Food and Drug Administration/Xavier University Global Medical Device Conference, 15439-15440 [2010-6865]
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15439
Federal Register / Vol. 75, No. 59 / Monday, March 29, 2010 / Notices
grantees that include Nonprofit
organizations and State, Local and
Tribal Governments. The evaluation for
each program will be designed to assess
progress and measure increased
organizational capacity of grantees in
each of the two SCF programs. The
purpose of this request will be to
establish the approved baseline
instruments for follow-up data
collection.
Respondents: SCF Grantees (both the
Nonprofit Capacity Building Program
and the Government Capacity Building
Program) made up of State, local, and
Tribal governments, as well as nonprofit
organizations.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Nonprofit Capacity Building Program Performance Progress Report (PPR) ..
Government Capacity Building Program PPR .................................................
cprice-sewell on DSK89S0YB1PROD with NOTICES
Estimated Total Annual Burden
Hours: 336.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: March 24, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010–6866 Filed 3–26–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Food and Drug Administration/Xavier
University Global Medical Device
Conference
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public conference.
SUMMARY: The Food and Drug
Administration (FDA) Cincinnati
District, in co-sponsorship with Xavier
University, is announcing a public
conference entitled ‘‘FDA/Xavier
University Global Medical Device
Conference.’’ This 3-day public
conference includes presentations from
key FDA officials, global regulators, and
industry experts. The public conference
has three separate tracks of interest for
quality, regulatory affairs, and clinical
research professionals, and is intended
for companies of all sizes and
employees at all levels.
Dates and Times: The public
conference will be held on May 5, 2010,
from 8 a.m. to 5 p.m.; May 6, 2010, from
8 a.m. to 5 p.m.; and May 7, 2010, from
8 a.m. to 1 p.m.
Location: The public conference will
be held on the campus of Xavier
University, 3800 Victory Pkwy.,
Cincinnati, OH 45207, 513–745–3073 or
513–745–3396.
Contact Persons:
For information regarding this notice:
Gina Brackett, Food and Drug
Administration, 6751 Steger Dr.,
Cincinnati, OH 45237, 513–679–
2700, ext 167, FAX: 513–679–272,
e-mail: gina.brackett@fda.hhs.gov.
For information regarding the
conference and registration: Marla
Phillips, Xavier University, 3800
Victory Pkwy., Cincinnati, OH
45207, 513–745–3073, e-mail:
phillipsm4@xavier.edu.
PO 00000
Frm 00039
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Number of
responses per
respondent
Average
burden hours
per response
4
4
Total burden
hours
1
1
140
196
Registration: There is a registration
fee. The conference registration fees
cover the cost of the presentations,
training materials, receptions,
breakfasts, lunches, dinners, and dinner
speakers for the 3 days of the
conference. Early registration ends April
5, 2010. Standard registration ends May
4, 2010. There will be onsite
registration. The cost of registration is as
follows:
TABLE 1.—REGISTRATION FEES1
Attendee
Fee by
April 5th
Fee by
May 4th
Industry
$995
$1,200
Small Business
(<100 employees)
$800
$1,000
Academic
$600
$700
Student
$200
$250
FDA Employee
Fee
Waived
Fee
Waived
1 The fourth registration from the same company is free.
The following forms of payment will be
accepted: American Express, Visa,
Mastercard, and company checks.
To register online for the public
conference, please visit the
‘‘Registration’’ link on the conference
Web site at https://
www.XavierMedCon.com. 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.
To register by mail, please send your
name, title, firm name, address,
telephone and fax numbers, e-mail, and
payment information for the fee to
Xavier University, Attention: Sue
Bensman, 3800 Victory Parkway,
Cincinnati, OH 45207. An e-mail will be
sent confirming your registration.
Attendees are responsible for their
own accommodations. The conference
headquarter hotel is the Downtown
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15440
Federal Register / Vol. 75, No. 59 / Monday, March 29, 2010 / Notices
cprice-sewell on DSK89S0YB1PROD with NOTICES
Cincinnati Hilton Netherlands Plaza, 35
West 5th Street, Cincinnati, OH, 45202,
513–421–9100. To make reservations
online, please visit the ‘‘Venue/
Logistics’’ link at https://
www.XavierMedCon.com to make
reservations.
If you need special accommodations
due to a disability, please contact Marla
Phillips (see Contact Persons) at least 7
days in advance of the conference.
SUPPLEMENTARY INFORMATION: The
public conference helps fulfill the
Department of Health and Human
Services and FDA’s important mission
to protect the public health. The
conference will provide those engaged
in FDA-regulated medical devices (for
humans) with information on the
following topics:
• Global compliance,
• Global approval process,
• Global harmonization,
• Recalls and corrections and
removals,
• Common 483 observations,
• What happens after an inspection,
• Medical device reports,
• Regulatory impact of design and
process changes,
• Integrating internal and external
resources for clinical trials,
• New ways of doing biostatistics,
• Innovative clinical study design,
• Challenges in conducting global
clinical trials,
• Comparison of design history file
and dechnical dossier,
• Integrating risk management in
device/combination products,
• Design controls: Human factors,
• Labeling and promotion,
• Corrective and preventive actions,
• International filing requirements,
• Promotion of device prior to
approval,
• Combination product filings—tips
for successful application,
• The role of information technology
in clinical trials and post-approval
process,
• Bioresearch monitoring early
intervention initiatives for electronic
records, and
• Handling images and other nontraditional electronic data.
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 conference 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
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stakeholders and the public. The
conference also is consistent with the
Small Business Regulatory Enforcement
Fairness Act of 1996 (Public Law 104–
121) by providing outreach activities by
Government agencies to small
businesses.
Dated: March 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–6865 Filed 3–26–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0001]
Guidance for Industry on Standards for
Securing the Drug Supply Chain—
Standardized Numerical Identification
for Prescription Drug Packages;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Standards for Securing the
Drug Supply Chain-Standardized
Numerical Identification for
Prescription Drug Packages.’’ This
guidance is being issued under the
Federal Food, Drug, and Cosmetic Act
(the act), which requires FDA to develop
standards for standardized numerical
identifiers for prescription drugs.
DATES: Submit written or electronic
comments on agency guidances at any
time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave, Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002; or the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. The
guidance may also be obtained by mail
by calling CBER at 1–800–835–4709 or
301–827–1800. Send one self-addressed
adhesive label to assist that office in
processing your requests. Submit
written comments on the guidance to
the Division of Docket Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
PO 00000
Frm 00040
Fmt 4703
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electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Ilisa B.G. Bernstein, Office of the
Commissioner/Office of Policy,
Food and Drug Administration,
10903 New Hampshire Ave., Silver
Spring, MD 20993–0002, 301–796–
4840, e-mail:
ilisa.bernstein@fda.hhs.gov;
Stephen Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852, 301–827–
6210; or
Meredith Francis, Center for Drug
Evaluation and Research, 10903
New Hampshire Ave., Silver
Spring, MD 20993–0002, 301–796–
3476, email:
Meredith.frances@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Standards for Securing the Drug
Supply Chain-Standardized Numerical
Identification for Prescription Drug
Packages.’’ In the Federal Register of
January 16, 2009 (74 FR 3054), a draft
version of this guidance was made
available for public comment.
On September 27, 2007, the Food and
Drug Administration Amendments Act
of 2007 (FDAAA) (Public Law 110–85)
was signed into law. Section 913 of this
legislation created section 505D of the
act, which requires the Secretary of
Health and Human Services (the
Secretary) to develop standards and
identify and validate effective
technologies for the purpose of securing
the drug supply chain against
counterfeit, diverted, subpotent,
substandard, adulterated, misbranded,
or expired drugs. Section 505D of the
act directs the Secretary to consult with
specific entities to prioritize and
develop standards for the identification,
validation, authentication, and tracking
and tracing of prescription drugs. The
statute also directs that no later than 30
months after the date of enactment of
FDAAA, the Secretary shall develop a
standardized numerical identifier (SNI)
to be applied to a prescription drug at
the point of manufacturing and
repackaging at the package or pallet
level, sufficient to facilitate the
identification, validation,
authentication, and tracking and tracing
of the prescription drug. An SNI applied
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]]>Agencies
[Federal Register Volume 75, Number 59 (Monday, March 29, 2010)]
[Notices]
[Pages 15439-15440]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-6865]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Food and Drug Administration/Xavier University Global Medical
Device Conference
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public conference.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) Cincinnati District, in
co-sponsorship with Xavier University, is announcing a public
conference entitled ``FDA/Xavier University Global Medical Device
Conference.'' This 3-day public conference includes presentations from
key FDA officials, global regulators, and industry experts. The public
conference has three separate tracks of interest for quality,
regulatory affairs, and clinical research professionals, and is
intended for companies of all sizes and employees at all levels.
Dates and Times: The public conference will be held on May 5, 2010,
from 8 a.m. to 5 p.m.; May 6, 2010, from 8 a.m. to 5 p.m.; and May 7,
2010, from 8 a.m. to 1 p.m.
Location: The public conference will be held on the campus of
Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-
3073 or 513-745-3396.
Contact Persons:
For information regarding this notice: Gina Brackett, Food and Drug
Administration, 6751 Steger Dr., Cincinnati, OH 45237, 513-679-2700,
ext 167, FAX: 513-679-272, e-mail: gina.brackett@fda.hhs.gov.
For information regarding the conference and registration: Marla
Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207,
513-745-3073, e-mail: phillipsm4@xavier.edu.
Registration: There is a registration fee. The conference
registration fees cover the cost of the presentations, training
materials, receptions, breakfasts, lunches, dinners, and dinner
speakers for the 3 days of the conference. Early registration ends
April 5, 2010. Standard registration ends May 4, 2010. There will be
onsite registration. The cost of registration is as follows:
Table 1.--Registration Fees\1\
------------------------------------------------------------------------
Attendee Fee by April 5th Fee by May 4th
------------------------------------------------------------------------
Industry $995 $1,200
------------------------------------------------------------------------
Small Business (<100 $800 $1,000
employees)
------------------------------------------------------------------------
Academic $600 $700
------------------------------------------------------------------------
Student $200 $250
------------------------------------------------------------------------
FDA Employee Fee Waived Fee Waived
------------------------------------------------------------------------
\1\ The fourth registration from the same company is free.
The following forms of payment will be accepted: American Express,
Visa, Mastercard, and company checks.
To register online for the public conference, please visit the
``Registration'' link on the conference Web site at https://www.XavierMedCon.com. 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.
To register by mail, please send your name, title, firm name,
address, telephone and fax numbers, e-mail, and payment information for
the fee to Xavier University, Attention: Sue Bensman, 3800 Victory
Parkway, Cincinnati, OH 45207. An e-mail will be sent confirming your
registration.
Attendees are responsible for their own accommodations. The
conference headquarter hotel is the Downtown
[[Page 15440]]
Cincinnati Hilton Netherlands Plaza, 35 West 5th Street, Cincinnati,
OH, 45202, 513-421-9100. To make reservations online, please visit the
``Venue/Logistics'' link at https://www.XavierMedCon.com to make
reservations.
If you need special accommodations due to a disability, please
contact Marla Phillips (see Contact Persons) at least 7 days in advance
of the conference.
SUPPLEMENTARY INFORMATION: The public conference helps fulfill the
Department of Health and Human Services and FDA's important mission to
protect the public health. The conference will provide those engaged in
FDA-regulated medical devices (for humans) with information on the
following topics:
Global compliance,
Global approval process,
Global harmonization,
Recalls and corrections and removals,
Common 483 observations,
What happens after an inspection,
Medical device reports,
Regulatory impact of design and process changes,
Integrating internal and external resources for clinical
trials,
New ways of doing biostatistics,
Innovative clinical study design,
Challenges in conducting global clinical trials,
Comparison of design history file and dechnical dossier,
Integrating risk management in device/combination
products,
Design controls: Human factors,
Labeling and promotion,
Corrective and preventive actions,
International filing requirements,
Promotion of device prior to approval,
Combination product filings--tips for successful
application,
The role of information technology in clinical trials and
post-approval process,
Bioresearch monitoring early intervention initiatives for
electronic records, and
Handling images and other non-traditional electronic data.
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 conference 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 conference also is consistent with the
Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law
104-121) by providing outreach activities by Government agencies to
small businesses.
Dated: March 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6865 Filed 3-26-10; 8:45 am]
BILLING CODE 4160-01-S
