Training Program for Regulatory Project Managers; Information Available to Industry, 6867 [2016-02515]

Download as PDF Federal Register / Vol. 81, No. 26 / Tuesday, February 9, 2016 / Notices 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. 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: SUMMARY: mstockstill on DSK4VPTVN1PROD with NOTICES 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. 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 II. The Site Tours Program 17:54 Feb 08, 2016 Jkt 238001 PO 00000 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. 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: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 https://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 In this program, over a 2- to 3-day period, small groups (five or less) of regulatory project managers, including a VerDate Sep<11>2014 6867 Submit written/paper submissions as follows: Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\09FEN1.SGM 09FEN1

Agencies

[Federal Register Volume 81, Number 26 (Tuesday, February 9, 2016)]
[Notices]
[Page 6867]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02515]



[[Page 6867]]

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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 drug-specific 
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
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