83 FR 6028 - Training Program for Regulatory Project Managers; Information Available to Industry
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 29 (February 12, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 29 (February 12, 2018)
| Page Range | 6028-6028 | |
| FR Document | 2018-02793 |
[Federal Register Volume 83, Number 29 (Monday, February 12, 2018)] [Notices] [Page 6028] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02793] ----------------------------------------------------------------------- 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 send proposed agendas to the Agency by April 13, 2018. 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, [email protected]. 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 the following: (1) Firsthand exposure to industry's drug development processes and (2) 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 that want to learn more about this training opportunity or that are interested in offering a site tour should respond by sending a proposed agenda by email directly to Dan Brum (see DATES and FOR FURTHER INFORMATION CONTACT). Dated: February 6, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-02793 Filed 2-9-18; 8:45 am] BILLING CODE 4164-01-P
![6028 Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / Notices
not limited to: Must be timely (see primary goal, CDER has initiated Offices in the firms’ respective regions.
DATES), must be filed in accordance with various training and development Firms that want to learn more about this
§ 10.20, must contain sufficient facts to programs to promote high performance training opportunity or that are
merit an FDA investigation, and must in its regulatory project management interested in offering a site tour should
certify that a true and complete copy of staff. CDER seeks to significantly respond by sending a proposed agenda
the petition has been served upon the enhance review efficiency and review by email directly to Dan Brum (see
patent applicant. (See H. Rept. 857, part quality by providing the staff with a DATES and FOR FURTHER INFORMATION
1, 98th Cong., 2d sess., pp. 41–42, 1984.) better understanding of the CONTACT).
Petitions should be in the format pharmaceutical industry and its Dated: February 6, 2018.
specified in 21 CFR 10.30. operations. To this end, CDER is Leslie Kux,
Submit petitions electronically to continuing its training program to give
Associate Commissioner for Policy.
https://www.regulations.gov at Docket regulatory project managers the
[FR Doc. 2018–02793 Filed 2–9–18; 8:45 am]
No. FDA–2013–S–0610. Submit written opportunity to tour pharmaceutical
BILLING CODE 4164–01–P
petitions (two copies are required) to the facilities. The goals are to provide the
Dockets Management Staff (HFA–305), following: (1) Firsthand exposure to
Food and Drug Administration, 5630 industry’s drug development processes
DEPARTMENT OF HEALTH AND
Fishers Lane, Rm. 1061, Rockville, MD and (2) a venue for sharing information
HUMAN SERVICES
20852. about project management procedures
Dated: February 6, 2018.
(but not drug-specific information) with Food and Drug Administration
industry representatives.
Leslie Kux, [Docket No. FDA–2014–E–2373]
Associate Commissioner for Policy. II. The Site Tours Program
[FR Doc. 2018–02767 Filed 2–9–18; 8:45 am] In this program, over a 2- to 3-day Determination of Regulatory Review
BILLING CODE 4164–01–P period, small groups (five or less) of Period for Purposes of Patent
regulatory project managers, including a Extension; IMBRUVICA
senior level regulatory project manager, AGENCY: Food and Drug Administration,
DEPARTMENT OF HEALTH AND can observe operations of HHS.
HUMAN SERVICES pharmaceutical manufacturing and/or ACTION: Notice.
packaging facilities, pathology/
Food and Drug Administration toxicology laboratories, and regulatory SUMMARY: The Food and Drug
[Docket No. FDA–2014–N–0179] affairs operations. Neither this tour nor Administration (FDA or the Agency) has
any part of the program is intended as determined the regulatory review period
Training Program for Regulatory a mechanism to inspect, assess, judge, for IMBRUVICA and is publishing this
Project Managers; Information or perform a regulatory function, but is notice of that determination as required
Available to Industry meant rather to improve mutual by law. FDA has made the
understanding and to provide an avenue determination because of the
AGENCY: Food and Drug Administration, for open dialogue. During the Site Tours submission of an application to the
HHS. Program, regulatory project managers Director of the U.S. Patent and
ACTION: Notice. will also participate in daily workshops Trademark Office (USPTO), Department
with their industry counterparts, of Commerce, for the extension of a
SUMMARY: The Food and Drug
focusing on selective regulatory issues patent which claims that human drug
Administration’s (FDA’s) Center for
important to both CDER staff and product.
Drug Evaluation and Research (CDER) is
industry. The primary objective of the
announcing the continuation of the DATES: Anyone with knowledge that any
daily workshops is to learn about the
Regulatory Project Management Site of the dates as published (in the
team approach to drug development,
Tours and Regulatory Interaction SUPPLEMENTARY INFORMATION section) are
including drug discovery, preclinical
Program (the Site Tours Program). The incorrect may submit either electronic
evaluation, tracking mechanisms, and
purpose of this document is to invite or written comments and ask for a
regulatory submission operations. The
pharmaceutical companies interested in redetermination by April 13, 2018. See
overall benefit to regulatory project
participating in this program to contact ‘‘Petitions’’ in the SUPPLEMENTARY
managers will be exposure to project
CDER. INFORMATION section for more
management, team techniques, and
DATES: Pharmaceutical companies may information.
processes employed by the
send proposed agendas to the Agency by pharmaceutical industry. By ADDRESSES: You may submit comments
April 13, 2018. participating in this program, the as follows. Please note that late,
FOR FURTHER INFORMATION CONTACT: Dan regulatory project manager will grow untimely filed comments will not be
Brum, Center for Drug Evaluation and professionally by gaining a better considered. Electronic comments must
Research, Food and Drug understanding of industry processes and be submitted on or before April 13,
Administration, 10903 New Hampshire procedures. 2018. The https://www.regulations.gov
Ave., Bldg. 22, Rm. 5480, Silver Spring, electronic filing system will accept
MD 20993–0002, 301–796–0578, III. Site Selection comments until midnight Eastern Time
dan.brum@fda.hhs.gov. All travel expenses associated with at the end of April 13, 2018. Comments
SUPPLEMENTARY INFORMATION: the Site Tours Program will be the received by mail/hand delivery/courier
daltland on DSKBBV9HB2PROD with NOTICES
responsibility of CDER; therefore, (for written/paper submissions) will be
I. Background selection will be based on the considered timely if they are
An important part of CDER’s availability of funds and resources for postmarked or the delivery service
commitment to make safe and effective each fiscal year. Selection will also be acceptance receipt is on or before that
drugs available to all Americans is based on firms having a favorable date. Furthermore, any interested
optimizing the efficiency and quality of facility status as determined by FDA’s person may petition FDA for a
the drug review process. To support this Office of Regulatory Affairs District determination regarding whether the
VerDate Sep<11>2014 19:23 Feb 09, 2018 Jkt 244001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\12FEN1.SGM 12FEN1](https://thefederalregister.org/doc/83_FR_6057/page/1.svg)
Document Created: 2018-11-01 08:42:44
Document Modified: 2018-11-01 08:42:44
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Pharmaceutical companies may send proposed agendas to the Agency by April 13, 2018. | |
| 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, [email protected] | |
| FR Citation | 83 FR 6028 |
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