12804 Federal Register / Vol. 66, No. 40 / Wednesday, February 28, 2001 / Notices

A copy of the supporting statement for

this information collection is available

on the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: February 22, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–4852 Filed 2–27–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N–1852]

Agency Information Collection

Activities; Announcement of OMB

Approval; Postmarketing Studies for

Approved Human Drug and Licensed

Biological Products; Status Reports

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Postmarketing Studies for Approved

Human Drug and Licensed Biological

Products; Status Reports’’ has been

approved by the Office of Management

and Budget (OMB) under the Paperwork

Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

SUPPLEMENTARY INFORMATION: In the

Federal Register of October 30, 2000 (65

FR 64607), the agency announced that

the proposed information collection had

been submitted to OMB for review and

clearance under 44 U.S.C. 3507. An

agency may not conduct or sponsor, and

a person is not required to respond to,

a collection of information unless it

displays a currently valid OMB control

number. OMB has now approved the

information collection and has assigned

OMB control number 0910–0433. The

approval expires on February 29, 2004.

A copy of the supporting statement for

this information collection is available

on the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: February 22, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–4853 Filed 2–27–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1575]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Nutrition

Labeling; Declaration of Caloric

Amounts and Serving Sizes for Breath

Mints

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995.

DATES: Submit written comments on the

collection of information by March 30,

2001.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Wendy

Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: In

compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

Nutrition Labeling; Declaration of

Caloric Amounts and Serving Sizes for

Breath Mints—21 CFR 101.9(b) and

(c)(1) (OMB Control Number 0910–

0364)—Extension

Section 403(q) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 343(q)) requires that the label or

labeling of a food bear nutrition

information, including information on:

(1) The serving size and number of

servings per container, and (2) the

number of calories present in a serving

of the food. Under FDA’s nutrition

labeling regulations in § 101.9(d)(3) (21

CFR 101.9(d)(3)), the nutrition facts

panel of the food label must disclose the

serving size of the food product and the

number of servings in each package.

Under § 101.9(c)(1), the nutrition facts

panel must disclose the number of

calories present in a serving of the food.

In the Federal Register of December

30, 1997 (62 FR 67775), FDA published

a proposed rule to amend the nutrition

labeling regulations by changing the

label serving size for the product

category ‘‘Hard candies, breath mints’’

to one unit. FDA proposed this change

in response to a petition to provide a

serving size for breath mints that more

accurately reflects the amount

customarily consumed per eating

occasion. In a related issue, FDA also

proposed to: (1) Modify the rounding

rules for calories to allow the

declaration of caloric amounts of less

than 5 calories on the nutrition label,

and (2) require that the number of

calories declared on the nutrition label

of a food product be consistent with any

claims about caloric content that are

made in its labeling. As a result of this

proposed rule, manufacturers, packers,

or distributors who make labeling

claims that their products contain

between 1 and 5 calories would be

required to change the declaration of the

amount of calories on the nutrition

label. In addition, manufacturers of

small breath mints would be required,

under § 101.9(b), to change the serving

size and, under § 101.9(c) and (d), to

modify the amounts and daily values for

nutrients listed in the nutrition label for

their products. The proposal included

burden estimates for the proposed

changes and solicited public comment.

In the interim, however, FDA is seeking

an extension of OMB approval for the

current regulations.

In the Federal Register of December 5,

2000 (65 FR 75940), the agency

requested comments on the proposed

collection of information. No comments

were received.

FDA estimates the burden of this

collection of information as follows:

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