Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Notices 66283 

S.A.’’ Received comments, those filed in 

a timely manner (see DATES), 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. 

• 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.gpo.gov/ 

fdsys/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. 

FOR FURTHER INFORMATION CONTACT: Paul 

Hart, Center for Tobacco Products, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. G335, 

Silver Spring, MD 20993, 1–877–CTP– 

1373, AskCTP@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 15, 

2017 (82 FR 27487), FDA published a 

notice of availability for MRTPAs 

submitted by Philip Morris Products 

S.A. for its IQOS products and gave the 

public 180 days to comment on the 

applications. FDA issued a subsequent 

notice in the Federal Register of 

November 22, 2017 (82 FR 55616), 

extending the period for public 

comment and announcing its intent to 

issue a notice in a future edition of the 

Federal Register announcing when the 

comment period will close. FDA 

recently received amendments to the 

MRTPAs and has made them available 

for public comment. In this notice, FDA 

is announcing that the period for public 

comment on these MRTPAs, including 

amendments, will close on February 11, 

2019. 

FDA is required by section 911(e) of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 387k) (FD&C Act) to 

make an MRTPA available to the public 

(except for matters in the application 

that are trade secrets or otherwise 

confidential commercial information) 

and to request comments by interested 

persons on the information contained in 

the application and on the label, 

labeling, and advertising accompanying 

the application. The determination of 

whether an order is appropriate under 

section 911(g) of the FD&C Act is based 

on the scientific information submitted 

by the applicant as well as the scientific 

evidence and other information that is 

made available to the Agency, including 

through public comments. 

In the event FDA receives additional 

amendments or otherwise needs to 

modify the comment period closing 

date, FDA will notify the public via the 

Agency’s web page for the MRTPAs (see 

section II) and by other means of public 

communication, such as by email to 

individuals who have signed up to 

receive email alerts. FDA does not 

intend to issue additional notices in the 

Federal Register regarding amendments 

or the comment period for these 

MRTPAs. To receive email alerts, visit 

FDA’s email subscription service 

management website (http://go.fda.gov/ 

subscriptionmanagement), provide an 

email address, scroll down to the 

‘‘Tobacco’’ heading, select ‘‘Modified 

Risk Tobacco Product Application 

Updates’’, and click ‘‘Submit’’. To 

encourage public participation 

consistent with section 911(e) of the 

FD&C Act, FDA is making the redacted 

MRTPAs that are the subject of this 

notice available electronically (see 

section II). 

II. Electronic Access 

Persons with access to the internet 

may access the application documents 

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

TobaccoProducts/Labeling/ 

MarketingandAdvertising/ucm54

6281.htm. 

Dated: December 18, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–27807 Filed 12–21–18; 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 

Uthra Rajamani, Ph.D. (Respondent), 

former project scientist in the Induced 

Pluripotent Stem Cell Core Facility, 

Cedars-Sinai Medical Center (CSMC). 

Dr. Rajamani engaged in research 

misconduct in research supported by 

National Center for Advancing 

Translational Science (NCATS), 

National Institutes of Health (NIH), 

grant UL1 TR000124. The 

administrative actions, including 

supervision for a period of one (1) year, 

were implemented beginning on 

November 27, 2018, and are detailed 

below. 

FOR FURTHER INFORMATION CONTACT: 

Wanda K. Jones, Dr.P.H., Interim 

Director, Office of Research Integrity, 

1101 Wootton Parkway, Suite 750, 

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: 

Uthra Rajamani, Ph.D., Cedars-Sinai 

Medical Center: Based on the report of 

an inquiry conducted by CSMC, the 

Respondent’s admission, and additional 

analysis conducted by ORI in its 

oversight review, ORI found that Dr. 

Uthra Rajamani, former project scientist 

in the Induced Pluripotent Stem Cell 

Core Facility, CSMC, engaged in 

research misconduct in research 

supported by NCATS, NIH, grant UL1 

TR000124. 

ORI found that Respondent engaged 

in research misconduct by falsifying 

data that were included in the following 

paper: Nature Communications 

8(219):1–15, 2017 (hereafter referred to 

as ‘‘Nature Communications 2017’’). 

ORI found that Respondent 

knowingly and intentionally falsified 

western blot images in Nature 

Communications 2017 by using the 

same western blot panel to represent the 


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66284 Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Notices 

expression of different proteins from 

whole cell lysates exposed to different 

endocrine disrupting chemical (EDC) 

treatments. Specifically, Respondent: 

• Digitally altered the original image 

to darken the western blot panel for 

COX IV expression in Figure 4b in 

Nature Communications 2017 and 

represented the blot as the expression 

of: 

—pNF-kB p65 Figure 4b in Nature 

Communications 2017 

—NF-kB p65 Figure 4b in Nature 

Communications 2017 

—p50 Figure 4b in Nature 

Communications 2017 

—p105 Figure 4b in Nature 

Communications 2017 

—p100 Figure 4b Nature 

Communications 2017 

• Digitally altered the original image 

by superimposing a darker band over 

the original bands in lanes 2 and 4 of 

the western blot panel for COX IV 

expression in whole cell lysates exposed 

to different endocrine disrupting 

chemical (EDC) treatments in Figure 4b 

in Nature Communications 2017 and 

represented the falsified blot in Figure 

6a in Nature Communications 2017 as 

expression of: 

— P-p65 Figure 6a in Nature 

Communications 2017 

— p50 Figure 6a in Nature 

Communications 2017 

— p105 Figure 6a in Nature 

Communications 2017 

— p52 Figure 6a in Nature 

Communications 2017 

• Reused and relabeled the blot from 

Figure 3d in Cell Stem Cell 22:698–712, 

2018 to falsely represent BiP expression 

under different experimental conditions 

in Figure 3d in Nature Communications 

2017. 

As a result of its inquiry, CSMC 

recommended that Nature 

Communications 2017 be retracted. 

Dr. Rajamani entered into a Voluntary 

Settlement Agreement (Agreement) and 

voluntarily agreed: 

(1) To have her research supervised 

for a period of one (1) year beginning on 

November 27, 2018; Respondent agrees 

that prior to submission of an 

application for U.S. Public Health 

Service (PHS) support for a research 

project on which Respondent’s 

participation is proposed and prior to 

Respondent’s participation in any 

capacity on PHS-supported research, 

Respondent shall ensure that a plan for 

supervision of Respondent’s duties is 

submitted to ORI for approval; the 

supervision plan must be designed to 

ensure the scientific integrity of 

Respondent’s research contribution; 

Respondent agrees that she shall not 

participate in any PHS-supported 

research until such a supervision plan is 

submitted to and approved by ORI; 

Respondent agrees to maintain 

responsibility for compliance with the 

agreed upon supervision plan; 

(2) that for a period of one (1) year 

beginning on November 27, 2018, any 

institution employing her shall submit, 

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 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; 

(3) that if no supervisory plan is 

provided to ORI, Respondent will 

provide certification to ORI at the 

conclusion of the supervision period 

that she has not engaged in, applied for, 

or had her name included on any 

application, proposal, or other request 

for PHS funds without prior notification 

to ORI; 

(4) to exclude herself from serving in 

any advisory capacity to PHS including, 

but not limited to, service on any PHS 

advisory committee, board, and/or peer 

review committee, or as a consultant for 

a period of one (1) year beginning on 

November 27, 2018; and 

(5) that as a condition of the 

Agreement, Respondent will request 

that Nature Communications 8(219):1– 

15, 2017 be retracted. 

Wanda K. Jones, 

Interim Director, Office of Research Integrity. 

[FR Doc. 2018–27874 Filed 12–21–18; 8:45 am] 

BILLING CODE 4150–31–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Organization, Functions, and 

Delegations of Authority; Part G; 

Indian Health Service 

Part G, of the Statement of 

Organization, Functions, and 

Delegations of Authority of the 

Department of Health and Human 

Services (HHS), as amended at 70 FR 

24087, May 6, 2005, as amended at 75 

FR 38112, July 1, 2010, and most 

recently as amended at 79 FR 65671, 

November 5, 2014, is hereby amended 

to reflect a reorganization of the Indian 

Health Service (IHS) Headquarters (HQ). 

The IHS proposes a reorganization at 

IHS HQ to strengthen operations and 

oversight responsibilities to ensure 

quality health care by establishing an 

Office of Quality. 

Delete the functional statements for 

the IHS HQ Office of the Director, Office 

of Clinical and Preventive Services, and 

Office of Management Services, and 

replace with the following revised 

statements, which includes a new Office 

of Quality: 

Chapter GA—Office of the Director 

Section GA–10, Indian Health Service— 

Organization 

The IHS is an Operating Division 

within the Department of Health and 

Human Services (HHS) and is under the 

leadership and direction of a Director 

who is directly responsible to the 

Secretary of Health and Human 

Services. The IHS Headquarters is 

proposing to reorganize the following 

major components: Office of the 

Director (GA), Office of Clinical and 

Preventive Services (GAF), Office of 

Management Services (GAL), and the 

Office of Quality (OQ). 

Section GA–20, Indian Health Service— 

Functions 

Office of the Director (OD) (GA) 

Provides overall direction and 

leadership for the IHS: (1) Establishes 

goals and objectives for the IHS 

consistent with the mission of the IHS 

and ensures agency performance is 

managed through goals/objectives, 

achievements, and/or improved 

outcomes; (2) provides for the full 

participation of Indian tribes in the 

programs and services provided by the 

Federal Government; (3) develops 

health care policy; (4) ensures the 

delivery of quality comprehensive 

health services; (5) advocates for the 

health needs and concerns of American 

Indians/Alaska Natives (AI/AN); (6) 

promotes the IHS programs at the local, 

state, national, and international levels; 

(7) develops and demonstrates 

alternative methods and techniques of 

health services management and 

delivery with maximum participation 

by Indian tribes and Indian 

organizations; (8) supports the 

development of individual and tribal 

capacities to participate in Indian health 

programs through means and modalities 

that they deem appropriate to their 

needs and circumstances; (9) the IHS 

will carry out the responsibilities of the 

United States to Indian tribes and 

individual Indians; (10) affords Indian 

people an opportunity to enter a career 

in the IHS by applying Indian 

preference; (11) ensures full application 

of the principles of Equal Employment 

Opportunity laws and the Civil Rights 

Act in managing the human resources of 


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