Federal Register / Vol. 65, No. 229 / Tuesday, November 28, 2000 / Notices 70917

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.

Use of Impact-Resistant Lenses in

Eyeglasses and Sunglasses (OMB

Control Number 0910–0182)—Extension

Under section 519 of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360(i)), every manufacturer or

importer of a device intended for human

use shall establish and maintain

records. This regulation is designed to

protect the eyeglass and sunglass wearer

from potential eye injury resulting from

shattering of ordinary eyeglass lenses,

and it requires that eyeglasses and

sunglasses be fitted with impactresistant lenses. Section 801.410(f) (21

CFR 801.410(f)) requires that the results

of impact tests and description of the

test method and apparatus also be kept

for a period of 3 years. These records are

valuable to FDA when investigating eye

injury complaints.

The expected respondents to this

collection are manufacturers of impactresistant lenses. FDA estimates the

burden of this collection of information

as follows:

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of Recordkeepers Annual Frequency of

Recordkeeping Total Annual Records Hours perRecordkeeper Total Hours

801.410(f) 30 769,000 23,070,00 .0008 18,456

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

The Vision Council of America

(www.visionsite.org) provided sales

figures that were used in estimating the

burden for this collection. Beginning in

1998, a growth rate of 2.6 percent for the

distribution of lenses began, and it was

assumed that this growth rate continued

in 1999 and 2000. This resulted in an

increase in the number of eyeglasses

shipped annually to 89 million lenses

shipped by year 2000.

By also assuming that the glass/plastic

lenses-produced ratio remained as in

previous years (22 percent glass and 78

percent plastic), that glass lenses must

be tested individually, and only 5

percent of the plastic lenses must be

tested, then 23,070,000 lenses should be

tested. This figure was derived by taking

22 percent of 89 million glass lenses

(19,600,000) and adding it to 5 percent

of the remaining plastic lenses (5

percent x 69,400,000 = 3,470,000).

Next, divide the total tests

(23,070,000) by 30 manufacturers to

return the annual frequency of

recordkeeping figure of 769,000.

Previously, FDA and industry experts

estimated that on average, each test

could be completed and recorded in 3

seconds. Industry, therefore, could

complete 1,200 tests per hour.

Therefore, it is estimated that the total

burden for this collection is 19,225

hours, which is calculated by taking the

total records figure (23,070,000) and

dividing it by tests per hour (1,200). The

total hours was calculated by

multiplying the total number of records

(23,070,000) and the hours per record

(.0008).

There is no burden estimated for

maintaining sale or distribution records

under § 801.410(e) since firms are

retaining their records as a normal and

customary business practice for reasons

of product liability.

Dated: November 20, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–30329 Filed 11–27–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 95N–0220]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request;

Substances Approved for Use in the

Preparation of Meat and Poultry

Products

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 December

28, 2000.

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.

Petition for Approval of Substances for

Use in the Preparation of Meat and

Poultry Products—21 CFR 71.1 and

171.1

Sections 409 and 721 of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 348 and 379e) require FDA to

evaluate the safety and regulate the use

of food and color additives used as

ingredients in or on all foods. These

sections also authorize FDA to accept

petitions for approval of food and color

additives. The Federal Meat Inspection

Act and the Poultry Products Inspection

Act (21 U.S.C. 601(m)(2) and 453(g)(2),

respectively) authorize the

administration of the Food Safety and

Inspection Service (FSIS), U.S.

Department of Agriculture to determine

the suitability of the use of a substance

in meat and poultry products.

Regulations of the two agencies

regarding petition submissions at times

include conditions, formats, and terms

that are not fully consistent with one

another because of the different

statutory mandates. Under the current

process, FDA and FSIS conduct

separate, sequential reviews of petitions,

each agency applying its respective

70918 Federal Register / Vol. 65, No. 229 / Tuesday, November 28, 2000 / Notices

procedures to ascertain that a substance

is lawful for the use intended in or on

products containing meat or poultry.

When petitioning for approval for the

use of substances in meat and poultry

products, the applicants must provide

four copies of the petition to FDA,

rather than the three copies as currently

specified in §§ 71.1 and 171.1 (21 CFR

71.1 and 171.1). FDA will then forward

a copy of the petition or relevant

portions of the petition to FSIS so that

both agencies can perform the necessary

reviews simultaneously, thus reducing

the time it takes to authorize an

ingredient for use in meat and poultry

products. The petitioners are not

required to submit any new information

to either FDA or FSIS.

This regulation results from a

coordinated effort by the two agencies to

ease the paperwork burden on regulated

industries through streamlining the

Federal Government’s food ingredient

approval process for substances used in

meat and poultry products.

Description of Respondents:

Businesses or other for profit.

In the Federal Register of August 25,

2000 (65 FR 51758), 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:

TABLE 1.—ESTIMATED ANNUAL INCREASE IN REPORTING HOUR BURDEN1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Increase in

Hours per

Response

Total Increase

in Hours

71.1 and 171.1 10 1 10 2 20

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

Based on FDA’s past experience with

food and color additive petitions and on

discussions with FSIS about its past

experience, it will receive 10 petitions

annually that request approval for use of

a substance in meat and poultry

products. Submission of a petition for

the use of a substance in meat and

poultry products is a one-time event.

FDA estimates that the respondent

would expend 2 hours to make a fourth

photocopy of the petition, necessary for

FDA to send to FSIS to conduct a

simultaneous review. FDA, therefore,

estimates that the total burden of data

collection under §§ 71.1 and 171.1 will

increase by 20 hours per year because of

the requirement to submit a fourth copy

of petitions when a substance is to be

used in meat or poultry products.

Dated: November 20, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–30330 Filed 11–27–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 82F–0349, 90F–0188, 91F–

0169, 93F–0157, 93F–0199, 95F–0011, 96F–

0032, 96F–0223, 98F–0226, 98F–0288, 98F–

0289, 99F–0052, 99F–0460, 99F–1074, 99F–

2244, 99F–2245, 99F–5012, and 00F–0089]

Withdrawal of Food Additive Petitions

Subsequently Converted to Food

Contact Notifications

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 18 food additive

petitions proposing that the food

additive regulations be amended to

provide for the safe use of certain new

food additives. The petitioners

subsequently requested that their

petitions be converted to food-contact

notifications for review under the

agency’s new premarket notification

(PMN) program for food-contact

substances. The requested uses are now

the subjects of effective notifications.

FOR FURTHER INFORMATION CONTACT:

Sylvia D. Dodson, Center for Food

Safety and Applied Nutrition (HFS–

215), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3087.

SUPPLEMENTARY INFORMATION: In notices

published in the Federal Register on the

dates indicated in the table below, FDA

announced the filing of 18 food additive

petitions. These petitions proposed to

amend the food additive regulations in

the sections listed in the table to

provide for the safe use of the listed

substances intended for use in foodcontact articles. Since publication of

these filing notices, the petitioners have

requested that their respective petitions

be converted to food-contact

notifications for review under the

agency’s new PMN process for foodcontact substances and that their

petitions be withdrawn when the

corresponding notifications become

effective. These petitions were

converted to notifications and

subsequently reviewed under the PMN

process. The requested uses are now the

subjects of effective notifications. The

corresponding food additive petitions

are now withdrawn without prejudice to

a future filing (21 CFR 171.7).

TABLE 1.

FAP No.1 and Docket

No.

FNC

No.2

FR Citation and

Date Company Section/Part Additive Use

3B4354,

93F–0199

28 59 FR 59410,

Nov. 17, 1994

Asahi Chemical

Industry Co.,

Ltd., c/o Regulatory Assistance Corp.

175.105 and

177.1810

Maleic anhydride modified hydrogenated styrene butadiene

block polymer.

Not Specified.

7A4539,

98F–0226

31 63 FR 18921,

Apr. 16, 1998

Nalco Chemical

Co.

173.310 Disodium or dipotassium fluorescein.In boilers where

steam may contact food.