Laboratory Animal Welfare: Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals, 27335-27336 [2011-11490]
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Federal Register / Vol. 76, No. 91 / Wednesday, May 11, 2011 / Notices
withdraw the accelerated approval of
Avastin for [the MBC indication],
subject to Genentech’s conduct of a new
confirmatory study of Avastin with
paclitaxel’’ (Letter from Michael Labson
to the Presiding Officer, April 8, 2011,
page 1). CDER has stated the issue,
‘‘Whether CDER has appropriately
exercised its authority by proposing to
withdraw approval of the MBC
indication, rather than allowing the
indication to remain on the label while
the sponsor designs and conducts
additional studies intended to verify the
drug’s clinical benefit’’ (CDER’s
Statement of Questions Presented, page
3). Ultimately, while stated differently,
the parties seem to agree that there is an
issue of the propriety of CDER’s
proposed withdrawal of this indication
now as opposed to the alternative of
continuing the approval of the breast
cancer indication while Genentech
performs new clinical studies of Avastin
with paclitaxel to verify the clinical
benefit of the MBC indication. This
statement of the issue raises the
question of why, to confirm an
indication for combination use with
paclitaxel, Genentech proposed, and
CDER agreed, that Genentech could rely
on studies of Avastin in combination
with chemotherapeutic agents other
than paclitaxel. It appears that the
explanation is that these studies were
already ongoing at the time of the initial
approval and both CDER and Genentech
believed, at that time, that the results of
these studies could provide evidence to
verify the claim that Avastin, combined
with paclitaxel, would have the effect
indicated in the approved labeling.
FDA is addressing the issue of
whether to maintain the accelerated
approval while additional studies are
conducted as the third issue for this
hearing as follows:
Issue 3. If the Commissioner agrees
with the grounds for withdrawal set out
in issue 1, issue 2.A, or issue 2.B,
should FDA nevertheless continue the
approval of the breast cancer indication
while the sponsor designs and conducts
additional studies intended to verify the
drug’s clinical benefit?
While the parties would state the issues
differently, the three issues stated in
this notice will be those upon which the
Commissioner expects to decide this
matter. If Genentech prevails on issues
1, 2.A, and 2.B, the approval will be
continued. If CDER prevails on issue 1,
2.A, or 2.B, the question of withdrawal
will depend on issue 3.
In addition to the issues 1, 2.A, 2.B,
and 3, Genentech has proposed to raise
issues concerning the consistency of
CDER’s position here with CDER’s
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decisions with respect to other products
for the treatment of MBC or of other
products approved under the
accelerated approval program. Issues
with respect to FDA action on other
products are not relevant to this
proceeding. Each decision to withdraw
or not to withdraw the approval of a
product must be made on its own
merits. If the decision with respect to
another product is in error, that would
not justify continuing that error with
respect to the MBC indication for
Avastin. Moreover, as a practical matter,
it would not be possible to evaluate the
different circumstances associated with
decisions with respect to other products
in the context of this or any hearing.
FDA has consistently rejected attempts
to bring evidence with respect to
decisions on other products into
hearings on approval or withdrawal of
approval of products and will not
deviate from that position here.
B. Process
As further specified previously in this
document, the hearing will be held in
the Agency’s White Oak Conference
Center on June 28 and 29, 2011.
Although no statute or regulation
requires that separation of functions be
applied to this proceeding, the Agency
is observing separation of functions as a
matter of policy in this matter. As the
Center responsible for the proposed
action, CDER, like Genentech, will be a
party to the hearing and will be
responsible for presenting its position at
the hearing in accordance with § 601.43
and part 15.
In accordance with § 601.43(e)(2), no
person other than the Presiding Officer,
the three designated representatives for
each party, and the members of the
advisory committee may question
witnesses present at the hearing.
Because this is a public hearing, it is
subject to our regulations concerning
the policy and procedures for electronic
media coverage of public agency
administrative proceedings (§§ 10.200
through 10.206 (21 CFR 10.200 through
10.206)). These procedures are primarily
intended to expedite media access to
our public proceedings. Representatives
of the electronic media may be
permitted, subject to certain limitations,
to videotape, film, or otherwise record
our public administrative proceedings,
including the testimony of witnesses in
the proceedings. Accordingly, the
parties and nonparty participants to this
hearing, and all other interested
persons, are directed to §§ 10.200
through 10.206, for a more complete
explanation of those regulations’ effect
on this hearing.
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27335
III. 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
(see Registration and Requests to Make
Oral Presentation). 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 the 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: May 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–11539 Filed 5–6–11; 4:15 pm]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Laboratory Animal Welfare: Proposed
Adoption and Implementation of the
Eighth Edition of the Guide for the
Care and Use of Laboratory Animals
AGENCY:
National Institutes of Health,
HHS.
Notice of Additional Extension
of Comment Period.
ACTION:
NIH is further extending the
period for public comments on (1) NIH’s
adoption of the eighth edition of the
Guide for the Care and Use of
Laboratory Animals (Guide) as a basis
for evaluation of institutional programs
receiving or proposing to receive Public
Health Service (PHS) support for
activities involving animals; and (2) if
NIH decides to adopt the eighth edition
of the Guide, NIH’s proposed
implementation plan, which would
require that institutions complete at
least one semiannual program and
facility evaluation using the eighth
edition of the Guide as the basis for
evaluation by March 31, 2012. NIH will
consider comments on (1) The adoption
of the Guide and (2) the implementation
plan. The notice on the proposed
adoption and implementation plan for
the eighth edition of the Guide was
published in the Federal Register on
February 24, 2011 (76 FR 10379). The
comment period is extended by an
additional 30 days and thus will end on
May 24, 2011. Additionally, character
limits on the comment form fields have
been removed.
SUMMARY:
E:\FR\FM\11MYN1.SGM
11MYN1
27336
Federal Register / Vol. 76, No. 91 / Wednesday, May 11, 2011 / Notices
Written comments on the
adoption and implementation of the
eighth edition of the Guide must be
received by NIH on or before May 24,
2011, in order to be considered.
ADDRESSES: Public comments may be
entered at: https://grants.nih.gov/grants/
olaw/2011guidecomments/add.htm.
Character limits on the comment form
fields have been removed. If the
character limit previously in place
prevented you from submitting your
entire comment, please resubmit by the
deadline in order to be considered.
Comments will be made publicly
available. Personally identifiable
information (except organizational
affiliations) will be removed prior to
making comments publicly available.
FOR FURTHER INFORMATION CONTACT:
Office of Laboratory Animal Welfare,
Office of Extramural Research, National
Institutes of Health, RKL1, Suite 360,
6705 Rockledge Drive, Bethesda, MD
20892–7982; telephone 301–496–7163.
SUPPLEMENTARY INFORMATION:
DATES:
mstockstill on DSKH9S0YB1PROD with NOTICES
I. Background
The Guide, first published in 1963, is
a widely accepted primary reference on
animal care and use. Recommendations
in the Guide are based on published
data, scientific principles, expert
opinion, and experience with methods
and practices that are determined to be
consistent with high quality, humane
animal care and use. The eighth edition
of the Guide was published in January
2011 following a study by the Institute
for Laboratory Animal Research of the
National Academy of Sciences (NAS).
The NAS study process began in 2008
and followed the requirements of
Section 15 of the Federal Advisory
Committee Act. The NAS study process
is described at the NAS Web site:
https://www.nationalacademies.org/
studyprocess/.
Since 1985, the PHS Policy on
Humane Care and Use of Laboratory
Animals, authorized by Public Law 99–
158, 42 U.S.C. 289d, and incorporated
by reference at 42 CFR 52.8 and 42 CFR
52a.8, has required that institutions
receiving PHS support for animal
activities base their animal care and use
programs on the current edition of the
Guide and comply, as applicable, with
the Animal Welfare Act and other
Federal statutes and regulations relating
to animal activities. The PHS Policy is
applicable to all PHS-conducted or
-supported activities (including
research, research training,
experimentation, biological testing, or
related purposes) involving live
vertebrate animals.
VerDate Mar<15>2010
17:18 May 10, 2011
Jkt 223001
The eighth edition of the Guide
contains substantive changes and
additions from the previous edition. To
gain insight from institutions on the
impact of changes to the Guide on their
animal care and use programs, NIH
seeks comments on whether it should
adopt the eighth edition of the Guide.
NIH simultaneously proposes an
implementation plan for the eighth
edition of the Guide and seeks
comments on the proposed plan.
The implementation plan proposed by
NIH would require institutions to
complete at least one semiannual
program and facility evaluation, using
the eighth edition of the Guide as the
basis for evaluation, by March 31, 2012.
For such an evaluation to be considered
complete by NIH, it would need to
include reasonable and specific plans
and schedules for corrections of
deficiencies where appropriate.
II. Electronic Access
The eighth edition of the Guide is
available on the NIH Office of
Laboratory Animal Welfare Web site at
https://olaw.nih.gov.
Dated: May 4, 2011.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2011–11490 Filed 5–10–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Board
of Scientific Counselors, NIA.
The meeting 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 below
in advance of the meeting.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Institute on Aging, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
PO 00000
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the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors, NIA.
Date: June 14–15, 2011.
Closed: June 14, 2011, 8 a.m. to 8:30 a.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Boulevard, 3rd Floor Conference Room,
Baltimore, MD 21224.
Open: June 14, 2011, 8:30 a.m. to 12 p.m.
Agenda: Committee discussion, individual
presentations, laboratory overview.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Boulevard, 3rd Floor Conference Room,
Baltimore, MD 21224.
Closed June 14, 2011, 12 p.m. to 1:15 p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Boulevard, 3rd Floor Conference Room,
Baltimore, MD 21224.
Open: June 14, 2011, 1:15 p.m. to 3:15 p.m.
Agenda: Committee discussion, individual
presentations, laboratory overview.
Agenda: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Boulevard, 3rd Floor Conference Room,
Baltimore, MD 21224.
Closed: June 14, 2011, 3:15 p.m. to 3:30
p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Boulevard, 3rd Floor Conference Room,
Baltimore, MD 21224.
Open: June 14, 2011, 3:30 p.m. to 4:15 p.m.
Agenda: Committee discussion, individual
presentations, laboratory overview.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Boulevard, 3rd Floor Conference Room,
Baltimore, MD 21224.
Closed: June 14, 2011, 4:15 p.m. to 5:50
p.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Boulevard, 3rd Floor Conference Room,
Baltimore, MD 21224.
Closed: June 15, 2011, 8 a.m. to 8:30 a.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Boulevard, 3rd Floor Conference Room,
Baltimore, MD 21224.
Open: June 15, 2011, 8:30 p.m. to 11:15
a.m.
Agenda: Committee discussion, individual
presentations, laboratory overview.
E:\FR\FM\11MYN1.SGM
11MYN1
Agencies
[Federal Register Volume 76, Number 91 (Wednesday, May 11, 2011)]
[Notices]
[Pages 27335-27336]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-11490]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Laboratory Animal Welfare: Proposed Adoption and Implementation
of the Eighth Edition of the Guide for the Care and Use of Laboratory
Animals
AGENCY: National Institutes of Health, HHS.
ACTION: Notice of Additional Extension of Comment Period.
-----------------------------------------------------------------------
SUMMARY: NIH is further extending the period for public comments on (1)
NIH's adoption of the eighth edition of the Guide for the Care and Use
of Laboratory Animals (Guide) as a basis for evaluation of
institutional programs receiving or proposing to receive Public Health
Service (PHS) support for activities involving animals; and (2) if NIH
decides to adopt the eighth edition of the Guide, NIH's proposed
implementation plan, which would require that institutions complete at
least one semiannual program and facility evaluation using the eighth
edition of the Guide as the basis for evaluation by March 31, 2012. NIH
will consider comments on (1) The adoption of the Guide and (2) the
implementation plan. The notice on the proposed adoption and
implementation plan for the eighth edition of the Guide was published
in the Federal Register on February 24, 2011 (76 FR 10379). The comment
period is extended by an additional 30 days and thus will end on May
24, 2011. Additionally, character limits on the comment form fields
have been removed.
[[Page 27336]]
DATES: Written comments on the adoption and implementation of the
eighth edition of the Guide must be received by NIH on or before May
24, 2011, in order to be considered.
ADDRESSES: Public comments may be entered at: https://grants.nih.gov/grants/olaw/2011guidecomments/add.htm. Character limits on the comment
form fields have been removed. If the character limit previously in
place prevented you from submitting your entire comment, please
resubmit by the deadline in order to be considered. Comments will be
made publicly available. Personally identifiable information (except
organizational affiliations) will be removed prior to making comments
publicly available.
FOR FURTHER INFORMATION CONTACT: Office of Laboratory Animal Welfare,
Office of Extramural Research, National Institutes of Health, RKL1,
Suite 360, 6705 Rockledge Drive, Bethesda, MD 20892-7982; telephone
301-496-7163.
SUPPLEMENTARY INFORMATION:
I. Background
The Guide, first published in 1963, is a widely accepted primary
reference on animal care and use. Recommendations in the Guide are
based on published data, scientific principles, expert opinion, and
experience with methods and practices that are determined to be
consistent with high quality, humane animal care and use. The eighth
edition of the Guide was published in January 2011 following a study by
the Institute for Laboratory Animal Research of the National Academy of
Sciences (NAS). The NAS study process began in 2008 and followed the
requirements of Section 15 of the Federal Advisory Committee Act. The
NAS study process is described at the NAS Web site: https://www.nationalacademies.org/studyprocess/.
Since 1985, the PHS Policy on Humane Care and Use of Laboratory
Animals, authorized by Public Law 99-158, 42 U.S.C. 289d, and
incorporated by reference at 42 CFR 52.8 and 42 CFR 52a.8, has required
that institutions receiving PHS support for animal activities base
their animal care and use programs on the current edition of the Guide
and comply, as applicable, with the Animal Welfare Act and other
Federal statutes and regulations relating to animal activities. The PHS
Policy is applicable to all PHS-conducted or -supported activities
(including research, research training, experimentation, biological
testing, or related purposes) involving live vertebrate animals.
The eighth edition of the Guide contains substantive changes and
additions from the previous edition. To gain insight from institutions
on the impact of changes to the Guide on their animal care and use
programs, NIH seeks comments on whether it should adopt the eighth
edition of the Guide. NIH simultaneously proposes an implementation
plan for the eighth edition of the Guide and seeks comments on the
proposed plan.
The implementation plan proposed by NIH would require institutions
to complete at least one semiannual program and facility evaluation,
using the eighth edition of the Guide as the basis for evaluation, by
March 31, 2012. For such an evaluation to be considered complete by
NIH, it would need to include reasonable and specific plans and
schedules for corrections of deficiencies where appropriate.
II. Electronic Access
The eighth edition of the Guide is available on the NIH Office of
Laboratory Animal Welfare Web site at https://olaw.nih.gov.
Dated: May 4, 2011.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2011-11490 Filed 5-10-11; 8:45 am]
BILLING CODE 4140-01-P