Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 / Notices 36923

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

IVOMEC EPRINEXTM Pour-On for Beef

and Dairy Cattle and is publishing this

notice of that determination as required

by law. FDA has made the

determination because of the

submission of an application to the

Commissioner of Patents and

Trademarks, Department of Commerce,

for the extension of a patent which

claims that animal drug product.

ADDRESSES: Written comments and

petitions should be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

FOR FURTHER INFORMATION CONTACT:

Brian J. Malkin, Office of Health Affairs

(HFY–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–6620.

SUPPLEMENTARY INFORMATION: The Drug

Price Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98–417)

and the Generic Animal Drug and Patent

Term Restoration Act (Pub. L. 100–670)

generally provide that a patent may be

extended for a period of up to 5 years

so long as the patented item (human

drug product, animal drug product,

medical device, food additive, or color

additive) was subject to regulatory

review by FDA before the item was

marketed. Under these acts, a product’s

regulatory review period forms the basis

for determining the amount of extension

an applicant may receive.

A regulatory review period consists of

two periods of time: a testing phase and

an approval phase. For animal drug

products, the testing phase begins when

the exemption to permit the clinical

investigations of the drug becomes

effective and runs until the approval

phase begins. The approval phase starts

with the initial submission of an

application to market the animal drug

product and continues until FDA grants

permission to market the drug product.

Although only a portion of a regulatory

review period may count toward the

actual amount of extension that the

Commissioner of Patents and

Trademarks may award (for example,

half the testing phase must be

subtracted as well as any time that may

have occurred before the patent was

issued), FDA’s determination of the

length of a regulatory review period for

an animal drug product will include all

of the testing phase and approval phase

as specified in 35 U.S.C. 156(g)(1)(B).

FDA recently approved for marketing

the animal drug product IVOMEC

EPRINEXTM Pour-On for Beef and Dairy

Cattle (eprinomectin). IVOMEC

EPRINEXTM Pour-On for Beef and Dairy

Cattle is indicated for treatment and

control of gastrointestinal nematodes

(adults and fourth stage larvae, L4),

lungworms (adults and L4), cattle grubs

(all parasitic stages), lice, mange mites,

and flies. Subsequent to this approval,

the Patent and Trademark Office

received a patent term restoration

application for IVOMEC EPRINEXTM

Pour-On for Beef and Dairy Cattle (U.S.

Patent No. 4,427,663) from Merck & Co.,

Inc., and the Patent and Trademark

Office requested FDA’s assistance in

determining the patent’s eligibility for

patent term restoration. In a letter dated

November 7, 1997, FDA advised the

Patent and Trademark Office that this

animal drug product had undergone a

regulatory review period and that the

approval of IVOMEC EPRINEXTM

Pour-On for Beef and Dairy Cattle

represented the first permitted

commercial marketing or use of the

product. Shortly thereafter, the Patent

and Trademark Office requested that

FDA determine the product’s regulatory

review period.

FDA has determined that the

applicable regulatory review period for

IVOMEC EPRINEXTM Pour-On for Beef

and Dairy Cattle is 2,492 days. Of this

time, 2,475 days occurred during the

testing phase of the regulatory review

period, while 17 days occurred during

the approval phase. These periods of

time were derived from the following

dates:

1. The date an exemption under

section 512(j) of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

360b(j)) became effective: June 22, 1990.

FDA has verified the applicant’s claim

that the date the investigational new

animal drug application became

effective was on June 22, 1990.

2. The date the application was

initially submitted with respect to the

animal drug product under section

512(b) of the act: March 31, 1997. The

applicant claims March 27, 1997, as the

date the new animal drug application

(NADA) for IVOMEC EPRINEXTM

Pour-On for Beef and Dairy Cattle

(NADA 141–079) was initially

submitted. However, FDA records

indicate that the date of FDA’s official

acknowledgement letter assigning a

number to NADA 141–079 was March

31, 1997, which is considered to be the

initially submitted date for NADA 141–

079.

3. The date the application was

approved: April 16, 1997. FDA has

verified the applicant’s claim that

NADA 141-079 was approved on April

16, 1997.

This determination of the regulatory

review period establishes the maximum

potential length of a patent extension.

However, the U.S. Patent and

Trademark Office applies several

statutory limitations in its calculations

of the actual period for patent extension.

In its application for patent extension,

this applicant seeks 1,255 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before September 8, 1998, submit

to the Dockets Management Branch

(address above) written comments and

ask for a redetermination. Furthermore,

any interested person may petition FDA,

on or before January 4, 1999 publication

in the Federal Register), for a

determination regarding whether the

applicant for extension acted with due

diligence during the regulatory review

period. To meet its burden, the petition

must contain sufficient facts to merit an

FDA investigation. (See H. Rept. 857,

part 1, 98th Cong., 2d sess., pp. 41–42,

1984.) Petitions should be in the format

specified in 21 CFR 10.30.

Comments and petitions should be

submitted to the Dockets Management

Branch (address above) in three copies

(except that individuals may submit

single copies) and identified with the

docket number found in brackets in the

heading of this document. Comments

and petitions may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: June 23, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health

Affairs.

[FR Doc. 98–18141 Filed 7–7–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 78N–0070; DESI 1626]

Combination Drugs Containing

Theophylline, Ephedrine Sulfate, and

Hydroxyzine Hydrochloride;

Withdrawal of Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

approval of the new drug applications

(NDA’s) for Marax Tablets and Marax
36924 Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 / Notices

Syrup. FDA is also declaring all

identical, similar, and related drug

products, not otherwise subject to an

approved drug application, unlawful,

including Brofed Tablets and

Hydroxyzine Compound Syrup. Each of

these products contains theophylline,

ephedrine sulfate, and hydroxyzine

hydrochloride. The basis of the

withdrawals is that there is a lack of

substantial evidence that these

combination drugs are effective for the

treatment of bronchial asthma.

EFFECTIVE DATE: August 7, 1998.

ADDRESSES: Requests for applicability of

this notice to a specific product should

be identified with the Docket and DESI

numbers found in brackets in the

heading of this document and directed

to the 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:

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: As part of

the agency’s drug efficacy program, in a

notice published in the Federal Register

of September 17, 1984 (49 FR 36443),

the Commissioner of Food and Drugs

granted an evidentiary hearing before an

administrative law judge on the

proposal to withdraw approval of NDA

11–768 for Marax Tablets and NDA 12–

879 for Marax Syrup, each containing

theophylline, ephedrine sulfate, and

hydroxyzine hydrochloride. The NDA’s

are held by J. B. Roerig, Division of

Pfizer, Inc. (Pfizer), 235 East 42d St.,

New York, NY 10017.

Other party participants were:

1. Barre-National, Inc., 4128 Haywood

Ave., Baltimore, MD 21215 (Barre);

Hydroxyzine Compound Syrup (no

NDA).

2. Cord Laboratories, Inc. (now

Geneva Pharmaceuticals, Inc.), 2555

West Midway Blvd., Broomfield, CO

80038 (Cord); Brofed Tablets (no NDA).

3. Barrows Research Group, Inc., 99

West Hawthorne Ave., Valley Stream,

NY 11580 (Barrows). Unnamed drug

product. Barrows later withdrew its

hearing request.

Subsequently, in accordance with

agreements to resolve, by other means,

the issue of their drug products’

effectiveness, Pfizer, Barre, and Cord

withdrew their hearing requests. Under

those agreements, FDA has concluded

that Marax Tablets and Marax Syrup

have not been shown to be effective, and

FDA is now withdrawing approval of

the NDA’s for these products.

This notice applies to any drug

product that is identical, related, or

similar to these products and is not the

subject of an approved NDA (21 CFR

310.6). Such products include

Hydroxyzine Compound Syrup and

Brofed Tablets, each of which contains

theophylline, ephedrine sulfate, and

hydroxyzine hydrochloride. Any person

who wishes to determine whether a

specific product is covered by this

notice should write to the Division of

Prescription Drug Compliance and

Surveillance (address above).

The Director of the Center for Drug

Evaluation and Research, under section

505 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 355) and under

the authority delegated to her (21 CFR

5.82), finds that on the basis of new

information before her with respect to

Marax Tablets and Marax Syrup,

evaluated together with the evidence

available to her when the applications

were approved, there is a lack of

substantial evidence that the products

will have the effect they purport or are

represented to have under the

conditions of use prescribed,

recommended, or suggested in their

labeling.

Therefore, based on the foregoing

finding, approvals and all the

amendments and supplements thereto

of NDA 11–768 and NDA 12–879 are

withdrawn effective August 7, 1998.

Shipment in interstate commerce of the

products listed above or of any

identical, related, or similar product

that is not the subject of an approved

NDA will then be unlawful.

Dated: June 15, 1998.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 98–18140 Filed 7–7–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Anti-Infective Drugs Advisory

Committee; Notice of Meeting;

Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

notice that appears in the Federal

Register of June 25, 1998 (63 FR 34655).

The notice announced a meeting of the

Anti-Infective Drugs Advisory

Committee, which was scheduled for

July 29, 30, and 31, 1998. The document

was published with an error. This

document corrects that error.

FOR FURTHER INFORMATION CONTACT:

Carolyn C. Harris, Office of Policy (HF–

27), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–443–2994.

In FR Doc. 98–16934 appearing on

page 34655 in the Federal Register of

Thursday, June 25, 1998, the following

correction is made:

On page 34655, under the Agenda

caption, in the 2d column, beginning in

the 1st line, ‘‘http://www.fda.gov/cder/

guidance.htm’’ is corrected to read

‘‘http://www.fda.gov/cder/guidance/

index.htm’’.

Dated: July 1, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–18144 Filed 7–7–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

Notice of Hearing: Reconsideration of

Disapproval of New York Title XXI

State Plan Amendment (SPA)

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice of hearing.

SUMMARY: This notice announces an

administrative hearing on July 29, 1998;

10:00 a.m., Thirty-Eighth floor, 26

Federal Plaza, New York, New York

10278 to reconsider our decision to

disapprove New York Title XXI SPA.

CLOSING DATE: Requests to participate in

the hearing as a party must be received

by the presiding officer by July 23, 1998.

FOR FURTHER INFORMATION CONTACT: Stan

Katz, Presiding Officer, HCFA, C1–09–

13, 7500 Security Boulevard, Baltimore,

Maryland 21244, Telephone: (410)–786–

2661.

SUPPLEMENTARY INFORMATION: This

notice announces an administrative

hearing to reconsider our decision to

disapprove the New York Title XXI

State Plan Amendment (SPA) submitted

March 26, 1998.

Section 1116 of the Social Security

Act (the Act) and 42 CFR Part 430

establish Department procedures that

provide an administrative hearing for

reconsideration of a disapproval of a

State plan or plan amendment. These

requirements are made applicable under