Federal Register / Vol. 77, No. 30 / Tuesday, February 14, 2012 / Rules and Regulations 8119 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 870 is 

amended as follows: 

PART 870—CARDIOVASCULAR 

DEVICES 

■ 1. The authority citation for 21 CFR 

part 870 continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 371. 

■ 2 Section 870.3460 is added to 

subpart D to read as follows: 

§ 870.3460 Endovascular Suturing System. 

(a) Identification. An endovascular 

suturing system is a medical device 

intended to provide fixation and sealing 

between an endovascular graft and the 

native artery. The system is comprised 

of the implant device and an 

endovascular delivery device used to 

implant the endovascular suture. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) The device should be 

demonstrated to be biocompatible; 

(2) Sterility and shelf life testing 

should demonstrate the sterility of 

patient-contacting components and the 

shelf-life of these components; 

(3) Non-clinical and clinical 

performance testing should demonstrate 

substantial equivalence in safety and 

effectiveness, including durability, 

compatibility, migration resistance, 

corrosion resistance, and delivery and 

deployment; 

(4) Non-clinical testing should 

evaluate the compatibility of the device 

in an magnetic resonance (MR) 

environment; 

(5) Appropriate analysis and nonclinical testing should validate 

electromagnetic compatibility (EMC) 

and electrical safety; 

(6) The sale, distribution, and use of 

the device are restricted to prescription 

use in accordance with 21 CFR 801.109 

of this chapter; and 

(7) Labeling must bear all information 

required for the safe and effective use of 

the device as outlined in § 801.109(c) of 

this chapter, including a detailed 

summary of the non-clinical and 

clinical evaluations pertinent to use of 

the device. 

Dated: February 9, 2012. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2012–3398 Filed 2–13–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF STATE 

22 CFR Part 41 

[Public Notice 7796] 

Visas: Issuance of Full Validity L Visas 

to Qualified Applicants 

AGENCY: State Department. 

ACTION: Final rule. 

SUMMARY: This rule permits the issuance 

of L visas with validity periods based on 

the visa reciprocity schedule; whereas 

the current rule limits L visas to the 

petition validity period, which is 

determined by the Department of 

Homeland Security. 

DATES: This rule is effective February 

14, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Lauren A. Prosnik, Legislation and 

Regulations Division, Visa Services, 

Department of State, 2401 E Street NW., 

Room L–603D, Washington, DC 20520– 

0106, (202) 663–1260. 

SUPPLEMENTARY INFORMATION: 

Why is the department promulgating 

this rule? 

Current Department regulations 

require that L visa duration be limited 

to the validity period of the petition, 

which, under Department of Homeland 

Security (DHS) regulations, cannot 

exceed three years. Petitioners may 

apply to U.S. Citizenship and 

Immigration Services (USCIS) for 

extension of petition validity in 

increments of up to two years, but the 

total period of stay may not exceed five 

years for aliens employed in a 

specialized knowledge capacity, or 

seven years for aliens employed in a 

managerial or executive capacity. The 

Department is changing this regulation 

to delink visa and petition validity 

periods, as currently required by 22 CFR 

41.54(c), ‘‘Validity of visa’’. As a result, 

L visa validity will be governed by 22 

CFR 41.112, which provides that, except 

as provided in paragraphs (c) and (d) of 

that section, a nonimmigrant visa shall 

have the validity prescribed in 

schedules provided to consular officers 

by the Department, which reflect the 

reciprocal treatment the applicant’s 

country accords U.S. nationals, U.S. 

permanent residents, or aliens granted 

refugee status in the United States. The 

change would assist beneficiaries of 

petitions for L status who are nationals 

of countries for which the reciprocity 

schedule prescribes visa validity for a 

longer period of time than the initial 

validity indicated in the petition 

approved by DHS and who have 

extended their L stay while in the 

United States. Subject to 22 CFR 

41.112(c), such individuals generally 

would not need to apply again for an L 

visa at a U.S. Embassy or Consulate 

overseas if they were to travel outside 

the United States during the period 

indicated in the applicable reciprocity 

schedule, as is currently required when 

petition validity has been extended. 

Under 8 CFR 214.2(l)(11), an alien may 

apply for admission in L status only 

while the individual or blanket petition 

is valid. 

Regulatory Findings 

Administrative Procedure Act 

This regulation involves a foreign 

affairs function of the United States and, 

therefore, in accordance with 5 U.S.C. 

553(a)(1), is not subject to the rule 

making procedures set forth at 5 U.S.C. 

553. 

Regulatory Flexibility Act/Executive 

Order 13272: Small Business 

Because this final rule is exempt from 

notice and comment rulemaking under 

5 U.S.C. 553, it is exempt from the 

regulatory flexibility analysis 

requirements set forth at sections 603 

and 604 of the Regulatory Flexibility 

Act (5 U.S.C. 603 and 604). Nonetheless, 

consistent with section 605(b) of the 

Regulatory Flexibility Act (5 U.S.C. 

605(b)), the Department certifies that 

this rule will not have a significant 

economic impact on a substantial 

number of small entities. This regulates 

individual aliens applying for visas 

under INA § 101(A)(15)(L) and does not 

affect any small entities, as defined in 

5 U.S.C. 601(6). 

Unfunded Mandates Reform Act of 1995 

Section 202 of the Unfunded 

Mandates Reform Act of 1995, Public 

Law 104–4, 109 Stat. 48, 2 U.S.C. 1532, 

generally requires agencies to prepare a 

statement before proposing any rule that 

may result in an annual expenditure of 

$100 million or more by State, local, or 

tribal governments, or by the private 

sector. This rule will not result in any 

such expenditure, nor will it 

significantly or uniquely affect small 

governments. 

Small Business Regulatory Enforcement 

Fairness Act of 1996 

This rule is not a major rule as 

defined by 5 U.S.C. 804, for purposes of 

congressional review of agency 

rulemaking under the Small Business 

Regulatory Enforcement Fairness Act of 

1996, Public Law 104–121. This rule 

will not result in an annual effect on the 

economy of $100 million or more; a 

major increase in costs or prices; or 

adverse effects on competition, 


pmangrum on DSK3VPTVN1PROD with RULES
8120 Federal Register / Vol. 77, No. 30 / Tuesday, February 14, 2012 / Rules and Regulations 

employment, investment, productivity, 

innovation, or the ability of United 

States-based companies to compete with 

foreign-based companies in domestic 

and import markets. 

Executive Order 12866 

The Department of State has reviewed 

this proposed rule to ensure its 

consistency with the regulatory 

philosophy and principles set forth in 

Executive Order 12866 and has 

determined that the benefits of this final 

regulation justify its costs. The 

Department does not consider this final 

rule to be an economically significant 

action within the scope of section 3(f)(1) 

of the Executive Order since it is not 

likely to have an annual effect on the 

economy of $100 million or more or to 

adversely affect in a material way the 

economy, a sector of the economy, 

competition, jobs, the environment, 

public health or safety, or State, local or 

tribal governments or communities. 

Executive Orders 12372 and 13132: 

Federalism 

This regulation will 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. Nor will the rule 

have federalism implications warranting 

the application of Executive Orders No. 

12372 and No. 13132. 

Executive Order 12988: Civil Justice 

Reform 

The Department has reviewed the 

regulations in light of sections 3(a) and 

3(b)(2) of Executive Order No. 12988 to 

eliminate ambiguity, minimize 

litigation, establish clear legal 

standards, and reduce burden. 

Executive Order 13563: Improving 

Regulation and Regulatory Review 

The Department has considered this 

rule in light of Executive Order 13563, 

dated January 18, 2011, and affirms that 

this regulation is consistent with the 

guidance therein. 

Paperwork Reduction Act 

This rule does not impose information 

collection requirements under the 

provisions of the Paperwork Reduction 

Act, 44 U.S.C. Chapter 35. 

List of Subjects in 22 CFR Part 41 

Documentation of nonimmigrants. 

For the reasons stated in the 

preamble, the Department of State 

amends 22 CFR part 41 to read as 

follows: 

PART 41—[AMENDED] 

■ 1. The authority citation for part 41 

continues to read as follows: 

Authority: 8 U.S.C. 1104; Pub. L. 105–277, 

112 Stat. 2681–795 through 2681–801; 8 

U.S.C. 1185 note (section 7209 of Pub. L. 

108–458, as amended by section 546 of Pub. 

L. 109–295). 

■ 2. Section 41.54 is revised to read as 

follows: 

§ 41.54 Intracompany transferees 

(executives, managers, and specialized 

knowledge employees) 

(a) Requirements for L classification. 

An alien shall be classifiable under the 

provisions of INA section 101(a)(15)(L) 

if: 

(1) The consular officer is satisfied 

that the alien qualifies under that 

section; and either 

(2) In the case of an individual 

petition, the consular officer has 

received official evidence of the 

approval by DHS of a petition to accord 

such classification or of the extension 

by DHS of the period of authorized stay 

in such classification; or 

(3) In the case of a blanket petition, 

(i) The alien has presented to the 

consular officer official evidence of the 

approval by DHS of a blanket petition 

listing only those intracompany 

relationships and positions found to 

qualify under INA section 101(a)(15)(L); 

(ii) The alien is otherwise eligible for 

L–1 classification pursuant to the 

blanket petition; and, 

(iii) The alien requests that he or she 

be accorded such classification for the 

purpose of being transferred to, or 

remaining in, qualifying positions 

identified in such blanket petition; or 

(4) The consular officer is satisfied the 

alien is the spouse or child of an alien 

so classified and is accompanying or 

following to join the principal alien. 

(b) Petition approval. The approval of 

a petition by DHS does not establish 

that the alien is eligible to receive a 

nonimmigrant visa. 

(c) Alien not entitled to L–1 

classification under individual petition. 

The consular officer must suspend 

action on the alien’s application and 

submit a report to the approving DHS 

office if the consular officer knows or 

has reason to believe that an alien 

applying for a visa as the beneficiary of 

an approved individual petition under 

INA section 101(a)(15)(L) is not entitled 

to such classification as approved. 

(d) Labor disputes. Citizens of Canada 

or Mexico shall not be entitled to 

classification under this section if the 

Secretary of Homeland Security and the 

Secretary of Labor have certified that: 

(1) There is in progress a strike or 

lockout in the course of a labor dispute 

in the occupational classification at the 

place or intended place of employment; 

and, 

(2) The alien has failed to establish 

that the alien’s entry will not affect 

adversely the settlement of the strike or 

lockout or the employment of any 

person who is involved in the strike or 

lockout. 

(e) Alien not entitled to L–1 

classification under blanket petition. 

The consular officer shall deny L 

classification based on a blanket 

petition if the documentation presented 

by the alien claiming to be a beneficiary 

thereof does not establish to the 

satisfaction of the consular officer that 

(1) The alien has been continuously 

employed by the same employer, an 

affiliate or a subsidiary thereof, for one 

year within the three years immediately 

preceding the application for the L visa; 

(2) The alien was rendering services 

in a capacity that is managerial, 

executive, or involves specialized 

knowledge throughout that year; or 

(3) The alien is destined to render 

services in such a capacity, as identified 

in the petition and in an organization 

listed in the petition. 

(f) Former exchange visitor. Former 

exchange visitors who are subject to the 

two-year foreign residence requirement 

of INA section 212(e) are ineligible to 

apply for visas under INA section 

101(a)(15)(L) until they have fulfilled 

the residence requirement or obtained a 

waiver of the requirement. 

Dated: January 31, 2012. 

Janice L. Jacobs, 

Assistant Secretary for Consular Affairs, 

Department of State. 

[FR Doc. 2012–3455 Filed 2–13–12; 8:45 am] 

BILLING CODE 4710–06–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9576] 

RIN 1545–BF73 

Definition of a Taxpayer 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Final regulations. 

SUMMARY: This document contains final 

Income Tax Regulations which provide 

guidance relating to the determination 

of who is considered to pay a foreign 

income tax for purposes of the foreign 

tax credit. These regulations provide 

rules for identifying the person with 

legal liability to pay the foreign income 


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