Federal Register / Vol. 60, No. 77 / Friday, April 21, 1995 / Notices 19949

premarket approval application (PMA)

was not referred to the Circulatory

System Devices Panel of the Medical

Devices Advisory Committee, an FDA

advisory committee, for review and

recommendation because the

information in the PMA substantially

duplicates information previously

reviewed by this panel. On March 10,

1995, CDRH approved the application

by a letter to the applicant from the

Director of the Office of Device

Evaluation, CDRH.

A summary of the safety and

effectiveness data on which CDRH

based its approval is on file in the

Dockets Management Branch (address

above) and is available from that office

upon written request. Requests should

be identified with the name of the

device and the docket number found in

brackets in the heading of this

document.

Opportunity for Administrative Review

Section 515(d)(3) of the act (21 U.S.C.

360e(d)(3)) authorizes any interested

person to petition, under section 515(g)

of the act, for administrative review of

CDRH’s decision to approve this

application. A petitioner may request

either a formal hearing under part 12 (21

CFR part 12) of FDA’s administrative

practices and procedures regulations or

a review of the application and CDRH’s

action by an independent advisory

committee of experts. A petition is to be

in the form of a petition for

reconsideration under § 10.33(b) (21

CFR 10.33(b)). A petitioner shall

identify the form of review requested

(hearing or independent advisory

committee) and shall submit with the

petition supporting data and

information showing that there is a

genuine and substantial issue of

material fact for resolution through

administrative review. After reviewing

the petition, FDA will decide whether to

grant or deny the petition and will

publish a notice of its decision in the

Federal Register. If FDA grants the

petition, the notice will state the issue

to be reviewed, the form of review to be

used, the persons who may participate

in the review, the time and place where

the review will occur, and other details.

Petitioners may, at any time on or

before May 22, 1995, file with the

Dockets Management Branch (address

above) two copies of each petition and

supporting data and information,

identified with the name of the device

and the docket number found in

brackets in the heading of this

document. Received petitions may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 515(d), 520(h) (21 U.S.C. 360e(d),

360j(h))) and under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Director, Center for Devices and

Radiological Health (21 CFR 5.53).

Dated: April 6, 1995.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 95–9950 Filed 4–20–95; 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:

Subcommittee Meeting of the Food

Advisory Committee

Date, time, and place. May 8 and 9,

1995, 8:30 a.m., Days Inn—Downtown

Convention Center, Franklin Square I

Ballroom, 1201 K St. NW., Washington,

DC.

Type of meeting and contact person.

Open subcommittee discussion, May 8,

1995, 8:30 a.m. to 5:15 p.m.; open

subcommittee discussion, May 9, 1995,

8:30 a.m. to 10 a.m.; open public

hearing, 10 a.m. to 11 a.m., unless

public participation does not last that

long; open subcommittee discussion, 11

a.m. to 2 p.m.; Lynn A. Larsen, Center

for Food Safety and Applied Nutrition

(HFS–5), Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–4727,

Catherine M. DeRoever, Advisory

Committee Staff (HFS–22), 202–205–

4251, FAX 202–205–4970, or FDA

Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area), Food

Advisory Committee, code 10564.

General function of the committee.

The committee provides advice on

emerging food safety, food science, and

nutrition issues that FDA considers of

primary importance in the next decade.

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 by close of business May

1, 1995, 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. If necessary, comments may

be limited to 5 minutes.

Open committee discussion. The

subcommittee will review the Center for

Food Safety and Applied Nutrition’s

Microbiology Research Program in the

context of the Center’s science program.

A peer review panel will be asked to

present its findings to the

subcommittee. More detailed

information regarding the meeting

agenda that may become available prior

to the meeting will be provided to the

public via the 800 number listed above.

Circulatory System Devices Panel of

the Medical Devices Advisory

Committee

Date, time, and place. May 8 and 9,

1995, 8:30 a.m., Holiday Inn—

Gaithersburg, Walker and Whetstone

Ballrooms, Two Montgomery Village

Ave., Gaithersburg, MD. A limited

number of overnight accommodations

have been reserved at the Holiday Inn—

Gaithersburg. Attendees requiring

overnight accommodations may contact

the hotel at 301–948–8900 and reference

the FDA Panel meeting block.

Reservations will be confirmed at the

group rate based on availability.

Type of meeting and contact person.

Open public hearing, May 8, 1995, 8:30

a.m. to 9:30 a.m., unless public
19950 Federal Register / Vol. 60, No. 77 / Friday, April 21, 1995 / Notices

participation does not last that long;

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

4:30 p.m.; open public hearing, May 9,

1995, 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 4:30 p.m.; Ramiah Subramanian,

Center for Devices and Radiological

Health (HFZ–450), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–443–8320, or

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area),

Circulatory System Devices Panel, code

12625.

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 April 28, 1995,

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

relating to the review of four premarket

approval applications; on May 8, 1995,

the committee will discuss two

hemostasis devices and on May 9, 1995,

two pacemaker devices.

Veterinary Medicine Advisory

Committee

Date, time, and place. May 10 and 11,

1995, 8:30 a.m., Holiday Inn—Bethesda,

Versailles Ballroom III, 8120 Wisconsin

Ave., Bethesda, MD.

Type of meeting and contact person.

Open committee discussion, May 10,

1995, 8:30 a.m. to 10:30 a.m.; open

public hearing, 10:30 a.m. to 3 p.m.,

unless public participation does not last

that long; open committee discussion, 3

p.m. to 4:30 p.m.; open committee

discussion, May 11, 1995, 8:30 a.m. to

9:30 a.m.; open public hearing, 9:30 a.m.

to 11 a.m., unless public participation

does not last that long; open committee

discussion, 11 a.m. to 12 m.; Gary E.

Stefan, Center for Veterinary Medicine

(HFV–244), 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1769, or

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area),

Veterinary Medicine Advisory

Committee, code 12546.

General function of the committee.

The committee reviews and evaluates

available data concerning the safety and

effectiveness of marketed and

investigational new animal drugs, feeds,

and devices for use in the treatment and

prevention of animal disease and

increased animal production.

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 May 9, 1995, 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 amount of time

required to make their comments.

Open committee discussion. On May

10, 1995, the committee will discuss

veterinary medical issues related to

implementation of the Animal

Medicinal Drug Use Clarification Act of

1994 (extra-label animal drug use). On

May 11, 1995, the committee will

discuss options for obtaining approvals

for minor use (orphan) animal drugs.

Science Board to the Food and Drug

Administration

Date, time, and place. May 16, 1995,

8:30 a.m., Holiday Inn—Eisenhower

Metro, Eisenhower Ballroom, 2460

Eisenhower Ave., Alexandria, VA.

Type of meeting and contact person.

Open committee discussion, 8:30 a.m. to

2:30 p.m.; open public hearing, 2:30

p.m. to 3:30 p.m., unless public

participation does not last that long;

open committee discussion, 3:30 p.m. to

5 p.m.; Anita O’Connor, Office of

Science (HF–33), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–5839, or

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area),

Science Board to the Food and Drug

Administration, code 12603.

General function of the board. The

board shall provide advice primarily to

the agency’s Senior Science Advisor

and, as needed, to the Commissioner

and other appropriate officials on

specific complex and technical issues as

well as emerging issues within the

scientific community in industry and

academia. Additionally, the board will

provide advice to the agency on keeping

pace with technical and scientific

evolutions in the fields of regulatory

science; on formulating an appropriate

research agenda; and on upgrading its

scientific and research facilities to keep

pace with these changes. It will also

provide the means for critical review of

agency sponsored intramural and

extramural scientific research programs.

Agenda—Open public hearing.

Interested persons may present data,

information, or views, orally or in

writing, on issues pending before the

board. Those desiring to make formal

presentations must notify the contact

person before May 2, 1995, and submit

a brief statement of the general nature of

the evidence or arguments they wish to

present, and the names and addresses of

proposed participants. Each presenter

will be limited in time and not all

requests to speak may be able to be

accommodated. All written statements

submitted in a timely manner will be

provided to the board.

Open committee discussion. The

board will discuss issues related to the

testing strategy for toxicity and

carcinogenicity of substances regulated

by FDA. The discussion is designed to

give the agency direction for future

program development.

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
Federal Register / Vol. 60, No. 77 / Friday, April 21, 1995 / Notices 19951

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: April 17, 1995.

Linda A. Suydam,

Interim Deputy Commissioner for Operations.

[FR Doc. 95–9889 Filed 4–20–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 93N–0005]

Regulation of Positron Emission

Tomography Radiopharmaceutical

Drug Products; Guidance; Public

Workshop; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

notice that appeared in the Federal

Register of February 27, 1995 (60 FR

10594). The document published

guidance on the regulation of positron

emission tomography (PET)

radiopharmaceutical drug products and

announced a public workshop to

facilitate an understanding of regulatory

requirements regarding these products.

The document was published with some

typographical errors. This document

corrects those errors.

FOR FURTHER INFORMATION CONTACT:

LaJuana D. Caldwell, Office of Policy

(HF–27), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–2994.

In FR Doc. 95–4691, appearing on

page 10594 in the Federal Register of

February 27, 1995, the following

corrections are made:

1. On page 10594, in the third

column, in the title heading,

‘‘TomographyRadiopharmaceutical’’ is

corrected to read ‘‘Tomography

Radiopharmaceutical’’.

2. On page 10595, in the third

column, in the third full paragraph, in

the 4th line from the bottom,

‘‘§ 1A207.10’’ is corrected to read

‘‘§ 207.10’’.

3. On page 10596, in the first column,

in the first full paragraph, in line 8,

‘‘§ 1A361.1’’ is corrected to read

‘‘§ 361.1’’.

4. On page 10596, in the first column,

in the second paragraph, in lines 4 and

20, ‘‘§ 1A361.1(c)’’ is corrected to read

‘‘§ 361.1(c)’’.

5. On page 10596, in the second

column, in the first full paragraph, in

line 3, ‘‘§ 1A361.1(c)(3)’’ is corrected to

read ‘‘§ 361.1(c)(3)’’.

Dated: April 14, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–9844 Filed 4–20–95; 8:45 am]

BILLING CODE 4160–01–F

SOCIAL SECURITY ADMINISTRATION

Agency Forms Submitted to the Office

of Management and Budget for

Clearance

Normally on Fridays, the Social

Security Administration publishes a list

of information collection packages that

have been submitted to the Office of

Management and Budget (OMB) for

clearance in compliance with Public

Law 96–511, The Paperwork Reduction

Act. The following clearance packages

have been submitted to OMB since the

last list was published in the Federal

Register on Friday, April 7, 1995.

(Call Reports Clearance Officer on (410) 965–

4142 for copies of package.)

1. Measuring Public Perception of the

Value of Social Security—0960–0551.

The information on these questionnaires

is used by the Social Security

Administration (SSA) to measure public

perception of the value of Social

Security and to determine whether the

Personal Earnings and Benefit Statement

(PEBES) affects public confidence in

Social Security. The control group

respondents are members of the general

public who have not received an SSAinitiated PEBES. The study group

respondents are members of the general

public who have received recently an

SSA-initiated PEBES.

SSA has requested and received

expedited approval for this collection of

information (both the study group

collection instrument and the control

group collection instrument) from OMB

and is, accordingly, publishing in the

Federal Register a copy of each of the

collection instruments (5 CFR

1320.18(g)).

Number of Respondents: 6,000

Frequency of Response: 1

Average Burden Per Response: 15

minutes

Estimated Annual Burden: 1,500 hours

OMB Desk Officer: Laura Oliven

Written comments and

recommendations regarding these

information collections should be sent

directly to the appropriate OMB Desk

Officer designated above at the

following address: Office of

Management and Budget, OIRA, New

Executive Office Building, Room 10230,

Washington, DC 20503.

Dated: April 17, 1995.

Charlotte Whitenight,

Reports Clearance Officer, Social Security

Administration.

Measuring Public Perception of the Value of

Social Security (Control Group)

Your Name lllllllllllllll

Your Social Security Number lll-llllll

1. Are you aware that Social Security pays

benefits (circle all that you are aware of):

a. To you when you retire?

b. To you if you became disabled?

c. To your spouse if you became disabled

or retired?

d. To your young children if you became

disabled or retired?

e. To your widow if you should die?

f. To your young children should you die?

2. How important is it for you to plan

financially for your retirement?

a. Very important

b. Somewhat important