Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Rural Health Care Coordination Program Performance Improvement and Measurement System Database, OMB No. 0906-0024-Reinstate With Changes, 29586-29588 [2021-11542]
Download as PDF
<![CDATA[
jbell on DSKJLSW7X2PROD with NOTICES
29586
Federal Register / Vol. 86, No. 104 / Wednesday, June 2, 2021 / Notices
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
SANDOSTATIN (octreotide acetate)
injection, EQ 0.2 mg base/mL and EQ 1
mg base/mL, is the subject of NDA
19667, held by Novartis
Pharmaceuticals Corporation. NDA
19667 was initially approved on
October 21, 1988, and the EQ 0.2 mg
base/mL and EQ 1 mg base/mL strengths
were approved on June 12, 1991.
SANDOSTATIN is indicated to reduce
blood levels of growth hormone and
IGF–I (somatomedin C) in acromegaly
patients who have had inadequate
response to or cannot be treated with
surgical resection, pituitary irradiation,
and bromocriptine mesylate at
maximally tolerated doses.
SANDOSTATIN is also indicated for the
symptomatic treatment of patients with
metastatic carcinoid tumors where it
suppresses or inhibits the severe
diarrhea and flushing episodes
associated with the disease.
SANDOSTATIN is also indicated for the
treatment of profuse watery diarrhea
associated with vasoactive intestinal
peptide-secreting tumors.
In a letter received by the Agency on
May 11, 2020, Novartis Pharmaceuticals
Corporation notified FDA that
VerDate Sep<11>2014
17:49 Jun 01, 2021
Jkt 253001
SANDOSTATIN (octreotide acetate)
injection, EQ 0.2 mg base/mL and EQ 1
mg base/mL, was being discontinued,
and FDA moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book. Caplin
Steriles Limited submitted a citizen
petition dated February 5, 2021 (Docket
No. FDA–2021–P–0163), under 21 CFR
10.30, requesting that the Agency
determine whether SANDOSTATIN
(octreotide acetate) injection, EQ 0.2 mg
base/mL and EQ 1 mg base/mL, was
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that SANDOSTATIN
(octreotide acetate) injection, EQ 0.2 mg
base/mL and EQ 1 mg base/mL, was not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that SANDOSTATIN
(octreotide acetate) injection, EQ 0.2 mg
base/mL and EQ 1 mg base/mL, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
SANDOSTATIN (octreotide acetate)
injection, EQ 0.2 mg base/mL and EQ 1
mg base/mL, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that this drug product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list SANDOSTATIN
(octreotide acetate) injection, EQ 0.2 mg
base/mL and EQ 1 mg base/mL, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to this
drug product. Additional ANDAs for
this drug product may also be approved
by the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
Dated: May 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–11575 Filed 6–1–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Rural Health Care
Coordination Program Performance
Improvement and Measurement
System Database, OMB No. 0906–
0024—Reinstate With Changes
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than July 2, 2021.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Rural Health Care Coordination Program
Performance Improvement and
Measurement System Database, OMB
No. 0906–0024—Reinstate with
Changes.
Abstract: The Rural Health Care
Coordination (Care Coordination)
program is authorized under Section
330A(e) of the Public Health Service
(PHS) Act (42 U.S.C. 254(e)), as
amended, to ‘‘improve access and
SUMMARY:
E:\FR\FM\02JNN1.SGM
02JNN1
29587
Federal Register / Vol. 86, No. 104 / Wednesday, June 2, 2021 / Notices
quality of care through the application
of care coordination strategies with the
focus areas of collaboration, leadership
and workforce, improved outcomes, and
sustainability in rural communities.’’
This authority permits the Federal
Office of Rural Health Policy to support
rural health consortiums/networks
aiming to achieve the overall goals of
improving access, delivery, and quality
of care through the application of care
coordination strategies in rural
communities.
This ICR was discontinued in January
2020. HRSA is requesting a
reinstatement with changes as it was
decided to re-compete this pilot
program.
The proposed Rural Health Care
Coordination Program draft measures
for information collection reflect
changes to the Clinical Measures section
which was previously in section eight
and now currently in section six. The
Clinical Measures Section now expands
previous project focus from three
chronic diseases (i.e., Type 2 diabetes,
Congestive Heart Failure, and Chronic
Obstructive Pulmonary Disease) to an
inclusive list of clinical measures in
order to reflect a patient’s overall health
and well-being as well as the
organizations’ overall improved
outcomes for the project. Proposed
revisions also include measures to
examine key elements cited for a
successful rural care coordination
program: (1) Collaboration, (2)
leadership and workforce, (3) improved
outcomes, and (4) sustainability.
1. Collaboration—Utilizing a
collaborative approach to coordinate
and deliver health care services through
a consortium, in which member
organizations actively engage in
integrated, coordinated, patient-
centered delivery of health care
services.
2. Leadership and Workforce—
Developing and strengthening a highly
skilled care coordination workforce to
respond to vulnerable populations’
unmet needs within the rural
communities.
3. Improved Outcomes—Expanding
access and improving care quality and
delivery, and health outcomes through
evidence-based model and/or promising
practices tailored to meet the local
populations’ needs.
4. Sustainability—Developing and
strengthening care coordination
program’s financial sustainability by
establishing effective revenue sources
such as expanded service
reimbursement, resource sharing, and/or
contributions from partners at the
community, county, regional, and state
levels.
With the continuing shift in the
healthcare environment towards
provision of value-based care and
utilization of reimbursement strategies
through Centers for Medicare and
Medicaid Services quality reporting
programs, the latest competitive Rural
Health Care Coordination Program
cohort also aligned with this shift. An
increased number of sophisticated
applicants leveraging increasingly
intricate reporting methodologies for
quality, data collection, utilization and
analysis has resulted in an estimate of
burden hours more in line with the
realities of the health care landscape. In
addition, the total number of responses
has increased to 10 since the previous
Notice of Award. This is due to a new
Rural Health Care Coordination Program
grant cycle with an increased number of
awardees therefore an increased number
of respondents.
A 60-day notice published in the
Federal Register on November 30, 2020,
vol. 85, No. 230; pp. 76585–86. There
were no public comments.
Need and Proposed Use of the
Information: For this program,
performance measures were drafted to
provide data to the program and to
enable HRSA to provide aggregate
program data required by Congress
under the Government Performance and
Results Act of 1993. These measures
cover the principal topic areas of
interest to the Office of Rural Health
Policy, including: (a) Access to care; (b)
population demographics; (c) staffing;
(d) consortium/network; (e)
sustainability; and (f) project specific
domains. All measures will speak to
HRSA’s progress toward meeting the
goals set.
Likely Respondents: The respondents
would be recipients of the Rural Health
Care Coordination Program funding.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Rural Health Care Coordination Grant Program Measures
jbell on DSKJLSW7X2PROD with NOTICES
Total ..............................................................................
VerDate Sep<11>2014
17:49 Jun 01, 2021
Jkt 253001
PO 00000
Frm 00042
Fmt 4703
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
10
1
10
3.5
35
10
........................
10
........................
35
Sfmt 9990
E:\FR\FM\02JNN1.SGM
02JNN1
29588
Federal Register / Vol. 86, No. 104 / Wednesday, June 2, 2021 / Notices
HRSA specifically requests comments
on: (1) The necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021–11542 Filed 6–1–21; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the Advisory Committee on
Infant Mortality
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Advisory
Committee on Infant Mortality (ACIM)
has scheduled a public meeting.
Information about ACIM and the agenda
for this meeting can be found on the
ACIM website at https://www.hrsa.gov/
advisory-committees/infant-mortality/
index.html.
DATES: June 22, 2021, 12:00 p.m.–4:00
p.m. Eastern Time (ET) and June 23,
2021, 12:00 p.m.–4:00 p.m. ET.
ADDRESSES: This meeting will be held
via webinar. The webinar link and login information will be available at
ACIM’s website before the meeting:
https://www.hrsa.gov/advisorycommittees/infant-mortality/.
FOR FURTHER INFORMATION CONTACT:
Vanessa Lee, MPH, Acting Designated
Federal Official, Maternal and Child
Health Bureau, HRSA, 5600 Fishers
Lane, Rockville, Maryland 20857; 301–
443–0543; or SACIM@hrsa.gov.
SUPPLEMENTARY INFORMATION: The ACIM
is authorized by section 222 of the
Public Health Service Act (42 U.S.C.
217a), as amended. The Committee is
governed by provisions of Public Law
92–463, as amended, (5 U.S.C. App. 2),
which sets forth standards for the
formation and use of Advisory
Committees.
The ACIM advises the Secretary of
HHS on department activities and
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:49 Jun 01, 2021
Jkt 253001
programs directed at reducing infant
mortality and improving the health
status of pregnant women and infants.
The ACIM represents a public-private
partnership at the highest level to
provide guidance and focus attention on
the policies and resources required to
address the reduction of infant mortality
and the improvement of the health
status of pregnant women and infants.
With a focus on life course, the ACIM
addresses disparities in maternal health
to improve maternal health outcomes,
including preventing and reducing
maternal mortality and severe maternal
morbidity. The ACIM provides advice
on how best to coordinate myriad
federal, state, local, and private
programs and efforts that are designed
to deal with the health and social
problems impacting infant mortality and
maternal health, including
implementation of the Healthy Start
program and maternal and infant health
objectives from the National Health
Promotion and Disease Prevention
Objectives (i.e., Healthy People 2030).
The agenda for the June 22–23, 2021,
meeting is being finalized and may
include the following topics: Discussion
of recommendations by ACIM to the
Secretary; updates from HRSA’s
Maternal and Child Health Bureau, and
other federal agencies; the Centers for
Disease Control and Prevention’s
Pregnancy Risk Assessment Monitoring
System survey; and patient-physician
racial concordance in health care.
Agenda items are subject to change as
priorities dictate. Refer to the ACIM
website for any updated information
concerning the meeting.
Members of the public will have the
opportunity to provide written or oral
comments. Requests to submit a written
statement or make oral comments to the
ACIM should be sent to Vanessa Lee,
using the email address above at least 3
business days prior to the meeting.
Public participants may submit written
statements in advance of the scheduled
meeting by emailing SACIM@hrsa.gov.
Oral comments will be honored in the
order they are requested and may be
limited as time allows.
Individuals who plan to attend and
need special assistance or another
reasonable accommodation should
notify Vanessa Lee at the contact
information listed above at least 10
business days prior to the meeting.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021–11504 Filed 6–1–21; 8:45 am]
BILLING CODE 4165–15–P
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health.
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; Music and Health.
Date: June 24, 2021.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: W. Ernest Lyons, PhD,
Scientific Review Administrator, Scientific
Review Branch, NINDS/NIH/DHHS,
Neuroscience Center, 6001 Executive Blvd.,
Suite 3208, MSC 9529, Rockville, MD 20852,
301–496–4056, lyonse@ninds.nih.gov.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; Small Vessel VCID
Biomarkers Validation Consortium Sites &
Coordinating Center Review (U01 & U24).
Date: June 25, 2021.
Time: 10:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: Mir Ahamed Hossain,
PhD, Scientific Review Officer, Scientific
Review Branch, NINDS/NIH/DHHS,
Neuroscience Center, 6001 Executive Blvd.,
Suite 3208, MSC 9529, Rockville, MD 20852,
301–496–9223, mirahamed.hossain@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
E:\FR\FM\02JNN1.SGM
02JNN1
]]>Agencies
[Federal Register Volume 86, Number 104 (Wednesday, June 2, 2021)]
[Notices]
[Pages 29586-29588]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11542]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; Rural Health Care
Coordination Program Performance Improvement and Measurement System
Database, OMB No. 0906-0024--Reinstate With Changes
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act of 1995, HRSA
has submitted an Information Collection Request (ICR) to the Office of
Management and Budget (OMB) for review and approval. Comments submitted
during the first public review of this ICR will be provided to OMB. OMB
will accept further comments from the public during the review and
approval period.
DATES: Comments on this ICR should be received no later than July 2,
2021.
ADDRESSES: Submit your comments, including the ICR Title, to the desk
officer for HRSA, either by email to [email protected] or by
fax to (202) 395-5806.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email the HRSA Information
Collection Clearance Officer at [email protected] or call (301) 443-
1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: Rural Health Care
Coordination Program Performance Improvement and Measurement System
Database, OMB No. 0906-0024--Reinstate with Changes.
Abstract: The Rural Health Care Coordination (Care Coordination)
program is authorized under Section 330A(e) of the Public Health
Service (PHS) Act (42 U.S.C. 254(e)), as amended, to ``improve access
and
[[Page 29587]]
quality of care through the application of care coordination strategies
with the focus areas of collaboration, leadership and workforce,
improved outcomes, and sustainability in rural communities.'' This
authority permits the Federal Office of Rural Health Policy to support
rural health consortiums/networks aiming to achieve the overall goals
of improving access, delivery, and quality of care through the
application of care coordination strategies in rural communities.
This ICR was discontinued in January 2020. HRSA is requesting a
reinstatement with changes as it was decided to re-compete this pilot
program.
The proposed Rural Health Care Coordination Program draft measures
for information collection reflect changes to the Clinical Measures
section which was previously in section eight and now currently in
section six. The Clinical Measures Section now expands previous project
focus from three chronic diseases (i.e., Type 2 diabetes, Congestive
Heart Failure, and Chronic Obstructive Pulmonary Disease) to an
inclusive list of clinical measures in order to reflect a patient's
overall health and well-being as well as the organizations' overall
improved outcomes for the project. Proposed revisions also include
measures to examine key elements cited for a successful rural care
coordination program: (1) Collaboration, (2) leadership and workforce,
(3) improved outcomes, and (4) sustainability.
1. Collaboration--Utilizing a collaborative approach to coordinate
and deliver health care services through a consortium, in which member
organizations actively engage in integrated, coordinated, patient-
centered delivery of health care services.
2. Leadership and Workforce--Developing and strengthening a highly
skilled care coordination workforce to respond to vulnerable
populations' unmet needs within the rural communities.
3. Improved Outcomes--Expanding access and improving care quality
and delivery, and health outcomes through evidence-based model and/or
promising practices tailored to meet the local populations' needs.
4. Sustainability--Developing and strengthening care coordination
program's financial sustainability by establishing effective revenue
sources such as expanded service reimbursement, resource sharing, and/
or contributions from partners at the community, county, regional, and
state levels.
With the continuing shift in the healthcare environment towards
provision of value-based care and utilization of reimbursement
strategies through Centers for Medicare and Medicaid Services quality
reporting programs, the latest competitive Rural Health Care
Coordination Program cohort also aligned with this shift. An increased
number of sophisticated applicants leveraging increasingly intricate
reporting methodologies for quality, data collection, utilization and
analysis has resulted in an estimate of burden hours more in line with
the realities of the health care landscape. In addition, the total
number of responses has increased to 10 since the previous Notice of
Award. This is due to a new Rural Health Care Coordination Program
grant cycle with an increased number of awardees therefore an increased
number of respondents.
A 60-day notice published in the Federal Register on November 30,
2020, vol. 85, No. 230; pp. 76585-86. There were no public comments.
Need and Proposed Use of the Information: For this program,
performance measures were drafted to provide data to the program and to
enable HRSA to provide aggregate program data required by Congress
under the Government Performance and Results Act of 1993. These
measures cover the principal topic areas of interest to the Office of
Rural Health Policy, including: (a) Access to care; (b) population
demographics; (c) staffing; (d) consortium/network; (e) sustainability;
and (f) project specific domains. All measures will speak to HRSA's
progress toward meeting the goals set.
Likely Respondents: The respondents would be recipients of the
Rural Health Care Coordination Program funding.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install, and utilize technology and
systems for the purpose of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Rural Health Care Coordination 10 1 10 3.5 35
Grant Program Measures.........
-------------------------------------------------------------------------------
Total....................... 10 .............. 10 .............. 35
----------------------------------------------------------------------------------------------------------------
[[Page 29588]]
HRSA specifically requests comments on: (1) The necessity and
utility of the proposed information collection for the proper
performance of the agency's functions, (2) the accuracy of the
estimated burden, (3) ways to enhance the quality, utility, and clarity
of the information to be collected, and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021-11542 Filed 6-1-21; 8:45 am]
BILLING CODE 4165-15-P
