[Federal Register Volume 88, Number 197 (Friday, October 13, 2023)]
[Notices]
[Pages 70997-70998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22650]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-4177]


Quality Considerations for Topical Ophthalmic Drug Products; 
Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Quality 
Considerations for Topical Ophthalmic Drug Products.'' This draft 
guidance discusses certain quality considerations for ophthalmic drug 
products (i.e., solutions, suspensions, emulsions, gels, ointments, and 
creams) intended for topical delivery in and around the eye. 
Specifically, this draft guidance discusses approaches to evaluating 
visible particulate matter, extractables and leachables, and impurities 
and degradation products; use of in vitro drug release/dissolution 
testing as an optional quality control strategy for certain ophthalmic 
dosage forms; recommendations for design and delivery and dispensing 
features of container closure systems; and recommendations for 
stability studies. The draft guidance applies to ophthalmic drug 
products approved under new drug applications (NDAs), abbreviated new 
drug applications (ANDAs), and biologics license applications (BLAs), 
as well as to over-the-counter (OTC) monograph drugs.

DATES: Submit either electronic or written comments on the draft 
guidance by December 12, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2023-D-4177 for ``Quality Considerations for Topical Ophthalmic 
Drug Products.'' 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. 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: Ranjani Prabhakara, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 6648, Silver Spring, MD 20993-0002, 240-
402-4652.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Quality Considerations for Topical Ophthalmic Drug 
Products.'' This draft guidance provides information regarding quality 
considerations for ophthalmic drug products consistent with the 
requirements outlined in section 501(a)(2)(B) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(B)) and 21 CFR parts 210 
and 211 for all drug products, 21 CFR part 601 for biological products, 
21 CFR part 4 for combination products, and, for ophthalmic drug 
products with a United States Pharmacopeia (USP) monograph, the 
applicable criteria from the USP. The draft guidance also provides 
recommendations to industry on the documentation that should be 
submitted in the chemistry, manufacturing, and controls (CMC) section 
of NDAs,

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ANDAs, and BLAs for certain CMC attributes for ophthalmic drug 
products.
    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 ``Quality 
Considerations for Topical Ophthalmic Drug Products.'' 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 parts 314 and 601 have been approved under OMB control 
numbers 0910-0001 and 0910-0338, respectively. The collections of 
information in 21 CFR parts 210 and 211 have been approved under OMB 
control number 0910-0139.

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: October 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22650 Filed 10-12-23; 8:45 am]
BILLING CODE 4164-01-P