Appointment of Administrative Dispute Resolution Board Members, 33317 [2021-13461]
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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:
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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
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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
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Office of the Secretary, HHS.
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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
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DATES: Comments on the ICR must be
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]]>Agencies
[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Page 33317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13461]
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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 ex-officio, 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
