Withdrawl of Publication, 14022 [2011-5845]
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14022
Federal Register / Vol. 76, No. 50 / Tuesday, March 15, 2011 / Notices
ESTIMATE OF ANNUALIZED BURDEN HOURS—Continued
CDI Surveillance Case Report Form—Partial ...........................................................
CDI Surveillance Health Interview .............................................................................
Dated: March 9, 2011.
Carol Walker,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2011–5919 Filed 3–14–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Withdrawl of Publication
This is to serve notice that the
following Federal Register notice
published on March 1, 2011, page
11250, is being rescinded:
Dated: March 9, 2011.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–5845 Filed 3–14–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0554]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Reports of Corrections and Removals
AGENCY:
Food and Drug Administration,
srobinson on DSKHWCL6B1PROD with NOTICES
HHS.
ACTION:
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.
SUMMARY:
VerDate Mar<15>2010
16:50 Mar 14, 2011
Jkt 223001
10
10
Fax written comments on the
collection of information by April 14,
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 0910–0359. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Submission for OMB Review: Comment
Request
Title: Child Care and Development
Fund Tribal Plan Preprint—ACF–118–
A.
OMB No.: 0970–0198.
The original notice published on
February 9, 2011, pages 7218–7219 is
still in effect.
Number of
responses per
respondent
Number of
respondents
Respondent
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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Medical Devices; Reports of Corrections
and Removals—(OMB Control Number
0910–0359)—(Extension)
The collection of information required
under the reports of corrections and
removals, part 806 (21 CFR part 806),
implements section 519(g) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 360i(g)), as
amended by the Food and Drug
Administration Modernization Act of
1997 (21 U.S.C. 301) (Pub. L. 105–115).
Each device manufacturer or importer
under § 806.10 shall submit a written
report to FDA of any action initiated to
correct or remove a device to reduce a
risk to health posed by the device, or to
remedy a violation of the FD&C Act
caused by the device that may present
a risk to health, within 10 working days
of initiating such correction or removal.
Each device manufacturer or importer of
a device who initiates a correction or
removal of a device that is not required
to be reported to FDA under § 806.20
shall keep a record of such correction or
removal.
The information collected in the
reports of corrections and removals will
be used by FDA to identify marketed
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50
Average burden
per response
(in hours)
15/60
45/60
devices that have serious problems and
to ensure that defective devices are
removed from the market. This will
assure that FDA has current and
complete information regarding these
corrections and removals and to
determine whether recall action is
adequate.
Respondents to this collection of
information are manufacturers and
importers of medical devices. FDA
reviewed reports of device corrections
and removals submitted to the Agency
for the previous 3 years as part of
responding to the current request for
approval of the information collection
requirements for §§ 806.10 and 806.20.
This information was obtained through
the Agency’s voluntary recall provisions
(i.e., 21 CFR part 7). The specific
information requested was the total
number of class I, II, and III recalls for
the last 3 years. This information was
obtained from the Agency’s Recall
Enterprise System—a database of all
recalls submitted to the Agency.
This information is relevant since a
§ 806.10 report is required for all class
I and II recalls. Although class III recalls
are not required to be submitted to FDA
(by § 806.10), a record must be kept in
the firm’s § 806.20 file. Therefore, the
number of class I and II recalls can be
used to estimate the maximum number
of reports that are required to be
submitted under § 806.10. Also, the
recordkeeping burden can be estimated
based upon the number of class III
recalls, which are not required to be
reported, but must be retained in a
§ 806.20 file.
FDA has determined that estimates of
the reporting burden for § 806.10 should
be revised to reflect a projected 7.3
percent increase (from the last PRA
numbers) in reports submitted to FDA
as class I and II. FDA also estimates the
recordkeeping burden in § 806.20
should be revised to reflect a reduction
of 6.8 percent (from the last PRA
numbers) in records filed and
maintained under § 806.20. The
estimates of time needed to collect part
806 information have not changed.
In the Federal Register of November
23, 2010 (75 FR 71446), FDA published
a 60-day notice requesting public
comment on the proposed collection of
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[Federal Register Volume 76, Number 50 (Tuesday, March 15, 2011)]
[Notices]
[Page 14022]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5845]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Withdrawl of Publication
This is to serve notice that the following Federal Register notice
published on March 1, 2011, page 11250, is being rescinded:
Submission for OMB Review: Comment Request
Title: Child Care and Development Fund Tribal Plan Preprint--ACF-
118-A.
OMB No.: 0970-0198.
The original notice published on February 9, 2011, pages 7218-7219
is still in effect.
Dated: March 9, 2011.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011-5845 Filed 3-14-11; 8:45 am]
BILLING CODE 4184-01-P
