Draft Revised FWA Form and Terms of Assurance – Request for Comments

September 23, 2010

Links to the Draft Revised FWA Form and Terms of Assurance and Federal Register Notice of Availability:

The draft revised FWA form can be accessed at:
http://www.hhs.gov/ohrp/sites/default/files/ohrp/documents/form092310rev.pdf

The draft revised FWA Terms of Assurance can be accessed at:
http://www.hhs.gov/ohrp/sites/default/files/ohrp/documents/terms092310rev.pdf

A copy of the Federal Register notice announcing the availability of the draft revised FWA form and Terms of Assurance can be accessed at:
http://edocket.access.gpo.gov/2010/2010-23759.htm or http://edocket.access.gpo.gov/2010/pdf/2010-23759.pdf.

Background:

OHRP is announcing the availability of the draft revised FWA form and Terms of Assurance, and is seeking comment on these draft documents. Institutions engaged in non-exempt human subjects research conducted or supported by the Department of Health and Human Services must hold an OHRP-approved FWA. The draft revised FWA form and Terms of Assurance, when finalized, will supersede the current FWA documents available on the OHRP website at http://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/index.html. The current FWA form has been approved by the Office of Management and Budget for use through May 31, 2011. Federal Register notice of availability referenced above describes key changes in the revised draft FWA documents in comparison to the current FWA documents.

OHRP will consider all comments before implementing any revisions to the FWA documents.

When and How to Submit Comments:

Submit comments by October 25, 2010.

You may submit comments, identified by docket ID number HHS-OPHS-2010-0023, by one of the following methods:

• Federal eRulemaking Portal: https://www.regulations.gov. Enter the above docket ID number in the “Enter Keyword or ID” field and click on “Search.” On the next web page, click on the “Submit a Comment” action and follow the instructions.
• Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Irene Stith-Coleman, Ph.D., OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.

OHRP strongly encourages commenters to submit comments via the Federal eRulmaking Portal. Comments received, including any personal information, will be posted without change to the docket at https://www.regulations.gov as they are submitted, usually within 1 week after submission. While the comment period remains open, individuals may also provide comments in response to already submitted comments that have been posted to the docket.

For Further Information Contact:

Irene Stith-Coleman, Ph.D., OHRP,
1101 Wootton Parkway, Suite 200,
Rockville, MD 20852, 240-453-6900;
E-mail: Irene.Stith-Coleman@hhs.gov.