2012 Parenteral Drug Association/Food and Drug Administration Joint Regulatory Conference; Compliance Through Quality Systems: Implementing and Advancing a Sustainable Global Quality Culture, 47078-47079 [2012-19295]
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47078
Federal Register / Vol. 77, No. 152 / Tuesday, August 7, 2012 / Notices
agencies, and the private sector to:
Improve the effectiveness and efficiency
of programs; and foster sound growth
and development of children and their
families.
The Division provides guidance,
analysis, technical assistance and
oversight in ACF on: strategic planning
and performance measurement for all
ACF programs, including child and
family development; statistical, policy
and program analysis; surveys, research
and evaluation methodologies;
demonstration testing and model
development; synthesis and
dissemination of research and
demonstration findings; and application
of emerging technologies to improve the
effectiveness of programs and service
delivery.
The Division conducts, manages, and
coordinates major cross-program,
leading-edge research, demonstration,
and evaluation studies; develops policyrelevant research priorities; and
manages and conducts statistical,
policy, and program analyses related to
children and families. Division staff also
provides consultation, coordination,
direction and support for research
activities related to children and
families across ACF programs.
IV. Under Chapter KM, Office of
Planning, Research and Evaluation, add
KM.20 Functions, Paragraph D as
follows:
D. The Division of Family
Strengthening, in cooperation with ACF
programs and others, works with
Federal counterparts, States, community
agencies, and the private sector to:
Improve the effectiveness and efficiency
of programs; assure the protection of
children, youth, and other vulnerable
populations; strengthen families; and
foster sound growth and development of
children, youth and their families.
The Division provides guidance,
analysis, technical assistance and
oversight in ACF on: child, youth and
family development; child safety;
statistical, policy and program analysis;
surveys, research and evaluation
methodologies; demonstration testing
and model development; synthesis and
dissemination of research and
demonstration findings; and application
of emerging technologies to improve the
effectiveness of programs and service
delivery.
The Division conducts, manages, and
coordinates major cross-program,
leading-edge research, demonstration,
and evaluation studies; develops policyrelevant research priorities; and
manages and conducts statistical,
policy, and program analyses related to
strengthening families. Division staff
also provides consultation,
coordination, direction and support for
research activities related to
strengthening families across ACF
programs.
Dated: July 10, 2012.
George H. Sheldon,
Acting Assistant Secretary for Children and
Families.
[FR Doc. 2012–19019 Filed 8–6–12; 8:45 am]
BILLING CODE 4184–79–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
2012 Parenteral Drug Association/Food
and Drug Administration Joint
Regulatory Conference; Compliance
Through Quality Systems:
Implementing and Advancing a
Sustainable Global Quality Culture
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public conference.
The Food and Drug
Administration (FDA), in cosponsorship
with Parenteral Drug Association (PDA),
is announcing a public conference
entitled ‘‘Compliance Through Quality
Systems: Implementing and Advancing
a Sustainable Global Quality Culture.’’
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
SUMMARY:
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 10, 2012,
from 7 a.m. to 6 p.m.; September 11,
2012, from 7:30 a.m. to 6:15 p.m.; and
September 12, 2012, from 7:30 a.m. to
12:15 p.m.
Location: The public conference will
be held at the Baltimore Marriott
Waterfront Hotel, 700 Aliceanna St.,
Baltimore, MD 21202, 410–385–3000,
Fax: 410–895–1900.
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.
Accommodations: Attendees are
responsible for their own
accommodations. To make reservations
at the Baltimore Marriott Waterfront
Hotel at the reduced conference rate,
contact the Baltimore Marriott
Waterfront Hotel (see Location)—cite
the meeting code ‘‘PDA.’’ Room rates
are: Single: $229, plus 15.5 percent state
and local taxes and Double: $229, plus
15.5 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 10, 2012. The cost of
registration is as follows:
mstockstill on DSK4VPTVN1PROD with NOTICES
TABLE 1—COST OF REGISTRATION
Through
August 10, 2012
Affiliation
Member ........................................................................................................................................................
Nonmember .................................................................................................................................................
Government/Health Authority Member ........................................................................................................
Government/Health Authority Nonmember 1 ...............................................................................................
Academic Member .......................................................................................................................................
Academic Nonmember 1 ..............................................................................................................................
Student Member ..........................................................................................................................................
VerDate Mar<15>2010
16:52 Aug 06, 2012
Jkt 226001
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
E:\FR\FM\07AUN1.SGM
$1,700
1,949
530
700
700
800
280
07AUN1
After
August 10, 2012
$1,900
2,149
530
700
700
800
280
47079
Federal Register / Vol. 77, No. 152 / Tuesday, August 7, 2012 / Notices
TABLE 1—COST OF REGISTRATION—Continued
Through
August 10, 2012
Affiliation
Student Nonmember 1 .................................................................................................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
1 Applicable
310
nonmember rates.
Please visit PDA’s Web site: https://
www.pda.org/pdafda2012 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
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:
https://www.pda.org/pdafda2012.
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: 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
VerDate Mar<15>2010
310
After
August 10, 2012
16:52 Aug 06, 2012
Jkt 226001
• 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.
Dated: August 1, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–19295 Filed 8–6–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of Availability of Draft Policy
Document for Comment
Health Resources and Services
Administration (HRSA), HHS.
ACTION: This is a Notice of Availability
and request for comments on a draft
AGENCY:
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
Agency Guidance (‘‘Policy Information
Notice’’ (PIN)). The draft PIN provides
clarification on the sliding fee discount
program and related requirements for
federally-funded health centers and
Federally Qualified Health Center
(FQHC) Look-Alikes. The draft PIN,
‘‘Clarification of Sliding Fee Discount
Program Requirements,’’ is available on
the Internet at https://
www.bphc.hrsa.gov/policiesregulations/
policies/draftsforcomment.html.
Comments must be received by
the close of business on September 28,
2012.
ADDRESSES: Comments should be
submitted to OPPDSFPIN@hrsa.gov by
the close of business on September 28,
2012.
SUMMARY: HRSA believes that
community input is valuable to the
development of policies and policy
documents related to the
implementation of HRSA programs,
including the Health Center Program.
Therefore, we are requesting comments
on the PIN referenced above. Comments
will be reviewed and analyzed, and a
final PIN, along with a summary and
general response to the comments, will
be published as soon as possible after
the deadline for receipt of comments.
Background: HRSA provides grants to
eligible health centers under Section
330 of the Public Health Service Act
(PHS Act) to support the delivery of
preventive and primary care services to
medically-underserved communities
and vulnerable populations. In 2011,
grants helped fund approximately 1,200
health center grantees, which provided
services at more than 8,500 health care
delivery sites and served more than 20.2
million people. There are also
approximately 100 FQHC Look-Alikes.
As described in section 1861(aa)(4) and
section 1905(l)(2)(B) of the Social
Security Act, FQHC Look-Alikes do not
receive Federal funding under Section
330 of the PHS Act. However, in order
to receive the FQHC Look-Alike
designation and benefits, FQHC LookAlikes must meet the statutory,
regulatory, and policy requirements for
Health Centers Programs under Section
330.
A key requirement of the Health
Center Program is for a health center to
establish a ‘‘sliding fee discount
DATES:
E:\FR\FM\07AUN1.SGM
07AUN1
]]>Agencies
[Federal Register Volume 77, Number 152 (Tuesday, August 7, 2012)]
[Notices]
[Pages 47078-47079]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19295]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
2012 Parenteral Drug Association/Food and Drug Administration
Joint Regulatory Conference; Compliance Through Quality Systems:
Implementing and Advancing a Sustainable Global Quality Culture
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public conference.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA), in cosponsorship with
Parenteral Drug Association (PDA), is announcing a public conference
entitled ``Compliance Through Quality Systems: Implementing and
Advancing a Sustainable Global Quality Culture.'' 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 10,
2012, from 7 a.m. to 6 p.m.; September 11, 2012, from 7:30 a.m. to 6:15
p.m.; and September 12, 2012, from 7:30 a.m. to 12:15 p.m.
Location: The public conference will be held at the Baltimore
Marriott Waterfront Hotel, 700 Aliceanna St., Baltimore, MD 21202, 410-
385-3000, Fax: 410-895-1900.
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.
Accommodations: Attendees are responsible for their own
accommodations. To make reservations at the Baltimore Marriott
Waterfront Hotel at the reduced conference rate, contact the Baltimore
Marriott Waterfront Hotel (see Location)--cite the meeting code
``PDA.'' Room rates are: Single: $229, plus 15.5 percent state and
local taxes and Double: $229, plus 15.5 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 10, 2012. The cost of registration is as follows:
Table 1--Cost of Registration
------------------------------------------------------------------------
Through August After August 10,
Affiliation 10, 2012 2012
------------------------------------------------------------------------
Member............................ $1,700 $1,900
Nonmember......................... 1,949 2,149
Government/Health Authority Member 530 530
Government/Health Authority 700 700
Nonmember \1\....................
Academic Member................... 700 700
Academic Nonmember \1\............ 800 800
Student Member.................... 280 280
[[Page 47079]]
Student Nonmember \1\............. 310 310
------------------------------------------------------------------------
\1\ Applicable nonmember rates.
Please visit PDA's Web site: https://www.pda.org/pdafda2012 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 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:
https://www.pda.org/pdafda2012.
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: 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: August 1, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-19295 Filed 8-6-12; 8:45 am]
BILLING CODE 4160-01-P
