25492 Federal Register / Vol. 65, No. 85 / Tuesday, May 2, 2000 / Notices

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

a voluntary consumer survey about food

safety.

DATES: Submit written comments on the

collection of information by July 3,

2000.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. All comments should be

identified with the docket number

found in brackets in the heading of this

document.

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: Under the

PRA (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information,

including each proposed extension of an

existing collection of information,

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information set forth in this document.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Food Safety Survey (OMB Control

Number 0910–0345)—Extension

Under section 903(b)(2) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

393(b)(2)), FDA is authorized to conduct

research relating to foods and to

conduct educational and public

information programs relating to the

safety of the nation’s food supply. FDA

is planning to conduct a consumer

survey about food safety under this

authority. The food safety survey will

provide information about consumers’

food safety awareness, knowledge,

concerns, and practices. A nationally

representative sample of 2,000 adults in

households with telephones and

cooking facilities will be selected at

random and interviewed by telephone.

Participation will be voluntary. Detailed

information will be obtained about risk

perception, perceived sources of food

contamination, knowledge of particular

microorganisms, safe care label use,

food handling practices, consumption of

raw foods from animals, information

sources, and perceived foodborne

illness and food allergy experience.

Most of the questions to be asked are

identical to ones asked in the 1998 Food

Safety Survey. Because of recent

national consumer education campaigns

about food safety and the large amount

of media attention to food safety issues

in the past few years, consumer

attitudes, knowledge, and practices are

likely to have changed greatly since the

1998 survey. FDA needs current

information to support consumer

education programs and regulatory

development. In addition, FDA needs

information from the consumer

perspective on several new areas related

to food safety. New areas include

attitudes toward genetically modified

foods, irradiated foods, and organically

grown foods; handling of leftovers and

foods associated with listeria

monocytogenes contamination; washing

practices for fresh fruits and vegetables;

reaction to warning statements on

unpasteurized juice and to handling

statements on eggs; disability status; and

perceived food allergy.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of respondents

Annual

frequency per

response

Total annual

responses

Hours per

response Total hours

2,000 1 2,000 .5 1,000

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

The burden estimate is based on

FDA’s experience with the 1998 survey

mentioned in the previous paragraph.

Dated: April 26, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–10839 Filed 5–1–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–2117–N]

Medicare, Medicaid, and CLIA

Programs; Clinical Laboratory

Improvement Amendments of 1988

Removal of Exemption of Laboratories

in the State of Oregon

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: This notice removes the

Clinical Laboratory Improvement

Amendments of 1988 (CLIA) exemption

previously granted to laboratories

within the State of Oregon. Section

353(p) of the Public Health Service Act

grants us the authority to exempt from

CLIA clinical laboratories located in a

State that enacts and implements laws

with requirements equal to or more

stringent than the CLIA requirements.

EFFECTIVE DATE: The provisions of this

notice are effective on May 2, 2000.

FOR FURTHER INFORMATION CALL: Judith

Yost, (410) 786–3531.

SUPPLEMENTARY INFORMATION:

Federal Register / Vol. 65, No. 85 / Tuesday, May 2, 2000 / Notices 25493

I. Background

Section 353 of the Public Health

Service Act (PHSA), as amended by the

Clinical Laboratory Improvement Act of

1988 (CLIA), requires laboratories that

perform tests on human specimens to

meet the requirements we establish.

Laboratories that also request to be paid

for services furnished to Medicare

beneficiaries must meet the

requirements of section 353 of the

PHSA, as stipulated in section 6141 of

the Omnibus Budget Reconciliation Act

of 1989, Public Law 101–239. Subject to

specific exceptions, laboratories must

have a current and valid CLIA certificate

to test human specimens to receive

payment from the Medicare or Medicaid

programs. Regulations implementing

section 353 of the PHSA are contained

in 42 CFR part 493 (Laboratory

Requirements).

Section 353(p) of the PHSA authorizes

us to exempt from the CLIA

requirements laboratories located in a

State that applies laboratory licensure

requirements equal to or more stringent

than those of CLIA. Part 493, subpart E

(Accreditation by a Private, Nonprofit

Accreditation Organization or

Exemption Under an Approved State

Laboratory Program) implements section

353(p) of the PHSA.

Section 493.553 sets forth the

information that must be submitted with

a State licensure program’s application

for CLIA approved status. Sections

493.551 and 493.553 provide that we

may exempt from CLIA requirements,

for a period not to exceed 6 years, State

licensed or approved laboratories in a

State if the State licensure program

meets specific conditions. After that

time, the State must re-apply to us for

continued exemption. Section

493.575(f) provides that we will publish

a notice in the Federal Register

containing justification for removing the

CLIA approved status of a State

licensure program.

II. CLIA Exemption of Licensed Oregon

State Laboratories

The State of Oregon’s period of

exemption began on June 13, 1996, with

the publication of our notice entitled,

‘‘Medicare, Medicaid, and CLIA

Programs; Clinical Laboratory

Improvement Amendments of 1988

Exemption of Laboratories in the State

of Oregon,’’ in the Federal Register (61

FR 30072). That exemption period

expired December 31, 1999. The State of

Oregon has formally notified us that it

will not be re-applying for exemption of

its licensed laboratories located within

the State. Without an application for

continued approval of Oregon’s

licensure program, we cannot continue

to exempt Oregon laboratories from the

CLIA requirement.

III. Removal of CLIA Approval of the

State of Oregon’s Laboratory Licensure

Program

The nearly 41⁄2-year exemption period

that we granted to laboratories in the

State of Oregon expired on December

31, 1999. Therefore, we are removing

the CLIA approved status of Oregon’s

licensure program effective May 2, 2000.

Authority: Section 353 of the Public Health

Service Act (42 U.S.C. 263a).

Dated: March 3, 2000.

Nancy-Ann Min DeParle,

Administrator, Health Care Financing

Administration.

[FR Doc. 00–10882 Filed 5–1–00; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–1134–N]

Medicare Program; Open Public

Meeting on May 18, 2000 to Discuss

the Coverage of Drugs and Biologicals

that Cannot be Self-Administered

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice of meeting.

SUMMARY: This notice announces a

public meeting to obtain input on the

Medicare program policy for drugs and

biologicals which cannot be selfadministered and are furnished as an

incident to a physician’s professional

service. The meeting will provide an

opportunity for providers, suppliers,

beneficiaries, beneficiary advocates, and

other interested parties to furnish

information and raise issues about the

program’s policy concerning the selfadministration of drugs and biologicals.

DATES: The meeting is scheduled for

May 18, 2000 from 9:30 a.m. until 3:30

p.m.

ADDRESSES: The meeting will be held at

the Health Care Financing

Administration headquarters, in the

auditorium, 7500 Security Boulevard,

Baltimore, Maryland 21244–1850.

FOR FURTHER INFORMATION CONTACT:

Heidi Adams, (410) 786–1620.

SUPPLEMENTARY INFORMATION: 

Background

As suggested by the report language

accompanying section 219 of the

Department of Health and Human

Services Appropriations Act, 2000

(Public Law 106–113), we are

announcing the first of two ‘‘town hall’’

meetings to discuss our current policy

regarding Medicare coverage of drugs

and biologicals which cannot be selfadministered and are furnished as an

incident to a physician’s professional

service.

The purpose of the May 18th meeting

is to obtain focused input on how this

statutory provision should reasonably

be interpreted; how the evolution of

medical technology has affected

physician practice in selfadministration; how different

interpretations of the provision might

affect considerations of fairness and

equity among beneficiary populations;

and how physician practice may be

affected by different interpretations. Due

to time constraints and the need to focus

on the above topics, the agency is

unable to undertake a discussion of

options or ideas that require a statutory

change.

The format of the meeting will

include an introduction and opening

statements by the administration,

followed by 15-minute presentations by

panel members. These statements will

discuss the historical development of

the ‘‘self-administered’’ issue and will

examine the current policy and

information that has been gathered on

the issue. Following the short

presentations, the meeting will move to

an open dialogue.

Individuals interested in making a

presentation at the meeting or who need

special arrangements should contact

Heidi Adams at (410) 786–1620 or via

e-mail at HAdams@hcfa.gov no later

than May 7, 2000. Individuals should

identify the topics they wish to discuss

during their presentation. Because of

time constraints, only a limited number

of individuals will be able to make

presentations. In an effort to assure that

all viewpoints are represented, we will

notify participants who are selected to

make a presentation. We will not assign

presentation times until after May 7,

2000.

While the meeting is open to the

public, attendance is limited to space

available. Individuals must register in

advance as described below.

Registration

The Center for Health Plans and

Providers will handle registration for

the meeting. Individuals may register by

sending a fax to the attention of Heidi

Adams at (410) 786–0169. At the time

of registration, please provide your

name, address, telephone number,

company name and fax number.

Receipt of your fax will constitute

confirmation of your registration.