Regulatory Site Visit Training Program, 4713-4714 [E7-1576]
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Federal Register / Vol. 72, No. 21 / Thursday, February 1, 2007 / Notices
Dated: January 25, 2007.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 07–431 Filed 1–31–07; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4184–01–M
[Docket No. 2004N–0408]
Food and Drug Administration
Regulatory Site Visit Training Program
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Food and Drug Administration,
HHS.
Food and Drug Administration
ACTION:
[Docket No. 2006N–0239]
SUMMARY: The Food and Drug
Administration’s (FDA’s) Center for
Biologics Evaluation and Research
(CBER) is reannouncing the 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 notice is to invite
biologics facilities to contact CBER for
more information if they are interested
in participating in this program.
DATES: Submit written or electronic
requests for participation in this
program by March 5, 2007. The request
should include a description of your
facility relative to products regulated by
CBER. Please specify the physical
address of the site you are offering.
ADDRESSES: If your biologics facility is
interested in offering a site visit or
learning more about this training
opportunity for CBER staff, you should
submit a request to participate in the
program to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic requests to https://
www.fda.gov/dockets/ecomments.
If your biologics facility responded to
the previous RSVP notice announced in
the Federal Register of April 11, 2006
(71 FR 18340), and your facility wishes
to continue to be considered for this
year’s program, please notify CBER of
your continued interest by sending an email to matt@cber.fda.gov.
FOR FURTHER INFORMATION CONTACT:
Lonnie Warren-Myers, Division of
Manufacturers Assistance and Training,
Center for Biologics Evaluation and
Research (HFM–49), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–2000, FAX: 301–827–3079, email: matt@cber.fda.gov.
SUPPLEMENTARY INFORMATION:
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Infectious Disease in
Xenotransplantation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Infectious Disease in
Xenotransplantation’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
In the
Federal Register of October 31, 2006 (71
FR 63768), the agency announced that
the proposed information collection had
been submitted to OMB for review and
clearance under 44 U.S.C. 3507. An
agency may not conduct or sponsor, and
a person is not required to respond to,
a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0456. The
approval expires on January 31, 2010. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.fda.gov/
ohrms/dockets.
rwilkins on PROD1PC63 with NOTICES
SUPPLEMENTARY INFORMATION:
Dated: January 25, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–1550 Filed 1–31–07; 8:45 am]
BILLING CODE 4160–01–S
VerDate Aug<31>2005
16:47 Jan 31, 2007
Jkt 211001
PO 00000
Notice.
Frm 00034
Fmt 4703
Sfmt 4703
4713
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 timely
delivery of biological products to
patients. To support this primary goal,
CBER has initiated various training and
development programs to promote high
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 improve: (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, and through these
annual notices, is requesting those firms
that have previously applied and are
still interested in participating, to
reaffirm their interest, as well as
encouraging new interested parties to
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
packaging facilities, quality control and
pathology/toxicology laboratories, and
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
All travel expenses associated with
the site visits will be the responsibility
of CBER; 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 CBER or another agency for
which we have a memorandum of
understanding.
E:\FR\FM\01FEN1.SGM
01FEN1
4714
Federal Register / Vol. 72, No. 21 / Thursday, February 1, 2007 / Notices
Dated: January 22, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–1576 Filed 1–31–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
University of Arkansas/Food and Drug
Administration Food Labeling
Workshop; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
SUMMARY: The Food and Drug
Administration (FDA), Office of
Regulatory Affairs, Southwest Regional
Small Business Representative (SWR
SBR) Program, in collaboration with The
University of Arkansas (UA), is
announcing a public workshop entitled
‘‘UA/FDA Food Labeling Workshop.’’
This public workshop is intended to
provide information about FDA food
labeling regulations and other related
subjects to the regulated industry,
particularly small businesses and
startups.
Date and Time: This public workshop
will be held on April 10, 2007, from 8
a.m. to 5 p.m., and on April 11, 2007,
from 8 a.m. to 4 p.m.
Location: The public workshop will
be held at the Continuing Education
Center, 2 East Center St., Fayetteville,
AR (located downtown).
Contact: David Arvelo, Small
Business Representative, Food and Drug
Administration, Southwest Regional
Office, 4040 North Central Expressway,
suite 900, Dallas, TX 75204, 214–253–
4952, FAX: 214–253–4970, or e-mail:
david.arvelo@fda.hhs.gov.
For information on accommodation
options, contact Steven C. Seideman,
2650 North Young Ave., Institute of
Food Science & Engineering, University
of Arkansas, Fayetteville, AR 72704,
479–575–4221, FAX: 479–575–2165, or
e-mail: seideman@uark.edu.
Registration: You are encouraged to
register by March 23, 2007. The
University of Arkansas has a $150
registration fee to cover the cost of
facilities, materials, speakers, and
breaks. Seats are limited; please submit
your registration as soon as possible.
Course space will be filled in order of
receipt of registration. Those accepted
into the course will receive
confirmation. Registration will close
after the course is filled. Registration at
the site is not guaranteed but may be
possible on a space available basis on
the day of the public workshop
beginning at 8 a.m. The cost of
registration at the site is $200 payable
to: ‘‘The University of Arkansas.’’ If you
need special accommodations due to a
disability, please contact Steven C.
Seideman (see Contact) at least 7 days
in advance.
Registration Form Instructions: To
register, please complete the following
form and submit along with a check or
money order for $150 payable to the
‘‘The University of Arkansas.’’ Mail to:
Institute of Food Science & Engineering,
University of Arkansas, 2650 North
Young Ave., Fayetteville, AR 72704.
UNIVERSITY OF ARKANSAS/FOOD AND DRUG ADMINISTRATION FOOD LABELING WORKSHOP REGISTRATION FORM
Name:
Affiliation:
Mailing Address:
City/State/Zip Code:
Phone:
Fax:
E-mail:
rwilkins on PROD1PC63 with NOTICES
Special Accommodations Required:
Transcripts: Transcripts of the public
workshop will not be available due to
the format of this workshop. Course
handouts may be requested at cost
through the Freedom of Information
Office (HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857,
approximately 15 working days after the
public workshop at a cost of 10 cents
per page.
SUPPLEMENTARY INFORMATION: This
public workshop is being held in
response to the large volume of food
labeling inquiries from small food
manufacturers and startups originating
VerDate Aug<31>2005
16:47 Jan 31, 2007
Jkt 211001
from the area covered by the FDA Dallas
District Office. The SWR SBR presents
these workshops to help achieve
objectives set forth in section 406 of the
Food and Drug Administration
Modernization Act of 1997 (21 U.S.C.
393), which include working closely
with stakeholders and maximizing the
availability and clarity of information to
stakeholders and the public. This is
consistent with the purposes of the SBR
Program, which are in part to respond
to industry inquiries, develop
educational materials, sponsor
workshops and conferences to provide
firms, particularly small businesses,
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
with firsthand working knowledge of
FDA’s requirements and compliance
policies. This workshop is also
consistent with the Small Business
Regulatory Enforcement Fairness Act of
1996 (Public Law 104–121), as outreach
activities by government agencies to
small businesses.
The goal of this public workshop is to
present information that will enable
manufacturers and regulated industry to
better comply with labeling
requirements, especially in light of
growing concerns about obesity and
food allergens. Information presented
will be based on agency position as
E:\FR\FM\01FEN1.SGM
01FEN1
]]>Agencies
[Federal Register Volume 72, Number 21 (Thursday, February 1, 2007)]
[Notices]
[Pages 4713-4714]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-1576]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0408]
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 reannouncing the 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 notice is to invite biologics
facilities to contact CBER for more information if they are interested
in participating in this program.
DATES: Submit written or electronic requests for participation in this
program by March 5, 2007. The request should include a description of
your facility relative to products regulated by CBER. Please specify
the physical address of the site you are offering.
ADDRESSES: If your biologics facility is interested in offering a site
visit or learning more about this training opportunity for CBER staff,
you should submit a request to participate in the program to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
requests to https://www.fda.gov/dockets/ecomments.
If your biologics facility responded to the previous RSVP notice
announced in the Federal Register of April 11, 2006 (71 FR 18340), and
your facility wishes to continue to be considered for this year's
program, please notify CBER of your continued interest by sending an e-
mail to matt@cber.fda.gov.
FOR FURTHER INFORMATION CONTACT: Lonnie Warren-Myers, Division of
Manufacturers Assistance and Training, Center for Biologics Evaluation
and Research (HFM-49), Food and Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852-1448, 301-827-2000, FAX: 301-827-
3079, e-mail: matt@cber.fda.gov.
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 timely
delivery of biological products to patients. To support this primary
goal, CBER has initiated various training and development programs to
promote high 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 improve: (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, and
through these annual notices, is requesting those firms that have
previously applied and are still interested in participating, to
reaffirm their interest, as well as encouraging new interested parties
to 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 packaging facilities, quality
control and pathology/toxicology laboratories, and 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
All travel expenses associated with the site visits will be the
responsibility of CBER; 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 CBER
or another agency for which we have a memorandum of understanding.
[[Page 4714]]
Dated: January 22, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-1576 Filed 1-31-07; 8:45 am]
BILLING CODE 4160-01-S
