Federal Register / Vol. 65, No. 77 / Thursday, April 20, 2000 / Notices 21201

nutrition. It is also indicated in other

situations where intravenous

administration is required. Such

situations include surgery, extensive

burns, fractures and other trauma,

severe infectious diseases, and comatose

states, which may provoke a stress

situation with profound alterations in

the body’s metabolic demands and

consequent tissue depletion of

nutrients. This product (administered in

intravenous fluids under proper

dilution) contributes intake of these

vitamins that are necessary toward

maintaining the body’s normal

resistance and repair processes.

The physician should not await the

development of clinical signs of vitamin

deficiency before initiating vitamin

therapy.

Patients with multiple vitamin

deficiencies or with markedly increased

requirements may be given multiples of

the daily dosage for 2 or more days, as

indicated by the clinical status. Clinical

testing indicates that some patients do

not maintain adequate levels of certain

vitamins when this formulation in

recommended amounts is the sole

source of vitamins.

(c) Contraindications:

Known hypersensitivity to any of the

vitamins or excipients in this product or

a preexisting hypervitaminosis. Allergic

reaction has been known to occur

following intravenous administration of

thiamine and vitamin K. The

formulation is contraindicated prior to

blood sampling for detection of

megaloblastic anemia, as the folic acid

and the cyanocobalamin in the vitamin

solution can mask serum deficits.

In addition, the following sections

required by 21 CFR 201.57 should read

as follows:

1. Precautions: (The following

paragraph should be added and should

appear in bold type.)

Caution should be exercised when

administering this multivitamin

formulation to patients on warfarin

sodium-type anticoagulant therapy. In

such patients, periodic monitoring of

prothrombin time is essential in

determining the appropriate dosage of

anticoagulant therapy.

2. Drug Reactions: This section is

revised to read ‘‘Drug Interactions’’ and

to add aminophylline 125 mg and

ampicillin 500 mg to this list.

Supplements to approved NDA’s or

ANDA’s providing for appropriate

revision of the labeling of drug products

affected by this notice should be

submitted on or before June 19, 2000.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 201(n), 502, 505, 52 Stat. 1041,

1050–1053, as amended (21 U.S.C.

321(n), 352, 355)) and under the

authority delegated to the Director of the

Center for Drug Evaluation and Research

(21 CFR 5.70).

Dated: March 28, 2000.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 00–9848 Filed 4–19–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

General and Plastic Surgery Devices

Panel of the Medical Devices Advisory

Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: General and

Plastic Surgery Devices Panel of the

Medical Devices Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on May 8, 2000, 8 a.m. to 5 p.m.

Location: Marriott Washingtonian

Center, Salons F and G, 9751

Washingtonian Blvd., Gaithersburg, MD.

Contact Person: David Krause, Center

for Devices and Radiological Health

(HFZ–410), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–594–3090,

ext. 141, or FDA Advisory Committee

Information Line, 1–800–741–8138

(301–443–0572 in the Washington, DC

area), code 12519. Please call the

Information Line or access the Internet

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

panelmtg.html for up-to-date

information on this meeting.

Agenda: The committee will discuss,

make recommendations, and vote on

two premarket approval applications

for: (1) An in situ polymerizable surgical

mesh intended to be used to seal air

leaks following thoracic cavity surgery;

and (2) an interactive wound and burn

dressing intended to be used for the

treatment of diabetic foot ulcers.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by May 1, 2000. Oral

presentations from the public will be

scheduled between approximately 8:15

a.m. and 8:45 a.m., 11:15 a.m. and 11:45

a.m., 1:15 p.m. and 1:45 p.m., and 4

p.m. and 4:30 p.m. Time allotted for

each presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before May 1, 2000, and submit

a brief statement of the general nature of

the evidence or arguments they wish to

present, the names and addresses of

proposed participants, and an

indication of the approximate time

requested to make their presentation.

FDA regrets that it was unable to

publish this notice 15 days prior to the

General and Plastic Surgery Devices

Panel of the Medical Devices Advisory

Committee meeting. Because the agency

believes there is some urgency to bring

these issues to public discussion and

qualified members of the General and

Plastic Surgery Devices Panel of the

Medical Devices Advisory Committee

were available at this time, the

Commissioner of Food and Drugs

concluded that it was in the public

interest to hold this meeting even if

there was not sufficient time for the

customary 15-day public notice.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: April 14, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–9908 Filed 4–19–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Neurological Devices Panel of the

Medical Devices Advisory Committee;

Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Neurological

Devices Panel of the Medical Devices

Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.