75940 Federal Register / Vol. 65, No. 234 / Tuesday, December 5, 2000 / Notices

State Allotment percentage

Alabama ................................ 59.48

Alaska ................................... 48.91

Arizona .................................. 55.89

Arkansas ............................... 61.01

California ............................... 48.04

Colorado ............................... 45.34

Connecticut ........................... 31.28

Delaware ............................... 46.32

District of Columbia .............. 30.47

Florida ................................... 50.80

Georgia ................................. 52.27

Hawaii ................................... 50.75

Idaho ..................................... 59.88

Illinois .................................... 45.27

Indiana .................................. 54.08

Iowa ...................................... 54.58

Kansas .................................. 52.98

Kentucky ............................... 59.13

Louisiana .............................. 59.38

Maine .................................... 56.91

Maryland ............................... 43.39

Massachusetts ...................... 38.66

Michigan ............................... 50.76

Minnesota ............................. 46.26

Mississippi ............................ 63.55

Missouri ................................ 53.49

Montana ................................ 61.15

Nebraska .............................. 52.59

Nevada ................................. 45.54

New Hampshire .................... 45.92

New Jersey ........................... 37.46

New Mexico .......................... 61.30

New York .............................. 40.91

North Carolina ...................... 53.73

North Dakota ........................ 59.09

Ohio ...................................... 52.15

Oklahoma ............................. 59.47

Oregon .................................. 52.39

Pennsylvania ........................ 49.81

Rhode Island ........................ 48.60

South Carolina ...................... 58.73

South Dakota ........................ 56.50

Tennessee ............................ 55.06

Texas .................................... 52.96

Utah ...................................... 59.18

Vermont ................................ 54.70

Virginia .................................. 48.07

Washington ........................... 47.49

West Virginia ........................ 62.93

Wisconsin ............................. 52.03

Wyoming ............................... 54.03

American Samoa .................. 70.00

Guam .................................... 70.00

N. Mariana Islands ............... 70.00

Puerto Rico ........................... 70.00

Virgin Islands ........................ 70.00

Dated: November 27, 2000.

Patricia Montoya,

Commissioner, Administration for Children,

Youth and Families.

[FR Doc. 00–30887 Filed 12–4–00; 8:45 am]

BILLING CODE 4184–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1575]

Agency Information Collection

Activities; Proposed Collection;

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 an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995 (the

PRA), Federal agencies are required to

publish notice in the Federal Register

concerning each proposed collection of

information, including each proposed

extension of an existing collection of

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

information collection requirements

regarding the nutrition labeling of

breath mints.

DATES: Submit written or electronic

comments on the collection of

information by February 5, 2001.

ADDRESSES: Submit electronic

comments on the collection of

information to http://

www.accessdata.fda.gov/scripts/oc/

dockets/edockethome.cfm. Submit

written comments on the collection of

information to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. All

comments should be identified with the

docket number found in brackets in the

heading of this document.

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: Under the

PRA (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information,

including each proposed extension of an

existing collection of information,

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information set forth in this document.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Nutrition Labeling; Declaration of

Caloric Amounts and Serving Sizes for

Breath Mints—21 CFR 101.9(b) and

101.9(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,

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