OMB Clearances and Clinical Exemptions

This SOP has internal roles only.

Purpose

To obtain approval, when necessary, from the Office of Management and Budget (OMB) for NIH-sponsored collections of information gathered from ten 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 ten 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 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

• Work with the project clearance officer at the NIH Office of Policy for Extramural Research Administration (OPERA) and program staff to ensure that all necessary materials are included.
  • Find guidance on clinical exemption requests at Project Clearance Branch (PCB).
  • Use the Add New Clinical Exemption Request form.
• Inform program staff when the package has been approved by OMB.

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

Contact for NIAID Staff, Rockledge 1, MSC 7974, room 3509

NIAID Project Clearance Liaison

Contact for NIAID Staff, Fernwood Blvd., room 2NE86

Clinical Exemptions

Contact for NIAID Staff, Rockledge 1, MSC 7974, room 3509

DEA

Contact for NIAID Staff, 6700B Rockledge Dr., MSC 7610, room 2140

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Links

NIH Policy Manual Web site