104 Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Notices 

their underlying persistent cancer pain. 

From May 2012 and continuing until 

December 2015, Mr. Rowan participated 

in a conspiracy whereby employees of 

Insys bribed medical practitioners in 

various States to get those practitioners 

to increase prescribing SUBSYS to their 

patients, many of whom did not have 

cancer. Mr. Rowan, along with his coconspirators, measured the effect of 

these bribes on each practitioner’s 

prescribing habits and on the revenue 

that each bribed practitioner generated 

for Insys. Mr. Rowan, along with his coconspirators, reduced or eliminated 

bribes paid to those practitioners who 

failed to meet the minimum 

prescription requirements or failed to 

generate enough revenue to justify 

additional bribes. 

To further this conspiracy, Mr. Rowan 

was involved in a scheme with his coconspirators whereby Insys executives 

conspired to mislead and defraud health 

insurance providers to ensure those 

providers approved payment for 

SUBSYS. Insys achieved this goal by 

establishing the ‘‘Insys Reimbursement 

Center,’’ which was designed to shift the 

burden of seeking prior authorization 

for SUBSYS from practitioners to Insys. 

This allowed Insys to determine what 

medical information was presented to 

insurers. Mr. Rowan and his coconspirators directed Insys employees 

to mislead insurers to obtain payment 

authorization. 

As a result of this conviction, FDA 

sent Mr. Rowan by certified mail on 

August 3, 2020, a notice proposing to 

permanently debar him 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(a)(2)(B) of the FD&C Act, that Mr. 

Rowan was convicted of a felony under 

Federal law for conduct relating to the 

regulation of a drug product under the 

FD&C Act. The proposal also offered Mr. 

Rowan an opportunity to request a 

hearing, providing 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 

an election not to use the opportunity 

for a hearing and a waiver of any 

contentions concerning this action. Mr. 

Rowan received the proposal on August 

7, 2020. He did not request a hearing 

within the timeframe prescribed by 

regulation and has, therefore, waived 

his opportunity for a hearing and any 

contentions concerning his debarment 

(21 CFR part 12). 

II. Findings and Order 

Therefore, the Assistant 

Commissioner, Office of Human and 

Animal Food Operations, under section 

306(a)(2)(B) of the FD&C Act, under 

authority delegated to the Assistant 

Commissioner, finds that Mr. Rowan 

has been convicted of a felony under 

Federal law for conduct otherwise 

relating to the regulation of a drug 

product under the FD&C Act. 

As a result of the foregoing finding, 

Mr. Rowan is permanently debarred 

from providing services in any capacity 

to a person with an approved or 

pending drug product application, 

effective (see DATES) (see sections 

306(a)(2)(B) and 306(c)(2)(A)(ii) of the 

FD&C Act). 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 Mr. 

Rowan, 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 Mr. 

Rowan 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 (21 

U.S.C. 335b(a)(7))). In addition, FDA 

will not accept or review any 

abbreviated new drug application from 

Mr. Rowan during his period of 

debarment, other than in connection 

with an audit under section 306 of the 

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

FD&C Act). Note that, for purposes of 

section 306 of the FD&C Act, a ‘‘drug 

product’’ is defined as a drug subject to 

regulation under section 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) (see section 201(dd) of the FD&C 

Act (21 U.S.C. 321(dd))). 

Any application by Mr. Rowan for 

special termination of debarment under 

section 306(d)(4) of the FD&C Act 

should be identified with Docket No. 

FDA–2020–N–1412 and sent to the 

Dockets Management Staff (see 

ADDRESSES). The public availability of 

information in these submissions is 

governed by 21 CFR 10.20. 

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, 240–402–7500. 

Dated: December 28, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–29045 Filed 12–31–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1129] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; National 

Agriculture and Food Defense Strategy 

Survey 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection requirements for a voluntary 

survey for the Department of Health and 

Human Services (HHS), the U.S. 

Department of Agriculture (USDA), and 

the Department of Homeland Security 

(DHS), which will inform the FDA Food 

Safety Modernization Act (FSMA), 

National Agriculture and Food Defense 

Strategy (NAFDS) Report to Congress. 

The proposed survey will be used to 

determine what food defense activities, 

if any, State, local, territorial, and/or 

tribal (SLTT) agencies have completed 

to date. The information will be 

compared to the initial baseline data 

collected by State(s) in 2018. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 5, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before March 5, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of March 5, 2021. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Notices 105 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–N–1129 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; National 

Agriculture and Food Defense Strategy 

Survey.’’ Received comments, those 

filed in a timely manner (see 

ADDRESSES), will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

National Agriculture and Food Defense 

Strategy Survey 

OMB Control Number 0910–0855— 

Extension 

We are seeking OMB approval of the 

NAFDS under section 108 of FSMA. 

This is a voluntary survey of SLTT 

governments intended to gauge 

government activities in food and 

agriculture defense from intentional 

contamination and emerging threats. 

The collected information will be 

included in the mandatory NAFDS 

followup Report to Congress. The 

authority for us to collect the 

information derives from the 

Commissioner of Food and Drugs’ 

authority provided in section 

1003(d)(2)(c) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 

393(d)(2)(c)). 

Protecting the nation’s food and 

agriculture supply against intentional 

contamination and other emerging 

threats is an important responsibility 

shared by SLTT governments as well as 

private sector partners. On January 4, 

2011, the President signed into law 

FSMA. FSMA focuses on ensuring the 

safety of the U.S. food supply by 

shifting the efforts of Federal regulators 

from response to prevention and 

recognizes the importance of 

strengthening existing collaboration 

among all stakeholders to achieve 

common public health and security 

goals. FSMA identifies some key 

priorities for working with partners in 

areas such as reliance on Federal, State, 

and local agencies for inspections; 

improving foodborne illness 

surveillance; and leveraging and 

enhancing State and local food safety 

and defense capacities. Section 108 of 

FSMA (NAFDS) requires HHS and 

USDA, in coordination with DHS, to 

work together with State, local, 

106 Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Notices 

territorial, and tribal governments to 

monitor and measure progress in food 

defense. 

In 2015, the initial NAFDS Report to 

Congress detailed the specific Federal 

response to food and agriculture defense 

goals, objectives, key initiatives, and 

activities that HHS, USDA, DHS, and 

other stakeholders planned to 

accomplish to meet the objectives 

outlined in FSMA. The NAFDS charts a 

direction for how Federal Agencies, in 

cooperation with SLTT governments 

and private sector partners, protect the 

nation’s food supply against intentional 

contamination. Not later than 4 years 

after the initial NAFDS Report to 

Congress (2015), and every 4 years 

thereafter (i.e., 2019, 2023, 2027, etc.), 

HHS, USDA, and DHS are required to 

revise and submit an updated report to 

the relevant committees of Congress. 

FDA is the Agency primarily 

responsible for obtaining the 

information from Federal and SLTT 

partners to complete the NAFDS Report 

to Congress. An interagency working 

group will conduct the survey and 

collect and update the NAFDS as 

directed by FSMA, including 

developing metrics and measuring 

progress for the evaluation process. 

The survey of Federal and State 

partners will be used to determine what 

food defense activities, if any, Federal 

and/or SLTT agencies have completed 

(or are planning on completing) from 

2021 to 2025. Planning for the local, 

territorial, and tribal information 

collections will commence during this 

period of renewal. The survey will 

continue to be repeated approximately 

every 2 to 4 years, as described in 

section 108 of FSMA. The NAFDS 

survey is being administered for the 

purpose of monitoring progress in food 

and agricultural defense by government 

agencies. 

A purposive sampling strategy is 

employed, such that the government 

agencies participating in food and 

agricultural defense are asked to 

respond to the voluntary survey. Food 

defense leaders responsible for 

conducting food defense activities 

during a food emergency for their 

jurisdiction are identified and will 

receive an emailed invitation to 

complete the survey online; they will be 

provided with a web link to the survey. 

The survey will be conducted 

electronically on the FDA.gov web 

portal, and results will be analyzed by 

the interagency working group. 

Description of Respondents: 

Respondents to this collection are SLTT 

government representatives (survey 

respondents) who are food defense 

leaders responsible for conducting food 

defense activities during a food 

emergency for their jurisdictions. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

SLTT Surveys .......................................... 500 1 500 0.33 (20 minutes) ...... 165 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The FDA Office of Partnerships 

reviewed the questionnaire and 

provided the estimate of time to 

complete the survey. The total burden is 

based on our previous experiences 

conducting surveys. The burden has 

been revised to reflect the total number 

of states and possible number of local, 

tribal, and territorial entities that may 

partake of the survey. Based on a review 

of the information collection since our 

last request for OMB approval, we have 

increased our burden estimate by 149 

hours (from 16.17 to 165 hours) and 451 

respondents (from 49 to 500 

respondents). 

Dated: December 29, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–29082 Filed 12–31–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2020–D–1825 and FDA– 

2020–D–1138] 

Guidance Documents Related to 

Coronavirus Disease 2019; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of FDA 

guidance documents related to the 

Coronavirus Disease 2019 (COVID–19) 

public health emergency (PHE). This 

notice of availability (NOA) is pursuant 

to the process that FDA announced, in 

the Federal Register of March 25, 2020, 

for making available to the public 

COVID–19-related guidances. The 

guidances identified in this notice 

address issues related to the COVID–19 

PHE and have been issued in 

accordance with the process announced 

in the March 25, 2020, notice. The 

guidances have been implemented 

without prior comment, but they remain 

subject to comment in accordance with 

the Agency’s good guidance practices. 

DATES: The announcement of the 

guidances is published in the Federal 

Register on January 4, 2021. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov.