78038 Federal Register / Vol. 69, No. 249 / Wednesday, December 29, 2004 / Notices 

20447, Attn: ACF Reports Clearance 

Officer. E-mail address: 

grjohnson@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project,725 17th Street, NW., 

Washington, DC 20503, Attn: Desk 

Officer for ACF, E-mail address: 

Katherine_t.tastrich@eop.gov.

Dated: December 22, 2004. 

Robert Sargis, 

Reports Clearance Officer.

[FR Doc. 04–28464 Filed 12–28–04; 8:45 am] 

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0509]

Proposed Referral Program from the 

Food and Drug Administration to the 

National Oceanic and Atmospheric 

Administration Seafood Inspection 

Program for the Certification of Live 

and Perishable Fish and Fishery 

Products for Export to the European 

Union and the European Free Trade 

Association; Extension of Comment 

Period

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice; extension of comment 

period.

SUMMARY: The Food and Drug 

Administration (FDA) is extending to 

January 25, 2005, the comment period 

for the notice that appeared in the 

Federal Register of November 26, 2004 

(69 FR 68948). In the notice, FDA 

announced the availability and 

requested comments on the draft 

guidance entitled ‘‘Proposed Referral 

Program from the Food and Drug 

Administration to the National Oceanic 

and Atmospheric Administration 

Seafood Inspection Program for the 

Certification of Live and Perishable Fish 

and Fishery Products for Export to the 

European Union and the European Free 

Trade Association.’’ The agency is 

taking this action in response to 

requests for an extension to allow 

interested persons additional time to 

submit comments.

DATES: Submit written or electronic 

comments by January 25, 2005.

ADDRESSES: Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http://

www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Tim 

Hansen, Center for Food Safety and 

Applied Nutrition (HFS–415), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 301–

436–1405, e-mail: 

thansen@cfsan.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of November 

26, 2004 (69 FR 68948), FDA published 

a notice with a 30-day comment period 

on a draft guidance entitled ‘‘Proposed 

Referral Program from the Food and 

Drug Administration to the National 

Oceanic and Atmospheric 

Administration Seafood Inspection 

Program for the Certification of Live and 

Perishable Fish and Fishery Products for 

Export to the European Union and the 

European Free Trade Association.’’

The agency has received several 

requests for an extension of the 

comment period for the notice, ranging 

from an additional 30 to 90 days. Each 

request conveyed concern that the 

current 30-day comment period does 

not allow sufficient time to develop a 

meaningful or thoughtful response to 

the draft guidance document.

FDA has considered the requests for 

additional time to submit comments and 

is extending the comment period for the 

notice and related guidance document 

for 30 days, until January 25, 2005. The 

agency believes that a 30-day extension 

allows adequate time for interested 

persons to submit comments without 

significantly delaying implementation 

of this important program.

II. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on this document. Submit a 

single copy of electronic comments or 

two paper copies of any mailed 

comments, except that individuals may 

submit one paper copy. Comments are 

to be identified with the docket number 

found in brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

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

Monday through Friday.

Dated: December 23, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–28573 Filed 12–27–04; 10:43 

am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket N0. 2003D–0568]

Guidance for Industry and FDA Staff; 

Class II Special Controls Guidance 

Document: Vascular and 

Neurovascular Embolization Devices; 

Availability

AGENCY: Food and Drug Administration, 

HHS

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Vascular and 

Neurovascular Embolization Devices.’’

Elsewhere in this issue of the Federal 

Register, FDA is publishing a final rule 

to change the names, revise the 

identifications, and reclassify the two 

devices from class III (premarket 

approval) into class II (special controls). 

This guidance document describes a 

means by which the vascular 

embolization device and the 

neurovascular embolization device may 

comply with the requirement of special 

controls for class II devices. We are also 

announcing the withdrawal of the 1994 

draft guidance document entitled 

‘‘Guidance on Biocompatibility 

Requirements for Long Term 

Neurological Implants: Part 3—Implant 

Model,’’ dated September 12, 1994.

DATES: Submit written or electronic 

comments on agency guidances at any 

time.

ADDRESSES: Submit written requests for 

single copies of the guidance on a 3.5′′

diskette of the guidance entitled ‘‘Class 

II Special Controls Guidance Document: 

Vascular and Neurovascular 

Embolization Devices’’ to the Division 

of Small Manufacturers, International, 

and Consumer Assistance (DSMICA) 

(HFZ–220), Center for Devices and 

Radiological Health (CDRH) (HFZ–220), 

Food and Drug Administration, 1350 

Piccard Dr., Rockville, MD 20850. Send 

a self-addressed adhesive label to assist 

that office in processing your request, or 

fax your request to 301–442–8818. See 

the SUPPLEMENTARY INFORMATION section 

for information on electronic access to 

the guidance.

Federal Register / Vol. 69, No. 249 / Wednesday, December 29, 2004 / Notices 78039

Submit written comments on the 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http://

www.fda.gov/dockets/ecomments.

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

In the Federal Register of February 

25, 2004 (69 FR 8667), FDA published 

a proposed rule to reclassify two 

embolization devices 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 revised a November 1, 2002, 

guidance document entitled ‘‘Guidance 

for Neurological Embolization Devices’’

and published it in the Federal Register

of February 25, 2004 (69 FR 9667) as a 

draft class II special controls guidance 

document to support the reclassification 

of these device types. Interested persons 

were invited to comment on the draft 

guidance by May 25, 2004. FDA 

received one comment. The comment 

was supportive of the guidance 

document but made some suggestions 

on the guidance’s content. FDA 

considered the suggestions and made 

appropriate revisions. FDA is now 

identifying 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.

The guidance document provides a 

means by which a vascular embolization 

device or a neurovascular embolization 

device may comply with the 

requirement of special controls for class 

II devices. Following the effective date 

of the final reclassification rule, any 

firm submitting a premarket notification 

(510(k)) for a vascular embolization 

device or a neurovascular embolization 

device will need to address the issues 

covered in the special controls guidance 

document. However, the firm need only 

show that its device meets the 

recommendations of the guidance 

document or in some other way 

provides equivalent assurances of safety 

and effectiveness.

We are also withdrawing the draft 

guidance document entitled ‘‘Guidance 

on Biocompatibility Requirements for 

Long Term Neurological Implants: Part 

3—Implant Model’’ because it contains 

outdated information. Archived copies 

of CDRH guidance documents that have 

been withdrawn are available from the 

DSMICA (see ADDRESSES).

II. Significance of Guidance

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on vascular and 

neurovascular embolization devices. It 

does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if the 

approach satisfies the requirements of 

the applicable statute and regulations.

III. Electronic Access

To receive a copy of the guidance 

entitled ‘‘Class II Special Controls 

Guidance Document: Vascular and 

Neurovascular Embolization Devices’’

by fax machine, call the CDRH FactsOn-Demand system at 800–899–0381 or 

301–827–0111 from a touch-tone 

telephone. Press 1 to enter the system. 

At the second voice prompt press 1 to 

order a document. Enter the document 

number (1234) followed by the pound 

sign (#). Follow the remaining voice 

prompts to complete your request.

Persons interested in obtaining a copy 

of the guidance also may do so by using 

the Internet. CDRH maintains an entry 

on the Internet for easy access to 

information including text, graphics, 

and files that may be downloaded to a 

personal computer with Internet access. 

Updated on a regular basis, the CDRH 

home page includes device safety alerts, 

Federal Register reprints, information 

on premarket submissions (including 

lists of approved applications and 

manufacturers’ addresses), small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov.cdrh. A search 

capability for all CDRH guidance 

documents is available at http://www/

fda/gov/cdrh/guidance.html.

IV. Paperwork Reduction Act of 1995

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501–

3520) (the PRA). The collections of 

information addressed in the guidance 

document have been approved by OMB 

in accordance with the PRA under the 

regulations governing 510(k) 

submissions (21 CFR part 807, subpart 

E, OMB control number 0910–0120) and 

the regulations governing good 

manufacturing practices (quality system 

regulation) (21 CFR part 820, OMB 

control number 0910–0073). The 

labeling provisions addressed in the 

guidance document have been approved 

by OMB under the PRA, OMB control 

number 0910–0485.

V. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Comments 

received may be seen in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday.

Dated: December 15, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and 

Radiological Health.

[FR Doc. 04–28438 Filed 12–28–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[FEMA–1558–DR] 

West Virginia; Amendment No. 7 to 

Notice of a Major Disaster Declaration

AGENCY: Federal Emergency 

Management Agency, Emergency 

Preparedness and Response Directorate, 

Department of Homeland Security.

ACTION: Notice.

SUMMARY: This notice amends the notice 

of a major disaster for the State of West 

Virginia (FEMA–1558–DR), dated 

September 20, 2004, and related 

determinations.

EFFECTIVE DATE: December 17, 2004.