[Federal Register Volume 80, Number 194 (Wednesday, October 7, 2015)]
[Notices]
[Pages 60689-60690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25564]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Town Hall Meeting on the Federal Policy for the Protection
of Human Subjects Notice of Proposed Rulemaking; Notice
AGENCY: Department of Health and Human Services, Office of the
Assistant Secretary for Health, Office for Human Research Protections.
ACTION: Notice.
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SUMMARY: The Department of Health and Human Services (HHS), Office of
the Assistant Secretary for Health, Office for Human Research
Protections (OHRP), is announcing 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 fifteen
other federal departments and agencies published in the Federal
Register on September 8, 2015, (80 FR No. 173, pp. 53933-54061). 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 during the open
public comment period 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. Details about how to submit questions before the Town Hall
Meeting are provided below.
DATES: The public Town Hall Meeting will be held on October 20, 2015,
from 9 a.m. to 5 p.m.
Deadline for Registration To Attend the Town Hall Meeting: 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 Written Questions Prior to the Town Hall
Meeting: Written questions on the NPRM must be received no later than 5
p.m. on October 13, 2015, in order to be responded to at the October
20, 2015, Town Hall Meeting.
ADDRESSES: Meeting Location: The Town Hall Meeting will be held at the
Department of Health and Human Services, Hubert H. Humphrey Building,
200 Independence Ave. SW., Great Hall, Washington, DC 20201; Metro:
Federal Center SW station. In addition, we are providing an alternative
to attending the meeting in person--the public may view the meeting via
webcast. Information on that option is provided in section D of this
notice. An archived version of the webcast will be posted on OHRP's Web
site after the 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 [email protected], 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.
Individuals who need special accommodations should contact staff
listed in the FOR FURTHER INFORMATION CONTACT section of this notice.
Submission of Questions for the Public 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.
FOR FURTHER INFORMATION CONTACT: Dr. Irene Stith-Coleman, Director,
Division of Policy and Assurances, Office for Human Research
Protections, Department of Health and Human Services, 1101 Wootton
Parkway, Suite 200; Rockville, MD 20852, phone 240-453-6900; email
[email protected].
SUPPLEMENTARY INFORMATION:
I. Public Town Hall Meeting
A. Purpose of the Meeting
The public Town Hall Meeting is intended to provide an opportunity
for the public to obtain responses from federal government
representatives on a range of questions related to the Federal Policy
for the Protection of Human Subjects NPRM that HHS and fifteen other
federal departments and agencies published in the Federal Register on
September 8, 2015, (80 FR No. 173, pp. 53933-54061), in order to
clarify the NPRM proposals and better inform public comment on the
NPRM.
B. 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
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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.
C. Security and Building Guidelines
Because the public Town Hall Meeting will be located on federal
property, for security reasons, any persons wishing to attend this
meeting must register by the date specified in the DATES section of
this notice. Please allow sufficient time to go through the security
checkpoints. It is suggested that you arrive at the Hubert H. Humphrey
Building no later than 8:30 a.m. if you are attending the public
meeting.
Security measures include the following:
Presentation of government-issued photographic
identification to the Federal Guard Service personnel.
Passing through a metal detector and inspection of items
brought into the building. We note that all items brought to HHS are
subject to inspection.
Note: Individuals who are not registered in advance will not be
permitted to enter the building and will be unable to attend the
meeting in person. The public may not enter the building earlier than
45 minutes prior to the convening of the meeting. All visitors must be
escorted while in the building.
D. Webcast Information
Information on the option to view the meeting by webcast will be
posted at a later time on the OHRP Web site at http://www.hhs.gov/ohrp.
Please continue to check the OHRP Web site for updates. An archived
version of the webcast will be posted on OHRP's Web site after the
meeting.
II. Transcripts
As soon as a transcript of the public meeting is available, it will
be accessible on the OHRP Web site, http://www.hhs.gov/ohrp. A
transcript also will be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the PHS FOIA Office, 7700 Wisconsin Avenue, Suite
#920, Bethesda, MD 20857; telephone (301) 492-4800; fax (301) 492-4848;
email [email protected].
Dated: October 2, 2015.
Karen B. DeSalvo,
Acting Assistant Secretary for Health.
[FR Doc. 2015-25564 Filed 10-6-15; 8:45 am]
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