Federal Register / Vol. 62, No. 3 / Monday, January 6, 1997 / Notices 765

General function of the committee.

The Nonprescription Drugs Advisory

Committee reviews and evaluates

available data concerning the safety and

effectiveness of over-the-counter

(nonprescription) human drug products

for use in the treatment of a broad

spectrum of human symptoms and

diseases. The Cardiovascular and Renal

Drugs Advisory Committee reviews and

evaluates data on the safety and

effectiveness of marketed and

investigational human drugs for used in

cardiovascular and renal 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 January 8, 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

committees will jointly discuss issues

relevant to professional labeling

indications for aspirin. A citizen

petition requested that the

Commissioner of Food and Drugs

approve various vascular professional

labeling indications for aspirin. FDA has

already acted on some of the issues

raised, while others have not been

resolved. FDA is now soliciting advice

and opinions from the advisory

committees regarding the use of aspirin

for expanded professional labeling

indications for aspirin. Issues to be

discussed include the use of aspirin in

patients deemed to be at elevated risk of

cardiovascular events due to some form

of vascular disease or other conditions

implying an increased risk of occlusive

vascular disease (i.e., patients

undergoing coronary, cerebral, or

peripheral arterial revascularization

procedures; patients with chronic

nonvalvular atrial fibrillation; patients

requiring hemodialysis access with a

fistula or shunt; patients with chronic

stable angina; and other patients

deemed to be at elevated risk). The

agency encourages investigators,

academicians, and members of the

pharmaceutical industry with

information about the use of aspirin in

patients at increased risk of

cardiovascular events to respond to this

notice.

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

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, 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,

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.

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: December 20, 1996.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–92 Filed 1–3–97; 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:
766 Federal Register / Vol. 62, No. 3 / Monday, January 6, 1997 / Notices

National Mammography Quality

Assurance Advisory Committee

Date, time, and place. January 13,

1997, 9 a.m., and January 14 and 15,

1997, 8 a.m., Bethesda Marriott Hotel,

Grand Ballroom, 5151 Pooks Hill Rd.,

Bethesda, MD. A limited number of

overnight accommodations have been

reserved at the hotel. Attendees

requiring overnight accommodations

may contact the hotel at 301–897–9400

and reference the FDA Committee

meeting block. Reservations will be

confirmed at the group rate based on

availability.

Type of meeting and contact person.

Open public hearing, January 13, 1997,

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

participation does not last that long;

open committee discussion, 10 a.m. to

6:30 p.m.; open committee discussion,

January 14, 1997, 8 a.m. to 6 p.m.; open

committee discussion, January 15, 1997,

8 a.m. to 3 p.m.; Charles K. Showalter,

Center for Devices and Radiological

Health (HFZ–240), Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850, 301–594–3332, or

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area),

National Mammography Quality

Assurance Advisory Committee, code

12397. Please call the hotline for

information concerning any possible

changes.

General function of the committee.

The committee advises the agency on

developing appropriate quality

standards and regulations for the use of

mammography facilities.

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 2, 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

January 13, 14, and 15, 1997, the

committee will discuss the proposed

final regulations under the

Mammography Quality Standards Act

(MQSA) of 1992. Copies of the proposed

final regulations may be obtained by

submitting a written request to MQSA,

c/o KRA, 1010 Wayne Ave., suite 850,

Silver Spring, MD 20910, or faxing a

request to 301–495–9410.

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

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,

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.

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: December 20, 1996.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–93 Filed 1–3–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4153–D–01]

Revocation and Redelegation of

Authority to FHA Comptroller

AGENCY: Office of the Assistant

Secretary for Housing—Federal Housing

Commissioner, HUD.

ACTION: Notice of revocation, and

redelegation of authority to the FHA

Comptroller.

SUMMARY: To assist in the efficient

management of the Office of Housing,

the Assistant Secretary for Housing—

Federal Housing Commissioner is

herein transferring, from the Deputy

Assistant Secretary for Operations, to

the FHA Comptroller, authority

regarding asset sales of Secretary-held

multifamily mortgages.

EFFECTIVE DATE: November 8, 1996.

FOR FURTHER INFORMATION CONTACT:

Robert G. Hunt, Director, Management

Services Division, Office of Housing,

Room 9116, Department of Housing and

Urban Development, Washington, DC

20410, (202) 708–0826. A

telecommunications device for the

hearing impaired is available via the

Federal Information Relay Service at 1–

800–877–8339.

SUPPLEMENTARY INFORMATION: In this

document, the Assistant Secretary for

Housing—Federal Housing

Commissioner is transferring

responsibilities related to the asset sales