2011 Parenteral Drug Association/Food and Drug Administration Joint Public Conference; Quality and Compliance in Today's Regulatory Enforcement Environment, 50741-50742 [2011-20791]
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Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Notices
Act to expand the situations in which
FDA may order postmarket surveillance
and allow longer surveillance periods in
certain circumstances. This guidance
document is intended to assist device
manufacturers subject to a section 522
postmarket surveillance order by
providing an overview of section 522 of
the FD&C Act, procedural information
on how to fulfill section 522 obligations,
and recommendations on the format,
content, and review of postmarket
surveillance study submissions.
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: August 10, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–20727 Filed 8–15–11; 8:45 am]
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. To
receive ‘‘Procedures for Handling
Section 522 Postmarket Surveillance
Studies’’ you may either send an e-mail
request to dsmica@fda.hhs.gov to
receive an electronic copy of the
document or send a fax request to 301–
847–8149 to receive a hard copy. Please
use the document number 1754 to
identify the guidance you are
requesting.
emcdonald on DSK2BSOYB1PROD with NOTICES
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on ‘‘Procedures for Handling Section
522 Postmarket Surveillance Studies.’’ It
does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
AGENCY:
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 822 have
been approved under OMB control
number 0910–0449.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
2011 Parenteral Drug Association/Food
and Drug Administration Joint Public
Conference; Quality and Compliance in
Today’s Regulatory Enforcement
Environment
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 ‘‘Quality
and Compliance in Today’s Regulatory
Enforcement Environment.’’ The
conference will span 21⁄2 days and 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 19, 2011,
from 7 a.m. to 6 p.m.; September 20,
2011, from 7:30 a.m. to 6:15 p.m.; and
September 21, 2011, from 7:30 a.m. to
12:15 p.m.
Location: The public conference will
be held at the Renaissance Hotel, 999
Ninth St., NW., Washington, DC 20001,
202–898–9000, FAX: 202–289–0947.
PO 00000
Frm 00027
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50741
Contact: Wanda Neal, Parenteral Drug
Association, PDA Global Headquarters,
Bethesda Towers, 4350 East West Hwy.,
suite 200, Bethesda, MD 20814, 301–
656–5900, FAX: 301–986–1093, e-mail:
info@pda.org.
Accommodations: Attendees are
responsible for their own
accommodations. To make reservations
at the Renaissance Hotel at the reduced
conference rate, contact the Renaissance
Hotel (see Location)—cite the meeting
code ‘‘PDA.’’ Room rates are: Single:
$288, plus 14.5% state and local taxes
and Double: $288, 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 19, 2011. The cost of
registration is as follows:
COST OF REGISTRATION
Affiliation
PDA Members ..............................
NonMembers ................................
PDA Member Government/Health
Authority ....................................
NonMember Government/Health
Authority ....................................
PDA Member Academic ...............
NonMember Academic .................
PDA Member Students .................
NonMember Students ...................
Fee
$1,895
2,144
700
800
700
780
280
310
Please visit PDA’s Web site: https://
www.pda.org/pdafda2011 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 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
E:\FR\FM\16AUN1.SGM
16AUN1
emcdonald on DSK2BSOYB1PROD with NOTICES
50742
Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Notices
Internet, go to PDA’s Web site: https://
www.pda.org/pdafda2011.
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 public 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:
• Accountability in a Global
Environment—Enforcement and Supply
Chain
• Office of International Programs 101
& Foreign Inspections
• International Conference on
Harmonization Q11
• New Regulations—Status Update
• First Cycle Review
• Drug Safety
• Good Inspection Practices—
Domestic
• Process Validation
• Emerging Regulations for Positron
Emission Tomography
• FDA/Pharmaceutical Inspection Cooperation Scheme
• Standards
• International Compliance Update
• Good Manufacturing Practice Life
Cycle
• Supply Chain
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
VerDate Mar<15>2010
18:07 Aug 15, 2011
Jkt 223001
Enforcement Fairness Act of 1996 (Pub.
L. 104–121), as outreach activities by
Government Agencies to small
businesses.
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: August 9, 2011.
Anna P. Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
Dated: August 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–20829 Filed 8–15–11; 8:45 am]
[FR Doc. 2011–20791 Filed 8–15–11; 8:45 am]
BILLING CODE 4140–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
National Heart, Lung, and Blood
Institute Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflict: Cardiovascular Sciences
Dates: September 9, 2011
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Yuanna Cheng, MD, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4138,
MSC 7814, Bethesda, MD 20892, (301)435–
1195, Chengy5@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Social
Science and Population Studies: Second
Panel.
Dates: September 19, 2011.
Time: 8:30 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Melrose Hotel, 2430 Pennsylvania
Ave., NW., Washington, DC 20037.
Contact Person: Suzanne Ryan, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3139,
MSC 7770, Bethesda, MD 20892, (301) 435–
1712, ryansj@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
T35 Training Grant in Pediatric Respiratory,
Sleep, and Transfusion Medicine.
Date: September 7, 2011.
Time: 2 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Stephanie L Constant,
PhD, Scientific Review Officer, Office of
Scientific Review/DERA, National Heart,
Lung, and Blood Institute, 6701 Rockledge
Drive, Room 7189, Bethesda, MD 20892, 301–
443–8784, constantsl@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: August 10, 2011.
Anna P. Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–20845 Filed 8–15–11; 8:45 am]
BILLING CODE 4140–01–P
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]]>Agencies
[Federal Register Volume 76, Number 158 (Tuesday, August 16, 2011)]
[Notices]
[Pages 50741-50742]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20791]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
2011 Parenteral Drug Association/Food and Drug Administration
Joint Public Conference; Quality and Compliance in Today's Regulatory
Enforcement Environment
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 ``Quality and Compliance in Today's Regulatory Enforcement
Environment.'' The conference will span 2\1/2\ days and 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 19,
2011, from 7 a.m. to 6 p.m.; September 20, 2011, from 7:30 a.m. to 6:15
p.m.; and September 21, 2011, from 7:30 a.m. to 12:15 p.m.
Location: The public conference will be held at the Renaissance
Hotel, 999 Ninth 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, FAX: 301-986-1093, e-mail:
info@pda.org.
Accommodations: Attendees are responsible for their own
accommodations. To make reservations at the Renaissance Hotel at the
reduced conference rate, contact the Renaissance Hotel (see Location)--
cite the meeting code ``PDA.'' Room rates are: Single: $288, plus 14.5%
state and local taxes and Double: $288, 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 19, 2011. The cost of registration is as follows:
Cost of Registration
------------------------------------------------------------------------
Affiliation Fee
------------------------------------------------------------------------
PDA Members.................................................. $1,895
NonMembers................................................... 2,144
PDA Member Government/Health Authority....................... 700
NonMember Government/Health Authority........................ 800
PDA Member Academic.......................................... 700
NonMember Academic........................................... 780
PDA Member Students.......................................... 280
NonMember Students........................................... 310
------------------------------------------------------------------------
Please visit PDA's Web site: https://www.pda.org/pdafda2011 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 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
[[Page 50742]]
Internet, go to PDA's Web site: https://www.pda.org/pdafda2011.
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 public 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:
Accountability in a Global Environment--Enforcement and
Supply Chain
Office of International Programs 101 & Foreign Inspections
International Conference on Harmonization Q11
New Regulations--Status Update
First Cycle Review
Drug Safety
Good Inspection Practices--Domestic
Process Validation
Emerging Regulations for Positron Emission Tomography
FDA/Pharmaceutical Inspection Co-operation Scheme
Standards
International Compliance Update
Good Manufacturing Practice Life Cycle
Supply Chain
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 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-20791 Filed 8-15-11; 8:45 am]
BILLING CODE 4160-01-P
