3462 Federal Register / Vol. 65, No. 14 / Friday, January 21, 2000 / Notices

imported foods when necessary to deter

premature and illegal entry into the

United States; and (6) enhance

enforcement against violations of U.S.

laws related to the importation of foods,

including through the imposition of

civil monetary penalties.

The public meetings also will include

an overview of the President’s directive

and a review of the new operational

procedures proposed to accomplish

each of the six objectives. The meetings

will provide a forum for discussion of

the proposed procedures. In addition to

a plenary session, the meetings will

provide the opportunity for additional

discussion of the specific objectives.

Three breakout sessions to discuss the

following are planned: (A) Secured

storage, increased bonds, enforcement

activities; (B) destruction and marking

of refused foods; and (C) standards for

the use of private laboratories. The U.S.

Customs Service will jointly present the

objectives with FDA. Transcripts of the

public meetings are not planned.

If you would like to attend a public

meeting, send registration information

(including name, title, firm name,

mailing address, telephone number, fax

number, e-mail address, and selection of

breakout session A, B, or C) to the

contact person listed for the meeting

you wish to attend at least 7 days prior

to the meeting date. Attendance will be

limited due to seating capacity. There is

no registration fee for this meeting.

Meeting Address Date and Local Time FDA Contact Person

IRVINE: Los Angeles District Office, 19900

MacArthur Blvd., suite 300, Irvine, CA 92612.

Thursday, February 10, 2000, 9 a.m. to 12

noon.

Irene Gomez, 222 West 6th St., suite 700,

San Pedro, CA 90731, 310–831–6123, ext.

103, e-mail: igomez@ora.fda.gov.

WASHINGTON: Hubert H. Humphrey Bldg.,

200 D St. SW., rm. 800, Washington, DC

20204.

Thursday, February 17, 2000, 9 a.m. to 12

noon.

Peter A. Salsbury, Executive Operations Staff

(HFS–022), 200 C St. SW., Washington,

DC 20204, 202–205–4299, e-mail:

psalsbur@bangate. fda.gov.

Dated: January 12, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–1410 Filed 1–20–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99P–1720]

Approval of an Alternate Requirement

of the User Labeling Requirements for

Devices Containing Dry Natural

Rubber that Contact Humans;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a document entitled

‘‘Approval of an Alternative

Requirement of the User Labeling

Requirements for Devices that Contain

Dry Natural Rubber that Contact

Humans.’’ FDA granted a petition

submitted by the Health Industry

Manufacturers Association (HIMA), on

behalf of in vitro diagnostic device (IVD)

manufacturers, that requested a variance

from placing the warning statement

about dry natural rubber on the

immediate IVD package (vial) label.

FDA is announcing the availability of its

response to HIMA’s petition in order to

inform affected manufacturers and the

public.

ADDRESSES: Submit written requests for

single copies on a 3.5 diskette of the

document entitled ‘‘Approval of an

Alternate Requirement of the User

Labeling Requirements for Devices that

Contain Dry Natural Rubber that Contact

Humans’’ to the contact person named

below. See the SUPPLEMENTARY

INFORMATION section for information on

electronic access to the alternative

requirement document.

FOR FURTHER INFORMATION CONTACT: John

J. Farnham, Center for Devices and

Radiological Health (HFZ–321), Food

and Drug Administration, 2094 Gaither

Rd., Rockville, MD 20852, 301–594–

4616.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of September

30, 1997 (62 FR 51021), FDA issued a

final rule, codified in 21 CFR

§ 801.437(e), requiring labeling

statements on medical devices

containing dry natural rubber that are

intended to contact or likely to contact

humans. The rule became effective on

September 30, 1998. On June 3, 1999,

HIMA requested a variance for in vitro

diagnostic products that have vial labels

too small to accommodate the required

statement. The petition said that

manufacturers of the products could

place the warning on the outer package,

as well as on a package insert. On

September 10, 1999, FDA issued a letter

granting HIMA’s petition.

II. Electronic Access

In order to receive the document

entitled ‘‘Approval of an Alternative

Requirement of the User Labeling

Requirements for Devices that Contain

Dry Natural Rubber that Contact

Humans,’’ via your fax machine, call the

CDRH Facts-On-Demand (FOD) system

at 800–899–0381 or 301–827–0111 from

the touch-tone telephone. At the first

Federal Register / Vol. 65, No. 14 / Friday, January 21, 2000 / Notices 3463

voice prompt press 1 to access the

Division of Small Manufacturers

Assistance (DSMA) Facts, at second

voice prompt press 2, and then enter the

document number (1148) followed by

the pound sign (#). Then follow the

remaining voice prompts to complete

your request.

Persons interested in obtaining a copy

of the alternative requirement may also

do so using the Internet. CDRH

maintains an entry on the Internet for

easy access to information including

text, graphic, 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 ‘‘Approval of an

Alternative Requirement of the User

Labeling Requirements for Devices that

Contain Dry Natural Rubber that Contact

Humans,’’ 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, labeling matters, and other

device-oriented information. The CDRH

home page may be accessed at http://

www.fda.gov/cdrh. The document

entitled ‘‘Approval of an Alternative

Requirement of the User Labeling for

Devices that Contain Dry Natural

Rubber that Contact Humans’’ will be

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

Dated: January 9, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–1409 Filed 1–20–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D–4956]

Guidance for Industry: Alternative to

Certain Prescription Device Labeling

Requirements; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance entitled

‘‘Alternative to Certain Prescription

Device Labeling Requirements.’’ The

FDA Modernization Act of 1997

(FDAMA) amended the Federal Food,

Drug, and Cosmetic Act (the act) to

require, at a minimum, that before

dispensing, the labels of prescription

drug products contain the symbol ‘‘Rx

only’’ instead of the textual prohibition

‘‘Caution: Federal law prohibits

dispensing without prescription.’’

Through this guidance, the Center for

Devices and Radiological Health (CDRH)

announces that, in its enforcement

discretion, it will apply a similar

amended standard for labeling of

prescription devices.

DATES: Submit written comments

concerning the guidance document at

any time.

ADDRESSES: Submit written comments

on the guidance document to the

contact person listed below. Submit

written requests for single copies on a

3.5′′ diskette of the guidance document

entitled ‘‘Alternative to Certain

Prescription Device Labeling

Requirements’’ 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

to assist that office in processing your

request, or fax your request to 301–443–

8818. See the SUPPLEMENTARY

INFORMATION section for information on

electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT:

Casper E. Uldriks, Center for Devices

and Radiological Health (HFZ–300),

Food and Drug Administration, 2094

Gaither Rd., Rockville, MD 20850, 301–

594–4692.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

the guidance ‘‘Alternative to Certain

Prescription Device Labeling

Requirements.’’ Section 126 of Title I of

FDAMA (Public Law 105–115), signed

into law by President Clinton on

November 21, 1997, amends

prescription drug labeling requirements

required by section 503(b)(4) of the act

(21 U.S.C. 353(b)(4)) to require, at a

minimum, that prior to dispensing, the

label of prescription products contain

the symbol ‘‘Rx only.’’ The agency

announced this change for prescription

drugs in the Federal Register of March

13, 1998 (63 FR 12473).

FDAMA did not direct the agency to

amend the prescription device labeling

regulation, found in the Code of Federal

Regulations (CFR) at § 801.109(b)(1) (21

CFR 801.109 (b)(1)); however, CDRH

believes manufacturers, repackers,

relabelers, and distributors of

prescription devices may wish to use

the same symbol statement, ‘‘Rx only,’’

as an alternative to the text required by

regulation. This alternative simplifies

the labeling and still conveys, by

custom and practice, essentially the

same meaning. CDRH would like to

minimize the burden on manufacturers,

repackers, relabelers, and distributors

that face many labeling requirements.

Therefore, the agency will not object to

the use of the statement ‘‘Rx only’’ as an

alternative to the prescription device

statement required by § 801.109(b)(1).

This means that FDA will not view the

use of the alternative symbol statement

‘‘Rx only’’ as a violation of the labeling

requirements for prescription devices

that would cause the device to be

considered misbranded under section

502(f)(1) of the act (21 U.S.C. 352(f)(1)).

The alternative labeling may be

implemented at the discretion of the

firm responsible for labeling. Devices

already in commercial distribution may

immediately implement the labeling

change. Devices undergoing premarket

review may implement the change once

the firm is notified the product may be

marketed. In vitro diagnostic devices

also fall within the scope of this

guidance.

II. Significance of Guidance

This guidance document represents

the agency’s current thinking on the use

of alternative labeling to prescription

device labeling requirements. 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), which set

forth the agency’s policies and

procedures for the development,

issuance, and use of guidance

documents (62 FR 8961, February 27,

1997). This guidance document is

issued as a Level 1 guidance consistent

with GGP’s. Public comment before

implementation of this guidance is not

necessary because the guidance presents

a less burdensome policy that is

consistent with the public health.

III. Electronic Access

In order to receive ‘‘Alternative to

Certain Prescription Device Labeling

Requirements’’ via your fax machine,

call the CDRH Facts–On–Demand (FOD)

system at 800–899–0381 or 301–827–

0111 from a touch-tone telephone. At

the first voice prompt press 1 to access

DSMA Facts, at the second voice

prompt press 2, and then enter the

document number 1150 followed by the

pound sign (#). Then follow the

remaining voice prompts to complete

your request.

Persons interested in obtaining a copy

of the guidance may also do so using the