Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices 51403 

Drug Schedule 

Tetrahydrocannabinols (7370) ..... I 

Methamphetamine (1105) ............ II 

Pentobarbital (2270) ..................... II 

Nabilone (7379) ............................ II 

With regard to Gamma 

Hydroxybutyric Acid (2010), 

Tetrahydrocannabinols (7370), and 

Methamphetamine (1105) only, the 

company manufactures these controlled 

substances in bulk solely for domestic 

distribution within the United States to 

customers engaged in dosage-form 

manufacturing. 

With regard to Nabilone (7379) only, 

the company presently manufactures a 

small amount of this controlled 

substance in bulk solely to conduct 

manufacturing process development 

within the company. It is the company’s 

intention that, when the manufacturing 

process is refined to the point that its 

Nabilone bulk product is available for 

commercial use, the company will 

export the controlled substance in bulk 

solely to customers engaged in dosageform manufacturing outside the United 

States. The company is aware of the 

requirement to obtain a DEA registration 

as an exporter to conduct this activity. 

No comments or objections have been 

received. DEA has considered the 

factors in 21 U.S.C. 823(a) and 

determined that the registration of 

Norac, Inc. to manufacture the listed 

basic classes of controlled substances is 

consistent with the public interest at 

this time. DEA has investigated Norac, 

Inc. to ensure that the company’s 

registration is consistent with the public 

interest. The investigation has included 

inspection and testing of the company’s 

physical security systems, verification 

of the company’s compliance with state 

and local laws, and a review of the 

company’s background and history. 

Therefore, pursuant to 21 U.S.C. 823(a), 

and in accordance with 21 CFR 1301.33, 

the above named company is granted 

registration as a bulk manufacturer of 

the basic classes of controlled 

substances listed. 

Dated: August 9, 2011. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration. 

[FR Doc. 2011–21073 Filed 8–17–11; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Manufacturer of Controlled 

Substances; Notice of Registration 

By Notice dated April 13, 2011, and 

published in the Federal Register on 

April 20, 2011, 76 FR 22146, Stepan 

Company, Natural Products Dept., 100 

W. Hunter Avenue, Maywood, New 

Jersey 07607, made application by 

renewal to the Drug Enforcement 

Administration (DEA) to be registered as 

a bulk manufacturer of the following 

basic classes of controlled substances: 

Drug Schedule 

Cocaine (9041) ............................. II 

Ecgonine (9180) ........................... II 

The company plans to manufacture 

the listed controlled substances in bulk 

for distribution to its customers. 

No comments or objections have been 

received. DEA has considered the 

factors in 21 U.S.C. 823(a), and 

determined that the registration of 

Stepan Company to manufacture the 

listed basic classes of controlled 

substances is consistent with the public 

interest at this time. DEA has 

investigated Stepan Company to ensure 

that the company’s registration is 

consistent with the public interest. The 

investigation has included inspection 

and testing of the company’s physical 

security systems, verification of the 

company’s compliance with state and 

local laws, and a review of the 

company’s background and history. 

Therefore, pursuant to 21 U.S.C. 823(a), 

and in accordance with 21 CFR 1301.33, 

the above named company is granted 

registration as a bulk manufacturer of 

the basic classes of controlled 

substances listed. 

Dated: August 10, 2011. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration. 

[FR Doc. 2011–21081 Filed 8–17–11; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Manufacturer of Controlled 

Substances; Notice of Registration 

By Notice dated April 25, 2011, and 

published in the Federal Register on 

May 4, 2011, 76 FR 25375, Rhodes 

Technologies, 498 Washington Street, 

Coventry, Rhode Island 02816, made 

application by renewal to the Drug 

Enforcement Administration (DEA) to 

be registered as a bulk manufacturer of 

the following basic classes of controlled 

substances: 

Drug Schedule 

Tetrahydrocannabinols (7370) ..... I 

Methylphenidate (1724) ................ II 

Codeine (9050) ............................. II 

Dihydrocodeine (9120) ................. II 

Oxycodone (9143) ........................ II 

Hydromorphone (9150) ................ II 

Hydrocodone (9193) ..................... II 

Oripavine (9330) ........................... II 

Thebaine (9333) ........................... II 

Oxymorphone (9652) ................... II 

Noroxymorphone (9668) .............. II 

Fentanyl (9801) ............................ II 

The company plans to manufacture 

the listed controlled substances in bulk 

for conversion and sale to dosage form 

manufacturers. 

No comments or objections have been 

received. DEA has considered the 

factors in 21 U.S.C. 823(a) and 

determined that the registration of 

Rhodes Technologies to manufacture 

the listed basic classes of controlled 

substances is consistent with the public 

interest at this time. DEA has 

investigated Rhodes Technologies to 

ensure that the company’s registration is 

consistent with the public interest. The 

investigation has included inspection 

and testing of the company’s physical 

security systems, verification of the 

company’s compliance with state and 

local laws, and a review of the 

company’s background and history. 

Therefore, pursuant to 21 U.S.C. 823(a), 

and in accordance with 21 CFR 1301.33, 

the above named company is granted 

registration as a bulk manufacturer of 

the basic classes of controlled 

substances listed. 

Dated: August 10, 2011. 

Joseph T. Rannazzisi, 

Deputy Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration. 

[FR Doc. 2011–21080 Filed 8–17–11; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 05–16] 

Lyle E. Craker, PhD; Order Regarding 

Officially Noticed Evidence and Motion 

for Reconsideration 

Lyle E. Craker, PhD (Respondent) has 

requested that I reconsider the Final 

Order I issued on January 7, 2009 (74 FR 

2101), which denied his application to 

mstockstill on DSK4VPTVN1PROD with NOTICES

51404 Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices 

become registered as a bulk 

manufacturer of marijuana. For the 

reasons provided below, Respondent 

has failed to demonstrate that the Final 

Order contains any erroneous material 

findings of fact or conclusions of law. 

Accordingly, Respondent’s motion for 

reconsideration does not provide a basis 

for altering the decision in the Final 

Order to deny his application. 

I. Post-Final-Order Proceedings 

Following the issuance of the January 

7, 2009, Final Order, Respondent 

submitted a letter to me dated January 

21, 2009, noting that, in several places 

in the Final Order, I indicated I was 

taking official notice of certain 

documents that were not submitted 

during the administrative hearing. With 

respect to such documents, the Final 

Order states: ‘‘To allow Respondent the 

opportunity to refute the facts of which 

I take official notice, Respondent may 

file a motion for reconsideration within 

fifteen days of service of this order 

which shall commence with the mailing 

of the order.’’ Thus, Respondent had 

until January 23, 2009, to file a motion 

for reconsideration of the facts of which 

I took official notice. In his January 21, 

2009, letter, Respondent requested an 

extension of this filing deadline until 

January 30, 2009. I granted this request 

for an extension by letter dated January 

22, 2009. 

On January 30, 2009, Respondent 

submitted to me a document entitled 

‘‘Request for Opportunity Under 5 

U.S.C. 556(e) To Respond to New 

Officially Noticed Evidence and Motion 

for Reconsideration.’’ In this document, 

Respondent provided a preliminary 

response to those documents of which 

I took official notice. However, 

Respondent asked for additional time to 

supplement his preliminary response, 

given the length of the Final Order as 

well as that of the documents of which 

I took official notice. I granted this 

request, allowing Respondent until 

March 11, 2009, to supplement his 

response and motion. I further 

instructed that counsel for the 

Government would have to submit its 

response no later than 15 days after 

being served with Respondent’s 

submission. 

On March 11, 2009, Respondent 

submitted ‘‘Respondent’s Supplemental 

Brief in Support of Request Under 5 

U.S.C. 556(e) To Respond to New 

Officially Noticed Evidence and Motion 

for Reconsideration.’’ In this document, 

Respondent provided the legal and 

factual bases for his motion for 

reconsideration of the Final Order. Also 

in the document, Respondent requested 

that the administrative hearing be 

reopened so that he may call additional 

witnesses in view of certain documents 

of which I took official notice in the 

final order. The Government submitted 

its response on April 13, 2009. In view 

of these submissions, and to clarify 

Respondent’s request, I issued an 

interim order on May 18, 2009, directing 

Respondent to submit a list of all 

witnesses he would call if his request to 

reopen the administrative hearing were 

granted and to provide a summary of the 

proposed testimony for each witness. 

This interim order further instructed 

Respondent to indicate precisely which 

documents he sought to introduce for 

purposes of his motion for 

reconsideration and, for each document, 

whether he wanted me to take official 

notice of it, or whether he wished to 

introduce it through witnesses if his 

request to reopen the hearing were 

granted. 

On June 5, 2009, Respondent 

submitted his ‘‘Witness List and 

Document List in Support of Motion for 

Reconsideration.’’ On December 2, 2010, 

I issued an order granting in part, and 

denying in part, Respondent’s request 

that I take official notice of certain 

documents. The order denied 

Respondent’s request that I reopen the 

hearing to allow him to call additional 

witnesses. Having ruled on which new 

documents would be considered part of 

the record (through my taking official 

notice thereof), the order then gave 

Respondent an additional opportunity 

to file a final brief in support his motion 

for reconsideration. The order stated 

that Respondent was required to submit 

such brief on or before March 7, 2011, 

and that the Government’s responsive 

brief was due no later than 30 days after 

receipt of Respondent’s brief. 

Respondent submitted his brief on 

March 7, 2011 (hereafter, ‘‘Respondent’s 

latest submission’’), and the 

Government submitted its responsive 

brief on April 1, 2011. 

II. Respondent’s Additional Proposed 

Documentary Exhibits 

Respondent’s request to introduce 

additional documents for purposes of 

his motion for reconsideration was 

addressed at length in my December 2, 

2010, Order. For each such document 

Respondent sought to introduce, the 

December 2, 2010, Order stated (pages 

23–27) whether I would take official 

notice of the document, and the reasons 

therefor. Only one category of 

documents that Respondent sought to 

introduce was left unresolved by the 

December 2, 2010, Order. As to this 

category, the order stated (page 26): 

If Respondent submits all of the 

correspondence between Chemic and HHS 

(or any of its components) relating to this 

application [Chemic’s application to HHS to 

receive marijuana for research] that he has in 

his possession or can reasonably access 

(including, but not limited to, any such 

correspondence on the MAPS website, such 

as the January 23, 2009, letter from HHS to 

Chemic), I will take official notice of all such 

correspondence. 

Thus, the only additional documents 

that might be considered at this juncture 

for inclusion in the record (by my taking 

official notice thereof) are the 

‘‘correspondence between Chemic and 

HHS’’ described in the above-quoted 

sentence. Respondent’s latest brief seeks 

to introduce 11 new documents (which 

Respondent labels Exhibits A–K). 

However, only four of these documents 

(Exhibits C, I, J, and K) appear to be 

correspondence between Chemic and 

HHS. The remaining seven documents 

(A, B, D, E, F, G, and H) do not appear 

to be correspondence between Chemic 

and HHS, and Respondent makes no 

assertion in his brief that they are such. 

The Government asserts in its 

responsive brief that these Exhibits A, B, 

E, F, G, and H are not ‘‘correspondence’’ 

and further that ‘‘Respondent has not 

laid any foundation to demonstrate that 

these exhibits were provided to HHS by 

Chemic.’’ For this reason, among others, 

the Government objects to including 

these documents in the record. 

Accordingly, I rule as follows with 

respect to these latest proposed exhibits: 

(1) I will take official notice of 

Exhibits C, I, J, and K; and 

(2) As Exhibits A, B, D, E, F, G, and 

H do not comport with the instructions 

contained in the December 2, 2010, 

Order, I will not take official notice of 

these documents, and they will not be 

considered part of the administrative 

record considered by the agency in this 

adjudication. 

III. Respondent’s Motion for 

Reconsideration 

Given the number of written 

submissions made by Respondent 

following the issuance of the January 7, 

2009, Final Order, along with the 

Government’s responses thereto and the 

interim orders I issued regarding these 

submissions, it is important to reiterate 

here the purpose for which Respondent 

was given an opportunity to file a 

motion for reconsideration. That 

purpose was stated in the January 7, 

2009, Final Order: ‘‘To allow 

Respondent the opportunity to refute 

the facts of which I take official notice, 

Respondent may file a motion for 

reconsideration within fifteen days of 

service of this order which shall 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices 51405 

1The CSA appeal provision, 21 U.S.C. 877, states: 

‘‘All final determinations, findings, and conclusions 

of the [Administrator of DEA] under this subchapter 

shall be final and conclusive decisions of the 

matters involved, except that any person aggrieved 

by a final decision of the [Administrator] may 

obtain review of the decision in the United States 

Court of Appeals * * *.’’ This provision suggests 

that—outside of the scenario provided by the DEA 

regulations and APA in which a party, on timely 

request, seeks the opportunity to controvert facts of 

which the agency took official notice—DEA is not 

obligated to allow parties to seek reconsideration of 

final orders regarding applications for registration. 

DEA also adheres to the Supreme Court’s decision 

in Interstate Commerce Comm’n v. Bhd. of 

Locomotive Eng’rs, 482 U.S. 270 (1987), regarding 

the reopening of proceedings where it is alleged 

that new evidence or changed circumstances render 

the agency’s original order inappropriate. See also 

Fry v. DEA, 353 F.3d 1041, 1044 (9th Cir. 2003). 

2See, e.g., 74 FR at 2106 (noting testimony of 

Rick Doblin, the Director of MAPS, that ‘‘what 

we’re trying to do is get the Public Health Service 

and NIDA out of the picture’’). 

commence with the mailing of the 

order.’’ 74 FR at 2108 n.24. This was 

restated in the interim orders I issued 

following the Final Order. As explained 

in the Final Order and the December 2, 

2010, Order, this opportunity to seek 

reconsideration of facts of which the 

agency takes official notice is derived 

from the Administrative Procedure Act 

(5 U.S.C. 556(e)) and the DEA 

regulations (21 CFR 1316.59(e)). 

Respondent’s post-Final-Order 

submissions have, in many respects, 

gone beyond seeking reconsideration of 

facts of which I took official notice. 

Respondent has essentially sought broad 

reconsideration of the factual and legal 

bases for the Final Order—generally 

without predicating such arguments on 

the taking of official notice of any fact. 

Neither the Controlled Substances Act 

(CSA) nor the DEA regulations provide 

for such a broad-based motion for 

reconsideration of a Final Order.1

Nonetheless, in the exercise of my 

discretion, taking into account the 

complex and sometimes novel issues 

involved in this matter, I have 

considered all of the arguments 

Respondent has submitted in his postFinal-Order submissions—including 

those that go beyond the scope of what 

is permitted by 5 U.S.C. 556(e) and 21 

CFR 1316.59(e). 

The arguments contained in 

Respondent’s post-Final-Order 

submissions are, for the most part, 

reiterations of the same arguments that 

were addressed at length and rejected in 

the Final Order. In a few instances, as 

noted below, Respondent does present 

some slightly different assertions than 

he previously offered. However, even in 

these instances, Respondent’s core 

contentions remain those that I 

previously rejected. Furthermore, 

Respondent fails in these latest 

submissions to rebut the fundamental 

reasons that were provided in the Final 

Order for denying his application. 

A. Respondent’s Arguments Relating to 

the Review of Research Protocols by the 

Department of Health and Human 

Services 

In his post-Final-Order submissions, 

Respondent continues to focus on what 

was his primary theme throughout the 

adjudication proceedings leading up to 

the Final Order: his desire to have the 

Public Health Service and the National 

Institute on Drug Abuse (NIDA) 

removed from the process by which the 

Department of Health and Human 

Services (HHS) carries out its statutory 

duty to review proposed research 

involving marijuana. For purposes of 

context, it is repeated here, as explained 

in the Final Order, that under the CSA 

(21 U.S.C. 823(f)), the Secretary of HHS 

is responsible for reviewing all 

proposed research involving schedule I 

controlled substances. Specifically, 

section 823(f) provides that, with 

respect to applications for registration 

by practitioners wishing to conduct 

research with schedule I controlled 

substances, ‘‘the Secretary * * * shall 

determine the qualifications and 

competency of each practitioner 

requesting registration, as well as the 

merits of the research protocol.’’ 

(Emphasis added.) Thus, under section 

823(f), a research proposal involving 

marijuana may only go forward where 

the Secretary both (1) Deems the 

practitioner qualified and competent 

and (2) determines the research protocol 

to be meritorious. Or, as stated by HHS 

in its 1999 announcement of its policies 

for providing marijuana to researchers: 

‘‘To receive such a registration [under 

§ 823(f)], a researcher must first be 

determined by HHS to be qualified and 

competent, and the proposed research 

must be determined by HHS to have 

merit.’’ 74 FR at 2120 n.70 (emphasis 

added in Final Order). 

Respondent does not dispute that the 

statute assigns the foregoing functions to 

the Secretary of HHS. However, 

Respondent objects to the manner in 

which these functions are carried out 

within HHS. In particular, Respondent 

seeks to have the Public Health Service 

and NIDA stripped of any role in this 

process.2

For purposes of addressing this issue, 

it is useful to repeat the following parts 

of the Final Order, which discussed the 

scientific review process that has been 

utilized by HHS since 1999 to evaluate 

marijuana research proposals: 

[I]n 1999, due in part to an increased 

interest in marijuana research and taking into 

account the IOM report, HHS decided to 

change the procedures by which it would 

supply marijuana to researchers. The new 

procedures were announced in a document 

released by NIH on May 21, 1999. In the 

announcement, ‘‘HHS recognize[d] the need 

for objective evaluations of the potential 

merits of cannabinoids for medical uses[,]’’ 

and that ‘‘[i]f a positive benefit is found, 

* * * the need to stimulate development of 

alternative, safer dosage forms.’’ Toward this 

end, NIH explained that the new procedures 

were designed to increase the availability of 

marijuana for research purposes by, among 

other things, making such marijuana 

‘‘available on a cost-reimbursable basis.’’ 

This new procedure allowed researchers who 

were privately funded to obtain marijuana 

from HHS by reimbursing the NIDA 

contractor for the cost of the marijuana. This 

was a departure from the prior practice (pre1999), whereby HHS only made marijuana 

available to persons who received NIH 

funding. The new procedures implemented 

by HHS in 1999 remain in effect today. 

* * * * * 

At the administrative hearing in this case, 

Steven Gust, PhD, Special Assistant to the 

Director of NIDA, explained that, in addition 

to seeking to facilitate research into the 

possible medical utility of marijuana, the 

new procedures implemented by HHS in 

1999 were intended ‘‘to make the process 

more standardized, and to * * * provide 

some expertise that did not really exist at 

NIDA in terms of reviewing applications that 

involved * * * the use of marijuana * * * 

for treatment of diseases.’’ Accordingly, HHS 

‘‘established a separate peer review process 

that * * * moved the review into the Public 

Health Service [a component of HHS] * * * 

where additional expertise from other NIH 

Institutes and other Federal agencies’’ could 

be utilized in reviewing the scientific merit 

of the applications. Dr. Gust further 

explained that the members of the review 

committee are drawn from the various 

specialty institutes of NIH, and the Substance 

Abuse and Mental Health Services 

Administration (SAMHSA). Dr. Gust also 

testified that the ‘‘scientific bar has been set 

very low, [so] that any project that has 

scientific merit is approved,’’ and that 

‘‘anything that gets approved gets NIDA 

marijuana.’’ As of April 2004, HHS had 

approved at least seventeen pre-clinical or 

clinical studies of marijuana, which were 

sponsored by the California Center for 

Medical Cannabis Research (CMCR). 

According to one witness who testified on 

behalf of Respondent, all of the CMCRsponsored researchers who applied to NIDA 

for marijuana did in fact receive marijuana 

from NIDA. 

* * * * * 

In his testimony, Dr. Gust explained the 

term ‘‘peer review’’ as follows: ‘‘Peer review 

is a process that has been used, certainly by 

NIH, and I think in other agencies in the 

Department of Health and Human Services, 

and probably the Federal Government, where 

outside expertise is acquired and outside 

opinions on the scientific merit of specific 

research proposals.’’ Dr. Gust added that the 

NIH peer review committees ‘‘review 

mstockstill on DSK4VPTVN1PROD with NOTICES

51406 Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices 

3 It is unclear whether Respondent is suggesting 

that I should refuse to accept at face value what 

HHS stated in its correspondence with Chemic and 

instead conclude—without any evidentiary basis for 

doing so—that the HHS scientists who are 

responsible for reviewing proposed marijuana 

research have conspired for years to carry out an 

elaborate ruse aimed at thwarting marijuana 

research. If this is Respondent’s mind-set, adopting 

it would be the antithesis of the principle inherent 

to the Administrative Procedure Act (APA) that 

agency action must be presumed to be valid where 

a reasonable basis exists for its decision. See, e.g., 

Kern County Farm Bureau v. Allen, 450 F.3d 1072, 

1076 (9th Cir. 2006). It is also at odds with the APA 

concept that bars a reviewing court—much less a 

member of the public—from substituting its 

judgment for that of the agency. Id. 

proposals three times a year for the NIH, and 

there are—occasionally a Federal employee 

participates in one of those reviews, but 

probably 90 percent or more of the 

participants are researchers who are in the 

private sector, for the most part in academic 

institutions.’’ 

74 FR at 2015, 2119 n.67 (footnotes and 

citations omitted). 

Again, it is Respondent’s contention 

that the involvement of the Public 

Health Service and NIDA in reviewing 

proposed marijuana research protocols 

has the effect of blocking legitimate 

research into marijuana. Indeed, the 

primary argument Respondent puts 

forth in support of his proposed 

registration is that the current system by 

which the United States Government 

makes marijuana available to 

researchers fails to provide an adequate 

supply of marijuana within the meaning 

of 21 U.S.C. 823(a)(1)—precisely 

because, in Respondent’s opinion, the 

Public Health Service and NIDA have 

‘‘institutional biases’’ against certain 

types of marijuana research. 

This argument was carefully 

examined in the Final Order. See 74 FR 

at 2107–08, 2119–20. Respondent’s 

post-Final-Order submissions as to this 

issue are not materially different from 

the claims that were rejected in the 

Final Order. In fact, the new documents 

that Respondent has submitted 

following the Final Order, and of which 

I have taken official notice, provide 

further confirmation of certain 

determinations made in the Final Order. 

Respondent’s latest submission contains 

no citations to actual evidence in the 

record that supports his claims of 

‘‘institutional biases’’ or ‘‘political’’ 

motivation on the part of the Public 

Health Service and NIDA. 

As to this issue, the Final Order 

stated, among other things: 

Respondent also introduced into evidence 

a letter from the President of Chemic to HHS 

responding to several points raised by the 

PHS Committee in denying Chemic’s 

application. Respondent’s letter does not, 

however, establish that HHS impermissibly 

denied Chemic’s application for marijuana. 

To the contrary, the evidence supports the 

conclusion that HHS (acting through the PHS 

Committee) made its determination not to 

supply marijuana on this occasion based on 

scientific considerations, finding that 

Chemic’s then-latest proposed study was 

duplicative of prior and ongoing research 

and not likely to provide useful data. 

74 FR at 2109 (emphasis added; footnote 

and citation omitted). As noted, I 

granted Respondent’s post-Final-Order 

request to introduce additional 

correspondence between Chemic and 

HHS relating to Chemic’s proposed 

research protocol involving marijuana. 

Respondent produced six additional 

pieces of correspondence between 

Chemic and HHS relating to this matter 

that were not produced in the 

administrative hearing. As indicated 

above and in the December 2, 2010, 

Order, I have taken official notice of all 

six of these documents. Each of these 

documents further confirms that HHS’s 

rejection of the Chemic protocol was— 

as the Final Order found—based purely 

on scientific merit. 

It is difficult to understand why 

Respondent would seek to introduce at 

this juncture six letters between Chemic 

and HHS that reaffirm what was found 

in the Final Order—and how 

Respondent construes these letters as 

‘‘rebuttal’’ evidence. The statements by 

HHS in these letters are, without 

question, focused entirely on the 

scientific inadequacies of various 

iterations of Chemic’s research proposal. 

The letters demonstrate that the HHS 

scientists have actively engaged in a 

dialogue with Chemic for many years, 

and have gone to great lengths to 

explain to Chemic each of the areas in 

which Chemic needs to revise its 

protocol so that it can be deemed 

scientifically meritorious. The letters 

thereby reaffirm that HHS (including, 

but not limited to, the Public Health 

Service and NIDA) has never indicated 

any opposition (political, philosophical, 

or otherwise) to any category of 

marijuana research. To the contrary, the 

letters—particularly the most recent one 

submitted by Respondent, dated January 

23, 2009—actually show that HHS is 

interested in Chemic’s proposal and 

willing to supply Chemic with 

marijuana, provided that Chemic 

provides validation data that is 

necessary to support Chemic’s scientific 

measurements. In short, the evidence 

continues to point squarely to the 

conclusion that HHS is doing precisely 

what it is required to do under 21 U.S.C. 

823(f): Allow only those schedule I 

research proposals that it determines to 

be scientifically meritorious to go 

forward. As the Final Order stated: 

‘‘That Respondent finds this process to 

be scientifically rigorous—and thereby 

not automatically accepting of any 

proposed study sponsored by MAPS— 

provides no basis for any valid objection 

or any contention that the HHS supply 

of marijuana is inadequate.’’ 74 FR at 

2120 (footnotes omitted).3

Moreover, Respondent’s ‘‘institutional 

bias’’ theory is belied by the following 

crucial fact. As stated in the Final 

Order: ‘‘The record reflects that since 

HHS changed its policies in 1999 to 

make marijuana more readily available 

to researchers (by, among other things, 

allowing privately funded researchers to 

obtain marijuana), every one of the 17 

CMCR [California Center for Medical 

Cannabis Research]-sponsored preclinical or clinical studies that 

requested marijuana from NIDA was 

provided with marijuana.’’ 74 FR at 

2119. Despite the enormity of this fact 

in relation to Respondent’s 

‘‘institutional bias’’ claim, Respondent 

makes only the following vague 

reference to it in his latest submission 

(page 9): ‘‘Though the DEA points to 

other marijuana research that NIDA has 

allowed, none of these studies aimed to 

develop marijuana into a legal 

prescription medicine.’’ What 

Respondent downplays as ‘‘other 

marijuana research that NIDA has 

allowed’’ is, in fact, seventeen different 

clinical trials involving marijuana 

proposed by CMCR—all of which were 

approved by the Public Health Service 

and NIDA. As stated in the Final Order: 

Any suggestion that the HHS scientific 

review process is unduly rigorous is belied 

by the testimony of Dr. Gust that the 

‘‘scientific bar has been set very low, [so] that 

any project that has scientific merit is 

approved,’’ and that ‘‘anything that gets 

approved gets NIDA marijuana’’ (Tr. at 1700– 

01) as well as the uncontroverted evidence 

that every one of the 17 CMCR-sponsored 

research protocols submitted to HHS was 

deemed scientifically meritorious by HHS 

and was supplied with marijuana (GX 31, at 

3; Tr. 694–95). 

74 FR at 2120 n.71. 

As for Respondent’s contention that 

‘‘none of these studies aimed to develop 

marijuana into a legal prescription 

medicine,’’ this too is contradicted by 

the record. As stated in the Final Order: 

The California research studies were 

conducted pursuant to a law enacted by 

California in 1999 known as the Marijuana 

Research Act of 1999. Cal. Health & Safety 

Code § 11362.9. This state law established 

the ‘‘California Marijuana Research Program’’ 

to develop and conduct studies on the 

potential medical utility of marijuana. Id. 

(The program is also referred to as the 

‘‘Center for Medicinal Cannabis Research’’ 

(CMCR). Tr. 396.) The state legislature 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices 51407 

4The process by which FDA approves new drugs 

for marketing is summarized in the Final Order. 74 

FR at 2106 n.21. 

5As stated in the Final Order, no clinical trials 

involving marijuana—not even the 17 CMCR 

studies—have advanced beyond Phase 1 of the 

three phases required for FDA approval of a new 

drug. 74 FR at 2107 n.23. The proposed Chemic 

study does not even appear to be a clinical trial, let 

alone a study more advanced in the phases of FDA 

approval than the CMCR studies. 

6While the letter itself is dated February 1, 2000, 

Respondent failed to present evidence indicating 

when Dr. Russo submitted his third protocol, or 

when HHS began its review of that protocol. Thus, 

it remains uncertain whether this third protocol 

was evaluated under the pre-1999 or post-1999 HHS 

procedures. 

appropriated a total of $9 million for the 

marijuana research studies. Tr. 397. 

74 FR at 2105–06 n.16. It is thus beyond 

question that the CMCR studies were 

aimed at what Respondent characterizes 

as ‘‘develop[ing] marijuana into a legal 

prescription medicine.’’ 4

For the same reasons, the record 

contradicts Respondent’s related claim 

that the involvement of the Public 

Health Service and NIDA in 

determining the scientific merit of 

proposed marijuana research ‘‘renders 

the supply [of marijuana] inadequate 

because entire categories of legitimate 

medical research are effectively 

foreclosed.’’ Respondent fails to explain 

what ‘‘categories of legitimate medical 

research’’ are supposedly being 

foreclosed. Again, it seems (but is 

unclear) that Respondent is suggesting 

that the Chemic research proposal, and/ 

or Dr. Russo’s proposal (see below), 

were more geared toward ‘‘develop[ing] 

marijuana into a legal prescription 

medicine’’ than were the 17 CMCR 

studies. In other words, Respondent 

appears to be suggesting that the Public 

Health Service and NIDA went into 

their alleged ‘‘institutional bias’’ mode 

when reviewing the Chemic and Russo 

proposals, but turned off that mode 

when reviewing the 17 CMCR proposals 

because the latter were less geared 

toward developing marijuana into an 

FDA-approved medicine. If this is what 

Respondent is suggesting, there is no 

evidentiary foundation for such a claim 

as neither Chemic’s proposal nor Dr. 

Russo’s could be characterized as closer 

than the CMCR studies to the goal of 

obtaining FDA approval of marijuana as 

a drug.5

To address further the portion of 

Respondent’s latest submission 

pertaining to Dr. Russo, the following 

part of the Final Order is recited: 

[Dr. Ethan Russo] sought funding from 

NIDA to study the use of marijuana to treat 

migraine headaches beginning around 1996. 

The precise dates of the events related to Dr. 

Russo are somewhat unclear as Respondent 

presented these events through the testimony 

of Mr. Doblin. (Dr. Russo did not testify.) 

Based on Mr. Doblin’s testimony, it appears 

that during 1996–97, NIDA twice rejected Dr. 

Russo’s protocol for reasons which are not 

clearly established by the record. However, 

according to Mr. Doblin, Dr. Russo conceded 

that, on both of these two occasions when 

NIDA rejected his protocol, NIDA’s bases for 

doing so did include ‘‘some valid critiques.’’ 

Mr. Doblin testified that Dr. Russo 

subsequently attempted for a third time to 

obtain marijuana from NIDA, but on this 

third occasion he decided not to seek 

government funding but to seek private 

funding to purchase the marijuana from 

NIDA. According to Mr. Doblin, this third 

protocol submitted by Dr. Russo was 

approved by both the FDA and Dr. Russo’s 

institutional review board, but NIDA again 

refused to supply marijuana. When asked 

when this last denial by NIDA occurred, Mr. 

Doblin testified: ‘‘I think it was 1999.’’ 

As noted above, NIH announced on May 

21, 1999, HHS’s new procedures for making 

marijuana available to researchers. Bearing in 

mind that Respondent had the burden of 

proving any proposition of fact that he 

asserted in the hearing, 21 CFR 1301.44(a), 

nothing in Mr. Doblin’s testimony, or any 

other evidence presented by Respondent, 

established that HHS denied Dr. Russo’s 

request for marijuana under the new 

procedures implemented by the agency in 

1999. Indeed, Respondent produced no 

evidence showing that HHS has denied 

marijuana to any clinical researcher with an 

FDA-approved protocol subsequent to the 

adoption of the 1999 guidelines. 

74 FR at 2108 (citations omitted). 

In his post-Final-Order submissions, 

Respondent submitted a letter dated 

February 1, 2000, from the Public 

Health Service and NIDA to Dr. Russo 

(Exhibit C to Respondent’s March 11, 

2009, Supplemental Brief). In the 

December 2, 2010, Order, I granted 

Respondent’s request to take official 

notice of this document. As Respondent 

indicates, this letter was issued after 

HHS announced in 1999 its new 

procedures for providing marijuana to 

researchers. Even assuming, arguendo, 

that this letter demonstrates that the 

third protocol submitted by Dr. Russo 

was evaluated by HHS under the new 

procedures established in 1999,6 this 

does not materially alter the conclusions 

in the Final Order. This is because the 

Final Order stated, in essence, that even 

if Dr. Russo’s proposal had been 

evaluated by HHS under the post-1999 

procedures, ‘‘the evidence indicates that 

the denials involving * * * Dr. Russo 

were based on HHS finding [his] 

protocols to be lacking in scientific 

merit.’’ See 74 FR at 2119 n.68. 

The most recent document submitted 

by Respondent regarding Dr. Russo (the 

February 1, 2000, letter from Public 

Health Service to Dr. Russo) confirms 

yet again that the Public Health Service 

and NIDA focus on scientific merit in 

reviewing proposed marijuana research. 

The February 1, 2000, letter advised Dr. 

Russo that a scientific review of his 

protocol had been conducted by the 

Center for Scientific Review (CSR) of the 

National Institutes of Health on behalf 

of the Public Health Service, and that 

the CSR recommended certain changes 

to the protocol. If, the letter continued, 

such changes were incorporated into a 

new protocol and submitted by Dr. 

Russo, the Public Health Service would 

reconsider his request. Among the 

specific changes that Dr. Russo was 

advised to make were the following: 

Including a placebo arm; taking steps to 

account for possible attrition of research 

subjects; and ensuring that research 

subjects received equivalent doses of 

THC. These are quintessentially 

scientific refinements that the 

researcher was being asked to make— 

not, as Respondent alleges, a refusal to 

allow a category of research to take 

place. 

Thus, even when viewing 

Respondent’s newly submitted evidence 

regarding Dr. Russo as an example of a 

denial by HHS of marijuana under the 

post-1999 HHS procedures, it is in the 

same category as the Chemic protocols: 

A denial based on scientific merit under 

the post-1999 procedures. This would 

bring the total figures under the post1999 procedures to the following: 17 

studies approved and supplied with 

marijuana; two studies denied until the 

researcher makes certain changes in the 

protocol to render the proposal 

scientifically meritorious. Stated 

alternatively, under the post-1999 

procedures, HHS’s approval rate for 

marijuana studies is at least 89.5 

percent, with the possibility of that 

figure rising to 100 percent if two of the 

researchers were willing to make 

adjustments to their protocols to make 

them scientifically meritorious. 

Respondent’s latest submission also 

refers to certain documentary and 

testimonial statements by NIDA 

officials, which Respondent contends 

support his claim of ‘‘institutional bias.’’ 

As these statements were part of the 

record that the parties addressed in their 

pre-Final-Order submissions, and since 

the Final Order already addressed this 

type of argument by Respondent, it is 

not necessary to reexamine this issue at 

length here. Moreover, the actions by 

HHS in response to actual research 

proposals are by far the best evidence of 

the agency’s true willingness to supply 

marijuana to researchers, and these 

actions render inconsequential any 

attempt by Respondent to surmise 

‘‘institutional bias’’ from abstract 

statements isolated from the documents 

mstockstill on DSK4VPTVN1PROD with NOTICES

51408 Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices 

7Although HHS’s actual record in supplying 

marijuana to researchers is the best evidence of its 

willingness to do so, the following testimony of Dr. 

Gust at the hearing explains how HHS took steps 

in 1999 to ensure the availability of marijuana to 

researchers—including those interested in pursuing 

medical uses of marijuana—irrespective of NIDA’s 

mission: 

It was about this time [1999] when there was 

some increased interest in research, in pursuing the 

medical use of marijuana, and in an effort to make 

the process more standardized, and to basically 

provide some expertise that did not really exist at 

NIDA in terms of reviewing applications that 

involved primarily the use of marijuana or any 

other substance for that matter for treatment of 

diseases, which did not really fall within NIDA’s 

mission, the department [HHS] established a 

separate peer review process that made the 

review—that moved the review into the Public 

Health Service at the time where additional 

expertise from other NIH Institutes and other 

Federal agencies could be brought to bear to help— 

and help provide reviews, appropriate reviews, of 

the scientific merit of these applications. 

Tr. 1632–33. Thus, Respondent’s attempt to focus 

on NIDA’s particular mission, without regard to the 

mission of other components of HHS involved in 

review of marijuana research proposals, and 

without regard to the overall aims of the procedures 

established by HHS in 1999 for providing marijuana 

to researchers, is misplaced. 

8Moreover, not even those functions expressly 

listed in FDA’s statutory mission statement are 

carried out solely by the FDA. As stated in the very 

next subsection after the one cited by Respondent, 

21 U.S.C. 393(c), which is entitled ‘‘Interagency 

collaboration’’: ‘‘The Secretary [of HHS] shall 

implement programs and policies that will foster 

collaboration between the [FDA], the National 

Institutes of Health, and other science-based 

Federal agencies, to enhance the scientific and 

technical expertise available to the Secretary in the 

conduct of the duties of the Secretary with respect 

to the development, clinical investigation, 

evaluation, and postmarket monitoring of emerging 

medical therapies, including complementary 

therapies. * * *’’ 

9Under 21 U.S.C. 823(f), Congress assigned to the 

Secretary of HHS sole discretion to determine how 

HHS carries out its responsibility to review the 

scientific merit of schedule I research proposals. 

10Respondent uses this particular wording on 

page 9 of his latest submission, and he reiterates the 

assertion numerous times in the document. 

11As Respondent seems to concede, Chemic’s 

proposed research involving marijuana is not a 

clinical trial. Accordingly, Respondent does not 

appear to be suggesting that Chemic submitted an 

IND to the FDA for its research proposal. Thus, it 

does not appear that Respondent is including the 

Chemic situation in his category of ‘‘research 

projects [that] have been blocked by NIDA in spite 

of FDA-approved protocols.’’ 

12The FDA may also notify the investigator that 

the clinical investigation may begin earlier than 30 

days after the FDA receives the IND. 21 CFR 

312.40(b)(2). 

13The word ‘‘approve’’ (or ‘‘approval’’) is a term 

of art in the FDCA. The FDA ‘‘approves’’ new drug 

applications upon an adequate showing of safety 

and efficacy for the uses in the proposed labeling, 

which allows a drug to be legally marketed. 21 

U.S.C. 355; 21 CFR 314. An effective IND is 

considered ‘‘accepted,’’ not ‘‘approved,’’ by FDA. 

14 I am assuming, for the sake of discussion, that 

Dr. Russo and Dr. Abrams submitted INDs and that 

the FDA did not issue clinical holds, even though 

Respondent did not introduce such INDs or call Dr. 

Russo or Dr. Abrams to testify. 

15See 21 CFR 312.42(b) (grounds for imposition 

of a clinical hold of a Phase 1 study under an IND). 

16See 74 FR at 2105. 

and testimony. The same considerations 

apply with respect to Respondent’s 

argument that NIDA’s mission stands as 

an obstacle to allowing legitimate 

marijuana research to take place. This 

argument was addressed in the Final 

Order and is overwhelmingly refuted by 

the evidence of HHS’s actual track 

record in supplying marijuana to 

researchers.7

Respondent also asserts that two 

provisions of the Federal Food, Drug, 

and Cosmetic Act (FDCA) and an FDA 

regulation mandate that the FDA—and 

not NIDA—must carry out the Secretary 

of HHS’s responsibility under 21 U.S.C. 

823(f) to determine the scientific merit 

of proposed marijuana research. 

Specifically, Respondent cites 21 U.S.C. 

393(b) (FDA’s mission statement), 21 

U.S.C. 355 (new drug approval process), 

and 21 CFR 312.22(a) (general 

principles of submission of an 

investigational new drug application 

(IND)), in support of this assertion. 

This assertion is mistaken in a 

number of respects, including, but not 

limited to, the following. First, the fact 

that the FDA’s statutory mission 

statement lists certain functions by no 

means precludes other agencies within 

HHS from having overlapping 

functions.8 Second, while FDA is 

indeed the agency within HHS that is 

chiefly responsible for administering the 

new drug approval process under 21 

U.S.C. 355, this is a distinctly different 

function than the determination under 

21 U.S.C. 823(f) of the scientific merit of 

proposed research involving schedule I 

controlled substances. There is certainly 

no basis for Respondent (or any other 

member of the public) to dictate to the 

Secretary that the same agency within 

HHS that carries out the former function 

must also carry out the latter.9 Third, 

although the review by FDA of an IND 

may (depending on the phase of the 

investigation) be similar in certain 

respects to the review under § 823(f) of 

a schedule I research proposal, the two 

types of reviews are distinct 

administrative functions carried out 

within HHS. This is evident from the 

first sentence of the very regulation that 

Respondent cites, 21 CFR 312.22(a), 

which states: ‘‘FDA’s primary objectives 

in reviewing an IND are, in all phases 

of the investigation, to assure the safety 

and rights of subjects, and in Phase 2 

and 3, to help assure that the quality of 

the scientific evaluation of drugs is 

adequate to permit an evaluation of the 

drug’s effectiveness and safety.’’ Thus, 

in reviewing an IND for a Phase 1 

investigation, FDA’s primary objective 

is to assure the safety and rights of 

subjects—not to assess the scientific 

quality of the clinical investigation. This 

is especially notable since, as stated 

above, none of the clinical trials 

involving marijuana that have been 

proposed to HHS has advanced beyond 

Phase 1. 

The foregoing discussion also sheds 

light on another assertion made by 

Respondent in his latest submission: 

That ‘‘several research projects have 

been blocked by NIDA in spite of FDAapproved protocols.’’ 10 Preliminarily, it 

should be noted that Respondent fails to 

specify exactly what he means here by 

‘‘several research projects.’’ The record 

reveals only two clinical research 

proposals submitted to HHS involving 

marijuana that did not receive 

marijuana: Dr. Abrams’s proposal (in the 

pre-1999 era) and Dr. Russo’s 

proposal.11 In addition, it is important 

at this juncture to correct an error in 

terminology. FDA does not ‘‘approve’’ 

INDs. Rather, the IND process works as 

follows. An investigator seeking to use 

an investigational new drug in a clinical 

trial must submit an IND for the drug to 

the FDA. 21 CFR 312.40. The IND 

automatically goes into effect 30 days 

after the FDA receives the IND,12 unless 

the FDA notifies the sponsor that the 

investigation is subject to a clinical 

hold. Id. 

Thus, it is incorrect for Respondent to 

state that the FDA ‘‘approved’’ any 

‘‘protocols’’ for proposed marijuana 

research.13 More accurately stated, the 

most that can be inferred from the 

evidence is that the FDA reviewed INDs 

submitted by Dr. Abrams and Dr. Russo, 

and that the FDA did not place a 

clinical hold on either proposed 

investigation.14 However, as just 

explained, the FDA regulations indicate 

that, for Phase 1 investigations, FDA’s 

review of an IND focuses primarily on 

the safety and rights of subjects—not the 

scientific quality of the clinical 

investigation. Thus, while the FDA 

appears to have concluded that allowing 

Dr. Russo’s and Dr. Abrams’s Phase 1 

studies to proceed would not have 

presented an unacceptable risk of harm 

to the human research subjects,15 there 

is no evidentiary basis to conclude that 

FDA evaluated the scientific quality of 

either proposal—and particularly no 

basis to conclude that FDA determined 

that the studies were scientifically 

meritorious within the meaning of 21 

U.S.C. 823(f). 

As stated in the Final Order, under 

the procedures implemented by HHS in 

1999 for reviewing proposed marijuana 

research, the review by FDA on an IND 

is one part of that process.16 Yet, 

Respondent seems to want FDA’s 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices 51409 

17Several provisions of the CSA reference the 

IND provision of the FDCA. For example, 21 U.S.C. 

827(c)(2)(A) expressly excludes ‘‘research 

conducted in conformity with an exemption 

granted under [21 U.S.C. 355(i)]’’ from the CSA’s 

recordkeeping requirements. 

18 Illustrative of this point is Respondent’s 

statement in his latest submission (page 14) that ‘‘if 

a research protocol is good enough for the FDA, it 

should be good enough to be carried out.’’ 

19Prior to 1999, NIDA entered into two contracts: 

one with the grower and one with the entity that 

produced the cigarettes. In 1999, NIDA decided that 

a single contract should be awarded for both 

activities, which resulted in the contractor (a 

division of the University of Mississippi) 

continuing to grow the marijuana, but 

subcontracting to Research Triangle Institute the 

responsibility of producing the cigarettes. 74 FR at 

2122 n.79. 

20Respondent is incorrect, however, in asserting 

that the Final Order stated that NIDA carries out all 

the functions under article 23, paragraph 2. No such 

statement appears in the Final Order. 

review of an IND for Phase 1 

investigations—which focuses on the 

safety and rights of subjects, rather than 

the scientific quality of the clinical 

investigation—to serve as the entire 

review process, i.e., to supplant the fullfledged evaluation of the scientific merit 

required by 21 U.S.C. 823(f). Had 

Congress intended such a result, it 

could have easily stated in 21 U.S.C. 

823(f) that the only scientific 

prerequisite to conducting research with 

a schedule I controlled substance is that 

an IND be in effect with respect to such 

research.17 But it is evident from the 

language of § 823(f) that Congress 

intended HHS to conduct a different 

type of evaluation of the scientific merit 

of research proposals than that which 

will suffice for purposes of an IND. It is 

unclear whether Respondent fails to 

understand this distinction between the 

review by FDA of a Phase 1 IND and the 

review of the scientific merit of a 

research proposal under § 823(f), or if 

Respondent does understand this 

distinction and simply wishes that the 

less rigorous review (the Phase 1 IND 

review) would suffice so that even those 

marijuana research proposals that lack 

scientific merit could be carried out.18

For the reasons noted above, neither of 

the foregoing is a legally valid position. 

In sum, Respondent’s motion for 

reconsideration provides no basis for 

deviating from the conclusions in the 

Final Order relating to the process by 

which HHS determines the scientific 

merit of proposed marijuana research 

pursuant to 21 U.S.C. 823(f). Congress 

assigned to the Secretary of HHS 

responsibility for deciding how to carry 

out that function within HHS, and the 

evidence demonstrates that the 

procedures established by HHS in 1999, 

including the Public Health Service 

interdisciplinary review process, 

properly focus on the scientific merit of 

research proposals. As the Final Order 

indicated, that process makes marijuana 

available to all researchers who meet the 

criteria of § 823(f), and Respondent’s 

post-Final-Order submissions provide 

no evidence suggesting otherwise. 

Respondent’s desire to substitute his 

opinion for that of the Secretary as to 

what type of scientific review should be 

carried out under § 823(f), and who 

within HHS should carry it out, is 

legally untenable. 

Respondent’s claim that the supply of 

marijuana is inadequate is dependent on 

his supposition that the current HHS 

process for supplying marijuana to 

researchers improperly denies 

marijuana to researchers. That 

supposition was found in the Final 

Order to be without merit, and his latest 

submission warrants no departure from 

that finding, as explained above. 

Accordingly, Respondent has provided 

no basis to change the conclusion in the 

Final Order that he failed to meet his 

burden of proving that the supply of 

marijuana is inadequate within the 

meaning of 21 U.S.C. 823(a)(1). 

B. Respondent’s Arguments Relating to 

the Single Convention on Narcotic 

Drugs, 1961 

Respondent seeks reconsideration of 

the determinations in the Final Order 

relating to the Single Convention on 

Narcotic Drugs, 1961 (Single 

Convention). Respondent’s post-FinalOrder arguments relating to the Single 

Convention are not predicated on the 

taking of official notice of any fact. 

Nonetheless, as indicated, I have 

considered these arguments. 

Respondent’s core contentions regarding 

the Single Convention were addressed 

in the Final Order and, therefore, it is 

unnecessary to repeat all of that 

discussion here. However, in view of his 

latest submissions, a few points warrant 

reiteration and/or clarification. 

Under 21 U.S.C. 823(a), DEA must 

deny an application by a person seeking 

to become registered as a bulk 

manufacturer of a schedule I controlled 

substance if the agency determines that 

such registration would be inconsistent 

with United States obligations under 

applicable international drug control 

treaties—i.e., the Single Convention. 

When it comes to marijuana (referred to 

under the treaty as ‘‘cannabis’’), one of 

the key principles of the Single 

Convention is that the federal 

government maintain a monopoly over 

the wholesale distribution of the drug. 

As to this point, the Final Order recited 

the following statement from the 

Official Commentary to the Single 

Convention: 

Countries * * * which produce * * * 

cannabis * * *, [i]n so far as they permit 

private farmers to cultivate the plants * * *, 

cannot establish with sufficient exactitude 

the quantities harvested by individual 

producers. If they allowed the sale of the 

crops to private traders, they would not be 

in a position to ascertain with reasonable 

exactitude the amounts which enter their 

controlled trade. The effectiveness of their 

control re ́gime would thus be considerably 

weakened. In fact, experience has shown that 

permitting licensed private traders to 

purchase the crops results in diversion of 

large quantities of drugs into illicit channels. 

* * * [T]he acquisition of the crops and the 

wholesale and international trade in these 

agricultural products cannot be entrusted to 

private traders, but must be undertaken by 

governmental authorities in the producing 

countries. Article 23 * * * and article 28 

* * * therefore require a government 

monopoly of the wholesale and international 

trade in the agricultural product in question 

in the country which authorizes its 

production. 

74 FR at 2115 (citing Commentary at 

278). 

As indicated in the Final Order, the 

United States has, since 1968, 

implemented this aspect of the treaty 

through the following system carried 

out within HHS. NIDA enters into a 

contract with a private grower, with the 

grower being obligated under the 

contract to produce the amount and 

quantity of marijuana specified by NIDA 

and to produce marijuana cigarettes to 

supply researchers as directed by 

NIDA.19 Throughout the 44 years since 

the United States ratified the Single 

Convention in 1967, the entire United 

States supply of marijuana for 

researchers has been distributed through 

this system. In this manner, the United 

States Government has always 

monopolized the wholesale trade in 

marijuana, consistent with its 

obligations under the treaty. 

It is true, as Respondent points out in 

his post-Final-Order submissions, that 

the Single Convention (article 23, 

paragraph 3) calls upon parties to carry 

out the functions of article 23 by a 

single government agency. It is also true, 

as Respondent indicates, that the United 

States fails to adhere strictly to this 

provision of the treaty as both DEA and 

HHS carry out certain functions set forth 

in article 23, paragraph 2.20 Specifically, 

DEA carries out those functions of 

article 23 paragraph 2 that are 

encompassed by the DEA registration 

system, and HHS (through NIDA) carries 

out those functions relating to 

purchasing the marijuana and 

maintaining a monopoly over the 

wholesale distribution. That these 

mstockstill on DSK4VPTVN1PROD with NOTICES

51410 Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices 

21Whether, in the absence of Congressional 

action, DEA could promulgate regulations that 

would result in DEA alone carrying out all the 

functions of article 23 is beyond the scope of this 

adjudication. 

22Although Respondent argues that the 

Government does not take actual physical 

possession of the marijuana grown by the NIDA 

contractor (as contemplated by article 23, paragraph 

2(d)), one could conclude that the NIDA contract 

process does fulfill this obligation. For the reasons 

indicated above, this does not compel DEA to 

abandon the provision of article 23 requiring a 

government monopoly on the wholesale 

distribution of marijuana. See 74 FR at 2114 

(‘‘taking possession and engaging in wholesale 

distribution are two separate activities under the 

Convention’’). 

23For ease of understanding, the National Center 

is sometimes referred to here and in the Final Order 

as ‘‘the University of Mississippi.’’ 

functions are divided among the two 

agencies—rather than being carried out 

by a single agency—is a result of the 

existing statutes, regulations, and 

Congressional appropriations.21

Nonetheless, when evaluating an 

application for registration under 21 

U.S.C. 823(a), DEA must attempt to 

conform with the provisions of the 

Single Convention to the fullest extent 

possible under the existing statutory 

and regulatory framework. Accordingly, 

even in the absence of a single 

government agency carrying out all the 

functions referred to in article 23, 

paragraph 2, DEA must seek to adhere 

to the other provisions of this article 

that are attainable within the existing 

statutory and regulatory framework, 

including that which calls upon the 

United States Government to 

monopolize the wholesale distribution 

of marijuana.22

Therefore, for the reasons detailed in 

the Final Order, Respondent’s stated 

goal of becoming registered for the 

purpose of ending the Government 

monopoly on the wholesale distribution 

of marijuana to researchers is directly at 

odds with the Single Convention, which 

independently warrants denial of his 

application. Respondent seems to 

continue to either ignore and/or 

misunderstand this fundamental aspect 

of the treaty. In his latest submission, 

Respondent states (pages 20–21): ‘‘It is 

certainly true Dr. Craker seeks to 

cultivate marijuana outside NIDA’s 

monopoly, but it does not follow that 

Dr. Craker seeks to cultivate marijuana 

outside the structures of any 

government regulation. * * * Dr. Craker 

and [Mr. Doblin] are in no way opposed 

to the regulation of marijuana by 

[DEA].’’ (Emphasis in original.) This 

statement suggests that Respondent 

believes incongruously that as long as 

he agrees to comply with the DEA 

regulations relating to registration and 

security, his proposed registration 

should be deemed consistent with the 

Single Convention. Based on this flawed 

assumption, Respondent is effectively 

arguing that the provision of the Single 

Convention requiring a Government 

monopoly over the wholesale 

distribution of marijuana may be 

jettisoned whenever an applicant for 

registration promises to comply with the 

DEA regulations governing registration 

and security. 

Respondent also continues to argue 

that the marijuana he seeks to grow is 

‘‘exempt’’ from the Single Convention 

requirement of a government monopoly 

over the wholesale distribution of 

marijuana. According to Respondent, 

because he is seeking to supply 

marijuana to researchers for the purpose 

of conducting research that he hopes 

will someday lead to the FDA approval 

of marijuana as medicine, the marijuana 

he is seeking to grow should be deemed 

‘‘medicinal cannabis’’ within the 

meaning of the Single Convention and 

thus the government monopoly set forth 

in article 23, paragraph 2(e) should be 

considered inapplicable to his proposed 

activity. The Government correctly 

suggests in its responsive brief (pages 

8–9) that Respondent’s interpretation 

would vitiate the language of article 23, 

paragraph 2(e). As I stated in the 

December 2, 2010, Order, it is 

theoretically possible that a marijuanaderived drug might be approved by the 

FDA in the future that would constitute 

‘‘medicinal cannabis’’ within the 

meaning of the Single Convention. 

However, no drug product derived from 

marijuana has been approved by the 

FDA and, therefore, there is currently no 

such thing as ‘‘medicinal cannabis’’ in 

the United States. For this reason, the 

exception in article 23, paragraph 2(e) 

for ‘‘medicinal cannabis’’ has no bearing 

on this adjudication. 

For purposes of the Single 

Convention, the marijuana that 

Respondent seeks to produce is clearly 

‘‘cannabis’’ subject to the government 

monopoly under article 23, paragraph 

2(e). As to this point, the Final Order 

observed: 

In its 2005 Annual Report, the 

[International Narcotics Control Board] 

reiterated: ‘‘Articles 23 and 28 of the [Single] 

Convention provide for a national cannabis 

agency to be established in countries where 

the cannabis plant is cultivated licitly for the 

production of cannabis, even if the cannabis 

produced is used for research purposes 

only.’’ 

74 FR at 2115 (footnote omitted). 

Respondent also makes the following 

statement in his latest submission 

(pages 15–16): ‘‘Additionally, the 

conduct of the one currently DEAlicensed manufacturer, who has been 

permitted by DEA to grow large 

amounts of marijuana outside of the 

NIDA contract, disproves the theory that 

marijuana grown for any purpose other 

than to supply NIDA-approved research 

would violate the Convention.’’ 

(Emphasis in original.) Respondent is 

referring here to the cultivation of 

marijuana by the National Center for 

Natural Products Research (National 

Center), a division of the University of 

Mississippi.23 As explained in the Final 

Order, in 1999, DEA and the National 

Center entered into a Memorandum of 

Agreement (MOA) under which the 

National Center was granted an 

additional registration to manufacture 

marijuana and THC independent of its 

contract with NIDA. 74 FR at 2104 n.13. 

The Final Order further explained: 

As set forth in the MOA, the purpose of the 

registration was ‘‘to allow the Center to 

develop a new product formulation for 

effecting delivery of THC in a 

pharmaceutically acceptable dosage form 

suppository * * * and to provide crude THC 

extract to a DEA-registered manufacturer of 

THC for further purification.’’ The MOA 

further stated that, under the terms thereof, 

the Center would ‘‘manufacture marijuana for 

the purpose of extracting THC therefrom.’’ 

Subsequently, the Center submitted a new 

application for a registration to bulk 

manufacture marijuana and THC ‘‘to prepare 

marihuana extract for further purification 

into bulk active [THC] for use in launching 

FDA-approved pharmaceutical products.’’ 

DEA has not yet issued a final order as to this 

application. (DEA publishes in the Federal 

Register all final orders on applications for 

registration to bulk manufacture schedule I 

and II controlled substances.) 

The MOA further provided that ‘‘[i]n 

accordance with articles 23 and 28 of the 

Single Convention on Narcotic Drugs * * * 

private trade in ‘cannabis’ is strictly 

prohibited. Therefore, the Center shall not 

distribute any quantity of marijuana to any 

person other than an authorized DEA 

employee.’’ Continuing, the MOA explained 

that ‘‘[t]he Single Convention does not 

prohibit private trade in ‘cannabis 

preparations,’ ’’ and noted that this term, 

‘‘within the meaning of the Single 

Convention, is a mixture, solid or liquid 

containing cannabis, cannabis resin, or 

extracts or tinctures of cannabis.’’ Because 

‘‘[t]he THC that the Center will extract from 

marijuana [is] considered such a ‘cannabis 

preparation[,]’ * * * the Center may, in 

accordance with the Single Convention, 

distribute the crude THC extract to private 

entities’’ provided the Center otherwise 

complies with the CSA and DEA regulations. 

The MOA also set forth a detailed series of 

controls to maintain accountability of the 

marijuana from acquisition of the seeds 

through the extraction of THC from the 

harvested material. 

Id. (emphasis added; citations omitted). 

The Final Order further stated: 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices 51411 

In 2005, the University of Mississippi 

applied for a new registration to manufacture 

marijuana ‘‘to prepare marihuana extract for 

further purification into bulk active [THC] for 

use in launching FDA-approved 

pharmaceutical products.’’ DEA has not yet 

issued a final order as to this application and 

the University therefore does not currently 

have DEA authorization to undertake such 

activity. As with Respondent’s application, 

DEA may only grant the pending University 

of Mississippi application if the agency 

determines that the University has 

demonstrated that the registration would be 

consistent with United States treaty 

obligations and the public interest. In making 

such determinations, DEA will not simply 

rely on the prior issuance of registration 

under the 1999 MOA but will consider the 

application anew, in view of the current 

circumstances and consistent with this final 

order. Among other things that must be 

considered with respect to the pending 

University of Mississippi application, I note 

that the Commentary to the Single 

Convention states the following with respect 

to the exemption for ‘‘opium preparations’’ 

under Article 23, paragraph (e): ‘‘Opiumproducing countries may thus authorize 

private manufacture of, and private 

international and domestic wholesale trade 

in, medicinal opium and opium preparations. 

The opium other than medicinal opium 

needed for such manufacture must however 

be procured from the national opium 

agency.’’ Commentary at 284 (emphasis 

added). Whether the University of 

Mississippi’s proposed registration would be 

consistent with this aspect of the treaty has 

not yet been determined by DEA and is not 

the subject of this adjudication. 

74 FR at 2118 n.61 (emphasis in 

original; citations omitted). 

When viewing the foregoing 

statements from the Final Order in 

juxtaposition with Respondent’s latest 

assertions regarding the National Center, 

two points should be considered. First, 

the above statements reflect that as part 

of the 1999 MOA with the National 

Center, DEA insisted—as it has in 

Respondent’s case—on adherence to the 

principle under the Single Convention 

of prohibiting private trading in 

cannabis. The National Center has never 

been permitted to distribute marijuana 

to any persons except upon the specific 

instructions of NIDA through the system 

described above. Second, contrary to 

Respondent’s assertion, DEA has never 

taken the position that ‘‘marijuana 

grown for any purpose other than to 

supply NIDA-approved research would 

violate the Convention.’’ Rather, as just 

noted, DEA has consistently taken the 

position that, in accordance with the 

Single Convention, the Government 

must maintain a monopoly on the 

wholesale distribution of cannabis. 

One other argument made by 

Respondent in his latest submission 

warrants a brief response. Respondent 

repeatedly makes erroneous assertions 

about the legal and factual 

circumstances surrounding his 

application, then denounces the 

situation as a ‘‘catch-22.’’ For example, 

on page 17 of his latest submission, 

Respondent describes the following as a 

‘‘catch-22’’: ‘‘Medical marijuana does 

not exist, according to DEA, unless it is 

an FDA-approved medicine, but Dr. 

Craker’s license to supply marijuana for 

the research necessary to test such a 

medicine and secure FDA approval 

cannot be granted because medical 

marijuana does not exist.’’ In fact, not 

only DEA, but also the United States 

Supreme Court, interpreting the text of 

the CSA, has stated—unanimously— 

that marijuana is not medicine. In 

United States v. Oakland Cannabis 

Buyers’ Cooperative, 532 U.S. 483, 491 

(2001), the Court stated: ‘‘[F]or purposes 

of the [CSA], marijuana has ’no 

currently accepted medical use’ at all.’’ 

Moreover, Respondent, in denouncing 

the notion that marijuana must gain 

FDA-approval to be considered 

medicine, is objecting to what has been 

a cornerstone of the FDCA for 50 

years—that a drug may not be marketed 

as medicine in this country unless the 

FDA has determined, based on 

submissions of scientific evidence 

established in clinical trials, that the 

drug is safe and effective for the 

treatment of a disease or condition. As 

for Respondent’s contention that 

marijuana research cannot go forward 

unless he becomes registered to grow 

marijuana, as explained above in section 

A., this is flatly refuted by the fact that 

HHS and DEA authorized 17 of the last 

17 marijuana research proposals 

submitted by CMCR—all of which were 

aimed at establishing a scientific 

foundation for the FDA approval of 

marijuana. Thus, Respondent’s use of 

the term ‘‘catch-22’’ is empty rhetoric. 

C. Respondent’s Arguments Relating to 

the Involvement of Rick Doblin in 

Respondent’s Proposed Activities 

Respondent also seeks 

reconsideration of my determinations in 

the Final Order relating the involvement 

of Rick Doblin in Respondent’s 

application and proposed activities. 

Again, in the exercise of my discretion, 

I have considered Respondent’s posthearing submissions as to this issue, 

even though they do not arise out of the 

taking of official notice of any fact. 

To briefly recap, the Final Order 

listed the various ways in which Mr. 

Doblin was involved in Respondent’s 

application process and how Mr. Doblin 

would have a role in Respondent’s 

activities if the application were 

granted. 74 FR at 2126. The Final Order 

then stated: 

In short, Mr. Doblin has mapped out and 

assisted in most acts, if not every act, that 

Respondent has taken toward applying for a 

registration to manufacture marijuana and, if 

the registration were granted, Mr. Doblin 

would continue to maintain responsibility for 

managing and monitoring the activities of the 

registrant. Given this level of involvement by 

Mr. Doblin—and the passive, if not 

subservient, nature of Respondent’s 

involvement—it is appropriate under factor 

six to consider the following conduct by Mr. 

Doblin relating to controlled substances. 

First, Mr. Doblin admits that he smokes 

marijuana for ‘‘recreational use’’ on a weekly 

basis. Thus, Mr. Doblin violates federal and 

state laws relating to controlled substances 

on a weekly basis. This demonstrates that Mr. 

Doblin has disregard for the controlled 

substances laws. It is simply inconceivable 

that DEA would—consistent with its 

obligations under the CSA—grant a 

registration to engage in certain activities 

involving controlled substances where it is 

clear that a person who will have any role 

in the oversight and management of such 

activities routinely engages in the illegal use 

of controlled substances. It is still more 

untenable where that person has the level of 

oversight and management that Mr. Doblin 

would have—and where the controlled 

substance he illegally uses is the very 

controlled substance the applicant seeks to 

produce. Indeed, it is remarkable that Mr. 

Doblin would—given his admitted illegal 

involvement in controlled substances—ask 

DEA to effectively grant him permission to 

take on such a prominent role in the 

manufacture of the most widely abused 

illegal controlled substance in the United 

States. 

Id. (emphasis in original; citations and 

footnotes omitted). 

In his latest submission, Respondent 

points out that in the Final Order, under 

the fifth public interest factor (21 U.S.C. 

823(a)(5)), I concluded that if the 

registration were granted, Respondent 

would have in the establishment (i.e., in 

his growing facility) effective controls 

against diversion. 74 FR 2125–26. 

Respondent contends that this 

conclusion precludes me from 

concluding under the sixth public 

interest factor (21 U.S.C. 823(a)(6)) that 

Mr. Doblin’s involvement in 

Respondent’s activity weighs against 

granting his application. 

It is plain when comparing the text of 

factor five with that of factor six that a 

favorable finding with respect to factor 

five does not preclude an unfavorable 

finding under factor six. As explained in 

the Final Order, under public interest 

factor five, ‘‘the existence in the 

establishment of effective control 

against diversion’’ includes, among 

other considerations, appropriate 

physical security and employee 

screening as required by the DEA 

mstockstill on DSK4VPTVN1PROD with NOTICES

51412 Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices 

1The Show Cause Order alleged that in March 

2001, Registrant and DEA entered into a 

Memorandum of Agreement (MOA) which settled a 

Show Cause Proceeding filed in April 2000 based 

on the allegations described above. Show Cause 

Order at 2. The Show Cause Order also alleged that 

under the MOA, Registrant surrendered his 

registration and was allowed to reapply no earlier 

than March 2004, and that in October 2004, DEA 

issued him a new registration. Id. 

regulations as confirmed through a DEA 

on-site inspection of the premises. 74 

FR at 2128 (citing 21 CFR 1310.71– 

1301.93). Factor six, in contrast, is a 

catchall category that is designed to give 

DEA wide latitude to consider all 

evidence that might reasonably bear on 

the suitability of an applicant for 

registration. In other words, even if a 

registrant has promised to undertake 

security procedures sufficient to obtain 

a favorable finding under factor five, if 

other evidence (not covered by factors 

one through five) casts doubt on 

whether the applicant can be entrusted 

with the responsibility of a DEA 

manufacturing registration, such 

evidence may be considered under 

factor six. 

Consider, for example, if a person 

were seeking to become registered as a 

manufacturer of oxycodone, and the 

applicant promised to install and 

maintain in the facility all the physical 

security measures and employee 

screening procedures required by the 

regulations. Assume further that 

evidence came to light that the main 

investor in the facility, who planned to 

make the decisions as to how the facility 

would distribute oxycodone, admitted 

that he obtains oxycodone illegally and 

uses it for ‘‘recreational’’ purposes on a 

weekly basis. In such circumstances, it 

would certainly be appropriate for DEA 

to draw an adverse inference under 

factor six based on such person’s illicit 

activity involving oxycodone— 

regardless of whether the applicant 

made assurances that it would comply 

with the security regulations. Thus, I 

cannot adopt Respondent’s suggestion 

that Mr. Doblin’s regular marijuana use 

should be ignored as a factor relevant to 

his application. 

Nonetheless, it bears repeating that 

the ultimate decision in this matter did 

not turn on consideration of Mr. 

Doblin’s marijuana activity. As stated in 

the Final Order, two other independent 

grounds existed for denying the 

application and, therefore, the same 

result would have been reached had I 

determined that Mr. Doblin’s marijuana 

activity were irrelevant. 

To be clear, if I determined that the 

proposed registration were consistent 

with United States obligations under the 

Single Convention and further that the 

supply of marijuana available to 

researchers in the United States were 

inadequate within the meaning of 21 

U.S.C. 823(a)(1), it is conceivable that 

arrangements could have been made to 

mitigate the concerns regarding Mr. 

Doblin’s marijuana activity. For 

example, under a conditional grant of 

registration or memorandum of 

agreement, sufficient terms perhaps 

could have been imposed to ensure that 

Mr. Doblin would not be allowed to 

have access to the growing facility and 

would have no role in any decision 

making relating to management of the 

facility or the distribution of marijuana. 

However, consideration of such an 

approach was not feasible here given the 

other grounds for denying the 

application. 

IV. Conclusion 

For the foregoing reasons, 

Respondent’s motion for 

reconsideration is hereby denied. The 

administrative record is modified as 

indicated herein and in my December 2, 

2010, order. The January 14, 2009, Final 

Order, as supplemented by this order, is 

effective on September 7, 2011. 

Dated: August 8, 2011. 

Michele M. Leonhart, 

Administrator. 

[FR Doc. 2011–21064 Filed 8–17–11; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Joe C. Fermo, M.D.; Revocation of 

Registration 

On September 30, 2009, the Deputy 

Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration, issued an Order to 

Show Cause to Joe C. Fermo, M.D. 

(Registrant), of Tulsa, Oklahoma. The 

Show Cause Order proposed the 

revocation of Registrant’s DEA 

Certificate of Registration, BF7430781, 

as well as the denial of any pending 

applications to renew or modify his 

registration, on the ground that his 

‘‘continued registration would be 

inconsistent with the public interest.’’ 

Show Cause Order at 1 (citing 21 U.S.C. 

823(f) and 824(a)(4)). 

The Show Cause Order specifically 

alleged that on February 23, 1990, 

Registrant was convicted in the District 

Court for Oklahoma County, State of 

Oklahoma, of ten counts of submitting 

false claims to the Oklahoma 

Department of Human Services in 

violation of Oklahoma law, and that on 

June 20, 1990, the United States 

Department of Health and Human 

Services excluded him from 

participating in federal health care 

programs under 42 U.S.C. 1320a–7(a). 

Id. at 1–2. The Order further alleged that 

based on his convictions, on June 21, 

1990, the Oklahoma State Board of 

Medical Licensure placed his medical 

license on probation and that Registrant 

materially falsified three separate 

applications (in 1991, 1994, and 1997) 

to renew his DEA registration by failing 

to disclose the state board’s action. Id. 

at 2 (citing 21 U.S.C. 824(a)(1)).1

Finally, the Show Cause Order alleged 

that on August 27, September 24, and 

September 26, 2007, an undercover 

officer had obtained prescriptions from 

Registrant for alprazolam (at all three 

visits) and propoxyphene (at the first 

two visits), both of which are schedule 

IV controlled substances. Id. The Order 

further alleged that these prescriptions 

lacked a legitimate medical purpose and 

were issued outside of the usual course 

of professional practice in violation of 

Federal and State laws. Id. (citing 21 

CFR 1306.04 and Okla. Admin. Code 

475.30–1–3(a)). 

On or about October 5, 2009, the 

Show Cause Order, which also notified 

Registrant of his right to either request 

a hearing on the allegations or to submit 

a written statement in lieu of a hearing, 

the procedures for doing so, and the 

consequence if he failed to do so, was 

served on Registrant by certified mail 

addressed to him at the address of his 

registered location. Id. at 2–3 (citing 21 

CFR 1301.43). Since service of the Show 

Cause Order, more than thirty days have 

now passed and neither Registrant, nor 

anyone purporting to represent him, has 

either requested a hearing or submitted 

a written statement in lieu of a hearing. 

See 21 CFR 1301.43(b)–(d). Accordingly, 

I find that Registrant has waived his 

rights to a hearing or to submit a written 

statement. Id. 1301.43(d). I therefore 

issue this Decision and Final Order 

without a hearing based on relevant 

evidence contained in the investigative 

record submitted by the Government. 

Findings 

Registrant is the holder of DEA 

Certificate of Registration, BF7430781, 

which authorizes him to dispense 

controlled substances in schedules II 

through V as a practitioner at the 

registered location of 5970 E. 31 St., 

Suite O, Tulsa, Oklahoma. While his 

registration was to expire on September 

30, 2010, on August 13, 2010, Registrant 

filed a renewal application. In 

accordance with the Administrative 

Procedure Act and DEA regulations, I 

find that Registrant’s registration 

remains in effect pending the issuance 

mstockstill on DSK4VPTVN1PROD with NOTICES