Agency Forms Undergoing Paperwork Reduction Act Review, 2612-2614 [2024-00652]
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Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Notices
be publicly available or able to be made
public. Materials that are considered
confidential; marketing materials; study
types not included in the review; or
information on topics not included in
the review cannot be used by the EPC
Program. This is a voluntary request for
information, and all costs for complying
with this request must be borne by the
submitter.
The draft of this review will be posted
on AHRQ’s EPC Program website and
available for public comment for a
period of 4 weeks. If you would like to
be notified when the draft is posted,
please sign up for the email list at:
https://www.effectivehealthcare.
ahrq.gov/email-updates.
The review will answer the following
questions. This information is provided
as background. AHRQ is not requesting
that the public provide answers to these
questions.
Guiding Questions
The brief will be facilitated by guiding
questions (GQs), documenting research
and key informant input:
GQ1. Which prioritization criteria for
health care quality measures have been
proposed?
• What settings and intended use
were the criteria developed for?
• How are the criteria defined and
operationalized?
• In what context have these criteria
been used?
• How are the criteria similar or
different from the current NHQDR
criteria?
GQ2. How should the current NHQDR
measure selection prioritization criteria
be updated?
• What is the operationalized
definition of each updated prioritization
criteria?
• What type of health care quality
measures would help the NHQDR’s
primary audience monitor the
effectiveness of health policy levers?
GQ3. How should the new NHDQR
measure selection prioritization criteria
be applied?
PICOTS (Populations, Interventions,
Comparators, Outcomes, Timing, and
Setting)
CRITERIA FOR INCLUSION/EXCLUSION OF STUDIES IN THE REVIEW
Domain
Inclusion
Population ............
• Publications that address quality of care indicators, criteria, or benchmarks. We will accept the authors’ definition
of quality of care. Quality indicators may include care
processes-related measures (e.g., follow-up post discharge, continuity of care, medication errors), heath services utilization measures (e.g., hospital readmission,
emergency department visit), care satisfaction (e.g., patient satisfaction, care needs met, trust in care provider),
or health outcomes (e.g., mortality, physical functional status, mental functioning, quality of life) used as quality indicators; care disparities may either address differences in
provided health services, focus on care services or health
outcomes of priority populations.
• Publications that describe a process of developing, selecting, applying, comparing, evaluating, or prioritizing measures, i.e., procedures, guiding principles, suggested selection criteria, proposed decision rules, or consensus finding
methods; publications must describe an empirical ongoing
or completed process to select measures used to assess
care quality of a healthcare delivery organization or
healthcare system.
• Healthcare, specifically healthcare delivery organizations ..
Concept ................
Context .................
ddrumheller on DSK120RN23PROD with NOTICES1
Other limiters .......
Exclusion
• Reports published in English-language journal manuscripts, trial records, and gray literature in the public domain from the outlined sources.
• Publications not addressing quality of care, disparities, or
social determinants of health.
• Publications describing only the need for quality of care
measures, only quality of care measures without describing the process of how to select measures, only discussing the importance of selecting measures, suggesting
measures only for individual clinical areas or patient populations, or only describing hypothetical steps to select
measures.
• Studies in contexts outside of healthcare, not specific to
healthcare, or not applicable to the U.S. health care system.
• Data reported in abbreviated format (e.g., conference abstracts) will be excluded; studies not published in English.
• Systematic reviews will be retained for reference mining.
Searches will be conducted without
date restriction.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: January 8, 2024.
Marquita Cullom,
Associate Director.
Centers for Disease Control and
Prevention
[FR Doc. 2024–00617 Filed 1–12–24; 8:45 am]
[30Day–24–0621]
BILLING CODE 4160–90–P
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘National
Youth Tobacco Survey 2024–2026’’ to
the Office of Management and Budget
(OMB) for review and approval. CDC
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previously published a ‘‘Proposed Data
Collection Submitted for Public
Comment and Recommendations’’
notice on June 5, 2023 to obtain
comments from the public and affected
agencies. CDC received five comments
related to the previous notice. This
notice serves to allow an additional 30
days for public and affected agency
comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
E:\FR\FM\16JAN1.SGM
16JAN1
2613
Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Notices
functions of the agency, including
whether the information will have
practical utility;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) 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 submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. Direct written
comments and/or suggestions regarding
the items contained in this notice to the
Attention: CDC Desk Officer, Office of
Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
Proposed Project
National Youth Tobacco Survey 2024–
2026 (OMB Control No. 0920–0621,
Exp. 1/31/2024)—Revision—National
Center for Chronic Disease Prevention
and Health Promotion (NCCDPHP),
Centers for Disease Control and
Prevention (CDC)
Background and Brief Description
Tobacco use is the leading cause of
preventable disease and death in the
United States, and nearly all tobacco use
begins during youth and young
adulthood. A limited number of health
risk behaviors, including tobacco use,
account for the overwhelming majority
of immediate and long-term sources of
morbidity and mortality. Because many
health risk behaviors are established
during adolescence, there is a critical
need for public health programs
directed towards youth, and for
information to support these programs.
Since 2004, the Centers for Disease
Control and Prevention (CDC) has
periodically collected information about
tobacco use among adolescents
(National Youth Tobacco Survey
(NYTS) 2004, 2006, 2009, 2011–2023
(OMB Control No. 0920–0621, Exp. 01/
31/2024). This surveillance activity
builds on previous surveys funded by
the American Legacy Foundation in
1999, 2000, and 2002. At present, the
NYTS is the most comprehensive source
of nationally representative tobaccorelated data among students in grades
9–12, moreover, the NYTS is the only
source of such data for students in
grades 6–8. The NYTS has provided
national estimates of tobacco use
behaviors, information about exposure
to pro- and anti-tobacco influences, and
information about tobacco-related racial
and ethnic disparities. Information
collected through the NYTS is used to
identify trends over time, to inform the
development of tobacco cessation
programs for youth, and to evaluate the
effectiveness of existing interventions
and programs.
CDC plans to request OMB approval
to conduct additional cycles of the
NYTS in 2024, 2025, and 2026. The
survey will be conducted among
nationally representative samples of
students attending public and private
schools in grades 6–12. The survey will
be digital, web-based, self-administered,
and will be taken on school or personal
computers, tablets, or mobile devices.
Information supporting the NYTS also
will be collected from state-, district-,
and school-level administrators and
teachers. During the 2024–2026
timeframe, changes will be incorporated
that reflect CDC’s ongoing collaboration
with FDA and the need to measure
progress toward meeting strategic goals
established by the Family Smoking
Prevention and Tobacco Control Act.
Information collection will occur
annually and may include a number of
new questions, as well as increased
representation of minority youth.
The survey will examine the
following topics: Use of e-cigarettes,
cigarettes, cigars, smokeless tobacco,
hookahs, roll-your-own cigarettes,
pipes, snus, dissolvable tobacco, bidis,
heated tobacco products, and nicotine
pouches; knowledge and attitudes;
media and advertising; access to tobacco
products and enforcement of restrictions
on access; secondhand smoke and ecigarette aerosol exposure; social
determinants of health such as family/
household affluence; provision of
school- and community-based
interventions, and cessation.
Results of the NYTS will continue to
be used to inform and evaluate the
National Comprehensive Tobacco
Control Program, provide data to inform
the Department of Health and Human
Service’s Tobacco Control Strategic
Action Plan, and provide national
benchmark data for state-level Youth
Tobacco Surveys. Information collected
through the NYTS also is expected to
provide multiple measures and data for
monitoring progress on seven tobaccorelated objectives for Healthy People
2030.
CDC requests OMB approval for an
estimated 22,086 annual burden hours
over each of the next three years. There
are no costs to respondents other than
their time to participate.
ddrumheller on DSK120RN23PROD with NOTICES1
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondent
Form name
State administrators ........................................
District administrators .....................................
School administrators .....................................
Teachers .........................................................
Students ..........................................................
State-level Recruitment Script for the NYTS
District-level Recruitment Script for the NYTS
School-level Recruitment Script for the NYTS
Data Collection Checklist ...............................
National Youth Tobacco Survey ....................
Screening for Cognitive Interviews ................
Cognitive Interviews .......................................
Pilot Testing ...................................................
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42
308
420
1,497
28,109
300
30
100
16JAN1
Number of
responses per
respondent
1
1
1
1
1
1
2
1
Average
burden per
response
(in hours)
30/60
30/60
30/60
15/60
45/60
10/60
120/60
45/60
2614
Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 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. 2024–00652 Filed 1–12–24; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket Number CDC–2020–0046, NIOSH–
233–C]
Request for Public Comment on NIOSH
Initial Recommendations To Change
the Status of Liraglutide and
Pertuzumab on the NIOSH List of
Antineoplastic and Other Hazardous
Drugs in Healthcare Settings
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Request for comment.
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), requests public
comment on two draft reevaluations
with initial recommendations to change
the status of two drugs, liraglutide and
pertuzumab, on the NIOSH List of
Antineoplastics and Other Hazardous
Drugs in Healthcare Settings (List). The
reevaluations were developed based on
the process described in the NIOSH
Procedures for Developing the NIOSH
List of Hazardous Drugs in Healthcare
Settings. Based on the reevaluations, the
NIOSH initial recommendations are to
remove liraglutide and pertuzumab from
the List.
DATES: Electronic or written comments
must be received by February 15, 2024.
ADDRESSES: You may submit comments,
identified by CDC–2020–0046 and
docket number NIOSH–233–C, by either
of the following methods:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: National Institute for
Occupational Safety and Health, NIOSH
Docket Office, 1090 Tusculum Avenue,
MS C–34, Cincinnati, Ohio 45226–1998.
Instructions: All information received
in response to this notice must include
the agency name and docket number
(CDC–2020–0046; NIOSH–233–C). All
relevant comments, including any
personal information provided, will be
posted without change to https://
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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18:57 Jan 12, 2024
Jkt 262001
www.regulations.gov. Do not submit
comments by email. CDC does not
accept comments by email. For access to
the docket to read background
documents or comments received, go to
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: R.
Todd Niemeier, Ph.D., National Institute
for Occupational Safety and Health,
MS–C15, 1090 Tusculum Avenue,
Cincinnati, OH 45226. Telephone: (513)
533–8166.
SUPPLEMENTARY INFORMATION: NIOSH
seeks public comments on its
reevaluations with initial
recommendations to change the status
of two drugs, pertuzumab and
liraglutide, on the NIOSH List of
Antineoplastic and Other Hazardous
Drugs in Healthcare Settings (the List).
The NIOSH reevaluations were
conducted based on the process
described in the NIOSH Procedures for
Developing the NIOSH List of
Hazardous Drugs in Healthcare Settings,
available at https://www.cdc.gov/niosh/
docs/2016-161/.
NIOSH reevaluated the placement of
pertuzumab on the NIOSH List in
response to a request for reevaluation
from the manufacturer. Based on this
reevaluation, the initial NIOSH
recommendation is to remove
pertuzumab from the NIOSH List. In its
reevaluation NIOSH determined that,
due to the intrinsic molecular properties
of pertuzumab and the nature of the
specific hazard posed by exposure to
pertuzumab, it is not likely to pose a
hazard to workers in healthcare settings.
The potential adverse health effect
relevant to pertuzumab occupational
exposure is the increased potential for
fetal developmental abnormalities due
to oligohydramnios during pregnancy
[FDA 2012]. However, the development
of oligohydramnios during pregnancy is
reversible and would require repeated
exposures to pertuzumab that are high
enough to cause oligohydramnios
through the relevant period of
development. Pertuzumab has limited
dermal, oral, and inhalation
bioavailability due to its intrinsic
molecular properties. Repeated
unintended exposures resulting from
needlestick injuries at levels high
enough to result in sustained
oligohydramnios is unlikely. For these
reasons, pertuzumab is not expected to
pose a hazard to workers in healthcare
workplaces.
NIOSH reevaluated the placement of
liraglutide on the NIOSH List in
response to a request for reevaluation
from the manufacturer. Based on this
reevaluation, the initial NIOSH
recommendation is to remove
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
liraglutide from the NIOSH List. In its
reevaluation NIOSH determined that,
due to the intrinsic molecular properties
of liraglutide and the nature of the
specific hazard posed by exposure to
liraglutide, it is not likely to pose a
hazard to workers in healthcare settings.
In animal studies liraglutide was
reported to cause C-cell specific thyroid
tumors [FDA 2009]. This carcinogenic
effect was due to mitogenic activity, and
the progression required continued
liraglutide exposure. The relevance of Ccell specific thyroid tumor formation in
response to liraglutide exposure to
humans is unknown but cannot be ruled
out. Potential fetal developmental
abnormalities are also seen in some
animal studies, and there may be risk to
the fetus in pregnant patients. However,
the intrinsic molecular properties of the
liraglutide peptide greatly decrease
dermal, oral, and inhalation
bioavailability, and the hazards related
to liraglutide exposure would require
repeated needlestick injuries. Systemic
exposures in workplaces are not likely
to reach levels required for the potential
adverse effects to pose a hazard.
In addition to providing the
opportunity for public comment, NIOSH
is conducting external peer review of its
reevaluations. NIOSH has completed the
peer review of pertuzumab and will
conduct the peer review of liraglutide
concurrently with the public review.
The charges to the public and peer
reviewers are provided below.
Public and Peer Review Charge for the
Reevaluation of Pertuzumab on the
NIOSH List of Hazardous Drugs
The manufacturer’s request to
reevaluate the inclusion of pertuzumab
on the NIOSH List proposed that
pertuzumab does not present a potential
hazard to healthcare worker exposures
because the properties of the drug limit
the potential for exposure and therefore
adverse health effects from that
exposure. NIOSH developed a scenario
for worker exposure to pertuzumab to
evaluate this proposal. Based on this
scenario NIOSH determined that
pertuzumab does not meet the NIOSH
definition of a hazardous drug and
recommends that it be removed from the
List. Please review the NIOSH
reevaluation of pertuzumab and
consider the following questions.
1. Is this an appropriate method for
evaluating the potential for exposure to
pertuzumab?
2. Is oligohydramnios the best health
effect to evaluate? If not, what other
health effect(s) should be evaluated and
why?
E:\FR\FM\16JAN1.SGM
16JAN1
]]>Agencies
[Federal Register Volume 89, Number 10 (Tuesday, January 16, 2024)]
[Notices]
[Pages 2612-2614]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00652]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-24-0621]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled ``National Youth Tobacco Survey 2024-2026''
to the Office of Management and Budget (OMB) for review and approval.
CDC previously published a ``Proposed Data Collection Submitted for
Public Comment and Recommendations'' notice on June 5, 2023 to obtain
comments from the public and affected agencies. CDC received five
comments related to the previous notice. This notice serves to allow an
additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) Evaluate whether the proposed collection of information is
necessary for the proper performance of the
[[Page 2613]]
functions of the agency, including whether the information will have
practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) 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 submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570. Comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. Direct
written comments and/or suggestions regarding the items contained in
this notice to the Attention: CDC Desk Officer, Office of Management
and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202)
395-5806. Provide written comments within 30 days of notice
publication.
Proposed Project
National Youth Tobacco Survey 2024-2026 (OMB Control No. 0920-0621,
Exp. 1/31/2024)--Revision--National Center for Chronic Disease
Prevention and Health Promotion (NCCDPHP), Centers for Disease Control
and Prevention (CDC)
Background and Brief Description
Tobacco use is the leading cause of preventable disease and death
in the United States, and nearly all tobacco use begins during youth
and young adulthood. A limited number of health risk behaviors,
including tobacco use, account for the overwhelming majority of
immediate and long-term sources of morbidity and mortality. Because
many health risk behaviors are established during adolescence, there is
a critical need for public health programs directed towards youth, and
for information to support these programs.
Since 2004, the Centers for Disease Control and Prevention (CDC)
has periodically collected information about tobacco use among
adolescents (National Youth Tobacco Survey (NYTS) 2004, 2006, 2009,
2011-2023 (OMB Control No. 0920-0621, Exp. 01/31/2024). This
surveillance activity builds on previous surveys funded by the American
Legacy Foundation in 1999, 2000, and 2002. At present, the NYTS is the
most comprehensive source of nationally representative tobacco-related
data among students in grades 9-12, moreover, the NYTS is the only
source of such data for students in grades 6-8. The NYTS has provided
national estimates of tobacco use behaviors, information about exposure
to pro- and anti-tobacco influences, and information about tobacco-
related racial and ethnic disparities. Information collected through
the NYTS is used to identify trends over time, to inform the
development of tobacco cessation programs for youth, and to evaluate
the effectiveness of existing interventions and programs.
CDC plans to request OMB approval to conduct additional cycles of
the NYTS in 2024, 2025, and 2026. The survey will be conducted among
nationally representative samples of students attending public and
private schools in grades 6-12. The survey will be digital, web-based,
self-administered, and will be taken on school or personal computers,
tablets, or mobile devices. Information supporting the NYTS also will
be collected from state-, district-, and school-level administrators
and teachers. During the 2024-2026 timeframe, changes will be
incorporated that reflect CDC's ongoing collaboration with FDA and the
need to measure progress toward meeting strategic goals established by
the Family Smoking Prevention and Tobacco Control Act. Information
collection will occur annually and may include a number of new
questions, as well as increased representation of minority youth.
The survey will examine the following topics: Use of e-cigarettes,
cigarettes, cigars, smokeless tobacco, hookahs, roll-your-own
cigarettes, pipes, snus, dissolvable tobacco, bidis, heated tobacco
products, and nicotine pouches; knowledge and attitudes; media and
advertising; access to tobacco products and enforcement of restrictions
on access; secondhand smoke and e-cigarette aerosol exposure; social
determinants of health such as family/household affluence; provision of
school- and community-based interventions, and cessation.
Results of the NYTS will continue to be used to inform and evaluate
the National Comprehensive Tobacco Control Program, provide data to
inform the Department of Health and Human Service's Tobacco Control
Strategic Action Plan, and provide national benchmark data for state-
level Youth Tobacco Surveys. Information collected through the NYTS
also is expected to provide multiple measures and data for monitoring
progress on seven tobacco-related objectives for Healthy People 2030.
CDC requests OMB approval for an estimated 22,086 annual burden
hours over each of the next three years. There are no costs to
respondents other than their time to participate.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
State administrators.................. State-level Recruitment 42 1 30/60
Script for the NYTS.
District administrators............... District-level 308 1 30/60
Recruitment Script for
the NYTS.
School administrators................. School-level Recruitment 420 1 30/60
Script for the NYTS.
Teachers.............................. Data Collection 1,497 1 15/60
Checklist.
Students.............................. National Youth Tobacco 28,109 1 45/60
Survey.
Screening for Cognitive 300 1 10/60
Interviews.
Cognitive Interviews.... 30 2 120/60
Pilot Testing........... 100 1 45/60
----------------------------------------------------------------------------------------------------------------
[[Page 2614]]
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. 2024-00652 Filed 1-12-24; 8:45 am]
BILLING CODE 4163-18-P
