Questions_and_Answers_No._4_12-R-0006.pdf

Questions and Answers #4 HR0011-12-R-0006

Q1. The RFP states in the paragraph on Facilities:

The offeror shall demonstrate its ability to grow, express and process the final product proteins (including all downstream processes necessary for the requested purification) of at least 300 kg of the plant biomass per month in established and validated production facilities.

We would greatly appreciate a specific definition of the term "validate" as it is used in the guidance text of the solicitation. As you know, the precise meaning of this term has critically important consequences in the development of FDA-approved facilities, operations and procedures. While this term could be interpreted to mean that the facility and all its equipment, systems, methods and monitoring systems have been validated for GMP production, it is not clear that the term is intended to mean validated in this sense.

A1. The term, "validated", is used in this context to request information from the performer that describes their proven and established capability/facility to process 300 kg of Nicotiana Benthamiana plant biomass per month. This phrase is not used in regard to any particular FDA status.

Q2. The solicitation says "The offeror shall outline the degree to which the offeror's proposed personnel represent any performance risk." Can you please elaborate on, or specify, what is meant by "performance risk"? What might be an example of a personnel performance risk?

A2. Examples of personnel performance risk include: whether the proposed personnel are currently employed or will be hired after contract award, the extent to which personnel critical to accomplishment of the effort are spread between a prime and its subcontractors and the extent to which management oversight mitigates any associated risk, the extent to which personnel will be dedicated to the proposed effort, whether the offeror believes, based on their recent and relevant performance, that the proposed personnel will perform successfully, and any risk known only to the offeror.

Q3. Can you please let me know if the 25 page limit includes resumes? Also, please can you let me know if the cover page and contents page are included in the 25 page limit.

A3. The combined synopsis/solicitation states the following:

- The proposal shall not exceed 25 pages.

- The page limitation for full proposals includes all figures, tables, and charts.

- The proposal may include an attached bibliography of relevant technical papers or research notes (published and unpublished), which document the technical ideas and approach upon which the proposal is based. Copies of not more than three (3) relevant papers can be included with the submission. The bibliography and attached papers are not included in the page count provided above.

The cover page and the contents page are included in the page count. The page limit includes resumes.

Q4. Can you please let me know whether typical full resumes are unnecessary if brief bios are included in the 25 page submission?

A4. The combined synopsis/solicitation states the following with regard to the content of resumes:

The offeror shall provide resumes for each proposed personnel and clearly state any specialties that enhance the ability to complete the technical approach.

The offeror must decide if a brief bio or typical full resume will suffice to address the specialties of the personnel proposed.

Q5. Our proposal is going to be too large to send as an email attachment. Is there a site where we could upload a large document (about 20 Mb).

A5. As a reminder, the combined synopsis/solicitation states the following with regard to proposal composition and length:

Proposal Format: All full proposals must be in the format provided below. Nonconforming proposals may be rejected without review.

- All pages shall be printed on 8-1/2 by 11 inch paper with type not smaller than 12 point.

- The proposal shall not exceed 25 pages.

- The page limitation for full proposals includes all figures, tables, and charts.

- The proposal may include an attached bibliography of relevant technical papers or research notes (published and unpublished), which document the technical ideas and approach upon which the proposal is based.

Copies of not more than three (3) relevant papers can be included with the submission. The bibliography and attached papers are not included in the page counts given below.

- The submission of other supporting materials along with the proposals is strongly discouraged and will not be considered for review.

We do not have a site where proposals can be uploaded. You may submit multiple emails that clearly identify the sections of your proposal. You might consider using Winzip or saving the proposal as a reduced PDF.

We suggest that your proposal contain a header and footer that includes the page number and differentiates between the discrete elements of the proposal.

Q6. My company is forming a consortium with three other entities to make a joint proposal in response to Base Notice: Plant Based Proteins - HR0011-12-R-0006. My question regards the technicalities of proper proposal submission. We do not yet have a formally established legal entity for our consortium with its own Federal Tax I.D., CAGE code or DUNS number. Is the appropriate approach under these circumstances to list those numbers for all four entities as part of a single proposal submission?

A6. We will not prescribe business organization solutions for your proposal. Be advised that we will assess the acceptability of all proposals submitted against the selection criteria in the solicitation. After the selection of successful proposals, contracts can only be awarded to organizations that are legal entities. We anticipate making contract awards within 60 days of proposal submittal.