Federal Register / Vol. 65, No. 234 / Tuesday, December 5, 2000 / Notices 75941

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.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ADDITIONAL REPORTING BURDEN 1

21 CFR Section No. of

Respondents

Total No. of

Responses

Hours per

Response

Total Operating

Costs Total Hours

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

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

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: November 28, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–30828 Filed 12–4–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1283]

Agency Information Collection

Activities; Announcement of OMB

Approval; Reporting and

Recordkeeping Requirements and

Availability of Sample Electronic

Products for Manufacturers and

Distributors of Electronic Products

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Reporting and Recordkeeping

Requirements and Availability of

Sample Electronic Products for

Manufacturers and Distributors of

Electronic Products’’ has been approved

by the Office of Management and

Budget (OMB) under the Paperwork

Reduction Act of 1995.

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 the

Federal Register of September 13, 2000

(65 FR 55262), 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 0910–0025. The

approval expires on November 30, 2003.

A copy of the supporting statement for

this information collection is available

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

ohrms/dockets.

Dated: November 28, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–30830 Filed 12–4–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1311]

Agency Information Collection

Activities; Announcement of OMB

Approval; Export of Medical Devices—

Foreign Letters of Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Export of Medical Devices—Foreign

Letters of Approval’’ has been approved

by the Office of Management and

Budget (OMB) under the Paperwork

Reduction Act of 1995.

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 the

Federal Register of September 12, 2000

(65 FR 55027), 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