Federal Register / Vol. 83, No. 247 / Thursday, December 27, 2018 / Notices 66715 

Privacy Impact Assessment(s): No 

impact(s). 

Needs and Uses: The Commission 

adopted the Contest Rule in 1976 to 

address concerns about the manner in 

which broadcast stations were 

conducting contests over the air. The 

Contest Rule generally requires stations 

to broadcast material contest terms fully 

and accurately the first time the 

audience is told how to participate in a 

contest, and periodically thereafter. In 

addition, stations must conduct contests 

substantially as announced. These 

information collection requirements are 

necessary to ensure that broadcast 

licensees conduct contests with due 

regard for the public interest. 

The Contest Rule permit broadcasters 

to meet their obligation to disclose 

contest material terms on an internet 

website in lieu of making broadcast 

announcements. Under the amended 

Contest Rule, broadcasters are required 

to (i) announce the relevant internet 

website address on air the first time the 

audience is told about the contest and 

periodically thereafter; (ii) disclose the 

material contest terms fully and 

accurately on a publicly accessible 

internet website, establishing a link or 

tab to such terms through a link or tab 

on the announced website’s home page, 

and ensure that any material terms 

disclosed on such a website conform in 

all substantive respects to those 

mentioned over the air; (iii) maintain 

contest material terms online for at least 

thirty days after the contest has ended; 

and (v) announce on air that the 

material terms of a contest have changed 

(where that is the case) within 24 hours 

of the change in terms on a website, and 

periodically thereafter, and to direct 

consumers to the website to review the 

changes. 

Federal Communications Commission. 

Marlene Dortch, 

Secretary, Office of the Secretary. 

[FR Doc. 2018–28128 Filed 12–26–18; 8:45 am] 

BILLING CODE 6712–01–P 

FEDERAL ELECTION COMMISSION 

Sunshine Act Meeting 

TIME AND DATE: Tuesday, January 8, 2019 

at 10:00 a.m. 

PLACE: 1050 First Street NE, 

Washington, DC. 

STATUS: This Meeting Will be Closed to 

the Public. 

MATTERS TO BE CONSIDERED: Compliance 

matters pursuant to 52 U.S.C. 30109. 

Matters concerning participation in 

civil actions or proceedings or 

arbitration. 

Additional Information: 

This meeting will be cancelled if the 

Commission is not open due to a 

funding lapse. 

* * * * * 

CONTACT PERSON FOR MORE INFORMATION: 

Judith Ingram, Press Officer, Telephone: 

(202) 694–1220. 

Laura E. Sinram, 

Deputy Secretary of the Commission. 

[FR Doc. 2018–28165 Filed 12–21–18; 11:15 am] 

BILLING CODE 6715–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; National and Tribal Evaluation 

of the 2nd Generation of the Health 

Profession Opportunity Grants (OMB 

#0970–0462) 

AGENCY: Office of Planning, Research, 

and Evaluation; Administration for 

Children and Families; HHS. 

ACTION: Request for Public Comment. 

SUMMARY: The Administration for 

Children and Families (ACF), U.S. 

Department of Health and Human 

Services (HHS) is proposing data 

collection activities as part of the Health 

Profession Opportunity Grants (HPOG) 

to Serve TANF Recipients and Other 

Low Income Individuals. ACF has 

developed a multi-pronged research and 

evaluation approach for the HPOG 

Program to better understand and assess 

the activities conducted and their 

results. Two rounds of HPOG grants 

have been awarded—the first in 2010 

(HPOG 1.0) and the second in 2015 

(HPOG 2.0). There are federal 

evaluations associated with each round 

of grants. HPOG grants provide funding 

to government agencies, communitybased organizations, post-secondary 

educational institutions, and tribalaffiliated organizations to provide 

education and training services to 

Temporary Assistance for Needy 

Families (TANF) recipients and other 

low-income individuals, including 

tribal members. Under HPOG 2.0, ACF 

provided grants to five tribal-affiliated 

organizations and 27 non-tribal entities. 

OMB previously approved data 

collection under OMB Control Number 

0970–0462 for the HPOG 2.0 National 

and Tribal Evaluation. The first 

submission, approved in August 2015, 

included baseline data collection 

instruments and the grant performance 

management system. A second 

submission, approved in June 2017, 

included additional data collection for 

the National Evaluation impact study, 

the National Evaluation descriptive 

study, and the Tribal Evaluation. A 

third submission for National 

Evaluation impact study data collection 

was approved in June 2018. The 

proposed data collection activities 

described in this Federal Register 

Notice will provide data for the impact, 

descriptive, and cost benefit studies of 

the 27 non-tribal grantees participating 

in the National Evaluation of HPOG 2.0. 

DATES: Comments due within 60 days of 

publication. In compliance with the 

requirements of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

the Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

ADDRESSES: Copies of the proposed 

collection of information can be 

obtained and comments may be 

forwarded by writing to the 

Administration for Children and 

Families, Office of Planning, Research, 

and Evaluation, 330 C Street SW, 

Washington, DC 20201, Attn: OPRE 

Reports Clearance Officer. Email 

address: OPREinfocollection@

acf.hhs.gov. All requests should be 

identified by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: The National Evaluation 

pertains only to the 27 non-tribal 

grantees that received HPOG 2.0 

funding. The design for the National 

Evaluation features an impact study, a 

descriptive study, and a cost benefit 

study. The National Evaluation is using 

an experimental design to measure and 

analyze key participant outcomes 

including completion of education and 

training, receipt of certificates and/or 

degrees, earnings, and employment in a 

healthcare career. The impact 

evaluation will assess the outcomes for 

study participants that were offered 

HPOG 2.0 training, financial assistance, 

and support services, compared to 

outcomes for a control group that were 

not offered HPOG 2.0 services. 

ACF and the study team estimates 

that the non-tribal grantees will 

randomize about 40,000 applicants. As 

detailed in the burden estimates below, 

the study team will only survey a subset 

of those randomized. 

The goal of the descriptive study is to 

describe and assess the implementation, 

systems change, outcomes, and other 

important information about the 

operations of the 27 non-tribal HPOG 

grantees, which are operating 38 distinct 

programs. To achieve these goals, it is 


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66716 Federal Register / Vol. 83, No. 247 / Thursday, December 27, 2018 / Notices 

necessary to collect data about the nontribal HPOG programs’ design and 

implementation, HPOG partner and 

program networks, the composition and 

intensity of HPOG services received by 

participants, participant characteristics 

and HPOG experiences, and participant 

outputs and outcomes. 

The cost benefit study will estimate 

the costs of providing the HPOG 2.0 

programs and compare the costs with 

gains in participant employment and 

earnings measured in the impact 

analysis. To achieve this goal, it is 

necessary to collect information from 

the 38 HPOG 2.0 programs on the cost 

of providing education and training and 

associated services. 

This Notice provides the opportunity 

to comment on proposed new 

information collection activities for the 

HPOG 2.0 National Evaluation’s impact, 

descriptive, and cost-benefit studies. 

The information collection activities 

to be submitted in the request package 

include: 

1. Screening Interview to identify 

respondents for the HPOG 2.0 National 

Evaluation descriptive study secondround telephone interviews. 

2. HPOG 2.0 National Evaluation 

descriptive study second-round 

telephone interview guide for program 

management, staff, partners, and 

stakeholders. These interviews will 

confirm or update information collected 

in a first round of calls, approved in 

June 2017. The second round interviews 

will update or confirm any new 

information about the HPOG program 

context and about program 

administration, activities and services, 

partner and stakeholder roles and 

networks, and respondent perceptions 

of the program’s strengths. 

3. HPOG 2.0 National Evaluation 

descriptive study program operator 

interview guide will collect information 

for the systems study from HPOG 2.0 

programs operators. These interviews 

will collect information on how local 

service delivery systems (i.e., the 

economic and service delivery 

environment in which specific HPOG 

2.0 programs operate) may have 

influenced HPOG program design and 

implementation and how HPOG 2.0 

implementation may have influenced 

these local systems. 

4. HPOG 2.0 National Evaluation 

descriptive study partner interview 

guide will collect information for the 

systems study from HPOG 2.0 partner 

organizations. 

5. HPOG 2.0 National Evaluation 

descriptive study participant in-depth 

interview guide will collect qualitative 

information about the experiences of 

treatment group members participating 

in HPOG 2.0 program services. 

6. Intermediate Follow-up Survey for 

the HPOG 2.0 National Evaluation 

impact study will collect information 

from both treatment and control group 

members at the 27 non-tribal grantees, 

approximately 36 months after baseline 

data collection and random assignment. 

7. HPOG 2.0 National Evaluation 

impact study instrument for a Pilot 

Study of Phone-Based Skills Assessment 

will collect information from HPOG 2.0 

study participants in a subset of nontribal grantee programs. The phonebased questionnaire will pilot an 

assessment of respondents’ literacy and 

numeracy skills to inform the selection 

of survey questions for inclusion in the 

intermediate follow-up survey. 

8. HPOG 2.0 National Evaluation 

Program Cost Survey will collect 

information from program staff at the 27 

non-tribal grantees to support the costbenefit study. 

At this time, the Department does not 

foresee the need for any subsequent 

requests for clearance for the HPOG 2.0 

National and Tribal Evaluations. 

Respondents: HPOG impact study 

participants from the 27 non-tribal 

HPOG 2.0 grantees (treatment and 

control group); HPOG program 

managers; HPOG program staff; and 

representatives of partner agencies and 

stakeholders, including support service 

providers, educational and vocational 

training partners, Workforce Investment 

Boards, and TANF agencies. 

This information collection request is 

for 3 years. 

ANNUAL BURDEN ESTIMATES

Instrument 

Total 

number of 

respondents 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual burden 

hours 

Screening interview to identify respondents for the HPOG 

2.0 National Evaluation descriptive study second-round 

telephone interviews ......................................................... 38 13 1 .5 7 

HPOG 2.0 National Evaluation descriptive study second 

round telephone interview protocol .................................. 190 63 1 1.25 79 

HPOG 2.0 National Evaluation descriptive study program 

operator interview guide ................................................... 16 5 1 1.25 6 

HPOG 2.0 National Evaluation descriptive study partner 

interview guide ................................................................. 112 37 1 1 37 

HPOG 2.0 National Evaluation descriptive study participant in-depth interview guide ........................................... 140 47 1 1.33 63 

Intermediate follow-up survey for the HPOG 2.0 National 

Evaluation impact study ................................................... 4,000 1,333 1 1 1,333 

HPOG 2.0 National Evaluation impact study instrument for 

a Pilot Study of Phone-Based Skills Assessment ........... 300 100 1 .75 75 

HPOG 2.0 National Evaluation program cost survey .......... 38 13 1 6 78 

Estimated Total Annual Burden 

Hours: 1,678. 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 


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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. 


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