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OMB Clearances and Clinical Exemptions SOP

Lock icon: This link will not work for public visitors.Some links will work for NIAID staff only.

This SOP has internal roles only.

This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, and Links.

Purpose

To obtain approval, when necessary, from the Office of Management and Budget (OMB) for NIH-sponsored collections of information gathered from 10 or more persons, for reporting, record keeping, and disclosure requirements.

Procedure

The Paperwork Reduction Act requires that an NIH institute get OMB approval to collect information from 10 or more persons, except when it has an exemption.

For clinical research, NIAID applies for a clinical exemption from OMB clearance—see chapter 1825, NIH Manual

When a clinical exemption does not apply, NIAID must get OMB clearance by taking the following steps.

Program Staff

For exceptional cases that require an OMB control number signifying OMB approval, prepare a package with the following.

  • Describe how the proposed collection:
    • Is appropriate to the Institute's mission.
    • Imposes the least burden on respondents and will help achieve program objectives.
    • Does not duplicate available information.
    • Has practical use to the federal government.
  • Indicate that all reasonable steps have been taken to minimize costs of collecting, processing, and using the information to both government and respondents.

To put a package together:

  • Contact the Lock icon: This link will not work for public visitors.NIAID project clearance liaison. Though part of the Office of Acquisitions, the liaison handles clearances for all of NIAID.
  • Find out what documents you need to complete to qualify for OMB approval.
  • Submit your package to the NIAID project clearance liaison.

NIAID Project Clearance Liaison

Project Clearance Officer, NIH OPERA

  • Work with OMB to get final approval for the package and inform the NIAID project clearance liaison when the package has been approved by OMB.

Contacts

Paperwork Reduction Act, OMB clearances

Lock icon: This link will not work for public visitors.Contact for NIAID Staff

NIAID Project Clearance Liaison

Lock icon: This link will not work for public visitors.Contact for NIAID Staff

Clinical Exemptions

Lock icon: This link will not work for public visitors.Contact for NIAID Staff

DEA

Lock icon: This link will not work for public visitors.Contact for NIAID Staff

If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. Thanks for helping us clarify and expand our knowledge base.

Links

NIH Policy Manual Web site

Last Updated January 10, 2014

Last Reviewed March 27, 2012