Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices 106519 

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. 

FOR FURTHER INFORMATION CONTACT: 

Jessica Seo, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, Rm. 2417, Silver Spring, 

MD 20993–0002, 301–796–7699, email: 

CRDAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last-minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check 

FDA’s website at https://www.fda.gov/ 

AdvisoryCommittees/default.htm and 

scroll down to the appropriate advisory 

committee meeting link, or call the 

advisory committee information line to 

learn about possible modifications 

before the meeting. 

SUPPLEMENTARY INFORMATION: Agenda: 

The meeting presentations will be 

heard, viewed, captioned, and recorded 

through an online teleconferencing and/ 

or video conferencing platform. The 

Committee will discuss supplemental 

new drug application (sNDA) 218276 S– 

004, for FABHALTA (iptacopan) oral 

capsules, submitted by Novartis 

Pharmaceuticals Corporation, for the 

treatment of adults with complement 3 

glomerulopathy (C3G). 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference and/or video conference 

meeting will be available at the location 

of the advisory committee meeting and 

at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. The online presentation of 

materials will include slide 

presentations with audio and video 

components to allow the presentation of 

materials in a manner that most closely 

resembles an in-person advisory 

committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the Committee. All electronic and 

written submissions to the Docket (see 

ADDRESSES) on or before February 7, 

2025, will be provided to the 

Committee. Oral presentations from the 

public will be scheduled between 

approximately 1:15 p.m. and 2:15 p.m. 

Eastern Time. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, whether they would like to 

present online or in-person, and an 

indication of the approximate time 

requested to make their presentation on 

or before January 30, 2025. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. Similarly, room 

for interested persons to participate inperson may be limited. If the number of 

registrants requesting to speak in-person 

during the open public hearing is 

greater than can be reasonably 

accommodated in the venue for the inperson portion of the advisory 

committee meeting, FDA may conduct a 

lottery to determine the speakers who 

will be invited to participate in-person. 

The contact person will notify 

interested persons regarding their 

request to speak by January 31, 2025. 

Persons attending FDA’s advisory 

committee meetings are advised that 

FDA is not responsible for providing 

access to electrical outlets. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Jessica Seo 

(see FOR FURTHER INFORMATION CONTACT) 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.). This meeting notice 

also serves as notice that, pursuant to 21 

CFR 10.19, the requirements in 21 CFR 

14.22(b), (f), and (g) relating to the 

location of advisory committee meetings 

are hereby waived to allow for this 

meeting to take place using an online 

meeting platform in conjunction with 

the physical meeting room (see 

location). This waiver is in the interest 

of allowing greater transparency and 

opportunities for public participation, 

in addition to convenience for advisory 

committee members, speakers, and 

guest speakers. The conditions for 

issuance of a waiver under 21 CFR 10.19 

are met. 

Dated: December 20, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31309 Filed 12–27–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–D–5601] 

E6(R3) Good Clinical Practice: Annex 

2; International Council for 

Harmonisation; 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 ‘‘E6(R3) 

Good Clinical Practice: Annex 2.’’ The 

draft guidance was prepared under the 

auspices of the International Council for 

Harmonisation of Technical 

Requirements for Pharmaceuticals for 

Human Use (ICH). The draft guidance is 

the second annex to ‘‘E6(R3) Good 

Clinical Practice’’ published June of 

2023. This annex provides additional 

considerations for the application of 

good clinical practices to a variety of 

trial designs and data sources. 


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106520 Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices 

Specifically, this draft guidance 

discusses trials with decentralized and 

pragmatic elements and real-world data 

sources. This draft guidance highlights 

the importance of quality by design and 

focusing efforts and resources on critical 

aspects of the trials that might impact 

the safety of participants and the 

reliability of results. The draft guidance 

is intended to encourage innovation in 

trial design and provides flexible, 

modern, and clear good clinical 

practices for conducting trials, while 

avoiding unnecessary complexities. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by February 28, 2025 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– 

2024–D–5601 for ‘‘E6(R3) Good Clinical 

Practice: Annex 2.’’ 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, or 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 that office in processing 

your requests. The guidance may also be 

obtained by calling CBER at 1–800–835– 

4709 or 240–402–8010. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: Amy Chi, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6334, Silver Spring, 

MD 20993–0002, amy.chi@fda.hhs.gov; 

or James Myers, 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. 

Regarding the ICH: Jill Adleberg, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6364, Silver Spring, 

MD 20993–0002, 301–796–5259, 

Jill.Adleberg@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘E6(R3) Good Clinical Practice: Annex 

2.’’ The draft guidance was prepared 

under the auspices of ICH. ICH seeks to 

achieve greater regulatory 

harmonization worldwide to ensure that 

safe, effective, and high-quality 

medicines are developed, registered, 

and maintained in the most resourceefficient manner. 

By harmonizing the regulatory 

requirements in regions around the 

world, ICH guidelines enhance global 

drug development, improve 

manufacturing standards, and increase 

the availability of medications. For 

example, ICH guidelines have 

substantially reduced duplicative 

clinical studies, prevented unnecessary 

animal studies, standardized the 

reporting of important safety 

information, and standardized 

marketing application submissions. 

The six Founding Members of the ICH 

are FDA; the Pharmaceutical Research 

and Manufacturers of America; the 

European Commission; the European 

Federation of Pharmaceutical Industries 

Associations; the Japanese Ministry of 


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Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices 106521 

Health, Labour, and Welfare; and the 

Japanese Pharmaceutical Manufacturers 

Association. The Standing Members of 

the ICH Association include Health 

Canada and Swissmedic. ICH 

membership continues to expand to 

include other regulatory authorities and 

industry associations from around the 

world (refer to https://www.ich.org). 

ICH works by engaging global 

regulatory and industry experts in a 

detailed, science-based, and consensusdriven process that results in the 

development of ICH guidelines. The 

regulators around the world are 

committed to consistently adopting 

these consensus-based guidelines, 

realizing the benefits for patients and for 

industry. 

As a Founding Regulatory Member of 

ICH, FDA plays a major role in the 

development of each of the ICH 

guidelines, which FDA then adopts and 

issues as guidance for industry. FDA’s 

guidance documents do not establish 

legally enforceable responsibilities. 

Instead, they describe the Agency’s 

current thinking on a topic and should 

be viewed only as recommendations, 

unless specific regulatory or statutory 

requirements are cited. 

In November 2024, the ICH Assembly 

endorsed the draft guideline entitled 

‘‘E6(R3) Good Clinical Practice: Annex 

2’’ and agreed that the guideline should 

be made available for public comment. 

The draft guideline is the product of the 

Efficacy Expert Working Group of the 

ICH. FDA and the Efficacy Expert 

Working Group will consider comments 

on this draft. 

The draft guidance provides guidance 

on good clinical practices for trial 

design and conduct, with a focus on 

trials with decentralized and pragmatic 

elements as well as trials that utilize 

real-world data. Since the original E6 

guidance was published in 1996, 

clinical trials have evolved significantly 

with new designs and technological 

innovations. Annex 2 provides 

additional considerations to the 

previously published draft guidance 

entitled ‘‘E6(R3) Good Clinical Practice 

(GCP),’’ which includes a Principles 

document and Annex 1. This draft 

guidance, entitled ‘‘E6(R3) Good 

Clinical Practice: Annex 2,’’ is intended 

to be read and implemented with E6(R3) 

Principles and Annex 1. 

This draft guidance has been left in 

the original ICH format. The final 

guidance will be reformatted and edited 

to conform with FDA’s good guidance 

practices regulation (21 CFR 10.115) and 

style before publication. The draft 

guidance, when finalized, will represent 

the current thinking of FDA on ‘‘E6(R3) 

Good Clinical Practice: Annex 2.’’ 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 (44 U.S.C. 3501– 

3502). The collections of information in 

21 CFR part 312.145 pertaining to good 

clinical practices have been approved 

under OMB control number 0910–0014. 

The collections of information in 21 

CFR parts 50 and 56 pertaining to 

protection of human subjects, 

institutional review boards, and 

informed consent have been approved 

under OMB control number 0910–0130. 

The collections of information in 21 

CFR part 11 pertaining to electronic 

records and electronic signatures have 

been approved under OMB control 

number 0910–0303. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.regulations.gov, https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

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

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https:// 

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents. 

Dated: December 20, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31275 Filed 12–27–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5702] 

Transfer of Regulatory Responsibility 

From the Center for Devices and 

Radiological Health to the Center for 

Biologics Evaluation and Research; 

Medical Maggots and Medicinal 

Leeches 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; announcement of 

transfer. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

transfer of regulatory responsibility for 

medical maggots and medicinal leeches 

to the Center for Biologics Evaluation 

and Research (CBER). These products 

are currently regulated by the Center for 

Devices and Radiological Health 

(CDRH). FDA is transferring regulatory 

responsibility of these products to CBER 

because these products are living 

organisms that more closely align with 

products regulated by CBER. This action 

affects only Center assignment and does 

not change requirements applicable to 

these products. 

DATES: FDA is transferring regulatory 

responsibility to CBER on December 30, 

2024. 

FOR FURTHER INFORMATION CONTACT: 

Annette Marthaler, Office of 

Combination Products, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Silver Spring, MD 20993, 

301–796–8930, annette.marthaler@

fda.hhs.gov or combination@fda.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the transfer of regulatory 

responsibility for medical maggots 

(Phaenicia sericacta (blow fly) larvae) 

and medicinal leeches (Hirudo 

medicinalis) from CDRH to CBER. 

Medical maggots (including maggots 

and larvae) (product code NQK) (also 

referred to as maggot therapy) are 

harvested and provided disinfected for 

use in debriding non-healing necrotic 

skin and soft tissue wounds, including 

pressure ulcers, venous stasis ulcers, 

neuropathic foot ulcers, and nonhealing traumatic or post-surgical 

wounds. Medicinal leeches (product 

code NRN) belong to the Annelida 

worm classification. The animal is a 

bloodsucking aquatic animal living in 

fresh water indicated as an adjunct to 

graft tissue healing when problems of 

venous congestion may delay healing, or 

to overcome the problem of venous 

congestion by creating prolonged 

localized bleeding. 

FDA is transferring the regulatory 

responsibility for medical maggots and 

medicinal leeches to CBER so that these 

products are regulated by the same 

Center that regulates other living 

organisms for human use. The transfer 

will help ensure the consistent and 

effective regulation of products that are 

living organisms for human use. This 

transfer affects only Center assignment 

and does not change requirements 

applicable to these products. 

For the transferred products, 

submissions, communications, and 

required reports should be directed to 

CBER after December 30, 2024. CDRH 

will continue to handle submissions 


ddrumheller on DSK120RN23PROD with NOTICES1