Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Notices 89705 

compliance-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. 2023–28675 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–2021–N–0039] 

Electronic Submissions; Update to the 

Specifications for Preparing and 

Submitting Postmarket Individual Case 

Safety Reports for Vaccines; Technical 

Specification 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) Center 

for Biologics Evaluation and Research 

(CBER) is announcing the availability of 

version 2.3 of the Specifications for 

Preparing and Submitting Postmarket 

Individual Case Safety Reports (ICSRS) 

for Vaccines (Specifications). The 

version update is not applicable to 

CBER-regulated drug products marketed 

for human use with approved New Drug 

Applications (NDAs) and Abbreviated 

New Drug Applications (ANDAs); 

CBER-regulated therapeutic biological 

products marketed for human use with 

approved Biologic License Applications 

(BLAs); Whole Blood or blood 

components; and human cells, tissues, 

and cellular and tissue-based products 

(HCT/Ps) regulated solely under the 

Public Health Service Act. 

ADDRESSES: You may submit either 

electronic or written comments 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– 

2021–N–0039 for ‘‘Electronic 

Submissions; Update to the 

Specifications for Preparing and 

Submitting Postmarket Individual Case 

Safety Reports for Vaccines; Technical 

Specification’’. 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 laws. 

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. 

FOR FURTHER INFORMATION CONTACT: 

Victoria Wagman, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

Background 

CBER is announcing the availability 

of version 2.3 of the Specifications for 

Preparing and Submitting Postmarket 

ICSRs for Vaccines (available at https:// 

www.fda.gov/industry/about-esg/cbervaccine-icsr-implementation). The 

version update has been prepared to 

provide updated specifications on 

submitting re-challenge information, to 

correct values for the ‘Vaccination 

Facility Type’ (FDA.G.k.4.r.14.8), and to 

record modifications to the ‘Attachment 

File Name’ (FDA.C.1.6.1.r.3) as well as 

various document formatting 

refinements. In addition, version 2.3 

includes updated business rules 

(Appendix I of the Specifications) 

which provide details on data field 

specifications. The version update is not 

applicable to CBER-regulated drug 

products marketed for human use with 

approved NDAs and ANDAs; CBERregulated therapeutic biological 

products marketed for human use with 

approved BLAs; Whole Blood or blood 

components; and HCT/Ps regulated 

solely under section 361 of the Public 

Health Service Act (42 U.S.C. 264). 

At this time, all existing eVAERS 

submitters (vaccine manufacturers and 

others responsible for reporting ICSRs 

for vaccines) have successfully 

transitioned to reporting in version 2.2. 


khammond on DSKJM1Z7X2PROD with NOTICES
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