24706 Federal Register / Vol. 65, No. 82 / Thursday, April 27, 2000 / Notices

F. FDA’s Role in Switches

• Under what circumstances should

FDA actively propose OTC marketing

for a drug in the absence of support

from the drug sponsor?

• Should FDA be more active in

initiating switches of prescription

products to OTC use?

III. Notice of Hearing Under 21 CFR

Part 15

The Commissioner of Food and Drugs

(the Commissioner) is announcing that

the public hearing will be held in

accordance with part 15 (21 CFR part

15). The presiding officer will be the

Commissioner or her designee. The

presiding officer will be accompanied

by a panel of Public Health Service

employees with relevant expertise.

Persons who wish to participate in the

part 15 hearing must file a written

notice of participation with the Dockets

Management Branch (address above)

prior to June 2, 2000. To ensure timely

handling, any outer envelope should be

clearly marked with the Docket No.

00N–1256 and the statement ‘‘FDA

Regulation of OTC Drug Products

Hearing.’’ Groups should submit two

copies. The notice of participation

should contain the person’s name;

address; telephone number; affiliation,

if any; the sponsor of the presentation

(e.g., the organization paying travel

expenses or fees), if any; brief summary

of the presentation; and approximate

amount of time requested for the

presentation. The agency requests that

interested persons and groups having

similar interests consolidate their

comments and present them through a

single representative. FDA will allocate

the time available for the hearing among

the persons who file notices of

participation as described above. If time

permits, FDA may allow interested

persons attending the hearing who did

not submit a written notice of

participation in advance to make an oral

presentation at the conclusion of the

hearing.

After reviewing the notices of

participation and accompanying

information, FDA will schedule each

appearance and notify each participant

by telephone of the time allotted to the

person and the approximate time the

person’s oral presentation is scheduled

to begin. The hearing schedule will be

available at the hearing. After the

hearing, the hearing schedule will be

placed on file in the Dockets

Management Branch under Docket No.

00N–1256.

Under § 15.30(f), the hearing is

informal, and the rules of evidence do

not apply. No participant may interrupt

the presentation of another participant.

Only the presiding officer and panel

members may question any person

during or at the conclusion of each

presentation.

Public hearings under part 15 are

subject to FDA’s policy and procedures

for electronic media coverage of FDA’s

public administrative proceedings (part

10, subpart C (21 CFR part 10, subpart

C)). Under § 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. The hearing will be

transcribed as stipulated in § 15.30(b).

The transcript of the hearing will be

available on the Internet at http://

www.fda.gov/ohrms/dockets and orders

for copies of the transcript can be placed

at the meeting or through the Freedom

of Information Staff (HFI–35), 5600

Fishers Lane, Rockville, MD 20857.

Any handicapped persons requiring

special accommodations to attend the

hearing should direct those needs to the

contact person listed above.

To the extent that the conditions for

the hearing, as described in this notice,

conflict with any provisions set out in

part 15, this notice acts as a waiver of

those provisions as specified in

§ 15.30(h).

IV. Request for Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written notices of participation

and comments for consideration at the

hearing by June 2, 2000. To permit time

for all interested persons to submit data,

information, or views on this subject,

the administrative record of the hearing

will remain open following the hearing

until August 25, 2000. Persons who

wish to provide additional materials for

consideration should file these materials

with the Dockets Management Branch

(address above) by August 25, 2000.

Two copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document. Received comments may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

Dated: April 17, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–10456 Filed 4–26–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Vaccines and Related Biological

Products Advisory Committee; Notice

of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). At least one portion of the

meeting will be closed to the public.

Name of Committee: Vaccines and

Related Biological Products Advisory

Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on May 11, 2000, 8 a.m. to 5:30

p.m. and on May 12, 2000, 8 a.m. to 3

p.m.

Location: Holiday Inn, Kennedy

Grand Ballroom, 8777 Georgia Ave.,

Silver Spring, MD.

Contact Person: Nancy T. Cherry or

Denise H. Royster, Center for Biologics

Evaluation and Research (HFM–71),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12391. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On May 11, 2000, the

committee will hear updates on

activities in the Office of Vaccines

Research and Review. The committee

will also be informed of issues

pertaining to the status of vaccines for

the prevention of rotavirus disease. On

May 12, 2000, the committee will

review issues relating to the

development of policy regarding the use

of various types of neoplastic cells as

substrates for vaccine manufacture.

Procedure: On May 11, 2000, from

9:15 a.m. to 1:45 p.m., and on May 12,

2000, from 9:15 a.m. to 3 p.m., the

meeting is open to the public. Interested

persons may present data, information,

or views, orally or in writing, on issues

pending before the committee. Written

submissions may be made to the contact

person by May 4, 2000. Oral

presentations from the public will be

scheduled between approximately 12:20

p.m. to 12:50 p.m. on May 11, 2000, and

between approximately 10:35 a.m. to

10:50 a.m. and between approximately

Federal Register / Vol. 65, No. 82 / Thursday, April 27, 2000 / Notices 24707

1:30 p.m. to 1:45 p.m. on May 12, 2000.

Time allotted for each presentation may

be limited. Those desiring to make

formal oral presentations should notify

the contact person before May 4, 2000,

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 requested to make

their presentation.

Closed Committee Deliberations: On

May 11, 2000, from 8 a.m. to 9 a.m., and

from approximately 1:45 p.m. to 5:30

p.m., and on May 12, 2000, from 8 a.m.

to 9 a.m., the meeting will be closed to

permit discussion and review of trade

secret and/or confidential information.

(5 U.S.C. 552b(c)(4)). These portions

will be closed to permit discussion of

pending investigational new drug

applications or pending product

licensing applications.

FDA regrets that it was unable to

publish this notice 15 days prior to the

May 11 and 12, 2000, Vaccines and

Related Biological Products Advisory

Committee meeting. Because the agency

believes there is some urgency to bring

these issues to public discussion and

qualified members of the Vaccines and

Related Biological Products Advisory

Committee were available at this time,

the Commissioner of Food and Drugs

concluded that it was in the public

interest to hold this meeting even if

there was not sufficient time for the

customary 15-day public notice.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: April 21, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–10457 Filed 4–26–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–0315]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: New Collection; Title of

Information Collection: Collection of

Data on Physician Encounters from

Medicare+Choice Organizations; HCFA

Form Number: HCFA–R–0315

(OMB#0938–NEW); Use HCFA requires

physician encounter data from

Medicare+Choice organizations to

develop and implement a risk

adjustment payment methodology as

required by the Balanced Budget Act of

1997; Frequency: Monthly; Affected

Public: Business or other for-profit, Notfor-profit institutions; Number of

Respondents: 300; Total Annual

Responses: 75.6 million; Total Annual

Hours: 938,700.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail you

request, including your address, phone

number, OMB number, and HCFA

document identifier, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Information Services,

Security and Standards Group, Division

of HCFA Enterprise Standards,

Attention: Julie Brown, Room N2–14–

26, 7500 Security Boulevard, Baltimore,

Maryland 21244–1850.

Dated: April 17, 2000.

John P. Burke, III,

Reports Clearance Officer, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 00–10478 Filed 4–26–00; 8:45 am]

BILLING CODE 4120–03–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–1133–N]

Medicare Program; May 12, 2000,

Meeting of the Citizens Advisory Panel

on Medicare Education

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice of meeting.

SUMMARY: In accordance with section

10(a) of the Federal Advisory Committee

Act, this notice announces a meeting of

the Citizens Advisory Panel on

Medicare Education (the Panel) on May

12, 2000. This Committee advises and

makes recommendations to the

Secretary of the Department of Health

and Human Services (the Secretary) and

the Administrator of the Health Care

Financing Administration (HCFA) on

opportunities for HCFA to optimize the

effectiveness of the National Medicare

Education Program and other HCFA

programs that help Medicare

beneficiaries understand Medicare and

the range of Medicare options available

with the passage of the

Medicare+Choice Program. The Panel

meeting is open to the public.

DATES: The meeting is scheduled for

May 12, 2000, from 8:00 a.m. until 4:30

p.m.

ADDRESSES: The meeting will be held at

the Phoenix Park Hotel, 520 North

Capitol Street, NW., Washington, DC

20001, (202) 638–6900.

FOR FURTHER INFORMATION CONTACT:

Susana Perry, Executive Director, CBS,

Partnership Development Group, Health

Care Financing Administration, 7500

Security Boulevard S1–08–07,

Baltimore, MD 21244–1850, (410) 786–

1076.

Please refer to the HCFA Advisory

Committees Information Line (1–877–

449–5659 toll free 410–786–9379 local)

or the Internet (http://www.hcfa.gov/

events/apme/homepage.htm) for

additional information and updates on

committee activities or by contacting the

Executive Director at (http://

www.APME@hcfa.gov). Press inquiries

are handled through the HCFA Press

Office at (202) 690–6145.

SUPPLEMENTARY INFORMATION: The

Federal Advisory Committee Act (5

U.S.C. App. 2, Section 10(a)), Public

Law 92–463, grants the Secretary the

authority to establish an advisory

committee if the Secretary finds the

committee necessary and in the public

interest. The Secretary signed the