Port Access Route Study: In the Chukchi Sea, Bering Strait and Bering Sea, 14147 [2015-05372]
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Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
employing modified release
technologies, only immediate release
formulations would be candidates for
the in vitro BE assessment. For orally
administered products, in vitro BE
would be limited to disintegrated
dosage forms. In cases when the
administered drug acts both locally and
systemically, blood level data may be
used to confirm drug product BE of the
systemic effects (and to confirm
comparability of in vivo product
disintegration in cases where multiple
drugs are combined in a single solid oral
dosage forms), while the additional in
vitro dissolution data could be used to
support the comparability of the local
actions.
The in vitro BE approach should not
be construed as a biowaiver, but rather
as an alternative set of tests that would
be handled in a manner consistent with
that of an in vivo BE study. Specifically,
(1) because an in vitro BE approach is
not a biowaiver, sponsors would still
need to meet the same environmental
safety and human food safety
requirements associated with products
undergoing in vivo BE studies; (2) one
in vitro study may not suffice when
there are multiple product strengths
(e.g., varying concentrations of an intramammary infusion); and (3) the in vitro
method could be applied both to fully
soluble and poorly soluble compounds.
In vitro BE determinations would be
based upon a battery of in vitro
dissolution studies and
physicochemical tests. Links to
additional background material are
provided on the Agency’s Web site at:
https://www.fda.gov/AnimalVeterinary/
NewsEvents/WorkshopsConferences
Meetings/ucm435459.htm.
To assist FDA in developing guidance
for demonstrating in vitro BE, with this
notice the Agency is convening an open
forum, providing a summary of what the
Agency envisions as considerations
pivotal to the BE assessment and
inviting public comment on the various
components of an in vitro BE
determination.
II. Participation in a Public Meeting
While oral presentations from specific
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documentation should be submitted
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comments to https://
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comments to the Division of Dockets
Management (HFA–305), Food and Drug
VerDate Sep<11>2014
19:00 Mar 17, 2015
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Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. It is only
necessary to send one set of comments.
Identify comments with the docket
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rulemaking. Please be advised that as
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AnimalVeterinary/NewsEvents/
WorkshopsConferencesMeetings/
ucm435459.htm. It may also be viewed
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Additionally, the public can access
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meeting remotely using this link will
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Animal Veterinary/News Events/
WorkshopsConferences Meetings/
ucm435459.htm.
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14147
Dated: March 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–06119 Filed 3–17–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[USCG–2014–0941]
Port Access Route Study: In the
Chukchi Sea, Bering Strait and Bering
Sea
AGENCY:
ACTION:
Coast Guard, DHS.
Notice; withdrawal.
The Coast Guard published a
document in the Federal Register of
February 19, 2015, (80 FR 8892)
concerning the Port Access Route Study
(PARS) in the Chukchi Sea, Bering Strait
and Bering Sea. The February 19, 2015,
PARS document was erroneously
published and should be disregarded in
its entirety.
SUMMARY:
If
you have questions on this notice of
study or any of the meetings, call or
email LT Kody Stitz, Seventeenth Coast
Guard District (dpw); telephone (907)
463–2270; email Kody.J.Stitz@uscg.mil
or Mr. David Seris, Seventeenth Coast
Guard District (dpw); telephone (907)
463–2267; email David.M.Seris@
uscg.mil.
FOR FURTHER INFORMATION CONTACT:
For
correct information on the Port Access
Route Study please see the Notice of
Study published in the Federal Register
on December 5, 2014 (79 FR 72157); and
the Notice of Public Meetings published
in the Federal Register on February 25,
2015 (80 FR 10137).
To electronically access all
information referenced in this notice of
correction visit https://
www.regulations.gov and search for
‘‘USCG–2014–0941’’.
SUPPLEMENTARY INFORMATION:
Dated: March 3, 2015.
D.B. Abel,
Rear Admiral, U.S. Coast Guard, Commander,
Seventeenth Coast Guard District.
[FR Doc. 2015–05372 Filed 3–17–15; 8:45 am]
BILLING CODE 9110–04–P
E:\FR\FM\18MRN1.SGM
18MRN1
]]>Agencies
[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)]
[Notices]
[Page 14147]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05372]
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DEPARTMENT OF HOMELAND SECURITY
Coast Guard
[USCG-2014-0941]
Port Access Route Study: In the Chukchi Sea, Bering Strait and
Bering Sea
AGENCY: Coast Guard, DHS.
ACTION: Notice; withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Coast Guard published a document in the Federal Register
of February 19, 2015, (80 FR 8892) concerning the Port Access Route
Study (PARS) in the Chukchi Sea, Bering Strait and Bering Sea. The
February 19, 2015, PARS document was erroneously published and should
be disregarded in its entirety.
FOR FURTHER INFORMATION CONTACT: If you have questions on this notice
of study or any of the meetings, call or email LT Kody Stitz,
Seventeenth Coast Guard District (dpw); telephone (907) 463-2270; email
Kody.J.Stitz@uscg.mil or Mr. David Seris, Seventeenth Coast Guard
District (dpw); telephone (907) 463-2267; email David.M.Seris@uscg.mil.
SUPPLEMENTARY INFORMATION: For correct information on the Port Access
Route Study please see the Notice of Study published in the Federal
Register on December 5, 2014 (79 FR 72157); and the Notice of Public
Meetings published in the Federal Register on February 25, 2015 (80 FR
10137).
To electronically access all information referenced in this notice
of correction visit https://www.regulations.gov and search for ``USCG-
2014-0941''.
Dated: March 3, 2015.
D.B. Abel,
Rear Admiral, U.S. Coast Guard, Commander, Seventeenth Coast Guard
District.
[FR Doc. 2015-05372 Filed 3-17-15; 8:45 am]
BILLING CODE 9110-04-P
