[Federal Register Volume 90, Number 5 (Wednesday, January 8, 2025)]
[Notices]
[Pages 1504-1505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00213]
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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Developing Drugs for Optical Imaging; Draft Guidance for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.
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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the availability of a draft guidance for industry entitled ``Developing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DATES: Submit either electronic or written comments on the draft
guidance by April 8, 2025 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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.
[[Page 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/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-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]
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