Attachment 08 Amendment 2_RFQ_ 75N95023R00065_QandA.pdf
PDF 167 KB Posted
- Attached to
- Regulatory Affairs Consultant Support Services Federal contract opportunity
- Solicitation number
- 75N95023R00065
About this file
This document contains responses to questions regarding solicitation number 75N95023R00065 for Regulatory Affairs Consultant Support Services from the Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse. The responses clarify that the selected consultant would work with NIH medical writers on producing FDA documents, and that the consultant should have experience working with medical writing teams in the past. The document also notes that the correct evaluation criteria for regulatory affairs consultants is in Attachment 7A, not the original Attachment 7. Finally, it states that recurring software subscription fees for services like Office 365 could be recovered as other direct costs, but laptop costs are excluded. The NIH prefers to receive a loaded hourly rate for proposed personnel.
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| Attachment 09 Amend 3_RFQ_ 75N95023R00065_QandA.pdf | ||
| Attachment 7A - EVALUATION CRITERIA Regulatory Affairs.pdf | ||
| Combined_Synopsis_Solicitation 75N95023R00065.pdf | ||
| Attachment 5 - Information and Physical Access Security.pdf | ||
| Attachment 4 - Representations and Certification.pdf | ||
| Attachment 3 - Additional Terms and Conditions.pdf | ||
| Attachment 6 - Invoicing Instructions With IPP_Updated_04212022.pdf | ||
| Attachment 2 - Price Template_07.17.23.xlsx | XLSX spreadsheet | |
| Attachment 1 - Statement of Work - SOW.pdf | ||
| Attachment 7 - EVALUATION CRITERIA.pdf |
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Text version
Responses to Questions
Questions and Answers
1.) “Consultants must have access to a team which will help them produce FDA and other Regulatory Agency documents. Consultant must have worked with this team for a reasonable amount of time.” Question – Does this mean that selected Regulatory Affairs Consultant would not be working with the NIH medical writers on the BPN Program to produce FDA documents? Please confirm if NIH meant that the Regulatory Affairs (RA) consultant would work with the NIH medical writers in the BPN program to produce the FDA documents but that the RA should have experience working with medical writer teams in the past to produce regulatory submission documents.
As a general rule, NINDS would prefer to Regulatory Affair Consultants work with their own team of medical writers.
2.) The evaluation criteria for the Regulatory Affairs Consultant role seems to be the same as the Medical Writer Consultant Support Services role that was released as a separate solicitation. Is this the correct evaluation criterion for the Regulatory Affairs consultant role?
No, this was not the correct attachment. Amendment 01 was posted on July 20, 2023 to replace Attachment 7 - EVALUATION CRITERIA with Attachment 7A - EVALUATION CRITERIA Regulatory Affairs. Please see Attachment 7A - EVALUATION CRITERIA Regulatory Affairs.
3.) Can we utilize ODC to recover reasonable recurring costs for any equipment associated service expenses such as per user monthly subscription fees for office365/IT security/software etc? Laptop cost is excluded. These software services would be part of dedicated IT equipment that would be assigned to an SME to exclusively support the NIH BPN contract and would be necessary to provide secure connectivity in conformance with NIH standards, report writing, team communication, timekeeping etc. Since this is a part-time contract and the anticipated hours are low and infrequent, but these software service costs are incurred monthly for each assigned user for direct performance of the contract, would government permit the expensing of these recurring per user service costs through
ODC?
NINDS would like to receive a loaded rate/hour for proposed personnel.
File details come from the government source that posted it. Updated .