Question_ _Answer_CMC_Development_Solicitation.pdf

Solicitation Number No. HHS-NIH-NIDA-SSSA-CSS-16-287 Questions & Answers (Q&A)

May 19, 2016

1. Please confirm that the Technical Proposal front matter (cover page, table of contents, etc.) and appendices (CVs/resumes, etc.) are excluded from the 40 single-sided page limit.

Complete Offeror registration in the U.S. System for Award Management (SAM) shall meet the requirements for Representations and Certifications with proposals. Please ensure your company is registered as “Active” in SAM, note this in your technical proposal, and do not submit any additional representations and certifications.

2. The NAICS classification paragraph states that the intended procurement is classified under NAICS code 541690 with a Size Standard of $14 Million. However, the Set-Aside states the acquisition is available for full and open competition. This appears to be contradictory, would you kindly clarify?

NAICS code classification is required for all procurements, regardless of set-aside status. The Government confirms this requirement is unrestricted and available for full and open competition.

3. In Appendix A, 2.c. Contractor - Employee Non-Disclosure Agreement(s), No time frame for submission of the Non-Disclosure Agreement is specified. Should it be assumed that the NDA is to be submitted with the proposal?

No, please do not submit Non-Disclosure Agreements with a proposal. Non-Disclosure Agreements shall be signed by the successful offeror(s) following award.

4. Appendix A, 6.d. Contractor and subcontractor employee training indicates that HHS-furnished initial and refresher security and privacy education and awareness training be completed before consultants will be granted access to systems operated by the Contractor. Is this training covered under the minimum 30 hours for the first project year, or will it need to be billed separately? If the latter, how many hours of training are required?

Yes, the training will be covered under the minimum 30 hours for the first project year and will not be billed separately. This training is offered online and is expected to take between 1 and 2 hours to complete.

5. FIPS 140-2 and 201 compliance is likely to require new laptop computers designated specifically for the projects (-287 and -288). Will computers be supplied (i.e. “on loan), or will designated computers need to be purchased? If the latter, will equipment purchase be reimbursable?

No, computers will not be supplied. If computers need to be purchased it will be at the contractors expense, they will not be reimbursed. The contractor should quote any other direct costs anticipated in its business proposal for Government consideration.

6. Will there be investigational products that are biologics/device combinations?

There may be biologic/device combinations in the program.

7. Does the scope of work cover attending or moderating the pre-IND meeting?

No, the scope of work does not cover attending or moderating the pre-IND meeting.

However, consultants may be asked to review and comment on pre-IND packages.

8. Does the scope of work cover pre-pre-IND meetings for gene therapies?

No, the scope of work does not cover attending or moderating pre-pre-IND meetings for gene therapies. The scope of work covers offering advice prior to and post pre-pre-IND meetings for gene therapies.

9. Does the scope of work cover review of documents for the Recombinant DNA Advisory Committee (RAC) or the Institutional Biosafety Committee (IBC) for gene therapies?

No, the scope of work does not cover review of documents for the Recombinant DNA Advisory Committee (RAC) or the Institutional Biosafety Committee (IBC) for gene therapies.

10. Does the scope of work cover additional FDA meetings such as End-of-Phase 2 meetings?

The scope of work does include offering advice up to Phase 1 clinical trials, but does not cover End of Phase 2 meetings.

11. Does the scope of work cover requests for Orphan Drug Designation?

Yes, the scope of work covers offering advice related to requests for Orphan Drug or any other Designations. Many therapies for neurological disorders could be eligible for Orphan Drug Designation.

The scope of work does not cover writing the Orphan Drug Designation application.

However, consultants may be asked to review and comment on Orphan Drug Designation packages. The investigator of the therapy is responsible for writing the Orphan Drug Designation application.

12. Does the scope of work cover requests for Breakthrough Designation?

The scope of work covers offering advice related to requests for Breakthrough or any other Designations. The scope of work does not cover writing the Breakthrough Designation application.

However, consultants may be asked to review and comment on Breakthrough

Designation packages. The investigator of the therapy is responsible for writing the Breakthrough Designation application.

13. Does the 40 page length include the following? Title Page, Table of Contents, List of Abbreviations.

No, the 40-page length limit does not include the title page, table of contents, or list of abbreviations. Please label these pages with Roman numerals instead.

14. Are the CV’s excluded from the 40 page limit?

Yes, CV’s are excluded from the 40 page limit.

15. Are appendices excluded for the 40 page limit?

Yes, appendices are excluded from the 40 page limit.