Federal Register / Vol. 62, No. 54 / Thursday, March 20, 1997 / Notices 13387

STATUS: Closed.

MATTERS TO BE CONSIDERED:

1. Proposals relating to Federal

Reserve System benefits.

2. Proposed minutes of the Committee

on Employee Benefits meetings.

3. Any items carried forward from a

previously announced meeting.

CONTACT PERSON FOR MORE INFORMATION:

Mr. Joseph R. Coyne, Assistant to the

Board; (202) 452–3204.

Dated: March 18, 1997.

William W. Wiles,

Secretary of the Board.

[FR Doc. 97–7189 Filed 3–18–97; 11:35 am]

BILLING CODE 6210–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Universal Newborn Hearing Ad Hoc

Group; Teleconference Meetings

The National Center for

Environmental Health (NCEH) of the

Centers for Disease Control and

Prevention (CDC) announces the

following meetings.

Name: Teleconference meetings of the Ad

Hoc Group for Universal Newborn Hearing

Screening (UNHS).

Times and Dates: 2 p.m.–3 p.m., April 1,

1997; 2 p.m.–3 p.m., May 6, 1997; 2 p.m.–

3 p.m., June 3, 1997; 2 p.m.–3 p.m., July 1,

1997; 2 p.m.–3 p.m., August 5, 1997; 2 p.m.–

3 p.m., September 2, 1997.

Place: National Center for Environmental

Health, Division of Birth Defects and

Developmental Disabilities (DBDDD), Room

2103A, Building 101, 4770 Buford Highway,

NE, Atlanta, Georgia 30341. Telephone 770/

488–7400.

Status: Open for participation by anyone

with an interest in UNHS. All participants in

the monthly conference calls are, by

definition, members of the Ad Hoc Group for

Universal Newborn Hearing Screening.

Persons wishing to participate must E-mail or

fax their request 1 week prior to the

scheduled teleconference date. The e-mail

address is unhs@cdc.gov; the fax number is

770/488–7361. Participants will be notified

of the toll-free teleconference phone number

and a caller code. Each participant will have

the responsibility to call in to connect to the

conference call. The conference bridge

number is limited to 238 callers.

Purpose: This meeting will provide a

forum for persons associated with UNHS

programs to report and review relevant

activities. Each conference call will be

comprised of a series of scheduled

presentations. Each presentation will be

followed by a brief question and answer

period. The agenda for the conference call

will be determined by the Division of Birth

Defects and Developmental Disabilities in

collaboration with the Office of Disability

and Health, NCEH, (pending approval); in

consultation with the National Institute on

Deafness and Communicative Disorders,

National Institutes of Health; the Bureau of

Maternal and Child Health, Health Resources

and Services Administration; Office of

Special Education and Rehabilitative

Services, Department of Education; and

others interested in newborn hearing

screening.

Suggestions and feedback are invited by

conference call planners. Participants

requesting to be on the agenda or wishing to

make written comments can send their

requests or comments to the E-mail address

or fax number noted above.

Matters Discussed: Topics to be discussed

during the meetings include progress on

State and National activities to implement

UNHS; progress on establishing State and

National data systems on UNHS; and

guidelines for establishing screening,

diagnosis, and intervention protocols.

For further information contact: June

Holstrum, DBDDD, NCEH, CDC, 4770 Buford

Highway, NE, M/S F–15, Atlanta, Georgia

30341, telephone 770/488–7401, fax 770/

488–7361.

Dated: March 14, 1997.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 97–7016 Filed 3–19–97; 8:45 am]

BILLING CODE 4163–18–P

Food and Drug Administration

[Docket No. 96E–0442]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; CEREBYX

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

CEREBYX 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 CEREBYX

(fosphenytoin sodium). CEREBYX is

indicated for short-term parenteral

administration when other means of

phenytoin administration are

unavailable, inappropriate, or deemed

less advantageous. Subsequent to this

approval, the Patent and Trademark

Office received a patent term restoration

application for CEREBYX (U.S. Patent

No. 4,260,769) from Warner-Lambert 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

January 21, 1997, FDA advised the

Patent and Trademark Office that this

human drug product had undergone a

regulatory review period and that the

approval of CEREBYX 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
13388 Federal Register / Vol. 62, No. 54 / Thursday, March 20, 1997 / Notices

CEREBYX is 3,748 days. Of this time,

3,218 days occurred during the testing

phase of the regulatory review period,

while 530 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: May 4, 1986. FDA has

verified the applicant’s claim that the

date that the investigational new drug

application became effective was on

May 4, 1986.

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 23, 1995. The

applicant claims July 14, 1994, as the

date the new drug application (NDA) for

CEREBYX (NDA 20–450) was initially

submitted. However, FDA records

indicate that NDA 20–450, received by

the agency on July 15, 1994, was

incomplete. FDA refused this

application and notified the applicant of

this fact by letter dated September 12,

1994. The completed NDA was then

received on February 23, 1995, which is

considered to be the NDA initially

submitted date.

3. The date the application was

approved: August 5, 1996. FDA has

verified the applicant’s claim that NDA

20–450 was approved on August 5,

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 1,826 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before May 20, 1997, 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 September 22, 1997, 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: March 12, 1997.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 97–6976 Filed 3–19–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96E–0440]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; HYCAMTINTM

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

HYCAMTINTM 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 HYCAMTINTM

(topotecan hydrochloride).

HYCAMTINTM is indicated for the

treatment of patients with metastatic

carcinoma of the ovary after failure of

initial or subsequent chemotherapy.

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for

HYCAMTINTM (U.S. Patent No.

5,004,758) from SmithKline Beecham

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

January 13, 1997, FDA advised the

Patent and Trademark Office that this

human drug product had undergone a

regulatory review period and that the

approval of HYCAMTINTM 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

HYCAMTINTM is 2,644 days. Of this

time, 2,485 days occurred during the

testing phase of the regulatory review

period, while 159 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: March 4, 1989. The

applicant claims January 30, 1989, as

the date the investigational new drug

application (IND) for HYCAMTINTM

(IND 32,693) became effective. However,

FDA records indicate that IND 32,693

was received at FDA on February 2,

1989, and became effective 30 days later

on March 4, 1989.

2. The date the application was

initially submitted with respect to the

human drug product under section