Federal Register / Vol. 63, No. 137 / Friday, July 17, 1998 / Notices 38657

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

QUADRAMET (samarium sm 153

EDTMP). QUADRAMET is indicated

for relief of pain in patients with

confirmed osteoblastic metastatic bone

lesions that enhance radionuclide bone

scan. Subsequent to this approval, the

Patent and Trademark Office received a

patent term restoration application for

QUADRAMET (U.S. Patent No.

4,898,724) from The Dow Chemical 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

November 7, 1997, FDA advised the

Patent and Trademark Office that this

human drug product had undergone a

regulatory review period and that the

approval of QUADRAMET 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

QUADRAMET is 2,844 days. Of this

time, 2,189 days occurred during the

testing phase of the regulatory review

period, 655 days occurred during the

approval phase. These periods of time

were derived from the following dates:

1. The date an exemption under

section 505 of the Federal Food, Drug,

and Cosmetic Act (the act) became

effective (21 U.S.C. 355): June 16, 1989.

The applicant claims January 28,

1986, as the date the investigational new

drug application (IND) for

QUADRAMET (IND 33,240) became

effective for purposes of regulatory

review period determination. Applicant

also states the notice of clinical

investigation exemption was submitted

on May 16, 1989. However, FDA records

indicate that the IND effective date was

June 16, 1989, which was 30 days after

FDA receipt of IND 33,240.

2. The date the application was

initially submitted with respect to the

human drug product under section 505

of the act: June 13, 1995.

FDA has verified the applicant’s claim

that the new drug application (NDA) for

QUADRAMET (NDA 20,570) was

initially submitted on June 13, 1995.

3. The date the application was

approved: March 28, 1997. FDA has

verified the applicant’s claim that NDA

20,570 was approved on March 28,

1997.

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 1,412 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before September 15, 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 13, 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 23, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health

Affairs.

[FR Doc. 98–19027 Filed 7–16–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Nonprescription Drugs Advisory

Committee: Amendment of Notice

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

amendment to the notice of meeting of

the Nonprescription Drugs Advisory

Committee. This meeting was

announced in the Federal Register of

June 26, 1998 (63 FR 34902). The

amendment is being made to cancel the

entire session on July 28, 1998. There

are no other changes.

FOR FURTHER INFORMATION CONTACT:

Rhonda W. Stover or Angie Whitacre,

Center for Drug Evaluation and Research

(HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–7001, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12541.

SUPPLEMENTARY INFORMATION: In the

Federal Register of June 26, 1998 (63 FR

34902), FDA announced that a meeting

of the Nonprescription Drugs Advisory

Committee would be held on July 28

and 29, 1998.

1. On page 34902, in the third

column, the ‘‘Date and Time’’ portion is

amended to read as follows:

Date and Time: The meeting will be

held on July 29, 1998, 8:30 a.m. to 5

p.m.

2. On page 34902, beginning in the

third column, the ‘‘Agenda’’ portion is

amended by removing the first

paragraph.
38658 Federal Register / Vol. 63, No. 137 / Friday, July 17, 1998 / Notices

3. On page 34903, in the first column,

under the ‘‘Procedure’’ portion, in the

ninth line, ‘‘July 28 and 29’’ is corrected

to read ‘‘July 29’’.

Dated: July 10, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–19031 Filed 7–17–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Nucleic Acid Testing for Hepatitis C

Virus (HCV) and Other Viruses in

Blood Donors; Public Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

The Food and Drug Administration

(FDA) is announcing the following

public workshop: Nucleic Acid Testing

for Hepatitis C Virus (HCV) and Other

Viruses in Blood Donors. The topic to be

discussed is the exploration of the

current state of technology and

implementation of nucleic acid testing

for screening blood donors.

Date and Time: The workshop will be

held on Wednesday, September 16,

1998, 8:30 a.m. to 5 p.m.

Location: The workshop will be held

at the Parklawn Bldg., 3d floor,

conference rooms D and E, 5600 Fishers

Lane, Rockville, MD 20857.

Contact: Joseph Wilczek, Center for

Biologics Evaluation and Research

(HFM–350), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–827–

6129, FAX 301–827–2843.

Registration: Mail or fax registration

information (including name, title, firm

name, address, telephone, and fax

number) to the contact person by

Friday, September 4, 1998. Registration

at the site will done on a space available

basis on the day of the workshop,

beginning at 7:30 a.m. There is no

registration fee for the workshop. Space

is limited, therefore interested parties

are encouraged to register early.

If you need special accommodations

due to a disability, please contact Joseph

Wilczek at least 7 days in advance.

Agenda: The public workshop is

intended to discuss nucleic acid testing

that currently is the most sensitive

method available to further reduce

disease transmission by blood

transfusion in the early window phase

of infection. Nucleic acid testing is

being implemented for blood donor

screening by testing plasma pools, and

pool testing may be useful by serving as

an interim measure until screening of

individual blood donations is

technologically feasible.

Regulatory and scientific topics to be

discussed at the workshop include

donor testing issues, pooling strategies,

and test validation and reference

materials for standardization of various

nucleic acid technologies.

Transcripts: Transcripts of the

meeting may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, 5600 Fishers Lane, rm.

12A–16, Rockville, MD 20857,

approximately 15 working days after the

meeting at a cost of 10 cents per page.

Dated: July 9, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–19110 Filed 7–16–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Oncologic Drugs Advisory Committee;

Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Oncologic Drugs

Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on September 1, 1998, 8:30 a.m. to

5:30 p.m., and September 2 and 3, 1998,

8 a.m. to 5:30 p.m.

Location: Holiday Inn, Versailles

Ballroom, 8120 Wisconsin Ave.,

Bethesda, MD.

Contact Person: Karen M. TempletonSomers, Center for Drug Evaluation and

Research (HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–7001, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12542. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On September 1, 1998, the

committee will discuss: (1) New drug

application (NDA) 20–893 MetaretTM

(suramin hexasodium for injection),

Parke-Davis Pharmaceutical Research,

indicated for the treatment of patients

with hormone refractory prostate

cancer; and (2) NDA 20–892 ValstarTM

(valrubicin 40 milligrams/milliliter),

Anthra Pharmaceuticals, Inc., indicated

for intravesical use in the treatment of

patients with biopsy-proven carcinoma

in situ of the urinary bladder who are

refractory to bacille Calmette-Gu ̃ erin

(BCG) immunotherapy and for whom

cystectomy is contraindicated. On

September 2, 1998, the committee will

discuss: (1) NDA supplement 17–970/S–

040 Nolvadex (tamoxifen citrate),

Zeneca Pharmaceuticals, indicated for

the prevention of breast cancer in

women at high risk; and (2) biologics

license application (BLA) 98–0369

HerceptinTM (trastuzumab), Genentech,

Inc., indicated for the treatment of

patients with metastatic breast cancer

who have tumors which overexpress

HER2. On September 3, 1998, the

committee will discuss: (1) NDA

supplement 20–571/S–08 CamptosarTM

(irinotecan hydrochloride injection),

Pharmacia & Upjohn, indicated for the

treatment of patients with metastatic

carcinoma of the colon or rectum whose

disease has recurred or progressed

following a 5-FU-based therapy; and (2)

NDA supplement 20–451/S–003

Photofrin (porfimer sodium) for

injection, QLT PhotoTherapeutics, Inc.,

indicated for the reduction of

obstruction and palliation of symptoms

in patients with completely or partially

obstructing endobronchial nonsmall cell

lung cancer.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by August 14, 1998. Oral

presentations from the public will be

scheduled between approximately 8:45

a.m. and 9:15 a.m., on September 1,

1998, and between approximately 8:15

a.m. and 8:45 a.m., on September 2 and

3, 1998. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before August 14, 1998, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).