Attachment 01 Amend 1_CSS 75N95025Q00109.pdf

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Biological Therapeutics Product Development Subject Matter Expert Consultants
Solicitation number
NIH-NINDS-CSS-75N95025Q00109
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This is a Questions and Answers document for solicitation NIH-NINDS-CSS-75N95025Q00109, regarding Biological Therapeutics Product Development Subject Matter Expert Consultants. The document clarifies four key points about the solicitation: 1) The government is seeking multiple vendors rather than a sole source, 2) While there is a 10-page limit for proposals, resumes are excluded from this limit and can be unlimited, 3) Vendors are permitted to propose discount rates for SME categories by adding new lines to the Excel price template for fully burdened labor rates, and 4) The opportunity is a small business set-aside.

The solicitation is being issued by the National Institute of Neurological Disorders and Stroke (NINDS) seeking subject matter experts in biological therapeutics development to support NIH drug discovery and development programs through Phase 1 clinical trials. Areas of expertise include chemistry, manufacturing, controls, pharmacokinetics, toxicology, regulatory affairs, medical writing, biostatistics, and quality assurance/control.

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Questions and Answers

Biological Therapeutics Product Development Subject Matter Expert Consultants-NIH-NINDS-CSS-75N95025Q00109

1.) With this solicitation, is the Government seeking a SOLE SOURCE or would the Government consider multiple vendors?

Answer: For this solicitation, the government is seeking multiple vendors.

2.) If we submit resumes for multiple Subject Matter Experts (SMEs) the 10 page limit would limit the amount of SME specialties we could submit.

Will the government consider increasing the page limit to accommodate more candidates?

Answer: Yes, the government will consider increasing the page limit to accommodate more candidates. The 10-page limit does not include resumes, which can be unlimited.

3.) Attachment #4 – Price Template instructions indicate to only change the highlighted cells. As this requirement is looking for various high level SMEs we anticipate wanting to provide a discount rate on certain proposed key personnel/SME categories. Is this acceptable? If yes, how would you like us to propose discount rates (such as adding new lines fully burdened labor rate lines, etc.)?

Answer: Yes, is this acceptable. Yes, you can manipulate the Excel Spread sheet to add new lines to incorporate the fully burdened labor rate lines.

4.) Is this opportunity is a small business set-aside, or full and open competition?

Answer: It is a small business set-aside.

File details come from the government source that posted it. Updated .