Amended Procedures for Advisory Panel Meetings; Draft Guidance; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D-0172]

Amended Procedures for Advisory Panel Meetings; Draft Guidance;

Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the

availability of a draft guidance entitled ``Amended Procedures for

Advisory Panel Meetings.'' The purpose of the guidance document is to

establish standard operating procedures to be followed by the Center

for Devices and Radiological Health (CDRH), the Center for Biologics

Evaluation and Research (CBER), FDA personnel, and interested persons

outside FDA in carrying out the Federal Food, Drug, and Cosmetic Act

(the act), as amended through the Food and Drug Administration

Modernization Act of 1997 (FDAMA).

DATES: Written comments concerning the draft guidance must be received

by June 29, 1998. After the close of the comment period, written

comments may be submitted at any time to the contact person listed

below.

ADDRESSES: Written comments concerning the draft guidance that are

submitted within the 90 days comment period must be addressed to the

Dockets Management Branch (HFA-305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. Comments should be

identified with the docket number found in brackets in heading of this

document. Submit written requests for singles copies of the draft

guidance to the Division of Small Manufacturers Assistance (DSMA),

Center for Devices and Radiological Health (HFZ-220), Food and Drug

Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-

addressed adhesive labels to assist that office in processing your

request, or fax your request to 301-443-8818. See the SUPPLEMENTARY

INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Nancy J. Pluhowski, Center for Devices

and Radiological Health (HFZ-400), Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850, 301-594-2022.

SUPPLEMENTARY INFORMATION:

I. Background

The guidance document entitled ``Amended Procedures for Advisory

Panel Meetings'' was developed to establish standard operating

procedures to be followed by the CDRH, CBER, FDA personnel, and

interested persons outside FDA in carrying out section 513(b)(6) of the

act (21 U.S.C. 360c(b)(6)) as amended by section 208 of FDAMA.

Beginning on February 19, 1998, section 513(b)(6)(A) of the act

requires that FDA provide to any person whose device is subject to a

classification panel review be given the same access to data and

information submitted to a classification panel except data and

information that are not available for public disclosure under the

Freedom of Information Act (5 U.S.C. 552). FDAMA further amended the

act to require any person whose device is under review by a

classification panel to have the opportunity to submit information

based on the data or information provided in the application to the

panel for its review. It also provides the same opportunity as the

Secretary of Health and Human Services to participate in panel

meetings. Section 513(b)(6)(B) of the act requires that adequate time

be provided for initial presentations and for response to any differing

views by persons whose devices are specifically the subject of a

classification panel, and that free and open participation by all

interested persons be encouraged.

II. Significance of Guidance

The guidance document represents the agency's current thinking on

the amended procedures for advisory panel meetings. It does not create

or confer any rights for or on any person and does not operate to bind

FDA or the public. An alternative approach may be used if such approach

satisfies the requirements of the applicable statute, regulations, or

both.

The guidance document entitled ``Amended Procedures for Advisory

Panel Meetings'' is a Level 1 guidance document under FDA's Good

Guidance Practices Policy. Public comment prior to implementation of

the guidance document is not required because the guidance is needed to

implement new statutory requirements enacted by FDAMA.

III. Comments

Interested persons may, on or before June 29, 1998, submit to the

Dockets Management Branch (address above) written comments regarding

this guidance document. 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 guidance document and received comments may be seen

in the office above between 9 a.m. and 4 p.m., Monday through Friday.

After June 29, 1998, written comments may be submitted at any time to

the contact person listed above.

IV. Electronic Access

In order to receive the draft guidance entitled ``Amended

Procedures for Advisory Panel Meetings'' via your fax machine, call the

CDRH Facts-On-Demand 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 413, followed by the pound sign (#). Then follow the remaining

voice prompt 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 WWW for easy access to information including text, graphics, and

files that may be downloaded to a personal computer with access to the

Web. Updated on a regular basis, the CDRH home page includes the

guidance document entitled ``Amended Procedures for Advisory Panel

Meetings,'' device safety alerts, Federal Register reprints,

information on premarket submissions

[[Page 15427]]

(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 home page may be accessed at http://www.fda.gov/

cdrh. The guidance document entitled ``Amended Procedures for Advisory

Panel Meetings'' will be available at http://www.fda.gov/cdrh.

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. From there follow instructions for logging in, and at the BBS

TOPICS PAGE, arrow down to the FDA home page (do not select the first

CDRH entry). Then select Medical Devices and Radiological Health. From

there select CENTER FOR DEVICES AND RADIOLOGICAL HEALTH for general

information, or arrow down for specific topics.

Dated: March 25, 1998.

D.B. Burlington,

Director, Center for Devices and Radiological Health.

[FR Doc. 98-8301 Filed 3-30-98; 8:45 am]

BILLING CODE 4160-01-F