Federal Register / Vol. 65, No. 220 / Tuesday, November 14, 2000 / Notices 68151

thus may trigger a regulatory response

by the agency. FDA is issuing this

clarification because some domestic

firms have questioned whether records

can be made available after an

inspection (rather than during) and

some foreign firms have canceled

scheduled inspections by FDA, but

offered to make records available for

review. This guidance applies to foreign

processors that export fish and fishery

products to the United States as well as

to domestic processors.

DATES: Submit written comments on the

draft guidance by December 14, 2000.

General comments on agency guidance

documents are welcome at any time.

ADDRESSES: Copies of this draft

guidance for industry are available on

the Internet at http://vm.cfsan.fda.gov/

dms/guidance.html. Submit written

requests for single copies of the draft

guidance to the Industry Activities Staff,

Office of Constituent Operations (HFS–

565), Center for Food Safety and

Applied Nutrition, Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204. Send one selfaddressed adhesive label to assist that

office in processing your reuqests.

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.

FOR FURTHER INFORMATION CONTACT:

Mary I. Snyder, Center for Food Safety

and Applied Nutrition (HFS–415), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3133.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a draft

guidance for industry entitled ‘‘Refusal

of Inspection or Access to HACCP

Records Pertaining to the Safe and

Sanitary Processing of Fish and Fishery

Products.’’ This guidance is intended to

clarify that on-site inspection of a

processing facility and concurrent

review of HACCP records are essential

elements of FDA’s Seafood HACCP

program as set forth at part 123 (21 CFR

part 123). These regulations require

processors of fish and fishery products

to operate preventive control systems

for human food safety that incorporate

the principles of HACCP. The

regulations further provide that fish and

fishery products are adulterated under

section 402(a)(4) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 342(a)(4)) if their processor fails

to have and implement a HACCP plan

when one is necessary, or otherwise

fails to meet any of the requirements of

the regulations, including allowing the

official review of records (§ 123.6(g)).

Processors must make their HACCP

records and plans available ‘‘for official

review and copying at reasonable times’’

(§ 123.9(c)). The agency expects that it

will regard the failure to provide records

and plans by a domestic or foreign

processor as a significant program

violation, even if a firm volunteers the

documents after the inspection.

FDA believes that the best way for a

regulatory authority to determine

whether a processor is effectively

operating a HACCP system is by

inspecting the processor to assess

whether the system is operating

properly and is appropriate for the

circumstances. Review of monitoring

and other records generated by the

HACCP system is a critical component

of an inspection because it allows the

inspector to match records against

practices and conditions being observed

in the plant and it discourages fraud.

Thus, FDA always has intended that its

review of processors’ HACCP plans and

records would occur as part of an

inspection of a processor’s entire

HACCP system.

For domestic processors, failure to

allow an inspection would not only

violate the HACCP regulations; it is also

a prohibited act under section 301(f) of

the act (21 U.S.C. 331(f)). Moreover, if

a domestic processor refuses an FDA

inspection, FDA can obtain an

inspectional warrant from the U.S.

district court in which the processor is

located.

Failure to allow an FDA inspection by

a foreign processor can also result in a

regulatory response. The definition of

‘‘processor’’ at § 123.3(l) specifically

includes persons in foreign countries.

Thus, like domestic processors, foreign

processors who ship to the United

States must operate under conditions

that satisfy FDA’s HACCP regulations,

including the requirement that records

be made available during the course of

an FDA inspection.

This draft guidance is being issued

consistent with FDA’s good guidance

practices (65 FR 56468, September 19,

2000). The draft guidance represents the

agency’s current thinking on refusal of

inspection or access to HACCP records

that pertain to the safe and sanitary

processing of fish and fishery products.

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

requirements of the applicable statutes

and regulations.

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the draft

guidance. 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 are

available for public examination in the

Dockets Management Branch between 9

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

Friday.

Dated: October 30, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–29011 Filed 11–13–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D–1020]

Medical Devices Draft Guidance on

Over the Counter (OTC) Screening

Tests for Drugs of Abuse: Guidance

for 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 ‘‘Over the Counter (OTC)

Screening Tests for Drugs of Abuse:

Guidance for Premarket Notifications.’’

FDA is issuing this draft guidance to

provide information about studies and

labeling considerations applicable to

OTC screening tests that use urine as the

clinical specimen for any combination

of one or more of these drugs:

Amphetamine (and, or

methamphetamine), cocaine,

cannabinoids, opiates, and

phencyclidine. This draft guidance

defines OTC use for the purposes of this

document as use in home, workplace,

insurance, and sports settings, and

includes requests for comments on

confirmatory testing and OTC alcohol

testing. 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 ‘‘Over the

Counter (OTC) Screening Tests for

Drugs of Abuse: Guidance for 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 self-addressed adhesive labels

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