Change Memo - SCTOD Collection - OMB 0915-0310

01262023 - Change Memo - SCTOD Collection - OMB 0915-0310.docx

Stem Cell Therapeutic Outcomes Database

Change Memo - SCTOD Collection - OMB 0915-0310

OMB: 0915-0310

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Health Resources and Services

DEPARTMENT OF HEALTH & HUMAN SERVICES Administration

Shape1

Rockville, MD 20857



DATE: July 26, 2024

TO: Kelsi Feltz, OMB Desk Officer

FROM: Samantha Miller, 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 (SCTOD) Collection (OMB 0915-0310 expiration date 08/31/2025).

Purpose: The purpose of this request is to request minor revisions to the pre-transplant and post-transplant data collection to maintain current and effective data collection. This memo explains the changes and supporting rationale.

Two pre-transplant variables are revised to include updates in the instructions. First, ‘none’ is added as a response option for the question “Additional drugs given (peri-transplant) period” (see Table 1, Item ID PRE001). Second, redundancy in the overall instructions with the specific question about clinical trials is removed (see Table 1, Item ID PRE564).

Post-transplant variables are similarly revised to remove redundant instructional text, including 17 instances of language referring to a date of last report in individual questions and to replace with instructional text at the top of the information collection, and to remove navigational instructions to enable the accurate collection of data regarding the use of additional cellular therapy. Finally, additional clarifying instructional text is added to improve data collection on chimerism results (see Table 2, Item ID POST076).

Time Sensitivity: The SCTOD data collection changes must be completed in a timely manner to fulfill C.W. Bill Young Cell Transplantation Program requirements. These nominal changes are considered non-substantive. Approval of these changes is needed by March 1, 2023, to implement the changes in the data collection system during the scheduled Spring 2023 release. If this timeline is not met, the next release of data collection forms is scheduled approximately three months later.

Burden: The changes requested are non-substantive and do not substantially change the estimated reporting burden for patients with these indications and may even lead to reductions in the burden by clarifying instructions for users.



SUMMARY OF PROPOSED NON-SUBSTANTIVE CHANGES FOR STEM CELL THERAPEUTIC OUTCOMES DATABASE VARIABLES.

Further details can be found in Attachment 1 (complete spreadsheet of data collection to support the SCTOD).

Table 1: Proposed Changes to Pre-Transplant Variables

Item ID

Information Collection Domain Sub-Type

Information Collection update:

Proposed Information Collection Data Element (if applicable)

Proposed Information Collection Data Element Response Option(s)

Rationale for Information Collection Update

PRE001

Additional Drugs Given In the Peri-Transplant Period

Change/Clarification of Response Options

ALG, ALS, ATG, ATS, Alemtuzumab, Defibrotide, KGF, Ursodiol, none

(check all that apply)

Capture data accurately

PRE564

Pre-Transplant Essential Data

Change/Clarification of Information Requested

Is the recipient participating in a clinical trial?

no, yes

Capture data accurately



Table 2: Proposed Changes to Post-Transplant Variables

Item ID

Information Collection Domain Sub-Type

Information Collection Domain Sub-Type

Information Collection update:

Proposed Information Collection Data Element (if applicable)

Proposed Information Collection Data Element Response Option(s)


Rationale for Information Collection Update

POST010

Post-Transplant Essential Data

 

Change/Clarification of Information Requested

Did the recipient receive a subsequent HCT?


Instruction text (since date of last report) for the individual question is extraneous as it is applied in the overall instructions for questions at this time point of data collection

POST015

Post-Transplant Essential Data

 

Change/Clarification of Information Requested and Response Option

Has the recipient received a cellular therapy? (e.g., CAR-T, DCI)

no, yes


Instruction text change to remove navigation instructions

POST025

Post-Transplant Essential Data

 

Change/Clarification of Information Requested

Did acute GVHD develop?


Instruction text (since date of last report) for the individual question is extraneous as it is applied in the overall instructions for questions at this time point of data collection

POST027

Post-Transplant Essential Data

Graft vs. Host Disease

Change/Clarification of Information Requested

Did acute GVHD persist?


Instruction text (since date of last report) for the individual question is extraneous as it is applied in the overall instructions for questions at this time point of data collection

POST043

Post-Transplant Essential Data

Graft vs. Host Disease

Change/Clarification of Information Requested

Did chronic GVHD develop?


Instruction text (since date of last report) for the individual question is extraneous as it is applied in the overall instructions for questions at this time point of data collection

POST045

Post-Transplant Essential Data

Graft vs. Host Disease

Change/Clarification of Information Requested

Did chronic GVHD persist?


Instruction text (since date of last report) for the individual question is extraneous as it is applied in the overall instructions for questions at this time point of data collection

POST054

Post-Transplant Essential Data

 

Change/Clarification of Information Requested

Did veno-occlusive disease (VOD) / sinusoidal obstruction syndrome (SOS) develop?


Instruction text (since date of last report) for the individual question is extraneous as it is applied in the overall instructions for questions at this time point of data collection

POST056

Post-Transplant Essential Data

 

Change/Clarification of Information Requested

Did the recipient develop COVID-19 (SARS-CoV-2)?


Instruction text (since date of last report) for the individual question is extraneous as it is applied in the overall instructions for questions at this time point of data collection

POST065

Post-Transplant Essential Data

Allogenic Recipients of Cord Blood units, Beta Thalassemia, and/or Sickle Cell Disease

Change/Clarification of Information Requested

Were chimerism studies performed?


Instruction text (since date of last report) for the individual question is extraneous as it is applied in the overall instructions for questions at this time point of data collection

POST076

Post-Transplant Essential Data

Chimerism Study Performed

Change/Clarification of Information Requested

Method

PCR "Single nucleotide polymorphisms (SNPS) (includes quantitative PCR, real time PCR, sequencing, other), Fluorescent in situ hybridization (FISH) for XX/XY, Karyotyping for XX/XY, Other, Restriction fragment-length polymorphisms (RFLP), VNTR or STR, micro or mini satellite

Capture data accurately

POST084

Disease Assessment at the Time of Best Response to HCT

 

Change/Clarification of Information Requested

Compared to the disease status prior to the preparative regimen, what was the best response to HCT?


Instruction text (since date of last report) for the individual question is extraneous as it is applied in the overall instructions for questions at this time point of data collection

POST107

Post-HCT Therapy

 

Change/Clarification of Information Requested

Was therapy given for reasons other than relapse, persistent, or progressive disease? (Include any maintenance and consolidation therapy.)


Instruction text (since date of last report) for the individual question is extraneous as it is applied in the overall instructions for questions at this time point of data collection

POST112

Post-HCT Therapy

 

Change/Clarification of Information Requested

Did a fecal microbiota transplant (FMT) occur?


Instruction text (since date of last report) for the individual question is extraneous as it is applied in the overall instructions for questions at this time point of data collection

POST119

Relapse or Progression Post-HCT

 

Change/Clarification of Information Requested

Was intervention given for relapsed, persistent, or progressive disease?


Instruction text (since date of last report) for the individual question is extraneous as it is applied in the overall instructions for questions at this time point of data collection



Attachment:

  1. Current SCTOD Information Collections_incremental changes 2023-01-06

File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
File Title01242023- Change Memo - SCTOD Collection - OMB 0915-0310 - REDLINE
AuthorWindows User
File Modified0000-00-00
File Created2024-07-26

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