89706 Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Notices 

All eVAERS submitters are expected to 

transition from version 2.2 to the 

current version 2.3 as soon as possible. 

Additional information about 

electronically submitting postmarket 

individual case safety reports (ICSRs) 

for vaccines to VAERS is available at 

https://www.fda.gov/industry/aboutesg/cber-vaccine-icsr-implementation. 

Dated: December 21, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–28594 Filed 12–27–23; 8:45 am] 

BILLING CODE 4164–01–P 

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Draft Guidance for Industry; 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. 

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draft guidance for industry entitled 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revised draft guidance discusses certain 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revised draft guidance discusses 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The revised draft guidance applies to 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 overthe-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revises the draft guidance for industry of 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. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Notices 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/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-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] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–4299] 

Potency Assurance for Cellular and 

Gene Therapy Products; Draft 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing the availability of a draft 

guidance entitled ‘‘Potency Assurance 

for Cellular and Gene Therapy 

Products.’’ FDA is issuing this draft 

guidance to provide recommendations 

to help assure the potency of human 

cellular therapy or gene therapy (CGT) 

products at all stages of the product 

lifecycle. FDA is recommending a 

comprehensive approach to potency 

assurance of CGT products that is 

grounded in quality risk management. 

For investigational products, we 

describe how to progressively 

implement a strategy for potency 

assurance during product development 

and provide additional considerations 

to help assure the potency of products 

that are undergoing rapid clinical 

development. For licensed products, we 

describe requirements for potency 

assurance, including testing required for 

lot release. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by March 27, 2024 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: 


khammond on DSKJM1Z7X2PROD with NOTICES