Federal Register / Vol. 80, No. 72 / Wednesday, April 15, 2015 / Notices 20233 

Dated: March 8, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08618 Filed 4–14–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Joint Workshop on Drug Transporters 

in Absorption, Distribution, 

Metabolism, and Excretion: From the 

Bench to the Bedside 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) is announcing a public workshop 

entitled ‘‘Drug Transporters in 

Absorption, Distribution, Metabolism, 

and Excretion (ADME): From the Bench 

to the Bedside.’’ The public workshop is 

an American Association of 

Pharmaceutical Scientists/International 

Transporter Consortium (AAPS/ITC) 

Joint Workshop, cosponsored with 

AAPS, the American Society for Clinical 

Pharmacology and Therapeutics, and 

the European Federation for 

Pharmaceutical Sciences. The goals of 

this public workshop are to provide an 

opportunity for scientists in academia, 

industry, and regulatory agencies to 

exchange ideas about the cutting edge 

science in transporters, and to facilitate 

and enhance translational applications 

of new development in transporter 

research in drug development and 

regulatory review of new therapeutics. 

Date and Time: The public workshop 

will be held on April 20, 2015, from 

8:15 a.m. to 7 p.m.; April 21, 2015, from 

8 a.m. to 6:30 p.m.; and April 22, 2015, 

from 8 a.m. to 3:45 p.m. 

Location: The public workshop will 

be held at the Renaissance Baltimore 

Harborplace Hotel, 202 East Pratt St., 

Baltimore, MD 21202. The hotel’s phone 

number is 410–547–1200. 

Contacts: FDA: Lei Zhang, Food and 

Drug Administration, Center for Drug 

Evaluation and Research, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 3196, 

Silver Spring, MD 20993, 301–796– 

1635, email: leik.zhang@fda.hhs.gov. 

AAPS: For questions related to this 

event, please contact AAPS at 

registration@aaps.org. 

Registration: Workshop information 

and the registration link are posted at 

the AAPS meetings and professional 

development conference site. To register 

for the workshop, please visit http://

www.aaps.org/Meetings_and_

Professional_Development/Conference_

Mini_Sites/AAPS_WS_Transporters15/

Register/. The cost of registration is as 

follows: 

AAPS Member .......................... $1,815 

Nonmember .............................. 2,190 

Government .............................. 675 

Academic .................................. 880 

Student ..................................... 110 

The registration fee will be waived for 

50 FDA employees. If you need special 

accommodations because of a disability, 

please contact AAPS at registration@

aaps.org. Onsite registration on the day 

of the workshop will be available. 

Additional Information About the 

Workshop: The workshop agenda and 

additional background materials will be 

accessible at http://www.fda.gov/Drugs/ 

NewsEvents/ucm439157.htm to all 

registrants. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Transporters serve an important role 

in the ADME of drugs, and in turn could 

affect their safety or efficacy. The 

AAPS/ITC joint transporter workshop in 

2015 aims to continue on the success of 

preceding AAPS workshops on Drug 

Transporters meetings (2003, 2005, 

2007, 2009, 2011, 2013) and ITC 

transporter workshops (2008 and 2012) 

to provide an opportunity for scientists 

in academia, industry, and regulatory 

agencies to exchange ideas about the 

cutting-edge science. Key areas of focus 

will include the following: 

• Transporter tools of the future (e.g., 

organs-on-a-chip, humanized mouse 

models, and transporter imaging); 

• Interplay of drug metabolism and 

transporters; 

• ‘‘State of the art’’ sessions on: 

Æ Emerging transporters, 

Æ Endogenous biomarkers to assess 

transporter-mediated drug efficacy and 

toxicity or to predict drug-drug 

interactions, and 

Æ Quantitative transporter proteomics 

in translational drug metabolism and 

pharmacokinetics; 

• ‘‘Hot Topics’’ in the translation of 

transporter data to the clinic; 

• Prospective transporter substrate 

modeling; and 

• Review of comments related to 

transporters following recent guidances 

issued from the regulatory agencies, 

including FDA, European Medicines 

Agency, and Pharmaceuticals and 

Medical Devices Agency (Japan). 

II. Goals and Objectives 

• To provide a forum for open 

interchange, dissemination, and 

discussion of cutting edge science in 

transporters among scientists from 

academia, industry, and regulatory 

agencies. 

• To develop a mutual understanding 

on what needs to be done in transporter 

research and how to translate 

knowledge obtained from the bench to 

bedside. 

• To facilitate and enhance 

translational applications of new 

development in transporter research in 

drug development and regulatory 

review of new therapeutics. 

Dated: April 8, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08614 Filed 4–14–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Request for Nomination for Industry 

Representatives and Participation 

From Industry Organizations on Public 

Advisory Committees 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting that 

any industry organizations interested in 

participating in the selection of 

nonvoting industry representatives to 

serve on its public advisory committees 

for the Center for Drug Evaluation and 

Research (CDER) notify FDA in writing. 

FDA is also requesting nominations for 

nonvoting industry representatives to 

serve on CDER’s public advisory 

committees. A nominee may either be 

self-nominated or nominated by an 

organization to serve as a nonvoting 

industry representative. Nominations 

will be accepted for current vacancies 

effective with this notice. 

DATES: Any industry organization 

interested in participating in the 

selection of an appropriate nonvoting 

member to represent industry interests 

must send a letter stating that interest to 

FDA by May 15, 2015, (see sections I 

and II of this document for further 

details). Concurrently, nomination 

materials for prospective candidates 

should be sent to FDA by May 15, 2015. 

ADDRESSES: All statements of interest 

from interested industry organizations 

interested in participating in the 

selection process of nonvoting industry 

representative nominations should be 


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