51876 Federal Register / Vol. 76, No. 161 / Friday, August 19, 2011 / Rules and Regulations 

(3) The routine uses FHFA or FHFA– 

OIG may make of the information; and 

(4) The effects on the individual, if 

any, of not providing the information. 

(d) Ensure that the employee’s office 

does not maintain a system of records 

without public notice and notify 

appropriate officials of the existence or 

development of any system of records 

that is not the subject of a current or 

planned public notice; 

(e) Maintain all records that are used 

in making any determination about an 

individual with such accuracy, 

relevance, timeliness, and completeness 

as is reasonably necessary to ensure 

fairness to the individual in the 

determination; 

(f) Except for disclosures made under 

FOIA, make reasonable efforts, prior to 

disseminating any record about an 

individual, to ensure that the record is 

accurate, relevant, timely, and complete; 

(g) When required by the Privacy Act, 

maintain an accounting in the specified 

form of all disclosures of records by 

FHFA or FHFA–OIG to persons, 

organizations, or Federal agencies; 

(h) Maintain and use records with 

care to prevent the unauthorized or 

inadvertent disclosure of a record to 

anyone; and 

(i) Notify the appropriate official of 

any record that contains information 

that the Privacy Act does not permit 

FHFA or FHFA–OIG to maintain. 

§ 1204.11 May FHFA–OIG obtain Privacy 

Act records from other Federal agencies for 

law enforcement purposes? 

(a) The FHFA Inspector General is 

authorized under the Inspector General 

Act of 1978, as amended, to make 

written requests under 5 U.S.C. 

552a(b)(7) for transfer of records 

maintained by other Federal agencies 

which are necessary to carry out an 

authorized law enforcement activity 

under the Inspector General Act of 1978, 

as amended. 

(b) The FHFA Inspector General 

delegates the authority under paragraph 

(a) of this section to the following 

FHFA–OIG officials— 

(1) Principal Deputy Inspector 

General; 

(2) Deputy Inspector General for 

Audits; 

(3) Deputy Inspector General for 

Investigations; 

(4) Deputy Inspector General for 

Evaluations; and 

(5) Deputy Inspector General for 

Administration. 

(c) The officials listed in paragraph (b) 

of this section may not further delegate 

or re-delegate the authority described in 

paragraph (a) of this section. 

Dated: August 11, 2011. 

Edward J. DeMarco, 

Acting Director, Federal Housing Finance 

Agency. 

[FR Doc. 2011–21250 Filed 8–18–11; 8:45 am] 

BILLING CODE 8070–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 886 

[Docket No. FDA–2011–M–0570] 

Medical Devices; Ophthalmic Devices; 

Classification of the Eyelid Thermal 

Pulsation System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

eyelid thermal pulsation system 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 rule is effective September 

19, 2011. The classification was 

effective on June 28, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Marc Robboy, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2256, Silver Spring, 

MD 20993–0002, 301–796–6860. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In accordance with section 513(f)(1) of 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) (21 U.S.C. 360c(f)(1)), 

devices that were not in commercial 

distribution before May 28, 1976 (the 

date of enactment of the Medical Device 

Amendments of 1976), generally 

referred to as postamendments devices, 

are classified automatically by statute 

into class III without any FDA 

rulemaking process. These devices 

remain in class III and require 

premarket approval, unless and until 

the device is classified or reclassified 

into class I or II, or FDA issues an order 

finding the device to be substantially 

equivalent, in accordance with section 

513(i) of the FD&C Act (21 U.S.C. 

360c(i)), to a predicate device that does 

not require premarket approval. The 

Agency determines whether new 

devices are substantially equivalent to 

predicate devices by means of 

premarket notification procedures in 

section 510(k) of the FD&C Act (21 

U.S.C. 360(k)) and part 807 of the 

regulations (21 CFR part 807). 

Section 513(f)(2) of the FD&C Act 

provides that any person who submits a 

premarket notification under section 

510(k) of the FD&C Act for a device that 

has not previously been classified may, 

within 30 days after receiving an order 

classifying the device into class III 

under section 513(f)(1) of the FD&C Act, 

request FDA to classify the device under 

the criteria set forth in section 513(a)(1) 

of the FD&C Act. FDA will, within 60 

days of receiving this request, classify 

the device by written order. This 

classification will be the initial 

classification of the device. Within 30 

days after the issuance of an order 

classifying the device, FDA must 

publish a notice in the Federal Register 

announcing this classification. 

In accordance with section 513(f)(1) of 

the FD&C Act, FDA issued an order on 

July 12, 2010, classifying the LipiFlow®

Thermal Pulsation System into class III, 

because it was not substantially 

equivalent to a device that was 

introduced or delivered for introduction 

into interstate commerce for commercial 

distribution before May 28, 1976, or a 

device which was subsequently 

reclassified into class I or class II. On 

August 6, 2010, TearScience, Inc., 

submitted a petition requesting 

classification of the LipiFlow® Thermal 

Pulsation System under section 513(f)(2) 

of the FD&C Act. The manufacturer 

recommended that the device be 

classified into class II. (Ref. 1) 

In accordance with section 513(f)(2) of 

the FD&C Act, FDA reviewed the 

petition in order to classify the device 

under the criteria for classification set 

forth in section 513(a)(1) of the FD&C 

Act. FDA classifies devices into class II 

if general controls by themselves are 

insufficient to provide reasonable 

assurance of safety and effectiveness, 

but there is sufficient information to 

establish special controls to provide 

reasonable assurance of the safety and 

effectiveness of the device for its 

intended use. After review of the 

information submitted in the petition, 

FDA determined that the device can be 

classified into class II with the 

establishment of special controls. FDA 

believes these special controls will 

provide reasonable assurance of the 

safety and effectiveness of the device. 

The device is assigned the generic 

name eyelid thermal pulsation system, 

and it is identified as 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, 


wreier-aviles on DSKDVH8Z91PROD with RULES
Federal Register / Vol. 76, No. 161 / Friday, August 19, 2011 / Rules and Regulations 51877 

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. 

FDA has identified the following risks 

to health associated with this type of 

device and the measures required to 

mitigate these risks: 

Identified risk Mitigation measures 

Infection ..................... Sterility and Shelf 

Life Testing. 

Adverse tissue reaction.Biocompatibility. 

Electrical shock ......... Electrical Safety 

Testing. 

Electromagnetic interference.Electromagnetic 

Compatibility 

(EMC) Testing; Labeling. 

Thermal damage ....... Temperature Performance Testing. 

Mechanical damage .. Pressure Performance Testing. 

Malfunction ................ Non-clinical and Clinical Performance 

Testing. 

User error .................. Labeling. 

FDA believes that the following 

special controls can address these risks 

to health and provide reasonable 

assurance of safety and effectiveness: 

(1) Appropriate analysis/testing should 

validate electromagnetic compatibility 

(EMC) and safety of exposure to nonionizing 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 

affect safety and effectiveness. 

Therefore, on June 28, 2011, FDA issued 

an order to the petitioner classifying the 

device into class II. FDA is codifying the 

classification of the device by adding 

§ 886.5200. 

Following the effective date of this 

final classification rule, any firm 

submitting a 510(k) premarket 

notification for an eyelid thermal 

pulsation system will need to comply 

with the special controls named in the 

regulation. 

Section 510(m) of the FD&C Act 

provides that FDA may exempt a class 

II device from the premarket notification 

requirements under section 510(k) of the 

FD&C Act, if FDA determines that 

premarket notification is not necessary 

to provide reasonable assurance of the 

safety and effectiveness of the device. 

For this type of device, FDA has 

determined that premarket notification 

is necessary to provide reasonable 

assurance of the safety and effectiveness 

of the device. Therefore, this device 

type is not exempt from premarket 

notification requirements. Persons who 

intend to market this type of device 

must submit to FDA a premarket 

notification, prior to marketing the 

device, which contains information 

about the eyelid thermal pulsation 

system they intend to market. 

II. Environmental Impact 

The Agency has determined under 21 

CFR 25.34(b) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

III. Analysis of Impacts 

FDA has examined the impacts of the 

final rule under Executive Order 12866, 

Executive Order 13563, the Regulatory 

Flexibility Act (5 U.S.C. 601–612), and 

the Unfunded Mandates Reform Act of 

1995 (Pub. L. 104–4). Executive Orders 

12866 and 13563 direct agencies to 

assess all costs and benefits of available 

regulatory alternatives and, when 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

agency believes that this final rule is not 

a significant regulatory action under 

Executive Order 12866. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because reclassification of this 

device from class III to class II will 

relieve manufacturers of the device of 

the cost of complying with the 

premarket approval requirements of 

section 515 of the FD&C act (21 U.S.C. 

360e), and may permit small potential 

competitors to enter the marketplace by 

lowering their costs, the Agency 

certifies that the final rule will not have 

a significant economic impact on a 

substantial number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $136 

million, using the most current (2010) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

IV. Federalism 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. Section 4(a) 

of the Executive order requires agencies 

to ‘‘construe * * * a Federal statute to 

preempt State law only where the 

statute contains an express preemption 

provision or there is some other clear 

evidence that the Congress intended 

preemption of State law, or where the 

exercise of State authority conflicts with 

the exercise of Federal authority under 

the Federal statute.’’ Federal law 

includes an express preemption 

provision that preempts certain state 

requirements ‘‘different from or in 

addition to’’ certain Federal 

requirements applicable to devices. (See 

section 521 of the FD&C Act (21 U.S.C. 

360k) Medtronic Inc., v. Lohr, 518 U.S. 

470 (1996); Riegel v. Medtronic, Inc., 

128 S. Ct. 999 (2008)). The special 

controls established by this final rule 

create ‘‘requirements’’ for specific 

medical devices under 21 U.S.C. 360k, 

even though product sponsors have 

some flexibility in how they meet those 

requirements. See Papike v. Tambrands, 

Inc., 107 F. 3d 737, 740–42 (9th Cir. 

1997). 

V. Paperwork Reduction Act of 1995 

This final rule establishes special 

controls that refer to currently approved 

collections of information found in 

other FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 

32501–3520). The collections of 

information in 21 CFR part 807, supbart 

E, have been approved under OMB 

control number 0910–0120; the 

collections of information in 21 CFR 

part 801 have been approved under 

OMB control number 0910–0485. 

VI. References 

The following references have been 

placed on display in the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852, 

and may be seen by interested persons 


wreier-aviles on DSKDVH8Z91PROD with RULES
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. 


wreier-aviles on DSKDVH8Z91PROD with RULES