Delegation of Authority Under Section 564A(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3a(e)), 66707 [2022-24044]
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Federal Register / Vol. 87, No. 213 / Friday, November 4, 2022 / Notices
health interventions will help state and
local health departments determine the
appropriate level of follow up needed
based on the traveler’s level of risk and
rapidly identify any travelers with
symptoms that may need to be
prioritized for more targeted public
health measures, such as quarantine,
due to a higher risk of exposure to
Ebola. State and local health
departments will utilize the contact
information provided by CDC to
prioritize and identify the level of
follow up needed based on the level of
risk of exposure to Ebola and determine
if additional targeted public health
measures are necessary. The purpose of
this evaluation will be to gather
feedback from state and local health
departments regarding traveler
monitoring activities and determine the
usability of contact information and
public health risk assessment
information shared by CDC.
CDC anticipates certain time and cost
burdens to respondents and record
keepers due to the requirements and
requests OMB approval for an estimated
4,550 annual burden hours. There are
no costs to respondents other than their
time to participate.
ESTIMATED ANNUALIZED BURDEN HOURS
Information collection tool
Traveler ..........
Risk Assessment and Post-Arrival Monitoring Outcome
REDCap Reporting.
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–24047 Filed 11–3–22; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Delegation of Authority Under Section
564A(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb–3a(e))
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services.
ACTION: Notice.
AGENCY:
CDC has redelegated the
authority under the Federal Food, Drug,
and Cosmetic (FD&C) Act to create and
issue amended emergency use
instructions (EUI) to inform healthcare
providers or individuals to whom an
eligible product, as defined under the
FD&C Act, is to be administered,
concerning the product’s approved,
licensed, or cleared conditions of use
that deviate from approved labeling,
standard clinical practice, and/or
standard medical modality (e.g.,
individual prescription within the
patient-clinician relationship). This
notice announces the redelegation of the
above-mentioned authority, without the
authority to redelegate, from the
Director, CDC, to the Director, National
Center for Immunizations and
Respiratory Diseases (NCIRD).
DATES: This delegation was approved by
the Director, CDC, and is effective
October 28, 2022.
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
respondents
Respondent
VerDate Sep<11>2014
18:12 Nov 03, 2022
Jkt 259001
350
Only the
Director, CDC, can issue original EUIs.
The Director, NCIRD, may only issue
amendments that are substantially
within the scope of the original EUI and
only for countermeasures within the
scope of the NCIRD Director’s official
responsibilities. This authority shall be
exercised under section 564A(e) of the
FD&C Act (21 U.S.C. 360bbb–3a(e)), and
any related HHS policies. This
delegation became effective on October
28, 2022. The Director, CDC, affirms and
ratifies any actions taken that involve
the exercise of the authority delegated
herein prior to the effective date of this
delegation.
SUPPLEMENTARY INFORMATION:
Sherri A. Berger,
Chief of Staff, Centers for Disease Control
and Prevention.
[FR Doc. 2022–24044 Filed 11–3–22; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–23–1301; Docket No. CDC–2022–
0126]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
SUMMARY:
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
52
Average
burden
per response
(in minutes)
15/60
Total burden
hours
4,550
general public and other federal
agencies the opportunity to comment on
a continuing information collection, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed information
collection project titled Templates for
Extramural Data Management Plans.
The aim of this collection is to provide
contract and cooperative agreement
applicants and awardees with templates
for the creation of data management
plans (DMPs).
DATES: CDC must receive written
comments on or before January 3, 2023.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2022–
0126 by either of the following methods:
• Federal eRulemaking Portal:
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Jeffrey M. Zirger, Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS H21–8, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
www.regulations.gov. Please note:
Submit all comments through the
Federal eRulemaking portal
(www.regulations.gov) or by U.S. mail to
the address listed above.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffrey M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS
H21–8, Atlanta, Georgia 30329;
Telephone: 404–639–7570; Email: omb@
cdc.gov.
E:\FR\FM\04NON1.SGM
04NON1
]]>Agencies
[Federal Register Volume 87, Number 213 (Friday, November 4, 2022)]
[Notices]
[Page 66707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24044]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Delegation of Authority Under Section 564A(e) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3a(e))
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: CDC has redelegated the authority under the Federal Food,
Drug, and Cosmetic (FD&C) Act to create and issue amended emergency use
instructions (EUI) to inform healthcare providers or individuals to
whom an eligible product, as defined under the FD&C Act, is to be
administered, concerning the product's approved, licensed, or cleared
conditions of use that deviate from approved labeling, standard
clinical practice, and/or standard medical modality (e.g., individual
prescription within the patient-clinician relationship). This notice
announces the redelegation of the above-mentioned authority, without
the authority to redelegate, from the Director, CDC, to the Director,
National Center for Immunizations and Respiratory Diseases (NCIRD).
DATES: This delegation was approved by the Director, CDC, and is
effective October 28, 2022.
SUPPLEMENTARY INFORMATION: Only the Director, CDC, can issue original
EUIs. The Director, NCIRD, may only issue amendments that are
substantially within the scope of the original EUI and only for
countermeasures within the scope of the NCIRD Director's official
responsibilities. This authority shall be exercised under section
564A(e) of the FD&C Act (21 U.S.C. 360bbb-3a(e)), and any related HHS
policies. This delegation became effective on October 28, 2022. The
Director, CDC, affirms and ratifies any actions taken that involve the
exercise of the authority delegated herein prior to the effective date
of this delegation.
Sherri A. Berger,
Chief of Staff, Centers for Disease Control and Prevention.
[FR Doc. 2022-24044 Filed 11-3-22; 8:45 am]
BILLING CODE 4163-18-P
