21200 Federal Register / Vol. 65, No. 77 / Thursday, April 20, 2000 / Notices

Dated: April 13, 2000.

Nancy Cheal,

Acting Associate Director for Policy,

Planning, and Evaluation, Centers for Disease

Control and Prevention (CDC).

[FR Doc. 00–9886 Filed 4–19–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 79N–0113; DESI 2847]

Parenteral Multivitamin Products;

Drugs for Human Use; Drug Efficacy

Study Implementation; Amendment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

conditions for marketing an effective

adult parenteral multivitamin drug

product that published in the Federal

Register of September 17, 1984 (49 FR

36446). The agency is notifying

manufacturers of modifications in the

adult formulation and certain portions

of the labeling for the products.

DATES: Supplements to approved new

drug applications (NDA’s) and

abbreviated new drug applications

(ANDA’s) are due on or before June 19,

2000.

ADDRESSES: Communication in response

to this notice should be identified with

the reference number DESI 2847 and

directed to the attention of the

appropriate office named below.

Supplements to full NDA’s (identify

with NDA number): Division of

Metabolic and Endocrine Drug

Products (HFD–510), Center for

Drug Evaluation and Research,

Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857.

Original ANDA’s: Office of Generic

Drugs (HFD–600), Center for Drug

Evaluation and Research, Food and

Drug Administration, 7500 Standish

Pl., Rockville, MD 20855.

Requests for opinion of the

applicability of this notice to a

specific product: Division of

Prescription Drug Compliance and

Surveillance (HFD–330), Food and

Drug Administration, 7500 Standish

Pl., Rockville, MD 20855.

FOR FURTHER INFORMATION CONTACT:

Mary E. Catchings, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

September 17, 1984 (49 FR 36446), FDA

announced the conditions for marketing

an effective parenteral multivitamin

preparation. The effective 12-vitamin

formulation set forth in the notice was

based on the clinical evaluation of a

guideline formulation recommended in

1975 by the American Medical

Association (AMA). The notice also

stated that, because parenteral

multivitamin products are used and

evaluated in patients with a variety of

disease conditions, future adjustments

to the formulation may be necessary.

On August 21, 1985, FDA’s Division

of Metabolic and Endocrine Drug

Products and the AMA’s Division of

Personal and Public Health Policy

sponsored a public workshop on

‘‘Multivitamin Preparations for

Parenteral Use.’’ At the workshop,

additional data from clinical testing of

the 1975 AMA formulation and a variety

of other data were presented and

discussed in light of available

information on parenteral vitamin

therapy. After examining the data, the

AMA–FDA workshop committee

recommended that the dosage of

vitamins B1, B6, C, and folic acid be

increased and that vitamin K be added

to the formulation. Based on a review of

the committee’s recommendations, the

Director of the Center for Drug

Evaluation and Research has concluded

that the 1975 AMA formulation for

parenteral multivitamins should be

modified to reflect the advice of the

committee.

Accordingly, this notice amends

portions of the section Conditions for

Approval and Marketing in the

September 17, 1984, notice as follows

(in accordance with current labeling

practice, amounts previously listed in

international units (IU) have been

converted to weights):

Paragraph 1(a)(i) is revised as follows:

1. Adult formulation (intended for

ages 11 and older)

Ingredient Amount per Unit Dose

Fat Soluble Vitamins

A (retinol) 1 milligram (mg)

D (ergocalciferol or cholecalciferol) 5 micrograms (μg)

E (alpha-tocopherol) 10 mg

K (phylloquinone) 150 μg

Water-Soluble Vitamins

C (ascorbic acid) 200 mg

Folic acid 600 μg

Niacin 40 mg

B2 (riboflavin) 3.6 mg

B1 (thiamine) 6.0 mg

B6 (pyridoxine) 6.0 mg

B12 (cyanocobalamin) 5 μg

Pantothenic acid 15.0 mg

Biotin 60 μg

2. Labeling conditions.

(a) The label must bear the statement

‘‘Rx only.’’

(b) Indication. Paragraph 2(b)(i)(a) is

revised as follows (This language may

be editorially adapted to a specific

product’s labeling, as appropriate.):

Adult. This formulation is indicated

as a daily multivitamin maintenance

dosage for adults and for children age 11

and above receiving parenteral

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.