Attachment B_60-Day FRN_HMRF nFORM

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Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Number of
respondents
(total over
request period)

Instrument

Project Directors and Leaders Site Visit Discussion Guide
(Instrument 2) ...................................................................
Staff Site Visit Discussion Guide (Instrument 3) .................
Nonprofit or Partner Organizations Site Visit Discussion
Guide (Instrument 4) ........................................................

Estimated Total Annual Burden
Hours: 189.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the agency’s functions,
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
information collection on respondents,
including through using automated
collection techniques or other forms of
information technology. Consideration
will be given to comments and
suggestions submitted within 60 days of
this publication.
Authority: 42 U.S.C. 613, 42 U.S.C. 1397,
42 U.S.C. 711, and 42 U.S.C. 603(a)(2).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–26248 Filed 11–27–20; 8:45 am]
BILLING CODE 4184–09–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request; Healthy
Marriage and Responsible Fatherhood
Performance Measures and Additional
Data Collection (New Collection)
Office of Planning, Research,
and Evaluation, Administration for
Children and Families, HHS.
ACTION: Request for public comment.
TKELLEY on DSKBCP9HB2PROD with NOTICES

AGENCY:

The Administration for
Children and Families (ACF), Office of
Family Assistance (OFA), has had
administrative responsibility for federal
funding of programs that strengthen
families through healthy marriage and
relationship education and responsible
fatherhood programming since 2006

SUMMARY:

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Number of
responses per
respondent
(total over
request period)

Frm 00067

Fmt 4703

Total burden
(in hours)

Annual
burden
(in hours)

60
108

1
1

2
1.5

120
162

60
81

72

1

1

72

36

through the Healthy Marriage (HM) and
Responsible Fatherhood (RF) Grant
Programs. ACF required the 2015 cohort
of HMRF grantees—which received 5year grants in September 2015—to
collect and report performance
measures about program operations,
services, and clients served (OMB
#0970–0460). A performance measures
data collection system called nFORM
(Information, Family Outcomes,
Reporting, and Management) was
implemented with the 2015 cohort to
improve the efficiency of data collection
and reporting and the quality of data.
This system allows for streamlined and
standardized submission of grantee
performance data through regular
progress reports and supports granteeled and federal research projects. ACF
will continue performance measure and
other data collection activities for the
HMRF grant program with a new cohort
of grantees who received 5-year awards
in September 2020. ACF is requesting
comment on a new data collection to
support these activities with the 2020
HMRF grantee cohort. ACF has made
changes to the previous cohort’s data
collection instruments and performance
reports for use in the new cohort. This
new grantee cohort is expected to begin
collecting performance measure data
and reporting to ACF in April 2021.
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,
ACF 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 emailing
[email protected].
Alternatively, copies can also be
obtained 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. All requests,

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Average
burden per
response
(in hours)

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emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: ACF proposes to collect a
set of performance measures from all
HMRF grantees. These measures collect
standardized information in the
following areas:
• Applicant characteristics;
• Program operations;
• Service delivery; and
• Participant outcomes:
Æ Entrance survey, with five versions:
(1) HM Program Entrance Survey for
Adult-Focused Programs, (2) HM
Program Entrance Survey for YouthFocused Programs, (3) RF Program
Entrance Survey for Community-Based
Fathers, (4) RF Program Entrance Survey
for Community-Based Mothers, and (5)
RF Program Entrance Survey for
Reentering Fathers.
Æ Exit survey, with five versions: (1)
HM Program Exit Survey for AdultFocused Programs, (2) HM Program Exit
Survey for Youth-Focused Programs, (3)
RF Program Exit Survey for CommunityBased Fathers, (4) RF Program Exit
Survey for Community-Based Mothers,
and (5) RF Program Exit Survey for
Reentering Fathers.
The measures used by the 2015
grantee cohort were developed in 2014
after extensive review of the research
literature and grantees’ past measures.
The performance measures, data
collection instruments, and data
collection system were revised in 2020
based on a targeted analysis of existing
measures, feedback from key
stakeholders, and discussions with ACF
staff and the 2015 cohort of grantees.
ACF required the 2015 cohort of
grantees to submit data on these
standardized measures on a quarterly
basis and proposes the same
requirement for the 2020 cohort. In
addition to the performance measures
mentioned above, ACF proposes to
repeat collection for these data
submissions:
• Semi-annual Performance Progress
Report (PPR), with two versions: (1)
Performance Progress Report for HM

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76581

Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices

The estimated burden for completing
and updating this template is included
in the table below.
Respondents: Respondents include
HM and RF grantee staff and program
applicants and participants (participants
are called ‘‘clients’’).

Performance Progress Report for RF
Programs.
Grantees in the new cohort will also
be required to engage in continuous
quality improvement (CQI) planning
and implementation using a proposed
CQI plan template developed by ACF.

Programs, and (2) Performance Progress
Report for RF Programs; and
• Quarterly Performance Report
(QPR), with two versions: (1) Quarterly
Performance Progress Report for HM
Programs, and (2) Quarterly

ANNUAL BURDEN ESTIMATES
Annual
number of
respondents

Number of
responses
per
respondent
(total over
request
period)

Average
burden per
response
(in hours)

Total
burden
(in hours)

Annual
burden
(in hours)

Instrument

Respondent

1: Applicant Characteristics ...............

Program applicants ...........................
Program staff ....................................
Program staff ....................................
Program staff ....................................
Program clients (entrance) ...............
Program clients (exit) ........................
Program staff (entrance and exit on
paper).
Program staff ....................................

273,839
408
136
2,040
257,409
169,965
32

91,280
408
136
2,040
85,803
56,655
32

1
224
12
126
1
1
1,169

0.25
0.10
0.32
0.50
0.42
0.42
0.10

68,460
27,384
526.32
128,706
108,111.78
71,385
11,220

22,820
9,128
175.44
42,902
36,037.26
23,795
3,740

136

136

6

3

2,448

816

Program staff ....................................

136

136

6

1

816

272

Program staff ....................................

136

136

3

4

1,632

544

2: Program Operations ......................
3: Service Delivery Data ....................
4: Entrance and Exit Surveys ............

5:

Semi-annual
Performance
Progress Report (PPR).
6: Quarterly Performance Report
(QPR).
7: CQI Plan ........................................

Estimated Total Annual Burden
Hours: 140,230.
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.
Authority: Sec. 403. [42 U.S.C. 603].
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–26266 Filed 11–27–20; 8:45 am]
BILLING CODE 4184–73–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
TKELLEY on DSKBCP9HB2PROD with NOTICES

Number of
respondents
(total over
request
period)

Food and Drug Administration
[Docket No. FDA–2020–N–1337]

John Kapoor: Final Debarment Order
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

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The Food and Drug
Administration (FDA or Agency) is
issuing an order under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) permanently debarring John
Kapoor 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 John Kapoor was convicted
of a felony under Federal law for
conduct that relates to the regulation of
a drug product under the FD&C Act.
John Kapoor was given notice of the
proposed permanent debarment and an
opportunity to request a hearing to show
why he should not be debarred. Mr.
Kapoor, through counsel, submitted a
letter to FDA, which commented on
some of the factual circumstances
surrounding the case. In the letter, he
also stated that he did not intend to
request a hearing nor, however, would
he acquiesce to debarment. As of August
26, 2020 (30 days after receipt of the
notice), Mr. Kapoor has not requested a
hearing. His failure to request a hearing
constitutes a waiver of his right to a
hearing concerning this action.
DATES: This order is applicable
November 30, 2020.
ADDRESSES: Submit applications for
special termination of debarment to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852, 240–402–7500, or https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa, (ELEM–4029) Division
SUMMARY:

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of Enforcement, Office of Strategic
Planning and Operational Policy, Office
of Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857, debarments@
fda.hhs.gov, 240–402–8743.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(B) of the FD&C Act
(21 U.S.C. 335a(a)(2)(B)) requires
debarment of an individual from
providing services in any capacity to a
person that has an approved or pending
drug product application if FDA finds
that the individual has been convicted
of a felony under Federal law for
conduct relating to the regulation of any
drug product under the FD&C Act. On
January 23, 2020, Mr. Kapoor was
convicted as defined in section 306(l)(1)
of the FD&C Act when judgment was
entered against him in the U.S. District
Court for the District of Massachusetts,
after a jury verdict, to one count of
Racketeering Conspiracy in violation of
18 U.S.C. 1962(d). The pattern of
racketeering activity he was convicted
of included engaging in multiple acts of
mail fraud (18 U.S.C. 1341) and wire
fraud (18 U.S.C. 1343).
The factual basis for this conviction is
as follows: Mr. Kapoor was the founder
and majority owner of Insys
Therapeutics Inc. (Insys), a Delaware
Corporation, with headquarters in
Chandler, Arizona. In addition, he held
executive management positions at
Insys, including Executive Chairman of
the Board of Directors and, for a time,

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