Federal Register / Vol. 63, No. 13 / Wednesday, January 21, 1998 / Notices 3141

Public Health System Reporting

Requirements

This program is not subject to the

Public Health System Reporting

Requirements.

Catalog of Federal Domestic Assistance

Number

The Catalog of Federal Domestic

Assistance number for this program is

93.283.

Other Requirements

Paperwork Reduction Act

Projects that involve the collection of

information from 10 or more individuals

and funded by the cooperative

agreement will be subject to review and

approval by the Office of Management

and Budget (OMB) under the Paperwork

Reduction Act.

Human Subjects

The applicant must comply with the

Department of Health and Human

Services Regulations, 45 CFR part 46,

regarding the protection of human

subjects. Assurances must be provided

to demonstrate that the project will be

subject to initial and continuing review

by an appropriate institutional review

committee. The applicant will be

responsible for providing assurance in

accordance with the appropriate

guidelines and forms provided in the

application kit.

Women, Racial and Ethnic Minorities

It is the policy of the CDC to ensure

that individuals of both sexes and the

various racial and ethnic groups will be

included in CDC-supported research

projects involving human subjects,

whenever feasible and appropriate.

Racial and ethnic groups are those

defined in OMB Directive No. 15 and

include American Indian or Alaska

Native, Asian, Black or African

American, Hispanic or Latino, and

Native Hawaiian or other Pacific

Islander. Applicants shall ensure that

women, racial and ethnic minority

populations are appropriately

represented in applications for research

involving human subjects. Where clear

and compelling rationale exists that

inclusion is inappropriate or not

reasonable, this situation must be

explained as part of the application.

This policy does not apply to research

studies when the investigator cannot

control the race, ethnicity and/or sex of

subjects. Further guidance to this policy

is contained in the Federal Register,

Vol. 60, No. 179, Friday, September 15,

1995, pages 47947–47951 (a copy is

included in the application kit).

Application Submission and Deadline

The original and two copies of the

application, PHS Form 5161–1 (OMB

Number 0937–0189), must be submitted

to Ron Van Duyne, Grants Management

Officer, Attention: Patrick A. Smith,

Grants Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Mailstop E–13,

Room 321, Atlanta, Georgia 30305, on or

before February 23, 1998. 1. Deadline: Applications shall be

considered as meeting the deadline if

they are either: a. Received on or before the deadline

date; or

b. Sent on or before the deadline date

and received in time for submission to

the objective review group. (Applicants

should request a legibly dated U.S.

Postal Service postmark or obtain a

legibly dated receipt from a commercial

carrier or U.S. Postal Service. Private

metered postmarks shall not be

acceptable proof of timely mailing.) 2. Late Applications: Applications

which do not meet the criteria in 1.a. or

1.b. above are considered late

applications. Late applications shall not

be considered in the current

competition for funding and will be

returned to the applicant.

Where To Obtain Additional

Information

To receive additional written

information call 1–888–GRANTS4. You

will be asked to leave your name,

address, and telephone number and will

need to refer to NCEH Announcement

98019. You will receive a complete

program description, information on

application procedures, and application

forms. CDC will not send application

kits by facsimile or express mail. Please refer to announcement number

98019 when requesting information and

submitting an application. If you have questions after reviewing

the contents of all the documents,

business management technical

assistance may be obtained from Patrick

Smith, Grants Management Specialist,

Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, NE.,

Mailstop E–13, Atlanta, Georgia 30305,

telephone (404) 842–6803, Internet:

phs3@cdc.gov. Programmatic technical assistance

may be obtained from Lawrence E.

Posey, Health Studies Branch, Division

of Environmental Health, National

Center for Environmental Health,

Centers for Disease Control and

Prevention (CDC), 1600 Clifton Road,

NE., Mailstop F–46, Atlanta, Georgia

30333, telephone (770) 488–7350,

Internet: lep1@cdc.gov.

Potential applicants may obtain a

copy of ‘‘Healthy People 2000’’ (Full

Report; Stock No. 017–001–00474–0) or

‘‘Healthy People 2000’’ (Summary

Report; Stock No. 017–001–00473–1)

referenced in the INTRODUCTION may be

obtained through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

telephone (202) 512–1800.

This and other CDC announcements

are available through the CDC homepage

on the Internet. The address for the CDC

homepage is: http://www.cdc.gov.

Dated: January 14, 1998.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 98–1327 Filed 1–20–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0531]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request

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 (the PRA).

DATES: Submit written comments on the

collection of information by February

20, 1998.

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: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Margaret R. 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 section 3507 of the

PRA (44 U.S.C. 3507), FDA has

submitted the following proposed
3142 Federal Register / Vol. 63, No. 13 / Wednesday, January 21, 1998 / Notices

collection of information to OMB for

review and clearance.

Exemptions and Variances from the

Performance Standard for Electrode

Lead Wires and Patient Cables

FDA regulations in part 898 (21 CFR

part 898) mandate a performance

standard for electrode lead wires and

patient cables. The purpose of the

performance standard is to prevent

electrocution from the use of

unprotected electrode lead wires and

patient cables with medical devices. To

provide maximum flexibility in

situations where the electrical accidents

can be prevented in other ways, § 898.14

provides that any person subject to the

performance standard may submit a

petition under 21 CFR 10.30 requesting

an exemption or variance from the

standard. The petition must

demonstrate why compliance with the

standard is unnecessary or unfeasible

and what alternate means will be used

to protect the public health. FDA will

use this information to determine

whether granting an exemption is in the

best interests of the public health.

Allowing for exemptions and variances

will provide for flexibility while

assuring public health protection.

Section 898.14 is stayed pending OMB

clearance. FDA will announce the

effective date of § 898.14 in the Federal

Register. Anticipated respondents to

this collection of information are

medical device manufacturers and

distributors, and health care facilities.

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

10.30 50 1 50 10 500

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

Dated: January 8, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–1294 Filed 1–20–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0015]

Medical Devices; Exemptions From

Premarket Notification; Class II

Devices

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is publishing a

list of class II (special controls) devices,

subject to certain limitations, that are

now exempt from the premarket

notification requirements under the

Food and Drug Administration

Modernization Act of 1997 (the

FDAMA). FDA believes that these

exemptions will relieve manufacturers

from the need to submit premarket

notification submissions for these

devices and will enable FDA to redirect

the resources that would be spent on

reviewing such submissions to more

significant public health issues. FDA is

taking this action in order to meet a

requirement of the FDAMA.

DATES: Effective January 21, 1998.

Comments on this notice should be

submitted within 90 days of

publication. The agency will review any

comments submitted within the 90-day

comment period and will consider

whether the list of class II devices that

are exempt from the premarket

notification requirements should be

modified.

ADDRESSES: Submit written comments

on this notice to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Heather S. Rosecrans, Center for Devices

and Radiological Health (HFZ–404),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1190.

SUPPLEMENTARY INFORMATION:

I. Statutory Background

Under section 513 of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360c), FDA must classify

devices into one of three regulatory

classes: Class I, class II, or class III. FDA

classification of a device is determined

by the amount of regulation necessary to

provide a reasonable assurance of safety

and effectiveness. Under the Medical

Device Amendments of 1976 (the 1976

amendments (Pub. L. 94–295)), as

amended by the the Safe Medical

Devices Act of 1990 (the SMDA (Pub. L.

101–629)), devices are to be classified

into class I (general controls) if there is

information showing that the general

controls of the act are sufficient to

assure safety and effectiveness; into

class II (special controls), if general

controls, by themselves, are insufficient

to provide reasonable assurance of

safety and effectiveness, but there is

sufficient information to establish

special controls to provide such

assurance; and into class III (premarket

approval), if there is insufficient

information to support classifying a

device into class I or class II and the

device is a life-sustaining or lifesupporting device or is for a use which

is of substantial importance in

preventing impairment of human

health, or presents a potential

unreasonable risk of illness or injury.

Most generic types of devices that

were on the market before the date of

the 1976 amendments (May 28, 1976)

(generally referred to as preamendments

devices) have been classified by FDA

under the procedures set forth in section

513(c) and (d) of the act through the

issuance of classification regulations

into one of these three regulatory

classes. Devices introduced into

interstate commerce for the first time on

or after May 28, 1976 (generally referred

to as postamendments devices) are

classified through the premarket

notification process under section

510(k) of the act (21 U.S.C. 360(k)).

Section 510(k) of the act and the

implementing regulations, 21 CFR part

807, require persons who intend to

market a new device to submit a

premarket notification report containing

information that allows FDA to

determine whether the new device is

‘‘substantially equivalent’’ within the

meaning of section 513(I) of the act to

a legally marketed device that does not

require premarket approval. Unless

exempted from premarket notification

requirements, persons may not market a

new device, under section 510(k),

unless they receive a substantial

equivalence order from FDA or an order

reclassifying the device into class I or

class II (section 513(I) of the act).

On November 21, 1997, the President

signed into law the FDAMA. Section