Federal Register / Vol. 62, No. 157 / Thursday, August 14, 1997 / Notices 43535

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97F–0336]

General Electric Co.; Filing of Food

Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that General Electric Co. has filed a

petition proposing that the food additive

regulations be amended to change the

intrinsic viscosity specifications for

poly(2,6-dimethyl-1,4-phenylene) oxide

resins intended for use in contact with

food.

FOR FURTHER INFORMATION CONTACT: Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS–215), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3081.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),

notice is given that a food additive

petition (FAP 7B4551) has been filed by

General Electric Co., One Lexan Lane,

Mt. Vernon, IN 47620–9364. The

petition proposes to amend the food

additive regulations in § 177.2460

Poly(2,6-dimethyl-1,4-phenylene) oxide

resins to change the intrinsic viscosity

specifications for the poly(2,6-dimethyl1,4-phenylene) oxide resins intended for

use in contact with food from ‘‘not less

then 0.40 deciliter per gram’’ to ‘‘not

less than 0.30 deciliter per gram’’ as

determined by ASTM method D1243–

79.

The agency has determined under 21

CFR 25.24(9) that this action is of the

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

Dated: July 31, 1997.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 97–21436 Filed 8–13–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0314]

Prescription Drug Products;

Levothyroxine Sodium

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that orally administered drug products

containing levothyroxine sodium are

new drugs. There is new information

showing significant stability and

potency problems with orally

administered levothyroxine sodium

products. Also, these products fail to

maintain potency through the expiration

date, and tablets of the same dosage

strength from the same manufacturer

vary from lot to lot in the amount of

active ingredient present. This lack of

stability and consistent potency has the

potential to cause serious health

consequences to the public.

Manufacturers who wish to continue to

market orally administered

levothyroxine sodium products must

submit new drug applications (NDA’s);

manufacturers who contend that a

particular drug product is not subject to

the new drug requirements of the

Federal Food, Drug, and Cosmetic Act

(the act) should submit a citizen

petition. FDA has determined that orally

administered levothyroxine sodium

products are medically necessary, and

accordingly the agency is allowing

current manufacturers 3 years to obtain

approved NDA’s.

EFFECTIVE DATE: August 14, 1997.

DATES: A citizen petition claiming that

a particular drug product is not subject

to the new drug requirements of the act

should be submitted no later than

October 14, 1997.

After August 14, 2000, any orally

administered drug product containing

levothyroxine sodium, marketed on or

before the date of this notice, that is

introduced or delivered for introduction

into interstate commerce without an

approved application, unless found by

FDA to be not subject to the new drug

requirements of the act under a citizen

petition submitted for that product, will

be subject to regulatory action.

ADDRESSES: All communications in

response to this notice should be

identified with Docket No. 97N–0314

and directed to the appropriate office

named below:

Applications under section 505 of the

act (21 U.S.C. 355): Documents and

Records Section (HFA–224), 5600

Fishers Lane, Rockville, MD 20857.

Citizen petitions (see § 10.30 (21 CFR

10.30)) contending that a particular drug

product is not subject to the new drug

requirements of the act: Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

Requests for an opinion on the

applicability of this notice to a specific

product: Division of Prescription Drug

Compliance and Surveillance (HFD–

330), Center for Drug Evaluation and

Research, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855.

FOR FURTHER INFORMATION CONTACT:

Christine F. Rogers, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION:

I. Background

Levothyroxine sodium is the sodium

salt of the levo isomer of the thyroid

hormone thyroxine (T4). Thyroid

hormones affect protein, lipid, and

carbohydrate metabolism; growth; and

development. They stimulate the

oxygen consumption of most cells of the

body, resulting in increased energy

expenditure and heat production, and

possess a cardiostimulatory effect that

may be the result of a direct action on

the heart.

Levothyroxine sodium was first

introduced into the market before 1962

without an approved NDA, apparently

in the belief that it was not a new drug.

Orally administered levothyroxine

sodium is used as replacement therapy

in conditions characterized by

diminished or absent thyroid function

such as cretinism, myxedema, nontoxic

goiter, or hypothyroidism. The

diminished or absent thyroid function

may result from functional deficiency,

primary atrophy, partial or complete

absence of the thyroid gland, or the

effects of surgery, radiation, or

antithyroid agents. Levothyroxine

sodium may also be used for

replacement or supplemental therapy in

patients with secondary (pituitary) or

tertiary (hypothalamic) hypothyroidism.

Hypothyroidism is a common

condition. In the United States, 1 in

every 4,000 to 5,000 babies is born

hypothyroid. Hypothyroidism has a

prevalence of 0.5 percent to 1.3 percent

in adults. In people over 60, the

prevalence of primary hypothyroidism