26194 Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 / Notices

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

withdrawal, without prejudice to a

future filing, of a food additive petition

(FAP 6B4517) proposing that the food

additive regulations be amended to

provide for the safe use of diethylene

glycol as a component of a pulp

bleaching medium used in the

manufacture of paper and paperboard

intended for use in contact with food.

FOR FURTHER INFORMATION CONTACT:

Andrew J. Zajac, Center for Food Safety

and Applied Nutrition (HFS–215), Food

and Drug Administration, 200 Ct. SW.,

Washington, DC 20204, 202–418–3095.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

September 30, 1996 (61 FR 51118), FDA

announced that a food additive petition

(FAP 6B4517) had been filed by

MacMillan Bloedel, Ltd., c/o Camplong

& Associates, Inc., P.O. Box 238,

Schomberg, Ontario L0G 1T0, Canada.

The filing notice stated that the petition

proposed to amend the food additive

regulations in § 176.170 Components of

paper and paperboard in contact with

aqueous and fatty foods (21 CFR

176.170) to provide for the safe use of

diethylene glycol as a pulp bleaching

agent for paper and paperboard

intended for use in contact with food.

Upon further review, FDA has

determined that the petition proposed

the use of diethylene glycol as a

component of a pulp bleaching medium

used in the manufacture of food-contact

paper and paperboard. MacMillan

Bloedel, Ltd. has now withdrawn the

petition without prejudice to a future

filing (21 CFR 171.7).

Dated: April 10, 1998.

Laura M. Tarantino,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 98–12541 Filed 5–11–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98F–0195]

Vanetta S.p.A.; Filing of Food Additive

Petition (Animal Use) Menadione

Nicotinamide Bisulfite

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Vanetta S.p.A. has filed a petition

to allow the use of menadione

nicotinamide bisulfite in swine diets as

a source of vitamin K activity and

niacin.

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:

Michaela G. Alewynse, Center for

Veterinary Medicine (HFV–228), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

6657.

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 food additive

petition (FAP 2239) has been filed by

Vanetta S.p.A., Via Alzia Trento 10,

Milano, Corsico, Italy. The petition

proposes to amend the food additive

regulations in part 573 Food Additives

Permitted in the Feed and Drinking

Water of Animals (21 CFR part 573) to

provide for use of menadione

nicotinamide bisulfite in swine diets as

a source of vitamin K activity and

niacin.

The agency has determined under 21

CFR 25.32 that this action is of the 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.

Dated: April 24, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–12540 Filed 5–11–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Food Advisory Committee; Notice of

Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Food Advisory

Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on June 15 and 16, 1998, 8 a.m. to

6 p.m.; and June 17, 1998, 8 a.m. to 1

p.m..

Location: Sheraton Reston Hotel,

Grand Ballroom, 11810 Sunrise Valley

Dr., Reston, VA.

Contact: Lynn A. Larsen, Center for

Food Safety and Applied Nutrition

(HFS–5), 202–205–4727, or Catherine

M. DeRoever (HFS–22), 202–205–4251,

FAX 202–205–4970, Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204, or FDA

Advisory Committee Information Line,

1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 10564.

Please call the Information Line for upto-date information on this meeting.

Agenda: The committee will receive

and undertake a scientific discussion

about new data that have become

available regarding the food additive

olestra.

In the Federal Register of January 30,

1996 (61 FR 3118), FDA approved

olestra for use as a food additive to

replace conventional fats in

prepackaged savory snacks. Olestra is a

sucrose polyester formed with long

chain fatty acids. The agency

determined, based on its evaluation of

the evidence in the record at that time,

that there is a reasonable certainty that

no harm will result from the use of

olestra in savory snacks. At the time of

approval, the petitioner, Proctor and

Gamble Co. (P&G), agreed to perform

additional studies of olestra exposure

(both amounts consumed and patterns

of consumption) and the effects of

olestra consumption. P&G also agreed to

provide FDA with access to all data and

reports of those studies as such

information became available. At the

time of olestra’s approval, FDA

committed to review all data received

from P&G’s studies, as well as any other

new data that bear on the safe use of this

additive, and present such information

to the committee within 30 months of

the approval.

Committee discussion will focus on

data gathered from passive surveillance

of complaints attributed to olestra

consumption; the active surveillance of

populations consuming savory snacks,

including olestra snacks; any additional

new data that have become available

that bear on the safety of olestra (such

as data and information on the health

significance of carotenoids); and various

other studies submitted by P&G (e.g.,

rechallenge, home consumption, and

acute consumption test). The committee

will consider whether these newly

developed data are consistent with the

original safety decision or whether the

new data contradict FDA’s original

determination that there is a reasonable

certainty of no harm from the use of
Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 / Notices 26195

olestra in savory snacks. The committee

will also discuss the bearing, if any, of

these new data on the required label

statement for olestra containing snacks.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by June 5, 1998. Oral

presentations from the public will be

scheduled in three sessions. The

approximate session schedules and the

topics upon which presentations at each

should be focussed are: (1) Passive

surveillance and special gastrointestinal

studies on June 16, 1998, 8 a.m. to 9

a.m.; (2) active surveillance and new

information on carotenoids on June 16,

1998, 4 p.m. to 4:30 p.m.; and (3)

labeling on June 17, 1998, 10:30 a.m. to

11 a.m. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before June 5, 1998, and submit

a brief statement of the general nature of

the evidence or arguments they wish to

present, the names and addresses of

proposed participants, and an

indication of the approximate time

requested to make their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: May 4, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–12449 Filed 5–11–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Advisory Council; Notice of Meeting

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

the Federal Advisory Committee Act

(Public Law 92–463), announcement is

made of the following National

Advisory body scheduled to meet

during the month of June 1998.

Name: Advisory Commission on

Childhood Vaccines (ACCV).

Date and Time: June 10, 1998; 9:00 a.m.—

5:00 p.m.; June 11, 1998; 9:00 a.m.—12:00

Noon.

Place: Parklawn Building, Conference

Rooms G & H, 5600 Fishers Lane, Rockville,

Maryland 20857.

The meeting is open to the public.

Agenda: Items will include, but not be

limited to: an update on legislative proposals,

an update on Vaccine Information

Statements, an update on vaccines in clinical

trials, an update on the Vaccine Adverse

Events Reporting System, an update on the

Vaccine Safety Action Plan, and reports from

the Department of Justice, the National

Vaccine Program Office, and routine program

reports.

Public comment will be permitted before

lunch and at the end of the Commission

meeting on June 10, 1998, and before

adjournment on June 11, 1998. Oral

presentations will be limited to 5 minutes per

public speaker. Persons interested in

providing an oral presentation should submit

a written request, along with a copy of their

presentation to: Ms. Melissa Palmer,

Principal Staff Liaison, Division of Vaccine

Injury Compensation, Bureau of Health

Professions, Health Resources and Services

Administration, Room 8A–35, 5600 Fishers

Lane, Rockville, MD 20857, Telephone (301)

443–6593. Requests should contain the name,

address, telephone number, and any business

or professional affiliation of the person

desiring to make an oral presentation. Groups

having similar interests are requested to

combine their comments and present them

through a single representative. The

allocation of time may be adjusted to

accommodate the level of expressed interest.

The Division of Vaccine Injury Compensation

will notify each presenter by mail or

telephone of their assigned presentation time.

Persons who do not file an advance request

for a presentation, but desire to make an oral

statement, may sign-up in Conference Rooms

G and H on June 10–11, 1998. These persons

will be allocated time as time permits.

Anyone requiring information regarding

the Commission should contact Ms. Palmer,

Division of Vaccine Injury Compensation,

Bureau of Health Professions, Health

Resources and Services Administration,

Room 8A–35, 5600 Fishers Lane, Rockville,

Maryland 20857, Telephone (301) 443–6593.

Agenda items are subject to change as

priorities dictate.

Dated: May 6, 1998.

Jane M. Harrison,

Acting Director, Division of Policy Review

and Coordination.

[FR Doc. 98–12609 Filed 5–11–98; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration (SAMHSA)

Notice of Meeting

Pursuant to Public Law 92–463,

notice is hereby given of the following

meeting of the SAMHSA Special

Emphasis Panel I in May 1998.

A summary of the meeting and a

roster of the members may be obtained

from: Ms. Dee Herman, Committee

Management Liaison, SAMHSA, Office

of Policy and Program Coordination,

Division of Extramural Activities,

Policy, and Review, 5600 Fishers Lane,

Room 17–89, Rockville, Maryland

20857. Telephone: 301–443–7390.

Substantive program information may

be obtained from the individual named

as Contact for the meeting listed below.

The meeting will include the review,

discussion and evaluation of individual

grant applications. These discussions

could reveal personal information

concerning individuals associated with

the applications. Accordingly, this

meeting is concerned with matters

exempt from mandatory disclosure in

Title 5 U.S.C. 552b(c)(6) and 5 U.S.C.

App.2, § 10(d).

Committee Name: SAMHSA Special

Emphasis Panel I (SEP I).

Meeting Dates: May 26–29, 1998.

Place: Residence Inn, Calvert Room,

7335 Wisconsin Avenue, Bethesda, MD

20815.

Closed: May 26–28, 1998 9:00 a.m.–

5:00 p.m.; May 29, 1998 9:00 a.m.–

adjournment.

Panel: Center for Mental Health

Services Circles of Care.

Contact: Richard A. Peabody, Room

17–89, Parklawn Building, Telephone:

301–443–9919 and FAX: 301–443–3437.

Dated: May 6, 1998.

Jeri Lipov,

Committee Management Officer, Substance

Abuse and Mental Health Services

Administration.

[FR Doc. 98–12447 Filed 5–11–98; 8:45 am]

BILLING CODE 4162–20–P

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4369–N–01]

Notice of Proposed Information

Collection for Public Comment

AGENCY: Office of the Assistant

Secretary for Community Planning and

Development, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

will be submitted to the Office of

Management and Budget (OMB) for

review, as required by the Paperwork

Reduction Act. The Department is

soliciting public comments on the

subject proposal.

DATES: Comments due: July 13, 1998.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. comments should refer to

the proposal by name and/or OMB

Control Number and should be sent to:

Ms. Shelia Jones, Reports Liaison

Officer, Office of the Assistant Secretary

for Community Planning and

Development, Department of Housing

and Urban Development, 451–7th