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

3464 Federal Register / Vol. 65, No. 14 / Friday, January 21, 2000 / Notices

Internet. 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 guidance

‘‘Alternative to Certain Prescription

Device Labeling Requirements,’’ 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. The

guidance ‘‘Alternative to Certain

Prescription Device Labeling

Requirements’’ will be available at http:

//www.fda.gov/cdrh/oc.

IV. Comments

Interested persons may at any time,

submit written comments regarding this

guidance document to the contact

person listed above. Such comments

will be considered when determining

whether to amend the current guidance.

Dated: January 9, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–1407 Filed 1–20–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Indian Health Service

Health Professions Preparatory,

Pregraduate, and Indian Health

Professions Scholarship Programs

AGENCY: Indian Health Service, HHS.

ACTION: Update of Standing Notice of

Availability of Funds for Health

Professionals Preparatory, Pregraduate,

and Indian Health Professions

Scholarship Programs published in 62

FR 5443, February 5, 1997.

SUMMARY: The Indian Health Service

(IHS) announces the availability of

approximately $3,750,000 to fund

scholarships for the for the Health

Professions Preparatory and Pregraduate

Scholarship Programs for FY 2000

awards. These programs are authorized

by section 103 of the Indian Health Care

Improvement Act (IHCIA), Pub.L. 94–

437, as amended by Pub.L. 100–713,

Pub.L. 102–573, and Pub.L. 104–313.

The Indian Health Scholarship

(Professions) authorized by section 104

of the IHCIA, Pub.L. 94–437, as

amended by Pub.L. 100–713, Pub.L.

102–573, and Pub.L. 104–313, has

approximately $7,895,000 available for

FY 2000 awards.

Part-time and full-time scholarships

will be funded for each of the three

scholarships programs for the academic

year 2000–2001.

The Health Professions Preparatory

Scholarship Grant Program is listed as

No. 93.123 in the Office of Management

and Budget.

Catalog of Federal Domestic

Assistance (CFDA). The Health

Professions Pregraduate Scholarship

Grant Program is listed as No. 93.971

and the Indian Health Professions

Scholarship Grant Program is listed as

No. 93.972 in the CFDA.

DATE: The application deadline for both

new and continuing applicants is April

1, 2000. If April 1 falls on the weekend,

the application will be due on the

following Monday. Applications will be

considered as meeting the deadline if

they are received by the appropriate

Scholarship Coordinator on the

deadline date or postmarked on or

before the deadline date. (Applicants

should request a legibly dated U.S.

Postal Service postmark or obtain a

legibly dated receipt from a commercial

carrier or U.S. Postal Service. Private

metered postmarks will not be

acceptable as proof of timely mailing.)

Applications: New applicants

applying for scholarships under the

three programs must use the forms

contained in the ‘‘Application for

Participation in the IHS Scholarship

Program’’ (OMB No. 0917–0006, 04/30/

2001). Application packets may be

obtained by calling or writing to the

addresses listed below.

FOR FURTHER INFORMATION CONTACT:

Please address application inquiries to

the appropriate Indian Health Service

Area Scholarship Coordinator, as listed

below.

IHS area office and States/locality served Scholarship coordinator/address

Aberdeen Area IHS:

Iowa, Nebraska, North Dakota, South Dakota .................................. Ms. Lila Jean Topalian, Scholarship Coordinator, Aberdeen Area IHS,

Federal Building, Room 309, 115 4th Avenue, SE., Aberdeen, SD

57401, Tele: 602–226–7553.

Alaska Area IHS:

Alaska ................................................................................................ Acting Scholarship Coordinator, Alaska Area IHS, 4141 Ambassador

Drive, Rm. 349, Anchorage, Alaska 99508, Tele: 907–729–1332.

Albuquerque Area IHS:

Colorado, New Mexico ...................................................................... Ms. Alvina Waseta, Scholarship Coordinator, Albuquerque Area IHS,

5300 Homestead Road, NE, Albuquerque, NM 87110, Tele: 505–

248–4513.

Bemidji Area IHS:

Illinois, Indiana, Michigan, Minnesota, Wisconsin ............................. Ms. Barbara Fairbanks, Scholarship Coordinator, Bemidji Area IHS,

522 Minnesota Avenue, NW, Bemidji, MN 56601, Tele: 218–759–

3350.

Billings Area IHS:

Montana, Wyoming ........................................................................... Mr. Sandy MacDonald, Scholarship Coordinator, Billings Area IHS,

Area Personnel Office, P.O. Box 2143, 2900 4th Avenue, North, Billings, MT 59103, Tele: 406–247–7210.

California Area IHS:

California, Hawaii .............................................................................. Ms. Mona Celli, Scholarship Coordinator, California Area IHS, 1825

Bell Street, Suite 200, Sacramento, CA 95825, Tele: 916–566–7033.

Nashville Area IHS:

Alabama, Arkansas, Connecticut, Delaware, Florida, Georgia, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Mississippi,

New Hampshire, New Jersey, New York, North Carolina, Ohio,

Pennsylvania, Rhode Island, South Carolina, Tennessee,

Vermont, Virginia, West Virginia, District of Columbia.

Mr. Jesse Thomas, Scholarship Coordinator, Nashville Area IHS, 711

Stewarts Ferry Pike, Nashville, TN 37214, Tele: 615–736–2436.