Federal Register / Vol. 63, No. 139 /Tuesday, July 21, 1998 / Notices 39097

6. Acute bacterial exacerbation of

chronic bronchitis,

7. Secondary bacterial infection of

acute bronchitis,

8. Acute otitis media,

9. Acute uncomplicated gonorrhea,

10. Acute sinusitus,

11. Complicated urinary tract

infections and pyelonephritis,

12. Bacterial prostatitis,

13. Early Lyme disease,

14. Empiric therapy of febrile

neutropenia,

15. Vulvovaginal candidiasis,

16. Streptococcal pharyngitis and

tonsillitis,

17. Bacterial meningitis, and

18. Bacterial vaginosis.

Key aspects of these draft guidances will

be discussed in a July 1998 advisory

committee meeting. After the meeting,

ODE IV will work toward finalizing

these guidances.

The next step will involve developing

draft guidance documents for the

following proposed indications:

1. Nongonoccocal urethritis/cervicitis,

2. Endocarditis,

3. Uncomplicated intra-abdominal

infections,

4. Complicated intra-abdominal

infections,

5. Gynecologic infections (except

sexually transmitted disease and pelvic

inflammatory disease),

6. Pelvic inflammatory disease,

7. Osteomyelitis (acute and chronic),

8. Acute bacterial arthritis, and

9. Helicobacter pylori infections.

Once developed, the agency expects that

it will release the guidances in draft for

review and comment, with key elements

discussed before the advisory

committee.

ODE IV also is considering developing

guidance during the next few years for

the following agents:

1. Agents to treat opportunistic

infections related to AIDS;

2. Antimycobacterial agents;

3. Antifungal agents;

4. Antiparasitic agents;

5. Immunologic/transplant agents;

6. Antiviral agents;

7. Dermatologic surgical scrubs, etc.;

8. Agents to treat sepsis/septic shock;

and

9. Agents used in surgical

prophylaxis.

As with the other guidances, it is

expected that these guidances will first

be issued in draft for review and

comment and discussed before the

advisory committee.

III. Comments

ODE IV is seeking suggestions and

recommendations for future guidance

development. Interested persons may

submit comments to the Dockets

Management Branch (address above).

Two copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document. Received comments may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

Dated: July 13, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–19319 Filed 7–20–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97E–0358]

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. 4,703,063) from Yamanouchi

Pharmaceutical Co., 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 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

drug application became effective was

on on August 19, 1987.
39098 Federal Register / Vol. 63, No. 139 /Tuesday, July 21, 1998 / Notices

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 1,825 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before September 21, 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 19, 1998, 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 26, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health

Affairs.

[FR Doc. 98–19379 Filed 7–20–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 98N–0473, 98P–0275, 98P–

0215, 98P–0216, and 98P–0338]

Medical Devices; Exemptions From

Premarket Notification; Class II

Devices

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is publishing a

list of petitions requesting exemption

from the premarket notification

requirements for certain class II devices.

FDA is publishing this notice in order

to obtain comments on these petitions

in accordance with procedures

established by the Food and Drug

Administration Modernization Act of

1997 (FDAMA).

DATES: Written comments by August 20,

1998.

ADDRESSES: Submit written comments

on this notice to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Heather S. Rosecrans, Center for Devices

and Radiological Health (HFZ–404),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1190.

SUPPLEMENTARY INFORMATION:

I. Statutory Background

Under section 513 of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360c), FDA must classify

devices into one of three regulatory

classes: Class I, class II, or class III. FDA

classification of a device is determined

by the amount of regulation necessary to

provide a reasonable assurance of safety

and effectiveness. Under the Medical

Device Amendments of 1976 (the 1976

amendments (Pub. L. 94–295)), as

amended by the Safe Medical Devices

Act of 1990 (the SMDA (Pub. L. 101–

629)), devices are to be classified into

class I (general controls) if there is

information showing that the general

controls of the act are sufficient to

assure safety and effectiveness; into

class II (special controls), if general

controls, by themselves, are insufficient

to provide reasonable assurance of

safety and effectiveness, but there is

sufficient information to establish

special controls to provide such

assurance; and into class III (premarket

approval), if there is insufficient

information to support classifying a

device into class I or class II and the

device is a life-sustaining or lifesupporting device or is for a use which

is of substantial importance in

preventing impairment of human

health, or presents a potential

unreasonable risk of illness or injury.

Most generic types of devices that

were on the market before the date of

the 1976 amendments (May 28, 1976)

(generally referred to as preamendments

devices) have been classified by FDA

under the procedures set forth in section

513(c) and (d) of the act through the

issuance of classification regulations

into one of these three regulatory

classes. Devices introduced into

interstate commerce for the first time on

or after May 28, 1976 (generally referred

to as postamendments devices) are

classified through the premarket

notification process under section

510(k) of the act (21 U.S.C. 360(k)).

Section 510(k) of the act and the

implementing regulations, 21 CFR part

807, require persons who intend to

market a new device to submit a

premarket notification report (510(k))

containing information that allows FDA

to determine whether the new device is

‘‘substantially equivalent’’ within the

meaning of section 513(i) of the act to

a legally marketed device that does not

require premarket approval.

On November 21, 1997, the President

signed into law FDAMA (Pub. L. 105–

115). Section 206 of FDAMA, in part,

added a new section 510(m) to the act.

Section 510(m)(1) of the act requires

FDA, within 60 days after enactment of

FDAMA, to publish in the Federal

Register a list of each type of class II

device that does not require a report

under section 510(k) of the act to

provide reasonable assurance of safety

and effectiveness. Section 510(m) of the

act further provides that a 510(k) will no

longer be required for these devices

upon the date of publication of the list

in the Federal Register. FDA published

that list in the Federal Register of

January 21, 1998 (63 FR 3142).

Section 510(m)(2) of the act provides

that, 1 day after date of publication of

the list under section 510(m)(1), FDA

may exempt a device on its own

initiative or upon petition of an

interested person, if FDA determines

that a 510(k) is not necessary to provide

reasonable assurance of the safety and

effectiveness of the device. This section

requires FDA to publish in the Federal

Register a notice of intent to exempt a

device, or of the petition, and to provide

a 30-day comment period. Within 120

days of publication of this document,

FDA must publish in the Federal

Register its final determination