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)

Page Range		60689-60690
FR Document		2015-25564

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 Issue 194 (Wednesday, October 7, 2015)

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 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.
    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 
Irene.Stith-Coleman@hhs.gov.

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 FOIARequest@psc.hhs.gov.

    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

Federal Register / Vol. 80, No. 194 / Wednesday, October 7, 2015 / Notices 60689

orally or in writing, on issues pending Rulemaking (NPRM) that HHS and person must register to attend.
before the Committee. Written fifteen other federal departments and Registration may be completed by
submissions may be made to the contact agencies published in the Federal sending an email to OHRP@hhs.gov,
person prior to the meeting date. Oral Register on September 8, 2015, (80 FR with the subject line ‘‘Registration for
comments from the public will be No. 173, pp. 53933–54061). The goal of OHRP Town Hall Meeting;’’ or a request
scheduled prior to the lunch break and the NPRM is to modernize, strengthen, to register may be sent to: Registration
at the conclusion of each meeting. Time and make more effective the Federal for OHRP Town Hall Meeting, Office for
allotted for each presentation will be Policy for the Protection of Human Human Research Protections,
limited to three minutes. If the number Subjects that was promulgated as a Department of Health and Human
of speakers requesting to comment is Common Rule in 1991. The NPRM seeks Services, 1101 Wootton Parkway, Suite
greater than can be reasonably comments on proposals to better protect 200; Rockville, MD 20852. Please
accommodated during the scheduled human subjects involved in research, include your name, address, telephone
open public session, ONC will take while facilitating valuable research and number, email address, and fax number.
written comments after the meeting. reducing burden, delay, and ambiguity Registration to attend the Town Hall
Persons attending ONC’s advisory for investigators. To be assured Meeting will be accepted on a first-
committee meetings are advised that the consideration, comments on the NPRM come, first-served basis. If seating
agency is not responsible for providing must be received no later than capacity has been reached, you will be
wireless access or access to electrical December 7, 2015. notified that the meeting has reached
outlets. The purpose of the public Town Hall capacity.
ONC welcomes the attendance of the meeting is for OHRP, HHS agencies, and Individuals who need special
public at its advisory committee other Common Rule departments and accommodations should contact staff
meetings. Seating is limited at the agencies to provide responses to listed in the FOR FURTHER INFORMATION
location, and ONC will make every questions from the public about the CONTACT section of this notice.
effort to accommodate persons with NPRM during the open public comment Submission of Questions for the Public
physical disabilities or special needs. If period in order to clarify the NPRM Town Hall Meeting
you require special accommodations proposals and better inform public
due to a disability, please contact comment on the NPRM. The public will Submit electronic questions about the
Michelle Consolazio at least seven (7) be able to ask questions during the NPRM, identified with docket number
days in advance of the meeting. Town Hall Meeting, and to submit HHS–OPHS–2015–0009 to: http://
ONC is committed to the orderly questions before the meeting. Details www.regulations.gov. Submit written
conduct of its advisory committee about how to submit questions before questions about the NPRM to: Questions
meetings. Please visit our Web site at the Town Hall Meeting are provided for OHRP Public Town Hall Meeting,
http://www.healthit.gov/facas/ for below. Office for Human Research Protections,
procedures on public conduct during Department of Health and Human
DATES: The public Town Hall Meeting
advisory committee meetings. Services, 1101 Wootton Parkway, Suite
will be held on October 20, 2015, from 200, Rockville, MD 20852.
Notice of this meeting is given under
9 a.m. to 5 p.m.
the Federal Advisory Committee Act FOR FURTHER INFORMATION CONTACT: Dr.
Deadline for Registration To Attend
(Pub. L. 92–463, 5 U.S.C., App. 2). Irene Stith-Coleman, Director, Division
the Town Hall Meeting: The deadline to
Dated: September 30, 2015. register to attend the town hall meeting of Policy and Assurances, Office for
Michelle Consolazio, and requests for special Human Research Protections,
accommodations must be received no Department of Health and Human
FACA lead, Office of Policy, Office of the
National Coordinator for Health Information later than 5:00 p.m. on October 13, Services, 1101 Wootton Parkway, Suite
Technology. 2015. 200; Rockville, MD 20852, phone 240–
[FR Doc. 2015–25558 Filed 10–6–15; 8:45 am] Deadline for Submission of Written 453–6900; email Irene.Stith-Coleman@
Questions Prior to the Town Hall hhs.gov.
BILLING CODE 4150–45–P
Meeting: Written questions on the SUPPLEMENTARY INFORMATION:
NPRM must be received no later than 5
I. Public Town Hall Meeting
DEPARTMENT OF HEALTH AND p.m. on October 13, 2015, in order to be
HUMAN SERVICES responded to at the October 20, 2015, A. Purpose of the Meeting
Town Hall Meeting. The public Town Hall Meeting is
Public Town Hall Meeting on the ADDRESSES: Meeting Location: The intended to provide an opportunity for
Federal Policy for the Protection of Town Hall Meeting will be held at the the public to obtain responses from
Human Subjects Notice of Proposed Department of Health and Human federal government representatives on a
Rulemaking; Notice Services, Hubert H. Humphrey Building, range of questions related to the Federal
AGENCY: Department of Health and 200 Independence Ave. SW., Great Hall, Policy for the Protection of Human
Human Services, Office of the Assistant Washington, DC 20201; Metro: Federal Subjects NPRM that HHS and fifteen
Secretary for Health, Office for Human Center SW station. In addition, we are other federal departments and agencies
Research Protections. providing an alternative to attending the published in the Federal Register on
ACTION: Notice. meeting in person—the public may view September 8, 2015, (80 FR No. 173, pp.
the meeting via webcast. Information on
asabaliauskas on DSK5VPTVN1PROD with NOTICES

53933–54061), in order to clarify the
SUMMARY: The Department of Health and that option is provided in section D of NPRM proposals and better inform
Human Services (HHS), Office of the this notice. An archived version of the public comment on the NPRM.
Assistant Secretary for Health, Office for webcast will be posted on OHRP’s Web
Human Research Protections (OHRP), is site after the meeting. B. Format of the Town Hall Meeting
announcing a public Town Hall Meeting Registration and Special The meeting will be conducted by a
to respond to questions related to the Accommodations: While there is no panel of HHS officials. In addition,
Federal Policy for the Protection of registration fee, individuals planning to other federal government officials will
Human Subjects Notice of Proposed attend the public Town Hall Meeting in be available to respond to relevant

VerDate Sep<11>2014 18:12 Oct 06, 2015 Jkt 238001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\07OCN1.SGM 07OCN1

60690 Federal Register / Vol. 80, No. 194 / Wednesday, October 7, 2015 / Notices

questions. The majority of the meeting Dated: October 2, 2015. Dated: October 2, 2015.
will be reserved for responding to Karen B. DeSalvo, Melanie J. Gray,
questions from the public, including Acting Assistant Secretary for Health. Program Analyst, Office of Federal Advisory
questions submitted in advance of the [FR Doc. 2015–25564 Filed 10–6–15; 8:45 am] Committee Policy.
meeting and during the meeting. BILLING CODE 4150–36–P [FR Doc. 2015–25480 Filed 10–6–15; 8:45 am]
Depending on the nature and number of BILLING CODE 4140–01–P
questions received in advance of the
meeting, it may not be possible to DEPARTMENT OF HEALTH AND
respond to all of the questions that were HUMAN SERVICES DEPARTMENT OF HEALTH AND
submitted, or to respond individually to HUMAN SERVICES
each of the submitted questions. National Institutes of Health
National Institutes of Health
C. Security and Building Guidelines Office of the Director, National
Institutes of Health Notice of Meeting National Institute on Aging; Notice of
Because the public Town Hall Closed Meeting
Meeting will be located on federal Pursuant to section 10(a) of the
property, for security reasons, any Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
persons wishing to attend this meeting Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
must register by the date specified in the amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Office
DATES section of this notice. Please hereby given of the following meeting.
of AIDS Research Advisory Council. The meeting will be closed to the
allow sufficient time to go through the
The meeting will be open to the public in accordance with the
security checkpoints. It is suggested that
public, with attendance limited to space provisions set forth in sections
you arrive at the Hubert H. Humphrey
available. Individuals who plan to 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Building no later than 8:30 a.m. if you
attend and need special assistance, such as amended. The grant applications and
are attending the public meeting.
as sign language interpretation or other the discussions could disclose
Security measures include the reasonable accommodations, should confidential trade secrets or commercial
following: notify the Contact Person listed below property such as patentable material,
• Presentation of government-issued in advance of the meeting. and personal information concerning
photographic identification to the Name of Committee: Office of AIDS individuals associated with the grant
Federal Guard Service personnel. Research Advisory Council. applications, the disclosure of which
• Passing through a metal detector Date: November 12, 2015. would constitute a clearly unwarranted
Time: 8:30 a.m. to 5:00 p.m. invasion of personal privacy.
and inspection of items brought into the Agenda: The next meeting of the Office of
building. We note that all items brought AIDS Research Advisory Council (OARAC) Name of Committee: National Institute on
to HHS are subject to inspection. will be devoted to presentations and Aging Special Emphasis Panel, Classification
discussions on ‘‘HIV/AIDS Vaccine of Pro- and Anti-Aging Proteins RFA.
Note: Individuals who are not Date: November 3, 2015.
registered in advance will not be Research’’. In addition, an update will be
provided on the new OAR processes and the Time: 9:00 a.m. to 4:00 p.m.
permitted to enter the building and will Agenda: To review and evaluate grant
latest changes made to the HHS treatment
be unable to attend the meeting in and prevention guidelines by the OARAC applications.
person. The public may not enter the Working Groups responsible for the Place: Doubletree Hotel Bethesda,
building earlier than 45 minutes prior to guidelines. (Formerly Holiday Inn Select), 8120
the convening of the meeting. All Place: National Institutes of Health, 5601 Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Bita Nakhai, Ph.D.,
visitors must be escorted while in the Fishers Lane, First Floor, Room 1D13,
Scientific Review Branch, National Institute
building. Rockville, MD 20852.
on Aging, Gateway Bldg., 2C212, 7201
Contact Person: Amelia Hall, M.A.,
D. Webcast Information Wisconsin Avenue, Bethesda, MD 20814,
Program Analyst, Office of AIDS Research,
301–402–7701, nakhaib@nia.nih.gov.
Office of the Director, NIH, 5601 Fishers
Information on the option to view the Lane, Room 2E63, Rockville, MD 20852, (Catalogue of Federal Domestic Assistance
meeting by webcast will be posted at a (301) 435–4732; hallam@mail.nih.gov. Program Nos. 93.866, Aging Research,
later time on the OHRP Web site at National Institutes of Health, HHS)
Any interested person may file written
http://www.hhs.gov/ohrp. Please comments with the Council by forwarding Dated: October 2, 2015.
continue to check the OHRP Web site the statement to the Contact Person listed on Melanie J. Gray,
for updates. An archived version of the this notice. The statement should include the Program Analyst, Office of Federal Advisory
webcast will be posted on OHRP’s Web name, address, telephone number and when Committee Policy.
site after the meeting. applicable, the business or professional
[FR Doc. 2015–25483 Filed 10–6–15; 8:45 am]
affiliation. Information is also available on
II. Transcripts the OAR’s home page: http:// BILLING CODE 4140–01–P
www.oar.nih.gov.
As soon as a transcript of the public (Catalogue of Federal Domestic Assistance
meeting is available, it will be accessible Program Nos. 93.14, Intramural Research DEPARTMENT OF HEALTH AND
on the OHRP Web site, http:// Training Award; 93.22, Clinical Research HUMAN SERVICES
www.hhs.gov/ohrp. A transcript also Loan Repayment Program for Individuals
asabaliauskas on DSK5VPTVN1PROD with NOTICES

will be available in either hardcopy or from Disadvantaged Backgrounds; 93.232, National Institutes of Health
on CD–ROM, after submission of a Loan Repayment Program for Research
Generally; 93.39, Academic Research Center for Scientific Review; Notice of
Freedom of Information request. Written
Enhancement Award; 93.936, NIH Acquired Closed Meetings
requests are to be sent to the PHS FOIA Immunodeficiency Syndrome Research Loan
Office, 7700 Wisconsin Avenue, Suite Repayment Program; 93.187, Undergraduate Pursuant to section 10(d) of the
#920, Bethesda, MD 20857; telephone Scholarship Program for Individuals from Federal Advisory Committee Act, as
(301) 492–4800; fax (301) 492–4848; Disadvantaged Backgrounds, National amended (5 U.S.C. App.), notice is
email FOIARequest@psc.hhs.gov. Institutes of Health, HHS) hereby given of the following meetings.

VerDate Sep<11>2014 18:12 Oct 06, 2015 Jkt 238001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 E:\FR\FM\07OCN1.SGM 07OCN1

Document Created: 2015-12-15 08:49:49
Document Modified: 2015-12-15 08:49:49

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		The public Town Hall Meeting will be held on October 20, 2015, from 9 a.m. to 5 p.m.
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]
FR Citation		80 FR 60689