Amend. No. 3 - RFP Female

ATTACHMENT NO. 1

Amendment No. 3, RFP No.NIH-NICHD-CRHB-2012-03

OPTIONAL PROPOSAL FOR PHAMACOKINETIC EVALUATION UNDER TASK ORDER 2

1. SUCCESSFUL EXPERIENCE WITH SIMILAR PK STUDIES 25 Points

Demonstrate and provide documentation of successful recruitment and retention of subjects in a pharmacokinetic study of an investigational drug.

Demonstrate ability to recruit rapidly once enrollment period begins.

Demonstrate ability to consistently generate high quality data.

Specific points will be based on:

1) Recruitment total relative to projected target number (5 pts).

2) Enrollment rate throughout the entire enrollment period (5 pts)

3) Success early in the enrollment period (first 3 months) (5 pts)

4) High retention rate of enrolled subjects (5 pts)

5) Total number of completed subjects (5 pts)

2. EXPERTISE 25 Points

Demonstrated expertise of the investigator and key support staff in the performance of PK studies.

TOTAL 50 Points