Delegation of Authority, 30141 [2023-10041]
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Federal Register / Vol. 88, No. 90 / Wednesday, May 10, 2023 / Notices
lotter on DSK11XQN23PROD with NOTICES1
spanning at least seven different
countries, were associated with more
than 300 fatalities—mostly in children
under the age of 5.2 At this time, FDA
has no indication that any contaminated
products connected to these recent
international incidents have entered the
U.S. drug supply chain.
This guidance is intended to replace
the 2007 guidance and to alert the
industry that in addition to glycerin,
there are other components at a high
risk of contamination with DEG and EG,
including, but not limited to, propylene
glycol, maltitol solution, hydrogenated
starch hydrolysate, and sorbitol solution
(hereinafter, ‘‘high-risk components’’).
This guidance provides
recommendations, including analytical
testing, to help pharmaceutical
manufacturers, repackers, other
suppliers of high-risk components, and
compounders, prevent the use of
glycerin and other high-risk components
that are contaminated with DEG or EG.
The guidance represents the current
thinking of FDA on ‘‘Testing of
Glycerin, Propylene Glycol, Maltitol
Solution, Hydrogenated Starch
Hydrolysate, Sorbitol Solution, and
Other High-Risk Drug Components for
Diethylene Glycol and Ethylene
Glycol.’’ It does not establish any rights
for any person and is not binding on
FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
action-to-protect-children-from-contaminatedmedicines. The WHO has issued global medical
alerts addressing these incidents in The Gambia
(October 5, 2022), Indonesia (November 6, 2022),
Uzbekistan (January 11, 2023), and the Marshall
Islands and Micronesia (Apr 25, 2023). See Medical
Product Alert N°6/2022: Substandard
(contaminated) paediatric medicines, World Health
Organization, October 5, 2022, available at https://
www.who.int/news/item/05-10-2022-medicalproduct-alert-n-6-2022-substandard(contaminated)-paediatric-medicines; Medical
Product Alert N°7/2022: Substandard
(contaminated) paediatric liquid dosage medicines,
World Health Organization, November 2, 2022,
available at https://www.who.int/news/item/02-112022-medical-product-alert-n-7-2022-substandard(contaminated)-paediatric-liquid-dosage-medicines;
Medical Product Alert N°1/2023: Substandard
(contaminated) liquid dosage medicines, World
Health Organization, January 11, 2023, available at
https://www.who.int/news/item/11-01-2023medical-product-alert-n-1-2023-substandard(contaminated)-liquid-dosage-medicines; and
Medical Product Alert N°4/2023: Substandard
(contaminated) syrup medicines, World Health
Organization, Apr 25, 2023, available at https://
www.who.int/news/item/25-04-2023-medicalproduct-alert-n-4-2023—substandard(contaminated)-syrup-medicines.
2 See WHO urges action to protect children from
contaminated medicines, World Health
Organization, January 23, 2023, available at https://
www.who.int/news/item/23-01-2023-who-urgesaction-to-protect-children-from-contaminatedmedicines.
VerDate Sep<11>2014
17:49 May 09, 2023
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II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collection of
information is subject to review by OMB
under the PRA. The collection of
information for CGMP requirements has
been approved under OMB control
number 0910–0139.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: May 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–09973 Filed 5–9–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental
Health Services Administration,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
The Secretary of the United
States Department of Health and Human
Services delegated his authorities to the
Assistant Secretary for Mental Health
and Substance Use within the Substance
Abuse and Mental Health Services
Administration (SAMHSA) on May 4,
2023. This action is necessary to
complete rulemaking being undertaken
in conjunction with the Drug
Enforcement Administration.
SUPPLEMENTARY INFORMATION: Notice is
hereby given that the Secretary of the
United States Department of Health and
Human Services (HHS) has delegated to
the Assistant Secretary for Mental
Health and Substance Use within the
Substance Abuse and Mental Health
Services Administration (SAMHSA) the
authorities vested in the Secretary of
HHS under Title 21, Chapter 13,
Subchapter I, Part A, Section 802(54)(G)
of the United States Code (21 U.S.C.
802(54)(G)) on May 4, 2023.
21 U.S.C. 802(54)(G) authorizes the
Secretary of HHS and the Attorney
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
General to issue regulations (including
in 42 CFR chapter I, if appropriate) that
define the term ‘‘practice of
telemedicine’’ for purposes of Title 21,
Chapter 13, Subchapter I, as the practice
of medicine in accordance with
applicable Federal and State laws by a
practitioner (other than a pharmacist)
who is at a location remote from the
patient and is communicating with the
patient, or health care professional who
is treating the patient, using a
telecommunications system referred to
in section 1395m(m) of title 42, which
practice is being conducted under any
circumstances that the Attorney General
and the Secretary have jointly, by
regulation, determined to be consistent
with effective controls against diversion
and otherwise consistent with the
public health and safety.
These authorities may not be
redelegated and shall be exercised
under the Department’s policy on
regulations and the existing delegation
of authority to approve and issue
regulations. In addition, I hereby ratify
and affirm any actions taken by the
Assistant Secretary for Mental Health
and Substance Use, or other SAMHSA
officials, which involved the exercise of
the authorities delegated prior to the
effective date of the delegation on May
4, 2023.
Xavier Becerra,
Secretary of Health and Human Services.
Delegation of Authority
SUMMARY:
30141
[FR Doc. 2023–10041 Filed 5–9–23; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
National Indian Health Outreach and
Education
Announcement Type: New.
Funding Announcement Number:
HHS–2023–IHS–NIHOE–0001.
Assistance Listing (Catalog of Federal
Domestic Assistance or CFDA) Number:
93.933.
Key Dates
Application Deadline Date: July 10,
2023.
Earliest Anticipated Start Date: July
24, 2023.
I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS) is
accepting applications for a cooperative
agreement for the National Indian
Health Outreach and Education
(NIHOE) program. This program is
authorized under the Snyder Act, 25
E:\FR\FM\10MYN1.SGM
10MYN1
]]>Agencies
[Federal Register Volume 88, Number 90 (Wednesday, May 10, 2023)]
[Notices]
[Page 30141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10041]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Delegation of Authority
AGENCY: Substance Abuse and Mental Health Services Administration,
Department of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Secretary of the United States Department of Health and
Human Services delegated his authorities to the Assistant Secretary for
Mental Health and Substance Use within the Substance Abuse and Mental
Health Services Administration (SAMHSA) on May 4, 2023. This action is
necessary to complete rulemaking being undertaken in conjunction with
the Drug Enforcement Administration.
SUPPLEMENTARY INFORMATION: Notice is hereby given that the Secretary of
the United States Department of Health and Human Services (HHS) has
delegated to the Assistant Secretary for Mental Health and Substance
Use within the Substance Abuse and Mental Health Services
Administration (SAMHSA) the authorities vested in the Secretary of HHS
under Title 21, Chapter 13, Subchapter I, Part A, Section 802(54)(G) of
the United States Code (21 U.S.C. 802(54)(G)) on May 4, 2023.
21 U.S.C. 802(54)(G) authorizes the Secretary of HHS and the
Attorney General to issue regulations (including in 42 CFR chapter I,
if appropriate) that define the term ``practice of telemedicine'' for
purposes of Title 21, Chapter 13, Subchapter I, as the practice of
medicine in accordance with applicable Federal and State laws by a
practitioner (other than a pharmacist) who is at a location remote from
the patient and is communicating with the patient, or health care
professional who is treating the patient, using a telecommunications
system referred to in section 1395m(m) of title 42, which practice is
being conducted under any circumstances that the Attorney General and
the Secretary have jointly, by regulation, determined to be consistent
with effective controls against diversion and otherwise consistent with
the public health and safety.
These authorities may not be redelegated and shall be exercised
under the Department's policy on regulations and the existing
delegation of authority to approve and issue regulations. In addition,
I hereby ratify and affirm any actions taken by the Assistant Secretary
for Mental Health and Substance Use, or other SAMHSA officials, which
involved the exercise of the authorities delegated prior to the
effective date of the delegation on May 4, 2023.
Xavier Becerra,
Secretary of Health and Human Services.
[FR Doc. 2023-10041 Filed 5-9-23; 8:45 am]
BILLING CODE 4162-20-P
