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Amended Procedures for Advisory Panel Meetings; Draft Guidance;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availability of a draft guidance entitled ``Amended Procedures for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DATES: Written comments concerning the draft guidance must be received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ADDRESSES: Written comments concerning the draft guidance that are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 Submit written requests for singles copies of the draft
guidance to the Division of Small Manufacturers Assistance (DSMA),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