7790 Federal Register / Vol. 62, No. 34 / Thursday, February 20, 1997 / Notices

issues related to toxicological testing

methods, will provide an update on its

activities. The Science Board

Subcommittee on FDA Research will

present a report to the board on a

strategy for optimizing the quality and

mission relevance of agency research

programs.

Vaccines and Related Biological

Products Advisory Committee

Date, time, and place. March 14,

1997, 12:30 p.m., National Institutes of

Health, Bldg. 29, conference room 121,

8800 Rockville Pike, Bethesda, MD.

Type of meeting and contact person.

This meeting will be held by a

telephone conference call. A speaker

telephone will be provided in the

conference room to allow public

participation in the meeting. Open

committee discussion, 12:30 p.m. to 2

p.m.; open public hearing, 2 p.m. to 3

p.m., unless public participation does

not last that long; Nancy T. Cherry or

Denise A. Royster, Center for Biologics

Evaluation and Research (HFM–21),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852,

301–827–0314, or FDA Advisory

Committee Information Hotline, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), Vaccines and

Related Biological Products Advisory

Committee, code 12388. Please call the

hotline for information concerning any

possible changes.

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness of

vaccines intended for use in the

diagnosis, prevention, or treatment of

human diseases.

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 March 1, 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

committee will discuss the influenza

virus vaccine’s formulation for 1997 and

1998.

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: February 12, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–4305 Filed 2–18–97; 11:00 am]

BILLING CODE 4160–01–F

[Docket No. 97N–0042]

Review of the Adverse Event Reporting

System for Postmarketing

Surveillance; Public Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of public meeting.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

public meeting to provide the

pharmaceutical industry and other

interested persons with information on

the plans, progress, and technical

specifications developed under the

reengineering of the Center for Drug

Evaluation and Research’s (CDER’s)

postmarketing surveillance program.

The primary focus of the meeting will

be the electronic submission of adverse

drug reaction (ADR) reports under the

new adverse event reporting system

(AERS), which is currently under

development as a major component of

the reengineering effort.

DATES: The public meeting will be held

on Monday, March 17, 1997, from 9:30

a.m. to 5 p.m. There is no registration

fee for the meeting. Because space is

limited, interested persons are

encouraged to register by March 7, 1997.

ADDRESSES: The public meeting will

held at the DoubleTree Hotel, 1750

Rockville Pike, Rockville, MD 20852.

Persons interested in attending should

fax their registration to Robert Nelson at

301–480–2825. The facsimile should

include the participant’s name and title;

organization name, if any; address; and

telephone and fax numbers.

Three weeks prior to the public

meeting, a copy of the meeting agenda

will be available through CDER’s Faxon-Demand, 301–827–0577 or 800–342–
Federal Register / Vol. 62, No. 34 / Thursday, February 20, 1997 / Notices 7791

2722, under the index ‘‘AERS Public

Meeting,’’ document No. 0510.

Information about the meeting will be

available via Internet using the World

Wide Web (WWW). To connect to the

CDER home page, type http://

www.fda.gov/cder and go to the

‘‘What’s Happening’’ section. Also

available on the CDER home page is a

link to the new AERS home page, which

contains a brief summary of the

materials that will be discussed at the

meeting. Information distributed at the

public meeting will be available from

the Freedom of Information Office (HFI–

35), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, approximately 10 business days

after the meeting at a cost of 10 cents

per page.

The agenda will be placed on display,

under the docket number found in

brackets in the heading of this

document, at the Dockets Management

Branch (HFA–305), 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Robert C. Nelson, Food and Drug

Administration, Center for Drug

Evaluation and Research (HFD–700),

5600 Fishers Lane, Rockville, MD

20857, 301–827–3206.

SUPPLEMENTARY INFORMATION: The

primary purpose of FDA’s

postmarketing surveillance program is

to identify potentially serious drug

safety problems, focusing especially on

newly marketed drugs. Although

premarket testing discloses a general

safety profile of a new drug’s

comparatively common adverse effects,

the larger and more diverse patient

populations exposed to the marketed

drug provides, for the first time, the

opportunity to collect information on

rare, latent, and long-term effects.

Reports are obtained from a variety of

sources, including patients, treating

physicians, foreign regulatory agencies,

and clinical investigators. Over 75

percent of the ADR reports that FDA

receives are routed from health care

practitioners through pharmaceutical

companies. The remainder of the reports

come directly to FDA through the

agency’s MedWatch program.

FDA’s computerized spontaneous

reporting system (SRS) contains 1.4

million ADR reports for human drugs

and therapeutic biologics. FDA plans to

replace SRS with AERS by September

1997. All SRS historical data will be

migrated to AERS. AERS will enable

FDA to receive reports from

pharmaceutical companies by electronic

submission, transmitted data base to

data base through standardized

pathways. The technical specifications

of the AERS computerized system will

be described at the public meeting and

made available to participants,

especially as they relate to the electronic

submission of expedited and periodic

ADR reports.

FDA has participated in the

development of several guidelines by

the International Conference on

Harmonisation of Technical

Requirements for Registration of

Pharmaceuticals for Human Use (ICH)

that relate to the submission of ADR

reports under the AERS system:

‘‘Clinical Safety Data Management:

Definitions and Standards for Expedited

Reporting’’ (E2A); ‘‘Clinical Safety Data

Management: Data Elements for

Transmission of Individual Case Safety

Reports’’ (E2B); and ‘‘Clinical Safety

Data Management: Periodic Safety

Update Reports for Marketed Drugs’’

(E2C). In addition, two other guidelines

are currently under development by

ICH: ‘‘Medical Terminology

(MEDDRA)’’ (M1) and ‘‘Electronic

Standards for the Transfer of Regulatory

Information (ESTRI)’’ (M2).

At the public meeting, FDA will

explain how it intends to incorporate

these recommended standards into the

requirements for the electronic

submission of ADR reports under AERS.

The meeting will include a general

discussion of CDER’s plans to propose

revisions to its postmarketing ADR

reporting regulations. The goals of this

rulemaking are to implement the

recommendations in the ICH guidelines

and to enhance the quality of ADR

reports received by the agency. The

agency hopes to familiarize the

pharmaceutical industry with the

procedures for the electronic

submission of ADR reports under AERS

so that they are prepared to comply with

any revised regulations that may issue

as a result of the rulemaking initiative.

Additional information on the

technical specifications of the AERS

system will be placed on display, as

they are available in final form, at the

Dockets Management Branch (address

above) between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: February 13, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–4161 Filed 2–19–97; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[Form # HCFA–P–15A]

Emergency Clearance: Public Information

Collection Requirements Submitted to the

Office of Management and Budget (OMB)

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 (DHSS), has submitted

to the Office of Management and Budget

(OMB) the following request for

Emergency review. We are requesting an

emergency review because the

collection of this information is needed

prior to the expiration of the normal

time limits under OMB’s regulations at

5 CFR, Part 1320, thus causing the

disruption of this collection of

information, which is essential to the

agency’s mission of ensuring that

beneficiary needs are evaluated and

implemented, to the extent possible, in

a cost-effective manner. The Agency

cannot reasonably comply with the

normal clearance procedures because

public harm is likely to result if normal

clearance procedures are followed.

Without this information, HCFA would

not be able to properly determine the

services needed by beneficiaries or the

most cost efficient manner to meet

beneficiary needs, possibly resulting in

the denial of beneficiary warranted

services and a loss of program dollars.

HCFA is requesting that OMB provide

a 24-hour review and a 180-day

approval. During this 180-day period

HCFA will pursue OMB clearance of

this collection as stipulated by 5 CFR

1320.5.

1. Type of Information Collection

Request: Revision of a currently

approved collection; Title of

Information Collection: Medicare

Current Beneficiary Survey (MCBS)

Round 18; Form No.: HCFA–P–15A;

Use: The MCBS is a continuous,

multipurpose survey of a nationally

representative sample of aged and

disabled persons for Medicare. The

survey provides a comprehensive source

of information on beneficiary

characteristics, needs, and satisfaction

with Medicare-related activities. The

proposed MCBS revisions will focus on

the evaluation of beneficiary

informational needs. This information

will enable HCFA to better coordinate

and integrate its current communication

objectives effectively and efficiently;

Frequency: On occasion; Affected

Public: Individuals and households;

Number of Respondents: 16,000; Total

Annual Responses: 16,000; Total

Annual Hours: 16,000.