Pharmaceutical Supply Chain; Public Workshop, 16157-16158 [2010-7151]
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16157
Federal Register / Vol. 75, No. 61 / Wednesday, March 31, 2010 / Notices
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1,2–DICHLOROETHENE, CIS- .....................................................................................................................
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PALLADIUM ...................................................................................................................................................
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ACETONE ......................................................................................................................................................
DIBENZOFURAN ...........................................................................................................................................
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BUTYL BENZYL PHTHALATE ......................................................................................................................
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SYNTHETIC VITREOUS FIBERS .................................................................................................................
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Evaluation Set 24 Proposed Substances:
Today’s notice also invites voluntary
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listed in this notice. Nominations are
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nominator, including full name, title,
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telephone number.
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VerDate Nov<24>2008
CAS Nos.
19:40 Mar 30, 2010
Jkt 220001
Dated: March 26, 2010.
Ken Rose,
Associate Director, Office of Policy, Planning
and Evaluation, National Center for
Environmental Health/Agency for Toxic
Substances and Disease Registry.
[FR Doc. 2010–7169 Filed 3–30–10; 8:45 am]
BILLING CODE 4163–70–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Pharmaceutical Supply Chain; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public workshop entitled ‘‘2010 PDA/
FDA Pharmaceutical Supply Chain
Workshop—Enough Talk: Let’s Find
and Implement Solutions.’’ The
workshop, cosponsored with the
Parenteral Drug Association (PDA), will
focus on solutions to reduce the risk to
product quality in the pharmaceutical
supply chain.
Date and Time: The conference will
be held on Monday, April 26, 2010,
from 8 a.m. to 6 p.m.; Tuesday, April 27,
2010, from 7:15 a.m. to 5:45 p.m.; and
Wednesday, April 28, 2010, from 7:15
a.m. to 1:15 p.m.
Location: The public workshop will
be held at the Hyatt Regency Bethesda,
7400 Wisconsin Ave., 1 Bethesda Metro
PO 00000
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000075–15–0
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007664–39–3
016984–48–8
007664–41–7
065357–62–2
010049–04–4
059536–65–1
001163–19–5
NONE
Center, Bethesda, MD 20814; Phone:
301–657–1234; FAX: 301–657–6453.
Contact: Wanda Neal, Parenteral Drug
Association, PDA Global Headquarters,
Bethesda Towers, 4350 East-West Hwy.,
Suite 200, Bethesda, MD 20814; Phone:
301–656–5900, ext. 149.
Accommodations: Attendees are
responsible for their own
accommodations. To make reservations
at the Hyatt Regency Bethesda, at the
reduced conference rate, contact the
Hyatt Regency Bethesda (see Location),
citing meeting code ‘‘PDA.’’ Room Rates
are: Single: $209, plus 13% state and
local taxes and Double: $234, plus 13%
state and local taxes. Reservations can
be made on a space and rate availability
basis.
Registration: You are encouraged to
register at your earliest convenience.
The PDA registration fees cover the cost
of facilities, materials, and breaks. Seats
are limited; please submit your
registration as soon as possible.
Conference space will be filled in order
of receipt of registration. Those accepted
in to the conference will receive
confirmation. Registration will close
after applicable conference is filled.
Onsite registration will be available on
a space-available basis on the day of the
public conference beginning at 7 a.m. on
Monday, April 26, 2010.
The cost of registration is as follows:
PDA
PDA
PDA
PDA
PDA
PDA
PDA
PDA
E:\FR\FM\31MRN1.SGM
Members
Nonmembers
Member Government
Nonmember Government
Member Health Authority
Nonmember Health Authority
Member Academic
Nonmember Academic
31MRN1
$1850
$2099
$530
$530
$700
$800
$700
$780
16158
Federal Register / Vol. 75, No. 61 / Wednesday, March 31, 2010 / Notices
PDA Member Students
PDA Nonmember Students
$280
$310
If you need special accommodations
due to a disability, please contact
Wanda Neal, PDA (see Contact) at least
7 days in advance of the workshop.
Registration instructions: To register,
please submit your name, affiliation,
mailing address, phone, FAX number,
and e-mail address, along with a check
or money order payable to ‘‘PDA.’’ Mail
to: PDA, Global Headquarters, Bethesda
Towers, 4350 East-West Hwy., Suite
200, Bethesda, MD 20814. To register
via the Internet, go to See PDA Web site,
www.pda.org/supplychain2010 (FDA
has verified the Web site address, but is
not responsible for subsequent changes
to the Web site after this document
publishes in the Federal Register). The
registrar will also accept payment by
major credit cards (VISA/MasterCard
only). For more information on the
meeting, or for questions on registration,
contact the PDA: Phone: 301–656–5900,
FAX: 301–986–1093, or e-mail:
info@pda.org.
A reliable
supply of high quality, safe, and
effective drug products and drug
ingredients depends upon a series of
controls across the entire supply chain
from sourcing of incoming starting
materials to distribution controls to
marketing. Recent experiences in the
market have highlighted the need for
effective controls across the supply
chain. There is a surge in global
cooperation and efforts toward
harmonization of good manufacturing
practices (GMPs) and good distribution
practices (GDPs) and controls pertaining
to the supply chain among members of
industry and regulatory agencies.
Understanding and securing the entire
ingredient manufacturing and
distribution chain helps to ensure the
quality and safety of medicines for
patients.
Through a series of plenary sessions
and working group breakout sessions,
the workshop will provide participants
the opportunity to:
• Hear from senior FDA personnel on
the current regulatory environment.
• Share improvements in programs
and technology.
• Identify any barriers to securing the
entire ingredient manufacturing and
distribution chain and associated
actions to implement effective solutions.
Personnel with experience related to
supply chain issues, including quality
and technical functions, will find this
level of information exchange with
members of industry and regulatory
agencies useful to their specific areas.
jlentini on DSKJ8SOYB1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Nov<24>2008
19:40 Mar 30, 2010
Jkt 220001
Dated: March 25, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–7151 Filed 3–30–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
United States Immigration and
Customs Enforcement
Agency Information Collection
Activities: Extension of an Existing
Information Collection; Comment
Request
ACTION: 30-Day notice of information
collection for review; Form G–79A,
Information Relating to Beneficiary of
Private Bill; OMB Control No. 1653–
0026.
The Department of Homeland
Security, U.S. Immigration and Customs
Enforcement (USICE), has submitted the
following information collection request
for review and clearance in accordance
with the Paperwork Reduction Act of
1995. The information collection was
previously published in the Federal
Register on January 19, 2010 Vol. 75 No.
11 2881, allowing for a 60 day public
comment period. No comments were
received on this information collection.
The purpose of this notice is to allow
an additional 30 days for public
comments. Comments are encouraged
and will be accepted for thirty days
April 30, 2010. Written comments and
suggestions from the public and affected
agencies regarding items contained in
this notice and especially with regard to
the estimated public burden and
associated response time should be
directed to the Office of Information and
Regulatory Affairs, Office of
Management and Budget. Comments
should be addressed to OMB Desk
Officer, for U. S. Immigration and
Customs Enforcement, Department of
Homeland Security, and sent via
electronic mail to
oira_submission@omb.eop.gov or faxed
to (202) 395–5806.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information should address one or more
of the following four points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(2) Evaluate the accuracy of the
agencies estimate of the burden of the
PO 00000
Frm 00093
Fmt 4703
Sfmt 9990
proposed collection of information,
including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses.
Overview of This Information
Collection:
(1) Type of Information Collection:
Extension of a currently approved
information collection.
(2) Title of the Form/Collection:
Information Relating to Beneficiary of
Private Bill.
(3) Agency form number, if any, and
the applicable component of the
Department of Homeland Security
sponsoring the collection: Form G–79A.
U.S. Immigration and Customs
Enforcement.
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract: Primary: Individuals or
Households. The information collected
on the Form G–79A is necessary for U.S.
Immigration and Customs Enforcement
to provide reports to Congress on
Private Bills when requested.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: 100 responses at 60 minutes (1
hour) per response.
(6) An estimate of the total public
burden (in hours) associated with the
collection: 100 annual burden hours.
Requests for a copy of the proposed
information collection instrument, with
instructions; or inquiries for additional
information should be requested via email to: forms.ice@dhs.gov with ‘‘Form
G–79A’’ in the subject line.
Dated: March 26, 2010.
Joseph M. Gerhart,
Chief, Records Management Branch, U.S.
Immigration and Customs Enforcement,
Department of Homeland Security.
[FR Doc. 2010–7186 Filed 3–30–10; 8:45 am]
BILLING CODE 9111–28–P
E:\FR\FM\31MRN1.SGM
31MRN1
]]>Agencies
[Federal Register Volume 75, Number 61 (Wednesday, March 31, 2010)]
[Notices]
[Pages 16157-16158]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-7151]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Pharmaceutical Supply Chain; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``2010 PDA/FDA Pharmaceutical Supply Chain Workshop--
Enough Talk: Let's Find and Implement Solutions.'' The workshop,
cosponsored with the Parenteral Drug Association (PDA), will focus on
solutions to reduce the risk to product quality in the pharmaceutical
supply chain.
Date and Time: The conference will be held on Monday, April 26,
2010, from 8 a.m. to 6 p.m.; Tuesday, April 27, 2010, from 7:15 a.m. to
5:45 p.m.; and Wednesday, April 28, 2010, from 7:15 a.m. to 1:15 p.m.
Location: The public workshop will be held at the Hyatt Regency
Bethesda, 7400 Wisconsin Ave., 1 Bethesda Metro Center, Bethesda, MD
20814; Phone: 301-657-1234; FAX: 301-657-6453.
Contact: Wanda Neal, Parenteral Drug Association, PDA Global
Headquarters, Bethesda Towers, 4350 East-West Hwy., Suite 200,
Bethesda, MD 20814; Phone: 301-656-5900, ext. 149.
Accommodations: Attendees are responsible for their own
accommodations. To make reservations at the Hyatt Regency Bethesda, at
the reduced conference rate, contact the Hyatt Regency Bethesda (see
Location), citing meeting code ``PDA.'' Room Rates are: Single: $209,
plus 13% state and local taxes and Double: $234, plus 13% state and
local taxes. Reservations can be made on a space and rate availability
basis.
Registration: You are encouraged to register at your earliest
convenience. The PDA registration fees cover the cost of facilities,
materials, and breaks. Seats are limited; please submit your
registration as soon as possible. Conference space will be filled in
order of receipt of registration. Those accepted in to the conference
will receive confirmation. Registration will close after applicable
conference is filled. Onsite registration will be available on a space-
available basis on the day of the public conference beginning at 7 a.m.
on Monday, April 26, 2010.
The cost of registration is as follows:
PDA Members $1850
PDA Nonmembers $2099
PDA Member Government $530
PDA Nonmember Government $530
PDA Member Health Authority $700
PDA Nonmember Health Authority $800
PDA Member Academic $700
PDA Nonmember Academic $780
[[Page 16158]]
PDA Member Students $280
PDA Nonmember Students $310
If you need special accommodations due to a disability, please
contact Wanda Neal, PDA (see Contact) at least 7 days in advance of the
workshop.
Registration instructions: To register, please submit your name,
affiliation, mailing address, phone, FAX number, and e-mail address,
along with a check or money order payable to ``PDA.'' Mail to: PDA,
Global Headquarters, Bethesda Towers, 4350 East-West Hwy., Suite 200,
Bethesda, MD 20814. To register via the Internet, go to See PDA Web
site, www.pda.org/supplychain2010 (FDA has verified the Web site
address, but is not responsible for subsequent changes to the Web site
after this document publishes in the Federal Register). The registrar
will also accept payment by major credit cards (VISA/MasterCard only).
For more information on the meeting, or for questions on registration,
contact the PDA: Phone: 301-656-5900, FAX: 301-986-1093, or e-mail:
info@pda.org.
SUPPLEMENTARY INFORMATION: A reliable supply of high quality, safe, and
effective drug products and drug ingredients depends upon a series of
controls across the entire supply chain from sourcing of incoming
starting materials to distribution controls to marketing. Recent
experiences in the market have highlighted the need for effective
controls across the supply chain. There is a surge in global
cooperation and efforts toward harmonization of good manufacturing
practices (GMPs) and good distribution practices (GDPs) and controls
pertaining to the supply chain among members of industry and regulatory
agencies. Understanding and securing the entire ingredient
manufacturing and distribution chain helps to ensure the quality and
safety of medicines for patients.
Through a series of plenary sessions and working group breakout
sessions, the workshop will provide participants the opportunity to:
Hear from senior FDA personnel on the current regulatory
environment.
Share improvements in programs and technology.
Identify any barriers to securing the entire ingredient
manufacturing and distribution chain and associated actions to
implement effective solutions.
Personnel with experience related to supply chain issues, including
quality and technical functions, will find this level of information
exchange with members of industry and regulatory agencies useful to
their specific areas.
Dated: March 25, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-7151 Filed 3-30-10; 8:45 am]
BILLING CODE 4160-01-S
