Medical Devices; Petition for an Administrative Stay of Action: Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior, 50950-50951 [2020-16595]
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Federal Register / Vol. 85, No. 161 / Wednesday, August 19, 2020 / Rules and Regulations
an agreement if the fee did not exceed
$27 under § 1026.52(b)(1)(ii)(A) and $38
under § 1026.52(b)(1)(ii)(B), through
December 31, 2017.
F. Card issuers were permitted to
impose a fee for violating the terms of
an agreement if the fee did not exceed
$27 under § 1026.52(b)(1)(ii)(A) and $38
under § 1026.52(b)(1)(ii)(B), through
December 31, 2018.
G. Card issuers were permitted to
impose a fee for violating the terms of
an agreement if the fee did not exceed
$28 under § 1026.52(b)(1)(ii)(A) and $39
under § 1026.52(b)(1)(ii)(B), through
December 31, 2019.
H. Card issuers were permitted to
impose a fee for violating the terms of
an agreement if the fee did not exceed
$29 under § 1026.52(b)(1)(ii)(A) and $40
under § 1026.52(b)(1)(ii)(B), through
December 31, 2020.
3. Delinquent balance for charge card
accounts. Section 1026.52(b)(1)(ii)(C)
provides that, when a charge card issuer
that requires payment of outstanding
balances in full at the end of each
billing cycle has not received the
required payment for two or more
consecutive billing cycles, the card
issuer may impose a late payment fee
that does not exceed three percent of the
delinquent balance. For purposes of
§ 1026.52(b)(1)(ii)(C), the delinquent
balance is any previously billed amount
that remains unpaid at the time the late
payment fee is imposed pursuant to
§ 1026.52(b)(1)(ii)(C). Consistent with
§ 1026.52(b)(2)(ii), a charge card issuer
that imposes a fee pursuant to
§ 1026.52(b)(1)(ii)(C) with respect to a
late payment may not impose a fee
pursuant to § 1026.52(b)(1)(ii)(B) with
respect to the same late payment. The
following examples illustrate the
application of § 1026.52(b)(1)(ii)(C):
i. Assume that a charge card issuer
requires payment of outstanding
balances in full at the end of each
billing cycle and that the billing cycles
for the account begin on the first day of
the month and end on the last day of the
month. At the end of the June billing
cycle, the account has a balance of
$1,000. On July 5, the card issuer
provides a periodic statement disclosing
the $1,000 balance consistent with
§ 1026.7. During the July billing cycle,
the account is used for $300 in
transactions, increasing the balance to
$1,300. At the end of the July billing
cycle, no payment has been received
and the card issuer imposes a $25 late
payment fee consistent with
§ 1026.52(b)(1)(ii)(A). On August 5, the
card issuer provides a periodic
statement disclosing the $1,325 balance
consistent with § 1026.7. During the
August billing cycle, the account is used
VerDate Sep<11>2014
15:52 Aug 18, 2020
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for $200 in transactions, increasing the
balance to $1,525. At the end of the
August billing cycle, no payment has
been received. Consistent with
§ 1026.52(b)(1)(ii)(C), the card issuer
may impose a late payment fee of $40,
which is 3% of the $1,325 balance that
was due at the end of the August billing
cycle. Section 1026.52(b)(1)(ii)(C) does
not permit the card issuer to include the
$200 in transactions that occurred
during the August billing cycle.
ii. Same facts as above except that, on
August 25, a $100 payment is received.
Consistent with § 1026.52(b)(1)(ii)(C),
the card issuer may impose a late
payment fee of $37, which is 3% of the
unpaid portion of the $1,325 balance
that was due at the end of the August
billing cycle ($1,225).
iii. Same facts as in paragraph A
above except that, on August 25, a $200
payment is received. Consistent with
§ 1026.52(b)(1)(ii)(C), the card issuer
may impose a late payment fee of $34,
which is 3% of the unpaid portion of
the $1,325 balance that was due at the
end of the August billing cycle ($1,125).
In the alternative, the card issuer may
impose a late payment fee of $35
consistent with § 1026.52(b)(1)(ii)(B).
However, § 1026.52(b)(2)(ii) prohibits
the card issuer from imposing both fees.
*
*
*
*
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Dated: July 17, 2020.
Laura Galban,
Federal Register Liaison, Bureau of Consumer
Financial Protection.
[FR Doc. 2020–15900 Filed 8–18–20; 8:45 am]
BILLING CODE 4810–AM–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 882 and 895
[Docket No. FDA–2016–N–1111]
Medical Devices; Petition for an
Administrative Stay of Action:
Electrical Stimulation Devices for SelfInjurious or Aggressive Behavior
AGENCY:
Food and Drug Administration,
HHS.
Final rule; notification of
administrative stay.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
providing notice of a stay of the
effectiveness of provisions for devices in
use on specific individuals who have or
would need to obtain a physiciandirected transition plan as of the date of
publication on March 6, 2020, of the
SUMMARY:
PO 00000
Frm 00014
Fmt 4700
Sfmt 4700
final regulation banning electrical
stimulation devices (ESDs) for selfinjurious or aggressive behavior. FDA is
publishing this notification in response
to petitions for an administrative stay of
action in accordance with regulatory
requirements.
DATES: FDA is administratively staying
temporarily the final regulation
published on March 6, 2020 (85 FR
13312), for those devices in use on
specific individuals as described in
SUPPLEMENTARY INFORMATION. FDA will
publish a document in the Federal
Register lifting the stay or taking further
action as needed.
ADDRESSES: For access to the docket, go
to https://www.regulations.gov and
insert the docket number, found in
brackets in the heading of this
document, into the ‘‘Search’’ box and
follow the prompts and/or go to the
Dockets Management Staff, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,
between 9 a.m. and 4 p.m., Monday
through Friday. Publicly available
submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT:
Rebecca Nipper, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1540, Silver Spring,
MD 20993–0002, 301–796–6527,
rebecca.nipper@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of March 6, 2020 (85
FR 13312), FDA issued a final regulation
banning electrical stimulation devices
(ESDs) for self-injurious behavior (SIB)
or aggressive behavior (AB). This final
regulation provided two operational
dates. The ban is in effect for all devices
as of April 6, 2020, 30 days after the
date of publication. However, for
devices in use on specific individuals as
of the date of publication and subject to
a physician-directed transition plan,
compliance is required on September 2,
2020, 180 days after the date of
publication of the final rule.
FDA received two requests under 21
CFR 10.35 to immediately and
indefinitely stay these dates for the final
regulation banning ESDs for SIB or AB.
The first petition, dated March 20, 2020,
is from Eckert Seamans Cherin & Mellot,
LLC on behalf of their client, the Judge
Rotenberg Educational Center, Inc. (JRC)
(see Docket No. FDA–2020–P–1166). As
described below, FDA temporarily
granted this petition (JRC petition) in
part on March 27, 2020. The second
petition, dated March 24, 2020, is from
Todd & Weld, LLP on behalf of their
clients the parents and guardians of
certain patients at JRC, as well as the
patients themselves, and the JRC Parents
and Friends Association, Inc. (see
E:\FR\FM\19AUR1.SGM
19AUR1
jbell on DSKJLSW7X2PROD with RULES
Federal Register / Vol. 85, No. 161 / Wednesday, August 19, 2020 / Rules and Regulations
Docket No. FDA–2020–P–1181). This
petition (Parent petition) was routed for
review and response after FDA’s March
27, 2020, letter granting JRC’s request
for a stay in part. Although filed by
different parties, the Parent petition
requested the same action as the JRC
petition and did not necessitate a
different response or change in the stay
FDA granted in response to the JRC
petition. Both petitions request a stay
based on all four criteria for a
mandatory stay or, alternatively, based
on being ‘‘in the public interest and in
the interest of justice’’ for a
discretionary stay (§ 10.35 (21 CFR
10.35(e))). Because the petitions request
the same action for substantially similar
reasons, FDA has determined that its
March 27, 2020, response to the JRC
petition is equally applicable to the
Parent petition. FDA notes that both sets
of petitioners filed legal challenges to
the ban in the U.S. Court of Appeals for
the D.C. Circuit, which challenges have
now been consolidated before that
court.
By a letter dated March 27, 2020, FDA
responded to the JRC petition granting
in part a discretionary temporary stay.
As the letter states, it is in the public
health interest and interest of justice to
stay the compliance date for devices
subject to the ban that are currently in
use on specific individuals who would
need to obtain a physician-directed
transition plan to cease use of such
devices. The stay is in the public
interest and interest of justice because of
the ongoing national emergency caused
by ‘‘severe acute respiratory syndrome
coronavirus 2’’ (SARS–CoV–2) and the
disease it causes ‘‘Coronavirus Disease
2019 (COVID–19).’’ Specifically, the
creation or implementation of a
physician-directed transition plan has
the potential to increase the risk of
transmission or exposure to COVID–19,
and it may divert healthcare delivery
resources from other uses during the
pandemic.
The stay is intended to remain in
effect for the duration of the public
health emergency related to COVID–19
declared by HHS, including any
renewals made by the Secretary in
accordance with section 319(a)(2) of the
PHS Act (42 U.S.C. 247d(a)(2)). Once
the public health emergency ends, FDA
will substantively respond to the
petitions, and issue another notification
in the Federal Register, if necessary, in
accordance with § 10.35. If the public
health emergency ends while the
consolidated legal challenge in the D.C.
Circuit is still pending, the stay will
continue in effect until: (1) FDA
substantively responds to the petitions
and (2) if FDA does not grant the
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15:52 Aug 18, 2020
Jkt 250001
petitions, the parties have had adequate
time and reasonable opportunity to
obtain a ruling from the D.C. Circuit
regarding a stay of FDA’s response to
the petitions.
FDA’s partial stay is limited to those
devices currently in use on specific
individuals who have or would need to
obtain a physician-directed transition
plan to cease use of such devices in
order to comply with the final
regulation banning ESDs. For all other
devices, the ban became effective on,
and required compliance by, April 6,
2020.
Dated: July 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–16595 Filed 8–17–20; 4:15 pm]
BILLING CODE 4164–01–P
DEPARTMENT OF JUSTICE
Office of the Attorney General
[Docket No. OAG 165; AG Order No. 4769–
2020]
Prohibition on the Issuance of
Improper Guidance Documents Within
the Justice Department
Office of the Attorney General,
Department of Justice.
ACTION: Interim final rule; request for
comments.
AGENCY:
This rule codifies in the
regulations of the Department of Justice
(‘‘Department’’) the Memorandum for
All Components from Attorney General
Jefferson B. Sessions III titled,
‘‘Prohibition on Improper Guidance
Documents’’ (Nov. 16, 2017), consistent
with Executive Order 13891,
‘‘Promoting the Rule of Law Through
Improved Agency Guidance
Documents’’ (Oct. 9, 2019).
DATES: Effective date: This rule is
effective August 19, 2020. Comments:
Comments are due on or before
September 18, 2020.
ADDRESSES: To ensure proper handling
of comments, please reference Docket
No. OAG 165 on all electronic and
written correspondence. The
Department encourages the electronic
submission of all comments through
https://www.regulations.gov using the
electronic comment form provided on
that site. For easy reference, an
electronic copy of this document is also
available at that website. It is not
necessary to submit paper comments
that duplicate the electronic
submission, as all comments submitted
SUMMARY:
Frm 00015
Fmt 4700
to https://www.regulations.gov will be
posted for public review and are part of
the official docket record. However,
should you wish to submit written
comments through regular or express
mail, they should be sent to: Robert
Hinchman, Senior Counsel, Office of
Legal Policy, U.S. Department of Justice,
Room 4252 RFK Building, 950
Pennsylvania Avenue NW, Washington,
DC 20530. Comments received by mail
will be considered timely if they are
postmarked on or before September 18,
2020. The electronic Federal
eRulemaking portal will accept
comments until midnight Eastern Time
at the end of that day.
FOR FURTHER INFORMATION CONTACT:
Robert Hinchman, Senior Counsel,
Office of Legal Policy, U.S. Department
of Justice, Room 4252 RFK Building,
950 Pennsylvania Avenue NW,
Washington, DC 20530, telephone (202)
514–8059 (not a toll-free number).
SUPPLEMENTARY INFORMATION:
I. Posting of Public Comments
28 CFR Part 50
PO 00000
50951
Sfmt 4700
Please note that all comments
received are considered part of the
public record and made available for
public inspection online at https://
www.regulations.gov. Information made
available for public inspection includes
personal identifying information (such
as your name, address, etc.) voluntarily
submitted by the commenter.
If you wish to submit personal
identifying information (such as your
name, address, etc.) as part of your
comment, but do not wish it to be
posted online, you must include the
phrase ‘‘PERSONAL IDENTIFYING
INFORMATION’’ in the first paragraph
of your comment. You must also locate
all the personal identifying information
that you do not want posted online in
the first paragraph of your comment and
identify what information you want the
agency to redact. Personal identifying
information identified and located as set
forth above will be placed in the
agency’s public docket file, but not
posted online.
If you wish to submit confidential
business information as part of your
comment but do not wish it to be posted
online, you must include the phrase
‘‘CONFIDENTIAL BUSINESS
INFORMATION’’ in the first paragraph
of your comment. You must also
prominently identify confidential
business information to be redacted
within the comment. If a comment has
so much confidential business
information that it cannot be effectively
redacted, the agency may choose not to
post that comment (or to post that
comment only partially) on https://
E:\FR\FM\19AUR1.SGM
19AUR1
]]>Agencies
[Federal Register Volume 85, Number 161 (Wednesday, August 19, 2020)]
[Rules and Regulations]
[Pages 50950-50951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16595]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 882 and 895
[Docket No. FDA-2016-N-1111]
Medical Devices; Petition for an Administrative Stay of Action:
Electrical Stimulation Devices for Self-Injurious or Aggressive
Behavior
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; notification of administrative stay.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is providing
notice of a stay of the effectiveness of provisions for devices in use
on specific individuals who have or would need to obtain a physician-
directed transition plan as of the date of publication on March 6,
2020, of the final regulation banning electrical stimulation devices
(ESDs) for self-injurious or aggressive behavior. FDA is publishing
this notification in response to petitions for an administrative stay
of action in accordance with regulatory requirements.
DATES: FDA is administratively staying temporarily the final regulation
published on March 6, 2020 (85 FR 13312), for those devices in use on
specific individuals as described in SUPPLEMENTARY INFORMATION. FDA
will publish a document in the Federal Register lifting the stay or
taking further action as needed.
ADDRESSES: For access to the docket, go to https://www.regulations.gov
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Publicly
available submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527,
[email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of March 6, 2020 (85
FR 13312), FDA issued a final regulation banning electrical stimulation
devices (ESDs) for self-injurious behavior (SIB) or aggressive behavior
(AB). This final regulation provided two operational dates. The ban is
in effect for all devices as of April 6, 2020, 30 days after the date
of publication. However, for devices in use on specific individuals as
of the date of publication and subject to a physician-directed
transition plan, compliance is required on September 2, 2020, 180 days
after the date of publication of the final rule.
FDA received two requests under 21 CFR 10.35 to immediately and
indefinitely stay these dates for the final regulation banning ESDs for
SIB or AB. The first petition, dated March 20, 2020, is from Eckert
Seamans Cherin & Mellot, LLC on behalf of their client, the Judge
Rotenberg Educational Center, Inc. (JRC) (see Docket No. FDA-2020-P-
1166). As described below, FDA temporarily granted this petition (JRC
petition) in part on March 27, 2020. The second petition, dated March
24, 2020, is from Todd & Weld, LLP on behalf of their clients the
parents and guardians of certain patients at JRC, as well as the
patients themselves, and the JRC Parents and Friends Association, Inc.
(see
[[Page 50951]]
Docket No. FDA-2020-P-1181). This petition (Parent petition) was routed
for review and response after FDA's March 27, 2020, letter granting
JRC's request for a stay in part. Although filed by different parties,
the Parent petition requested the same action as the JRC petition and
did not necessitate a different response or change in the stay FDA
granted in response to the JRC petition. Both petitions request a stay
based on all four criteria for a mandatory stay or, alternatively,
based on being ``in the public interest and in the interest of
justice'' for a discretionary stay (Sec. 10.35 (21 CFR 10.35(e))).
Because the petitions request the same action for substantially similar
reasons, FDA has determined that its March 27, 2020, response to the
JRC petition is equally applicable to the Parent petition. FDA notes
that both sets of petitioners filed legal challenges to the ban in the
U.S. Court of Appeals for the D.C. Circuit, which challenges have now
been consolidated before that court.
By a letter dated March 27, 2020, FDA responded to the JRC petition
granting in part a discretionary temporary stay. As the letter states,
it is in the public health interest and interest of justice to stay the
compliance date for devices subject to the ban that are currently in
use on specific individuals who would need to obtain a physician-
directed transition plan to cease use of such devices. The stay is in
the public interest and interest of justice because of the ongoing
national emergency caused by ``severe acute respiratory syndrome
coronavirus 2'' (SARS-CoV-2) and the disease it causes ``Coronavirus
Disease 2019 (COVID-19).'' Specifically, the creation or implementation
of a physician-directed transition plan has the potential to increase
the risk of transmission or exposure to COVID-19, and it may divert
healthcare delivery resources from other uses during the pandemic.
The stay is intended to remain in effect for the duration of the
public health emergency related to COVID-19 declared by HHS, including
any renewals made by the Secretary in accordance with section 319(a)(2)
of the PHS Act (42 U.S.C. 247d(a)(2)). Once the public health emergency
ends, FDA will substantively respond to the petitions, and issue
another notification in the Federal Register, if necessary, in
accordance with Sec. 10.35. If the public health emergency ends while
the consolidated legal challenge in the D.C. Circuit is still pending,
the stay will continue in effect until: (1) FDA substantively responds
to the petitions and (2) if FDA does not grant the petitions, the
parties have had adequate time and reasonable opportunity to obtain a
ruling from the D.C. Circuit regarding a stay of FDA's response to the
petitions.
FDA's partial stay is limited to those devices currently in use on
specific individuals who have or would need to obtain a physician-
directed transition plan to cease use of such devices in order to
comply with the final regulation banning ESDs. For all other devices,
the ban became effective on, and required compliance by, April 6, 2020.
Dated: July 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-16595 Filed 8-17-20; 4:15 pm]
BILLING CODE 4164-01-P
