Change Request memo

Date: November 5, 2021

To: Office of Management and Budget (OMB)

Through: Reports Clearance Officer, DHHS

Project Clearance Chief, NIH

Project Clearance Liaison, NCI

From: Michael Montello, Pharm. D., CTEP (National Cancer Institute)

Subject: Nonmaterial/Non-substantive change request for:

CTEP Branch and Support Contracts Forms and Surveys (National Cancer Institute)

(OMB #0925-0753, Expiration Date: 05/31/2024)

This is a request for OMB to approve non-substantive changes to the attached Cancer Therapy Evaluation Program (CTEP) Branch and Support Contracts Forms and Surveys documents. The updates to the documents are to provide clarification of instructions and add field values (which were missing from the paper forms).

Three files are provided – the Original (old version), a Clean revised form, and a Revised Marks. All the changes can be seen in tracked changes and comments.

Summary of Changes:

Attachment A02 CTSU-IRB Certification

• Removed date and will rely on version number only.

• Added checkboxes in Box 10 that were inadvertently left off.

• Clarified instruction in Box 12 to reference Box 11.

• Removed a line of instructions below Box 14.

• Pushed “In Reference to Protocol #” row to the table on the next page.

• Added a “Row 20” to the table at the end.

Attachment A06 Clinical Brochure

• Updated instructions as hard copies are no longer used, and brochures are distributed electronically.

• Replaced mailing address with email address.

• Formatting changes to the CTSU Internal Reminders and updated footnote.

Attachment A07 Supply Request Form

• Updated instructions since applications are now accepted through the Portal and not by mail.

• Removed Shipping Preference and Please Note sections below Contact Name Table.

• Formatting changes to the CTSU Internal Reminders and updated footnote.

Your full consideration is appreciated.

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