66282 Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

21 CFR section and activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Filing a Request for a Hearing on Medicated Feed Mill License (515.30(c)).1 1 1 4 .................... 4 

Total .............................................................................. ........................ ........................ ........................ ........................ 29 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section and activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Maintenance of Records for Approved Labeling for Each 

‘‘Type B’’ and ‘‘Type C’’ Feed (510.305).

837 1 837 0.03 (2 minutes).25 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

These estimates are based on our 

experience with medicated feed mill 

license applications. We estimate that 

we will receive 14 medicated feed mill 

license applications, 54 supplemental 

applications, 29 requests for voluntary 

revocation, and that these submissions 

will take approximately 15 minutes per 

response, as shown in table 1, rows 1 

through 3. We estimate that preparing a 

request for a hearing under § 515.30(c) 

takes approximately 4 hours, as shown 

in table 1, row 4. In table 2, we estimate 

that 837 licensees will keep the records 

required by 21 CFR 510.305 expending 

a total of 25 hours annually. 

Our estimated burden for the 

information collection reflects an 

overall decrease of 2 hours and a 

corresponding decrease of 56 responses/ 

records. We attribute this adjustment to 

a net decrease in the number of 

submissions we received over the last 

few years. 

Dated: December 18, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–27812 Filed 12–21–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–3001] 

Modified Risk Tobacco Product 

Applications for IQOS System With 

Marlboro Heatsticks, IQOS System 

With Marlboro Smooth Menthol 

Heatsticks, and IQOS System With 

Marlboro Fresh Menthol Heatsticks 

Submitted by Philip Morris Products 

S.A.; Closing of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; closing of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

closing date for the period for public 

comment on modified risk tobacco 

product applications (MRTPAs) 

submitted by Philip Morris Products 

S.A. for its IQOS system products. FDA 

recently received amendments to these 

MRTPAs and has made them available 

for public comment. 

DATES: Submit either electronic or 

written comments by February 11, 2019 

to ensure FDA considers your comment 

before completing its review of the 

applications. 

ADDRESSES: 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– 

2017–D–3001 for ‘‘Modified Risk 

Tobacco Product Applications for IQOS 

system with Marlboro Heatsticks, IQOS 

system with Marlboro Smooth Menthol 

Heatsticks, and IQOS system with 

Marlboro Fresh Menthol Heatsticks 

submitted by Philip Morris Products 


amozie on DSK3GDR082PROD with NOTICES1
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 


amozie on DSK3GDR082PROD with NOTICES1