Meeting of the Secretary's Advisory Committee on Human Research Protections, 33316-33317 [2021-13362]

Download as PDF khammond on DSKJM1Z7X2PROD with NOTICES 33316 Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices 6. Chad Adaway, Birmingham, Alabama, Court of Federal Claims No: 21–1311V 7. John Buen, Boston, Massachusetts, Court of Federal Claims No: 21–1314V 8. Robert Ben, Colorado Springs, Colorado, Court of Federal Claims No: 21–1315V 9. David Plaut, Fort Collins, Colorado, Court of Federal Claims No: 21–1316V 10. Ciara Johnson, Durango, Colorado, Court of Federal Claims No: 21–1317V 11. Lindsay Walker on behalf of R.W., Aurora, Colorado, Court of Federal Claims No: 21–1318V 12. Dana Hilden, Phoenix, Arizona, Court of Federal Claims No: 21–1321V 13. Debbie L. Tice, Jackson, Mississippi, Court of Federal Claims No: 21–1322V 14. Rhonda Boyd, Huntsville, Alabama, Court of Federal Claims No: 21–1323V 15. Janice Walker, Ventura, California, Court of Federal Claims No: 21–1325V 16. Mary Patricia Turner, Washington, District of Columbia, Court of Federal Claims No: 21–1327V 17. Kara Mahuron, Washington, District of Columbia, Court of Federal Claims No: 21–1328V 18. Estate of James Leroy Doebler, Deceased, Pascagoula, Mississippi, Court of Federal Claims No: 21–1331V 19. Marlena Lloyd and Jeffrey Lloyd on behalf of C.L., Boston, Massachusetts, Court of Federal Claims No: 21–1332V 20. Keith Montague, Boston, Massachusetts, Court of Federal Claims No: 21–1333V 21. Daniel Murphy, Philadelphia, Pennsylvania, Court of Federal Claims No: 21–1334V 22. Jennifer Huch and Lucas Huch on behalf of L.L.L.H., Bedford, Texas, Court of Federal Claims No: 21–1335V 23. Michelle Gill on behalf of A.G., Phoenix, Arizona, Court of Federal Claims No: 21– 1336V 24. Thomas Burbank, Plainville, Connecticut, Court of Federal Claims No: 21–1337V 25. Clifton Foley and Kelli Foley on behalf of N.F., Deceased, Burlington, North Carolina, Court of Federal Claims No: 21–1338V 26. Juanita Artman, Washington, District of Columbia, Court of Federal Claims No: 21–1340V 27. Ramon K. Jusino and Ann M. Jusino on behalf of W.J. Staten Island, New York, Court of Federal Claims No: 21–1342V 28. Nardia Thompson Harris, Nanuet, New York, Court of Federal Claims No: 21– 1345V 29. Michael Williamson, Murfreesboro, Tennessee, Court of Federal Claims No: 21–1346V 30. John Allain, Sulphur, Louisiana, Court of Federal Claims No: 21–1349V 31. Jennifer Clark, Chattanooga, Tennessee, Court of Federal Claims No: 21–1350V 32. Robert Silver, Shelby, North Carolina, Court of Federal Claims No: 21–1351V 33. Kelsey Hamonds, Edgewood, Kentucky, Court of Federal Claims No: 21–1352V 34. Mindy Schuehrer, Marie, Michigan, Court of Federal Claims No: 21–1353V 35. Hortencia Torres, Annandale, Virginia, Court of Federal Claims No: 21–1356V 36. Laurel Bennett, Washington, District of Columbia, Court of Federal Claims No: VerDate Sep<11>2014 19:19 Jun 23, 2021 Jkt 253001 21–1357V 37. Marie Tully, Washington, District of Columbia, Court of Federal Claims No: 21–1358V 38. Donna Fulbright, Washington, District of Columbia, Court of Federal Claims No: 21–1359V 39. Jovonna Beyer, New York, New York, Court of Federal Claims No: 21–1362V 40. Richard Munoz, Plant City, Florida, Court of Federal Claims No: 21–1369V 41. Josephine Feitel, Georgetown, Texas, Court of Federal Claims No: 21–1370V 42. Austin Reid, Louisville, Kentucky, Court of Federal Claims No: 21–1374V 43. Elizabeth Fellows, Kansas City, Missouri, Court of Federal Claims No: 21–1378V 44. Stephen R. Hunt, Athens, Ohio, Court of Federal Claims No: 21–1379V 45. Raymond Milligan, Jr., Sulphur Springs, Texas, Court of Federal Claims No: 21– 1382V 46. Tina Paxson, Bloomington, Indiana, Court of Federal Claims No: 21–1383V 47. Rashawnda L. Benton, Greensboro, North Carolina, Court of Federal Claims No: 21–1384V 48. Jerome Dacurawat, Alexandria, Virginia, Court of Federal Claims No: 21–1389V 49. Krystal Kilgore, Morristown, Tennessee, Court of Federal Claims No: 21–1390V 50. Jeffrey A. Ridenour, Lima, Ohio, Court of Federal Claims No: 21–1392V 51. Lori Kathleen Ogden Erickson, Milton, Washington, Court of Federal Claims No: 21–1395V 52. Angela Saporito, Nutley, New Jersey, Court of Federal Claims No: 21–1398V 53. Shawn Wilson-Blount, White Plains, New York, Court of Federal Claims No: 21– 1400V 54. Geeta Karra, Philadelphia, Pennsylvania, Court of Federal Claims No: 21–1402V 55. Jonathan Charter, Manchester, Connecticut, Court of Federal Claims No: 21–1404V 56. Tammy Walden on behalf of J.F., Phoenix, Arizona, Court of Federal Claims No: 21–1406V 57. Bruce A. Ades, Denver, Colorado, Court of Federal Claims No: 21–1407V 58. Wendy O’Neil, Englewood, New Jersey, Court of Federal Claims No: 21–1410V [FR Doc. 2021–13312 Filed 6–23–21; 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 Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health. ACTION: Notice. AGENCY: 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 SUMMARY: PO 00000 Frm 00111 Fmt 4703 Sfmt 4703 Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP, the full meeting agenda, and instructions for linking to public access will be posted on the SACHRP website at https:// www.hhs.gov/ohrp/sachrp-committee/ meetings/. DATES: The meeting will be held on Wednesday, July 21, from 11:00 a.m. until 4:30 p.m., and Thursday, July 22, 2021, from 11:00 a.m. until 4:30 p.m. (times are tentative and subject to change). The confirmed times and agenda will be posted on the SACHRP website when this information becomes available. ADDRESSES: This meeting will be held via webcast. Members of the public may also attend the meeting via webcast. Instructions for attending via webcast will be posted one week prior to the meeting at https://www.hhs.gov/ohrp/ sachrp-committee/meetings/. 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. 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 11:00 a.m., on Wednesday, July 21, followed by opening remarks from Dr. Jerry Menikoff, Director of OHRP and Dr. Douglas Diekema, SACHRP Chair. The meeting will begin with presentation of recommendations on justice as an ethical concept in 45 E:\FR\FM\24JNN1.SGM 24JNN1 Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices CFR 46, followed by an expert panel discussion on the impact of artificial intelligence algorithms on Institutional Review Board considerations for human subjects protections. The day will conclude with discussion of a new SACHRP charge addressing the current system of engagement and the interpretation of HHS support in 45 CFR 46. The second day, July 22, will include discussion of consideration of risks to third parties in research, and continue discussion of topics from the first day’s agenda. Other topics may be added; for the full and updated meeting agenda, see https://www.dhhs.gov/ohrp/ sachrp-committee/meetings/. The meeting will adjourn by 4:30 p.m. July 22. The public will have an opportunity to send comment to SACHRP during the meeting’s public comment session or to submit written public comment in advance. Persons who wish to provide public comment should review instructions at https://www.hhs.gov/ ohrp/sachrp-committee/meetings/ index.html and respond by midnight July 16th, 2021, ET. Individuals submitting written statements as public comment should submit their comments to SACHRP at SACHRP@hhs.gov. Comments are limited to three minutes each. Time will be allotted for public comment on both days. Note that public comment must be relevant to topics currently being addressed by SACHRP. Dated: June 14, 2021. Julia G. Gorey, Executive Director, Secretary’s Advisory Committee on Human Research Protections, Office for Human Research Protections. [FR Doc. 2021–13362 Filed 6–23–21; 8:45 am] BILLING CODE 4150–36–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Appointment of Administrative Dispute Resolution Board Members Office of the Secretary, HHS. Notice. AGENCY: ACTION: On December 14, 2020, the Department of Health and Human Services published in the Federal Register a final rule (‘‘Rule’’) establishing the 340B Drug Pricing Program (340B Program) Administrative Dispute Resolution (ADR) Board (hereafter, ‘‘the Board’’). See 85 FR 80632 (Dec. 14, 2020). According to the Rule, the purpose of the 340B Program’s ADR process is to resolve (1) claims by khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:19 Jun 23, 2021 Jkt 253001 covered entities that they have been overcharged for covered outpatient drugs by manufacturers and (2) claims by manufacturers, after a manufacturer has conducted an audit as authorized by section 340B(a)(5)(C) of the Public Health Service Act, that a covered entity has violated the prohibitions on diversion or duplicate discounts. The Rule states that Board members from the Centers for Medicare & Medicaid Services (CMS) and the Health Resources and Services Administration (HRSA) must have relevant expertise and experience in drug pricing or drug distribution. The Rule also states that Board members from the Office of the General Counsel (OGC) must have expertise and experience in handling complex litigation. From the 340B ADR Board, the HRSA Administrator will select three voting members, one from each of the three HHS operating/staff divisions involved (i.e., CMS, HRSA, OGC) to form 340B ADR Panels that will review claims and, pursuant to delegated authority from the Secretary, make certain final agency decisions. All previous appointments to the Board are revoked. Based on recommendations from OGC, CMS, and HRSA, I hereby appoint the following Board members, who shall serve a term of two years, to be extended for additional terms upon agreement by the member and the head of his or her operating/staff division. Sean R. Keveney, Deputy General Counsel, the Office of the General Counsel, Department of Health and Human Services; Andy J. Miller, National Complex Litigation and Investigations Division Attorney, the Office of the General Counsel, Department of Health and Human Services; Glenn Clark, Public Health Advisor, HIV/AIDS Bureau, Health Resources and Services Administration, Department of Health and Human Services; CAPT Christina Meade, Area Regional Pharmacy Consultant, Office of Regional Operations, Health Resources and Services Administration, Department of Health and Human Services; CDR Timothy Lape, Division of Medicare Health Plans Operations, Medicare Branch, Centers for Medicare & Medicaid Services, Department of Health and Human Services; Adele Pietrantoni, Office of Program Operations and Local Engagement, Division of Drug and Health Plan Operations, Centers for Medicare & Medicaid Services, Department of Health and Human Services; Chantelle Britton, Senior Advisor, Office of Pharmacy Affairs, Health PO 00000 Frm 00112 Fmt 4703 Sfmt 4703 33317 Resources and Services Administration, Department of Health and Human Services, as ex-officio, non-voting member; and Julie Zadecky, Pharmacist, Office of Pharmacy Affairs, Health Resources and Services Administration, Department of Health and Human Services, as exofficio, non-voting member. Dated: June 21, 2021. Xavier Becerra, Secretary, Department of Health and Human Services. [FR Doc. 2021–13461 Filed 6–23–21; 8:45 am] BILLING CODE 4150–26–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: OS–0955–0003] Agency Information Collection Request. 30-Day Public Comment Request Office of the Secretary, HHS. Notice. AGENCY: ACTION: In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. DATES: Comments on the ICR must be received on or before July 26, 2021. ADDRESSES: Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. FOR FURTHER INFORMATION CONTACT: Sherrette Funn, Sherrette.Funn@hhs.gov or (202) 795–7714. When submitting comments or requesting information, please include the document identifier 0955–0003–30D and project title for reference. SUMMARY: Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection SUPPLEMENTARY INFORMATION: E:\FR\FM\24JNN1.SGM 24JNN1

Agencies

[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33316-33317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13362]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


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

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

ACTION: Notice.

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

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, the 
full meeting agenda, and instructions for linking to public access will 
be posted on the SACHRP website at https://www.hhs.gov/ohrp/sachrp-committee/meetings/.

DATES: The meeting will be held on Wednesday, July 21, from 11:00 a.m. 
until 4:30 p.m., and Thursday, July 22, 2021, from 11:00 a.m. until 
4:30 p.m. (times are tentative and subject to change). The confirmed 
times and agenda will be posted on the SACHRP website when this 
information becomes available.

ADDRESSES: This meeting will be held via webcast. Members of the public 
may also attend the meeting via webcast. Instructions for attending via 
webcast will be posted one week prior to the meeting at https://www.hhs.gov/ohrp/sachrp-committee/meetings/.

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].

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 11:00 a.m., on 
Wednesday, July 21, followed by opening remarks from Dr. Jerry 
Menikoff, Director of OHRP and Dr. Douglas Diekema, SACHRP Chair. The 
meeting will begin with presentation of recommendations on justice as 
an ethical concept in 45

[[Page 33317]]

CFR 46, followed by an expert panel discussion on the impact of 
artificial intelligence algorithms on Institutional Review Board 
considerations for human subjects protections. The day will conclude 
with discussion of a new SACHRP charge addressing the current system of 
engagement and the interpretation of HHS support in 45 CFR 46. The 
second day, July 22, will include discussion of consideration of risks 
to third parties in research, and continue discussion of topics from 
the first day's agenda. Other topics may be added; for the full and 
updated meeting agenda, see https://www.dhhs.gov/ohrp/sachrp-committee/meetings/. The meeting will adjourn by 4:30 p.m. July 22.
    The public will have an opportunity to send comment to SACHRP 
during the meeting's public comment session or to submit written public 
comment in advance. Persons who wish to provide public comment should 
review instructions at https://www.hhs.gov/ohrp/sachrp-committee/meetings/ and respond by midnight July 16th, 2021, ET. 
Individuals submitting written statements as public comment should 
submit their comments to SACHRP at [email protected]. Comments are limited 
to three minutes each.
    Time will be allotted for public comment on both days. Note that 
public comment must be relevant to topics currently being addressed by 
SACHRP.

    Dated: June 14, 2021.
Julia G. Gorey,
Executive Director, Secretary's Advisory Committee on Human Research 
Protections, Office for Human Research Protections.
[FR Doc. 2021-13362 Filed 6-23-21; 8:45 am]
BILLING CODE 4150-36-P
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