Attachment 09 Amend 3_RFQ_ 75N95023R00065_QandA.pdf
PDF 149 KB Posted
- Attached to
- Regulatory Affairs Consultant Support Services
- Solicitation number
- 75N95023R00065
About this file
This document provides responses to questions from potential offerors for solicitation number 75N95023R00065 from the Department of Health and Human Services National Institutes of Health National Institute on Drug Abuse. The solicitation seeks regulatory affairs consultant support services. Key details include that loaded hourly rates are required for proposed medical writers and quality control specialists. Rates for medical writers must be calculated based on a 2,000 hour work year and cannot exceed $106 per hour. Consultants may work on other contracts provided there are no conflicts of interest. Past experience can be included in technical or business proposals but providing historical rates is not required. The number of bids typically received varies and no estimate can be provided.
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Responses to Questions
Questions and Answers
1.) We applied for a Government entity ID today – but it looks like this could take weeks to be finalized. Do we need to have this fully in place before we can put in a bid for a solicitation, or can we bid as long as we have applied?
Yes, you can submit a proposal, however an active SAM.gov registration is required prior to award.
2.) To clarify our understanding of rate: As we see it, the rate that we submit for the consultant needs to come in below that of Executive Level II salary (medical writer), which is $212,100. With the stated possible hours for the medical writer as a maximum of 800 for the year, does that mean that we can break that hourly rate down to not exceed $265/hour – or do we need to base that annual salary on assumed full-time (2000 hours), therefore making the maximum rate $106/hour?
NINDS is requesting loaded rates. The Executive Level II salary rate is to be calculated based on 2,000 hours per year.
3.) When writing the price narrative, what should be included? Examples of similar jobs and the rate we have historically charged? Other supporting material?
Please provide loaded rates for each Key Personnel proposed. Past experience can be included in either the technical proposal or business proposal. Providing historical rates is not required.
4.) If we were to win a bid, could our consultants still be engaged in other contracts at the same time
(assuming no conflict of interest)?
Consultants can work on other contracts assuming that there is no conflict of interest.
5.) With regards to the key personnel included in the medical writers proposal: Should we include both medical writers and QC specialists, or is this role looking for individuals who can do the full spectrum of work? If we do include two different types of consultants, how is the best way to differentiate the rates that we would apply to each?
Provide information about each proposed Key Personnel and provide rates if applicable.
6.) It is understood that the writer will liaise with the LDT. However, who will provide technical guidance to the writer on a day-to-day basis, will it be the LDT or the contractor?
There will be no day-to-day guidance to medical writers by the LDT. The Contractor is required to produce documents such as Drug Dossiers or IND Applications using data provided by LDT members or drug asset holder.
7.) How many bids typically come in for these solicitations?
Responses to Questions
The number of bids received for solicitations varies. We cannot specify a number.
8.) Will the hours for the Medical Writer be part of the Regulatory Affairs Consultant budget (20- 800 hours)?
No, these are two separate Combined Synopsis/Solicitations (CSS). Please refer to the requirements and evaluation criteria in the CSS.
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