Federal Register / Vol. 66, No. 45 / Wednesday, March 7, 2001 / Notices 13769

1 In accordance with 45 CFR 96.85, each State’s estimated median income for a 4-person family is multiplied by the following percentages to

adjust for family size: 52% for one person, 68% for two persons, 84% for three persons, 100% for four persons, 116% for five persons, and

132% for six persons. For family sizes greater than six persons, add 3% for each additional family member and multiply the new percentage by

the State’s estimated median income for a 4-person family. 2Prepared by the Bureau of the Census from the March 1999 Current Population Survey, 1990 Decennial Census of Population and Housing,

and 1998 per capita personal income estimates, by state, from the Bureau of Economic Analysis (BEA). In 1999, BEA revised its methodology in

estimating per capita personal income estimates. BEA’s revised methodology is reflected in the FY 2002 state 4-person family median income

estimates. For further information, contact the Housing and Household Economic Statistics Division at the Bureau of the Census (301–457–

3242).

[FR Doc. 01–5536 Filed 3–6–01; 8:45 am]

BILLING CODE 4184–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1599]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Use of

Impact-Resistant Lenses in Eyeglasses

and Sunglasses

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 April 6,

2001.

ADDRESSES: Submit written comment 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.

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. The regulation in

§ 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.

In the Federal Register of November

28, 2000 (65 FR 70916), the agency

requested comments on the proposed

collection of information. One comment

was received. The comment stated the

estimate seems to include only the time

for testing, but omitted the cost of the

materials and their disposal. It stated

that the estimate did not explicitly

address whether this testing is

destructive in nature. These costs are

material.

FDA’s attempt at addressing these

issues was limited by the Vision

Council of America’s (VCA) reluctance

to provide any more information than

what had been included in FDA’s

original submission. VCA informed FDA

that there was a restriction on

information because VCA had promised

their clients that they would not release

certain data that was considered critical.

Because of this limited amount of

information from FDA’s most reliable

source (VCA), FDA was limited to the

estimated burden that was included in

the original submission (OMB control

number 0910–0182).

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 per

Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours

801.410(f) 30 769,000 23,070,000 .0008 19,225

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

2Due to an inadvertent error, the recordkeeping burden hours for § 801.410(f) that appeared in a notice issued in the FEDERAL REGISTER of November 28, 2000, were incorrect. Table 1 of this document contains the correct estimates.

VCA provided sales figures

(www.visionsite.org) 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

13770 Federal Register / Vol. 66, No. 45 / Wednesday, March 7, 2001 / Notices

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

(.0008).

There is no burden estimated for

maintaining sale or distribution records

under § 801.410(e) because firms are

retaining their records as a normal and

customary business practice for reasons

of product liability.

Dated: March 1, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–5472 Filed 3–6–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00E–1235]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; AciphexTM

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

AciphexTM and is publishing this notice

of that determination as required by

law. FDA has made the determination

because of the submission of an

application to the Commissioner of

Patents and Trademarks, Department of

Commerce, for the extension of a patent

which claims that human drug product.

ADDRESSES: Submit written comments

and petitions to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Claudia V. Grillo, Regulatory Policy

Staff (HFD–007), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–594–2041.

SUPPLEMENTARY INFORMATION: The Drug

Price Competition and Patent Term

Restoration Act of 1984 (Public Law 98–

417) and the Generic Animal Drug and

Patent Term Restoration Act (Public

Law 100–670) generally provide that a

patent may be extended for a period of

up to 5 years so long as the patented

item (human drug product, animal drug

product, medical device, food additive,

or color additive) was subject to

regulatory review by FDA before the

item was marketed. Under these acts, a

product’s regulatory review period

forms the basis for determining the

amount of extension an applicant may

receive.

A regulatory review period consists of

two periods of time: A testing phase and

an approval phase. For human drug

products, the testing phase begins when

the exemption to permit the clinical

investigations of the drug becomes

effective and runs until the approval

phase begins. The approval phase starts

with the initial submission of an

application to market the human drug

product and continues until FDA grants

permission to market the drug product.

Although only a portion of a regulatory

review period may count toward the

actual amount of extension that the

Commissioner of Patents and

Trademarks may award (for example,

half the testing phase must be

subtracted as well as any time that may

have occurred before the patent was

issued), FDA’s determination of the

length of a regulatory review period for

a human drug product will include all

of the testing phase and approval phase

as specified in 35 U.S.C. 156(g)(1)(B).

FDA recently approved for marketing

the human drug product AciphexTM

(rabeprazole sodium). AciphexTM is

indicated for healing of erosive or

ulcerative gastroesophageal reflux

disease (GERD), maintenance of healing

of erosive or ulcerative GERD, healing of

duodenal ulcer, and treatment of

pathological hypersecretory conditions,

including Zollinger-Ellison Syndrome.

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for

AciphexTM (U.S. Patent No. 5,045,552)

from Eisai Co., Ltd., and the Patent and

Trademark Office requested FDA’s

assistance in determining this patent’s

eligibility for patent term restoration. In

a letter dated April 12, 2000, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of AciphexTM

represented the first permitted

commercial marketing or use of the

product. Shortly thereafter, the Patent

and Trademark Office requested that

FDA determine the product’s regulatory

review period.

FDA has determined that the

applicable regulatory review period for

AciphexTM is 2,922 days. Of this time,

2,415 days occurred during the testing

phase of the regulatory review period,

while 507 days occurred during the

approval phase. These periods of time

were derived from the following dates:

1. The date an exemption under

section 505 of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

355) became effective: August 21, 1991.

FDA has verified the applicant’s claim

that the date the investigational new

drug application became effective was

on August 21, 1991.

2. The date the application was

initially submitted with respect to the

human drug product under section 505

of the act: March 31, 1998. FDA has

verified the applicant’s claim that the

new drug application (NDA) for

AciphexTM (NDA 20–973) was initially

submitted on March 31, 1998.

3. The date the application was

approved: August 19, 1999. FDA has

verified the applicant’s claim that NDA

20–973 was approved on August 19,

1999.

This determination of the regulatory

review period establishes the maximum

potential length of a patent extension.

However, the U.S. Patent and

Trademark Office applies several

statutory limitations in its calculations

of the actual period for patent extension.

In its application for patent extension,

this applicant seeks 1,713 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may

submit to the Dockets Management

Branch (address above) written

comments and ask for a redetermination

by May 7, 2001. Furthermore, any

interested person may petition for a

determination regarding whether the

applicant for extension acted with due

diligence during the regulatory review

period by September 4, 2001. To meet

its burden, the petition must contain

sufficient facts to merit an FDA

investigation. (See H. Rept. 857, part 1,

98th Cong., 2d sess., pp. 41–42, 1984.)

Petitions should be in the format

specified in 21 CFR 10.30.

Comments and petitions should be

submitted to the Dockets Management

Branch. Three copies of any information

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Comments

and petitions may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: February 16, 2001.

Jane A. Axelrad,

Associate Director for Policy, Center for Drug

Evaluation and Research.

[FR Doc. 01–5513 Filed 3–6–01; 8:45 am]

BILLING CODE 4160–01–S