Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Premarket Notification, 81616 [2010-32508]
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Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Notices
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following:
Office of Management and Budget,
Paperwork Reduction Project. Fax: 202–
395–7285. E-mail:
OIRA_SUBMISSION@OMB.EOP.GOV.
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: December 22, 2010.
Robert Sargis,
Reports Clearance Officer.
Dated: December 21, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–32508 Filed 12–27–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0447]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Third Party Review Program Under the
Food and Drug Administration
Modernization Act
[FR Doc. 2010–32592 Filed 12–27–10; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
AGENCY:
[Docket No. FDA–2010–N–0198]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Premarket Notification
ACTION:
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Premarket Notification’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
SUMMARY:
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, e-mail:
Daniel.Gittleson@fda.hhs.gov.
In the
Federal Register of August 11, 2010 (75
FR 48696), the Agency announced that
the proposed information collection had
been submitted 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 0910–0120. The
approval expires on December 31, 2013.
A copy of the supporting statement for
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
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Food and Drug Administration,
HHS.
VerDate Mar<15>2010
23:49 Dec 27, 2010
Jkt 223001
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(the PRA).
SUMMARY:
Fax written comments on the
collection of information by January 27,
2011.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0375. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
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, e-mail:
Daniel.Gittleson@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
PO 00000
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Medical Devices; Third Party Review
Program Under the Food and Drug
Administration Modernization Act—
(OMB Control Number 0910–0375)—
Extension
Section 210 of the Food and Drug
Administration Modernization Act
(FDAMA) established section 523 of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 360m),
directing FDA to accredit persons in the
private sector to review certain
premarket notifications (510(k)s).
Participation in this third-party review
program by accredited persons is
entirely voluntary. A third party
wishing to participate will submit a
request for accreditation to FDA.
Accredited third-party reviewers have
the ability to review a manufacturer’s
510(k) of the FD&C Act (21 U.S.C. 360)
submission for selected devices. After
reviewing a submission, the reviewer
will forward a copy of the 510(k)
submission, along with the reviewer’s
documented review and
recommendation to FDA. Third-party
reviewers should maintain records of
their 510(k) reviews and a copy of the
510(k) for a reasonable period of time,
usually a period of 3 years.
This information collection will allow
FDA to continue to implement the
accredited person review program
established by FDAMA and improve the
efficiency of 510(k) review for low- to
moderate-risk devices.
Respondents to this information
collection are businesses or other forprofit organizations.
I. Reporting
510(k) Reviews Conducted by
Accredited Third Parties
According to FDA’s data in 2009, the
Agency has experienced that the
number of 510(k)s submitted for thirdparty review is approximately 260
annually, which is 26 annual reviews
per each of the 10 accredited reviewers.
II. Recordkeeping
Third party reviewers are required to
keep records of their review of each
submission. According to FDA’s in
2009, the Agency anticipates
approximately 260 submissions of
510(k)s for third-party review per year.
In the Federal Register of September
22, 2010 (75 FR 57801), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. FDA received one
comment; however, it was not PRA
related.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\28DEN1.SGM
28DEN1
]]>Agencies
[Federal Register Volume 75, Number 248 (Tuesday, December 28, 2010)]
[Notices]
[Page 81616]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-32508]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0198]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Premarket Notification
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Premarket Notification'' 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, e-mail:
Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of August 11, 2010
(75 FR 48696), the Agency announced that the proposed information
collection had been submitted 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 0910-0120.
The approval expires on December 31, 2013. A copy of the supporting
statement for this information collection is available on the Internet
at https://www.reginfo.gov/public/do/PRAMain.
Dated: December 21, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-32508 Filed 12-27-10; 8:45 am]
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