49120 Federal Register / Vol. 78, No. 156 / Tuesday, August 13, 2013 / Rules and Regulations 

pertain to food and therefore should not 

be construed to be a statement of the 

likelihood that section 301(ll) of the 

FD&C Act applies. 

X. Objections 

This rule is effective as shown in the 

DATES section of this document; except 

as to any provisions that may be stayed 

by the filing of proper objections. Any 

person who will be adversely affected 

by this regulation may file with the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

objections. Each objection shall be 

separately numbered, and each 

numbered objection shall specify with 

particularity the provisions of the 

regulation to which objection is made 

and the grounds for the objection. Each 

numbered objection on which a hearing 

is requested shall specifically so state. 

Failure to request a hearing for any 

particular objection shall constitute a 

waiver of the right to a hearing on that 

objection. Each numbered objection for 

which a hearing is requested shall 

include a detailed description and 

analysis of the specific factual 

information intended to be presented in 

support of the objection in the event 

that a hearing is held. Failure to include 

such a description and analysis for any 

particular objection shall constitute a 

waiver of 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. 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, but FDA is not 

responsible for any subsequent changes 

to Web sites after this document 

publishes in the Federal Register.) 

1. M. A. B. Habib, M. Parvin, T. C. 

Huntington, and M. R. Hasan. 2008. ‘‘A 

Review on Culture, Production and Use 

of Spirulina as Food for Humans and 

Feeds for Domestic Animals and Fish.’’ 

FAO Fisheries and Aquaculture Circular 

No. 1034. Rome, FAO (ftp://ftp.fao.org/ 

docrep/fao/011/i0424e/i0424e00.pdf). 

2. Memorandum from N. Belai, Color 

Technology Team, OCAC, CFSAN, FDA 

to F. Ellison, Division of Petition Review, 

OFAS, CFSAN, FDA, December 12, 2012. 

3. Letter from L. Tarantino, Office of Food 

Additive Safety, CFSAN, FDA to J. Dore, 

Cyanotech Corporation, Agency 

Response Letter GRAS Notice No. GRN 

000127, October 6, 2003, (http:// 

www.fda.gov/Food/ 

IngredientsPackagingLabeling/GRAS/ 

NoticeInventory/ucm153944.htm). 

4. Letter from D. Keefe, Office of Food 

Additive Safety, CFSAN, FDA to S. Cho, 

Nutra Source, Agency Response Letter 

GRAS Notice No. GRN 000394, June 4, 

2012, (http://www.fda.gov/Food/ 

IngredientsPackagingLabeling/GRAS/ 

NoticeInventory/ucm313046.htm). 

5. Letter from D. Keefe, Office of Food 

Additive Safety, CFSAN, FDA to J. 

Endres, AIBMR Life Sciences, Inc., 

Agency Response Letter GRAS Notice 

No. GRN 000417, August 10, 2012, 

(http://www.fda.gov/Food/ 

IngredientsPackagingLabeling/GRAS/ 

NoticeInventory/ucm319628.htm). 

6. Letter from D. Keefe, Office of Food 

Additive Safety, CFSAN, FDA to H. 

Newman, Desert Lake Technologies, 

LLC, Agency Response Letter GRAS 

Notice No. GRN 000424, December 6, 

2012, (http://www.fda.gov/Food/ 

IngredientsPackagingLabeling/GRAS/ 

NoticeInventory/ucm335743.htm). 

7. Memorandum from D. Folmer, Division of 

Petition Review, CFSAN, FDA to F. 

Ellison, Division of Petition Review, 

CFSAN, FDA, May 31, 2012. 

8. Memorandum from G. Erives, Division of 

Petition Review, CFSAN, FDA to F. 

Ellison, Division of Petition Review, 

CFSAN, FDA, October 2, 2012. 

List of Subjects in 21 CFR Part 73 

Color additives, Cosmetics, Drugs, 

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. Add § 73.530 to subpart A to read 

as follows: 

§ 73.530 Spirulina extract. 

(a) Identity. (1) The color additive 

spirulina extract is prepared by the 

filtered aqueous extraction of the dried 

biomass of Arthrospira platensis. The 

color additive contains phycocyanins as 

the principal coloring components. 

(2) Color additive mixtures for food 

use made with spirulina extract may 

contain only those diluents that are 

suitable and are listed in this subpart as 

safe for use in color additive mixtures 

for coloring foods. 

(b) Specifications. Spirulina extract 

must conform to the following 

specifications and must be free from 

impurities, other than those named, to 

the extent that such other impurities 

may be avoided by good manufacturing 

practice: 

(1) Lead, not more than 2 milligrams 

per kilogram (mg/kg) (2 part per million 

(ppm)); 

(2) Arsenic, not more than 2 mg/kg (2 

ppm); 

(3) Mercury, not more than 1 mg/kg (1 

ppm); and 

(4) Negative for microcystin toxin. 

(c) Uses and restrictions. Spirulina 

extract may be safely used for coloring 

candy 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. 

(d) Labeling requirements. The label 

of the color additive and of any mixture 

prepared therefrom intended solely or 

in part for coloring purposes must 

conform to § 70.25 of this chapter. 

(e) Exemption from certification. 

Certification of this color additive is not 

necessary for the protection of the 

public health, and therefore batches 

thereof are exempt from the certification 

requirements of section 721(c) of the 

Federal Food, Drug, and Cosmetic Act. 

Dated: August 6, 2013. 

Susan M. Bernard, 

Director, Office of Regulations, Policy and 

Social Sciences, Center for Food Safety and 

Applied Nutrition. 

[FR Doc. 2013–19550 Filed 8–12–13; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF THE INTERIOR 

Bureau of Indian Affairs 

25 CFR Part 11 

[BIA–2013–0001; 134/A0J351010.999900/ 

AAKL008000] 

RIN 1076–AF16 

Courts of Indian Offenses 

AGENCY: Bureau of Indian Affairs, 

Interior. 

ACTION: Final rule. 


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Federal Register / Vol. 78, No. 156 / Tuesday, August 13, 2013 / Rules and Regulations 49121 

SUMMARY: The Bureau of Indian Affairs 

(BIA) is confirming the interim final 

rule published and effective on March 3, 

2013, addressing the addition of two 

Indian tribes to the list of tribes with 

Courts of Indian Offenses (also known 

as CFR Courts), and deletion of five 

tribes from those under the jurisdiction 

of CFR Courts. The March 3, 2013, 

publication stated that the BIA would 

review comments on the interim final 

rule and either confirm the rule or 

initiate a proposed rulemaking. BIA did 

not receive any comments, and therefore 

confirms the rule without change. 

DATES: Effective August 13, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Appel, Acting Director, Office 

of Regulatory Affairs & Collaborative 

Action, (202) 273–4680; 

elizabeth.appel@bia.gov. 

SUPPLEMENTARY INFORMATION: This rule 

revises a section of 25 CFR part 11 to 

add the following Indian tribes to the 

list of tribes with established Courts of 

Indian Offenses (also known as CFR 

Courts): The Seneca-Cayuga Tribe and 

the Skull Valley Band of Goshute 

Indians. Adding these tribes will allow 

for the administration of justice until 

the added tribes put into effect a lawand-order code that establishes a court 

system that meets regulatory 

requirements or until the tribe adopts a 

legal code and establishes a judicial 

system in accordance with its 

constitution and bylaws or other 

governing documents. 

The rule also revises a section of 25 

CFR 11.100(c) to remove five tribes from 

the list of those with established CFR 

Courts. The tribes removed from the list 

are the Seminole Nation, the Miami 

Tribe, the Wyandotte Tribe, the 

Choctaw Nation of Oklahoma, and the 

Quapaw Tribe of Indians. 

On March 3, 2013, we published an 

interim final rule with a request for 

comment at 78 FR 14017. We stated in 

the interim final rule that we would 

review any comments received and, by 

a future publication, address any 

comments received and either confirm 

the interim final rule with or without 

change or initiate a proposed 

rulemaking. We received no comments 

on the interim final rule. 

Therefore, the interim rule published 

March 3, 2013, at 78 FR 14017, is 

confirmed as final without change. 

Dated: August 1, 2013. 

Kevin K. Washburn, 

Assistant Secretary—Indian Affairs. 

[FR Doc. 2013–19596 Filed 8–12–13; 8:45 am] 

BILLING CODE 4310–W7–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2013–0103] 

Safety Zone; Luna Pier Fireworks, 

Luna Pier, MI 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of enforcement of 

regulation. 

SUMMARY: The Coast Guard will enforce 

the safety zone for the Luna Pier 

Fireworks Show, Luna Pier, MI, from 

9:25 p.m. until 10:25 p.m. on August 24, 

2013. Enforcement of this zone is 

necessary to ensure the safety of life on 

the navigable waters of the United 

States immediately prior to, during, and 

immediately after the associated marine 

event. During the aforementioned 

period, the Coast Guard will enforce 

restrictions upon, and control 

movement of, vessels on those waters of 

Lake Erie within a 300-yard radius of 

the fireworks launch site at the Clyde E. 

Evens Municipal Pier, located at 

position 41°48′32′′ N, 83°26′23′′ W (NAD 

83) immediately prior to, during, and 

immediately after the fireworks event. 

DATES: The regulation in 33 CFR 

165.941(a)(16) will be enforced from 

9:25 p.m. until 10:25 p.m. on August 24, 

2013. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this notice, call 

or email MST1 Ian Fallon, Response 

Department, Marine Safety Unit Toledo, 

420 Madison Ave., Suite 700, Toledo, 

OH 43604; telephone (419) 418–6036, 

email Ian.M.Fallon@uscg.mil. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce the safety zone listed 

in 33 CFR 165.941(a)(16) Luna Pier 

Fireworks Show, Luna Pier, MI from 

9:25 p.m. to 10:35 p.m. on August 24, 

2013. 

Under the provisions of 33 CFR 

165.23, entry into, transiting, or 

anchoring within this safety zone during 

the enforcement period is prohibited 

unless authorized by the Captain of the 

Port Detroit or his designated 

representative. Vessels that wish to 

transit through the safety zone may 

request permission from the Captain of 

the Port Detroit or his designated 

representative. Requests must be made 

in advance and approved by the Captain 

of Port before transits will be 

authorized. Approvals will be granted 

on a case by case basis. The Captain of 

the Port may be contacted via U.S. Coast 

Guard Sector Detroit on channel 16, 

VHF–FM. The Coast Guard will give 

notice to the public via Local Notice to 

Mariners and VHF radio broadcasts that 

the regulation is being enforced. 

This notice is issued under authority 

of 33 CFR 165.941(a)(16) and 5 U.S.C. 

552(a). If the Captain of the Port 

determines that the safety zone need not 

be enforced for the full duration stated 

in this notice, he or she may suspend 

such enforcement and notify the public 

of the suspension via a Broadcast Notice 

to Mariners. 

Dated: July 29, 2013. 

J. E. Ogden, 

Captain, U.S. Coast Guard, Captain of the 

Port Detroit. 

[FR Doc. 2013–19506 Filed 8–12–13; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 65 

[Docket ID FEMA–2013–0002] 

Changes in Flood Elevation 

Determinations 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: Modified Base (1% annualchance) Flood Elevations (BFEs) are 

finalized for the communities listed 

below. These modified BFEs will be 

used to calculate flood insurance 

premium rates for new buildings and 

their contents. 

DATES: The effective dates for these 

modified BFEs are indicated on the 

following table and revise the Flood 

Insurance Rate Maps (FIRMs) in effect 

for the listed communities prior to this 

date. 

ADDRESSES: The modified BFEs for each 

community are available for inspection 

at the office of the Chief Executive 

Officer of each community. The 

respective addresses are listed in the 

table below. 

FOR FURTHER INFORMATION CONTACT: Luis 

Rodriguez, Chief, Engineering 

Management Branch, Federal Insurance 

and Mitigation Administration, Federal 

Emergency Management Agency, 500 C 

Street SW., Washington, DC 20472, 

(202) 646–4064, or (email) 

Luis.Rodriguez3@fema.dhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Federal Emergency Management Agency 

(FEMA) makes the final determinations 


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