106516 Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices 

Lynne.Yao@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 guidance for industry entitled ‘‘E11A 

Pediatric Exploration.’’ The guidance 

was prepared under the auspices of ICH. 

ICH seeks to achieve greater regulatory 

harmonization worldwide to ensure that 

safe, effective, 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 

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 the Federal Register of August 29, 

2022 (87 FR 52788), FDA published a 

notice announcing the availability of a 

draft guidance entitled ‘‘E11A Pediatric 

Extrapolation.’’ The notice gave 

interested persons an opportunity to 

submit comments by October 28, 2022. 

After consideration of the comments 

received and revisions to the guideline, 

a final draft of the guideline was 

submitted to the ICH Assembly and 

endorsed by the regulatory agencies in 

August 2024. 

This guidance finalizes the draft 

guidance issued on August 29, 2022. 

The final guidance includes clarification 

and minor formatting changes to its 

recommendations on pediatric 

extrapolation concepts and approaches. 

The guidance was restructured for easier 

navigability and includes additional 

details on key concepts like study 

designs, modeling approaches, and the 

role of biomarkers. Additionally, the 

final guidance includes updates to the 

figure on the continuum of pediatric 

extrapolation. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘E11A Pediatric 

Extrapolation.’’ 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 relating to submission of 

investigational new drug applications, 

including efficient approaches to 

clinical trial design and study protocols, 

have been approved under OMB control 

number 0910–0014. The collections of 

information relating to submission of 

new drug applications have been 

approved under OMB control number 

0910–0001. The collections of 

information relating to submission of 

biologics license applications have been 

approved under OMB control number 

0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain the 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 16, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31026 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–4490] 

Combined Food and Drug 

Administration and Sponsor Oncologic 

Drugs Advisory Committee Briefing 

Document; 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 

‘‘Combined FDA and Sponsor Oncologic 

Drugs Advisory Committee (ODAC) 

Briefing Document.’’ This draft 

guidance provides recommendations to 

sponsors regarding use and 

development of a combined version of 

the ODAC briefing document, as part of 

the Oncology Center of Excellence’s 

(OCE) Project Point/Counterpoint 

initiative. This single document 

includes information that customarily 

would be contained in separate briefing 

documents prepared individually by the 

Sponsor and FDA. Project Point/ 

Counterpoint is an option for advisory 

committee meetings for oncology 

products. Sponsors in non-oncology 

therapeutic areas who want to discuss 

whether a combined advisory 

committee briefing document may be 

appropriate for their applications 

should contact the relevant review 

division. This briefing document format 

may provide efficiencies by allowing 

Sponsors and FDA to choose to use a 

single document that provides the views 

of the Sponsor and FDA on key issues. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices 106517 

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–4490 for ‘‘Combined FDA and 

Sponsor Oncologic Drugs Advisory 

Committee (ODAC) Briefing Document.’’ 

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: 

Jennifer Gao or Jamie Brewer, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 240–402–4683 or 240– 

402–4463; 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, 240– 

402–5923. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Combined FDA and Sponsor Oncologic 

Drugs Advisory Committee (ODAC) 

Briefing Document.’’ This guidance 

provides recommendations to sponsors 

regarding use and development of a 

combined version of the briefing 

document for matters before the ODAC, 

as part of the OCE Project Point/ 

Counterpoint initiative. This single 

briefing document includes information 

that customarily would be contained in 

separate briefing documents prepared 

individually by the Sponsor and FDA. 

Project Point/Counterpoint is an option 

for advisory committee meetings for 

oncology products. Sponsors in nononcology therapeutic areas who want to 

discuss whether a combined advisory 

committee briefing document may be 

appropriate for their applications 

should contact the relevant review 

division. 

Sponsors and FDA customarily 

prepare their own separate ODAC 

briefing documents. This can lead to 

repetition of information (i.e., trial 

design, endpoints, eligibility criteria, 

etc.) and increases the number of 

documents that ODAC committee 

members need to review. Additionally, 

ODAC committee members may need to 

go back and forth from each briefing 

document to consider the Sponsor’s and 

FDA’s position on each issue. Project 

Point/Counterpoint may provide 

efficiencies by allowing Sponsors and 

FDA to choose to use a single document 

that provides the views of the Sponsor 

and FDA on key issues. 

The combined briefing document was 

first piloted for use at an ODAC meeting 

in December 2019. This format 

decreases the number of documents 

ODAC members must review by 

providing the applicant’s and FDA’s 

positions in one document. It serves as 

a stand-alone document containing the 

background information and an 

objective description of the data for the 

clinical trial or topic under discussion 

at ODAC, followed by the positions of 

the Sponsor and FDA. 

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 ‘‘Combined FDA and Sponsor 


ddrumheller on DSK120RN23PROD with NOTICES1
106518 Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices 

Oncologic Drugs Advisory Committee 

(ODAC) Briefing Document.’’ 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 

FDA tentatively concludes that this 

draft guidance contains no collection of 

information. Therefore, clearance by the 

Office of Management and Budget under 

the Paperwork Reduction Act of 1995 is 

not required. 

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: December 18, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31305 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–5717] 

Cardiovascular and Renal Drugs 

Advisory Committee; Notice of 

Meeting; Establishment of a Public 

Docket; Request for Comments— 

Supplemental New Drug Application 

218276 S–004 for FABHALTA 

(iptacopan) Oral Capsules in the 

Treatment of Adults With C3G 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Cardiovascular and Renal 

Drugs Advisory Committee (the 

Committee). The general function of the 

Committee is to provide advice and 

recommendations to FDA on regulatory 

issues. The meeting will be open to the 

public. FDA is establishing a docket for 

public comment on this document. 

DATES: The meeting will be held on 

February 24, 2025, from 9 a.m. to 5 p.m. 

Eastern Time. 

ADDRESSES: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

The public will also have the option to 

participate, and the advisory committee 

meeting will be heard, viewed, 

captioned, and recorded through an 

online teleconferencing and/or video 

conferencing platform. 

Answers to commonly asked 

questions about FDA advisory 

committee meetings, including 

information regarding special 

accommodations due to a disability, 

visitor parking, and transportation, may 

be accessed at: https://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2024–N–5717. 

The docket will close on February 21, 

2025. Please note that late, untimely 

filed comments will not be considered. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of February 21, 2025. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are received on or before that 

date. 

Comments received on or before 

February 7, 2025, will be provided to 

the Committee. Comments received after 

that date will be taken into 

consideration by FDA. In the event that 

the meeting is cancelled, FDA will 

continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 

You may submit comments 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–N–5717 for ‘‘Cardiovascular and 

Renal Drugs Advisory Committee; 

Notice of Meeting; Establishment of a 

Public Docket; Request for Comments— 

Supplemental New Drug Application 

(sNDA) 218276 S–004 for FABHALTA 

(iptacopan) Oral Capsules in the 

Treatment of Adults with C3G.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), 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.’’ FDA 

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 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 the information as 

‘‘confidential.’’ Any information marked 


ddrumheller on DSK120RN23PROD with NOTICES1