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 


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