[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