Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators; Correction, 32367 [2011-13871]
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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solution, 10 mg/mL, was withdrawn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withdrawn for reasons of safety or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was withdrawn for reasons of safety or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withdrawn from sale for reasons of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.
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.
SUMMARY:
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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Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:
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
https://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
FEMA-POLICY@dhs.gov. 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 https://www.regulations.gov,
and will include any personal
information you provide. Therefore,
SUMMARY:
E:\FR\FM\06JNN1.SGM
06JNN1
Agencies
[Federal Register Volume 76, Number 108 (Monday, June 6, 2011)]
[Notices]
[Page 32367]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-13871]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1999-D-0742 (formerly Docket No. 1999D-4396)]
Draft Guidance for Clinical Investigators, Industry, and FDA
Staff: Financial Disclosure by Clinical Investigators; Correction
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.
SUPPLEMENTARY INFORMATION: 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)''.
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