74966 Federal Register / Vol. 89, No. 178 / Friday, September 13, 2024 / Notices 

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 

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: 

Candace Nalls, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5214, Silver Spring, 

MD 20993–0002, 301–636–0510, 

Candace.Nalls@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 the 

Agency’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 coming to the 

meeting. 

SUPPLEMENTARY INFORMATION: Agenda: 

On November 7, 2024, the Committee 

will discuss, make recommendations, 

and vote on clinical information related 

to a De Novo request for the ProSense 

Cryoablation System sponsored by 

IceCure Medical Ltd. The discussion 

will focus on the sponsor’s proposed 

indication: ‘‘for use in the treatment of 

patients with early stage, low-risk breast 

cancer for the treatment of breast cancer 

with adjuvant endocrine therapy.’’ 

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, and the background 

material will be posted on FDA’s 

website after the meeting. Background 

material 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. 

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 October 17, 

2024, will be provided to the 

Committee. Oral presentations from the 

public will be scheduled on November 

7, 2024, between approximately 1:45 

p.m. and 2:45 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, and an 

indication of the approximate time 

requested to make their presentation on 

or before October 10, 2024. 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. The contact 

person will notify interested persons 

regarding their request to speak by 

October 15, 2024. 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 Ann Marie 

Williams at Annmarie.Williams@

fda.hh.gov or 301–796–5966 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/AboutAdvisory

Committees/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.). 

Dated: September 10, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–20889 Filed 9–12–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–3878] 

New Drugs Regulatory Program 

Modernization: Integrated Assessment 

of Marketing Applications and 

Integrated Review Documentation; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

seeking public comments on the ‘‘New 

Drugs Regulatory Program 

Modernization: Integrated Assessment 

of Marketing Applications and 

Integrated Review Documentation.’’ The 

purpose is to seek public comments/ 

feedback on the Integrated Review 

documentation generated by the 

Integrated Assessment of Marketing 

Applications for new drug products 

developed as part of the New Drugs 

Regulatory Program Modernization. The 

Agency hopes to receive public 

feedback on how this Integrated Review 

documentation can continue supporting 

our stakeholders’ needs. 

DATES: Submit either electronic or 

written comments on the notice by 

December 12, 2024. 


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Federal Register / Vol. 89, No. 178 / Friday, September 13, 2024 / Notices 74967 

ADDRESSES: You may submit comments 

as follows. 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 

December 12, 2024. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

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–3878 for ‘‘New Drugs 

Regulatory Program Modernization: 

Integrated Assessment of Marketing 

Applications and Integrated Review 

Documentation; Request for 

Comments.’’ 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.’’ 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. 

FOR FURTHER INFORMATION CONTACT: 

Rhonda M. Hearns-Stewart, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 6460, 

Silver Spring, MD 20993–0002, 240– 

402–3180, Rhonda.Hearns-Stewart@

fda.hhs.gov, with the subject line 

‘‘Collecting Public Feedback on the 

Integrated Review.’’ 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Integrated Assessment of 

Marketing Applications, which is part of 

FDA’s New Drugs Regulatory Program 

Modernization, includes a new review 

template for the assessment and 

documentation of new drug product 

marketing applications (e.g., new drug 

applications (NDAs) or biologics license 

applications (BLAs)) in the Center for 

Drug Evaluation and Research. The 

resultant Integrated Review is the 

product of an interdisciplinary team 

assessment process that provides 

collaborative discussions of key review 

issues that span multiple disciplines 

and includes resolution of important 

issues pertinent to benefit-risk 

assessments. This interdisciplinary 

approach facilitates clarity of decision 

making and ensures input from relevant 

disciplines in the consideration of 

scientific issues. FDA believes the 

format and content of the Integrated 

Review documentation will provide 

sufficient detail concerning the 

evidence of efficacy and assessment of 

risk and risk management as well as a 

clearer description of FDA’s analysis of 

the scientific issues raised by the 

application and the scientific reasoning 

supporting the benefit-risk 

determination. The overall objective is 

to more effectively communicate the 

basis for FDA’s decision on 

applications. 

This new Integrated Review 

document replaces the previous 

documentation, which included a 

separate review document authored by 

each discipline. It also replaces the 

multidisciplinary review (i.e., 

Unireview) in which each discipline 

provided a separate review section but 

within a single review document. FDA 

implemented the Integrated Review 

documentation for new molecular 

entities, original BLAs, and select 

efficacy supplements. FDA plans to 

expand the scope to other marketing 

application types in the near future. 

The following guiding principles 

informed the Integrated Review 

documentation: 

• The importance of conducting an 

issue-focused assessment, 

• Enhanced communication within 

the review team, and 

• Strong interdisciplinary 

collaboration. 

The Integrated Review documentation 

template has three main components: 

• Executive Summary: 

Æ Represents FDA’s conclusions 

regarding key scientific and 

regulatory issues while describing 

any differences of scientific opinion 

or perspective, 


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74968 Federal Register / Vol. 89, No. 178 / Friday, September 13, 2024 / Notices 

Æ Provides a summary of FDA’s 

decision and assessment of the 

application, including FDA’s 

benefit-risk determination (as 

currently employed in marketing 

application reviews), and 

Æ Provides an overall Agency 

assessment, including an overview 

of the major decisions made during 

the review process, and a brief 

discussion of the basis for the 

decisions. 

• Interdisciplinary Assessment: 

Æ Includes succinct, integrated, 

focused analyses of the evidence of 

benefit, risk and risk management, 

and therapeutic individualization 

(e.g., special populations, drug 

interactions). 

Æ Highlights key review issues 

(including analyses specific to key 

issues) the review team thinks are 

pertinent to the decision-making 

process. Issues are presented and 

assessed in an interdisciplinary 

manner. 

Æ Includes any dissenting data 

interpretations. 

• Additional Analyses and Information: 

Æ Includes Discipline-Specific 

Appendices 

Æ Contains assessments and analyses 

that are supportive and/or 

important to key facts/data or 

conclusions included in the overall 

review and, in certain instances, 

may include discipline-specific 

content (e.g., relevant 

pharmacology/toxicology 

information), 

Æ May contain work that did not 

directly impact the overall 

assessment of benefit-risk, 

regulatory action, labeling, or riskmitigation plans, and 

Æ Includes separate reviews of 

reviewers who disagree with 

significant elements of the 

Executive Summary and 

Interdisciplinary Assessment 

sections or the decision of the 

Signatory Authority. 

In general, the first two parts of the 

Integrated Review document are 

expected to provide a complete 

explanation of FDA’s action and 

supporting analyses, with the third 

component (the additional analyses and 

information) providing additional detail 

on the comprehensive analyses FDA 

conducted in its review of the drug 

application. The target audiences for 

this document are diverse and include 

those with a specific interest in the 

application, such as the lay public, drug 

sponsors, researchers, and others who 

are seeking to understand the basis for 

FDA’s decision. 

II. Integrated Review Documentation 

As part of FDA’s ongoing evaluation 

of the Integrated Review documentation, 

the Agency welcomes comments and 

any relevant information specific to the 

Integrated Review that stakeholders 

wish to share in a submission to the 

docket. However, we emphasize that the 

focus is to seek input that prioritizes 

feedback specifically on characteristics 

of the Integrated Review document. 

Please see information and examples 

relevant to the Integrated Review at 

https://www.fda.gov/drugs/news-eventshuman-drugs/new-drugs-regulatoryprogram-modernization-integratedassessment-marketing-applications-and. 

Furthermore, we anticipate that the 

most informative suggestions would not 

be specific to an indication, a 

therapeutic area, or a disease but rather 

apply across multiple indications, 

therapeutic areas, or diseases. The 

Agency is interested in receiving 

responses to the following questions/ 

topics, in addition to any general 

comments the public might have. For 

convenience, it would be helpful if 

commenters refer to the numbered 

question and topic when submitting 

responses and comments. 

1. We are interested in preserving for 

stakeholders what they find most useful 

in FDA reviews. 

a. Comparing the Integrated Review to 

previous review documentation, is there 

any information you are having 

difficulty locating? 

b. Are you able to use the Integrated 

Review for the same purpose that you 

used previous reviews? If not, please 

provide specific examples. 

2. We are interested in specific 

recommendations about any areas of the 

Integrated Review documentation of the 

Integrated Assessment that can be 

improved to meet the needs of 

stakeholders. 

3. We are interested in stakeholders’ 

views regarding the advantages and 

disadvantages of an interdisciplinary 

assessment presentation of key review 

issues and the resultant integration of 

the assessments of multiple disciplines 

into a single Integrated Review 

document. 

4. We would like to know whether the 

new format of the Integrated Review 

documentation for the Integrated 

Assessment provides clarity of benefitrisk assessments and informs your 

knowledge of FDA’s basis for making 

decisions. 

5. Based on the integrated review, 

were the issues that concerned the 

review team clear and understandable? 

If so, what helped achieve this? If not, 

what can be improved? 

Dated: September 10, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–20891 Filed 9–12–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–2803] 

Sandoz Inc., et al.; Withdrawal of 

Approval of 20 Abbreviated New Drug 

Applications; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register on June 21, 2024. The 

document announced the withdrawal of 

approval of 20 abbreviated new drug 

applications (ANDAs) from multiple 

applicants, withdrawn as of July 22, 

2024. The document indicated that FDA 

was withdrawing approval of the ANDA 

076648 for nitrofurantoin 

(monohydrate/macrocrystals) capsules, 

75 milligrams (mg) and 25 mg, held by 

Aurobindo Pharma USA Inc., 279 

Princeton-Hightstown Rd., East 

Windsor, NJ 08520; and the ANDA 

090723 for duloxetine hydrochloride 

capsules, delayed-release pellets, 

Equivalent to (EQ) 20 mg base, EQ 30 

mg base, and EQ 60 mg base, held by 

Marksans Pharma, Inc., U.S. Agent for 

Marksans Pharma Ltd., 150 Motor 

Pkwy., Suite 401, 4th Floor, Rm. 430, 

Hauppauge, NY 11788. Before FDA 

withdrew the approval of these ANDAs, 

Aurobindo Pharma USA Inc., and 

Marksans Pharma, Inc., U.S. Agent for 

Marksans Pharma Ltd., informed FDA 

that they did not want the approval of 

the ANDAs withdrawn. Because 

Aurobindo Pharma USA Inc. and 

Marksans Pharma, Inc., U.S. Agent for 

Marksans Pharma Ltd., timely requested 

that approval of their respective ANDAs 

not be withdrawn, the approvals are still 

in effect. This notice corrects these 

errors. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1676, 

Silver Spring, MD 20993–0002, 301– 

796–3471, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of Friday, June 21, 

2024 (89 FR 52057), appearing on page 


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