6190 Federal Register / Vol. 81, No. 24 / Friday, February 5, 2016 / Proposed Rules 

(r)(1)(iii) of this AD, if those actions were 

performed before the effective date of this AD 

using Messier-Dowty Service Bulletin A33/

34–32–284, including Appendix A, dated 

May 11, 2010, which is not incorporated by 

reference in this AD. 

(9) This paragraph provides credit for the 

corresponding actions required by 

paragraphs (n)(1) and (r)(1)(ii) of this AD, if 

those actions were performed before the 

effective date of this AD using Messier-Dowty 

Service Bulletin A33/34–32–278, including 

Appendixes A and B, dated February 17, 

2010, which is not incorporated by reference 

in this AD. 

(q) Clarification of Inspection Compliance 

Times 

After accomplishment of the one-time 

detailed inspection required by paragraph (h) 

of this AD, the repetitive actions required by 

paragraph (g) of this AD remain applicable, 

and must be done within the compliance 

times specified in paragraph (g) of this AD. 

(r) Parts Installation Limitations 

(1) After modification of an airplane, as 

required by paragraph (k) of this AD, or as 

specified in paragraphs (n)(1) and (n)(2) of 

this AD, do not install an MLG bogie beam 

on any airplane unless it is done in 

compliance with the requirements of 

paragraph (r)(1)(i), (r)(1)(ii), or (r)(1)(iii) of 

this AD. 

(i) The MLG bogie beam has been modified 

and re-identified in accordance with the 

Accomplishment Instructions of Airbus 

Mandatory Service Bulletin A330–32–3237 

or A340–32–4279, both Revision 1, both 

dated October 14, 2011, as applicable. 

(ii) The MLG bogie beam has been 

inspected and all applicable corrective 

actions have been done in accordance with 

the Accomplishment Instructions of MessierDowty Service Bulletin A33/34–32–278, 

Revision 1, dated August 24, 2011; and 

modified in accordance with the 

Accomplishment Instructions of MessierDowty Service Bulletin A33/34–32–283 or 

A33/34–32–284, both Revision 1, both dated 

July 10, 2012. 

(iii) The MLG bogie beam has a serial 

number listed in Appendix A of MessierDowty Service Bulletin A33/34–32–283 or 

A33/34–32–284, both Revision 1, both dated 

July 10, 2012. 

(2) As of the effective date of this AD, 

except as specified in paragraph (r)(1) of this 

AD, installation of an MLG bogie beam on an 

airplane is allowed, provided that following 

the installation it is inspected and all 

applicable repairs and corrective actions 

have been done in accordance with the 

requirements of this AD. 

(s) Related Information 

(1) Refer to Mandatory Continuing 

Airworthiness Information (MCAI) European 

Aviation Safety Agency (EASA) AD 2013– 

0267R1, dated March 4, 2014, corrected 

March 8, 2014, for related information. This 

MCAI may be found in the AD docket on the 

Internet at http://www.regulations.gov by 

searching for and locating Docket No. FAA– 

2013–0828. 

(2) For Airbus service information 

identified in this AD, contact Airbus SAS, 

Airworthiness Office—EAL, 1 Rond Point 

Maurice Bellonte, 31707 Blagnac Cedex, 

France; telephone: +33 5 61 93 36 96; fax: 

+33 5 61 93 45 80; email: 

airworthiness.A330-A340@airbus.com; 

Internet http://www.airbus.com. 

(3) For Messier-Dowty service information 

identified in this AD, contact Messier-Dowty: 

Messier Services Americas, Customer 

Support Center, 45360 Severn Way, Sterling, 

VA 20166–8910; telephone 703–450–8233; 

fax 703–404–1621; Internet https://techpubs.

services/messier-dowty.com. 

(4) You may view this service information 

at the FAA, Transport Airplane Directorate, 

1601 Lind Avenue SW., Renton, WA. For 

information on the availability of this 

material at the FAA, call 425–227–1221. 

Issued in Renton, Washington, on January 

27, 2016. 

Michael Kaszycki, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. 2016–02161 Filed 2–4–16; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–433] 

Schedules of Controlled Substances: 

Placement of PB-22, 5F-PB-22, ABFUBINACA and ADB-PINACA into 

Schedule I 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Drug Enforcement 

Administration proposes placing 

quinolin-8-yl 1-pentyl-1H-indole-3- 

carboxylate (PB-22; QUPIC), quinolin-8- 

yl 1-(5-fluoropentyl)-1H-indole-3- 

carboxylate (5-fluoro-PB-22; 5F-PB-22), 

N-(1-amino-3-methyl-1-oxobutan-2-yl)- 

1-(4-fluorobenzyl)-1H-indazole-3- 

carboxamide (AB-FUBINACA) and N-(1- 

amino-3,3-dimethyl-1-oxobutan-2-yl)-1- 

pentyl-1H-indazole-3-carboxamide 

(ADB-PINACA), including their 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. This proposed scheduling action is 

pursuant to the Controlled Substances 

Act which requires that such actions be 

made on the record after opportunity for 

a hearing through formal rulemaking. If 

finalized, this action would impose the 

regulatory controls and administrative, 

civil, and criminal sanctions applicable 

to schedule I controlled substances on 

persons who handle (manufacture, 

distribute, import, export, engage in 

research, conduct instructional 

activities or chemical analysis, or 

possess), or propose to handle PB-22, 

5F-PB-22, AB-FUBINACA, or ADBPINACA. 

DATES: Interested persons may file 

written comments on this proposal in 

accordance with 21 CFR 1308.43(g). 

Comments must be submitted 

electronically or postmarked on or 

before March 7, 2016. Commenters 

should be aware that the electronic 

Federal Docket Management System 

will not accept comments after 11:59 

p.m. Eastern Time on the last day of the 

comment period. 

Interested persons, defined at 21 CFR 

1300.01 as those ‘‘adversely affected or 

aggrieved by any rule or proposed rule 

issuable pursuant to section 201 of the 

Act (21 U.S.C. 811),’’ may file a request 

for hearing or waiver of hearing 

pursuant to 21 CFR 1308.44 and in 

accordance with 21 CFR 1316.45 and/or 

1316.47, as applicable. Requests for 

hearing and waivers of an opportunity 

for a hearing or to participate in a 

hearing must be received on or before 

March 7, 2016. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–433’’ on all electronic and 

written correspondence, including any 

attachments. 

• Electronic comments: The Drug 

Enforcement Administration encourages 

that all comments be submitted 

electronically through the Federal 

eRulemaking Portal which provides the 

ability to type short comments directly 

into the comment field on the Web page 

or attach a file for lengthier comments. 

Please go to http://www.regulations.gov 

and follow the online instructions at 

that site for submitting comments. Upon 

completion of your submission you will 

receive a Comment Tracking Number for 

your comment. Please be aware that 

submitted comments are not 

instantaneously available for public 

view on Regulations.gov. If you have 

received a Comment Tracking Number, 

your comment has been successfully 

submitted and there is no need to 

resubmit the same comment. 

• Paper comments: Paper comments 

that duplicate the electronic submission 

are not necessary. Should you wish to 

mail a paper comment, in lieu of an 

electronic comment, it should be sent 

via regular or express mail to: Drug 

Enforcement Administration, Attn: DEA 

Federal Register Representative/ODW, 

8701 Morrissette Drive, Springfield, 

Virginia 22152. 

• Hearing requests: All requests for a 

hearing and waivers of participation 

must be sent to: Drug Enforcement 

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Federal Register / Vol. 81, No. 24 / Friday, February 5, 2016 / Proposed Rules 6191 

1As discussed in a memorandum of 

understanding entered into by the Food and Drug 

Administration (FDA) and the National Institute on 

Drug Abuse (NIDA), the FDA acts as the lead agency 

within the HHS in carrying out the Secretary’s 

scheduling responsibilities under the CSA, with the 

concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. 

The Secretary of the HHS has delegated to the 

Assistant Secretary for Health of the HHS the 

authority to make domestic drug scheduling 

recommendations. 58 FR 35460, July 1, 1993. 

Administration, Attn: Administrator, 

8701 Morrissette Drive, Springfield, 

Virginia 22152. All requests for hearing 

and waivers of participation should be 

sent to: (1) Drug Enforcement 

Administration, Attn: Hearing Clerk/LJ, 

8701 Morrissette Drive, Springfield, 

Virginia 22152; and (2) Drug 

Enforcement Administration, Attn: DEA 

Federal Register Representative/ODW, 

8701 Morrissette Drive, Springfield, 

Virginia 22152. 

FOR FURTHER INFORMATION CONTACT: 

Barbara J. Boockholdt, Office of 

Diversion Control, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152; Telephone: (202) 598–6812. 

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments 

Please note that all comments 

received in response to this docket are 

considered part of the public record. 

They will, unless reasonable cause is 

given, be made available by the Drug 

Enforcement Administration (DEA) for 

public inspection online at http://

www.regulations.gov. Such information 

includes personal identifying 

information (such as your name, 

address, etc.) voluntarily submitted by 

the commenter. The Freedom of 

Information Act (FOIA) applies to all 

comments received. If you want to 

submit personal identifying information 

(such as your name, address, etc.) as 

part of your comment, but do not want 

it to be made publicly available, you 

must include the phrase ‘‘PERSONAL 

IDENTIFYING INFORMATION’’ in the 

first paragraph of your comment. You 

must also place all of the personal 

identifying information you do not want 

made publicly available in the first 

paragraph of your comment and identify 

what information you want redacted. 

If you want to submit confidential 

business information as part of your 

comment, but do not want it to be made 

publicly available, you must include the 

phrase ‘‘CONFIDENTIAL BUSINESS 

INFORMATION’’ in the first paragraph 

of your comment. You must also 

prominently identify the confidential 

business information to be redacted 

within the comment. 

Comments containing personal 

identifying information or confidential 

business information identified as 

directed above will be made publicly 

available in redacted form. If a comment 

has so much confidential business 

information that it cannot be effectively 

redacted, all or part of that comment 

may not be made publicly available. 

Comments posted to http://

www.regulations.gov may include any 

personal identifying information (such 

as name, address, and phone number) 

included in the text of your electronic 

submission that is not identified as 

directed above as confidential. 

An electronic copy of this document 

and supplemental information to this 

proposed rule are available at http://

www.regulations.gov for easy reference. 

Request for Hearing, or Waiver of 

Participation in Hearing 

Pursuant to 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 the 

Administrative Procedure Act (APA), 5 

U.S.C. 551–559. 21 CFR 1308.41– 

1308.45; 21 CFR part 1316, subpart D. 

In accordance with 21 CFR 1308.44(a)– 

(c), requests for hearing, notices of 

appearance, and waivers of an 

opportunity for a hearing or to 

participate in a hearing may be 

submitted only by interested persons, 

defined as those ‘‘adversely affected or 

aggrieved by any rule or proposed rule 

issuable pursuant to section 201 of the 

Act (21 U.S.C. 811).’’ 21 CFR 1300.01. 

Such requests or notices must conform 

to the requirements of 21 CFR 

1308.44(a) or (b), and 1316.47 or 

1316.48, as applicable, and include a 

statement of interest of the person in the 

proceeding and the objections or issues, 

if any, concerning which the person 

desires to be heard. Any waiver must 

conform to the requirements of 21 CFR 

1308.44(c) and may include a written 

statement regarding the interested 

person’s position on the matters of fact 

and law involved in any hearing. 

Please note that pursuant to 21 U.S.C. 

811(a), the purpose and subject matter 

of a hearing held in relation to this 

rulemaking is restricted to: ‘‘(A) 

find[ing] that such drug or other 

substance has a potential for abuse, and 

(B) mak[ing] with respect to such drug 

or other substance the findings 

prescribed by subsection (b) of section 

812 of this title for the schedule in 

which such drug is to be placed * * *.’’ 

All requests for hearing and waivers 

participation must be sent to the DEA 

using the address information provided 

above. 

Legal Authority 

The DEA implements and enforces 

Titles II and III of the Comprehensive 

Drug Abuse Prevention and Control Act 

of 1970, as amended. Titles II and III are 

referred to as the ‘‘Controlled 

Substances Act’’ and the ‘‘Controlled 

Substances Import and Export Act,’’ 

respectively, and are collectively 

referred to as the ‘‘Controlled 

Substances Act’’ or the ‘‘CSA’’ for the 

purpose of this action. 21 U.S.C. 801– 

971. The DEA publishes the 

implementing regulations for these 

statutes in title 21 of the Code of Federal 

Regulations (CFR), chapter II. The CSA 

and its implementing regulations are 

designed to prevent, detect, and 

eliminate the diversion of controlled 

substances and listed chemicals into the 

illicit market while providing for the 

legitimate medical, scientific, research, 

and industrial needs of the United 

States. Controlled substances have the 

potential for abuse and dependence and 

are controlled to protect the public 

health and safety. 

Under the CSA, controlled substances 

are classified into one of five schedules 

based upon their potential for abuse, 

their currently accepted medical use, 

and the degree of dependence the 

substance may cause. 21 U.S.C. 812. The 

initial schedules of controlled 

substances established by Congress are 

found at 21 U.S.C. 812(c), and the 

current list of scheduled substances is 

published at 21 CFR part 1308. 

Pursuant to 21 U.S.C. 811(a)(1), the 

Attorney General may, by rule, ‘‘add to 

such a schedule or transfer between 

such schedules any drug or other 

substance if he (A) finds that such drug 

or other substance has a potential for 

abuse, and (B) makes with respect to 

such drug or other substance the 

findings prescribed by subsection (b) of 

section 812 of this title for the schedule 

in which such drug is to be placed 

* * *.’’ The Attorney General has 

delegated scheduling authority under 21 

U.S.C. 811 to the Administrator of the 

DEA. 28 CFR 0.100. 

The CSA provides that proceedings 

for the issuance, amendment, or repeal 

of the scheduling of any drug or other 

substance may be initiated by the 

Attorney General (1) on her own 

motion; (2) at the request of the 

Secretary of the Department of Health 

and Human Services (HHS); 1 or (3) on 

the petition of any interested party. 21 

U.S.C. 811(a). This proposed action is 

supported by a recommendation from 

the Assistant Secretary of the HHS and 

an evaluation of all other relevant data 

by the DEA. If finalized, this action 

would impose the regulatory controls 

and administrative, civil, and criminal 

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6192 Federal Register / Vol. 81, No. 24 / Friday, February 5, 2016 / Proposed Rules 

2Comprehensive Drug Abuse Prevention and 

Control Act of 1970, H.R. Rep. No. 91–1444, 91st 

Cong., Sess. 1 (1970); reprinted in 1970 

U.S.C.C.A.N. 4566, 4603. 

sanctions of schedule I controlled 

substances on any person who handles 

or proposes to handle PB-22, 5F-PB-22, 

AB-FUBINACA, or ADB-PINACA. 

Background 

On February 10, 2014, the DEA 

published a final order in the Federal 

Register amending 21 CFR 1308.11(h) to 

temporarily place quinolin-8-yl 1- 

pentyl-1H-indole-3-carboxylate (PB-22; 

QUPIC); quinolin-8-yl 1-(5- 

fluoropentyl)-1H-indole-3-carboxylate 

(5-fluoro-PB-22; 5F-PB-22); N-(1-amino3-methyl-1-oxobutan-2-yl)-1-(4- 

fluorobenzyl)-1H-indazole-3- 

carboxamide (AB-FUBINACA); and N- 

(1-amino-3,3-dimethyl-1-oxobutan-2-yl)- 

1-pentyl-1H-indazole-3-carboxamide 

(ADB-PINACA) into schedule I of the 

CSA pursuant to the temporary 

scheduling provisions of 21 U.S.C. 

811(h). 79 FR 7577. That final order, 

which became effective on the date of 

publication, was based on findings by 

the Deputy Administrator of the DEA 

that the temporary scheduling of these 

four synthetic cannabinoids (SCs) was 

necessary to avoid an imminent hazard 

to the public safety pursuant to 21 

U.S.C. 811(h)(1). At the time the final 

order took effect, section 201(h)(2) of the 

CSA, 21 U.S.C. 811(h)(2), required that 

the temporary scheduling of a substance 

expire at the end of two years from the 

date of issuance of the scheduling order, 

and it provided that, during the 

pendency of proceedings under 21 

U.S.C. 811(a)(1) with respect to the 

substance, temporary scheduling of that 

substance could be extended for up to 

1 year. Pursuant to 21 U.S.C. 811(h)(2), 

the temporary scheduling of PB-22; 

QUPIC, 5F-PB-22, AB-FUBINACA, and 

ADB-PINACA expires on February 9, 

2016, unless extended. An extension of 

the temporary order is being ordered by 

the DEA Administrator in a separate 

action. 

These four SCs have not been 

investigated for medical use nor are they 

intended for human use. With no 

known legitimate use and safety 

information, manufacturers are 

surreptitiously adulterating plant 

material with these SCs and distributors 

are selling the associated products 

which pose potentially dangerous 

consequences to the consumer. 

The Assistant Secretary of Health for 

the U.S. Department of Health and 

Human Services (HHS) has advised that 

there are no exemptions or approvals in 

effect for PB-22, 5F-PB-22, ABFUBINACA, or ADB-PINACA under 

section 505 (21 U.S.C. 355) of the 

Federal Food, Drug, and Cosmetic Act. 

As stated by the HHS, PB-22, 5F-PB-22, 

AB-FUBINACA, and ADB-PINACA have 

no known accepted medical use. They 

are not the subject of any approved new 

drug applications (NDAs) or 

investigational new drug applications 

(INDs), and are not currently marketed 

as approved drug products. The HHS 

recommends that PB-22, 5F-PB-22, ABFUBINACA, ADB-PINACA, and their 

salts be placed into schedule I of the 

Controlled Substances Act (CSA). 

Proposed Determination To Schedule 

PB-22, 5F-PB-22, AB-FUBINACA, and 

ADB-PINACA 

Pursuant to 21 U.S.C. 811(a)(1), 

proceedings to add a drug or substance 

to those controlled under the CSA may 

be initiated by the Attorney General, or 

her delegate, the DEA Administrator. On 

December 30, 2014, the DEA requested 

scientific and medical evaluations and 

scheduling recommendations from the 

Assistant Secretary of Health for the 

U.S. Department of Health and Human 

Services (HHS) for PB-22, 5F-PB-22, ABFUBINACA and ADB-PINACA pursuant 

to 21 U.S.C. 811(b). Upon receipt of the 

scientific and medical evaluations and 

scheduling recommendations from the 

HHS dated January 19, 2016, the DEA 

reviewed the documents and all other 

relevant data and conducted its own 

eight-factor analysis of the abuse 

potential of PB-22, 5F-PB-22, ABFUBINACA and ADB-PINACA pursuant 

to 21 U.S.C. 811(c). Included below is a 

brief summary of each factor as 

analyzed by the HHS and the DEA, and 

as considered by the DEA in its 

proposed scheduling action. Please note 

that both the DEA 8-Factor and HHS 8- 

Factor analyses and the Assistant 

Secretary’s January 19, 2016, letter, are 

available in their entirety under the tab 

‘‘Supporting Documents’’ of the public 

docket of this action at http://

www.regulations.gov, under Docket 

Number ‘‘DEA–433.’’ 

1. The Drug’s Actual or Relative 

Potential for Abuse: The term ‘‘abuse’’ is 

not defined in the CSA. However, the 

legislative history of the CSA suggests 

that the DEA consider the following 

criteria in determining whether a 

particular drug or substance has a 

potential for abuse 2: 

(a) There is evidence that individuals 

are taking the drug or drugs containing 

such a substance in amounts sufficient 

to create a hazard to their health or to 

the safety of other individuals or of the 

community; or 

(b) There is significant diversion of 

the drug or drugs containing such a 

substance from legitimate drug 

channels; or 

(c) Individuals are taking the drug or 

drugs containing such a substance on 

their own initiative rather than on the 

basis of medical advice from a 

practitioner licensed by law to 

administer such drugs in the course of 

his professional practice; or 

(d) The drug or drugs containing such 

a substance are new drugs so related in 

their action to a drug or drugs already 

listed as having a potential for abuse to 

make it likely that the drug will have 

the same potentiality for abuse as such 

drugs, thus making it reasonable to 

assume that there may be significant 

diversions from legitimate channels, 

significant use contrary to or without 

medical advice, or that it has a 

substantial capability of creating 

hazards to the health of the user or to 

the safety of the community. 

Review of scientific and medical 

literature indicates that the ingestion of 

synthetic cannabinoids leads to adverse 

health effects. Specifically, adverse 

effects following ingestion have 

included: Seizures, neurotoxicity and 

death for PB-22; respiratory failure, 

organ failure, and death for 5F-PB-22; 

diaphoresis, nausea, confusion, 

tachycardia and death for ABFUBINACA; and anxiety, delirium, 

psychosis, aggression, seizures and 

death for ADB-PINACA. 

The American Association of Poison 

Control Centers (AAPCC) has reported 

7,779 exposures to SCs from January 1 

through December 31, 2015. The 

significance of this value is based upon 

reporting of human exposures to SCs 

since 2011. While 2012–2014 saw a 

reduction in exposure calls to the 

AAPCC, 2015 records demonstrate 

resurgence in calls to poison centers 

regarding SCs. In addition, the largest 

monthly tally ever recorded by AAPCC 

in reference to SCs occurred in April 

2015, with 1,511 calls. 

The HHS stated that there are no 

FDA-approved drug products containing 

PB-22, 5F-PB-22, AB-FUBINACA, and 

ADB-PINACA in the United States and 

there appear to be no legitimate sources 

for these substances as marketed drugs. 

According to the HHS, because PB-22, 

5F-PB-22, AB-FUBINACA and ADBPINACA are not approved for medical 

use and are not formulated or available 

for clinical use, the human use of these 

substances is assumed to be on an 

individual’s own initiative, rather than 

on the basis of medical advice from a 

practitioner licensed by law to 

administer drugs. Further, AAPCC 

reports, published scientific and 

medical literature, and law enforcement 

reports indicate that individuals are 

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taking these SCs on their own initiative, 

rather than on the medical advice of a 

licensed practitioner. As noted by the 

HHS, pharmacological studies 

sponsored by NIDA have demonstrated 

that PB-22, 5F-PB-22, AB-FUBINACA, 

and ADB-PINACA are similar to other 

schedule I SCs. All four of these 

substances, similar to other schedule I 

SCs, display high affinity binding and 

potent agonist functional activity at the 

cannabinoid (CB1) receptor, while drug 

discrimination studies have 

demonstrated the ability of all four 

substances to substitute for delta-9- 

tetrahydrocannabinol (THC) (see Factor 

2). The results supporting CB1 agonist 

activity of PB-22 and 5F-PB-22 are 

consistent with the similar findings 

reported in published literature. 

2. Scientific Evidence of the Drug’s 

Pharmacological Effects, if Known: In 

vitro receptor binding and functional 

assays were conducted with PB-22, 5FPB-22, AB-FUBINACA, and ADBPINACA. In addition, drug 

discrimination assays using Sprague 

Dawley rats were performed to identify 

drugs with similar subjective effects to 

THC. These results indicate that PB-22, 

5F-PB-22, AB-FUBINACA, and ADBPINACA, similar to other schedule I 

SCs, bind to CB1 receptors with high 

affinity and act as agonists at CB1 

receptors. 

Based on results from the receptor 

binding (Ki), CB1 functional assay, and 

drug discrimination studies, the HHS 

concluded that PB-22, 5F-PB-22, ABFUBINACA, and ADB-PINACA act as 

full psychoactive cannabinoid agonists 

with no antagonist activity and that 

these four substances are more potent 

than THC, the principal psychoactive 

chemical in marijuana (schedule I), and 

are similar in activity to JWH-018 

(schedule I). 

3. The State of Current Scientific 

Knowledge Regarding the Drug or Other 

Substance: The DEA is not aware of any 

currently accepted medical uses for PB22, 5F-PB-22, AB-FUBINACA or ADBPINACA. A letter dated November 7, 

2013 was sent from the DEA Deputy 

Administrator to the Assistant Secretary 

for Health of the Department for Health 

and Human Services as notification of 

intent to temporarily place these four 

substances in schedule I and solicited 

information, including whether there 

was an exemption or approval in effect 

for the substances in question under the 

Federal Food, Drug and Cosmetic Act. 

The Assistant Secretary of Health 

responded that there were no current 

INDs or NDAs for these synthetic 

cannabinoids in a letter to the DEA 

Assistant Administrator dated January 

27, 2014. The scientific and medical 

evaluations provided by the HHS also 

stated that PB-22, 5F-PB-22, ABFUBINACA, and ADB-PINACA have no 

currently accepted medical use. These 

SCs are not the subject of an approved 

NDAs or INDs, and are not currently 

marketed as approved drug products. In 

recent overdoses, PB-22, 5F-PB-22, ABFUBINACA, and ADB-PINACA have 

been found to be laced on green plant 

material, similar to the SCs that have 

been previously encountered. 

4. Its History and Current Pattern of 

Abuse: Since the initial identification of 

JWH-018 (November 2008), many 

additional synthetic cannabinoids have 

been found to be applied on plant 

material and encountered as designer 

drug products. A major concern, as 

reiterated by public health officials and 

medical professionals, remains the 

targeting and direct marketing of SCs 

and SC-containing products to 

adolescents and youth. The Monitoring 

the Future project, begun in 1975, 

studies changes in beliefs, attitudes, and 

behavior of young people in the United 

States. While the Monitoring the Future 

survey reported decreases in prevalence 

amongst 8th, 10th, and 12th grade 

students over the past two years, 

AAPCC reports for SCs in 2015 were the 

highest observed since reporting began 

in 2011. Reports in 2015 more than 

doubled compared to those shown for 

2011. Smoking mixtures of these 

substances abused for the purpose of 

achieving intoxication has resulted in 

numerous emergency department visits 

and calls to poison control centers. As 

reported by the AAPCC, adverse effects 

including severe agitation, anxiety, 

racing heartbeat, high blood pressure, 

nausea, vomiting, seizures, tremors, 

intense hallucinations, psychotic 

episodes, suicide, and other harmful 

thoughts and/or actions can occur 

following ingestion of SCs. 

Presentations at emergency departments 

directly linked to the abuse of PB-22, 

5F-PB-22, AB-FUBINACA, and ADBPINACA have resulted in similar 

symptoms, including severe agitation, 

seizures, and/or death. 

5. The Scope, Duration, and 

Significance of Abuse: PB-22 and 5F-PB22 are synthetic cannabinoids that have 

pharmacological effects similar to the 

schedule I hallucinogen THC. PB-22 and 

5F-PB-22 were not reported in the 

scientific literature prior to their 

appearance on the illicit drug market. A 

report from March 2013 identified PB22 as a component of dried plant 

material obtained via the Internet 

between July 2012 and January 2013 in 

Japan. 

AB-FUBINACA is also a synthetic 

cannabinoid that has pharmacological 

effects similar to the schedule I 

hallucinogen THC. First appearing in a 

2009 patent filed by the pharmaceutical 

manufacturer Pfizer, AB-FUBINACA 

was first reported in the scientific 

literature as a component of so-called 

‘‘herbal products’’ purchased via the 

Internet in July 2012. 

ADB-PINACA was first encountered 

in the United States following reports of 

serious adverse events in Georgia on 

August 23, 2013. Reports of ADBPINACA were not found in the scientific 

literature prior to its emergence on the 

designer drug market. The Georgia 

Bureau of Investigation (GBI) reported 

on September 12, 2013 that ADBPINACA, was detected in ‘‘herbal 

incense’’ products sold under the brand 

name ‘‘Crazy Clown.’’ It was later 

confirmed by the Centers for Disease 

Control and Prevention (CDC) as the 

substance responsible for severe adverse 

events in at least 22 persons who 

consumed the product. In addition, on 

August 30, 2013, the Colorado 

Department of Public Health and 

Environment (CDPHE) was notified by 

several hospitals of an increase in the 

number of patients visiting their 

emergency departments with altered 

mental status after using synthetic 

cannabinoids. On September 8, 2013, 

the CDPHE, with the assistance of the 

CDC, began an epidemiologic 

investigation whereby 221 cases of 

severe illness due to ingestion of a 

synthetic cannabinoid were identified. 

Those that presented at emergency 

rooms in the Denver, Colorado area 

around September 1, 2013 had 

symptoms similar to those found in the 

August 2013 Georgia incident. 

Laboratory analysis of samples from the 

Colorado incident confirmed that the 

substance abused in the ‘‘herbal 

incense’’ products was ADB-PINACA. 

The AAPCC report published on April 

23, 2015 showed a marked spike in 

poison center exposure calls throughout 

the United States in 2015 related to SCs. 

The AAPCC reported 1,512 exposure 

calls in April 2015, representing an 

almost three-fold increase in exposures 

to SCs as compared to the previous 

largest monthly tally (657 exposures in 

January 2012) since reporting began in 

2011. For the first time since reporting 

began by the AAPCC in 2011, the 

number of SC cases in 2015 has 

dramatically risen, more than doubling 

those reported in 2014. The numbers of 

SC cases reported in 2015 were the 

highest ever recorded. 

6. What, if Any, Risk There is to the 

Public Health: As stated by the HHS, 

based solely on their pharmacological 

similarity to JWH-018 and THC and 

their potency, the subjective risks to the 

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6194 Federal Register / Vol. 81, No. 24 / Friday, February 5, 2016 / Proposed Rules 

3PB-22, 5F-PB-22, AB-FUBINACA and ADBPINACA are currently subject to schedule I controls 

on a temporary basis, pursuant to 21 U.S.C. 811(h). 

79 FR 7577, Feb. 10, 2014. 

public health of PB-22, 5F-PB-22, ABFUBINACA, and ADB-PINACA are 

similar to those of other SCs, which are 

controlled in schedule I of the CSA. 

Warnings regarding the dangers 

associated with abuse of synthetic 

cannabinoids and their products have 

been issued by numerous state public 

health departments and poison control 

centers and private organizations. Some 

of the common clinical effects reported 

in emergency rooms in response to the 

abuse of synthetic cannabinoids include 

vomiting, anxiety, agitation, irritability, 

seizures, hallucinations, tachycardia, 

elevated blood pressure, and loss of 

consciousness. 

At least ten deaths have been reported 

involving the four SCs, including at 

least 3 involving PB-22, 5 involving 5FPB-22, 1 involving AB-FUBINACA, and 

1 involving ADB-PINACA. As 

mentioned above, there are reported 

instances of emergency department 

admissions in association with the 

abuse of PB-22 and 5F-PB-22. 

Additional deaths involving a variety of 

SCs have been reported, along with 

additional instances of severe toxic 

effects following ingestion of SCs. 

7. Its Psychic or Physiological 

Dependence Liability: As stated by the 

HHS, PB-22, 5F-PB-22, AB-FUBINACA 

and ADB-PINACA have 

pharmacological profiles that are similar 

to other schedule I SCs. Thus it is 

reasonable to assume that PB-22, 5F-PB22, AB-FUBINACA and ADB-PINACA 

possess physiological and psychological 

dependence liability that is similar to 

that of other schedule I cannabinoids 

(THC and JWH-018). While PB-22, 5FPB-22, AB-FUBINACA and ADBPINACA are pharmacologically related 

to JWH-018, no studies regarding the 

psychic or physiological dependence 

liability of PB-22, 5F-PB-22, ABFUBINACA, or ADB-PINACA have been 

identified. 

8. Whether the Substance is an 

Immediate Precursor of a Substance 

Already Controlled Under the CSA: PB22, 5F-PB-22, AB-FUBINACA, and ADBPINACA are not considered an 

immediate precursor of any controlled 

substance of the CSA. 

Conclusion: After considering the 

scientific and medical evaluation 

conducted by the HHS, the HHS’s 

recommendation, and the DEA’s own 

eight-factor analysis, the DEA finds that 

the facts and all relevant data constitute 

substantial evidence of the potential for 

abuse of PB-22, 5F-PB-22, ABFUBINACA and ADB-PINACA. As such, 

the DEA hereby proposes to schedule 

PB-22, 5F-PB-22, AB-FUBINACA and 

ADB-PINACA as controlled substances 

under the CSA. 

Proposed Determination of Appropriate 

Schedule 

The CSA establishes five schedules of 

controlled substances known as 

schedules I, II, III, IV, and V. The CSA 

also outlines the findings required to 

place a drug or other substance in any 

particular schedule. 21 U.S.C. 812(b). 

After consideration of the analysis and 

recommendation of the Assistant 

Secretary for HHS and review of all 

other available data, the Administrator 

of the DEA, pursuant to 21 U.S.C. 811(a) 

and 21 U.S.C. 812(b)(1), finds that: 

1. PB-22, 5F-PB-22, AB-FUBINACA 

and ADB-PINACA have a high potential 

for abuse that is comparable to other 

schedule I substances such as delta 9- 

tetrahydrocannabinol (THC) and JWH018; 

2. PB-22, 5F-PB-22, AB-FUBINACA 

and ADB-PINACA have no currently 

accepted medical use in treatment in the 

United States; and 

3. There is a lack of accepted safety 

for use of PB-22, 5F-PB-22, ABFUBINACA and ADB-PINACA under 

medical supervision. 

Based on these findings, the 

Administrator of the DEA concludes 

that quinolin-8-yl 1-pentyl-1H-indole-3- 

carboxylate (PB-22; QUPIC), quinolin-8- 

yl 1-(5-fluoropentyl)-1H-indole-3- 

carboxylate (5-fluoro-PB-22; 5F-PB-22), 

N-(1-amino-3-methyl-1-oxobutan-2-yl)- 

1-(4-fluorobenzyl)-1H-indazole-3- 

carboxamide (AB-FUBINACA), and N- 

(1-amino-3,3-dimethyl-1-oxobutan-2-yl)- 

1-pentyl-1H-indazole-3-carboxamide 

(ADB-PINACA), including their salts, 

isomers and salts of isomers, whenever 

the existence of such salts, isomers, and 

salts of isomers is possible, warrant 

control in schedule I of the CSA. 21 

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

Requirements for Handling PB-22, 5FPB-22, AB-FUBINACA and ADBPINACA 

If this rule is finalized as proposed, 

PB-22, 5F-PB-22, AB-FUBINACA, and 

ADB-PINACA would continue 3 to be 

subject to the CSA’s schedule I 

regulatory controls and administrative, 

civil, and criminal sanctions applicable 

to the manufacture, distribution, 

dispensing, importing, exporting, 

research, and conduct of instructional 

activities, including the following: 

1. Registration. Any person who 

handles (manufactures, distributes, 

dispenses, imports, exports, engages in 

research, or conducts instructional 

activities or chemical analysis with, or 

possesses) PB-22, 5F-PB-22, ABFUBINACA, or ADB-PINACA, or who 

desires to handle PB-22, 5F-PB-22, ABFUBINACA, or ADB-PINACA, would be 

required to be registered with the DEA 

to conduct such activities pursuant to 

21 U.S.C. 822, 823, 957, and 958 and in 

accordance with 21 CFR parts 1301 and 

1312. 

2. Security. PB-22, 5F-PB-22, ABFUBINACA, or ADB-PINACA would be 

subject to schedule I security 

requirements and would need to be 

handled and stored pursuant to 21 

U.S.C. 821, 823 and in accordance with 

21 CFR 1301.71–1301.93. 

3. Labeling and Packaging. All labels 

and labeling for commercial containers 

of PB-22, 5F-PB-22, AB-FUBINACA, or 

ADB-PINACA would need to be in 

compliance with 21 U.S.C. 825 and 

958(e), and be in accordance with 21 

CFR part 1302. 

4. Quota. Only registered 

manufacturers would be permitted to 

manufacture PB-22, 5F-PB-22, ABFUBINACA, or ADB-PINACA in 

accordance with a quota assigned 

pursuant to 21 U.S.C. 826 and in 

accordance with 21 CFR part 1303. 

5. Inventory. Any person who 

becomes registered with the DEA after 

the effective date of the final rule must 

take an initial inventory of all stocks of 

controlled substances (including PB-22, 

5F-PB-22, AB-FUBINACA, and ADBPINACA) on hand on the date the 

registrant first engages in the handling 

of controlled substances pursuant to 21 

U.S.C. 827 and 958, and in accordance 

with 21 CFR 1304.03, 1304.04, and 

1304.11. 

After the initial inventory, every DEA 

registrant must take a new inventory of 

all stocks of controlled substances 

(including PB-22, 5F-PB-22, ABFUBINACA, and ADB-PINACA) on 

hand every two years, pursuant to 21 

U.S.C. 827 and 958, and in accordance 

with 21 CFR 1304.03, 1304.04, and 

1304.11. 

6. Records and Reports. Every DEA 

registrant would be required to maintain 

records and submit reports with respect 

to PB-22, 5F-PB-22, AB-FUBINACA, 

and/or ADB-PINACA pursuant to 21 

U.S.C. 827 and 958(e), and in 

accordance with 21 CFR parts 1304 and 

1312. 

7. Order Forms. Every DEA registrant 

who distributes PB-22, 5F-PB-22, ABFUBINACA, or ADB-PINACA would be 

required to comply with the order form 

requirements, pursuant to 21 U.S.C. 828, 

and 21 CFR part 1305. 

8. Importation and Exportation. All 

importation and exportation of PB-22, 

5F-PB-22, AB-FUBINACA, or ADBPINACA would need to be in 

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Federal Register / Vol. 81, No. 24 / Friday, February 5, 2016 / Proposed Rules 6195 

compliance with 21 U.S.C. 952, 953, 

957, and 958, and in accordance with 21 

CFR part 1312. 

9. Liability. Any activity involving PB22, 5F-PB-22, AB-FUBINACA, or ADBPINACA not authorized by, or in 

violation of, the CSA or its 

implementing regulations would be 

unlawful, and could subject the person 

to administrative, civil, and/or criminal 

sanctions. 

Regulatory Analyses 

Executive Orders 12866 and 13563 

In accordance with 21 U.S.C. 811(a), 

this proposed scheduling action is 

subject to formal rulemaking procedures 

performed ‘‘on the record after 

opportunity for a hearing,’’ which are 

conducted pursuant to the provisions of 

5 U.S.C. 556 and 557. The CSA sets 

forth the criteria for scheduling a drug 

or other substance. Such actions are 

exempt from review by the Office of 

Management and Budget (OMB) 

pursuant to section 3(d)(1) of Executive 

Order 12866 and the principles 

reaffirmed in Executive Order 13563. 

Executive Order 12988 

This proposed regulation meets the 

applicable standards set forth in 

sections 3(a) and 3(b)(2) of Executive 

Order 12988 to eliminate drafting errors 

and ambiguity, minimize litigation, 

provide a clear legal standard for 

affected conduct, and promote 

simplification and burden reduction. 

Executive Order 13132 

This proposed rulemaking does not 

have federalism implications warranting 

the application of Executive Order 

13132. The proposed rule does not have 

substantial direct effects on the States, 

on the relationship between the national 

government and the States, or the 

distribution of power and 

responsibilities among the various 

levels of government. 

Executive Order 13175 

This proposed rule does not have 

tribal implications warranting the 

application of Executive Order 13175. It 

does not have substantial direct effects 

on one or more Indian tribes, on the 

relationship between the Federal 

government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

government and Indian tribes. 

Regulatory Flexibility Act 

The Administrator, in accordance 

with the Regulatory Flexibility Act 

(RFA), 5 U.S.C. 601–602, has reviewed 

this proposed rule and by approving it 

certifies that it will not have a 

significant economic impact on a 

substantial number of small entities. On 

February 10, 2014, the DEA published a 

final order to temporarily place these 

four SCs into schedule I of the CSA 

pursuant to the temporary scheduling 

provisions of 21 U.S.C. 811(h). The DEA 

estimates that all entities handling or 

planning to handle these SCs have 

already established and implemented 

the systems and processes required to 

handle PB-22, 5F-PB-22, ABFUBINACA, or ADB-PINACA. There are 

currently 25 registrations authorized to 

handle PB-22, 5F-PB-22, ABFUBINACA, and/or ADB-PINACA 

specifically, as well as a number of 

registered analytical labs that are 

authorized to handle schedule I 

controlled substances generally. These 

25 registrations represent 18 entities, of 

which 8 are small entities. Therefore, 

the DEA estimates eight small entities 

are affected by this proposed rule. 

A review of the 25 registrations 

indicates that all entities that currently 

handle PB-22, 5F-PB-22, ABFUBINACA, or ADB-PINACA also 

handle other schedule I controlled 

substances, and have established and 

implemented (or maintain) the systems 

and processes required to handle PB-22, 

5F-PB-22, AB-FUBINACA, or ADBPINACA. Therefore, the DEA anticipates 

that this proposed rule will impose 

minimal or no economic impact on any 

affected entities; and thus, will not have 

a significant economic impact on any of 

the eight affected small entities. 

Therefore, the DEA has concluded that 

this proposed rule will not have a 

significant effect on a substantial 

number of small entities. 

Unfunded Mandates Reform Act of 1995 

In accordance with the Unfunded 

Mandates Reform Act (UMRA) of 1995, 

2 U.S.C. 1501 et seq., the DEA has 

determined and certifies that this action 

would not result in any Federal 

mandate that may result ‘‘in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100,000,000 or more 

(adjusted for inflation) in any one year 

* * *.’’ Therefore, neither a Small 

Government Agency Plan nor any other 

action is required under UMRA of 1995. 

Paperwork Reduction Act of 1995 

This action does not impose a new 

collection of information under the 

Paperwork Reduction Act of 1995. 44 

U.S.C. 3501–3521. This action would 

not impose recordkeeping or reporting 

requirements on State or local 

governments, individuals, businesses, or 

organizations. An agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Reporting and recordkeeping 

requirements. 

For the reasons set out above, the DEA 

proposes to amend 21 CFR part 1308 as 

follows: 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ 1. The authority citation for 21 CFR 

part 1308 continues to read as follows: 

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

unless otherwise noted. 

■ 2. In § 1308.11: 

■ a. Add new paragraphs (d)(48) 

through (d)(51); and 

■ b. Remove paragraphs (h)(7) through 

(10); and 

■ c. Redesignate paragraphs (h)(11) 

through (24) as (h)(7) through (20). 

The additions to read as follows: 

§ 1308.11 Schedule I. 

* * * * * 

(d) * * * 

(48) quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22) ............................................................................................................... (7222) 

(49) quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB-22; 5F-PB-22) ................................................................. (7225) 

(50) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA) .................................. (7012) 

(51) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA) .............................................. (7035) 

* * * * * 

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6196 Federal Register / Vol. 81, No. 24 / Friday, February 5, 2016 / Proposed Rules 

Dated: February 2, 2016. 

Chuck Rosenberg, 

Acting Administrator. 

[FR Doc. 2016–02305 Filed 2–4–16; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[Docket Number USCG–2015–1055] 

RIN 1625–AA08 

Special Local Regulation; Charleston 

Race Week, Charleston Harbor, 

Charleston, SC 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Coast Guard proposes to 

establish a special local regulation on 

the waters of Charleston Harbor in 

Charleston, SC during the Charleston 

Race Week from April 15, 2016 through 

April 17, 2016. This special local 

regulation is necessary to ensure the 

safety of participants, spectators, and 

the general public during the event. 

This proposed rulemaking would 

prohibit persons and vessels from being 

in the regulated area unless authorized 

by the Captain of the Port Charleston or 

a designated representative. 

DATES: Comments and related material 

must be received by the Coast Guard on 

or before March 7, 2016. 

ADDRESSES: You may submit comments 

identified by docket number USCG– 

2015–1055 using the Federal 

eRulemaking Portal at http://

www.regulations.gov. See the ‘‘Public 

Participation and Request for 

Comments’’ portion of the 

SUPPLEMENTARY INFORMATION section for 

further instructions on submitting 

comments. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this proposed 

rulemaking, call or email Lieutenant 

John Downing, Sector Charleston Office 

of Waterways Management, Coast 

Guard; telephone (843) 740–3184, email 

John.Z.Downing@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

I. Table of Abbreviations 

CFR Code of Federal Regulations 

DHS Department of Homeland Security 

E.O. Executive order 

FR Federal Register 

NPRM Notice of proposed rulemaking 

Pub. L. Public Law 

§ Section 

U.S.C. United States Code 

COTP Captain of the Port 

II. Background, Purpose, and Legal 

Basis 

On November 18, 2015, the 

Charleston Ocean Racing Association 

notified the Coast Guard that it will be 

sponsoring a series of sailboat races 

from 8:30 a.m. to 5 p.m. from April 15, 

2016 through April 17, 2016. The legal 

basis for the proposed rule is the Coast 

Guard’s Authority to establish special 

local regulations: 33 U.S.C 1233. The 

purpose of the proposed rule is to 

ensure safety of life on the navigable 

water of the United States during the 

Charleston Race Week. 

III. Discussion of Proposed Rule 

The COTP proposes to establish a 

special local regulation on the waters of 

Charleston Harbor in Charleston, South 

Carolina during Charleston Race Week. 

The races are scheduled to take place 

from Friday, April 15, 2016 through 

Sunday, April 17, 2016. Approximately 

285 sailboats are anticipated to 

participate in the races, and 

approximately 30 spectator vessels are 

expected to attend the event. Persons 

and vessels desiring to enter, transit 

through, anchor in, or remain within the 

regulated area may contact the Captain 

of the Port Charleston by telephone at 

(843) 740–7050, or a designated 

representative via VHF radio on channel 

16, to request authorization. If 

authorization to enter, transit through, 

anchor in, or remain within the 

regulated area is granted by the Captain 

of the Port Charleston or a designated 

representative, all persons and vessels 

receiving such authorization must 

comply with the instructions of the 

Captain of the Port Charleston or a 

designated representative. The Coast 

Guard will provide notice of the special 

local regulation by Local Notice to 

Mariners, Broadcast Notice to Mariners, 

and on-scene designated 

representatives. 

IV. Regulatory Analyses 

We developed this proposed rule after 

considering numerous statutes and 

executive orders related to rulemaking. 

Below we summarize our analyses 

based on a number of these statutes and 

executive orders. 

A. Regulatory Planning and Review 

E.O.s 12866 and 13563 direct agencies 

to assess the costs and benefits of 

available regulatory alternatives and, if 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits. E.O. 13563 emphasizes the 

importance of quantifying both costs 

and benefits, of reducing costs, of 

harmonizing rules, and of promoting 

flexibility. This NPRM has not been 

designated a ‘‘significant regulatory 

action,’’ under E.O. 12866. Accordingly, 

the NPRM has not been reviewed by the 

Office of Management and Budget. This 

proposed rule is not a significant 

regulatory action under section 3(f) of 

Executive Order 12866, Regulatory 

Planning and Review, as supplemented 

by Executive Order 13563, Improving 

Regulation and Regulatory Review, and 

does not require an assessment of 

potential costs and benefits under 

section 6(a)(3) of Executive Order 12866 

or under section 1 of Executive Order 

13563. The Office of Management and 

Budget has not reviewed it under those 

Orders. 

The economic impact of this proposed 

rule is not significant for the following 

reasons: (1) Non-participant persons and 

vessels may enter, transit through, 

anchor in, or remain within the 

regulated area during the enforcement 

periods if authorized by the Captain of 

the Port Charleston or a designated 

representative; (2) vessels not able to 

enter, transit through, anchor in, or 

remain within the regulated area 

without authorization from the Captain 

of the Port Charleston or a designated 

representative may operate in the 

surrounding areas during the 

enforcement period; and (3) the Coast 

Guard will provide advance notification 

of the special local regulation to the 

local maritime community by Local 

Notice to Mariners and Broadcast Notice 

to Mariners. 

B. Impact on Small Entities 

The Regulatory Flexibility Act of 

1980, (5 U.S.C. 601–612), as amended 

requires Federal agencies to consider 

the potential impact of regulations on 

‘‘small entities’’ comprises small 

businesses, not-for-profit organizations 

that are independently owned and 

operated and are not dominant in their 

fields, and governmental jurisdictions 

with populations of less than 50,000. 

The Coast Guard certifies under 5 U.S.C. 

605(b) that this proposed rule would not 

have a significant economic impact on 

a substantial number of small entities. 

We have considered the impact of this 

proposed rule on small entities. This 

rule may affect the following entities, 

some of which may be small entities: 

the owner or operators of vessels 

intending to enter, transit through, 

anchor in, or remain within the 

regulated area during the enforcement 

period. For the reasons discussed in 

Regulatory Planning and Review section 

above, this rule will not have a 

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