79296 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Rules and Regulations 

Medicine (HFV–170), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8197, 

e-mail: john.harshman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Taro 

Pharmaceuticals U.S.A., Inc., 3 Skyline 

Dr., Hawthorne, NY 10532, filed 

ANADA 200–457 that provides for 

veterinary prescription use of 

Mupirocin Ointment USP, 2% for the 

treatment of bacterial skin infections in 

dogs. Taro Pharmaceuticals U.S.A., 

Inc.’s Mupirocin Ointment USP, 2% is 

approved as a generic copy of Pfizer, 

Inc.’s BACTODERM Ointment approved 

under NADA 140–839. The ANADA is 

approved as of November 29, 2010, and 

the regulations are amended in 21 CFR 

524.1465 to reflect the approval. 

In addition, Taro Pharmaceuticals 

U.S.A., Inc., has not been previously 

listed in the animal drug regulations as 

a sponsor of an approved application. 

Accordingly, the tables in 21 CFR 

510.600(c) are being amended to add 

entries for this firm. 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), a 

summary of safety and effectiveness 

data and information submitted to 

support approval of this application 

may be seen in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852, between 

9 a.m. and 4 p.m., Monday through 

Friday. 

The Agency has determined under 21 

CFR 25.33 that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’ 

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

List of Subjects 

21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

21 CFR Part 524 

Animal drugs. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR parts 510 and 524 are amended as 

follows: 

PART 510—NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 510 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 360b, 371, 379e. 

■ 2. In § 510.600, in the table in 

paragraph (c)(1) alphabetically add an 

entry for ‘‘Taro Pharmaceuticals U.S.A., 

Inc.’’; and in the table in paragraph (c)(2) 

numerically add an entry for ‘‘051672’’ 

to read as follows: 

§ 510.600 Names, addresses, and drug 

labeler codes of sponsors of approved 

applications. 

* * * * * 

(c) * * * 

(1) * * * 

Firm name and address Drug labeler 

code 

* * * * * 

Taro Pharmaceuticals 

U.S.A., Inc., 3 Skyline Dr., 

Hawthorne, NY 10532 ...... 051672 

* * * * * 

(2) * * * 

Drug labeler 

code Firm name and address 

* * * * * 

051672 ........ Taro Pharmaceuticals U.S.A., 

Inc., 3 Skyline Dr., Hawthorne, NY 10532. 

* * * * * 

PART 524—OPHTHALMIC AND 

TOPICAL DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 3. The authority citation for 21 CFR 

part 524 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

§ 524.1465 [Amended] 

■ 4. In paragraph (b) of § 524.1465, 

remove ‘‘Nos. 000069 and 025463’’ and 

in its place add ‘‘Nos. 000069, 025463, 

and 051672’’. 

Dated: December 10, 2010. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2010–31870 Filed 12–17–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–331F] 

Schedules of Controlled Substances: 

Placement of 5-Methoxy-N,NDimethyltryptamine into Schedule I of 

the Controlled Substances Act 

AGENCY: Drug Enforcement 

Administration (DEA), Department of 

Justice. 

ACTION: Final rule. 

SUMMARY: With the issuance of this final 

rule, the Deputy Administrator of the 

Drug Enforcement Administration 

(DEA) places the substance 5-methoxyN,N-dimethyltryptamine (5-MeO-DMT), 

including its salts, isomers and salts of 

isomers whenever the existence of such 

salts, isomers, and salts of isomers is 

possible, into schedule I of the 

Controlled Substances Act (CSA). This 

action by the DEA Deputy 

Administrator is based on a scheduling 

recommendation from the Assistant 

Secretary for Health of the Department 

of Health and Human Services (DHHS) 

and a DEA review indicating that 5- 

MeO-DMT meets the criteria for 

placement in schedule I of the CSA. 

This final rule will impose the criminal 

sanctions and regulatory controls of 

schedule I substances under the CSA on 

the manufacture, distribution, 

dispensing, importation, exportation, 

and possession of 5-MeO-DMT. 

DATES: Effective Date: January 19, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Christine A. Sannerud, PhD, Chief, Drug 

and Chemical Evaluation Section, Office 

of Diversion Control, Drug Enforcement 

Administration, 8701 Morrissette Drive, 

Springfield, Virginia 22152, Telephone: 

(202) 307–7183. 

SUPPLEMENTARY INFORMATION: 

Background 

In accordance with 21 U.S.C. 811(b) of 

the CSA, DEA gathered and reviewed 

the available information regarding the 

pharmacology, chemistry, trafficking, 

actual abuse, pattern of abuse, and the 

relative potential for abuse of 5- 

methoxy-N,N-dimethyltryptamine (5- 

MeO-DMT). On February 21, 2007, the 

Deputy Administrator of the DEA 

submitted these data to the Assistant 

Secretary for Health, Department of 

Health and Human Services. In 

accordance with 21 U.S.C. 811(b), the 

Deputy Administrator also requested a 

scientific and medical evaluation and a 

scheduling recommendation for 5-MeOVerDate Mar<15>2010 19:04 Dec 17, 2010 Jkt 223001 PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 E:\FR\FM\20DER1.SGM 20DER1

jlentini on DSKJ8SOYB1PROD with RULES
Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Rules and Regulations 79297 

DMT from the Assistant Secretary for 

Health. 

5-MeO-DMT is related to the schedule 

I hallucinogens N,Ndimethyltryptamine (DMT), 2,5- 

dimethoxy-4-methylamphetamine 

(DOM), lysergic acid diethylamide 

(LSD) and mescaline in its 

pharmacological properties and 

hallucinogenic effects. In animal drug 

discrimination studies, DOM, LSD, 

mescaline, DMT, and alphamethyltryptamine (AMT) fully 

substitute for the discriminative 

stimulus cue of 5-MeO-DMT. In in vitro 

receptor binding studies, 5-MeO-DMT, 

similar to DMT and other schedule I 

hallucinogens, binds to central 

serotonin 2 (5-HT2) receptors. Anecdotal 

reports from humans who have used 5- 

MeO-DMT describe hallucinogenic 

effects similar to those produced by 

DMT. 5-MeO-DMT, however, is reported 

to be 4 to 5-fold more potent than DMT 

when administered by inhalation, 

sublingual or oral (if encapsulated) 

routes of administration. 

Evidence of 5-MeO-DMT trafficking 

was first reported in 1999 by Federal 

law enforcement officials. Though 5- 

MeO-DMT is likely to be underreported 

because it is not a controlled substance, 

from January 1999 to December 2009, 

law enforcement officials encountered 

23 cases involving 35 drug exhibits 

pertaining to the trafficking, distribution 

and abuse of 5-MeO-DMT, according to 

the System to Retrieve Information from 

Drug Evidence (STRIDE), a Federal 

database of drug exhibits analyzed by 

DEA laboratories. The drug exhibits 

analyzed by DEA laboratories comprised 

89 grams of powder and 10 milliliters of 

liquid containing 5-MeO-DMT. From 

January 2004 to December 2009, the 

National Forensic Laboratory 

Information System (NFLIS), a database 

of drug analyses conducted by State and 

local forensic laboratories, reported 27 

State and local drug cases involving 32 

drug exhibits identified as 5-MeO-DMT. 

The risks to the public health 

associated with the abuse of 5-MeODMT are similar to the risks associated 

with those of schedule I hallucinogens. 

There have been reports of emergency 

room admissions and a death associated 

with the abuse of 5-MeO-DMT. 5-MeODMT has never been approved by the 

Food and Drug Administration (FDA) 

for marketing as a human drug product 

in the United States and there are no 

recognized therapeutic uses of 5-MeODMT in the United States. 

Notice of Proposed Rulemaking 

On December 18, 2008, the Principal 

Deputy Assistant Secretary for Health, 

Department of Health and Human 

Services (DHHS), sent the Deputy 

Administrator of the DEA a scientific 

and medical evaluation and a letter 

recommending that 5-MeO-DMT and its 

salts be placed into schedule I of the 

CSA. Enclosed with the letter was a 

document prepared by FDA entitled, 

‘‘Basis for the Recommendation To 

Control 5-Methoxy-Dimethyltryptamine 

(5-MeO-DMT) in Schedule I of the 

Controlled Substances Act.’’ The 

document contained a review of the 

factors which the CSA requires the 

Secretary to consider (21 U.S.C. 811(b)). 

After a review of the available data, 

including the scientific and medical 

evaluation and the scheduling 

recommendation from DHHS, the 

Deputy Administrator of the DEA 

published a Notice of Proposed 

Rulemaking entitled ‘‘Schedules of 

Controlled Substances: Placement of 5- 

Methoxy-Dimethyltryptamine into 

Schedule I of the Controlled Substances 

Act’’ on August 21, 2009 (74 FR 42217), 

which proposed placement of 5-MeODMT in schedule I of the CSA. The 

proposed rule provided an opportunity 

for all interested persons to submit their 

written comments on or before 

September 21, 2009. 

After the comment period closed on 

September 21, 2009, DEA discovered 

that the supporting documents 

referenced in the proposed rule were 

not posted to the electronic docket, thus 

not available for review. DEA reopened 

the public comment period (October 28, 

2009, Notice of Proposed Rulemaking) 

(74FR55502) for an additional 30 days 

to ensure all interested members of the 

public had an opportunity to review all 

the materials and provide comments. 

Comments submitted on or before 

November 27, 2009, were considered. 

Comments Received 

The DEA received 22 comments in 

response to the August 21, 2009, and 

October 28, 2009, Notices of Proposed 

Rulemaking. Five comments were 

received in response to the first Notice 

of Proposed Rulemaking. An additional 

17 comments were received during the 

30-day reopening of the comment 

period. One of the comments submitted 

contained only supporting materials for 

another comment that was submitted. 

All commenters were concerned 

citizens, none of whom identified 

themselves as representing 

organizations. 

Support for the rule as proposed: One 

commenter supported the proposal to 

schedule 5-MeO-DMT in schedule I. 

DEA appreciates the support of this 

commenter for this final rule. 

Twenty of the comments were in 

opposition to the proposed scheduling 

of 5-MeO-DMT in schedule I of the CSA. 

Various reasons for the disapproval of 

the scheduling of 5-MeO-DMT were 

provided. Most comments can be 

grouped into the following general 

categories: (1) Those concerned that the 

comment or request for hearing period 

was inadequate and requesting an 

extension of the comment or request for 

hearing period, (2) those concerned that 

5-MeO-DMT is a naturally occurring 

substance and thus should not be 

controlled, (3) those that questioned the 

pharmacological and abuse potential 

findings considered by DEA and DHHS 

for the purpose of scheduling 5-MeODMT, (4) those concerned that the 

proposed scheduling would limit access 

to 5-MeO-DMT for research, and (5) 

those that alleged violations of the 

Establishment Clause and/or the Free 

Exercise Clause of the First Amendment 

or raised other legal challenges. 

Length of comment or request for 

hearing period: Several commenters felt 

that the length of the comment or 

request for hearing period was too short 

and requested that the comment or 

request for hearing period be extended, 

to as much as 24 months. Some 

commenters noted the need to research 

pharmacological, religious or other 

evidence regarding 5-MeO-DMT and 

prepare comments and stated there was 

not enough time before the comment 

period closed to obtain or prepare this 

information. 

In response to these comments, DEA 

does not believe that a further extension 

or reopening of the comment or request 

for hearing period is necessary or 

warranted. Pharmacological and abuse 

data on 5-MeO-DMT are publicly 

available and easily retrievable. The 

period for comments and requests for 

hearings with regard to the Notices of 

Proposed Rulemaking was thirty (30) 

days from the date of publication of 

each Notice of Proposed Rulemaking. 

Interested persons who wished to 

submit written data, views or arguments 

have had ample opportunity to use the 

information in the medical and 

scientific literature, which are available 

to the public from various resources 

(e.g., U.S. National Library of Medicine, 

public libraries, and Web sites of 

scientific journals), along with the 

supplemental information provided by 

DEA (i.e., DEA’s scheduling review 

document and FDA’s scientific and 

medical evaluation and scheduling 

recommendation) as well as other 

sources of information such as 

publications by Federal agencies (e.g., 

reports from DEA’s NFLIS, National 

Institute on Drug Abuse’s (NIDA) 

National Survey on Drug Use and 

Health, Substance Abuse and Mental 


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79298 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Rules and Regulations 

Health Services Administration’s Drug 

Abuse Warning Network, and NIDA’s 

Monitoring the Future) to submit 

meaningful comments on 5-MeO-DMT 

that can be supported by data or 

scientific arguments. These data are 

publicly available and easily retrievable. 

DEA has considered the amount of time 

needed to obtain and review documents 

and supporting materials relevant to the 

commenter’s position, prepare the 

comment, and submit the comment and 

finds that a 30-day comment period 

provides a meaningful opportunity for 

interested persons to submit comments 

or request a hearing. While commenters 

indicated that an extension of the 

comment period would allow time for 

further research regarding 5-MeO-DMT, 

DEA notes that this scheduling action 

does not prevent such research from 

occurring. Any person wishing to 

conduct research using 5-MeO-DMT 

may do so provided that the person has 

obtained a schedule I researcher 

registration with DEA, has the 

appropriate research protocols in place 

with FDA, and meets all other 

requirements. 

Use of http://www.regulations.gov: 

Several commenters discussed the use 

of http://www.regulations.gov, the 

government’s online Federal Docket 

Management System (FDMS). 

Commenters stated that the document 

reopening the comment period was 

posted to the electronic docket on 

http://www.regulations.gov on October 

28, 2009, but that certain supporting 

materials were not posted until 

November 3, 2009. In a related 

comment, a commenter objected to the 

‘‘splitting’’ of the electronic docket for 

the reopening of the comment period 

from the electronic docket for the Notice 

of Proposed Rulemaking. The 

commenter indicated that ‘‘splitting’’ the 

dockets made it difficult to view all 

docket components and made it 

‘‘extremely difficult to communicate to 

others where and how to locate, view, 

or comment on Docket No. DEA–331.’’ 

DEA disagrees with these comments. 

The supporting documents were posted 

to the electronic docket (Docket ID DEA 

2009–0008) on September 30, 2009, and 

October 2, 2009. DEA acknowledges that 

the electronic docket for the Notice of 

Proposed Rulemaking was separate from 

the electronic docket for the reopening 

of the comment period. This electronic 

method of posting, however, merely 

supplemented the notice provisions 

required by the Administrative 

Procedure Act (5 U.S.C. 553). Both the 

Notice of Proposed Rulemaking and the 

extension of the comment period were 

published in the Federal Register (74 

FR 42217, August 21, 2009, and 74 FR 

55502, October 28, 2009, respectively), 

in accordance with administrative law 

requirements. Although not required to 

do so, DEA posted a Statement for the 

Record in the Federal Docket 

Management System (FDMS) Docket ID 

DEA–2009–0008 (the August 21, 2009, 

Notice of Proposed Rulemaking) to alert 

the public that the Notice of Proposed 

Rulemaking to reopen the comment 

period was located in FDMS Docket ID 

DEA–2009–0013. 

5-MeO-DMT is a naturally occurring 

substance: Some commenters objected 

to the proposed scheduling of 5-MeODMT because 5-MeO-DMT is a naturally 

occurring substance. DEA has 

considered these comments and 

acknowledges the biological presence of 

5-MeO-DMT in humans and in certain 

toads and plant species. However, DEA 

disagrees with the contention that the 

fact that 5-MeO-DMT is a naturally 

occurring substance prevents it from 

being controlled. DHHS and DEA have 

considered the eight factors 

determinative of control set out in 21 

U.S.C. 811(c), and DEA has considered 

the recommendations of DHHS in 

making the findings under 21 U.S.C. 812 

that warrant placement in schedule I of 

the CSA. 

Insufficient data: Several commenters 

believed that insufficient data exist to 

support the placement of 5-MeO-DMT 

into schedule I. For example, a few 

commenters argued that 5-MeO-DMT 

does not have toxic effects or lead to 

addiction or harmful behavior. In 

addition, a commenter incorrectly stated 

that there were no reported deaths 

associated with the use of 5-MeO-DMT. 

Other commenters suggested that the 

scheduling of 5-MeO-DMT be 

postponed until more research could be 

done. 

DEA does not agree with these 

statements. The studies used to assess 

abuse potential of 5-MeO-DMT are 

widely held as the standard methods of 

evaluation. Behavioral effects of 5-MeODMT in animals and humans were 

found to be similar to those of the 

schedule I hallucinogens. Preclinical 

studies indicated that 5-MeO-DMT has 

pharmacological effects at serotonin 

receptors. In humans, 5-MeO-DMT 

produced subjective responses similar 

to DMT and other schedule I 

hallucinogens. In addition, DEA finds 

that the abuse of 5-MeO-DMT presents 

a safety hazard to the health of 

individuals. There are reports of 

emergency room admissions and a death 

associated with the abuse of 5-MeODMT. After careful consideration of 

preclinical and clinical studies and in 

accordance with 21 U.S.C. 811(a) and 

(b) and considering the factors 

enumerated in 21 U.S.C. 811(c), the 

Deputy Administrator of the DEA finds 

that 5-MeO-DMT has high abuse 

potential supporting placement in 

schedule I under the CSA. 

Control of DMT: One commenter 

questioned the evidence considered by 

DEA to make the findings to control 

‘‘DMT.’’ DEA finds that this comment is 

not relevant to the present scheduling 

action as this Final Rule pertains to the 

scheduling of 5-MeO-DMT. However, if 

the commenter intended to refer to 5- 

MeO-DMT and not DMT, the reasons for 

controlling 5-MeO-DMT have already 

been provided. 

Prohibition or restriction of use in 

research: Commenters expressed 

concern that the proposed scheduling of 

5-MeO-DMT will prohibit or 

significantly restrict the use of 5-MeODMT in research. The DEA does not 

agree. As noted previously, persons 

interested in using 5-MeO-DMT for 

research purposes can still use this 

substance provided that they have a 

DEA schedule I researcher registration 

and meet all other statutory and 

regulatory criteria. This registration can 

be obtained by submitting an 

application for schedule I registration in 

accordance with 21 CFR 1301.18. 

Constitutional concerns: Several 

commenters raised concerns that the 

proposed rule would substantially 

impair religious liberty. The 

commenters raised two specific 

concerns with respect to religion. First, 

the commenters questioned the 

proposed rule on the ground that the 

CSA, which authorizes this rulemaking, 

violates both the Free Exercise Clause 

and the Establishment Clause of the 

First Amendment. DEA has fully 

considered these concerns, and does not 

believe any change in the rule is 

necessary. With respect to the Free 

Exercise Clause, one commenter 

claimed that the CSA is not a neutral 

law of general applicability under 

Employment Division v. Smith, 494 U.S. 

872 (1990), because the CSA includes 

exemptions for the use of alcohol, 

certain research and medical uses of 

certain substances, and the sacramental 

use of peyote by the Native American 

Church. This concern has been raised 

previously in litigation, and courts have 

concluded that the CSA does not 

interfere with the free exercise of 

religion in violation of the First 

Amendment. See Olsen v. Mukasey, 541 

F.3d 827 (8th Cir. 2008); O Centro 

Espirita Beneficiente Uniao do Vegetal 

v. Mukasey, No. 00–1647 (D. N. M. June 

16, 2008). The commenter raised similar 

concerns about the CSA with respect to 

the Establishment Clause of the First 

Amendment. Once again, courts have 


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Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Rules and Regulations 79299 

upheld the validity of the CSA in the 

face of related challenges and concluded 

that the statute does not represent an 

establishment of religion in 

contravention of the First Amendment. 

Peyote Way Church of God v. 

Thornburgh, 922 F.2d 1210 (5th Cir. 

1991); United States v. Valazquez, 2009 

WL 2823730 (W.D. Okla. Aug. 31, 2009). 

Another commenter suggested that if 

the final rule scheduling 5-MeO-DMT is 

issued without change, DEA should 

consider ‘‘providing special exemption 

for religious use.’’ The commenter did 

not provide any specific details about 

the kind of exemption that he believed 

would be appropriate. Accordingly, 

DEA lacks the information necessary to 

evaluate this comment. 

Finally, one commenter questioned 

DEA’s finding that the proposed rule 

does not have federalism implications 

warranting the application of Executive 

Order 13132. DEA has considered this 

concern and concurs with the 

conclusion that the placement of 5- 

MeO-DMT and its salts into schedule I 

of the CSA does not preempt or modify 

any provision of State law; nor does it 

impose enforcement responsibilities on 

any State; nor does it diminish the 

power of any State to enforce its own 

laws. 

Scheduling of 5-MeO-DMT 

Based on the recommendation of the 

Assistant Secretary for Health, received 

in accordance with section 201(b) of the 

Act (21 U.S.C. 811(b)), the independent 

review of the available data by DEA, and 

after a review of the comments received 

in response to the Notice of Proposed 

Rulemaking and the notice reopening 

the comment period, the Deputy 

Administrator, pursuant to sections 

201(a) and 201(b) of the Act (21 U.S.C. 

811(a) and 811(b)), finds that: 

(1) 5-MeO-DMT has a high potential 

for abuse. 

(2) 5-MeO-DMT has no currently 

accepted medical use in treatment in the 

United States. 

(3) There is a lack of accepted safety 

for use of 5-MeO-DMT under medical 

supervision. 

Based on these findings, the Deputy 

Administrator of the DEA concludes 

that 5-MeO-DMT and its salts warrant 

control in schedule I of the CSA (21 

U.S.C. 812 (b)(1)). 

Regulatory Requirements 

As noted below, 5-MeO-DMT will be 

subject to regulatory controls and 

administrative, civil and criminal 

sanctions applicable to the manufacture, 

distribution, dispensing, importation 

and exportation of a schedule I 

controlled substance, including the 

following: 

Registration. Any person who 

manufactures, distributes, dispenses, 

imports or exports 5-MeO-DMT or who 

engages in research or conducts 

instructional activities with respect to 5- 

MeO-DMT, or who proposes to engage 

in such activities, must submit an 

application for schedule I registration in 

accordance with part 1301 of Title 21 of 

the Code of Federal Regulations. Any 

person who is currently engaged in any 

of the above activities and is not 

registered with DEA must submit an 

application for registration on or before 

January 19, 2011 and may continue their 

activities until DEA has approved or 

denied that application. 

Security. 5-MeO-DMT is subject to 

schedule I security requirements and 

must be manufactured, distributed and 

stored in accordance with §§ 1301.71; 

1301.72(a), (c), and (d); 1301.73; 

1301.74; 1301.75(a) and (c); and 1301.76 

of Title 21 of the Code of Federal 

Regulations on or after January 19, 2011. 

Labeling and Packaging. All labels 

and labeling for commercial containers 

of 5-MeO-DMT which are distributed on 

or after January 19, 2011 must comply 

with the requirements of §§ 1302.03 

through 1302.07 of Title 21 of the Code 

of Federal Regulations on or after 

January 19, 2011. 

Quotas. Quotas for 5-MeO-DMT must 

be established pursuant to the 

requirements of part 1303 of Title 21 of 

the Code of Federal Regulations. 

Inventory. Every registrant required to 

keep records and who possesses any 

quantity of 5-MeO-DMT must keep an 

inventory of all stocks of 5-MeO-DMT 

on hand pursuant to §§ 1304.03, 1304.04 

and 1304.11 of Title 21 of the Code of 

Federal Regulations on or after January 

19, 2011. Every registrant who desires 

registration in schedule I to handle 5- 

MeO-DMT must conduct an inventory 

of all stocks of the substance. 

Records. All registrants who handle 5- 

MeO-DMT must keep records pursuant 

to §§ 1304.03, 1304.04, 1304.21, 

1304.22, and 1304.23 of Title 21 of the 

Code of Federal Regulations on or after 

January 19, 2011. 

Reports. All registrants required to 

submit reports in accordance with 

§ 1304.33 of Title 21 of the Code of 

Federal Regulations must do so 

regarding 5-MeO-DMT on and after 

January 19, 2011. 

Order Forms. All registrants involved 

in the distribution of 5-MeO-DMT must 

comply with the order form 

requirements of part 1305 of Title 21 of 

the Code of Federal Regulations on and 

after January 19, 2011. 

Importation and Exportation. All 

importation and exportation of 5-MeODMT must be in compliance with part 

1312 of Title 21 of the Code of Federal 

Regulations on or after January 19, 2011. 

Criminal Liability. Any activity with 

5-MeO-DMT not authorized by, or in 

violation of, the Controlled Substances 

Act or the Controlled Substances Import 

and Export Act shall be unlawful on or 

after January 19, 2011. 

Regulatory Certifications 

Executive Order 12866 

In accordance with the provisions of 

the CSA (21 U.S.C. 811(a)), this action 

is a formal rulemaking ‘‘on the record 

after opportunity for a hearing.’’ Such 

proceedings are conducted pursuant to 

the provisions of 5 U.S.C. 556 and 557 

and, as such, are exempt from review by 

the Office of Management and Budget 

pursuant to Executive Order 12866, 

section 3(d)(1). 

Regulatory Flexibility Act 

The Deputy Administrator, in 

accordance with the Regulatory 

Flexibility Act (5 U.S.C. 601–612), has 

reviewed this final rule and by 

approving it certifies that it will not 

have a significant economic impact on 

a substantial number of small entities. 

This action involves the control of a 

substance with no currently accepted 

medical use in treatment in the United 

States. This final rule will place 5-MeODMT into schedule I of the Controlled 

Substances Act. 

Executive Order 12988 

This regulation meets the applicable 

standards set forth in Sections 3(a) and 

3(b)(2) of Executive Order 12988 Civil 

Justice Reform. 

Executive Order 13132 

This rulemaking does not preempt or 

modify any provision of State law; nor 

does it impose enforcement 

responsibilities on any State; nor does it 

diminish the power of any State to 

enforce its own laws. Accordingly, this 

rulemaking does not have federalism 

implications warranting the application 

of Executive Order 13132. 

Unfunded Mandates Reform Act of 1995 

This rule will not result in the 

expenditure by State, local and Tribal 

governments, in the aggregate, or by the 

private sector, of $126,400,000 or more 

(adjusted for inflation) in any one year, 

and will not significantly or uniquely 

affect small governments. Therefore, no 

actions were deemed necessary under 

provisions of the Unfunded Mandates 

Reform Act of 1995. 


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79300 Federal Register / Vol. 75, No. 243 / Monday, December 20, 2010 / Rules and Regulations 

Congressional Review Act 

This rule is not a major rule as 

defined by § 804 of the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (Congressional Review Act). This 

rule will not result in an annual effect 

on the economy of $100,000,000 or 

more; a major increase in costs or prices: 

or significant adverse effects on 

competition, employment, investment, 

productivity, innovation, or on the 

ability of United States-based 

companies to compete with foreign 

based companies in domestic and 

export markets. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Narcotics, Prescription drugs. 

Under the authority vested in the 

Attorney General by section 201(a) of 

the CSA (21 U.S.C. 811(a)), and 

delegated to the Administrator of DEA 

by Department of Justice regulations (28 

CFR 0.100), and redelegated to the 

Deputy Administrator pursuant to 28 

CFR 0.104, the Deputy Administrator 

hereby amends 21 CFR part 1308 as 

follows: 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ 1. The authority citation for part 1308 

continues to read as follows: 

Authority: 21 U.S.C. 811, 812, 871(b) 

unless otherwise noted. 

■ 2. Section 1308.11 is amended by: 

■ A. Redesignating existing paragraphs 

(d)(15) through (d)(34) as paragraphs 

(d)(16) through (d)(35); and 

■ B. Adding a new paragraph (d)(15). 

§ 1308.11 Schedule I. 

* * * * * 

(d) * * * 

(15) 5-methoxy-N,Ndimethyltryptamine 7431. Some trade or 

other names: 5-methoxy-3-[2- 

(dimethylamino)ethyl]indole; 5-MeODMT 

* * * * * 

Dated: December 13, 2010. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. 2010–31854 Filed 12–17–10; 8:45 am] 

BILLING CODE 4410–09–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R04–OAR–2009–0041–201058; FRL– 

9241–1] 

Approval and Promulgation of 

Implementation Plans; Mississippi; 

Prevention of Significant Deterioration 

Rules: Nitrogen Oxides as a Precursor 

to Ozone 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is taking final action to 

approve a portion of a revision to the 

Mississippi State Implementation Plan 

(SIP), submitted by the Mississippi 

Department of Environmental Quality 

(MDEQ), to EPA on November 28, 2007. 

The revision amends Mississippi’s 

prevention of significant deterioration 

(PSD) permitting regulations in the SIP 

to address permit requirements 

promulgated in the 1997 8-Hour Ozone 

National Ambient Air Quality Standards 

(NAAQS) Implementation Rule-Phase II 

(hereafter referred to as the ‘‘Ozone 

Implementation New Source Review 

(NSR) Update’’). The Ozone 

Implementation NSR Update revised 

permit requirements relating to the 

implementation of the 1997 8-hour 

ozone NAAQS specifically 

incorporating nitrogen oxides (NOX) as 

a precursor to ozone. EPA’s approval of 

Mississippi’s provisions to include NOX

as an ozone precursor into the 

Mississippi SIP is based on EPA’s 

determination that Mississippi’s SIP 

revision related to these provisions 

complies with Federal requirements. 

DATES: Effective Date: This rule will be 

effective January 19, 2011. 

ADDRESSES: EPA has established a 

docket for this action under Docket 

Identification No. EPA–R04–OAR– 

2009–0041. All documents in the docket 

are listed on the http:// 

www.regulations.gov Web site. Although 

listed in the index, some information is 

not publicly available, i.e., Confidential 

Business Information or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either 

electronically through http:// 

www.regulations.gov or in hard copy at 

the Regulatory Development Section, 

Air Planning Branch, Air, Pesticides and 

Toxics Management Division, U.S. 

Environmental Protection Agency, 

Region 4, 61 Forsyth Street, SW., 

Atlanta, Georgia 30303–8960. EPA 

requests that if at all possible, you 

contact the person listed in the FOR

FURTHER INFORMATION CONTACT section to 

schedule your inspection. The Regional 

Office’s official hours of business are 

Monday through Friday, 8:30 to 4:30 

excluding Federal holidays. 

FOR FURTHER INFORMATION CONTACT: For 

information regarding the Mississippi 

SIP, contact Ms. Twunjala Bradley, 

Regulatory Development Section, Air 

Planning Branch, Air, Pesticides and 

Toxics Management Division, U.S. 

Environmental Protection Agency, 

Region 4, 61 Forsyth Street, SW., 

Atlanta, Georgia 30303–8960. 

Telephone number: (404) 562–9352; email address: bradley.twunjala@epa.gov. 

For information regarding NSR/PSD, 

contact Ms. Yolanda Adams, Air 

Permits Section, at the same address 

above. Telephone number: (404) 562– 

9214; e-mail address: 

adams.yolanda@epa.gov. For 

information regarding 8-hour ozone 

NAAQS, contact Ms. Jane Spann, 

Regulatory Development Section, at the 

same address above. Telephone number: 

(404) 562–9029; e-mail address: 

spann.jane@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background 

II. Today’s Action 

III. Final Action 

IV. Statutory and Executive Order Reviews 

I. Background 

On July 18, 1997, EPA promulgated a 

revised 8-hour ozone NAAQS of 0.08 

parts per million—also referred to as the 

1997 8-hour ozone NAAQS. On April 

30, 2004, EPA designated areas as 

attainment, nonattainment and 

unclassifiable for the 1997 8-hour ozone 

NAAQS. As part of the 2004 

designations, EPA also promulgated an 

implementation rule for the 1997 8-hour 

ozone NAAQS in two phases. Phase I of 

EPA’s 1997 8-hour ozone 

implementation rule (Phase 1 Rule), 

published on April 30, 2004, and 

effective on June 15, 2004, provided the 

implementation requirements for 

designating areas under subpart 1 and 

subpart 2 of the CAA. 69 FR 23857. 

On November 29, 2005, EPA 

promulgated the second phase for 

implementation provisions related to 

the 1997 8-hour ozone NAAQS which 

finalized regulations to implement the 

8-hour NAAQS for PSD permitting 

purposes—also known as the Phase II 

Rule. 70 FR 71612. The Phase II Rule 

addressed control and planning 

requirements as they applied to areas 


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