32828 Federal Register / Vol. 66, No. 117 / Monday, June 18, 2001 / Notices

In compliance with the requirements

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

Paperwork Reduction Act of 1995, the

Administration for Children and

Families is soliciting public comment

on the specific aspects of the

information collection described above.

Copies of the proposed collection of

information can be obtained and

comments may be forwarded by writing

to the Administration for Children and

Families, Office of Information Services,

370 L’Enfant Promenade, SW.,

Washington, DC 20447, Attn: ACF

Reports Clearance Officer. All requests

should be identified by the title of the

information collection.

The Department specifically requests

comments on: (a) Whether the proposed

collection of information is necessary

for the proper performance of the

functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

the quality, utility, and clarity of the

information to be collected; and (d)

ways to minimize the burden of the

collection of information on

respondents, including through the use

of automated collection techniques or

other forms of information technology.

Consideration will be given to

comments and suggestions submitted

within 60 days of this publication.

Dated: June 12, 2001.

Bob Sargis,

Reports Clearance Officer.

[FR Doc. 01–15202 Filed 6–15–01; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0238]

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

notice announcing that it has received a

petition requesting exemption from the

premarket notification requirements for

the F-Spoon device, a manual

compression device that allows a

radiologist to press on the abdomen

during a fluoroscopic procedure without

exposing his or her hand to the x-ray

beam. The device is classified as an

accessory to the image-intensified

fluoroscopic x-ray system. FDA intends

to expand the exemption to other

fluoroscopic compression devices such

as other types of spoons and

compression paddles. FDA is publishing

this notice in order to obtain comments

on this petition in accordance with

procedures established by the Food and

Drug Administration Modernization Act

of 1997 (FDAMA).

DATES: Submit written comments by

July 18, 2001.

ADDRESSES: Submit written comments

on this notice to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

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 (Public Law 94–295)), as

amended by the Safe Medical Devices

Act of 1990 (the SMDA) (Public Law

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

ensure 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 that 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.

On November 21, 1997, the President

signed into law FDAMA (Public Law

105–115). Section 206 of FDAMA, in

part, added a new section 510(m) to the

act. Section 510(m)(1) of the act requires

FDA, within 60 days after enactment of

FDAMA, to publish in the Federal

Register a list of each type of class II

device that does not require a report

under section 510(k) of the act to

provide reasonable assurance of safety

and effectiveness. Section 510(m) of the

act further provides that a 510(k) will no

longer be required for these devices

upon the date of publication of the list

in the Federal Register. FDA published

that list in the Federal Register of

January 21, 1998 (63 FR 3142). In the

Federal Register of November 3, 1998

(63 FR 59222), FDA published a final

rule codifying these exemptions.

Section 510(m)(2) of the act provides

that, 1 day after date of publication of

the list under section 510(m)(1), FDA

may exempt a device on its own

initiative or upon petition of an

interested person, if FDA determines

that a 510(k) is not necessary to provide

reasonable assurance of the safety and

effectiveness of the device. This section

requires FDA to publish in the Federal

Register a notice of intent to exempt a

device, or of the petition, and to provide

a 30-day comment period. Within 120

days of publication of this document,

FDA must publish in the Federal

Register its final determination

regarding the exemption of the device

that was the subject of the notice. If FDA

fails to respond to a petition under this

section within 180 days of receiving it,

the petition shall be deemed granted.

II. Criteria for Exemption

There are a number of factors FDA

may consider to determine whether a

510(k) is necessary to provide

reasonable assurance of the safety and

effectiveness of a class II device. These

Federal Register / Vol. 66, No. 117 / Monday, June 18, 2001 / Notices 32829

factors are discussed in the guidance the

agency issued on February 19, 1998,

entitled ‘‘Procedures for Class II Device

Exemptions From Premarket

Notification, Guidance for Industry and

CDRH Staff.’’ That guidance can be

obtained through the Internet on the

CDRH home page at http://

frwebgate.access.gpo. gov/cgi-bin/

leaving.cgi? from=leavingFR.html&log=

linklog&to=http:// www.fda.gov/cdrh or

by facsimile through CDRH Facts-onDemand at 1–800–899–0381 or 301–

827–0111. Press 1 to enter the system.

At the second voice prompt press 1 to

order a document. Enter the document

number (159) followed by the pound

sign (#). Follow the remaining voice

prompts to complete the request.

III. Petition

FDA received the following petition

requesting an exemption from

premarket notification for a class II

device: the F-Spoon device, a manual

compression device that allows a

radiologist to press on the abdomen

during a fluoroscopic procedure without

exposing his or her hand to the x-ray

beam. The device is classified as an

accessory to the image-intensified

fluoroscopic x-ray system (21 CFR

892.1650). FDA is expanding the generic

type of device being considered for

exemption to other fluoroscopic

compression devices such as other types

of spoons and compression paddles.

IV. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

petition by July 18, 2001. Two copies of

any comments 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. The petition and received

comments may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: June 4, 2001.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 01–15198 Filed 6–15–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Final Notice on Increasing Income

Levels Used To Identify a ‘‘LowIncome’’ Family and Announcement of

New Annual ‘‘Low-Income’’ Levels for

Various Health Professions and

Nursing Programs Included in Titles VII

and VIII of the Public Health Service

Act

AGENCY: Health Resources and Services

Administration, HHS.

ACTION: Notice.

SUMMARY: This notice provides the

Department’s response to comments on

increasing low-income levels and

announces the new ‘‘low-income’’ levels

for various programs included in titles

VII and VIII of the Public Health Service

(PHS) Act, which use the U.S. Bureau of

the Census ‘‘low-income’’ levels to

determine eligibility for program

participation. The Department

periodically publishes in the Federal

Register low-income levels used to

determine eligibility for grants and

cooperative agreements to institutions

providing training for (1) disadvantaged

individuals, (2) individuals from a

disadvantaged background, or (3)

individuals from ‘‘low-income’’

families.

SUPPLEMENTARY INFORMATION:

This notice announces the proposed

increase in income levels intended for

use in determining eligibility for

participation in the following programs:

Advanced Education Nursing (section

811)

Allied Health Special Projects (section

755)

Basic Nurse Education and Practice

(section 831)

Dental Public Health (section 768)

Faculty Loan Repayment and Minority

Faculty Fellowship Program (section

738)

General and Pediatric Dentistry (section

747)

Health Administration Traineeships and

Special Projects (section 769)

Health Careers Opportunity Program

(section 739)

Loans to Disadvantaged Students

(section 724)

Physician Assistant Training (section

747)

Primary Care Residency Training

(section 747)

Public Health Traineeships (section 767)

Quentin N. Burdick Program for Rural

Interdisciplinary Training (section

754)

Residency Training in Preventive

Medicine (section 768)

Scholarships for Disadvantaged

Students (section 737)

Public Health Training Centers (section

766)

Nursing Workforce Diversity (section

821)

These programs generally award

grants to accredited schools of

medicine, osteopathic medicine, public

health, dentistry, veterinary medicine,

optometry, pharmacy, allied health,

podiatric medicine, nursing,

chiropractic, public or private nonprofit

schools which offer graduate programs

in behavioral health and mental health

practice, and other public or private

nonprofit health or education entities to

assist the disadvantaged to enter and

graduate from health professions and

nursing schools. Some programs

provide for the repayment of health

professions or nursing education loans

for disadvantaged students.

Response to Comments

The Department published a notice in

the Federal Register on March 30, 2001

(66 FR 17433) requesting public

comments on increasing income levels

used to identify a ‘‘low-income’’ family

for the purpose of providing training in

the various health professions and

nursing programs included in titles VII

and VIII of the PHS Act. The

Department received five letters. Each

commenter supported the new formula

that increases income levels used to

identify a ‘‘low-income’’ family.

Low-Income Levels

The Secretary defines a ‘‘low-income’’

family for programs included in titles

VII and VIII of the PHS Act as having

an annual income that does not exceed

200 percent of the Department’s poverty

guidelines. The Department’s poverty

guidelines are based on poverty

thresholds published by the U.S. Bureau

of the Census, adjusted annually for

changes in the Consumer Price Index.

The Secretary annually adjusts the

low-income levels based on the

Department’s poverty guidelines and

makes them available to persons

responsible for administering the

applicable programs. The following

income figures will be used for health

professions and nursing grant

applications requesting FY 2002

funding.