63956 Federal Register / Vol. 88, No. 179 / Monday, September 18, 2023 / Notices 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Public Health Ethics and 

Regulations, Office of Science, Centers for 

Disease Control and Prevention. 

[FR Doc. 2023–20067 Filed 9–15–23; 8:45 am] 

BILLING CODE 4163–70–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–23–23FJ] 

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 ‘‘Evaluating 

Deep Learning Algorithm Assessment of 

Digital Photographs for Dental Public 

Health Surveillance’’ 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 two comments. 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 

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 

Evaluating Deep Learning Algorithm 

Assessment of Digital Photographs for 

Dental Public Health Surveillance— 

New—National Center for Chronic 

Disease Prevention and Health 

Promotion (NCCDPHP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

By age 19, 57% of U.S. adolescents 

have experienced tooth decay and 17% 

have at least one decayed tooth needing 

treatment. Prevalence of untreated tooth 

decay among non-Hispanic Black and 

Mexican American adolescents is about 

30% higher than among non-Hispanic 

White adolescents, and among lowincome, almost twice the prevalence of 

higher-income adolescents. Untreated 

tooth decay will not resolve and can 

cause pain, infection, and difficulties in 

learning. Poor oral health in youth is 

associated with both lower school 

attendance and grades. More than 34 

million school hours are lost annually 

due to unplanned dental visits for acute 

care needs. Reducing the percentage of 

youths who have experienced tooth 

decay and the percentage with untreated 

tooth decay are national health goals 

(Healthy People 2030). 

There are two highly effective 

interventions to prevent tooth decay. 

Dental sealants prevent about 80% of 

cavities over two years in the permanent 

molars where about 90% of tooth decay 

occurs. Fluoride can prevent decay in 

permanent teeth by 15% to 43% per 

year depending on mode of delivery. 

Although the American Dental 

Association recommends dentists 

provide topical fluoride and dental 

sealants to youth at risk for caries, 

uptake of these services is low with 

about 20% of low-income youth 

receiving them during an annual dental 

visit. Access to these preventive services 

as measured by dental sealant 

prevalence and receipt of preventive 

dental services among low-income 

children are national health goals. 

The Centers for Disease Control and 

Prevention (CDC) has collected national 

data on caries, sealant, and fluorosis 

prevalence in the National Health and 

Nutrition Examination Survey 

(NHANES) for over 30 years and has 

supported State oral health programs to 

collect data on caries and sealant 

prevalence through cooperative 

agreements since 2001. Twenty States 

are currently funded from September 

2018 to August 2023 by Actions to 

Improve Oral Health Outcomes, CDC– 

RFA–DP18–1810. Collecting these data 

can be resource intensive as they are 

obtained through visual/tactile 

examinations conducted by dental 

professionals. These data, however, 

have enabled Federal and State agencies 

to: (1) prioritize groups at elevated risk 

for enhanced prevention efforts; (2) 

monitor trends in children’s oral health 

status and disparities; (3) inform 

planning, implementation and 

evaluation of effective oral health 

interventions, programs, and policies; 

(4) measure progress toward Healthy 

People objectives; and (5) educate the 

public and policy makers regarding 

cross-cutting public health programs. 

Having local estimates of these 

measures would enable decision-makers 

to better prioritize communities for 

programs that increase access to 

preventive dental services. 

CDC is examining the feasibility and 

validity of using digital photos taken by 

non-dental professionals, which in turn 

would be analyzed by deep learning 

algorithms to assess youth’s oral health 

status in lieu of human examination. 

This deep learning assessment tool 

ultimately could be used by public 

health officials for dental public health 

surveillance at the local, State, and 

national level. It is anticipated that 

obtaining information on dental 

conditions via deep learning assessment 

of digital images as opposed to human 

assessment will: (1) be more cost 

effective as it would not require dental 

personnel; and (2) improve the accuracy 

of assessment due to minimal bias and 

less confounding factors associated with 

the examiner (e.g., subjective index and 

thresholding). This tool also would offer 

mobility, simplicity, and affordability 

for rapid and scalable adaptation in 

community-based settings. 

In order to train and test the deep 

learning algorithms to identify caries, 

sealants, and fluorosis, data on these 

conditions as assessed by standardized 

examiners and corresponding photos are 

required. The CDC requests a one-year 

OMB approval for the one-time 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 179 / Monday, September 18, 2023 / Notices 63957 

collection of oral health data from 1,000 

middle- and high-school students in 

Colorado communities with naturally 

occurring fluoride in the tap water at or 

exceeding one part per million. CDC is 

funding the Colorado State Health 

Department to implement the collection 

by recruiting eligible schools and dental 

examiners, gaining consent, arranging 

logistics, and collecting de-identified 

examination data and photos taken by 

the dental examiners. CDC is funding a 

national expert in dental public health 

data collection to train the examiners. 

Finally, CDC is funding researchers at 

Purdue University to develop phototaking protocols and deep learning 

algorithms to identify dental conditions. 

Data collected for each student will 

include: (1) human assessment of 

fluorosis severity in the six upper 

anterior teeth, and caries/sealant 

assessment of the occlusal surfaces of 

the eight permanent molars; and (2) 

nine smartphone digital photos of the 

upper anterior teeth and 24 intraoral 

camera digital photos of the occlusal 

surfaces of the eight permanent molars. 

Digital photos of the teeth and the 

completed paper screening form will be 

uploaded to a HIPAA compliant cloud 

storage box that can only be accessed by 

examiners and designated CDC 

researchers with administrative rights. 

CDC is authorized to collect this 

information under the Public Health 

Service Act, title 42, section 247b–14, 

Oral health promotion and disease 

prevention; and the Public Health 

Service Act, title 42, section 301. 

CDC proposes using data collected 

from 750 students to train the deep 

learning algorithms to assess caries, 

sealants, and fluorosis and data from 

250 students to evaluate the accuracy of 

the algorithms in terms of agreement 

with standardized examiner assessment. 

Manuscripts on: (1) the methodologies 

used to ensure sufficient photo quality 

when taken under field conditions; and 

(2) the performance of the deep learning 

algorithms will be submitted to peerreviewed journals. The deep learning 

tool, if sufficiently accurate, will be 

piloted in one data collection cycle of 

NHANES that is administered by the 

National Centers for Health Statistics 

(NCHS). Ultimately, the tool would be 

shared with the State and local oral 

health programs and other pertinent 

partners. 

CDC requests OMB clearance for data 

collection for one year. The total 

estimated annualized burden hours are 

827. There are no costs to student 

respondents other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hr) 

Child ............................ Screening/photo/form ......................................................................... 1,000 1 16/60 

Parent or caretaker ..... Consent .............................................................................................. 1,000 1 1/60 

Screener ..................... Screening/photo form includes training, travel, screening and 

photos, and ongoing technical assistance.

6 1 90/60 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Public Health Ethics and 

Regulations, Office of Science, Centers for 

Disease Control and Prevention. 

[FR Doc. 2023–20066 Filed 9–15–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Board of Scientific Counselors, 

National Institute for Occupational 

Safety and Health; Notice of Charter 

Renewal 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice of charter renewal. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), within 

the Department of Health and Human 

Services (HHS), announces the renewal 

of the charter of the Board of Scientific 

Counselors, National Institute for 

Occupational Safety and Health (BSC, 

NIOSH). 

FOR FURTHER INFORMATION CONTACT: 

Maria Strickland, M.P.H., Designated 

Federal Officer, Board of Scientific 

Counselors, National Institute for 

Occupational Safety and Health, Centers 

for Disease Control and Prevention, 

Department of Health and Human 

Services, 400 7th Street SW, Suite 5W, 

Constitution Center, Washington, 

District of Columbia 20024. Telephone: 

(202) 245–0649; Email: MStrickland2@

cdc.gov. 

SUPPLEMENTARY INFORMATION: CDC is 

providing notice under 5 U.S.C. 1001– 

1014. This charter has been renewed for 

a two-year period through February 3, 

2025. 

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. 

[FR Doc. 2023–20092 Filed 9–15–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–0643] 

Labeling for Biosimilar and 

Interchangeable Biosimilar Products; 

Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘Labeling 

for Biosimilar and Interchangeable 

Biosimilar Products.’’ This draft 

guidance is intended to help applicants 

develop draft labeling for proposed 


lotter on DSK11XQN23PROD with NOTICES1