2008012responses2.pdf

NIHAO2008012 Responses to Questions #2 July 10, 2008

Question 1:

1. Please clarify the requirement that studies will be limited to adult subjects and the definition of a child (“an individual under the age of 21 years”) on page 60. Are volunteers ages 18-20 considered children? Are they to be excluded from participating in these studies?

Response:

The guidelines from the FDA in 21 CFR 50 'Protection of Human Subjects', Subpart A, 50.3 'Definitions' states ‘'Children' means persons who have not attained the legal age for consent to treatments or procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the clinical investigation will be conducted.’ Offerors should follow the FDA guidelines.

Question 2:

In the Statement of Work, item 5(2) states that “in the absence of inpatient studies, up to 200 adults will be studied per year in an outpatient setting.” However, item 5(3) states “The contractor shall provide an estimate of the number and size of outpatient studies that can substitute for inpatient studies. It is estimated that outpatient studies would involve 20 to 30 volunteers followed for 30 to 60 days.” Should it be assumed that in the absence of inpatient studies, 200 volunteers per year should be enrolled in outpatient studies in groups of 20 to 30?

Response:

The offeror should provide a plan of the number and size of outpatient studies that they can substitute for inpatient studies. If they can conduct outpatient studies in larger groups, they need not be restricted to groups of 20 to 30.