41398 Federal Register / Vol. 62, No. 148 / Friday, August 1, 1997 / Notices

such approach satisfies the applicable

statute, regulations, or both.

II. Comments

Interested persons may, on or before

October 30, 1997, submit to the Dockets

Management Branch (address above)

written comments regarding this draft

guidance. 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. The draft

guidance and received comments may

be seen in the office above between 9

a.m. and 4 p.m., Monday through

Friday.

III. Electronic Access

In order to receive the ‘‘Medical

Device Labeling—Suggested Form and

Content’’ draft guidance via your fax

machine, call the CDRH Facts-OnDemand system at 800–899–0381 or

301–827–0111 from a touch-tone

telephone. At the first voice prompt

press 1 to access DSMA Facts, at second

voice prompt press 2, and then enter the

document number 119 followed by the

pound sign (#). Then follow the

remaining voice prompts to complete

your request.

Persons interested in obtaining a copy

of the draft guidance may also do so

using the World Wide Web (www).

CDRH maintains an entry on the World

Wide Web for easy access to information

including text, graphics, and files that

may be downloaded to a PC with access

to the Web. Updated on a regular basis,

the CDRH homepage includes the

‘‘Medical Device Labeling—Suggested

Form and Content’’ draft guidance,

device safety alerts, Federal Register

reprints, information on premarket

submissions (including lists of approved

applications and manufacturers’

addresses), small manufacturers’

assistance, information on video

conferencing and electronic

submissions, mammography matters,

and other device-oriented information.

The CDRH homepage may be accessed

at ‘‘http://www.fda.gov/cdrh’’. The

‘‘Medical Device Labeling—Suggested

Form and Content’’ draft guidance is

available at ‘‘http://www.fda.gov/cdrh/

draftgui.html’’.

A text-only version of the CDRH Web

site is also available from a computer or

VT–100 compatible terminal by dialing

800–222–0185 (terminal settings are 8/

1/N). Once the modem answers, press

Enter several times and then select

menu choice 1: FDA BULLETIN BOARD

SERVICE. Select menu choice 1–FDA

Bulletin Board Service. At login prompt

type ‘‘bbs’’ and hit Enter, at password

prompt type ‘‘bbs’’ and hit Enter, at this

screen, hit Enter (brings you to FDA

Home Page), using tab key, select

Medical Devices/Radiological Health—

hit Enter, using

tab key, select Topic Index—hit Enter,

using tab key, select ‘‘L’’—hit Enter,

under ‘‘Labeling’’ is the title of the draft

guidance ‘‘Medical Device LabelingSuggested Form and Content’’—select

text file—hit Enter, use space bar to

move page to page, in order to view the

whole document.

Dated: July 2, 1997.

Joseph A. Levitt.

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–20313 Filed 07–31–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0312]

Medical Devices; Device Labeling

Requirements; Notice of Public

Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of public meeting.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

open public meeting to discuss the draft

guidance entitled ‘‘Medical Device

Labeling—Suggested Format and

Content,’’ which is being announced

elsewhere in the issue of the Federal

Register, and to identify other concerns

that manufacturers and others may have

regarding the medical device labeling

regulation or the labeling procedures

used by the Center for Devices and

Radiological Health (CDRH). Revision of

the labeling requirements for in vitro

diagnostic products is not being

considered at this time. Health care

practitioners and lay users of medical

devices are encouraged to participate in

the public meeting.

DATES: The public meeting will be held

on September 5, 1997, from 9 a.m. to 5

p.m. Written notices of participation

should be filed by August 22, 1997.

Submit written comments by September

24, 1997.

ADDRESSES: The public meeting will be

held at the Double Tree Hotel, 1750

Rockville Pike, Rockville, MD 20852.

Submit written notices of participation

and written comments to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Patricia A. Kingsley, Center for Devices

and Radiological Health (HFZ–230),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–443–2436, or via Internet at

‘‘PAK@cdrh.fda.gov’’.
Federal Register / Vol. 62, No. 148 / Friday, August 1, 1997 / Notices 41399

SUPPLEMENTARY INFORMATION:

I. Background

The labeling of most medical devices

is regulated by part 801 (21 CFR part

801). Since the original Medical Device

Amendments of 1976, the agency has

issued a number of guidance documents

to assist applicants in developing

effective and informative medical

device labeling. These documents

include the General Program

Memorandum #G91–1, entitled ‘‘Device

Labeling Guidance,’’ as well as

numerous device-specific documents.

Over time, the agency has received

feedback that manufacturers have some

concerns with part 801 and other agency

procedures concerning device labeling.

In addition, the agency has heard from

users of devices that medical device

labeling is less useful than it might be.

These comments have encouraged the

agency to reevaluate its labeling

regulations and guidance.

Concerns about the effectiveness of

communication through labeling of FDA

regulated products extend beyond

medical devices. Research on label

content and format preferences in the

user community has been conducted

and a public hearing has been held by

the Center for Drug Evaluation and

Research. The results of the research are

available in the transcript of the public

hearing in Docket No. 95N–0314. CDRH

conducted research with health care

practitioners to determine how they use

device labeling and what would make it

more useful to them. The report entitled

‘‘Draft Initial Report on Medical Device

Labeling: Health Care Practitioners’

Medical Device Information and

Labeling Needs—Results of Qualitative

Research’’ is available via the internet

on CDRH’s homepage at ‘‘http://

www.fda.gov/cdrh/humfac/

hufacact.html#Draft Initial Report’’. The

results of the research were used in the

development of the draft guidance

entitled ‘‘Medical Device Labeling—

Suggested Format and Content,’’ which

was placed on the FDA homepage in

April 1997, and is being announced

elsewhere in this issue of the Federal

Register.

The agency notes that labeling of in

vitro diagnostic products are regulated

under 21 CFR 809.10 and are not subject

to the draft guidance, nor will they be

the subject of discussion at the

September 5, 1997, public meeting.

II. Medical Device Labeling Issues

FDA is soliciting comments on the

notice of availability, which is

published elsewhere in this issue of the

Federal Register. The draft guidance

which was previously posted on FDA’s

homepage also solicited comments. The

agency also wants to gather information

on broader regulatory and procedural

issues regarding labeling that may be

important to manufacturers, users, and

FDA. For that reason, the agency is

holding a public meeting to discuss

issues raised by the suggestions in the

draft guidance, the present labeling

regulation in part 801, and any other

concerns that manufacturers and the

user community may have with medical

device labeling.

The agency is particularly interested

in responses to the following questions:

1. For which types of devices would

labeling consistent with the draft

guidance be inappropriate? Why would

it be inappropriate?

2. Should there be different labeling

requirements for different types of

medical devices?

3. What are specific labeling

requirements for over-the-counter

devices?

4. Are there other types of devices

that should have labeling format and

content requirements that are different

from those discussed in the draft

guidance?

5. The draft guidance recommended

the development of a summary

document called the Essential

Prescribing Information (EPI) label. Are

there any devices for which such a piece

or section of labeling might not be

applicable? Why not?

6. What are the benefits to industry

and/or the user community of adopting

the content and format discussed in the

draft labeling guidance?

7. What costs would be incurred by

industry for adopting a consistent

format design and highlight

information? What are the costs of

making the labeling change? What

factors significantly affect labeling

costs? How frequently is device labeling

revised? What strategies can be used to

lessen the cost to industry?

8. Should CDRH implement

consistent format and content and the

EPI as requirements for medical device

labeling?

9. Are there recommendations in the

guidance that create new impediments

to developing labeling for the

international marketplace? Are there

ways that CDRH could facilitate

harmonization efforts in device

labeling? Should provisions be made for

the use of symbols in device labeling?
41400 Federal Register / Vol. 62, No. 148 / Friday, August 1, 1997 / Notices

10. What methods are available to

provide users with more access to

device labeling?

11. Are there other issues with the

labeling regulation or the labeling

procedures used by CDRH that the

agency should address?

12. Relating to FDA’s medical device

reporting system, what are the concerns

if the agency would require

manufacturers to submit periodic

summary reports for common and

anticipated adverse events that are

listed in the device labeling, in lieu of

individual incident reports. The

agency’s interest in requiring summary

reporting for anticipated adverse events

already listed in the labeling is to

improve the signals received in the

medical device reporting system and to

reduce repeat reports of known

problems when further agency action is

unlikely. What adverse events should

still be reported individually, even if the

events are anticipated and listed in the

labeling?

Interested persons who wish to

participate may, on or before August 22,

1997, submit notice of participation to

the Dockets Management Branch

(address above). All notices of

participation submitted should be

identified with the docket number

found in brackets in the heading of this

document and should contain the name,

address, telephone number, business

affiliation of the person requesting to

make a presentation, a brief summary of

the presentation, and the approximate

time requested for the presentation.

Individuals or groups having similar

interests are requested to consolidate

their comments and present them

through a single representative. FDA

may require joint presentations by

persons with common interests. FDA

will allocate the time available for the

meeting among the persons who

properly file a notice of appearance.

Persons who are unable to participate

on the day of the meeting are

encouraged to submit written comments

to the Dockets Management Branch

(address above). 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: July 24, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–20312 Filed 7-31-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Dental Research;

Notice of Closed Meeting

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

National Institute of Dental Research

Special Emphasis Panel (SEP) meeting:

Name of SEP: National Institute of Dental

Research Special Emphasis Panel-Review of

R01s & R29 (97–43).

Date: August 12, 1997.

Time: 9:30 a.m.

Place: Natcher Building, Rm. 4AN–44F,

National Institutes of Health, Bethesda, MD

20892, (teleconference).

Contact Person: Dr. George Hausch, Chief,

Grants Review Section, 4500 Center Drive,

Natcher Building, Room 4AN–44F, Bethesda,

MD 20892, (301) 594–2372.

Purpose/Agenda: To evaluate and review

grant applications and/or contract proposals.

This notice is being published less than

fifteen days prior to the above meeting due

to the urgent need to meet timing limitations

imposed by the review and funding cycle.

The meeting will be closed in accordance

with the provisions set forth in secs.

552b(c)(4) and 552b(c)(6), Title 5, U.S.C.

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

(Catalog of Federal Domestic Assistance

Program No. 93.121, Oral Diseases and

Disorders Research)

Dated: July 29, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–20324 Filed 7–31–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute on Deafness and

Other Communication Disorders;

Notice of Meeting

Notice is hereby given of a meeting of

the NIDCD Work Group on Peer Review

on August 21–23, 1997 in Conference

Room 10, Building 31, the National

Institutes of Health, 9000 Rockville

Pike, Bethesda, MD 20892. The meeting

will be held to discuss issues involving

the initial review of grant applications

and will be held from 3 to 5 p.m. on

August 21, 8:30 a.m. to 5 p.m. on

August 22, and from 8:30 a.m. to 12

p.m. on August 23.

The entire meeting is open to the

public. Individuals who plan to attend

and need special assistance, such as

sign language interpretation or other

reasonable accommodations, should

contact Craig A. Jordan, Ph.D., Division

of Extramural Activities, NIDCD, EPS

Room 400C, Bethesda, MD 20892, 301–

496–8693 in advance of the meeting.

Dated: July 29, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–20325 Filed 7–31–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Environmental

Health Sciences; Notice of Meeting of

National Advisory Environmental

Health Sciences Council

Pursuant to Pub. L. 92–463, notice is

hereby given of the meeting of the

National Advisory Environmental

Health Sciences Council, September 15–

16, 1997, Building 101 Conference

Room, South Campus, Research

Triangle Park, North Carolina.

This meeting will be open to the

public from 9:00 a.m. to approximately

3:45 p.m. on September 15 for the report

of the Director, NIEHS, and for

discussion of the NIEHS budget,

program policies and issues, recent

legislation, and other items of interest.

Attendance by the public will be limited

to space available.

In accordance with the provisions set

forth in secs. 552b(c)(4) and 552b(c)(6),

Title 5 U.S.C. and sec. 10(d) of Pub. L.

92–463, the meeting will be closed to

the public from approximately 3:45 p.m.

on September 15 to adjournment on

September 16, for the review,

discussion, and evaluation of individual

grant applications. These applications

and the discussions could reveal

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

contact the Executive Secretary in

advance of the meeting.

Dr. Anne Sassaman, Director, Division

of Extramural Research and Training,