1504 Federal Register / Vol. 90, No. 5 / Wednesday, January 8, 2025 / Notices 

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may obtain the draft guidance at https:// 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 30, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–00237 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–D–3780] 

Developing Drugs for Optical Imaging; 

Draft Guidance for Industry; 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 

‘‘Developing Drugs for Optical 

Imaging.’’ The purpose of this guidance 

is to provide recommendations to 

sponsors regarding clinical trial design 

features that support development and 

approval of optical imaging drugs that 

are used in conjunction with imaging 

devices and intended as intraoperative 

aids for the detection of pathology such 

as tumors or to enhance the conspicuity 

of normal anatomical structures. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by April 8, 2025 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

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

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2024–D–3780 for ‘‘Developing Drugs for 

Optical Imaging.’’ Received comments 

will be placed in the docket and, except 

for those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; or the Office of Policy, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5431, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Libero Marzella, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993, 301–796–2050; or Erica Takai, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 5456, Silver Spring, MD 20993– 

0002, 301–796–6353. 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Developing Drugs for Optical 

Imaging.’’ The purpose of this guidance 

is to provide recommendations to 

sponsors regarding clinical trial design 

features that support development and 

approval of optical imaging drugs that 

are used in conjunction with imaging 

devices and intended as intraoperative 

aids for detection of pathology such as 

tumors or to enhance the conspicuity of 

normal anatomical structures. 


lotter on DSK11XQN23PROD with NOTICES1
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 


lotter on DSK11XQN23PROD with NOTICES1