[Federal Register Volume 66, Number 138 (Wednesday, July 18, 2001)]
[Notices]
[Page 37483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-17976]



[[Page 37483]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0297]


Medical Devices; Availability of Information Given to Advisory 
Committee Members in Connection with CDRH Open Public Panel Meetings; 
Draft Guidance for Industry and FDA Staff; Availability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availability of the draft guidance entitled ``Availability of 
Information Given to Advisory Committee Members in Connection with CDRH 
Open Public Panel Meetings; Draft Guidance for Industry and FDA 
Staff.'' This document provides guidance to the Center for Devices and 
Radiological Health (CDRH) staff and to industry whose device is the 
subject of an open advisory committee meeting. The Federal Advisory 
Committee Act (FACA) generally requires FDA to make available to the 
public the information given to panel members, except for material that 
is exempt under the Freedom of Information Act (FOIA). This draft 
guidance describes the process CDRH intends to follow when making this 
information publicly available. This draft guidance also describes how 
these materials should be assembled and timeframes for their 
availability. This draft guidance is neither final nor is it in effect 
at this time.

DATES: Submit written or electronic comments concerning this guidance 
by October 16, 2001.

ADDRESSES: Submit written requests for single copies on a 3.5" diskette 
of the draft guidance document entitled ``Availability of Information 
Given to Advisory Committee Members in Connection with CDRH Open Public 
Panel Meetings; Draft Guidance for Industry and FDA Staff'' to the 
Division of Small Manufacturers Assistance (HFZ-220), Center for 
Devices and Radiological Health, 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.
    Submit written comments on the document to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

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

    FACA provides at section 10(b) that materials that are made 
available to an advisory committee in connection with an open advisory 
committee meeting shall also be made available to the public, if the 
materials are not exempt from disclosure under FOIA. This FACA 
provision is intended to facilitate meaningful public participation at 
such meetings. CDRH has now developed a process to make materials 
provided to advisory committee members in connection with open public 
meetings available for public disclosure, whenever practicable before 
or at the time of the meeting. This process also ensures that those 
materials exempt from disclosure under FOIA are protected. This draft 
guidance is designed to minimize the amount of time and resources spent 
in reviewing, redacting (the deletion of nondisclosable information), 
and publishing this information so that panel meetings can proceed when 
they are scheduled and in compliance with the requirements of FACA.

II. Significance of Guidance

    This draft guidance document represents the agency's current 
thinking on the availability of information given to advisory committee 
members in connection with CDRH open public 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 applicable statutes and regulations.
    The agency has adopted good guidance practices (GGPs), and 
published the final rule, which set forth the agency's regulations for 
the development, issuance, and use of guidance documents (21 CFR 
10.115; 65 FR 56468, September 19, 2000). This draft guidance document 
is issued as a level 1 guidance in accordance with the GGP regulations.

III. Electronic Access

    In order to receive ``Availability of Information Given to Advisory 
Committee Members in Connection with CDRH Open Public Panel Meetings; 
Draft Guidance for Industry and FDA Staff'' via your fax machine, call 
the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a 
touch-tone telephone. Press 1 to enter the system. At the second voice 
prompt press 1 to order a document. Enter the document number 1341 
followed by the pound sign (#). 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 Internet. CDRH maintains an entry on the Internet 
for easy access to information including text, graphics, and files that 
may be downloaded to a personal computer with Internet access. Updated 
on a regular basis, the CDRH home page includes the civil money penalty 
guidance documents package, 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.

IV. Comments

    Interested persons may submit to Dockets Management Branch (address 
above) written or electronic comments regarding this draft guidance by 
October 16, 2001. Submit two copies of any comments, 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 document and any received comment may be seen in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: July 12, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 01-17976 Filed 7-17-01; 8:45 am]
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