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: 

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 

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/index.html. 

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/index.html. 

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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 119 / Thursday, June 24, 2021 / Notices 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/index.html. 

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 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: 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 

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 

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 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: 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. 

SUPPLEMENTARY INFORMATION: 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 


khammond on DSKJM1Z7X2PROD with NOTICES