Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 / Notices 37397

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN (REGISTERED LICENSE HOLDERS)1 2—Continued

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

Total burden hours 550

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

2 Mixer-feeders.

3There is no burden because medicated feeds are consumed on site (§ 225.110 Distribution records; § 225.115 Complaint files).

TABLE 3.—ESTIMATED ANNUAL RECORDKEEPING BURDEN (NONREGISTERED)1 2

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

225.142 13,000 24 316,800 0.41 132,000

225.158 13,000 24 316,800 0.25 79,200

225.180 13,000 24 316,800 0.16 52,800

225.202 13,000 24 316,800 1.5 475,200

Total burden hours 739,200

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

2 Commercial feed mills.

TABLE 4.—ESTIMATED ANNUAL RECORDKEEPING BURDEN (NONREGISTERED)1 2

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

225.142 45,000 3 135,000 0.16 22,500

225.158 45,000 3 135,500 0.16 22,500

225.180 45,000 3 135,500 0.083 11,250

225.202 45,000 3 135,500 0.5 67,500

Total burden hours 123,750

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

2 Mixer-feeders.

The estimate of the times required for

record preparation and maintenance is

based on agency communications with

industry. Other information needed to

calculate the total burden hours (i.e.,

number of recordkeepers, number of

medicated feeds being manufactured,

etc.) is derived from agency records and

experience.

Dated: June 30, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–18398 Filed 7–9–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96E–0452]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; VERLUMATM

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

VERLUMATM 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 human biological 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 human

biological products, the testing phase

begins when the exemption to permit

the clinical investigations of the

biological becomes effective and runs

until the approval phase begins. The

approval phase starts with the initial

submission of an application to market

the human biological product and

continues until FDA grants permission

to market the biological 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
37398 Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 / Notices

length of a regulatory review period for

a human biological 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 human biological product

VERLUMATM (nofetumomab).

VERLUMATM is indicated for the

detection of extensive stage disease in

patients with biopsy confirmed,

previously untreated small cell lung

cancer. Subsequent to this approval, the

Patent and Trademark Office received a

patent term restoration application for

VERLUMATM (U.S. Patent No.

4,897,255) from NeoRx Corp., and the

Patent and Trademark Office requested

FDA’s assistance in determining this

patent’s eligibility for patent term

restoration. In a letter dated July 9,

1997, FDA advised the Patent and

Trademark Office that this human

biological product had undergone a

regulatory review period and that the

approval of VERLUMATM represented

the first permitted commercial

marketing or use of the product. Shortly

thereafter, the Patent and Trademark

Office requested that the FDA determine

the product’s regulatory review period.

FDA has determined that the

applicable regulatory review period for

VERLUMATM is 3,360 days. Of this

time, 925 days occurred during the

testing phase of the regulatory review

period, 2,435 days occurred during the

approval phase. These periods of time

were derived from the following dates:

1. The date an exemption under

section 351 of the Public Health Service

Act became effective: June 11, 1987. The

applicant claims September 4, 1987, as

the date the investigational new drug

application (IND) became effective.

However, FDA records indicate that the

IND effective date was June 11, 1987,

which was 30 days after FDA receipt of

the IND.

2. The date the application was

initially submitted with respect to the

human biological product under section

351 of the Public Health Service Act:

December 21, 1989. FDA has verified

the applicant’s claim that the Product

License Application (PLA) for

VERLUMATM (PLA 90–0150) was

initially submitted on December 21,

1989.

3. The date the application was

approved: August 20, 1996. FDA has

verified the applicant’s claim that PLA

90–0150 was approved on August 20,

1996.

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 1,298 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 6, 1999, 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 29, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health

Affairs.

[FR Doc. 98–18408 Filed 7–9–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97E–0061]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; STROMECTOL

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

STROMECTOL 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 human 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 human 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 human 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

a human 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 human drug product

STROMECTOL (ivermectin).

STROMECTOL is indicated for

treatment of strongyloidiasis and

onchocerciasis. Subsequent to this

approval, the Patent and Trademark

Office received a patent term restoration

application for STROMECTOL (U.S.

Patent No. 4,199,569) from Merck & Co.,

Inc., and the Patent and Trademark

Office requested FDA’s assistance in

determining this patent’s eligibility for

patent term restoration. In a letter dated

March 7, 1997, FDA advised the Patent

and Trademark Office that this human

drug product had undergone a

regulatory review period and that the