Advisory Committee; Patient Engagement Advisory Committee; Renewal, 68261-68262 [2021-26118]
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Federal Register / Vol. 86, No. 228 / Wednesday, December 1, 2021 / Notices
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agency of the time and place of the
hearing, and the issues to be considered.
If we subsequently notify the state
Medicaid agency of additional issues
that will be considered at the hearing,
we will also publish that notice in the
Federal Register.
Any individual or group that wants to
participate in the hearing as a party
must petition the presiding officer
within 15 days after publication of this
notice, in accordance with the
requirements contained at 42 CFR
430.76(b)(2). Any interested person or
organization that wants to participate as
amicus curiae must petition the
presiding officer before the hearing
begins in accordance with the
requirements contained at 42 CFR
430.76(c). If the hearing is later
rescheduled, the presiding officer will
notify all participants.
The notice to South Carolina
announcing an administrative hearing to
reconsider the disapproval of its SPAs
reads as follows:
Robert M. Kerr
Director, South Carolina Department of
Health and Human Services, Post Office
Box 8206, Columbia, SC 29202–8206
Dear Mr. Kerr:
I am responding to the July 19, 2021
request for reconsideration of the decision to
disapprove South Carolina’s State Plan
amendment (SPA) 19–0004–A. South
Carolina SPA 19–0004–A was submitted to
the Centers for Medicare & Medicaid Services
(CMS) on June 28, 2019 and disapproved on
May 21, 2021. I am scheduling a hearing on
the request for reconsideration to be held on
January 12, 2022, at the Department of Health
and Human Services, Division of Medicaid
Field Operations, South, Centers for
Medicare & Medicaid Services, Division of
Medicaid and Children’s Health Operations,
61 Forsyth St., Suite 4T20, Atlanta, Georgia
30303–8909.
I am designating Mr. Benjamin R. Cohen as
the presiding officer. If these arrangements
present any problems, please contact Mr.
Cohen at (410) 786–3169. In order to
facilitate any communication that may be
necessary between the parties prior to the
hearing, please notify the presiding officer to
indicate acceptability of the hearing date that
has been scheduled and provide names of the
individuals who will represent the State at
the hearing. If the hearing date is not
acceptable, Mr. Cohen can set another date
mutually agreeable to the parties. The
hearing will be governed by the procedures
prescribed by federal regulations at 42 CFR
part 430.
This SPA requested CMS approval to
update annual supplemental teaching
physician (STP) payment program using the
Average Commercial Rate (ACR)
methodology effective April 1, 2019. This
SPA included Greenville Memorial Hospital,
and Palmetto Health Richland/USC.
The issues to be considered at the hearing
are whether South Carolina SPA 19–0004–A
is inconsistent with the requirements of:
VerDate Sep<11>2014
17:08 Nov 30, 2021
Jkt 256001
• Section 1902(a)(2) of the Social Security
Act (the Act), providing that the state plan
must assure adequate funding for the nonfederal share of expenditures from state or
local sources, such that the lack of adequate
funds from local sources will not result in
lowering the amount, duration, scope, or
quality of care and services available under
the plan.
• Sections 1903(a) and 1905(b) of the Act,
providing that states receive a statutorily
determined Federal Medicaid Assistance
Percentage (FMAP) for allowable state
expenditures on medical assistance.
• Section 1903(w)(1)(A)(i)(I) of the Act,
providing that, notwithstanding the previous
provisions of section 1903, for purposes of
determining the amount to be paid to a State
(as defined in paragraph (7)(D)) under
subsection (a)(1) for quarters in any fiscal
year, the total amount expended during such
fiscal year as medical assistance under the
State plan (as determined without regard to
section 1903(w)) shall be reduced, inter alia,
by the sum of any revenues received by the
State (or by a unit of local government in the
State) during the fiscal year from providerrelated donations other than bona fide
provider-related donations, as defined in
section 1903(w)(2)(B).
• Section 1903(w)(2)(A) of the Act,
providing that, in section 1903(w), except as
provided in section 1903(w)(6), the term
‘‘provider-related donation’’ means any
donation or other voluntary payment
(whether in cash or in kind) made (directly
or indirectly) to a State or unit of local
government by—(i) a health care provider (as
defined in section 1903(w)(7)(B)), (ii) an
entity related to a health care provider (as
defined in section 1903(w)(7)(C)), or (iii) an
entity providing goods or services under the
State plan for which payment is made to the
State under paragraph (2), (3), (4), (6), or (7)
of section 1903(a).
• Section 1903(w)(2)(B) of the Act,
providing that, for purposes of section
1903(w)(1)(A)(i)(I), the term ‘‘bona fide
provider-related donation’’ means a providerrelated donation that has no direct or indirect
relationship (as determined by the Secretary)
to payments made under title XIX to that
provider, to providers furnishing the same
class of items and services as that provider,
or to any related entity, as established by the
State to the satisfaction of the Secretary. The
Secretary may by regulation specify types of
provider-related donations described in the
previous sentence that will be considered to
be bona fide provider-related donations.
• Section 1903(w)(6)(A) of the Act,
providing that, notwithstanding the
provisions of section 1903(w), the Secretary
may not restrict States’’ use of funds where
such funds are derived from State or local
taxes (or funds appropriated to State
university teaching hospitals) transferred
from or certified by units of government
within a State as the non-Federal share of
expenditures under title XIX, regardless of
whether the unit of government is also a
health care provider, except as provided in
section 1902(a)(2), unless the transferred
funds are derived by the unit of government
from donations or taxes that would not
otherwise be recognized as the non-Federal
share under section 1903.
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Fmt 4703
Sfmt 4703
68261
• 42 CFR 433.54(b), (c)(2), and (c)(3),
providing that provider-related donations
will be determined to have no direct or
indirect relationship to Medicaid payments if
those donations are not returned to the
individual provider, the provider class, or
related entity under a hold harmless
provision or practice, as described in 42 CFR
433.54(c). A hold harmless practice exists if,
inter alia, all or any portion of the Medicaid
payment to the donor, provider class, or
related entity, varies based only on the
amount of the donation, including where
Medicaid payment is conditional on receipt
of the donation; or if the State (or other unit
of government) receiving the donation
provides for any direct or indirect payment,
offset, or waiver such that the provision of
that payment, offset, or waiver directly or
indirectly guarantees to return any portion of
the donation to the provider (or other parties
responsible for the donation).
In the event that CMS and the State come
to agreement on resolution of the issues
which formed the basis for disapproval, these
SPAs may be moved to approval prior to the
scheduled hearing.
Sincerely,
Chiquita Brooks-LaSure,
Administrator
cc: Benjamin R. Cohen
The Administrator of the Centers for
Medicare & Medicaid Services (CMS),
Chiquita Brooks-LaSure, having
reviewed and approved this document,
authorizes Evell J. Barco Holland, who
is the Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
Section 1116 of the Social Security
Act (42 U.S.C. section 1316; 42 CFR
section 430.18) (Catalog of Federal
Domestic Assistance Program No.
13.714. Medicaid Assistance Program.)
Dated: November 26, 2021.
Evell J. Barco Holland,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2021–26136 Filed 11–30–21; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–2809]
Advisory Committee; Patient
Engagement Advisory Committee;
Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of Federal
advisory committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
SUMMARY:
E:\FR\FM\01DEN1.SGM
01DEN1
lotter on DSK11XQN23PROD with NOTICES1
68262
Federal Register / Vol. 86, No. 228 / Wednesday, December 1, 2021 / Notices
renewal of the Patient Engagement
Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Patient
Engagement Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until the October 6, 2023,
expiration date.
DATES: Authority for the Patient
Engagement Advisory Committee would
have expired on October 6, 2021, unless
the Commissioner had formally
determined that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Letise Williams, Office of the Center
Director, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5407, Silver Spring,
MD 20993–0002, 301–796–8398,
Letise.Williams@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services and by the General Services
Administration, FDA is announcing the
renewal of the Patient Engagement
Advisory Committee (the Committee).
The Committee is a discretionary
Federal advisory committee established
to provide advice to the Commissioner.
The Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective devices for human use and, as
required, any other product for which
the Food and Drug Administration has
regulatory responsibility.
The Committee provides advice to the
Commissioner on complex scientific
issues relating to medical devices, the
regulation of devices, and their use by
patients. Agency guidance and policies,
clinical trial or registry design, patient
preference study design, benefit-risk
determinations, device labeling, unmet
clinical needs, available alternatives,
patient reported outcomes, devicerelated quality of life measures, or
health status issues are among the topics
that may be considered by the
Committee. The Committee provides
relevant skills and perspectives to
improve communication of benefits,
risks, and clinical outcomes, and
increase integration of patient
perspectives into the regulatory process
for medical devices. It performs its
duties by identifying new approaches,
promoting innovation, recognizing
unforeseen risks or barriers, and
identifying unintended consequences
that could result from FDA policy.
VerDate Sep<11>2014
17:08 Nov 30, 2021
Jkt 256001
Pursuant to its Charter the Committee
shall consist of a core of nine voting
members, including the Chair. Members
and the Chair are selected by the
Commissioner or designee from among
authorities who are knowledgeable in
areas such as clinical research, patient
experience, healthcare needs of patient
groups in the United States, or are
experienced in the work of patient and
health professional organizations,
methodologies for patient-reported
outcomes and eliciting patient
preferences, and strategies for
communicating benefits, risks and
clinical outcomes to patients and
research subjects, as well as other
relevant areas. Members will be invited
to serve for overlapping terms of up to
4 years. Non-Federal members of this
committee will serve as Special
Government Employees, representative
or Ex-Officio members. Federal
members will serve as Regular
Government Employees or Ex-Officios.
The core of voting members may
include one technically qualified
member, selected by the Commissioner
or designee, who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented organizations or other
interested persons. The Commissioner
or designee shall also have the authority
to select from a group of individuals
nominated by industry to serve
temporarily as non-voting members who
are identified with industry interests.
The number of temporary members
selected for a particular meeting will
depend on the meeting topic.
The Commissioner or designee shall
also have the authority to select
members of other scientific and
technical FDA advisory committees
(normally not to exceed 10 members) to
serve temporarily as voting members
and to designate consultants to serve
temporarily as voting members when:
(1) Expertise is required that is not
available among current voting standing
members of the Committee (when
additional voting members are added to
the Committee to provide needed
expertise, a quorum will be based on the
combined total of regular and added
members), or (2) to comprise a quorum
when, because of unforeseen
circumstances, a quorum is or will be
lacking. Because of the size of the
Committee and the variety in the types
of issues that it will consider, FDA may,
in connection with a particular
committee meeting, specify a quorum
that is less than a majority of the current
voting members. The Agency’s
regulations (21 CFR 14.22(d)) authorize
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
a committee charter to specify quorum
requirements.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/advisory-committees/
committees-and-meeting-materials/
patient-engagement-advisory-committee
or by contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no
change has been made to the committee
name or description of duties, no
amendment will be made to 21 CFR
14.100.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: November 23, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–26118 Filed 11–30–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Assistant Secretary for
Administration
Privacy Act of 1974; System of
Records
Office of the Assistant
Secretary for Administration,
Department of Health and Human
Services (HHS).
ACTION: Notice of a new system of
records.
AGENCY:
In accordance with the
requirements of the Privacy Act of 1974,
as amended, the U.S. Department of
Health and Human Services (HHS) is
establishing a new departmentwide
system of records, 09–90–2103,
Accommodation Records About HHS
Civilian Employees, Contractors and
Visitors.
SUMMARY:
The new system of records is
applicable December 1, 2021, subject to
a 30-day period in which to comment
on the routine uses.
ADDRESSES: The public should address
written comments by email to
beth.kramer@hhs.gov or by mail to Beth
Kramer, HHS Privacy Act Officer, FOIA/
Privacy Act Division—Suite 729H,
Office of the Assistant Secretary for
Public Affairs, 200 Independence Ave.
SW, Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT:
General questions may be submitted to
Beth Kramer, HHS Privacy Act Officer,
DATES:
E:\FR\FM\01DEN1.SGM
01DEN1
]]>Agencies
[Federal Register Volume 86, Number 228 (Wednesday, December 1, 2021)]
[Notices]
[Pages 68261-68262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26118]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-2809]
Advisory Committee; Patient Engagement Advisory Committee;
Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of Federal advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
[[Page 68262]]
renewal of the Patient Engagement Advisory Committee by the
Commissioner of Food and Drugs (the Commissioner). The Commissioner has
determined that it is in the public interest to renew the Patient
Engagement Advisory Committee for an additional 2 years beyond the
charter expiration date. The new charter will be in effect until the
October 6, 2023, expiration date.
DATES: Authority for the Patient Engagement Advisory Committee would
have expired on October 6, 2021, unless the Commissioner had formally
determined that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Letise Williams, Office of the Center
Director, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5407, Silver
Spring, MD 20993-0002, 301-796-8398, [email protected].
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services and by the General Services
Administration, FDA is announcing the renewal of the Patient Engagement
Advisory Committee (the Committee). The Committee is a discretionary
Federal advisory committee established to provide advice to the
Commissioner. The Committee advises the Commissioner or designee in
discharging responsibilities as they relate to helping to ensure safe
and effective devices for human use and, as required, any other product
for which the Food and Drug Administration has regulatory
responsibility.
The Committee provides advice to the Commissioner on complex
scientific issues relating to medical devices, the regulation of
devices, and their use by patients. Agency guidance and policies,
clinical trial or registry design, patient preference study design,
benefit-risk determinations, device labeling, unmet clinical needs,
available alternatives, patient reported outcomes, device-related
quality of life measures, or health status issues are among the topics
that may be considered by the Committee. The Committee provides
relevant skills and perspectives to improve communication of benefits,
risks, and clinical outcomes, and increase integration of patient
perspectives into the regulatory process for medical devices. It
performs its duties by identifying new approaches, promoting
innovation, recognizing unforeseen risks or barriers, and identifying
unintended consequences that could result from FDA policy.
Pursuant to its Charter the Committee shall consist of a core of
nine voting members, including the Chair. Members and the Chair are
selected by the Commissioner or designee from among authorities who are
knowledgeable in areas such as clinical research, patient experience,
healthcare needs of patient groups in the United States, or are
experienced in the work of patient and health professional
organizations, methodologies for patient-reported outcomes and
eliciting patient preferences, and strategies for communicating
benefits, risks and clinical outcomes to patients and research
subjects, as well as other relevant areas. Members will be invited to
serve for overlapping terms of up to 4 years. Non-Federal members of
this committee will serve as Special Government Employees,
representative or Ex-Officio members. Federal members will serve as
Regular Government Employees or Ex-Officios. The core of voting members
may include one technically qualified member, selected by the
Commissioner or designee, who is identified with consumer interests and
is recommended by either a consortium of consumer-oriented
organizations or other interested persons. The Commissioner or designee
shall also have the authority to select from a group of individuals
nominated by industry to serve temporarily as non-voting members who
are identified with industry interests. The number of temporary members
selected for a particular meeting will depend on the meeting topic.
The Commissioner or designee shall also have the authority to
select members of other scientific and technical FDA advisory
committees (normally not to exceed 10 members) to serve temporarily as
voting members and to designate consultants to serve temporarily as
voting members when: (1) Expertise is required that is not available
among current voting standing members of the Committee (when additional
voting members are added to the Committee to provide needed expertise,
a quorum will be based on the combined total of regular and added
members), or (2) to comprise a quorum when, because of unforeseen
circumstances, a quorum is or will be lacking. Because of the size of
the Committee and the variety in the types of issues that it will
consider, FDA may, in connection with a particular committee meeting,
specify a quorum that is less than a majority of the current voting
members. The Agency's regulations (21 CFR 14.22(d)) authorize a
committee charter to specify quorum requirements.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/advisory-committees/committees-and-meeting-materials/patient-engagement-advisory-committee
or by contacting the Designated Federal Officer (see FOR FURTHER
INFORMATION CONTACT). In light of the fact that no change has been made
to the committee name or description of duties, no amendment will be
made to 21 CFR 14.100.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: November 23, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26118 Filed 11-30-21; 8:45 am]
BILLING CODE 4164-01-P
