Public Town Hall Meeting on the Federal Policy for the Protection of Human Subjects Notice of Proposed Rulemaking
OHRP Announces Public Town Hall Meeting on the Federal Policy for the Protection of Human Subjects NPRM
The Office for Human Research Protections (OHRP) in the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), has announced a public Town Hall Meeting to respond to questions related to the Federal Policy for the Protection of Human Subjects Notice of Proposed Rulemaking (NPRM) that HHS and 15 other Federal Departments and Agencies published in the Federal Register on September 8, 2015 (80 FR No. 173, pp. 53933-54061). A copy of the Notice announcing the Town Hall Meeting was put on public display on October 6, 2015 by the Office of the Federal Register and can be accessed at: https://www.federalregister.gov/articles/2015/10/07/2015-25564/meetings-public-town-hall-meeting-on-the-federal-policy-for-the-protection-of-human-subjects-notice.
The goal of the NPRM is to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. The NPRM seeks comments on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. To be assured consideration, comments on the NPRM must be received no later than December 7, 2015.
The purpose of the public Town Hall meeting is for OHRP, HHS agencies, and other Common Rule departments and agencies to provide responses to questions from the public about the NPRM in order to clarify the NPRM proposals and better inform public comment on the NPRM. The public will be able to ask questions during the Town Hall Meeting, and to submit questions before the meeting.
The public Town Hall Meeting will be held on October 20, 2015, from 9 a.m. to 5 p.m., in the Hubert H. Humphrey Building, 200 Independence Ave., SW, Great Hall, Washington, DC 20201. The closest metro subway location is the Federal Center SW station. The public also may view the meeting via webcast.
Format of the Town Hall Meeting: The meeting will be conducted by a panel of HHS officials. In addition, other Federal Government officials will be available to respond to relevant questions. The majority of the meeting will be reserved for responding to questions from the public, including questions submitted in advance of the meeting and during the meeting. Depending on the nature and number of questions received in advance of the meeting, it may not be possible to respond to all of the questions that were submitted, or to respond individually to each of the submitted questions.
Deadline for Registration to Attend the Town Hall Meeting and Special Accommodation Requests: The deadline to register to attend the town hall meeting and requests for special accommodations must be received no later than 5:00 p.m. on October 13, 2015.
Deadline for Submission of Questions Prior to the Town Hall Meeting: Written or electronically submitted questions about the NPRM must be received no later than 5:00 p.m. on October 13, 2015, in order to be responded to at the Town Hall Meeting. See below for additional information on how to submit questions prior to the Town Hall Meeting.
Registration and Special Accommodations: While there is no registration fee, individuals planning to attend the public Town Hall Meeting in person must register to attend. Registration may be completed by sending an email to OHRP@hhs.gov, with the subject line “Registration for OHRP Town Hall Meeting,” or a request to register may be sent to: Registration for OHRP Town Hall Meeting, Office for Human Research Protections, Department of Health and Human Services, 1101 Wootton Parkway, Suite 200; Rockville, MD 20852. Please include your name, address, telephone number, email address and fax number.
Registration to attend the Town Hall Meeting will be accepted on a first-come, first-served basis. If seating capacity has been reached, you will be notified that the meeting has reached capacity.
How to Submit Questions Prior to the Town Hall Meeting: Submit electronic questions about the NPRM, identified with docket number HHS-OPHS-2015-0009, to: http://www.regulations.gov. Submit written questions about the NPRM to: Questions for OHRP Public Town Hall Meeting, Office for Human Research Protections, Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852.