Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Reports of Corrections and Removals, 14022-14023 [2011-5916]
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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11250, is being rescinded: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
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
438
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
E:\FR\FM\15MRN1.SGM
15MRN1
14023
Federal Register / Vol. 76, No. 50 / Tuesday, March 15, 2011 / Notices
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
806.10 .................................................................................................
1 There
Number of
responses per
respondent
Number of
respondents
CFR section
666
Total annual
responses
1
666
Average
burden per
response
(in hours)
Total
hours
10
6660
Average
burden per
recordkeeping
(in hours)
Total
hours
10
900
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED AVERAGE ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
CFR section
806.20 .................................................................................................
1 There
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–P–0177]
Determination that ROCEPHIN
(Ceftriaxone Sodium) Injection, 250
Milligrams, 500 Milligrams, 1 Gram, 2
Grams, and 10 Grams Base/Vial,
Approved Under New Drug Application
050585, Were Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) has determined
ROCEPHIN (ceftriaxone sodium)
Injection, 250 milligrams (mg), 500mg, 1
gram (g), 2g, and 10g base/vial,
approved under new drug application
(NDA) 050585, were not withdrawn
from sale for reasons of safety or
effectiveness. This determination will
allow FDA to approve abbreviated new
drug applications (ANDAs) for any of
these products if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Patrick Raulerson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6368,
Silver Spring, MD 20993–0002, 301–
796–3522.
srobinson on DSKHWCL6B1PROD with NOTICES
SUMMARY:
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In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
applicants must, with certain
exceptions, show that the drug for
which they are seeking approval
contains the same active ingredient in
the same strength and dosage form as
the ‘‘listed drug,’’ which is a version of
the drug that was previously approved.
ANDA applicants do not have to repeat
the extensive clinical testing otherwise
necessary to gain approval of an NDA.
The only clinical data required in an
ANDA are data to show that the drug
that is the subject of the ANDA is
bioequivalent to the listed drug.
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
a drug is removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
Under § 314.161(a)(1) (21 CFR
314.161(a)(1)), the Agency must
determine whether a listed drug was
withdrawn from sale for reasons of
safety or effectiveness before an ANDA
that refers to that listed drug may be
approved. FDA may not approve an
SUPPLEMENTARY INFORMATION:
[FR Doc. 2011–5916 Filed 3–14–11; 8:45 am]
ACTION:
90
Total annual
records
1
90
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
AGENCY:
Number of
records per
recordkeeper
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
ANDA that does not refer to a listed
drug.
ROCEPHIN (ceftriaxone sodium)
Injection, 250mg, 500mg, 1g, 2g, and 10g
base/vial, are the subject of NDA 050585
held by F. Hoffman-La Roche Ltd. (La
Roche). ROCEPHIN (ceftriaxone
sodium) is a semisynthetic
cephalosporin antibiotic for intravenous
or intramuscular administration and is
indicated for the treatment of certain
infections as described in the labeling.
The drug products approved under NDA
050585 are currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Steven H. Sklar of Leydig, Voit &
Mayer, Ltd., submitted a citizen petition
dated April 3, 2009 (Docket No. FDA–
2009–P–0177), under 21 CFR 10.30,
requesting that FDA determine that
ROCEPHIN (ceftriaxone sodium)
Injection, 250mg, 500mg, 1g, 2g, and 10g
base/vial, approved under NDA 050585,
were withdrawn from sale for reasons
other than safety or effectiveness.
After considering the citizen petition
and reviewing Agency records, FDA has
determined under § 314.161 that
ROCEPHIN (ceftriaxone sodium)
Injection, 250mg, 500mg, 1g, 2g, and 10g
base/vial, approved under NDA 050585,
were not withdrawn from sale for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that these
products were withdrawn from sale for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
these products from sale. We have also
independently evaluated the relevant
literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that any of these products were
E:\FR\FM\15MRN1.SGM
15MRN1
]]>Agencies
[Federal Register Volume 76, Number 50 (Tuesday, March 15, 2011)]
[Notices]
[Pages 14022-14023]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5916]
-----------------------------------------------------------------------
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, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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.
DATES: Fax written comments on the collection of information by April
14, 2011.
ADDRESSES: 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.
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: 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 Sec. 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 Sec. 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 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 Sec. Sec. 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 Sec. 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 Sec. 806.10), a record must be
kept in the firm's Sec. 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 Sec. 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 Sec. 806.20 file.
FDA has determined that estimates of the reporting burden for Sec.
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 Sec. 806.20 should
be revised to reflect a reduction of 6.8 percent (from the last PRA
numbers) in records filed and maintained under Sec. 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
[[Page 14023]]
information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
CFR section Number of responses per Total annual per response Total
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
806.10................................... 666 1 666 10 6660
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Average Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Average burden
Number of Number of Total annual per Total
CFR section recordkeepers records per records recordkeeping hours
recordkeeper (in hours)
----------------------------------------------------------------------------------------------------------------
806.20................................... 90 1 90 10 900
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: March 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5916 Filed 3-14-11; 8:45 am]
BILLING CODE 4160-01-P
