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a revised draft guidance for industry 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This revised draft guidance provides 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revised draft guidance also provides 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This revised draft guidance revises 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the draft guidance may have been 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
89708 Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Notices 

• 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–4299 for ‘‘Potency Assurance 

for Cellular and Gene Therapy 

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 guidance to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist the office in processing your 

requests. The guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–8010. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Myrna Hanna, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft document 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 CGT products that 

are regulated as biological products 

under section 351 of the Public Health 

Service Act (42 U.S.C. 262). 

In this draft guidance, we provide 

recommendations for developing a 

science- and risk-based strategy to help 

assure the potency of human CGT 

products. A potency assurance strategy 

is a multifaceted approach that reduces 

risks to the potency of a product 

through: (1) manufacturing process 

design, (2) manufacturing process 

control, (3) material control, (4) inprocess testing, and (5) potency lot 

release assays. The goal of a potency 

assurance strategy is to ensure that 

every lot of a product released will have 

the specific ability or capacity to 

achieve the intended therapeutic effect. 

In this draft guidance, we emphasize 

that potency assays and their 

corresponding acceptance criteria 

should be designed to make meaningful 

contributions to potency assurance by 

reducing risks to product potency. We 

provide illustrative examples of 

approaches to potency assay 

development that are grounded in 

quality risk management. Due to the 

diversity of CGT products and the 

product-specific nature of potency 

assays, the recommendations in this 

draft guidance regarding the selection 

and design of potency assays are 

necessarily general. 

This draft guidance, when finalized, 

is intended to supersede the document 

entitled ‘‘Guidance for Industry: 

Potency Tests for Cellular and Gene 

Therapy Products,’’ dated January 2011. 

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 potency assurance for cellular and 

gene therapy 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 part 211 have 

been approved under OMB control 

number 0910–0139; the collections of 

information in 21 CFR 312.23 have been 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 248 / Thursday, December 28, 2023 / Notices 89709 

approved under OMB control number 

0910–0014; the collections of 

information in 21 CFR 600.14 have been 

approved under OMB control number 

0910–0458; and the collections of 

information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338. 

III. Electronic Access

Persons with access to the internet

may obtain the draft guidance at https:// 

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, http://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. 2023–28596 Filed 12–27–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: Advanced 

Nursing Education Program Specific 

Form OMB No. 0915–0375—Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than February 26, 

2024. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N39, 5600 Fishers 

Lane, Rockville, Maryland 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Joella Roland, the HRSA 

Information Collection Clearance 

Officer, at (301) 443–3983. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

Advanced Nursing Education (ANE) 

Program Specific Form OMB No. 0915– 

0375—Revision 

Abstract: HRSA provides advanced 

nursing education grants to educational 

institutions to increase the supply, 

distribution, quality of, and access to 

advanced education nurses through the 

ANE Programs. The ANE Programs are 

authorized by section 811 of the Public 

Health Service Act (42 U.S.C. 296j), as 

amended. This clearance request is for 

continued approval of the information 

collection OMB No. 0915–0375 with 

revisions. This revision request seeks to 

add the Advanced Nursing EducationNurse Practitioner Residency and 

Fellowship (ANE–NPRF) Program and 

the Maternity Care Nursing Workforce 

Expansion Program to the ANE Program 

Specific Form, and to remove programs 

that have closed, which include the 

Advanced Nursing Education-Nurse 

Practitioner Residency (ANE–NPR) 

Program and the Advanced Nursing 

Education-Nurse Practitioner Residency 

Integration Program. The activities 

previously supported under the ANE– 

NPR and the Advanced Nursing 

Education-Nurse Practitioner Residency 

Integration Program are now supported 

under the ANE–NPRF Program. 

Need and Proposed Use of the 

Information: Section 811 of the Public 

Health Service Act provides the 

Secretary of Health and Human Services 

with the authority to award grants to 

and enter into contracts with eligible 

entities to meet the costs of: (1) projects 

that support the enhancement of 

advanced nursing education and 

practice; and (2) traineeships for 

individuals in advanced nursing 

education programs. Under this section, 

HRSA makes awards to entities who 

train and support nurses characterized 

as ‘‘advanced education nurses.’’ In 

awarding such grants, funding 

preference is given to applicants with 

projects that will substantially benefit 

rural or underserved populations or 

help meet public health nursing needs 

in state or local health departments; 

special consideration is given to an 

eligible entity that agrees to extend the 

award to train advanced education 

nurses who will practice in designated 

Health Professional Shortage Areas. 

The ANE Program Specific Form 

allows HRSA to effectively target 

funding and measure the impact of the 

ANE Programs in meeting the legislative 

intent and program goals of supporting 

the enhancement of advanced nursing 

education and creating opportunities for 

individuals in advanced nursing 

education programs to increase the 

number of advanced practice nurses, 

especially in rural and underserved 

areas. Additionally, collecting this data 

assists HRSA in carrying out the most 

impactful program and ensuring 

resources are used responsibly. The 

proposed updates to this information 

collection are to accurately list the 

current ANE Programs. 

Likely Respondents: Likely 

respondents will be current ANE 

Programs awardees and new applicants 

to ANE Programs. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name 

(includes the ANE program specific tables and attachments) 

Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Advanced Nursing Education Workforce ............................. 156 1 156 7 1,092 

Nurse Anesthetist Traineeship ............................................. 64 1 64 7 448 


khammond on DSKJM1Z7X2PROD with NOTICES