Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Notices 76121 

2024–D–3163 for ‘‘Considerations for 

Generating Clinical Evidence From 

Oncology Multiregional Clinical 

Development Programs.’’ 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copies of the draft guidance to the 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 to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, 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. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: Lola 

Fashoyin-Aje, Oncology Center of 

Excellence, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 240– 

402–0205; or Sandra Casak, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 2200, 

Silver Spring, MD 20993, 301–796– 

3812; 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– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Considerations for Generating Clinical 

Evidence From Oncology Multiregional 

Clinical Development Programs.’’ This 

draft guidance is intended for sponsors 

who are planning global oncology 

clinical development programs for drugs 

to support a marketing application. The 

paramount consideration for FDA when 

evaluating MRCTs is whether the results 

are applicable to the intended use 

population in the United States, and to 

U.S. standard oncological care. 

Therefore, when planning a 

multiregional clinical development 

program, which includes all clinical 

trials intended to support approval in 

the United States, including the pivotal 

trials, the evidence generated should be 

derived from study populations that 

enable the results to be interpretable in 

the context of U.S. patients with the 

disease or condition and U.S. medical 

practice. 

FDA is providing more detailed 

recommendations for MRCTs conducted 

to provide the evidence to support the 

safe and effective use of cancer drugs in 

the U.S. population. This guidance 

expands on principles described in 

FDA’s existing guidance documents 

related to this topic, by providing 

additional recommendations for the 

planning, design, conduct, and analysis 

of an oncology MRCT that may facilitate 

FDA’s assessment of applicability of the 

data to the U.S. population with the 

cancer being investigated and to U.S. 

medical practice. 

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 ‘‘Considerations for Generating 

Clinical Evidence From Oncology 

Multiregional Clinical Development 

Programs.’’ 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 312 have 

been approved under OMB control 

number 0910–0014; the collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001; 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/drugs/guidancecompliance-regulatory-information/ 

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

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: September 11, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–20995 Filed 9–16–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Findings of Research Misconduct 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: Findings of research 

misconduct have been made against 

Arunoday K. Bhan, Ph.D. (Respondent), 

who was formerly a Research Fellow, 

Department of Pediatrics, Boston 

Children’s Hospital (BCH), Harvard 


ddrumheller on DSK120RN23PROD with NOTICES1
76122 Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Notices 

Medical School (HMS), and a former 

Staff Scientist, Department of Surgery, 

City of Hope Medical Center (COH). 

Respondent engaged in research 

misconduct in research supported by 

U.S. Public Health Service (PHS) funds, 

specifically National Heart, Lung, and 

Blood Institute (NHLBI), National 

Institutes of Health (NIH), grant T32 

HL066987. The questioned research was 

included in two grant applications 

submitted for PHS funds, specifically 

R03 CA270990–01 and R21 CA272364– 

01 submitted to the National Cancer 

Institute (NCI), NIH. The administrative 

actions, including supervision for a 

period of four (4) years, were 

implemented beginning on August 21, 

2024, and are detailed below. 

FOR FURTHER INFORMATION CONTACT: 

Sheila Garrity, JD, MPH, MBA, 

Director, Office of Research Integrity, 

1101 Wootton Parkway, Suite 240, 

Rockville, MD 20852, (240) 453–8200. 

SUPPLEMENTARY INFORMATION: Notice is 

hereby given that the Office of Research 

Integrity (ORI) has taken final action in 

the following case: 

Arunoday K. Bhan, Ph.D., Boston 

Children’s Hospital, Harvard Medical 

School and City of Hope Medical 

Center: Based on the report of an 

investigation conducted by HMS and 

COH and additional analysis conducted 

by ORI in its oversight review, ORI 

found that Dr. Arunoday K. Bhan 

(Respondent), former Research Fellow, 

Department of Pediatrics, BCH, HMS, 

and a former Staff Scientist, Department 

of Surgery, COH, engaged in research 

misconduct in research supported by 

PHS funds, specifically NHLBI, NIH, 

grant T32 HL066987. The questioned 

research was included in two (2) grant 

applications submitted for PHS funds, 

specifically R03 CA270990–01 and R21 

CA272364–01 submitted to the National 

Cancer Institute (NCI), NIH. 

ORI found that Respondent engaged 

in research misconduct by intentionally 

and knowingly falsifying, fabricating, 

and/or plagiarizing data in the following 

one (1) published paper and two (2) 

grant applications: 

• Human induced pluripotent stem 

cell-derived platelets loaded with 

lapatinib effectively target HER2+ breast 

cancer metastasis to the brain. Sci Rep. 

2021 Oct 15;11(1):16866. doi: 10.1038/ 

s41598–021–96351–2 (hereafter referred 

to as Sci Rep. 2021). Retraction in: Sci 

Rep. 2024 Mar 12;14(1):5972. doi: 

10.1038/s41598–024–56291–z. 

• R03 CA270990–01, ‘‘Human 

induced pluripotent stem cell derived 

platelets and platelet derived 

extracellular vesicles mediated delivery 

of chemotherapeutics for breast to brain 

metastasis treatment,’’ submitted to NCI, 

NIH, on June 15, 2021 (hereafter referred 

to as R03 CA270990–01). 

• R21 CA272364–01, ‘‘Off-the-shelf 

engineered human induced pluripotent 

stem cell derived platelets mediated 

delivery of HER2 inhibitors for HER2+ 

Breast to brain metastasis tumors 

immunotherapy,’’ submitted to NCI, 

NIH, on September 29, 2021 (hereafter 

referred to as R21 CA272364–01). 

Specifically, ORI found that 

Respondent intentionally and 

knowingly falsified, fabricated, and/or 

plagiarized: 

• Figure 2D of Sci Rep. 2021, Figure 

4A of R03 CA270990–01, and Figure 4A 

of R21 CA272364–01 by relabeling the 

transmission electron microscopy (TEM) 

image as Lapatinib-loaded platelet 

derived from the commercially available 

human induced pluripotent stem cell 

(hiPSC) line DF–19–9–7T when it was 

actually from a non-drug loaded platelet 

derived from a human donor sample, 

without appropriate citation to the 

researcher who generated the image 

• Supplementary Figure SIB of Sci 

Rep. 2021 by relabeling the fluorescence 

microcopy images as from a culture of 

the hiPSC line DF–19–9–7T when these 

were actually from a derivative of the 

hiPSC line 1157 .2, without appropriate 

citation to the researcher who generated 

the image 

• Supplementary Figure SlE of Sci 

Rep. 2021 by relabeling the TEM image 

as from a megakaryocyte on day 6 of 

maturation obtained directly by 

differentiation of the hiPSC line DF–19– 

9–7T when it was actually from an 

immortalized megakaryocyte cell line 

(four days after doxycycline-withdrawal 

induction of differentiation) previously 

derived from hiPSC line 1156 

• Supplementary Figure S1C of Sci 

Rep. 2021 by relabeling the karyotype 

image as from the hiPSC line DF–19–9– 

7T when it was actually from the hiPSC 

line 1156, without appropriate citation 

to the researcher who generated the 

image 

Respondent entered into a Voluntary 

Settlement Agreement (Agreement) and 

voluntarily agreed to the following: 

(1) Respondent will have his research 

supervised for a period of four (4) years 

beginning with the effective date of the 

Agreement (the ‘‘Supervision Period’’). 

Prior to the submission of an 

application for PHS support for a 

research project on which Respondent’s 

participation is proposed and prior to 

Respondent’s participation in any 

capacity in PHS-supported research, 

Respondent will submit a plan for 

supervision of Respondent’s duties to 

ORI for approval. The supervision plan 

must be designed to ensure the integrity 

of Respondent’s research. Respondent 

will not participate in any PHSsupported research until such a 

supervision plan is approved by ORI. 

Respondent will comply with the 

agreed-upon supervision plan. 

(2) The requirements for Respondent’s 

supervision plan are as follows: 

i. A committee of 2–3 senior faculty 

members at the institution who are 

familiar with Respondent’s field of 

research, but not including 

Respondent’s supervisor or 

collaborators, will provide oversight and 

guidance for a period of four (4) years 

from the effective date of the 

Agreement. The committee will review 

primary data from Respondent’s 

laboratory on a quarterly basis and 

submit a report to ORI at six (6) month 

intervals setting forth the committee 

meeting dates and Respondent’s 

compliance with appropriate research 

standards and confirming the integrity 

of Respondent’s research. 

ii. The committee will conduct an 

advance review of each application for 

PHS funds, or report, manuscript, or 

abstract involving PHS-supported 

research in which Respondent is 

involved. The review will include a 

discussion with Respondent of the 

primary data represented in those 

documents and will include a 

certification to ORI that the data 

presented in the proposed application, 

report, manuscript, or abstract are 

supported by the research record. 

(3) During the Supervision Period, 

Respondent will ensure that any 

institution employing him submits, in 

conjunction with each application for 

PHS funds, or report, manuscript, or 

abstract involving PHS-supported 

research in which Respondent is 

involved, a certification to ORI and the 

PHS funding agency that the data 

provided by Respondent are based on 

actual experiments or are otherwise 

legitimately derived and that the data, 

procedures, and methodology are 

accurately reported in the application, 

report, manuscript, or abstract. 

(4) If no supervision plan is provided 

to ORI, Respondent will provide 

certification to ORI at the conclusion of 

the Supervision Period that his 

participation was not proposed on a 

research project for which an 

application for PHS support was 

submitted and that he has not 

participated in any capacity in PHSsupported research. 

(5) During the Supervision Period, 

Respondent will exclude himself 

voluntarily from serving in any advisory 

or consultant capacity to PHS including, 

but not limited to, service on any PHS 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 180 / Tuesday, September 17, 2024 / Notices 76123 

advisory committee, board, and/or peer 

review committee. 

Dated: September 10, 2024. 

Sheila Garrity, 

Director, Office of Research Integrity, Office 

of the Assistant Secretary for Health. 

[FR Doc. 2024–21016 Filed 9–16–24; 8:45 am] 

BILLING CODE 4150–31–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID Clinical Trial 

Implementation Cooperative Agreement (U01 

Clinical Trial Required). 

Date: October 9, 2024. 

Time: 2:00 p.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3G56, 

Rockville, MD 20892 (Video Assisted 

Meeting). 

Contact Person: Poonam Tewary, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institute of Allergy and Infectious 

Diseases, National Institutes of Health, 5601 

Fishers Lane, Room 3G56, Rockville, MD 

20892, (301) 761–7219, tewaryp@

mail.nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID Investigator Initiated 

Program Project Applications (P01 Clinical 

Trial Not Allowed). 

Date: October 11, 2024. 

Time: 10:00 a.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3G56, 

Rockville, MD 20892 (Video Assisted 

Meeting). 

Contact Person: Poonam Tewary, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institute of Allergy and Infectious 

Diseases, National Institutes of Health, 5601 

Fishers Lane, Room 3G56, Rockville, MD 

20892, (301) 761–7219 tewaryp@

mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: September 11, 2024. 

Lauren A. Fleck, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–21025 Filed 9–16–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Deafness and 

Other Communication Disorders; 

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: National Institute on 

Deafness and Other Communication 

Disorders Special Emphasis Panel; 

Conference Grant Applications Review. 

Date: October 8, 2024. 

Time: 3:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. 

Contact Person: Kausik Ray, Ph.D., 

Scientific Review Officer, National Institute 

on Deafness and Other Communication 

Disorders, National Institutes of Health, 6001 

Executive Blvd., Rockville, MD 20852, 301– 

402–3587, rayk@nidcd.nih.gov. 

Name of Committee: National Institute on 

Deafness and Other Communication 

Disorders Special Emphasis Panel NIDCD 

Clinical Research Center Grant (P50) Review 

Date: November 8, 2024. 

Time: 1:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. 

Contact Person: Kausik Ray, Ph.D., 

Scientific Review Officer, National Institute 

on Deafness and Other Communication 

Disorders, National Institutes of Health, 6001 

Executive Blvd., Rockville, MD 20852, 301– 

402–3587, rayk@nidcd.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.173, Biological Research 

Related to Deafness and Communicative 

Disorders, National Institutes of Health, HHS) 

Dated: September 12, 2024. 

Victoria E. Townsend, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–21120 Filed 9–16–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID Investigator Initiated 

Program Project Applications (P01 Clinical 

Trial Not Allowed). 

Date: October 10, 2024. 

Time: 11:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, 3G58, Rockville, 

MD 20892 (Video Assisted Meeting). 

Contact Person: Anuja Mathew, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institute of Allergy and Infectious 

Diseases, National Institutes of Health, 5601 

Fishers Lane, Room 3G58, Rockville, MD 

20892, 301–761–6911, anuja.mathew@

nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 


ddrumheller on DSK120RN23PROD with NOTICES1