82 FR 12110 - Meeting of the Secretary's Advisory Committee on Human Research Protections

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 82, Issue 38 (February 28, 2017)

Page Range		12110-12111
FR Document		2017-03895

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: http://www.dhhs.gov/ ohrp/sachrp-committee/meetings/index.html.

Federal Register, Volume 82 Issue 38 (Tuesday, February 28, 2017)

[Federal Register Volume 82, Number 38 (Tuesday, February 28, 2017)]
[Notices]
[Pages 12110-12111]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-03895]


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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 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: http://www.dhhs.gov/ohrp/sachrp-committee/meetings/index.html.

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: [email protected].

[[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.thefederalregister.org/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 [email protected] 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

12110 Federal Register / Vol. 82, No. 38 / Tuesday, February 28, 2017 / Notices

40. Kristy Boone on behalf of Kaylee Anne 69. Elizabeth A. Harris, North Kansas City, 102. Michael Howells, Washington, District
Boone, Deceased, Wellesley Hills, Missouri, Court of Federal Claims No: 17– of Columbia, Court of Federal Claims No: 17–
Massachusetts, Court of Federal Claims No: 0099V. 0142V.
17–0054V. 70. Eugenio Paulo De Souza, Ringoes, New 103. Valeria Hernandez on behalf of S. H.,
41. Ryan Horton and Karin Jonch-Clausen Jersey, Court of Federal Claims No: 17– Whittier, California, Court of Federal Claims
on behalf of L.E.H., Deceased, Baraboo, 0100V. No: 17–0143V.
Wisconsin, Court of Federal Claims No: 17– 71. Cheryl Garvin, Boston, Massachusetts, 104. Kyle James Wetterling, Newton, Iowa,
0055V. Court of Federal Claims No: 17–0101V. Court of Federal Claims No: 17–0144V.
42. Donna Nault, Fort Scott, Kansas, Court 72. Maria Peters, O’Fallon, Missouri, Court 105. Debra Vizzi, Novi, Michigan, Court of
of Federal Claims No: 17–0056V. of Federal Claims No: 17–0102V. Federal Claims No: 17–0145V.
43. Dale MacLaughlin, Clayton, New York, 73. Devora Stamm, Lakewood, New Jersey, 106. Shanna Kristine Brown, Birmingham,
Court of Federal Claims No: 17–0057V. Court of Federal Claims No: 17–0103V. Alabama, Court of Federal Claims No: 17–
44. Teresa Voors on behalf of W.V., 74. Willis J. DeNuto on behalf of Andrea 0146V.
Farmington Hills, Michigan, Court of Federal DeNuto, Deceased, Lyndhurst, New Jersey, 107. Mark Bracken and Jacki Bracken on
Claims No: 17–0058V. Court of Federal Claims No: 17–0104V. behalf of J. B., Gilbert, Arizona, Court of
45. Lisa Johnson, Charlotte, North Carolina, 75. Tracy Gambrill and Kevin Gambrill on Federal Claims No: 17–0147V.
Court of Federal Claims No: 17–0059V. behalf of R. G., Little Rock, Arkansas, Court 108. Jeffrey Heaney, Beverly Hills,
46. Arthur Binkowitz, West Palm Beach, of Federal Claims No: 17–0105V. California, Court of Federal Claims No: 17–
Florida, Court of Federal Claims No: 17– 76. Marcia Miller, Mankato, Minnesota, 0148V.
0061V. Court of Federal Claims No: 17–0106V. 109. Rodney McDonald, Brooklyn, New
47. Teresa Turko, Schertz, Texas, Court of 77. Willie D. Webb, Tulsa, Oklahoma, York, Court of Federal Claims No: 17–0149V.
Federal Claims No: 17–0062V. Court of Federal Claims No: 17–0107V. 110. John Hopper, Joplin, Missouri, Court
48. Patricia Heckman, Onalaska, 78. Jeffrey Caputo, Lima, Ohio, Court of of Federal Claims No: 17–0150V.
Wisconsin, Court of Federal Claims No: 17– Federal Claims No: 17–0108V. 111. Laurence Lewis, Boston,
0063V. 79. Frances Ruzicka, Piermont, New York, Massachusetts, Court of Federal Claims No:
49. Anthony Rizzo, Middletown, New Court of Federal Claims No: 17–0109V. 17–0151V.
York, Court of Federal Claims No: 17–0066V. 80. Mary M. Schoeller, Baraboo, 112. Dennis Schaeffer, Hanover, Maryland,
50. Mary Mallory, Washington, District of Wisconsin, Court of Federal Claims No: 17– Court of Federal Claims No: 17–0152V.
Columbia, Court of Federal Claims No: 17– 0111V. [FR Doc. 2017–03856 Filed 2–27–17; 8:45 am]
0068V. 81. Jean Lallensack, Boston, Massachusetts, BILLING CODE 4165–15–P
51. Jennifer Curtis, Rancho Cucamonga, Court of Federal Claims No: 17–0112V.
California, Court of Federal Claims No: 17– 82. Tiffany Cooper, Ludowici, Georgia,
0069V. Court of Federal Claims No: 17–0114V. DEPARTMENT OF HEALTH AND
52. Rita Pingel, Perryville, Missouri, Court 83. Gloria Harman, Lake Worth, Florida,
Court of Federal Claims No: 17–0116V.
HUMAN SERVICES
of Federal Claims No: 17–0070V.
53. Amanda Samuels, Wellesley, 84. Harriet Paul, Harrisburg, Pennsylvania,
Meeting of the Secretary’s Advisory
Massachusetts, Court of Federal Claims No: Court of Federal Claims No: 17–0117V.
17–0071V. 85. Jennifer Blankenship, Lincoln, Committee on Human Research
54. Deborah Kent, Hart, Michigan, Court of Nebraska, Court of Federal Claims No: 17– Protections
Federal Claims No: 17–0073V. 0118V. AGENCY: Office of the Assistant
55. Mark A. Soprano, Cortland, New York, 86. Angela Chambers, Tulsa, Oklahoma,
Secretary for Health, Office of the
Court of Federal Claims No: 17–0074V. Court of Federal Claims No: 17–0120V.
56. Richard R. Bernard, Orlando, Florida, 87. Cindy Vinck, Evanston, Illinois, Court Secretary, Department of Health and
Court of Federal Claims No: 17–0076V. of Federal Claims No: 17–0121V. Human Services.
57. Alfreda Aberto and Wilber Lopez on 88. Chelsea Bossenbroek, Westmont, ACTION: Notice.
behalf of J.L.A., Sacramento, California, Court Illinois, Court of Federal Claims No: 17–
of Federal Claims No: 17–0077V. 0122V. SUMMARY: Pursuant to Section 10(a) of
58. Stanley K. Paul, Susanville, California, 89. Jennifer L. Good, Champaign, Illinois, the Federal Advisory Committee Act,
Court of Federal Claims No: 17–0078V. Court of Federal Claims No: 17–0124V. notice is hereby given that the
59. Luke Caredio and Jamielee Caredio on 90. Elizabeth Harrison, Baton Rouge, Secretary’s Advisory Committee on
behalf of D.C., San Mateo, California, Court Louisiana, Court of Federal Claims No: 17– Human Research Protections (SACHRP)
of Federal Claims No: 17–0079V. 0126V. will hold a meeting that will be open to
60. Glendella May, Cape Girardeau, 91. Bonita Rosner, Kenosha, Wisconsin, the public. Information about SACHRP
Missouri, Court of Federal Claims No: 17– Court of Federal Claims No: 17–0127V.
92. Gloria Aulston, Baltimore, Maryland,
and the full meeting agenda will be
0081V.
61. Michael Lauer, Whitefish Bay, Court of Federal Claims No: 17–0128V. posted on the SACHRP Web site at:
Wisconsin, Court of Federal Claims No: 17– 93. William Branson, Hudson, Wyoming, http://www.dhhs.gov/ohrp/sachrp-
0082V. Court of Federal Claims No: 17–0131V. committee/meetings/index.html.
62. Yvonnda D. Fykerud, Greensboro, 94. Steve Helms, Vinton, Iowa, Court of DATES: The meeting will be held on
North Carolina, Court of Federal Claims No: Federal Claims No: 17–0132V. Wednesday, March 15, 2017, from 8:30
17–0084V. 95. Joanna Oakley, Lawrenceville, Georgia, a.m. until 5:00 p.m. and Thursday,
63. Lauren Shaw, Jacksonville, Florida, Court of Federal Claims No: 17–0133V. March 16, 2017, from 8:30 a.m. until
Court of Federal Claims No: 17–0085V. 96. Kellie Duncan, Kenosha, Wisconsin,
64. Janice Kilpatrick, Washington, District Court of Federal Claims No: 17–0134V.
4:30 p.m.
of Columbia, Court of Federal Claims No: 17– 97. Gary Naylor, Palmdale, California, ADDRESSES: Fishers Lane Conference
0089V. Court of Federal Claims No: 17–0135V. Center, Terrace Level, 5635 Fishers
65. Raymond Flacke, Chicago, Illinois, 98. Lois Oliver, Burlington, Kentucky, Lane, Rockville, Maryland 20852.
Court of Federal Claims No: 17–0090V. Court of Federal Claims No: 17–0136V. FOR FURTHER INFORMATION CONTACT: Julia
mstockstill on DSK3G9T082PROD with NOTICES

66. Deborah Easterbrook, Mankato, 99. Tanya Mckoy, Murfreesboro, Gorey, J.D., Executive Director,
Minnesota, Court of Federal Claims No: 17– Tennessee, Court of Federal Claims No: 17–
SACHRP; U.S. Department of Health
0091V. 0138V.
67. Sheryl Longin, Los Angeles, California, 100. Judith Celic, Boston, Massachusetts, and Human Services, 1101 Wootton
Court of Federal Claims No: 17–0093V. Court of Federal Claims No: 17–0139V. Parkway, Suite 200, Rockville,
68. Dolores Thompson, St. Petersburg, 101. Irving Kodimer, Woodland Hills, Maryland 20852; telephone: 240–453–
Florida, Court of Federal Claims No: 17– California, Court of Federal Claims No: 17– 8141; fax: 240–453–6909; email address:
0098V. 0140V. SACHRP@hhs.gov.

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Federal Register / Vol. 82, No. 38 / Tuesday, February 28, 2017 / Notices 12111

SUPPLEMENTARY INFORMATION: Under the days. Note that public comment must be of Health/NIAID, 5601 Fishers Lane,
authority of 42 U.S.C. 217a, Section 222 relevant to issues being addressed by MSC9823 Bethesda, MD 20892–9823, (240)
of the Public Health Service Act, as the SACHRP. 669–5068, zhuqing.li@nih.gov.
amended, SACHRP was established to Public attendance at the meeting is (Catalogue of Federal Domestic Assistance
provide expert advice and limited to space available. Individuals Program Nos. 93.855, Allergy, Immunology,
recommendations to the Secretary of who plan to attend and need special and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Health and Human Services, through assistance, such as sign language
Research, National Institutes of Health, HHS)
the Assistant Secretary for Health, on interpretation or other reasonable
issues and topics pertaining to or accommodations, should notify one of Dated: February 23, 2017.
associated with the protection of human the designated SACHRP points of Natasha M. Copeland,
research subjects. contact at the address/phone number Program Analyst, Office of Federal Advisory
The Subpart A Subcommittee (SAS) listed above at least one week prior to Committee Policy.
was established by SACHRP in October the meeting. On-site registration is [FR Doc. 2017–03896 Filed 2–27–17; 8:45 am]
2006 and is charged with developing required for participation in the live BILLING CODE 4140–01–P
recommendations for consideration by public comment session. Individuals
SACHRP regarding the application of who would like to submit written
subpart A of 45 CFR part 46 in the statements as public comment should DEPARTMENT OF HEALTH AND
current research environment. email or fax their comments to SACHRP HUMAN SERVICES
The Subcommittee on Harmonization at SACHRP@hhs.gov at least five
(SOH) was established by SACHRP at its business days prior to the meeting. National Institutes of Health
July 2009 meeting and charged with
Dated: February 23, 2017. Center for Scientific Review; Notice of
identifying and prioritizing areas in
which regulations and/or guidelines for Julia G. Gorey, Closed Meetings
human subjects research adopted by Executive Director, Secretary’s Advisory
various agencies or offices within HHS Committee on Human Research Protections. Pursuant to section 10(d) of the
would benefit from harmonization, [FR Doc. 2017–03895 Filed 2–27–17; 8:45 am] Federal Advisory Committee Act, as
consistency, clarity, simplification and/ BILLING CODE 4150–36–P
amended (5 U.S.C. App.), notice is
or coordination. The SACHRP meeting hereby given of the following meetings.
will open to the public at 8:30 a.m., on The meetings will be closed to the
Wednesday, March 15, 2017, followed DEPARTMENT OF HEALTH AND public in accordance with the
by opening remarks from Dr. Jerry HUMAN SERVICES provisions set forth in sections
Menikoff, Director of OHRP and 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Executive Secretary of SACHRP, and Dr. National Institutes of Health as amended. The grant applications and
Stephen Rosenfeld, SACHRP Chair. Dr. the discussions could disclose
National Institute of Allergy and confidential trade secrets or commercial
Menikoff will then lead a discussion Infectious Diseases; Notice of Closed
focusing on selected sections of the new property such as patentable material,
Meeting and personal information concerning
Common Rule, which was published
January 19, 2017, with an effective date Pursuant to section 10(d) of the individuals associated with the grant
of January 19, 2018 (see https:// Federal Advisory Committee Act, as applications, the disclosure of which
www.gpo.gov/fdsys/pkg/FR-2017-01-19/ amended (5 U.S.C. App.), notice is would constitute a clearly unwarranted
html/2017-01058.htm). hereby given of the following meeting. invasion of personal privacy.
The SOH will present their The meeting will be closed to the Name of Committee: Center for Scientific
recommendations for considerations of public in accordance with the Review Special Emphasis Panel; Molecular
the new Common Rule’s compliance provisions set forth in sections and Imaging Dynamics in Psychiatry.
dates and transition provisions, as well 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Date: March 14, 2017.
as for the interpretation and as amended. The grant applications and Time: 2:00 p.m. to 6:00 p.m.
implementation of the new broad the discussions could disclose Agenda: To review and evaluate grant
consent provision. The SAS will discuss confidential trade secrets or commercial applications.
property such as patentable material, Place: National Institutes of Health, 6701
their report on the interpretation of the
Rockledge Drive, Bethesda, MD 20892,
new exemption involving benign and personal information concerning (Telephone Conference Call).
behavioral interventions. individuals associated with the grant Contact Person: Julius Cinque, MS.,
The Wednesday meeting will adjourn applications, the disclosure of which Scientific Review Officer, Center for
at approximately 5:00 p.m. would constitute a clearly unwarranted Scientific Review, National Institutes of
The Thursday, March 16, meeting will invasion of personal privacy. Health, 6701 Rockledge Drive, Room 5186,
begin at 8:30 a.m. with Name of Committee: National Institute of MSC 7846, Bethesda, MD 20892, (301) 435–
recommendations from the SOH on the Allergy and Infectious Diseases Special 1252, cinquej@csr.nih.gov.
FDA Draft Guidance ‘‘Use of Real-World Emphasis Panel NIAID; Clinical Trial This notice is being published less than 15
Evidence to Support Regulatory Implementation Cooperative Agreement days prior to the meeting due to the timing
Decision-Making for Medical Devices,’’ (U01). limitations imposed by the review and
issued July 27, 2016. SOH will also Date: March 22, 2017. funding cycle.
present recommendations on the return Time: 2:00 p.m. to 4:00 p.m. Name of Committee: Center for Scientific
of incidental findings to research Agenda: To review and evaluate Review Special Emphasis Panel; Member
mstockstill on DSK3G9T082PROD with NOTICES

subjects. The SAS will present cooperative agreement applications. Conflict: Learning and Memory.
Place: National Institutes of Health, 5601 Date: March 20, 2017.
recommendations surrounding the new Fishers Lane, Rockville, MD 20892, Time: 9:00 a.m. to 4:00 p.m.
Common Rule’s expedited review (Telephone Conference Call). Agenda: To review and evaluate grant
requirements. Contact Person: Zhuqing (Charlie) Li, applications.
The meeting will adjourn at 4:30 p.m. Ph.D., Scientific Review Officer, Scientific Place: National Institutes of Health, 6701
March 16, 2017. Time for public Review Program, Division of Extramural Rockledge Drive, Bethesda, MD 20892,
comment sessions will be allotted both Activities, Room # 3G41B, National Institutes (Virtual Meeting).

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Document Created: 2017-02-27 23:53:36
Document Modified: 2017-02-27 23:53:36

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 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.
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;
FR Citation		82 FR 12110