51878 Federal Register / Vol. 76, No. 161 / Friday, August 19, 2011 / Rules and Regulations 

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

through Friday. 

1. Petition from TearScience, Inc., August 6, 

2010. 

List of Subjects in 21 CFR Part 886 

Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 886 is 

amended as follows: 

PART 886—OPHTHALMIC DEVICES 

■ 1. The authority citation for 21 CFR 

part 886 continues to read as follows: 

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

360j, 371. 

■ 2. Section 886.5200 is added to 

subpart F to read as follows: 

§ 886.5200 Eyelid thermal pulsation 

system. 

(a) Identification. An eyelid thermal 

pulsation system is an electricallypowered device intended for use in the 

application of localized heat and 

pressure therapy to the eyelids. The 

device is used in adult patients with 

chronic cystic conditions of the eyelids, 

including meibomian gland dysfunction 

(MGD), also known as evaporative dry 

eye or lipid deficiency dry eye. The 

system consists of a component that is 

inserted around the eyelids and a 

component to control the application of 

heat and pressure to the eyelids. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Appropriate analysis/testing 

should validate electromagnetic 

compatibility (EMC) and safety of 

exposure to non-ionizing radiation; 

(2) Design, description, and 

performance data should validate 

safeguards related to the temperature 

and pressure aspects of the device, 

including during fault conditions; 

(3) Performance data should 

demonstrate the sterility of patientcontacting components and the shelflife of these components; 

(4) The device should be 

demonstrated to be biocompatible; and 

(5) Performance data should 

demonstrate that any technological 

changes do not adversely effect safety 

and effectiveness. 

Dated: August 12, 2011. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2011–21195 Filed 8–18–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9538] 

RIN 1545–BK14 

Modifications of Certain Derivative 

Contracts; Correction 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Correction to final and 

temporary regulations. 

SUMMARY: This document describes 

corrections to final and temporary 

regulations (TD 9538) that address when 

a transfer or assignment of certain 

derivative contracts does not result in 

an exchange to the nonassigning 

counterparty for purposes of § 1.1001– 

1(a). These regulations were published 

in the Federal Register on Friday, July 

22, 2011. 

DATES: This correction is effective on 

August 19, 2011, and is applicable on 

July 22, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Andrea M. Hoffenson, (202) 622–3920 

(not a toll-free number). 

SUPPLEMENTARY INFORMATION: 

Background 

The final and temporary regulations 

that are the subject of this correction are 

under section 1001 of the Internal 

Revenue Code. 

Need for Correction 

As published July 22, 2011 (76 FR 

43892), final and temporary regulations 

(TD 9538) contain errors that may prove 

to be misleading and are in need of 

clarification. 

Correction of Publication 

Accordingly, the publication of the 

final and temporary regulations (TD 

9538) which were the subject of FR Doc. 

2011–18529 is corrected as follows: 

1. On page 43892, column 3, in the 

preamble, under the paragraph heading 

‘‘Explanation of Provisions’’, first 

paragraph of the column, lines 5, 6, and 

7, the language ‘‘in securities or a 

clearinghouse transfers or assigns a 

derivative contract to another dealer in 

securities or’’ is corrected to read ‘‘or a 

clearinghouse transfers or assigns a 

derivative contract to another dealer 

or’’. 

2. On page 43892, column 3, in the 

preamble, under the paragraph heading 

‘‘Explanation of Provisions’’, first 

paragraph of the column, lines 12 and 

13, the language ‘‘those described in 

section 475(c)(2)(D), 475(c)(2)(E), or 

475(c)(2)(F). In addition,’’ is corrected to 

read ‘‘those described in sections 

475(c)(2)(D), 475(c)(2)(E), 475(c)(2)(F), 

475(e)(2)(B), 475(e)(2)(C), or 

475(e)(2)(D), or § 1.446–3(c)(1). In 

addition,’’. 

3. On page 43892, column 3, in the 

preamble, under the paragraph heading 

‘‘Special Analyses’’, the last line of the 

paragraph, the language ‘‘on their 

impact on small business.’’ is corrected 

to read ‘‘on their impact on small 

businesses.’’. 

LaNita Van Dyke, 

Chief, Publications and Regulations Branch, 

Legal Processing Division, Associate Chief 

Counsel (Procedure and Administration). 

[FR Doc. 2011–21179 Filed 8–18–11; 8:45 am] 

BILLING CODE 4830–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9538] 

RIN 1545–BK14 

Modifications of Certain Derivative 

Contracts; Correction 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Correcting amendment. 

SUMMARY: This document describes 

correcting amendments to final and 

temporary regulations (TD 9538) that 

address when a transfer or assignment 

of certain derivative contracts does not 

result in an exchange to the 

nonassigning counterparty for purposes. 

These regulations were published in 

the Federal Register on Friday, July 22, 

2011. 

DATES: This correction is effective on 

August 19, 2011, and is applicable 

beginning July 22, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Andrea M. Hoffenson, (202) 622–3920 

(not a toll-free number). 

SUPPLEMENTARY INFORMATION: 

Background 

The final and temporary regulations 

that are the subject of this correction are 

under section 1001 of the Internal 

Revenue Code. 

Need for Correction 

As published July 22, 2011 (76 FR 

43892), the final and temporary 

regulations (TD 9538) contain errors that 

may prove to be misleading and are in 

need of clarification. 


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