60d FRN

Attachment 2_60-day Federal Register Notice.pdf

[NCEZID] Airline and Vessel and Traveler Information Collection (42 CFR Part 71)

60d FRN

OMB: 0920-1180

Document [pdf]
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Federal Register / Vol. 88, No. 81 / Thursday, April 27, 2023 / Notices

conclusion of the open meeting on May
4, 2023.
PLACE: 1050 First Street NE,
Washington, DC and virtual. (This
meeting will be a hybrid meeting.)
STATUS: This meeting will be closed to
the public.
MATTERS TO BE CONSIDERED:
Compliance matters pursuant to 52
U.S.C. 30109.
Matters relating to internal personnel
decisions, or internal rules and
practices.
Investigatory records compiled for
law enforcement purposes and
production would disclose investigative
techniques.
Information the premature disclosure
of which would be likely to have a
considerable adverse effect on the
implementation of a proposed
Commission action.
Matters concerning participation in
civil actions or proceedings or
arbitration.
CONTACT PERSON FOR MORE INFORMATION:
Judith Ingram, Press Officer, Telephone:
(202) 694–1220.
(Authority: Government in the Sunshine Act,
5 U.S.C. 552b.)
Vicktoria J. Allen,
Deputy Secretary of the Commission.

https://www.federalreserve.gov/foia/
request.htm. Interested persons may
express their views in writing on the
standards enumerated in the BHC Act
(12 U.S.C. 1842(c)).
Comments regarding each of these
applications must be received at the
Reserve Bank indicated or the offices of
the Board of Governors, Ann E.
Misback, Secretary of the Board, 20th
Street and Constitution Avenue NW,
Washington, DC 20551–0001, not later
than May 30, 2023.
A. Federal Reserve Bank of Atlanta
(Erien O. Terry, Assistant Vice
President) 1000 Peachtree Street NE,
Atlanta, Georgia 30309; Comments can
also be sent electronically to
[email protected]:
1. Smith & Hood Holding Company,
L.L.C., Amite, Louisiana, and First
Guaranty Bancshares, Inc., Hammond,
Louisiana; to acquire Lone Star Bank,
Houston, Texas.
Board of Governors of the Federal Reserve
System.
Michele Taylor Fennel,
Deputy Associate Secretary of the Board.
[FR Doc. 2023–08949 Filed 4–26–23; 8:45 am]
BILLING CODE P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

[FR Doc. 2023–09059 Filed 4–25–23; 4:15 pm]
BILLING CODE 6715–01–P

Centers for Disease Control and
Prevention
FEDERAL RESERVE SYSTEM

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Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The public portions of the
applications listed below, as well as
other related filings required by the
Board, if any, are available for
immediate inspection at the Federal
Reserve Bank(s) indicated below and at
the offices of the Board of Governors.
This information may also be obtained
on an expedited basis, upon request, by
contacting the appropriate Federal
Reserve Bank and from the Board’s
Freedom of Information Office at

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[60Day–FY–2023; Docket No. CDC–2023–
0032]

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
general public and other federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled Airline and Vessel Traveler
Information Collection. The information
collected will be used to conduct
contact tracing and public health
follow-up on travelers who have been
identified in a risk exposure zone on a
conveyance where a traveler was

SUMMARY:

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confirmed or suspected of traveling with
infectious with a communicable disease
of public health importance.
DATES: CDC must receive written
comments on or before June 26, 2023.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2023–
0032 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.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,

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Federal Register / Vol. 88, No. 81 / Thursday, April 27, 2023 / Notices
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected;
4. Minimize the burden of the
collection of information 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 submissions
of responses; and
5. Assess information collection costs.
Proposed Project
Airline and Vessel Traveler
Information Collection (OMB Control
No. 0920–1180, Exp. 6/30/2023)—
Revision—National Center for Emerging
and Zoonotic Infectious Diseases
(NCEZID), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The rapid speed and tremendous
volume of international travel,
commerce, and human migration enable
infectious disease threats to disperse
worldwide in 24 hours—less time than
the incubation period of most
communicable diseases. These and
other forces intrinsic to modern
technology and ways of life favor the
emergence of new communicable
diseases and the reemergence or
increased severity of known
communicable diseases. Stopping a
communicable disease outbreak—
whether it is naturally occurring or
intentionally caused—requires the use
of the most rapid and effective public
health tools available. Basic public
health practices, such as collaborating
with airlines in the identification and
notification of potentially exposed
travelers, are critical tools in the fight
against the introduction, transmission,
and spread of communicable disease in
the United States. The collection of
timely, accurate, and complete

• Address while in the United States
(number and street, city, state, and zip
code), except that U.S. citizens and
lawful permanent residents will provide
address of permanent residence in the
U.S. (number and street, city, state, and
zip code; as applicable);
• Primary contact phone number to
include country code;
• Secondary contact phone number to
include country code;
• Email address;
• Airline name;
• Flight number;
• City of departure;
• Departure date and time;
• City of arrival;
• Arrival date and time; and
• Seat number for all passengers
CDC also requests seat configuration
for the requested contact area (example:
AB/aisle/CDE/aisle/FG, bulkhead in
front of row 9), identification on the
manifest of the crew and what zone
crew were assigned to, the identification
of any babes-in-arms, and finally CDC
requests the total number of passengers
on board if measles is the cause of the
investigation, due to the highly
infectious nature of the disease. CDC
then uses this passenger and crew
manifest information to coordinate with
state and local health departments or
International Health Regulation (IHR)
National Focal Points (NFPs) so they
can follow-up with residents who live
or are currently located in their
jurisdiction. In most cases, the manifests
are issued for air travel and state and
local health departments or IHR NFPs
are responsible for the contact
investigations; airlines and vessels may
take responsibility for follow-up of crew
members. In rare cases, CDC may use
the manifest data to perform the contact
investigation directly.
CDC requests OMB approval for an
estimated 875 annual burden hours.
There are no costs to respondents other
than their time to participate.

conveyance and traveler information
enables CDC to notify state and local
health departments in order for them to
make contact with individuals who may
have been exposed to a communicable
disease during travel, or due to an
outbreak of disease in a geographic
location and identify appropriate next
steps.
Section 361 of the Public Health
Service Act (42 U.S.C. 264) authorizes
the Secretary of the Department of
Health and Human Services (DHHS) to
make and enforce regulations necessary
to prevent the introduction,
transmission, or spread of
communicable diseases from foreign
countries into the United States, or from
one State or possession into any other
State or possession. Regulations that
implement federal quarantine authority
are currently promulgated in 42 CFR
parts 70 and 71. Part 71 contains
regulations to prevent the introduction,
transmission, and spread of
communicable diseases into the states
and possessions of the United States.
Passenger and crewmember manifests
are used to collect travelers information
from airlines and vessels after travel has
been completed and when a disease is
confirmed or there is a suspected
exposure. Manifests include locating
and contact information, as well as
information concerning where
passengers sat while aboard an airline or
their location (e.g. cabin numbers) and
activities aboard a vessel. Manifests
collect the following data elements:
• Full name (last, first, and, if
available, middle or others);
• Date of birth;
• Sex;
• Country of residence;
• If a passport is required; passport
number, passport country of issuance,
and passport expiration date;
• If a travel document, other than a
passport is required, travel document
type, travel document number, travel
document country of issuance and
travel document expiration date;

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

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Airline Medical Officer or Equivalent/
Analysist/Travel Specialist/Manager Equivalent.
Total ...........................................

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Number of
respondents

Form name

International Manifest Template/Informal Manifest Request Template.
...........................................................

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Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

350

1

150/60

875

........................

........................

........................

875

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Federal Register / Vol. 88, No. 81 / Thursday, April 27, 2023 / Notices

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
[FR Doc. 2023–08909 Filed 4–26–23; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2020–0046; NIOSH–233–
C]

Hazardous Drugs: Procedures for
Developing the NIOSH List of
Hazardous Drugs in Healthcare
Settings and Managing Hazardous
Drug Exposures: Information for
Healthcare Settings
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: General notice.
AGENCY:

The National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC), in the
Department of Health and Human
Services (HHS), announces the
following final documents are available
in the docket and on the NIOSH
website: Procedures for Developing the
NIOSH List of Hazardous Drugs in
Healthcare Settings and Managing
Hazardous Drug Exposures: Information
for Healthcare Settings.
DATES: The documents announced in
this notice are available on April 27,
2023.
ADDRESSES: The documents announced
in this notice are available in the docket
at www.regulations.gov and through the
NIOSH Hazardous Drug Exposures in
Healthcare website at https://
www.cdc.gov/niosh/topics/hazdrug/
default.html.
FOR FURTHER INFORMATION CONTACT:
Jerald Ovesen, NIOSH, Robert A. Taft
Laboratories, 1090 Tusculum Avenue,
MS–C15, Cincinnati, OH 45226;
Telephone: (513) 533–8472 (not a tollfree number); Email: [email protected].
SUPPLEMENTARY INFORMATION: This
notice is organized as follows:
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SUMMARY:

I. Public Participation
II. Background
III. Procedures for Developing the NIOSH List
of Hazardous Drugs in Healthcare
Settings
A. Section II. Purposes
1. Application to Occupational Settings
2. Coordination With U.S. Pharmacopeia
(USP)

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B. Section III. Background
1. Exposure to Drugs in Healthcare Settings
C. Section IV. NIOSH Definition of a
Hazardous Drug
1. Investigational Drugs
2. Over-the-Counter Drugs
3. Veterinary Drugs
D. Section V. Identifying, Screening,
Evaluating, and Reviewing a Drug for
Placement on the List
1. Section V.A. Step 1: Identifying
Potentially Hazardous Drugs
2. Section V.B. Step 2: Screening
Potentially Hazardous Drugs
3. Section V.C. Step 3: Evaluating
Potentially Hazardous Drugs
a. Toxicity Criteria
b. Developmental and Reproductive
Toxicity
c. Organ Toxicity at Low Dose
d. Tabular Arrangement of Hazardous
Drugs on the List
4. Section V.D. Step 4: Peer Review of
Potentially Hazardous Drugs and Section
V.E. Step 5: Public Review of Potentially
Hazardous Drugs
IV. Managing Hazardous Drug Exposures:
Information for Healthcare Settings
A. Peer Review
1. Charge 1.a. What additional information
would improve [the document’s]
usefulness and why?
2. Charge 1.b. What changes could be made
to improve the utility of the information?
3. Charge 1.c. What information is
redundant, incorrect, missing, or not
needed? Please Explain
4. Charge 2. Please Provide any Additional
Studies or Scientific Information That
Evaluate or Validate Engineering, Work
Practice, or Administrative Controls To
Reduce Exposures to Hazardous Drugs in
Healthcare Settings
5. Charge 3. Please Provide any Additional
Studies or Scientific Information That
Support or Validate the Use of the
NIOSH Recommended Control Strategies
or Alternative Strategies To Control
Exposures to Hazardous Drugs
6. Charge 4. Please Provide any Additional
Studies or Scientific Information That
Support or Validate Evidence-Based
Strategies or Approaches for Controlling
Exposures to Hazardous Drugs That Are
Different From Those That NIOSH Has
Proposed
7. Charge 5.a. What additional information
would improve the usefulness of [the
Table of Control approaches in chapter
8] and why?
8. Charge 5.b. What structural or format
changes could be made to improve the
utility of [the Table of Control
approaches]?
9. Charge 5.c. What information is
redundant, incorrect, missing, or not
needed [in the Table of Control
approaches]? Please Explain
10. Charge 6. What improvements could be
made to this risk management
information to make it more useful to
employers and healthcare workers?
Please Provide Specific Examples
11. Charge 7. Please Provide Information
About Your Professional Experience, if
any, of Implementing Control Strategies

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for Exposures to Hazardous Drugs in
Healthcare or Similar Settings. Please
Describe What You Found to be Most or
Least Effective and Why. Include
Relevant Publications if Available
12. Charge 8. Please Provide any
Additional Comments or Suggestions
Either as a List Below or Using Track
Changes in the Attached Draft Document
B. Public Comments
1. Glossary
2. Chapter 1.0 Purpose and Scope
3. Chapter 6.0 Risk Management Plan
a. Section 6.2 Engineering Controls
—Closed System Transfer Devices
b. Section 6.3 Administrative Controls
—Alternative Duty
—Cleaning
—Counting Tablets
c. Section 6.4 Personal Protective
Equipment
—Use of Gloves
—Use of Gowns, Sleeve Covers, and Head
Covers
—Use of Respirators
d. Section 6.5 Surface Contamination
e. Section 6.6 Medical Surveillance
4. Chapter 7.0 Waste and Spill Control
a. Section 7.1 Hazardous Drug Waste and
Section 7.2 Spill Control
—Waste Designation and Handling
5. Chapter 8.0 Control Approaches for
Safe Handling of Hazardous Drugs by
Activity and Formulations
a. Section 8.1 Introduction to Table of
Control Approaches
b. Section 8.2 Control Approaches by
Activity and Formulation
—Receiving and Packaging
—Transportation
—Compounding of Drugs
—Administration
6. USP <800>
7. Other Topics
V. Summary of Changes to Documents
A. Procedures for Developing the NIOSH
List of Hazardous Drugs in Healthcare
Settings
B. Managing Hazardous Drug Exposures:
Information for Healthcare Settings

I. Public Participation
In a Federal Register notice published
on May 1, 2020 (85 FR 25439), NIOSH
invited the public to participate in the
development of a suite of tools designed
to assist with the identification of
hazardous drugs and appropriate
handling practices: (1) Procedures for
Developing the NIOSH List of
Hazardous Drugs in Healthcare Settings;
(2) NIOSH List of Hazardous Drugs in
Healthcare Settings, and (3) Managing
Hazardous Drug Exposures: Information
for Healthcare Settings.
The Procedures for Developing the
NIOSH List of Hazardous Drugs in
Healthcare Settings (Procedures)
establish the NIOSH definition of a
hazardous drug and a methodology for
evaluating chemical properties, preclinical information, and available
clinical information about each drug.
The Procedures also clarify how

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