30-day notice

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Federal Register / Vol. 77, No. 111 / Friday, June 8, 2012 / Notices

location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at http://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. All electronic and
written submissions submitted to the
Docket (see the ADDRESSES section of
this document) on or before October 15,
2012, will be provided to the committee.
Oral presentations from the public will
be scheduled between approximately
8:15 a.m. and 9:15 a.m. on October 30,
2012. Those individuals interested in
making formal oral presentations should
notify the contact person and submit a
brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before October 4, 2012. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by October 5, 2012.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Kristina
Toliver at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
http://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm111462.htm for
procedures on public conduct during
advisory committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: June 4, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–13868 Filed 6–7–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0494]

Pfizer, Inc.; Withdrawal of Approval of
Familial Adenomatous Polyposis
Indication for CELEBREX
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA) is withdrawing
approval of the familial adenomatous
polyposis (FAP) indication for
CELEBREX (celecoxib) Capsules held by
Pfizer, Inc. (Pfizer), 235 East 42nd St.,
New York, NY 10017–5755. Pfizer has
voluntarily requested that approval of
this indication be withdrawn, thereby
waiving its opportunity for a hearing.
DATES: Effective June 8, 2012.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6250,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: FDA
approved the FAP indication for
CELEBREX on December 23, 1999,
under the Agency’s accelerated approval
regulations, 21 CFR part 314, subpart H.
In addition to FAP, CELEBREX is
indicated for the relief of the signs and
symptoms of osteoarthritis, rheumatoid
arthritis, juvenile rheumatoid arthritis
in patients 2 years and older, ankylosing
spondylitis, primary dysmenorrhea, and
for the management of acute pain in
adults. Withdrawal of approval of the
FAP indication does not affect any other
approved indication for CELEBREX. On
February 2, 2011, FDA requested that
Pfizer voluntarily withdraw the FAP
indication for CELEBREX (celecoxib)
Capsules from the market because the
postmarketing study intended to verify
clinical benefit and required as a
condition of approval under subpart H
was never completed. In a letter dated
February 3, 2011, Pfizer requested that
FDA withdraw the FAP indication for
CELEBREX (celecoxib) Capsules from
the market. In that letter, Pfizer waived
any opportunity for a hearing otherwise
provided under 21 CFR 314.150 and
314.530, and noted that withdrawal of
the FAP indication was not ‘‘due to any
new efficacy or safety data.’’ In FDA’s
letter of February 4, 2011, the Agency
acknowledged Pfizer’s agreement to
permit FDA to withdraw the FAP
indication for CELEBREX (celecoxib)
SUMMARY:

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Capsules under 21 CFR 314.150(d) and
waive its opportunity for a hearing.
Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(e)) and 21 CFR
314.150(d), and under authority
delegated by the Commissioner to the
Director, Center for Drug Evaluation and
Research, approval of the FAP
indication for CELEBREX (celecoxib)
Capsules is withdrawn (see DATES).
Dated: May 4, 2012.
Janet Woodcock,
Director, Center for Drug Evaluation and
Research.
[FR Doc. 2012–13900 Filed 6–7–12; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
Agency Information Collection
Activities: Form I–102; Revision of an
Existing Information Collection;
Comment Request
30-Day Notice of Information
Collection Under Review; Form I–102,
Application for Replacement/Initial
Nonimmigrant Arrival-Departure
Document.

ACTION:

The Department of Homeland
Security, U.S. Citizenship and
Immigration Services (USCIS) will be
submitting the following information
collection request to the Office of
Management and Budget (OMB) for
review and clearance in accordance
with the Paperwork Reduction Act of
1995. The information collection was
previously published in the Federal
Register on February 28, 2012 at 77 FR
12070, allowing for a 60-day public
comment period. USCIS did not receive
any comments for this information
collection.
The purpose of this notice is to allow
an additional 30 days for public
comments. Comments are encouraged
and will be accepted until July 9, 2012.
This process is conducted in accordance
with 5 CFR 1320.10.
Written comments and/or suggestions
regarding the item(s) contained in this
notice, especially regarding the
estimated public burden and associated
response time, should be directed to the
Department of Homeland Security
(DHS), and to the Office of Management
and Budget (OMB) USCIS Desk Officer.
Comments may be submitted to: USCIS,
Chief Regulatory Coordinator,
Regulatory Coordination Division,
Office of Policy and Strategy, Clearance

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Federal Register / Vol. 77, No. 111 / Friday, June 8, 2012 / Notices
Office, 20 Massachusetts Avenue,
Washington, DC 20529. Comments may
also be submitted to DHS via email at
uscisfrcomment@dhs.gov, to the OMB
USCIS Desk Officer via facsimile at 202–
395–5806 or via email at
oira_submission@omb.eop.gov.
When submitting comments by email
please make sure to add OMB Control
Number 1615–0079 in the subject box.
Written comments and suggestions from
the public and affected agencies should
address one or more of the following
four points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(2) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses.

mstockstill on DSK4VPTVN1PROD with NOTICES

Overview of This Information
Collection
(1) Type of Information Collection:
Revision of an existing information
collection.
(2) Title of the Form/Collection:
Application for Replacement/Initial
Nonimmigrant Arrival-Departure
Document.
(3) Agency form number, if any, and
the applicable component of the
Department of Homeland Security
sponsoring the collection: Form I–102;
U.S. Citizenship and Immigration
Services (USCIS).
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract: Primary: Individuals or
households. Nonimmigrants temporarily
residing in the United States use this
form to request a replacement of their
arrival evidence document.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: 17,700 responses at .416 hours
(25 minutes) per response.
(6) An estimate of the total public
burden (in hours) associated with the
collection: 7,363.2 annual burden hours.

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If you need a copy of the information
collection instrument, please visit the
Web site at:
http://www.regulations.gov/.
We may also be contacted at: USCIS,
Regulatory Coordination Division,
Office of Policy and Strategy, 20
Massachusetts Avenue NW.,
Washington, DC 20529, Telephone
number 202–272–1470.
Dated: May 23, 2012.
Laura Dawkins,
Acting Chief Regulatory Coordinator,
Regulatory Coordination Division, Office of
Policy and Strategy, U.S. Citizenship and
Immigration Services, Department of
Homeland Security.
[FR Doc. 2012–13799 Filed 6–7–12; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
Agency Information Collection
Activities: Form I–590, Extension of a
Currently Approved Information
Collection; Comment Request
30-Day Notice of Information
Collection Under Review: Form I–590,
Registration for Classification as
Refugee.

ACTION:

The Department of Homeland
Security, U.S. Citizenship and
Immigration Services (USCIS) will be
submitting the following information
collection request to the Office of
Management and Budget (OMB) for
review and clearance in accordance
with the Paperwork Reduction Act of
1995. The information collection was
previously published in the Federal
Register on March 12, 2012, at 77 FR
14535, allowing for a 60-day public
comment period. USCIS did not receive
any comments for this information
collection.
The purpose of this notice is to allow
an additional 30 days for public
comments. Comments are encouraged
and will be accepted until July 9, 2012.
This process is conducted in accordance
with 5 CFR 1320.10.
Written comments and/or suggestions
regarding the item(s) contained in this
notice, especially regarding the
estimated public burden and associated
response time, should be directed to the
Department of Homeland Security
(DHS), and to the Office of Management
and Budget (OMB) USCIS Desk Officer.
Comments may be submitted to: USCIS,
Chief, Regulatory Coordination
Division, Office of Policy and Strategy,

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Clearance Office, 20 Massachusetts
Avenue NW., Washington, DC 20529.
Comments may also be submitted to
DHS via email
uscisfrcomment@dhs.gov, and to the
OMB USCIS Desk Officer via facsimile
at 202–395–5806 or via email at
oira_submission@omb.eop.gov. When
submitting comments by email please
make sure to add OMB Control Number
1615–0068 in the subject box. Written
comments and suggestions from the
public and affected agencies should
address one or more of the following
four points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(2) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses.
Overview of This Information
Collection
(1) Type of Information Collection:
Extension of a currently approved
information collection.
(2) Title of the Form/Collection:
Registration for Classification as
Refugee.
(3) Agency form number, if any, and
the applicable component of the
Department of Homeland Security
sponsoring the collection: Form I–590;
U.S. Citizenship and Immigration
Services (USCIS).
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract: Primary: Individuals or
Households. Form I–590 provides a
uniform method for applicants to apply
for refugee status and contains the
information needed for USCIS to
adjudicate such applications.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: 100,000 responses at .583
hours (35 minutes) per response.
(6) An estimate of the total public
burden (in hours) associated with the
collection: 58,300 annual burden hours.

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