Release of OHRP Draft Guidance on The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l))

Today the Office for Human Research Protections announces the release of a draft guidance document entitled “The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l)).”  This document is available for public comment.  To be assured consideration, comments must be received at one of the addresses provided below, no later than 11:59 p.m. Eastern Standard Time on Monday, February 11, 2019.

You may submit comments, identified by docket ID number HHS–OPHS–2019–0001 by one of the following methods:

(1) Enter the following link into your web browser’s address bar: https://www.regulations.gov/docket/HHS-OPHS-2019-0001.  

(2) Mail/Hand delivery/Courier [For paper, disk, or CD–ROM submissions] to: Lauren Hartsmith, J.D., OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.

Comments received, including any personal information, will be posted without change to https://www.regulations.gov.

For further information contact: Lauren Hartsmith, Office for Human Research Protections (OHRP), Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852; telephone: 240–453–6900 or 1–866–447–4777; facsimile: 301–402–2071; email Lauren.Hartsmith@hhs.gov.

In addition to obtaining a copy of the draft guidance document from the docket, you may also obtain a copy on OHRP’s website at: https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/index.html.

Additional information on the revised Common Rule can be accessed at: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html.

Comments are due by February 11, 2019