49634 Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Notices 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. All electronic and 

written submissions submitted to the 

Docket (see the ADDRESSES section) on 

or before November 3, 2017, will be 

provided to the committee. Oral 

presentations from the public will be 

scheduled between approximately 9:35 

a.m. and 9:45 a.m., 10:55 a.m. and 11:05 

a.m., 12 noon and 12:10 p.m., 2:05 p.m. 

and 2:15 p.m., 3:25 p.m. and 3:35 p.m., 

and 4:30 p.m. and 4:40 p.m. on 

November 20, 2017, and between 

approximately 9:40 a.m. and 9:50 a.m. 

and 11:10 a.m. and 11:20 a.m. on 

November 21, 2017. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before October 

26, 2017. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by October 27, 2017. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Cindy Chee at 

least 7 days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: October 20, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–23223 Filed 10–25–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0961] 

Matthew Schroeder; Denial of Hearing; 

Final Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is denying 

Matthew Schroeder’s (Schroeder’s) 

request for a hearing and is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) 

permanently debarring Schroeder 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 Schroeder 

was convicted of a felony under Federal 

law for conduct relating to the 

regulation of a drug product under the 

FD&C Act. Schroeder failed to file with 

the Agency information and analyses 

sufficient to create a basis for a hearing 

concerning this action. 

DATES: This order is applicable October 

26, 2017. 

ADDRESSES: Any application by 

Schroeder for special termination of 

debarment under section 306(d) of the 

FD&C Act (application) may be 

submitted as follows: 

Electronic Submissions 

• Federal eRulemaking Portal: 

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

instructions for submitting comments. 

An application submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

application will be made public, you are 

solely responsible for ensuring that your 

application 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 

application, that information will be 

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

• If you want to submit an 

application with confidential 

information that you do not wish to be 

made available to the public, submit the 

application 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 a written/paper application 

submitted to the Dockets Management 

Staff, FDA will post your application, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: Your application must 

include the Docket No. FDA–2013–N– 

0961. An application will be placed in 

the docket and, unless 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. 

• Confidential Submissions—To 

submit an application with confidential 

information that you do not wish to be 

made publicly available, submit your 

application 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 your application. 

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 application 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.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket, 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 between 9 a.m. 


ethrower on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 82, No. 206 / Thursday, October 26, 2017 / Notices 49635 

and 4 p.m., Monday through Friday. 

Publicly available submissions may be 

seen in the docket. 

FOR FURTHER INFORMATION CONTACT: Julie 

Finegan, Office of Scientific Integrity, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 1, Rm. 

4218, Silver Spring, Maryland 20993, 

301–796–8618. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On October 11, 2012, the U.S. District 

Court for the Northern District of 

Georgia entered a criminal judgment 

against Matthew Schroeder under his 

guilty plea. Schroeder pled guilty to a 

felony under the FD&C Act, namely 

aiding and abetting, with the intent to 

defraud or mislead, in the dispensing of 

phenazepam without a prescription, 

resulting in the phenazapam being 

misbranded while held for sale after 

shipment in interstate commerce in 

violation of sections 301(k), 503(b)(1), 

303(a)(2) of the FD&C Act (21 U.S.C. 

331(k), 353(b)(1) and 333(a)(2)) and 18 

U.S.C. 2. Specifically, Schroeder, 

through his company, Novel Research 

Supply, and eBay ID, 

‘‘finemineralsfossilssio2’’ sold 

phenazepam and 

methylenedioxypyrovalerone. Both are 

unapproved drugs and are used by drug 

users for recreational purposes. 

According to FDA’s September 24, 2014, 

letter to Schroeder, in August 2010, 

Kevin Lewis purchased phenazepam on 

eBay from ‘‘finemineralsfossilssio2’’ and 

later died after ingesting phenazepam 

through an injection. 

Schroeder is subject to debarment 

based on a finding, under section 

306(a)(2) of the FD&C Act (21 U.S.C. 

335a(a)(2)), that he was convicted of a 

felony under Federal law for conduct 

relating to the regulation of a drug 

product under the FD&C Act. By the 

letter dated September 24, 2014, FDA 

notified Schroeder of a proposal to 

permanently debar him from providing 

services in any capacity to a person 

having an approved or pending drug 

product application. Schroeder 

requested a hearing on the proposal and 

special termination of debarment. 

Schroeder acknowledges his conviction 

under Federal law, but argues that 

multiple mitigating factors merit a 

hearing or special termination of 

debarment. 

Under the authority delegated to him 

by the Commissioner of Food and 

Drugs, the Director of the Office of 

Scientific Integrity (OSI) has considered 

Schroeder’s request for a hearing. 

Hearings will not be granted on issues 

of policy or law, on mere allegations, 

denials, or general descriptions of 

positions and contentions, or on data 

and information insufficient to justify 

the factual determination urged (see 21 

CFR 21.24(b)). 

The Director of OSI considered 

Schroeder’s arguments and concludes 

that they are unpersuasive and fail to 

raise a genuine issue of fact requiring a 

hearing. 

II. Arguments 

In his request for hearing, Schroeder 

first argues that he took voluntary steps 

to mitigate the dangers posed by the 

drugs by putting warnings against 

human consumption on the sales 

packaging and Web site. Schroeder 

states that he discontinued drug sales 

after an FDA investigator contacted him 

and that he fully disclosed all of his 

wrongdoing. Schroeder next argues that 

he cooperated with investigations and 

provided testimony against the drug 

suppliers. Third, Schroeder argues that 

he ended all his activities concerning 

drug sales and has not violated the 

FD&C Act since September 2010. He 

also states that his phenazepam sales 

only spanned two months. Fourth, 

Schroeder addresses Kevin Lewis’ death 

and purchases. Schroeder states that in 

the case against another drug supplier, 

the prosecutor determined that Kevin 

Lewis died from long-term IV drug use, 

rather than the phenazepam purchased 

from Schroeder’s eBay account. 

Schroeder also clarifies that Kevin 

Lewis purchased the phenazepam by 

using his mother’s eBay account. 

Finally, Schroeder alleges that he does 

not pose a recidivism risk. 

Section 306(a)(2) of the FD&C Act 

provides FDA with the authority to 

debar an individual who has been 

convicted of certain Federal felonies. 

The only relevant factual issue is 

whether Schroeder was actually 

convicted of a felony under Federal law 

for conduct relating to the development 

or approval of a drug product or 

otherwise relating to the regulation of a 

drug product under the FD&C Act. 

Schroeder does not dispute that he pled 

guilty to a felony under the FD&C Act, 

specifically aiding and abetting, with 

the intent to defraud and mislead, in the 

dispensing of phenazepam without a 

prescription, resulting in the 

phenazepam being misbranded while 

held for sale after shipment in interstate 

commerce. Accordingly, Schroeder’s 

arguments fail to raise a genuine and 

substantial issue of fact as to whether he 

was convicted of a felony under Federal 

law for conduct relating to the 

regulation of a drug product under the 

FD&C Act. 

Along with his request for a hearing, 

Schroeder also requested a special 

termination of debarment. Under 

section 306(d), a debarred individual 

may apply for special termination of 

debarment. While the debarment period 

can be limited to less than permanent, 

the individual must be debarred for at 

least 1 year. Schroeder is not yet 

debarred, so his request for special 

termination of debarment is not 

appropriate for consideration at this 

time. 

III. Findings and Order 

Therefore, the Director of OSI, under 

section 306(a)(2) of the FD&C Act and 

under the authority delegated to him, 

finds that Matthew Schroeder has been 

convicted of a felony under Federal law 

for conduct relating to the regulation of 

a drug product under the FD&C Act. 

As a result of the foregoing findings, 

Matthew Schroeder is permanently 

debarred from providing services in any 

capacity to a person with an approved 

or pending drug product application 

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), 

effective (see DATES) (21 U.S.C. 

335a(c)(1)(B) and (c)(2)(A)(ii) and 21 

U.S.C. 321(dd)). Any person with an 

approved or pending drug product 

application who knowingly uses the 

services of Schroeder, in any capacity 

during his period of debarment, will be 

subject to civil money penalties. See 

section 307(a)(6) of the FD&C Act (21 

U.S.C. 335b(a)(6)). If Schroeder, during 

his period of debarment, provides 

services in any capacity to a person with 

an approved or pending drug product 

application, he will be subject to civil 

money penalties. See 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 

applications submitted by or with the 

assistance of Schroeder during his 

period of debarment. 

Dated: October 20, 2017. 

G. Matthew Warren, 

Director, Office of Scientific Integrity. 

[FR Doc. 2017–23275 Filed 10–25–17; 8:45 am] 

BILLING CODE 4164–01–P 


ethrower on DSK3G9T082PROD with NOTICES