80 FR 14147 - Port Access Route Study: In the Chukchi Sea, Bering Strait and Bering Sea
DEPARTMENT OF HOMELAND SECURITY
Coast Guard Federal Register Volume 80, Issue 52 (March 18, 2015)
Coast Guard
Federal Register Volume 80, Issue 52 (March 18, 2015)
| Page Range | 14147-14147 | |
| FR Document | 2015-05372 |
[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)] [Notices] [Page 14147] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-05372] ======================================================================= ----------------------------------------------------------------------- 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 [email protected] or Mr. David Seris, Seventeenth Coast Guard District (dpw); telephone (907) 463-2267; email [email protected]. 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 http://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
![Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices 14147
employing modified release Administration, 5630 Fishers Lane, Rm. Dated: March 12, 2015.
technologies, only immediate release 1061, Rockville, MD 20852. It is only Leslie Kux,
formulations would be candidates for necessary to send one set of comments. Associate Commissioner for Policy.
the in vitro BE assessment. For orally Identify comments with the docket [FR Doc. 2015–06119 Filed 3–17–15; 8:45 am]
administered products, in vitro BE number found in brackets in the BILLING CODE 4164–01–P
would be limited to disintegrated heading of this document. Received
dosage forms. In cases when the comments may be seen in the Division
administered drug acts both locally and of Dockets Management between 9 a.m.
systemically, blood level data may be and 4 p.m., Monday through Friday, and
used to confirm drug product BE of the DEPARTMENT OF HOMELAND
will be posted to the docket at http:// SECURITY
systemic effects (and to confirm
www.regulations.gov.
comparability of in vivo product
disintegration in cases where multiple Coast Guard
III. Comments, Transcripts, and
drugs are combined in a single solid oral Recorded Video
dosage forms), while the additional in [USCG–2014–0941]
vitro dissolution data could be used to Information and data submitted
support the comparability of the local voluntarily to FDA during the public Port Access Route Study: In the
actions. meeting will become part of the Chukchi Sea, Bering Strait and Bering
The in vitro BE approach should not administrative record for the rulemaking Sea
be construed as a biowaiver, but rather and will be accessible to the public at
as an alternative set of tests that would http://www.regulations.gov. The AGENCY: Coast Guard, DHS.
be handled in a manner consistent with transcript of the proceedings from the ACTION: Notice; withdrawal.
that of an in vivo BE study. Specifically, public meeting will become part of the
(1) because an in vitro BE approach is administrative record for the SUMMARY: The Coast Guard published a
not a biowaiver, sponsors would still rulemaking. Please be advised that as
need to meet the same environmental document in the Federal Register of
soon as a transcript is available, it will February 19, 2015, (80 FR 8892)
safety and human food safety
be accessible at http:// concerning the Port Access Route Study
requirements associated with products
undergoing in vivo BE studies; (2) one www.regulations.gov under the docket (PARS) in the Chukchi Sea, Bering Strait
in vitro study may not suffice when number found in brackets in the and Bering Sea. The February 19, 2015,
there are multiple product strengths heading of this document, and at FDA’s PARS document was erroneously
(e.g., varying concentrations of an intra- Web site at http://www. fda. gov/ published and should be disregarded in
mammary infusion); and (3) the in vitro AnimalVeterinary/NewsEvents/ its entirety.
method could be applied both to fully WorkshopsConferencesMeetings/
ucm435459.htm. It may also be viewed FOR FURTHER INFORMATION CONTACT: If
soluble and poorly soluble compounds.
at the Division of Dockets Management you have questions on this notice of
In vitro BE determinations would be
based upon a battery of in vitro (HFA–305), Food and Drug study or any of the meetings, call or
dissolution studies and Administration, 5630 Fishers Lane, Rm. email LT Kody Stitz, Seventeenth Coast
physicochemical tests. Links to 1061, Rockville, MD 20852. A transcript Guard District (dpw); telephone (907)
additional background material are will also be available in either hardcopy 463–2270; email Kody.J.Stitz@uscg.mil
provided on the Agency’s Web site at: or on CD–ROM, after submission of a or Mr. David Seris, Seventeenth Coast
http://www.fda.gov/AnimalVeterinary/ Freedom of Information request. Written Guard District (dpw); telephone (907)
NewsEvents/WorkshopsConferences requests are to be sent to the Division 463–2267; email David.M.Seris@
Meetings/ucm435459.htm. of Freedom of Information (ELEM– uscg.mil.
To assist FDA in developing guidance
1029), Food and Drug Administration, SUPPLEMENTARY INFORMATION: For
for demonstrating in vitro BE, with this
12420 Parklawn Dr., Element Bldg., correct information on the Port Access
notice the Agency is convening an open
forum, providing a summary of what the Rockville, MD 20857. Route Study please see the Notice of
Agency envisions as considerations Additionally, the public can access Study published in the Federal Register
pivotal to the BE assessment and the meeting remotely by using the on December 5, 2014 (79 FR 72157); and
inviting public comment on the various following Adobe Connect link: https:// the Notice of Public Meetings published
components of an in vitro BE collaboration. fda. gov/cvm_ in the Federal Register on February 25,
determination. bioequivalence_meeting/. The link will 2015 (80 FR 10137).
II. Participation in a Public Meeting become active shortly before the To electronically access all
meeting begins at 9 a.m. on April 16, information referenced in this notice of
While oral presentations from specific 2015. Anyone interested in viewing the
individuals and organizations may be correction visit http://
meeting remotely using this link will www.regulations.gov and search for
limited due to time constraints during need to register as a guest using the
the public meeting, stakeholders may ‘‘USCG–2014–0941’’.
registration information in this
submit electronic or written comments Dated: March 3, 2015.
document. The Agency will be
discussing any issues of concern to the D.B. Abel,
recording the meeting for subsequent
mstockstill on DSK4VPTVN1PROD with NOTICES
administrative record (the docket) for Rear Admiral, U.S. Coast Guard, Commander,
the rulemaking. All relevant data and viewing by the public. Once the
recording has been made 508 compliant, Seventeenth Coast Guard District.
documentation should be submitted
it will be accessible at FDA’s CVM Web [FR Doc. 2015–05372 Filed 3–17–15; 8:45 am]
with the comments. Submit electronic
comments to http:// site at http://www. fda. gov/ BILLING CODE 9110–04–P
www.regulations.gov. Submit written Animal Veterinary/News Events/
comments to the Division of Dockets WorkshopsConferences Meetings/
Management (HFA–305), Food and Drug ucm435459.htm.
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Document Created: 2018-02-21 09:39:25
Document Modified: 2018-02-21 09:39:25
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice; withdrawal. | |
| 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 [email protected] or Mr. David Seris, Seventeenth Coast Guard District (dpw); telephone (907) 463-2267; email [email protected] | |
| FR Citation | 80 FR 14147 |
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