Change Request Memo

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

National Institutes of Health

National Heart, Lung, and

Blood Institute

Bethesda, Maryland 20892

Date: 12/06/2016

TO: Stephanie Mok, OMB

Through: Kevin Purkiser, NHLBI

Darius Taylor, DHHS

FROM: Mikia Currie, Chief, Project Clearance Branch

SUBJECT: Change Request to a Currently Approved Form (0925-0717 Electronic Prior Approval Submission System (ePASS) (NHLBI) Expiration Date 5/31/2018)

NHLBI’s ePASS system, which received OMB Clearance in 2015, was to allow NHLBI to get certain grantee requests and information sharing (such as requesting a change of effort, using unspent funds, no cost extensions, etc.) through a new automated system called ePASS, instead of previous inefficient ways such as email and hardcopy.

Now NHLBI would like to include some more requests and information sharing from grantees through this system, such as patient enrollment monitoring and conflict of interest certification for clinical trial management. This modification won’t increase burden to the grantee community; it only switches how grantee requests and information sharing are transmitted to NHLBI.

Thus with this modification, ePASS will help grantees submit their information in a better way than simply emailing it in, for the reasons stated in the original OMB Clearance, such as streamlined processes, authorized approvals and added security, as well as reducing the redundancy of tools used by grantees to submit prior approval requests.

Thank you for your consideration of this modification request.

Kevin Purkiser