Amendment_1_-_BAA-NIAID-DAIT-NIHAI2015042.pdf

Amendment #1 to BAA-NIAID-DAIT-NIHAI2015042 “Development of Radiation/Nuclear Medical Countermeasures or Biodosimetry Devices”

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

Amendment No.: 1 (1st posting)

Issue Date: January 14, 2016

Effective Date:

Proposal Due Date:

January 14, 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 remains 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 – 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:

Is a researcher in a foreign government lab eligible to apply?

Response 1:

Yes, foreign governments are eligible.

Question 2:

Would having a US partner be of benefit and if so, should they be as a co-PI or just in a supportive role?

Response 2:

There are no restrictions on co-investigators (see page 65 of the BAA).

Question 3:

Can a foreign investigator be on the key personnel team?

Response 3:

A foreign investigator can be a consultant or subcontractor.

Question 4:

Can multiple Principal Investigators be from different institutions?

Response 4:

Yes

Question 5:

Can one of the Principal Investigators be from a University?

Response 5:

Yes

Question 6:

If there are two Principal Investigators from two different institutions - is work carried out at each institution directly paid by the federal government? Or is one of the institutions, by definition, a subcontractor?

Response 6:

One institution must serve as the Prime Contractor and the second institution/Principle investigator will serve as a Subcontractor. The Prime Contractor will be the only one invoicing the government directly.

Question 7:

Is there any limit to the cost of equipment that can be purchased with these grants?

Response 7:

This BAA solicitation will result in the award of one or more Contracts. This is not a Grant application.

Proposed equipment must be included in the budget proposal and will be reviewed and evaluated.

Question 8:

If a project contains several subprojects, can the funding agency choose to fund only some of the sub-projects or, if one of the subprojects is not considered fundable, would the entire proposal be rejected?

Response 8:

Please refer to page 50 of the solicitation, subparagraph 5, Alternate Proposals, where it states that offeror, at their discretion, may submit alternate proposals, or proposals which deviate from the requirements.

Question 9:

Is there any minimum size of project cost or length that is acceptable?

Response 9:

There is no minimum project cost, however; NIAID expects awarding up to multiple contracts and that the average annual total cost (direct and indirect costs combined) for all awards is up to $6M. The project length for which funding is requested should be consistent with the nature and complexity of the proposed research. The period of performance proposed by an offeror should not exceed three years (see attachment 3).

Question 10:

Could Development of Radiation/Nuclear Medical Countermeasures or Biodosimetry Devices be relevant to stem cell therapy development in case of radiation?

Response 10:

Yes, stem cells used as cellular therapy against acute radiation syndrome would be considered a medical countermeasure and would be applicable to this solicitation as stated on p 96 (Attachment 5: Research and Technical Objectives):

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 11:

The BAA states that a “MCM OR biomarker” should be proposed. Can we blend both with emphasis on MCM OR should we use two different proposals?

Response 11:

According to page 96 in the referenced solicitation: “The scope of this work to be funded under this BAA is the development of MCMs or biodosimetry biomarkers/devices.” Therefore, the application must be submitted for either MCM or Biomarker. However, if the Biomarker provides information for determining the mechanism of action of the MCM, then the application should be submitted as an “MCM” application as stated on page 97: “Mechanism of action studies relevant to human mechanism of action.”

Alternatively, two separate applications could be submitted; one for MCM and one for Biomarker.

Question 12:

Can we use Delayed Effects of Acute Radiation Exposure (DEARE) models?

Response 12:

Yes, DEARE models are relevant to this solicitation.

Question 13:

Do radionuclide decorporation agents fall under the areas of interest of this BAA?

Response 13:

Yes, radionuclide decorporation agents are within the area of interest of this solicitation. While they are not specifically named, there is no language in the document that excludes them, thus would fall under the MCM category. Please see excerpt from page 96 below that states the scope of work that could potentially be funded:

“The scope of this work to be funded under this BAA is the development of MCMs or biodosimetry biomarkers/devices.

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.”

Question 14:

Is an MCM that is indicated for the treatment of full-thickness CRI applicable to this current solicitation or is this BAA limited to countermeasures intended to treat total body (ARS) exposures?

Response 14:

There is no language in the solicitation excluding an MCM indicated for treatment of full-thickness CRI, as long as the radiation being administered is ionizing radiation, as stated on page 96 (highlighted for clarity):

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.

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 15:

Page 17, Article H.10, does this project require multiple principal investigators?

Response 15:

No, Multiple investigators are not required.

Question 16:

Page 42: System for Award Management (SAM), who needs to register in the SAM system to submit the proposal related information, the principal investigator or the Institute Contracting office?

Response 16:

The business representative of the contracting organization must register the contractor into the SAM system.

Question 17:

Page 86: under “Evaluation of Options” -What is the “option provision(s) and period(s)” referred to?

Response 17:

Please refer to Article B.2. Estimated Cost – Option, page 4 of the solicitation for information on the topic.

Question 18:

Attachment 5, Page 5: “The announcement is intended to support development activities for on lead candidate MCM or biodosimetry biomarker/device”. Does this mean the BAA will fund two contracts: one for MCM proposal and the other for biodosimetry biomarker/device proposal?

Response 18:

This BAA solicitation will result in the award of one or more Contracts. Two separate applications could be submitted; one for MCM and one for Biomarker.

Question 19:

Attachment 5, Page 6 under “A. Non-clinical Research and Development including”, further under For Biodosimetry Biomarkers/Devices, point 8: Efficacy studies in appropriate animal modes. Does the proposal require to include an animal study? Is it allowable to use only human blood to test the device efficacy?

Response 19:

The statement from Attachment 5 (cited in the above question) indicates the type of work that could be supported by this solicitation, thus the term “including”. The list as shown, does not indicate all the studies that must be done:

Subtitle as written on page 5 (Attachment 5): “A. Non-clinical Research and Development including:”

Question 20:

Attachment 6: Page 9, Section 3, item 5), Meeting minutes or synopses from discussions with CBER/CDER/CDRH (FDA), if any, that are relevant to development activities for the proposed MCM. Is this requirement about meeting minutes with FDA for the MCM proposal only? Are FDA minutes required to be included in the proposal?

Response 20:

The statement from Attachment 6 (cited in the above question) indicates that FDA minutes are to be included only if they exist:

Question 21:

Attachment 6: Page 9, Section 4: Not clear about the term “each offeror” in the middle of the paragraph. Does this mean the proposal requires to have the statement of work from primary contract and each subcontracts separately?

Can a SOW be an integrated one but clearly list who (primary or subcontractors) will be responsible for each task?

Response 21:

Yes, The SOW can be an integrated one with divided responsibilities.