62868 Federal Register / Vol. 60, No. 235 / Thursday, December 7, 1995 / Notices

New Orleans and Nashville Districts,

and Center for Food Safety and Applied

Nutrition) is announcing a free public

meeting as a followup to a meeting held

in April 1995. The New Orleans and

Nashville Offices of FDA will meet with

interested persons in the States of

Alabama, Louisiana, Mississippi, and

Tennessee to address specific issues of

concern to the seafood processing

industry, other stakeholders, and FDA.

Because the Interstate Shellfish

Sanitation Conference addressed the

issue of Vibrio vulnificus in raw oysters,

this meeting will not cover that issue.

Any other seafood issue will be open for

discussion. The agency is holding this

meeting to promote the President’s

initiative for a partnership approach

between front-line regulators and the

people affected by the work of

regulatory agencies, and to create local

partnerships.

DATES: The public meeting will be held

on Friday, January 19, 1996, from 10

a.m. to 3:30 p.m.

ADDRESSES: The public meeting will be

held at the Grand Casino Hotel Gulfport,

3305 West Beach Blvd., Gulfport, MS

39501, 601–870–7770 or 1–800–354–

2450.

FOR FURTHER INFORMATION CONTACT:

Sandra S. Baxter, FDA Nashville

District, 297 Plus Park Blvd., Nashville,

TN 37217, 615–781–5372, FAX 615–

781–5383.

SUPPLEMENTARY INFORMATION: In the

Federal Register of April 20, 1995 (60

FR 19753), FDA announced that a series

of Grassroots Regulatory Partnership

Meetings would be held. This document

announces a followup meeting to the

one held on April 25, 1995, in Atlanta,

GA. Those persons interested in

attending this public meeting should

FAX or send their registration, and

comments or questions desired to be

addressed to the meeting to the above

contact person by January 5, 1996.

There is no registration fee for this

meeting. However, due to space

limitations, early registration is

required. The goal of this meeting is to

listen to concerns and ideas of the

regulated seafood industry and other

stakeholders, and to identify possible

next steps for the agency.

Dated: December 1, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–29767 Filed 12–6–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95E–0311 ]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; VALTREX

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

VALTREX 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 VALTREX

(valacyclovir hydrochloride).

VALTREX is indicated for the

treatment of herpes zoster (shingles) in

immunocompetent adults. Subsequent

to this approval, the Patent and

Trademark Office received a patent term

restoration application for VALTREX

(U.S. Patent No. 4,957,924) from

Burroughs Wellcome Co., 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 VALTREX

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

VALTREX is 1,907 days. Of this time,

1,541 days occurred during the testing

phase of the regulatory review period,

while 366 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: April 5, 1990. The

applicant claims March 6, 1990, as the

date the investigational new drug

application (IND) became effective. The

applicant claims that FDA waived the

30-day post-submission review period

and the effective date of the IND relates

back to the date of submission, March

6, 1990. According to FDA records, a

safety meeting was held on March 23,

1990, for IND 34,526. The meeting is

held within 30 days of receipt of an IND

to determine its safety in humans. At

the meeting it was agreed by the

reviewing disciplines that the study was

reasonably safe to proceed. There is no

record of any waiver for this IND. If a

waiver had been issued, there would

have been no need to have the safety

review meeting. Therefore, the correct

IND effective date for IND 34,526 is

April 5, 1990, 30 days after agency

receipt of IND 34,526.

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: June 23, 1994. FDA has
Federal Register / Vol. 60, No. 235 / Thursday, December 7, 1995 / Notices 62869

verified the applicant’s claim that the

new drug application (NDA) for

VALTREX (NDA 20–487) was initially

submitted on June 23, 1994.

3. The date the human drug was

approved: June 23, 1995. FDA has

verified the applicant’s claim that NDA

20–487 was approved on June 23, 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 1,052 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

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. 95–29809 Filed 12–6–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95E–0302]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; ULTANETM

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

ULTANETM 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:

Brain 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 ULTANETM

(sevoflurane). ULTANETM is indicated

for induction and maintenance of

general anesthesia in adult and pediatric

patients for inpatient and outpatient

surgery. Subsequent to this approval,

the Patent and Trademark Office

received a patent term restoration

application for ULTANETM (U.S. Patent

No. 4,250,334) from Baxter

International, 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 September 25, 1995, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of ULTANETM

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

ULTANETM is 3,418 days. Of this time,

3,086 days occurred during the testing

phase of the regulatory review period,

while 332 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: January 29, 1986. The

applicant claims January 10, 1986, as

the date the investigational new drug

(IND) became effective. However, FDA

records indicate that the correct IND

effective date was January 29, 1985,

which was 30 days after FDA receipt of

IND 27,645 on December 30, 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: July 11, 1994. The

applicant claims July 8, 1994, as the

date the new drug application (NDA) for

ULTANETM (NDA 20–478) was initially

submitted. However, FDA records

indicate that the applicant submitted

NDA 20–478 on July 8, 1994, and the

agency received the NDA on July 11,

1994, which is considered to be the

NDA initially submitted date.

3. The date the application was

approved: June 7, 1995. FDA has

verified the applicant’s claim that NDA

20–478 was approved on June 7, 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 1,826 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,