Some links will work for NIAID staff only.
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This SOP has internal roles only.
Standard Operating Procedure Table of Contents
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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 IC 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. The exemption is usually approved for grants, so OMB clearance is typically only necessary for contracts.
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 IC 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
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,
6700-B Rockledge Dr., MSC 7612, room 3155
Clinical Exemptions
Contact
for NIAID Staff,
Rockledge 1, MSC 7974, room 3509
DEA
Contact
for NIAID Staff,
6700-B Rockledge Dr., MSC 7610, room 2140
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
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