
[Federal Register: September 7, 2010 (Volume 75, Number 172)]
[Notices]               
[Page 54349-54351]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07se10-41]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0007]

 
Animal Models--Essential Elements To Address Efficacy Under the 
Animal Rule; Notice of Public Meeting; and Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; and reopening of comment period.

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SUMMARY: The Food and Drug Administration's (FDA or agency) Center for 
Biologics Evaluation and Research (CBER) and Center for Drug Evaluation 
and Research (CDER) are announcing a public meeting to solicit comments 
and concerns of industry, other government agencies, and interested 
parties on the regulatory and scientific challenges as addressed in the 
draft document entitled ``Guidance for

[[Page 54350]]

Industry: Animal Models--Essential Elements to Address Efficacy Under 
the Animal Rule'' dated January 2009 (Draft Guidance), and as related 
to the development of medical countermeasures under the ``Animal Rule'' 
with respect to chemical, biological, radiological, or nuclear (CBRN) 
threats. Comments on these issues will be considered in connection with 
the development of a final version of the Draft Guidance.

DATES:  The public meeting will be held on November 5, 2010, from 8 
a.m. to 5:30 p.m. Attendees who wish to request to make an oral 
presentation at the public meeting must register and submit their 
comments electronically by October 1, 2010. All non-presenting 
attendees must register electronically by October 27, 2010. See section 
III under SUPPLEMENTARY INFORMATION for the electronic submission of 
registration information, and the electronic submission of a request to 
make an oral presentation and the comments to be presented. The comment 
period for the Draft Guidance has been reopened until January 5, 2011.

ADDRESSES: The public meeting will be held at the FDA White Oak 
Complex, 10903 New Hampshire Ave., Bldg. 31, rm. 1503, Silver Spring, 
MD, 20993-0002.
    Submit electronic comments on the Draft Guidance to http://
www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. See section IV under SUPPLEMENTARY 
INFORMATION for information on submission of comments. See section I 
under SUPPLEMENTARY INFORMATION for electronic access to the Draft 
Guidance.

FOR FURTHER INFORMATION CONTACT:
    Eris Mackey, Career Development and Directed Training Branch, 
Center for Biologics Evaluation and Research (HFM-49), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852, 
301-827-2000, e-mail: AnimalModelGuidance@fda.hhs.gov; or
    Susie Dill, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6183, Silver 
Spring, MD 20993-0002, 301-796-3437, e-mail: 
AnimalModelGuidance@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 21, 2009 (74 FR 3610), FDA 
announced the availability of a draft document entitled ``Guidance for 
Industry, ``Animal Models--Essential Elements to Address Efficacy Under 
the Animal Rule'' dated January 2009 (Draft Guidance). The purpose of 
the Draft Guidance, when finalized, is to assist sponsors in 
identifying the critical characteristics of an animal model that should 
be addressed when efficacy of an investigational product will be 
established under the ``Animal Rule'' (May 31, 2002, 67 FR 37988). FDA 
requested comments on the Draft Guidance by March 23, 2009. In 2010, 
reviews to assess our nation's preparedness against CBRN threats, as 
well as the major issues and challenges to achieving the desired state 
of emergency preparedness, were conducted under the auspices of the 
Public Health Emergency Medical Countermeasure Enterprise. Among the 
many issues noted was the difficulty of the regulatory path when 
developing drug or biological products for approval or licensure, 
respectively, under the ``Animal Rule.'' Therefore, to address this and 
related issues, FDA is holding a public meeting to solicit comments and 
concerns on the challenges related to the development of medical 
countermeasures under the Animal Rule for CBRN threats. FDA will 
consider the oral comments presented at the public meeting and comments 
submitted to docket on the Draft Guidance in developing the final 
version of the Guidance. The Draft Guidance can be found on the 
Internet at http://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/ucm078923.pdf.

II. Purpose and Scope of Meeting

    The purpose of this meeting is to receive comments from a broad 
group of stakeholders on the regulatory and scientific challenges 
related to the development of medical countermeasures under the Animal 
Rule (21 CFR 314.600 for drugs; 21 CFR 601.90 for biological products) 
for CBRN threats as addressed in the Draft Guidance. Each session will 
have a panel composed of FDA representatives from CBER and CDER to 
interact with the presenter as necessary to clarify comments and 
provide limited scientific discussion as appropriate. FDA is 
particularly interested in obtaining information and public comment on 
the following areas:
    Topic Area A: (1) Natural course of the CBRN agent-induced disease 
or condition; and (2) Pathophysiologic comparability of the CBRN agent-
induced disease or condition between animals and humans.
    Topic Area B: (1) Characteristics of the CBRN agent; and (2) Host 
susceptibility in response to the agent.
    Topic Area C: Characterization of medical intervention.
    Topic Area D: Design considerations for the animal efficacy 
studies.
    Topic Area E: General comments.

III. Registration and Requests for Oral Presentations

A. Registration

    The FDA Conference Center at the White Oak Complex is a Federal 
facility with security procedures and limited seating. There is no 
registration fee for the public meeting; however, advance registration 
is required for all attendees including members of the press and FDA 
employees. Registrations will be confirmed in the order in which they 
are received. Attendees who wish to make an oral presentation at the 
public meeting must register and submit their comments electronically 
by October 1, 2010 (see section III.B for additional information on 
requests for oral presentations). All non-presenting attendees must 
register electronically by October 27, 2010. To register 
electronically, attendees must e-mail contact information (including 
name, title, affiliation, address, e-mail, and telephone number), and 
any requests to make oral presentations to: 
AnimalModelGuidance@fda.hhs.gov.
    If you need special accommodations because of a disability, please 
contact FDA (see FOR FURTHER INFORMATION CONTACT) at least 7 days 
before the meeting.

B. Requests for Oral Presentations

    Attendees who wish to make an oral presentation at the public 
meeting must register for the meeting, request to present, and submit 
their comments electronically to AnimalModelGuidance@fda.hhs.gov by 
October 1, 2010.
    In section II under SUPPLEMENTARY INFORMATION of this notice, FDA 
has specified five topic areas for comment. Presenters will also need 
to identify by letter (A through E) the topic area or areas on which 
they will comment. Submitted comments to be presented at the public 
meeting that exceed 10 pages should include a one-page executive 
summary. Oral presentations are limited to statements; slide 
presentations will not be permitted.
    FDA will do its best to accommodate requests to make oral 
presentations, and

[[Page 54351]]

will determine the amount of time allotted to each presenter and the 
approximate time that each oral presentation is scheduled to begin. 
Prior to the meeting, presenters will be notified of their allotted 
time and the approximate scheduled time of their remarks. An agenda of 
the public meeting, including the oral presentation schedule, will be 
available approximately 3 days before the public meeting at the 
Division of Dockets Management (Docket No. FDA-2009-D-0007) and on the 
Internet at http://www.regulations.gov.
    Pre-registered participants will receive additional information on 
parking and public transportation with their e-mail registration 
confirmation.

IV. Comments on the Draft Guidance

    Regardless of attendance at the public meeting, interested persons 
may submit either electronic or written comments regarding the Draft 
Guidance. Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (see 
ADDRESSES). It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number FDA-2009-D-0007. Although you can 
comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to 
ensure that the agency considers your comment on this draft guidance 
before it begins work on the final version of the guidance, submit 
either electronic or written comments on Draft Guidance by January 5, 
2011. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Transcripts

    Transcripts of the meeting will be available for review at the 
Division of Dockets Management and on the Internet at http://
www.regulations.gov approximately 45 days after the meeting. A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to Division of Freedom of Information (HFI-35), Office 
of Management Programs, Food and Drug Administration, 5600 Fishers 
Lane, rm. 6-30, Rockville, MD 20857.

    Dated: September 1, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-22198 Filed 9-3-10; 8:45 am]
BILLING CODE 4160-01-S

