Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Notices 27149

and on consultation with industry, FDA

estimates that preparation of reports and

information required by this section

require 5,805 hours (135 hours per

respondent).

3. § 814.84—Reports: 430 Burden Hours

Postapproval requirements described

in § 814.82 (above) require a periodic

report. FDA has determined

respondents meeting the criteria of

§ 814.84 will submit reports on a

periodic basis. As stated previously, the

range of PMAs fitting this category

averaged approximately 43 per year.

These reports have minimal information

requirements. FDA estimates that

respondents will construct their report

and meet their requirements in

approximately 10 hours. This estimate

is based on FDA’s experience and on

consultation with industry. FDA

estimates that the periodic reporting

required by this section take 430 hours.

The total hours for statutory burden is

1,750. This burden estimate was based

on actual real FDA data tracked from

January 1, 1998, to the present, and an

estimate was derived to forecast future

expectations with regard to this

statutory data.

B. Recordkeeping

The recordkeeping burden in this

section involves the maintenance of

records used to trace patients and the

organization and indexing of records

into identifiable files to ensure the

device’s continued safety and

effectiveness. These records would be

required only of those manufacturers

who have an approved PMA and who

had original clinical research in support

of that PMA. For a typical year’s

submissions, 70 percent of the PMAs are

eventually approved and 75 percent of

those have original clinical trial data.

Therefore, approximately 43 PMAs a

year (62 annual submissions times 70

percent) would be subject to these

requirements. Also, because the

requirements apply to all active PMAs,

all holders of active PMA applications

must maintain these records. PMAs

have been required since 1976, and

there are 900 active PMAs that could be

subject to these requirements, based on

actual FDA data. Each study has

approximately 200 subjects, and, at an

average of 5 minutes per subject, there

is a total burden per study of 1,000

minutes, or 17 hours. The aggregate

burden for all 900 holders of approved

original PMAs, therefore, is 15,300

hours (900 approved PMAs with clinical

data x 17 hours per PMA).

The applicant determines which

records should be maintained during

product development to document and/

or substantiate the device’s safety and

effectiveness. Records required by the

current good manufacturing practices

for medical devices regulation (21 CFR

part 820) may be relevant to a PMA

review and may be submitted as part of

an application. In individual instances,

records may be required as conditions to

approval to ensure the device’s

continuing safety and effectiveness.

Dated: May 11, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–12277 Filed 5–15–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00E–1412]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; Uvasorb HA88

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for Uvasorb

HA88 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

that claims that food additive.

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, 301–594–5645.

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 as 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 food additives,

the testing phase begins when a major

health or environmental effects test

involving the food additive begins and

runs until the approval phase begins.

The approval phase starts with the

initial submission of a petition

requesting the issuance of a regulation

for use of the food additive and

continues until FDA grants permission

to market the food additive 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 food additive will include all of the

testing phase and approval phase as

specified in 35 U.S.C. section

156(g)(2)(B).

FDA recently approved for marketing

the food additive Uvasorb HA88.

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for Uvasorb

HA88 (U.S. Patent No. 4,477,615) from

3V Partecipazioni Industriali S.p.A., and

the Patent and Trademark Office

requested FDA’s assistance in

determining this patent’s eligibility for

patent term restoration. In a letter dated

August 4, 2000, FDA advised the Patent

and Trademark Office that this food

additive had undergone a regulatory

review period and that the approval of

Uvasorb HA88 represented the first

permitted commercial marketing or use

of the product. Subsequently, 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

Uvasorb HA88 is 3,482 days. Of this

time, 684 days occurred during the

testing phase of the regulatory review

period, and 2,798 days occurred during

the approval phase. These periods of

time were derived from the following

dates:

1. The date a major health or

environmental effects test (test)

involving this food additive additive

product was begun: November 2, 1989.

FDA has verified the applicant’s claim

that the test was begun on November 2,

1989.

2. The date the petition requesting the

issuance of a regulation for use of the

additive (petition) was initially

27150 Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Notices

submitted with respect to the food

additive product under section 409 of

the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 348): September 16, 1991.

FDA has verified the applicant’s claim

that the petition was initially submitted

on September 16, 1991.

3. The date the petition became

effective: May 14, 1999. FDA has

verified the applicant’s claim that the

regulation for the additive became

effective/commercial marketing was

permitted on May 14, 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 1,827 days of patent

term extension.

Anyone with knowledge that any of

the dates as published are incorrect may

submit to the Dockets Management

Branch (address above) written

comments and ask for a redetermination

by July 16, 2001. Furthermore, any

interested person may petition FDA for

a determination regarding whether the

applicant for extension acted with due

diligence during the regulatory review

period by November 12, 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: March 2, 2001.

Jane A Axelrad,

Associate Director for Policy, Center for Drug

Evaluation and Research.

[FR Doc. 01–12228 Filed 5–15–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0191]

Medical Devices; Global Harmonization

Task Force; Study Group 1; Working

Draft ‘‘Medical Devices Classification;’’

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the draft document

entitled ‘‘Medical Devices

Classification.’’ Study Group 1 of the

Global Harmonization Task Force

(GHTF) has prepared this document on

premarket regulation of medical

devices. This document is intended to

provide information only and represents

a harmonized proposal that may be used

by governments developing or updating

their premarket regulation schemes for

medical devices. This draft document is

not being issued as an FDA guidance.

Elements of the approach set forth in

this document may not be consistent

with current U.S. regulatory

requirements. However, FDA is

publishing the draft at this time to give

the public an opportunity to comment

on the document before the agency

resumes discussions with other

countries. Public comments will help

FDA decide whether and how the

agency can adapt these

recommendations to our own regulatory

requirements.

DATES: Submit written comments

concerning this at any time. FDA must

submit its comments on this draft to

GHTF by July 1, 2001. FDA will

consider any comments that it receives

after it prepares its comments for GHTF

in future discussions with GHTF on this

issue.

ADDRESSES: Submit written comments

on the document to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

See the SUPPLEMENTARY INFORMATION

section for information on electronic

access to the document. Submit written

requests for single copies on a 3.5′′

diskette of the draft document entitled

‘‘Medical Devices Classification’’ to the

Division of Small Manufacturers

Assistance (HFZ–220), Center for

Devices and Radiological Health, Food

and Drug Administration, 1350 Piccard

Dr., Rockville, MD 20850. Send two selfaddressed adhesive labels to assist that

office in processing your request, or fax

your request to 301–443–8818.

FOR FURTHER INFORMATION CONTACT:

Kathy M. Poneleit, Center for Devices

and Radiological Health (HFZ–440),

Food and Drug Administration, 2098

Gaither Rd., Rockville, MD 20850, 301–

594–3084.

SUPPLEMENTARY INFORMATION:

I. Background

FDA has participated in a number of

activities to promote the international

harmonization of regulatory

requirements. The GHTF was

established in 1992 to facilitate medical

device harmonization. Subsequent

meetings have been held on a yearly

basis in various locations throughout

the world. The most recent GHTF

meeting was held in September 2000, in

Ottawa, Canada. The GHTF is a

voluntary consortium of representatives

from medical device regulatory

authorities and trade associations from

around the world, including Canada,

Japan, and the European Union.

The objective of the GHTF is to

encourage harmonization of regulatory

systems for medical devices in order to

facilitate trade while recognizing the

right of participating members to

enforce regulatory requirements

considered most suitable to protect the

public health of their citizens. One of

the ways this objective is achieved is by

identifying and developing areas of

international cooperation that can

reduce differences in systems

established to regulate medical devices.

In an effort to accomplish these

objectives, the GHTF has formed four

study groups to draft documents and

carry on other activities designed to

facilitate global harmonization. This

notice is a result of documents that have

been developed by Study Group 1.

Study Group 1 was formed in January

1993, and was originally tasked with

identifying differences between various

premarket regulatory systems. In 1995,

the group was asked to propose areas of

potential harmonization for premarket

device regulations and offer guidance

that could help lead to harmonization.

As a result of their efforts, this group

has developed the document entitled

‘‘Medical Devices Classification.’’ This

GHTF document suggests some general

guidelines for classification of medical

devices to encourage harmonization. It

recommends that there is a need to

classify medical devices based on their

risk to patients, users, and other

persons; and that there is a benefit for

manufacturers and regulatory

authorities if a globally harmonized

classification system is developed. The