74 Federal Register / Vol. 61, No. 1 / Tuesday, January 2, 1996 / Notices

human drug product had undergone a

regulatory review period and that the

approval of ADENOSCAN 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

ADENOSCAN is 2,688 days. Of this

time, 768 days occurred during the

testing phase of the regulatory review

period, while 1,920 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: January 9, 1988. The

applicant claims December 10, 1987, as

the date the investigational new drug

application (IND) became effective.

However, FDA records indicate that the

IND effective date was January 9, 1988,

which was 30 days after FDA receipt of

the IND on December 10, 1987.

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 14, 1990. The

applicant claims February 9, 1990, as

the date the new drug application

(NDA) for ADENOSCAN (NDA 20–

059) was initially submitted. However,

while FDA records indicate that the

applicant submitted NDA 20–059 on

February 9, 1990, FDA received the

NDA on February 14, 1990, which is

considered to be the date the NDA was

initially submitted.

3. The date the human drug was

approved: May 18, 1995. FDA has

verified the applicant’s claim that NDA–

059 was approved on May 18, 1995.

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 159 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before March 4, 1996, 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 1, 1996, 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: December 21, 1995.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 95–31555 Filed 12–29–95; 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:

Immunology Devices Panel of the

Medical Devices Advisory Committee

Date, time, and place. January 22,

1996, 9:30 a.m., Gaithersburg Hilton

Hotel, Salons D & E, 620 Perry Pkwy.,

Gaithersburg, MD. A limited number of

overnight accommodations have been

reserved at the hotel. Attendees

requiring overnight accommodations

may contact the hotel at 301–977–8900

and reference FDA Panel meeting block.

Reservations will be confirmed at the

group rate based on availability.

Type of meeting and contact person.

Open public hearing, 9:30 a.m. to 10:30

a.m., unless participation does not last

that long; open committee discussion,

10:30 a.m. to 4 p.m. For information

regarding the analyte specific reagents

classification—Kaiser J. Aziz, Center for

Devices and Radiological Health (HFZ–

440), Food and Drug Administration,

2098 Gaither Rd., Rockville, MD 20850,

301–594–3084. For information

regarding the conduct of the meeting—

Peter E. Maxim, Center for Devices and

Radiological Health (HFZ–440), Food

and Drug Administration, 2098 Gaither

Rd., Rockville, MD 20850, 301–594–

1293, or FDA Advisory Committee

Information Hotline, 1–800–741–8138

(301–443–0572 in the Washington, DC

area), Immunology Devices Panel, code

12516.

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 January 8, 1996,

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 consider the

classification of analyte specific

reagents as in vitro diagnostic devices.

FDA intends to develop a regulatory

scheme to handle products currently

being used by clinical laboratories as

materials for in-house (‘‘home brew’’)

assays. Analyte specific reagents are

chemical, poly or monoclonal

antibodies, proteins, nucleic acid

sequences, which, by their physiochemical reaction with substances in a

specimen, allow a test procedure to

distinguish or quantify an individual

chemical substance or ligand in a

biological specimen. These are used in

the production of in-house tests which

are of high complexity under the

Clinical Laboratory Improvement Act of
Federal Register / Vol. 61, No. 1 / Tuesday, January 2, 1996 / Notices 75

1988. They are considered medical

devices. Currently, such reagents are

being made widely available to clinical

laboratories under ‘‘research use only’’

or ‘‘investigational use only’’ labeling or

as unlabeled components of a final test.

FDA believes that most analyte

specific reagents may be considered for

classification as class I devices and

exempted from the premarket

notification (510(k)) procedure in

subpart E of 21 CFR part 807 if the

reagents do not make analytical or

clinical performance claims. FDA is

currently considering an approach

under which such analyte specific

reagents would be subject to other

general controls: (1) Registration and

listing, (2) medical device reporting

requirements, and (3) good

manufacturing practice requirements.

FDA is also considering establishing

restrictions under section 520(e) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360j(e)) on the sale,

distribution, or use of the devices.

The issue of classification and the

nature of appropriate restrictions will be

the subject of the panel meeting.

Although FDA believes that most

analyte specific reagents may be

considered for regulation in this way,

the agency also believes that a small

number of analyte specific reagents (e.g.,

those used to diagnose communicable

diseases through blood or other means)

would be more properly classified into

class II or III and subject to the

premarket controls (510(k) or premarket

approval) applicable to such

classification.

FDA public advisory committee

meetings 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. There are no closed portions

for the meetings announced in this

notice. The dates and times reserved for

the open portions of each committee

meeting are listed above.

The open public hearing portion of

each meeting 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, rm. 12A–16, 5600

Fishers Lane, 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,

rm. 1–23, 12420 Parklawn Dr.,

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.

This notice is issued under section

10(a)(1) and (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: December 21, 1995.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 95–31554 Filed 12–29–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Bureau of Reclamation

Conservation Advisory Group, Yakima

River Basin Water Enhancement

Project, Yakima, WA

AGENCY: Bureau of Reclamation,

Interior.

ACTION: Notice of meetings.

SUMMARY: Title XII, The Act of October

31, 1994 (Public Law 103–434), directs

the Secretary of the Interior, in

consultation with the State of

Washington, the Yakama Indian Nation,

Yakima River Basin Water Conservation

Advisory Group and a Facilitator within

12 months of enactment. The purpose of

the Conservation Advisory Group is to

provide technical advice and counsel to

the Secretary and the State on the

structure, implementation, and

oversight of the Yakima River Basin

Water Conservation Program.

DATES: Meetings will be held at the

Upper Columbia Area Office, Bureau of

Reclamation, 1917 Marsh Road, Yakima,

Washington, beginning at 12 noon on

the following dates: January 16, 1996,

February 20, 1996, March 19, 1996.

FOR FURTHER INFORMATION CONTACT:

Walt Fite, Program Manager, Yakima

River Water Enhancement Project, PO

Box 1749, Yakima, Washington 98907,

(509) 575–5848 ext. 267.

SUPPLEMENTARY INFORMATION: The Basin

Conservation Program is structured to

provide economic incentives with

cooperative Federal, State, and local

funding to stimulate the identification

and implementation of structural and

nonstructural cost-effective water

conservation measures in the Yakima

River basin. Improvements in the

efficiency of water delivery and use will

result in improved streamflows for fish

and wildlife and improve the reliability

of water supplies for irrigation.

Dated: December 20, 1995.

Jim Cole,

Area Manager, Upper Columbia Area Office,

Bureau of Reclamation, Yakima, Washington.

[FR Doc. 95–31551 Filed 12–29–95; 8:45 am]

BILLING CODE 4310–94–M