Developing Drugs for Optical Imaging; Draft Guidance for Industry; Availability

• Published date: 08 January 2025
• FR Document: 2025-00213
• Citation: 90 FR 1504
• Pages: 1504-1505
• Section: Notices
• Issuer: Health and Human Services Department,Food and Drug Administration

Federal Register, Volume 90 Issue 5 (Wednesday, January 8, 2025)

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                Developing Drugs for Optical Imaging; Draft Guidance for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                the availability of a draft guidance for industry entitled ``Developing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                DATES: Submit either electronic or written comments on the draft
                guidance by April 8, 2025 to ensure that the Agency considers your
                comment on this draft guidance before it begins work on the final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