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