BAA-NIAID-DMID-NIH-AI-2014007_-_Amend_1___7-9-2014.pdf

AMENDMENT No. 001

BAA-NIAID-DMID-NIH-AI-2014007

TARGETING THERAPEUTICS DEVELOPMENT TO RELIEVE BOTTLENECKS: OPTIMIZING

LEAD THERAPEUTIC COMPOUNDS AGAINST INFECTIOUS PATHOGENS

Solicitation Number: BAA-NIAID-DMID-NIH-AI-2014007

Amendment Number: One (001)

Amendment Issue Date: July 9, 2014

Proposal Due Date: Wednesday, August 13, 2014 3:30 PM EST

(UNCHANGED)

Issued By: Sevag Kasparian Contracting Officer Office of Acquisitions, DEA National Institute of Allergy and Infectious Diseases National Institutes of Health 6700-B Rockledge Drive Room 3212, MSC 7612 Bethesda, MD 20892-7612

Point of Contact: Mr. Sevag Kasparian, Contracting Officer Email: Sevag.Kasparian@nih.gov

The purpose of this amendment is as follows:

NOTICE:

Deadline for receipt of Solicitation questions is Wednesday, July 16, 2014. Questions received after this date will not be considered.

CLARIFICATION, QUESTION AND RESPONSE regarding this BAA is attached below.

Questions will not be responded to individually but will only be responded to via periodic published amendments.

The date specified for receipt of proposals is unchanged at Wednesday, August 13, 2014, at

3:30 PM EST.

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

mailto:Sevag.Kasparian@nih.gov

BAA-NIAID-DMID-NIH-AI-2014007

TARGETING THERAPEUTICS DEVELOPMENT TO RELIEVE BOTTLENECKS: OPTIMIZING

LEAD THERAPEUTIC COMPOUNDS AGAINST INFECTIOUS PATHOGENS

In response to inquiries received, the following clarifications are provided:

• In FY 2015 NIAID plans to award a total of $4 million for base period activities estimated to fund three to five contracts. Offerors can propose options that are necessary to complete the work and are subject to negotiation. The amount of funding available for proposed option periods are subject to the availability of funds and programmatic needs for future fiscal years.

The number of awards will be determined following peer review, negotiations and allocation of funds.

• Pursuing new indications for a therapeutic drug that has already been clinically-tested does not meet the stated objectives of the BAA as stated in the solicitation: “The primary objective of this BAA is to support the advancement of promising lead therapeutics to the clinical drug candidate stage.”

• The BAA supports development and defines a broad spectrum anti-viral as a “Therapeutic with activity against more than one of the NIAID Category A, B and C viral threat agent AND including activity against at least one of the following viral pathogens: Ebola virus, Marburg virus, Variola major, Dengue virus, Chikungunya virus and human influenza virus.” Each of the listed viruses are considered discreet pathogens. Because immunity to discreet strains of influenza do not confer cross-protective immunity against other strains of influenza, each strain is considered a discreet viral pathogen.

• The BAA supports lead candidate optimization including medicinal chemistry to improve drug property.

• Biopharmaceutical refers to molecules derived from biotechnology processes as opposed to those that are fully chemically synthesized. . This BAA supports development of therapeutic candidates that can be chemically synthesized. This BAA does not define a molecular weight threshold, but lead compounds and small molecule drug candidates have molecular weight range that is distinct from proteins and antibodies Products derived from biotechnology, such as proteins, are not supported. As a lead compound, peptides must be chemically synthesized.

• This BAA supports “chemical synthesis of analogs to develop structure-activity relationship profiles.” Analogs must be prepared by chemical synthesis with the goal of improving activity and drug-like properties.

• A broad spectrum anti-bacterial is a therapeutic with activity against more than one of the NIAID Category A, B and C bacterial threat agent AND must exhibit activity against at least one of the following bacterial pathogens: Bacillus anthracis, Francisella tularensis, Yersinia pestis, Burkholderia pseudomallei, B. mallei, and Rickettsia prowazekii.

• In vivo efficacy data is not required but, if available, should be submitted with the proposal.

• “First non-severable phase” and “base period” mean the same thing.

• A government collaborator may not serve as a Principal Investigator (PI) representing a prime contractor. Additionally, the government collaborator must have appropriate approvals from their agency to perform work under a government contract.

Question 1: Are non-profit organizations eligible to apply for this solicitation? The project we have in mind does meet the requirements for support, but we are unsure of the institutional requirements.

Response 1: Non-profit organizations are eligible to respond to this announcement.

Question 2: Has a contractor performed similar work to this for the government in the past? If available, please provide the incumbent contract number. If you are unable to provide a contract number, is it safe to assume this is a new requirement for the government?

Response 2: This is a new requirement. However, NIAID has supported similar broad agency announcements in the past.

Question 3: Is there any guidelines on the proposed budget for this contract and overall length of the technical proposal?

Response 3: Refer to section III – General Proposal Instructions & Information that starts on page 5 of the BAA.

Question 4: What sensitivity level does the system need to be to process the data for the BAA?

What are the data transmission and retrieval requirements for the BAA?

Response 4: The Pre-solicitation security level was determined to be moderate, for all categories, by the Information Systems Security Officer (ISSO). NIH Secure Email and File Transfer system (SEFT) is the data transmission and retrieval system to be used for contracts awarded under this requirement. After proposals are reviewed and scored, the ISSO will perform a pre-award security level assessment with offerors selected for negotiations and additional information about SEFT will be provided.

Question 5: Does NIH expect the following documentation: E-Authentication, Privacy Threshold Analysis/Impact Assessment, Risk Assessment and System Security Plan?

Response 5: Refer to Section C - Information Security Requirements on page 27 of the BAA where it states, “The government will require each offeror selected for negotiations to submit an E-Authentication Risk Assessment, E-Authentication Threshold Analysis and a System Security Plan with the their Final Proposal Revision to be reviewed by the ISSO and Contracting Officer.”

Question 6: Is NIH expecting external entities to access our institution from the Internet? If not, than an E-Authentication is not required.

Response 6: No, See Question 7 response.

Question 7: Will the BAA data include PII (Personally Identifiable Information)?

Response 7: This BAA does not request nor require PII.

Question 8: In FAR 15-403-4 the threshold for requiring certified cost analysis data is set to $700,000. Does that threshold apply to the entire contract, or only those items subcontracted out?

Response 8: The $700,000 threshold for requiring certified cost analysis data applies to the entire contract and each subcontractor if adequate competition is not obtained.

Question 9: Does the $700,000 threshold for requiring certified cost data apply to cases where the sum of a variety of tasks to be completed by a subcontractor exceeds this value, or only when a single task or purchase exceeds this threshold value?

Response 9: The $700,000 threshold applies for requiring certified cost data where the sum of a variety of tasks to be completed by a subcontractor exceeds this value and if adequate competition is not obtained.

Question 10: For activities outsourced to vendors (such as animal PK or toxicology studies or in vitro metabolism experiments), what data will be required to satisfy the requirement for fair and reasonable prices, and what are the dollar thresholds for requiring this data?

Response 10: Refer to Section VII - Business Proposal Instructions that starts on Page 27 of the BAA.

Question 11: For special or unique subcontractors, i.e., a group with an exceptionally extensive collection of Category A and B priority pathogens who will conduct in vitro and in vivo experiments in a certified BSL-3 facility), what data will be required to satisfy the requirements for fair and reasonable pricing associated with the work they will carry out?

Response 11: Refer to Section VII - Business Proposal Instructions that starts on Page 27 of the BAA.

Question 12: On Page 4 of the solicitation it states that “organizations responding to this BAA must have documented expertise in drug discovery and development, including demonstrated knowledge of regulatory guidelines and submission processes for candidate products directed against biological threats identified as NIAID Category A, B and C Priority Pathogens.” Does it matter if key personnel have not worked together in the past?

Response 12: Organizations must have documented expertise; there is no requirement for prior collaborative relationships. Provide documentation, assurance letters and plans to support how this collaborative relationship will work.

Question 13: On page 23, E1 it requires the offeror submit a “detailed laboratory layout.” Is a description of the lab and square footage information sufficient, or is a detailed diagram of the lab required?

Response 13: A description of the lab and square footage along with a general diagram would be sufficient.