Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 / Notices 37399

approval of STROMECTOL

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

STROMECTOL is 2,291 days. Of this

time, 2,055 days occurred during the

testing phase of the regulatory review

period, while 236 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) (21 U.S.C.

355) became effective: August 17, 1990.

The applicant claims July 17, 1990, as

the date the investigational new drug

application (IND) became effective.

However, FDA records indicate that the

IND effective date was August 17, 1990,

which was 30 days after FDA receipt of

the IND.

2. The date the application was

initially submitted with respect to the

human drug product under section 505

of the act: April 1, 1996. The applicant

claims March 29, 1996, as the date the

new drug application (NDA) for

STROMECTOL (NDA 50–742) was

initially submitted. However, FDA

records indicate that NDA 50–742 was

submitted on April 1, 1996.

3. The date the application was

approved: November 22, 1996. FDA has

verified the applicant’s claim that NDA

50–742 was approved on November 22,

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 1,026 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before September 8, 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 6, 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. 98–18400 Filed 7–9–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97E–0359]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; FlowmaxTM

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

FlowmaxTM 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,

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 FlowmaxTM

(tamsulosin hydrochloride). FlowmaxTM

is indicated for the treatment of the

signs and symptoms of benign prostatic

hyperplasia (BPH). Subsequent to this

approval, the Patent and Trademark

Office received a patent term restoration

application for FlowmaxTM (U.S. Patent

No. 4,868,216) from Yamanouchi

Pharmaceutical, 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 FlowmaxTM

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

FlowmaxTM is 3,529 days. Of this time,

3,163 days occurred during the testing

phase of the regulatory review period,

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 of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

355) became effective: August 19, 1987.

FDA has verified the applicant’s claim

that the date the investigational new
37400 Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 / Notices

drug application became effective was

on August 19, 1987.

2. The date the application was

initially submitted with respect to the

human drug product under section 505

of the act: April 15, 1996. FDA has

verified the applicant’s claim that the

new drug application (NDA) for

FlowmaxTM (NDA 20–579) was initially

submitted on April 15, 1996.

3. The date the application was

approved: April 15, 1997. FDA has

verified the applicant’s claim that NDA

20–579 was approved on April 15, 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 1,669 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before September 8, 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 6, 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. 98–18407 Filed 7–9–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Antimicrobial Drugs and Resistance;

Notice of Public Meeting

AGENCY: Food and Drug

Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

public meeting to discuss the

development of drug products for the

treatment of resistant bacteria, including

selective spectrum agents. The purpose

of the meeting is to provide information

on the agency’s plans for future public

scientific discussions of issues unique

to the development of these drug

products and to invite members of the

public to provide comments on the

agency’s plans.

DATES: The public meeting will be held

on Tuesday, July 28, 1998, from 2 p.m.

to 6 p.m.

ADDRESSES: The public meeting will be

held in conference rooms G and H,

Parklawn Bldg., 5600 Fishers Lane,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Thomas H. Hassall, Center for Drug

Evaluation and Research (HFD–104),

Food and Drug Administration, 9201

Corporate Blvd., Rockville, MD 20850,

301–827–2489.

SUPPLEMENTARY INFORMATION: FDA will

hold a public meeting on July 28, 1998,

to discuss its plans for a presentation at

a fall 1998 advisory committee meeting

and possible future meetings on the

development of drug products to treat

resistant bacteria, including selective

spectrum agents. At the fall 1998

advisory committee meeting, FDA plans

to discuss issues unique to the

development of such products,

including clinical trial design and

labeling issues. At the meeting, FDA

will present its thoughts on the issues

that should be presented to the advisory

committee and will solicit public input

on the structure of the discussion and

additional issues that should be

presented.

There is no registration for this

meeting, however, space is limited.

Persons interested in attending the

meeting should contact the person listed

above.

An agenda for the public meeting will

be available 2 weeks before the meeting,

via the Internet using the World Wide

Web (WWW). To connect to the CDER

home page, type ‘‘http://www.fda.gov/

cder’’ and go to the ‘‘What’s Happening’’

section.

Dated: July 3, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–18397 Filed 7–9–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

1998 FDA Science Forum—

Biotechnology: Advances,

Applications, and Regulatory

Challenges

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of meeting.

The Food and Drug Administration’s

(FDA’s) Office of Science is announcing

the following meeting: ‘‘1998 FDA

Science Forum—Biotechnology:

Advances, Applications, and Regulatory

Challenges.’’ The Forum will bring FDA

research and review scientists together

with representatives of industry,

academia, Government agencies,

consumer groups, and the public to

discuss the impact of the enormous

advances in biotechnology on product

development and regulation.

Date and Time: The meeting will be

held on Tuesday and Wednesday,

December 8 and 9, 1998; registration

from 7:00 a.m. to 8:30 a.m.; meeting

from 8:30 a.m. to 6:00 p.m. on December

8, and 8:30 a.m. to 5:00 p.m. on

December 9.

Location: The meeting will be held at

the Washington Convention Center, rms.

29–32 (lower level) and Hall C (upper

level) 900 Ninth Street, NW.,

Washington, DC 20001.

Contact: American Association of

Pharmaceutical Scientists at

<meetings@aaps.org>, 703–518–8429, or

Susan A. Homire, Food and Drug

Administration, Office of Science (HF–

32), 5600 Fishers Lane, Rockville, MD,

20857, 301–827–3366, e-mail

<shomire@bangate.fda.gov>.

Registration: Registration information

will be available in mid-July.

Attendance will be limited; therefore,

interested parties are encouraged to

register early.

If you need special accommodations

due to a disability, please contact the

American Association of

Pharmaceutical Scientists at least 3

weeks in advance.

Agenda: The program will encompass

bioengineered products, novel

therapeutic and preventive approaches,

diagnostics and detection

methodologies, and safety and efficacy