Federal Register / Vol. 87, No. 20 / Monday, January 31, 2022 / Notices 4941 

denial. Careless or negligent handling of 

controlled substances creates the 

opportunity for diversion and [can] 

justify the revocation of an existing 

registration . . .’’ Bobby D. Reynolds, 

N.P., Tina L. Killebrew, N.P., & David R. 

Stout, N.P., 80 FR 28643, 28662 (2015) 

(quoting Paul J. Caragine, Jr. 63 FR 

51592, 51601 (1998). In fact, the Agency 

has found in favor of revocation in cases 

where registrants have failed to 

document their prescribing decisions— 

a violation which has been clearly 

established in this case. The Agency has 

repeatedly emphasized that 

‘‘[c]onscientious documentation is . . . 

not just a ministerial act, but a key 

treatment tool and vital indicator to 

evaluate whether the physician’s 

prescribing practices are within the 

usual course of professional practice.’’ 

Cynthia M. Cadet, M.D., 76 FR 19,450, 

19,464 (2011) (internal citation and 

quotation omitted); see also Kaniz F. 

Khan-Jaffery, M.D., 85 FR 45,667, 45,686 

(2020) (‘‘DEA’s ability to assess whether 

controlled substances registrations are 

consistent with the public interest is 

predicated upon the ability to consider 

the evidence and rationale of the 

practitioner at the time that she 

prescribed a controlled substance— 

adequate documentation is critical to 

that assessment.’’). 

The case at hand demonstrates 

prescribing beneath the applicable 

standard of care and outside the usual 

course of professional practice in 

California to multiple patients over the 

course of many years. I agree with the 

Chief ALJ that this conduct was 

egregious and I agree with his rationale 

for sanction. As stated above, for many 

reasons, I cannot find that I can entrust 

Respondent with a registration. 

Accordingly, I reject Respondent’s 

Exceptions and affirm the RD’s 

conclusion that Respondent’s 

registration should be revoked. 

Order 

Pursuant to 28 CFR 0.100(b) and the 

authority vested in me by 21 U.S.C. 

824(a)(4) and 21 U.S.C. 823(f), I hereby 

revoke DEA Certificate of Registration 

No. BC1317165 issued to Bradley H. 

Chesler, M.D. Pursuant to 28 CFR 

0.100(b) and the authority vested in me 

by 21 U.S.C. 824(a) and 21 U.S.C. 823(f), 

I further hereby deny any pending 

application of Bradley H. Chesler, M.D., 

to renew or modify this registration, as 

well as any other pending application of 

Bradley H. Chesler, M.D. for registration 

in California. This Order is effective 

March 2, 2022. 

Anne Milgram, 

Administrator. 

[FR Doc. 2022–01838 Filed 1–28–22; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–947] 

Bulk Manufacturer of Controlled 

Substances Application: Siegfried 

USA, LLC 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Siegfried USA, LLC. has 

applied to be registered as a bulk 

manufacturer of basic class(es) of 

controlled substance(s). Refer to 

Supplementary Information listed below 

for further drug information. 

DATES: Registered bulk manufacturers of 

the affected basic class(es), and 

applicants therefore, may file written 

comments on or objections to the 

issuance of the proposed registration on 

or before April 1, 2022 Such persons 

may also file a written request for a 

hearing on the application on or before 

April 1, 2022. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.33(a), this 

is notice that on December 8, 2021, 

Siegfried USA, LLC., 33 Industrial Park 

Road, Pennsville, New Jersey 08070– 

3244, applied to be registered as a bulk 

manufacturer of the following basic 

class(es) of controlled substance(s): 

Controlled substance Drug 

code Schedule 

Gamma Hydroxybutyric Acid .. 2010 I 

Dihydromorphine ..................... 9145 I 

Hydromorphinol ....................... 9301 I 

Amphetamine .......................... 1100 II 

Lisdexamfetamine ................... 1205 II 

Methylphenidate ...................... 1724 II 

Amobarbital ............................. 2125 II 

Pentobarbital ........................... 2270 II 

Secobarbital ............................ 2315 II 

Phenylacetone ........................ 8501 II 

Codeine ................................... 9050 II 

Oxycodone .............................. 9143 II 

Hydromorphone ...................... 9150 II 

Hydrocodone ........................... 9193 II 

Methadone .............................. 9250 II 

Methadone intermediate ......... 9254 II 

Morphine ................................. 9300 II 

Oripavine ................................. 9330 II 

Controlled substance Drug 

code Schedule 

Thebaine ................................. 9333 II 

Opium tincture ........................ 9630 II 

Oxymorphone ......................... 9652 II 

Tapentadol .............................. 9780 II 

The company plans to manufacture 

the above-listed controlled substance in 

bulk for development of a new active 

pharmaceutical ingredient (API) and 

validation for a Drug Master File 

submission to the Food and Drug 

Administration. No other activity for 

this drug code is authorized for this 

registration. 

Brian S. Besser, 

Acting Assistant Administrator. 

[FR Doc. 2022–01816 Filed 1–28–22; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 22–4] 

Austin J. Kosier, M.D.; Decision and 

Order 

On September 30, 2021, the Acting 

Assistant Administrator, Diversion 

Control Division, Drug Enforcement 

Administration (hereinafter, DEA or 

Government), issued an Order to Show 

Cause (hereinafter, OSC) to Austin J. 

Kosier, M.D. (hereinafter, Respondent) 

of Zanesville, Ohio. OSC, at 1 and 3. 

The OSC proposed the revocation of 

Respondent’s Certificate of Registration 

No. FK6714504. It alleged that 

Respondent ‘‘[does] not have authority 

to dispense or prescribe controlled 

substances in the [s]tate of Ohio, the 

state in which [Respondent is] 

registered with DEA.’’ Id. at 1 (citing 21 

U.S.C. 824(a)(3)). 

Specifically, the OSC alleged that on 

or about May 12, 2021, the State 

Medical Board of Ohio issued an Order 

suspending Respondent’s state license 

to practice medicine and surgery. Id. at 

2. The Order was effective immediately 

and ordered that Respondent 

‘‘immediately cease the practice of 

medicine and surgery in Ohio.’’ Id. 

The OSC notified Respondent of the 

right to request a hearing on the 

allegations or to submit a written 

statement, while waiving the right to a 

hearing, the procedures for electing each 

option, and the consequences for failing 

to elect either option. Id. at 2 (citing 21 

CFR 1301.43). The OSC also notified 

Respondent of the opportunity to 

submit a corrective action plan. Id. at 3 

(citing 21 U.S.C. 824(c)(2)(C)). 


khammond on DSKJM1Z7X2PROD with NOTICES