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[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Developing Drugs for Optical Imaging; Draft Guidance for 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the availability of a draft guidance for industry entitled ``Developing 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DATES: Submit either electronic or written comments on the draft 
guidance by April 8, 2025 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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]
BILLING CODE 4164-01-P
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