Federal Register / Vol. 69, No. 248 / Tuesday, December 28, 2004 / Rules and Regulations 77621

■ 11. Add a new part 571 to read as 

follows:

PART 571—FAIR CREDIT REPORTING

Subpart A—General Provisions 

Sec. 

571.1 Purpose and scope. 

571.2 [Reserved] 

571.3 Definitions.

Subparts B–H [Reserved]

Subpart I—Duties of Users of Consumer 

Reports Regarding Identity Theft 

571.80–82 [Reserved] 

§ 571.83 Disposal of consumer information.

Authority: 12 U.S.C. 1462a, 1463, 1464, 

1467a, 1828, 1831p–1, 1881–1884; 15 U.S.C. 

1681s and 1681w; 15 U.S.C. 6801 and 

6805(b)(1).

Subpart A—General Provisions

§ 571.1 Purpose and scope. 

(a) Purpose. The purpose of this part 

is to establish standards regarding 

consumer report information. In 

addition, the purpose of this part is to 

specify the extent to which you may 

obtain, use, or share certain information. 

This part also contains a number of 

measures you must take to combat 

consumer fraud and related crimes, 

including identity theft. 

(b) Scope.

(1) [Reserved] 

(2) Institutions covered. (i) Except as 

otherwise provided in this paragraph 

(b)(2), this part applies to savings 

associations whose deposits are insured 

by the Federal Deposit Insurance 

Corporation (and federal savings 

association operating subsidiaries in 

accordance with § 559.3(h)(1) of this 

chapter). 

(ii) [Reserved] 

(iii) [Reserved]

§ 571.2 [Reserved]

§ 571.3 Definitions. 

As used in this part, unless the 

context requires otherwise: 

(a)–(d) [Reserved] 

(e) Consumer means an individual. 

(f)–(n) [Reserved] 

(o) You means savings associations 

whose deposits are insured by the 

Federal Deposit Insurance Corporation 

and federal savings association 

operating subsidiaries.

Subparts B–H [Reserved]

Subpart I—Duties of Users of 

Consumer Reports Regarding Identity 

Theft

§ 571.80–82 [Reserved]

§ 571.83 Disposal of consumer 

information. 

(a) In general. You must properly 

dispose of any consumer information 

that you maintain or otherwise possess 

in accordance with the Interagency 

Guidelines Establishing Information 

Security Standards, as set forth in 

appendix B to part 570, to the extent 

that you are covered by the scope of the 

Guidelines. 

(b) Rule of construction. Nothing in 

this section shall be construed to: 

(1) Require you to maintain or destroy 

any record pertaining to a consumer that 

is not imposed under any other law; or 

(2) Alter or affect any requirement 

imposed under any other provision of 

law to maintain or destroy such a 

record.

By the Office of Thrift Supervision,

Dated: November 30, 2004. 

James E. Gilleran, 

Director.

[FR Doc. 04–27962 Filed 12–27–04; 8:45 am] 

BILLING CODE 4819–13–P;6210–10–P;6714–01–P;6720–

01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. 1998N–1111]

Gastroenterology-Urology Devices; 

Classification for External Penile 

Rigidity Devices

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug 

Administration (FDA) is classifying 

external penile rigidity devices intended 

to create or maintain sufficient penile 

rigidity for sexual intercourse into class 

II (special controls). FDA also is 

exempting these devices from premarket 

notification requirements. Elsewhere in 

this issue of the Federal Register, FDA 

is announcing the availability of the 

guidance document that will serve as 

the special control for the device.

DATES: This rule is effective January 27, 

2005.

FOR FURTHER INFORMATION CONTACT:

Janine Morris, Center for Devices and 

Radiological Health (HFZ–470), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–594–2194.

SUPPLEMENTARY INFORMATION:

I. Background

The Federal Food, Drug, and Cosmetic 

Act (the act) (21 U.S.C. 301 et seq.) as 

amended by the Medical Device 

Amendments of 1976 (the 1976 

amendments) (Public Law 94–295), the 

Safe Medical Devices Act of 1990 

(Public Law 101–629), the Food and 

Drug Administration Modernization Act 

of 1997 (FDAMA) (Public Law 105–

115), and the Medical Device User Fee 

and Modernization Act of 2002 (Public 

Law 107–250), established a 

comprehensive system for the regulation 

of medical devices intended for human 

use. Section 513 of the act (21 U.S.C. 

360c) established three categories 

(classes) of devices, depending on the 

regulatory controls needed to provide 

reasonable assurance of their safety and 

effectiveness. The three categories of 

devices are class I (general controls), 

class II (special controls), and class III 

(premarket approval).

Under section 513 of the act, FDA 

refers to devices that were in 

commercial distribution before May 28, 

1976 (the date of enactment of the 1976 

amendments), as ‘‘preamendments 

devices.’’ FDA classifies these devices 

after the agency takes the following 

steps: (1) Receives a recommendation 

from a device classification panel (an 

FDA advisory committee); (2) publishes 

the panel’s recommendation for 

comment, along with a proposed 

regulation classifying the device; and (3) 

publishes a final regulation classifying 

the device. FDA has classified most 

preamendments devices under these 

procedures.

FDA refers to devices that were not in 

commercial distribution before May 28, 

1976, as ‘‘postamendments devices.’’

These devices are classified 

automatically by statute (section 513(f) 

of the act into class III without any FDA 

rulemaking process. These devices 

remain in class III and require 

premarket approval, unless and until 

FDA initiates the following procedures: 

(1) FDA reclassifies the device into class 

I or II; (2) FDA issues an order 

classifying the device into class I or II 

in accordance with new section 

513(f)(2) of the act, as amended by 

FDAMA; or (3) FDA issues an order 

finding the device to be substantially 

equivalent, under section 513(i) of the 

act, to a predicate device that does not 

require premarket approval.

The agency determines whether new 

devices are substantially equivalent to 

77622 Federal Register / Vol. 69, No. 248 / Tuesday, December 28, 2004 / Rules and Regulations 

predicate devices by means of the 

premarket notification procedures in 

section 510(k) of the act (21 U.S.C. 

360(k)) and part 807 of the regulations 

(21 CFR part 807).

Consistent with the act and the 

regulations, FDA consulted with the 

Gastroenterology and Urology Devices 

Panel (the panel), an FDA advisory 

committee, regarding the classification 

of this device.

FDAMA added a new section 510(m) 

to the act (21 U.S.C. 360(m)). New 

section 510(m) of the act provides that 

a class II device may be exempted from 

the premarket notification requirements 

under section 510(k) of the act, if the 

agency determines that premarket 

notification is not necessary to assure 

the safety and effectiveness of the 

device. FDA has determined that 

premarket notification is not necessary 

to assure the safety and effectiveness of 

external penile rigidity devices.

FDA believes that for devices of a type 

generally exempt from premarket 

notification, certain modifications to 

these devices may change the intended 

use of these devices to an intended use 

that is of substantial importance in 

preventing impairment of human 

health, or may cause these devices to 

present unreasonable risks of illness or 

injury. Accordingly, devices changed in 

this manner would require premarket 

notification. For example, FDA 

considers a class II device to be subject 

to premarket notification requirements 

if the device operates using a different 

fundamental scientific technology than 

that used by a legally marketed device 

in that generic type.

II. Regulatory History of the Device

In the Federal Register of March 17, 

2004 (69 FR 12598), FDA proposed to 

classify external penile rigidity devices 

intended to create or maintain sufficient 

penile rigidity for sexual intercourse 

into class II (special controls). FDA also 

proposed to exempt the devices from 

premarket notification requirements. 

Also in the Federal Register of March 

17, 2004 (69 FR 26398), FDA announced 

the availability of a draft guidance 

document that FDA intended to serve as 

the special control for external penile 

rigidity devices. FDA invited interested 

persons to comment on the draft 

guidance document and invited 

comment on the proposed regulation by 

June 15, 2004. FDA received no 

comments on the proposed rule or draft 

guidance.

III. Summary of Final Rule

In accordance with 21 CFR 

860.84(g)(2), FDA is classifying external 

penile rigidity devices into class II 

(special controls). FDA is codifying the 

classification of external penile rigidity 

devices by adding § 876.5020. The 

agency is also exempting these devices 

from premarket notification 

requirements. The guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: External Penile 

Rigidity Devices’’ will serve as the 

special control for external penile 

rigidity devices. Following the effective 

date of the final classification rule, 

manufacturers will need to address the 

issues covered in this special control 

guidance. However, the manufacturer 

need only show that its device meets the 

recommendations of the guidance or in 

some other way provides equivalent 

assurances of safety and effectiveness. 

For the convenience of the reader, in 

part 876 (21 CFR part 876) FDA is also 

adding § 876.1(e) to inform the reader 

where to find guidance documents 

referenced in that part.

IV. Analysis of Comments and FDA’s 

Response

FDA received no comments on the 

proposed rule. Therefore, under section 

513 of the act, FDA is adopting the 

summary of reasons for the panel’s 

recommendation and the summary of 

data upon which the panel’s 

recommendation is based. FDA is also 

adopting the assessment of the risks to 

public health stated in the proposed 

rule published on March 17, 2004. FDA 

is issuing this final rule which classifies 

the generic type of device, external 

penile rigidity devices, into class II 

(special controls). In addition, FDA, on 

its own initiative, is exempting external 

penile rigidity devices from premarket 

notification requirements.

V. 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.

VI. Analysis of Impacts

FDA has examined the impacts of the 

final rule under Executive Order 12866, 

the Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (Public Law 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. This final rule will relieve a 

burden and simplify marketing by 

exempting the devices from premarket 

notification requirements. The guidance 

document is based on existing review 

practices and will not impose new 

burdens on manufacturers of these 

devices. The agency, therefore, certifies 

that this 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 million 

or more (adjusted annually for inflation) 

in any 1 year. The current threshold 

after adjustment for inflation is $110 

million. 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 the final rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the rule does not 

contain policies conferring 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. Accordingly, the 

agency has concluded that the rule does 

not contain policies that have 

federalism implications as defined in 

the Executive order. As a result, a 

federalism summary impact statement is 

not required.

VIII. Paperwork Reduction Act of 1995

FDA concludes that this rule contains 

no collection of information that is 

subject to review by the Office of 

Management and Budget under the 

Paperwork Reduction Act of 1995.

IX. 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. 

These references may be seen by 

Federal Register / Vol. 69, No. 248 / Tuesday, December 28, 2004 / Rules and Regulations 77623

interested persons between 9 a.m. and 4 

p.m., Monday through Friday.

1. Gastroenterology and Urology Devices 

Panel of the Medical Devices Advisory 

Committee transcript, August 7, 1997.

2. Lewis J.H. et al., ‘‘A Way to Help Your 

Patients Who Use Vacuum Devices,’’

Contemporary Urology, vol. 3, No. 12: 15–24, 

1991.

3. Montague, D.K. et al., ‘‘Clinical 

Guidelines Panel on Erectile Dysfunction: 

Summary Report on the Treatment of Erectile 

Dsyfunction,’’ Journal of Urology, 156: 2007–

2011, 1996.

4. NIH Consensus Statement, ‘‘Impotence,’’

National Institutes of Health, vol. 10, No. 4, 

1992.

List of Subjects in 21 CFR Part 876

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 876 is 

amended as follows:

PART 876—GASTROENTEROLOGYUROLOGY DEVICES

1. The authority citation for 21 CFR 

part 876 continues to read as follows:

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

360j, 360l, 371.

2. Section 876.1 is amended by 

adding paragraph (e) to read as follows:

§ 876.1 Scope.

* * * * *

(e) Guidance documents referenced in 

this part are available on the Internet at 

http://www.fda.gov/cdrh/guidance.html.

3. Section 876.5020 is added to 

subpart F to read as follows:

§ 876.5020 External penile rigidity devices.

(a) Identification. External penile 

rigidity devices are devices intended to 

create or maintain sufficient penile 

rigidity for sexual intercourse. External 

penile rigidity devices include vacuum 

pumps, constriction rings, and penile 

splints which are mechanical, powered, 

or pneumatic devices.

(b) Classification. Class II (special 

controls). The devices are exempt from 

the premarket notification procedures in 

subpart E of part 807 of this chapter 

subject to the limitations in § 876.9. The 

special control for these devices is the 

FDA guidance document entitled ‘‘Class 

II Special Controls Guidance Document: 

External Penile Rigidity Devices.’’ See 

§ 876.1(e) for the availability of this 

guidance document.

Dated: December 15, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and 

Radiological Health.

[FR Doc. 04–28252 Filed 12–27–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. 2004N–0530]

Medical Devices; Obstetrical and 

Gynecological Devices; Classification 

of the Assisted Reproduction Laser 

System

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

assisted reproduction laser system into 

class II (special controls). The special 

control that will apply to the device is 

the guidance document entitled ‘‘Class 

II Special Controls Guidance Document: 

Assisted Reproduction Laser Systems.’’

The agency is classifying this device 

into class II (special controls) in order 

to provide a reasonable assurance of 

safety and effectiveness of the device. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a notice of 

availability of the guidance document 

that is the special control for this 

device.

DATES: This rule is effective January 27, 

2005. The classification was effective 

November 4, 2004.

FOR FURTHER INFORMATION CONTACT:

Michael Bailey, Center for Devices and 

Radiological Health (HFZ–400), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–594–1180, ext. 130.

SUPPLEMENTARY INFORMATION:

I. Background

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

the Federal Food, Drug, and Cosmetic 

Act (the 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 (the amendments), 

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 act, to a predicate device 

that does not require premarket 

approval. The agency determines 

whether new devices are substantially 

equivalent to previously marketed 

devices by means of premarket 

notification procedures in section 510(k) 

of the act (21 U.S.C. 360(k)) and part 807 

(21 CFR part 807) of FDA’s regulations.

Section 513(f)(2) of the act provides 

that any person who submits a 

premarket notification under section 

510(k) of the act for a device that has not 

previously been classified may, within 

30 days after receiving an order 

classifying the device in class III under 

section 513(f)(1) of the act, request FDA 

to classify the device under the criteria 

set forth in section 513(a)(1) of the act. 

FDA shall, within 60 days of receiving 

such a request, classify the device by 

written order. This classification shall 

be the initial classification of the device. 

Within 30 days after the issuance of an 

order classifying the device, FDA must 

publish a document in the Federal 

Register announcing such classification 

(section 513(f)(2) of the act).

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

the act, FDA issued a document on 

August 10, 2004, classifying the 

Hamilton Thorne Zona Infrared Laser 

Optical System (ZILOS-tkr) 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 25, 2004, Hamilton Thorne 

Biosciences, Inc., submitted a petition 

requesting classification of this device 

under section 513(f)(2) of the act. The 

manufacturer recommended that the 

device be classified into class II (Ref. 1).

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

the act, FDA reviewed the petition in 

order to classify the device under the 

criteria for classification set forth in 

513(a)(1) of the act. Devices are to be 

classified 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 has determined that 

the device can be classified in class II 

with the establishment of special 

controls. FDA believes that class II 

special controls, in addition to general 

controls, will provide reasonable 

assurance of the safety and effectiveness 

of the device.

The device is assigned the generic 

name assisted reproduction laser system 

and it is identified as a device that 

images, targets, and controls the power 

and pulse duration of a laser beam used 

to ablate a small tangential hole in, or