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

Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Notices 27151

classification framework presumes that

the risk presented by a particular device

depends on its intended purpose and

the effectiveness of the risk management

techniques applied during the design,

manufacture, and use of that device.

The document also suggests that the

regulatory controls applied should be

proportional to the level of risk

associated with a medical device and

should increase with the associated

degree of risk presented by the medical

device. The GHTF document suggests

four global classifications of devices.

This document also presents a

decision tree logic that may help

regulatory authorities develop different

parameters that might be used to

classify specific devices.

When FDA discusses draft documents

with representatives of other countries,

we seek public comment on the

resulting documents. We believe that it

is important to publish draft documents

for comment at the same time as other

countries so we may review the public

comments and resume discussions in a

timely manner. Because other countries

do not follow our good guidance

practices (GGPs), we do not require draft

documents that result from international

discussions to comply with the format

requirements of our GGP regulation. The

GGP regulation does require that any

final FDA guidance that results from

international discussions will comply

with the GGP regulation.

II. Electronic Access

In order to receive ‘‘Medical Devices

Classification’’ via your fax machine,

call the CDRH Facts-On-Demand system

at 800–899–0381 or 301–827–0111 from

a touch-tone telephone. Press 1 to enter

the system. At the second voice prompt

press 1 to order a document. Enter the

document number (1327) followed by

the pound sign (#). Follow the

remaining voice prompts to complete

your request.

Persons interested in obtaining a copy

of the draft document may also do so

using the Internet. CDRH maintains an

entry on the Internet for easy access to

information including text, graphics,

and files that may be downloaded to a

personal computer with Internet access.

Updated on a regular basis, the CDRH

home page includes the civil money

penalty guidance documents package,

device safety alerts, Federal Register

reprints, information on premarket

submissions (including lists of approved

applications and manufacturers’

addresses), small manufacturers’

assistance, information on video

conferencing and electronic

submissions, Mammography Matters,

and other device-oriented information.

The CDRH home page may be accessed

at http://www.fda.gov/cdrh.

III. Comments

Interested persons may, at any time,

submit to the Dockets Management

Branch (address above) written

comments regarding this draft guidance.

FDA must submit its written comments

to the GHTF by July 1, 2001. FDA will

consider any comments that it receives

in a timely manner, while preparing

those comments. FDA will consider any

public comments that it receives after

preparation of its comments to GHTF in

future discussions on this issue. Submit

two copies of any comments, 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. The guidance

document and received comments may

be seen in the Dockets Management

Branch between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: May 7, 2001.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 01–12226 Filed 5–15–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–10041]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, HHS.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: New collection; Title of

Information Collection: Long Term Care

Awareness Project; Form No.: HCFA–

10041 (OMB# 0938–NEW); Use: HCFA

needs to collect data to pilot test a

national campaign to educate current

and future Medicare beneficiaries and

their families about long term health

care needs, as requested in the Clinton

Fiscal Year 2000 Budget, to design and

implement a nationwide campaign.

Respondents will be from two groups:

55–70 year-olds and 18–64 years old

persons with disability; Frequency:

Quarterly; Affected Public: Individuals

or households; Number of Respondents:

7,800; Total Annual Responses: 3,900;

Total Annual Hours: 800.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Information Services,

Security and Standards Group, Division

of HCFA Enterprise Standards,

Attention: Julie Brown, Attn. 10041,

Room N2–14–26, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850.

Dated: May 8, 2001.

Julie Brown,

Acting Reports Clearance Officer, Security

and Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 01–12342 Filed 5–15–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Center for Scientific Review; Notice of

Closed Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meeting.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,