Guidance for Industry on Irritable Bowel Syndrome-Clinical Evaluation of Drugs for Treatment; Availability; Correction, 35689 [2012-14485]
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Federal Register / Vol. 77, No. 115 / Thursday, June 14, 2012 / Notices
adopted this process as a means to
develop and disseminate productspecific BE recommendations and
provide a meaningful opportunity for
the public to consider and comment on
those recommendations. Under that
process, draft recommendations are
posted on FDA’s Web site and
announced periodically in the Federal
Register. The public is encouraged to
submit comments on those
recommendations within 60 days of
their announcement in the Federal
Register. FDA considers any comments
received and either publishes final
recommendations or publishes revised
draft recommendations for comment.
Recommendations were last announced
in the Federal Register of March 28,
2012 (77 FR 18827). This notice
announces draft product-specific
recommendations, either new or
revised, that are being posted on FDA’s
Web site concurrently with publication
of this notice.
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II. Drug Products for Which New Draft
Product-Specific BE Recommendations
Are Available
FDA is announcing new draft
product-specific BE recommendations
for drug products containing the
following active ingredients:
A
Aliskiren hemifumarate; amlodipine
besylate
Alvimopan
Azilsartan medoxomil
B
Bacitracin
Boceprevir
C
Cefpodoxime proxetil (multiple
reference listed drugs (RLDs))
Cefprozil (multiple RLDs)
Cetirizine HCl
Ciprofloxacin HCl; hydrocortisone
Clomiphene citrate
D
Dabigatran etexilate mesylate
Dexamethasone; tobramycin
Dinoprostone
Diphenhydramine; ibuprofen
E
Erythromycin
F
Famotidine; ibuprofen
G
Gabapentin enacarbil
I
Itraconazole
K
Ketoconazole
L
Lacosamide
M
Malathion
Morphine sulfate; naltrexone HCl
P
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35689
Dated: June 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
Podofilox
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Rotigotine
Rufinamide
[FR Doc. 2012–14477 Filed 6–13–12; 8:45 am]
T
Tapentadol HCl
Tetrabenazine
BILLING CODE 4160–01–P
Zolpidem tartrate
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Z
III. Drug Products for Which Revised
Draft Product-Specific BE
Recommendations Are Available
FDA is announcing revised draft
product-specific BE recommendations
for drug products containing the
following active ingredients:
D
Dexamethasone; tobramycin (multiple
RLDs)
E
Everolimus
L
Loteprednol etabonate
Loteprednol etabonate; tobramycin
S
Sorafenib tosylate
For a complete history of previously
published Federal Register notices
related to product-specific BE
recommendations, please go to https://
www.regulations.gov and enter docket
number FDA–2007–D–0369.
These draft and revised draft
guidances are being issued consistent
with FDA’s good guidance practices
regulation (21 CFR 10.115). These
guidances represent the Agency’s
current thinking on product-specific
design of BE studies to support ANDAs.
They do not create or confer any rights
for or on any person and do not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
IV. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments on any of the specific BE
recommendations posted on FDA’s Web
site. Identify comments with the docket
number found in brackets in the
heading of this document. The
guidances, notices, and received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Food and Drug Administration
[Docket No. FDA–2010–D–0146]
Guidance for Industry on Irritable
Bowel Syndrome—Clinical Evaluation
of Drugs for Treatment; Availability;
Correction
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 31, 2012 (77 FR 32124).
The document announced the
availability of a guidance for industry
entitled ‘‘Irritable Bowel Syndrome—
Clinical Evaluation of Drugs for
Treatment.’’ The document was
published with an incorrect docket
number. This document corrects that
error.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Joyce Strong, Office of Policy and
Planning, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 3208, Silver Spring,
MD 20993–0002, 301–796–9148.
In FR Doc.
2012–13143, appearing on page 32124
in the Federal Register of Thursday,
May 31, 2012, the following correction
is made:
1. On page 32124, in the first column,
in the headings section of the document,
‘‘[Docket No. FDA–2012–D–0146]’’ is
corrected to read ‘‘[Docket No. FDA–
2010–D–0146]’’.
SUPPLEMENTARY INFORMATION:
Dated: June 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–14485 Filed 6–13–12; 8:45 am]
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V. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
PO 00000
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[Federal Register Volume 77, Number 115 (Thursday, June 14, 2012)]
[Notices]
[Page 35689]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14485]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0146]
Guidance for Industry on Irritable Bowel Syndrome--Clinical
Evaluation of Drugs for Treatment; Availability; 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 31, 2012 (77 FR 32124).
The document announced the availability of a guidance for industry
entitled ``Irritable Bowel Syndrome--Clinical Evaluation of Drugs for
Treatment.'' The document was published with an incorrect docket
number. This document corrects that error.
FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy and
Planning, 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. 2012-13143, appearing on page
32124 in the Federal Register of Thursday, May 31, 2012, the following
correction is made:
1. On page 32124, in the first column, in the headings section of
the document, ``[Docket No. FDA-2012-D-0146]'' is corrected to read
``[Docket No. FDA-2010-D-0146]''.
Dated: June 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14485 Filed 6-13-12; 8:45 am]
BILLING CODE 4160-01-P
