Please complete the human subjects section of the Research & Related Other Project Information form prior to completing this form.

The following items are taken from the Research & Related Other Project Information form and displayed here for your reference. Any changes to these fields must be made on the Research & Related Other Project Information form and may impact the data items you are required to complete on this form.

           Are Human Subjects Involved?      Yes

           Is the Project Exempt from Federal regulations?      Yes

           Exemption number:  2

If No to Human Subjects

Does the proposed research involve human specimens and/or data?

No additional human subject information is required

If Yes to Human Subjects

Add a record for each proposed Human Subject Study (including Clinical Trials and Observational Studies)

Public reporting burden for this collection of information is estimated to average 4-14 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.  An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.  Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0001 and 0925-0002).  Do not return the completed form to this address.