Amendment_2_-_BAA-NIAID-DAIT-NIHAI2015042.pdf

Amendment #2 to BAA-NIAID-DAIT-NIHAI2015042 “Development of Radiation/Nuclear Medical Countermeasures or Biodosimetry Devices”

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

Amendment No.: 2

Issue Date: February 4, 2016

Effective Date:

Proposal Due Date:

February 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 5

This amendment is to revise the attachment 5 (see highlighted area) of the BAA. See attachment titled BAA- NIAID-DAIT-NIHAI2015042 Attachment 5 Amended 2-4-16.pdf

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 this Amendment # 1 for additional Questions & Answers.

Question 1:

I was wondering if you have ever successfully contracted to a foreign government and if so, can you please share the mechanism through which the money transfer was completed.

Response 1:

Payments will be made via electronic funds transfer. Payment information may be found on Attachment 20 of the BAA solicitation. If you have any further questions, feel free to submit them in writing.

Question 2:

If a prime contractor subcontracts out work to a Company X to do task A - can Company X subcontract out, to Company Y, to do a part of the work of task A?

Or does the Prime Contractor need to set up a subcontract with each Company X and Y?

Response 2:

It is up to the prime contractor to choose how each subcontract is setup. Either scenario would be acceptable, however it is ultimately the Prime Contractors responsibility to meet the requirements described in the Statement of Work in the contract.

Question 3:

When will I get access to the electronic submission system after putting in a request?

Response 3:

Please contact the eCPS administrators at eCPSAdministrator@niaid.nih.gov to for access issues.

Question 4:

Is skin protection, mitigation or treatment from radiation exposure an area of interest? Is CNS protection, mitigation or treatment from radiation exposure an area of interest?

Response 4:

There is no language in the solicitation excluding an MCM indicated for skin or CNS, as stated on page 96:

The goal of this BAA is to advance the development of safe and effective MCMs to mitigate or treat tissue injuries arising from exposure to ionizing radiation from a radiological or nuclear incident thereby leading to a reduction in radiation-associated morbidities and mortalities or the development and translation of biodosimetry biomarkers/devices for use in determining triage and treatment strategies of large populations.

Specifically, this initiative is intended to support research and development of the most promising new approaches (including but not limited to: biologics, drugs, cytokines, free radical scavengers, anti-inflammatory agents, antibiotics, cellular therapies, anti-fibrotics, and anti-apoptics) and medical products that measure, mitigate and/or treat radiation-induced tissue injuries.

Question 5:

Is there a pre-selection process involving a white paper and Quad chart?

Response 5:

Applications for this solicitation will be evaluated through peer or scientific review in accordance with the specified evaluation criteria, as stated on page 43 under General Information (excerpt of text below). There is no pre-selection process (such as white papers or quad charts). For evaluation criteria, please see Section M: Evaluation Factors for Award starting on page 86 of the solicitation.

d. Proposals received as a result of the BAA shall be evaluated in accordance with evaluation criteria specified therein through a peer or scientific review process. Written evaluation reports on individual proposals will be necessary but proposals need not be evaluated against each other since they are not submitted in accordance with a common work statement.

Question 6:

Is a commercial partner considered favorable in the application review?

Response 6:

The solicitation is available to the public. Offerors who are capable of providing or fulfilling the government requirements as stated in the solicitation can submit a proposal.

Question 7:

Will NIAID entertain a proposal with a subcontractor who is separately submitting a primary contract for a different countermeasure?

Response 7:

There are no restrictions on who may submit a proposal in response to the solicitation.

Question 8:

Based on our reading of the FISMA language in the BAA-NIAID-DAIT-NIH-AI2015042, it is our estimation that our proposed contract application in response to this BAA will not require FISMA level compliance. Therefore, we request confirmation in regards to eligibility of our application to BAA-NIAID-DAIT-NIH-AI2015042.

Response 8:

Offerors are at their own discretion as to how they choose to address FISMA compliance and that information could be presented in the Business Proposal as it will not be Peer Reviewed as part of the Technical Proposal Evaluation. Please note, the deliverable requirements (BAA pages 54-60: Security Plan, Risk Assessment, FIPS 199 Assessment, Security Certification and Accreditation) related to IT Systems Security are not required at time of proposal submission, but within 30 days of an eventual contract award.

Question 9:

The solicitation, it appears to focus on ARS (Acute Radiation Syndrome). We assume NIAID would only consider funding MCMs that are effective post exposure – correct? We are unclear if early stage proof of concept studies would be responsive to this BAA?

Response 9:

That is correct, this solicitation focuses on MCMs that are effective 24 hours or more, post radiation exposure, as stated in Attachment 5: Research and Technical Objectives on page 96:

The MCMs chosen for further development shall already have efficacy data (i.e., demonstrating clinically-relevant and statistically-significant reduction in mortality and/or major morbidity in appropriate animal models predictive of the human response) when administered/used at least 24 hours (or longer) after radiation exposure. The U. S. Government is looking to purchase and stockpile MCMs for civilian use that yield a significant medical benefit (reduction in morbidity and/or mortality) when administered at greater than 24 hours after radiation exposure, are suitable for a mass casualty incident (e.g., the preferred routes of administration are oral, subcutaneous, inhaled, transdermal or intramuscular), and are safe to use in normal, healthy individuals (in case appropriate biodosimetry is not available to confirm radiation dose received prior to initiating treatment).

Question 10:

Are Phase 1 human trials safety trials covered under this BAA?

Response 10:

This solicitation does not support Phase I human safety trials as stated on page 99 of the announcement (see excerpt below from Attachment 5: Research and Technical Objectives):

The following research activities are not within the scope of work for this BAA and the contract will not provide funds to support:

1. Screening activities to identify MCMs, biomarkers or devices.

2. Non-biologically-based dosimetric methods and/or environmental testing/sampling devices (e.g. thermo-luminescent detectors (TLDs), fortuitous dosimeters, radiation portals, etc.).

3. Performance of clinical safety trials.

4. Performance of pivotal animal efficacy studies.

Question 11:

My business does not have an indirect cost rate established. Where may I get more information?

Response 11:

Please see the excerpt from the NIH OALM homepage regarding indirect rates. A link to the text can be found below for additional information.

https://oalm.od.nih.gov/IndirectCostsFAQ#processstart

The grants management/contract specialist should contact the DFAS Indirect Cost Branch (301-496-2444 or dfas-idc@nih.gov) at the first indication that a commercial organization will most likely be receiving an award. This notification would enable DFAS to start the process of negotiating an indirect cost rate(s).

DFAS’ initial step is to send the organization a letter requesting an indirect cost rate proposal – refer to http://oamp.od.nih.gov/dfas/IdCSubmission.aspfor more information.

Question 12:

On page 4 of Attachment 5 it states: “MCM drug candidates should increase survival by mitigating and/or treating acute or delayed radiation injury.”

On page 6 of Attachment 5 it states: “Organization selected under this BAA will have identified a promising lead MCM candidate and have preliminary data demonstrating increased survival by mitigating or treating Acute Radiation Syndrome (ARS) in vivo …” This does not mention delayed radiation injury.

It is unclear if MCM’s for DEARE indications will be funded or is this BAA limited to ARS?

Response 12:

Yes, in vivo preliminary data is required for MCMs targeting either ARS or DEARE.

Question 13:

In attachment 5, under Research and technical objective, it says “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.”

Does this mean the proposal should only propose a single mitigating agent?

Is a proposal to develop a combination therapy mitigating treatment acceptable under this BAA?

Response 13:

NIAID would regard the combination of the two drugs as the MCM since they must be given together as a treatment. In this case, a combination would be considered the lead candidate.

Question14:

Regarding attachment 3. It states, "NIAID estimates that the average annual cost (direct and indirect costs combined) is up to $6M total per year for all contracts.” Our question - Is there a cap on total dollar amount per year per contract?

Response 14:

The proposed cost per year per contract for which funding is requested should be consistent with the nature and complexity of the proposed research. Award(s) will be made based on the availability of funds and the priority of program needs.