Privacy Act Memo

DATE:

July 3, 2024

TO:

Tali Johnson
Chief, Pharmaceutical Management Branch
Cancer Therapy Evaluation Program
National Cancer Institute (NCI)

FROM:

NIH Privacy Act Officer

SUBJECT: Applicability of the Privacy Act: “Investigational Agent Accountability Record Forms in the
Conduct of Investigational Trials for the Treatment of Cancer
(National Cancer Institute/DCTD/CTEP)”
I have reviewed the NCI submission for OMB to approve the request for Investigational Agent Accountability
Record Forms in the Conduct of Investigational Trials for the Treatment of Cancer (National Cancer
Institute/DCTD/CTEP). The purposes of the collection are to provide a standardized method of tracking agent
disposition across all institutions participating in trials for which the NCI provides agents. Institutional auditors
verify information on the agent accountability forms for compliance. In addition, PMB staff review
Investigational Agent Accountability Record Forms against records maintained in PMB systems to ensure no
inappropriate use or diversion of investigational agents.
I have determined that the Privacy Act will apply because the application involves the collection of personally
identifiable information (PII) and that information is used as unique identifiers to retrieve records. The PII that
will be collected are name, email address, phone number, education records, certificates, mailing address,
month and year of birth, medical licenses, patient identification, patient initials, and clinical trial support history
and trainings. This data collection is covered by NIH Privacy Act System of Records 09-25-0200, “Clinical,
Basic and Population-based Research Studies of the National Institutes of Health (NIH), HHS/NIH/OD.”
If you have questions, please contact me at (301) 402-6469.

Dustin B.
Close -S
Dustin Close
NIH Privacy Act Officer

Cc: Diane Kreinbrink, NCI PRA Liaison

Digitally signed by
Dustin B. Close -S
Date: 2024.07.02
12:07:02 -04'00'