[Federal Register Volume 88, Number 248 (Thursday, December 28, 2023)]
[Notices]
[Pages 89706-89707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-28595]
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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;
Revised Draft Guidance for Industry; Availability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the availability of a revised draft guidance for industry entitled
``Quality Considerations for Topical Ophthalmic Drug Products.'' This
revised draft guidance discusses certain quality considerations for
ophthalmic drug products (i.e., gels, ointments, creams, and liquid
formulations such as solutions, suspensions, and emulsions) intended
for topical delivery in and around the eye. Specifically, this revised
draft guidance discusses microbiological considerations; approaches to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 The revised draft guidance applies to marketed
products including 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, drugs compounded by outsourcing facilities, and
the drug or biological product constituent part of a combination
product. This guidance revises the draft guidance for industry of the
same name issued in October 2023.
DATES: Submit either electronic or written comments on the revised
draft guidance by February 26, 2024 to ensure that the Agency considers
your comment on this revised draft guidance before it begins work on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 revised 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 revised draft guidance document.
[[Page 89707]]
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 revised draft guidance for
industry entitled ``Quality Considerations for Topical Ophthalmic Drug
Products.'' This revised 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 (FD&C 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 U.S. Pharmacopeia (USP) monograph, the applicable
criteria from the USP. The revised draft guidance also provides
recommendations to industry on the documentation that should be
submitted in the chemistry, manufacturing, and controls (CMC) section
of NDAs, ANDAs, and BLAs for certain CMC attributes for ophthalmic drug
products.
This revised draft guidance revises the guidance of the same name
published on October 13, 2023 (88 FR 70997). FDA is revising this draft
guidance to address microbiological considerations related to product
sterility for all ophthalmic drug products subject to current good
manufacturing practice (CGMP) requirements and the prevention of
contamination of ophthalmic drug products packaged in multidose
containers, given several recent recalls of ophthalmic drug products
and instances of consumer injury and death from microbiologically
contaminated ophthalmic drug products.
FDA is also revising the draft guidance to clarify its stated
scope. As originally published, the scope explicitly included NDA,
ANDA, and BLA products regulated by the Center for Drug Evaluation and
Research; OTC monograph drugs marketed under section 505G of the FD&C
Act (21 U.S.C. 355h); and combination products. It was not FDA's
intention to specifically exclude products that are not marketed under
an approved application or under section 505G of the FD&C Act; however,
the draft guidance may have been interpreted that way. Therefore, FDA
is clarifying that the guidance also applies to other drugs that, while
also subject to CGMP requirements, are not marketed under a drug
application, including drugs compounded by outsourcing facilities
pursuant to section 503B of the FD&C Act (21 U.S.C. 353b).
This revised draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The revised 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. Previous Submission of Comments
In commenting on this revised draft guidance, you do not need to
reiterate comments that you previously submitted regarding the draft
guidance issued on October 13, 2023. Your previously submitted comments
will still be considered. You may instead submit updates to previously
submitted comments, as needed, and comments related to the new section
on microbiological considerations and the clarified scope of this
revised draft guidance.
III. 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 part 314 for NDAs and ANDAs have been approved under OMB
control number 0910-0001. The collections of information in 21 CFR part
601 for BLAs have been approved under OMB control number 0910-0338. The
collections of information in 21 CFR parts 210 and 211 pertaining to
CGMP have been approved under OMB control number 0910-0139. The
collections of information in 21 CFR 201.56 and 201.57 relating to
certain prescription product labeling requirements have been approved
under OMB control number 0910-0572. The collections of information for
section 351(k) submission of the Public Health Service Act (42 U.S.C.
262(k)) have been approved under OMB control number 0910-0718. The
collections of information pertaining to human drug compounding under
section 503B of the FD&C Act have been approved under OMB control
number 0910-0858.
IV. Electronic Access
Persons with access to the internet may obtain the revised 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 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28595 Filed 12-27-23; 8:45 am]
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