14842 Federal Register / Vol. 80, No. 54 / Friday, March 20, 2015 / Rules and Regulations 

specifically state whether you are 

requesting a hearing on the particular 

provision that you specify in that 

numbered objection. If you do not 

request a hearing for any particular 

objection, you waive the right to a 

hearing on that objection. If you request 

a hearing, your objection must include 

a detailed description and analysis of 

the specific factual information you 

intend to present in support of the 

objection in the event that a hearing is 

held. If you do not include such a 

description and analysis for any 

particular objection, you waive the right 

to a hearing on the objection. 

It is only necessary to send one set of 

documents. Identify documents with the 

docket number found in brackets in the 

heading of this document. Any 

objections received in response to the 

regulation may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. We will publish 

notice of the objections that we have 

received or lack thereof in the Federal 

Register. 

XI. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

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

through Friday, and are available 

electronically at http://

www.regulations.gov. (FDA has verified 

the Web site addresses in this reference 

section, but FDA is not responsible for 

any subsequent changes to Web sites 

after this document publishes in the 

Federal Register.) 

1. Memorandum to the File from A. Zajac, 

Division of Petition Review, February 27, 

2015. 

2. Memorandum from D. Doell, Chemistry 

Review Group, Division of Petition 

Review, to L. Dye, Regulatory Group II, 

Division of Petition Review, June 20, 

2014. 

3. Institute of Medicine. Dietary Reference 

Intakes for Vitamin A, Vitamin K, 

Arsenic, Boron, Chromium, Copper, 

Iodine, Iron, Manganese, Molybdenum, 

Nickel, Silicon, Vanadium, and Zinc. 

Washington, DC: The National 

Academies Press, 2001. 

4. Memorandum from S. Thurmond, 

Toxicology Team, Division of Petition 

Review, to L. Dye, Regulatory Group II, 

Division of Petition Review, September 

9, 2014. 

5. Memorandum from N. Hepp, Color 

Technology Team, Office of Cosmetics 

and Colors, to L. Dye, Division of 

Petition Review, September 23, 2013. 

List of Subjects in 21 CFR Part 73 

Color additives, Cosmetics, Drugs, 

and Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, and redelegated to 

the Director, Center for Food Safety and 

Applied Nutrition, 21 CFR part 73 is 

amended as follows: 

PART 73—LISTING OF COLOR 

ADDITIVES EXEMPT FROM 

CERTIFICATION 

■ 1. The authority citation for 21 CFR 

part 73 continues to read as follows: 

Authority: 21 U.S.C. 321, 341, 342, 343, 

348, 351, 352, 355, 361, 362, 371, 379e. 

■ 2. Section 73.200 is amended by 

revising paragraphs (b)(1) and (c)(1) to 

read as follows: 

§ 73.200 Synthetic iron oxide. 

* * * * * 

(b) * * * 

(1) Synthetic iron oxide for human 

food use shall conform to the following 

specifications: 

Arsenic (as As), not more than 3 

milligrams per kilogram (mg/kg) (3 parts 

per million (ppm)). 

Lead (as Pb), not more than 5 mg/kg 

(5 ppm). 

Mercury (as Hg), not more than 1 mg/ 

kg (1 ppm). 

* * * * * 

(c) * * * 

(1) Synthetic iron oxide may be safely 

used for human food use subject to the 

following restrictions: 

(i) In sausage casings intended for 

human consumption in an amount not 

exceeding 0.10 percent by weight of the 

finished food. 

(ii) In soft and hard candy, mints, and 

chewing gum at levels consistent with 

good manufacturing practice, except 

that it may not be used to color foods 

for which standards of identity have 

been issued under section 401 of the 

Federal Food, Drug, and Cosmetic Act, 

unless the use of the added color is 

authorized by such standards. 

* * * * * 

Dated: March 17, 2015. 

Susan M. Bernard, 

Director, Office of Regulations, Policy and 

Social Sciences, Center for Food Safety and 

Applied Nutrition. 

[FR Doc. 2015–06418 Filed 3–19–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–406] 

Substances Temporarily Controlled 

Under Schedule I of the Controlled 

Substances Act 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule; technical 

amendments. 

SUMMARY: This final rule makes 

technical and conforming amendments 

to the Drug Enforcement Administration 

regulations listing substances 

temporarily controlled under schedule I 

of the Controlled Substances Act. This 

final rule eliminates references to 7 

substances that were previously subject 

to temporary control, but which have 

since been permanently controlled 

under schedule I, and redesignates 23 

other substances that are currently 

temporarily controlled under schedule I. 

This action makes no substantive 

changes to the affected regulation. 

DATES: This rule is effective March 20, 

2015. 

FOR FURTHER INFORMATION CONTACT: 

Imelda L. Paredes, Office of Diversion 

Control, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, Virginia 

22152; Telephone: (202) 598–6812. 

SUPPLEMENTARY INFORMATION: 

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. 

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Federal Register / Vol. 80, No. 54 / Friday, March 20, 2015 / Rules and Regulations 14843 

1Pub. L. 112–144, title XI, subtitle D, sections 

1151–1153. 

2See ‘‘Schedules of Controlled Substances: 

Temporary Placement of Five Synthetic 

Cannabinoids Into Schedule I of the Controlled 

Substances Act,’’ 76 FR 11075, Mar. 1, 2011 and 

‘‘Schedules of Controlled Substances: Extension of 

Temporary Placement of Five Synthetic 

Cannabinoids Into Schedule I of the Controlled 

Substances Act,’’ 77 FR 12201, Feb. 29, 2012. 

3See ‘‘Schedules of Controlled Substances: 

Temporary Placement of Three Synthetic 

Cathinones Into Schedule I,’’ 76 FR 65371, Oct. 21, 

2011. 

4 ‘‘Establishment of Drug Codes for 26 

Substances,’’ 78 FR 664, Jan. 4, 2013. 

5 ‘‘Schedules of Controlled Substances: 

Temporary Placement of Three Synthetic 

Cathinones Into Schedule I,’’ 76 FR 65371, Oct. 21, 

2011. 

6 ‘‘Schedules of Controlled Substances: Placement 

of Methylone Into Schedule I,’’ 78 FR 21818, Apr. 

12, 2013. 

Under the CSA, each controlled 

substance is classified into one of five 

schedules based upon its potential for 

abuse, 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 all controlled substances 

is published at 21 CFR part 1308. 21 

U.S.C. 812(a). 

The CSA provides the Attorney 

General with the authority to 

temporarily control a substance under 

schedule I for two years without regard 

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

if he/she finds that such action is 

necessary to avoid an imminent hazard 

to the public safety. 21 U.S.C. 811(h). If 

proceedings to permanently control a 

substance are initiated pursuant to 21 

U.S.C. 811(a)(1), the Attorney General 

may extend the temporary control for up 

to one year. 21 U.S.C. 811(h)(2). The 

Attorney General has delegated this 

authority to the Administrator of the 

DEA. 28 CFR 0.100. 

Technical Amendments 

The Synthetic Drug Abuse Prevention 

Act of 2012 (SDAPA) became effective 

on July 9, 2012.1 SDAPA amended the 

CSA by permanently controlling 

‘‘cannabimimetic agents’’ and 26 other 

specific substances in schedule I. At 

that time, some of the 26 permanently 

controlled substances were temporarily 

controlled and listed in 21 CFR 

1308.11(g), including the following 

substances: 1-pentyl-3-(1- 

naphthoyl)indole (JWH–018); 1-butyl-3- 

(1-naphthoyl)indole (JWH–073); 1-[2-(4- 

morpholinyl)ethyl]-3-(1- 

naphthoyl)indole (JWH–200); 5-(1,1- 

dimethyloctyl)-2-(3- 

hydroxycyclohexyl)-phenol 

(cannabicyclohexanol or CP–47,497 C8 

homologue); 2 4-methyl-Nmethylcathinone (mephedrone); and 

3,4-methylenedioxypyrovalerone 

(MDPV).3

On January 4, 2013, the DEA 

published a final rule permanently 

placing cannabimimetic agents and all 

26 substances specified in SDAPA into 

schedule I (including the 6 substances 

noted above that were previously 

temporarily controlled).4

The substance 3,4-methylenedioxy-Nmethylcathinone (methylone) was not 

permanently controlled through 

SDAPA. However, DEA temporarily 

controlled methylone on October 21, 

2011, pursuant to 21 U.S.C. 811(h), and 

listed it in 21 CFR 1308.11(g)(7).5 On 

January 4, 2013, subparagraph (g) of 21 

CFR 1308.11 was redesignated as 

subparagraph (h), and methylone was 

renumbered in section 1308.11(h)(1); it 

also inadvertently remained on the list 

of temporarily controlled substances in 

section 1308.11(h)(7). The DEA 

permanently controlled methylone in 

schedule I by a final rule published in 

the Federal Register on April 12, 2013.6

Because the above noted substances 

are permanently controlled in schedule 

I, the DEA is making technical and 

conforming amendments to the 

regulations by removing the above 

referenced 7 substances (JWH–018; 

JWH–073; JWH–200; CP–47,497 C8 

homologue; mephedrone; MDPV; and 

methylone) from the list of temporarily 

controlled substances and redesignating 

the numerical order of the remaining 

controlled substances that are currently 

subject to temporary control. 

Regulatory Analyses 

The Administrative Procedure Act 

An agency may find good cause to 

exempt a rule from certain provisions of 

the Administrative Procedure Act 

(APA), including notice of proposed 

rulemaking and the opportunity for 

public comment, if it is determined to 

be unnecessary, impracticable, or 

contrary to the public interest under 5 

U.S.C. 533(b)(3)(B). This rule provides 

technical and conforming amendments 

to the DEA’s regulations and imposes no 

new or substantive requirement on the 

public or DEA registrants. As such, the 

DEA has determined that notice and 

opportunity for public comment on this 

rule are unnecessary. In addition, 

because this is not a substantive rule 

and as the DEA finds good cause under 

5 U.S.C. 553(d)(3) for the above reasons, 

this final rule shall take effect upon the 

date of publication in the Federal 

Register. 

Executive Orders 12866 and 13563 

The Administrator certifies that this is 

not a significant regulatory action 

within the meaning of Executive Order 

12866 and the principles reaffirmed in 

Executive Order 13563, as it makes only 

technical amendments to the current 

regulations. Such actions are exempt 

from review by the Office of 

Management and Budget (OMB). 

Executive Order 12988 

This rule meets the applicable 

standards set forth in Sections 3(a) and 

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

Justice Reform 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 rule does not have federalism 

implications warranting the application 

of Executive Order 13132. This 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. 

Paperwork Reduction Act of 1995 

This rule does not involve a collection 

of information within the meaning of 

the Paperwork Reduction Act of 1995, 

44 U.S.C. 3501–3521. 

Executive Order 13175 

This rule does not have tribal 

implications warranting the application 

of Executive Order 13175. The rule 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. 

Congressional Review Act 

This rule is not a major rule as 

defined by Section 804 of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Congressional 

Review Act (CRA)). 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 for 

consumers, individual industries, 

Federal, State, or local government 

agencies, or geographic regions; or 

significant adverse effects on 

competition, employment, investment, 

productivity, innovation, or on the 

ability of United States-based 

companies to compete with foreignbased companies in domestic and 

export markets. However, pursuant to 

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14844 Federal Register / Vol. 80, No. 54 / Friday, March 20, 2015 / Rules and Regulations 

the CRA, the DEA has submitted a copy 

of this final rule to both Houses of 

Congress and to the Comptroller 

General. 

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, 21 CFR 

part 1308 is amended 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. 

§ 1308.11 [Amended] 

■ 2. Amend § 1308.11 by removing 

paragraphs (h)(1) through (8) and 

redesignating paragraphs (h)(9) through 

(31) as paragraphs (h)(1) through (23), 

respectively. 

Dated: March 12, 2015. 

Michele M. Leonhart, 

Administrator. 

[FR Doc. 2015–06460 Filed 3–19–15; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2015–0157] 

Drawbridge Operation Regulation; 

Cerritos Channel, Long Beach, CA 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of deviation from 

drawbridge regulation. 

SUMMARY: The Coast Guard has issued a 

temporary deviation from the operating 

schedule that governs the Commodore 

Schuyler F. Heim highway bridge across 

the Cerritos Channel, mile 4.9 at Long 

Beach, CA. The deviation is necessary to 

allow Southern California Edison 

Company to temporarily disconnect 

electric service to the bridge while 

performing circuit switching. This 

deviation allows the bridge to remain in 

the closed-to-navigation position during 

the deviation period. 

DATES: This deviation is effective 

without actual notice from March 20, 

2015 to 2 a.m. on March 23, 2015. For 

the purposes of enforcement, actual 

notice will be used from 10 p.m. on 

March 15, 2015, until March 20, 2015. 

ADDRESSES: The docket for this 

deviation, [USCG–2015–0157], is 

available at http://www.regulations.gov. 

Type the docket number in the 

‘‘SEARCH’’ box and click ‘‘SEARCH.’’ 

Click on Open Docket Folder on the line 

associated with this deviation. You may 

also visit the Docket Management 

Facility in Room W12–140 on the 

ground floor of the Department of 

Transportation West Building, 1200 

New Jersey Avenue SE., Washington, 

DC 20590, between 9 a.m. and 5 p.m., 

Monday through Friday, except Federal 

holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this temporary 

deviation, call or email David H. 

Sulouff, Chief, Bridge Section, Eleventh 

Coast Guard District; telephone 510– 

437–3516, email David.H.Sulouff@

uscg.mil. If you have questions on 

viewing the docket, call Cheryl Collins, 

Program Manager, Docket Operations, 

telephone 202–366–9826. 

SUPPLEMENTARY INFORMATION: California 

Department of Transportation has 

requested a temporary change to the 

operation of the Commodore Schuyler 

F. Heim highway bridge, mile 4.9, over 

Cerritos Channel, at Long Beach, CA. 

The drawbridge navigation span 

provides a vertical clearance of 37 feet 

above Mean High Water in the closedto-navigation position and a maximum 

of 43 feet due to construction falsework 

over the channel at the bridge. The draw 

opens on signal; except that, from 6:30 

a.m. to 8 a.m. and 3:30 p.m. to 6 p.m., 

Monday through Friday except Federal 

holidays, the draw need not be opened 

for the passage of vessels, as required by 

33 CFR 117.147(a). Navigation on the 

waterway is commercial and 

recreational. 

The drawspan will be secured in the 

closed-to-navigation position from 10 

p.m. on March 15, 2015 to 2 a.m. on 

March 16, 2015; and from 10 p.m. on 

March 22, 2015 to 2 a.m. on March 23, 

2015 to allow Southern California 

Edison Company to switch electrical 

power for the bridge to another source. 

This temporary deviation has been 

coordinated with the waterway users. 

No objections to the proposed 

temporary deviation were raised. 

Vessels able to pass through the 

bridge in the closed position may do so 

at anytime. The bridge will not be able 

to open for emergencies and there is an 

alternate route around Terminal Island 

for routine and emergency navigation. 

The Coast Guard will also inform the 

users of the waterway through our Local 

and Broadcast Notices to Mariners of the 

change in operating schedule for the 

bridge so vessel operators can arrange 

their transits to minimize any impact 

caused by the temporary deviation. 

In accordance with 33 CFR 117.35(e), 

the drawbridge must return to its regular 

operating schedule immediately at the 

end of the effective period of this 

temporary deviation. This deviation 

from the operating regulations is 

authorized under 33 CFR 117.35. 

Dated: March 11, 2015. 

D.H. Sulouff, 

District Bridge Chief, Eleventh Coast Guard 

District. 

[FR Doc. 2015–06491 Filed 3–19–15; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2015–0171] 

Drawbridge Operation Regulation; 

Duwamish Waterway, Seattle, WA 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of deviation from 

drawbridge regulation. 

SUMMARY: The Coast Guard has issued a 

temporary deviation from the operating 

schedule that governs the South Park 

highway bridge across the Duwamish 

Waterway, mile 3.8, at Seattle, WA. The 

deviation is necessary to enable timely 

completion of drawbridge maintenance. 

This deviation allows the drawbridge to 

remain closed to mariners needing a full 

channel, double bascule leaf drawbridge 

opening. Vessels that only require a 

single leaf, half channel drawbridge 

opening, will be given such an opening 

upon signal. 

DATES: This deviation is effective 

without actual notice from March 20, 

2015 to 11:59 p.m. on March 28, 2015. 

For the purposes of enforcement, actual 

notice will be used from 12:01 a.m. on 

March 17, 2015, until March 20, 2015. 

ADDRESSES: The docket for this 

deviation, [USCG–2015–0171] is 

available at http://www.regulations.gov. 

Type the docket number in the 

‘‘SEARCH’’ box and click ‘‘SEARCH.’’ 

Click on Open Docket Folder on the line 

associated with this deviation. You may 

also visit the Docket Management 

Facility in Room W12–140 on the 

ground floor of the Department of 

Transportation West Building, 1200 

New Jersey Avenue SE., Washington, 

DC 20590, between 9 a.m. and 5 p.m., 

Monday through Friday, except Federal 

holidays. 

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