Federal Register / Vol. 81, No. 26 / Tuesday, February 9, 2016 / Notices 6867 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0179] 

Training Program for Regulatory 

Project Managers; Information 

Available to Industry 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA’s) Center for 

Drug Evaluation and Research (CDER) is 

announcing the continuation of the 

Regulatory Project Management Site 

Tours and Regulatory Interaction 

Program (the Site Tours Program). The 

purpose of this document is to invite 

pharmaceutical companies interested in 

participating in this program to contact 

CDER. 

DATES: Pharmaceutical companies may 

submit proposed agendas to the Agency 

by April 11, 2016. 

FOR FURTHER INFORMATION CONTACT: Dan 

Brum, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 5480, Silver Spring, 

MD 20993–0002, 301–796–0578, 

dan.brum@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

An important part of CDER’s 

commitment to make safe and effective 

drugs available to all Americans is 

optimizing the efficiency and quality of 

the drug review process. To support this 

primary goal, CDER has initiated 

various training and development 

programs to promote high performance 

in its regulatory project management 

staff. CDER seeks to significantly 

enhance review efficiency and review 

quality by providing the staff with a 

better understanding of the 

pharmaceutical industry and its 

operations. To this end, CDER is 

continuing its training program to give 

regulatory project managers the 

opportunity to tour pharmaceutical 

facilities. The goals are to provide 

firsthand exposure to industry’s drug 

development processes, and a venue for 

sharing information about project 

management procedures (but not drugspecific information) with industry 

representatives. 

II. The Site Tours Program 

In this program, over a 2- to 3-day 

period, small groups (five or less) of 

regulatory project managers, including a 

senior level regulatory project manager, 

can observe operations of 

pharmaceutical manufacturing and/or 

packaging facilities, pathology/

toxicology laboratories, and regulatory 

affairs operations. Neither this tour nor 

any part of the program is intended as 

a mechanism to inspect, assess, judge, 

or perform a regulatory function, but is 

meant rather to improve mutual 

understanding and to provide an avenue 

for open dialogue. During the Site Tours 

Program, regulatory project managers 

will also participate in daily workshops 

with their industry counterparts, 

focusing on selective regulatory issues 

important to both CDER staff and 

industry. The primary objective of the 

daily workshops is to learn about the 

team approach to drug development, 

including drug discovery, preclinical 

evaluation, tracking mechanisms, and 

regulatory submission operations. The 

overall benefit to regulatory project 

managers will be exposure to project 

management, team techniques, and 

processes employed by the 

pharmaceutical industry. By 

participating in this program, the 

regulatory project manager will grow 

professionally by gaining a better 

understanding of industry processes and 

procedures. 

III. Site Selection 

All travel expenses associated with 

the Site Tours Program will be the 

responsibility of CDER; therefore, 

selection will be based on the 

availability of funds and resources for 

each fiscal year. Selection will also be 

based on firms having a favorable 

facility status as determined by FDA’s 

Office of Regulatory Affairs District 

Offices in the firms’ respective regions. 

Firms interested in offering a site tour 

or learning more about this training 

opportunity should respond by 

submitting a proposed agenda to Dan 

Brum directly (see DATES and FOR

FURTHER INFORMATION CONTACT). 

Dated: February 3, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–02515 Filed 2–8–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0395] 

Recommendations for Premarket 

Notifications for Lamotrigine and 

Zonisamide Assays; Guidance for 

Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Recommendations for Premarket 

Notifications for Lamotrigine and 

Zonisamide Assays.’’ This guidance 

document discusses information to be 

included in premarket notifications for 

zonisamide or lamotrigine assays. 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. General comments on Agency 

guidance documents are welcome at any 

time. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to http:// 

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on http://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

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