Attachment 01 Amend 1_RFQ_ 75N95023R00063_QandA.pdf
PDF 150 KB Posted
- Attached to
- Medical Writing Consulting Services
- Solicitation number
- 75N95023R00063
About this file
This document provides responses to questions regarding a request for quotation (RFQ) for medical writing consulting services. The solicitation is a small business set aside being issued by the National Institute on Drug Abuse, part of the National Institutes of Health within the Department of Health and Human Services. The RFQ seeks consulting services to produce documents such as drug dossiers and investigational new drug applications using data provided by the Laboratory of Drug Abuse. Offerors may propose up to five key personnel and a page limit of two pages for key personnel narratives. The travel expense is $1,500 per writer and work will be performed on an as needed basis, estimated at up to 800 hours annually by a medical writing team.
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Responses to Questions
Questions and Answers
1.) Based on the above reference to Limitations of Subcontracting, we presume that this solicitation requirement was meant to be a Total Small Business Set-aside but it is not designated as a Small business setaside in SAM.gov. Would you please clarify?
This requirement is a Small Business Set Aside.
2.) Can the government please confirm based on the language in the Combined Solicitation that offeror's may submit up to five (5) Key Personnel to cover the SOW level of effort.
The Offeror may submit up to five (5) key personnel.
3.) Can the government please confirm the page limit for Key Personnel Narrative is (no more than 2 pages) to match Phase II page limits?
The page limit for the Key Personnel Narrative is no more than
2 pages, however, CV of the key personnel can be included as an attachment to the proposal.
4.) Can the government please confirm the correct travel ODCs at $1200 or $1500 per writer?
The travel ODC is $1,500 per writer.
5.) We strive to produce the highest quality written documents. Will there be any hours allocated for quality control, such as copyediting and/or internal review of materials by the contractor?
NINDS would like to receive hourly rates which includes all processes needed to produce an acceptable document.
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.) There is a requirement of a consultant having experience in “being a senior leader in drug discovery projects in the biopharmaceutical industry.” Does that mean that the writer will also have experience as a scientist in drug development?
NINDS will prefer writers who have experience at senior levels in pharma who have led teams producing regulatory documents and drug dossiers.
8.) The project requires between three and ten hours weekly. Will this be consistently on a “week-
Responses to Questions to-week basis” or on a “as needed” basis?
The work will be on an as needed bases. NINDS may require estimates for producing drug dossiers if needed.
9.) Would like to confirm that the project would allocate 1 writer to various projects, vs. more than
1 writer to various projects totaling 800 hours.
The contractor can propose the level-of-effort in either manner. NINDS estimates that no more than 800 hours will be spent by a contractor [medical writing team] per year.
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