Public Town Hall Meeting on the Federal Policy for the Protection of Human Subjects Notice of Proposed Rulemaking; Notice, 60689-60690 [2015-25564]

Download as PDF Federal Register / Vol. 80, No. 194 / Wednesday, October 7, 2015 / Notices orally or in writing, on issues pending before the Committee. Written submissions may be made to the contact person prior to the meeting date. Oral comments from the public will be scheduled prior to the lunch break and at the conclusion of each meeting. Time allotted for each presentation will be limited to three minutes. If the number of speakers requesting to comment is greater than can be reasonably accommodated during the scheduled open public session, ONC will take written comments after the meeting. Persons attending ONC’s advisory committee meetings are advised that the agency is not responsible for providing wireless access or access to electrical outlets. ONC welcomes the attendance of the public at its advisory committee meetings. Seating is limited at the location, and ONC will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Michelle Consolazio at least seven (7) days in advance of the meeting. ONC is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.healthit.gov/facas/ for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (Pub. L. 92–463, 5 U.S.C., App. 2). Dated: September 30, 2015. Michelle Consolazio, FACA lead, Office of Policy, Office of the National Coordinator for Health Information Technology. [FR Doc. 2015–25558 Filed 10–6–15; 8:45 am] BILLING CODE 4150–45–P 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 Department of Health and Human Services, Office of the Assistant Secretary for Health, Office for Human Research Protections. ACTION: Notice. asabaliauskas on DSK5VPTVN1PROD with NOTICES AGENCY: 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 SUMMARY: VerDate Sep<11>2014 18:12 Oct 06, 2015 Jkt 238001 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 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 60689 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 firstcome, 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: https:// 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 E:\FR\FM\07OCN1.SGM 07OCN1 60690 Federal Register / Vol. 80, No. 194 / Wednesday, October 7, 2015 / Notices [FR Doc. 2015–25564 Filed 10–6–15; 8:45 am] Dated: October 2, 2015. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. BILLING CODE 4150–36–P [FR Doc. 2015–25480 Filed 10–6–15; 8:45 am] 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. Dated: October 2, 2015. Karen B. DeSalvo, Acting Assistant Secretary for Health. C. Security and Building Guidelines Office of the Director, National Institutes of Health Notice of Meeting 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 https://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. asabaliauskas on DSK5VPTVN1PROD with NOTICES II. Transcripts As soon as a transcript of the public meeting is available, it will be accessible on the OHRP Web site, https:// 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. VerDate Sep<11>2014 18:12 Oct 06, 2015 Jkt 238001 BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Office of AIDS Research Advisory Council. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. Name of Committee: Office of AIDS Research Advisory Council. Date: November 12, 2015. Time: 8:30 a.m. to 5:00 p.m. Agenda: The next meeting of the Office of AIDS Research Advisory Council (OARAC) will be devoted to presentations and discussions on ‘‘HIV/AIDS Vaccine Research’’. In addition, an update will be provided on the new OAR processes and the latest changes made to the HHS treatment and prevention guidelines by the OARAC Working Groups responsible for the guidelines. Place: National Institutes of Health, 5601 Fishers Lane, First Floor, Room 1D13, Rockville, MD 20852. Contact Person: Amelia Hall, M.A., Program Analyst, Office of AIDS Research, Office of the Director, NIH, 5601 Fishers Lane, Room 2E63, Rockville, MD 20852, (301) 435–4732; hallam@mail.nih.gov. Any interested person may file written comments with the Council by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation. Information is also available on the OAR’s home page: https:// www.oar.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93.232, Loan Repayment Program for Research Generally; 93.39, Academic Research Enhancement Award; 93.936, NIH Acquired Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds, National Institutes of Health, HHS) PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 National Institute on Aging; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute on Aging Special Emphasis Panel, Classification of Pro- and Anti-Aging Proteins RFA. Date: November 3, 2015. Time: 9:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: Doubletree Hotel Bethesda, (Formerly Holiday Inn Select), 8120 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Bita Nakhai, Ph.D., Scientific Review Branch, National Institute on Aging, Gateway Bldg., 2C212, 7201 Wisconsin Avenue, Bethesda, MD 20814, 301–402–7701, nakhaib@nia.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: October 2, 2015. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2015–25483 Filed 10–6–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. E:\FR\FM\07OCN1.SGM 07OCN1

Agencies

[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.

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

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: https://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 https://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, https://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
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