Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Medical Devices: The Pre-Submission Program and Meetings With FDA Staff; Withdrawal, 950 [2013-00009]
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Federal Register / Vol. 78, No. 4 / Monday, January 7, 2013 / Notices
The Director, Management Analysis
and Services Office has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention, and the Agency for Toxic
Substances and Disease Registry.
Dana Redford,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2013–00007 Filed 1–4–13; 8:45 am]
The Pre-Submission Program and
Meetings with FDA Staff’’ had been
submitted to the Office of Management
and Budget (OMB) for review and
clearance under the Paperwork
Reduction Act of 1995 and inviting the
public to submit comments on the
proposed study to OMB. As of the date
of this notice, FDA has not finalized the
policy document underlying this
information collection request. Thus,
FDA is withdrawing the proposed
collection of information published on
December 11, 2012, at this time.
Dated: December 31, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2013–00009 Filed 1–4–13; 8:45 am]
BILLING CODE 4160–01–P
Food and Drug Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2012–D–0530]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance on
Medical Devices: The Pre-Submission
Program and Meetings With FDA Staff;
Withdrawal
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Food and Drug Administration
[Docket Nos. FDA–2012–M–0712, FDA–
2012–M–0713, FDA–2012–M–0734, FDA–
2012–M–0735, FDA–2012–M–0814, FDA–
2012–M–0833, FDA–2012–M–0893, FDA–
2012–M–0965, FDA–2012–M–0968, FDA–
2012–M–1011, and FDA–2012–M–1013]
Medical Devices; Availability of Safety
and Effectiveness Summaries for
Premarket Approval Applications
Withdrawal of notice.
This document withdraws a
Food and Drug Administration (FDA)
notice that published in the Federal
Register of December 11, 2012 (77 FR
73662).
SUMMARY:
This notice is withdrawn on
January 7, 2013.
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: FDA
published a notice in the Federal
Register of December 11, 2012 (77 FR
73662), informing interested parties that
the proposed collection of information
entitled ‘‘Guidance on Medical Devices:
DATES:
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of premarket approval applications
(PMAs) that have been approved. This
list is intended to inform the public of
the availability of safety and
effectiveness summaries of approved
PMAs through the Internet and the
Agency’s Division of Dockets
Management.
ADDRESSES: Submit written requests for
copies of summaries of safety and
effectiveness data to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
SUMMARY:
Lane, rm. 1061, Rockville, MD 20852.
Please cite the appropriate docket
number as listed in table 1 of this
document when submitting a written
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the summaries of safety and
effectiveness.
FOR FURTHER INFORMATION CONTACT:
Nicole Wolanski, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1650, Silver Spring,
MD 20993–0002, 301–796–6570.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with sections 515(d)(4)
and (e)(2) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
360e(d)(4) and (e)(2)), notification of an
order approving, denying, or
withdrawing approval of a PMA will
continue to include a notice of
opportunity to request review of the
order under section 515(g) of the FD&C
Act. The 30-day period for requesting
reconsideration of an FDA action under
§ 10.33(b) (21 CFR 10.33(b)) for notices
announcing approval of a PMA begins
on the day the notice is placed on the
Internet. Section 10.33(b) provides that
FDA may, for good cause, extend this
30-day period. Reconsideration of a
denial or withdrawal of approval of a
PMA may be sought only by the
applicant; in these cases, the 30-day
period will begin when the applicant is
notified by FDA in writing of its
decision.
The regulations provide that FDA
publish a quarterly list of available
safety and effectiveness summaries of
PMA approvals and denials that were
announced during that quarter. The
following is a list of approved PMAs for
which summaries of safety and
effectiveness were placed on the
Internet from July 1, 2012, through
September 30, 2012. There were no
denial actions during this period. The
list provides the manufacturer’s name,
the product’s generic name or the trade
name, and the approval date.
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JULY 1,
2012, THROUGH SEPTEMBER 30, 2012
wreier-aviles on DSK7SPTVN1PROD with
PMA No., Docket No.
Applicant
Trade name
P980022/S010, FDA–2012–
M–0965.
P000008/S017, FDA–2012–
M–1013.
P100049, FDA–2012–M–
0893.
P010031/S232, FDA–2012–
M–0814.
Medtronic MiniMed, Inc .....
Allergan, Inc ......................
Guardian Telemetered Glucose Monitoring System
(TGMS).
LAP–BAND TM Adjustable Gastric Banding System .....
February 16, 2011.
Torax Medical, Inc .............
LINX TM Reflux Management System ...........................
March 22, 2012.
Medtronic, Inc ....................
Concerto/Concerto II; Consulta; Maximo
Protecta/Protecta XT Families of CRT–Ds.
April 4, 2012.
VerDate Mar<15>2010
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Approval date
II;
and
07JAN1
January 7, 2004.
]]>Agencies
[Federal Register Volume 78, Number 4 (Monday, January 7, 2013)]
[Notices]
[Page 950]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-00009]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0530]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance on Medical
Devices: The Pre-Submission Program and Meetings With FDA Staff;
Withdrawal
AGENCY: Food and Drug Administration, HHS.
ACTION: Withdrawal of notice.
-----------------------------------------------------------------------
SUMMARY: This document withdraws a Food and Drug Administration (FDA)
notice that published in the Federal Register of December 11, 2012 (77
FR 73662).
DATES: This notice is withdrawn on January 7, 2013.
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: FDA published a notice in the Federal
Register of December 11, 2012 (77 FR 73662), informing interested
parties that the proposed collection of information entitled ``Guidance
on Medical Devices: The Pre-Submission Program and Meetings with FDA
Staff'' had been submitted to the Office of Management and Budget (OMB)
for review and clearance under the Paperwork Reduction Act of 1995 and
inviting the public to submit comments on the proposed study to OMB. As
of the date of this notice, FDA has not finalized the policy document
underlying this information collection request. Thus, FDA is
withdrawing the proposed collection of information published on
December 11, 2012, at this time.
Dated: December 31, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-00009 Filed 1-4-13; 8:45 am]
BILLING CODE 4160-01-P
