60-Day Federal Register Notice

Federal Register / Vol. 90, No. 70 / Monday, April 14, 2025 / Notices
admitted and the Agency finds that it
failed to maintain complete and
accurate records of each controlled
substance received. As such, the Agency
finds substantial record evidence that
Registrant violated 21 CFR 1304.21(a).
The Agency further finds that Factors
B and D weigh in favor of denial of
Registrant’s application and that
Registrant’s registration would be
inconsistent with the public interest in
balancing the factors of 21 U.S.C.
823(g)(1). Accordingly, the Agency finds
that the Government established a
prima facie case, that Registrant did not
rebut that prima facie case, and that
there is substantial record evidence
supporting the revocation of Registrant’s
registration. 21 U.S.C. 823(g)(1).

ddrumheller on DSK120RN23PROD with NOTICES1

II. Sanction
Where, as here, the Government has
met its prima facie burden of showing
that Registrant’s registration is
inconsistent with the public interest due
to its numerous violations pertaining to
controlled substances, the burden shifts
to Registrant to show why it can be
entrusted with a registration. Morall,
412 F.3d. at 174; Jones Total Health
Care Pharmacy, 881 F.3d 823, 830 (11th
Cir. 2018); Garrett Howard Smith, M.D.,
83 FR 18882 (2018). The issue of trust
is necessarily a fact-dependent
determination based on the
circumstances presented by the
individual registrant. Jeffrey Stein, M.D.,
84 FR 46968, 46972 (2019); see also
Jones Total Health Care Pharmacy, 881
F.3d at 833. Moreover, as past
performance is the best predictor of
future performance, DEA
Administrators have required that a
registrant who has committed acts
inconsistent with the public interest
must accept responsibility for those acts
and demonstrate that it will not engage
in future misconduct. Jones Total
Health Care Pharmacy, 881 F.3d at 833.
A registrant’s acceptance of
responsibility must be unequivocal. Id.
at 830–31. In addition, a registrant’s
candor during the investigation and
hearing has been an important factor in
determining acceptance of
responsibility and the appropriate
sanction. Id. Further, DEA
However, the OSC/ISO does not contain sufficient
factual or legal analysis to enable to Agency to
assess the relevance or applicability of these
statutes. Section (a)(1)(A) pertains to institutional
pharmacies, and the OSC/ISO does not allege that
Registrant is an institutional pharmacy. Section
(c)(4) outlines requirements for patient records of
Schedule II controlled substances to be maintained
separately from patient records of controlled
substances in other schedules, and it outlines
additional requirements related to distribution
records and institutional pharmacies. Finally,
Section (c)(5) pertains to floor stock records.

VerDate Sep<11>2014

18:10 Apr 11, 2025

Jkt 265001

Administrators have found that the
egregiousness and extent of the
misconduct are significant factors in
determining the appropriate sanction.
Id. at 834 and n.4. DEA Administrators
have also considered the need to deter
similar acts by the specific registrant
and by the community of registrants.
Jeffrey Stein, M.D., 84 FR 46972–73.
Here, Registrant did not timely or
properly request a hearing and was
deemed to be in default. 21 CFR
1301.43(c)(1), (e), (f)(1); RFAA, at 1–9.
To date, Registrant has not filed a
motion with the Office of the
Administrator to excuse the default. 21
CFR 1301.43(c)(1). Registrant has thus
failed to answer the allegations
contained in the OSC and has not
otherwise availed itself of the
opportunity to refute the Government’s
case. As such, Registrant has made no
representations as to its future
compliance with the CSA nor made any
demonstration that it can be entrusted
with registration. Moreover, the
evidence presented by the Government
shows that Registrant violated the CSA,
further indicating that Registrant cannot
be entrusted.
Accordingly, the Agency will order
the revocation of Registrant’s
application.
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. FM2279431 issued to
Mariste Pharmacy. Further, pursuant to
28 CFR 0.100(b) and the authority
vested in me by 21 U.S.C. 823(g)(1), I
hereby deny any pending applications
of Mariste Pharmacy to renew or modify
this registration, as well as any other
pending application of Mariste
Pharmacy for additional registration in
Texas. This Order is effective May 14,
2025.
Signing Authority
This document of the Drug
Enforcement Administration was signed
on April 8, 2025, by Acting
Administrator Derek Maltz. That
document with the original signature
and date is maintained by DEA. For
administrative purposes only, and in
compliance with requirements of the
Office of the Federal Register, the
undersigned DEA Federal Register
Liaison Officer has been authorized to
sign and submit the document in
electronic format for publication, as an
official document of DEA. This
administrative process in no way alters

PO 00000

Frm 00053

Fmt 4703

Sfmt 4703

15587

the legal effect of this document upon
publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug
Enforcement Administration.
[FR Doc. 2025–06312 Filed 4–11–25; 8:45 am]
BILLING CODE 4410–09–P

DEPARTMENT OF LABOR
Office of Disability Employment Policy
[OMB Control No. 1230–0014]

Proposed Extension of Information
Collection: Retaining Employment and
Talent After Injury/Illness Network
(RETAIN) Demonstration Projects and
Evaluation
Office of Disability
Employment Policy, United States
Department of Labor.
ACTION: Notice of information
collections and request for comments.
AGENCY:

The Department of Labor
(DOL) Office of Disability Employment
Policy is soliciting comments regarding
this ODEP-sponsored information
collection for the Retaining Employment
and Talent After Injury/Illness Network
(RETAIN) Demonstration Projects and
Evaluation. As part of its continuing
effort to reduce paperwork and
respondent burden, DOL conducts a
pre-clearance request for comment to
provide the general public and Federal
agencies with an opportunity to
comment on proposed collections of
information in accordance with the
Paperwork Reduction Act of 1995. This
request helps to ensure that: requested
data can be provided in the desired
format; reporting burden (time and
financial resources) is minimized;
collection instruments are clearly
understood; and the impact of collection
requirements on respondents can be
properly assessed.
DATES: Comments pertaining to this
information collection are due on or
before June 13, 2025.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered.
Electronic Submission: Submit
electronic comments in the following
way:
Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket, with no changes. Because
your comment will be made public, you
SUMMARY:

E:\FR\FM\14APN1.SGM

14APN1

15588

Federal Register / Vol. 90, No. 70 / Monday, April 14, 2025 / Notices

ddrumheller on DSK120RN23PROD with NOTICES1

are responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as your or anyone else’s Social
Security number or confidential
business information.
• If your comment includes
confidential information that you do not
wish to be made available to the public,
submit the comment as a written/paper
submission.
Written/Paper Submissions: Submit
written/paper submissions in the
following way:
• Mail/Hand Delivery: Mail or visit
DOL, 200 Constitution Ave. NW, Room
S–5315, Washington, DC 20210.
• DOL–ODEP will post your comment
as well as any attachments, except for
information submitted and marked as
confidential, in the docket at https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
David Rosenblum by telephone at 202–
693–7840 (this is not a toll-free number)
or by email at DOL_PRA_PUBLIC@
dol.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In FY 2018, the Department of Labor
and the Social Security Administration
launched a collaboration to develop and
test promising stay-at-work/return-towork (SAW/RTW) early intervention
strategies and evaluate outcomes for
individuals who are experiencing work
disability.1 Each year, millions of
American workers leave the workforce
after experiencing an injury or illness,
and hundreds of thousands of these
workers go on to receive state or federal
disability benefits. The socio-economic
impacts of these injuries and illnesses
on individuals, employers, and all
levels of government can be significant
and long-lasting. SAW/RTW programs
succeed by returning injured workers to
productive work as soon as medically
possible by providing interim part-time
or light duty work and accommodations,
as necessary.
The RETAIN Demonstration Projects
are modeled after promising programs
currently operating in Washington State,
including the Centers of Occupational
Health and Education (COHE), the Early
Return to Work (ERTW), and the Stay at
Work programs. While these programs
1 For the purposes of RETAIN, the term ‘‘work
disability’’ is defined as an illness, injury, or
medical condition that has the potential to inhibit
or prevent continued employment or labor force
participation, and ‘‘federal disability benefits’’
refers specifically to the Social Security Disability
Insurance (SSDI) and Supplemental Security
Income (SSI) programs. See https://www.ssa.gov/
disability/ for more information on SSDI and SSI.

VerDate Sep<11>2014

18:10 Apr 11, 2025

Jkt 265001

operate within the state’s workers’
compensation system and are available
only to individuals experiencing workrelated injuries or illnesses, the RETAIN
Demonstration Projects provide
opportunities to improve SAW/RTW
outcomes for individuals with both
occupational and non-occupational
injuries and illnesses.
The primary goals of the RETAIN
Demonstration Projects are:
1. To increase employment retention
and labor force participation of
individuals who acquire, and/or are at
risk of developing, work disabilities;
and
2. To reduce long-term work disability
among project participants, including
the need for federal disability benefits
(i.e., Social Security Disability
Insurance [SSDI] and Supplemental
Security Income [SSI]).
During FY 2018, eight states received
funding through cooperative agreements
to create systems changes by developing
and implementing partnerships and
strategies to test the effects of the
provision of comprehensive,
coordinated health and employmentrelated services and supports to injured
or ill workers who have acquired, or are
at risk of developing, a work disability.
In Phase 1, these grantees completed
start-up activities and launched a small
pilot. In FY 2021, five of these grantees
(Kansas, Kentucky, Minnesota, Ohio,
and Vermont) were competitively
awarded Phase 2 funding for a
performance period of four years (2021–
2024), enabling them to expand and
scale up their pilot to full
implementation. This performance
period has been extended to 2025 for all
five grantees and subsequently to 2026
for four grantees, as they continue
sustainability activities.
The purpose of the RETAIN employee
participant information collection is to
understand and assess RETAIN program
start-up, pilot projects, and full
implementation. Two baseline forms are
required to be completed for each
participant enrolling in RETAIN,
whether in the treatment group or in the
control group. The first form is
completed by the enrollees themselves,
while the second form is completed by
a combination of the healthcare
provider and Return-to-Work
Coordinator, based on information
provided by the enrollee. This
information collection was approved by
OMB in May 2019 with an expiration
date of May 31, 2022, and it was
subsequently approved by OMB on June
1, 2022 for an extension with an
expiration date of June 30, 2025. An
extension is requested for another year,

PO 00000

Frm 00054

Fmt 4703

Sfmt 4703

to last through the end of Phase 2 for all
grantees.
This information collection is subject
to the Paperwork Reduction Act (PRA).
A Federal agency generally cannot
conduct or sponsor a collection of
information, and the public is generally
not required to respond to an
information collection, unless the OMB
approves it and displays a currently
valid OMB Control Number. In addition,
notwithstanding any other provisions of
law, no person shall generally be subject
to penalty for failing to comply with a
collection of information that does not
display a valid OMB Control Number.
See 5 CFR 1320.5(a) and 1320.6.
The DOL seeks PRA authorization for
this information collection for one (1)
year. OMB authorization for an
Information Collection Review cannot
be for more than three (3) years without
renewal. The DOL notes that currently
approved information collection
requirements submitted to the OMB
receive a month-to-month extension
while they undergo review.
II. Desired Focus of Comments
DOL is soliciting comments
concerning the proposed information
collection related to Retaining
Employment and Talent After Injury/
Illness Network (RETAIN)
Demonstration Projects and Evaluation.
DOL is particularly interested in
comments that:
• Evaluate whether the collection of
information is necessary for the proper
performance of the functions of the
Agency, including whether the
information has practical utility;
• Evaluate the accuracy of DOL’s
estimate of the burden related to the
information collection, including the
validity of the methodology and
assumptions used in the estimate;
• Suggest methods to enhance the
quality, utility, and clarity of the
information to be collected; and
• Minimize the burden of the
information collection on those who are
to respond, including through the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology, e.g., permitting
electronic submission of responses.
Background documents related to this
information collection request are
available at https://regulations.gov and
at DOL located at 200 Constitution Ave.
NW, Room S–5315, Washington, DC
20210. Questions about the information
collection requirements may be directed
to the person listed in the FOR FURTHER
INFORMATION section of this notice.

E:\FR\FM\14APN1.SGM

14APN1

Federal Register / Vol. 90, No. 70 / Monday, April 14, 2025 / Notices
III. Current Actions
This information collection request
concerns the Retaining Employment and
Talent After Injury/Illness Network
(RETAIN) Demonstration Projects and
Evaluation. DOL–ODEP has included
the number of respondents, responses,
burden hours, and burden costs
supporting this information collection
request below.
Type of Review: Extension.
Agency: DOL–ODEP.
OMB Control Number: 1230–0014.
Affected Public: Individuals or
Households.
Number of Respondents: 1,920.
Number of Responses: 1,920.
Annual Burden Hours: 640 hours.
Estimated Time per Response: 20
minutes.
Total Estimated Annual Other Costs
Burden: $0.
Comments submitted in response to
this notice will be summarized in the
request for Office of Management and
Budget approval of the proposed
information collection request; they will
become a matter of public record and
will be available at https://
www.reginfo.gov.
(Authority: 44 U.S.C. 3506(c)(2)(A))
Dated: March 28, 2025.
Jennifer Sheehy,
Deputy Assistant Secretary, Office of
Disability Employment Policy.
[FR Doc. 2025–06262 Filed 4–11–25; 8:45 am]
BILLING CODE 4510–FK–P

DEPARTMENT OF LABOR
Agency Information Collection
Activities; Submission for OMB
Review; Comment Request; Settlement
Agreements Between a Plan and a
Party in Interest
Notice of availability; request
for comments.

ACTION:

The Department of Labor
(DOL) is submitting this Employee
Benefits Security Administration
(EBSA)-sponsored information
collection request (ICR) to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act of 1995
(PRA). Public comments on the ICR are
invited.
DATES: The OMB will consider all
written comments that the agency
receives on or before May 14, 2025.
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/

ddrumheller on DSK120RN23PROD with NOTICES1

SUMMARY:

VerDate Sep<11>2014

18:10 Apr 11, 2025

Jkt 265001

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:
Michael Howell by telephone at 202–
693–6782, or by email at DOL_PRA_
[email protected].
SUPPLEMENTARY INFORMATION: This
information collection request relates to
two prohibited transaction class
exemptions (PTEs) that the Department
has granted, both of which involve
settlement agreements. These two
exemptions are described below.
PTE 94–71 exempts from certain
restrictions of ERISA and certain taxes
imposed by the Code, a transaction or
activity that is authorized, prior to the
execution of the transaction or activity,
by a settlement agreement, to which the
Department is a party, resulting from an
investigation of an employee benefit
plan conducted by the Department. The
following information collections are
among the conditions for the exemption:
(1) A party engaging in a settlement
agreement arising out of a Department
investigation must provide written
notice to the affected participants and
beneficiaries of the plan at least 30 days
prior to entry into the settlement
agreement. The notice must contain an
objective description of the transaction
or activity, the approximate date on
which the transaction will occur, the
address of the regional or district office
of the Department that negotiated the
settlement agreement, and a statement
informing participants and beneficiaries
of their right to forward their comments
to such office. (2) A copy of the notice
and a description of the method by
which it will be distributed must be
approved in advance by the regional or
district office of the Department which
negotiated the settlement.
PTE 2003–39 exempts from certain
restrictions of ERISA and certain taxes
imposed by the Code, transactions
arising out of the settlement of litigation
that involve: the release by the plan or
a plan fiduciary of legal claims against
parties in interest in exchange for
payment given by or on behalf of the
party in interest to the plan; an
extension of credit by a plan to a party
interest in connection with a settlement;
and the plan’s acquisition, holding, and
disposition of employer securities
received in settlement of litigation. The
relief is granted provided certain
conditions are met, such as the
requirement of an independent
fiduciary who has no relationship to, or
interest in, any parties in the litigation
to authorize the settlement and the

PO 00000

Frm 00055

Fmt 4703

Sfmt 4703

15589

settlement terms of the agreement and
any extension of credit are reasonable
and no less favorable than comparable
arm’s length agreement. The other
conditions include the following
information collections: (1) The terms of
the settlement must be specifically
described in a written agreement or
consent decree. (2) The fiduciary acting
on behalf of the plan must acknowledge
in writing that the person is a fiduciary
with respect to the settlement of the
litigation. (3) The plan fiduciary must
maintain records of the transaction for
six years and must disclose the records
on request to the Department and other
interested persons. For additional
substantive information about this ICR,
see the related notice published in the
Federal Register on July 9, 2024 (89 FR
56416).
Comments are invited on: (1) whether
the collection of information is
necessary for the proper performance of
the functions of the Department,
including whether the information will
have practical utility; (2) the accuracy of
the agency’s estimates of the burden and
cost of the collection of information,
including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility and
clarity of the information collection; and
(4) ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
automated collection techniques or
other forms of information technology.
This information collection is subject
to the PRA. A Federal agency generally
cannot conduct or sponsor a collection
of information, and the public is
generally not required to respond to an
information collection, unless the OMB
approves it and displays a currently
valid OMB Control Number. In addition,
notwithstanding any other provisions of
law, no person shall generally be subject
to penalty for failing to comply with a
collection of information that does not
display a valid OMB Control Number.
See 5 CFR 1320.5(a) and 1320.6.
DOL seeks PRA authorization for this
information collection for three (3)
years. OMB authorization for an ICR
cannot be for more than three (3) years
without renewal. The DOL notes that
information collection requirements
submitted to the OMB for existing ICRs
receive a month-to-month extension
while they undergo review.
Agency: DOL–EBSA.
Title of Collection: Settlement
Agreements Between a Plan and a Party
in Interest.
OMB Control Number: 1210–0091.
Affected Public: Private sector,
Businesses or other for-profits, Not-forprofit institutions.

E:\FR\FM\14APN1.SGM

14APN1