Amendment request memo_8_1_2011

Public Health Service

National Institutes of Health

National Heart, Lung, and Blood Institute

Bethesda, Maryland 20892

Date: August 1, 2011

To: Office of Management and Budget (OMB)

Through: Reports Clearance Officer, DHHS

Project Clearance Chief, NIH

Project Clearance Liaison, (NHLBI)

From: Simone Glynn, MD, MSC, MPH

Subject: Request for amendment to 0925-0630 (Expiration date: 04/30/2014) Transfusion-transmitted retrovirus and hepatitis virus rates and risk factors: Improving the safety of the US blood supply through hemovigilance (NHLBI)

Approved Incentive Scheme: Incentive of $75 for each case and $35 for each control for completing an interview has been approved by the OMB. The incentives are intended to recognize and thank each subject for taking the time to answer the questions as honestly as possible.

Requested change to the incentive scheme: Provide incentive of $50 to both cases and controls recruited only at the American Red Cross.

Reason for Request: We are requesting approval for a modification in the incentive scheme to accommodate the standard procedures at the American Red Cross that allows payments in denominations of $50 increments only. In our response to OMB (submitted on April 4), we have provided an explanation for two-tiered incentive plan for cases and controls because of the expected time difference to complete the interview. However, we are now proposing to use a flat $50 payment for both cases and controls at the American Red Cross to keep the procedures as simple as possible. We will continue the previously approved incentive scheme for the other participating centers (New York Blood Center and Blood Systems, Inc.). Please note that the American Red Cross has not started the study whereas New York Blood Center and Blood Systems, Inc. have started the study.

Simone Glynn, MD, MSC, MPH

Branch Chief

Transfusion Medicine and Cellular

Therapeutics Branch

Division of Blood Diseases and Resources

NHLBI, NIH, MSC 7950

6701 Rockledge Dr., Room 9142

Bethesda, MD 20892-7950

Tel: 301-435-0065

Fax: 301-435-0867

Email: [email protected]