36922 Federal Register / Vol. 63, No. 130 /Wednesday, July 8, 1998 / Notices

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

reinstatement of an existing collection

of information, before submitting the

collection to OMB for approval. To

comply with this requirement, FDA is

publishing notice of the proposed

collection of information listed below.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

New Animal Drugs for Investigational

Use (21 CFR Part 511) (OMB Control

Number 0910–0117—Reinstatement)

FDA has the responsibility under the

Federal Food, Drug, and Cosmetic Act

(the act), for approval of new animal

drugs for investigational use. Section

512(j) of the act (21 U.S.C. 360b(j)),

requires that a sponsor submit to FDA

a ‘‘Notice of Claimed Investigational

Exemption’’ INAD, prior to shipment of

the new animal drug for clinical tests in

animals. The regulations implementing

statutory requirements for INAD

approval have been codified under part

511 (21 CFR part 511). The INAD

application must contain, among other

things, the following specific

information: (1) Identity of the new

animal drug; (2) labeling; (3) statement

of compliance of any nonclinical

laboratory studies with good laboratory

practices; and (4) name and address of

each clinical investigator and the

approximate number of animals to be

treated or amount of new animal drug(s)

to be shipped. Part 511 also requires

that records be established and

maintained to document the

distribution and use of the

investigational drug to assure that its

use is safe, that distribution is

controlled to prevent potential abuse,

and that edible products of treated

animals will not be distributed for food

without proper authorization from FDA.

The agency utilizes these required

records under its ‘‘Bio-Research

Monitoring Program’’ to monitor the

validity of the studies and to assure that

proper use of the drug is maintained by

the investigator.

Investigational new animal drugs are

sponsored primarily by drug industry

firms, academic institutions, and the

government. Investigators may include

individuals from these entities as well

as research firms and members of the

medical profession. Respondents to this

collection of information are both

sponsors and investigators.

FDA estimates the burden for this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

511.1(b)(4) 190 6 1,147 8 9,176

511.1(b)(5) 190 1.5 287 140 40,180

511.1(b)(6) 190 .005 1 250 250

511.1(b)(8)(ii) 190 .005 1 20 20

511.1 (b)(9) 190 .16 30 8 240

Total Burden Hours 49,866

1There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

511.1(a)(3) 190 7.5 1,434 9 12,906

511.1(b)(3) 190 10 1,912 1 1,912

511.1(b)(7)(ii) 190 2 956 3.5 3,346

511.1(b)(8)(i) 190 4 956 3.5 3,346

Total Burden Hours 21,510

1There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimate of the time required for

reporting requirements, record

preparation, and maintenance for this

collection of information is based on

agency communication with industry.

Additional information needed to make

a final calculation of the total burden

hours (i.e., the number of respondents,

the number of recordkeepers, the

number of INAD applications received,

etc.) is derived from agency records.

Dated: June 30, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–18145 Filed 7–7–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98E–0308]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; IVOMEC EPRINEXTM

Pour-On for Beef and Dairy Cattle

AGENCY: Food and Drug Administration,

HHS.
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