This includes both Prime Contractor as well as any potential Subcontractor(s).

AMENDMENT #3 RFP NIAID-DAIDS-NIHAI2015029 4

Attachment 10: Additional Business proposal Instructions and Uniform Cost Assumptions, is hereby amended to: 1) revise the 1st paragraph under Business Proposal – Table of Contents; and 2) incorporate Section 5 – Conflict of Interest Mitigation – Task Area E.

As a result of the foregoing, the 1st paragraph under Business Proposal – Table of Contents is revised to read as follows (specifically, see bold and italicized text):

It is anticipated that NIAID will award base contract awards to multiple contractors for Task Areas A, B, C, and D; however, NIAID anticipates awarding a base contract to a single contractor for Task Area E. In order to ensure the independence and objectivity required for the functions carried out under Task Area E, if an offeror submits a proposal under Task Area E in addition to submitting a proposal under any of Task Areas A, B, C, and/or D, then the offeror shall provide a Conflict of Interest Mitigation Plan. This includes both Prime Contractor as well as any potential Subcontractor(s).

As a result of the foregoing, Section 5 – Conflict of Interest Mitigation – Task Area E, is hereby incorporated and shall read as follows:

SECTION 5: CONFLICT OF INTEREST MITIGATION – TASK AREA E

The NIAID has determined that a potential conflict of interest may exist if offerors submit proposals in response to Task Area E and one or more of Task Areas A-D of this solicitation. In performing the QA/QC activities described in the SOW for Task Area E, the potential conflict of interest may occur when the contractor is tasked with providing oversight for activities conducted under the SOW of the other Task Areas (A-D). In these instances, the contractor would need to monitor itself and any proposed subcontractors, in order to ensure that sufficient quality/regulatory oversight is performed to meet the appropriate regulatory guidelines (e.g., GLP, cGMP, etc.). This conflicting oversight role (Task Area E) might bias a contractor’s ability to provide an objective and non-biased QA/QC assessment of the activities performed under the other Task Areas (A-D).

Specific examples of potential conflicts of interest that may arise, as a result of performing work under the proposed contract, include the following:

1) Conduct of IND-enabling studies under GLP: Contractors should have established standard operating procedures (SOPs) for quality assurance, GLP administration, general GLP operations, protocols, data management, reporting, and record retention. The SOPs must be adhered to by all facilities or laboratories approved to conduct or provide support services for GLP studies. If a contractor is tasked under Task Area E to provide QA/QC oversight for GLP activities conducted under Task Area A, the contractor must provide an objective and non-biased approach for monitoring GLP compliance, including a risk mitigation strategy when non-compliance (e.g., SOP or protocol deviations, reporting deficiencies, etc.) is observed.

2) cGMP manufacturing of clinical drug products: Contractors should have well-established procedures to ensure that the manufacture of products for use in human

AMENDMENT #3 RFP NIAID-DAIDS-NIHAI2015029 5

clinical trials can meet the quality and regulatory requirements, as enforced by FDA.

Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories. If a contractor is tasked under Task Area E to provide QA/QC oversight for cGMP activities conducted under Task Area D, the contractor must provide an objective and non-biased approach for monitoring cGMP compliance, including a risk mitigation strategy when non-compliance (e.g., contamination issues, material mix-ups, protocol deviations, etc.) is observed.

For additional examples of Organization Conflicts of Interest, please refer to the Federal Acquisition Regulations, Part 9.5.

If it is determined that a potential conflict of interest exists as a result of the type of work the offeror and all proposed subcontractors currently carry out for NIAID under other federal grant/contract agreements, the offeror must address conflicts of interest that may arise and how they will be mitigated.

In order to address potential conflicts of interest, the offeror must provide a Conflict of Interest Mitigation Plan, which includes a detailed description of the individual and institutional conflicts of interest that may arise during the performance of the contract on the part of the offeror and all proposed subcontractors. The description should include proposed strategies, plans, policies and procedures to manage and mitigate individual and institutional conflicts of interest. The offeror should also describe organizational experience with mitigating/resolving conflict of interest issues for similar projects.

The Contracting Officer will evaluate the Conflict of Interest Mitigation Plan provided by offerors to determine if a potential conflict of interest can be properly mitigated. The proposed strategies and plans to mitigate the conflict of interest will be subject to negotiation and incorporated into any resultant contract award.

If an offeror is not submitting a proposal under Task Area E in addition to submitting a proposal under any of Task Areas A, B, C and/or D, then they do not need to submit a Conflict of Interest Mitigation Plan.

END OF AMENDMENT NO. 3, RFP No. NIAID-DAIDS-NIHAI2015029