4288 Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices 

the United States. It is not controlled 

internationally under the Convention on 

Psychotropic Substances or the Single 

Convention on Narcotic Drugs. The 

WHO Expert Committee on Drug 

Dependence reviewed ketamine at its 

34th, 35th, and 36th meetings. Ketamine 

is controlled in schedule III of the CSA 

in the United States, and additional 

controls may be necessary to fulfill U.S. 

obligations if ketamine is controlled 

under Schedule I of the Psychotropic 

Convention. FDA, on behalf of the 

Secretary of HHS, invites interested 

persons to submit comments on the 

notifications from the United Nations 

concerning these drug substances. FDA, 

in cooperation with the National 

Institute on Drug Abuse, will consider 

the comments on behalf of HHS in 

evaluating the WHO scheduling 

recommendations. Then, under section 

201(d)(2)(B) of the CSA, HHS will 

recommend to the Secretary of State 

what position the United States should 

take when voting on the 

recommendations for control of 

substances under the Psychotropic 

Convention at the CND meeting in 

March 2015. 

Comments regarding the WHO 

recommendations for control of AH7921 under the 1961 Single Convention 

will also be forwarded to the relevant 

Agencies for consideration in 

developing the U.S. position regarding 

narcotic substances at the CND meeting. 

IV. Submission of Comments and 

Opportunity for Public Meeting 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). 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. 

FDA does not presently plan to hold 

a public meeting. If any person believes 

that, in addition to written comments, a 

public meeting would contribute to the 

development of the U.S. position on the 

substances to be considered for control 

under the Psychotropic Convention, a 

request for a public meeting and the 

reasons for such a request should be 

sent to James R. Hunter (see FOR

FURTHER INFORMATION CONTACT) on or 

before February 6, 2015. 

The short time period for the 

submission of comments and requests 

for a public meeting is needed to ensure 

that HHS may, in a timely fashion, carry 

out the required action and be 

responsive to the United Nations. 

Dated: January 21, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–01408 Filed 1–26–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

American Association of 

Pharmaceutical Scientists/American 

College of Clinical Pharmacology/

American Society for Clinical 

Pharmacology and Therapeutics/Food 

and Drug Administration Cosponsored 

Workshop on ‘‘Evaluating and 

Modernizing Our Approaches for FoodEffect Assessment’’ 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA) is announcing a public workshop 

entitled ‘‘Evaluating and Modernizing 

our Approaches for Food-Effect 

Assessment,’’ cosponsored with the 

American Association of 

Pharmaceutical Scientists (AAPS), the 

American College of Clinical 

Pharmacology (ACCP), and the 

American Society for Clinical 

Pharmacology and Therapeutics 

(ASCPT). The goals of this public 

workshop are to facilitate discussion on 

current scientific approaches on 

assessing the effect of food on the 

pharmacokinetics and 

pharmacodynamics of drugs and to 

initiate constructive discussion and 

information sharing among relevant 

stakeholders on the influence of foodeffects on the pharmacokinetic 

properties of therapeutics in order to 

optimize dose and dosing regimens. 

Date and Time: The workshop will be 

held on February 2, 2015, from 8 a.m. 

to 5 p.m., February 3, 2015, from 8 a.m. 

to 5 p.m., and February 4, 2015, from 8 

a.m. to 12:15 p.m. 

Location: The workshop will be held 

at the Renaissance Baltimore 

Harborplace Hotel, 202 East Pratt St., 

Baltimore, MD 21202. 

Contacts: FDA: Padmaja Mummaneni, 

Food and Drug Administration, Center 

for Drug Evaluation and Research, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 2164, Silver Spring, MD 20993, 

301–796–2027, padmaja.mummaneni@

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_Food/Register/. 

The cost of registration is as follows: 

Member $1,690 

Nonmember $2,070 

Government $650 

Student $100 

The registration fee will be waived for 

50 FDA employees. If you need special 

accommodations because of disability, 

please contact AAPS at registration@

aaps.org. Onsite registration on the day 

of the workshop is available. 

Additional Information about the 

Workshop: The workshop agenda and 

additional background materials will be 

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

NewsEvents/ucm428914.htm to all 

registrants. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA’s guidance for industry entitled 

‘‘Food-Effect Bioavailability and Fed 

Bioequivalence Studies’’ (Food-Effect 

Guidance) is an important tool in the 

development of new oral therapeutics. 

Studies are conducted according to the 

principles described for every new drug 

that is intended to be administered by 

the oral route. The Food-Effect 

Guidance was first published in 2002. 

Since that time, numerous studies have 

been reported in the literature in an 

effort to address a number of different 

aspects related to assessing the effect of 

food on the pharmacokinetics and 

pharmacodynamics of drugs. 

Predominantly, these studies have 

addressed the impact of food 

composition on the physiology of drug 

absorption. In vitro studies have aimed 

at elucidating the individual 

mechanism(s) of drug absorption, and a 

number of in vivo studies have 

addressed the effects of different meal 

compositions on the pharmacokinetics 

of drugs. 

FDA has undertaken an effort to 

revise the 2002 Food-Effect Guidance 

and is seeking feedback from academia, 

industry, and other stakeholders on 

several issues. FDA, AAPS, ACCP, and 

ASCPT agreed to cosponsor this 

workshop to provide a forum for input 

on the best available science on this 

topic from academia, industry, other 

stakeholders, and regulators. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 17 / Tuesday, January 27, 2015 / Notices 4289 

II. Goals and Objectives 

• To provide a forum for open 

discussion between industry, academia, 

other stakeholders, and FDA around 

proposed changes to the Food-Effect 

Guidance. 

• To seek feedback from industry, 

academia, and other stakeholders on 

FDA’s proposals and to seek any 

additional input that will benefit 

decision making on a guidance revision 

on the topic. 

Dated: January 21, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–01409 Filed 1–26–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Food and Drug Administration/Xavier 

University PharmaLink Conference— 

Leadership in a Global Supply Chain 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public conference. 

SUMMARY: The Food and Drug 

Administration (FDA) Cincinnati 

District, in cosponsorship with Xavier 

University, is announcing a public 

conference entitled ‘‘FDA/Xavier 

University PharmaLink Conference: 

Leadership in a Global Supply Chain.’’ 

The PharmaLink conference seeks 

solutions to important and complicated 

issues by aligning with the strategic 

priorities of FDA and includes 

presentations from key FDA officials, 

global regulators, and industry experts. 

Each presentation challenges the status 

quo and conventional wisdom to create 

synergies focused on finding solutions 

which make a difference. The 

experience level of the audience has 

fostered engaged dialog that has led to 

innovative initiatives. 

Dates and Times: The public 

conference will be held on March 25, 

2015, from 8:30 a.m. to 5 p.m.; March 

26, 2015, from 8:30 a.m. to 5 p.m.; and 

March 27, 2015, from 8:30 a.m. to 12:45 

p.m. 

Location: The public conference will 

be held on the campus of Xavier 

University, 3800 Victory Pkwy., 

Cincinnati, OH 45207, 513–745–3073 or 

513–745–3020. 

Contact Persons: For information 

regarding this notice: Steven Eastham, 

Food and Drug Administration, 

Cincinnati South Office, 36 East 7th 

Street, Cincinnati, OH 45202, 513–246– 

4134, email: steven.eastham@fda.

hhs.gov. 

For information regarding the 

conference and registration: Marla 

Phillips, Xavier University, 3800 

Victory Pkwy., Cincinnati, OH 45207– 

5471, 513–745–3073, email: 

phillipsm4@xavier.edu. 

Registration: There is a registration 

fee. The conference registration fees 

cover the cost of the presentations, 

training materials, receptions, 

breakfasts, lunches, and dinners for the 

21⁄2 days of the conference. There will 

be onsite registration. The cost of 

registration is as follows: 

TABLE 1—REGISTRATION FEES 1

Attendee type Early rate 

(on or before 1/24/15) 

Advanced rate 

(1/25/15 to 2/24/15) 

Standard rate 

(after 2/24/15) 

Industry .................................................................................................... $1,295 $1,695 $1,895 

Small Business (<100 employees) .......................................................... 995 1,195 1,295 

Startup Manufacturer ............................................................................... 200 250 300 

Academic ................................................................................................. 200 250 300 

Media ....................................................................................................... Free Free Free 

Government ............................................................................................. Free Free Free 

1The fourth registration from the same company is free—all four attendees must register at the same time. 

The following forms of payment will 

be accepted: American Express, Visa, 

Mastercard, and company checks. 

To register online for the public 

conference, please visit the 

‘‘Registration’’ link on the conference 

Web site at http://

www.XavierPharmaLink.com. FDA has 

verified the Web site address, but is not 

responsible for subsequent changes to 

the Web site after this document 

publishes in the Federal Register. 

To register by mail, please send your 

name, title, firm name, address, 

telephone and fax numbers, email, and 

payment information for the fee to 

Xavier University, Attention: Mason 

Rick, 3800 Victory Pkwy., Cincinnati, 

OH 45207–5471. An email will be sent 

confirming your registration. 

Attendees are responsible for their 

own accommodations. The conference 

headquarter hotel is the Downtown 

Cincinnati Hilton Netherlands Plaza, 35 

West 5th Street, Cincinnati, OH 45202, 

513–421–9100. To make reservations 

online, please visit the ‘‘Venue & 

Logistics’’ link at http://

www.XavierPharmaLink.com. The hotel 

is expected to sellout during this 

timeframe, so early reservation in the 

conference room-block is encouraged. 

If you need special accommodations 

due to a disability, please contact Marla 

Phillips (see Contact Persons) at least 7 

days in advance of the conference. 

SUPPLEMENTARY INFORMATION: The 

public conference helps fulfill the 

Department of Health and Human 

Services’ and FDA’s important mission 

to protect the public health. The 

conference will engage those involved 

in FDA-regulated global supply chain 

quality and management through the 

following topics: 

• Major Changes at FDA Affecting You 

• FDA-Driven Initiatives through Food 

and Drug Administration Safety and 

Innovation Act Implementation 

• Held at the Border? Understand Why 

• Toyota Production System—Cultural 

Requirements 

• Barriers to Quality and Supply Chain 

Excellence 

• Establishing Good Supply Practices 

• Medicines and Healthcare Products 

Regulatory Agency Perspective on 

Global Supply Chain Challenges 

• Systematic Approach to Managing 

Your Global Supply Chain 

• Deep Dive Lunch Session—Clinically 

Relevant Metrics 

• Deep Dive Lunch Session—Data 

Integrity: How To Verify You Are 

Okay 

• Deep Dive Lunch Session—Integrity 

of Supply Workshop 

• Nobel Prize-Based Alignment 

Optimization 


asabaliauskas on DSK5VPTVN1PROD with NOTICES