[Federal Register Volume 61, Number 66 (Thursday, April 4, 1996)]
[Notices]
[Pages 15080-15081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8359]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95P-0110]


Guidance Documents; The Food and Drug Administration's 
Development and Use; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting on issues relating to the agency's development and use of 
guidance documents. The agency is holding this public meeting to 
further discuss issues that were raised in a citizen petition submitted 
by the Indiana Medical Devices Manufacturers Council, Inc. (IMDMC). The 
citizen petition requested that FDA control the development of guidance 
documents by written procedures that ensure the appropriate level of 
meaningful public participation.

DATES: The public meeting will be held on Friday, April 26, 1996, 9 
a.m. to 3 p.m.

ADDRESSES: The public meeting will be held at the National Institutes 
of Health, Warren Grant Magnuson Clinical Center, Bldg. 10, Masur 
Auditorium, 9000 Rockville Pike, Bethesda, MD 20892-1162. Those persons 
interested in attending this meeting should FAX their registration to 
Lisa Barclay by April 16, 1996.
    The notice of registration should include the registrant's name, 
address, telephone number, FAX number, and business affiliation, if 
any. Persons interested in making a presentation at the meeting should 
include a brief summary of the presentation, and the approximate amount 
of time requested for the presentation. FDA will allocate the time 
available for the public meeting among the persons who properly file 
notices of their intent to make a presentation at the meeting. If time 
permits, FDA may allow additional presentations from interested persons 
attending the meeting who did not submit a notice of their intent to 
make a presentation.
    Notices of registration should be received by April 16, 1996. There 
is no registration fee for this public meeting, but advance 
registration is required. Interested parties are encouraged to register 
early.
    Parking in the Clinical Center visitor area is reserved for 
Clinical Center patients and their visitors. If you must drive, please 
use an outlying parking lot, such as Lot 41B. Free shuttle bus service 
is provided from Lot 41B to the Clinical Center every 8 minutes during 
rush hour and every 15 minutes at other times. The National Institutes 
of Health campus may be reached by subway (Metro). Take the Red Line to 
the Medical Center stop. The same shuttle service is available from 
Metro to the Clinical Center.

FOR FURTHER INFORMATION CONTACT: Lisa Barclay, Office of Policy (HF-
23), Food and Drug Administration, 5600 Fishers Lane, rm. 14-101, 
Rockville, MD 20857, 301-827-3360, FAX 301-594-6777.
SUPPLEMENTARY INFORMATION: Issues relating to FDA's development and use 
of guidance documents were raised in a citizen petition submitted by 
the IMDMC. (See Docket No. 95P-0110). Specifically, the petition 
requested that FDA control the initiation, development, and issuance of 
guidance documents by written procedures that ensure the appropriate 
level of

[[Page 15081]]
meaningful public participation. FDA agreed to take steps to improve 
its guidance document procedures. In the Federal Register of March 7, 
1996 (61 FR 9181), FDA published a notice that sets forth its current 
thinking on ways to improve its guidance document procedures and 
solicited comment on these and additional ideas for improvement. The 
purpose of this public meeting is to further discuss the issues set 
forth in the notice published in the Federal Register of March 7, 1996 
(61 FR 9181).

    Dated: March 29, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-8359 Filed 4-1-96; 3:25 pm]
BILLING CODE 4160-01-F