Federal Register / Vol. 83, No. 247 / Thursday, December 27, 2018 / Notices 66717 

Authority: Section 2008 of the Social 

Security Act as enacted by Section 5507 of 

the Affordable Care Act. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2018–28018 Filed 12–26–18; 8:45 am] 

BILLING CODE 4184–72–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1989] 

Ranjan Bhandari: Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

issuing an order under the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) debarring Ranjan Bhandari, MD 

(Dr. Bhandari), for a period of 3 years 

from providing services in any capacity 

to a person that has an approved or 

pending drug product application. FDA 

bases this order on a finding that Dr. 

Bhandari was convicted of a 

misdemeanor under the FD&C Act for 

causing the introduction or delivery for 

introduction into interstate commerce of 

prescription drugs that were 

misbranded. In addition, FDA has 

determined that the type of conduct that 

served as the basis for the conviction 

undermines the process for the 

regulation of drugs. Dr. Bhandari was 

given notice of the proposed debarment 

and an opportunity to request a hearing 

within the timeframe prescribed by 

regulation. Dr. Bhandari failed to 

request a hearing. Dr. Bhandari’s failure 

to request a hearing constitutes a waiver 

of his right to a hearing concerning this 

action. 

DATES: This order is effective December 

27, 2018. 

ADDRESSES: Submit applications for 

termination of debarment to the Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kenny Shade (ELEM–4144), Division of 

Enforcement, Food and Drug 

Administration, 12420 Parklawn Dr., 

Rockville, MD 20857, 301–796–4640. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(b)(2)(B)(i)(I) of the FD&C 

Act (21 U.S.C. 335a(b)(2)(B)(i)(I)) 

permits debarment of an individual if 

FDA finds that the individual has been 

convicted of a misdemeanor under 

Federal law for conduct relating to the 

regulation of drug products under the 

FD&C Act, and if FDA finds that the 

type of conduct that served as the basis 

for the conviction undermines the 

process for the regulation of drugs. 

On December 9, 2013, in the U.S. 

District Court for the Northern District 

of Ohio, judgment was entered against 

Dr. Bhandari after he entered a plea of 

guilty to one count of misbranding in 

violation of section 301(a) of the FD&C 

Act (21 U.S.C. 331(a)), which is a 

misdemeanor offense under section 

303(a)(1) of the FD&C Act (21 U.S.C. 

333(a)(1)). FDA’s finding that debarment 

is appropriate is based on the 

misdemeanor conviction referenced 

herein. The factual basis for this 

conviction is as follows: Between June 

1, 2006, and March 31, 2008, Dr. 

Bhandari was a physician (oncologist) 

in Ohio. During this time, Dr. Bhandari 

purchased and received oncology drugs, 

including ZOMETA, IRINOTECAN, 

ELOXATIN, GEMZAR, HYCAMTIN, 

ARANESP, and TAXOTERE, from a 

drug distributor located in Canada. 

These new drugs originated outside the 

United States and were not approved by 

FDA for introduction or delivery for 

introduction into interstate commerce in 

the United States. Thus, Dr. Bhandari 

caused the introduction or delivery for 

introduction into interstate commerce of 

prescription drugs that were 

misbranded for lacking adequate 

directions for use in their labeling. 

As a result of this conviction, on 

August 29, 2018, FDA sent Dr. Bhandari 

a notice by certified mail proposing to 

debar him for 3 years from providing 

services in any capacity to a person that 

has an approved or pending drug 

product application. The proposal was 

based on a finding under section 

306(b)(2)(B)(i)(I) of the FD&C Act, that 

Dr. Bhandari was convicted of a 

misdemeanor under Federal law for 

conduct relating to the regulation of 

drug products under the FD&C Act, and 

that the type of conduct that served as 

the basis for the conviction undermines 

the process for the regulation of drugs. 

The proposal offered Dr. Bhandari an 

opportunity to request a hearing, 

provided him 30 days from the date of 

receipt of the letter in which to file the 

request, and advised him that failure to 

request a hearing constituted a waiver of 

the opportunity for a hearing and of any 

contentions concerning this action. Dr. 

Bhandari received the proposal on 

September 4, 2018. Dr. Bhandari did not 

request a hearing within the timeframe 

prescribed by regulation and, therefore, 

has waived his opportunity for a hearing 

and has waived any contentions 

concerning his debarment (21 CFR part 

12). 

II. Findings and Order 

Therefore, the Director, Office of 

Enforcement and Import Operations, 

Office of Regulatory Affairs, under 

section 306(b)(2)(B)(i)(I) of the FD&C 

Act, under authority delegated to the 

Director (Staff Manual Guide 1410.35), 

finds that Dr. Bhandari has been 

convicted of a misdemeanor under 

Federal law for conduct relating to the 

regulation of drug products under the 

FD&C Act, and that the type of conduct 

that served as the basis for the 

conviction undermines the process for 

the regulation of drugs. 

As a result of the foregoing findings 

and in consideration of the factors 

described in section 306(c)(3) of the 

FD&C Act, Dr. Bhandari is debarred for 

a period of 3 years from providing 

services in any capacity to a person with 

an approved or pending drug product 

application under sections 505, 512, or 

802 of the FD&C Act (21 U.S.C. 355, 

360b, or 382), or under section 351 of 

the Public Health Service Act (42 U.S.C. 

262), effective (see DATES) (see sections 

306(c)(1)(B), (c)(3), and 201(dd) of the 

FD&C Act (21 U.S.C. 335a(c)(1)(B), 

(c)(3), and 321(dd))). Any person with 

an approved or pending drug product 

application who knowingly employs or 

retains as a consultant or contractor, or 

otherwise uses the services of Dr. 

Bhandari, in any capacity during his 

debarment, will be subject to civil 

money penalties (section 307(a)(6) of the 

FD&C Act (21 U.S.C. 335b(a)(6)). If Dr. 

Bhandari provides services in any 

capacity to a person with an approved 

or pending drug product application 

during his period of debarment he will 

be subject to civil money penalties 

(section 307(a)(7) of the FD&C Act). 

In addition, FDA will not accept or 

review any abbreviated new drug 

applications submitted by or with the 

assistance of Dr. Bhandari during his 

period of debarment (section 

306(c)(1)(B) of the FD&C Act). 

Any application by Dr. Bhandari for 

termination of debarment under section 

306(d)(1) of the FD&C Act should be 

identified with Docket No. FDA–2018– 

N–1989 and sent to the Dockets 

Management Staff (see ADDRESSES). All 

such submissions are to be filed in four 

copies. The public availability of 

information in these submissions is 

governed by 21 CFR 10.20(j). 

Publicly available submissions will be 

placed in the docket and will be 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff (see 

ADDRESSES) between 9 a.m. and 4 p.m., 

Monday through Friday. 


khammond on DSK30JT082PROD with NOTICES
66718 Federal Register / Vol. 83, No. 247 / Thursday, December 27, 2018 / Notices 

Dated: December 19, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–27951 Filed 12–26–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: 

Environmental Information 

Documentation (EID), OMB No. 0915– 

0324—Revision 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than February 25, 

2019. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N136B, 5600 Fishers 

Lane, Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Lisa Wright-Solomon, the HRSA 

Information Collection Clearance Officer 

at (301) 443–1984. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference. 

Information Collection Request Title: 

HRSA Environmental Information and 

Documentation, OMB Number: 0915– 

0324—Revision. 

Abstract: HRSA proposes revisions to 

the Environmental Information and 

Documentation (EID) checklist, which 

consists of information that the agency 

is required to obtain to comply with the 

National Environmental Policy Act of 

1969 (NEPA). NEPA establishes the 

federal government’s national policy for 

protection of the environment. The EID 

checklist must be completed and 

submitted by applicants for HRSA funds 

that plan to engage in construction or 

other projects that would potentially 

impact the environment. HRSA utilizes 

the checklist to ensure that decisionmaking processes are consistent with 

NEPA. The revisions will update some 

of the language in the checklist. For 

example, to better align with 45 CFR 

part 75, HRSA proposes to change the 

term ‘‘grant’’ to ‘‘award’’ and ‘‘grantee’’ 

to ‘‘award recipient.’’ 

Need and Proposed Use of the 

Information: Applicants for HRSA funds 

must provide information and assurance 

of compliance with NEPA on the EID 

checklist. This information is reviewed 

during the pre-award stage. 

Likely Respondents: HRSA applicants 

applying for federal construction grants 

and cooperative agreements. 

Burden Statement: Burden in this 

context means the time expended by 

persons to generate, maintain, retain, 

disclose, or provide the information 

requested. This includes the time 

needed to review instructions; to 

develop, acquire, install, and utilize 

technology and systems for the purpose 

of collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information; to search 

data sources; to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

NEPA EID Checklist ............................................................ 1,500 1 1,500 1 1,500 

Total .............................................................................. 1,500 ........................ 1,500 ........................ 1,500 

HRSA specifically requests comments 

on (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions, (2) the accuracy of the 

estimated burden, (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Amy P. McNulty, 

Acting Director, Division of the Executive 

Secretariat. 

[FR Doc. 2018–28029 Filed 12–26–18; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Committee on Vital and Health 

Statistics: Meeting Pursuant to the 

Federal Advisory Committee Act, the 

Department of Health and Human 

Services (HHS) Announces the 

Following Advisory Committee 

Meeting 

Name: National Committee on Vital 

and Health Statistics (NCVHS), Full 

Committee Meeting. 

Dates and Times: Wednesday, 

February 6, 2019: 9:00 a.m.–5:30 p.m.; 

Thursday, February 7, 2019: 8:30 a.m.– 

3:00 p.m. 

Place: U.S. Department of Health and 

Human Services, Hubert H. Humphrey 

Building, 200 Independence Avenue 

SW, Rm. 505A, Washington, DC 20201. 

Status: Open. 

Purpose: At the February 6–7, 2019 

meeting, the Committee will deliberate 

draft recommendations for the HHS 

Secretary, move forward on activities 

outlined in the NCVHS 2019 workplan, 

and hold discussions on several health 

data policy topics. Anticipated action 

items during this meeting include: (1) A 

letter to the Secretary regarding 

recommendations for revisions to 

principles for adoption of health 

terminology and vocabulary standards 

and new principles for curation and 


khammond on DSK30JT082PROD with NOTICES