Federal Register / Vol. 66, No. 40 / Wednesday, February 28, 2001 / Notices 12803

that export certain animal-derived

products (e.g., shell eggs, dairy

products, game meat, game meat

products, animal casings, and gelatin) to

EC. FDA uses the information to

maintain lists of processors that have

demonstrated current compliance with

U.S. requirements and provides the lists

to EC quarterly. Inclusion on the list is

voluntary. EC member countries refer to

the lists at ports of entry to verify that

products offered for importation to EC

from the United States are from

processors that meet U.S. regulatory

requirements. Products processed by

firms not on the list are subject to

detention and possible refusal at the

port. FDA requests the following

information from each processor:

1. Business name and address;

2. Name and telephone number of

person designated as business contact;

3. Lists of products presently being

shipped to EC and those intended to be

shipped in the next 6 months;

4. Name and address of

manufacturing plants for each product;

5. Names and affiliations of any

Federal, State, or local governmental

agencies that inspect the plant,

government-assigned plant identifier,

such as plant number, and last date of

inspection; and

6. Assurance that the firm or

individual representing the firm and

submitting a certificate for signature to

FDA is aware of and knows that they are

subject to the provisions of section 1001

of Title 18, United States Code. This law

provides that it is a criminal offense to

knowingly and willfully make a false

statement or alter or counterfeit

documents in a matter within the

jurisdiction of a U.S. agency.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Products No. of

respondents

Annual

frequency per

response

Total annual responsesHours per

response Total hours

Shell eggs 10 1 10 0.25 2.5

Dairy 100 1 100 0.25 25

Game meat and meat products 10 1 10 0.25 2.5

Animal casings 15 1 15 0.25 3.75

Gelatin 6 1 6 0.25 1.5

Total 35.25

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

The estimated number of respondents

is based on the volume of exports and

responses received to date. The

estimated number of yearly responses

has decreased from the estimate in

FDA’s previous notice seeking comment

for this collection of information (63 FR

29738, June 1, 1998) because the actual

number of responses has been

decreasing. Companies do not need to

reapply unless they have a compliance

problem. An estimate for processors that

export gelatin also has been added

because these processors are now being

included in the listing process.

TABLE 2.—ESTIMATED ANNUAL REPORTING BURDEN (THIRD PARTY DISCLOSURE)1

Respondents No. of

respondents

Annual

frequency per

response

Total annual responsesHours per

response Total hours

Trade association 15 1 15 8 120

State 50 1 50 8 400

Total 520

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

The burden estimated for the trade

associations assumes the trade

associations will disseminate FDA’s

information request through mass

mailings to their membership or publish

it in their trade magazine or newsletter.

The burden estimated for State

authorities assumes dissemination of

information to the processors or

dissemination of information about

processors to FDA.

Dated: February 22, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–4851 Filed 2–27–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1440]

Agency Information Collection

Activities; Announcement of OMB

Approval; User Fee Cover Sheet

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘User Fee Cover Sheet’’ 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 December 5, 2000

(65 FR 75942), 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 0910–0297. The

approval expires on February 29, 2004.

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: