80 FR 60689 - Public Town Hall Meeting on the Federal Policy for the Protection of Human Subjects Notice of Proposed Rulemaking; Notice

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 80, Issue 194 (October 7, 2015)

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.

[Federal Register Volume 80, Number 194 (Wednesday, October 7, 2015)]
[Notices]
[Pages 60689-60690]
From the Federal Register Online  [www.thefederalregister.org]
[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

[[Page 60690]]

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]
 BILLING CODE 4150-36-P