Federal Register / Vol. 61, No. 104 / Wednesday, May 29, 1996 / Notices 26911

Because substantial compliance was

achieved in 1993 and 1995, section

403(q)(4)(C)(ii) of the act requires that

FDA reassess voluntary labeling

compliance and issue a report in 1997.

FDA will survey retail stores under

contract in November and December of

1996 to determine whether substantial

compliance in the voluntary provision

of labeling information for raw fruits,

vegetables, and fish continues to exist.

If substantial compliance is not met, the

agency will propose to modify § 101.43

to make the program mandatory.

The industry has informed the agency

that many retailers need new posters,

charts, or brochures, and rather than

reprinting the old values, they would

prefer to wait until they have the new

values to print the necessary materials.

The timeframe by which the agency

intends to publish a final rule to update

the voluntary labeling program,

however, may not allow food retailers

and trade associations adequate time to

print, distribute, and post nutrition

labeling information before the next

compliance survey. Therefore, because

FDA considers that both industry and

consumers will benefit if the most

current nutrition labeling values for the

20 most frequently consumed raw fruits,

vegetables, and fish are made available

for use in the voluntary program, FDA

is publishing these values at this time,

in advance of completion of work on the

final rule. The agency encourages

retailers to use these new values when

they print their posters, charts, or

brochures on raw fruits, vegetables, and

fish. However, because of the short

amount of time before the 1996 survey,

FDA is allowing retailers who choose to

participate in the voluntary nutrition

labeling program to use the old 1991

values or these new values.

Therefore, firms interested in

obtaining the nutrition labeling values

for the 20 most frequently consumed

raw fruits, vegetables, and fish should

submit a written request, accompanied

by a self-addressed adhesive label or a

fax number, to the Division of Technical

Evaluation (HFS–165), Office of Food

Labeling, Center for Food Safety and

Applied Nutrition, Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204.

Dated: May 20, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–13309 Filed 5–28–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96E–0045]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; COREG

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

COREG 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,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Brian J. Malkin, Office of Health Affairs

(HFY–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–1382.

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 COREG

(carvedilol). COREG is indicated for

the management of essential

hypertension. Subsequent to this

approval, the Patent and Trademark

Office received a patent term restoration

application for COREG (U.S. Patent

No. 4,503,067) from Boehringer

Mannheim GmbH, and the Patent and

Trademark Office requested FDA’s

assistance in determining this patent’s

eligibility for patent term restoration. In

a letter dated February 22, 1996, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of COREG

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

COREG is 3,625 days. Of this time,

2,727 days occurred during the testing

phase of the regulatory review period,

while 898 days occurred during the

approval phase. These periods of time

were derived from the following dates:

1. The date an exemption under

section 505(i) of the Federal Food, Drug,

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

became effective: October 13, 1985. FDA

has verified the applicant claim that the

day the investigational new drug

application became effective was on

October 13, 1985.

2. The date the application was

initially submitted with respect to the

human drug product under section

505(b) of the Federal Food, Drug, and

Cosmetic Act: March 31, 1993. FDA has

verified the applicant’s claim that the

new drug application (NDA) for

COREG (NDA 20–297) was initially

submitted on March 31, 1993.

3. The date the application was

approved: September 14, 1995. FDA has

verified the applicant’s claim the NDA

20–297 was approved on September 14,

1995.

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 1,825 days of patent

term extension.
26912 Federal Register / Vol. 61, No. 104 / Wednesday, May 29, 1996 / Notices

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before July 29, 1996, 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 November 25, 1996, 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: May 13, 1996.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 96–13307 Filed 5–28–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96E–0036]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; FOSAMAX

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

FOSAMAX 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,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Brian J. Malkin, Office of Health Affairs

(HFY–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–1382.

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 FOSAMAX

(alendronate sodium). FOSAMAX is

indicated for the treatment of

osteoporosis in postmenopausal women

and Paget’s disease of bone. Subsequent

to this approval, the Patent and

Trademark Office received a patent term

restoration application for FOSAMAX

(U.S. Patent No. 4,621,077) from

Instituto Gentili S.p.A., 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 1, 1996, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of FOSAMAX

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

FOSAMAX is 2,558 days. Of this time,

2,375 days occurred during the testing

phase of the regulatory review period,

while 183 days occurred during the

approval phase. These periods of time

were derived from the following dates:

1. The date an exemption under

section 505(i) of the Federal Food, Drug,

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

became effective: September 29, 1988.

FDA has verified the applicant’s claim

that the date that the investigational

new drug application (IND) became

effective was on September 29, 1988.

2. The date the application was

initially submitted with respect to the

human drug product under section

505(b) of the Federal Food, Drug, and

Cosmetic Act: March 31, 1995. FDA has

verified the applicant’s claim that the

new drug application (NDA) for

FOSAMAX (NDA 20–560) was

initially submitted on March 31, 1995.

3. The date the application was

approved: September 29, 1995. FDA has

verified the applicant’s claim that NDA

20–560 was approved on September 29,

1995.

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 1,369 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before July 29, 1996, 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 November 25, 1996, 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.