[Federal Register Volume 64, Number 16 (Tuesday, January 26, 1999)]
[Notices]
[Page 3954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1662]
[[Page 3954]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0172]
Guidance on Amended Procedures for Advisory Panel Meetings;
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 guidance document entitled ``Guidance on Amended
Procedures for Advisory Panel Meetings.'' The purpose of the guidance
document is to establish standard operating procedures (SOP's) 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 by the Food and Drug
Administration Modernization Act of 1997 (FDAMA).
DATES: Written comments concerning the guidance document may be
submitted at any time.
ADDRESSES: Submit written comments on the guidance document to one of
the contact persons listed below. Submit written requests for single
copies on a 3.5'' diskette of the guidance document entitled ``Guidance
on Amended Procedures for Advisory Panel Meetings'' 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
information on electronic access to the guidance document.
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; or William Freas, Center for Biologics Evaluation and Research
(HFM-21), Food and Drug Administration, 1401 Rockville Pike, Rockville,
MD 20852, 301-827-1295.
SUPPLEMENTARY INFORMATION:
I. Background
The guidance document entitled ``Guidance on Amended Procedures for
Advisory Panel Meetings'' was developed to establish SOP's to be
followed by 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. New section 513(b)(6)(A) of the act
requires that FDA provide to any person whose device is specifically
the subject of a classification panel review the same access as FDA to
data and information about the device as that submitted to the panel,
except for 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 FDA to provide such persons the
opportunity to submit information, based on the data or information
provided in the application under review, to the panel for its review.
Section 513(b)(6)(iii) amended the act to allow such persons the same
opportunity as FDA 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 parties
be encouraged. FDA announced the availability of the draft guidance
document entitled ``Guidance on Amended Procedures for Advisory Panel
Meetings'' in the Federal Register of March 31, 1998 (63 FR 15426). The
agency received one comment on the draft guidance document. FDA has
reviewed the comment and has made some revisions to clarify the
guidance. In addition, FDA agrees with the comment that another
guidance document entitled ``Policy and Guidance Handbook for FDA's
Advisory Committees'' should be subject to the agency's good guidance
practices (GGP's). That guidance document is currently being revised.
This revised guidance document entitled ``Guidance on Amended
Procedures for Advisory Panel Meetings'' supersedes the guidance
document that was announced on March 31, 1998.
II. Significance of Guidance
This 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 agency has adopted GGP's, which set forth the agency's policies
and procedures for the development, issuance, and use of guidance
documents (62 FR 8961, February 27, 1997). This guidance document is
issued as a Level 1 guidance consistent with GGP's.
III. Electronic Access
In order to receive the guidance document entitled ``Guidance on
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 prompts to complete your request.
Persons interested in obtaining a copy of the guidance document 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 ``Guidance
on Amended Procedures for Advisory Panel Meetings,'' 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 home page may be accessed at
http://www.fda.gov/cdrh. The guidance document entitled ``Guidance on
Amended Procedures for Advisory Panel Meetings'' will be available on
CDRH's website at http://www.fda.gov/cdrh/modern/modguid.html and on
CBER's website at http://www.fda.gov/cber/guidelines.htm.
IV. Comments
Interested persons may, at any time, submit written comments
regarding this guidance document to one of the contact persons listed
above. Such comments will be considered when determining whether to
amend the current guidance.
Dated: January 10, 1999.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 99-1662 Filed 1-25-99; 8:45 am]
BILLING CODE 4160-01-F