[Federal Register Volume 75, Number 172 (Tuesday, September 7, 2010)]
[Notices]
[Pages 54349-54351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22198]
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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the Animal Rule'' dated January 2009 (Draft Guidance), and as related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the development of a final version of the Draft Guidance.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period for the Draft Guidance has been reopened until January 5, 2011.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Submit electronic comments on the Draft Guidance to http://www.regulations.gov.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: [email protected]; 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:
[email protected].
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:
[email protected].
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 [email protected] 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
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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]
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