Attachment Y: 60-Day FRN For April 2019 Submission

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

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TIME AND DATE:

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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)
Office of Planning, Research,
and Evaluation; Administration for
Children and Families; HHS.
ACTION: Request for Public Comment.
AGENCY:

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

SUMMARY:

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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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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
Total
number of
respondents

Instrument

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Screening interview to identify respondents for the HPOG
2.0 National Evaluation descriptive study second-round
telephone interviews .........................................................
HPOG 2.0 National Evaluation descriptive study second
round telephone interview protocol ..................................
HPOG 2.0 National Evaluation descriptive study program
operator interview guide ...................................................
HPOG 2.0 National Evaluation descriptive study partner
interview guide .................................................................
HPOG 2.0 National Evaluation descriptive study participant in-depth interview guide ...........................................
Intermediate follow-up survey for the HPOG 2.0 National
Evaluation impact study ...................................................
HPOG 2.0 National Evaluation impact study instrument for
a Pilot Study of Phone-Based Skills Assessment ...........
HPOG 2.0 National Evaluation program cost survey ..........

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

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Annual
number of
respondents

Number of
responses per
respondent

Frm 00046

Annual burden
hours

38

13

1

.5

7

190

63

1

1.25

79

16

5

1

1.25

6

112

37

1

1

37

140

47

1

1.33

63

4,000

1,333

1

1

1,333

300
38

100
13

1
1

.75
6

75
78

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

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per response

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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
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.

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:

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SUMMARY:

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

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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

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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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