2016 OMB Request for Non-Substantive Change_SCTOD

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DATE:			December 8, 2016
TO:			Patrick Wells, OMB Desk Officer
FROM:		Lisa Wright-Solomon, HRSA Information Collection Clearance Officer
_____________________________________________________________________________________
Request:  	The Health Resources and Services Administration (HRSA) Division of Transplantation requests approval for non-substantive changes to the Stem Cell Therapeutic Outcomes Database Collection (OMB #0915-0310, expires 12/31/2019). 
Purpose: 	The Pre-Transplant Essential Data (pre-TED) Form 2400 will be split into two separate forms, the Pre-TED 2400, and Pre-TED Disease Classification Form 2402. This format change provides increased flexibility in data collection and form updates.  
Time Sensitivity:  	The SCTOD data collection must be completed in a timely manner in order to fulfil Program requirements. In order to collect data on these forms by mid-January, approval of these changes is needed by December 21. The next release for data collection forms is scheduled approximately three months later.
Burden:	The revisions included herein do not change the estimated reporting burden. 

PROPOSED CLARIFICATIONS AND REVISIONS FOR STEM CELL THERAPEUTIC OUTCOMES DATABASE FORMS:
Form 2400
    a. Question 52 - Addition 
Added question “Specify the number of these products intended to achieve hematopoietic engraftment”.  
Rationale: This will allow capture of more detailed data when a recipient receives an infusion of more than one product 

Form 2402
    a. Question 2 - Revision
Changed the option “Other acute leukemia” to “Acute leukemia of ambiguous lineage” 
Rationale: To align with the new WHO disease classifications

    b. Questions 3, 64, and 107 – Revision
Updated the disease options 
Rationale: To align with the new WHO disease classifications

    c. Question 111 – Removed
Removed question capturing Chronic Myelogenous Leukemia (CML) classification (formerly Q111)
Rationale: Determined to be unnecessary 

    d. Question 119 – Revision
Changed the text from “What was the disease status at last evaluation prior to the start of the preparative regimen?” to “What was the disease status?” 
Rationale: To harmonize with the CML disease insert

    e. Question 120 – Addition
Added question regarding level of response for CML disease status
Rationale: Collects information regarding molecular and cytogenetic detail questions around disease status; formerly asked as two questions 

    f. Questions 121 and 122 - Removed
Removed molecular and cytogenetic detail questions around disease status (formerly Q121 and 122). 
Rationale: This information is now captured as one question – question 120

    g. Question 171 - Addition
Added question to capture the original date of the MDS diagnosis if it has transformed to AML
Rationale: This was asked in previous versions of the form and found to be necessary

Attachments:
All revisions are indicated with tracked changes in the attached documents
    1. Pre-TED 2400
    2. Pre-TED Disease Classification Form 2402