Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products, 30928 [2013-12274]
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30928
Federal Register / Vol. 78, No. 100 / Thursday, May 23, 2013 / Notices
Dated: May 15, 2013.
Michele Meyer,
Assistant Director, Legislative and Regulatory
Activities Division, Office of the Comptroller
of the Currency.
Board of Governors of the Federal Reserve
System, May 16, 2013.
Robert deV. Frierson,
Secretary of the Board.
Dated at Washington, DC, this 15th day of
May, 2013.
Federal Deposit Insurance Corporation.
Valerie J. Best,
Assistant Executive Secretary.
[FR Doc. 2013–12220 Filed 5–22–13; 8:45 am]
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
Dated: May 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–12274 Filed 5–22–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
BILLING CODE 6210–01–P; 4810–33–P; 6714–01–P
General and Plastic Surgery Devices
Panel of the Medical Devices Advisory
Committee; Notice of Meeting
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Food and Drug Administration
[Docket No. FDA–2012–D–0429]
ACTION:
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance on Meetings With Industry
and Investigators on the Research and
Development of Tobacco Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
sroberts on DSK5SPTVN1PROD with NOTICES
Food and Drug Administration,
HHS.
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance on Meetings With Industry
and Investigators on the Research and
Development of Tobacco Products’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
December 13, 2012, the Agency
submitted a proposed collection of
information entitled ‘‘Guidance on
Meetings With Industry and
Investigators on the Research and
Development of Tobacco Products’’ to
OMB for review and clearance under 44
U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
OMB has now approved the information
collection and has assigned OMB
control number 0910–0731. The
approval expires on February 29, 2016.
A copy of the supporting statement for
VerDate Mar<15>2010
18:14 May 22, 2013
Jkt 229001
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: General and
Plastic Surgery Devices Panel of the
Medical Devices Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on June 26, 2013, from 8 a.m. to 5
p.m.
Location: Holiday Inn, Ballroom 2,
Montgomery Village Ave., Gaithersburg,
MD 20879. The hotel phone number is
301–948–8900.
Contact Person: Avena Russell, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm.
1535, Silver Spring, MD 20993–0002,
Avena.Russell@fda.hhs.gov, 301–796–
3805, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area). A notice in the Federal Register
about last minute modifications that
impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the Agency’s Web
site at https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
Agenda: On June 26, 2013, the
committee will discuss and make
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recommendations regarding the possible
reclassification of blood lancet devices.
The committee will discuss whether
new scientific data are sufficient to
support the reasonable assurance of
safety and effectiveness to develop
special controls that support regulation
of blood lancets from class I to class II
and class III. The four subsets of blood
lancets have been identified with the
following indications for use:
• Blood lancet with an integral sharps
injury prevention feature is for single
use only, disposable blood lancet with
a blade attached to a solid base which
includes an integral sharps injury
prevention feature that allows the
device to be used once and then renders
it inoperable and incapable of further
use and which is used to puncture the
skin to obtain a drop of blood for
diagnostic purposes;
• Blood lancet without an integral
sharps injury prevention feature is for
single use only, disposable blood lancet
with a blade attached to a solid base
which is used to puncture the skin to
obtain a drop of blood for diagnostic
purposes;
• Blood lancet for single patient use
only is a multiple use capable blood
lancet with a single use blade inserted
into a solid, reusable base which is used
only for a single patient to puncture the
skin to obtain a drop of blood for
diagnostic purposes; and
• Multiple use blood lancet for
multiple patient use is a multiple use
capable blood lancet with a single use
blade inserted into a solid, reusable base
which is used for multiple patients to
puncture the skin to obtain a drop of
blood for diagnostic purposes.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before June 7, 2013. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
E:\FR\FM\23MYN1.SGM
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[Federal Register Volume 78, Number 100 (Thursday, May 23, 2013)]
[Notices]
[Page 30928]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-12274]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0429]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Guidance on Meetings With Industry
and Investigators on the Research and Development of Tobacco Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Guidance on Meetings With Industry
and Investigators on the Research and Development of Tobacco Products''
has been approved by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On December 13, 2012, the Agency submitted a
proposed collection of information entitled ``Guidance on Meetings With
Industry and Investigators on the Research and Development of Tobacco
Products'' to OMB for review and clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number. OMB has now approved the information
collection and has assigned OMB control number 0910-0731. The approval
expires on February 29, 2016. A copy of the supporting statement for
this information collection is available on the Internet at https://www.reginfo.gov/public/do/PRAMain.
Dated: May 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-12274 Filed 5-22-13; 8:45 am]
BILLING CODE 4160-01-P
