Federal Register / Vol. 60, No. 235 / Thursday, December 7, 1995 / Notices 62865

ascertain ability to use a computerized

program for guideline review).

Written requests, together with the

signed confidentiality statement, should

be mailed to: Cheryl Campbell, Panel

Manager; Technical Resources

International, Inc. (TRI), 3202 Tower

Oaks Boulevard, Rockville, Maryland

20852–4200. (Fax number: (301) 231–

6377.) If faxing the request, the original

signed confidentiality statement must

also be mailed.

Automated review process: A

computerized guideline review process,

supported by AHCPR, enables

comments to be entered on a specially

formatted diskette. A diskette will be

furnished, with instructions, to those

requesting the draft guideline. To

facilitate the review process, it is

recommended that reviewers use the

computer diskette to record their

comments. Reviewers who do not use a

diskette will be asked to provide

typewritten comments.

Requests for a copy of the draft

guideline should include the following

information regarding the computer

system to be used for reviewing the

guideline: Type of computer: IBM/

compatible or Macintosh; and if IBM/

compatible: the size of disk drive (3.5′′

or 5.25′′).

For technical assistance or questions

regarding computer resources, call the

Guideline Review Technical Support at

(301) 231–5250 ext. 100 and ask for Ms.

Cheryl Campbell.

FOR ADDITIONAL INFORMATION: Additional

information on the guideline

development process is contained in the

AHCPR Program Note, ‘‘Clinical

Practice Guideline Development,’’

(AHCPR Publication No. 93–0023) dated

August 1993.

This document may be obtained from

the AHCPR Publications Clearinghouse,

P.O. Box 8547, Silver Spring, MD 20907;

or call toll-free: 1–800–358–9295.

Dated: December 1, 1995.

Clifton R. Gaus,

Administrator.

[FR Doc. 95–29865 Filed 12–6–95; 8:45 am]

BILLING CODE 4160–90–M

Food and Drug Administration

[Docket No. 95E–0300]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; CELLCEPT

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

CELLCEPT 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,

rm. 1–23, 12420 Parklawn Dr.,

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 CELLCEPT

(mycophenolate mofetil). CELLCEPT

is indicated for the prophylaxis of organ

rejection in patients receiving allogeneic

renal transplants. Subsequent to this

approval, the Patent and Trademark

Office received a patent term restoration

application for CELLCEPT (U.S. Patent

No. 4,753,935) from Syntex, 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

October 2, 1995, FDA advised the Patent

and Trademark Office that this human

drug product had undergone a

regulatory review period and that the

approval of CELLCEPT 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

CELLCEPT is 2,479 days. Of this time,

2,304 days occurred during the testing

phase of the regulatory review period,

while 175 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: July 21, 1988. The

applicant claims June 24, 1988, as the

date the investigational new drug

application (IND) became effective.

However, FDA records indicate that the

IND effective date was July 21, 1988,

which was 30 days after FDA receipt of

IND 31,747 on June 21, 1988.

2. The date the application was

initially submitted with respect to the

human drug product under section 507

of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 357): November 10, 1994.

FDA has verified the applicant’s claim

that the new drug application (NDA) for

CELLCEPT (NDA 50–722) was initially

submitted on November 10, 1994.

3. The date the application was

approved: May 3, 1995. FDA has

verified the applicant’s claim that NDA

50–722 was approved on May 3, 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 824 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before February 5, 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 June 5, 1996, for a

determination regarding whether the
62866 Federal Register / Vol. 60, No. 235 / Thursday, December 7, 1995 / Notices

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: November 30, 1995.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 95–29768 Filed 12–6–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95E–0299]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; ZINECARDTM

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

ZINECARDTM 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,

rm. 1–23, 12420 Parklawn Dr.,

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 ZINECARDTM

(dexrazoxane). ZINECARDTM is

indicated for reducing the incidence

and severity of cardomyopathy

associated with doxorubicin

administration in women with

metastatic breast cancer who have

received a cumulative doxorubicin dose

of 300 milligrams per square meter and

who, in their physician’s opinion,

would benefit from continuing therapy

with doxorubicin. Subsequent to this

approval, the Patent and Trademark

Office received a patent term restoration

application for ZINECARDTM (U.S.

Patent No. 4,275,063) from British

Technology Group Ltd., and the Patent

and Trademark Office requested FDA’s

assistance in determining this patent’s

eligibility for patent term restoration. In

a letter dated October 5, 1995, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of ZINECARDTM

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

ZINECARDTM is 2,748 days. Of this

time, 1,546 days occurred during the

testing phase of the regulatory review

period, while 1,202 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: November 18, 1987.

The applicant claims September 25,

1987, as the date the investigational new

drug application (IND) for ZINECARDTM

(IND 30,617) became effective. However,

FDA records indicate that the agency

received IND 30,617 on September 22,

1987. IND 30,617 was placed on clinical

hold on October 22, 1987, and was

removed from hold on November 18,

1987. The date IND 30,617 was removed

from hold, November 18, 1987, is the

IND effective date.

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: February 10, 1992. The

applicant claims February 7, 1992, as

the date the new drug application

(NDA) for ZINECARDTM (NDA 20–212)

was initially submitted. However, FDA

records indicate that FDA received NDA

20–212 on February 10, 1992, making

February 10, 1992, the beginning of the

NDA regulatory review period.

3. The date the application was

approved: May 26, 1995. FDA has

verified the applicant’s claim that NDA

20–212 was approved on May 26, 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.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before February 5, 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 June 5, 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