Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public Workshop, 6477-6478 [2011-2458]
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Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Notices
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. It is 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.
SUPPLEMENTARY INFORMATION:
I. Background
In 2010, CDRH held three Town Hall
meetings in Minneapolis, MN; Boston,
MA; and Los Angeles, CA to provide the
public with a new venue to discuss
issues of interest with the Center. Any
member of the public was invited to
provide comments to or ask questions of
CDRH participants. Due to the positive
feedback we received for holding these
meetings we plan to continue this
activity in 2011 in three different
locations.
II. Public Meeting
The objective of this public meeting is
to engage in a dialogue about issues that
are of importance to the public.
The public meeting will open with an
introduction of CDRH Senior Staff in
attendance. Following introductions, Dr.
Jeffrey Shuren, the Director of CDRH,
will describe CDRH’s Strategic Priorities
for 2011. Members of the public will
then be given the opportunity to present
comments to CDRH Senior Staff
followed by a Question and Answer
session during which any member of the
public may ask questions of the CDRH
Senior Staff on any topic of interest.
In advance of the meeting, additional
information, including a meeting agenda
with a speakers’ schedule, will be made
available on the Internet. This
information will be placed on file in the
public docket (docket number found in
brackets in the heading of this
document), which is available at
https://www.regulations.gov. This
information will also be available at
https://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm (select the appropriate
meeting from the list).
III. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. A transcript
will also be available 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 (HFI–35), Office
of Management Programs, Food and
Drug Administration, 5600 Fishers
Lane, rm. 6–30, Rockville, MD 20857.
Dated: February 1, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–2490 Filed 2–3–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Industry Exchange Workshop on Food
and Drug Administration Drug and
Device Requirements; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) Southwest
Regional Office, in co-sponsorship with
SUMMARY:
6477
the Association of Food and Drug
Officials (AFDO), the Mid-Continental
Association of Food and Drug Officials
(MCAFDO), and the FDA Medical
Device Industry Coalition, is
announcing a public workshop entitled
‘‘The Future of Medical Products
Regulation: Ensuring Safety and
Integrity in a Global Market’’. This 2-day
public workshop is intended to provide
information about FDA drug and device
regulation to the regulated industry.
Date and Time: The public workshop
will be held on June 20 and 21, 2011,
from 8 a.m. to 5 p.m.
Location: The public workshop will
be held at the Marriott Dallas/Plano at
Legacy Town Center, Plano, Texas, 7120
Dallas Pkwy., Plano, Texas 75024, 972–
473–6444, or toll-free 888–236–2427.
Attendees are responsible for their
own accommodations. To make
reservations at the Marriott Dallas/Plano
at Legacy Town Center, at the reduced
conference rate, contact the Marriott
Dallas/Plano at Legacy Town Center
before May 20, 2011, citing meeting
code ‘‘AFDO Conference’’.
Contact: David Arvelo, Food and Drug
Administration, 4040 North Central
Expressway, suite 900, Dallas, Texas
75204, 214–253–4952, FAX: 214–253–
4970, e-mail: David.Arvelo@fda.hhs.gov.
Registration: You are encouraged to
register by May 24, 2011. The AFDO
registration fees cover the cost of
facilities, materials, and breaks. Seats
are limited; therefore, 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 7:30 a.m. The cost of
registration follows:
COST OF REGISTRATION
srobinson on DSKHWCL6B1PROD with NOTICES
Government (AFDO/Mid-Continental AFDO Member) ........................................................................................................................
Government (Non-Member): ................................................................................................................................................................
Non-Government (AFDO/MCAFDO Member) .....................................................................................................................................
Non-Government (Non-Member) .........................................................................................................................................................
To be added to registration fee for public workshop registration postmarked after May 24, 2011 ....................................................
If you need special accommodations
due to a disability, please contact David
Arvelo (see Contact) at least 21 days in
advance of the workshop.
Registration instructions: To register,
please complete and submit an AFDO
Conference Registration Form, along
with a check or money order payable to
VerDate Mar<15>2010
16:05 Feb 03, 2011
Jkt 223001
‘‘AFDO’’. Please mail your completed
registration form and payment to:
AFDO, 2550 Kingston Rd., suite 311,
York, PA 17402. To register online,
please visit https://www.afdo.org. (FDA
has verified the Web site address, but is
not responsible for subsequent changes
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
$425.00
525.00
425.00
525.00
100.00
to the Web site after this document
publishes in the Federal Register.)
The registrar will also accept payment
through Visa and MasterCard credit
cards. For more information on the
public workshop, or for questions about
registration, please contact AFDO at
E:\FR\FM\04FEN1.SGM
04FEN1
6478
Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Notices
717–757–2888, FAX: 717–650–3650, or
e-mail: afdo@afdo.org.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The
public workshop helps fulfill the
Department of Health and Human
Services’ and FDA’s important mission
to protect the public health. The
workshop will provide FDA-regulated
drug and device entities with
information on a number of topics
concerning FDA requirements related to
the production and marketing of drugs
and/or devices. Topics for discussion
include the following:
• Globalization, Imports, and
Supplier Controls,
• Medical Product Theft and Criminal
Investigations,
• Proposed Changes to the 510(K)
Review Process,
• Health Fraud,
• Streamlining the FDA Enforcement
Process,
• The Future of Medical Products
Regulation,
• Medical Devices in Canada,
• The Freedom of Information Act,
• Medical Product Complaint
Investigations,
• Writing Corrective and Preventive
Actions Procedures and Documents to
Reflect Compliance Initiatives, and
• Top Ten FDA–483 Objectionable
Observations.
FDA has made education of the drug
and device manufacturing community a
high priority to help ensure the quality
of FDA-regulated drugs and devices.
The workshop helps to achieve
objectives set forth in section 406 of the
Food and Drug Administration
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.
National Institutes of Health
srobinson on DSKHWCL6B1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Dated: February 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–2458 Filed 2–3–11; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
16:05 Feb 03, 2011
Jkt 223001
Revision to Proposed Collection;
Comment Request; The National
Children’s Study (NCS), Vanguard
(Pilot) Study
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institute of Child Health and Human
Development (NICHD), the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on November 15,
2010, pages 69680–69681, and allowed
60 days for public comment. One
comment was received. The comment
questioned the value and utility of the
proposed data collection, stating that
this type of research is not needed. The
purpose of this notice is to allow an
additional 30 days for public comment.
The National Institutes of Health may
not conduct or sponsor, and the
respondent is not required to respond
to, an information collection that has
been extended, revised, or implemented
on or after October 1, 1995, unless it
displays a currently valid OMB control
number.
Proposed Collection: Title: Pilot Study
for the National Children’s Study Type
of Information Collection Request:
Revision. Affected entities: Households
and individuals. Types of respondents:
People potentially affected by this
action are pregnant women, women age
18–49 years of age, their husbands or
partners, and their children who live in
selected areas within National
Children’s Study sites. Health care
professionals, community leaders, and
child care personnel are also potentially
affected.
Frequency of Response: On occasion.
See burden table for estimated number
of annual responses for each
respondent.
Need and use of information
collection: The purpose of the proposed
methodological study is to continue the
Vanguard phase of the National
Children’s Study (NCS) to evaluate the
feasibility, acceptability, and cost of
recruitment strategies and study design
elements for a prospective, national
longitudinal study of child health and
development. In combination, the substudies encompassed by the Vanguard
Phase will be used to inform the design
SUMMARY:
PO 00000
Frm 00084
Fmt 4703
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of the Main Study of the National
Children’s Study.
We propose to continue data
collection among the 37 Vanguard
Study locations up to and including the
visit planned to take place when the
sample children have reached 24
months of age. This would align study
visits approved for the initial 7
Vanguard Study locations (which
extend past the birth visit to include a
3-, 6-, 9-, 12-, 18- and 24-month visit)
with the study visits approved for the 30
additional Vanguard Study locations
(which were initially proposed and
approved up to and including the birth
visit). Extending the data collection of
the 30 additional Vanguard Study
locations to 24 months of age would
support rigorous, empirical evaluation
of participant retention as it may relate
to recruitment strategy. A strong
understanding of how to encourage
retention of study participants,
particularly during the infancy and
early childhood years, will be essential
to planning the Main Study.
Additionally, continuing data collection
post-birth among the alternate
recruitment strategy study locations
allows us to generate additional data to
inform the development of study visit
procedures, both for future Vanguard
Study efforts and the Main Study.
We also propose reintroduction of a
limited set of study visit measures to all
37 of the Vanguard Study locations
engaged in data collection. Recall that
extensive measures, including
biospecimens, were previously
approved for use in the initial 7
Vanguard Study locations. When the
additional 30 locations were added, we
streamlined data collection to allow
focus on improving recruitment rates.
Now that we have the training for those
new locations (and retraining for the
initial locations) completed, it is an
opportune time to reintroduce selected
measures that have the benefit of field
experience. That field experience has
been used to improve their scientific
robustness, burden, and cost. These
improved measures now require field
testing to best inform their suitability for
the Main Study. Specifically, we would
like to reincorporate a father interview;
maternal blood and urine collection;
infant cord blood collection; home tap
water and dust collection; a pregnancy
health care log; and an infant and child
health care log. In addition to
supporting further testing of refined
items, including these measures in the
Recruitment Substudy would result in a
data collection scope more closely
mirroring the anticipated scope of the
Main Study, thereby allowing better
gauge of data collection scope and
E:\FR\FM\04FEN1.SGM
04FEN1
]]>Agencies
[Federal Register Volume 76, Number 24 (Friday, February 4, 2011)]
[Notices]
[Pages 6477-6478]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2458]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Industry Exchange Workshop on Food and Drug Administration Drug
and Device Requirements; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) Southwest Regional
Office, in co-sponsorship with the Association of Food and Drug
Officials (AFDO), the Mid-Continental Association of Food and Drug
Officials (MCAFDO), and the FDA Medical Device Industry Coalition, is
announcing a public workshop entitled ``The Future of Medical Products
Regulation: Ensuring Safety and Integrity in a Global Market''. This 2-
day public workshop is intended to provide information about FDA drug
and device regulation to the regulated industry.
Date and Time: The public workshop will be held on June 20 and 21,
2011, from 8 a.m. to 5 p.m.
Location: The public workshop will be held at the Marriott Dallas/
Plano at Legacy Town Center, Plano, Texas, 7120 Dallas Pkwy., Plano,
Texas 75024, 972-473-6444, or toll-free 888-236-2427.
Attendees are responsible for their own accommodations. To make
reservations at the Marriott Dallas/Plano at Legacy Town Center, at the
reduced conference rate, contact the Marriott Dallas/Plano at Legacy
Town Center before May 20, 2011, citing meeting code ``AFDO
Conference''.
Contact: David Arvelo, Food and Drug Administration, 4040 North
Central Expressway, suite 900, Dallas, Texas 75204, 214-253-4952, FAX:
214-253-4970, e-mail: David.Arvelo@fda.hhs.gov.
Registration: You are encouraged to register by May 24, 2011. The
AFDO registration fees cover the cost of facilities, materials, and
breaks. Seats are limited; therefore, 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 7:30 a.m. The cost of
registration follows:
Cost of Registration
------------------------------------------------------------------------
------------------------------------------------------------------------
Government (AFDO/Mid-Continental AFDO Member)........... $425.00
Government (Non-Member):................................ 525.00
Non-Government (AFDO/MCAFDO Member)..................... 425.00
Non-Government (Non-Member)............................. 525.00
To be added to registration fee for public workshop 100.00
registration postmarked after May 24, 2011.............
------------------------------------------------------------------------
If you need special accommodations due to a disability, please
contact David Arvelo (see Contact) at least 21 days in advance of the
workshop.
Registration instructions: To register, please complete and submit
an AFDO Conference Registration Form, along with a check or money order
payable to ``AFDO''. Please mail your completed registration form and
payment to: AFDO, 2550 Kingston Rd., suite 311, York, PA 17402. To
register online, please visit https://www.afdo.org. (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 through Visa and MasterCard
credit cards. For more information on the public workshop, or for
questions about registration, please contact AFDO at
[[Page 6478]]
717-757-2888, FAX: 717-650-3650, or e-mail: afdo@afdo.org.
SUPPLEMENTARY INFORMATION: The public workshop helps fulfill the
Department of Health and Human Services' and FDA's important mission to
protect the public health. The workshop will provide FDA-regulated drug
and device entities with information on a number of topics concerning
FDA requirements related to the production and marketing of drugs and/
or devices. Topics for discussion include the following:
Globalization, Imports, and Supplier Controls,
Medical Product Theft and Criminal Investigations,
Proposed Changes to the 510(K) Review Process,
Health Fraud,
Streamlining the FDA Enforcement Process,
The Future of Medical Products Regulation,
Medical Devices in Canada,
The Freedom of Information Act,
Medical Product Complaint Investigations,
Writing Corrective and Preventive Actions Procedures and
Documents to Reflect Compliance Initiatives, and
Top Ten FDA-483 Objectionable Observations.
FDA has made education of the drug and device manufacturing
community a high priority to help ensure the quality of FDA-regulated
drugs and devices. The workshop helps to achieve objectives set forth
in section 406 of the Food and Drug Administration 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: February 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-2458 Filed 2-3-11; 8:45 am]
BILLING CODE 4160-01-P
