Federal Register / Vol. 60, No. 74 / Tuesday, April 18, 1995 / Notices 19405

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.

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 (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 13, 1995.

Linda A. Suydam,

Interim Deputy Commissioner for Operations.

[FR Doc. 95–9576 Filed 4–13–95; 4:14 pm]

BILLING CODE 4160–01–F

Health Care Financing Administration

Public Information Collection

Requirements Submitted to the Office

of Management and Budget (OMB) for

Clearance

AGENCY: Health Care Financing

Administration, HHS.

The Health Care Financing

Administration (HCFA), Department of

Health and Human Services, has

submitted to OMB the following

proposals for the collection of

information in compliance with the

Paperwork Reduction Act (Public Law

96–511).

1. Type of Request: Reinstatement;

Title of Information Collection:

Medicaid, Limitations on Provider

Related Donations and Health Care

Related Taxes; Limitations on Payments

to Disproportionate Share Hospitals

(MB–62–IFC); Form No.: HCFA–R–148;

Use: Sections 2, 3, and 4 of Public Law

102–234 require States to report

information related to provider related

tax and donation programs and

aggregate disproportionate share

hospital payments. The requirements

included in this regulation implement

these statutory requirements;

Respondents: State or local government;

Number of Respondents: 51; Total

Annual Responses: 1,928; Total Annual

Hours Requested: 116,896.

Additional Information or Comments:

Call the Reports Clearance Office on

(410) 966–5536 for copies of the

clearance request packages. Written

comments and recommendations for the

proposed information collections

should be sent within 30 days of this

notice directly to the OMB Desk Officer

designated at the following address:

OMB Human Resources and Housing

Branch, Attention: Allison Eydt, New

Executive Office Building, Room 10235,

Washington, D.C. 20503.

Date: April 16, 1995.

Kathleen B. Larson,

Director, Management Planning and Analysis

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 95–9461 Filed 4–17–95; 8:45 am]

BILLING CODE 4120–03–P

Substance Abuse and Mental Health

Services Administration (SAMHSA);

Notice of Meeting

Pursuant to Public Law 92–463,

notice is hereby given of the meeting of

the Substance Abuse and Mental Health

Services Administration (SAMHSA)

National Advisory Council on May 15,

1995.