Request for Approval Non-substantial Change (25AN)

Request for Non-substantive Change

Direct Reading Methodologies, Sensors, and Robotics Technology Assessment in Lab/Simulator-based Settings

#0920-1441– Expiration date 09/30/2027

Justification for Non-substantive change:

NIOSH is requesting a non-substantive change request for 0920-1441 by using the “Request for genIC Approval” Form when requesting to debit hours from the umbrella genIC package to reduce redundancy and unnecessary complexity that an additional Supporting Statement A would have on individual packages submitted. The Request for genIC Approval Form for 0920-1441 was initially submitted with the package as a form of Supporting Statement A but later removed to reduce extra work and redundancy.

Existing documents being updated

A request to debit form is being added back into the protocol in lieu of a full SSA, considering the Master SSA already includes the justification and need for the effort. The form is attached, which describes the tool/method/intervention being studied, identifies the targeted respondent populations, includes a justification for any incentives offered, and assesses applicability of the Privacy Act including a completed Privacy Impact Assessment. A full Supporting Statement B will still be provided if any statistical methods are employed for sampling or analyses. The burden hours and costs will not be affected by these proposed changes.

Summary of proposed updates

1. Form Added: The “Request for genIC Approval” Form for 0920-1441, already reviewed, is added back into the package submission materials.

2. Master Supporting Statement A: Introductory information box

• “How data will be analyzed bullet”: In the original text, we deleted “full supporting statement A” to replace is with “completed request to debit form” as this was the intent of the effort and the normal process NIOSH has employed for genIC clearance submissions:

In addition to submission of the instruments utilized, all collections submitted under this generic pathway will include a full Supporting Statement A completed request to debit form that describes the tool/method/intervention under development, identifies the targeted respondent populations, includes a justification for any incentives offered, assesses applicability of the Privacy Act and includes a complete Privacy Impact Assessment if necessary, and an accompanying Supporting Statement Part B if any statistical methods are employed for sampling or analyses in the study.

Attachments:

1. OMB-approved Master Supporting Statement A (File name: SSA_NIOSH_Lab with VR Pkg_Final)

2. Revised Master Supporting Statement A (tracked changes version) (File name: SSA_NIOSH_Lab with VR Pkg_Change_Track)

3. Revised Master Supporting Statement A (clean version) (File name: SSA_NIOSH_Lab with VR Pkg_Change_Clean)

4. “Request for genIC Approval” Form to be used when requesting to debit hours from 0920-1441 (NIOSH genIC_0920-1441_Request to Debit Hours)