Federal Register / Vol. 66, No. 40 / Wednesday, February 28, 2001 / Notices 12805

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of respondents

Annual frequency

per

response2

Total annual responsesHours per

response Total operating costs Total hours

101.9(b) and (c)(1) 4 7.5 30 1 $15,000 30

1There are no capital costs or operating and maintenance costs associated with this collection of information.

2 Due to an inadvertent error, the ‘‘Annual Frequency per Response’’ column was omitted from the notice issued in the FEDERAL REGISTER of

December 5, 2000 (65 FR 75940). Table 1 of this document contains the inserted column.

The proposed modification of the

rules for the declaration of the amount

of calories and the proposed change of

the label serving size on the nutrition

facts panel would result in a one-time

burden created by the need for firms to

revise their labels. In addition to

changing the statement of calories and

the serving sizes, firms would have to

recalculate the number of servings per

container and any nutrient amounts and

daily values affected by the change in

serving size. Of those breath mints for

which FDA has information regarding

the size of the product, there are 4 firms

producing 5 brands of small breath

mints, or approximately 30 distinct

small breath mint labels. These are the

only firms that would be affected by this

proposed rule. FDA estimates that these

firms would require an average of 1

hour per label to comply with the

requirements of a final rule based on

this proposal. For breath mint products,

the average administrative, redesign,

and inventory disposal costs for a

labeling change of this type, with a 1-

year compliance period, would result in

a one-time operating cost of $500 per

label, or a total estimated operating cost

of $15,000.

Dated: February 22, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–4849 Filed 2–27–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01F–0026]

Avecia, Inc.; Withdrawal of Food

Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

withdrawal, without prejudice to a

future filing, of a food additive petition

(FAP 1B4726) proposing that the food

additive regulations be amended to

provide for the safe use of

poly(hexamethylenebiguanide)

hydrochloride as a preservative for foodcontact paper coating formulations.

FOR FURTHER INFORMATION CONTACT:

Mark A. Hepp, Center for Food Safety

and Applied Nutrition (HFS–215), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3098.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

January 23, 2001 (66 FR 7498), FDA

announced that a food additive petition

(FAP 1B4726) had been filed by Avecia,

Inc., 1405 Foulk Rd., P.O. Box 15457,

Wilmington, DE 19850–5457. 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) and § 176.180

Components of paper and paperboard

in contact with dry food (21 CFR

176.180) to provide for the safe use of

poly(hexamethylenebiguanide)

hydrochloride as a preservative for foodcontact paper coating formulations.

Avecia, Inc., has now withdrawn the

petition without prejudice to a future

filing (21 CFR 171.7).

Dated: February 14, 2001.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 01–4848 Filed 2–27–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Advisory Commission; 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 March 2001.

Name: Advisory Commission on

Childhood Vaccines (ACCV).

Date and Time: March 7, 2001; 9:00

a.m.–3:00 p.m.

Place: Parklawn Building, Conference

Rooms G and H, 5600 Fishers Lane,

Rockville, Maryland 20857.

The meeting is open to the public.

The full Commission will meet on

Wednesday, March 7, from 9:00 a.m. to

3:00 p.m. Agenda items will include,

but not be limited to: (1) A presentation

from Petitioners Attorneys’ Perspective;

(2) a discussion by the Chief Special

Master of the U.S. Court of Federal

Claims regarding its Alternative Dispute

Resolution General Order #11, and

soliciting comments from the public on

the development of a new website; (3)

and a report on the Institute of

Medicine’s Immunization Safety Review

Committee. Updates from the Division

of Vaccine Injury Compensation,

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 March 7, 2001.

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. Cheryl Lee,

Principal Staff Liaison, Division of

Vaccine Injury Compensation, Bureau of

Health Professions, Health Resources

and Services Administration, Room 8A–

46, 5600 Fishers Lane, Rockville, MD

20857, Telephone (301) 443–2124.

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

the Conference Room at the Parklawn

Building, 5600 Fishers Lane, Conference

Rooms G and H, Rockville, Maryland