76580 Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices 

ANNUAL BURDEN ESTIMATES—Continued 

Instrument 

Number of 

respondents 

(total over 

request period) 

Number of 

responses per 

respondent 

(total over 

request period) 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Annual 

burden 

(in hours) 

Project Directors and Leaders Site Visit Discussion Guide 

(Instrument 2) ................................................................... 60 1 2 120 60 

Staff Site Visit Discussion Guide (Instrument 3) ................. 108 1 1.5 162 81 

Nonprofit or Partner Organizations Site Visit Discussion 

Guide (Instrument 4) ........................................................ 72 1 1 72 36 

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) 

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), 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 

through the Healthy Marriage (HM) and 

Responsible Fatherhood (RF) Grant 

Programs. ACF required the 2015 cohort 

of HMRF grantees—which received 5- 

year 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 

OPREinfocollection@acf.hhs.gov. 

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, 

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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Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices 76581 

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 

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. 

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’’). 

ANNUAL BURDEN ESTIMATES

Instrument Respondent 

Number of 

respondents 

(total over 

request 

period) 

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) 

1: Applicant Characteristics ............... Program applicants ........................... 273,839 91,280 1 0.25 68,460 22,820 

Program staff .................................... 408 408 224 0.10 27,384 9,128 

2: Program Operations ...................... Program staff .................................... 136 136 12 0.32 526.32 175.44 

3: Service Delivery Data .................... Program staff .................................... 2,040 2,040 126 0.50 128,706 42,902 

4: Entrance and Exit Surveys ............ Program clients (entrance) ............... 257,409 85,803 1 0.42 108,111.78 36,037.26 

Program clients (exit) ........................ 169,965 56,655 1 0.42 71,385 23,795 

Program staff (entrance and exit on 

paper).

32 32 1,169 0.10 11,220 3,740 

5: Semi-annual Performance 

Progress Report (PPR).

Program staff .................................... 136 136 6 3 2,448 816 

6: Quarterly Performance Report 

(QPR).

Program staff .................................... 136 136 6 1 816 272 

7: CQI Plan ........................................ Program staff .................................... 136 136 3 4 1,632 544 

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 

Food and Drug Administration 

[Docket No. FDA–2020–N–1337] 

John Kapoor: Final 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) 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 

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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