Steven A. Holper, M.D.; Decision and Order, 64165-64166 [2020-22390]
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Federal Register / Vol. 85, No. 197 / Friday, October 9, 2020 / Notices
collection: The estimated annual public
burden associated with this collection is
540 hours, which is equal to 300 (# of
respondents) * 1 (# of responses per
respondents) * 1.8 (1 hour and 48
minutes).
If additional information is required
contact: Melody Braswell, Department
Clearance Officer, United States
Department of Justice, Justice
Management Division, Policy and
Planning Staff, Two Constitution
Square, 145 N Street NE, 3E.405A,
Washington, DC 20530.
Dated: October 6, 2020.
Melody Braswell,
Department Clearance Officer for PRA, U.S.
Department of Justice.
Controlled
substance
Drug code
5-Methoxy-N-Ndimethyltryptamine.
Norlevorphanol
Schedule
7431
I
9634
I
The company plans to manufacture
the above-listed controlled substances
as clinical trial and starting materials to
make compounds for distribution to its
customers. No other activity for these
drug codes is authorized for this
registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–22442 Filed 10–8–20; 8:45 am]
BILLING CODE P
[FR Doc. 2020–22453 Filed 10–8–20; 8:45 am]
BILLING CODE 4410–30–P
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
Steven A. Holper, M.D.; Decision and
Order
[Docket No. DEA–720]
Bulk Manufacturer of Controlled
Substances Application: Purisys, LLC
Drug Enforcement
Administration, Justice.
AGENCY:
ACTION:
Notice of application.
Purisys, LLC has applied to be
registered as a bulk manufacturer of
basic class(es) of controlled
substance(s). Refer to Supplemental
Information listed below for further
drug information.
SUMMARY:
Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before December 8, 2020. Such
persons may also file a written request
for a hearing on the application on or
before December 8, 2020
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on August 27, 2020,
Purisys, LLC, 1550 Olympic Drive,
Athens, Georgia 30601–1602, applied to
be registered as an bulk manufacturer of
the following basic class(es) of
controlled substances:
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:26 Oct 08, 2020
Jkt 253001
On October 22, 2019, the Acting
Assistant Administrator, Diversion
Control Division, Drug Enforcement
Administration (hereinafter,
Government or DEA), issued an Order to
Show Cause (hereinafter, OSC) to
Steven A. Holper, M.D., (hereinafter,
Registrant), of Las Vegas, Nevada.
Government’s Request for Final Agency
Action Exhibit (hereinafter, RFAAX) 5
(OSC), at 1. The OSC proposed the
revocation of Registrant’s Certificate of
Registration No. BH2498106. It alleged
that Registrant is without ‘‘authority to
handle controlled substances in Nevada,
the state in which [Registrant is]
registered with the DEA.’’ Id. (citing 21
U.S.C. 823(f) and 824(a)(3)).
Specifically, the OSC alleged that
Registrant’s state controlled substance
license expired on October 21, 2018. Id.
at 1–2. The OSC also alleged that
Registrant’s state medical license was
revoked by the Board of Medical
Examiners of the State of Nevada on
September 6, 2019. Id. at 2. The OSC
further alleged that Registrant is not
eligible to obtain or retain a DEA
registration because he lacks state
authority to handle controlled
substances in the state of Nevada. Id.
The OSC notified Registrant of the
right to either request a hearing on the
allegations or submit a written
statement in lieu of exercising the right
to a hearing, the procedures for electing
each option, and the consequences for
failing to elect either option. Id. (citing
21 CFR 1301.43). The OSC also notified
Registrant of the opportunity to submit
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
64165
a corrective action plan. Id. at 3 (citing
21 U.S.C. 824(c)(2)(C)).
A DEA Diversion Investigator
personally served Registrant with the
OSC on December 16, 2019. RFAAX 12,
at 2–3 (Declaration of Diversion
Investigator One). I find that more than
thirty days have now passed since the
Government accomplished service of
the OSC. Further, based on the
Government’s written representations, I
find that neither Registrant, nor anyone
purporting to represent Registrant,
requested a hearing, submitted a written
statement while waiving Registrant’s
right to a hearing, or submitted a
corrective action plan. RFAAX 11, at 3–
4 (Declaration of Diversion Investigator
Two). Accordingly, I find that Registrant
has waived the right to a hearing and
the right to submit a written statement
and corrective action plan. 21 CFR
1301.43(d) and 21 U.S.C. 824(c)(2)(C). I,
therefore, issue this Decision and Order
based on the record submitted by the
Government, which constitutes the
entire record before me. 21 CFR
1301.46.
Findings of Fact
Registrant’s DEA Registration
Registrant is the holder of DEA
Certificate of Registration No.
BH2498106 at the registered address of
3233 W. Charleston Blvd. 202, Las
Vegas, NV 89102. RFAAX 1 (Registrant’s
DEA Certificate of Registration).
Pursuant to this registration, Registrant
is authorized to dispense controlled
substances in schedules II through V as
a practitioner. Id. Registrant’s
registration will expire on its own terms
on October 31, 2020. Id.
DEA Investigation and the Status of
Registrant’s State Licenses
On July 22, 2019, Registrant was
sentenced in the United States District
Court for the District of Nevada on a
matter related to his conviction on one
count of unlawful distribution of a
controlled substance. RFAAX 11, at 2.
On August 12, 2019, a DEA Diversion
Investigator (hereinafter, DI Two) asked
Registrant, through his legal counsel, to
voluntarily surrender his DEA
registration. Id. Registrant declined. Id.
The General Counsel for the Nevada
State Board of Pharmacy (hereinafter,
Pharmacy Board) sent DI Two a letter
dated September 17, 2019, stating that
Registrant did not renew his Nevada
controlled substance license and did not
hold an active controlled substance
license with the Pharmacy Board.
RFAAX 4. According to the online
records of the Pharmacy Board,
Registrant’s controlled substance
E:\FR\FM\09OCN1.SGM
09OCN1
64166
Federal Register / Vol. 85, No. 197 / Friday, October 9, 2020 / Notices
license, license no. CS057748, expired
on October 31, 2018, id.; RFAAX 9
(Printout of Pharmacy Board website
dated March 25, 2020), and remains
closed,1 https://online.nvbop.org/#/
verifylicense (last visited September 24,
2020).
On September 6, 2019, the Nevada
State Board of Medical Examiners
(hereinafter, Medical Board) revoked
Registrant’s medical license, license no.
6061, pursuant to a settlement
agreement between Registrant and the
Investigative Committee of the Medical
Board. RFAAX 3 (Settlement
Agreement). The Investigative
Committee of the Medical Board had
filed a Complaint on April 3, 2019,
charging Registrant with ‘‘violating the
Medical Practice Act.’’ Id. at 1.
Specifically, the Complaint alleged ‘‘one
(1) violation of NRS 640.306(1)(c),
Illegal Dispensing of Controlled
Substances (Count 1), one (1) violation
of NRS 630.306(1)(p), Unsafe or
Unprofessional Conduct (Count II), and
one (1) violation of NRS 630.301(9),
Disreputable Conduct (Count III).’’ Id. at
1–2. Pursuant to the Settlement
Agreement, Registrant admitted to
Count 1 of the Complaint and agreed
that the Medical Board could issue an
order finding that Registrant ‘‘engaged
in conduct that is grounds for discipline
pursuant to the Medical Practice Act.’’
Id. at 4. The Settlement Agreement
stated that, upon adoption of the
Agreement by the Medical Board,
Registrant’s medical license would be
immediately revoked and Registrant
would be ineligible to apply for
reinstatement for a period of three years.
Id. The Medical Board adopted the
Settlement Agreement on September 6,
2019. Id. at 8.
Accordingly, I find that Registrant
currently is neither licensed to engage
in the practice of medicine nor licensed
to dispense controlled substances in
1 I take official notice of the online records of the
Nevada State Board of Pharmacy. Under the
Administrative Procedure Act, an agency ‘‘may take
official notice of facts at any stage in a proceeding—
even in the final decision.’’ United States
Department of Justice, Attorney General’s Manual
on the Administrative Procedure Act 80 (1947)
(Wm. W. Gaunt & Sons, Inc., Reprint 1979).
Pursuant to 5 U.S.C. 556(e), ‘‘[w]hen an agency
decision rests on official notice of a material fact
not appearing in the evidence in the record, a party
is entitled, on timely request, to an opportunity to
show the contrary.’’ Accordingly, Registrant may
dispute my finding by filing a properly supported
motion for reconsideration within fifteen calendar
days of the date of this Order. Any such motion
shall be filed with the Office of the Administrator
and a copy shall be served on the Government. In
the event Registrant files a motion, the Government
shall have fifteen calendar days to file a response.
Any such motion and response may be filed and
served by email (dea.addo.attorneys@
dea.usdoj.gov).
VerDate Sep<11>2014
17:26 Oct 08, 2020
Jkt 253001
Nevada, the state in which Registrant is
registered with the DEA.
Discussion
Pursuant to 21 U.S.C. 824(a)(3), the
Attorney General is authorized to
suspend or revoke a registration issued
under section 823 of the CSA ‘‘upon a
finding that the registrant . . . has had
his State license or registration
suspended . . . [or] revoked . . . by
competent State authority and is no
longer authorized by State law to engage
in the . . . dispensing of controlled
substances.’’ With respect to a
practitioner, the DEA has also long held
that the possession of authority to
dispense controlled substances under
the laws of the state in which a
practitioner engages in professional
practice is a fundamental condition for
obtaining and maintaining a
practitioner’s registration. See, e.g.,
James L. Hooper, M.D., 76 FR 71,371
(2011), pet. for rev. denied, 481 Fed.
Appx. 826 (4th Cir. 2012); Frederick
Marsh Blanton, M.D., 43 FR 27,616,
27,617 (1978).
This rule derives from the text of two
provisions of the CSA. First, Congress
defined the term ‘‘practitioner’’ to mean
‘‘a physician . . . or other person
licensed, registered, or otherwise
permitted, by . . . the jurisdiction in
which he practices . . . , to distribute,
dispense, . . . [or] administer . . . a
controlled substance in the course of
professional practice.’’ 21 U.S.C.
802(21). Second, in setting the
requirements for obtaining a
practitioner’s registration, Congress
directed that ‘‘[t]he Attorney General
shall register practitioners . . . if the
applicant is authorized to dispense . . .
controlled substances under the laws of
the State in which he practices.’’ 21
U.S.C. 823(f). Because Congress has
clearly mandated that a practitioner
possess state authority in order to be
deemed a practitioner under the CSA,
the DEA has held repeatedly that
revocation of a practitioner’s registration
is the appropriate sanction whenever he
is no longer authorized to dispense
controlled substances under the laws of
the state in which he practices. See, e.g.,
James L. Hooper, 76 FR at 71,371–72;
Sheran Arden Yeates, M.D., 71 FR
39,130, 39,131 (2006); Dominick A.
Ricci, M.D., 58 FR 51,104, 51,105 (1993);
Bobby Watts, M.D., 53 FR 11,919, 11,920
(1988); Frederick Marsh Blanton, 43 FR
at 27,617.
Nevada law gives authority to
‘‘practitioners’’ to dispense controlled
substances, Nev. Rev. Stat. § 453.337
(West 2020), and requires that ‘‘[e]very
practitioner . . . who dispenses any
controlled substance within this State
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
. . . shall obtain biennially a
registration issued by the [Pharmacy]
Board,’’ Nev. Rev. Stat. § 453.226(1)
(West 2020). Nevada law further defines
‘‘practitioner’’ to mean ‘‘a physician
. . . who holds a license to practice his
or her profession in this State and is
registered pursuant to [the Uniform
Controlled Substances Act].’’ Nev. Rev.
Stat. § 453.126(1) (West 2020).
Here, the undisputed evidence in the
record is that Registrant’s license to
practice medicine is revoked. As such,
he is not a ‘‘practitioner,’’ a physician
licensed to practice his profession in
Nevada and registered to dispense
controlled substances, according to
Nevada law. Further, under Nevada law,
a practitioner who dispenses a
controlled substance in Nevada must be
registered. The undisputed record
evidence is that Registrant’s Nevada
controlled substance license is expired.
Thus, because Registrant lacks authority
to dispense controlled substances in
Nevada, Registrant is not eligible to
maintain a DEA registration.
Accordingly, I will order that
Registrant’s DEA registration be
revoked.
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
824(a), I hereby revoke DEA Certificate
of Registration No. BH2498106 issued to
Steven A. Holper, M.D. Further,
pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
823(f), I hereby deny any pending
application of Steven A. Holper, M.D. to
renew or modify this registration, as
well as any pending application of
Steven A. Holper, M.D. for registration
in Nevada. This Order is effective
November 9, 2020.
Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020–22390 Filed 10–8–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Notice of Lodging Proposed Consent
Decree
In accordance with Departmental
Policy, 28 CFR 50.7, notice is hereby
given that a proposed Consent Decree in
United States v. D.R. Horton, Inc., Case
No. 8:20–cv–02271–CEH–CPT, was
lodged with the United States District
Court for the Middle District of Florida,
Tampa Division, on October 1, 2020.
This proposed Consent Decree
concerns a complaint filed by the
United States, pursuant to Sections 309
and 404 of the Clean Water Act
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[Federal Register Volume 85, Number 197 (Friday, October 9, 2020)]
[Notices]
[Pages 64165-64166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22390]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Steven A. Holper, M.D.; Decision and Order
On October 22, 2019, the Acting Assistant Administrator, Diversion
Control Division, Drug Enforcement Administration (hereinafter,
Government or DEA), issued an Order to Show Cause (hereinafter, OSC) to
Steven A. Holper, M.D., (hereinafter, Registrant), of Las Vegas,
Nevada. Government's Request for Final Agency Action Exhibit
(hereinafter, RFAAX) 5 (OSC), at 1. The OSC proposed the revocation of
Registrant's Certificate of Registration No. BH2498106. It alleged that
Registrant is without ``authority to handle controlled substances in
Nevada, the state in which [Registrant is] registered with the DEA.''
Id. (citing 21 U.S.C. 823(f) and 824(a)(3)).
Specifically, the OSC alleged that Registrant's state controlled
substance license expired on October 21, 2018. Id. at 1-2. The OSC also
alleged that Registrant's state medical license was revoked by the
Board of Medical Examiners of the State of Nevada on September 6, 2019.
Id. at 2. The OSC further alleged that Registrant is not eligible to
obtain or retain a DEA registration because he lacks state authority to
handle controlled substances in the state of Nevada. Id.
The OSC notified Registrant of the right to either request a
hearing on the allegations or submit a written statement in lieu of
exercising the right to a hearing, the procedures for electing each
option, and the consequences for failing to elect either option. Id.
(citing 21 CFR 1301.43). The OSC also notified Registrant of the
opportunity to submit a corrective action plan. Id. at 3 (citing 21
U.S.C. 824(c)(2)(C)).
A DEA Diversion Investigator personally served Registrant with the
OSC on December 16, 2019. RFAAX 12, at 2-3 (Declaration of Diversion
Investigator One). I find that more than thirty days have now passed
since the Government accomplished service of the OSC. Further, based on
the Government's written representations, I find that neither
Registrant, nor anyone purporting to represent Registrant, requested a
hearing, submitted a written statement while waiving Registrant's right
to a hearing, or submitted a corrective action plan. RFAAX 11, at 3-4
(Declaration of Diversion Investigator Two). Accordingly, I find that
Registrant has waived the right to a hearing and the right to submit a
written statement and corrective action plan. 21 CFR 1301.43(d) and 21
U.S.C. 824(c)(2)(C). I, therefore, issue this Decision and Order based
on the record submitted by the Government, which constitutes the entire
record before me. 21 CFR 1301.46.
Findings of Fact
Registrant's DEA Registration
Registrant is the holder of DEA Certificate of Registration No.
BH2498106 at the registered address of 3233 W. Charleston Blvd. 202,
Las Vegas, NV 89102. RFAAX 1 (Registrant's DEA Certificate of
Registration). Pursuant to this registration, Registrant is authorized
to dispense controlled substances in schedules II through V as a
practitioner. Id. Registrant's registration will expire on its own
terms on October 31, 2020. Id.
DEA Investigation and the Status of Registrant's State Licenses
On July 22, 2019, Registrant was sentenced in the United States
District Court for the District of Nevada on a matter related to his
conviction on one count of unlawful distribution of a controlled
substance. RFAAX 11, at 2. On August 12, 2019, a DEA Diversion
Investigator (hereinafter, DI Two) asked Registrant, through his legal
counsel, to voluntarily surrender his DEA registration. Id. Registrant
declined. Id.
The General Counsel for the Nevada State Board of Pharmacy
(hereinafter, Pharmacy Board) sent DI Two a letter dated September 17,
2019, stating that Registrant did not renew his Nevada controlled
substance license and did not hold an active controlled substance
license with the Pharmacy Board. RFAAX 4. According to the online
records of the Pharmacy Board, Registrant's controlled substance
[[Page 64166]]
license, license no. CS057748, expired on October 31, 2018, id.; RFAAX
9 (Printout of Pharmacy Board website dated March 25, 2020), and
remains closed,\1\ https://online.nvbop.org/#/verifylicense (last
visited September 24, 2020).
---------------------------------------------------------------------------
\1\ I take official notice of the online records of the Nevada
State Board of Pharmacy. Under the Administrative Procedure Act, an
agency ``may take official notice of facts at any stage in a
proceeding--even in the final decision.'' United States Department
of Justice, Attorney General's Manual on the Administrative
Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979).
Pursuant to 5 U.S.C. 556(e), ``[w]hen an agency decision rests on
official notice of a material fact not appearing in the evidence in
the record, a party is entitled, on timely request, to an
opportunity to show the contrary.'' Accordingly, Registrant may
dispute my finding by filing a properly supported motion for
reconsideration within fifteen calendar days of the date of this
Order. Any such motion shall be filed with the Office of the
Administrator and a copy shall be served on the Government. In the
event Registrant files a motion, the Government shall have fifteen
calendar days to file a response. Any such motion and response may
be filed and served by email ([email protected]).
---------------------------------------------------------------------------
On September 6, 2019, the Nevada State Board of Medical Examiners
(hereinafter, Medical Board) revoked Registrant's medical license,
license no. 6061, pursuant to a settlement agreement between Registrant
and the Investigative Committee of the Medical Board. RFAAX 3
(Settlement Agreement). The Investigative Committee of the Medical
Board had filed a Complaint on April 3, 2019, charging Registrant with
``violating the Medical Practice Act.'' Id. at 1. Specifically, the
Complaint alleged ``one (1) violation of NRS 640.306(1)(c), Illegal
Dispensing of Controlled Substances (Count 1), one (1) violation of NRS
630.306(1)(p), Unsafe or Unprofessional Conduct (Count II), and one (1)
violation of NRS 630.301(9), Disreputable Conduct (Count III).'' Id. at
1-2. Pursuant to the Settlement Agreement, Registrant admitted to Count
1 of the Complaint and agreed that the Medical Board could issue an
order finding that Registrant ``engaged in conduct that is grounds for
discipline pursuant to the Medical Practice Act.'' Id. at 4. The
Settlement Agreement stated that, upon adoption of the Agreement by the
Medical Board, Registrant's medical license would be immediately
revoked and Registrant would be ineligible to apply for reinstatement
for a period of three years. Id. The Medical Board adopted the
Settlement Agreement on September 6, 2019. Id. at 8.
Accordingly, I find that Registrant currently is neither licensed
to engage in the practice of medicine nor licensed to dispense
controlled substances in Nevada, the state in which Registrant is
registered with the DEA.
Discussion
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized
to suspend or revoke a registration issued under section 823 of the CSA
``upon a finding that the registrant . . . has had his State license or
registration suspended . . . [or] revoked . . . by competent State
authority and is no longer authorized by State law to engage in the . .
. dispensing of controlled substances.'' With respect to a
practitioner, the DEA has also long held that the possession of
authority to dispense controlled substances under the laws of the state
in which a practitioner engages in professional practice is a
fundamental condition for obtaining and maintaining a practitioner's
registration. See, e.g., James L. Hooper, M.D., 76 FR 71,371 (2011),
pet. for rev. denied, 481 Fed. Appx. 826 (4th Cir. 2012); Frederick
Marsh Blanton, M.D., 43 FR 27,616, 27,617 (1978).
This rule derives from the text of two provisions of the CSA.
First, Congress defined the term ``practitioner'' to mean ``a physician
. . . or other person licensed, registered, or otherwise permitted, by
. . . the jurisdiction in which he practices . . . , to distribute,
dispense, . . . [or] administer . . . a controlled substance in the
course of professional practice.'' 21 U.S.C. 802(21). Second, in
setting the requirements for obtaining a practitioner's registration,
Congress directed that ``[t]he Attorney General shall register
practitioners . . . if the applicant is authorized to dispense . . .
controlled substances under the laws of the State in which he
practices.'' 21 U.S.C. 823(f). Because Congress has clearly mandated
that a practitioner possess state authority in order to be deemed a
practitioner under the CSA, the DEA has held repeatedly that revocation
of a practitioner's registration is the appropriate sanction whenever
he is no longer authorized to dispense controlled substances under the
laws of the state in which he practices. See, e.g., James L. Hooper, 76
FR at 71,371-72; Sheran Arden Yeates, M.D., 71 FR 39,130, 39,131
(2006); Dominick A. Ricci, M.D., 58 FR 51,104, 51,105 (1993); Bobby
Watts, M.D., 53 FR 11,919, 11,920 (1988); Frederick Marsh Blanton, 43
FR at 27,617.
Nevada law gives authority to ``practitioners'' to dispense
controlled substances, Nev. Rev. Stat. Sec. 453.337 (West 2020), and
requires that ``[e]very practitioner . . . who dispenses any controlled
substance within this State . . . shall obtain biennially a
registration issued by the [Pharmacy] Board,'' Nev. Rev. Stat. Sec.
453.226(1) (West 2020). Nevada law further defines ``practitioner'' to
mean ``a physician . . . who holds a license to practice his or her
profession in this State and is registered pursuant to [the Uniform
Controlled Substances Act].'' Nev. Rev. Stat. Sec. 453.126(1) (West
2020).
Here, the undisputed evidence in the record is that Registrant's
license to practice medicine is revoked. As such, he is not a
``practitioner,'' a physician licensed to practice his profession in
Nevada and registered to dispense controlled substances, according to
Nevada law. Further, under Nevada law, a practitioner who dispenses a
controlled substance in Nevada must be registered. The undisputed
record evidence is that Registrant's Nevada controlled substance
license is expired. Thus, because Registrant lacks authority to
dispense controlled substances in Nevada, Registrant is not eligible to
maintain a DEA registration. Accordingly, I will order that
Registrant's DEA registration be revoked.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No.
BH2498106 issued to Steven A. Holper, M.D. Further, pursuant to 28 CFR
0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby
deny any pending application of Steven A. Holper, M.D. to renew or
modify this registration, as well as any pending application of Steven
A. Holper, M.D. for registration in Nevada. This Order is effective
November 9, 2020.
Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-22390 Filed 10-8-20; 8:45 am]
BILLING CODE 4410-09-P