2612 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 Exclusion 

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 not addressing quality of care, disparities, or 

social determinants of health. 

Concept ................ • 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.

• 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. 

Context ................. • Healthcare, specifically healthcare delivery organizations .. • Studies in contexts outside of healthcare, not specific to 

healthcare, or not applicable to the U.S. health care system. 

Other limiters ....... • Reports published in English-language journal manuscripts, trial records, and gray literature in the public domain from the outlined sources.• 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. 

Dated: January 8, 2024. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2024–00617 Filed 1–12–24; 8:45 am] 

BILLING CODE 4160–90–P 

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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 10 / Tuesday, January 16, 2024 / Notices 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 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. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

State administrators ........................................ State-level Recruitment Script for the NYTS 42 1 30/60 

District administrators ..................................... District-level Recruitment Script for the NYTS 308 1 30/60 

School administrators ..................................... School-level Recruitment Script for the NYTS 420 1 30/60 

Teachers ......................................................... Data Collection Checklist ............................... 1,497 1 15/60 

Students .......................................................... National Youth Tobacco Survey .................... 28,109 1 45/60 

Screening for Cognitive Interviews ................ 300 1 10/60 

Cognitive Interviews ....................................... 30 2 120/60 

Pilot Testing ................................................... 100 1 45/60 


ddrumheller on DSK120RN23PROD with NOTICES1
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 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Request for comment. 

SUMMARY: 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://

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 

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? 


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