Draft Guidance on the Open Public Hearing; Food and Drug Administration Advisory Committee Meetings; Availability, 7747 [05-2822]

Download as PDF Federal Register / Vol. 70, No. 30 / Tuesday, February 15, 2005 / Notices Reports Clearance Officer. All requests should be identified by the title of the information collection. E-mail: grjohnson@acf.hhs.gov. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility, (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: February 8, 2005. Robert Sargis, Reports Clearance, Officer. [FR Doc. 05–2826 Filed 2–14–05; 8:45 am] BILLING CODE 4184–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0042] Draft Guidance on the Open Public Hearing; Food and Drug Administration Advisory Committee Meetings; Availability AGENCY: Food and Drug Administration, HHS.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. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ‘‘The Open Public Hearing; FDA Advisory Committee Meetings.’’ This draft guidance is for members of the public who choose to participate in the open public hearing (OPH) session of an FDA advisory committee meeting. The draft guidance is intended to answer more fully questions about how the public may participate at an OPH session, and it includes topics such as meeting logistics and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 DATES: Submit written or electronic comments on this draft guidance by June 15, 2005.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 ADDRESSES: Submit written requests for single copies of the draft guidance to Linda Ann Sherman, Advisory VerDate jul<14>2003 17:50 Feb 14, 2005 Jkt 205001 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 Submit written comments on the draft guidance to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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 https://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, email: 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 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 7747 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 https://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] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D–0033] Draft Guidance for Industry on Internal Radioactive Contamination— Development of Decorporation Agents; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Internal Radioactive Contamination—Development of Decorporation Agents.’’ This draft document provides guidance to industry on the development of decorporation agents for the treatment of internal radioactive contamination when evidence is needed to demonstrate the effectiveness of the agents, but human efficacy studies are unethical or infeasible. In such instances, the Animal Efficacy Rule may be invoked to approve new medical products not previously marketed or new indications for previously marketed products. Specifically, this draft guidance addresses chemistry, manufacturing and controls (CMC) information; animal efficacy, safety pharmacology, and toxicology studies; clinical pharmacology, biopharmaceutics, and human safety studies; and postapproval commitments. DATES: Submit written or electronic comments on the draft guidance by May E:\FR\FM\15FEN1.SGM 15FEN1

Agencies

[Federal Register Volume 70, Number 30 (Tuesday, February 15, 2005)]
[Notices]
[Page 7747]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2822]


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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.

-----------------------------------------------------------------------

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 https://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 
https://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]
BILLING CODE 4160-01-S

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