60 Day Published Frn 1660-0106 6-6-11

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Federal Register / Vol. 76, No. 108 / Monday, June 6, 2011 / Notices
announced that it was withdrawing
approval of NDA 20–315, effective
December 7, 2007.
Charles O’Keeffe of the Virginia
Commonwealth University School of
Medicine submitted two citizen
petitions, one dated October 31, 2007
(Docket No. FDA–2007–P–0347), and
the second dated September 22, 2010
(Docket No. FDA–2010–P–0505), under
21 CFR 10.30, requesting that the agency
determine whether ORLAAM
(levomethadyl acetate HCl) oral
solution, 10 mg/mL, was withdrawn
from sale for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing agency records, FDA has
determined under § 314.161 that
ORLAAM (levomethadyl acetate HCl)
oral solution, 10 mg/mL, was not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that ORLAAM (levomethadyl
acetate HCl) oral solution, 10 mg/mL,
was withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of ORLAAM
(levomethadyl acetate HCl) oral
solution, 10 mg/mL, from sale. We have
also independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that this product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the agency will continue
to list ORLAAM (levomethadyl acetate
HCl) oral solution, 10 mg/mL, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to ORLAAM (levomethadyl acetate HCl)
oral solution, 10 mg/mL, may be
approved by the agency as long as they
meet all other legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
for this drug product should be revised
to meet current standards, the agency
will advise ANDA applicants to submit
such labeling.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

DEPARTMENT OF HOMELAND
SECURITY

Food and Drug Administration

Federal Emergency Management
Agency

[Docket No. FDA–1999–D–0742 (formerly
Docket No. 1999D–4396)]

[Docket ID FEMA–2011–0013; OMB No.
1660–0106]

Draft Guidance for Clinical
Investigators, Industry, and FDA Staff:
Financial Disclosure by Clinical
Investigators; Correction

Agency Information Collection
Activities, Proposed Collection;
Comment Request; Integrated Public
Alert and Warning Systems (IPAWS)
Inventory

AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice; correction.

SUMMARY: The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of May 24, 2011 (76 FR 30175).
The document announced the
availability of a draft guidance entitled
‘‘ Draft Guidance for Clinical
Investigators, Industry, and FDA Staff:
Financial Disclosure by Clinical
Investigators.’’The document was
published with an incorrect docket
number. This document corrects that
error.
FOR FURTHER INFORMATION CONTACT:
Joyce Strong, Office of Policy, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 3208,
Silver Spring, MD 20993–0002, 301–
796–9148.

In FR Doc.
2011–12623, appearing on page 30175,
in the Federal Register of Tuesday, May
24, 2011, the following correction is
made:
1. On page 30175, in the second
column, in the Docket No. heading,
‘‘[Docket No. FDA–1999–D–0792]
(Formerly FDA–1999–D–0792)’’ is
corrected to read ‘‘[Docket No. FDA–
1999–D–0742] (formerly Docket No.
1999D–4396)’’.

SUPPLEMENTARY INFORMATION:

Dated: May 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–13871 Filed 6–3–11; 8:45 am]
BILLING CODE 4160–01–P

Dated: May 31, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–13884 Filed 6–3–11; 8:45 am]
BILLING CODE 4160–01–P

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AGENCY: Federal Emergency
Management Agency, DHS.
ACTION: Notice.
SUMMARY: The Federal Emergency
Management Agency (FEMA), as part of
its continuing effort to reduce
paperwork and respondent burden,
invites the general public and other
Federal agencies to take this
opportunity to comment on a proposed
revision of a continuing information
collection. In accordance with the
Paperwork Reduction Act of 1995, this
notice seeks comments concerning the
proposed revision of the information
collection concerning public alert and
warning systems at the Federal, State,
territorial, Tribal and local levels of
government which is necessary for the
inventory and evaluation and
assessment of existing public alert and
warning resources and their integration
with the Integrated Public Alert and
Warning System.
DATES: Comments must be submitted on
or before August 5, 2011.
ADDRESSES: To avoid duplicate
submissions to the docket, please use
only one of the following means to
submit comments:
(1) Online. Submit comments at
http://www.regulations.gov under
Docket ID FEMA–2011–0013. Follow
the instructions for submitting
comments.
(2) Mail. Submit written comments to
Docket Manager, Office of Chief
Counsel, DHS/FEMA, 500 C Street, SW.,
Room 835, Washington, DC 20472–
3100.
(3) Facsimile. Submit comments to
(703) 483–2999.
(4) E-mail. Submit comments to
[email protected]. Include Docket
ID FEMA–2011–0013 in the subject line.
All submissions received must
include the agency name and Docket ID.
Regardless of the method used for
submitting comments or material, all
submissions will be posted, without
change, to the Federal eRulemaking
Portal at http://www.regulations.gov,
and will include any personal
information you provide. Therefore,

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Federal Register / Vol. 76, No. 108 / Monday, June 6, 2011 / Notices

submitting this information makes it
public. You may wish to read the
Privacy Act notice that is available via
the link in the footer of http://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Vincent Dumas, Business Operations
Specialist, National Continuity Program
IPAWS Division, FEMA, (202) 646–4269
for additional information. You may
contact the Records Management
Division for copies of the proposed
collection of information at facsimile
number (202) 646–3347 or e-mail
address: [email protected].
SUPPLEMENTARY INFORMATION:
Presidential Executive Order 13407
establishes the policy for an effective,
reliable, integrated, flexible, and
comprehensive system to alert and warn
the American people in situations of
war, terrorist attack, natural disaster, or
other hazards to public safety and well

being. The Executive Order requires that
DHS establish an inventory of public
alert and warning resources,
capabilities, and the degree of
integration at the Federal, State,
territorial, Tribal, and local levels of
government. The Integrated Public Alert
and Warning System (IPAWS)
implements the requirements of the
Executive Order. The information
collected has, and will continue to
consist of the public alert and warning
systems, as well as the communication
systems being used for collaboration
and situational awareness at the Local
Emergency Operations Center (EOC)
level and higher. This information will
help FEMA identify the technologies
currently in use or desired for inclusion
into IPAWS.
Collection of Information
Title: Integrated Public Alert and
Warning Systems (IPAWS) Inventory.

Type of Information Collection:
Revision of currently approved
collection.
OMB Number: 1660–0106.
Form Titles and Numbers: FEMA
Form 142–1–1, IPAWS Inventory.
Abstract: FEMA will be conducting an
inventory, evaluation and assessment of
the capabilities of Federal, State,
territorial, Tribal, and local government
alert and warning systems. The IPAWS
Inventory and Evaluation Survey
collects data that will facilitate the
integration of public alert and warning
systems. It also reduces Federal
planning costs by leveraging existing
State systems.
Affected Public: State, local,
territorial, and Tribal Government.
Estimated Total Annual Burden
Hours: 5,796 hours.

ANNUAL HOUR BURDEN
Data collection activity/instrument

Frequency of
responses

Hour burden
per response

Annual
responses

Total annual
burden hours

(A)

(B)

(C)

(D) = (A × B)

(C × D)

FEMA Form 142–1–1, IPAWS Inventory and Evaluation
Survey.

1,932

1

3 hours (180
min).

1,932

5,796

Total ................................................................................

1,932

........................

3 hours (180
min).

1,932

5,796

Estimated Cost: There are no annual
start-up or capital costs.
Comments

jlentini on DSK4TPTVN1PROD with NOTICES

Number of
respondents

Comments may be submitted as
indicated in the ADDRESSES caption
above. Comments are solicited to (a)
Evaluate whether the proposed data
collection is necessary for the proper
performance of the agency, including
whether the information shall have
practical utility; (b) evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) enhance the quality, utility, and
clarity of the information to be
collected; and (d) 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.

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Dated: May 11, 2011.
Lesia M. Banks,
Director, Records Management Division,
Mission Support Bureau, Federal Emergency
Management Agency, Department of
Homeland Security.
[FR Doc. 2011–13141 Filed 6–3–11; 8:45 am]
BILLING CODE 9110–14–P

DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Internal Agency Docket No. FEMA–3320–
EM; Docket ID FEMA–2011–0001]

Mississippi; Emergency and Related
Determinations
AGENCY: Federal Emergency
Management Agency, DHS.
ACTION: Notice.
SUMMARY: This is a notice of the
Presidential declaration of an
emergency for the State of Mississippi
(FEMA–3320–EM), dated May 4, 2011,
and related determinations.
DATES: Effective Date: May 4, 2011.

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FOR FURTHER INFORMATION CONTACT:
Peggy Miller, Office of Response and
Recovery, Federal Emergency
Management Agency, 500 C Street, SW.,
Washington, DC 20472, (202) 646–3886.
SUPPLEMENTARY INFORMATION: Notice is
hereby given that, in a letter dated May
4, 2011, the President issued an
emergency declaration under the
authority of the Robert T. Stafford
Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121–5207
(the Stafford Act), as follows:

I have determined that the emergency
conditions in certain areas of the State of
Mississippi resulting from flooding beginning
on April 27, 2011, and continuing, are of
sufficient severity and magnitude to warrant
an emergency declaration under the Robert T.
Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121 et seq. (‘‘the
Stafford Act’’). Therefore, I declare that such
an emergency exists in the State of
Mississippi.
You are authorized to provide appropriate
assistance for required emergency measures,
authorized under Title V of the Stafford Act,
to save lives and to protect property and
public health and safety, and to lessen or
avert the threat of a catastrophe in the
designated areas. Specifically, you are
authorized to provide assistance emergency

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