80 FR 8329 - Regulatory Site Visit Training Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 31 (February 17, 2015)

Page Range		8329-8330
FR Document		2015-03117

The Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) is announcing an invitation for participation in its Regulatory Site Visit Training Program (RSVP). This training program is intended to give CBER regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities. These visits are intended to allow CBER staff to directly observe routine manufacturing practices and to give CBER staff a better understanding of the biologics industry, including its challenges and operations. The purpose of this document is to invite biologics facilities to contact CBER for more information if they are interested in participating in this program.

Federal Register, Volume 80 Issue 31 (Tuesday, February 17, 2015)

[Federal Register Volume 80, Number 31 (Tuesday, February 17, 2015)]
[Notices]
[Pages 8329-8330]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-03117]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0824]


Regulatory Site Visit Training Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration's (FDA's) Center for 
Biologics Evaluation and Research (CBER) is announcing an invitation 
for participation in its Regulatory Site Visit Training Program (RSVP). 
This training program is intended to give CBER regulatory review, 
compliance, and other relevant staff an opportunity to visit biologics 
facilities. These visits are intended to allow CBER staff to directly 
observe routine manufacturing practices and to give CBER staff a better 
understanding of the biologics industry, including its challenges and 
operations. The purpose of this document is to invite biologics 
facilities to contact CBER for more information if they are interested 
in participating in this program.

DATES: Submit either an electronic or written request for participation 
in this program by March 19, 2015. The request should include a 
description of your facility relative to products regulated by CBER. 
Please specify the physical address(es) of the site(s) you are 
offering.

ADDRESSES: If your biologics facility is interested in offering a site 
visit, submit either an electronic request to http://www.regulations.gov or a written request to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. If you previously responded to earlier 
requests to participate in this program and you continue to be 
interested in participating, please renew your request through a 
submission to the Division of Dockets Management.

FOR FURTHER INFORMATION CONTACT: Loni Warren Henderson, Division of 
Manufacturers Assistance and Training, Center for Biologics Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002, 240-402-7800, FAX: 
301-595-1243, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    CBER regulates certain biological products including blood and 
blood products, vaccines, and cellular, tissue, and gene therapies. 
CBER is committed to advancing the public health through innovative 
activities that help ensure the safety, effectiveness, and availability 
of biological products to patients. To support this primary goal, CBER 
has initiated various training and development programs, including 
programs to further enhance performance of its compliance staff, 
regulatory review staff, and other relevant staff. CBER seeks to 
continuously enhance and update review efficiency and quality, and the 
quality of its regulatory efforts and interactions, by providing CBER 
staff with a better understanding of the biologics industry and its 
operations. Further, CBER seeks to enhance: (1) Its understanding of 
current industry practices and regulatory impacts and needs and (2) 
communication between CBER staff and industry. CBER initiated its RSVP 
in 2005. Through these annual notices, CBER is requesting that those 
firms that have previously applied and are still interested in 
participating reaffirm their interest. CBER is also requesting that new 
interested parties apply.

II. RSVP

A. Regulatory Site Visits

    In this program, over a period of time to be agreed upon with the 
facility, small groups of CBER staff may observe operations of 
biologics establishments, including for example, blood and tissue 
establishments. The visits may include the following: (1) Packaging 
facilities, (2) quality control and pathology/toxicology laboratories, 
and (3) regulatory affairs operations. These visits, or any part of the 
program, are not intended as a mechanism to inspect, assess, judge, or 
perform a regulatory function, but are meant to improve mutual 
understanding and to provide an avenue for open dialogue between the 
biologics industry and CBER.

B. Site Selection

    CBER will be responsible for all travel expenses associated with 
the site visits.

[[Page 8330]]

Therefore, selection of potential facilities will be based on the 
coordination of CBER's priorities for staff training as well as the 
limited available resources for this program. In addition to logistical 
and other resource factors to consider, a key element of site selection 
is a successful compliance record with FDA or another Agency with which 
we have a memorandum of understanding. If a site visit involves a visit 
to a separate physical location of another firm under contract to the 
applicant, the other firm also needs to agree to participate in the 
program, as well as have a satisfactory compliance history.

III. Requests for Participation

    Identify requests for participation with the docket number found in 
brackets in the heading of this document. Received requests are 
available for public examination in the Division of Dockets Management 
(see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03117 Filed 2-13-15; 8:45 am]
BILLING CODE 4164-01-P

8330 Federal Register / Vol. 80, No. 31 / Tuesday, February 17, 2015 / Notices

Therefore, selection of potential 21 May 2010 [HHS Ref. E–191–2009/0– small business initiative launched on 1
facilities will be based on the PCT–02]. The patent rights in this October 2011, and will comply with the
coordination of CBER’s priorities for invention have been assigned to the terms and conditions of 35 U.S.C. 209
staff training as well as the limited Government of the United States of and 37 CFR part 404. The prospective
available resources for this program. In America. exclusive evaluation option license, and
addition to logistical and other resource The prospective exclusive evaluation a subsequent exclusive
factors to consider, a key element of site option license territory may be commercialization license, may be
selection is a successful compliance worldwide, and the field of use may be granted unless the NIH receives written
record with FDA or another Agency limited to: evidence and argument that establishes
with which we have a memorandum of 1. Exclusive use of the Licensed Patent that the grant of the license would not
understanding. If a site visit involves a Rights to develop a test kit approved by the be consistent with the requirements of
visit to a separate physical location of FDA as a Class III medical device under the 35 U.S.C. 209 and 37 CFR part 404
another firm under contract to the Premarket approval (PMA) process, such test within fifteen (15) days from the date of
applicant, the other firm also needs to kit to be distributed in commerce for the this published notice.
agree to participate in the program, as purpose of identifying subgroups of breast Complete applications for a license in
well as have a satisfactory compliance cancer, colorectal cancer, and non-small cell the field of use filed in response to this
lung cancer patients that may benefit from
history. notice will be treated as objections to
treatment with a taxane therapy; and
III. Requests for Participation 2. Non-exclusive use of the Licensed Patent the grant of the contemplated exclusive
Rights to develop a test kit for which the FDA evaluation option license. Comments
Identify requests for participation issues an order, in the form of a letter, which and objections submitted to this notice
with the docket number found in finds Licensee’s device to be substantially will not be made available for public
brackets in the heading of this equivalent to one or more similar legally inspection and, to the extent permitted
document. Received requests are marketed devices, and states that the by law, will not be released under the
available for public examination in the Licensee’s device can be marketed in the U.S. Freedom of Information Act, 5 U.S.C.
Division of Dockets Management (see (i.e., 510(k) cleared), such test kit to be 552.
ADDRESSES) between 9 a.m. and 4 p.m., distributed in commerce for the purpose of
identifying subgroups of breast cancer, Dated: February 9, 2015.
Monday through Friday.
colorectal cancer, and non-small cell lung Richard U. Rodriguez,
Dated: February 10, 2015. cancer patients that may benefit from Acting Director, Office of Technology
Leslie Kux, treatment with a taxane therapy. Transfer, National Institutes of Health.
Associate Commissioner for Policy. Upon the expiration or termination of [FR Doc. 2015–03088 Filed 2–13–15; 8:45 am]
[FR Doc. 2015–03117 Filed 2–13–15; 8:45 am] the exclusive evaluation option license, BILLING CODE 4140–01–P
BILLING CODE 4164–01–P Taxor Diagnostics, LLC will have the
exclusive right to execute an exclusive
commercialization license which will DEPARTMENT OF HEALTH AND
DEPARTMENT OF HEALTH AND supersede and replace the exclusive HUMAN SERVICES
HUMAN SERVICES evaluation option license with no
greater field of use and territory than National Institutes of Health
National Institutes of Health granted in the exclusive evaluation
option license. National Institute of Environmental
Prospective Grant of Exclusive Health Sciences; Notice of Closed
License: Start-up Evaluation License DATES: Only written comments or
Meeting
for the Development of Theranostic applications for a license (or both)
Kits for Taxane-based Chemotherapy which are received by the NIH Office of Pursuant to section 10(d) of the
Technology Transfer on or before March Federal Advisory Committee Act, as
AGENCY: National Institutes of Health, 4, 2015 will be considered. amended (5 U.S.C. App.), notice is
HHS. ADDRESSES: Requests for copies of the hereby given of the following meeting.
ACTION: Notice. patent application, inquiries, comments, The meeting will be closed to the
SUMMARY: This is notice, in accordance and other materials relating to the public in accordance with the
with 35 U.S.C. 209 and 37 CFR part 404, contemplated exclusive evaluation provisions set forth in sections
that the National Institutes of Health, option license should be directed to: 552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
Department of Health and Human Patrick McCue, Ph.D., Licensing and as amended. The grant applications and
Services, is contemplating the grant to Patenting Manager, Office of the discussions could disclose
Taxor Diagnostics, LLC of an exclusive Technology Transfer, National Institutes confidential trade secrets or commercial
evaluation option license to practice the of Health, 6011 Executive Boulevard, property such as patentable material,
inventions embodied in the following Suite 325, Rockville, MD 20852–3804; and personal information concerning
US Patent, US Patent Application, and Telephone: (301) 435–5560; Facsimile: individuals associated with the grant
International Patent Application (and all (301) 402–0220; Email: mccuepat@ applications, the disclosure of which
foreign counterparts): US Patent No. mail.nih.gov. would constitute a clearly unwarranted
8,546,091, issued 01 October 2013, SUPPLEMENTARY INFORMATION: The invasion of personal privacy.
entitled, ‘‘Akt Phosphorylation at technology describes a method of Name of Committee: National Institute of
SER473 as an Indicator for Taxane- identifying cancer patients that will Environmental Health Sciences Special
Emphasis Panel; Worker Health and Safety
tkelley on DSK3SPTVN1PROD with NOTICES

based Chemotherapy’’ [HHS Ref. E–191– respond favorably to and benefit from
2009/0–US–07]; US Patent Application Training Review.
treatment with taxane-based therapy
Date: March 9–10, 2015.
serial no. 14/031,699, of the same name, depending on the phosphorylation Time: 8:00 a.m. to 5:00 p.m.
filed 19 September 2013 [HHS Ref. E– status of protein Akt-Serine 473 in Agenda: To review and evaluate grant
191–2009/0–US–08]; and International patient’s tumor biopsy sample. applications.
(PCT) Patent Application no. PCT/ The prospective exclusive evaluation Place: Sheraton Chapel Hill Hotel, One
US2010/035816, of the same name, filed license is being considered under the Europa Drive, Chapel Hill, NC 27517.

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Document Created: 2015-12-18 13:19:49
Document Modified: 2015-12-18 13:19:49

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		Submit either an electronic or written request for participation in this program by March 19, 2015. The request should include a description of your facility relative to products regulated by CBER.
Contact		Loni Warren Henderson, Division of Manufacturers Assistance and Training, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002, 240-402-7800, FAX: 301-595-1243, [email protected]
FR Citation		80 FR 8329

80 FR 8329 - Regulatory Site Visit Training Program

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 31 (February 17, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration