81 FR 69538 - Meeting of the Secretary's Advisory Committee on Human Research Protections

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 81, Issue 194 (October 6, 2016)

Page Range		69538-69539
FR Document		2016-24251

Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP Web site at: http://www.dhhs.gov/ohrp/sachrp-committee/meetings/index.html.

Federal Register, Volume 81 Issue 194 (Thursday, October 6, 2016)

[Federal Register Volume 81, Number 194 (Thursday, October 6, 2016)]
[Notices]
[Pages 69538-69539]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-24251]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the Secretary's Advisory Committee on Human Research 
Protections

AGENCY: Office of the Secretary, Office of the Assistant Secretary for 
Health, Department of Health and Human Services.

ACTION: Notice.

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SUMMARY: Pursuant to Section 10(a) of the Federal Advisory Committee 
Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's 
Advisory Committee on Human Research Protections (SACHRP) will hold a 
meeting that will be open to the public. Information about SACHRP and 
the full meeting agenda will be posted on the SACHRP Web site at: 
http://www.dhhs.gov/ohrp/sachrp-committee/meetings/index.html.

DATES: The meeting will be held on Tuesday, October 25, 2016, from 8:30 
a.m. until 5:00 p.m. and Wednesday, October 26, 2016, from 8:30 a.m. 
until 4:30 p.m.

ADDRESSES: Fishers Lane Conference Center, Terrace Level, 5635 Fishers 
Lane, Rockville, Maryland 20852.

FOR FURTHER INFORMATION CONTACT: Julia Gorey, J.D., Executive Director, 
SACHRP or Jerry Menikoff, M.D., J.D., Director, Office for Human 
Research Protections (OHRP); U.S. Department of Health and Human 
Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852; 
telephone: 240-453-8141; fax: 240-453-6909; email address: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the authority of 42 U.S.C. 217a, 
Section 222 of the Public Health Service Act, as

[[Page 69539]]

amended, SACHRP was established to provide expert advice and 
recommendations to the Secretary of Health and Human Services, through 
the Assistant Secretary for Health, on issues and topics pertaining to 
or associated with the protection of human research subjects.
    The meeting will open to the public at 8:30 a.m., on Tuesday, 
October 25, followed by opening remarks from Dr. Jerry Menikoff, 
Executive Secretary of SACHRP and OHRP Director, and Dr. Jeffrey 
Botkin, SACHRP Chair. The Subpart A Subcommittee (SAS) will then 
present their report, including recommendations regarding single IRB 
review and the draft joint OHRP-FDA draft guidance, ``Institutional 
Review Board (IRB) Written Procedures: Guidance for Institutions and 
IRBs.'' This will be followed by the Subcommittee on Harmonization's 
(SOH) report, including recommendations involving clustered randomized 
trials, benchmarking, and the ``NIH Guidelines for Research Involving 
Recombinant or Synthetic Nucleic Acid Molecules,'' Appendix M.
    SAS was established by SACHRP in October 2006. The subcommittee is 
charged with developing recommendations for consideration by SACHRP 
regarding the application of subpart A of 45 CFR part 46 in the current 
research environment.
    SOH was established by SACHRP at its July 2009 meeting and charged 
with identifying and prioritizing areas in which regulations and/or 
guidelines for human subjects research adopted by various agencies or 
offices within HHS would benefit from harmonization, consistency, 
clarity, simplification and/or coordination. On Wednesday, October 26, 
2016, SACHRP will discuss recommendations from the SOH on the FDA Draft 
Guidance ``Use of Real-World Evidence to Support Regulatory Decision-
Making for Medical Devices,'' issued July 27, 2016.
    The meeting will adjourn at 4:30 p.m. October 26, 2016. Time for 
public comment sessions will be allotted both days.
    Public attendance at the meeting is limited to space available. 
Individuals who plan to attend and need special assistance, such as 
sign language interpretation or other reasonable accommodations, should 
notify one of the designated SACHRP points of contact at the address/
phone number listed above at least one week prior to the meeting. 
Registration is required for participation in the on-site public 
comment session; individuals may register on the day of the meeting. 
Individuals who would like to submit written statements as public 
comment should email or fax their comments to SACHRP at [email protected] 
at least five business days prior to the meeting. Note that public 
comment must be relevant to agenda topics.

    Dated: October 3, 2016.
Julia Gorey,
Executive Director, Secretary's Advisory Committee on Human Research 
Protections.
[FR Doc. 2016-24251 Filed 10-5-16; 8:45 am]
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69538 Federal Register / Vol. 81, No. 194 / Thursday, October 6, 2016 / Notices

approval for pharmaceutical treatments Dated: September 30, 2016. the preparation of its 23rd report.
for these diseases. Under section 524, a Leslie Kux, COGME’s reports are submitted to the
sponsor of a human drug application for Associate Commissioner for Policy. Secretary of HHS; the Committee on
a qualified tropical disease may be [FR Doc. 2016–24232 Filed 10–5–16; 8:45 am] Health, Education, Labor, and Pensions
eligible for a voucher that can be used BILLING CODE 4164–01–P
of the Senate; and the Committee on
to obtain a priority review for any Energy and Commerce of the House of
application submitted under section Representatives.
505(b)(1) of the FD&C Act or section 351 DEPARTMENT OF HEALTH AND Members of the public will have the
of the Public Health Service Act. The HUMAN SERVICES opportunity to provide comments. Oral
guidance also provides information on comments will be honored in the order
using the priority review vouchers and Health Resources and Services they are requested and may be limited
on transferring priority review vouchers Administration as time allows. Requests to make oral
to other sponsors. comments or provide written comments
This guidance finalizes the draft Council on Graduate Medical to COGME should be made using the
guidance of the same name issued Education contact address or phone number above
October 2008 and includes the AGENCY: Health Resources and Service by October 13, 2016.
following substantive changes based on Administration (HRSA), Department of Jason E. Bennett,
public comment. Health and Human Services (HHS). Director, Division of the Executive Secretariat.
• The procedure for FDA to add ACTION: Notice of meeting. [FR Doc. 2016–24167 Filed 10–5–16; 8:45 am]
diseases to the list is described
• Clarification is provided for when a
BILLING CODE 4165–15–P
SUMMARY: In accordance with the
voucher can be used Federal Advisory Committee Act, notice
• A statement was added to say that is hereby given that a meeting is DEPARTMENT OF HEALTH AND
FDA may provide a preliminary scheduled for the Council on Graduate HUMAN SERVICES
nonbinding opinion, before approval, Medical Education (COGME). This
that an application appears to meet the meeting will be open to the public. Meeting of the Secretary’s Advisory
criteria for voucher eligibility Information about COGME and the Committee on Human Research
• Clarification is provided regarding agenda for this meeting can be obtained Protections
the eligibility of combination products by accessing the COGME Web site at
to receive a voucher http://www.hrsa.gov/ AGENCY: Office of the Secretary, Office
• Clarification is provided regarding advisorycommittees/bhpradvisory/ of the Assistant Secretary for Health,
the timing of payment of the priority COGME. Department of Health and Human
review user fee Services.
DATES: October 20, 2016, 10:00 a.m.–
• Clarification is provided regarding 4:30 p.m. ET
ACTION: Notice.
whether FDA can remove tropical
ADDRESSES: This meeting will be held SUMMARY: Pursuant to Section 10(a) of
diseases from the list
by webinar only. Information on the Federal Advisory Committee Act,
This guidance is being issued connecting to the webinar can be found U.S.C. Appendix 2, notice is hereby
consistent with FDA’s good guidance on the COGME Web site. given that the Secretary’s Advisory
practices regulation (21 CFR 10.115). Committee on Human Research
FOR FURTHER INFORMATION CONTACT:
The guidance represents the current Protections (SACHRP) will hold a
thinking of FDA on obtaining tropical Anyone requesting information
regarding COGME should contact Dr. meeting that will be open to the public.
disease priority review vouchers. It does Information about SACHRP and the full
not establish any rights for any person Kennita Carter, Designated Federal
Official, Division of Medicine and meeting agenda will be posted on the
and is not binding on FDA or the public. SACHRP Web site at: http://
You can use an alternative approach if Dentistry, Bureau of Health Workforce,
HRSA, in one of three ways: (1) Send a www.dhhs.gov/ohrp/sachrp-committee/
it satisfies the requirements of the meetings/index.html.
applicable statutes and regulations. request to the following address: Dr.
Kennita Carter, Designated Federal DATES: The meeting will be held on
II. Paperwork Reduction Act of 1995 Official, Division of Medicine and Tuesday, October 25, 2016, from 8:30
Dentistry, HRSA, 5600 Fishers Lane, a.m. until 5:00 p.m. and Wednesday,
This guidance contains information
15N–116, Rockville, Maryland 20857; October 26, 2016, from 8:30 a.m. until
collection provisions that are subject to
(2) call 301–945–3505; or (3) send an 4:30 p.m.
review by the Office of Management and
Budget (OMB) under the Paperwork email to KCarter@hrsa.gov. ADDRESSES: Fishers Lane Conference
Reduction Act of 1995 (44 U.S.C. 3501– SUPPLEMENTARY INFORMATION: COGME Center, Terrace Level, 5635 Fishers
3520). The collection of information in provides advice and recommendations Lane, Rockville, Maryland 20852.
this guidance was approved under OMB to the Secretary of HHS and to Congress FOR FURTHER INFORMATION CONTACT: Julia
control number 0910–0822. on a range of issues including the Gorey, J.D., Executive Director, SACHRP
supply and distribution of physicians in or Jerry Menikoff, M.D., J.D., Director,
III. Electronic Access the United States, current and future Office for Human Research Protections
Persons with access to the Internet physician shortages or excesses, foreign (OHRP); U.S. Department of Health and
may obtain the guidance at http:// medical school graduates, the nature Human Services, 1101 Wootton
sradovich on DSK3GMQ082PROD with NOTICES

www.fda.gov/Drugs/Guidance and financing of medical education Parkway, Suite 200, Rockville,
ComplianceRegulatoryInformation/ training, and the development of Maryland 20852; telephone: 240–453–
Guidances/default.htm, http:// performance measures and longitudinal 8141; fax: 240–453–6909; email address:
www.fda.gov/BiologicsBloodVaccines/ evaluation of medical education SACHRP@hhs.gov.
GuidanceCompliance programs. SUPPLEMENTARY INFORMATION: Under the
RegulatoryInformation/default.htm, or During the meeting, COGME members authority of 42 U.S.C. 217a, Section 222
http://www.regulations.gov. will discuss topics and issues related to of the Public Health Service Act, as

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Federal Register / Vol. 81, No. 194 / Thursday, October 6, 2016 / Notices 69539

amended, SACHRP was established to written statements as public comment Department of Health and Human
provide expert advice and should email or fax their comments to Services, 1101 Wootton Parkway, Room
recommendations to the Secretary of SACHRP at SACHRP@hhs.gov at least LL–100, Rockville, MD 20852,
Health and Human Services, through five business days prior to the meeting. Caitlin.Blood@HHS.gov (email), (240)
the Assistant Secretary for Health, on Note that public comment must be 453–8265 (telephone), (240) 453–8281
issues and topics pertaining to or relevant to agenda topics. (fax).
associated with the protection of human Dated: October 3, 2016. SUPPLEMENTARY INFORMATION: For three
research subjects. decades, Healthy People has provided a
Julia Gorey,
The meeting will open to the public
Executive Director, Secretary’s Advisory comprehensive set of national 10-year
at 8:30 a.m., on Tuesday, October 25,
Committee on Human Research Protections. health promotion and disease
followed by opening remarks from Dr.
[FR Doc. 2016–24251 Filed 10–5–16; 8:45 am] prevention objectives aimed at
Jerry Menikoff, Executive Secretary of
improving the health of all Americans.
SACHRP and OHRP Director, and Dr. BILLING CODE 4150–36–P
Healthy People 2020 objectives provide
Jeffrey Botkin, SACHRP Chair. The
Subpart A Subcommittee (SAS) will a framework by presenting a
then present their report, including DEPARTMENT OF HEALTH AND comprehensive picture of the nation’s
recommendations regarding single IRB HUMAN SERVICES health at the beginning of the decade,
review and the draft joint OHRP–FDA establishing national goals and targets to
Announcement of Solicitation of be achieved by the year 2020, and
draft guidance, ‘‘Institutional Review
Written Comments on Modifications of monitoring progress over time. The U.S.
Board (IRB) Written Procedures:
Healthy People 2020 Objectives Department of Health and Human
Guidance for Institutions and IRBs.’’
This will be followed by the Services is soliciting the submission of
AGENCY: Office of the Secretary, Office
Subcommittee on Harmonization’s written comments regarding a new
of the Assistant Secretary of Health,
(SOH) report, including objective proposed to be added to
Office of Disease Prevention and Health
recommendations involving clustered Healthy People 2020 since the fall 2015
Promotion, Department of Health and
randomized trials, benchmarking, and public comment period.
Human Services.
the ‘‘NIH Guidelines for Research Healthy People 2020 is the product of
ACTION: Notice. an extensive collaborative process that
Involving Recombinant or Synthetic
Nucleic Acid Molecules,’’ Appendix M. SUMMARY: The U.S. Department of relies on input from a diverse array of
SAS was established by SACHRP in Health and Human Services solicits individuals and organizations, both
October 2006. The subcommittee is written comments regarding a new within and outside the federal
charged with developing objective proposed to be added to government, with a common interest in
recommendations for consideration by Healthy People 2020 since the fall 2015 improving the nation’s health. Public
SACHRP regarding the application of public comment period. Public comments were a cornerstone of
subpart A of 45 CFR part 46 in the participation helps shape Healthy Healthy People 2020’s development.
current research environment. People 2020, its framework, objectives, During the first phase of planning for
SOH was established by SACHRP at organization, and targets. Healthy Healthy People 2020, HHS asked for the
its July 2009 meeting and charged with People provides opportunities for public public’s comments on the vision,
identifying and prioritizing areas in input periodically throughout the mission, and implementation of Healthy
which regulations and/or guidelines for decade to ensure that Healthy People People 2020. Those comments helped
human subjects research adopted by 2020 reflects current public health set the framework for Healthy People
various agencies or offices within HHS priorities and public input. The updated 2020. The public was also invited to
would benefit from harmonization, set of Healthy People 2020 objectives submit comments on proposed Healthy
consistency, clarity, simplification and/ will be incorporated on People 2020 objectives, which helped
or coordination. On Wednesday, www.HealthyPeople.gov. This set will shape the final set of Healthy People
October 26, 2016, SACHRP will discuss reflect further review and deliberation 2020 objectives.
recommendations from the SOH on the by the topic area workgroups, Federal The public is now invited to comment
FDA Draft Guidance ‘‘Use of Real-World Interagency Workgroup on Healthy on a new objective proposed to be
Evidence to Support Regulatory People 2020, and other Healthy People added to Healthy People 2020, which
Decision-Making for Medical Devices,’’ 2020 stakeholders. can be found at http://
issued July 27, 2016. www.healthypeople.gov/2020/about/
DATES: Written comments will be
The meeting will adjourn at 4:30 p.m. history-development/Public-Comment.
October 26, 2016. Time for public accepted until 5:00 p.m. ET on October This new objective was developed by
comment sessions will be allotted both 27, 2016. the HIV topic area workgroup led by the
days. ADDRESSES: Written comments will be Centers for Disease Control and
Public attendance at the meeting is accepted via an online public comment Prevention and Health Resources and
limited to space available. Individuals database at http:// Services Administration. It has been
who plan to attend and need special www.healthypeople.gov/2020/about/ reviewed by the Federal Interagency
assistance, such as sign language history-development/Public-Comment; Workgroup on Healthy People 2020 and
interpretation or other reasonable by mail at the Office of Disease is presented now for the public’s review
accommodations, should notify one of Prevention and Health Promotion, U.S. and comment. Comments are restricted
the designated SACHRP points of Department of Health and Human
sradovich on DSK3GMQ082PROD with NOTICES

to this specific HIV objective. Having
contact at the address/phone number Services, Attn: Public Comment, 1101 reached the midpoint in the decade,
listed above at least one week prior to Wootton Parkway, Room LL–100, Healthy People will not be soliciting
the meeting. Registration is required for Rockville, MD 20852; fax—(240) 453– proposals for additional new objectives.
participation in the on-site public 8281; or email—HP2020@hhs.gov. Written comments will be accepted at
comment session; individuals may FOR FURTHER INFORMATION CONTACT: http://www.healthypeople.gov/2020/
register on the day of the meeting. Caitie Blood, MPH, Office of Disease about/history-development/Public-
Individuals who would like to submit Prevention and Health Promotion, U.S. Comment. The public will also be able

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Document Created: 2016-10-06 02:38:26
Document Modified: 2016-10-06 02:38:26

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 meeting will be held on Tuesday, October 25, 2016, from 8:30 a.m. until 5:00 p.m. and Wednesday, October 26, 2016, from 8:30 a.m. until 4:30 p.m.
Contact		Julia Gorey, J.D., Executive Director, SACHRP or Jerry Menikoff, M.D., J.D., Director, Office for Human Research Protections (OHRP); U.S. Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852;
FR Citation		81 FR 69538