Withdrawal of Food and Drug Administration Notice Regarding Yong Sheng Jiao; Denial of Hearing; Final Debarment Order, 1505 [2025-00125]
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Federal Register / Vol. 90, No. 5 / Wednesday, January 8, 2025 / Notices
lotter on DSK11XQN23PROD with NOTICES1
This draft guidance is necessary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This draft guidance is being issued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The draft guidance, when finalized, will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
VerDate Sep<11>2014
17:50 Jan 07, 2025
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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.
1505
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]
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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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: December 26, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
AGENCY:
[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.
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,
SUMMARY:
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Food and Drug Administration
[Docket No. FDA–2024–N–0604]
Yong Sheng Jiao; Denial of Hearing;
Final Debarment Order
Food and Drug Administration,
HHS.
ACTION:
Notice.
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:
SUMMARY:
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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[Federal Register Volume 90, Number 5 (Wednesday, January 8, 2025)]
[Notices]
[Page 1505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00125]
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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
