68152 Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Notices

to assist that office in processing your

request, or fax your request to 301–443–

8818. Submit written comments on the

draft guidance to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

Comments should be identified with the

docket number found in brackets in the

heading of this document. See the

SUPPLEMENTARY INFORMATION section for

information on electronic access to the

guidance.

FOR FURTHER INFORMATION CONTACT: Jean

M. Cooper, Center for Devices and

Radiological Health (HFZ–440), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1243.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of December

30, 1998 (63 FR 71932), FDA announced

the availability for comment of a draft

guidance entitled ‘‘Guidance for

Premarket Submissions for Tests for

Screening Drugs of Abuse to Be Used By

The Consumer.’’ FDA invited interested

persons to comment on the draft

guidance by March 30, 1999. FDA is

replacing that draft guidance document

with a new draft guidance entitled

‘‘Over the Counter (OTC) Screening

Tests for Drugs of Abuse: Guidance for

Premarket Notifications.’’ This second

draft guidance provides more detailed

recommendations on what to include in

a premarket notification for this device,

and includes new information

addressing the relevant least

burdensome provisions of the Food and

Drug Administration Modernization Act

of 1997.

The draft guidance recommends

including in the premarket notification:

• OTC studies showing correct results

at concentrations 50 percent above and

50 percent below the cutoff;

• Description of the patient reporting

format;

• Studies on the stability of the

device; and

• The confirmatory laboratory’s

credentials.

The draft guidance also seeks public

comment on premarket review of OTC

alcohol tests.

The draft guidance also addresses

labeling for these devices.

As part of its efforts to ensure that

FDA considers the least burdensome

path to market, the agency has drafted

the guidance to:

• Clarify that OTC screening tests for

drugs of abuse ordinarily will be

reviewed as a premarket notification;

• Suggest the use of spiked urine

samples instead of urine obtained from

individuals using drugs; and

• Suggest combining drugs in these

spiked urine samples in order to reduce

the number of samples tested.

II. Significance of Guidance

This draft guidance represents the

agency’s current thinking on

submissions for OTC screening tests for

drugs of abuse. It does not create or

confer any rights for or on any person

and does not operate to bind FDA or the

public. An alternative approach may be

used if such approach satisfies the

applicable statute, regulations, or both.

The agency has adopted good

guidance practices (GGP’s), and

published the final rule, which set forth

the agency’s policies and procedures for

the development, issuance, and use of

guidance documents (65 FR 56468,

September 19, 2000). This guidance

document is issued as a Level 1

guidance consistent with the GGP’s.

III. Electronic Access

In order to receive the draft guidance

entitled ‘‘Over the Counter (OTC)

Screening Tests for Drugs of Abuse:

Guidance for Premarket Notifications’’

via your fax machine, call the CDRH

Facts-On-Demand system at 800–899–

0381 or 301–827–0111 from a touchtone telephone. Press 1 to enter the

system. At the second voice prompt

press 1 to order a document. Enter the

document number (2209) followed by

the pound sign (#). Follow the

remaining voice prompts to complete

your request.

Persons interested in obtaining a copy

of the guidance may also do so using the

Internet. The Center for Devices and

Radiological Health (CDRH) maintains

an entry on the Internet for easy access

to information including text, graphics,

and files that may be downloaded to a

personal computer with access to the

Internet. Updated on a regular basis, the

CDRH home page includes the civil

money penalty guidance documents

package, device safety alerts, Federal

Register reprints, information on

premarket submissions (including lists

of approved applications and

manufacturers’ addresses), small

manufacturers’ assistance, information

on video conferencing and electronic

submissions, mammography matters,

and other device-oriented information.

The CDRH home page may be accessed

at http://www.fda.gov/cdrh. ‘‘Over the

Counter (OTC) Screening Tests for

Drugs of Abuse: Guidance for Premarket

Notifications’’ is available at http://

www.fda.gov/cdrh/ode/guidance/

2209.pdf.

IV. Comments

Interested persons may submit to

Dockets Management Branch (address

above) written comments regarding this

draft guidance by February 12, 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 draft guidance and

received comments may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: November 2, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–29109 Filed 11–8–00; 4:21 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1587]

Medical Devices Draft Guidance on

Guidance for Prescription Use Drugs

of Abuse Assays Premarket

Notifications; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the draft guidance

entitled ‘‘Guidance for Prescription Use

Drugs of Abuse Assays Premarket

Notifications.’’ FDA is issuing this

guidance to express the general

principles FDA applies in evaluating

premarket notifications (510(k)s) for

prescription use drugs of abuse assays.

The principles described in this draft

guidance document apply only to in

vitro diagnostic (IVD) submissions for

510(k) clearance for these devices. This

draft guidance is neither final nor in

effect at this time.

DATES: Submit written comments on the

draft guidance by February 12, 2001.

ADDRESSES: Submit written requests for

single copies on a 3.5′′ diskette of the

draft guidance entitled ‘‘Guidance for

Prescription Use Drugs of Abuse Assays

Premarket Notifications’’ to the Division

of Small Manufacturers Assistance

(HFZ–220), Center for Devices and

Radiological Health, Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850. Send two selfaddressed adhesive labels to assist that

office in processing your request, or fax

Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Notices 68153

your request to 301–443–8818. Submit

written comments on the draft guidance

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Comments

should be identified with the docket

number found in brackets in the

heading of this document. See the

SUPPLEMENTARY INFORMATION section for

information on electronic access to the

draft guidance.

FOR FURTHER INFORMATION CONTACT: Jean

M. Cooper, Center for Devices and

Radiological Health (HFZ–440), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1243.

SUPPLEMENTARY INFORMATION:

I. Background

This draft guidance recommends data

and labeling that manufacturers should

submit in support of substantial

equivalence for prescription use drugs

of abuse assays. The recommendations

and general principles in this draft

guidance are provided to assist

manufacturers in the preparation of

premarket notifications (510(k)s) for

these devices. This document will

supersede the document, ‘‘Review

Criteria for Assessment of In Vitro

Diagnostic Devices for Drugs of Abuse

Assays Using Various Methodologies,’’

August 31, 1995. This draft guidance

explains the types of studies to conduct

and how to present the study data in

greater detail than the document it is

replacing.

II. Significance of Guidance

This draft guidance represents the

agency’s current thinking regarding data

and labeling for prescription use drugs

of abuse device submissions for 510(k)

clearance. It does not create or confer

any rights for or on any person and does

not operate to bind FDA or the public.

An alternative approach may be used if

such approach satisfies the applicable

statute, regulations, or both.

The agency has adopted good

guidance practices (GGP’s) and

published the final rule, which set forth

the agency’s regulations for the

development, issuance, and use of

guidance documents (65 FR 56468,

September 19, 2000). This guidance

document is issued as a Level 1 draft

guidance consistent with the GGP’s.

III. Electronic Access

In order to receive the draft guidance

entitled ‘‘Guidance for Prescription Use

Drugs of Abuse Assays Premarket

Notifications’’ via your fax machine, call

the CDRH Facts-On-Demand system at

800–899–0381 or 301–827–0111 from a

touch-tone telephone. Press 1 to enter

the system. At the second voice prompt

press 1 to order a document. Enter the

document number (152) followed by the

pound sign (#). Follow the remaining

voice prompts to complete your request.

Persons interested in obtaining a copy

of the guidance may also do so using the

Internet. The Center for Devices and

Radiological Health (CDRH) maintains

an entry on the Internet for easy access

to information including text, graphics,

and files that may be downloaded to a

personal computer with access to the

Internet. Updated on a regular basis, the

CDRH home page includes the civil

money penalty guidance documents

package, device safety alerts, Federal

Register reprints, information on

premarket submissions (including lists

of approved applications and

manufacturers’ addresses), small

manufacturers’ assistance, information

on video conferencing and electronic

submissions, mammography matters,

and other device-oriented information.

The CDRH home page may be accessed

at http://www.fda.gov/cdrh. ‘‘Guidance

for Prescription Use Drugs of Abuse

Assays Premarket Notifications’’ will be

available at http://www.fda.gov/cdrh/

ode/guidance/152.pdf.

IV. Comments

Interested persons may submit to

Dockets Management Branch (address

above) written comments regarding this

draft guidance by February 12, 2001.

Two copies of any comments are to be

submitted, except individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document. The draft guidance and

received comments may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: November 2, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–29110 Filed 11–8–00; 4:21 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of Inspector General

Program Exclusions: October 2000

AGENCY: Office of Inspector General,

HHS.

ACTION: Notice of program exclusions.

During the month of October 2000,

the HHS Office of Inspector General

imposed exclusions in the cases set

forth below. When an exclusion is

imposed, no program payment is made

to anyone for any items or services

(other than an emergency item or

service not provided in a hospital

emergency room) furnished, ordered or

prescribed by an excluded party under

the Medicare, Medicaid, and all Federal

Health Care programs.

In addition, no program payment is

made to any business or facility, e.g., a

hospital, that submits bills for payment

for items or services provided by an

excluded party. Program beneficiaries

remain free to decide for themselves

whether they will continue to use the

services of an excluded party even

though no program payments will be

made for items and services provided by

that excluded party. The exclusions

have national effect and also apply to all

Executive Branch procurement and nonprocurement programs and activities.

Subject, city, state Effective

date

PROGRAM-RELATED CONVICTIONS

ASKARI, SOHEILA ................... 11/20/2000

MONTGOMERY, AL

BEN, ERIC S ............................ 11/20/2000

PORT ST LUCIE, FL

CARNEVALI, STEVEN ERNEST JR ............................... 11/20/2000

PITTSBURGH, PA

CASPER, FRANCES C ............ 11/20/2000

VIRGINIA BCH, VA

CHACON, RAUL ENRIQUE ..... 11/20/2000

VALRICO, FL

CHAMBERS, CHARLES .......... 11/20/2000

ROOSEVELT, NY

CUCHEZ, MARIA ..................... 11/20/2000

BELL GARDENS, CA

CULLINAN, MICHAEL JOSEPH .................................... 11/20/2000

MORGANTOWN, WV

DE LOS SANTOS, RAMIRO .... 11/20/2000

EAGLE PASS, TX

DE LOS SANTOS GARCIA,

MARILU ................................. 11/20/2000

EAGLE PASS, TX

DEL TORO PHARMACY .......... 11/20/2000

MIAMI, FL

DENIS, ALFONSO ................... 11/20/2000

EL MONTE, CA

DIAZ, RACHEL M ..................... 11/20/2000

HIALEAH, FL

DONALDSON, JAMES FRED .. 11/20/2000

BERRIEN SPRINGS, MI

FERREIRO, CARLOS M .......... 11/20/2000

MIAMI, FL

FISHER, STEPHEN NEAL ....... 11/20/2000

PITTSBURGH, PA

FLORES, JOSE MARTIN ......... 11/20/2000

DOWNEY, CA

GALE, STACEY R .................... 11/20/2000

DONALSONVILLE, GA

GALIANO, CARMEN

SOCORRO ............................ 11/20/2000

MIAMI, FL

GARCIA, EDUARDO G ............ 11/20/2000