Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices 42117 

form and to aid in the enforcement of 

environmental laws. 

5. An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: An estimated 680 respondents 

will utilize the form, and it will take 

each respondent approximately 30 

minutes to complete the form. 

6. An estimate of the total public 

burden (in hours) associated with the 

collection: The estimated annual public 

burden associated with this collection is 

340 hours, which is equal to 680 (the 

total number of respondents) * .5 (30 

minutes). 

If additional information is required 

contact: Melody Braswell, Department 

Clearance Officer, United States 

Department of Justice, Justice 

Management Division, Policy and 

Planning Staff, Two Constitution 

Square, 145 N Street NE., 3E.405A, 

Washington, DC 20530. 

Melody Braswell, 

Department Clearance Officer for PRA, U.S. 

Department of Justice. 

[FR Doc. 2017–18841 Filed 9–5–17; 8:45 am] 

BILLING CODE 4410–FY–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–392] 

Importer of Controlled Substances 

Application: Siegfried USA, LLC 

ACTION: Notice of application. 

DATES: Registered bulk manufacturers of 

the affected basic classes, and 

applicants therefore, may file written 

comments on or objections to the 

issuance of the proposed registration in 

accordance with 21 CFR 1301.34(a) on 

or before October 6, 2017. Such persons 

may also file a written request for a 

hearing on the application pursuant to 

21 CFR 1301.43 on or before October 6, 

2017. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DRW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. All requests for hearing must be 

sent to: Drug Enforcement 

Administration, Attn: Administrator, 

8701 Morrissette Drive, Springfield, 

Virginia 22152. All requests for hearing 

should also be sent to: (1) Drug 

Enforcement Administration, Attn: 

Hearing Clerk/LJ, 8701 Morrissette 

Drive, Springfield, Virginia 22152; and 

(2) Drug Enforcement Administration, 

Attn: DEA Federal Register 

Representative/DRW, 8701 Morrissette 

Drive, Springfield, Virginia 22152. 

Comments and requests for hearings on 

applications to import narcotic raw 

material are not appropriate. 72 FR 3417 

(January 25, 2007). 

SUPPLEMENTARY INFORMATION: The 

Attorney General has delegated his 

authority under the Controlled 

Substances Act to the Administrator of 

the Drug Enforcement Administration 

(DEA), 28 CFR 0.100(b). Authority to 

exercise all necessary functions with 

respect to the promulgation and 

implementation of 21 CFR part 1301, 

incident to the registration of 

manufacturers, distributors, dispensers, 

importers, and exporters of controlled 

substances (other than final orders in 

connection with suspension, denial, or 

revocation of registration) has been 

redelegated to the Assistant 

Administrator of the DEA Diversion 

Control Division (‘‘Assistant 

Administrator’’) pursuant to section 7 of 

28 CFR part 0, appendix to subpart R. 

In accordance with 21 CFR 

1301.34(a), this is notice that on 

November 23, 2016, Siegfried USA, 

LLC, 33 Industrial Park Road, 

Pennsville, New Jersey 08070 applied to 

be registered as an importer of the 

following basic classes of controlled 

substances: 

Controlled substance Drug 

code Schedule 

Opium, raw ............................. 9600 II 

Poppy Straw Concentrate ....... 9670 II 

The company plans to import the 

listed controlled substances to 

manufacture bulk active 

pharmaceuticals ingredients (API) for 

distribution to its customers. 

Dated: August 28, 2017. 

Demetra Ashley, 

Acting Assistant Administrator. 

[FR Doc. 2017–18802 Filed 9–5–17; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–392] 

Importer of Controlled Substances 

Application: Akorn, Inc. 

ACTION: Notice of application. 

DATES: Registered bulk manufacturers of 

the affected basic classes, and 

applicants therefore, may file written 

comments on or objections on or before 

November 6, 2017. Such persons may 

also file a written request for a hearing 

on the application on or before October 

6, 2017. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DRW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. All requests for hearing must be 

sent to: Drug Enforcement 

Administration, Attn: Administrator, 

8701 Morrissette Drive, Springfield, 

Virginia 22152. All requests for hearing 

should also be sent to: (1) Drug 

Enforcement Administration, Attn: 

Hearing Clerk/LJ, 8701 Morrissette 

Drive, Springfield, Virginia 22152; and 

(2) Drug Enforcement Administration, 

Attn: DEA Federal Register 

Representative/DRW, 8701 Morrissette 

Drive, Springfield, Virginia 22152. 

SUPPLEMENTARY INFORMATION: The 

Attorney General has delegated his 

authority under the Controlled 

Substances Act to the Administrator of 

the Drug Enforcement Administration 

(DEA), 28 CFR 0.100(b). Authority to 

exercise all necessary functions with 

respect to the promulgation and 

implementation of 21 CFR part 1301, 

incident to the registration of 

manufacturers, distributors, dispensers, 

importers, and exporters of controlled 

substances (other than final orders in 

connection with suspension, denial, or 

revocation of registration) has been 

redelegated to the Assistant 

Administrator of the DEA Diversion 

Control Division (‘‘Assistant 

Administrator’’) pursuant to section 7 of 

28 CFR part 0, appendix to subpart R. 

In accordance with 21 CFR 

1301.34(a), this is notice that on May 26, 

2017, Akorn, Inc., 1222 W. Grand 

Avenue, Decatur, Illinois 62522 applied 

to be registered as an importer of 

remifentanil (9739), a basic class of 

controlled substance listed in schedule 

II. 

The company plans to import 

remifentanil in dosage form for 

distribution. 

Dated: August 28, 2017. 

Demetra Ashley, 

Acting Assistant Administrator. 

[FR Doc. 2017–18803 Filed 9–5–17; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Marcus W. Anderson, M.D.; Decision 

and Order 

On May 12, 2017, the Assistant 

Administrator, Diversion Control 

Division, Drug Enforcement 

Administration (DEA), issued an Order 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
42118 Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices 

1Although neither the DI’s affidavit nor the 

Request for Final Agency Action set forth the basis 

for the statement that this is the Registrant’s ‘‘last 

known address,’’ the record does show that the 

Florida Board of Medicine and Florida’s Assistant 

General Counsel for the Florida Department of 

Health both served Registrant at the 206 27th 

Avenue South, Myrtle Beach, South Carolina 

address. E.g., GX 3, at 6, 10. In addition, Florida’s 

administrative complaint also states that 

‘‘Respondent’s last known address is 206 27th 

Avenue South, Myrtle Beach, South Carolina.’’ Id. 

at 18. 

2The DI states in his Affidavit that he mailed the 

Show Cause Order on ‘‘May 19, 2016.’’ GX 4, at 2. 

Given that the Show Cause Order was not issued 

until May 12, 2017, I find that this was a 

typographic error, and that the DI intended to state 

that he mailed the Show Cause Order on May 19, 

2017. 

3The DI stated in his affidavit that ‘‘I accessed the 

USPS Web site at www.ups.com.’’ GX 4, at 2. 

Although ‘‘UPS’’ is a known acronym for another 

delivery service, United Parcel Service, I find that 

this too was a typographic error, and that the DI had 

intended to state that he accessed the USPS Web 

site at www.usps.com. For these reasons, I also find 

that such service was done by mail and not by 

personal service. In addition, as the DI states that 

he had checked the USPS Web site on ‘‘May 30, 

2017,’’ I find that his statement in the affidavit that 

the Web site indicated that the package had been 

delivered on ‘‘May 22, 2016,’’ id., was a 

typographical error and that the DI intended to state 

that the Web site indicated delivery on May 22, 

2017. 

4 In accordance with the Administrative 

Procedure Act (APA), an agency ‘‘may take official 

notice of facts at any stage in a proceeding-even in 

the final decision.’’ U.S. Dept. of Justice, Attorney 

General’s Manual on the Administrative Procedure 

Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 

1979). In accordance with the APA and DEA’s 

regulations, Registrant is ‘‘entitled on timely request 

to an opportunity to show to the contrary.’’ 5 U.S.C. 

556(e); see also 21 CFR 1316.59(e). To allow 

Registrant the opportunity to refute the facts of 

which I take official notice, Registrant may file a 

motion for reconsideration within 15 calendar days 

of the date of service of this Order which shall 

commence on the date this Order is mailed. 

to Show Cause to Marcus W. Anderson, 

M.D. (Registrant), of Saint Augustine, 

Florida. The Show Cause Order 

proposed the revocation of Registrant’s 

Certificate of Registration on the ground 

that he lacks ‘‘authority to handle 

controlled substances in the State of 

Florida, the State in which he is 

registered with the DEA.’’ Order to 

Show Cause, Government Exhibit (GX) 

1, at 1 (citing 21 U.S.C. 823(f), 

824(a)(3)). 

With respect to the Agency’s 

jurisdiction, the Show Cause Order 

alleged that Registrant is registered as a 

practitioner in schedules II through V, 

pursuant to DEA Certificate of 

Registration FA3645213, at the address 

of 300 Health Park Boulevard, Suite 

1004, Saint Augustine, Florida. Id. The 

Order also alleged that this registration 

does not expire until June 30, 2018. Id. 

As substantive grounds for the 

proceeding, the Show Cause Order 

alleged that Registrant’s ‘‘authority to 

prescribe and administer controlled 

substances in the State of Florida was 

suspended effective November 28, 

2016.’’ Id. As a result of the alleged 

suspension, the Order alleged that 

Registrant lacks ‘‘authority to handle 

controlled substances in the State of 

Florida.’’ Id. Thus, based on his lack of 

authority to dispense controlled 

substances in Florida, the Order 

asserted that ‘‘the DEA must revoke’’ his 

registration. Id. (citing 21 U.S.C. 

802(21), 823(f)(1), 824(a)(3)). 

The Show Cause Order notified 

Registrant of his right to request a 

hearing on the allegations or to submit 

a written statement in lieu of a hearing, 

the procedure for electing either option, 

and the consequence for failing to elect 

either option. Id. at 2 (citing 21 CFR 

1301.43). The Show Cause Order also 

notified Registrant of his right to submit 

a corrective action plan. Id. at 2–3 

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

The Government states that on May 

22, 2017, ‘‘DEA personally served a 

copy of the Order to Show Cause on 

[Registrant] at 206 27th Avenue South, 

Myrtle Beach, South Carolina.’’ 

Government Request for Final Agency 

Action (RFFA), at 2 (citing GX 4). 

Specifically, a DEA Diversion 

Investigator (DI) from the DEA’s 

Jacksonville, Florida, District Office 

states in a sworn affidavit that he mailed 

the Show Cause Order to Registrant’’ via 

United States Postal Service (‘‘USPS’’) 

Certified Mail’’ and ‘‘addressed the 

envelope to his last known address 1 at 

206 27th Avenue South, Myrtle Beach, 

South Carolina.’’ GX 4 at 2.2 ‘‘On or 

about May 30, 2017,’’ the DI ‘‘accessed 

the USPS Web site,’’ ‘‘entered the 

tracking number of the certified mail’’ 

that he had sent to the Myrtle Beach 

address, and stated that ‘‘[t]he Web site 

indicated that the package had been 

delivered on May 22, 201[7].’’ Id.3

On June 28, 2017, the Government 

forwarded its Request for Final Agency 

Action and an evidentiary record to my 

Office. Therein, the Government 

represents that it has received neither a 

hearing request nor ‘‘any other reply 

from’’ Registrant regarding the Show 

Cause Order. RFFA, at 2. Based on the 

Government’s representation and the 

record, I find that more than 30 days 

have passed since the Order to Show 

Cause was served on Registrant, and he 

has neither requested a hearing nor 

submitted a written statement in lieu of 

a hearing. See 21 CFR 1301.43(d). 

Accordingly, I find that Registrant has 

waived his right to a hearing or to 

submit a written statement and issue 

this Decision and Order based on 

relevant evidence submitted by the 

Government. I make the following 

findings. 

Findings of Fact 

Registrant is a physician who is 

registered as a practitioner in schedules 

II–V pursuant to Certificate of 

Registration FA3645213, at the address 

of 300 Health Park Boulevard, Suite 

1004, Saint Augustine, Florida. GX 2. 

The registration does not expire until 

June 30, 2018. Id. 

On November 22, 2016, the Board of 

Medicine for the State of Florida issued 

a ‘‘Final Order’’ stating that Registrant’s 

‘‘license to practice medicine in the 

State of Florida is hereby SUSPENDED 

until such time as he demonstrates the 

ability to practice medicine with 

reasonable skill and safety.’’ GX 3, at 4– 

5. The Order also stated that it would 

take effect upon being filed with the 

Clerk of the Florida Department of 

Health, which occurred on November 

28, 2016. GX 3, at 3, 5. In light of the 

passage of time since the effective date 

of the Order, I have queried the Florida 

Department of Health Web site 

regarding the status of Registrant’s 

license, and I take official notice that 

Registrant’s Florida medical license 

remains suspended as of the date of this 

decision.4 Based on the above, I find 

that Registrant does not currently have 

authority under the laws of Florida to 

dispense controlled substances. 

Discussion 

Pursuant to 21 U.S.C. 824(a)(3), the 

Attorney General is authorized to 

suspend or revoke a registration issued 

under section 823 of Title 21, ‘‘upon a 

finding that the registrant . . . has had 

his State license . . . suspended [or] 

revoked . . . by competent State 

authority and is no longer authorized by 

State law to engage in the . . . 

dispensing of controlled substances.’’ 

With respect to a practitioner, DEA has 

long held that the possession of 

authority to dispense controlled 

substances under the laws of the State 

in which a practitioner engages in 

professional practice is a fundamental 

condition for obtaining and maintaining 

a registration. See, e.g., James L. Hooper, 

76 FR 71371 (2011), pet. for rev. denied, 

481 Fed. Appx. 826 (4th Cir. 2012); see 

also Frederick Marsh Blanton, 43 FR 

27616 (1978) (‘‘State authorization to 

dispense or otherwise handle controlled 

substances is a prerequisite to the 

issuance and maintenance of a Federal 

controlled substances registration.’’). 

This rule derives from the text of two 

provisions of the CSA. First, Congress 

defined ‘‘the term ‘practitioner’ [to] 

mean[ ] a . . . physician . . . or other 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 171 / Wednesday, September 6, 2017 / Notices 42119 

5For the same reasons that led the Florida Board 

of Medicine to summarily suspend Registrant’s 

medical license, I find that the public interest 

necessitates that this Order be effective 

immediately. 21 CFR 1316.67. 

person licensed, registered or otherwise 

permitted, by . . . the jurisdiction in 

which he practices . . . to distribute, 

dispense, [or] administer . . . a 

controlled substance in the course of 

professional practice.’’ 21 U.S.C. 

802(21). Second, in setting the 

requirements for obtaining a 

practitioner’s registration, Congress 

directed that ‘‘[t]he Attorney General 

shall register practitioners . . . if the 

applicant is authorized to dispense . . . 

controlled substances under the laws of 

the State in which [s]he practices.’’ 21 

U.S.C. 823(f). Because Congress has 

clearly mandated that a practitioner 

possess state authority in order to be 

deemed a practitioner under the Act, 

DEA has held repeatedly that revocation 

of a practitioner’s registration is the 

appropriate sanction whenever he is no 

longer authorized to dispense controlled 

substances under the laws of the State 

in which he engages in professional 

practice. See, e.g., Calvin Ramsey, 76 FR 

20034, 20036 (2011); Sheran Arden 

Yeates, M.D., 71 FR 39130, 39131 

(2006); Dominick A. Ricci, 58 FR 51104, 

51105 (1993); Bobby Watts, 53 FR 

11919, 11920 (1988); Blanton, 43 FR 

27616 (1978). 

Moreover, because ‘‘the controlling 

question’’ in a proceeding brought 

under 21 U.S.C. 824(a)(3) is whether the 

holder of a practitioner’s registration ‘‘is 

currently authorized to handle 

controlled substances in the [S]tate,’’ 

Hooper, 76 FR at 71371 (quoting Anne 

Lazar Thorn, 62 FR 12847, 12848 

(1997)), the Agency has also long held 

that revocation is warranted even where 

a practitioner has lost his state authority 

by virtue of the State’s use of summary 

process and the State has yet to provide 

a hearing to challenge the suspension. 

Bourne Pharmacy, 72 FR 18273, 18274 

(2007); Wingfield Drugs, 52 FR 27070, 

27071 (1987). Thus, it is of no 

consequence that the Florida State 

Board of Medical Examiners has 

employed summary process in 

suspending Registrant’s state medical 

license. What is consequential is that 

Registrant is no longer currently 

authorized to dispense controlled 

substances in Florida, the State in 

which he is registered. I will therefore 

order that his registration be revoked. 

Order 

Pursuant to the authority vested in me 

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

as 28 CFR 0.100(b), I order that DEA 

Certificate of Registration No. 

FA3645213, issued to Marcus W. 

Anderson, M.D., be, and it hereby is, 

revoked. I further order that any 

pending application of Marcus W. 

Anderson to renew or modify the above 

registration, or any pending application 

of Marcus W. Anderson for any other 

registration, be, and it hereby is, denied. 

This Order is effective immediately.5

Dated: August 28, 2017. 

Chuck Rosenberg, 

Acting Administrator. 

[FR Doc. 2017–18784 Filed 9–5–17; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–392] 

Bulk Manufacturer of Controlled 

Substances Application: Stepan 

Company 

ACTION: Notice of application. 

DATES: Registered bulk manufacturers of 

the affected basic classes, and 

applicants therefore, may file written 

comments on or objections to the 

issuance of the proposed registration in 

accordance with 21 CFR 1301.33(a) on 

or before November 6, 2017. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DRW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. 

SUPPLEMENTARY INFORMATION: The 

Attorney General has delegated his 

authority under the Controlled 

Substances Act to the Administrator of 

the Drug Enforcement Administration 

(DEA), 28 CFR 0.100(b). Authority to 

exercise all necessary functions with 

respect to the promulgation and 

implementation of 21 CFR part 1301, 

incident to the registration of 

manufacturers, distributors, dispensers, 

importers, and exporters of controlled 

substances (other than final orders in 

connection with suspension, denial, or 

revocation of registration) has been 

redelegated to the Assistant 

Administrator of the DEA Diversion 

Control Division (‘‘Assistant 

Administrator’’) pursuant to section 7 of 

28 CFR part 0, appendix to subpart R. 

In accordance with 21 CFR 

1301.33(a), this is notice that on January 

20, 2017, Stepan Company, Natural 

Products Dept., 100 W. Hunter Avenue, 

Maywood, New Jersey 07607 applied to 

be registered as a bulk manufacturer of 

the following basic classes of controlled 

substances: 

Controlled substance Drug 

code Schedule 

Cocaine ................................... 9041 II 

Ecgonine ................................. 9180 II 

The company plans to manufacture 

the listed controlled substances in bulk 

for distribution to its customers. 

Dated: August 28, 2017. 

Demetra Ashley, 

Acting Assistant Administrator. 

[FR Doc. 2017–18789 Filed 9–5–17; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–392] 

Importer of Controlled Substances 

Application: KVK–Tech, Inc. 

ACTION: Notice of application. 

DATES: Registered bulk manufacturers of 

the affected basic classes, and 

applicants therefore, may file written 

comments on or objections to the 

issuance of the proposed registration in 

accordance with 21 CFR 1301.34(a) on 

or before October 6, 2017. Such persons 

may also file a written request for a 

hearing on the application pursuant to 

21 CFR 1301.43 on or before October 6, 

2017. 

ADDRESSES: Written comments should 

be sent to: Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative/DRW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. All requests for hearing must be 

sent to: Drug Enforcement 

Administration, Attn: Administrator, 

8701 Morrissette Drive, Springfield, 

Virginia 22152. All request for hearing 

should also be sent to: (1) Drug 

Enforcement Administration, Attn: 

Hearing Clerk/LJ, 8701 Morrissette 

Drive, Springfield, Virginia 22152; and 

(2) Drug Enforcement Administration, 

Attn: DEA Federal Register 

Representative/DRW, 8701 Morrissette 

Drive, Springfield, Virginia 22152. 

SUPPLEMENTARY INFORMATION: The 

Attorney General has delegated his 

authority under the Controlled 

Substances Act to the Administrator of 

the Drug Enforcement Administration 

(DEA), 28 CFR 0.100(b). Authority to 

exercise all necessary functions with 

respect to the promulgation and 

implementation of 21 CFR part 1301, 

incident to the registration of 

manufacturers, distributors, dispensers, 

importers, and exporters of controlled 

substances (other than final orders in 

connection with suspension, denial, or 


asabaliauskas on DSKBBXCHB2PROD with NOTICES