27146 Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Notices

Type of respondents Number. of

respondents

Number. of

responses per

respondent

Average

burden per

response

(in hours)

Total burden

in hours

Morgantown community members ................................................................... 200 1 90/60 300

Forklift operators .............................................................................................. 200 1 90/60 300

Various occupational groups ........................................................................... 400 1 90/60 600

Total ...................................................................................................... 800 ........................ ........................ 1,200

Dated: May 9, 2001.

Nancy Cheal,

Acting Associate Director for Policy, Planning

and Evaluation, Centers for Disease Control

and Prevention.

[FR Doc. 01–12372 Filed 5–15–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[30DAY–30–01]

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

Survey of User Satisfaction with

National Health Care Survey Data—

New—National Center for Health

Statistics (NCHS), Centers for Disease

Control and Prevention (CDC). This

Survey of User Satisfaction with

National Health Care Survey Data is

needed to provide current information

on the use and usefulness of the variety

of data products describing health care

delivery systems in the United States.

The National Health Care Survey

comprises several component surveys:

National Hospital Discharge Survey,

National Nursing Home Survey,

National Home and Hospice Care

Survey, National Ambulatory Medical

Care Survey, National Hospital

Ambulatory Medical Care Survey and

occasional other similar surveys when

funded, such as the National Health

Provider Inventory. Unlike other

national surveys conducted by CDC

National Center for Health Statistics, the

National Health Care surveys address

the health care delivery systems rather

than the vital statistics, health status,

health-related behavior, and access to

care experienced by individuals and

households who are consumers of the

health care delivery systems. Between

the years of 1968 and 1984, a number

of surveys were conducted to learn more

about National Center for Health

Statistics (NCHS) data users and to

assess the quality of data dissemination

activities conducted by NCHS. Studies

focusing solely on user satisfaction with

National Health Care Survey data

products have not been conducted since

1984. We need current specific

information on how well our users’

needs are being met, how to improve

our data products, and how to serve

current non-users of our data who are,

nonetheless, potential users. Our data

products consist mainly of published

reports and web-published data sets

including Data Highlights and E-Stats.

Our published reports include Advance

Data Reports, a newsletter-like summary

of more detailed analyses to be

published later, and Series Reports,

which are in-depth analyses of specific

topics addressed by our collected data.

As the contractor for this project, CHPS

Consulting will conduct a multi-mode

survey using a web-based survey for

those in the sample for whom an email

address is available and a mail survey

for those without an email address.

Current users will be asked questions

about what publications they use, how

they use them, and their opinion of the

timeliness, accessibility, format, and

quality of the data publications. Nonusers will be asked why they do not use

our publications, their current sources

of health care provider data, and how

we improve data products to meet their

needs. Our target population will

include the following groups of persons:

researchers, educators, health facility

administrators, practitioners, and

policymakers. Our goal for this survey is

to obtain 600 returned surveys with an

approximately equal number of returned

surveys from users and non-users. The

total annualized burden is 75 hours.

Respondents Number of

respondents

Number of

responses per

respondent

Avg. burden per

response (in hrs.)

Users .......................................................................................................................... 300 1 10/60

Non-Users .................................................................................................................. 300 1 5/60

Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Notices 27147

Dated: May 9, 2001.

Nancy Cheal,

Acting Associate Director for Policy, Planning

and Evaluation, Centers for Disease Control

and Prevention.

[FR Doc. 01–12373 Filed 5–15–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

[Program Announcement No. ACYF/HS

2001–07A]

Fiscal Year 2000 Discretionary

Announcement for Head Start Family

Worker Training and Credentialing

Initiative; Availability of Funds and

Request for Applications

AGENCY: Administration for Children,

Youth, and Families, ACF, DHHS.

ACTION: Notice; Correction.

SUMMARY: This document contains a

correction to the Notice that was

published in the Federal Register on

Thursday, May 3, 2001, Part II. On page

22294, first column (Item D), the August

1, 2001 closing date for the submission

of applications is incorrect. The correct

closing time and date for receipt of

applications is 5 p.m. EDT on July 2,

2001.

FOR FURTHER INFORMATION CONTACT: The

ACYF Operation Center at 1–800–351–

2293 for referral to the appropriate

contact person in ACYF for

programmatic questions or send an email to hs@icgnet.com

Dated: May 10, 2001.

James A. Harrell,

Acting Commissioner, Administration on

Children, Youth and Families.

[FR Doc. 01–12283 Filed 5–15–01; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0050]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Premarket

Approval of Medical Devices

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.

DATES: Submit written comments on the

collection of information by June 15,

2001.

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: Wendy

Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION:

I. Background

In compliance with 44 U.S.C. 3507,

FDA has submitted the following

proposed collection of information to

OMB for review and clearance.

Premarket Approval of Medical

Devices—21 CFR Part 814 (OMB

Control No. 0910–0231)—Extension

Section 515 of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

360(e)) sets forth the requirements for

premarket approval of certain class III

medical devices. Class III devices are

either preamendments devices that have

been classified into class III,

postamendments devices that are not

substantially equivalent to a

preamendments device, or transitional

devices. Class III devices are devices

such as implants, life sustaining or life

supporting devices, or devices which

otherwise present a potentially

unreasonable risk of illness or injury, or

for which are of substantial importance

in preventing impairment of human

health. Most premarket approval

applications (PMAs) are for

postamendments class III devices.

Under section 515 of the act, an

application must contain several pieces

of information including full reports of

all information concerning

investigations showing whether the

device is reasonably safe and effective.

The application should also include a

statement of components, ingredients,

and properties and of the principle or

principles of operation of such a device

and should also include a full

description of the methods used in, and

the facilities and controls used for the

manufacture and processing of the

device; and labeling specimens.

The implementing regulations,

contained in part 814 (21 CFR part 814),

further specify the contents of a PMA

for a class III medical device and the

criteria FDA employs in approving,

denying, or withdrawing approval of a

PMA and supplements to PMAs. The

regulation’s purpose is to establish an

efficient and thorough procedure for

FDA’s review of PMAs and supplements

to PMAs for certain class III (premarket

approval) medical devices. The

regulations contained in part 814

facilitate the approval of PMAs and

supplements to PMAs for devices that

have been shown to be reasonably safe

and effective and otherwise meet the

statutory criteria for approval. The

regulations also ensure the disapproval

of PMAs and supplements to PMAs for

devices that have not been shown to be

reasonably safe and effective and that do

not otherwise meet the statutory criteria

for approval.

The Food and Drug Modernization

Act of 1997 (FDAMA) (Public Law 105–

115) was enacted on November 21,

1997, to implement revisions to the act

by streamlining the process of bringing

safe and effective drugs, medical

devices, and other therapies to the U.S.

market. Several provisions of this act

affect the PMA process, such as section

515(d)(6) of the act. This section

provided that PMA supplements were

required for all device changes that

affect safety and effectiveness of a

device unless such changes are

modifications to manufacturing

procedures or method of manufacture.

This type of manufacturing change

requires a 30-day notice, or where FDA

finds such notice inadequate, a 135-day

PMA supplement.

To make the PMA process more

efficient, FDA has in the past 3 years

made changes to the PMA program

based on comments received, has

complied with changes to the program

mandated by FDAMA and has worked

towards completion of its PMA

reinvention efforts.

Respondents to this information

collection are persons filing a PMA

application or a PMA supplement with

FDA for approval of certain class III

medical devices. Part 814 defines a

person as any individual, partnership,

corporation, association, scientific or

academic establishment, government

agency or organizational unit, or other

legal entity. These respondents include

entities meeting the definition of

manufacturers such as manufacturers of

commercial medical devices in

distribution prior to May 28, 1976 (the

enactment date of the Medical Device

Amendments). Additionally, hospitals

that reuse single use devices (SUDs) are