Federal Register / Vol. 80, No. 52 / Wednesday, March 18, 2015 / Notices 14147 

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: 

http://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 

individuals and organizations may be 

limited due to time constraints during 

the public meeting, stakeholders may 

submit electronic or written comments 

discussing any issues of concern to the 

administrative record (the docket) for 

the rulemaking. All relevant data and 

documentation should be submitted 

with the comments. Submit electronic 

comments to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. It is only 

necessary to send one set of comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

III. Comments, Transcripts, and 

Recorded Video 

Information and data submitted 

voluntarily to FDA during the public 

meeting will become part of the 

administrative record for the rulemaking 

and will be accessible to the public at 

http://www.regulations.gov. The 

transcript of the proceedings from the 

public meeting will become part of the 

administrative record for the 

rulemaking. Please be advised that as 

soon as a transcript is available, it will 

be accessible at http://

www.regulations.gov under the docket 

number found in brackets in the 

heading of this document, and at FDA’s 

Web site at http://www. fda. gov/

AnimalVeterinary/NewsEvents/

WorkshopsConferencesMeetings/

ucm435459.htm. It may also be viewed 

at the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. A transcript 

will also be available in either hardcopy 

or on CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to the Division 

of Freedom of Information (ELEM– 

1029), Food and Drug Administration, 

12420 Parklawn Dr., Element Bldg., 

Rockville, MD 20857. 

Additionally, the public can access 

the meeting remotely by using the 

following Adobe Connect link: https://

collaboration. fda. gov/cvm_

bioequivalence_meeting/. The link will 

become active shortly before the 

meeting begins at 9 a.m. on April 16, 

2015. Anyone interested in viewing the 

meeting remotely using this link will 

need to register as a guest using the 

registration information in this 

document. The Agency will be 

recording the meeting for subsequent 

viewing by the public. Once the 

recording has been made 508 compliant, 

it will be accessible at FDA’s CVM Web 

site at http://www. fda. gov/

Animal Veterinary/News Events/

WorkshopsConferences Meetings/

ucm435459.htm. 

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: 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 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 

mstockstill on DSK4VPTVN1PROD with NOTICES