77898 Federal Register / Vol. 69, No. 249 / Wednesday, December 29, 2004 / Rules and Regulations 

Drug labeler 

code Firm name and address 

*****

000009 Pharmacia & Upjohn Co., a 

Division of Pfizer, Inc., 

235 East 42d St., New 

York, NY 10017

*****

Dated: December 10, 2004.

Steven D. Vaughn,

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine.

[FR Doc. 04–28461 Filed 12–28–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 870 and 882

[Docket No. 2003N–0567]

Cardiovascular and Neurological 

Devices; Reclassification of Two 

Embolization Devices

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug 

Administration (FDA) is issuing a final 

rule to reclassify two embolization 

device types from class III (premarket 

approval) into class II (special controls). 

The agency is also changing the names 

and revising the identifications of these 

devices. The vascular embolization 

device (previously the arterial 

embolization device) is intended to 

control hemorrhaging due to aneurysms, 

certain types of tumors, and 

arteriovenous malformations. The 

neurovascular embolization device 

(previously the artificial embolization 

device) is intended to permanently 

occlude blood flow to cerebral 

aneurysms and cerebral arteriovenous 

malformations. FDA is reclassifying 

these devices on its own initiative on 

the basis of new information. FDA is 

taking this action under the Federal 

Food, Drug, and Cosmetic Act (the act), 

as amended by the Medical Device 

Amendments of 1976 (the 1976 

amendments), the Safe Medical Devices 

Act of 1990, the Food and Drug 

Administration Modernization Act of 

1997, and the Medical Device User Fee 

and Modernization Act of 2002.

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 

these devices.

DATES: This rule is effective January 28, 

2005.

FOR FURTHER INFORMATION CONTACT:

Peter L. Hudson, Center for Devices and 

Radiological Health (HFZ–410), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–594–3090.

SUPPLEMENTARY INFORMATION:

I. Background

The act (21 U.S.C. 301 et seq.) 

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 initiates the following 

procedures: (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. The devices remain 

in class III and require premarket 

approval, unless FDA initiates the 

following procedures: (1) Reclassifies 

the device into class I or II; (2) issues an 

order classifying the device into class I 

or II in accordance with section 513(f)(2) 

of the act; or (3) issues, under section 

513(i) of the act, an order finding the 

device substantially equivalent to a 

predicate device that does not require 

premarket approval. As described in 

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

360(k)) and under part 807 of the 

regulations (21 CFR part 807), FDA 

determines whether new devices are 

substantially equivalent to predicate 

devices by means of premarket 

notification procedures. Through 

premarket notification procedures, a 

person may, without submission of a 

premarket approval application (PMA), 

market a preamendments device that 

has been classified into class III until 

FDA issues a final regulation under 

section 515(b) of the act (21 U.S.C. 

360e(b)) requiring premarket approval.

Section 513(e) of the act addresses the 

reclassification of classified devices. 

This section provides that FDA may, by 

rulemaking, reclassify a device based on 

‘‘new information.’’ Under section 

513(e) of the act, FDA can initiate 

reclassification or an interested person 

can petition FDA to reclassify a 

preamendments device. The term ‘‘new 

information,’’ as used in section 513(e) 

of the act, includes information 

developed after the date of the device’s 

original classification. This information 

could include a reevalution of the 

original data or information from the 

time of the device’s original 

classification that was not presented, 

available, or developed at that time. 

(See, e.g., Holland Rantos v. United 

States Department of Health, Education, 

and Welfare, 587 F.2d 1173, 1174 n.1 

(D.C. Cir. 1978); Upjohn v. Finch, 422 

F.2d 944 (6th Cir. 1970); Bell v. 

Goddard, 366 F.2d 177 (7th Cir. 1966).)

Reevaluation of the data previously 

used by FDA is an appropriate basis for 

subsequent regulatory action where the 

reevaluation is made in light of newly 

available regulatory authority (see Bellv. 

Goddard, supra, 366 F.2d at 181; 

Ethicon, Inc. v. FDA, 762 F.Supp. 382, 

389–91 (D.D.C. 1991)), or in light of 

changes in ‘‘medical science.’’ (See 

Upjohn v. Finch, supra, 422 F.2d at 

951.) Whether data before FDA are past 

or new data, the ‘‘new information’’ to 

support reclassification under section 

513(e) of the act must be ‘‘valid 

scientific evidence,’’ as defined in 

section 513(a)(3) of the act and 21 CFR 

860.7(c)(2). (See, e.g., General Medical 

Co. v. FDA, 770 F.2d 214 (D.C. Cir. 

1985); Contact Lens Assoc. v. FDA, 766 

F.2d 592 (D.C. Cir.), cert. denied, 474 

U.S. 1062 (1985).) FDA relies upon 

‘‘valid scientific evidence’’ in the 

classification process to determine the 

level of regulation for devices. When 

reclassifying a device, FDA can only 

consider valid scientific evidence that is 

publicly available. Publicly available 

information excludes trade secret and 

confidential commercial information, 

e.g., the contents of a pending PMA. 

(See section 520(c) of the act (21 U.S.C. 

360j(c).)

II. Regulatory History of the Devices

In the Federal Register of February 

25, 2004 (69 FR 8600), FDA issued a 

proposed rule to change the names, 

revise the identifications, and reclassify 

the two devices from class III (premarket 

Federal Register / Vol. 69, No. 249 / Wednesday, December 29, 2004 / Rules and Regulations 77899

approval) into class II (special controls). 

FDA identified the draft guidance 

document entitled ‘‘Class II Special 

Controls Guidance Document: Vascular 

and Neurovascular Embolization 

Devices’’ as the proposed special control 

capable of providing of providing 

reasonable assurance of the safety and 

effectiveness for these devices. The 

vascular embolization device 

(previously the arterial embolization 

device) is intended to control 

hemorrhaging due to aneurysms, certain 

types of tumors, and arteriovenous 

malformations. The neurovascular 

embolization device (previously the 

artificial embolization device) is 

intended to permanently occlude blood 

flow to cerebral aneurysms and cerebral 

arteriovenous malformations. FDA 

invited interested persons to comment 

on the proposed rule by May 25, 2004. 

FDA received one comment. The 

comment was supportive of the 

proposed reclassification but made 

suggestions on the guidance document’s 

content. FDA considered the 

suggestions and made appropriate 

revisions to the guidance document.

III. Conclusion

Based on the information discussed in 

the preamble to the proposed rule, FDA 

concludes that special controls, in 

conjunction with general controls, will 

provide reasonable assurance of the 

safety and effectiveness for these 

devices. Elsewhere in this issue of the 

Federal Register, FDA is announcing 

the availability of the guidance 

document entitled ‘‘Class II Special 

Controls Guidance Document: Vascular 

and Neurovascular Embolization 

Devices’’ as the guidance document that 

will serve as the special control for 

these devices. FDA believes that this 

special controls guidance document in 

addition to the general controls will 

provide reasonable assurance of the 

safety and effectiveness of these devices. 

Following the effective date of this rule, 

any firm submitting a 510(k) submission 

for these embolization devices will need 

to address the issues covered in the 

class II special controls guidance 

document. However, the firm need only 

show that its device meets the 

recommendations of the class II special 

controls guidance document or in some 

other way provides equivalent 

assurances of safety and effectiveness.

In addition to reclassifying these 

devices from class III into class II, FDA 

has revised the name and identification 

of 21 CFR parts 870.330 and 882.5950. 

FDA believes that renaming the arterial 

embolization device as the ‘‘vascular 

embolization device’’ and the artificial 

embolization device as the 

‘‘neurovascular embolization device’’

more accurately reflect the intended 

uses of these devices.

Section 870.1(e) (21 CFR 870.1(e)), 

which was included in the proposed 

rule, was previously added by a final 

rule published in the Federal Register

of October 28, 2003 (68 FR 61342). 

Section 882.1(e) (21 CFR 882.1(e)), 

which was included in the proposed 

rule, was previously added by a final 

rule published in the Federal Register

of December 18, 2003 (68 FR 70435).

IV. 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.

V. 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 (2 U.S.C. 1501 et. 

seq.). 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. Reclassification of these 

devices from class III into class II will 

relieve all manufacturers of the devices 

of the cost of eventually complying with 

the premarket approval requirements in 

section 515 of the act. Because 

reclassification will therefore reduce the 

regulatory costs associated with these 

devices and may permit small potential 

competitors to enter the marketplace by 

lowering their costs, the agency 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, 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 $110 

million. FDA does not expect this final 

rule to result in any 1-year expenditure 

that would meet or exceed this amount.

VI. 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 that 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. Accordingly, FDA 

has concluded that the rule does not 

contain policies that have federalism 

implications as defined in the Executive 

order and, consequently, a federalism 

summary impact statement is not 

required.

VII. Paperwork Reduction Act of 1995

This final rule does not contain 

information collection provisions that 

are subject to review by the Office of 

Management and Budget under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520).

List of Subjects in 21 CFR Parts 870 and 

882

Medical devices.

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR parts 870 and 

882 are 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 870.3300 is revised to read 

as follows:

§ 870.3300 Vascular embolization device.

(a) Identification. A vascular 

embolization device is an intravascular 

implant intended to control 

hemorrhaging due to aneurysms, certain 

types of tumors (e.g., nephroma, 

hepatoma, uterine fibroids), and 

arteriovenous malformations. This does 

not include cyanoacrylates and other 

embolic agents, which act by 

polymerization or precipitation. 

Embolization devices used in 

neurovascular applications are also not 

77900 Federal Register / Vol. 69, No. 249 / Wednesday, December 29, 2004 / Rules and Regulations 

included in this classification, see 

§ 882.5950 of this chapter.

(b) Classification. Class II (special 

controls.) The special control for this 

device is the FDA guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Vascular and 

Neurovascular Embolization Devices.’’

For availability of this guidance 

document, see § 870.1(e).

PART 882—NEUROLOGICAL DEVICES

■ 3. The authority citation for 21 CFR 

part 882 continues to read as follows:

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

360j, 371.

■ 4. Section 882.5950 is revised to read 

as follows:

§ 882.5950 Neurovascular embolization 

device.

(a) Identification. A neurovascular 

embolization device is an intravascular 

implant intended to permanently 

occlude blood flow to cerebral 

aneurysms and cerebral ateriovenous 

malformations. This does not include 

cyanoacrylates and other embolic 

agents, which act by polymerization or 

precipitation. Embolization devices 

used in other vascular applications are 

also not included in this classification, 

see § 870.3300.

(b) Classification. Class II (special 

controls.) The special control for this 

device is the FDA guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Vascular and 

Neurovascular Embolization Devices.’’

For availability of this guidance 

document, see § 882.1(e).

Dated: December 15, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and 

Radiological Health.

[FR Doc. 04–28437 Filed 12–28–04; 8:45 am]

BILLING CODE 4160–01–S

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52

[R03–OAR–2004–VA–0005; FRL–7853–7] 

Approval and Promulgation of Air 

Quality Implementation Plans; Virginia; 

Approval of the Control of VOC 

Emissions From Municipal Solid Waste 

Landfills in Northern Virginia

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Direct final rule.

SUMMARY: EPA is taking direct final 

action to approve a revision to the 

Commonwealth of Virginia (the 

Commonwealth) State Implementation 

Plan (SIP). The revision establishes 

regulations for the control of volatile 

organic compound (VOC) emissions 

from municipal solid waste landfills 

(MSWLs) located in the Northern 

Virginia Portion of the Metropolitan 

Washington, D.C. Ozone Nonattainment 

Area. (Northern Virginia). EPA is 

approving this revision to the SIP in 

accordance with the requirements of the 

Clean Air Act (CAA or the Act).

DATES: This rule is effective on February 

28, 2005, without further notice, unless 

EPA receives adverse written comment 

by January 28, 2005. If EPA receives 

such comments, it will publish a timely 

withdrawal of the direct final rule in the 

Federal Register and inform the public 

that the rule will not take effect.

ADDRESSES: Submit your comments, 

identified by Regional Material in 

Edocket (RME) ID Number R03–OAR–

2004–VA–0005 by one of the following 

methods: 

A. Federal eRulemaking Portal:

http://www.regulations.gov. Follow the 

on-line instructions for submitting 

comments. 

B. Agency Web site: http://

www.docket.epa.gov/rmepub/ RME, 

EPA’s electronic public docket and 

comment system, is EPA’s preferred 

method for receiving comments. Follow 

the on-line instructions for submitting 

comments. 

C. E-mail: Morris.Makeba@epa.gov.

D. Mail: R03–OAR–2003–VA–0005, 

Makeba Morris, Chief, Air Quality 

Planning Branch, Mailcode 3AP21, U.S. 

Environmental Protection Agency, 

Region III, 1650 Arch Street, 

Philadelphia, Pennsylvania 19103. 

E. Hand Delivery: At the previouslylisted EPA Region III address. Such 

deliveries are only accepted during the 

Docket’s normal hours of operation, and 

special arrangements should be made 

for deliveries of boxed information. 

Instructions: Direct your comments to 

RME ID No. R03–OAR–2004–VA–0005. 

EPA’s policy is that all comments 

received will be included in the public 

docket without change, and may be 

made available online at http://

www.docket.epa.gov/rmepub/, 

including any personal information 

provided, unless the comment includes 

information claimed to be Confidential 

Business Information (CBI) or other 

information whose disclosure is 

restricted by statute. Do not submit 

information that you consider to be CBI 

or otherwise protected through RME, 

regulations.gov or e-mail. The EPA RME 

and the Federal regulations.gov Web 

sites are an ‘‘anonymous access’’

system, which means EPA will not 

know your identity or contact 

information unless you provide it in the 

body of your comment. If you send an 

e-mail comment directly to EPA without 

going through RME or regulations.gov, 

your e-mail address will be 

automatically captured and included as 

part of the comment that is placed in the 

public docket and made available on the 

Internet. If you submit an electronic 

comment, EPA recommends that you 

include your name and other contact 

information in the body of your 

comment and with any disk or CD–ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. 

Docket: All documents in the 

electronic docket are listed in the RME 

index at http://www.docket.epa.gov/

rmepub/. Although listed in the index, 

some information is not publicly 

available, i.e., CBI or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either electronically in RME or 

in hard copy during normal business 

hours at the Air Protection Division, 

U.S. Environmental Protection Agency, 

Region III, 1650 Arch Street, 

Philadelphia, Pennsylvania 19103. 

Copies of the State submittal are 

available at the Virginia Department of 

Environmental Quality, 629 East Main 

Street, Richmond, Virginia 23219.

FOR FURTHER INFORMATION CONTACT:

Janice Lewis, (215) 814–2185, or by email at lewis.janice@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

On February 12, 2004, the 

Commonwealth submitted a revision to 

its State Implementation Plan (SIP). The 

SIP revision consists of regulations to 

control VOC emissions from Municipal 

Solid Waste Landfills (MSWLs) in the 

Northern Virginia portion of the 

Metropolitan Washington, D.C. Ozone 

Nonattainment Area. The regulation 

establishes emission standards for 

MSWLs, as well as operational, 

monitoring and reporting requirements. 

This revision applies to the Northern 

Virginia portion of the Metropolitan 

Washington, D.C. Ozone Nonattainment 

Area, and is not intended to apply to