Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Notices 4301

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 DIFFERIN

Solution (adapalene). DIFFERIN

Solution is indicated for the topical

treatment of acne vulgaris. Subsequent

to this approval, the Patent and

Trademark Office received a patent term

restoration application for DIFFERIN

Solution (U.S. Patent No. Re. 34,440)

from Centre International de Recherches

Dermatologiques (CIRD), 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 24, 1996, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of DIFFERIN

Solution 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

DIFFERIN Solution is 2,814 days. Of

this time, 1,651 days occurred during

the testing phase of the regulatory

review period, while 1,163 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: September 18, 1988.

FDA has verified the applicant’s claim

that the date that the investigational

new drug application became effective

was on September 18, 1988.

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: March 26, 1993. The

applicant claims March 19, 1993, as the

date the new drug application (NDA) for

DIFFERIN Solution (NDA 20–338) was

initially submitted. However, FDA

records indicate that NDA 20–338 was

submitted on March 26, 1993.

3. The date the application was

approved: May 31, 1996. FDA has

verified the applicant’s claim that NDA

20–338 was approved on May 31, 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 433 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before March 31, 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 July 28, 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: January 17, 1997.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 97–2141 Filed 1–28–97; 8:45 am]

BILLING CODE 4160–01–F

Advisory Committees; Notice of

Meetings

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: This notice announces

forthcoming meetings of public advisory

committees of the Food and Drug

Administration (FDA). This notice also

summarizes the procedures for the

meetings and methods by which

interested persons may participate in

open public hearings before FDA’s

advisory committees.

FDA has established an Advisory

Committee Information Hotline (the

hotline) using a voice-mail telephone

system. The hotline provides the public

with access to the most current

information on FDA advisory committee

meetings. The advisory committee

hotline, which will disseminate current

information and information updates,

can be accessed by dialing 1–800–741–

8138 or 301–443–0572. Each advisory

committee is assigned a 5-digit number.

This 5-digit number will appear in each

individual notice of meeting. The

hotline will enable the public to obtain

information about a particular advisory

committee by using the committee’s 5-

digit number. Information in the hotline

is preliminary and may change before a

meeting is actually held. The hotline

will be updated when such changes are

made.

MEETINGS: The following advisory

committee meetings are announced:

Drug Abuse Advisory Committee

Date, time, and place. February 10,

1997, 8:30 a.m., and February 11, 1997,

9 a.m., Holiday Inn—Gaithersburg,

Grand Ballroom, Two Montgomery

Village Ave., Gaithersburg, MD.

Type of meeting and contact person.

Open public hearing, February 10, 1997,

8:30 a.m. to 9:30 a.m.; unless public

participation does not last that long;

open committee discussion, 9:30 a.m. to

11 a.m.; closed presentation of data, 11

a.m. to 2 p.m.; closed committee

deliberations, 2 p.m. to 5:30 p.m.; open

public hearing, February 11, 1997, 9

a.m. to 10 a.m., unless public

participation does not last that long;

open committee discussion, 10 a.m. to

5:30 p.m.; Kimberly L. Topper, Center

for Drug Evaluation and Research (HFD–

21), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–443–5455, or FDA Advisory

Committee Information Hotline, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), Drug Abuse

Advisory Committee, code 12535.
4302 Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Notices

Please call the hotline for information

concerning any possible changes.

General function of the committee.

The committee advises on the scientific

and medical evaluation of information

gathered by the Department of Health

and Human Services and the

Department of Justice on the safety,

efficacy, and abuse potential of drugs

and recommends actions to be taken on

the marketing, investigation, and control

of such drugs.

Agenda—Open public hearing.

Interested persons may present data,

information, or views, orally or in

writing, on issues pending before the

committee. Those desiring to make

formal presentations should notify the

contact person before January 27, 1997,

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 required to make their

comments. This statement may be faxed

to Kimberly L. Topper at 301–443–0699,

or E-mailed to TOPPERK@cder.fda.gov.

Open committee discussion. On

February 10, 1997, the committee will

discuss QuitTM Brand silver acetate

lozenges, New Life Health Products, for

smoking cessation. On February 11,

1997, the committee will discuss new

drug application (NDA) 11–792, Soma

(carisoprodol generic tablets, Wallace

Laboratory), for muscle relaxation and

generic drugs containing carisoprodol.

The committee will consider a Drug

Enforcement Administration petition

regarding scheduling of carisoprodol

under the Controlled Substances Act.

Closed presentation of data. On

February 10, 1997, the committee will

hear trade secret and/or confidential

commercial information relevant to

pending investigational new drugs

(IND’s) and NDA’s. This portion of the

meeting will be closed to permit

discussion of this information (5 U.S.C.

552b(c)(4)).

Closed committee deliberations. On

February 10, 1997, the committee will

review trade secret and/or confidential

commercial information relevant to

pending IND’s or NDA’s. This portion of

the meeting will be closed to permit

discussion of this information. (5 U.S.C.

552b (c)(4)).

Endocrinologic and Metabolic Drugs

Advisory Committee

Date, time, and place. February 20

and 21, 1997, 8 a.m., Holiday Inn—

Bethesda, Versailles Ballrooms I and II,

8120 Wisconsin Ave., Bethesda, MD.

Type of meeting and contact person.

Open public hearing February 20, 1997,

8 a.m. to 9 a.m.; unless public

participation does not last that long;

open committee discussion, 9 a.m. to 4

p.m.; closed presentation of data,

February 21, 1997, 8 a.m. to 1 p.m.;

closed committee deliberations, 1 p.m.

to 4 p.m.; Kathleen R. Reedy or LaNise

S. Giles, Center for Drug Evaluation and

Research (HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–5455, or

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area),

Endocrinologic and Metabolic Drugs

Advisory Committee, code 12536.

Please call the hotline for information

concerning any possible changes.

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness of

marketed and investigational human

drugs for use in endocrine and

metabolic disorders.

Agenda—Open public hearing.

Interested persons may present data,

information, or views, orally or in

writing, on issues pending before the

committee. Those desiring to make

formal presentations should notify the

contact person before February 14, 1997,

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 required to make their

comments.

Open committee discussion. On

February 20, 1997, the committee will

hear presentations and discuss data

submitted regarding NDA 20–560/S–

003, Fosamax (alendronate sodium

tablets, Merck & Co.) for an expansion

of the indication to include the

prevention of postmenopausal

osteoporosis.

Closed presentation of data. On

February 21, 1997, the committee will

hear trade secret and/or confidential

commercial information relevant to

pending IND’s and NDA’s. This portion

of the meeting will be closed to permit

discussion of this information (5 U.S.C.

552b(c)(4)).

Closed committee deliberations. On

February 21, 1997, the committee will

discuss trade secret and/or confidential

commercial information relevant to

pending IND’s and NDA’s. This portion

of the meeting will be closed to permit

discussion of this information (5 U.S.C.

552b(c)(4)).

Each public advisory committee

meeting listed above may have as many

as four separable portions: (1) An open

public hearing, (2) an open committee

discussion, (3) a closed presentation of

data, and (4) a closed committee

deliberation. Every advisory committee

meeting shall have an open public

hearing portion. Whether or not it also

includes any of the other three portions

will depend upon the specific meeting

involved. The dates and times reserved

for the separate portions of each

committee meeting are listed above.

The open public hearing portion of

the meeting(s) shall be at least 1 hour

long unless public participation does

not last that long. It is emphasized,

however, that the 1 hour time limit for

an open public hearing represents a

minimum rather than a maximum time

for public participation, and an open

public hearing may last for whatever

longer period the committee

chairperson determines will facilitate

the committee’s work.

Public hearings are subject to FDA’s

guideline (subpart C of 21 CFR part 10)

concerning the policy and procedures

for electronic media coverage of FDA’s

public administrative proceedings,

including hearings before public

advisory committees under 21 CFR part

14. Under 21 CFR 10.205,

representatives of the electronic media

may be permitted, subject to certain

limitations, to videotape, film, or

otherwise record FDA’s public

administrative proceedings, including

presentations by participants.

Meetings of advisory committees shall

be conducted, insofar as is practical, in

accordance with the agenda published

in this Federal Register notice. Changes

in the agenda will be announced at the

beginning of the open portion of a

meeting.

Any interested person who wishes to

be assured of the right to make an oral

presentation at the open public hearing

portion of a meeting shall inform the

contact person listed above, either orally

or in writing, prior to the meeting. Any

person attending the hearing who does

not in advance of the meeting request an

opportunity to speak will be allowed to

make an oral presentation at the

hearing’s conclusion, if time permits, at

the chairperson’s discretion.

The agenda, the questions to be

addressed by the committee, and a

current list of committee members will

be available at the meeting location on

the day of the meeting.

Transcripts of the open portion 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.

The transcript may be viewed at the

Dockets Management Branch (HFA–

305), Food and Drug Administration,
Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Notices 4303

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857, approximately 15

working days after the meeting, between

the hours of 9 a.m. and 4 p.m., Monday

through Friday. Summary minutes of

the open portion of the meeting may be

requested in writing from the Freedom

of Information Office (address above)

beginning approximately 90 days after

the meeting.

The Commissioner has determined for

the reasons stated that those portions of

the advisory committee meetings so

designated in this notice shall be closed.

The Federal Advisory Committee Act

(FACA) (5 U.S.C. app. 2, 10(d)), permits

such closed advisory committee

meetings in certain circumstances.

Those portions of a meeting designated

as closed, however, shall be closed for

the shortest possible time, consistent

with the intent of the cited statutes.

The FACA, as amended, provides that

a portion of a meeting may be closed

where the matter for discussion involves

a trade secret; commercial or financial

information that is privileged or

confidential; information of a personal

nature, disclosure of which would be a

clearly unwarranted invasion of

personal privacy; investigatory files

compiled for law enforcement purposes;

information the premature disclosure of

which would be likely to significantly

frustrate implementation of a proposed

agency action; and information in

certain other instances not generally

relevant to FDA matters.

Examples of portions of FDA advisory

committee meetings that ordinarily may

be closed, where necessary and in

accordance with FACA criteria, include

the review, discussion, and evaluation

of drafts of regulations or guidelines or

similar preexisting internal agency

documents, but only if their premature

disclosure is likely to significantly

frustrate implementation of proposed

agency action; review of trade secrets

and confidential commercial or

financial information submitted to the

agency; consideration of matters

involving investigatory files compiled

for law enforcement purposes; and

review of matters, such as personnel

records or individual patient records,

where disclosure would constitute a

clearly unwarranted invasion of

personal privacy.

Examples of portions of FDA advisory

committee meetings that ordinarily shall

not be closed include the review,

discussion, and evaluation of general

preclinical and clinical test protocols

and procedures for a class of drugs or

devices; consideration of labeling

requirements for a class of marketed

drugs or devices; review of data and

information on specific investigational

or marketed drugs and devices that have

previously been made public;

presentation of any other data or

information that is not exempt from

public disclosure pursuant to the FACA,

as amended; and, deliberation to

formulate advice and recommendations

to the agency on matters that do not

independently justify closing.

This notice is issued under section

10(a)(1) and (a)(2) of the Federal

Advisory Committee Act (5 U.S.C. app.

2), and FDA’s regulations (21 CFR part

14) on advisory committees.

Dated: January 22, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–2168 Filed 1–28–97; 8:45 am]

BILLING CODE 4160–01–F

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: This notice announces a

forthcoming meeting of a public

advisory committee of the Food and

Drug Administration (FDA). This notice

also summarizes the procedures for the

meeting and methods by which

interested persons may participate in

open public hearings before FDA’s

advisory committees.

FDA has established an Advisory

Committee Information Hotline (the

hotline) using a voice-mail telephone

system. The hotline provides the public

with access to the most current

information on FDA advisory committee

meetings. The advisory committee

hotline, which will disseminate current

information and information updates,

can be accessed by dialing 1–800–741–

8138 or 301–443–0572. Each advisory

committee is assigned a 5-digit number.

This 5-digit number will appear in each

individual notice of meeting. The

hotline will enable the public to obtain

information about a particular advisory

committee by using the committee’s 5-

digit number. Information in the hotline

is preliminary and may change before a

meeting is actually held. The hotline

will be updated when such changes are

made.

MEETING: The following advisory

committee meeting is announced:

Radiological Devices Panel of the

Medical Devices Advisory Committee

Date, time, and place. February 24,

1997, 8 a.m., Corporate Bldg.,

conference room 020B, 9200 Corporate

Blvd., Rockville, MD. A limited number

of overnight accommodations have been

reserved at the Gaithersburg Marriott

Washingtonian Center, 9751

Washingtonian Blvd., Gaithersburg, MD.

Attendees requiring overnight

accommodations may contact the hotel

at 301–590–0044 and reference the FDA

Panel meeting block. Reservations will

be confirmed at the group rate based on

availability. Attendees with a disability

requiring special accommodations

should contact Christie Wyatt, KRA

Corp., 301–495–1591, ext. 267. The

availability of appropriate

accommodations cannot be assured

unless prior written notification is

received.

Type of meeting and contact person.

Open public hearing, 8 a.m. to 9:15 a.m.,

unless public participation does not last

that long; open committee discussion,

9:15 a.m. to 12 m.; closed committee

deliberations, 12 m. to 1 p.m.; open

committee discussion, 1 p.m. to 4:30

p.m.; John C. Monahan, Center for

Devices and Radiological Health (HFZ–

470), Food and Drug Administration,

9200 Corporate Blvd., Rockville, MD

20850, 301–594–1212, or FDA Advisory

Committee Information Hotline, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), Radiological

Devices Panel, code 12526. Please call

the hotline for information concerning

any possible changes.

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness of

marketed and investigational devices

and makes recommendations for their

regulation.

Agenda—Open public hearing.

Interested persons may present data,

information, or views, orally or in

writing, on issues pending before the

committee. Those desiring to make

formal presentations should notify the

contact person before February 17, 1997,

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 required to make their

comments.

Open committee discussion. The

committee will discuss general issues

related to a supplement to a premarket

approval application (PMA) for an

ultrasound contrast agent indicated for

use with ultrasound assessment of the

female reproductive organs to

demonstrate fallopian tube patency. The

committee will also discuss general

issues related to a PMA for an

ultrasound contrast agent indicated for

use in conjunction with diagnostic

ultrasound to provide opacification of

cardiac chambers, improve delineation

of endocardial borders, enhance the