Federal Register / Vol. 65, No. 76 / Wednesday, April 19, 2000 / Notices 20995

9. Soltani, M., D. Beighton, J. PhilpottHoward, N. Woodford, ‘‘Mechanisms of

Resistance to Quinupristin-dalfopristin

among Isolates of Enterococcus Faecium from

Animals, Raw Meat, and Hospital Patients in

Western Europe,’’ Antimicrobial Agents and

Chemotherapy, 44(2), pp. 433–436, 2000.

10. English, L. L., J. R. Hayes, D. G. White,

S. W. Joseph, L. E. Carr, and D. D. Wagner,

‘‘Antibiotic Susceptibility Profiles of

Enterococcus Isolates from the Poultry

Production Environment,’’ Abstract J17, 2000

FDA Science Forum FDA and the Science of

Safety: New Perspectives, p. 73, 2000.

Dated: April 11, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–9696 Filed 4–14–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 00D–1086, 00D–1087, 00D–

1088, 00D–1089, 00D–1090, and 00D–1091]

Guidance Documents for Premarket

Notification (510(k)) Submissions for

Six Devices; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of six guidance documents.

These six guidance documents are

intended to serve as special controls for

six devices that FDA has proposed

previously to reclassify from class III

(premarket approval) to class II (special

controls). Elsewhere in this issue of the

Federal Register, FDA is reopening the

comment period on the proposed

reclassification of the six devices and

one other device. FDA is now inviting

comment on these guidance documents

because they were not available for

comment at the time of the publication

of the proposed reclassification (64 FR

12774, March 15, 1999).

DATES: Submit written comments by

July 18, 2000.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Comments

should be identified with the docket

number for the appropriate guidance

document found in the SUPPLEMENTARY

INFORMATION section. Submit written

requests for single copies on a 3.5′′

diskette of one or more of these

guidance documents to the Division of

Small Manufacturers Assistance (HFZ–

220), Center for Devices and

Radiological Health, Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850. Send two selfaddressed adhesive labels to assist that

office in processing your request, or fax

your request to 301–443–8818. See the

SUPPLEMENTARY INFORMATION section for

information on electronic access to the

guidance documents.

FOR FURTHER INFORMATION CONTACT:

Joseph M. Sheehan, Center for Devices

and Radiological Health (HFZ–215),

Food and Drug Administration, 1350

Piccard Dr., Rockville, MD 20850, 301–

827–2974.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of March 15,

1999, FDA published a proposed rule to

reclassify 38 preamendments class III

devices into class II and to establish

special controls for these devices. FDA

invited interested persons to comment

on the proposed rule by June 14, 1999.

FDA received one request to reopen

the comment period for six devices. The

request noted that FDA had not made

the guidance documents that were

proposed as special controls for these

six devices available for comment

through FDA’s Good Guidance Practices

(GGP’s) (62 FR 8961, February 27, 1997).

The request further noted that it was

impossible to comment on the proposed

reclassification without the guidance

documents being available. Therefore,

the requester asked that FDA extend the

comment period until at least 90 days

after the guidance documents are

publicly available. FDA agreed with the

request. FDA also identified three

additional devices for which the agency

had not issued the guidance documents

proposed as special controls in

accordance with the GGP policy.

The agency is announcing the

availability of the following six

guidance documents (each with a

separate docket number) for six of these

nine devices. In the near future, FDA

will announce the availability of two

guidance documents that will address

the other three devices.

The six guidance documents, with

their docket numbers, and Facts-onDemand (FOD) numbers are as follows:

Guidance document Docket No. FOD No. 21 CFR Section Device name

Guidance for the Submission of Research and Marketing Applications for

Permanent Pacemaker Leads and for

Pacemaker Lead Adaptor 510(k) Submissions.

00D–1086 372 870.3260 Pacemaker lead adaptor.

Guidance Document for Vascular Prostheses 510(k) Submissions.00D–1087 1357 870.3450 Vascular graft prosthesis of less than 6

millimeter diameter.

Guidance for Annuloplasty Rings 510(k)

Submissions.

00D–1088 1358 870.3800 Annuloplasty ring.

Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions.00D–1089 1632 870.4230 Cardiopulmonary bypass defoamer.

Guidance for Cardiopulmonary Bypass

Arterial Line Blood Filter 510(k) Submissions.

00D–1090 1622 870.4260 Cardiopulmonary bypass arterial line

blood filter.

Guidance for Cardiopulmonary Bypass

Oxygenators 510(k) Submissions.

00D–1091 1361 870.4360 Cardiopulmonary bypass oxygenators.

These guidance documents represent

the agency’s current thinking on

premarket notifications for these

devices. These guidance documents do

not create or confer any rights for or on

any person and do not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the applicable statute,

regulations, or both. Under FDA’s GGP

policy, each of these guidance

documents is a Level 2 guidance.

20996 Federal Register / Vol. 65, No. 76 / Wednesday, April 19, 2000 / Notices

II. Electronic Access

In order to receive these guidance

documents via your fax machine, call

the CDRH FOD system at 800–899–0381

or 301–827–0111 from a touch-tone

telephone. Press 1 to enter the system

and enter the document number listed

above followed by the pound sign (#).

Follow the remaining voice prompts to

complete your request.

Persons interested in obtaining a copy

of these guidance documents 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 access to the

Internet. Updated on a regular basis, the

CDRH home page includes these

guidance documents, device safety

alerts, Federal Register reprints,

information on premarket submissions

(including lists of approved applications

and manufacturers’ addresses), small

manufacturers’ assistance, information

on video conferencing and electronic

submissions, mammography matters,

and other device-oriented information.

The CDRH home page may be accessed

at http://www.fda.gov/cdrh. These

guidance documents are also available

at http://www.fda.gov/cdrh/ODE.

III. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding

these guidance documents by July 18,

2000. Two copies of any comments are

to be submitted, except that individuals

may submit one copy. Comments are to

be identified with the docket number for

each guidance document as listed in the

table in the SUPPLEMENTARY INFORMATION

section of this document. If you wish to

comment on more than one guidance

document, please submit your

comments separately for each guidance

document. The guidance documents

and received comments may be seen in

the Dockets Management Branch

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

through Friday.

Dated: April 3, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–9710 Filed 4–18–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Industry Grassroots Meeting: Report

on Partnership Activities

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of meeting.

The Food and Drug Administration

(FDA), Office of Regulatory Affairs, San

Francisco District Office is announcing

the following meeting entitled ‘‘Industry

Grassroots Meeting: Report on

Partnership Activities.’’ The purpose of

the meeting is to report the Partnership

Among Industry and Regulators (PAIR)

Committee activities and to solicit input

from participants for future activities

and projects for the PAIR Committee.

The PAIR Committee was formed as a

result of an action item coming out of

a similar grassroots meeting held at the

Oakland Federal Bldg. in January of

1997.

Date and Time: The meeting will be

held on May 10, 2000, from 8 a.m. to 5

p.m.

Location: The meeting will be held at

the Oakland Federal Bldg., North

Tower, 3d Floor Auditorium, 1301 Clay

St., Oakland, CA 94612.

Contact: Jake Pearson, San Francisco

District Office (HFR–PA 160), 510–337–

6877, FAX 510–337–6701, e-mail

jpearson@ora.fda.gov, or Kathryn D.

Macropol (HFR–PA 140), 510–337–

6867, e-mail kmacropo@ora.fda.gov,

Food and Drug Administration, 1431

Harbor Bay Pkwy., Alameda, CA 94502.

Information is also available at the PAIR

website at http://www.pair-ca.org.

Registration: There is no charge to

attend the meeting; however,

registration is required. The meeting is

open to all interested in management

and regulatory affairs activities of

industries regulated by FDA. While

attendance would most benefit those

industries located in Northern

California, all interested groups are

encouraged to attend. You may register

via the Internet at http://www.pairca.org and by completing the online

registration form. Alternatively, you can

register by sending your name, title,

firm name, address, telephone, fax

number, and e-mail address (if

available) to the contacts listed above.

Please include any topics of interest you

would like to have included in the

program.

If you need special accommodations

due to a disability, please notify Jake

Pearson at least 7 days in advance.

Dated: April 12, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–9712 Filed 4–18–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D–4201]

Guidance for Industry: Dioxin in Anticaking Agents Used in Animal Feed

and Feed Ingredients; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a revised guidance for

industry (#98) entitled ‘‘Dioxin in Anticaking Agents Used in Animal Feed and

Feed Ingredients.’’ The guidance is

intended to notify members of the feed

industry of recent findings regarding the

presence of dioxins congeners that may

be present in anti-caking agents in

animal feeds and to offer general advice

regarding monitoring of these products.

This guidance has been revised in

response to comments.

DATES: Submit written comments at any

time.

ADDRESSES: Submit written comments

on this guidance document to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. Copies of the guidance

document entitled ‘‘Dioxin in Anticaking Agents Used in Animal Feed and

Feed Ingredients’’ may be obtained on

the Internet from the CVM home page at

http://www.fda.gov/cvm/fda/TOCs/

guideline.html. Persons without Internet

access may submit written requests for

single copies of the guidance to the

Communications Staff (HFV–12), Center

for Veterinary Medicine, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that

office in processing your requests.

FOR FURTHER INFORMATION CONTACT:

For general questions regarding the

guidance document: Judy A.

Gushee, Center for Veterinary

Medicine (HFV–230), Food and

Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

0150, e-mail: jgushee@cvm.fda.gov.

For scientific questions regarding the

guidance document: Randall A.