Federal Register / Vol. 66, No. 117 / Monday, June 18, 2001 / Notices 32827

Dated: June 11, 2001.

Chuck Gollmar,

Acting Associate Director for Policy,

Planning, and Evaluation, Centers for Disease

Control and Prevention.

[FR Doc. 01–15357 Filed 6–15–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[30DAY–32–01]

Agency Forms Undergoing Paperwork

Reduction Act Review

The Centers for Disease Control and

Prevention (CDC) publishes a list of

information collection requests under

review by the Office of Management and

Budget (OMB) in compliance with the

Paperwork Reduction Act (44 U.S.C.

chapter 35). To request a copy of these

requests, call the CDC Reports Clearance

Officer at (404) 639–7090. Send written

comments to CDC, Desk Officer; Human

Resources and Housing Branch, New

Executive Office Building, Room 10235;

Washington, DC 20503. Written

comments should be received within 30

days of this notice.

Proposed Project: National Survey of

STD Services Provided to U.S. College

Students—New—The National Center

for HIV, STD, and TB Prevention

(NCHSTP), Centers for Disease Control

and Prevention (CDC) plans to conduct

a survey of a sample of U.S. colleges

asking about health services available to

students with focus on sexually

transmitted disease (STD) testing and

management. The sample shall include

a broad range of colleges including 2

and 4 year, public and private, and rural

and urban colleges to determine under

what conditions, for which STDs, and

how colleges educate about STDs,

conduct testing and provide partner

management.

STDs have a large economic and

health impact throughout the United

States. Most college students are within

the age range with the highest rates for

STDs (15–24 year olds). Chlamydia

trachomatis is the most frequently

reported infectious disease in the

United States with prevalence rates of

4% to 18% in 16–24 year old women.

Infections with Chlamydia trachomatis

can result in pelvic inflammatory

disease and infertility. Many STDs

increase the risk of HIV transmission

and acquisition. Genital infections with

herpes simplex virus, human

papillomavirus, and Trichomonas

vaginalis have been reported at

increasing rates over the last 10 years.

This national survey will provide data

that will broaden the scientific

knowledge related to STD services and

management available to students at

U.S. colleges. The survey is intended to

(a) describe health insurance policies of

colleges; (b) describe preventive services

such as health education and condom

availability at colleges; (c) identify

characteristics of student health centers

including staffing, type of care, and

number of students seen; (d) identify

possible obstacles to accessing STD

services; (e) describe which STDs are

being tested for and what testing criteria

are applied; and (f) describe current

partner services including partner

notification practices and use of partnerdelivered therapy. The total response

burden is estimated at 455 hours.

Respondents Number of respondents

Number of response per respondent

(in hours)

Average burden per response

(in hours)

Health Service Manager .............................................................................................................. 455 1 30/60

Chief Administrative Officer ......................................................................................................... 455 1 30/60

Dated: June 11, 2001.

Chuck Gollmar,

Acting Associate Direct for Policy, Planning,

and Evaluation, Centers for Disease Control

and Prevention.

[FR Doc. 01–15358 Filed 6–15–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Proposed Information Collection

Activity; Comment Request

Proposed Projects

Title: State High Performance Bonus

System (HPBS) Transmission File

Layouts for HPBS Work Measures

OMB No. New Collection.

Description: The purpose of this

collection is to obtain data upon which

to base the computation for measuring

State performance in meeting the

legislative goals of TANF as specified in

section 403(a)(4) of the Social Security

Act and 45 CFR Part 270. Specifically,

DHHS will use the data to award the

portion of the bonus that rewards States

for their success in moving TANF

recipients from welfare to work. This

information collection will replace

Form ACF–200 in FY 2002 (Bonus Year

2002). States will not be required to

submit this information unless they

elect to compete on a work measure for

the TANF High Performance Bonus

awards.

Respondents: Respondents may

include any of the 50 States, Guam,

Puerto Rico, and the Virgin Islands.

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents

Number of

responses

per respondent

Average burden hours

per response

Total burden

hours

State High Performance Bonus System (HPBS) Transmission File Layouts

for HPBS Work Measures ............................................................................ 54 2 16 1,728

Estimated Total Annual Burden Hours ..................................................... ........................ ........................ ........................ 1,728

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