Proposed Data Collection Submitted for Public Comment and Recommendations, 66706-66707 [2022-24047]
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66706
Federal Register / Vol. 87, No. 213 / Friday, November 4, 2022 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–23–23AN; Docket No. CDC–2022–
0127]
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 information collection, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed information
collection project titled 2022 Ebola
Traveler Follow Up Evaluation.
Information collected will be used to
gather feedback from state and local
health department partners on CDC’s
interim guidance and post-arrival
management of travelers and to assess
the quality of contact information
provided to states.
DATES: CDC must receive written
comments on or before January 3, 2023.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2022–
0127 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;
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:12 Nov 03, 2022
Jkt 259001
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,
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
2022 Ebola Traveler Follow Up
Evaluation—New—National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC), National Center for
Emerging and Zoonotic Infectious
Diseases (NCEZID), Division of Global
Migration and Quarantine (DGMQ)
requests approval for a new information
collection. Section 361 of the Public
Health Service (PHS) Act (42 U.S.C.
264) authorizes the Secretary of Health
and Human Services (HHS) to make and
enforce regulations necessary to prevent
the introduction, transmission, or
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
spread of communicable diseases from
foreign countries into the United States.
Under its delegated authority, DGMQ
works to fulfill this responsibility
through a variety of activities, including
the operation of Quarantine Stations at
ports of entry and administration of
foreign quarantine regulations; 42 Code
of Federal Regulation part 71,
specifically 42 CFR 71.20—Public
health prevention measures to detect
communicable disease.
This information collection concerns
CDC’s statutory and regulatory authority
related to conducting public health
screening of travelers upon arrival to the
United States and assessing individual
travelers for public health risk following
a report of illness from a conveyance.
The purpose of this information
collection is to inform CDC and
interagency decision makers on state/
local health department activities
related to travelers coming from areas
affected by an Ebola outbreak
originating in Uganda. This information
will be used to (1) gather feedback from
state and local health department
partners on CDC’s interim guidance and
post-arrival management of travelers; (2)
assess the quality of contact information
provided to states by determining the
proportion of travelers that state and
local health departments were able to
contact for recommended assessment
and monitoring; and (3) inform the
development of future guidance and
recommendations for post-arrival
traveler management during Ebola
outbreaks abroad.
CDC collects international travelers’
contact information under authorities in
the Interim Final Rule: Control of
Communicable Diseases: Foreign
Quarantine and CDC’s Order
Requirement for Airlines and Operators
to Collect and Transmit Designated
Information for Passengers and Crew
Arriving Into the United States;
Requirement for Passengers to Provide
Designated Information. Traveler
contact information is sent to CDC
through an existing data-sharing
infrastructure in place between the
United States Department of Homeland
Security (DHS) and HHS/CDC and
approved in OMB Control No. 0920–
1354. Contact information for travelers
who have been to an area affected by the
outbreak during the 21 days prior to
arrival will be confirmed at the port of
entry. CDC will share contact
information for these travelers with state
and local health departments so that
they can do possible public health
follow up, including public health
assessment of exposure risk and
monitoring for Ebola symptoms, and
education to travelers. These public
E:\FR\FM\04NON1.SGM
04NON1
66707
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]
[Pages 66706-66707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24047]
[[Page 66706]]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-23-23AN; Docket No. CDC-2022-0127]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: 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 information
collection, as required by the Paperwork Reduction Act of 1995. This
notice invites comment on a proposed information collection project
titled 2022 Ebola Traveler Follow Up Evaluation. Information collected
will be used to gather feedback from state and local health department
partners on CDC's interim guidance and post-arrival management of
travelers and to assess the quality of contact information provided to
states.
DATES: CDC must receive written comments on or before January 3, 2023.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0127 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: [email protected].
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, 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
2022 Ebola Traveler Follow Up Evaluation--New--National Center for
Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and Prevention (CDC), National
Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division
of Global Migration and Quarantine (DGMQ) requests approval for a new
information collection. Section 361 of the Public Health Service (PHS)
Act (42 U.S.C. 264) authorizes the Secretary of Health and Human
Services (HHS) to make and enforce regulations necessary to prevent the
introduction, transmission, or spread of communicable diseases from
foreign countries into the United States. Under its delegated
authority, DGMQ works to fulfill this responsibility through a variety
of activities, including the operation of Quarantine Stations at ports
of entry and administration of foreign quarantine regulations; 42 Code
of Federal Regulation part 71, specifically 42 CFR 71.20--Public health
prevention measures to detect communicable disease.
This information collection concerns CDC's statutory and regulatory
authority related to conducting public health screening of travelers
upon arrival to the United States and assessing individual travelers
for public health risk following a report of illness from a conveyance.
The purpose of this information collection is to inform CDC and
interagency decision makers on state/local health department activities
related to travelers coming from areas affected by an Ebola outbreak
originating in Uganda. This information will be used to (1) gather
feedback from state and local health department partners on CDC's
interim guidance and post-arrival management of travelers; (2) assess
the quality of contact information provided to states by determining
the proportion of travelers that state and local health departments
were able to contact for recommended assessment and monitoring; and (3)
inform the development of future guidance and recommendations for post-
arrival traveler management during Ebola outbreaks abroad.
CDC collects international travelers' contact information under
authorities in the Interim Final Rule: Control of Communicable
Diseases: Foreign Quarantine and CDC's Order Requirement for Airlines
and Operators to Collect and Transmit Designated Information for
Passengers and Crew Arriving Into the United States; Requirement for
Passengers to Provide Designated Information. Traveler contact
information is sent to CDC through an existing data-sharing
infrastructure in place between the United States Department of
Homeland Security (DHS) and HHS/CDC and approved in OMB Control No.
0920-1354. Contact information for travelers who have been to an area
affected by the outbreak during the 21 days prior to arrival will be
confirmed at the port of entry. CDC will share contact information for
these travelers with state and local health departments so that they
can do possible public health follow up, including public health
assessment of exposure risk and monitoring for Ebola symptoms, and
education to travelers. These public
[[Page 66707]]
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Respondent Information collection tool respondents responses per response (in hours
respondent minutes)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Traveler....................................... Risk Assessment and Post-Arrival 350 52 15/60 4,550
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