Amendment_3_-_BAA-NIAID-DAIT-NIHAI2015042.pdf

Amendment No. 3 to BAA-NIAID-DAIT-NIHAI2015042 “Development of Radiation/Nuclear Medical Countermeasures or Biodosimetry Devices”

Amendment to Solicitation No.: BAA-NIAID-DAIT-NIHAI2015042

Amendment No.: 3

Issue Date: March 4, 2016

Effective Date:

Proposal Due Date:

March 4, 2016

March 22, 2016 at 3:00 p.m. (EST)

Issued By: Liem T. Nguyen Contracting Officer

NIH/NIAID

Office of Acquisitions 5601 Fishers Lane, MSC 9821 Rockville, MD 20892-9821

Point of Contact: Albert Nguyen, Contract Specialist nguyenal@niaid.nih.gov

Name and Address of Offeror: To All Potential Offerors

The above numbered solicitation is amended as set forth below. The hour and date specified for receipt of proposals remain unchanged. Offerors must acknowledge receipt of this amendment. Failure to provide your acknowledgement of this amendment may result in the rejection of your offer.

SECTION 1 – AMENDMENT TO ATTACHEMENT 15 and 16

BUSINESS PROPOSAL ATTACHMENTS

Attachment No. Title Location

Attachment 15:

Small Business Subcontracting Plan See attachment at end of this Amendment 3, titled “Small Business Subcontract Plan, revised 110415”

Attachment 16:

Breakdown of Proposed Estimated Costs (plus fee) w/Excel Spreadsheet https://oamp.od.nih.gov/content/breakdown-proposed-estimated-cost-plus-fee-and-labor-hours http://oamp.od.nih.gov/sites/default/files/DGS/cont racting-forms/spshexcl_dec2012.xlsx

SECTION 2 – QUESTIONS AND RESPONSES

This section of the amendment provides questions submitted by potential applicants/offerors and the responses provided by NIAID. The responses are offered for information only and do not modify or become part of this solicitation. This Amendment will be updated as needed to add further questions and their related responses. All potential offerors are advised to refer back to the solicitation and its amendments for additional Questions & Answers.

Question 1:

Links to Attachment 15 and 16 are not functioning.

Response 1:

Please see Section 1 of this Amendment for the updated links to Attachment 15 ”Small Business Subcontracting Plan” and Attachment 16 “Breakdown of Proposed Estimated Costs (plus fee) w/Excel Spreadsheet”

Question 2:

The fbo.gov announcement states that:

NIAID requires proposals to be submitted via two methods: (1) Disc (CD or DVD) and (2) Online via the NIAID electronic Contract Proposal Submission (eCPS) website.

The actual solicitation does not mention a CD/DVD anywhere. Where should the disc be sent to?

Response 2:

Online proposal submission through the eCPS website will be sufficient and be considered the Official Proposal Submission. A CD/DVD copy is not necessary. The fbo.gov announcement will be revised to correct the requirement. For directions on using eCPS, go to the website https://ecps.nih.gov/NIAID/home/howto

To access the eCPS website use: https://ecps.nih.gov/

Question 3:

What is the required (and desired if different) TRL for an incoming product for this BAA- [which version of TRL should we use for a drug candidate]?

Response 3:

There is no language in the solicitation specifying a required or desired Technology Readiness Level (TRL). Please refer to Attachment 5: Research and Technical Objectives page 97 & 98 of the solicitation for information on the requirement.

Question 4:

What is the expected (and desired if different) TRL at the end of the 3 years? For example, the RFP sounds like you anticipated these BAA’s to be a bridge to a BARDA BAA?

Response 4:

There is no language in the solicitation specifying an expected or desired TRL at the end of the 3-year contract. Please refer to Attachment 4: Research and Technical Objectives page 95 of the solicitation for information regarding the coordination between the NIH and other HHS sister agencies in the support of research and development of MCMs as well as the goals of this solicitation from NIAID.

Question 5:

What is the expected interactions with industry? For example is there a preference that the application to be from industry v University?

Response 5:

This solicitation is being published in the Fedbizopps website and is open to the public. Offerors who are capable of providing the services and can fulfill the government requirements as described in solicitation can submit a proposal.

Question 6:

Is there an application package /instructions for this solicitation?

Response 6:

Please refer to page 64 – 66 of the BAA for Technical Proposal Instruction and page 70-85 for Business Proposal instructions. Additional instructions are found in Attachment 1: Packaging and Delivery of Proposal (page 90 in PDF document) and Attachment 6: Additional Technical Proposal Instructions (page 100 in pdf document).

Question 7:

Is there a preference in this BAA for countermeasures for mitigation of ARS versus DEARE?

Response 7:

Please refer to Attachment 5, Research and Technical Objective (page 96), of the solicitation which states that “Offerors are invited to submit proposals to advance the development of one lead candidate MCM or biodosimetry biomarker/device that has shown concept feasibility data. MCM drug candidates should increase survival by mitigating and/or treating acute or delayed radiation injury.”

There is no preference.

Question 8:

The phrase "pivotal animal efficacy studies" is used in the solicitation but is not defined? Please provide a definition.

Response 8:

“Pivotal animal efficacy studies” produce the data that the FDA uses to decide whether or not to approve a drug for licensure. A pivotal study is well-controlled, randomized and usually double-blind.

Please refer to Attachment 5, Section A, Non-Clinical Research and Development, page 97), this BAA will support animal efficacy studies that lead up to future pivotal efficacy studies that could lead to eventual licensure of a drug:

Efficacy studies in animals to optimize route of administration, formulation, dose, dose schedule, and dose reduction factor (DRF). Studies should be designed to be suitable (species, endpoints, measurements) for predicting future pivotal efficacy studies under the U.S. Food and Drug Administration (FDA) Animal Rule (21 CFR 314.600-314.650, 601.90-601.95). Efficacy is defined hereafter as a statistically significant improvement in survival in an in vivo model of radiation injury when the MCM is first administered 24 hours or later after radiation exposure

Question 9:

Does the 150-page limitation for this BAA, as mentioned in Attachment 1 of the Solicitation, apply to the Technical Proposal only, or to the Technical Proposal and Business Proposal combined?

Response 9:

The page limitation applies only to the Technical Proposal. The Business Proposal has no page limitation.

Question 10:

Please advise if, under the subject BAA, contracting with another federal agency testing facility is allowable.

Response 10:

NIAID cannot contract directly with another federal government agency. If a contractor were to subcontract with another federal agency for a portion of the work, it will require an Interagency Agreement between the two federal agencies where funds are transferred directly from one agency to the other. Contractors may not bill the government directly for any work performed by any other government agency.

Question 11:

Is submission to the Food and Drug Administration FDA required and when would it be expected?

Response 11:

There is no language in the solicitation requiring FDA submission.

Question 12:

Reference - L.c.13.f, Subcontractors – requires a complete cost proposal in the same format at the offeror’s cost proposal. Our subcontractor’s proposal will include proprietary indirect rate data that would normally be provided in a sealed envelope for government officials only however the proposals are being delivered electronically using eCPS per Attachment 1. How can our subcontractors with proprietary data submit directly to the government?

Response 12:

The subcontractor may submit their proprietary data on a CD sealed in an envelope to the prime contractor which will then be forwarded to the NIAID office of acquisition, to the Contracts Office attention on or before the due date and time specified in the solicitation.

Albert Nguyen Contract Specialist Division of Allergy Immunology and Transplantation- Research Contracts Branch DHHS/NIH/NIAID/DEA Office of Acquisitions 5601 Fishers Lane, Room 3B57, MSC 9821 Rockville, Maryland 20852