[Federal Register Volume 64, Number 180 (Friday, September 17, 1999)]
[Notices]
[Pages 50517-50518]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-24236]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-2874]


Development of Guidance Documents for Medical Devices Regulated 
by the Center for Biologics Evaluation and Research; Stakeholders Input 
Under FDA Modernization Act of 1997; Public Meeting and Teleconference

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting and teleconference entitled ``Development of Guidance Documents 
for Medical Devices Regulated by the Center for Biologics Evaluation 
and Research-Stakeholders Input Under FDA Modernization Act of 1997.'' 
The goals of the public meeting and teleconference are to explain to 
stakeholders the process and development of medical device guidance 
documents under good guidance practices (GGP's) and how to participate 
in both processes and to give stakeholders the opportunity to provide 
input on what they think the Center for Biologics Evaluation and 
Research's (CBER's) priorities should be regarding medical devices 
regulated by CBER. The agency is also requesting comments prior to the 
meeting, from stakeholders on proposals of priorities for development 
of guidance documents related to CBER-regulated medical devices.

DATES: The meeting will be held on November 15, 1999, 1 p.m. to 4 p.m. 
(Eastern Time). The teleconference will be held on the same day. See 
Table 1 in section III of this document for the scheduled times and 
locations of the teleconference. The deadline for registration for the 
meeting or teleconference is November 8, 1999. Comments are requested 
before the meeting by October 1, 1999, or after the meeting by December 
15, 1999.

ADDRESSES:  The meeting will be held at the Masur Auditorium, National 
Institutes of Health, 9000 Rockville Pike, Bldg. 10, Bethesda, MD. See 
Table 1 in section III of this document for the scheduled locations of 
the teleconference. Submit written comments to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Melanie N. Whelan, Center for 
Biologics Evaluation and Research (HFM-43), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
3841, FAX 301-827-3079, or e-mail ``[email protected]''.

SUPPLEMENTARY INFORMATION: 

I. Background

    Under section 406(b) of the Food and Drug Administration 
Modernization Act of 1997 (FDAMA) (21 U.S.C. 393(f) and (g)), CBER held 
a series of public meetings to discuss its statutory obligations under 
FDAMA for biologics. The meetings were held in Washington, DC, on 
August 14, 1998 (63 FR 39877, July 24, 1998); in Oakland, CA, on August 
28, 1998; in Bethesda, MD, on December 1, 1998 (63 FR 58743, November 
2, 1998); and in San Francisco, CA, and Boston, MA, on April 28, 1999 
(64 FR 13804, March 22, 1999). The FDA Pacific Regional Office 
sponsored a grassroots meeting on September 15, 1998 (63 FR 42052, 
August 6, 1998), in Irvine, CA, with the biotechnology industry.
    At some of the earlier public meetings, a recurring theme was 
dissatisfaction with the handling of medical devices regulated by CBER. 
Important concerns were related to CBER procedures and standards for 
medical device products similar to products regulated by the Center for 
Devices and Radiological Health (CDRH). In response to these concerns, 
CBER developed the Device Action Plan in order to facilitate the 
implementation of the device provisions of FDAMA and to ensure 
consistency of policy and procedures between CBER and CDRH. CBER 
announced the completed Device Action Plan at the CBER Stakeholders 
Meetings held in San Francisco, CA, and Boston, MA, on April 28, 1999 
(64 FR 13804, March 22, 1999). The following issues have been outlined 
in the Device Action Plan: (1) Compliance and team biologics issues 
(application of certain good manufacturing practices (GMP's) and 
compliance policy), (2) enhancing communication with industry and 
within FDA, (3) coordination with CDRH, and (4) improvement of device 
review performance. The Device Action Plan has been posted on the CBER 
web site at ``http://www.fda.gov/cber/dap/dap.htm''.
    The public meeting and teleconference will be gathering information 
on all medical devices including those regulated under the Federal 
Food, Drug, and Cosmetic Act and those licensed under the Public Health 
Service Act. The public meeting and teleconference announced in this 
notice is intended to: (1) Explain to stakeholders the process and 
development of medical device guidance documents under GGP's and how 
they can participate in both processes, and (2) give stakeholders the 
opportunity to provide input on what they think CBER's priorities 
should be regarding the development of guidance documents related to 
medical devices regulated by CBER.
    In preparation for the November 15, 1999, public meeting, FDA is 
soliciting comments from stakeholders on proposals of priorities for 
development

[[Page 50518]]

of guidance documents related to medical devices regulated by CBER.

II. Comments

    Written comments should be identified with the docket number found 
in brackets in the heading of this document and submitted to the 
Dockets Management Branch (address above). All comments should be 
identified with the docket number found in brackets in the heading of 
this document. Stakeholders are encouraged to submit their written 
comments by Friday, October 1, 1999, in order to have the comments 
addressed at the meeting. Written comments may also be submitted after 
the meeting to the Dockets Management Branch (address above) by 
December 15, 1999. Two copies of any comments should be submitted, 
except that individuals may submit one copy. Received comments are 
available for public examination in the Dockets Management Branch 
(address above) between 9 a.m. and 4 p.m., Monday through Friday.

III. Scheduled Meetings

    The teleconference will be held in several locations throughout the 
country. The scheduled times and locations are listed as follows:

                   Table 1.--Teleconference Schedules
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       Address/Food and Drug
   Administration (FDA) District       Scheduled Time of Teleconference
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Denver District: Sixth & Kipling     11 a.m. to 2 p.m. Mountain Time.
 Sts., Denver Federal Center, Bldg.
 20, rm. B1409, Denver, CO 80225-
 0087
San Francisco District: 1431 Harbor  10 a.m. to 1 p.m. Pacific Time.
 Bay Pkwy., Alameda, CA 94502
Los Angeles District: 19900          10 a.m. to 1 p.m. Pacific Time.
 MacArthur Blvd., suite 300,
 Irvine, CA 92715-2445
Minneapolis District: 240 Hennepin   12 noon to 3 p.m. Central Time.
 Ave., Minneapolis, MN 55401
New England District: One Montvale   1 p.m. to 4 p.m. Eastern Time.
 Ave., Fourth Floor, Stoneham, MA
 02180
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IV. Registration

    Send registration information (including name, title, firm name, 
address, telephone, and fax number) for the public meeting or 
teleconference, by mail, fax or e-mail to the contact person by Monday, 
November 8, 1999. Registration at the site will be done on a space 
available basis on the day of the meeting. There is no registration fee 
for the meeting. Space is limited, therefore, interested parties are 
encouraged to register early.
    If you need special accommodations due to a disability, please 
contact Melanie N. Whelan (address above) at least 7 days in advance.

V. Transcripts

    Transcripts of the meeting may be requested in writing from the 
Freedom of Information Office (HFI-35), Food and Drug Administration, 
5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15 
working days after the meeting at a cost of 10 cents per page. The 
transcript of the meeting will also be available on the CBER web site 
at ``http://www.fda.gov/cber/minutes/workshop-min.htm''.


    Dated: September 10, 1999
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-24236 Filed 9-16-99; 8:45 am]
BILLING CODE 4160-01-F