Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Rules and Regulations 46187 

Cheese articles Appendix 1 Appendix 2 

Sum of 

appendix 

1 & 2 

Tokyo R. Uruguay R. Grand total Chapter 

4/2010 

EU–27 ................... 2,417,127 964,873 3,382,000 ........................ 2,025,000 5,407,000 5,407,000 

Romania ................ 0 0 0 ........................ 500,000 500,000 500,000 

Uruguay ................ 0 0 0 428,000 750,000 1,178,000 1,178,000 

Other Countries .... 0 13,064 13,064 ........................ ........................ 13,064 13,064 

SWISS OR 

EMMENTHALER 

CHEESE (NOTE 22) 5,182,610 1,468,704 6,651,314 823,519 380,000 7,854,833 7,854,833 

EU–27 ................... 3,918,461 1,233,533 5,151,994 393,006 380,000 5,925,000 5,925,000 

Switzerland ........... 1,230,651 188,836 1,419,487 430,513 ........................ 1,850,000 1,850,000 

Other Countries .... 33,498 46,335 79,833 ........................ ........................ 79,833 79,833 

CHEESE AND SUBSTITUTES FOR 

CHEESE (NOTE 23) 1,837,206 2,587,702 4,424,908 1,050,000 0 5,474,908 5,474,908 

EU–27 ................... 1,837,206 2,587,701 4,424,907 ........................ ........................ 4,424,907 4,424,907 

Israel ..................... 0 0 0 50,000 ........................ 50,000 50,000 

New Zealand ......... 0 0 0 1,000,000 ........................ 1,000,000 1,000,000 

Other Countries .... 0 1 1 ........................ ........................ 1 1 

SWISS OR 

EMMENTHALER 

CHEESE WITH EYE 

FORMATION (NOTE 

25) ............................ 13,609,024 8,688,307 22,297,331 9,557,945 2,620,000 34,475,276 34,475,276 

Argentina ............... 0 9,115 9,115 70,885 ........................ 80,000 80,000 

Australia ................ 209,698 0 209,698 290,302 ........................ 500,000 500,000 

Canada ................. 0 0 0 70,000 ........................ 70,000 70,000 

EU–27 ................... 10,081,002 6,395,826 16,476,828 4,003,172 2,420,000 22,900,000 22,900,000 

Iceland .................. 0 149,999 149,999 150,001 ........................ 300,000 300,000 

Israel ..................... 27,000 0 27,000 ........................ ........................ 27,000 27,000 

Norway .................. 2,480,021 1,175,289 3,655,310 3,227,690 ........................ 6,883,000 6,883,000 

Switzerland ........... 763,050 921,055 1,684,105 1,745,895 200,000 3,630,000 3,630,000 

Other Countries .... 48,253 37,023 85,276 ........................ ........................ 85,276 85,276 

TOTAL: 

CHEESE 

ARTICLES .. 55,069,411 32,831,232 87,900,643 22,764,145 24,921,000 135,585,788 135,585,788 

TOTAL: 

CHEESE & 

NONCHEESE .... 59,614,424 50,151,000 109,765,424 22,764,145 24,921,000 157,450,569 157,450,569 

[FR Doc. 2015–19083 Filed 8–3–15; 8:45 am] 

BILLING CODE 3410–10–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2015–3139; Directorate 

Identifier 2012–NM–139–AD; Amendment 

39–18224; AD 2015–15–14] 

RIN 2120–AA64 

Airworthiness Directives; BAE 

Systems (Operations) Limited 

Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), Department of 

Transportation (DOT). 

ACTION: Final rule; request for 

comments. 

SUMMARY: We are adopting a new 

airworthiness directive (AD) for all BAE 

Systems (Operations) Limited Model 

ATP airplanes. This AD requires a onetime inspection for solder deposited on 

the frangible plug of certain engine and 

auxiliary power unit (APU) fire 

extinguishers. This AD was prompted 

by reports of a fire extinguisher that 

failed to discharge due to solder 

deposited on the frangible plug of the 

fire extinguisher. We are issuing this AD 

to detect and correct solder deposited 

on the frangible plug of the fire 

extinguisher, which could result in 

failure of the fire extinguisher to 

discharge, and consequent inability to 

put out a fire in an engine or in the 

APU. 

DATES: This AD becomes effective 

August 19, 2015. 

The Director of the Federal Register 

approved the incorporation by reference 

of certain publications listed in this AD 

as of August 19, 2015. 

We must receive comments on this 

AD by September 18, 2015. 

ADDRESSES: You may send comments, 

using the procedures found in 14 CFR 

11.43 and 11.45, by any of the following 

methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Fax: 202–493–2251. 

• Mail: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE., 

Washington, DC 20590. 

• Hand Delivery: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE., 

Washington, DC, between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. 

For BAE Systems (Operations) 

Limited service information identified 

in this AD, contact BAE Systems 

(Operations) Limited, Customer 

Information Department, Prestwick 

International Airport, Ayrshire, KA9 

2RW, Scotland, United Kingdom; 

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46188 Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Rules and Regulations 

telephone: +44 1292 675207; fax: +44 

1292 675704; email: RApublications@

baesystems.com; Internet http://

www.baesystems.com/Businesses/

RegionalAircraft/index.htm. 

For Kidde Graviner service 

information identified in this AD, 

contact Kidde Graviner Limited, 

Mathisen Way, Colnbrook, Slough, 

Berkshire, SL3 0HB, United Kingdom; 

telephone: +44 (0)1753 683245, fax: +44 

(0)1753 685040. 

You may view this referenced 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. It is also 

available on the Internet at http://

www.regulations.gov by searching for 

and locating Docket No. FAA–2015– 

3139. 

Examining the AD Docket 

You may examine the AD docket on 

the Internet at http://

www.regulations.gov by searching for 

and locating Docket No. FAA–2015– 

3139; or in person at the Docket 

Operations office between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. The AD docket 

contains this AD, the regulatory 

evaluation, any comments received, and 

other information. The street address for 

the Docket Operations office (telephone: 

800–647–5527) is in the ADDRESSES

section. Comments will be available in 

the AD docket shortly after receipt. 

FOR FURTHER INFORMATION CONTACT: 

Todd Thompson, Aerospace Engineer, 

International Branch, ANM–116, 

Transport Airplane Directorate, FAA, 

1601 Lind Avenue SW., Renton, WA 

98057–3356; telephone: 425–227–1175; 

fax: 425–227–1149. 

SUPPLEMENTARY INFORMATION: 

Discussion 

The European Aviation Safety Agency 

(EASA), which is the Technical Agent 

for the Member States of the European 

Union, has issued EASA Airworthiness 

Directive 2012–0127R1, dated 

September 10, 2012 (referred to after 

this as the Mandatory Continuing 

Airworthiness Information, or ‘‘the 

MCAI’’), to correct an unsafe condition 

for all BAE Systems (Operations) 

Limited Model ATP airplanes. The 

MCAI states: 

A fire handle on a BAe 146 aeroplane was 

operated on the ground as a precautionary 

measure after the throttle cable on the 

affected engine failed, due to corrosion. The 

extinguisher failed to discharge. 

Investigation results revealed that excess 

solder, which had been deposited during 

overhaul on the frangible plug of the 

extinguisher, prevented the release of the 

extinguishant. Prompted by this report, 

Kidde Graviner, the fire extinguisher 

manufacturer, identified four further 

extinguishers of similar design that had the 

same issue. The ATP aeroplane extinguisher 

is one of those of a similar design. 

This condition, if not detected and 

corrected, could result in the failure of a fire 

bottle to discharge, which reduces the ability 

of the fire protection system to extinguish 

fires in the engine or Auxiliary Power Unit 

(APU) fire zones, possibly resulting in 

damage to the aeroplane and injury to the 

occupants. 

For the reasons described above, EASA 

issued AD 2012–0127 [dated July 10, 2012, 

http://ad.easa.europa.eu/ad/2012-0127R1] to 

require a one-time inspection of the affected 

Part Number (P/N) 57183 engine and APU 

fire extinguishers. In addition, this [EASA] 

AD prohibited installation of a fire 

extinguisher, unless it has passed the 

inspection as required by AD 2012–0127. 

Revision 1 of this [EASA] AD is issued to 

clarify that new extinguishers P/N 57183 may 

be fitted with no additional inspection 

required by this [EASA] AD. 

You may examine the MCAI on the 

Internet at http://www.regulations.gov 

by searching for and locating Docket No. 

FAA–2015–3139. 

Related Service Information Under 1 

CFR Part 51 

BAE Systems (Operations) Limited 

and Kidde Graviner have issued the 

following service information. 

• BAE Systems (Operations) Limited 

Service Bulletin ATP–26–016, dated 

October 4, 2011. The service 

information describes procedures for an 

inspection for solder deposited on the 

frangible plug of certain engine and 

APU fire extinguishers. 

• Kidde Graviner Service Bulletin 26– 

080, Revision 1, dated July 27, 2011. 

The service information describes 

procedures for an inspection for solder 

deposited on the frangible plug of 

certain engine and APU fire 

extinguishers. 

This service information is reasonably 

available because the interested parties 

have access to it through their normal 

course of business or by the means 

identified in the ADDRESSES section of 

this AD. 

FAA’s Determination and Requirements 

of This AD 

This product has been approved by 

the aviation authority of another 

country, and is approved for operation 

in the United States. Pursuant to our 

bilateral agreement with the State of 

Design Authority, we have been notified 

of the unsafe condition described in the 

MCAI and service information 

referenced above. We are issuing this 

AD because we evaluated all pertinent 

information and determined the unsafe 

condition exists and is likely to exist or 

develop on other products of the same 

type design. 

FAA’s Determination of the Effective 

Date 

Since there are currently no domestic 

operators of this product, notice and 

opportunity for public comment before 

issuing this AD are unnecessary. 

Comments Invited 

This AD is a final rule that involves 

requirements affecting flight safety, and 

we did not precede it by notice and 

opportunity for public comment. We 

invite you to send any written relevant 

data, views, or arguments about this AD. 

Send your comments to an address 

listed under the ADDRESSES section. 

Include ‘‘Docket No. FAA–2015–3139; 

Directorate Identifier 2012–NM–139– 

AD’’ at the beginning of your comments. 

We specifically invite comments on the 

overall regulatory, economic, 

environmental, and energy aspects of 

this AD. We will consider all comments 

received by the closing date and may 

amend this AD based on those 

comments. 

We will post all comments we 

receive, without change, to http://

www.regulations.gov, including any 

personal information you provide. We 

will also post a report summarizing each 

substantive verbal contact we receive 

about this AD. 

Costs of Compliance 

Currently, there are no affected 

airplanes on the U.S. Register. However, 

if an affected airplane is imported and 

placed on the U.S. Register in the future, 

the required actions will take about 1 

work-hour, at an average labor rate of 

$85 per work-hour. Based on these 

figures, we estimate the cost of this AD 

to be $85 per airplane. 

In addition, we estimate that any 

necessary follow-on actions will take 

about 1 work-hour and require parts 

costing $7,042, for a cost of $7,127 per 

product. 

Authority for This Rulemaking 

Title 49 of the United States Code 

specifies the FAA’s authority to issue 

rules on aviation safety. Subtitle I, 

section 106, describes the authority of 

the FAA Administrator. ‘‘Subtitle VII: 

Aviation Programs,’’ describes in more 

detail the scope of the Agency’s 

authority. 

We are issuing this rulemaking under 

the authority described in ‘‘Subtitle VII, 

Part A, Subpart III, Section 44701: 

General requirements.’’ Under that 

section, Congress charges the FAA with 

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Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Rules and Regulations 46189 

promoting safe flight of civil aircraft in 

air commerce by prescribing regulations 

for practices, methods, and procedures 

the Administrator finds necessary for 

safety in air commerce. This regulation 

is within the scope of that authority 

because it addresses an unsafe condition 

that is likely to exist or develop on 

products identified in this rulemaking 

action. 

Regulatory Findings 

We determined that this AD will not 

have federalism implications under 

Executive Order 13132. This AD will 

not have a substantial direct effect on 

the States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government. 

For the reasons discussed above, I 

certify that this AD: 

1. Is not a ‘‘significant regulatory 

action’’ under Executive Order 12866; 

2. Is not a ‘‘significant rule’’ under the 

DOT Regulatory Policies and Procedures 

(44 FR 11034, February 26, 1979); 

3. Will not affect intrastate aviation in 

Alaska; and 

4. Will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

Adoption of the Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA amends 14 CFR part 39 as 

follows: 

PART 39—AIRWORTHINESS 

DIRECTIVES 

■ 1. The authority citation for part 39 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

■ 2. The FAA amends § 39.13 by adding 

the following new airworthiness 

directive (AD): 

2015–15–14 BAE Systems (Operations) 

Limited: Amendment 39–18224. Docket 

No. FAA–2015–3139; Directorate 

Identifier 2012–NM–139–AD. 

(a) Effective Date 

This AD becomes effective August 19, 

2015. 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to all BAE Systems 

(Operations) Limited Model ATP airplanes, 

certificated in any category, all manufacturer 

serial numbers. 

(d) Subject 

Air Transport Association (ATA) of 

America Code 26, Fire Protection. 

(e) Reason 

This AD was prompted by reports of a fire 

extinguisher that failed to discharge due to 

solder deposited on the frangible plug of the 

fire extinguisher. We are issuing this AD to 

detect and correct solder deposited on the 

frangible plug of the fire extinguisher, which 

could result in failure of the fire extinguisher 

to discharge, and consequent inability to put 

out a fire in an engine or in the APU. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Inspection of Fire Extinguishers 

(1) For airplanes equipped with Kidde 

Graviner fire extinguishers having part 

number (P/N) 57183 (all dash numbers): 

Within 12 months after the effective date of 

this AD, inspect each affected fire 

extinguisher for solder deposited on the 

frangible plug of the fire extinguisher, in 

accordance with the Accomplishment 

Instructions of BAE Systems (Operations) 

Limited Service Bulletin ATP–26–016, dated 

October 4, 2011, and Kidde Graviner Service 

Bulletin 26–080, Revision 1, dated July 27, 

2011. If any solder deposit is detected, 

replace the fire extinguisher with a 

serviceable fire extinguisher before further 

flight, in accordance with the 

Accomplishment Instructions of BAE 

Systems (Operations) Limited Service 

Bulletin ATP–26–016, dated October 4, 2011. 

(2) Fire extinguishers that meet any 

condition identified in paragraph (g)(2)(i), 

(g)(2)(ii), or (g)(2)(iii) of this AD are 

compliant with the requirements of 

paragraph (g)(1) of this AD. 

(i) Fire extinguishers that have been 

overhauled by Kidde Graviner or Hugen. 

(ii) Fire extinguishers that have been 

overhauled as specified in Kidde Graviner 

Service Information Letter (SIL) 01–10, dated 

July 29, 2010. 

(iii) Fire extinguishers that have been 

overhauled as specified in Kidde Graviner 

Component Maintenance Manual with 

Illustrated Parts List 26–21–52, Automatic 

Extinguishers with Steel Containers Part 

Numbers 57133, 57135, 57145, and 57183 

Series, Revision 17, dated June 13, 2012. 

(h) Definition of ‘‘Overhaul’’ 

For the purpose of this AD, an overhaul is 

considered to include replacement of the 

operating head. Replacement of the pressure 

relief plug assembly only is not considered 

an overhaul. 

(i) Parts Installation Limitations 

As of the effective date of this AD, do not 

install a Kidde Graviner fire extinguisher 

having P/N 57183 (all dash numbers) on any 

airplane, unless the fire extinguisher meets 

any condition specified in paragraph (i)(1), 

(i)(2), (i)(3), (i)(4), or (i)(5) of this AD. 

(1) The fire extinguisher is new. 

(2) The fire extinguisher has passed the 

inspection as specified in the instructions of 

Kidde Graviner Service Bulletin 26–080, 

Revision 1, dated July 27, 2011. 

(3) The fire extinguisher has been 

overhauled by Kidde Graviner or Hugen. 

(4) The fire extinguisher has been 

overhauled as specified in the instructions of 

Kidde Graviner SIL 01–10, dated July 29, 

2010. 

(5) The fire extinguisher has been 

overhauled in accordance with Kidde 

Graviner Component Maintenance Manual 

with Illustrated Parts List 26–21–52, 

Automatic Extinguishers with Steel 

Containers Part Numbers 57133, 57135, 

57145, and 57183 Series, Revision 17, dated 

June 13, 2012. 

(j) Credit for Previous Actions 

This paragraph provides credit for the 

actions specified in paragraphs (g)(2)(iii) and 

(i)(5) of this AD, if those actions were 

performed before the effective date of this AD 

in accordance with the service information 

identified in paragraph (j)(1), (j)(2), (j)(3), or 

(j)(4) of this AD. These documents are not 

incorporated by reference in this AD. 

(1) Kidde Graviner Component 

Maintenance Manual with Illustrated Parts 

List 26–21–52, Automatic Extinguishers with 

Steel Containers Part Numbers 57133, 57135, 

57145, and 57183 Series, Revision 13, dated 

August 9, 2010. 

(2) Kidde Graviner Component 

Maintenance Manual with Illustrated Parts 

List 26–21–52, Automatic Extinguishers with 

Steel Containers Part Numbers 57133, 57135, 

57145, and 57183 Series, Revision 14, dated 

August 8, 2011. 

(3) Kidde Graviner Component 

Maintenance Manual with Illustrated Parts 

List 26–21–52, Automatic Extinguishers with 

Steel Containers Part Numbers 57133, 57135, 

57145, and 57183 Series, Revision 15, dated 

January 16, 2012. 

(4) Kidde Graviner Component 

Maintenance Manual with Illustrated Parts 

List 26–21–52, Automatic Extinguishers with 

Steel Containers Part Numbers 57133, 57135, 

57145, and 57183 Series, Revision 16, dated 

May 21, 2012. 

(k) Other FAA AD Provisions 

The following provisions also apply to this 

AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, International 

Branch, ANM–116, Transport Airplane 

Directorate, FAA, has the authority to 

approve AMOCs for this AD, if requested 

using the procedures found in 14 CFR 39.19. 

In accordance with 14 CFR 39.19, send your 

request to your principal inspector or local 

Flight Standards District Office, as 

appropriate. If sending information directly 

to the International Branch, send it to ATTN: 

Todd Thompson, Aerospace Engineer, 

International Branch, ANM–116, Transport 

Airplane Directorate, FAA, 1601 Lind 

Avenue SW., Renton, WA 98057–3356; 

telephone 425–227–1175; fax 425–227–1149. 

Information may be emailed to: 9-ANM-116- 

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46190 Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Rules and Regulations 

AMOC-REQUESTS@faa.gov. Before using 

any approved AMOC, notify your appropriate 

principal inspector, or lacking a principal 

inspector, the manager of the local flight 

standards district office/certificate holding 

district office. The AMOC approval letter 

must specifically reference this AD. 

(2) Contacting the Manufacturer: For any 

requirement in this AD to obtain corrective 

actions from a manufacturer, the action must 

be accomplished using a method approved 

by the Manager, International Branch, ANM– 

116, Transport Airplane Directorate, FAA; or 

the European Aviation Safety Agency 

(EASA); or BAE Systems (Operations) 

Limited’s EASA Design Organization 

Approval (DOA). If approved by the DOA, 

the approval must include the DOAauthorized signature. 

(l) Related Information 

(1) Refer to Mandatory Continuing 

Airworthiness Information (MCAI) EASA 

Airworthiness Directive 2012–0127R1, dated 

September 10, 2012, for related information. 

You may examine the MCAI on the Internet 

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

for and locating Docket No. FAA–2015–3139. 

(2) Service information identified in this 

AD that is not incorporated by reference is 

available at the addresses specified in 

paragraphs (m)(4), (m)(5), and (m)(6) of this 

AD. 

(m) Material Incorporated by Reference 

(1) The Director of the Federal Register 

approved the incorporation by reference 

(IBR) of the service information listed in this 

paragraph under 5 U.S.C. 552(a) and 1 CFR 

part 51. 

(2) You must use this service information 

as applicable to do the actions required by 

this AD, unless this AD specifies otherwise. 

(i) BAE Systems (Operations) Limited 

Service Bulletin ATP–26–016, dated October 

4, 2011. 

(ii) Kidde Graviner Service Bulletin 26– 

080, Revision 1, dated July 27, 2011. 

(3) For BAE Systems (Operations) Limited 

service information identified in this AD, 

contact BAE Systems (Operations) Limited, 

Customer Information Department, Prestwick 

International Airport, Ayrshire, KA9 2RW, 

Scotland, United Kingdom; telephone +44 

1292 675207; fax +44 1292 675704; email 

RApublications@baesystems.com; Internet 

http://www.baesystems.com/Businesses/

RegionalAircraft/index.htm. 

(4) For Kidde Graviner service information 

identified in this AD, contact Kidde Graviner 

Limited, Mathisen Way, Colnbrook, Slough, 

Berkshire, SL3 0HB, United Kingdom; 

Telephone: +44 (0)1753 683245, Fax: +44 

(0)1753 685040. 

(5) 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. 

(6) You may view this service information 

that is incorporated by reference at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at NARA, call 

202–741–6030, or go to: http://

www.archives.gov/federal-register/cfr/ibrlocations.html. 

Issued in Renton, Washington, on July 23, 

2015. 

Victor Wicklund, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. 2015–18710 Filed 8–3–15; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 73 

[Docket Nos. FDA–2014–C–1616 and FDA– 

2015–C–0245] 

Listing of Color Additives Exempt 

From Certification; Mica-Based 

Pearlescent Pigments; Confirmation of 

Effective Date 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; confirmation of 

effective date. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

confirming the effective date of July 9, 

2015, for the final rule that appeared in 

the Federal Register of June 8, 2015, 

and that amended the color additive 

regulations to expand the permitted 

uses of mica-based pearlescent pigments 

prepared from titanium dioxide and 

mica as color additives in cordials, 

liqueurs, flavored alcoholic malt 

beverages, wine coolers, cocktails, nonalcoholic cocktail mixers and mixes, 

and in egg decorating kits for coloring 

shell eggs. 

DATES: Effective date of final rule 

published in the Federal Register of 

June 8, 2015 (80 FR 32303), confirmed: 

July 9, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Ellen Anderson, Center for Food Safety 

and Applied Nutrition (HFS–265), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740– 

3835, 240–402–1309. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of June 8, 2015 (80 FR 

32303), we amended the color additive 

regulations in § 73.350 Mica-based 

pearlescent pigments (21 CFR 73.350) to 

expand the permitted uses of micabased pearlescent pigments prepared 

from titanium dioxide and mica as color 

additives in cordials, liqueurs, flavored 

alcoholic malt beverages, wine coolers, 

cocktails, non-alcoholic cocktail mixers 

and mixes, and in egg decorating kits for 

coloring shell eggs. 

We gave interested persons until July 

8, 2015, to file objections or requests for 

a hearing. We received no objections or 

requests for a hearing on the final rule. 

Therefore, we find that the effective date 

of the final rule that published in the 

Federal Register of June 8, 2015, should 

be confirmed. 

List of Subjects in 21 CFR Part 73 

Color additives, Cosmetics, Drugs, 

Foods, Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 321, 

341, 342, 343, 348, 351, 352, 355, 361, 

362, 371, 379e) and under authority 

delegated to the Commissioner of Food 

and Drugs, and redelegated to the 

Director, Office of Food Additive Safety, 

we are giving notice that no objections 

or requests for a hearing were filed in 

response to the June 8, 2015, final rule. 

Accordingly, the amendments issued 

thereby became effective July 9, 2015. 

Dated: July 29, 2015. 

Susan Bernard, 

Director, Office of Regulations, Policy and 

Social Sciences, Center for Food Safety and 

Applied Nutrition. 

[FR Doc. 2015–18996 Filed 8–3–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2015–N–2526] 

Medical Devices; Immunology and 

Microbiology Devices; Classification of 

Trichomonas Vaginalis Nucleic Acid 

Assay 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying a 

Trichomonas vaginalis nucleic acid 

assay into class II (special controls). The 

Agency is classifying the device into 

class II (special controls) in order to 

provide a reasonable assurance of safety 

and effectiveness of the device. 

DATES: This order is effective August 4, 

2015. The classification was applicable 

April 19, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Himani Bisht, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5565, Silver Spring, 

MD 20993–0002, 301–796–6189. 

SUPPLEMENTARY INFORMATION: 

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