76084 Federal Register / Vol. 85, No. 229 / Friday, November 27, 2020 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1347] 

Michael L. Babich: 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 Michael L. 

Babich 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 Mr. Babich was convicted 

of a felony under Federal law for 

conduct that relates to the regulation of 

a drug product under the FD&C Act. Mr. 

Babich was given notice of the proposed 

permanent debarment and an 

opportunity to request a hearing to show 

why he should not be debarred. As of 

September 2, 2020 (30 days after receipt 

of the notice), Mr. Babich had not 

responded. Mr. Babich’s failure to 

respond and request a hearing 

constitutes a waiver of his right to a 

hearing concerning this action. 

DATES: This order is applicable 

November 27, 2020. 

ADDRESSES: Submit applications for 

special termination of debarment to 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852, 240–402–7500, or at 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Jaime Espinosa, 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, or at 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 22, 2020, Mr. Babich 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 his plea of guilty, to one count of 

conspiracy in violation of 18 U.S.C. 371 

and one count of wire fraud in violation 

of 18 U.S.C. 1341. 

The factual basis for this conviction is 

as follows: Mr. Babich was the President 

and Chief Executive Officer of Insys 

Therapeutics, Inc. (Insys), a Delaware 

Corporation, with headquarters in 

Chandler, Arizona. Insys developed and 

owned a drug called SUBSYS, a liquid 

formulation of fentanyl to be applied 

under the tongue. FDA approved 

SUBSYS for the management of 

breakthrough pain in adult cancer 

patients who are already receiving and 

are already tolerant to opioid therapy for 

their underlying persistent cancer pain. 

From May 2012 and continuing until 

December 2015, Mr. Babich conspired 

with other employees of Insys to bribe 

and provide kickbacks, often mailed 

through the U.S. Postal service, to 

medical practitioners in various states to 

get those practitioners to increase 

prescribing SUBSYS to their patients, 

many of whom did not have cancer. The 

bribes and kickbacks took various forms, 

including honoraria for the 

practitioners’ participation in 

educational events and payment of the 

practitioner’s staff salaries. To further 

this conspiracy, Mr. Babich along with 

his co-conspirators devised a scheme 

whereby Insys executives conspired to 

mislead and defraud health insurance 

providers to ensure those providers 

approved payment for SUBSYS when it 

was prescribed for non-cancer patients. 

As a result of this conviction FDA 

sent Mr. Babich, by certified mail on 

July 16, 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. 

Babich 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. 

Babich 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. 

Babich received the proposal on August 

3, 2020. Mr. Babich 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. Babich 

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. Babich 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. 

Babich, 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. 

Babich 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 application 

from Mr. Babich 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, 382) or under section 351 of the 

Public Health Service Act (42 U.S.C. 

262) (section 201(dd) of the FD&C Act 

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

Any application by Mr. Babich for 

special termination of debarment under 

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

should be identified with Docket No. 

FDA–2020–N–1347 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. 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 85, No. 229 / Friday, November 27, 2020 / Notices 76085 

Dated: November 23, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–26226 Filed 11–25–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–4437] 

In-Use Stability Studies and 

Associated Labeling Statements for 

Multiple-Dose Injectable Animal Drug 

Products; Guidance for Industry; 

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 a final 

guidance for industry (GFI) #242 

entitled ‘‘In-Use Stability Studies and 

Associated Labeling Statements for 

Multiple-Dose Injectable Animal Drug 

Products.’’ The purpose of in-use 

stability testing is to establish a period 

of time during which a multiple-dose 

drug product may be used while 

retaining acceptable quality 

specifications once the container is 

opened (e.g., after a container has been 

needle-punctured). This guidance 

reflects the Agency’s current thinking 

on how to formulate in-use statements, 

as well as how to design and carry out 

in-use stability studies to support these 

in-use statements, for multiple-dose 

injectable drug products intended for 

use in animals. This current thinking 

pertains to both generic drug products 

and pioneer drug products regardless of 

whether the pioneer reference listed 

new animal drug (RLNAD) currently has 

an in-use statement on the labeling. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on November 27, 2020. 

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. 

• 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– 

2016–D–4437 for ‘‘In-Use Stability 

Studies and Associated Labeling 

Statements for Multiple-Dose Injectable 

Animal Drug Products.’’ Received 

comments 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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to the Policy and 

Regulations Staff (HFV–6), Center for 

Veterinary Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Kevin Rice, Center for Veterinary 

Medicine (HFV–140), Food and Drug 

Administration, 7500 Standish Place, 

Rockville, MD 20855, 240–402–0680, 

kevin.rice@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of January 4, 

2017 (82 FR 851), FDA published the 

notice of availability for a draft GFI #242 

entitled ‘‘In-Use Stability Studies and 

Associated Labeling Statements for 

Multiple-Dose Injectable Animal Drug 

Products.’’ The purpose of in-use 

stability testing is to establish a period 

of time during which a multiple-dose 

drug product may be used while 

retaining acceptable quality 

specifications once the container is 

opened (e.g., after a container has been 

needle-punctured). 

FDA received two comments on the 

draft guidance and those comments 

were considered as the guidance was 


jbell on DSKJLSW7X2PROD with NOTICES