Federal Register / Vol. 63, No. 108 / Friday, June 5, 1998 / Notices 30765

FDA has based these estimates on

conversations with industry and trade

association representatives, and from

internal review of the documents listed

in Tables 1 and 2 of this document.

Based on the trend in the past 3 years,

an estimated 5,000 submissions are

expected each year. FDA’s

administrative and technical staff, who

are familiar with the requirements for

submission of premarket notifications,

estimate that an average of 80 hours are

required to prepare a submission

(exclusive of preparing clinical data,

research, etc.). FDA, therefore, estimates

that a total of 400,000 hours of effort is

required for the 5,000 submissions. It is

also estimated that the respondents will

receive requests for an average of 20,000

documents. At an estimated one-half

hour to process these documents, an

additional 10,000 recordkeeping hours

are expected for this program.

Dated: May 28, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–14917 Filed 6–4–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 95N–0182]

KV Pharmaceutical Co.; Withdrawal of

Approval of Two Abbreviated New

Drug Applications and One

Abbreviated Antibiotic Application

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

approval of two abbreviated new drug

applications (ANDA’s) and one

abbreviated antibiotic drug application

(AADA) held by KV Pharmaceutical Co.

(KV), 2503 South Hanley Rd., St. Louis,

MO 63144. This action is being taken

because the applications contain untrue

statements of material fact, and the

drugs covered by these applications lack

substantial evidence of effectiveness.

EFFECTIVE DATE: June 5, 1998.

FOR FURTHER INFORMATION CONTACT:

David T. Read, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION: In the

Federal Register of June 26, 1995 (60 FR

32982), FDA published a notice offering

an opportunity for a hearing (NOOH) on

a proposal to withdraw approval of the

following abbreviated applications:

AADA 62–047, Erythromycin

Ethylsuccinate Oral Suspension, 200

and 400 milligrams (mg);

ANDA 71–929, Disopyramide

Phosphate Extended Release Capsules,

100 mg; and

ANDA 86–538, Nitroglycerin

Extended Release Capsules, 2.5 mg.

The grounds for the proposed

withdrawals were: (1) That the

applications contained untrue

statements of material fact, and (2) that

based upon new information evaluated

together with the evidence available

when the applications were approved,

there is a lack of substantial evidence

that the drugs will have the effect they

purport or are represented to have under

the conditions of use prescribed,

recommended, or suggested in their

labeling.

On July 26, 1995, KV requested a

hearing. Subsequently, in a letter dated

August 25, 1995, KV withdrew its

request for a hearing and requested

withdrawal of these applications

because the products are no longer

being marketed. (AADA 62–047 was

inadvertently included in a previous

Federal Register notice (61 FR 13506,

March 27, 1996) that withdrew a large

number of applications based on the

request of the applicants.)

Based on the information presented in

the June 26, 1995, notice, the Director of

the Center for Drug Evaluation and

Research, under section 505(e) of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 355(e)) and under

authority delegated to her (21 CFR 5.82),

finds that the applications listed above

contain untrue statements of material

fact (21 U.S.C. 355(e)(5)); and that on

the basis of new information before her

with respect to the drugs, evaluated

together with the evidence available to

her when the applications were

approved, there is a lack of substantial

evidence that the drugs will have the

effects they purport or are represented

to have under the conditions of use

prescribed, recommended, or suggested

in their labeling (21 U.S.C. 355(e)(3)).

Therefore, approval of the

applications listed above, and all their

amendments and supplements, is

hereby withdrawn, effective June 5,

1998. Distribution of these products in

interstate commerce without an

approved application is illegal and

subject to regulatory action.

Section 505(j)(7)(C) of the act requires

that FDA immediately remove from its

approved product list (‘‘Approved Drug

Products with Therapeutic Equivalence

Evaluation’’) (‘‘the list’’) any drug whose

approval was withdrawn for grounds

described in the first sentence of section

505(e) of the act. Such grounds apply to

this withdrawal. Notice is hereby given

that the drugs covered by these

applications are removed from the list.

Dated: May 28, 1998.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 98–14914 Filed 6–4–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Food Advisory Committee;

Amendment of Notice

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

amendment to the notice of meeting of

the Food Advisory Committee. This

meeting was announced in the Federal

Register of May 12, 1998 (63 FR 26194).

The amendment is being made to reflect

a change in the Procedure portion of the

meeting notice. The organization and

time of the oral presentations have been

changed. All oral presentations will be

made on June 16, 1998. There are no

other changes.

FOR FURTHER INFORMATION CONTACT:

Lynn A. Larsen, Center for Food Safety

and Applied Nutrition (HFS–5), 202–

205–4727, or Catherine M. DeRoever

(HFS–22), 202–205–4251, FAX 202–

205–4970, Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204, or FDA

Advisory Committee Information Line,

1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 10564.

SUPPLEMENTARY INFORMATION: In the

Federal Register of May 12, 1998 (63 FR

26194), FDA announced that oral

presentations from the public during the

Food Advisory Committee meeting

would be scheduled in three sessions

over 2 days. However, all oral

presentations have been combined into

one session. On page 26195, in the first

column, the Procedure portion of this

meeting notice is amended to read as

follows:

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 June 5, 1998. All oral

presentations are scheduled in a