[Federal Register Volume 63, Number 61 (Tuesday, March 31, 1998)]
[Notices]
[Pages 15426-15427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-8301]


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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Amended Procedures for Advisory Panel Meetings; Draft Guidance; 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availability of a draft guidance entitled ``Amended Procedures for 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DATES: Written comments concerning the draft guidance must be received 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ADDRESSES: Written comments concerning the draft guidance that are 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 Submit written requests for singles copies of the draft 
guidance to the Division of Small Manufacturers Assistance (DSMA), 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