Att 04 Additional Technical Instructions.pdf

Attachment 4 Page 1 of 1

Additional Technical Instructions

RFP No.: NIH-NICHD-CDBPM-10-15-RFP

RFP Title: Novel Technologies in Newborn Screening

1. Since positive tests for particular conditions should be a relatively rare event, the Offeror must consider data management when most of the samples tested will be those considered to be within the normal range.

2. While FDA guidance documents are non-binding on FDA or Industry, they offer a current stateof thought on scientific and regulatory issues relevant to a particular topic. The FDA guidance entitled "Class II

Special Controls Guidance Document: Newborn Screening Test Systems for Amino Acids, Free

Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry,"

(http://www.fda.gov/cdrh/oivd/guidance/1301.pdf) describes the FDA's current thinking and recommendations on the topic of tandem mass spectrometry in newborn screening. Though specific to tandem mass spectrometry, this publication offers additional insight into performance characteristics that apply to promising newborn screening technologies.

3. NlCHD encourages the contractor to utilize resources available through the Newborn Screening

Translational Research Network Coordinating Center (NBSTRN-CC).

http://www.fda.gov/cdrh/oivd/guidance/1301.pdf