Federal Register / Vol. 90, No. 5 / Wednesday, January 8, 2025 / Notices 1505 

This draft guidance is necessary 

because of the burgeoning interest in the 

development of novel optical imaging 

drugs and imaging devices to assist 

standard surgical procedures in a 

variety of clinical contexts. Surgeons 

use these imaging drugs with imaging 

devices during surgery to assist the 

standard of care direct visual inspection 

and palpation of tissue in the surgical 

field. The imaging drugs, for example, 

enhance the ability of the surgeon to 

distinguish tumors from normal tissue. 

Therefore, the drugs can increase the 

likelihood of a safe and complete 

removal of cancers and can minimize 

the risk of unintended injury to normal 

anatomical structures. The use of 

minimally invasive surgical approaches 

is a contributing factor driving the 

development of optical imaging 

products because of the loss of touch 

perception and more limited field of 

view with these procedures. For 

instance, the development of 

molecularly targeted fluorescent optical 

drugs aims to facilitate a surgeon’s 

ability to identify the margins of 

primary tumors and contiguous tumor 

lesions to achieve a surgical cure. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Developing Drugs for Optical 

Imaging.’’ It does not establish any 

rights for any person and is not binding 

on FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in 21 CFR 201.56 and 

201.57 relating to the content and 

format requirements for labeling of 

drugs and biologics have been approved 

under OMB control number 0910–0572. 

The collections of information in 21 

CFR part 312 relating to the 

investigational new drug application 

pathway, which includes clinical trials 

and clinical trial design, have been 

approved under OMB control number 

0910–0014. The collections of 

information in 21 CFR part 314 relating 

to the submission of new drug 

applications and abbreviated new drug 

applications have been approved under 

OMB control number 0910–0001. The 

collections of information in 21 CFR 

part 601 for the submission of biologics 

license applications have been approved 

under OMB control number 0910–0338. 

The collections of information in 21 

CFR part 812 relating to investigational 

device exemptions have been approved 

under OMB control number 0910–0078. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: December 26, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–00213 Filed 1–7–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–0604] 

Withdrawal of Food and Drug 

Administration Notice Regarding Yong 

Sheng Jiao; Denial of Hearing; Final 

Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing this 

notice to withdraw the December 5, 

2024, Federal Register notice entitled 

‘‘Yong Sheng Jiao; Denial of Hearing; 

Final Debarment Order’’ because the 

document provided the incorrect bases 

for debarment and omitted edited 

language. A corrected notice document 

is published elsewhere in this Federal 

Register. 

FOR FURTHER INFORMATION CONTACT: 

Karen Fikes, Office of Scientific 

Integrity, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 4232, Silver Spring, 

MD 20993, 301–796–9603. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of December 5, 2024 

(89 FR 96655), FDA published a notice 

entitled ‘‘Yong Sheng Jiao; Denial of 

Hearing; Final Debarment Order.’’ The 

notice incorrectly reflected language for 

debarment and omitted edited language. 

The published document did not evince 

all changes and edits relevant to this 

notice. For this reason, the notice, 

Docket No. FDA–2024–N–0604, as 

published in the Federal Register on 

December 5, 2024, is hereby withdrawn. 

Dated: December 31, 2024. 

George M. Warren, 

Director, Office of Scientific Integrity. 

[FR Doc. 2025–00125 Filed 1–7–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–0604] 

Yong Sheng Jiao; Denial of Hearing; 

Final Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

denying a request for a hearing 

submitted by Yong Sheng Jiao, also 

known as Yongsheng Jiao and Wilson 

Jiao (Jiao), and is issuing an order under 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) debarring Jiao for 5 

years from importing or offering for 

import any drug into the United States. 

FDA bases this order on a finding that 

Jiao was convicted of a felony under 

Federal law for conduct relating to the 

importation into the United States of 

any drug or controlled substance under 

the FD&C Act. In determining the 

appropriateness and period of Jiao’s 

debarment, FDA considered the relevant 

factors listed in the FD&C Act. Jiao 

submitted a request for hearing but 

failed to file with the Agency 

information and analyses sufficient to 

create a basis for a hearing. 

DATES: The order is applicable January 

8, 2025. 

ADDRESSES: Any application for 

termination of debarment by Jiao under 

section 306(d) of the FD&C Act (21 

U.S.C. 335a(d)) (application) may be 

submitted as follows: 

Electronic Submissions 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

An application submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

application will be made public, you are 

solely responsible for ensuring that your 

application does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 


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