Animal Models-Essential Elements To Address Efficacy Under the Animal Rule; Notice of Public Meeting; and Reopening of Comment Period, 54349-54351 [2010-22198]
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Federal Register / Vol. 75, No. 172 / Tuesday, September 7, 2010 / Notices
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
the discussions could disclose
confidential trade secrets or commercial
property such as patentable materials,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel, NIDA
Clinical Science Conference Grant (R13)
Review.
Date: September 29, 2010.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6101
Executive Boulevard, Rockville, MD 20852.
(Virtual Meeting)
Contact Person: Gerald L. McLaughlin,
PhD, Scientific Review Administrator, Office
of Extramural Affairs, National Institute on
Drug Abuse, NIH, DHHS, Room 220, MSC
8401, 6101 Executive Blvd., Bethesda, MD
20892–8401. 301–402–6626.
gm145a@nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel, NIDA
B/Start Small Grant Review.
Date: October 20, 2010.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6101
Executive Boulevard, Rockville, MD 20852.
(Virtual Meeting)
Contact Person: Gerald L. McLaughlin,
PhD, Scientific Review Administrator, Office
of Extramural Affairs, National Institute on
Drug Abuse, NIH, DHHS, Room 220, MSC
8401, 6101 Executive Blvd., Bethesda, MD
20892–8401. 301–402–6626.
gm145a@nih.gov.
Name of Committee: National Institute on
Drug Abuse Initial Review Group, Training
and Career Development Subcommittee.
Date: November 3–5, 2010.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Ritz-Carlton Hotel, 1150 22nd Street,
NW., Rockville, MD 20852, Washington, DC
20037.
Contact Person: Kristen V. Huntley, PhD,
Scientific Review Administrator, Office of
Extramural Affairs, National Institute on
Drug Abuse, NIH, DHHS, Room 220, MSC
8401, 6101 Executive Boulevard, Bethesda,
MD 20892–8401. 301–435–1433.
huntleyk@mail.nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel, NIDA
I/Start Small Grant Review.
Date: November 10, 2010.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6101
Executive Boulevard, Rockville, MD 20852.
(Virtual Meeting.)
Contact Person: Gerald L. McLaughlin,
PhD, Scientific Review Administrator, Office
of Extramural Affairs, National Institute on
Drug Abuse, NIH, DHHS, Room 220, MSC
VerDate Mar<15>2010
19:12 Sep 03, 2010
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8401, 6101 Executive Blvd., Bethesda, MD
20892–8401. 301–402–6626.
gm145a@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos.: 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
Dated: August 31, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–22183 Filed 9–3–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Negotiated Rulemaking Committee on
Designation of Medically Underserved
Populations and Health Professional
Shortage Areas; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Negotiated Rulemaking
Committee on Designation of Medically
Underserved Populations and Health
Professional Shortage Areas.
Date and time: September 22, 2010,
9:30 a.m. to 5 p.m.
September 23, 2010, 9 a.m. to 4:30
p.m.
September 24, 2010, 9 a.m. to12 p.m.
Place: The Legacy Hotel, Georgetown
Room, 1775 Rockville Pike, Rockville,
Maryland 20852, (301) 881–2300.
Status: The meeting will be open to
the public.
Purpose: The purpose of the
Negotiated Rulemaking Committee on
Designation of Medically Underserved
Populations and Health Professional
Shortage Areas is to establish a
comprehensive methodology and
criteria for Designation of Medically
Underserved Populations and Primary
Care Health Professional Shortage
Areas, using a Negotiated Rulemaking
(NR) process. It is hoped that use of the
NR process will yield a consensus
among technical experts and
stakeholders on a new rule, which will
then be published as an Interim Final
Rule in accordance with Section 5602 of
Public Law 111–148, the Patient
Protection and Affordable Care Act of
2010.
Agenda: The meeting will be held on
Wednesday, September 22, Thursday,
September 23 and Friday, September 24,
and will include an orientation to the
negotiated rulemaking process, ground
rules for Committee operations, and an
overview of the key topics on which the
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Committee will explore and seek
consensus. The Friday morning meeting
will include development of the agenda
for the next meeting, as well as an
opportunity for public comment.
FOR FURTHER INFORMATION CONTACT: For
more information, please contact Lauren
Krantz, Office of Shortage Designation,
Bureau of Health Professions, Health
Resources and Services Administration,
Room 9A–18, Parklawn Building, 5600
Fishers Lane, Rockville, Maryland
20857, Telephone (301) 443–9027, Email lkrantz@hrsa.gov, or visit https://
bhpr.hrsa.gov/shortage/.
SUPPLEMENTARY INFORMATION: Requests
from the public to make oral comments
or to provide written comments to the
Committee should be sent to Lauren
Krantz at the contact address above at
least 10 days prior to the meeting. The
meetings will be open to the public as
indicated below, with attendance
limited to space available. Individuals
who plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify the
Contact Person listed above at least 10
days prior to the meeting. Members of
the public will have the opportunity to
provide comments at the Friday
morning meeting.
Dated: September 1, 2010.
Sahira Rafiullah,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2010–22194 Filed 9–3–10; 8:45 am]
BILLING CODE 4165–15–P
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.
Notice of public meeting; and
reopening of comment period.
ACTION:
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
SUMMARY:
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Federal Register / Vol. 75, No. 172 / Tuesday, September 7, 2010 / Notices
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.
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.
DATES:
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 https://
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.
ADDRESSES:
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
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:
AnimalModel
Guidance@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:
AnimalModel
Guidance@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
15:24 Sep 03, 2010
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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 https://
www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatory
Information/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
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condition; and (2) Pathophysiologic
comparability of the CBRN agentinduced 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 AnimalModel
Guidance@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
E:\FR\FM\07SEN1.SGM
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Federal Register / Vol. 75, No. 172 / Tuesday, September 7, 2010 / Notices
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 https://
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 https://
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.
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
V. Transcripts
Transcripts of the meeting will be
available for review at the Division of
Dockets Management and on the
Internet at https://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
VerDate Mar<15>2010
15:24 Sep 03, 2010
Jkt 220001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Cell and Gene Therapy Clinical Trials
in Pediatric Populations; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA), Center for Biologics Evaluation
and Research (CBER) is announcing a
public workshop entitled ‘‘Cell and
Gene Therapy Clinical Trials in
Pediatric Populations.’’ The purpose of
the workshop is to gather information
from Institutional Review Boards (IRBs),
gene and cellular therapy clinical
researchers, and other stakeholders
regarding best practices related to cell
and gene therapy clinical trials in
pediatric populations, as well as
challenges and considerations in the
review of these clinical trials.
Date and Time: The public workshop
will be held on November 2, 2010, from
8 a.m. to 5:30 p.m.
Location: The public workshop will
be held at the Bethesda North Marriott
Hotel and Conference Center, 5701
Marinelli Rd., North Bethesda, MD
20852.
Contact Person: Bernadette Kawaley,
Center for Biologics Evaluation and
Research (HFM–43), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–2000, FAX 301–827–3079;
email: CBERTraining@fda.hhs.gov
(Subject line: Pediatrics Ethics
Workshop).
Registration: Email, mail or fax your
registration information (including
name, title, firm name, address,
telephone and fax numbers) to the
contact person by October 1, 2010.
There is no registration fee for the
public workshop. Early registration is
recommended because seating is
limited. Registration on the day of the
public workshop will be provided on a
space available basis beginning at 7:30
a.m.
If you need special accommodations
due to a disability, please contact
Bernadette Kawaley (see Contact
Person) at least 7 days in advance.
SUPPLEMENTARY INFORMATION: The
workshop will include presentations on
cell and gene therapy clinical trials in
pediatric populations. The workshop
will include panel discussions regarding
best practices related to cell and gene
therapy clinical trials in pediatric
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54351
populations including those related to:
(1) Evaluating these novel therapeutic
products prior to initiating pediatric
clinical studies; (2) identifying and
minimizing risks associated with the
administration of cell and gene therapy
products in pediatric populations; (3)
obtaining informed consent and assent;
and (4) conducting continuing review of
cell and gene therapy products in
pediatric populations. The workshop
also will include panel discussions
addressing the challenges and
considerations in the review of cell and
gene therapy clinical trials in pediatric
populations and the role of IRBs.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD. 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. A
transcript of the public workshop will
be available on the Internet at https://
www.fda.gov/BiologicsBloodVaccines/
NewsEvents/WorkshopsMeetings
Conferences/TranscriptsMinutes/
default.htm.
Dated: August 20, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–22168 Filed 9–3–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Statement of Organization, Functions,
and Delegations of Authority
Part C (Centers for Disease Control
and Prevention) of the Statement of
Organization, Functions, and
Delegations of Authority of the
Department of Health and Human
Services (45 FR 67772–76, dated
October 14, 1980, and corrected at 45 FR
69296, October 20, 1980, as amended
most recently at 75 FR 45134–45142,
dated August 2, 2010) is amended to
reflect the reorganization of the Office of
Health and Safety, Office of the Chief
Operating Officer, Office of the Director,
Centers for Disease Control and
Prevention.
E:\FR\FM\07SEN1.SGM
07SEN1
]]>Agencies
[Federal Register Volume 75, Number 172 (Tuesday, September 7, 2010)]
[Notices]
[Pages 54349-54351]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22198]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://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 https://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 https://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 https://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
