International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; 4F-MDMB-BICA (4F-MDMB-BUTICA); Brorphine; Metonitazene; Eutylone (bk-EBDB); BMDP (3,4-Methylenedioxy-N-benzylcathinone); Kratom (mitragynine, 7-hydroxymitragynine); Phenibut; Reopening Comment Period, 45738-45739 [2021-17498]
Download as PDF
45738
Federal Register / Vol. 86, No. 155 / Monday, August 16, 2021 / Notices
transfer fee, especially for international
wire transfers. Applicable wire transfer
fees must be included with payment to
ensure fees are paid in full. Questions
about wire transfer fees should be
addressed to the financial institution.
The account information for wire
transfers is as follows: U.S. Department
of the Treasury, TREAS NYC, 33 Liberty
St., New York, NY 10045, Acct. No.:
75060099, Routing No.: 021030004,
SWIFT: FRNYUS33. If needed, FDA’s
tax identification number is 53–
0196965.
B. Prescription Drug Program Fees
FDA will issue invoices and payment
instructions for FY 2022 program fees
under the new fee schedule in August
2021. Payment will be due on October
1, 2021. FDA will issue invoices in
December 2021 for products that qualify
for FY 2022 program fee assessments
after the August 2021 billing.
Dated: August 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–17505 Filed 8–13–21; 8:45 am]
BILLING CODE 4164–01–P
action to allow interested persons
additional time to submit comments.
These comments will be considered in
preparing a response from the United
States to the World Health Organization
(WHO) regarding the abuse liability and
diversion of these drugs. WHO will use
this information to consider whether to
recommend that certain international
restrictions be placed on these drug
substances.
FDA is reopening the comment
period for the notice published July 23,
2021 (86 FR 39038). Submit either
electronic or written comments by
August 24, 2021.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before August 24,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of August 24, 2021.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are received on or before that
date.
DATES:
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0739]
International Drug Scheduling;
Convention on Psychotropic
Substances; Single Convention on
Narcotic Drugs; 4F–MDMB–BICA (4F–
MDMB–BUTICA); Brorphine;
Metonitazene; Eutylone (bk-EBDB);
BMDP (3,4-Methylenedioxy-Nbenzylcathinone); Kratom
(mitragynine, 7-hydroxymitragynine);
Phenibut; Reopening Comment Period
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Notice; reopening comment
period.
AGENCY:
The Food and Drug
Administration (FDA or Agency) is
reopening the comment period for the
notice entitled ‘‘International Drug
Scheduling; Convention on
Psychotropic Substances; Single
Convention on Narcotic Drugs; 4F–
MDMB–BICA (4F–MDMB–BUTICA);
Brorphine; Metonitazene; Eutylone (bkEBDB); BMDP (3,4-Methylenedioxy-Nbenzylcathinone); Kratom (mitragynine,
7-hydroxymitragynine); Phenibut’’ that
appeared in the Federal Register of July
23, 2021. The Agency is taking this
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:21 Aug 13, 2021
Jkt 253001
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely 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 medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2021–N–0739 for ‘‘International Drug
Scheduling; Convention on
Psychotropic Substances; Single
Convention on Narcotic Drugs; 4F–
MDMB–BICA (4F–MDMB–BUTICA);
Brorphine; Metonitazene; Eutylone (bkEBDB); BMDP (3,4-Methylenedioxy-Nbenzylcathinone); Kratom (mitragynine,
7-hydroxymitragynine); Phenibut;
Request for Comments.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
E:\FR\FM\16AUN1.SGM
16AUN1
Federal Register / Vol. 86, No. 155 / Monday, August 16, 2021 / Notices
electronic and written/paper comments
received, 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, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
James R. Hunter, Center for Drug
Evaluation and Research, Controlled
Substance Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 5150, Silver Spring,
MD 20993–0002, 301–796–3156,
james.hunter@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 23,
2021 (86 FR 39038), FDA published a
notice entitled ‘‘International Drug
Scheduling; Convention on
Psychotropic Substances; Single
Convention on Narcotic Drugs; 4F–
MDMB–BICA (4F–MDMB–BUTICA);
Brorphine; Metonitazene; Eutylone (bkEBDB); BMDP (3,4-Methylenedioxy-Nbenzylcathinone); Kratom (mitragynine,
7-hydroxymitragynine); Phenibut’’ that
requested comments for consideration
in preparing a response from the United
States to the WHO regarding the abuse
liability and diversion of these drugs.
WHO will use this information to
consider whether to recommend that
certain international restrictions be
placed on these drug substances. To
allow interested persons additional time
to submit comments, FDA is reopening
the comment period until August 24,
2021.
Dated: August 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–17498 Filed 8–11–21; 4:15 pm]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
lotter on DSK11XQN23PROD with NOTICES1
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: The HRSA
Community-Based Outreach Reporting
Module, OMB # 0906–0064, Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
VerDate Sep<11>2014
17:21 Aug 13, 2021
Jkt 253001
HRSA requests an extension
to continue data collection for the
Community-Based Workforce for
COVID–19 Vaccine Outreach Programs
(CBO Programs) (OMB # 0906–0064). In
compliance with the requirement for
opportunity for public comment on
proposed data collection projects of the
Paperwork Reduction Act of 1995,
HRSA announces plans to submit an
Information Collection Request (ICR),
described below, to the Office of
Management and Budget (OMB). Prior
to submitting the ICR to OMB, HRSA
seeks comments from the public
regarding the burden estimate, below, or
any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than October 15, 2021.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or by mail to the
HRSA Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance
Officer, at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information collection request title for
reference.
Information Collection Request Title:
The HRSA Community-Based Outreach
Reporting Module, OMB # 0906–0064,
Extension.
Abstract: HRSA requests approval of
an extension of the current emergency
ICR to continue data collection for the
Community-Based Workforce for
COVID–19 Vaccine Outreach Programs
(CBO Programs), which support
nonprofit private or public
organizations to establish, expand, and
sustain a public health workforce to
prevent, prepare for, and respond to
COVID–19. This data is needed to
comply with requirements to monitor
funds distributed under the American
Rescue Plan Act of 2021 and in
accordance with OMB Memorandum
M–21–20.
Need and Proposed Use of the
Information: HRSA is requesting
approval from OMB for an extension of
the current emergency data collection
module to support HRSA’s Healthcare
Systems Bureau and Office of Planning,
Analysis, and Evaluation requirements
to monitor and report on funds
distributed. As part of the American
Rescue Plan Act of 2021, signed into
law on March 11, 2021 (Pub. L. 117–2),
SUMMARY:
PO 00000
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45739
HRSA has awarded nearly $250 million
to develop and support a communitybased workforce that will engage in
locally tailored efforts to build vaccine
confidence and bolster COVID–19
vaccinations in underserved
communities. In June and July, under
the CBO Programs, HRSA awarded
funding to over 140 local and national
organizations. These organizations are
responsible for educating and assisting
individuals in accessing and receiving
COVID–19 vaccinations. This includes
activities such as conducting direct faceto-face outreach and other forms of
direct outreach to community members
to educate them about the vaccine,
assisting individuals in making a
vaccine appointment, providing
resources to find convenient vaccine
locations, and assisting individuals with
transportation or other needs to get to a
vaccination site. The program will
address persistent health disparities by
offering support and resources to
vulnerable and medically underserved
communities, including racial and
ethnic minority groups and individuals
living in areas of high social
vulnerability.
HRSA is proposing a new data
reporting module—the CommunityBased Vaccine Outreach Program
Reporting Module—to collect
information on CBO Program-funded
activities. The CBO Program will collect
monthly progress report data from
funded organizations. This data will be
related to the public health workforce,
the vaccine outreach activities
performed by this workforce, and the
individuals who received vaccinations
by this workforce in a manner that
assesses equitable access to vaccine
services and that the most vulnerable
populations and communities are
reached. This data will allow HRSA to
clearly identify how the funds are being
used and monitored throughout the
period of performance and to ensure
that high-need populations are being
reached and vaccinated. Responses to
some data requirements are only
reported during the initial reporting
cycle (e.g., the name, location,
affiliation, etc. of the individual
supporting community outreach),
though respondents may update the
data should any of that change during
the duration of the reporting period.
Likely Respondents: Respondents are
community outreach workers employed
by entities supported by HRSA grant
funding over a period of either 6 months
(HRSA–21–136) or 12 months (HRSA–
21–140).
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
E:\FR\FM\16AUN1.SGM
16AUN1
Agencies
[Federal Register Volume 86, Number 155 (Monday, August 16, 2021)]
[Notices]
[Pages 45738-45739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17498]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0739]
International Drug Scheduling; Convention on Psychotropic
Substances; Single Convention on Narcotic Drugs; 4F-MDMB-BICA (4F-MDMB-
BUTICA); Brorphine; Metonitazene; Eutylone (bk-EBDB); BMDP (3,4-
Methylenedioxy-N-benzylcathinone); Kratom (mitragynine, 7-
hydroxymitragynine); Phenibut; Reopening Comment Period
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Notice; reopening comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is reopening
the comment period for the notice entitled ``International Drug
Scheduling; Convention on Psychotropic Substances; Single Convention on
Narcotic Drugs; 4F-MDMB-BICA (4F-MDMB-BUTICA); Brorphine; Metonitazene;
Eutylone (bk-EBDB); BMDP (3,4-Methylenedioxy-N-benzylcathinone); Kratom
(mitragynine, 7-hydroxymitragynine); Phenibut'' that appeared in the
Federal Register of July 23, 2021. The Agency is taking this action to
allow interested persons additional time to submit comments. These
comments will be considered in preparing a response from the United
States to the World Health Organization (WHO) regarding the abuse
liability and diversion of these drugs. WHO will use this information
to consider whether to recommend that certain international
restrictions be placed on these drug substances.
DATES: FDA is reopening the comment period for the notice published
July 23, 2021 (86 FR 39038). Submit either electronic or written
comments by August 24, 2021.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 24, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 24, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely 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 medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2021-N-0739 for ``International Drug Scheduling; Convention on
Psychotropic Substances; Single Convention on Narcotic Drugs; 4F-MDMB-
BICA (4F-MDMB-BUTICA); Brorphine; Metonitazene; Eutylone (bk-EBDB);
BMDP (3,4-Methylenedioxy-N-benzylcathinone); Kratom (mitragynine, 7-
hydroxymitragynine); Phenibut; Request for Comments.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the
[[Page 45739]]
electronic and written/paper comments received, 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, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: James R. Hunter, Center for Drug
Evaluation and Research, Controlled Substance Staff, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5150, Silver
Spring, MD 20993-0002, 301-796-3156, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 23, 2021 (86 FR 39038), FDA
published a notice entitled ``International Drug Scheduling; Convention
on Psychotropic Substances; Single Convention on Narcotic Drugs; 4F-
MDMB-BICA (4F-MDMB-BUTICA); Brorphine; Metonitazene; Eutylone (bk-
EBDB); BMDP (3,4-Methylenedioxy-N-benzylcathinone); Kratom
(mitragynine, 7-hydroxymitragynine); Phenibut'' that requested comments
for consideration in preparing a response from the United States to the
WHO regarding the abuse liability and diversion of these drugs. WHO
will use this information to consider whether to recommend that certain
international restrictions be placed on these drug substances. To allow
interested persons additional time to submit comments, FDA is reopening
the comment period until August 24, 2021.
Dated: August 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-17498 Filed 8-11-21; 4:15 pm]
BILLING CODE 4164-01-P