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  5. Paperwork Reduction Act Clearance System (PRACS)

Paperwork Reduction Act Clearance System (PRACS)

What is the purpose?

The Paperwork Reduction Act Clearance System (PRACS) is a system that allows for electronic submission, approval and tracking of NIH documents designed to collect public information that require clearance from the Office of Management and Budget (OMB). 

The system is designed for use by:

  • submitters of these requests (usually program staff at NIH),
  • liaisons at the Institute/Center who conduct the initial review and ensure the submission is complete and accurate, and
  • staff at OPERA’s Project Clearance Branch who serve as the NIH point of contact for OMB clearance functions concerning public information collection activities.

The Project Clearance Branch’s submission of these requests, called Information Collection Requests, to HHS and OMB happens outside of the PRACS module.

The process requires the IC to submit a 60-day Federal Register Notice informing the public that OMB clearance is being sought to collect this information and requesting comments over a 60-day period. In addition, the IC has to provide Supporting Statement A (SSA) and/or Supporting Statement B (SSB), if statistical methodologies are being implemented, along with survey instruments and other relevant documentation. Once the package is approved by the Project Clearance Branch, a 30-day Federal Register Notice is published to allow the public to send comments to OMB on the final package. The package is sent to HHS for review and then on to OMB. Relevant dates are entered manually into the PRACS module.

What are the features?

PRACS allows the following capabilities:

  • Create, submit, and track all types of PRA clearance requests
  • Upload and manage all request related documents
  • Provide real-time notifications of request review and workflow status
  • Provide a complete audit trail of each submission
  • Search for current and historical requests
  • Create comments during the review process
  • Route requests back to submitters at any point in workflow

PRACS supports the following types of requests:

  • Regular Request
  • Generic Request 
  • Generic Sub-Study
  • Request to Discontinue

Depending on the request type, PRACS supports the following ICRs:

  • New
  • Extension
  • Revision
  • Reinstatement without Change
  • Reinstatement with Change
  • Existing Collection In Use without an OMB Number
  • Non-substantive Change

What are the benefits?

PRACS reduces the amount of paperwork needed for information collection requests by allowing electronic request, submission, and review of ICRs.  

Who can use PRACS?

  • Program staff who request permission to conduct an ICR (‘requester’);
  • ‘Submitters’ who submit the request (could be same as program staff);
  • IC liaisons who conduct the initial review of submitted requests and forward to the PCB for process; and
  • PCB staff who process the requests (‘reviewers’) and send the package to OMB for clearance.