Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Rules and Regulations 22807 

submitting a 510(k) premarket 

notification for a TOCE will need to 

address the issues covered in the special 

controls guidance. However, the firm 

need only show that its device meets the 

recommendations of the guidance or in 

some other way provides equivalent 

assurances of safety and effectiveness. 

Section 510(m) of the FD&C Act 

(21 U.S.C. 360(m)) 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. FDA has 

determined that premarket notification 

is necessary to provide reasonable 

assurance of the safety and effectiveness 

of the TOCE and, therefore, this device 

type is not exempt from premarket 

notification requirements. 

V. Environmental Impact 

The agency has determined under 

21 CFR 25.34(b) that this reclassification 

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. 

VI. Analysis of Impacts 

FDA has examined the impacts of the 

final rule under Executive Order 12866 

and the Regulatory Flexibility Act 

(5 U.S.C. 601–612), and the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4). Executive Order 12866 directs 

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 the 

Executive order. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because the final rule 

reclassifying this device from class III to 

class II will relieve all manufacturers of 

the device of the cost of complying with 

the premarket approval requirements of 

section 515 of the FD&C Act, it will 

impose no significant economic impact 

on any small entities, and it may permit 

small potential competitors to enter the 

marketplace by lowering their costs, and 

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 

$135 million, using the most current 

(2009) 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. 

VII. 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 law 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, 740–742 (9th Cir. 1997). 

VIII. Paperwork Reduction Act of 1995 

This final rule contains no collections 

of information. Therefore, clearance by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3520) is not required. FDA concludes 

that the special controls guidance 

document identified by this rule 

contains information collection 

provisions that are subject to review and 

clearance by OMB under the PRA. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a notice 

announcing the availability of the 

guidance document entitled, ‘‘Class II 

Special Controls Guidance Document: 

Topical Oxygen Chamber for 

Extremities.’’ The notice contains an 

analysis of the paperwork burden for the 

guidance. 

List of Subjects in 21 CFR Part 878 

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 878 is 

amended as follows: 

PART 878—GENERAL AND PLASTIC 

SURGERY DEVICES 

■ 1. The authority citation for 21 CFR 

part 878 continues to read as follows: 

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

360j, 360l, 371. 

■ 2. Section 878.5650 is revised to read 

as follows: 

§ 878.5650 Topical oxygen chamber for 

extremities. 

(a) Identification. A topical oxygen 

chamber for extremities is a device that 

is intended to surround a patient’s limb 

and apply humidified oxygen topically 

at a pressure slightly greater than 

atmospheric pressure to aid healing of 

chronic skin ulcers such as bedsores. 

(b) Classification. Class II (special 

controls). The special control for this 

device is FDA’s ‘‘Class II Special 

Controls Guidance: Topical Oxygen 

Chamber for Extremities.’’ See § 878.1(e) 

for the availability of this guidance 

document. 

Dated: April 19, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–9899 Filed 4–22–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

[Docket ID: DoD–2011–OS–0008] 

32 CFR Part 321 

Privacy Act of 1974; Implementation 

AGENCY: Defense Security Service, DoD. 

ACTION: Direct final rule with request for 

comments. 

SUMMARY: The Defense Security Service 

is deleting an exemption rule for V5–05 

entitled ‘‘Joint Personnel Adjudication 

System (JPAS)’’ in its entirety. The 

system has been transferred to the Office 

of the Secretary of Defense. 

This direct final rule makes 

nonsubstantive changes to the Defense 


jdjones on DSKHWCL6B1PROD with RULES
22808 Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Rules and Regulations 

Security Service Privacy Program rules. 

These changes will allow the 

Department to transfer this system to 

another organization within the 

Department. This will improve the 

efficiency and effectiveness of DoD’s 

program by preserving the exempt status 

of the records when the purposes 

underlying the exemption are valid and 

necessary to protect the contents of the 

records. 

This rule is being published as a 

direct final rule as the Department of 

Defense does not expect to receive any 

adverse comments, and so a proposed 

rule is unnecessary. 

DATES: The rule will be effective on July 

5, 2011 unless comments are received 

that would result in a contrary 

determination. Comments will be 

accepted on or before June 24, 2011. 

ADDRESSES: You may submit comments, 

identified by docket number and title, 

by any of the following methods: 

• Federal Rulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Federal Docket Management 

System Office, Room 3C843, 1160 

Defense Pentagon, Washington, DC 

20301–1160. 

Instructions: All submissions received 

must include the agency name and 

docket number for this Federal Register 

document. The general policy for 

comments and other submissions from 

members of the public is to make these 

submissions available for public 

viewing on the Internet at http:// 

www.regulations.gov as they are 

received without change, including any 

personal identifiers or contact 

information. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Leslie Blake at (703) 325–9450. 

SUPPLEMENTARY INFORMATION: 

Direct Final Rule and Significant 

Adverse Comments 

DoD has determined this rulemaking 

meets the criteria for a direct final rule 

because it involves nonsubstantive 

changes dealing with DoD’s 

management of its Privacy Progams. 

DoD expects no opposition to the 

changes and no significant adverse 

comments. However, if DoD receives a 

significant adverse comment, the 

Department will withdraw this direct 

final rule by publishing a notice in the 

Federal Register. A significant adverse 

comment is one that explains: (1) Why 

the direct final rule is inappropriate, 

including challenges to the rule’s 

underlying premise or approach; or 

(2) why the direct final rule will be 

ineffective or unacceptable without a 

change. In determining whether a 

comment necessitates withdrawal of 

this direct final rule, DoD will consider 

whether it warrants a substantive 

response in a notice and comment 

process. 

Executive Order 12866, ‘‘Regulatory 

Planning and Review’’ and Executive 

Order 13563, ‘‘Improving Regulation 

and Regulatory Review’’ 

It has been determined that Privacy 

Act rules for the Department of Defense 

are not significant rules. The rules do 

not (1) Have an annual effect on the 

economy of $100 million or more or 

adversely affect in a material way the 

economy; a sector of the economy; 

productivity; competition; jobs; the 

environment; public health or safety; or 

State, local, or tribal governments or 

communities; (2) Create a serious 

inconsistency or otherwise interfere 

with an action taken or planned by 

another Agency; (3) Materially alter the 

budgetary impact of entitlements, 

grants, user fees, or loan programs, or 

the rights and obligations of recipients 

thereof; or (4) Raise novel legal or policy 

issues arising out of legal mandates, the 

President’s priorities, or the principles 

set forth in these Executive orders. 

Public Law 96–354, ‘‘Regulatory 

Flexibility Act’’ (5 U.S.C. Chapter 6) 

It has been determined that Privacy 

Act rules for the Department of Defense 

do not have significant economic impact 

on a substantial number of small entities 

because they are concerned only with 

the administration of Privacy Act 

systems of records within the 

Department of Defense. 

Public Law 96–511, ‘‘Paperwork 

Reduction Act’’ (44 U.S.C. Chapter 35) 

It has been determined that Privacy 

Act rules for the Department of Defense 

impose no additional information 

collection requirements on the public 

under the Paperwork Reduction Act of 

1995. 

Section 202, Public Law 104–4, 

‘‘Unfunded Mandates Reform Act’’ 

It has been determined that Privacy 

Act rulemaking for the Department of 

Defense does not involve a Federal 

mandate that may result in the 

expenditure by State, local and tribal 

governments, in the aggregate, or by the 

private sector, of $100 million or more 

and that such rulemaking will not 

significantly or uniquely affect small 

governments. 

Executive Order 13132, ‘‘Federalism’’ 

It has been determined that Privacy 

Act rules for the Department of Defense 

do not have federalism implications. 

The rules do not have substantial direct 

effects 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. 

List of Subjects in 32 CFR Part 321 

Privacy. 

Accordingly, 32 CFR 321 is amended 

as follows: 

PART 321—DEFENSE SECURITY 

SERVICE PRIVACY PROGRAM 

■ 1. The authority citation for 32 CFR 

part 321 continues to read as follows: 

Authority: Pub. L. 93–579, 88 Stat. 1896 

(5 U.S.C. 552a). 

■ 2. In § 321.13, remove and reserve 

paragraph (h) to read as follows: 

§ 321.13 Exemptions. 

* * * * * 

(h) [Reserved]. 

Dated: April 8, 2011. 

Patricia Topping, 

OSD Federal Register Liaison Officer, 

Department of Defense. 

[FR Doc. 2011–9747 Filed 4–22–11; 8:45 am] 

BILLING CODE 5001–06–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

[Docket ID: DoD–2011–OS–0009] 

32 CFR Part 323 

Privacy Act of 1974; Implementation 

AGENCY: Defense Logistics Agency, DoD. 

ACTION: Direct final rule with request for 

comments. 

SUMMARY: The Department of Defense is 

updating the Defense Logistics Agency 

Privacy Act Program Rules, by adding 

the exemption rules (j)(2), (k)(2), (k)(3), 

(k)(4), (k)(5), (k)(6), and (k)(7) for 

S510.30, Freedom of Information Act/ 

Privacy Act Requests and 

Administrative Appeal Records to 

accurately describe the basis for 

exempting the records. The S510.30 

system of records notice was printed on 

January 22, 2009 in the Federal 

Register. 

This direct final rule makes 

nonsubstantive changes to the Defense 

Logistics Agency Privacy Program rules. 

These changes will allow the 

Department to exempt records from 

certain portions of the Privacy Act. This 

will improve the efficiency and 

effectiveness of DoD’s program by 

preserving the exempt status of the 


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