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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 178 / Friday, September 13, 2024 / Notices 74969 

52058 in FR Doc. 2024–13660, the 

following correction is made: 

On page 52058, in the table, the 

entries for ANDA 076648 and ANDA 

090723 are removed. 

Dated: September 10, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–20873 Filed 9–12–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

Notice of Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Mental Health Initial Review Group; 

Effectiveness of Mental Health Interventions 

Study Section. 

Date: October 17–18, 2024. 

Time: 9:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: North Bethesda Marriott Hotel & 

Conference Center, Montgomery County 

Conference Center Facility, 5701 Marinelli 

Road, North Bethesda, MD 20852 (Hybrid 

Meeting). 

Contact Person: Claudio Dario Ortiz, Ph.D., 

Scientific Review Officer, Division of 

Extramural Activities, National Institute of 

Mental Health, National Institutes of Health, 

Neuroscience Center, 6001 Executive Blvd., 

Rockville, MD 20892, (240) 869–9245, email: 

claudio.ortiz@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program No. 93.242, Mental Health Research 

Grants, National Institutes of Health, HHS) 

Dated: September 10, 2024. 

Bruce A. George, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–20884 Filed 9–12–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR Panel: 

Innovative Research in Cancer 

Nanotechnology. 

Date: October 10–11, 2024. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: AC Hotel Bethesda, 4646 

Montgomery Avenue, Bethesda, MD 20814. 

Contact Person: Raj K Krishnaraju, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6190, 

MSC 7804, Bethesda, MD 20892, (301) 435– 

1047, kkrishna@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: September 9, 2024. 

Lauren A. Fleck, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–20788 Filed 9–12–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Brain Disorders and 

Clinical Neuroscience Integrated Review 

Group; Pathophysiology of Eye Disease—2 

Study Section. 

Date: October 9–10, 2024. 

Time: 8:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Washington Plaza Hotel, 10 Thomas 

Circle NW, Washington, DC 20005. 

Meeting Format: In person. 

Contact Person: Cibu Paul Thomas, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 1011–H, 

Bethesda, MD 20894, (301) 402–4341, 

thomascp@mail.nih.gov. 

Name of Committee: Social and 

Community Influences on Health Integrated 

Review Group; Psychosocial Development, 

Risk and Prevention Study Section. 

Date: October 10–11, 2024. 

Time: 8:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency, Bethesda, One 

Bethesda Metro Center, Bethesda, MD 20814. 

Meeting Format: In person. 

Contact Person: Anna L. Riley, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3114, 

MSC 7759, Bethesda, MD 20892, (301) 435– 

2889, rileyann@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; RFA–NS– 

24–021: HEAL Initiative: Individual 

Differences in Human Pain Conditions. 

Date: October 10–11, 2024. 

Time: 9:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The Westin Georgetown, 2350 M 

Street NW, Washington, DC 20037. 

Meeting Format: In person. 

Contact Person: Abu Saleh Mohammad 

Abdullah, Ph.D., Scientific Review Officer, 

Center for Scientific Review, National 

Institutes of Health, 6701 Rockledge Drive, 

Room 1003–L, Bethesda, MD 20892, (301) 

827–4043, abuabdullah.abdullah@nih.gov. 

Name of Committee: Integrative, 

Functional and Cognitive Neuroscience 

Integrated Review Group; Behavioral 

Neuroendocrinology, Neuroimmunology, 

Rhythms, and Sleep Study Section. 

Date: October 10–11, 2024. 

Time: 9:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: John N. Stabley, Ph.D., 

Scientific Review Officer, Center for 


khammond on DSKJM1Z7X2PROD with NOTICES