Meeting of the Secretary's Advisory Committee on Human Research Protections, 12110-12111 [2017-03895]

Download as PDF mstockstill on DSK3G9T082PROD with NOTICES 12110 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. VerDate Sep<11>2014 18:46 Feb 27, 2017 Jkt 241001 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. PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 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: http://www.dhhs.gov/ohrp/sachrpcommittee/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: SACHRP@hhs.gov. SUMMARY: E:\FR\FM\28FEN1.SGM 28FEN1 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 Frm 00033 Fmt 4703 Sfmt 4703 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). E:\FR\FM\28FEN1.SGM 28FEN1

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]


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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: 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