Meeting of the Secretary's Advisory Committee on Human Research Protections, 12110-12111 [2017-03895]
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Federal Register / Vol. 82, No. 38 / Tuesday, February 28, 2017 / Notices
40. Kristy Boone on behalf of Kaylee Anne
Boone, Deceased, Wellesley Hills,
Massachusetts, Court of Federal Claims No:
17–0054V.
41. Ryan Horton and Karin Jonch-Clausen
on behalf of L.E.H., Deceased, Baraboo,
Wisconsin, Court of Federal Claims No: 17–
0055V.
42. Donna Nault, Fort Scott, Kansas, Court
of Federal Claims No: 17–0056V.
43. Dale MacLaughlin, Clayton, New York,
Court of Federal Claims No: 17–0057V.
44. Teresa Voors on behalf of W.V.,
Farmington Hills, Michigan, Court of Federal
Claims No: 17–0058V.
45. Lisa Johnson, Charlotte, North Carolina,
Court of Federal Claims No: 17–0059V.
46. Arthur Binkowitz, West Palm Beach,
Florida, Court of Federal Claims No: 17–
0061V.
47. Teresa Turko, Schertz, Texas, Court of
Federal Claims No: 17–0062V.
48. Patricia Heckman, Onalaska,
Wisconsin, Court of Federal Claims No: 17–
0063V.
49. Anthony Rizzo, Middletown, New
York, Court of Federal Claims No: 17–0066V.
50. Mary Mallory, Washington, District of
Columbia, Court of Federal Claims No: 17–
0068V.
51. Jennifer Curtis, Rancho Cucamonga,
California, Court of Federal Claims No: 17–
0069V.
52. Rita Pingel, Perryville, Missouri, Court
of Federal Claims No: 17–0070V.
53. Amanda Samuels, Wellesley,
Massachusetts, Court of Federal Claims No:
17–0071V.
54. Deborah Kent, Hart, Michigan, Court of
Federal Claims No: 17–0073V.
55. Mark A. Soprano, Cortland, New York,
Court of Federal Claims No: 17–0074V.
56. Richard R. Bernard, Orlando, Florida,
Court of Federal Claims No: 17–0076V.
57. Alfreda Aberto and Wilber Lopez on
behalf of J.L.A., Sacramento, California, Court
of Federal Claims No: 17–0077V.
58. Stanley K. Paul, Susanville, California,
Court of Federal Claims No: 17–0078V.
59. Luke Caredio and Jamielee Caredio on
behalf of D.C., San Mateo, California, Court
of Federal Claims No: 17–0079V.
60. Glendella May, Cape Girardeau,
Missouri, Court of Federal Claims No: 17–
0081V.
61. Michael Lauer, Whitefish Bay,
Wisconsin, Court of Federal Claims No: 17–
0082V.
62. Yvonnda D. Fykerud, Greensboro,
North Carolina, Court of Federal Claims No:
17–0084V.
63. Lauren Shaw, Jacksonville, Florida,
Court of Federal Claims No: 17–0085V.
64. Janice Kilpatrick, Washington, District
of Columbia, Court of Federal Claims No: 17–
0089V.
65. Raymond Flacke, Chicago, Illinois,
Court of Federal Claims No: 17–0090V.
66. Deborah Easterbrook, Mankato,
Minnesota, Court of Federal Claims No: 17–
0091V.
67. Sheryl Longin, Los Angeles, California,
Court of Federal Claims No: 17–0093V.
68. Dolores Thompson, St. Petersburg,
Florida, Court of Federal Claims No: 17–
0098V.
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69. Elizabeth A. Harris, North Kansas City,
Missouri, Court of Federal Claims No: 17–
0099V.
70. Eugenio Paulo De Souza, Ringoes, New
Jersey, Court of Federal Claims No: 17–
0100V.
71. Cheryl Garvin, Boston, Massachusetts,
Court of Federal Claims No: 17–0101V.
72. Maria Peters, O’Fallon, Missouri, Court
of Federal Claims No: 17–0102V.
73. Devora Stamm, Lakewood, New Jersey,
Court of Federal Claims No: 17–0103V.
74. Willis J. DeNuto on behalf of Andrea
DeNuto, Deceased, Lyndhurst, New Jersey,
Court of Federal Claims No: 17–0104V.
75. Tracy Gambrill and Kevin Gambrill on
behalf of R. G., Little Rock, Arkansas, Court
of Federal Claims No: 17–0105V.
76. Marcia Miller, Mankato, Minnesota,
Court of Federal Claims No: 17–0106V.
77. Willie D. Webb, Tulsa, Oklahoma,
Court of Federal Claims No: 17–0107V.
78. Jeffrey Caputo, Lima, Ohio, Court of
Federal Claims No: 17–0108V.
79. Frances Ruzicka, Piermont, New York,
Court of Federal Claims No: 17–0109V.
80. Mary M. Schoeller, Baraboo,
Wisconsin, Court of Federal Claims No: 17–
0111V.
81. Jean Lallensack, Boston, Massachusetts,
Court of Federal Claims No: 17–0112V.
82. Tiffany Cooper, Ludowici, Georgia,
Court of Federal Claims No: 17–0114V.
83. Gloria Harman, Lake Worth, Florida,
Court of Federal Claims No: 17–0116V.
84. Harriet Paul, Harrisburg, Pennsylvania,
Court of Federal Claims No: 17–0117V.
85. Jennifer Blankenship, Lincoln,
Nebraska, Court of Federal Claims No: 17–
0118V.
86. Angela Chambers, Tulsa, Oklahoma,
Court of Federal Claims No: 17–0120V.
87. Cindy Vinck, Evanston, Illinois, Court
of Federal Claims No: 17–0121V.
88. Chelsea Bossenbroek, Westmont,
Illinois, Court of Federal Claims No: 17–
0122V.
89. Jennifer L. Good, Champaign, Illinois,
Court of Federal Claims No: 17–0124V.
90. Elizabeth Harrison, Baton Rouge,
Louisiana, Court of Federal Claims No: 17–
0126V.
91. Bonita Rosner, Kenosha, Wisconsin,
Court of Federal Claims No: 17–0127V.
92. Gloria Aulston, Baltimore, Maryland,
Court of Federal Claims No: 17–0128V.
93. William Branson, Hudson, Wyoming,
Court of Federal Claims No: 17–0131V.
94. Steve Helms, Vinton, Iowa, Court of
Federal Claims No: 17–0132V.
95. Joanna Oakley, Lawrenceville, Georgia,
Court of Federal Claims No: 17–0133V.
96. Kellie Duncan, Kenosha, Wisconsin,
Court of Federal Claims No: 17–0134V.
97. Gary Naylor, Palmdale, California,
Court of Federal Claims No: 17–0135V.
98. Lois Oliver, Burlington, Kentucky,
Court of Federal Claims No: 17–0136V.
99. Tanya Mckoy, Murfreesboro,
Tennessee, Court of Federal Claims No: 17–
0138V.
100. Judith Celic, Boston, Massachusetts,
Court of Federal Claims No: 17–0139V.
101. Irving Kodimer, Woodland Hills,
California, Court of Federal Claims No: 17–
0140V.
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102. Michael Howells, Washington, District
of Columbia, Court of Federal Claims No: 17–
0142V.
103. Valeria Hernandez on behalf of S. H.,
Whittier, California, Court of Federal Claims
No: 17–0143V.
104. Kyle James Wetterling, Newton, Iowa,
Court of Federal Claims No: 17–0144V.
105. Debra Vizzi, Novi, Michigan, Court of
Federal Claims No: 17–0145V.
106. Shanna Kristine Brown, Birmingham,
Alabama, Court of Federal Claims No: 17–
0146V.
107. Mark Bracken and Jacki Bracken on
behalf of J. B., Gilbert, Arizona, Court of
Federal Claims No: 17–0147V.
108. Jeffrey Heaney, Beverly Hills,
California, Court of Federal Claims No: 17–
0148V.
109. Rodney McDonald, Brooklyn, New
York, Court of Federal Claims No: 17–0149V.
110. John Hopper, Joplin, Missouri, Court
of Federal Claims No: 17–0150V.
111. Laurence Lewis, Boston,
Massachusetts, Court of Federal Claims No:
17–0151V.
112. Dennis Schaeffer, Hanover, Maryland,
Court of Federal Claims No: 17–0152V.
[FR Doc. 2017–03856 Filed 2–27–17; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Secretary’s Advisory
Committee on Human Research
Protections
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
Pursuant to Section 10(a) of
the Federal Advisory Committee Act,
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:
https://www.dhhs.gov/ohrp/sachrpcommittee/meetings/.
DATES: The meeting will be held on
Wednesday, March 15, 2017, from 8:30
a.m. until 5:00 p.m. and Thursday,
March 16, 2017, 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; 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:
SACHRP@hhs.gov.
SUMMARY:
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Federal Register / Vol. 82, No. 38 / Tuesday, February 28, 2017 / Notices
Under the
authority of 42 U.S.C. 217a, Section 222
of the Public Health Service Act, as
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 Subpart A Subcommittee (SAS)
was established by SACHRP in October
2006 and 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.
The Subcommittee on Harmonization
(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. The SACHRP meeting
will open to the public at 8:30 a.m., on
Wednesday, March 15, 2017, followed
by opening remarks from Dr. Jerry
Menikoff, Director of OHRP and
Executive Secretary of SACHRP, and Dr.
Stephen Rosenfeld, SACHRP Chair. Dr.
Menikoff will then lead a discussion
focusing on selected sections of the new
Common Rule, which was published
January 19, 2017, with an effective date
of January 19, 2018 (see https://
www.gpo.gov/fdsys/pkg/FR-2017-01-19/
html/2017-01058.htm).
The SOH will present their
recommendations for considerations of
the new Common Rule’s compliance
dates and transition provisions, as well
as for the interpretation and
implementation of the new broad
consent provision. The SAS will discuss
their report on the interpretation of the
new exemption involving benign
behavioral interventions.
The Wednesday meeting will adjourn
at approximately 5:00 p.m.
The Thursday, March 16, meeting will
begin at 8:30 a.m. with
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. SOH will also
present recommendations on the return
of incidental findings to research
subjects. The SAS will present
recommendations surrounding the new
Common Rule’s expedited review
requirements.
The meeting will adjourn at 4:30 p.m.
March 16, 2017. Time for public
comment sessions will be allotted both
mstockstill on DSK3G9T082PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
18:46 Feb 27, 2017
Jkt 241001
days. Note that public comment must be
relevant to issues being addressed by
the SACHRP.
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. On-site registration is
required for participation in the live
public comment session. Individuals
who would like to submit written
statements as public comment should
email or fax their comments to SACHRP
at SACHRP@hhs.gov at least five
business days prior to the meeting.
Dated: February 23, 2017.
Julia G. Gorey,
Executive Director, Secretary’s Advisory
Committee on Human Research Protections.
[FR Doc. 2017–03895 Filed 2–27–17; 8:45 am]
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; 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 of
Allergy and Infectious Diseases Special
Emphasis Panel NIAID; Clinical Trial
Implementation Cooperative Agreement
(U01).
Date: March 22, 2017.
Time: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate
cooperative agreement applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892,
(Telephone Conference Call).
Contact Person: Zhuqing (Charlie) Li,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, Room # 3G41B, National Institutes
PO 00000
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12111
of Health/NIAID, 5601 Fishers Lane,
MSC9823 Bethesda, MD 20892–9823, (240)
669–5068, zhuqing.li@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: February 23, 2017.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–03896 Filed 2–27–17; 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.
The meetings 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: Center for Scientific
Review Special Emphasis Panel; Molecular
and Imaging Dynamics in Psychiatry.
Date: March 14, 2017.
Time: 2:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Julius Cinque, MS.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5186,
MSC 7846, Bethesda, MD 20892, (301) 435–
1252, cinquej@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Learning and Memory.
Date: March 20, 2017.
Time: 9:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
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Agencies
[Federal Register Volume 82, Number 38 (Tuesday, February 28, 2017)]
[Notices]
[Pages 12110-12111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03895]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Secretary's Advisory Committee on Human Research
Protections
AGENCY: Office of the Assistant Secretary for Health, Office of the
Secretary, Department of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Pursuant to Section 10(a) of the Federal Advisory Committee
Act, 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: https://www.dhhs.gov/ohrp/sachrp-committee/meetings/.
DATES: The meeting will be held on Wednesday, March 15, 2017, from 8:30
a.m. until 5:00 p.m. and Thursday, March 16, 2017, 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; 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: SACHRP@hhs.gov.
[[Page 12111]]
SUPPLEMENTARY INFORMATION: Under the authority of 42 U.S.C. 217a,
Section 222 of the Public Health Service Act, as 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 Subpart A Subcommittee (SAS) was established by SACHRP in
October 2006 and 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.
The Subcommittee on Harmonization (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. The SACHRP meeting will open to the public at 8:30 a.m.,
on Wednesday, March 15, 2017, followed by opening remarks from Dr.
Jerry Menikoff, Director of OHRP and Executive Secretary of SACHRP, and
Dr. Stephen Rosenfeld, SACHRP Chair. Dr. Menikoff will then lead a
discussion focusing on selected sections of the new Common Rule, which
was published January 19, 2017, with an effective date of January 19,
2018 (see https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/html/2017-01058.htm).
The SOH will present their recommendations for considerations of
the new Common Rule's compliance dates and transition provisions, as
well as for the interpretation and implementation of the new broad
consent provision. The SAS will discuss their report on the
interpretation of the new exemption involving benign behavioral
interventions.
The Wednesday meeting will adjourn at approximately 5:00 p.m.
The Thursday, March 16, meeting will begin at 8:30 a.m. with
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. SOH will also present recommendations
on the return of incidental findings to research subjects. The SAS will
present recommendations surrounding the new Common Rule's expedited
review requirements.
The meeting will adjourn at 4:30 p.m. March 16, 2017. Time for
public comment sessions will be allotted both days. Note that public
comment must be relevant to issues being addressed by the SACHRP.
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. On-
site registration is required for participation in the live public
comment session. Individuals who would like to submit written
statements as public comment should email or fax their comments to
SACHRP at SACHRP@hhs.gov at least five business days prior to the
meeting.
Dated: February 23, 2017.
Julia G. Gorey,
Executive Director, Secretary's Advisory Committee on Human Research
Protections.
[FR Doc. 2017-03895 Filed 2-27-17; 8:45 am]
BILLING CODE 4150-36-P