Federal Register / Vol. 77, No. 54 / Tuesday, March 20, 2012 / Rules and Regulations 16157 

cycles until accomplishment of the 

requirements of paragraph (j) of this AD. 

(i) Detailed Inspection for Cracks (No 

Leakage Found) 

If no sign of fuel leakage is found during 

the most recent inspection required by 

paragraph (g) of this AD, within 450 flight 

cycles after accomplishing the inspection, 

repeat the general visual inspection required 

by paragraph (g) of this AD and do a detailed 

inspection for cracks on spar II, spar cap 

third, and main box lower skin of the wings, 

close to the rib 10, in accordance with Part 

II and Part III of the Accomplishment 

Instructions of EMBRAER Alert Service 

Bulletin 170–57–A053, dated February 13, 

2012. Repeat both inspections thereafter at 

intervals not to exceed 450 flight cycles. 

(j) Special Detailed Inspection (Leakage 

Found) 

If any fuel leakage is found during any 

inspection required by paragraph (g) or (i) of 

this AD: Within 150 flight cycles after the 

most recent inspection, do an eddy current 

special detailed inspection for cracks on spar 

II of the wings, and a defueled tank leak 

check for fuel leakage, in accordance with 

Part IV and Part V, as applicable, of the 

Accomplishment Instructions of EMBRAER 

Alert Service Bulletin 170–57–A053, dated 

February 13, 2012. 

(1) If any crack is found: Do the actions 

specified in paragraph (k) of this AD. 

(2) If no crack is found: Repeat the general 

visual inspection specified in paragraph (g) 

of this AD and the detailed inspection 

specified in paragraph (i) of this AD at 

intervals not to exceed 450 flight cycles. 

(k) Repair 

If any cracking or fuel leakage is found 

during any inspection or check required by 

this AD: Before further flight, repair using a 

method approved by either the Manager, 

International Branch, ANM–116, Transport 

Airplane Directorate, FAA; or the Ageˆncia 

Nacional de Aviac ̧a ̃o Civil (ANAC) (or its 

delegated agent). Repair of any crack 

terminates the repetitive inspection 

requirements required by this AD for that 

side of the wing. 

Note 2 to paragraph (k) of this AD: 

Guidance on the classification of ‘‘fuel 

leakage’’ and the disposition of fuel leaks can 

be found in Task 28–11–00–790–801–A, 

Wing Tank—Fueled Tank Leakage Check, of 

the EMBRAER 170/175 Aircraft Maintenance 

Manual. 

(l) Other FAA AD Provisions 

The following provisions also apply to this 

AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, International 

Branch, ANM–116, 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, ANM–116, send 

it to ATTN: Cindy Ashforth, Aerospace 

Engineer, International Branch, ANM–116, 

Transport Airplane Directorate, FAA, 1601 

Lind Avenue SW., Renton, Washington 

98057–3356; telephone 425–227–2768; fax 

425–227–1149. Information may be emailed 

to: 9-ANM-116-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) Airworthy Product: For any requirement 

in this AD to obtain corrective actions from 

a manufacturer or other source, use these 

actions if they are FAA-approved. Corrective 

actions are considered FAA-approved if they 

are approved by the State of Design Authority 

(or their delegated agent). You are required 

to assure the product is airworthy before it 

is returned to service. 

(m) Special Flight Permits 

Special flight permits, as described in 

Section 21.197 and Section 21.199 of the 

Federal Aviation Regulations (14 CFR 21.197 

and 21.199), are not allowed. 

(n) Related Information 

Refer to MCAI Brazilian Airworthiness 

Directive 2012–02–01, dated February 22, 

2012; and EMBRAER Alert Service Bulletin 

170–57–A053, dated February 13, 2012; for 

related information. 

(o) Material Incorporated by Reference 

(1) You must use the following service 

information to do the actions required by this 

AD, unless the AD specifies otherwise. The 

Director of the Federal Register approved the 

incorporation by reference (IBR) of the 

following service information under 5 U.S.C. 

552(a) and 1 CFR part 51: 

(i) Embraer Alert Service Bulletin 170–57– 

A053, dated February 13, 2012. 

(2) For service information identified in 

this AD, contact Empresa Brasileira de 

Aeronautica S.A. (EMBRAER), Technical 

Publications Section (PC 060), Av. Brigadeiro 

Faria Lima, 2170–Putim–12227–901 Sa ̃o Jose 

dos Campos—SP—BRASIL; telephone +55 12 

3927–5852 or +55 12 3309–0732; fax +55 12 

3927–7546; email distrib@embraer.com.br; 

Internet http://www.flyembraer.com. 

(3) You may review copies of the service 

information at the FAA, Transport Airplane 

Directorate, 1601 Lind Avenue SW., Renton, 

Washington. For information on the 

availability of this material at the FAA, call 

425–227–1221. 

(4) You may also review copies of the 

service information that is incorporated by 

reference at the National Archives and 

Records Administration (NARA). For 

information on the availability of this 

material at an NARA facility, call 202–741– 

6030, or go to http://www.archives.gov/

federal_register/code_of_federal_regulations/

ibr_locations.html. 

Issued in Renton, Washington, on March 7, 

2012. 

Ali Bahrami, 

Manager, Transport Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2012–6447 Filed 3–19–12; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF LABOR 

Employment and Training 

Administration 

20 CFR Part 655 

RIN 1205–AB58 

Changes to the Labor Certification 

Process for the Temporary NonAgricultural Employment of H–2B 

Aliens in the United States; Transition 

Period 

AGENCY: Employment and Training 

Administration, Department of Labor. 

ACTION: Guidance. 

SUMMARY: On February 21, 2012, the 

Department of Labor (the Department or 

DOL) published a Final Rule amending 

H–2B regulations governing the 

certification of temporary employment 

of nonimmigrant workers in temporary 

or seasonal non-agricultural 

employment. The Department’s H–2B 

Final Rule also created new regulations 

to provide for enhanced enforcement 

under the H–2B program requirements 

when employers fail to meet their 

obligations under the H–2B program. 

The Department also made changes to 

the Application for Temporary 

Employment Certification, ETA Form 

9142. 

The H–2B Final Rule becomes 

effective on April 23, 2012. All 

applications filed on or after that date 

will need to comply with all applicable 

program requirements. The purpose of 

this guidance is to provide transition 

procedures to ensure that employers 

filing H–2B applications on or after 

April 23, 2012, have sufficient 

information to file appropriately. 

DATES: This guidance is effective March 

20, 2012. 

FOR FURTHER INFORMATION CONTACT: 

William L. Carlson, Ph.D., 

Administrator, Office of Foreign Labor 

Certification, Employment and Training 

Administration, 200 Constitution 

Avenue NW., Room C–4312, 

Washington, DC 20210; Telephone: 

(202) 693–3010 (this is not a toll-free 

number). 

SUPPLEMENTARY INFORMATION: On 

February 21, 2012, the Department 

published a Final Rule amending the H– 

2B regulations at 20 CFR part 655, 

Subpart A. 76 FR 10038, Feb. 21, 2012. 

The rule becomes effective April 23, 

2012 and applies to all applications 

filed on or after that date. Among other 

things, the H–2B Final Rule provides for 

a return to the compliance-based 

certification model, by which employers 

file before conducting recruitment. The 


wreier-aviles on DSK5TPTVN1PROD with RULES
16158 Federal Register / Vol. 77, No. 54 / Tuesday, March 20, 2012 / Rules and Regulations 

H–2B Final Rule also includes a new 

registration process, to precede the 

filing of applications. 

Applications filed under Labor 

Certification Process and Enforcement 

for Temporary Employment in 

Occupations Other Than Agriculture or 

Registered Nursing in the United States 

(H–2B Workers), and Other Technical 

Changes, 73 FR 78020, Dec. 19, 2008 

(the current regulation), must be sent to 

the Office of Foreign Labor 

Certification’s (OFLC’s) Chicago 

National Processing Center (CNPC) and 

postmarked no later than midnight 

April 22, 2012, the last day before the 

effective date of the H–2B Final Rule. 

An application filed up to the effective 

date of the H–2B Final Rule must still 

comply in full with the requirements of 

the current regulations. Applications 

postmarked on or after April 23, 2012 

will be adjudicated in accordance with 

the requirements described in the H–2B 

Final Rule. 

Any application filed under the 

current regulation that is postmarked on 

or after April 23, 2012 or later will be 

rejected, and the employer (and its agent 

or attorney) will be informed of the need 

to file a new application in accordance 

with the provisions of the new H–2B 

Final Rule. 

To ensure a smooth transition from 

the current regulation and allow the 

OFLC to make the necessary changes to 

its program operations to accommodate 

the new planned registration process, 

the Department noted in the H–2B Final 

Rule, at 20 CFR 655.11(j), that it would 

announce in the Federal Register a 

separate transition period for the 

registration process. Employers who file 

H–2B applications with a start date of 

need before October 1, 2013 will not be 

required to obtain the pre-approved H– 

2B registration under 20 CFR 655.15, 

and the Department will continue to 

adjudicate temporary need during the 

processing of applications by reviewing 

the employer’s statement of temporary 

need in Section B of the ETA Form 

9142. Employers filing H–2B 

applications on or after April 23, 2012 

with a start date of need on or after 

October 1, 2013, must comply with all 

the requirements contained in the 

registration process unless the OFLC 

publishes additional guidance in the 

Federal Register. 

Employers with questions are 

encouraged to submit such questions to 

H–2B.Regulation@dol.gov. The 

Department will provide responses in 

the form of Frequently Asked Questions 

(FAQs) on its Web site. 

Signed in Washington, this 14th day of 

March, 2012. 

Jane Oates, 

Assistant Secretary, Employment and 

Training Administration. 

[FR Doc. 2012–6580 Filed 3–19–12; 8:45 am] 

BILLING CODE 4510–FP–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 211 

[Docket No. FDA–1997–N–0518] (formerly 

97N–0300) 

Current Good Manufacturing Practice 

in Manufacturing, Processing, Packing, 

or Holding of Drugs; Revision of 

Certain Labeling Controls 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

packaging and labeling control 

provisions of the current good 

manufacturing practice (CGMP) 

regulations for human and veterinary 

drug products by limiting the 

application of special control 

procedures for the use of cut labeling to 

immediate container labels, individual 

unit cartons, or multiunit cartons 

containing immediate containers that 

are not packaged in individual unit 

cartons. FDA is also permitting the use 

of any automated technique, including 

differentiation by labeling size and 

shape, that physically prevents incorrect 

labeling from being processed by 

labeling and packaging equipment when 

cut labeling is used. This action is 

intended to protect consumers from 

labeling errors more likely to cause 

adverse health consequences, while 

eliminating the regulatory burden of 

applying the rule to labeling unlikely to 

reach or adversely affect consumers. 

This action is also intended to permit 

manufacturers to use a broader range of 

error prevention and labeling control 

techniques than permitted by current 

CGMPs. 

DATES: This final rule is effective on 

March 20, 2013, except for the 

amendment adding § 211.122(g)(4), 

which is effective April 19, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Brian Hasselbalch, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 4364, 

Silver Spring, MD 20993–0002, 301– 

796–3279, email: 

brian.hasselbalch@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of July 29, 

1997 (62 FR 40489) (the proposed rule), 

FDA proposed to amend the packaging 

and labeling control provisions of the 

CGMP regulations for human and 

veterinary drug products by limiting the 

application of special control 

procedures for the use of cut labeling to 

immediate container labels, individual 

unit cartons, or multiunit cartons 

containing immediate containers that 

are not packaged in individual unit 

cartons, and to permit the use of any 

automated technique, including 

differentiation by labeling size and 

shape, that physically prevents incorrect 

labeling from being processed by 

labeling and packaging equipment when 

cut labeling—single labels for 

individual drug products that are ‘‘cut’’ 

from a sheet or roll of labels—is used. 

Persistent problems with drug 

product mislabeling and subsequent 

recalls led FDA in 1987 and in 1990 to 

review labeling procedures and product 

recalls. The review identified gangprinted and cut labeling as a leading 

cause of labeling mixups. Gang-printed 

labeling is defined in § 210.3(b)(22) (21 

CFR 210.3(b)(22)) as labeling derived 

from a sheet of material on which more 

than one item of labeling is printed. 

Each sheet includes labeling for a 

variety of products and, because of this, 

labeling for individual drug products 

must be separated from the labeling for 

other products. When labels are gangprinted, the labels for different drug 

products or different strengths for the 

same drug product are processed 

together, making them especially 

susceptible to mixups. Similarly, cut 

labeling is commonly placed in separate 

stacks before being transported to 

packaging and labeling lines for 

application to appropriate products. 

FDA found that stacks of labeling of 

similar size, shape, and color could 

easily be intermixed and, if the printer 

or manufacturer did not detect the error, 

incorrect labeling could be applied and 

a mislabeled drug product distributed. 

To reduce the frequency and likelihood 

of such mislabeling, FDA, in the Federal 

Register of August 3, 1993 (58 FR 

41348), amended the packaging and 

labeling control provisions of the CGMP 

regulations in part 211 (21 CFR part 

211) to provide specific conditions for 

the use of all gang-printed and cut 

labeling. Under § 211.122(f), use of 

gang-printed labeling for different drug 

products, or different strengths or net 


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