2013 Parenteral Drug Association/Food and Drug Administration Joint Regulatory Conference: Driving Quality and Compliance Throughout the Product Life Cycle in a Global Regulatory Environment, 20325-20326 [2013-07854]
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Federal Register / Vol. 78, No. 65 / Thursday, April 4, 2013 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Instrument
Total number
of respondents
Number of responses per
respondent
Average burden hours per
response
#3 Program Leadership/Managers/Supervisors Interview
Guide ................................................................................
#3 Instructional Staff Interview Guide ..................................
#3 Case Managers/Advisor Interview Guide .......................
#3 Partners Interview Guide ................................................
#4 Case Managers/Advisors Online Survey ........................
#5 Manager/Supervisor Online Survey ................................
#6 Instructional Staff Online Survey ....................................
#7 Study Participant Interview Guide ..................................
#7 Study Participant Check-in Call ......................................
Total Burden Hours: New Collection ............................
46
58
50
54
90
43
136
210
210
........................
1
1
1
1
1
1
1
2
1
........................
2
2
2
2
0.5
0.5
0.5
2.083
0.16
........................
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: OPRE Reports
Clearance Officer. All requests should
be identified by the title of the
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OIRA_SUBMISSION@OMB.EOP.GOV,
Attn: Desk Officer for the
Administration for Children and
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Steven M. Hanmer,
Reports Clearance Officer.
[FR Doc. 2013–07707 Filed 4–3–13; 8:45 am]
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Jkt 229001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
2013 Parenteral Drug Association/Food
and Drug Administration Joint
Regulatory Conference: Driving
Quality and Compliance Throughout
the Product Life Cycle in a Global
Regulatory Environment
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public conference.
The Food and Drug Administration
(FDA), in co-sponsorship with the
Parenteral Drug Association (PDA), is
announcing a public conference titled
‘‘Driving Quality and Compliance
Throughout the Product Life Cycle in a
Global Regulatory Environment.’’ The
conference will cover current issues
affecting the industry as well as explore
strategies and approaches for ensuring
conformance with regulations to
facilitate the development and
continuous improvement of safe and
effective medical products. The
conference establishes a unique forum
to discuss the foundations, emerging
technologies and innovations in
regulatory science, as well as the current
quality and compliance areas of
concerns. Meeting participants will hear
from FDA and industry speakers about
the requirements and best practices to
consider while implementing robust
quality systems in order to deliver the
best quality product.
Date and Time: The public conference
will be held on September 16, 2013,
from 7 a.m. to 6 p.m.; September 17,
2013, from 7:30 a.m. to 6:15 p.m.; and
September 18, 2013, from 7:30 a.m. to
12:15 p.m.
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
Total burden
hours
92
116
100
108
45
22
68
875
34
9,380
Average annual burden
hours
31
39
33
36
15
7
23
292
11
3,127
Location: The public conference will
be held at the Renaissance Washington
Hotel, 999 9th St. NW., Washington, DC
20001, 202–898–9000, FAX: 202–289–
0947.
Contact: Wanda Neal, Parenteral Drug
Association, PDA Global Headquarters,
Bethesda Towers, 4350 East West Hwy.,
suite 200, Bethesda, MD 20814, 301–
656–5900, ext. 111, FAX: 301–986–
1093, email: info@pda.org or Ken Nolan,
Office of the Commissioner, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, rm. 5314,
Silver Spring, MD 20993, 301–796–
8629, email:
kenneth.nolan@fda.hhs.gov.
Accommodations: Attendees are
responsible for their own
accommodations. To make reservations
at the Renaissance Washington Hotel at
the reduced conference rate, contact the
Renaissance Washington Hotel (see
Location)—cite the meeting code
‘‘PDA.’’ Room rates are: Single or
Double: $299, plus 14.5 percent State
and local taxes. Reservations can be
made on a space and rate availability
basis.
Registration: Attendees are
encouraged to register at their earliest
convenience. The PDA registration fees
cover the cost of facilities, materials,
and refreshments. Seats are limited;
please submit your registration as soon
as possible. Conference space will be
filled in order of receipt of registration.
Those accepted for the conference will
receive confirmation. Registration will
close after the conference is filled.
Onsite registration will be available on
a space available basis on each day of
the public conference beginning at 7
a.m. on September 16, 2013. The cost of
registration is as follows:
E:\FR\FM\04APN1.SGM
04APN1
20326
Federal Register / Vol. 78, No. 65 / Thursday, April 4, 2013 / Notices
COST OF REGISTRATION
Through
August 6, 2013
Affiliation
Member ............................................................................................................................................................
Nonmember .....................................................................................................................................................
Government/Health Authority Member ............................................................................................................
Government/Health Authority Nonmember * ...................................................................................................
Academic Member ...........................................................................................................................................
Academic Nonmember * ..................................................................................................................................
Student Member ..............................................................................................................................................
Student Nonmember * ......................................................................................................................................
After
August 6, 2013
$1,895
2,144
700
800
700
800
280
310
$2,095
2,344
700
800
700
800
280
310
* Applicable Nonmember rates.
Please visit PDA’s Web site at
https://www.pda.org/pdafda2013 to
confirm the prevailing registration fees.
(FDA has verified the Web site address,
but FDA is not responsible for any
subsequent changes to the Web site after
this document publishes in the Federal
Register.)
If you need special accommodations
due to a disability, please contact
Wanda Neal (see Contact), at least 7
days in advance of the conference.
Registration Instructions: To register,
please submit your name, affiliation,
mailing address, telephone, fax number,
and email address, along with a check
or money order payable to ‘‘PDA.’’ Mail
your registration information along with
your payment to: PDA, Global
Headquarters, Bethesda Towers, 4350
East West Hwy., suite 200, Bethesda,
MD 20814. To register via the Internet,
go to PDA’s Web site at https://
www.pda.org/pdafda2013.
The registrar will also accept payment
by major credit cards (VISA/American
Express/MasterCard only). For more
information on the meeting, or for
questions on registration, contact PDA
(see Contact).
Transcripts: Please be advised that as
soon as a transcript is available, it can
be obtained in either hardcopy or on
CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to Division of
Freedom of Information (ELEM–1029),
Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville,
MD 20857.
The PDA/
FDA Joint Regulatory Conference offers
the unique opportunity for participants
to join FDA representatives and
industry experts in face-to-face
dialogues. Each year, FDA speakers
provide updates on current efforts
affecting the development of global
regulatory strategies, while industry
professionals from some of today’s
leading pharmaceutical companies
present case studies on how they
wreier-aviles on DSK5TPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
14:48 Apr 03, 2013
Jkt 229001
employ global strategies in their daily
processes.
Through a series of sessions and
meetings, the conference will provide
participants with the opportunity to
hear directly from FDA experts and
representatives of global regulatory
authorities on best practices, including:
• Regulatory Submission and
Meetings.
• Quality Risk Management
Implementation.
• Manufacturing in the Future.
• Quality Systems.
• Regulatory Considerations During
Development.
• Cell Therapy Innovations.
• Life Cycle Management.
• Process Validation.
• Validation FDA Guidance.
• Challenges of Contract
Manufacturing Organizations.
• Contract Agreements.
• Drug Safety.
• Emerging Active Pharmaceutical
Ingredients (API) Regulations.
• Investigations.
• Emerging API Regulations.
• User Fees.
• Excipient Best Practices.
• Good Manufacturing Practices
Foreign Inspections Findings.
• Regulatory Process to Approval
(Inspectional Readiness).
• Combination Products and
Companion Diagnostics.
To help ensure the quality of FDAregulated products, the workshop helps
to achieve objectives set forth in section
406 of the FDA Modernization Act of
1997 (21 U.S.C. 393), which includes
working closely with stakeholders and
maximizing the availability and clarity
of information to stakeholders and the
public. The workshop also is consistent
with the Small Business Regulatory
Enforcement Fairness Act of 1996 (Pub.
L. 104–121), as outreach activities by
Government Agencies to small
businesses.
PO 00000
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Fmt 4703
Sfmt 4703
Dated: April 1, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2013–07854 Filed 4–3–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0126]
Draft Compliance Policy Guide Sec.
100.250 Food Facility Registration—
Human and Animal Food; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of draft Compliance Policy
Guide Sec. 100.250 Food Facility
Registration—Human and Animal Food
(the draft CPG). The draft CPG, when
finalized, will provide guidance for FDA
staff on issues related to food facility
registration under a section of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act), including the requirement
that certain food facilities register with
FDA, the requirement that registered
facilities biennially renew their
registrations with FDA, and FDA’s
authority to suspend a food facility’s
registration.
SUMMARY:
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comments on this draft
CPG before it begins work on the final
version of the CPG, submit either
electronic or written comments on the
draft CPG by May 6, 2013.
ADDRESSES: Submit written requests for
single copies of the draft CPG to the
Division of Compliance Policy (HFC–
230), Office of Enforcement, Food and
Drug Administration, 12420 Parklawn
Dr., Rockville, MD 20857. Send two selfDATES:
E:\FR\FM\04APN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 65 (Thursday, April 4, 2013)]
[Notices]
[Pages 20325-20326]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07854]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
2013 Parenteral Drug Association/Food and Drug Administration
Joint Regulatory Conference: Driving Quality and Compliance Throughout
the Product Life Cycle in a Global Regulatory Environment
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public conference.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA), in co-sponsorship with the
Parenteral Drug Association (PDA), is announcing a public conference
titled ``Driving Quality and Compliance Throughout the Product Life
Cycle in a Global Regulatory Environment.'' The conference will cover
current issues affecting the industry as well as explore strategies and
approaches for ensuring conformance with regulations to facilitate the
development and continuous improvement of safe and effective medical
products. The conference establishes a unique forum to discuss the
foundations, emerging technologies and innovations in regulatory
science, as well as the current quality and compliance areas of
concerns. Meeting participants will hear from FDA and industry speakers
about the requirements and best practices to consider while
implementing robust quality systems in order to deliver the best
quality product.
Date and Time: The public conference will be held on September 16,
2013, from 7 a.m. to 6 p.m.; September 17, 2013, from 7:30 a.m. to 6:15
p.m.; and September 18, 2013, from 7:30 a.m. to 12:15 p.m.
Location: The public conference will be held at the Renaissance
Washington Hotel, 999 9th St. NW., Washington, DC 20001, 202-898-9000,
FAX: 202-289-0947.
Contact: Wanda Neal, Parenteral Drug Association, PDA Global
Headquarters, Bethesda Towers, 4350 East West Hwy., suite 200,
Bethesda, MD 20814, 301-656-5900, ext. 111, FAX: 301-986-1093, email:
info@pda.org or Ken Nolan, Office of the Commissioner, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5314, Silver
Spring, MD 20993, 301-796-8629, email: kenneth.nolan@fda.hhs.gov.
Accommodations: Attendees are responsible for their own
accommodations. To make reservations at the Renaissance Washington
Hotel at the reduced conference rate, contact the Renaissance
Washington Hotel (see Location)--cite the meeting code ``PDA.'' Room
rates are: Single or Double: $299, plus 14.5 percent State and local
taxes. Reservations can be made on a space and rate availability basis.
Registration: Attendees are encouraged to register at their
earliest convenience. The PDA registration fees cover the cost of
facilities, materials, and refreshments. Seats are limited; please
submit your registration as soon as possible. Conference space will be
filled in order of receipt of registration. Those accepted for the
conference will receive confirmation. Registration will close after the
conference is filled. Onsite registration will be available on a space
available basis on each day of the public conference beginning at 7
a.m. on September 16, 2013. The cost of registration is as follows:
[[Page 20326]]
Cost of Registration
------------------------------------------------------------------------
Through August After August 6,
Affiliation 6, 2013 2013
------------------------------------------------------------------------
Member.............................. $1,895 $2,095
Nonmember........................... 2,144 2,344
Government/Health Authority Member.. 700 700
Government/Health Authority 800 800
Nonmember *........................
Academic Member..................... 700 700
Academic Nonmember *................ 800 800
Student Member...................... 280 280
Student Nonmember *................. 310 310
------------------------------------------------------------------------
* Applicable Nonmember rates.
Please visit PDA's Web site at https://www.pda.org/pdafda2013 to
confirm the prevailing registration fees. (FDA has verified the Web
site address, but FDA is not responsible for any subsequent changes to
the Web site after this document publishes in the Federal Register.)
If you need special accommodations due to a disability, please
contact Wanda Neal (see Contact), at least 7 days in advance of the
conference.
Registration Instructions: To register, please submit your name,
affiliation, mailing address, telephone, fax number, and email address,
along with a check or money order payable to ``PDA.'' Mail your
registration information along with your payment to: PDA, Global
Headquarters, Bethesda Towers, 4350 East West Hwy., suite 200,
Bethesda, MD 20814. To register via the Internet, go to PDA's Web site
at https://www.pda.org/pdafda2013.
The registrar will also accept payment by major credit cards (VISA/
American Express/MasterCard only). For more information on the meeting,
or for questions on registration, contact PDA (see Contact).
Transcripts: Please be advised that as soon as a transcript is
available, it can be obtained in either hardcopy or on CD-ROM, after
submission of a Freedom of Information request. Written requests are to
be sent to Division of Freedom of Information (ELEM-1029), Food and
Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD
20857.
SUPPLEMENTARY INFORMATION: The PDA/FDA Joint Regulatory Conference
offers the unique opportunity for participants to join FDA
representatives and industry experts in face-to-face dialogues. Each
year, FDA speakers provide updates on current efforts affecting the
development of global regulatory strategies, while industry
professionals from some of today's leading pharmaceutical companies
present case studies on how they employ global strategies in their
daily processes.
Through a series of sessions and meetings, the conference will
provide participants with the opportunity to hear directly from FDA
experts and representatives of global regulatory authorities on best
practices, including:
Regulatory Submission and Meetings.
Quality Risk Management Implementation.
Manufacturing in the Future.
Quality Systems.
Regulatory Considerations During Development.
Cell Therapy Innovations.
Life Cycle Management.
Process Validation.
Validation FDA Guidance.
Challenges of Contract Manufacturing Organizations.
Contract Agreements.
Drug Safety.
Emerging Active Pharmaceutical Ingredients (API)
Regulations.
Investigations.
Emerging API Regulations.
User Fees.
Excipient Best Practices.
Good Manufacturing Practices Foreign Inspections Findings.
Regulatory Process to Approval (Inspectional Readiness).
Combination Products and Companion Diagnostics.
To help ensure the quality of FDA-regulated products, the workshop
helps to achieve objectives set forth in section 406 of the FDA
Modernization Act of 1997 (21 U.S.C. 393), which includes working
closely with stakeholders and maximizing the availability and clarity
of information to stakeholders and the public. The workshop also is
consistent with the Small Business Regulatory Enforcement Fairness Act
of 1996 (Pub. L. 104-121), as outreach activities by Government
Agencies to small businesses.
Dated: April 1, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07854 Filed 4-3-13; 8:45 am]
BILLING CODE 4160-01-P
