Quality Considerations for Topical Ophthalmic Drug Products; Draft Guidance for Industry; Availability, 70997-70998 [2023-22650]

Download as PDF Federal Register / Vol. 88, No. 197 / Friday, October 13, 2023 / Notices 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Food and Drug Administration [Docket No. FDA–2023–D–4177] Quality Considerations for Topical Ophthalmic Drug Products; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Quality Considerations for Topical Ophthalmic Drug Products.’’ This draft guidance discusses certain quality considerations for ophthalmic drug products (i.e., solutions, suspensions, emulsions, gels, ointments, and creams) intended for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 Specifically, this draft guidance discusses approaches to evaluating visible particulate matter, extractables and leachables, and impurities and degradation products; use of in vitro drug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 The draft guidance applies to ophthalmic drug products approved under new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications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 overthe-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 DATES: Submit either electronic or written comments on the draft guidance by December 12, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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: lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: 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 VerDate Sep<11>2014 16:55 Oct 12, 2023 Jkt 262001 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 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 70997 ‘‘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-201509-18/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, E:\FR\FM\13OCN1.SGM 13OCN1 70998 Federal Register / Vol. 88, No. 197 / Friday, October 13, 2023 / Notices 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/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ regulatory-information/search-fdaguidance-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] Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Screening Framework Guidance for Providers and Users of Synthetic Nucleic Acids Administration for Strategic Preparedness and Response (ASPR), Department of Health and Human Services (HHS). ACTION: Notice. lotter on DSK11XQN23PROD with NOTICES1 AGENCY: The Administration for Strategic Preparedness and Response is issuing this screening framework guidance, which sets forth baseline standards for the gene and genome synthesis industry, as well as best practices for all entities involved in the SUMMARY: VerDate Sep<11>2014 16:55 Oct 12, 2023 Jkt 262001 provision, use, and transfer of synthetic nucleic acids, regarding screening orders and recipients and maintaining records. In addition, this guidance seeks to encourage best practices to address biosecurity concerns associated with the potential misuse of synthetic nucleic acids in order to bypass existing regulatory controls and commit unlawful acts. FOR FURTHER INFORMATION CONTACT: C. Matthew Sharkey, Administration for Strategic Preparedness and Response, Department of Health and Human Services, 400 7th St. SW, Washington, DC 20024; 202–868–9224, syndnaguidance@hhs.gov. SUPPLEMENTARY INFORMATION: A request for public comments on the issues covered in this Notice was published in the Federal Register (85 FR 52611 [Aug. 26, 2020]; 85 FR 69630 [Nov. 3, 2020], Review and Revision of the Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA) with a comment period of more than 120 days. Following consideration of the comments received in response to this Notice, HHS issued proposed draft revised guidance as a Federal Register Notice (87 FR 25495 [Apr. 29, 2022], Screening Framework Guidance for Providers and Users of Synthetic Oligonucleotides) and solicited additional comments for a period of 60 days. This Guidance was drafted through a deliberative interagency process to address the topics raised in public comments received in response to these prior Notices as well as other considerations. Responses received from these prior Notices and summaries of updates contained in this Guidance are available for public review at the following website https://aspr.hhs.gov/ legal/synna. I. Introduction Synthetic biology is an interdisciplinary field that focuses on the design and fabrication of novel biological components and systems as well as the redesign and fabrication of existing biological systems. Modern biotechnologies have made the conversion of different types of nucleic acids possible (e.g., RNA to DNA), and longer genomic sequences can now be constructed from very short nucleic acids with higher fidelity. Additionally, synthetic biology is not limited to naturally derived genetic material. Thus, this scientific field has the potential to generate existing or novel components, systems, or organisms PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 directly, using only genetic sequence data. Advances in nucleic acid synthesis technology and the open-source availability of genetic sequence data have significantly contributed to discovery and innovation in areas such as health and agriculture research and development. However, there are concerns among the scientific community, the nucleic acid synthesis industry, the U.S. government, and the public that individuals with ill intent could exploit biotechnology for harmful purposes. The U.S. government has acted to minimize risks to public health, agriculture, plants, animals, animal or plant products, and the environment due to biological pathogens and toxins. For instance, it has issued the Federal Select Agent Regulations, which regulate a subset of microbial organisms and toxins determined to have the potential to pose a severe threat to public health and safety, animal health, plant health, animal or plant products, or the environment. These regulations are administered jointly by the CDC, Division of Select Agents and Toxins and the Animal and Plant Health Inspection Service, Division of Agricultural Select Agents and Toxins, through the Federal Select Agent Program (FSAP),1 which sets forth requirements for the possession, use, and transfer of biological select agents and toxins. A second layer of regulation is provided by the Bureau of Industry and Security (BIS) Export Administration Regulations’ Commerce Control List (CCL),2 which identifies agents and genetic sequences that require licenses before export from the United States. However, these regulated pathogens and toxins do not represent the entirety of the potential risks to public health, agriculture, plants, animals, animal or plant products, or the environment that could arise from the misuse of synthetic nucleic acids. Non-regulated pathogens and toxins, as well as other novel types of nucleic acid sequences, may also pose significant risks if they are misused. To minimize these risks, a shift is needed from relying solely on lists of regulated pathogens and toxins to also assessing the risks associated with other nucleic acid sequences that may contribute to pathogenicity or harm if introduced into new genetic frameworks (i.e., Sequences of Concern [SOCs]). Also, modern molecular biological techniques allow the conversion between different types of nucleic acids (e.g., RNA to DNA, and 1 https://www.selectagents.gov/sat/list.htm. 2 https://www.bis.doc.gov/index.php/regulations/ commerce-control-list-ccl. E:\FR\FM\13OCN1.SGM 13OCN1

Agencies

[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]



[[Page 70997]]

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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.

-----------------------------------------------------------------------

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,

[[Page 70998]]

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
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