Proposed Data Collection Submitted for Public Comment and Recommendations, 18639-18641 [2024-05386]
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ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 51 / Thursday, March 14, 2024 / Notices
by wildland fire smoke include [NIOSH
2023]:
• Symptoms such as eye irritation, sore
throat, wheeze, and cough
• Asthma and chronic obstructive
pulmonary disease (COPD)
exacerbations
• Bronchitis and pneumonia
• Adverse birth outcomes
• Cardiovascular (heart and blood
vessel) outcomes
Long work shifts and physical
demands of the work performed
(resulting in higher breathing rates) may
impact a worker’s exposures and health
response to wildland fire smoke. Still,
the scientific community does not fully
understand how long-term, repeated
exposures, or other exposures to
wildland fire smoke may affect a
worker’s health. Additionally, very little
is known about how exposure to many
different compounds at the same time,
including compounds released from the
burning of man-made materials (such as
those found in the wildland-urban
interface), may affect a worker’s health.
NIOSH plans to review and assess the
available scientific evidence to support
the development of recommendations to
protect outdoor workers from wildland
fire smoke. NIOSH currently
recommends that employers be aware
that exposure to wildland fire smoke
may adversely affect the health of their
workforce and be prepared to take
action to limit their workers’ exposures
when a wildfire has emitted smoke in
and around their work environment
[NIOSH 2023].
It is also currently recommended that
employers and workers prepare for and
plan to implement procedures to reduce
exposures to smoke when necessary
[NIOSH 2023]. As NIOSH continues to
review and assess the scientific
literature, recommendations will be
developed and updated as necessary.
Additional information and
recommendations are available on the
NIOSH Safety and Health Topic Page on
Outdoor Workers Exposed to Wildfire
Smoke (https://www.cdc.gov/niosh/
topics/firefighting/wffsmoke.html).
NIOSH will update this Topic Page and
recommendations as necessary to be
consistent with the assessment of the
information obtained from this RFI and
the development of the hazard review.
To reiterate, this RFI is intended to
announce the opportunity for the public
to provide NIOSH with information
about approaches to assess and control
the hazards of wildland fire smoke to
outdoor workers to inform the
development of a hazard review
document. Scientific information
related to wildland fire smoke is
requested on the following topics:
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16:47 Mar 13, 2024
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• Properties and characteristics of
wildland fire smoke mixtures
• Potential for occupational exposures
to outdoor workers
• Health effects of exposures
• Outdoor worker populations at risk
• Exposure monitoring
• Risk management and control
• Research needs.
Reference
NIOSH [2023]. Outdoor workers exposed to
wildfire smoke. Cincinnati, OH: U.S.
Department of Health and Human
Services, Centers for Disease Control and
Prevention, National Institute for
Occupational Safety and Health, https://
www.cdc.gov/niosh/topics/firefighting/
wffsmoke.html.
John J. Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention, Department of Health and
Human Services.
[FR Doc. 2024–05403 Filed 3–13–24; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–24–0953; Docket No. CDC–2024–
0016]
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 continuing information collection, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed information
collection project titled Generic
Clearance for the Collection of
Qualitative Feedback on Agency Service
Delivery. The information collection
activities provide a means to garner
qualitative customer and stakeholder
feedback in an efficient, timely manner,
in accordance with the Federal
Government’s commitment to
improving service delivery.
DATES: CDC must receive written
comments on or before May 13, 2024.
SUMMARY:
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18639
You may submit comments,
identified by Docket No. CDC–2024–
0016 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,
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
ADDRESSES:
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Federal Register / Vol. 89, No. 51 / Thursday, March 14, 2024 / Notices
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
Generic Clearance for the Collection
of Qualitative Feedback on Agency
Service Delivery (OMB Control No.
0920–0953, Exp. 10/31/2024)—
Extension—National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The information collection activities
associated with this collection serve to
provide a means to garner qualitative
customer and stakeholder feedback in
an efficient, timely manner, in
accordance with the Federal
Government’s commitment to
improving service delivery. By
qualitative feedback we mean
information that provides useful
insights on perceptions and opinions,
but are not statistical surveys that yield
quantitative results that can be
generalized to the population of study.
This feedback will provide insights into
customer or stakeholder perceptions,
experiences and expectations, provide
an early warning of issues with service,
or focus attention on areas where
communication, training or changes in
operations might improve delivery of
products or services. These collections
will allow for ongoing, collaborative and
actionable communications between the
Agency and its customers and
stakeholders. It will also allow feedback
to contribute directly to the
improvement of program management.
• Information gathered will yield
qualitative information; the collections
will not be designed or expected to
yield statistically reliable results or used
as though the results are generalizable to
the population of study.
Feedback collected under CDC
generic clearances provides useful
information, but it does not yield data
that can be generalized to the overall
population. This type of generic
clearance for qualitative information
will not be used for quantitative
information collections that are
designed to yield reliably actionable
results, such as monitoring trends over
time or documenting program
performance. Such data uses require
more rigorous designs that address: the
target population to which
generalizations will be made; the
sampling frame; the sample design
(including stratification and clustering);
the precision requirements or power
calculations that justify the proposed
sample size; the expected response rate;
methods for assessing potential
nonresponse bias; the protocols for data
collection; and any testing procedures
that were or will be undertaken prior to
fielding the study. Depending on the
degree of influence the results are likely
to have, such collections may still be
eligible for submission for other generic
mechanisms that are designed to yield
quantitative results. As a general matter,
information collections will not result
in any new system of records containing
privacy information and will not ask
questions of a sensitive nature, such as
sexual behavior and attitudes, religious
beliefs, and other matters that are
commonly considered private.
CDC requests OMB approval for an
estimated 13,075 annual burden hours.
There is no cost to respondents other
than their time to participate.
The solicitation of feedback will target
areas such as: timeliness,
appropriateness, accuracy of
information, courtesy, efficiency of
service delivery, and resolution of
issues with service delivery. Responses
will be assessed to plan and inform
efforts to improve or maintain the
quality of service offered to the public.
If this information is not collected, vital
feedback from customers and
stakeholders on the Agency’s services
will be unavailable. CDC will only
submit a collection for approval under
these generic clearances if they meet the
following conditions:
• The collections are voluntary;
• The collections are low-burden for
respondents (based) on considerations
of total burden hours, total number of
respondents, or burden-hours per
respondent) and are low-cost for both
the respondents and the Federal
Government;
• The collections are
noncontroversial and do not raise issues
of concern to other Federal agencies;
• Any collection is targeted to the
solicitation of opinions from
respondents who have experience with
the program or may have experience
with the program in the near future;
• Personally identifiable information
(PII) is collected only to the extent
necessary and is not retained;
• Information gathered is intended to
be used only internally for general
service improvement and program
management purposes and is not
intended for release outside of the
agency (if released, the agency must
indicate the qualitative nature of the
information);
• Information gathered will not be
used for the purpose of substantially
informing influential policy decisions;
and
ddrumheller on DSK120RN23PROD with NOTICES1
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Annual
frequency
per response
Hours
per response
Total
hours
Type of respondents
Type of collections
Individuals and Households, Businesses and Organizations, State, Local or Tribal Government.
Print Surveys ................
Focus Groups ...............
Online Surveys .............
50,000
100
1500
1
1
1
15/60
2
15/60
12,500
200
375
Total ...............................................................
.......................................
........................
........................
........................
13,075
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Federal Register / Vol. 89, No. 51 / Thursday, March 14, 2024 / 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. 2024–05386 Filed 3–13–24; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2023–N–5323]
[Docket Nos. FDA–2023–E–1620 and FDA–
2023–E–1597]
Hoffmann-La Roche, Inc., et al.;
Withdrawal of Approval of Two New
Drug Applications; Correction
Determination of Regulatory Review
Period for Purposes of Patent
Extension; PYRUKYND
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Centers for Disease Control and
Prevention
Name of Committee: Disease, Disability,
and Injury Prevention and Control Special
Emphasis Panel (SEP)—PAR 18–812, NIOSH
Member Conflict Review.
Date: June 13, 2024.
Time: 1 p.m.–4 p.m., EDT.
Place: Teleconference.
Agenda: To review and evaluate grant
applications.
For Further Information Contact: Michael
Goldcamp, Ph.D., Scientific Review Officer,
Office of Extramural Programs, National
Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention,
1095 Willowdale Road, Morgantown, West
Virginia 26505. Telephone: (304) 285–5951;
Email: MGoldcamp@cdc.gov.
The Director, Office of Strategic Business
Initiatives, Office of the Chief Operating
Officer, Centers for Disease Control and
Prevention, has been delegated the authority
to sign Federal Register notices pertaining to
announcements of meetings and other
committee management activities, for both
the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Office of Strategic Business
Initiatives, Office of the Chief Operating
Officer, Centers for Disease Control and
Prevention.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register on December 18, 2023. The
document announced the withdrawal of
approval of two new drug applications
(NDA), withdrawn as of January 17,
2024. The document indicated that FDA
was withdrawing approval of NDA
022424, FLOWTUSS (guaifenesin 200
milligrams (mg)/5 milliliters (mL) and
hydrocodone bitartrate 2.5 mg/5 mL)
Oral Solution held by Chartwell RX
Sciences, LLC, 77 Brenner Dr., Congers,
NY 10920. Before FDA withdrew the
approval of this NDA, Chartwell RX
Sciences, LLC informed FDA that it did
not want the approval of the NDA
withdrawn. Because Chartwell RX
Sciences, LLC timely requested that
approval of NDA 022424 not be
withdrawn, the approval is still in
effect. This notice corrects that error.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
In the
Federal Register of Monday, December
18, 2023 (88 FR 87433), appearing on
page 87433 in FR Doc. 2023–27661, the
following correction is made:
On page 87433, in the table, the entry
for NDA 022424 is removed.
SUPPLEMENTARY INFORMATION:
Dated: March 11, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–05426 Filed 3–13–24; 8:45 am]
BILLING CODE 4164–01–P
BILLING CODE 4163–18–P
16:47 Mar 13, 2024
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
[FR Doc. 2024–05458 Filed 3–13–24; 8:45 am]
VerDate Sep<11>2014
AGENCY:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for PYRUKYND and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of
patents which claim that human drug
product.
SUMMARY:
Pursuant to 5 U.S.C. 1009(d), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended, and the Determination of
the Director, Office of Strategic Business
Initiatives, Office of the Chief Operating
Officer, CDC, pursuant to Public Law
92–463. The grant applications and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
ddrumheller on DSK120RN23PROD with NOTICES1
Food and Drug Administration,
HHS.
ACTION:
Notice of Closed Meeting
18641
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Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect must submit either electronic
or written comments and ask for a
redetermination by May 13, 2024.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
September 10, 2024. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
May 13, 2024. 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
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
E:\FR\FM\14MRN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 51 (Thursday, March 14, 2024)]
[Notices]
[Pages 18639-18641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05386]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-24-0953; Docket No. CDC-2024-0016]
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 continuing information
collection, as required by the Paperwork Reduction Act of 1995. This
notice invites comment on a proposed information collection project
titled Generic Clearance for the Collection of Qualitative Feedback on
Agency Service Delivery. The information collection activities provide
a means to garner qualitative customer and stakeholder feedback in an
efficient, timely manner, in accordance with the Federal Government's
commitment to improving service delivery.
DATES: CDC must receive written comments on or before May 13, 2024.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2024-
0016 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
[[Page 18640]]
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
Generic Clearance for the Collection of Qualitative Feedback on
Agency Service Delivery (OMB Control No. 0920-0953, Exp. 10/31/2024)--
Extension--National Institute for Occupational Safety and Health
(NIOSH), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The information collection activities associated with this
collection serve to provide a means to garner qualitative customer and
stakeholder feedback in an efficient, timely manner, in accordance with
the Federal Government's commitment to improving service delivery. By
qualitative feedback we mean information that provides useful insights
on perceptions and opinions, but are not statistical surveys that yield
quantitative results that can be generalized to the population of
study. This feedback will provide insights into customer or stakeholder
perceptions, experiences and expectations, provide an early warning of
issues with service, or focus attention on areas where communication,
training or changes in operations might improve delivery of products or
services. These collections will allow for ongoing, collaborative and
actionable communications between the Agency and its customers and
stakeholders. It will also allow feedback to contribute directly to the
improvement of program management.
The solicitation of feedback will target areas such as: timeliness,
appropriateness, accuracy of information, courtesy, efficiency of
service delivery, and resolution of issues with service delivery.
Responses will be assessed to plan and inform efforts to improve or
maintain the quality of service offered to the public. If this
information is not collected, vital feedback from customers and
stakeholders on the Agency's services will be unavailable. CDC will
only submit a collection for approval under these generic clearances if
they meet the following conditions:
The collections are voluntary;
The collections are low-burden for respondents (based) on
considerations of total burden hours, total number of respondents, or
burden-hours per respondent) and are low-cost for both the respondents
and the Federal Government;
The collections are noncontroversial and do not raise
issues of concern to other Federal agencies;
Any collection is targeted to the solicitation of opinions
from respondents who have experience with the program or may have
experience with the program in the near future;
Personally identifiable information (PII) is collected
only to the extent necessary and is not retained;
Information gathered is intended to be used only
internally for general service improvement and program management
purposes and is not intended for release outside of the agency (if
released, the agency must indicate the qualitative nature of the
information);
Information gathered will not be used for the purpose of
substantially informing influential policy decisions; and
Information gathered will yield qualitative information;
the collections will not be designed or expected to yield statistically
reliable results or used as though the results are generalizable to the
population of study.
Feedback collected under CDC generic clearances provides useful
information, but it does not yield data that can be generalized to the
overall population. This type of generic clearance for qualitative
information will not be used for quantitative information collections
that are designed to yield reliably actionable results, such as
monitoring trends over time or documenting program performance. Such
data uses require more rigorous designs that address: the target
population to which generalizations will be made; the sampling frame;
the sample design (including stratification and clustering); the
precision requirements or power calculations that justify the proposed
sample size; the expected response rate; methods for assessing
potential nonresponse bias; the protocols for data collection; and any
testing procedures that were or will be undertaken prior to fielding
the study. Depending on the degree of influence the results are likely
to have, such collections may still be eligible for submission for
other generic mechanisms that are designed to yield quantitative
results. As a general matter, information collections will not result
in any new system of records containing privacy information and will
not ask questions of a sensitive nature, such as sexual behavior and
attitudes, religious beliefs, and other matters that are commonly
considered private.
CDC requests OMB approval for an estimated 13,075 annual burden
hours. There is no cost to respondents other than their time to
participate.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Annual
Type of respondents Type of Number of frequency per Hours per Total hours
collections respondents response response
----------------------------------------------------------------------------------------------------------------
Individuals and Households, Print Surveys... 50,000 1 15/60 12,500
Businesses and Organizations, Focus Groups.... 100 1 2 200
State, Local or Tribal
Government.
Online Surveys.. 1500 1 15/60 375
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 13,075
----------------------------------------------------------------------------------------------------------------
[[Page 18641]]
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. 2024-05386 Filed 3-13-24; 8:45 am]
BILLING CODE 4163-18-P
