Federal Register / Vol. 63, No. 142 / Friday, July 24, 1998 / Notices 39877

remained subdued this year, primarily

as a consequence of large declines in

energy prices.

Most market interest rates have

declined slightly on balance over the

intermeeting period. Share prices in

U.S. equity markets have moved up a

little further. In foreign exchange

markets, the trade-weighted value of the

dollar in terms of major currencies has

changed little on net over the period.

However, the dollar has risen on

balance against the currencies of key

emerging market economies,

particularly those in Asia. Equity

markets in Asia have fallen substantially

over the period to near their lows of late

1997, while those in Europe have risen

to new highs.

M2 and M3 expanded briskly further

in April, but data for late April and

early May show M2 declining and M3

leveling out. The swing in these

measures seemed to be related largely to

movements of funds associated with tax

payments. Expansion of total domestic

nonfinancial debt appears to have

moderated somewhat after a pickup

earlier in the year.

The Federal Open Market Committee

seeks monetary and financial conditions

that will foster price stability and

promote sustainable growth in output.

In furtherance of these objectives, the

Committee at its meeting in February

established ranges for growth of M2 and

M3 of 1 to 5 percent and 2 to 6 percent

respectively, measured from the fourth

quarter of 1997 to the fourth quarter of

1998. The range for growth of total

domestic nonfinancial debt was set at 3

to 7 percent for the year. The behavior

of the monetary aggregates will continue

to be evaluated in the light of progress

toward price level stability, movements

in their velocities, and developments in

the economy and financial markets.

In the implementation of policy for

the immediate future, the Committee

seeks conditions in reserve markets

consistent with maintaining the federal

funds rate at an average of around 5-1/

2 percent. In the context of the

Committee’s long-run objectives for

price stability and sustainable economic

growth, and giving careful consideration

to economic, financial, and monetary

developments, a somewhat higher

federal funds rate would or a slightly

lower federal funds rate might be

acceptable in the intermeeting period.

The contemplated reserve conditions

are expected to be consistent with

considerable moderation in the growth

in M2 and M3 over coming months.

By order of the Federal Open Market

Committee, July 13, 1998.

Donald L. Kohn,

Secretary, Federal Open Market Committee.

[FR Doc. 98–19710 Filed 7–23–98; 8:45 am]

BILLING CODE 6210–01–F

FEDERAL RESERVE SYSTEM

Sunshine Act Meeting

AGENCY HOLDING THE MEETING: Board of

Governors of the Federal Reserve

System.

TIME AND DATE: 10:00 a.m., Wednesday,

July 29, 1998.

PLACE: Marriner S. Eccles Federal

Reserve Board Building, 20th and C

Streets, N.W., Washington, D.C. 20551.

STATUS: Closed.

MATTERS TO BE CONSIDERED:

1. Personnel actions (appointments,

promotions, assignments,

reassignments, and salary actions)

involving individual Federal Reserve

System employees.

2. Any matters carried forward from a

previously announced meeting.

CONTACT PERSON FOR MORE INFORMATION:

Lynn S. Fox, Assistant to the Board;

202–452–3204.

SUPPLEMENTARY INFORMATION: You may

call 202–452–3206 beginning at

approximately 5 p.m. two business days

before the meeting for a recorded

announcement of bank and bank

holding company applications

scheduled for the meeting; or you may

contact the Board’s Web site at http://

www.bog.frb.fed.us for an electronic

announcement that not only lists

applications, but also indicates

procedural and other information about

the meeting.

Dated: July 22, 1998.

Robert deV. Frierson,

Associate Secretary of the Board.

[FR Doc. 98–19942 Filed 7–22–98; 11:06 am]

BILLING CODE 6210–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. 98N–0339]

Public Meetings on Section 406(b) of

the FDA Modernization Act of 1997

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of meetings.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

following series of meetings on section

406(b) of the FDA Modernization Act of

1997 (FDAMA) to discuss how FDA can

best meet its statutory obligations under

the Federal Food, Drug, and Cosmetic

Act (the act). The agency intends to

involve participants from consumer and

scientific groups and the regulated

industry in drafting FDA’s

developmental plan to meet the

objectives of FDAMA.

DATES: Comments may be submitted by

September 11, 1998. For the dates of

each meeting, see section III of this

document.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852; e-mail

‘‘FDADockets@bangate.fda.gov’’ or via

the FDA website ‘‘http://www.fda.gov’’.

For the address of each meeting, see

section III of this document.

FOR FURTHER INFORMATION CONTACT:

Catherine P. Beck, Office of

Management and Systems (HF–20),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–3443.

SUPPLEMENTARY INFORMATION:

I. Background

Under section 406(b) of FDAMA, the

agency is required to consult with its

external stakeholders, specifically

‘‘appropriate scientific and academic

experts, health care professionals,

representatives of patient and consumer

advocacy groups, and the regulated

industry.’’ Following these

consultations, FDA is to develop and

publish a plan for achieving compliance

with each of its obligations under the

act.

Under section 406(b) of FDAMA, the

plan, which must be published in the

Federal Register by November 21, 1998,

should address, but may not be confined

to, the following six objectives: (1)

Maximizing the availability and clarity

of information about the agency

application and submission review

processes; (2) maximizing the

availability and clarity of information

for consumers and patients concerning

new products; (3) implementing

inspection and postmarket monitoring

provisions of the act; (4) assuring access

to the scientific and technical expertise

needed to carry out FDA’s obligations;

(5) establishing mechanisms, by July 1,

1999, for meeting specified time periods

for the review of applications and

submissions; and (6) eliminating

backlogs in the review of applications

and submissions.
39878 Federal Register / Vol. 63, No. 142 / Friday, July 24, 1998 / Notices

To help focus comments, FDA

requests that oral and/or written views

regarding how the agency can best meet

these six objectives of its modernization

plan address seven questions. An

information packet, available on the

FDA webpage or from the designated

contact persons listed in section III of

this document, provides substantive

background information; it is highly

recommended that those individuals or

groups who wish to make a presentation

or submit written comments obtain this

packet. Specific questions relate to each

objective as follows:

1. What can FDA do to improve its

explanation of the agency’s submission

review processes, and make

explanations more available to product

sponsors and other interested parties?

2. How can the agency maximize the

availability and clarity of information

concerning new products?

3. How can FDA work with its

partners to ensure that products—both

domestic and foreign—produced and

marketed by the regulated industry are

of high quality and provide necessary

consumer protection; and how can FDA

best establish and sustain an effective,

timely, and science-based postmarketing

surveillance system for reporting,

monitoring, evaluating, and correcting

problems associated with use/

consumption of FDA-regulated

products?

4. What approach should FDA use to

assure an appropriate scientific

infrastructure, with continued access to

the scientific and technical expertise

needed to meet its statutory obligations

and strengthen its science-based

decisionmaking process?

5. What do you believe FDA should

do to adequately meet the demands that

are beginning to burden the application

review process, especially for non-user

fee products, so that it can meet its

statutory obligations to achieve timely

product reviews?

6. What suggestions do you have for

the agency to eliminate backlogs in the

review process?

7. What other objectives related to the

agency’s statutory obligations or public

expectations—beyond the six

objectives—should be included in the

FDA plan?

II. Comments

Written comments should be

identified with the docket number

found in brackets in the heading of this

document and should be submitted by

September 11, 1998, to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

Comments can be sent to the Dockets

Management Branch at the following email address

‘‘FDADockets@bangate.fda.gov’’ or via

the FDA website ‘‘http://www.fda.gov’’.

III. Scheduled Meetings

The meetings will be held as follows:

TABLE 1

FDA Center/Region Meeting Address Date and Time Contact Person

Center for Biologics Evaluation and Research

(CBER—Washington,

DC)

Department of Health and Human Services, Hubert

H. Humphrey Bldg., Penthouse Conference Room

(rm. 800), 200 Independence Ave. SW., Washington, DC.

Friday, August 14, 1998,

from 9 a.m. to 5 p.m

Gail H. Sherman, HFM–42,

Food and Drug Administration, suite 200–N, 1401

Rockville Pike, Rockville MD

20852, 301–827–1315, FAX

301–827–3079, e-mail

‘‘SHERMAN@cber.fda.gov’’

Center for Drug Evaluation

and Research (CDER)

Department of Health and Human Services, Hubert

H. Humphrey Bldg., Penthouse Conference Room

(rm. 800), 200 Independence Ave. SW., Washington, DC.

Monday, August 17, 1998,

from 9 a.m. to 5 p.m.

Susan H. Carey, HFD–011,

Food and Drug Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–

827–1496, FAX 301–827–

0509, e-mail

‘‘CAREYS@cder.fda.gov’’

Center for Devices and

Radiological Health

(CDRH)

Department of Health and Human Services, Hubert

H. Humphrey Bldg., Penthouse Conference Room

(rm. 800), 200 Independence Ave. SW., Washington, DC.

Tuesday, August 18,

1998, from 9 a.m. to 5

p.m.

Ronald G. Jans, HFZ–205,

Food and Drug Administration, 1350 Piccard Dr. Rockville, MD 20850, 301–594–

3744, FAX 301–443–8810,

e-mail

‘‘RSJ@CDRH.FDA.GOV’’

Center for Veterinary Medicine (CVM)Department of Health and Human Services, Hubert

H. Humphrey Bldg., Penthouse Conference Room

(rm. 800), 200 Independence Ave. SW., Washington, DC.

Wednesday, August 19,

1998, from 9 a.m. to 5

p.m.

Linda A. Grassie, HFV–12,

Food and Drug Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–

827–6513, FAX 301–594–

1831, e-mail

‘‘LGrassie@bangate.fda.gov’’

CBER—San Francisco Oakland Federal Bldg., Royball Auditorium, 1301

Clay St., Oakland, CA.

Friday, August 28, 1998,

from 9 a.m. to 5 p.m.

Mark S. Roh, HFR–PA17, Pacific Regional Office, Food

and Drug Administration,

1301 Clay St., suite 1180–N,

Oakland, CA 94612, 510–

637–3980, FAX 510–637–

3977, e-mail

‘‘mroh@ora.fda.gov’’

A separate FDAMA section on the

FDA website will provide current

information about these public

meetings. It is highly recommended that

individuals who wish to present at these

public meetings, plan to attend the

entire day. Information will be

presented throughout the day about

FDA activities related to the FDA Plan.
Federal Register / Vol. 63, No. 142 / Friday, July 24, 1998 / Notices 39879

Each public meeting will provide an

opportunity for an open comment

session where attendees can express

their views.

IV. Registration and Requests for Oral

Presentations

Send registration information

(including name, title, firm name,

address, telephone, e-mail, and fax

number), and written material and

requests to make oral presentations, to

the appropriate contact person listed in

section III of this document by July 31,

1998.

If you need special accommodations

due to a disability, please contact the

appropriate contact person listed in

section III of this document at least 7

days in advance.

V. Additional Meetings

The public meeting for the Center for

Food Safety and Applied Nutrition

(CFSAN) was held on June 24 and 25,

1998. The comment period associated

with the CFSAN meeting closed on July

15, 1998. A summary of the views

presented at the CFSAN meeting is

available on the CFSAN website ‘‘http:/

/www.cfsan.fda.gov’’. For information

on the CFSAN meeting, contact Tracy S.

Summers, Center for Food Safety and

Applied Nutrition (HFS–1), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–4850,

FAX 202–205–5025, e-mail

‘‘tsummers@bangate.fda.gov’’.

An additional public meeting is being

planned for September 15, 1998, to

obtain stakeholder views on potential

recurring themes and the best approach

for consolidating these themes agency

wide. A separate notice of this meeting

will be published in the Federal

Register.

VI. Transcripts

Transcripts of these meetings 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 of the meeting will be

available for public examination at the

Dockets Management Branch (address

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

Monday through Friday, as well as on

the FDA website ‘‘http://www.fda.gov’’.

Dated: July 20, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–19816 Filed 7–21–98; 3:31 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Dental Products Panel of the Medical

Devices 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: Dental Products

Panel of the Medical Devices 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 August 4, 1998, 10:30 a.m. to

6:30 p.m., and August 5, 1998, 8 a.m. to

3 p.m.

Location: Corporate Bldg., conference

room 020B, 9200 Corporate Blvd.,

Rockville, MD.

Contact Person: Pamela D. Scott,

Center for Devices and Radiological

Health (HFZ–480), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–827–5283, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12518. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On August 4, 1998, the

committee will discuss: (1) Previously

unclassified devices for use in the

diagnosis and/or treatment of

temporomandibular joint dysfunction

and oral-facial pain, (2) devices that

FDA believes may fall within a present

device classification and those devices

that do not fall within a present device

classification and thus remain

unclassified, and (3) classification of the

devices that remain unclassified. On

August 5, 1998, the committee will

continue discussion of the classification

of devices for use in the diagnosis and/

or treatment of temporomandibular joint

dysfunction and oral-facial pain that

remain unclassified. The list of those

devices that FDA believes may fall

within a present device classification

and those devices that do not fall within

a present device classification and thus

remain unclassified will be placed on

the FDA web site at ‘‘http://

www.fda.gov/cdrh/degenint.html’’.

Procedure: On August 4, 1998, from

10:30 a.m. to 5:30 p.m. and on August

5, 1998, from 8 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 July 31, 1998. Oral

presentations from the public will be

scheduled between approximately 1:30

p.m. and 2:30 p.m. on August 4, 1998,

and between approximately 8:10 a.m.

and 8:40 a.m. on August 5, 1998. Near

the end of committee deliberations, a

30-minute open public session will be

conducted for interested persons to

address issues specific to the

classification before the committee.

Time allotted for each presentation may

be limited. Those desiring to make

formal oral presentations should notify

the contact person before July 31, 1998,

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

August 4, 1998, from 5:30 p.m. to 6:30

p.m., the meeting will be closed to

permit discussion of trade secret and/or

confidential information regarding

dental device issues (5 U.S.C.

552b(c)(4)). The meeting will discuss

classified device issues.

FDA regrets that it was unable to

publish this notice 15 days prior to the

August 4 and 5, 1998, Dental Products

Panel of the Medical Devices Advisory

Committee meeting. Because the agency

believes there is some urgency to bring

these issues to public discussion and

qualified members of the Dental

Products Panel of the Medical Devices

Advisory Committee were available at

this time, the Commissioner 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. I11Notice of this meeting

is given under the Federal Advisory

Committee Act (5 U.S.C. app. 2).

Dated: July 21, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–19945 Filed 7–22–98; 11:41 am]

BILLING CODE 4160–01–F