Federal Register / Vol. 63, No. 16 / Monday, January 26, 1998 / Notices 3749

deposit bond in lieu of cash or other

form of bid deposit.

B. Annual Reporting Burden

Respondents: 1,000; annual

responses: 1; average hours per

response: .25; burden hours: 250.

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: January 20, 1998.

Ida M. Ustad,

Deputy Associate Administrator, Office of

Acquisition Policy.

[FR Doc. 98–1771 Filed 1–23–98; 8:45 am]

BILLING CODE 6820–61–M

GENERAL SERVICES

ADMINISTRATION

[OMB Control No. 3090–0057]

Proposed Collection; Comment

Request Deposit Bond Individual-Sale

of Government Personal Property

AGENCY: Federal Supply Service, GSA.

ACTION: Notice of request for public

comments regarding reinstatement to a

previously approved OMB clearance

(3090–0057).

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

a reinstatement of a previously

approved information collection

requirement concerning Deposit Bond

Individual-Sale of Government Personal

Property.

DATES: Comment Due Date: March 27,

1998.

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: Edward

Springer, GSA Desk Officer, Room 3235,

NEOB, Washington, DC 20503, and to

Marjorie Ashby, General Services

Administration (MVP), 1800 F Street

NW, Washington, DC 20405.

FOR FURTHER INFORMATION CONTACT:

Andrea Dingle, Federal Supply Service

(703) 305–6190.

SUPPLEMENTARY INFORMATION:

A. Purpose

The GSA is requesting the Office of

Management and Budget (OMB) to

reinstate information collection, 3090–

0057 concerning Deposit Bond

Individual-Sale of Government Personal

Property. This form is used by a bidder

participating in sales of Government

personal property whenever the sales

invitation permits an individual type of

deposit bond in lieu of cash or other

form of bid deposit.

B. Annual Reporting Burden

Respondents: 500; annual responses:

1; average hours per response: .25;

burden hours: 125.

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: January 20, 1998.

Ida M. Ustad,

Deputy Associate Administrator, Office of

Acquisition Policy.

[FR Doc. 98–1772 Filed 1–23–98; 8:45 am]

BILLING CODE 6820–61–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Board of Scientific Counselors,

National Institute for Occupational

Safety and Health: Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), the Centers for Disease

Control and Prevention (CDC)

announces the following committee

meeting:

Name: Board of Scientific Counselors,

National Institute for Occupational Safety

and Health (BSC, NIOSH).

Time and Date: 9 a.m.–4:30 p.m., February

11, 1998.

Place: The Washington Court, Montpelier

Room, 525 New Jersey Avenue, NW,

Washington, DC 20001–1527.

Status: Open to the public, limited only by

the space available. The meeting room

accommodates approximately 50 people.

Purpose: The BSC, NIOSH is charged with

providing advice to the Director, NIOSH on

NIOSH research programs. Specifically, the

Board shall provide guidance on the

Institute’s research activities related to

developing and evaluating hypotheses,

systematically documenting findings, and

disseminating results.

Matters to be Discussed: Agenda items

include a report from the Director of NIOSH,

research program planning, state surveillance

activities, Workers’ Family Protection Task

Force, the NIOSH energy-related research

program, NIOSH Metal Working Fluids

Criteria Document, and future activities of

the Board.

Agenda items are subject to change as

priorities dictate.

Contact Person for More Information:

Bryan D. Hardin, Ph.D., Executive Secretary,

BSC, NIOSH, Room 715–H, Hubert H.

Humphrey Building, 200 Constitution

Avenue SW, Washington, DC, 20201,

telephone 202/205–8556, fax 202/260–4464,

e-mail bdh1@cdc.gov.

Dated: January 20, 1998.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 98–1722 Filed 1–23–98; 8:45 am]

BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98F–0014]

Bio-Cide International, Inc.; Filing of

Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Bio-Cide International, Inc., has

filed a petition proposing that the food

additive regulations be amended to

provide for the safe use of acidified

sodium chlorite solutions in processing

water and ice intended for use in

contact with seafood.

DATES: Written comments on the

petitioner’s environmental assessment

by February 25, 1998.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Robert L. Martin, Center for Food Safety

and Applied Nutrition (HFS–217), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3074.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),

notice is given that a petition (FAP

8A4568) has been filed by Bio-Cide

International, Inc., c/o Keller and

Heckman LLP, 1001 G St. NW., suite

500 West, Washington, DC 20001. The

petition proposes to amend the food

additive regulations in 21 CFR part 173

to provide for the safe use of acidified

sodium chlorite solutions in processing

water and ice intended for use in

contact with seafood.
3750 Federal Register / Vol. 63, No. 16 / Monday, January 26, 1998 / Notices

The potential environmental impact

of this action is being reviewed. To

encourage public participation

consistent with regulations promulgated

under the National Environmental

Policy Act (40 CFR 1501.4(b)), the

agency is placing the environmental

assessment submitted with the petition

that is the subject of this notice on

public display at the Dockets

Management Branch (address above) for

public review and comment. Interested

persons may, on or before February 25,

1998, submit to the Dockets

Management Branch (address above)

written comments. 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. Received

comments may be seen in the office

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

Monday through Friday. FDA will also

place on public display any

amendments to, or comments on, the

petitioner’s environmental assessment

without further announcement in the

Federal Register. If, based on its review,

the agency finds that an environmental

impact statement is not required and

this petition results in a regulation, the

notice of availability of the agency’s

finding of no significant impact and the

evidence supporting that finding will be

published with the regulation in the

Federal Register in accordance with 21

CFR 25.40(c).

Dated: January 7, 1998.

Laura M. Tarantino,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 98–1663 Filed 1–23–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0528]

Draft ‘‘Guidance for Industry: Efficacy

Studies to Support Marketing of Fibrin

Sealant Products Manufactured for

Commercial Use’’

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft document entitled

‘‘Guidance for Industry: Efficacy Studies

to Support Marketing of Fibrin Sealant

Products Manufactured for Commercial

Use.’’ After reviewing recent experience

with fibrin sealant products in clinical

studies conducted under Investigational

New Drug (IND) regulations, the agency

is proposing to accept applications for

licensure of fibrin sealant products

based on evidence from pivotal studies

in which the primary endpoint is

hemostasis effectiveness. As in the past,

other endpoints such as wound healing

or tissue sealing may serve as primary

endpoints for pivotal studies, depending

on the nature of the indications sought.

This draft document will provide

guidance to manufacturers of fibrin

sealant products for the design of

clinical trials intended to support

licensure.

DATES: Written comments may be

submitted at any time, however,

comments should be submitted by April

27, 1998, to ensure their adequate

consideration in preparation of the final

document.

ADDRESSES: Submit written requests for

single copies of the draft guidance

document ‘‘Guidance for Industry:

Efficacy Studies to Support Marketing of

Fibrin Sealant Products Manufactured

for Commercial Use’’ to the Office of

Communication, Training, and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research (CBER), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send one

self-addressed adhesive label to assist

that office in processing your requests.

The draft guidance document may also

be obtained by mail by calling the CBER

Voice Information System at 1–800–

835–4709 or 301–827–1800, or by fax by

calling the FAX Information System at

1–888–CBER–FAX or 301–827–3844.

Submit written comments on the draft

guidance document to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Paula S. McKeever, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a draft document entitled ‘‘Efficacy

Studies to Support Marketing of Fibrin

Sealant Products Manufactured for

Commercial Use.’’ This draft guidance

document represents the agency’s

current thinking with regard to

information on the efficacy studies to

support marketing of licensure of fibrin

sealant products manufactured for

commercial use. 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

requirements of the applicable statute,

regulations, or both. As with other

guidance documents, FDA does not

intend this draft document to be allinclusive and cautions that not all

information may be applicable to all

situations. The draft guidance document

is intended to provide information and

does not set forth requirements.

II. Comments

This draft document is being

distributed for comment purposes only,

and is not intended for implementation

as general guidance at this time.

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the draft

guidance document. Written comments

may be submitted at any time, however,

comments should be submitted by April

27, 1998, to ensure adequate

consideration in preparation of the final

document. Two copies of any comment

are to be submitted, except individuals

may submit one copy. Comments and

request for copies should be identified

with the docket number found in the

brackets in the heading of this

document. A copy of the draft 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.

III. Electronic Access

Persons with access to the internet

may obtain the draft document using the

World Wide Web (WWW). For WWW

access connect to CBER at ‘‘http://

www.fda.gov/cber/guidelines.htm’’.

Dated: January 13, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

The text of the draft guidance is set

forth below:

BILLING CODE 4160–01–F