70356 Federal Register / Vol. 65, No. 226 / Wednesday, November 22, 2000 / Notices

application for license as Ocean Freight

Forwarder—Ocean Transportation

Intermediary pursuant to section 19 of

the Shipping Act of 1984 as amended

(46 U.S.C. app. 1718 and 46 CFR 515).

Persons knowing of any reason why

the following applicant should not

receive a license are requested to

contact the Office of Transportation

Intermediaries, Federal Maritime

Commission, Washington, DC 20573.

Ocean Freight Forwarder—Ocean

Transportation Intermediary Applicant:

MTS Logistics, Inc., 390 Fifth Avenue,

Suite 701, New York, NY 10018,

Officers: Sedat Saka, President

(Qualifying Individual), Timur Fidan,

Secretary.

Dated: November 16, 2000.

Bryant L. VanBrakle,

Secretary.

[FR Doc. 00–29820 Filed 11–21–00; 8:45 am]

BILLING CODE 6730–01–P

FEDERAL RESERVE SYSTEM

Sunshine Act Meeting

TIME AND DATE: 11:00 a.m., Monday,

November 27, 2000.

PLACE: Marriner S. Eccles Federal

Reserve Board Building, 20th and C

Streets, N.W., Washington, D.C. 20551.

STATUS: Closed.

MATTERS TO BE CONSIDERED:

1. Personnel actions (appointments,

promotions, assignments,

reassignments, and salary actions)

involving individual Federal Reserve

System employees.

2. Any items carried forward from a

previously announced meeting.

CONTACT PERSON FOR MORE INFORMATION:

Lynn S. Fox, Assistant to the Board;

202–452–3204.

SUPPLEMENTARY INFORMATION: You may

call 202–452–3206 beginning at

approximately 5 p.m. two business days

before the meeting for a recorded

announcement of bank and bank

holding company applications

scheduled for the meeting; or you may

contact the Board’s Web site at http://

www.federalreserve.gov for an

electronic announcement that not only

lists applications, but also indicates

procedural and other information about

the meeting.

Dated: November 17, 2000.

Robert deV. Frierson,

Associate Secretary of the Board.

[FR Doc. 00–29942 Filed 11–17–00; 4:12 pm]

BILLING CODE 6210–01–P

GENERAL SERVICES

ADMINISTRATION

[OMB Control No. 3090–0040]

Submission for OMB Review;

Comment Request Entitled Application

for Shipping Instructions and Notice of

Availability

AGENCY: Federal Supply Service, GSA.

ACTION: Notice of request for public

comments regarding an extension to an

existing OMB clearance (3090–0040).

SUMMARY: Under the provisions of the

Paperwork Reduction Act of 1995 (44

U.S.C. chapter 35), the Office of

Acquisition Policy has submitted to the

Office of Management and Budget

(OMB) a request to review and approve

an extension of a previously approved

information collection requirement

concerning Application for Shipping

Instructions and Notice of Availability.

DATES: Comment Due Date: January 22,

2001.

ADDRESSES: Comments regarding this

burden estimate or any other aspect of

this collection of information, including

suggestions for reducing this burden,

should be submitted to: Marjorie Ashby,

General Services Administration (MVP),

1800 F Street NW., Washington, DC

20405.

FOR FURTHER INFORMATION CONTACT:

Marcia Crockett, Acquisition Operations

& Electronic Commerce Center, Supply

Management Division, (703) 305–7551.

SUPPLEMENTARY INFORMATION:

A. Purpose

The GSA is requesting the Office of

Management and Budget (OMB) to

approve information collection, 3090–

0400, concerning Application for

Shipping Instructions and Notice of

Availability. This information collection

supports and justifies the markup of the

six percent surcharge for the GSA export

reimbursable program. It also is used to

evaluate and obtain the best cube

utilization of shipping vans and

containers for export direct delivery

shipments. The form contains data

necessary to prepare Transportation

Control and Movement Documents

(TCMD) which are required when

material enters the Defense

Transportation System.

B. Annual Reporting Burden

Respondents: 360; Annual responses:

3,000; average hours per response: .20;

burden hours: 1,000.

Copy of Proposal

A copy of this proposal may be

obtained from the GSA Acquisition

Policy Division (MVP), Room 4011, GSA

Building, 1800 F Street NW.,

Washington, DC 20405, or by

telephoning (202) 501–3822, or by

faxing your request to (202) 501–3341.

Dated: November 15, 2000.

David A. Drabkin,

Deputy Associate Administrator, Office of

Acquisition Policy.

[FR Doc. 00–29850 Filed 11–21–00; 8:45 am]

BILLING CODE 6820–61–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1566]

Guidance for Industry and FDA

Reviewers: Class II Special Control

Guidance Document for AntiSaccharomyces cerevisiae (S.

cerevisiae) Antibody (ASCA)

Premarket Notifications; 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 ‘‘Guidance for Industry and

FDA Reviewers: Class II Special Control

Guidance Document for AntiSaccharomyces cerevisiae (S. cerevisiae)

Antibody (ASCA) Premarket

Notifications.’’ Elsewhere in this issue

of the Federal Register, FDA is issuing

a final rule classifying ASCA devices

into class II. FDA is issuing this

guidance to provide a means by which

ASCA devices may comply with the

requirements of class II special controls.

DATES: Submit written comments at any

time.

ADDRESSES: Submit written requests for

single copies on a 3.5′′ diskette of the

guidance document entitled ‘‘Guidance

for Industry and FDA Reviewers: Class

II Special Control Guidance Document

for Anti-Saccharomyces cerevisiae (S.

cerevisiae) Antibody (ASCA) Premarket

Notifications’’ 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 self-addressed adhesive labels

to assist that office in processing your

request, or fax your request to 301–443–

8818. Submit written comments

concerning this guidance 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

Federal Register / Vol. 65, No. 226 / Wednesday, November 22, 2000 / Notices 70357

docket number found in brackets in the

heading of this document. See the

SUPPLEMENTARY INFORMATION section for

information on electronic access to the

guidance.

FOR FURTHER INFORMATION CONTACT:

Deborah M. Moore, Center for Devices

and Radiological Health (HFZ–440),

Food and Drug Administration, 2098

Gaither Rd., Rockville, MD 20850, 301–

594–1293.

SUPPLEMENTARY INFORMATION:

I. Background

ASCA is a test system intended to

measure S. cerevisiae antibodies in

human serum or plasma as an aid in the

diagnosis of Crohn’s disease. The

guidance sets forth the risk associated

with this generic type of device, and

lists recommendations for submission of

a premarket notification. Designation of

this guidance as a special control means

that manufacturers of ASCA devices

who comply with either the

recommendations of this guidance or

some alternate means that provide

equivalent assurance of safety and

effectiveness will be able to market their

device after they have submitted a

premarket notification (510(k)) and

received a finding of substantial

equivalence for their device. The

guidance focuses on the following

issues: Labeling, design controls, and

clinical information. FDA believes that

this special control, when combined

with the general controls of the act, will

provide reasonable assurance of the

safety and effectiveness for this type of

device.

II. Significance of Guidance

This guidance document represents

the agency’s current thinking on the

submission of premarket notifications

for ASCA test systems. 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 such approach satisfies the

applicable statute, regulations, or both.

The agency has adopted good

guidance practices (GGP’s), which set

forth the agency’s policies and

procedures for the development,

issuance, and use of guidance

documents (65 FR 56468, September 19,

2000). This guidance document is

issued as a Level 2 guidance consistent

with GGP’s.

III. Electronic Access

In order to receive ‘‘Guidance for

Industry and FDA Reviewers: Class II

Special Control Guidance Document for

Anti-Saccharomyces cerevisiae (S.

cerevisiae) Antibody (ASCA) Premarket

Notifications’’ via your fax machine, call

the CDRH Facts-on-Demand system at

800–899–0381 or 301–827–0111 from a

touchtone telephone. At the first voice

prompt press 1 to access DSMA Facts,

at second voice prompt press 2, and

then enter the document number (1183)

followed by the pound sign (#). Then

follow the remaining voice prompts to

complete your request.

Persons interested in obtaining a copy

of the guidance may also do so 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 ‘‘Guidance

for Industry and FDA Reviewers: Class

II Special Control Guidance Document

for Anti-Saccharomyces cerevisiae (S.

cerevisiae) Antibody (ASCA) Premarket

Notifications,’’ 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.

IV. Comments

Interested persons may, at any time,

submit written comments regarding the

guidance to the Dockets Management

Branch (address above). Such comments

will be considered when determining

whether to amend the current guidance.

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

found in brackets in the heading of this

document. The guidance document and

received comments are available for

public examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: November 9, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–29842 Filed 11–21–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 00D–1557 and 00D–1558]

Guidance Documents for Premarket

Notification (510(k)) Submissions for

Indwelling Blood Gas Analyzers;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of two guidance documents.

These two guidance documents are

intended to serve as special controls for

three 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 three devices.

FDA is now inviting comment on these

two guidance documents because they

were not available for comment at the

time of the publication of the proposed

reclassification.

DATES: Submit written comments on the

agency guidances by February 20, 2001.

ADDRESSES: Submit written comments

on the agency guidances 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 table 1.

Submit written requests for single

copies on a 3.5′′ diskette of one or both

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 (64 FR 12774), FDA published a

proposed rule to reclassify 38