[Federal Register: February 15, 2005 (Volume 70, Number 30)]
[Notices]               
[Page 7747]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15fe05-76]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0042]

 
Draft Guidance on the Open Public Hearing; Food and Drug 
Administration Advisory Committee 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availability of a draft guidance document entitled ``The Open Public 
Hearing; FDA Advisory Committee Meetings.'' This draft guidance is for 
members of the public who choose to participate in the open public 
hearing (OPH) session of an FDA advisory committee meeting. The draft 
guidance is intended to answer more fully questions about how the 
public may participate at an OPH session, and it includes topics such 
as meeting logistics and administrative requirements.

DATES: Submit written or electronic comments on this draft guidance by 
June 15, 2005. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to Linda Ann Sherman, Advisory Committee Oversight and 
Management Staff (HF-4), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Submit written comments on the draft 
guidance to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov.dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.

FOR FURTHER INFORMATION CONTACT: Linda Ann Sherman, Office of the 
Commissioner (HF-4), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1220, e-mail: disclosure@oc.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance document 
entitled ``The Open Public Hearing; FDA Advisory Committee Meetings.''
    Guidance documents are prepared for FDA staff, applicants/sponsors, 
and the public that describe the agency's interpretation of, or policy 
on, a regulatory issue. Every committee meeting includes an OPH during 
which interested persons may present relevant information or views 
orally or in writing 21 CFR 14.25(a). The hearing is conducted in 
accordance with 21 CFR 14.29. FDA encourages the participation from all 
public speakers in its decisionmaking processes. The draft guidance is 
intended to answer more fully questions about how (including topics 
such as meeting logistics and administrative requirements) the public 
may participate at an OPH session. This includes, but is not limited 
to, general members of the public; individuals or spokespersons from 
the regulated industry; consumer advocacy groups; and professional 
organizations, societies, or associations.
    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices (21 CFR 10.115). The draft guidance, when 
finalized will represent the agency's current thinking on an FDA 
advisory committee open public hearing. 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 and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft guidance. 
Two paper copies of mailed comments are to be submitted, 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. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/advisory/default.htm in the policy and guidance 

section of FDA's advisory committee Intranet Web site.

    Dated: February 8, 2005.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 05-2822 Filed 2-14-05; 8:45 am]

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